10-Q 1 raptor10q053109final.htm RAPTOR FORM 10-Q MAY 31, 2009

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

x

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended May 31, 2009

[

]

TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT

For the transition period from _________ to __________

 

Commission file number 000-50720

 

Raptor Pharmaceuticals Corp.

(Exact name of small business issuer as specified in its charter)

 

Delaware

 

98-0379351

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

9 Commercial Blvd., Suite 200, Novato, CA 94949

(Address of principal executive offices)

(415) 382-8111

(Issuer’s telephone number)

N/A

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act, as amended, during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o

 

 

 

Accelerated filer o

 

 

Non-accelerated filer o (Do not check if smaller reporting company)

 

Smaller reporting company [ X ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x

There were 65,645,047 shares of the registrant’s common stock, $.001 par value per share outstanding at July 10, 2009.

DOCUMENTS INCORPORATED BY REFERENCE: None.

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

 

Table of Contents

 

 

Page

Part 1 - Financial Information

Item 1

Financial Statements

 

 

Condensed Consolidated Balance Sheets as of May 31, 2009 (unaudited) and August 31, 2008

2

 

Unaudited Condensed Consolidated Statements of Operations for the three month and nine month periods ended May 31, 2009 and 2008 and the cumulative period from September 8, 2005 (inception) to May 31, 2009

3

 

Unaudited Condensed Consolidated Statements of Cash Flows for the nine month periods ended May 31, 2009 and 2008 and the cumulative period from September 8, 2005 (inception) to May 31, 2009

5

 

Notes to Condensed Consolidated Financial Statements

6

Item 2

Management’s Discussion and Analysis or Plan of Operation

25

Item 3

Quantitative and Qualitative Disclosures about Market Risk

43

Item 4

Controls and Procedures

43

Part II - Other Information

Item 1

Legal Proceedings

45

Item 1A

Risk Factors

45

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

57

Item 3

Defaults Upon Senior Securities

58

Item 4

Submission Of Matters To A Vote Of Security Holders

58

Item 5

Other Information

58

Item 6

Exhibits

58

SIGNATURES

59

 

 

 

 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

 

Raptor Pharmaceuticals Corp.

 

(A Development Stage Company)

 

Condensed Consolidated Balance Sheets

 

 

 

 

 

 

 

 

May 31, 2009

 

August 31, 2008

 

ASSETS

 

(unaudited)

 

(1)

 

Current assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

 

492,963

 

$

7,546,912

 

 

Prepaid expenses and other

 

 

163,508

 

 

115,594

 

Total current assets

 

 

656,471

 

 

7,662,506

7,662,506

 

 

 

 

 

 

 

 

 

 

 

Intangible assets, net

 

 

2,559,417

 

 

2,663,291

2,663,291

Fixed assets, net

 

 

 

162,490

 

 

194,766

 

Deposits

 

 

 

100,207

 

 

100,207

 

 

 

Total assets

 

$

3,478,585

 

$

10,620,770

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

539,181

 

$

565,593

 

 

Accrued liabilities

 

 

246,121

 

 

432,434

 

 

Deferred rent

 

 

 

3,203

 

 

2,951

 

 

Capital lease liability – current

 

 

3,948

 

 

2,302

 

Total current liabilities

 

 

792,453

 

 

1,003,280

1,003,280

 

 

 

 

 

 

 

 

 

 

 

Capital lease liability - long-term

 

 

7,770

 

 

-

 

Total liabilities

 

 

 

800,223

 

 

1,003,280

 

 

 

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized, zero shares issued and outstanding

 

 

-

 

 

-

 

 

Common stock, $0.001 par value, 100,000,000 shares authorized 60,430,047 and 60,330,047 shares issued and outstanding as at May 31, 2009 and

 

 

 

 

 

 

 

 

August 31, 2008, respectively

 

 

60,430

 

 

60,330

 

 

Additional paid-in capital

 

 

22,547,701

 

 

22,212,449

 

 

Deficit accumulated during development stage

 

 

(19,929,769)

 

 

(12,655,289)

 

Total stockholders’ equity

 

 

2,678,362

 

 

9,617,490

10,620,770

 

 

Total liabilities and stockholders’ equity

 

$

3,478,585

 

$

10,620,770

 

(1) Derived from the Company’s audited consolidated financial statements as of August 31, 2008.

 

The accompanying notes are an integral part of these financial statements.

 

 

 

 

 

-2-

 

 

 

 

Raptor Pharmaceuticals Corp.

(A Development Stage Company)

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three month periods from March 1, to May 31,

 

 

 

2009

 

2008

 

 

 

 

 

 

 

 

Revenues:

$

-

 

$

-

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

General and administrative

 

671,348

 

 

534,906

Research and development

 

1,895,670

 

 

1,591,170

Total operating expenses

 

2,567,018

 

 

2,126,076

 

 

 

 

 

 

 

 

Loss from operations

 

(2,567,018)

 

 

(2,126,076)

 

 

 

 

 

 

 

 

Interest income

 

2,967

 

 

10,789

Interest expense

 

(595)

 

 

(16,168)

Net loss

$

(2,564,646)

 

$

(2,131,455)

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

Basic and diluted

$

(0.04)

 

$

(0.05)

 

 

 

 

 

 

 

 

Weighted average shares

 

 

 

 

 

outstanding used to compute:

 

 

 

 

 

Basic and diluted

 

60,430,047

 

 

40,675,305

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-3-

 

 

 

 

 

 

Raptor Pharmaceuticals Corp.

(A Development Stage Company)

Condensed Consolidated Statements of Operations

(unaudited)

 

 

 

For the nine months periods from

 

 

For the cumulative period from September

 

 

 

September 1, 2008 to May 31, 2009

 

September 1, 2007 to May 31, 2008

 

8, 2005 (inception) to May 31, 2009

 

 

 

 

 

 

 

 

 

 

 

Revenues:

$

-

 

$

-

 

$

-

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

1,935,612

 

 

1,588,035

 

 

6,203,859

 

Research and development

 

5,369,922

 

 

3,641,400

 

 

13,674,088

 

In-process research and development

 

-

 

 

240,625

 

 

240,625

 

 

Total operating expenses

7,305,534

 

 

5,470,060

 

 

20,118,572

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(7,305,534)

 

 

(5,470,060)

 

 

(20,118,572)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

32,930

 

 

51,583

 

 

298,089

 

Interest expense

 

(1,876)

 

 

(103,044)

 

 

(109,286)

 

 

Net loss

$

(7,274,480)

 

$

(5,521,521)

 

$

(19,929,769)

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

$

(0.12)

 

$

(0.15)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares

 

 

 

 

 

 

 

 

 

outstanding used to compute:

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

60,411,732

 

 

37,882,220

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.

 

 

 

 

 

 

 

 

 

 

-4-

 

 

 

 

 

 

 

 

 

 

 

 

Raptor Pharmaceuticals Corp.

(A Development Stage Company)

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

 

 

 

For the nine month periods from

 

For the cumulative period from September 8, 2005

September 1, 2008 to May 31, 2009

 

September 1, 2007 to May 31, 2008

(inception) to May 31, 2009

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(7,274,480)

 

$

(5,521,521)

 

$

(19,929,769)

 

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee stock-based compensation exp.

 

 

332,456

 

 

377,613

 

 

1,192,989

 

Consultant stock-based compensation exp.

 

 

39,705

 

 

220,780

 

 

399,225

 

Amortization of intangible assets

 

 

103,874

 

 

60,209

 

 

210,583

 

Depreciation of fixed assets

 

 

66,935

 

 

105,440

 

 

333,182

 

In-process research and development

 

 

-

 

 

240,625

 

 

240,625

 

Amortization of capitalized finder’s fee

 

 

-

 

 

102,000

 

 

102,000

 

Capitalized acquisition costs previously expensed

 

 

-

 

 

38,000

 

 

38,000

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

(47,914)

 

 

(20,222)

 

 

(163,507)

 

 

Intangible assets

 

 

-

 

 

-

 

 

(150,000)

 

 

Deposits

 

 

-

 

 

(79,999)

 

 

(100,207)

 

 

Accounts payable

 

 

(26,412)

 

 

295,913

 

 

539,181

 

 

Accrued liabilities

 

 

(186,313)

 

 

34,369

 

 

246,121

 

 

Deferred rent

 

 

252

 

 

(4,140)

 

 

3,203

 

 

Net cash used in operating activities

 

 

(6,991,897)

 

 

(4,150,933)

 

 

(17,038,374)

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

Purchase of fixed assets

 

 

(22,734)

 

 

(2,070)

 

 

(476,350)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the sale of common stock

 

 

-

 

 

2,360,000

 

 

15,000,000

 

 

Proceeds from the exercise of common stock warrants

 

 

-

 

 

1,925,000

 

 

3,895,000

 

 

Proceeds from the exercise of common stock options

 

 

-

 

 

-

 

 

8,700

 

 

Fundraising costs

 

 

(36,809)

 

 

(261,788)

 

 

(1,198,408)

 

 

Proceeds from the sale of common stock to initial investors

 

 

-

 

 

-

 

 

310,000

 

 

Proceeds from bridge loan

 

 

-

 

 

-

 

 

200,000

 

 

Repayment of bridge loan

 

 

-

 

 

-

 

 

(200,000)

 

 

Principal payments on capital lease

 

 

(2,509)

 

 

(1,849)

 

 

(7,605)

 

Net cash provided by (used in) financing activities

 

 

(39,318)

 

 

4,021,363

-

 

18,007,687

 

Net increase (decrease) in cash and cash equivalents

 

 

(7,053,949)

 

 

(131,640)

 

 

492,963

 

Cash and cash equivalents, beginning of period

 

 

7,546,912

 

 

2,627,072

 

 

-

 

Cash and cash equivalents, end of period

 

$

492,963

 

$

2,495,432

 

$

492,963

Supplemental disclosure of non-cash financing activities:

 

 

 

 

 

 

 

 

 

 

 

Acquisition of equipment in exchange for capital lease

 

$

14,006

 

$

-

 

$

21,403

 

 

Notes receivable issued in exchange for common stock

 

$

-

 

$

-

 

$

110,000

 

 

Common stock issued for a finder’s fee

 

$

-

 

$

102,000

 

$

102,000

 

 

Common stock issued in asset purchase

 

$

-

 

$

2,898,624

 

$

2,898,624

The accompanying notes are an integral part of these financial statements.

 

 

-5-

 

 

 

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(1) NATURE OF OPERATIONS AND BUSINESS RISKS

 

The accompanying condensed consolidated financial statements reflect the results of operations of Raptor Pharmaceuticals Corp. (the “Company” or “Raptor”) and have been prepared in accordance with the accounting principles generally accepted in the United States of America.

 

Raptor is a publicly-traded biotechnology company dedicated to speeding the delivery of new treatment options to patients by enhancing existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. The Company focuses on underserved patient populations where it can have the greatest potential impact. Raptor’s preclinical division bioengineers novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein (“RAP”) and related proteins, while Raptor’s clinical division advances clinical-stage product candidates towards marketing approval and commercialization. Raptor’s clinical programs include ConviviaTM for the potential treatment of aldehyde dehydrogenase (“ALDH2”) deficiency and DR Cysteamine for the potential treatment of nephropathic cystinosis, non-alcoholic steatohepatitis (“NASH”), and Huntington’s Disease. Raptor’s preclinical programs target cancer, neurodegenerative disorders and infectious diseases. HepTide™ is designed to utilize engineered RAP-based peptides conjugated to drugs to target delivery to the liver to potentially treat primary liver cancer and hepatitis. NeuroTrans™ represents engineered RAP peptides created to target receptors in the brain and are currently undergoing preclinical evaluation for their ability to enhance the transport of therapeutics across the blood-brain barrier. WntTide™ is based upon Mesd and Mesd peptides that the Company is studying in a preclinical breast cancer model for WntTide™’s potential inhibition of Wnt signaling through LRP5, which may block cancers dependent on signaling through LRP5 or LRP6. The Company’s fiscal year end is August 31.

 

The Company is subject to a number of risks, including: the need to raise capital through equity and/or debt financings; the uncertainty whether the Company’s research and development efforts will result in successful commercial products; competition from larger organizations; reliance on licensing proprietary technology of others; dependence on key personnel; uncertain patent protection; and dependence on corporate partners and collaborators.

 

See the section titled “Risk Factors” in Part II Item 1A of this Quarterly Report on Form 10-Q.

(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

(a) Basis of Presentation

 

The Company’s condensed consolidated financial statements include the accounts of the Company’s wholly owned subsidiaries, Raptor Pharmaceutical Inc. and Raptor Therapeutics Inc. (f/k/a Bennu Pharmaceuticals Inc.) incorporated in Delaware on September 8, 2005 (date of inception) and August 1, 2007, respectively. All inter-company accounts have been eliminated. The Company’s condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Through May 31, 2009, the Company had accumulated losses of approximately $19.9 million. Management expects to incur further losses for the foreseeable future. Management believes that the Company’s cash and cash equivalents at May 31, 2009 plus cash anticipated to be received by July 17, 2009 from the exercise of re-priced warrants and cash expected to be received by July 31, 2009 from a current financing will be sufficient to meet the Company’s obligations into the first calendar quarter of 2010. The Company’s cash and cash equivalents as of July 15, 2009, will be sufficient to meet its minimum obligations into the fourth calendar quarter of 2009. The Company is currently in the process of reviewing strategic partnerships, collaborations and merger candidates in order to fully fund its preclinical and clinical programs through the end of 2010. If the Company is not able to close a strategic transaction, the Company anticipates raising additional capital in the fourth calendar quarter of 2009. Until the Company can generate sufficient levels of cash from its operations, the Company expects to continue to finance future cash needs primarily through proceeds from equity or debt financings, loans and collaborative agreements with corporate partners or through a business combination with a company that has such financing in order to be able to sustain its operations until the Company can achieve profitability and positive cash flows, if ever.

 

The Company’s independent registered public accounting firm has audited our consolidated financial statements for the years ended August 31, 2008 and 2007. The October 28, 2008 audit opinion included a paragraph indicating substantial doubt as to the Company’s ability to continue as a going concern due to the fact that the Company is in the development stage and has not generated any revenue to date.

-6-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Management plans to seek additional debt and/or equity financing for the Company through private or public offerings or through a business combination or strategic partnership, but it cannot assure that such financing or transaction will be available on acceptable terms, or at all. The uncertainty of this situation raises substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the failure to continue as a going concern.

(b) Use of Estimates

The preparation of financial statements in conformity with United States generally accepted accounting principles requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

(c) Fair Value of Financial Instruments

The carrying amounts of certain of the Company’s financial instruments including cash and cash equivalents, prepaid expenses, accounts payable, accrued liabilities and capital lease liability approximate fair value due to their short maturities.

(d) Segment Reporting

 

The Company has determined that it operates in two operating segments, preclinical development and clinical development. Operating segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company in deciding how to allocate resources and in assessing performance. The Company’s chief executive officer assesses the Company’s performance and allocates its resources. Below is a break-down of the Company’s net loss and total assets by operating segment:

 

 

 

For the three month periods

 

 

from March 1 to May 31, 2009

 

from March 1 to May 31, 2008

 

 

Preclinical

 

Clinical

 

Total

 

Preclinical

 

Clinical

 

Total

Net loss

 

$(778,853)

 

$(1,785,793)

 

$(2,564,646)

 

$ (937,785)

 

$ (1,193,670)

 

$ (2,131,455)

Total assets

 

434,515

 

3,044,070

 

3,478,585

 

2,994,411

 

2,721,517

 

5,715,928

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the nine month periods

 

 

from September 1, 2008 to May 31, 2009

 

from September 1, 2007 to May 31, 2008

 

 

Preclinical

 

Clinical

 

Total

 

Preclinical

 

Clinical

 

Total

Net loss

 

$(2,384,237)

 

$(4,890,243)

 

$(7,274,480)

 

$ (2,776,682)

 

$ (2,744,839)

 

$ (5,521,521)

Total assets

 

434,515

 

3,044,070

 

3,478,585

 

2,994,411

 

2,721,517

 

5,715,928

(e) Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents.

(f) Intangible Assets

Intangible assets include the intellectual property and other rights relating to DR Cysteamine and to the RAP technology. The intangible assets are amortized using the straight-line method over the estimated useful life of 20 years, which is the life of the intellectual property patents. The 20 year estimated useful life is also based upon the typical development, approval, marketing and life cycle management timelines of pharmaceutical drug products.

 

-7-

 

 

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(g) Fixed Assets

 

Fixed assets, which mainly consist of leasehold improvements, lab equipment, computer hardware and software and capital lease equipment, are stated at cost. Depreciation is computed using the straight-line method over the related estimated useful lives, except for leasehold improvements and capital lease equipment, which are depreciated over the shorter of the useful life of the asset or the lease term. Significant additions and improvements that have useful lives estimated at greater than one year are capitalized, while repairs and maintenance are charged to expense as incurred.

(h) Impairment of Long-Lived Assets

The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or discounted estimates of future cash flows. The Company has not identified any such impairment losses to date.

(i) Income Taxes

Income taxes are recorded under the liability method, under which deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

(j) Research and Development

The Company is an early development stage company. Research and development costs are charged to expense as incurred. Research and development expenses include scientists’ salaries, lab collaborations, preclinical studies, clinical trials, clinical trial materials, regulatory and clinical consultants, lab supplies, lab services, lab equipment maintenance and small equipment purchased to support the research laboratory, amortization of intangible assets and allocated executive, human resources and facilities expenses.

(k) In-Process Research and Development

The Company records in-process research and development expense for a product candidate acquisition where there is not more than one potential product or usage for the assets being acquired. The Company reviews each product candidate acquisition to determine if the purchase price should be expensed as in-process research and development or capitalized and amortized over the life of the asset.

(l) Net Loss per Share

Net loss per share is calculated by dividing net loss by the weighted average shares of common stock outstanding during the period. Diluted net income per share is calculated by dividing net income by the weighted average shares of common stock outstanding and potential shares of common stock during the period. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted net loss per share as their effect is anti-dilutive. Potentially dilutive securities include:

 

 

May 31,

 

 

 

2009

 

2008

 

Warrants to purchase common stock

 

13,258,276

 

4,013,876

 

Options to purchase common stock

 

4,243,227

 

3,605,727

 

Total potentially dilutive securities

 

17,501,503

 

7,619,603

 

 

-8-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(m) Stock Option Plans

 

Effective September 1, 2006, the Company adopted the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004), Share-Based Payment (“SFAS 123R”) in accounting for its 2006 Equity Incentive Plan, as amended. Under SFAS 123R, compensation cost is measured at the grant date based on the fair value of the equity instruments awarded and is recognized over the period during which an employee is

required to provide service in exchange for the award, or the requisite service period, which is usually the vesting period. The fair value of the equity award granted is estimated on the date of the grant. The Company previously applied Accounting Principles Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations and provided the required pro forma disclosures required by SFAS No. 123, Accounting for Stock-Based Compensation. See Note 7, “Stock Option Plan” for further discussion of employee stock-based compensation.

(n) Recent Accounting Pronouncements

In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, Fair Value Measurements (“SFAS 157”). SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles, and expands disclosures about fair value measurements. SFAS 157 does not require any new fair value measurements; rather, it applies under other accounting pronouncements that require or permit fair value measurements. The provisions of SFAS 157 are to be applied prospectively as of the beginning of the fiscal year in which it is initially applied, with any transition adjustment recognized as a cumulative-effect adjustment to the opening balance of retained earnings. The provisions of SFAS 157 are effective for fiscal years beginning after November 15, 2007; therefore, the Company adopted SFAS 157 as of September 1, 2008 for financial assets and liabilities. In accordance with FASB Staff Position 157-2, Effective Date of FASB Statement No. 157, the Company elected to defer the adoption of the provisions of SFAS 157 for its non-financial assets and non-financial liabilities. The Company has determined that SFAS 157 had no material impact on its financial position for the three and nine month periods ended May 31, 2009.

 

In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Financial Liabilities, Including an Amendment of FASB Statement No. 115, which permits the measurement of many financial instruments and certain other asset and liabilities at fair value on an instrument-by-instrument basis (the fair value option). The guidance is applicable for fiscal years beginning after November 15, 2007; therefore, the Company adopted SFAS 159 as of September 1, 2008. The Company has determined that SFAS 159 had no material impact for the three and nine month periods ended May 31, 2009.

 

In June 2007, the Emerging Issues Task Force (“EITF”) reached a consensus on EITF No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities (“EITF 07-3”). EITF 07-3 specifies the timing of expense recognition for non-refundable advance payments for goods or services that will be used or rendered for research and development activities. EITF 07-3 was effective for fiscal years beginning after December 15, 2007, and early adoption is not permitted; therefore, the Company adopted EITF 07-3 as of September 1, 2008. The Company has determined that EITF 07-3 had no material impact on its financial results for the three and nine month periods ended May 31, 2009.

 

In December 2007, the EITF reached a consensus on EITF No. 07-1, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property (“EITF 07-1”). EITF 07-1 discusses the appropriate income statement presentation and classification for the activities and payments between the participants in arrangements related to the development and commercialization of intellectual property. The sufficiency of disclosure related to these arrangements is also specified. EITF 07-1 is effective for fiscal years beginning after December 15, 2008. As a result, EITF 07-1 is effective for the Company as of September 1, 2009. The Company is currently evaluating the impact of EITF 07-1 on its financial position and results of operations. Based upon the nature of the Company’s business, EITF 07-1 could have a material impact on its financial position and consolidated results of operations in future years.

 

-9-

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

In December 2007, FASB issued Statement No. 141 (Revised 2007), Business Combinations  (“SFAS 141(R)”) and SFAS No. 160,  Accounting and Reporting of Non-controlling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (“SFAS 160”). These statements will significantly change the financial accounting and reporting of business combination transactions and non-controlling (or minority) interests in consolidated financial statements. SFAS 141(R) requires companies to: (i) recognize, with certain exceptions, 100% of the fair values of assets acquired, liabilities assumed, and non-controlling interests in acquisitions of less than a 100% controlling interest when the acquisition constitutes a change in control of the acquired entity; (ii) measure acquirer shares issued in consideration for a business combination at fair value on the acquisition date; (iii) recognize contingent consideration arrangements at their acquisition-date fair values, with subsequent changes in fair value generally reflected in earnings; (iv) with certain exceptions, recognize pre-acquisition loss and gain contingencies at their acquisition-date fair values; (v) capitalize in-process research and development (“IPR&D”) assets acquired; (vi) expense, as incurred, acquisition-related transaction costs; (vii) capitalize acquisition-related restructuring costs only if the criteria in SFAS No. 146,  Accounting for Costs Associated with Exit or Disposal Activities, are met as of the acquisition date; and (viii) recognize changes that result from a business combination transaction in an acquirer’s existing income tax valuation allowances and tax uncertainty accruals as adjustments to income tax expense. SFAS 141(R) is required to be adopted concurrently with SFAS 160 and is effective for business combination transactions for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008 (our fiscal 2010). Early adoption of these statements is prohibited. The Company believes the adoption of these statements will have a material impact on significant acquisitions, if any, completed after September 1, 2009.

 

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities (“SFAS 161”). This statement will require enhanced disclosures about derivative instruments and hedging activities to enable investors to better understand their effects on an entity’s financial position, financial performance, and cash flows. It is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application encouraged. The Company adopted SFAS 161 on December 1, 2008 and has determined that SFAS 161 had no material impact on its financial results for the three and nine month periods ended May 31, 2009.

 

In May 2008, FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting Principles (“SFAS 162”). This standard is intended to improve financial reporting by identifying a consistent framework, or hierarchy, for selecting accounting principles to be used in preparing financial statements that are presented in conformity with U.S. GAAP for non-governmental entities. SFAS No. 162 is effective 60 days following the U.S. Securities and Exchange Commission’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, the meaning of “Present Fairly in Conformity with GAAP”. The Company is in the process of evaluating the impact, if any, of SFAS 162 on its condensed consolidated financial statements.

 

In May 2008, the FASB released FASB Staff Position (“FSP”) APB 14-1 Accounting For Convertible Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”) that alters the accounting treatment for convertible debt instruments that allow for either mandatory or optional cash settlements. FSP APB 14-1 specifies that issuers of such instruments should separately account for the liability and equity components in a manner that will reflect the entity’s nonconvertible debt borrowing rate when interest cost is recognized in subsequent periods. Furthermore, it would require recognizing interest expense in prior periods pursuant to retrospective accounting treatment. FSP APB 14-1 is effective for financial statements issued for fiscal years beginning after December 15, 2008; therefore, the Company anticipates adopting FSP APB 14-1 as of September 1, 2009. The Company is in the process of evaluating the impact, if any, of FSP APB 14-1 on its condensed consolidated financial statements.

 

In June 2008, the FASB issued EITF No. 07-5 (“EITF 07-5”), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, paragraph 11(a), and should be classified as a liability and marked-to-market. The statement is effective for fiscal years beginning

 

 

-10-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

after December 15, 2008 and interim periods within those fiscal years and is to be applied to outstanding instruments upon adoption with the cumulative effect of the change in accounting principle recognized as an adjustment to the opening balance of retained earnings. The Company is adopting EITF 07-5 as of September 1, 2009 and is in the process of evaluating the impact, if any, of EITF 07-5 on its condensed consolidated financial statements.

 

In April 2008, the FASB issued FSP SFAS No. 142-3, Determination of the Useful Life of Intangible Assets (“FSP SFAS 142-3”). FSP SFAS 142-3 provides guidance with respect to estimating the useful lives of recognized intangible assets acquired on or after the effective date and requires additional disclosure related to the renewal or extension of the terms of recognized intangible assets. FSP SFAS 142-3 is effective for fiscal years and interim periods beginning after December 15, 2008. The Company is adopting FSP SFAS 142-3 as of September 1, 2009 and is currently evaluating the impacts and disclosures of this standard, but does not expect FSP SFAS 142-3 to have a material impact on the Company’s condensed consolidated financial statements.

 

In May 2009, the FASB issued SFAS No. 165, Subsequent Events (“SFAS 165”). SFAS 165 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. SFAS 165 is effective for fiscal years and interim periods ending after June 15, 2009. The Company is adopting SFAS 165 as of September 1, 2009 and does not expect it to have a material impact on the Company’s condensed consolidated financial statements.

 

(3) INTANGIBLE ASSETS

 

On January 27, 2006, BioMarin Pharmaceutical Inc. (“BioMarin”) assigned the intellectual property and other rights relating to the RAP technology to the Company. As consideration for the assignment of the RAP technology, BioMarin will receive milestone payments based on certain financing and regulatory triggering events. No other consideration was paid for this assignment. The Company has recorded $150,000 of intangible assets on the condensed consolidated balance sheets as of May 31, 2009 and August 31, 2008 based on the estimated fair value of its agreement with BioMarin.

 

On December 14, 2007, the Company acquired the intellectual property and other rights to develop DR Cysteamine to treat various indications from the University of California at San Diego (“UCSD”) by way of a merger with Encode Pharmaceuticals, Inc. (“Encode”), a privately held research and development company, which held the intellectual property license with UCSD. The intangible assets, recorded at approximately $2.6 million acquired in the merger with Encode, were primarily based on the value of the Company’s common stock and warrants issued to the Encode stockholders as reflected in the table below:

 

Raptor common stock issued (number of shares)

3,444,297

Raptor common stock issuable upon marketing approval by a regulatory agency of DR Cysteamine for Cystinosis (number of shares)

351,359

Total shares of common stock used to value the transaction

3,795,656

Average closing price of Raptor’s common stock 2 days before and after the close of the merger

$ 0.586

Value of Raptor common stock portion of transaction

$ 2,224,254

Value (based on Carpenter model) of warrants issued in connection with transaction, net of legal fees

395,746

Intangible asset (IP license) related to the Encode merger, gross

$ 2,620,000

Intangible asset related to NeuroTransTM purchase from BioMarin, gross

150,000

Total gross intangible assets

2,770,000

Less accumulated amortization

(210,583)

Intangible assets, net

$2,559,417

 

The intangible assets are being amortized monthly over 20 years, which are the life of the intellectual property patents and the estimated useful life. The 20 year estimated useful life is also based upon the typical development, approval, marketing and life cycle management timelines of pharmaceutical drug products. During the three month and nine month periods ended May 31, 2009 and 2008 and the cumulative period from September 8, 2005 (inception) to May 31, 2009, the Company amortized $34,625, $103,874, $34,625, $60,208, and $210,583, respectively, of intangible assets to research and development expense.

-11-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The following table summarizes the actual and estimated amortization expense for our intangible assets for the periods indicated:

 

Amortization period

 

Amortization expense

September 8, 2005 (inception) to August 31, 2006 – actual

 

$

4,375

Fiscal year ending August 31, 2007 – actual

 

 

7,500

Fiscal year ending August 31, 2008 – actual

 

 

94,833

Fiscal year ending August 31, 2009 – estimate

 

 

138,500

Fiscal year ending August 31, 2010 – estimate

 

 

138,500

Fiscal year ending August 31, 2011 – estimate

 

 

138,500

Fiscal year ending August 31, 2012 – estimate

 

 

138,500

Fiscal year ending August 31, 2013 – estimate

 

 

138,500

 

(4) FIXED ASSETS

 

Fixed assets consisted of:

 

 

Category

 

May 31, 2009

 

August 31, 2008

 

Estimated useful lives

Leasehold improvements

 

$

113,422

 

$

113,422

 

Shorter of life of asset or lease term

Office furniture

 

 

3,188

 

 

3,188

 

7 years

Laboratory equipment

 

 

277,303

 

 

277,303

 

5 years

Computer hardware and software

 

 

80,437

 

 

59,703

 

 

3 years

Capital lease equipment

 

 

14,006

 

 

7,397

 

Shorter of life of asset or lease term

Total at cost

 

 

488,356

 

 

461,013

 

 

Less: accumulated depreciation

 

 

(325,866)

 

 

(266,247)

 

 

Total fixed assets, net

 

$

162,490

 

$

194,766

 

 

 

Depreciation expense for the three and nine month periods ended May 31, 2009 and 2008 and the cumulative period from September 8, 2005 (inception) to May 31, 2009 was $21,169, $66,935, $35,261, $105,440 and $333,182, respectively. Accumulated depreciation on capital lease equipment was $2,873 and $5,446 as of May 31, 2009 and August 31, 2008, respectively.

 

(5) ACCRUED LIABILITIES

 

 

Accrued liabilities consisted of:

 

 

 

May 31, 2009

 

August 31, 2008

Consulting – research and development

 

$

58,322

 

$

7,578

Accrued vacation

 

 

40,524

 

 

17,728

Milestone fees

 

 

40,000

 

 

-

Legal fees

 

 

38,670

 

 

51,503

Salaries and wages

 

 

30,801

 

 

44,165

Auditing and tax preparation fees

 

 

29,070

 

 

66,307

Lab reagents

 

 

8,734

 

 

27,024

Preclinical studies

 

 

-

 

 

48,165

Consulting - administrative

 

 

-

 

 

30,000

Clinical trial costs

 

 

-

 

 

114,514

Patent costs

 

 

-

 

 

10,000

Prepaid conference expense

 

 

-

 

 

5,490

Other

 

 

-

 

 

9,960

Total accrued liabilities

 

$

246,121

 

$

432,434

 

-12-

 

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(6) IN-PROCESS RESEARCH AND DEVELOPMENT

 

On October 17, 2007, the Company purchased certain assets of Convivia, Inc. (“Convivia”) including intellectual property, know-how and research reports related to a product candidate targeting liver aldehyde dehydrogenase (“ALDH2”) deficiency, a genetic metabolic disorder. The Company issued an aggregate of 437,500 shares of its restricted, unregistered common stock to the seller and other third parties in settlement of the asset purchase. Pursuant to Financial Accounting Standard (“FAS”) 2 Paragraph 11(c), Intangibles Purchased From Others, the Company has expensed the value of the common stock issued in connection with this asset purchase as in-process research and development expense. The amount expensed was based upon the closing price of Raptor’s common stock on the date of the closing of the asset purchase transaction of $0.55 per share multiplied by the aggregate number of shares of Raptor common stock issued or 437,500 for a total expense of $240,625 recorded on Raptor’s condensed consolidated statement of operations during the nine month period ended May 31, 2008.

 

(7) STOCK OPTION PLAN

 

Effective September 1, 2006, the Company began recording compensation expense associated with stock options and other forms of equity compensation in accordance with SFAS 123R, as interpreted by Staff Accounting Bulletin No. 107 (“SAB 107”). Prior to September 1, 2006, the Company accounted for stock options according to the provisions of Accounting Principles Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations, and therefore no related compensation expense was recorded for awards granted with no intrinsic value. The Company adopted the modified prospective transition method provided for under SFAS 123R, and consequently has not retroactively adjusted results from prior periods. Under this transition method, compensation cost associated with stock options now includes: (1) quarterly amortization related to the remaining unvested portion of all stock option awards granted prior to September 1, 2006, based on the grant date value estimated in accordance with the original provisions of SFAS 123; and (2) quarterly amortization related to all stock option awards granted subsequent to September 1, 2006, based on the grant date fair value estimated in accordance with the provisions of SFAS 123R. In addition, the Company records consulting expense over the vesting period of stock options granted to consultants. The compensation expense for stock-based compensation awards includes an estimate for forfeitures and is recognized over the requisite service period of the options, which is typically the period over which the options vest, using the straight-line method. The Company accounts for stock options issued to third parties, including consultants, in accordance with the provisions of the EITF Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services.

Employee stock-based compensation expense for the three and nine month periods ended May 31, 2009 and 2008 and for the cumulative period from September 8, 2005 (inception) to May 31, 2009 was $107,165, $332,456, $109,295, $321,613, and $1,192,989 of which cumulatively $1,011,731 was included in general and administrative expense and $181,258 was included in research and development expense. No employee stock compensation costs were recognized for the period from September 8, 2005 (inception) to August 31, 2006, which was prior to the Company’s adoption of SFAS 123R.

 

 

 

 

 

 

-13-

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Stock-based compensation expense was based on the Black-Scholes option-pricing model assuming the following:

 

 

 

 

Period*

Risk-free interest rate

 

 

Expected life of stock option

 

 

Annual

volatility

 

Annual

turnover rate

September 8, 2005 (inception) to August 31, 2006**

 

5%

 

10 years

 

100%

 

0%

 

Quarter ended November 30, 2006

 

5%

 

8 years

 

100%

 

10%

 

Quarter ended February 28, 2007

 

5%

 

8 years

 

100%

 

10%

 

Quarter ended May 31, 2007

 

5%

 

8 years

 

100%

 

10%

 

Quarter ended August 31, 2007

 

4%

 

8 years

 

100%

 

10%

 

Quarter ended November 30, 2007

 

3.75%

 

8 years

 

109%

 

10%

 

Quarter ended February 29, 2008

 

2%

 

8 years

 

119%

 

10%

 

Quarter ended May 31, 2008

 

2%

 

8 years

 

121%

 

10%

 

Quarter ended August 31, 2008

 

2.5%

 

8 years

 

128%

 

10%

 

Quarter ended November 30, 2008

 

1.5%

 

7 years

 

170%

 

10%

 

Quarter ended February 28, 2009

 

2.0%

 

7 years

 

220%

 

10%

 

Quarter ended May 31, 2009

 

2.6%

 

7 years

 

233%

 

10%

 

*Dividend rate is 0% for all period presented.

 

**Stock-based compensation expense was recorded on the condensed consolidated statements of operations commencing on the effective date of SFAS 123R, September 1, 2006. Prior to September 1, 2006, stock based compensation was reflected only in the footnotes to the condensed consolidated statements of operations, with no effect on the condensed consolidated statements of operations, per the guidelines of APB No. 25. Consultant stock-based compensation expense has been recorded on the condensed consolidated statements of operations since inception.

 

If factors change and different assumptions are employed in the application of SFAS 123R, the compensation expense recorded in future periods may differ significantly from what was recorded in the current period.

 

The Company recognizes as an expense the fair value of options granted to persons who are neither employees nor directors. The fair value of expensed options was based on the Black-Scholes option-pricing model assuming the same factors shown in the stock-based compensation expense table above. Stock-based compensation expense for consultants for the three and nine month periods ended May 31, 2009 and 2008 and for the cumulative period from September 8, 2005 (inception) to May 31, 2009, were $16,910, $39,705, $12,293, $216,405 and $399,225, respectively, of which cumulatively $101,836 was included in general and administrative expense and $297,389 was included in research and development expense.

 

 

 

-14-

 

 

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

A summary of the activity in the 2006 Equity Compensation Plan, as amended, is as follows:  

 

  

Option shares

 

Weighted

average

exercise

price

  

Exercisable

  

Weighted

average fair

value of

options

granted

Outstanding at September 8, 2005

  

-

 

-

 

-

 

-

Granted

  

2,488,400

 

$0.62

 

-

 

$0.48

Exercised

  

-

 

-

 

-

 

-

Canceled

  

-

 

-

 

-

 

-

Outstanding at August 31, 2006

  

2,488,400

 

$0.62

 

17,200

 

$0.61

Granted

 

460,900

 

$0.60

 

-

 

$0.52

Exercised

 

(14,500)

 

$0.60

 

-

 

$0.52

Canceled

 

-

 

-

 

 

 

-

Outstanding at August 31, 2007

 

2,934,800

 

$0.61

 

1,172,081

 

$0.53

Granted

 

958,427

 

$0.53

 

-

 

$0.51

Exercised

 

-

 

-

 

-

 

-

Canceled

 

-

 

-

 

-

 

-

Outstanding at August 31, 2008

 

3,893,227

 

$0.59

 

2,577,347

 

$0.56

Granted

 

75,000

 

$0.25

 

-

 

$0.24

Exercised

 

-

 

-

 

-

 

-

Canceled

 

-

 

-

 

-

 

-

Outstanding at November 30, 2008

 

3,968,227

 

$0.59

 

2,848,221

 

$0.55

Granted

 

125,000

 

$0.35

 

31,250

 

$0.30

Exercised

 

-

 

-

 

-

 

-

Canceled

 

-

 

-

 

-

 

-

Outstanding at February 28, 2009

 

4,093,227

 

$0.58

 

3,167,279

 

$0.54

Granted

 

150,000

 

$0.20

 

-

 

$0.20

Exercised

 

-

 

-

 

-

 

-

Canceled

 

-

 

-

 

-

 

-

Outstanding at May 31, 2009

 

4,243,227

 

$0.57

 

3,468,372

 

$0.53

 

The weighted average intrinsic values of stock options outstanding and stock options exercisable as of May 31, 2009 and 2008 were $23,250, $766, $0 and $0, respectively.

 

There were 1,742,273 options available for grant under the 2006 Equity Compensation Plan, as amended, as of May 31, 2009. As of May 31, 2009, the options outstanding consisted of the following:

 

 

Options outstanding

  

Options exercisable

 

 

 

Range of exercise prices

  

Number of options

outstanding (#)

  

Weighted

average

remaining

contractual

life (yrs.)

  

Weighted

average

exercise

price ($)

  

Number of

options

exercisable (#)

  

Weighted

average

exercise

price ($)

$0 to $0.60

  

3,654,827

  

7.80

  

 

0.55

  

2,879,972

  

 

0.58

$0.601 to $0.70

  

588,400

  

7.00

  

 

0.67

  

588,400

  

 

0.67

 

  

4,243,227

  

 7.69

  

 

 0.57

  

3,468,372

  

 

 0.60

 

  

 

  

 

  

 

 

  

 

  

 

 

 

 

 

 

 

 

-15-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

At May 31, 2009, the total unrecognized compensation cost was approximately $222,000. The weighted average period over which it is expected to be recognized is two and three quarters years.

(8) ISSUANCE OF COMMON STOCK

ISSUANCE OF COMMON STOCK PURSUANT TO COMMON STOCK WARRANT EXERCISES AND STOCK OPTION EXERCISES

 

During the cumulative period from September 8, 2005 (inception) through May 31, 2009, the Company received $3.895 million from the exercises of common stock warrants issued in the Company’s May 2006 financing. The Company issued an aggregate of 6,491,667 shares of common stock for the warrants, which had an exercise price of $0.60 per share and expired on November 25, 2007.

 

During the cumulative period from September 8, 2005 (inception) through May 31, 2009, the Company received $8,700 from the exercise of stock options resulting in the issuance of 14,500 shares of common stock. Total common stock outstanding as of May 31, 2009 was 60,430,047 shares.

 

ISSUANCE OF COMMON STOCK PURSUANT TO AN ASSET PURCHASE AGREEMENT WITH CONVIVIA, INC.              

 

On October 18, 2007, the Company purchased certain assets of Convivia, Inc. (“Convivia”) including intellectual property, know-how and research reports related to a product candidate targeting liver aldehyde dehydrogenase (“ALDH2”) deficiency, a genetic metabolic disorder. The Company hired Convivia’s chief executive officer and founder, Thomas E. (Ted) Daley, as President of its clinical division. In exchange for the assets related to the ALDH2 deficiency program, the Company issued to Convivia 200,000 shares of its restricted, unregistered common stock, an additional 200,000 shares of its restricted, unregistered common stock to a third party in settlement of a convertible loan between the third party and Convivia, and another 37,500 shares of restricted, unregistered common stock in settlement of other obligations of Convivia. Mr. Daley, as the former sole stockholder of Convivia (now dissolved), may earn additional shares of the Company based on certain triggering events or milestones related to the development of Convivia assets. In addition, Mr. Daley may earn cash bonuses based on the same triggering events pursuant to his employment agreement. In January 2008, Mr. Daley earned a $30,000 cash bonus pursuant to his employment agreement for executing the Patheon formulation agreement for manufacturing ConviviaTM. In March 2008, Mr. Daley earned a $10,000 cash bonus pursuant to his employment agreement and was issued 100,000 shares of valued at $56,000 based on the execution of an agreement to supply the Company with the active pharmaceutical ingredient for ConviviaTM pursuant to the asset purchase agreement. In October 2008, Mr. Daley was issued 100,000 shares of restricted Raptor common stock valued at $27,000 and earned a $30,000 cash bonus (pursuant to Mr. Daley’s employment agreement) pursuant to the fulfillment of a clinical milestone. Pursuant to FAS 2, Paragraph 11(c), the accounting guidelines for expensing research and development costs, the Company has expensed the value of the stock issued in connection with this asset purchase (except for milestone bonuses, which are expensed as compensation expense) as in-process research and development expense in the amount of $240,625 on its condensed consolidated statement of operations for the nine month period ended May 31, 2008.

 

 

 

 

 

 

-16-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

               MERGER OF RAPTOR’S CLINICAL DEVELOPMENT SUBSIDIARY AND ENCODE PHARMACEUTICALS, INC.

 

                On December 14, 2007, the Company entered into a Merger Agreement (the “Merger Agreement”), dated as of the same date, by and between the Company, its clinical development subsidiary and Encode Pharmaceuticals, Inc. (“Encode”), a privately held development stage company. Pursuant to the Merger Agreement, a certificate of merger was filed with the Secretary of State of the State of Delaware and Encode was merged with and into the Company’s clinical development subsidiary. The existence of Encode ceased as of the date of the Merger Agreement. Pursuant to the Merger Agreement and the certificate of merger, the Company’s clinical development subsidiary, as the surviving corporation, continued as a wholly-owned subsidiary of the Company. Under the terms of and subject to the conditions set forth in the Merger Agreement, the Company issued 3,444,297 shares of restricted, unregistered shares of the Company’s common stock, par value $.001 per share (the “Common Stock”) to the stockholders of Encode (the “Encode Stockholders”), options (“Company Options”) to purchase 357,427 shares of Common Stock to the optionholders of Encode (the “Encode Optionholders”), and warrants (“Company Warrants”) to purchase 1,098,276 restricted, unregistered shares of Common Stock to the warrantholders of Encode (the “Encode Warrantholders”, and together with the Encode Stockholders and Encode Optionholders, the “Encode Securityholders”), as of the date of such Agreement. Such Common Stock, Company Options to purchase Common

Stock, and Company Warrants to purchase Common Stock combine for an aggregate amount of 4.9 million shares of Common Stock issuable to the Encode Securityholders as of the closing of the Merger. The purchase price was valued at $2.6 million, which is reflected as intangible assets on the Company’s consolidated balance sheet as of August 31, 2008, primarily based on the value the Company’s common stock and warrants issued to Encode stockholders. The Encode Securityholders are eligible to receive up to an additional 2.4 million shares of Common Stock, Company Options and Company Warrants to purchase Common Stock in the aggregate based on certain triggering events related to regulatory approval of DR Cysteamine, an Encode product program described below, if completed within the five year anniversary date of the Merger Agreement. The Company recorded this transaction as an asset purchase rather than a business combination, as Encode had not commenced planned principle operations, such as generating revenues from its drug product candidate.

 

                As a result of the Merger, the Company received the exclusive worldwide license to DR Cysteamine (“License Agreement”), developed by clinical scientists at the UCSD, School of Medicine. DR Cysteamine is a proprietary enterically coated formulation of cysteamine bitartrate, a cystine depleting agent currently approved by the U.S. Food and Drug Administration (“FDA”). Cysteamine bitartrate is prescribed for the management of the genetic disorder known as nephropathic cystinosis (“cystinosis”), a lysosomal storage disease. The active ingredient in DR Cysteamine has also demonstrated potential in studies as a treatment for other metabolic and neurodegenerative diseases, such as Huntington’s Disease and Non-alcoholic steatohepatitis (“NASH”).

 

                In consideration of the grant of the license, prior to the merger, Encode paid an initial license fee and the Company will be obligated to pay an annual maintenance fee until it begins commercial sales of any products developed pursuant to the License Agreement. In addition to the maintenance fee, the Company will be obligated to pay during the life of the License Agreement: milestone payments ranging from $20,000 to $750,000 for orphan indications and from $80,000 to $1,500,000 for non-orphan indications upon the occurrence of certain events, if ever; royalties on commercial net sales from products developed pursuant to the License Agreement ranging from 1.75% to 5.5%; a percentage of sublicense fees ranging from 25% to 50%; a percentage of sublicense royalties; and a minimum annual royalty commencing the year the Company begins commercially selling any products pursuant to the License Agreement, if ever. Under the License Agreement, the Company is obligated to fulfill predetermined milestones within a specified number of years ranging from 0.75 to 6 years from the effective date of the License Agreement, depending on the indication. To the extent that the Company fails to perform any of the obligations, UCSD may terminate the license or otherwise cause the license to become non-exclusive. As of May 31, 2009, the Company accrued $40,000 due to UCSD for the milestone related to the first patient dosing in the NASH trial which commenced in October 2008.           

 

-17-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

               ISSUANCES OF COMMON STOCK AND WARRANTS IN CONNECTION WITH THE SALE OF UNITS IN A PRIVATE PLACEMENT

 

                On May 21, 2008 (the “Initial Closing”) Raptor entered into a Securities Purchase Agreement (the “Purchase Agreement”), with eight investors (the “Initial Investors”) for the private placement of units of the Company, each unit comprised of one share of Raptor’s Common Stock and one warrant to purchase one half of one share of Raptor’s Common Stock, at a purchase price of $0.50 per unit. Immediately subsequent to the Initial Closing, the Company and each Initial Investor entered into an Amendment to the Securities Purchase Agreement, principally in order to increase the amount able to be raised by the Company in the private placement and to extend the outside closing date of such private placement (the “Amendment”, and, together with the Purchase Agreement, the “Amended Purchase Agreement”), dated as of May 21, 2008.

 

                At the Initial Closing, the Company sold an aggregate of 4,420,000 shares of Common Stock (the “Initial Shares”) to the Initial Investors for aggregate gross proceeds of $2,210,000 and issued to the Initial Investors warrants (the “Initial Warrants”). The Initial Warrants, exercisable for two years from the Initial Closing, entitle the Initial Investors to purchase up to an aggregate of 2,210,000 shares of Common Stock of the Company (the “Initial Warrant Stock”) and have an exercise price of either $0.75 or $0.90 per share, depending on when such Initial Warrants are exercised, if at all.

 

                Pursuant to the Amended Purchase Agreement, the Company agreed to prepare and file a registration statement (the “Registration Statement”) within 60 days after the Initial Closing with the Securities and Exchange Commission under the Securities Act, on a Form S-1, covering the Shares and Warrant Stock sold pursuant to the Amended Purchase Agreement (the “Restricted Stock”) as well as Common Stock underlying warrants issued to placement agents each subject to volume limitations, and to use its commercially reasonable efforts to cause the Registration Statement to become effective with the SEC thereafter and to remain effective until the earlier to occur of the date (i) that is the second anniversary of the Initial Closing, (ii) the date the Restricted Securities may be sold under Rule 144 during any 90-day period and (iii) such time as all of the Restricted Securities have been publicly sold. The Company filed the Form S-1 in July 2008, which the SEC declared effective on August 7, 2008.

 

                Following the effectiveness of the Registration Statement, the Company may, at any time, but no more than twice during any 12-month period, suspend the effectiveness of such registration for up to 45 calendar days, as appropriate (a “Suspension Period”), by giving notice to the holders of shares of Restricted Stock, if the Company shall have determined that the Company may be required to disclose any material corporate development which disclosure may have a material adverse effect on the Company.

 

                On May 30, 2008 Raptor sold an additional $150,000 of units at the same terms as outlined in the May 21, 2008 closing discussed above. As a result, the Company issued 300,000 shares of the Company’s Common Stock and warrants to purchase 150,000 shares of the Company’s Common Stock.

 

                On June 27, 2008 Raptor sold an additional $7,640,000 of units at the same terms as outlined in the May 21, 2008 closing discussed above. As a result, the Company issued 15,280,000 shares of the Company’s Common Stock and warrants to purchase 7,640,000 shares of the Company’s Common Stock.

 

                In connection with the May / June 2008 private placement, the Company issued warrants and a cash fee to placement agents to compensate them for placing investors into the financing. Placement agents were issued warrants exercisable for 7% of Common Stock issued and issuable under the warrants issued to investors as part of the financing units and a cash fee based upon the proceeds of the sale of the units of the private placement. In connection with the sale of units, the Company issued placement agent warrants to purchase 2,100,000 shares of Raptor’s Common Stock at an exercise price of $0.55 per share for a five year term and cash fees to placement agents totaling $700,000. Of the placement agents compensated, Limetree Capital was issued warrants to purchase 1,882,650 shares of Raptor’s Common Stock and cash commission of $627,550. One of our Board members serves on the board of Limetree Capital.

 

-18-

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

                On April 29, 2009, in order to reflect current market prices, the Company notified the holders of warrants purchased in the May/June 2008 private placement that the Company was offering, in exchange for such warrants, new warrants to purchase Raptor’s common stock at an exercise price of $0.30 per share, but only to the extent such exchange and exercise, including the delivery of the exercise price, occur prior to or on July 17, 2009. If the exchange and exercise do not occur by that date, then the original, unexercised warrants with an exercise price of $0.90 per share remain in place in accordance with the warrant agreement and such original, unexercised warrants will retain their original expiration date of May 21, 2010.

 

The following is a summary of common stock outstanding as of May 31, 2009:

 

 

 

 

 

Common Stock

Transaction

 

Date

 

Issued

 

 

 

 

 

Founders’ shares

 

Sept. 2005

 

6,000,000

Seed round

 

Feb. 2006

 

2,000,000

PIPE concurrent with reverse merger

 

May 2006

 

8,333,333

Shares issued in connection with reverse merger

 

May 2006

 

13,300,000

Warrant exercises

 

Jan. - Nov. 2007

 

6,491,667

Stock option exercises

 

Mar. 2007

 

14,500

Loan finder’s fee

 

Sept. 2007

 

200,000

Convivia asset purchase

 

Oct. 2007- Nov. 2008

 

637,500

Encode merger DR Cysteamine asset purchase

 

Dec. 2007

 

3,444,297

Shares issued pursuant to consulting agreement

 

May 2008

 

8,750

PIPE - initial tranche

 

May 2008

 

4,420,000

PIPE – second tranche

 

May 2008

 

300,000

PIPE – third tranche

 

June 2008

 

15,280,000

Total shares of common stock outstanding

 

 

 

60,430,047

 

 

(9) WARRANTS

 

 

The table reflects the number common stock warrants outstanding as of May 31, 2009:

 

Summary of outstanding warrants:

 

Number of shares exercisable

 

Exercise price

 

Expiration date

 

Issued in lieu of deferred legal fees

 

60,000

 

$ 0.60

 

2/13/2011

 

Issued in connection with Encode merger

 

97,480

 

$ 0.56

 

12/13/2015

 

Issued in connection with Encode merger

 

1,000,796

 

$ 0.67

 

12/13/2015

 

Issued to PIPE investors in May / June 2008

 

10,000,000

 

$0.75 / $0.90

*

5/21/2010

 

Issued to placement agents in May / June 2008

 

2,100,000

 

$ 0.55

 

5/21/2013

 

Total warrants outstanding

 

13,258,276

 

$ 0.70

**

 

 

 

 

 

 

 

 

* First year exercisable at $0.75; second year exercisable at $0.90; from April 29, 2009 to July 17, 2009 warrants that were exercised during this period and for which the Company received the exercise price payment were re-priced to $0.30

 

 

 

 

 

** Average exercise price

 

 

 

 

 

 

 

 

 

-19-

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(10) COMMITMENTS AND CONTINGENCIES

CONTRACTUAL OBLIGATIONS WITH BIOMARIN

 

Pursuant to the terms of the asset purchase agreement the Company entered into with BioMarin Pharmaceutical Inc. (“BioMarin”) for the purchase of intellectual property related to our receptor-associated protein (“RAP”) based technology (including NeuroTransTM), we are obligated to make the following milestone payments to BioMarin upon the achievement of the following events:

 

 

$50,000 (paid by the Company in June 2006) within 30 days after Raptor receives total aggregate debt or equity financing of at least $2,500,000;

 

 

$100,000 (paid by the Company in June 2006) within 30 days after Raptor receives total aggregate debt or equity financing of at least $5,000,000;

 

 

$500,000 upon the Company’s filing and acceptance of an investigational new drug application for a drug product candidate based on the NeuroTransTM product candidate;

 

 

$2,500,000 upon the Company’s successful completion of a Phase II human clinical trial for a drug product candidate based on the NeuroTransTM product candidate;

 

 

$5,000,000 upon on the Company’s successful completion of a Phase III human clinical trial for a drug product candidate based on the NeuroTrans TM product candidate;

 

 

$12,000,000 within 90 days of the Company’s obtaining marketing approval from the FDA or other similar regulatory agencies for a drug product candidate based on the NeuroTransTM product candidate;

 

 

$5,000,000 within 90 days of the Company’s obtaining marketing approval from the FDA or other similar regulatory agencies for a second drug product candidate based on the NeuroTransTM product candidate;

 

 

$5,000,000 within 60 days after the end of the first calendar year in which the Company’s aggregated revenues derived from drug product candidates based on the NeuroTransTM product candidate exceed $100,000,000; and

 

 

$20,000,000 within 60 days after the end of the first calendar year in which the Company’s aggregated revenues derived from drug product candidates based on the NeuroTransTM product candidate exceed $500,000,000.

 

In addition to these milestone payments, the Company is also obligated to pay BioMarin a royalty at a percentage of the Company’s aggregated revenues derived from drug product candidates based on the NeuroTransTM product candidate. On June 9, 2006, the Company made a milestone payment in the amount of $150,000 to BioMarin because the Company raised $5,000,000 in its May 25, 2006 private placement financing. If the Company becomes insolvent or if the Company breaches its asset purchase agreement with BioMarin due to non-payment and the Company does not cure its non-payment within the stated cure period, all of the Company’s rights to the RAP technology (including NeuroTransTM ) will revert back to BioMarin.

 

                

 

 

 

 

-20-

 

 

 

 

                

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

CONTRACTUAL OBLIGATIONS WITH THOMAS E. DALEY (ASSIGNEE OF THE DISSOLVED CONVIVIA, INC.)

 

Pursuant to the terms of the asset purchase agreement (“Asset Purchase Agreement”), the Company entered into with Convivia, Inc. and Thomas E. Daley for the purchase of intellectual property related to its 4-MP product candidate program, Mr. Daley will be entitled to receive the following, if at all, in such amounts and only to the extent certain future milestones are accomplished by the Company (or any of its subsidiaries thereof), as set forth below:

 

 

100,000 shares of Raptor’s restricted, unregistered Common Stock within fifteen (15) days after the Company enters into a manufacturing license or other agreement to produce any product that is predominantly based upon or derived from any assets purchased from Convivia (“Purchased Assets”) in quantity (“Product”) if such license agreement is executed within one (1) year of execution of the Asset Purchase Agreement or, if thereafter, 50,000 shares of Raptor’s restricted, unregistered Common Stock. Should the Company obtain a second such license or agreement for a Product, Mr. Daley will be entitled to receive 50,000 shares of the Company’s restricted, unregistered Common Stock within 30 days of execution of such second license or other agreement. On March 31, 2008, the Company issued 100,000 shares of Raptor’s Common Stock valued at $56,000 to Mr. Daley pursuant to this milestone reflecting the execution of an agreement to supply the active pharmaceutical ingredient for ConviviaTM, combined with the execution of a formulation agreement to produce the oral formulation of ConviviaTM.

 

 

100,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after it receives its first patent allowance on any patents which constitute part of the Purchased Assets in any one of certain predetermined countries (“Major Market”).

 

 

50,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after the Company receives its second patent allowance on any patents which constitute part of the Purchased Assets different from the patent referenced in the immediately preceding bullet point above in a Major Market.

 

 

100,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days of completing predetermined benchmarks in a Major Market by the Company or its licensee of the first phase II human clinical trial for a Product (“Successful Completion”) if such Successful Completion occurs within one (1) year of execution of the Asset Purchase Agreement or, if thereafter, 50,000 shares of the Company’s restricted, unregistered Common Stock within thirty (30) days of such Successful Completion. In October 2008, the Company issued 100,000 shares of Raptor’s Common Stock valued at $27,000 and a $30,000 cash bonus (pursuant to Mr. Daley’s employment agreement) to Mr. Daley pursuant to the fulfillment of this milestone.

 

 

50,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days of a Successful Completion in a Major Market by the Company’s or its licensee of the second phase II human clinical trial for a Product (other than the Product for which a distribution is made under the immediately preceding bullet point above).

 

 

100,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after the Company or its licensee applies for approval to market and sell a Product in a Major Market for the indications for which approval is sought (“Marketing Approval”).

 

 

50,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after the Company or its licensee applies for Marketing Approval in a Major Market (other than the Major Market for which a distribution is made under the immediately preceding bullet point above).

 

 

-21-

 

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

200,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after the Company or its licensee obtains the first Marketing Approval for a Product from the applicable regulatory agency in a Major Market.

 

 

100,000 shares of the Company’s restricted, unregistered Common Stock within fifteen (15) days after the Company or its licensee obtains Marketing Approval for a Product from the applicable regulatory agency in a Major Market (other than the Major Market for which a distribution is made under the immediately preceding bullet point above).

 

As discussed above, in aggregate, the Company has issued to Mr. Daley, 200,000 shares of Raptor’s common stock valued at $83,000 and paid $30,000 in cash bonuses related to ConviviaTM milestones along with another $20,000 in cash bonuses related to employment milestones pursuant to Mr. Daley’s employment agreement.

 

CONTRACTUAL OBLIGATIONS WITH FORMER ENCODE STOCKHOLDERS AND UCSD RELATING TO THE ACQUISITION OF THE DR CYSTEAMINE LICENSE

 

As a result of the merger between our clinical subsidiary and Encode, as discussed in Note 8 above, the Encode Securityholders are eligible to receive up to an additional 2.4 million shares of Raptor’s common stock, Company Options and Company Warrants to purchase Raptor’s common stock in the aggregate based on certain triggering events related to regulatory approval of DR Cysteamine, an Encode product program, if completed within the five year anniversary date of the merger agreement.

 

Also as a result of the merger, the Company will be obligated to pay an annual maintenance fee to UCSD for the exclusive license to develop DR Cysteamine for certain indications of $15,000 until it begins commercial sales of any products developed pursuant to the License Agreement. In addition to the maintenance fee, the Company will be obligated to pay during the life of the License Agreement: milestone payments ranging from $20,000 to $750,000 for orphan indications and from $80,000 to $1,500,000 for non-orphan indications upon the occurrence of certain events, if ever; royalties on commercial net sales from products developed pursuant to the License Agreement ranging from 1.75% to 5.5%; a percentage of sublicense fees ranging from 25% to 50%;  a percentage of sublicense royalties; and a minimum annual royalty commencing the year we begin commercially selling any products pursuant to the License Agreement, if ever. Under the License Agreement, the Company is obligated to fulfill predetermined milestones within a specified number of years ranging from 0.75 to 6 years from the effective date of the License Agreement, depending on the indication. In addition, the Company is obligated to, among other things, secure $1 million in funding prior to December 18, 2008 (which the Company has fulfilled by raising $10 million in its May/June 2008 private placement) and annually spend at least $200,000 for the development of products (which, as of its fiscal year ended August 31, 2008, the Company has fulfilled by spending approximately $900,000 on such programs) pursuant to the License Agreement. As of May 31, 2009, the Company accrued $40,000 due to UCSD for the milestone related to the first patient dosing in the NASH trial which commenced in October 2008. To the extent that the Company fails to perform any of its obligations under the License Agreement, then UCSD may terminate the license or otherwise cause the license to become non-exclusive.

 

 

OFFICE LEASES

In March 2006, the Company entered into a lease for the Company’s executive offices and research laboratory in Novato, California. Base monthly payments were $5,206 per month subject to annual rent increase of between 3% to 5%, based on the Consumer Price Index (“CPI”). In March 2006, the Company paid $20,207 as a security deposit on this lease, which expired in March 2009. Effective April 1, 2007, the Company leased additional office space adjoining the existing leased space, increasing our base rent to $9,764 per month without extending the term of the original lease. The original lease allows for one three-year extension at the market rate and up to $18,643 in reimbursement for tenant improvements. In June 2008, the Company’s rent increased to $10,215 reflecting a CPI increase of 3% plus an increase in operating costs for the period from April 1, 2008 to March 31, 2009. In

 

-22-

 

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 2008, the Company executed a lease addendum replacing the one three-year extension with two two-year

extensions commencing on April 1, 2009 and renegotiated the first two-year extension base rent to $10,068 with an adjustment after the first year for CPI between 3% (minimum) and 5% (maximum). During the three and nine month periods ended May 31, 2009 and 2008 and the cumulative period from September 8, 2005 (inception) to May 31, 2009, the Company paid $31,904, $94,195, $31,378, $93,462 and $333,759, respectively, in rent.

 

The minimum future lease payments under this operating lease assuming a 3% CPI increase per year are as follows:

Period

Amount

June 1, 2009 through August 31, 2009

$30,679

Fiscal year ending August 31, 2010

124,226

September 1, 2010 to March 31, 2011

73,698

 

CAPITAL LEASE

In June 2006, the Company leased a photocopier machine for 36 months at $242 per month. There was no purchase option at the end of the lease. Based on the fair value and estimated useful life of the photocopier and the life of the lease and the photocopier, the Company has accounted for the lease as a capital lease. In September 2008, the Company replaced the originally leased photocopier with a new photocopier which is subject to a 39-month lease at $469 per month. There were no penalties imposed for cancelling the original lease.

The future lease payments under the capital lease are as follows:

Period

Amount

June 1, 2009 through August 31, 2009

$ 1,406

Fiscal year ending August 31, 2010

5,625

Fiscal year ending August 31, 2011

5,625

September 1, 2011 to December 31, 2011

1,875

Total future capital lease payments

14,531

Less interest

(2,813)

Total current and long-term capital lease liability

$ 11,718

Interest rate on the capital lease is 17% based on the lessor’s implicit rate of return.

 

RESEARCH COLLABORATION AGREEMENT

In September 2008, the Company signed a research collaboration agreement with a research hospital. The research collaboration agreement requires the Company to pay an aggregate of $150,000 over one year, which includes the salary, benefits and overhead of one research scientist along with laboratory equipment and supplies necessary to carry out the research at the university.

The future commitments pursuant to the research agreement are as follows:

Period

Amount

June 1, 2009 through August 31, 2009

$5,000

                

 

 

-23-

 

 

 

RAPTOR PHARMACEUTICALS CORP.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

CLINICAL STUDY AGREEMENT

In May 2009, the Company entered into a clinical study collaboration agreement with the University of California, San Diego, to study DR Cysteamine in patients with cystinosis. Also in May 2009, the Company entered into an agreement with a clinical research organization to monitor the cystinosis trial. The future commitments pursuant to these clinical study agreements are as follows:

Period

Amount

June 1, 2009 through August 31, 2009

$284,387

 

 

FORMULATION / MANUFACTURING AGREEMENT

In April 2008, the Company executed an agreement with a contract manufacturing organization to formulate and manufacture DR Cysteamine for its cystinosis program. The costs are invoiced to the Company in installments throughout the formulation and manufacturing process. Also in July 2008, the Company executed a supply agreement with a contract manufacturer for the active pharmaceutical agreement of DR Cysteamine. The future commitments pursuant to these contracts are as follows:

Period

Amount

June 1, 2009 through August 31, 2009

$813,740

(11) SUBSEQUENT EVENTS

In June 2009, the Company entered into a collaboration and license agreement with F. Hoffmann – La Roche Ltd. and Hoffmann – La Roche Inc. , an international pharmaceutical company, in which the Company gave worldwide development rights to its proprietary NeuroTransTM technology platform which is being developed to potentially aid therapeutics and diagnostics cross the blood-brain barrier. The Company may earn future milestone payments, if at all, based on development milestones The agreement also includes a collaboration agreement in which both the Company and Roche will develop and test certain molecules attached to NeuroTransTM for their ability to cross the blood-brain barrier and potentially a second-phase collaboration to be determined after the initial phase of collaboration. The Company will receive an initial collaboration fee to cover its costs of the collaboration and may earn additional collaboration fees, should Roche and the Company enter into a second phase of collaboration.

                In June 2009, the Company commenced its DR Cysteamine Phase IIb pilot clinical trial to treat up to six cystinosis patients. The Company estimates the trial will cost approximately $300,000 and clinical data from this trial is anticipated to be released in the third calendar quarter of 2009.

 

                In April 2009, the Company exchanged warrants issued by it in connection with the 2008 private placement for new warrants having an exercise price of $0.30 per share solely to the extent that such new warrants are exercised on or prior July, 17, 2009. As of July 10, 2009, approximately $1.6 million of proceeds have been received from warrant exercises.

 

 

 

 

 

-24-

 

 

 

 

Item 2.

Management’s Discussion and Analysis or Plan of Operation.

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, these statements can be identified by the use of terminology such as “believes,” “expects,” “anticipates,” “plans,” “may,” “might,” “will,” “could,” “should,” “would,” “projects,” “anticipates,” “predicts,” “intends,” “continues,” “estimates,” “potential,” “opportunity” or the negative of these terms or other comparable terminology. All statements, other than statements of historical facts, included in this Quarterly Report, including our financial condition, future results of operation, projected revenues and expenses, business strategies, operating efficiencies or synergies, competitive positions, growth opportunities for existing intellectual properties, technologies, products, plans, and objectives of management, markets for our securities, and other matters, are about us and our industry that involve substantial risks and uncertainties and constitute forward-looking statements for the purpose of the safe harbor provided by Section 27A of the Securities Act  and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements, wherever they occur, are necessarily estimates reflecting the best judgment of our senior management on the date on which they were made, or if no date is stated, as of the date of this Quarterly Report. You should not place undue reliance on these statements, which only reflect information available as of the date that they were made. Our business’ actual operations, performance, development and results might differ materially from any forward-looking statement due to various known and unknown risks, uncertainties, assumptions and contingencies, including those described in the section titled “Risk Factors,” and including, but not limited to, the following:

 

 

-

our need for, and our ability to obtain, additional funds;

 

-

uncertainties relating to clinical trials and regulatory reviews;

 

-

our dependence on a limited number of therapeutic compounds;

 

-

the early stage of the products we are developing;

 

-

the acceptance of any future products by physicians and patients;

 

-

competition and dependence on collaborative partners;

 

-

loss of key management or scientific personnel;

 

-

our ability to obtain adequate intellectual property protection and to enforce these rights;

 

-

our ability to avoid infringement of the intellectual property rights of others; and

 

-

the other factors and risks described under the section captioned “Risk Factors” as well as other factors not identified therein.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, the factors discussed in this Quarterly Report could cause actual results or outcomes to differ materially and/or adversely from those expressed in any forward-looking statements made by us or on our behalf, and therefore we cannot guarantee future results, levels of activity, performance or achievements and you should not place undue reliance on any such forward-looking statements. We cannot give you any assurance that the forward-looking statements included in this Quarterly Report will prove to be accurate and the forward-looking events discussed in this Quarterly Report may not occur. In light of the significant uncertainties inherent in the forward-looking statements included in this Quarterly Report, you should not regard the inclusion of this information as a representation by us or any other person that the results or conditions described in those statements or our objectives and plans will be achieved.

 

New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

 

All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Unless required by U.S. federal securities laws and the rules and regulations of the SEC, we do not undertake any obligation and disclaim any intention to update or release publicly any revisions to these forward-looking statements after the filing of this Quarterly Report to reflect later events or circumstances or to reflect the occurrence of unanticipated events or any other reason.

 

 

-25-

 

 

 

 

PLAN OF OPERATION

 

You should read the following discussion in conjunction with our condensed consolidated financial statements as of May 31, 2009, and the notes to such condensed consolidated financial statements included elsewhere in this Quarterly Report. All references to “the Company”, “we”, “our” and “us” include the activities of Raptor Pharmaceuticals Corp. and its wholly-owned subsidiaries, Raptor Pharmaceutical Inc. and Raptor Therapeutics Inc. (f/k/a Bennu Pharmaceuticals Inc.) (“Raptor Therapeutics”).

 

This “Management’s Discussion and Analysis of Financial Condition or Plan of Operation” section contains forward-looking statements. Please see “Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those discussed below and elsewhere in this Quarterly Report, particularly under the heading “Risk Factors.”

 

Plan of Operation and Overview

 

We believe that we are building a balanced pipeline of drug candidates that may expand the reach and benefit of existing therapeutics. Our product portfolio includes both candidates from our proprietary drug targeting platforms and in-licensed and acquired product candidates.

 

Our current pipeline includes four clinical development programs plus three preclinical programs that are based upon our proprietary drug-targeting platforms.

 

Clinical Development Programs

 

Our four clinical development programs are based on existing therapeutics that we are reformulating for potential improvement and application in different disease indications.

 

These clinical development programs include the following.

 

 

DR Cysteamine for the potential treatment of: nephropathic cystinosis (“cystinosis”), a rare genetic disorder; non-alcoholic steatohepatitis (“NASH”), a metabolic disorder of the liver; Huntington’s Disease (“HD”), an inherited neurodegenerative disease; and

 

 

Convivia™ for the potential management of acetaldehyde toxicity due to alcohol consumption by individuals with aldehyde dehydrogenase or ALDH2 deficiency, an inherited metabolic disorder.

 

Preclinical Programs

 

Our preclinical platforms consist of targeted therapeutics, which we are developing for the potential treatment of multiple indications, including liver diseases, neurodegenerative diseases and breast cancer:

 

Our receptor-associated protein (“RAP”) platform consists of: HepTide™ for the potential treatment of primary liver cancer and hepatitis C; and NeuroTrans™ to potentially deliver therapeutics across the blood-brain barrier.

 

Our mesoderm development protein (“Mesd”) platform consists of WntTide™ for the potential treatment of breast cancer.

 

Future Activities

 

Over the next 12 months, we plan to conduct research and development activities based upon our DR Cysteamine product candidate, our ConviviaTM product candidate, our RAP-based platform, our Mesd-based peptides, and future in-licensed technologies and acquired technologies. A brief summary of our primary objectives in the next 12 months for our research and development activities is provided below. Our plans for research and development activities over the next 12 months can only be implemented if we are successful in raising significant funds during this period. In addition, there can be no assurances that our research and development activities will be successful. We need to make important progress towards achieving at least one of our major clinical objectives or our ability to continue as a going concern will be adversely impacted due to the potential inability for us to raise additional capital.

 

-26-

 

 

 

 

 

Clinical Development Programs

We develop clinical-stage drug product candidates which are: internally discovered therapeutic candidates based on our novel drug delivery platforms and in-licensed or purchased clinical-stage products which may be new chemical entities in mid-to-late stage clinical development, currently approved drugs with potential efficacy in additional indications, and treatments that we could repurpose or reformulate as potentially more effective or convenient treatments for a drug’s currently approved indications.

 

Development of DR Cysteamine for the Potential Treatment of Nephropathic Cystinosis and Other Diseases

 

Our DR Cysteamine product candidate is a proprietary delayed-release, enteric-coated microbead formulation of cysteamine bitartrate contained in a gelatin capsule. We are investigating DR Cysteamine for the potential treatment of: cystinosis, NASH and HD.

 

Immediate-release cysteamine bitartrate, a cystine-depleting agent, is currently the only FDA and EMEA approved drug to treat cystinosis. Immediate-release cysteamine is effective at preventing or delaying kidney transplants in cystinosis patients, however, patient compliance is challenging due to the requirement for frequent dosing and gastrointestinal side effects. Our DR Cysteamine for the potential treatment of cystinosis is designed to mitigate some of these difficulties. It is expected to be dosed twice daily, compared to the current every-six-hour dosing schedule. In addition, DR Cysteamine is designed to pass through the stomach and deliver the drug directly to the small intestine, where it is more easily absorbed into the bloodstream and may result in fewer gastrointestinal side effects.

The FDA granted orphan drug designation for: DR Cysteamine for the treatment of cystinosis in 2006; DR Cysteamine for the treatment of Batten Disease in 2008; and cysteamine for the treatment of Huntington’s Disease in 2008. In October 2008, we commenced a clinical trial in collaboration with UCSD to investigate a prototype formulation of DR Cysteamine for the treatment of NASH in juvenile patients.

In June 2009, we commenced our Phase IIb clinical trial, in which we have enrolled three cystinosis patients and plan to enroll up to three additional cystinosis patients with a history of compliance using the currently available immediate-release form of cysteamine bitartrate. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Release of data from the study is expected in the third calendar quarter of 2009. We plan to follow the Phase IIb clinical study with a pivotal, Phase III clinical study in cystinosis patients anticipated to commence in the fourth calendar quarter of 2009. We also plan to support a clinical trial investigating DR Cysteamine in HD patients in collaboration with a French institution in the second half of 2009.

Development of ConviviaTM for Liver Aldehyde Dehydrogenase (“ALDH2”) Deficiency

 

Convivia™ is our proprietary oral formulation of 4-methylpyrazole (“4-MP”) intended for the potential treatment of acetaldehyde toxicity resulting from alcohol consumption in individuals with ALDH2 deficiency, which is an inherited disorder of the body’s ability to breakdown ethanol, commonly referred to as alcohol intolerance. 4-MP is presently marketed in the U.S. and E.U. in an intravenous form as an anti-toxin. ConviviaTM is designed to lower systemic acetaldehyde levels and reduce symptoms, such as tachycardia and flushing, associated with alcohol consumption by ALDH2-deficient individuals. ConviviaTM is a capsule designed to be taken approximately 30 minutes prior to consuming an alcoholic beverage.

 

In 2008 we completed a Phase IIa dose escalation clinical trial of oral 4-MP with ethanol in ALDH2 deficient patients. The study results demonstrated that the active ingredient in ConviviaTM significantly reduced heart palpitations (tachycardia), which are commonly experienced by ALDH2 deficient people who drink, at all dose levels tested. The study also found that the 4-MP significantly reduced peak acetaldehyde levels and total acetaldehyde exposure in a subset of the study participants who possess specific genetic variants of the liver ADH and ALDH2 enzymes. We believe that this subset represents approximately one-third of the ALDH2 deficient adult population. We are actively seeking corporate partnerships with pharmaceutical companies in selected Asian countries to continue clinical development of ConviviaTM in those countries.

 

-27-

 

 

 

 

 

 

Preclinical Development Programs

 

We are also developing a drug-targeting platform based on the proprietary use of the human protein called receptor-associated protein, or RAP, and the mesoderm development protein, or Mesd. We believe that these proteins may have therapeutic applications in cancer, infectious diseases and neurodegenerative diseases, among others.

These applications are based on the assumption that our targeting molecules can be engineered to bind to a selective subset of receptors with restricted tissue distribution under particular conditions of administration. We believe these selective tissue distributions can be used to deliver drugs to the liver or to other tissues, such as the brain.

In addition to selectively transporting drugs to specific tissues, selective receptor binding constitutes a means by which receptor function might be specifically controlled, either through modulating its binding capacity or its prevalence on the cell surface. Mesd is being engineered for this latter application.

 

Development of HepTideTM for Hepatocellular Carcinoma (“HCC”) and Hepatitis C

 

Drugs currently used to treat primary liver cancer are often toxic to other organs and tissues. We believe that the pharmacokinetic behavior of RAP (i.e., the determination of the fate or disposition of RAP once administered to a living organism) may diminish the non-target toxicity and increase the on-target efficacy of attached therapeutics.

In preclinical studies of our radio-labeled HepTideTM (a variant of RAP), HepTideTM, our proprietary drug-targeting peptide was shown to distribute predominately to the liver. Radio-labeled HepTideTM which was tested in a preclinical research model of HCC, at the National Research Council in Winnipeg, Manitoba, Canada, showed 4.5 times more delivery to the liver than the radio-labeled control. Another study of radio-labeled HepTideTM in a non-HCC preclinical model, showed 7 times more delivery to the liver than the radio-labeled control, with significantly smaller amounts of radio-labeled HepTideTM delivery to other tissues and organs.

HCC is caused by the malignant transformation of hepatocytes, epithelial cells lining the vascular sinusoids of the liver, or their progenitors. HepTideTM has shown to bind to lipoprotein receptor-related protein (“LRP1”) receptors on hepatocytes. We believe that the pharmacokinetics and systemic toxicity of a number of potent anti-tumor agents may be controlled in this way.

There are additional factors that favor the suitability of RAP as an HCC targeting agent:

 

RAP is captured by hepatocytes with efficiency, primarily on first-pass.

 

Late-stage HCC is perfused exclusively by the hepatic artery, while the majority of the liver is primarily perfused through the portal vein. 

Our studies have shown that the RAP receptor, LRP1, is well-expressed on human HCC and under-expressed on non-cancerous, but otherwise diseased, hepatocytes. Also, high levels of LRP1 expression are maintained on metastasized HCC. These factors will favor delivery of RAP peptide-conjugated anti-tumor agents to tumor cells, whether in the liver or at metastasized sites.

We are evaluating conjugates between HepTideTM and a chemotherapeutic for testing in vitro and in appropriate preclinical models for the potential treatment of HCC.

We are also evaluating conjugates between HepTideTM and an antiviral agent for testing in vitro and in appropriate preclinical models for the potential treatment of hepatitis C.

Development of NeuroTransTM for the Potential Treatment of Diseases Affecting the Brain

Nearly 1,000 known genetic and neurodegenerative diseases affect the brain. Drugs often have difficulty reaching these disease-affected areas because the brain has evolved a protective barrier, commonly referred to as the blood-brain barrier.

 

-28-

 

 

 

 

Part of the solution to the medical problem of neurodegenerative diseases is the creation of effective brain targeting and delivery technologies. One of the most obvious ways of delivering therapeutics to the brain is via the brain’s extensive vascular network. Treating these diseases by delivering therapeutics into the brain in a minimally invasive way, including through a natural receptor mediated transport mechanism called transcytosis, is a vision shared by many researchers and clinicians in the neuroscience and neuromedical fields.

NeuroTrans™ is our proprietary RAP-based technology program to research the delivery of therapeutics across the blood-brain barrier. We believe our NeuroTrans™ platform may provide therapies that will be safer, less intrusive and more effective than current approaches in treating a wide variety of brain disorders.

In preclinical studies, NeuroTrans™ has been conjugated to a variety of protein drugs, including enzymes and growth factors, without interfering with the function of either fusion partner. Studies indicate that radio-labeled NeuroTrans™ may be transcytosed across the blood-brain barrier and, that fusions between NeuroTrans™ and therapeutic proteins may be manufactured economically.

 

We worked with Dr. William Mobley, while he was a professor and Chairman of the Department of Neurology and Neurological Sciences, and his lab at Stanford University to study the brain transport behavior of NeuroTrans™ candidates. In the first year of our collaboration, a number of RAP-based peptide transport candidates were tested for their ability to bind to receptors that are thought to reside on the cells that line the blood-brain barrier. From these experiments, a lead candidate peptide was selected. In the second year of our collaboration, we completed preclinical evaluations which we believe support that NeuroTrans™ conjugates injected into the blood stream have the ability to seek out, bind to, and rapidly enter the cells that line the blood-brain barrier. These experiments support the NeuroTrans™ peptide’s ability to enhance the transport of cargo molecules into the cells that line the blood-brain barrier. This collaboration has lapsed.

In June 2009, we entered into a collaboration and licensing agreement with F. Hoffman – La Roche Ltd. and Hoffman – La Roche Inc. (“Roche”) to evaluate therapeutic delivery across the blood-brain barrier utilizing NeuroTrans™. Under terms of the agreement, Roche has funded studies of select molecules attached to NeuroTransTM. The agreement provides Roche with an exclusive worldwide license to NeuroTransTM for use in the delivery of diagnostic and therapeutic molecules across the blood-brain barrier. Roche’s and our scientists will actively collaborate on the project. We have received an initial upfront payment for the collaboration to cover our portion of the initial studies, and may earn, if at all, development milestone payments and royalties in exchange for the licensing of NeuroTransTM to Roche.

 Development of WntTideTM for the Potential Treatment of Cancer

 

Human mesoderm development protein (“Mesd”) is a chaperone protein necessary for the proper folding of LRP5 and LRP6, two receptor proteins that have been shown to have the following effects:

 

 

-LRP5 is a protein involved in the regulation of bone mass.

 

 

-Wnt-signaling through LRP 6 has been shown to make breast cancer cells more aggressive. Studies by Dr. 

Guojun Bu, our scientific advisor and professor of Pediatrics, Cell Biology and Physiology at Washington        University in St. Louis, have shown that extracellular Mesd or an Mesd-based peptide inhibit signaling through LRP5.

WntTide™ is our proprietary, Mesd-based peptide that we are developing as a potential therapeutic to inhibit the growth and metastasis of tumors over-expressing LRP5 or LRP6.

In November 2006, we licensed the use of Mesd from Washington University in St. Louis for the potential treatment of cancer and bone density disorders. In June 2007, our preclinical study demonstrated that both Mesd and WntTide™ accelerated bone loss in a model of osteoporosis, suggesting inhibition of a key cellular signaling pathway was taking place. These findings indicate that WntTide™ may treat diseases known to be caused by an over-activation of the Wnt pathway, including certain forms of breast cancer. In April 2009, Washington University conducted a preclinical study of WntTide™ in a breast cancer model which showed tumor inhibition. The results of this study were presented at the 2nd Annual Wnt Conference in Washington, D.C., in June 2009 and will be published in the second calendar half of 2009. We are currently evaluating the next steps with researchers at Washington University in the continued development of WntTideTM.

 

-29-

 

 

 

 

 

Other Development Areas

 

 Securing Additional and Complementary Technology Licenses from Others

 

We intend to continue to extend our development of RAP, RAP-variants and Mesd to applications in other potential therapeutics. We plan to establish additional research collaborations with prominent universities and research labs currently working on the development of potential targeting molecules, and to secure licenses from these universities and labs for technology resulting from the collaboration. No assurances can be made regarding our ability to establish such collaborations over the next 12 months, or at all. We intend to focus our in-licensing and product candidate acquisition activities on identifying complementary therapeutics, therapeutic platforms that offer a number of therapeutic targets, and clinical-stage therapeutics based on existing approved drugs in order to create proprietary reformulations to improve safety and efficacy or to expand such drugs’ clinical indications through additional clinical trials.

 

Business Development Activities

 

As part of our ongoing business development activities, we intend to seek out industry partners interested in potential clinical applications of our proprietary molecules and co-development or drug partnerships. In the cancer area, we plan to contact institutions and companies with an expressed interest in developing therapeutics to our potential anti-cancer targets. Out-licensing arrangements with these companies may include technology transfer, partnerships, or joint ventures. Joint activities may include drug product candidate development, drug product candidate manufacturing, preclinical testing or clinical research studies. We plan to enter partnerships with one or more pharmaceutical companies in Asian countries for development and commercialization of our ConviviaTM   product candidate. We also plan to seek distribution or co-development agreements with one or more companies for ex-US territories for our DR Cysteamine product candidate. There can be no assurance that we will be able to identify appropriate industry partners or, if we are able to, that we will be able to enter into mutually acceptable agreements with them on terms that are satisfactory to us, or at all.

 

We also intend to continue our efforts to in-license or acquire clinical stage products and preclinical drugs or drug technologies. These products may be in later stage clinical development or already approved and on the market. We may obtain these products through collaborations, joint ventures or through merger and/or acquisitions with other biotechnology companies.

 

Strategic Acquisitions

 

Purchase of ConviviaTM

 

In October 2007, we purchased certain assets of Convivia, Inc. (“Convivia”) including intellectual property, know-how and research reports related to a product candidate targeting liver aldehyde dehydrogenase (“ALDH2”) deficiency, a genetic metabolic disorder. We hired Convivia’s chief executive officer and founder, Thomas E. (Ted) Daley, as President of our clinical development division. In exchange for the assets related to the ALDH2 deficiency program, what we now call ConviviaTM, we issued to Convivia 200,000 shares of our common stock, an additional 200,000 shares of our common stock to a third party in settlement of a convertible loan between the third party and Convivia, and another 37,500 shares of our common stock in settlement of other obligations of Convivia. Mr. Daley, as the former sole stockholder of Convivia, may earn additional shares of our common stock based on certain triggering events or milestones related to the development of the Convivia assets. In addition, Mr. Daley may earn cash bonuses based on the same triggering events pursuant to his employment agreement. In January 2008, Mr. Daley earned a $30,000 cash bonus pursuant to his employment agreement as a result of the milestone of our execution of a formulation agreement for manufacturing ConviviaTM with Patheon. In March 2008, we issued to Mr. Daley 100,000 shares of our common stock pursuant to our Convivia purchase agreement as a result of the milestone of our execution of an agreement to supply us with the active pharmaceutical ingredient for ConviviaTM and two $10,000 cash bonuses pursuant to his employment agreement for reaching his six-month and one-year employment anniversaries. In October 2008, we issued to Mr. Daley 100,000 shares of our common stock valued at $27,000 and a $30,000 cash bonus as a result of fulfilling a clinical milestone.

 

 

 

 

-30-

 

 

 

 

 

 

Purchase of DR Cysteamine

 

In December 2007, through a merger between Encode Pharmaceuticals, Inc. (“Encode”) and our wholly owned subsidiary, Raptor Therapeutics, we purchased certain assets, including the clinical development rights to DR Cysteamine. Under the terms of and subject to the conditions set forth in the merger agreement, we issued 3,444,297 shares of our common stock to the stockholders of Encode (“Encode Stockholders”), options (“Company Options”) to purchase up to, in the aggregate, 357,427 shares of our common stock to the optionholders of Encode (“Encode Optionholders”), and warrants (“Company Warrants”) to purchase up to, in the aggregate, 1,098,276 shares of our common stock to the warrantholders of Encode (“Encode Warrantholders”, and together with the Encode Stockholders and Encode Optionholders, the “Encode Securityholders”), as of the date of such agreement. Such common stock, Company Options to purchase our common stock, and Company Warrants to purchase our common stock combine for an aggregate amount of 4.9 million shares of our common stock issuable to the Encode Securityholders as of the closing of the merger. The Encode Securityholders are eligible to receive up to an additional 2.4 million shares of our common stock, Company Options and Company Warrants to purchase our common stock in the aggregate based on certain triggering events related to regulatory approval of DR Cysteamine, an Encode product program, if completed within the five year anniversary date of the merger agreement.

 

As a result of the Encode merger, we received the exclusive worldwide license to DR Cysteamine (“License Agreement”), developed by clinical scientists at the UCSD, School of Medicine. In consideration of the grant of the license, prior to the merger with Raptor Therapeutics, Encode paid an initial license fee and we are obligated to pay an annual maintenance fee of $15,000 until we begin commercial sales of any products developed pursuant to the License Agreement. In addition to the maintenance fee, we are obligated to pay during the life of the License Agreement: milestone payments ranging from $20,000 to $750,000 for orphan indications and from $80,000 to $1,500,000 for non-orphan indications upon the occurrence of certain events, if ever; royalties on commercial net sales from products developed pursuant to the License Agreement ranging from 1.75% to 5.5%; a percentage of sublicense fees ranging from 25% to 50%;  a percentage of sublicense royalties; and a minimum annual royalty commencing the year we begin commercially selling any products pursuant to the License Agreement, if ever. Under the License Agreement, we are obligated to fulfill predetermined milestones within a specified number of years ranging from 0.75 to 6 years from the effective date of the License Agreement, depending on the indication. In addition, we are obligated, among other things, to spend annually at least $200,000 for the development of products (which we satisfied, as of our fiscal year ended August 31, 2008 by spending approximately $900,000 on such programs) pursuant to the License Agreement. As of May 31, 2009, we accrued $40,000 due to UCSD for the milestone related to the first patient dosing in the NASH trial which commenced in October 2008. To the extent that we fail to perform any of our obligations under the License Agreement, then UCSD may terminate the license or otherwise cause the license to become non-exclusive.

 

Application of Critical Accounting Policies

 

Our condensed consolidated financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles used in the U.S. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. These estimates and assumptions are affected by management’s application of accounting policies. We believe that understanding the basis and nature of the estimates and assumptions involved with the following aspects of our condensed consolidated financial statements is critical to an understanding of our condensed consolidated financial position.

 

We believe the following critical accounting policies require us to make significant judgments and estimates in the preparation of our condensed consolidated financial statements.

 

Fair Value of Financial Instruments

 

The carrying amounts of certain of our financial instruments including cash and cash equivalents, prepaid expenses, accounts payable, accrued liabilities and capital lease liability approximate fair value due to their short maturities.

 

Cash and Cash Equivalents

 

We consider all highly liquid investments with original maturities of three months or less to be cash equivalents.

 

-31-

 

 

 

 

Intangible Assets

 

Intangible assets include the intellectual property and other rights relating to DR Cysteamine and our RAP technology. Our intangible assets are amortized using the straight-line method over the estimated useful life of 20 years, which is the life of our intellectual property patents. The 20 year estimated useful life is also based upon the typical development, approval, marketing and life cycle management timelines of pharmaceutical drug products.

 

Fixed Assets

 

Fixed assets, which mainly consist of leasehold improvements, lab equipment, computer hardware and software and capital lease equipment, are stated at cost. Depreciation is computed using the straight-line method over the related estimated useful lives, except for leasehold improvements and capital lease equipment, which are depreciated over the shorter of the useful life of the asset or the lease term. Significant additions and improvements that have useful lives estimated at greater than one year are capitalized, while repairs and maintenance are charged to expense as incurred.

 

Impairment of Long-Lived Assets

 

We evaluate our long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or discounted estimates of future cash flows. We have not identified any such impairment losses to date.

 

Income Taxes

 

Income taxes are recorded under the liability method, under which deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

 

Research and Development 

We are an early development stage company. Research and development costs are charged to expense as incurred. Research and development expenses include scientists’ salaries, lab collaborations, preclinical studies, clinical trials, clinical trial materials, regulatory and clinical consultants, lab supplies, lab services, lab equipment maintenance and small equipment purchased to support the research laboratory, amortization of intangible assets and allocated executive, human resources and facilities expenses.

 

In-Process Research and Development

 

We record in-process research and development expense for a product candidate acquisition where there is not more than one potential product or usage for the assets being acquired. We review each product candidate acquisition to determine if the purchase price should be expensed as in-process research and development or capitalized and amortized over the life of the asset.

 

Stock-Based Compensation

 

In May 2006, our stockholders approved the 2006 Equity Compensation Plan (the “Plan”). The Plan’s term is ten years and allows for the granting of options to our employees, directors and consultants. Typical option grants are for ten years with exercise prices at or above market price based on the last closing price as of the date prior to the grant date as quoted on the Over-the-Counter Bulletin Board and vest over four years as follows:  6/48ths on the six month anniversary of the date of grant; and 1/48th per month thereafter.

 

Effective September 1, 2006, our stock-based compensation is accounted for in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 123(R) (“SFAS 123(R)”), Share-Based Payment and related interpretations. Under the fair value recognition provisions of this statement, share-based compensation cost is measured at the grant date based on the value of the award and is recognized as expense over the vesting period. Determining the fair value of share-based awards at the grant date requires judgment, including estimating future stock price volatility and employee stock option exercise behavior. If actual results differ significantly from these estimates, stock-based compensation expense and results of operations could be materially impacted.

 

-32-

 

 

 

 

In March 2005, the SEC issued Staff Accounting Bulletin (“SAB”) No. 107 (“SAB 107”), which offers guidance for SFAS 123(R). SAB 107 was issued to assist preparers by simplifying some of the implementation challenges of SFAS 123(R) while enhancing the information that investors receive. SAB 107 creates a framework that is premised on two overarching themes:  (a) considerable judgment will be required by preparers to successfully implement SFAS 123(R), specifically when valuing employee stock options; and (b) reasonable individuals, acting in good faith, may conclude differently on the fair value of employee stock options. Key topics covered by SAB 107 include valuation models, expected volatility and expected term. We are applying the principles of SAB 107 in conjunction with our adoption of SFAS 123(R).

 

For the three month period ended May 31, 2009, stock-based compensation expense was based on the Black-Scholes option-pricing model assuming the following:  risk-free interest rate of 2.6%; 7 year expected life; 233% volatility; 10% turnover rate; and 0% dividend rate.

 

We based our Black-Scholes inputs on the following factors:  the risk-free interest rate was based upon our review of current constant maturity treasury bill rates for seven years; the expected life was based upon our assessment of the ten-year term of the stock options issued along with the fact that we are a development-stage company and our anticipation that option holders will exercise stock options when the company is at a more mature stage of development; the volatility was based on the actual volatility of our common stock price as quoted on the over the counter bulletin board; the turnover rate was based on our assessment of the size of our company and the minimum potential for employee turnover at the current development-stage of our company; and the dividend rate was based on our current decision to not pay dividends on our stock at our current development stage.

 

If factors change and different assumptions are employed in the application of SFAS 123(R), the compensation expense recorded in future periods may differ significantly from what was recorded in the current period. See Note 7 of our condensed consolidated financial statements for further discussion of our accounting for stock based compensation.

 

We recognize as consulting expense the fair value of options granted to persons who are neither employees nor directors. Stock options issued to consultants are accounted for in accordance with the provisions of EITF Issue No. 96-18, Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. The fair value of expensed options is based on the Black-Scholes option-pricing model assuming the same factors as stock-based compensation expense discussed above.

 

On November 10, 2005, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position (“FSP”) No. FAS 123(R)-3 Transition Election Related to Accounting for Tax Effects of Share-Based Payment Awards. This FSP provides a practical transition election related to the accounting for the tax effects of share-based payment awards to employees, as an alternative to the transition guidance for the additional paid-in capital pool (APIC pool) in paragraph 81 of SFAS 123(R). The alternative transition method includes simplified methods to establish the beginning balance of the APIC pool related to the tax effects of employee stock-based compensation, and to determine the subsequent impact on the APIC pool and statements of cash flows of the tax effects of employee stock-based compensation awards that are outstanding upon adoption of SFAS 123(R). The guidance in this FSP is effective after November 10, 2005. We may take up to one year from the later of adoption of SFAS 123(R) or the effective date of this FSP to evaluate our available transition alternatives and make our one-time election. We have elected the “short-form” method to calculating excess tax benefits available for use in offsetting future tax shortfalls in accordance with FSP FAS 123(R)-3.

 

Results of Operations

 

Three month periods ended May 31, 2009 and 2008

 

General and Administrative

 

General and administrative expenses (including officer and employee compensation allocated to general and administrative expenses) for the quarter ended May 31, 2009 increased by $0.14 million compared to the prior year’s comparable period. The increase was primarily due to an increase of $0.11 million in intellectual property expenses associated with preclinical and clinical programs, an increase of $0.10 million in employee salaries, benefits, recruiting and other employment-related costs due to employee raises that occurred in July 2008 and the hiring of a Chief Medical Officer in April 2009, a $0.09 million increase in consultant expense related to business development and strategic advisory services, a $0.02 million increase in press releases issued, all of which were partially offset by (i) a $0.09 million increase in allocation of support services to research and development expenses, (ii) a $0.07 million decrease in milestone-related bonuses that occurred in the third fiscal quarter of 2008, but did not repeat in the third fiscal quarter of 2009 and (iii) a $0.02 million decrease in amortization and depreciation due to fixed assets that became fully depreciated in the third fiscal quarter of 2009.

 

-33-

 

 

 

 

Research and Development

 

Research and development expenses (including officer and employee compensation allocated to research and development) for the quarter ended May 31, 2009 increased by $0.3 million over the prior year’s comparable period primarily due to the costs associated with the formulation manufacturing expenses of our proprietary formulation of DR Cysteamine of $0.22 million in preparation for our clinical trial in cystinosis, a $0.20 million increase representing our ongoing NASH clinical trial expenses, an increase of $0.11 million in research and development consulting related to the preparation of our IND for DR Cysteamine for cystinosis, an increase of $0.09 million in salaries and benefits due to the hiring of our director of program management in October 2008 and our Chief Medical Officer in April 2009, an increase of $0.03 million related to preclinical testing that did not occur in the prior year, a $0.09 increase of support services to research and development due to the increase in headcount of the research and development department, all of which were partially offset by (i) a decrease in lab collaboration fees of $0.06 million due to the lapse of the Stanford collaboration on NeuroTransTM, (ii) a decrease of $0.18 million in HepTideTM conjugates produced for studies in the prior year, and (iii) a decrease of $0.2 million in clinical trial expense related to the ConviviaTM clinical trial in the prior year which did not reoccur in the current year.

 

Research and development expenses include the following: (in $ millions)

 

 

 

Estimated

Cumulative through

Three month period ended May 31,

Nine month period ended May 31,

Major Program (stage of development)

next 12 months

May 31, 2009

2009

2008

2009

2008

DR Cysteamine – All Indications (clinical)

 

5.1

 

4.1

 

1.3

 

0.2

 

3.1

 

0.5

ConviviaTM (clinical)

-

2.0

-

0.7

0.3

1.0

HepTideTM (preclinical)

0.1

1.5

0.1

0.3

0.3

0.5

NeuroTransTM (preclinical)

-

0.7

-

0.1

0.1

0.2

WntTideTM (preclinical)

-

0.3

-

-

0.1

0.1

Minor or Inactive Programs

-

0.7

-

-

0.1

0.1

R & D Personnel and Other Costs Not Allocated to Programs

 

1.8

 

4.4

 

0.5

 

0.3

 

1.4

 

1.2

Total Research & Development Expenses

 

7.0

 

13.7

 

1.9

 

1.6

 

5.4

 

3.6

 

Major Program expenses recorded as general and administrative expenses: (in $ millions)

 

 

Estimated

Cumulative through

Three month period ended May 31,

Nine month period ended May 31,

Major Program (stage of development)

next 12 months

May 31, 2009

2009

2008

2009

2008

DR Cysteamine – All Indications (clinical)

 

0.03

 

0.17

 

0.01

 

0.01

 

0.09

 

0.04

ConviviaTM (clinical)

0.01

0.06

0.02

0.03

0.02

0.09

HepTideTM (preclinical)

0.04

0.15

0.05

0.01

0.05

0.01

NeuroTransTM (preclinical)

0.03

0.12

-

-

0.02

0.02

WntTideTM (preclinical)

0.02

0.05

-

-

-

-

 

Additional major program expenses include patent fees and patent expenses which were recorded as general and administrative expenses as these fees are to support patent applications (not issued patents).

 

Any of our major programs could be partnered for further development and/or could be accelerated, slowed or ceased due to scientific results or challenges in funding our Company. We will need significant additional funding in order to pursue our plans for the next 12 months. In addition, the timing and costs of development of our programs beyond the next 12 months is highly uncertain and difficult to estimate. See Item 1A titled Risk Factors for further discussion about the risks and uncertainties pertaining to drug development.

 

Current Status of Major Programs

 

Please refer to our Plan of Operations and Overview in Item 1 for a detailed discussion of each of our major programs. In summary, DR Cysteamine is being developed in cystinosis, NASH, and Huntington’s Disease. In April 2009, we submitted an Investigation New Drug (“IND”) application to allow us to study DR Cysteamine in cystinosis patients in a Phase IIb clinical trial. In June 2009, we began dosing patients in our cystinosis trial. In February 2009, we completed enrollment of our NASH clinical trial. Both our NASH and

-34-

 

 

 

 

cystinosis clinical trials are currently ongoing. We anticipate studying DR Cysteamine in Huntington’s Disease patients in the clinic in the second half of 2009.

 

Our ConviviaTM product candidate completed its initial clinical study in 2008 and we are actively seeking to partner any further development of our ConviviaTM product candidate with an Asian company where its potential market exists. NeuroTransTM is currently being studied under a collaboration agreement with Roche. HepTideTM and WntTideTM are undergoing preclinical proof of concept studies, which will require further study prior to potentially moving into a clinical phase of development.

 

Interest Income

 

Interest income decreased by $8,000 over the equivalent quarter of the prior fiscal year due to the significant decrease in money market interest rates from 1.5% during the three month period ended May 31, 2008 to approximately 0.5% during the three month period ended May 31, 2009 and the lower cash balances maintained in the current fiscal quarter compared to the equivalent period in the prior year.

 

Interest expense

 

Interest expense decreased by $16,000 over the equivalent quarter of the prior fiscal year due to the capitalized finder’s fee for a convertible loan of 200,000 shares of our common stock valued at $102,000, which was amortized as interest expense from August 2007 to April 2008, the term of the convertible loan. No draws were made on the convertible loan prior to its expiration in April 2008.

 

Nine month periods ended May 31, 2009 and 2008

 

General and Administrative

 

General and administrative expenses (including officer and employee compensation allocated to general and administrative expenses) for the nine month period ended May 31, 2009 increased by $0.35 million compared to the prior year’s comparable period. The increase was primarily due to an increase of $0.25 million in employee salaries, bonuses, benefits and other employment-related costs due to employee raises that occurred in July 2008, milestone related bonuses paid in October 2008 and recruiting fees related to the hiring of our director of program management in October 2008 offset by prior year’s bonuses not repeated in the current year, plus an increase of $0.22 million in administrative consulting due to the retention of a strategic business advisor in May 2008, an increase of $0.08 million of board fees and expenses due to the addition of a new board member in July 2008, an increase of $0.03 million related to attendance at trade shows, all of which were partially offset by (i) a $0.09 million decrease in legal fees related to due diligence and the closing of two strategic acquisitions during the prior year nine month period that did not recur in the current year, (ii) a decrease of $0.04 million in amortization and depreciation related to fully depreciated fixed assets and (iii) the increase of support services allocation to research and development expenses of $0.1 million.

 

Research and Development

 

Research and development expenses (including officer and employee compensation allocated to research and development) for the nine month period ended May 31, 2009 increased by $1.73 million over the prior year’s comparable period primarily due to the costs associated with the formulation manufacturing expenses of our proprietary formulation of DR Cysteamine of $1.00 million in preparation for our clinical trial in cystinosis, an increase of $0.50 million in research and development consulting related to the preparation for our pre-IND meeting with the FDA and in preparation for our IND submission, an increase of $0.20 million in milestone payments for the commencement of the NASH trial in October 2008, an increase of $0.22 million in clinical trial costs for our NASH indication, an increase of $0.17 million in salaries and benefits due to the hiring of our director of program management in October 2008 and our Chief Medical Officer in April 2009, an increase of $0.1 million in preclinical studies of our DR Cysteamine program in NASH which occurred in the current year, an increase of $0.1 million in allocated support services, all of which were partially offset by (i) a decrease in lab collaboration fees of $0.2 million due to the lapse of the Stanford collaboration on NeuroTransTM, (ii) a decrease of $0.2 million due to the ConviviaTM clinical trial in the prior year that did not repeat in the current year, (iii) a decrease of $0.1 million of HepTideTM conjugates that were manufactured in the prior year but did not repeat in the current year, (iv) a decrease of $0.04 million in preclinical studies due to the reduction of resources allocated to preclinical programs and (v) a decrease of $0.02 million in tradeshow costs which we incurred in the prior year but not in the current year.

 

In-Process Research and Development Expenses

 

In-process research and development expenses decreased by $0.2 million over the nine month period ended May 31,

-35-

 

 

 

 

 

 

2008 due to the recording of the purchase of our ConviviaTM program during the nine month period ended May 31, 2008. No such expense was incurred in the nine month period ended May 31, 2009. In-process research and development expenses were calculated based on the value of our stock issued in connection with the purchase of certain intellectual property rights to develop ConviviaTM (4-MP) for the treatment of acetaldehyde toxicity.

 

Interest Income

 

Interest income decreased by $19,000 during the nine month period ended May 31, 2009 over the nine month period ended May 31, 2008 due to the significant decrease in money market interest rates from 4% to 4.5% in 2008 to approximately 0.5% to 1.5% in 2009, partially offset by a higher money market balance during the nine month period ended May 31, 2009.

 

Interest expense

 

Interest expense decreased by $0.1 million in the nine month period ended May 31, 2009 over the nine month period ended May 31, 2008 due to the capitalized finder’s fee of 200,000 shares of our common stock valued at $102,000, which was amortized as interest expense from August 2007 to April 2008, the term of the convertible loan. No draws were made on the convertible loan prior to its expiration.

 

Liquidity and Capital Resources

 

Capital Resource Requirements

 

As of May 31, 2009, we had approximately $0.5 million in cash, approximately $0.8 million in current liabilities and approximately $(0.1) million of net working capital deficit. Our forecasted average monthly cash expenditures for the next twelve months are approximately $691,000.

 

We believe that our cash and cash equivalents balances as of May 31, 2009 plus cash anticipated to be received by July 17, 2009 from the exercise of re-priced warrants and cash expected to be received by July 31, 2009 from a current financing will be sufficient to meet our obligations into the first calendar quarter of 2010. Our cash and cash equivalents as of July 15, 2009, will be sufficient to meet our minimum obligations into the fourth calendar quarter of 2009. We are currently in the process of reviewing strategic partnerships, collaborations and merger candidates in order to fully fund our preclinical and clinical programs through the end of 2010. If we are not able to close a strategic transaction, we anticipate raising additional capital in the fourth calendar quarter of 2009.

 

On April 29, 2009, in order to reflect current market prices, we notified holders of warrants purchased in the May/June 2008 private placement that we were offering, in exchange for such warrants, new warrants to purchase Raptor’s common stock at an exercise price of $0.30 per share, but only to the extent such exchange and exercise, including the delivery of the exercise price, occur prior to or on July 17, 2009. If the exchange and exercise do not occur by that date, then the original, unexercised warrants with an exercise price of $0.90 per share remain in place in accordance with the warrant agreement and such original unexercised warrants will retain their original expiration date of May 21, 2010. As of July 10, 2009, approximately $1.6 million was received in warrant exercises in exchange for the issuance of 5,215,000 shares of our common stock.

 

There can be no assurance that we will be able to obtain funds required for our continued operation. There can be no assurance that additional financing (including the financing that we are currently pursuing) will be available to us or,

if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain financing on a timely basis, we will not be able to meet our obligations as they become due and we will be forced to scale down or

perhaps even cease the operation of our business. This also may be the case if we become insolvent or if we breach our asset purchase agreement with BioMarin or our licensing agreements with Washington University and UCSD due to non-payment (and we do not cure our non-payment within the stated cure period). If this happens, we would lose all rights to the RAP technology assigned to us by BioMarin and/or the rights to Mesd licensed to us by Washington University and/or the rights to DR Cysteamine licensed to us by UCSD, depending on which agreement is breached. If we lose our rights to the intellectual property related to the RAP technology purchased by us from BioMarin, our agreement with Roche would likely be terminated and any milestone or royalty payments from Roche to us would thereafter cease to accrue.

 

 

-36-

 

 

 

 

 

 

 

We will need to raise significant long-term financing in order to implement our 12 month operating plan. If we are able to raise significant additional financing, for the next 12 months we intend to expend a total of approximately $8.3 million to implement our operating plan of researching and developing our RAP based platform, our licensed technologies, as well as ConviviaTM and DR Cysteamine.

 

Specifically, we estimate our operating expenses and working capital requirements for the next 12 months to be as follows:

 

Estimated spending for the next 12 months:

 

 

Research and development activities

 $

6,000,000

Research and development compensation and benefits

 

1,050,000

General and administrative activities

 

600,000

General and administrative compensation and benefits

 

630,000

Capital expenditures

 

20,000

Total estimated spending for the next 12 months

$

8,300,000

 

We anticipate that we will not be able to generate revenues from the sale of products until we further develop our drug product candidates and obtain the necessary regulatory approvals to market our future drug product candidates, which could take several years or more, if we are able to do so at all. Accordingly, our cash flow projections are subject to numerous contingencies and risk factors beyond our control, including successfully developing our drug product candidates, market acceptance of our drug product candidates, competition from well-funded competitors, and our ability to manage our expected growth. It is likely that for many years, we will not be able to generate internal positive cash flow from the sales of our drug product candidates sufficient to meet our operating and capital expenditure requirements.

 

There is substantial doubt about our ability to continue as a going concern as the continuation of our business is dependent upon obtaining further long-term financing, the successful development of our drug product candidates and related technologies, the successful and sufficient market acceptance of any product offerings that we may introduce and, finally, the achievement of a profitable level of operations. The issuance of additional equity securities by us is likely to result in a significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, including on acceptable terms, will increase our liabilities and future cash commitments.

 

Research and Development Activities 

We plan to conduct further research and development, seeking to improve upon our RAP-based and in-licensed technology and run several clinical trials for DR Cysteamine in the next 12 months. We plan to conduct research and development activities by our own laboratory staff and also by engaging contract research organizations, clinical research organizations and contract manufacturing organizations. We also plan to incur costs for the production of our clinical study drug candidate, DR Cysteamine, clinical trials, clinical and medical advisors and consulting and collaboration fees. Assuming we obtain additional long-term financing, we anticipate our research and development costs for the next 12 months, excluding in-house research and development compensation, will be approximately $6.0 million. We will need to scale down our research and development plans and expenses detailed herein in the next fiscal year if we are not able to raise significant additional financing over the next 12 months as detailed in the section titled “Capital Resource Requirements.”

 

Officer and Employee Compensation

 

We currently employ five executive officers. We also have two permanent scientific staff members, one permanent clinical development staff member, one permanent finance staff member and one temporary part-time research intern. Assuming we obtain significant additional long-term financing, we anticipate spending up to approximately

 

-37-

 

 

 

 

 

 

$1.68 million in officer and employee compensation during the next 12 months, of which $1.05 million is allocated to research and development expenses and $0.63 million is allocated to general and administrative expenses. We will need to scale down our officer and employee compensation expenses detailed herein in the next fiscal year if we are not able to raise significant additional financing over the next 12 months as detailed in the section titled “Capital Resource Requirements.”

 

General and Administrative

Assuming we obtain additional long-term financing, we anticipate spending approximately $0.60 million on general and administrative costs in the next 12 months. These costs will consist primarily of legal and accounting fees, patent legal fees, investor relations expenses, board fees and expenses, insurance, rent and facility support expenses, excluding finance and administrative compensation. We will need to scale down our general and administrative plans and expenses detailed herein in the next fiscal year if we are not able to raise significant additional financing over the next 12 months as detailed in the section titled “Capital Resource Requirements.”

 

Capital Expenditures 

We anticipate spending approximately $20,000 in the next 12 months on capital expenditures for lab equipment and office furniture. We will need to scale down our capital expenditures detailed herein in the next fiscal year if we are not able to raise significant additional financing over the next 12 months as detailed in the section titled “Capital Resource Requirements.”

 

Contractual Obligations with BioMarin

 

Pursuant to the terms of the asset purchase agreement we entered into with BioMarin for the purchase of intellectual property related to our RAP based technology (including NeuroTransTM),   we are obligated to make the following milestone payments to BioMarin upon the achievement of the following events:

 

        

-    

$50,000 (paid by us in June 2006) within 30 days after we receive total aggregate debt or equity financing of at least $2,500,000;

 

-

$100,000 (paid by us in June 2006) within 30 days after we receive total aggregate debt or equity financing of at least $5,000,000;

 

-

$500,000 upon our filing and acceptance of an investigational new drug application for a drug product candidate based on our NeuroTransTM product candidate;

 

-

$2,500,000 upon our successful completion of a Phase II human clinical trial for a drug product candidate based on our NeuroTransTM product candidate;

 

-

$5,000,000 upon our successful completion of a Phase III human clinical trial for a drug product candidate based on our NeuroTransTM product candidate;

 

-

$12,000,000 within 90 days of our obtaining marketing approval from the FDA or other similar regulatory agencies for a drug product candidate based on our NeuroTransTM product candidate;

 

-

$5,000,000 within 90 days of our obtaining marketing approval from the FDA or other similar regulatory agencies for a second drug product candidate based on our NeuroTransTM product candidate;

 

-

$5,000,000 within 60 days after the end of the first calendar year in which our aggregated revenues derived from drug product candidates based on our NeuroTransTM product candidate exceed $100,000,000; and

 

-

$20,000,000 within 60 days after the end of the first calendar year in which our aggregated revenues derived from drug product candidates based on our NeuroTransTM product candidate exceed $500,000,000.

 

In addition to these milestone payments, we are also obligated to pay BioMarin a royalty at a percentage of our aggregated revenues derived from drug product candidates based on our NeuroTransTM product candidate. On June 9, 2006, we made a milestone payment in the amount of $150,000 to BioMarin because we raised $5,000,000 in our May 25, 2006 private placement financing. If we become insolvent or if we breach our asset purchase agreement with BioMarin due to non-payment and we do not cure our non-payment within the stated cure period, all of our rights to RAP technology (including NeuroTransTM) will revert back to BioMarin.

 

Contractual Obligations with Thomas E. Daley (assignee of the dissolved Convivia, Inc.)

 

Pursuant to the terms of the asset purchase agreement (“Asset Purchase Agreement”) that we entered into with Convivia, Inc. and Thomas E. Daley, pursuant to which we purchased intellectual property related to our 4-MP product candidate program, Mr. Daley will be entitled to receive the following, if at all, in such amounts and only to the extent certain future milestones are accomplished by us, as set forth below:

 

-38-

 

 

 

 

 

100,000 shares of our restricted, unregistered common stock within fifteen (15) days after we enter into a manufacturing license or other agreement to produce any product that is predominantly based upon or derived from any assets purchased from Convivia (“Purchased Assets”) in quantity (“Product”) if such license agreement is executed within one (1) year of execution of the Asset Purchase Agreement or, if thereafter, 50,000 shares of our restricted, unregistered common stock. Should we obtain a second such license or agreement for a Product, Mr. Daley will be entitled to receive 50,000 shares of our restricted, unregistered common stock within 30 days of execution of such second license or other agreement. On March 31, 2008, we issued 100,000 shares of our common stock valued at $56,000 to Mr. Daley pursuant to this milestone reflecting the execution of an agreement to supply the active pharmaceutical ingredient for ConviviaTM, combined with the execution of a formulation agreement to produce the oral formulation of ConviviaTM.

100,000 shares of our restricted, unregistered common stock within fifteen (15) days after we receive our first patent allowance on any patents which constitute part of the Purchased Assets in any one of certain predetermined countries (“Major Market”).

50,000 shares of our restricted, unregistered common stock within fifteen (15) days after we receive our second patent allowance on any patents which constitute part of the Purchased Assets different from the patent referenced in the immediately preceding bullet point above in a Major Market.

 

 

 

 

 

100,000 shares of our restricted, unregistered common stock within fifteen (15) days of completion of predetermined benchmarks in a Major Market by us or our licensee of the first phase II human clinical trial for a Product (“Successful Completion”) if such Successful Completion occurs within one (1) year of execution of the Asset Purchase Agreement or, if thereafter, 50,000 shares of our restricted, unregistered common stock within thirty (30) days of such Successful Completion. In October 2008, we issued 100,000 shares of our common stock valued at $27,000 and a $30,000 cash bonus (pursuant to Mr. Daley’s employment agreement) to Mr. Daley pursuant to the fulfillment of this milestone.

50,000 shares of our restricted, unregistered common stock within fifteen (15) days of a Successful Completion in a Major Market by us or our licensee of the second  phase II human clinical trial for a Product (other than the Product for which a distribution is made under the immediately preceding bullet point above).

 

100,000 shares of our restricted, unregistered common stock within fifteen (15) days after we or our licensee applies for approval to market and sell a Product in a Major Market for the indications for which approval is sought (“Marketing Approval”).

 

50,000 shares of our restricted, unregistered common stock within fifteen (15) days after we or our licensee applies for Marketing Approval in a Major Market (other than the Major Market for which a distribution is made under the immediately preceding bullet point above).

 

200,000 shares of our restricted, unregistered common stock within fifteen (15) days after we or our licensee obtains the first Marketing Approval for a Product from the applicable regulatory agency in a Major Market.

 

100,000 shares of our restricted, unregistered common stock within fifteen (15) days after we or our licensee obtains Marketing Approval for a Product from the applicable regulatory agency in a Major Market (other than the Major Market for which a distribution is made under the immediately preceding bullet point above).

 

As discussed above, in aggregate, we issued to Mr. Daley, 200,000 shares of Raptor’s common stock valued at $83,000 and paid $30,000 in cash bonuses related to ConviviaTM milestones along with another $20,000 in cash bonuses related to employment milestones pursuant to Mr. Daley’s employment agreement.

 

Contractual Obligations with Former Encode Stockholders

 

Pursuant to the terms of the merger agreement (“Merger Agreement”) we entered into with Encode Pharmaceuticals, Inc. and Nicholas Stergis, former Encode securityholders will be entitled to receive the following, if at all, in such amounts and only to the extent certain future milestones are accomplished by us, as set forth below:

  

Restricted, unregistered common stock, stock options to purchase our common stock, and warrants to purchase our common stock in an amount equal to, in the aggregate, Five Hundred Thousand (500,000) shares of our common stock upon the receipt by us at any time prior to the fifth-year anniversary of the Merger Agreement of approval to market and sell a product for the treatment of Cystinosis predominantly based upon and derived from the assets acquired from Encode (“Cystinosis Product”), from the applicable regulatory agency (e.g., FDA and European Agency for the Evaluation of European Medical Products or EMEA) in a given major market in the world.

 

 

 

-39-

 

 

 

 

 

Restricted, unregistered common stock, stock options to purchase our common stock, and warrants to purchase our common stock in an amount equal to One Million Nine Hundred Thousand (1,900,000) shares of our common stock upon the receipt by us at any time prior to the fifth anniversary of the Merger Agreement of approval to market and sell a product, other than a Cystinosis Product, predominantly based upon and derived from the assets acquired from Encode, from the applicable regulatory agency (e.g., FDA and EMEA) in a given major market in the world.

 

If within five years from the date of the Merger Agreement, there occurs a transaction or series of related transactions that results in the sale of all or substantially all of the assets acquired from Encode other than to our affiliate in such case where such assets are valued at no less than $2.5 million, the former Encode securityholders will be entitled to receive, in the aggregate, restricted, unregistered common stock,  stock options to purchase our common stock, and warrants to purchase our common stock in an amount equal to 2.4 million shares of common stock, less the aggregate of all milestone payments previously made or owing, if any.

 

Pursuant to the terms of the Merger Agreement, we will at any time following 140 days from the closing date of the merger and prior to the expiration of the fourth anniversary of the Merger Agreement, grant to an Encode stockholder the right to demand the registration of its portion of the initial restricted, unregistered common stock issued to it in connection with the execution of the Merger Agreement and future restricted, unregistered common stock issued to it in the future relating to the milestone payments outlined above, if any.

 

Contractual Obligations with UCSD

 

As a result of the merger of our clinical subsidiary and Encode, we received the exclusive worldwide license to DR Cysteamine (“License Agreement”) for use in the field of human therapeutics for metabolic and neurologic disorders, developed by clinical scientists at the UCSD, School of Medicine. DR Cysteamine is a proprietary, delayed-release, enteric-coated microbead formulation of cysteamine bitartrate, a cystine depleting agent currently approved by the FDA. Cysteamine bitartrate is prescribed for the management of the genetic disorder known as nephropathic cystinosis (“cystinosis”), a lysosomal storage disease. The active ingredient in DR Cysteamine has also demonstrated potential in studies as a treatment for other metabolic and neurodegenerative diseases, such as Huntington’s Disease (“HD”) and Non-alcoholic steatohepatitis (“NASH”).

 

In consideration of the grant of the license, prior to the merger, Encode paid an initial license fee and we will be obligated to pay an annual maintenance fee of $15,000 until we begin commercial sales of any products developed pursuant to the License Agreement. In addition to the maintenance fee, we will be obligated to pay during the life of

the License Agreement: milestone payments ranging from $20,000 to $750,000 for orphan indications and from $80,000 to $1,500,000 for non-orphan indications upon the occurrence of certain events, if ever; royalties on commercial net sales from products developed pursuant to the License Agreement ranging from 1.75% to 5.5%; a percentage of sublicense fees ranging from 25% to 50%;  a percentage of sublicense royalties; and a minimum annual royalty commencing the year we begin commercially selling any products pursuant to the License Agreement, if ever. Under the License Agreement, we are obligated to fulfill predetermined milestones within a specified number of years ranging from 0.75 to 6 years from the effective date of the License Agreement, depending on the indication. In addition, we are obligated to, among other things, annually spend at least $200,000 for the development of products (which, as of our fiscal year ended August 31, 2008, we have fulfilled by spending approximately $900,000 on such programs) pursuant to the License Agreement. As of May 31, 2009, we accrued $40,000 due to UCSD for the milestone related to the first patient dosing in the NASH trial which commenced in October 2008. To the extent that we fail to perform any of our obligations under the License Agreement, UCSD may terminate the license or otherwise cause the license to become non-exclusive.

 

Off-Balance Sheet Arrangements

 

We do not have any outstanding derivative financial instruments, off-balance sheet guarantees, interest rate swap transactions or foreign currency contracts. We do not engage in trading activities involving non-exchange traded contracts.

 

Reverse Acquisition

 

We treated the merger of Raptor Pharmaceuticals Corp., a Delaware corporation, into its subsidiary, Raptor Pharmaceutical Inc., as a reverse acquisition and the reverse acquisition has been accounted for as a recapitalization.

 

For accounting purposes, Raptor Pharmaceutical Inc. is considered the acquirer in the reverse acquisition. The historical financial statements are those of Raptor Pharmaceutical Inc. consolidated with its parent, Raptor

 

 

Pharmaceuticals Corp. and its other subsidiary, Raptor Therapeutics. Earnings per share for periods prior to the merger have been restated to reflect the number of equivalent shares received by the acquiring company.

-40-

Going Concern

 

Due to the uncertainty of our ability to meet our current operating and capital expenses, in their reports on our audited financial statements for the years ended August 31, 2008, 2007 and for the period September 8, 2005 (inception) to August 31, 2006, our independent registered public accounting firm, Burr, Pilger & Mayer, LLP included an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Our financial statements contain additional note disclosures describing the circumstances that led to this disclosure by our independent registered public accounting firm.

 

New Accounting Pronouncements.

In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, Fair Value Measurements (SFAS 157”). SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles, and expands disclosures about fair value measurements. SFAS 157 does not require any new fair value measurements; rather, it applies under other accounting pronouncements that require or permit fair value measurements. The provisions of SFAS 157 are to be applied prospectively as of the beginning of the fiscal year in which it is initially applied, with any transition adjustment recognized as a cumulative-effect adjustment to the opening balance of retained earnings. The provisions of SFAS 157 are effective for fiscal years beginning after November 15, 2007; therefore, we adopted SFAS 157 as of September 1, 2008 for financial assets and liabilities. In accordance with FASB Staff Position 157-2, Effective Date of FASB Statement No. 157, we elected to defer the adoption of the provisions of SFAS 157 for our non-financial assets and non-financial liabilities. We have determined that SFAS 157 had no material impact on our financial results for the three and nine month periods ended May 31, 2009.

 

In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Financial Liabilities, Including an Amendment of FASB Statement No. 115, which permits the measurement of many financial instruments and certain other asset and liabilities at fair value on an instrument-by-instrument basis (the fair value option). The guidance is applicable for fiscal years beginning after November 15, 2007; therefore, we adopted SFAS 159 as of September 1, 2008. We have determined that SFAS 159 had no material impact on our financial results for the three and nine month periods ended May 31, 2009.

 

In June 2007, the Emerging Issues Task Force (“EITF”) reached a consensus on EITF No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities (“EITF 07-3”). EITF 07-3 specifies the timing of expense recognition for non-refundable advance payments for goods or services that will be used or rendered for research and development activities. EITF 07-3 was effective for fiscal years beginning after December 15, 2007, and early adoption is not permitted; therefore, we adopted EITF 07-3 as of September 1, 2008. We have determined that EITF 07-3 had no material impact on our financial results for the three and nine month periods ended May 31, 2009.

 

In December 2007, the EITF reached a consensus on EITF No. 07-1, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property (“EITF 07-1”). EITF 07-1 discusses the appropriate income statement presentation and classification for the activities and payments between the participants in arrangements related to the development and commercialization of intellectual property. The sufficiency of disclosure related to these arrangements is also specified. EITF 07-1 is effective for fiscal years beginning after December 15, 2008. As a result, EITF 07-1 is effective for us as of September 1, 2009. We are currently evaluating the impact of EITF 07-1 on our financial position and results of operations. Based upon the nature of our business, EITF 07-1 could have a material impact on our financial position and consolidated results of operations in future years.

 

In December 2007, FASB issued Statement No. 141 (Revised 2007), Business Combinations  (“SFAS 141(R)”) and SFAS No. 160,  Accounting and Reporting of Non-controlling Interests in Consolidated Financial Statements , an amendment of ARB No. 51 (“SFAS 160”). These statements will significantly change the financial accounting and reporting of business combination transactions and non-controlling (or minority) interests in consolidated financial statements. SFAS 141(R) requires companies to: (i) recognize, with certain exceptions, 100% of the fair values of assets acquired, liabilities assumed, and non-controlling interests in acquisitions of less than a 100% controlling interest when the acquisition constitutes a change in control of the acquired entity; (ii) measure acquirer shares issued in consideration for a business combination at fair value on the acquisition date; (iii) recognize contingent consideration arrangements at their acquisition-date fair values, with subsequent changes in fair value generally reflected in earnings; (iv) with certain exceptions, recognize pre-acquisition loss and gain contingencies at their acquisition-date fair values; (v) capitalize in-process research and development (“IPR&D”) assets acquired; (vi) expense, as incurred, acquisition-related transaction costs; (vii) capitalize acquisition-related restructuring costs

 

 

only if the criteria in SFAS No. 146,  Accounting for Costs Associated with Exit or Disposal Activities , are met as of the acquisition date; and (viii) recognize changes that result from a business combination transaction in an acquirer’s

-41-

 

existing income tax valuation allowances and tax uncertainty accruals as adjustments to income tax expense. SFAS 141(R) is required to be adopted concurrently with SFAS 160 and is effective for business combination transactions for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008 (our fiscal 2010). Early adoption of these statements is prohibited. We believe the adoption of these statements will have a material impact on significant acquisitions, if any, completed after September 1, 2009.

 

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities (“SFAS 161”). This statement will require enhanced disclosures about derivative instruments and hedging activities to enable investors to better understand their effects on an entity’s financial position, financial performance, and cash flows. It is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application encouraged. We adopted SFAS 161 on December 1, 2008 and have determined that SFAS 161 had no material impact on our financial results for the three and nine month periods ended May 31, 2009.

 

In May 2008, FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting Principles (“SFAS 162”). This standard is intended to improve financial reporting by identifying a consistent framework, or hierarchy, for selecting accounting principles to be used in preparing financial statements that are presented in conformity with U.S. GAAP for non-governmental entities. SFAS No. 162 is effective 60 days following the U.S. Securities and Exchange Commission’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, the meaning of “Present Fairly in Conformity with GAAP”. We are in the process of evaluating the impact, if any, of SFAS 162 on our condensed consolidated financial statements.

 

In May 2008, the FASB released FASB Staff Position (“FSP”) APB 14-1 Accounting For Convertible Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”) that alters the accounting treatment for convertible debt instruments that allow for either mandatory or optional cash settlements. FSP APB 14-1 specifies that issuers of such instruments should separately account for the liability and equity components in a manner that will reflect the entity’s nonconvertible debt borrowing rate when interest cost is recognized in subsequent periods. Furthermore, it would require recognizing interest expense in prior periods pursuant to retrospective accounting treatment. FSP APB 14-1 is effective for financial statements issued for fiscal years beginning after December 15, 2008; therefore, we anticipate adopting FSP APB 14-1 as of September 1, 2009. We are in the process of evaluating the impact, if any, of FSP APB 14-1 on our condensed consolidated financial statements.

 

In June 2008, the FASB issued EITF No. 07-5 (“EITF 07-5”), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, paragraph 11(a), and should be classified as a liability and marked-to-market. The statement is effective for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years and is to be applied to outstanding instruments upon adoption with the cumulative effect of the change in accounting principle recognized as an adjustment to the opening balance of retained earnings. We are adopting EITF 07-5 as of September 1, 2009 and are in the process of evaluating the impact, if any, of EITF 07-5 on our condensed consolidated financial statements.

 

In April 2008, the FASB issued FSP SFAS No. 142-3, Determination of the Useful Life of Intangible Assets (“FSP SFAS 142-3”). FSP SFAS 142-3 provides guidance with respect to estimating the useful lives of recognized intangible assets acquired on or after the effective date and requires additional disclosure related to the renewal or extension of the terms of recognized intangible assets. FSP SFAS 142-3 is effective for fiscal years and interim periods beginning after December 15, 2008. We are adopting FSP SFAS 142-3 as of September 1, 2009 and are currently evaluating the impacts and disclosures of this standard, but do not expect FSP SFAS 142-3 to have a material impact on our condensed consolidated financial statements.

 

In May 2009, the FASB issued SFAS No. 165, Subsequent Events (“SFAS 165”). SFAS 165 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. SFAS 165 is effective for fiscal years and interim periods ending after June 15, 2009. We are adopting SFAS 165 as of September 1, 2009 and do not expect it to have a material impact on the our condensed consolidated financial statements.

 

 

 

 

 

 

 

-42-

 

Item 3. Quantitative And Qualitative Disclosures About Market Risk.

 

Interest Rate Market Risk

 

Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio. By policy, we place our investments with highly rated credit issuers and limit the amount of credit exposure to any one issuer. As stated in our policy, we seek to improve the safety and likelihood of preservation of our invested funds by limiting default risk and market risk.

 

We mitigate default risk by investing in high credit quality securities and by positioning our portfolio to respond appropriately to a significant reduction in a credit rating of any investment issuer or guarantor. The portfolio includes only marketable securities with active secondary or resale markets to ensure portfolio liquidity.

 

As of May 31, 2009, our investment portfolio does not include any investments with significant exposure to the subprime mortgage market issues. Based on our investment portfolio, which consists 100% of money market accounts, and interest rates at May 31, 2009, we believe that a 100 basis point decrease in interest rates could result in a potential loss of future interest income of approximately $4,930 annually, however it would have no effect on the fair value of the money market principal balances.

 

Of our total consolidated cash and cash equivalent balance of approximately $0.5 million, our money market balances represent $0.3 million or 60%.

 

Our debt obligations consist of our capital lease to finance our photocopier, which carries a fixed imputed interest rate and, as a result, we are not exposed to interest rate market risk on our capital lease obligations The carrying value of our capital lease obligation approximates its fair value at May 31, 2009.

 

Item 4. Controls and Procedures.

As of May 31, 2009, we performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that the material financial and non-financial information required to be disclosed in our quarterly report and filed with the SEC is recorded, processed, summarized and reported timely within the time period specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Securities Act, of 1933 as amended, is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on our evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15(d)-15(e) of the Securities Exchange Act of 1934, as amended) as of May 31, 2009, are effective at such reasonable assurance level.

Our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15(d)-15(f) of the Securities Exchange Act of 1934, as amended. The Company’s internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial reporting includes policies and procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions; (ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisitions, use or disposition of assets that could have a material effect on our financial statements.

Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

 

 

 

-43-

 

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our internal control over financial reporting as of May 31, 2009. Based on this evaluation, our management concluded that the Company’s internal controls over financial reporting were effective as of May 31, 2009.

This management report on internal control over financial reporting shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended or otherwise subject to the liabilities of that Section.

This Quarterly Report does not include an attestation report of the our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to an attestation report of our registered public accounting firm pursuant to temporary rules of the SEC that permit us to provide only management’s report in this Quarterly Report.

 

Changes in Internal Control Over Financial Reporting

During the most recent fiscal quarter, there have not been any significant changes in our internal controls over financial reporting or in other factors that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-44-

 

 

 

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings.

 

We know of no material, active or pending legal proceedings against us, nor are we involved as a plaintiff in any material proceedings or pending litigation. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial stockholders are an adverse party or have a material interest adverse to us.

Item 1A. Risk Factors.

RISK FACTORS THAT MAY AFFECT FUTURE RESULTS

 

An investment in our common stock involves a high degree of risk. Before investing in our common stock, you should consider carefully the specific risks detailed in this “Risk Factors” section before making a decision to invest in our common stock, together with all of the other information contained in this Quarterly Report. If any of these risks occur, our business, results of operations and financial condition could be harmed, the price of our common stock could decline, and you may lose all or part of your investment.

 

Risks Related To Our Business

 

If we fail to obtain the capital necessary to fund our operations, our financial results, financial condition and our ability to continue as a going concern will be adversely affected and we will have to delay or terminate some or all of our product development programs.

 

Our condensed consolidated financial statements as of May 31, 2009 have been prepared assuming that we will continue as a going concern. As of May 31, 2009, we had an accumulated deficit of approximately $19.9 million. We expect to continue to incur losses for the foreseeable future and will have to raise substantial cash to fund our planned operations.

 

We believe that our cash and cash equivalents balances as of May 31, 2009 plus cash anticipated to be received by July 17, 2009 from the exercise of re-priced warrants and cash expected to be received by July 31, 2009 from a current financing, will be sufficient to meet our obligations into the first calendar quarter of 2010. Our cash and cash equivalents as of July 15, 2009, will be sufficient to meet our minimum obligations into the fourth calendar quarter of 2009. We are currently in the process of reviewing strategic partnerships, collaborations and merger candidates in order to fully fund our preclinical and clinical programs through the end of 2010. If we are not able to close a strategic transaction, we anticipate raising additional capital in the fourth calendar quarter of 2009. These estimates are based on assumptions that may prove to be wrong. In addition to the activities described herein above, we anticipate that we will need to raise funds in the future for the continued development of our drug development programs. We will need to sell equity or debt securities to raise significant additional funds. The sale of additional securities is likely to result in additional dilution to our stockholders. Additional financing, may not be available in amounts or on terms satisfactory to us or at all. We may be unable to raise additional financing due to a variety of factors, including our financial condition, the status of our research and development programs, and the general condition of the financial markets. If we fail to raise significant additional financing, we will have to delay or terminate some or all of our research and development programs, our financial condition and operating results will be adversely affected and we may have to cease our operations.

 

If we obtain significant additional financing, we expect to continue to spend substantial amounts of capital on our operations for the foreseeable future. The amount of additional capital we will need depends on many factors, including:

 

        

-    

the progress, timing and scope of our preclinical studies and clinical trials;

 

-

the time and cost necessary to obtain regulatory approvals;

 

-

the time and cost necessary to develop commercial manufacturing processes, including quality systems, and to build or acquire manufacturing capabilities;

 

-

the time and cost necessary to respond to technological and market developments; and

 

-

any changes made or new developments in our existing collaborative, licensing and other corporate relationships or any new collaborative, licensing and other commercial relationships that we may establish.

Moreover, our fixed expenses such as rent, collaboration and license payments and other contractual commitments are substantial and will likely increase in the future. These fixed expenses are likely to increase because we expect to

-45-

 

 

 

 

enter into:

 

        

-   

additional licenses and collaborative agreements;

 

 

 

 

 

-

contracts for manufacturing, clinical and preclinical research, consulting, maintenance and administrative services; and

 

        

-    

financing facilities.

 

We are an early development stage company and have not generated any revenues to date and have a limited operating history. Many of our drug product candidates are in the concept stage and have not undergone significant testing in preclinical studies or any testing in clinical trials. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our drug product candidates will ever be approved for sale or generate commercial revenues. We have a limited relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of drug product candidates either in preclinical testing or in clinical trials, failure to establish business relationships, and competitive disadvantages against larger and more established companies.

 

We will need make important progress towards achieving at least one of our major clinical objectives, as outlined under “Plan of Operation” above or our ability to continue as a going concern will be adversely impacted by limiting our ability to raise additional capital.

 

The current disruptions in the financial markets could affect our ability to obtain financing on favorable terms (or at all).

 

The U.S. credit markets have recently experienced historic dislocations and liquidity disruptions which have caused financing to be unavailable in many cases and, even if available, have caused the cost of prospective financings to increase. These circumstances have materially impacted liquidity in the debt markets, making financing terms for borrowers able to find financing less attractive, and in many cases have resulted in the unavailability of certain types of debt financing. Continued uncertainty in the debt and equity markets may negatively impact our ability to access financing on favorable terms or at all. In addition, Federal legislation to deal with the current disruptions in the financial markets could have an adverse affect on our ability to raise other types of financing.

 

Even if we are able to develop our drug product candidates, we may not be able to receive regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which would adversely affect our financial results and financial condition and we would have to delay or terminate some or all of our research product development programs.

 

All of our drug product candidates are theoretical and will require extensive additional research and development, including preclinical testing and clinical trials, as well as regulatory approvals, before we can market them.

 

We cannot predict if or when any of the drug product candidates we intend to develop will be approved for marketing. There are many reasons that we may fail in our efforts to develop our drug product candidates. These include:

 

          

-   

the possibility that preclinical testing or clinical trials may show that our drug product candidates are ineffective and/or cause harmful side effects;

 

-

our drug product candidates may prove to be too expensive to manufacture or administer to patients;

 

-

our drug product candidates may fail to receive necessary regulatory approvals from the FDA or foreign regulatory authorities in a timely manner, or at all;

 

-

our drug product candidates, if approved, may not be produced in commercial quantities or at reasonable costs;

 

-

our drug product candidates, if approved, may not achieve commercial acceptance;

 

-

regulatory or governmental authorities may apply restrictions to our drug product candidates, which could adversely affect their commercial success; and

 

-

the proprietary rights of other parties may prevent us or our potential collaborative partners from marketing our drug product candidates.

 

If we fail to develop our drug product candidates, our financial results and financial condition will be adversely affected, we will have to delay or terminate some or all of our research product development programs and may be forced to cease operations. -46-

 

 

 

 

 

If we are limited in our ability to utilize acquired or licensed technologies, we may be unable to develop, out-license, market and sell our product candidates, which could cause delayed new product introductions, and/or adversely affect our reputation, any of which could have a material adverse effect on our business, prospects, financial condition, and operating results. 

 

We have acquired and licensed certain proprietary technologies, discussed in the following risk factors, and plan to further license and acquire various patents and proprietary technologies owned by third parties. These agreements are critical to our product development programs. These agreements may be terminated, and all rights to the technologies and product candidates will be lost, if we fail to perform our obligations under these agreements and licenses in accordance with their terms including, but not limited to, our ability to make all payments due under such agreements. Our inability to continue to maintain these technologies could materially adversely affect our business, prospects, financial condition, and operating results. In addition, our business strategy depends on the successful development of these licensed and acquired technologies into commercial products, and, therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license, market and sell our product candidates, delay new product introductions, and/or adversely affect our reputation, any of which could have a material adverse effect on our business, prospects, financial condition, and operating results.

 

If the purchase or licensing agreements we entered into are terminated, we will lose the right to use or exploit our owned and licensed technologies, in which case we will have to delay or terminate some or all of our research and development programs, our financial condition and operating results will be adversely affected and we may have to cease our operations.

 

We entered into an asset purchase agreement with BioMarin for the purchase of intellectual property related to the RAP technology, a licensing agreement with Washington University for Mesd, and a licensing agreement with UCSD for DR Cysteamine. BioMarin, Washington University and UCSD may terminate their respective agreements with us upon the occurrence of certain events, including if we enter into certain bankruptcy proceedings or if we materially breach our payment obligations and fail to remedy the breach within the permitted cure periods. Although we are not currently involved in any bankruptcy proceedings or in breach of these agreements, there is a risk that we may be in the future, giving BioMarin, Washington University and UCSD the right to terminate their respective agreements with us. We have the right to terminate these agreements at any time by giving prior written notice. If the BioMarin, Washington University or UCSD agreements  are  terminated  by  either  party, we would  be forced  to assign back to BioMarin, in the case of the BioMarin agreement, all of our rights, title and interest in and to the intellectual property related to the RAP technology, would lose our rights to the Mesd technology, in the case of the Washington University agreement and would lose our rights to DR Cysteamine, in the case of UCSD. Under such circumstances, we would have no further right to use or exploit the patents, copyrights or trademarks in those respective technologies. If this happens, we will have to delay or terminate some or all of our research and development programs, our financial condition and operating results will be adversely affected, and we may have to cease our operations. If we lose our rights to the intellectual property related to the RAP technology purchased by us from BioMarin, our agreement with Roche would likely be terminated and any milestone or royalty payments from Roche to us would thereafter cease to accrue.

 

If we fail to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to develop our drug product candidates.

 

Our competitors compete with us to attract established biotechnology and pharmaceutical companies or organizations for acquisitions, joint ventures, licensing arrangements or other collaborations. Collaborations include licensing proprietary technology from, and other relationships with, academic research institutions. If our competitors successfully enter into partnering arrangements or license agreements with academic research institutions, we will then be precluded from pursuing those specific opportunities. Since each of these opportunities is unique, we may not be able to find a substitute. Other companies have already begun many drug development programs, which may target diseases that we are also targeting, and have already entered into partnering and licensing arrangements with academic research institutions, reducing the pool of available opportunities.

 

Universities and public and private research institutions also compete with us. While these organizations primarily have educational or basic research objectives, they may develop proprietary technology and acquire patents that we may need for the development of our drug product candidates. We will attempt to license this proprietary technology, if available. These licenses may not be available to us on acceptable terms, if at all. If we are unable to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to develop new products.

 

-47-

 

 

 

 

 

 

If we do not achieve our projected development goals in the time frames we announce and expect, the credibility of our management and our technology may be adversely affected and, as a result, our financial condition may suffer.

 

For planning purposes, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we may publicly announce the expected timing of some of these milestones. All of these milestones will be based on a variety of assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in many cases for reasons beyond our control. If we do not meet these milestones as publicly announced, our stockholders may lose confidence in our ability to meet these milestones and, as a result, the price of our common stock may decline.

 

Our product development programs will require substantial additional future funding which could impact our operational and financial condition.

 

It will take several years before we are able to develop marketable drug product candidates, if at all. Our product development programs will require substantial additional capital to successfully complete them, arising from costs to: 

        

-    

conduct research, preclinical testing and human studies;

 

-

establish pilot scale and commercial scale manufacturing processes and facilities; and

 

-

establish and develop quality control, regulatory, marketing, sales, finance and administrative capabilities to support these programs.

 

Our future operating and capital needs will depend on many factors, including:

 

        

-    

the pace of scientific progress in our research and development programs and the magnitude of these programs;

 

-

the scope and results of preclinical testing and human clinical trials;

 

-

our ability to obtain, and the time and costs involved in obtaining regulatory approvals;

 

-

our ability to prosecute, maintain, and enforce, and the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

 

-

competing technological and market developments;

 

-

our ability to establish additional collaborations;

 

-

changes in our existing collaborations;

 

-

the cost of manufacturing scale-up; and

 

-

the effectiveness of our commercialization activities.

 

We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include the success of our research initiatives, regulatory approvals, the timing of events outside our direct control such as negotiations with potential strategic partners and other factors. Any of these uncertain events can significantly change our cash requirements as they determine such one-time events as the receipt or payment of major milestones and other payments.

 

Significant additional funds will be required to support our operations and if we are unable to obtain them on favorable terms, we may be required to cease or reduce further development or commercialization of our drug product programs, to sell some or all of our technology or assets, to merge with another entity or cease operations.

 

If we fail to demonstrate efficacy in our preclinical studies and clinical trials our future business prospects, financial condition and operating results will be materially adversely affected.

 

The success of our development and commercialization efforts will be greatly dependent upon our ability to demonstrate drug product candidate efficacy in preclinical studies, as well as in clinical trials. Preclinical studies involve testing drug product candidates in appropriate non-human disease models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in humans. If

 

-48-

 

 

 

certain preclinical data reveals potential safety issues or the results are inconsistent with an expectation of the drug product candidate’s efficacy in humans, the regulatory agencies may require additional more rigorous testing, before allowing human clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our drug product candidates or technologies if, in the judgment of our management and advisors, the preclinical test results do not support further development.

 

Moreover, success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and preclinical testing. The clinical trial process may fail to demonstrate that our drug product candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a drug product candidate and may delay development of other drug product candidates. Any delay in, or termination of, our preclinical testing or clinical trials will delay the filing of our investigational new drug application (“IND”) and new drug application (“NDA”) with the FDA and, ultimately, our ability to commercialize our drug product candidates and generate product revenues. In addition, some of our clinical trials will involve small patient populations. Because of the small sample size, the results of these early clinical trials may not be indicative of future results. Following successful preclinical testing, drug product candidates will need to be tested in a clinical development program to provide data on safety and efficacy prior to becoming eligible for product approval and licensure by regulatory agencies. From first clinical trial through product approval can take at least eight years, on average in the U.S.

 

If any of our future clinical development drug product candidates become the subject of problems, including those related to, among others:

 

        

-    

efficacy or safety concerns with the drug product candidates, even if not justified;

 

-

unexpected side-effects;

 

-

regulatory proceedings subjecting the drug product candidates to potential recall;

 

-

publicity affecting doctor prescription or patient use of the drug product candidates;

 

-

pressure from competitive products; or

 

-

introduction of more effective treatments;

 

our ability to sustain our development programs will become critically compromised. For example, efficacy or safety concerns may arise, whether or not justified, that could lead to the suspension or termination of our clinical programs.

 

Each clinical phase is designed to test attributes of drug product candidates and problems that might result in the termination of the entire clinical plan can be revealed at any time throughout the overall clinical program. The failure to demonstrate efficacy in our clinical trials would have a material adverse effect on our future business prospects, financial condition and operating results.

 

If we do not obtain the support of new, and maintain the support of existing, key scientific collaborators, it may be difficult to establish products using our technologies as a standard of care for various indications, which may

limit our revenue growth and profitability and could have a material adverse effect on our business, prospects, financial condition and operating results.

 

We will need to establish relationships with additional leading scientists and research institutions. We believe that such relationships are pivotal to establishing products using our technologies as a standard of care for various indications. Although we have established a Medical and Scientific Advisory Board and research collaborations, there is no assurance that our Advisory Board members and our research collaborators will continue to work with us or that we will be able to attract additional research partners. If we are not able to maintain existing or establish new scientific relationships to assist in our research and development, we may not be able to successfully develop our drug product candidates.

 

 

 

 

-49-

 

 

 

 

If we fail to obtain or maintain orphan drug exclusivity for some of our drug product candidates, our competitors may sell products to treat the same conditions and our revenues will be reduced.

 

As part of our business strategy, we intend to develop some drugs that may be eligible for FDA and European Union (“EU”) orphan drug designation. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, defined as a patient population of less than 200,000 in the U.S. The company that first obtains FDA approval for a designated orphan drug for a given rare disease receives marketing exclusivity for use of that drug for the stated condition for a period of seven years. Orphan drug exclusive marketing rights may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a 10-year period of market exclusivity.

 

Because the extent and scope of patent protection for some of our drug products is particularly limited, orphan drug designation is especially important for our products that are eligible for orphan drug designation. For eligible drugs, we plan to rely on the exclusivity period under Orphan Drug Act designation to maintain a competitive position. If we do not obtain orphan drug exclusivity for our drug products that do not have patent protection, our competitors may then sell the same drug to treat the same condition and our revenues will be reduced.

 

Even though we have obtained orphan drug designation for DR Cysteamine for the potential treatment of nephropathic cystinosis, the potential treatment of Huntington’s Disease and the potential treatment of Batten Disease and even if we obtain orphan drug designation for our future drug product candidates, due to the uncertainties associated with developing pharmaceutical products, we may not be the first to obtain marketing approval for any orphan indication. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care. Orphan drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

 

The fast-track designation for our drug product candidates, if obtained, may not actually lead to a faster review process and a delay in the review process or in the approval of our products will delay revenue from the sale of the products and will increase the capital necessary to fund these product development programs.

 

Although we have received Orphan Drug Designations from the FDA as described above, our drug product candidates may not receive an FDA fast-track designation or priority review. Without fast-track designation, submitting an NDA and getting through the regulatory process to gain marketing approval is a lengthy process. Under fast-track designation, the FDA may initiate review of sections of a fast-track drug’s NDA before the application is complete. However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, the fast-track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. Under the FDA policies, a drug candidate is eligible for priority review, or review within a six-month time frame from the time a complete NDA is accepted for filing, if the drug candidate provides a significant improvement compared to marketed drugs in the treatment, diagnosis or prevention of a disease. A fast-track designated drug candidate would ordinarily meet the FDA’s criteria for priority review. The fast-track designation for our drug product candidates, if obtained, may not actually lead to a faster review process and a delay in the review process or in the approval of our products will delay revenue from the sale of the products and will increase the capital necessary to fund these product development programs.

 

Because the target patient populations for some of our products are small, we must achieve significant market share and obtain high per-patient prices for our products to achieve profitability.

 

Our clinical development of DR Cysteamine targets diseases with small patient populations, including nephropathic cystinosis and Huntington’s Disease. If we are successful in developing DR Cysteamine and receive regulatory approval to market DR Cysteamine for a disease with a small patient population, the per-patient prices at which we could sell DR Cysteamine for these indications are likely to be relatively high in order for us to recover our development costs and achieve profitability. We believe that we will need to market DR Cysteamine for these indications worldwide to achieve significant market penetration of this product.

 

-50-

 

 

 

 

 

 

 

We may not be able to market or generate sales of our products to the extent anticipated.

 

Assuming that we are successful in developing our drug product candidates and receive regulatory clearances to market our products, our ability to successfully penetrate the market and generate sales of those products may be limited by a number of factors, including the following:

 

        

-    

Certain of our competitors in the field have already received regulatory approvals for and have begun marketing similar products in the U.S., the EU, Japan and other territories, which may result in greater physician awareness of their products as compared to ours.

 

-

Information from our competitors or the academic community indicating that current products or new products are more effective than our future products could, if and when it is generated, impede our market penetration or decrease our future market share.

 

-

Physicians may be reluctant to switch from existing treatment methods, including traditional therapy agents, to our future products.

 

-

The price for our future products, as well as pricing decisions by our competitors, may have an effect on our revenues.

 

-

Our future revenues may diminish if third-party payers, including private healthcare coverage insurers and healthcare maintenance organizations, do not provide adequate coverage or reimbursement for our future products.

 

There are many difficult challenges associated with developing proteins that can be used to transport therapeutics across the blood-brain barrier.

 

Our RAP technology has a potential clinical use as a drug transporter through the blood-brain barrier. However, we do not know that our technology will work or work safely. Many groups and companies have attempted to solve the critical medical challenge of developing an efficient method of transporting therapeutic proteins from the blood stream into the brain. Unfortunately, these efforts to date have met with little success due in part to a lack of adequate understanding of the biology of the blood-brain barrier and to the enormous scientific complexity of the transport process itself.

 

In the research and development of our RAP technology, we will certainly face many of the same issues that have caused these earlier attempts to fail. It is possible that:

 

        

-    

we or our collaborator/licensee will not be able to produce enough RAP drug product candidates for testing;

 

 

-

the pharmacokinetics, or where the drug distributes in the body, of our RAP drug product candidates will preclude sufficient binding to the targeted receptors on the blood-brain barrier;

 

 

-

the targeted receptors are not transported across the blood-brain barrier;

 

 

-

other features of the blood-brain barrier, apart from the cells, block access molecules to brain tissue after transport across the cells;

 

 

-

the targeted receptors are expressed on the blood-brain barrier at densities insufficient to allow adequate transport of our RAP drug product candidates into the brain;

 

        

-    

targeting of the selected receptors induces harmful side-effects which prevent their use as drugs, or

 

-

that our or our collaborator/licensee’s RAP drug product candidates themselves cause unacceptable side-effects.

 

Any of these conditions may preclude the use of RAP or RAP fusion compounds from potentially treating diseases affecting the brain.

 

If our competitors succeed in developing products and technologies that are more effective than our own, or if scientific developments change our understanding of the potential scope and utility of our drug product candidates, then our technologies and future drug product candidates may be rendered less competitive.

 

We face significant competition from industry participants that are pursuing similar technologies that we are pursuing and are developing pharmaceutical products that are competitive with our drug product candidates. Nearly

 

-51-

 

 

 

all of our industry competitors have greater capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development, obtaining regulatory approval and pharmaceutical product manufacturing and marketing than we do. With these additional resources, our competitors may be able to respond to the rapid and significant technological changes in the biotechnology and pharmaceutical industries faster than we can. Our future success will depend in large part on our ability to maintain a competitive position with respect to these technologies. Rapid technological development, as well as new scientific developments, may result in our compounds, drug product candidates or processes becoming obsolete before we can recover any of the expenses incurred to develop them. For example, changes in our understanding of the appropriate population of patients who should be treated with a targeted therapy like we are developing may limit the drug’s market potential if it is subsequently demonstrated that only certain subsets of patients should be treated with the targeted therapy.

 

Our reliance on third parties, such as collaborators, university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, preclinical testing or clinical trials if they fail to perform under our agreements with them.

 

In the course of product development, we may engage university laboratories, other biotechnology or companies or contract or clinical manufacturing organizations to manufacture drug material for us to be used in preclinical and clinical testing and collaborators and contract or clinical research organizations to conduct and manage preclinical studies and clinical trials. If we engage these organizations to help us with our preclinical and clinical programs, many important aspects of this process have been and will be out of our direct control. If any of these organizations we may engage in the future fail to perform their obligations under our agreements with them or fail to perform preclinical testing and/or clinical trials in a satisfactory manner, we may face delays in completing our clinical trials, as well  as commercialization of any of our drug product candidates. Furthermore, any loss or delay in obtaining contracts with such entities may also delay the completion of our clinical trials, regulatory filings and the potential market approval of our drug product candidates.

 

The use of any of our drug product candidates in clinical trials may expose us to liability claims.

 

The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of our drug product candidates. While we are in clinical stage testing, our drug product candidates could potentially harm people or allegedly harm people and we may be subject to costly and damaging product liability claims. Some of the patients who participate in clinical trials are already critically ill when they enter a trial. The waivers we obtain may not be enforceable and may not protect us from liability or the costs of product liability litigation. Although we currently carry a $3 million clinical product liability insurance policy, it may not be sufficient to cover future claims. We currently do not have any clinical or product liability claims or threats of claims filed against us.

 

If we are unable to protect our proprietary technology, we may not be able to compete as effectively.

 

Where appropriate, we seek patent protection for certain aspects of our technology. Patent protection may not be available for some of the drug product candidates we are developing. If we must spend significant time and money protecting our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business and financial prospects may be harmed.

 

 

 

 

 

 

 

 

 

 

-52-

 

 

 

 

 

The patent positions of biopharmaceutical products are complex and uncertain.

 

We own or license patent applications related to certain of our drug product candidates. However, these patent applications do not ensure the protection of our intellectual property for a number of reasons, including the following:

 

        

-    

We do not know whether our patent applications will result in issued patents. For example, we may not have developed a method for treating a disease before others developed similar methods.

 

-

Competitors may interfere with our patent process in a variety of ways. Competitors may claim that they invented the claimed invention prior to us. Competitors may also claim that we are infringing on their patents and therefore cannot practice our technology as claimed under our patents, if issued. Competitors may also contest our patents, if issued, by showing the patent examiner that the invention was not original, was not novel or was obvious. In litigation, a competitor could claim that our patents, if issued, are not valid for a number of reasons. If a court agrees, we would lose that patent. As a company, we have no meaningful experience with competitors interfering with our patents or patent applications.

 

-

Enforcing patents is expensive and may absorb significant time of our management. Management would spend less time and resources on developing drug product candidates, which could increase our operating expenses and delay product programs.

 

-

Receipt of a patent may not provide much practical protection. If we receive a patent with a narrow scope, then it will be easier for competitors to design products that do not infringe on our patent.

 

-

In addition, competitors also seek patent protection for their technology. Due to the number of patents in our field of technology, we cannot be certain that we do not infringe on those patents or that we will not infringe on patents granted in the future. If a patent holder believes our drug product candidate infringes on its patent, the patent holder may sue us even if we have received patent protection for our technology. If someone else claims we infringe on their technology, we would face a number of issues, including the  following:

 

-  Defending a lawsuit takes significant time and can be very expensive.

 

-  If the court decides that our drug product candidate infringes on the competitor’s patent, we may have to pay substantial damages for past infringement.

 

 

- The court may prohibit us from selling or licensing the drug product candidate unless the patent holder licenses the patent to us. The patent holder is not required to grant us a license. If a license is available, we may have to pay substantial royalties or grant cross licenses to our patents.

 

-  Redesigning our drug product candidates so it does not infringe may not be possible or could require substantial funds and time.

 

It is also unclear whether our trade secrets are adequately protected. While we use reasonable efforts to protect our trade secrets, our employees or consultants may unintentionally or willfully disclose our information to competitors. Enforcing  a  claim  that  someone  else  illegally  obtained  and  is  using  our  trade  secrets,  like patent litigation, is  expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets. Our competitors may independently develop equivalent knowledge, methods and know-how.

 

We may also support and collaborate in research conducted by government organizations, hospitals, universities or other educational institutions. These research partners may be unwilling to grant us any exclusive rights to technology or products derived from these collaborations prior to entering into the relationship.

 

If we do not obtain required licenses or rights, we could encounter delays in our product development efforts while we attempt to design around other patents or even be prohibited from developing, manufacturing or selling drug product candidates requiring these licenses. There is also a risk that disputes may arise as to the rights to technology or drug product candidates developed in collaboration with other parties.

 

-53-

 

 

 

 

 

 

 

Our future success depends, in part, on the continued service of our management team.

 

Our success is dependent in part upon the availability of our senior executive officers, including our Chief Executive Officer, Dr. Christopher M. Starr, our Chief Scientific Officer, Dr. Todd C. Zankel, our Chief Financial Officer, Kim R. Tsuchimoto, Ted Daley, the President of our clinical development subsidiary and Dr. Patrice P. Rioux, Chief Medical Officer of our clinical development subsidiary. The loss or unavailability to us of any of these individuals or key research and development personnel, and particularly if lost to competitors, could have a material adverse effect on our business, prospects, financial condition, and operating results. We have no key-man insurance on any of our employees.

 

Our success depends on our ability to manage our growth.

 

If we are able to raise significant additional financing, we expect to continue to grow our Company, which could strain our managerial, operational, financial and other resources. With the addition of our clinical-stage programs and with our plans to in-license and acquire additional clinical-stage product candidates, we will be required to retain experienced personnel in the regulatory, clinical and medical areas over the next several years. Also, as our preclinical pipeline diversifies through the acquisition or in-licensing of new molecules, we will need to hire additional scientists to supplement our existing scientific expertise over the next several years.

 

Our staff, financial resources, systems, procedures or controls may be inadequate to support our operations and our management may be unable to take advantage of future market opportunities or manage successfully our relationships with third parties if we are unable to adequately manage our anticipated growth and the integration of new personnel.

 

Our executive offices and laboratory facility is located near known earthquake fault zones, and the occurrence of an earthquake or other catastrophic disaster could cause damage to our facility and equipment, or that of our third-party manufacturers or single-source suppliers, which could materially impair our ability to continue our product development programs.

 

Our executive offices and laboratory facility are located in the San Francisco Bay Area near known earthquake fault zones and are vulnerable to significant damage from earthquakes. We and the third-party manufacturers with whom we contract and our single-source suppliers of raw materials are also vulnerable to damage from other types of disasters, including fires, floods, power loss and similar events. If any disaster were to occur, our ability to continue our product development programs, could be seriously, or potentially completely impaired. The insurance we maintain may not be adequate to cover our losses resulting from disasters or other business interruptions.

 

We will incur increased costs as a result of recently enacted and proposed changes in laws and regulations.

 

We face burdens relating to the recent trend toward stricter corporate governance and financial reporting standards. Legislation or regulations such as Section 404 of the Sarbanes-Oxley Act of 2002 follow the trend of imposing stricter corporate governance and financial reporting standards have led to an increase in the costs of compliance for companies similar to ours, including increases in consulting, auditing and legal fees. New rules could make it more difficult or more costly for us to obtain certain types of insurance, including directors’ and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain  the  same  or  similar  coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers. Failure to comply with these new laws and regulations may impact market perception of our financial condition and could materially harm our business. Additionally, it is unclear what additional laws or regulations may develop, and we cannot predict the ultimate impact of any future changes in law.

 

 

 

 

 

 -54-

 

 

 

 

RISKS RELATED TO OUR COMMON STOCK

 

We are obligated to issue additional common stock based on our contractual obligations, if we meet certain triggering events, if at all. When we issue such additional common stock, this will result in dilution to common stockholders at the time such additional common stock is issued.

 

Future milestone payments, as more fully set forth under “Contractual Obligations with Thomas E. Daley (as assignee of the dissolved Convivia, Inc.)” and “Contractual Obligations with Former Encode Securityholders” above, relating to our acquisition of the Convivia assets and merger with Encode will result in dilution. We may be required to make additional contingent payments of up to 3.1 million shares of our common stock, in the aggregate, under the terms of our acquisition of Convivia assets and merger with Encode, based on milestones related to certain future marketing and development approvals obtained with respect to Convivia and Encode product candidates. The issuance of any of these shares will result in further dilution to our existing stockholders.

 

In May and June 2008, pursuant to a securities purchase agreement for a private placement of units, we issued 20 million shares of our common stock and two-year warrants to purchase up to, in the aggregate, 10 million shares of our common stock as well as five-year warrants to purchase up to, in the aggregate, 2.1 million shares of our common stock to placement agents in such private placement. On April 29, 2009, in order to reflect current market prices, we notified holders of warrants purchased in the May/June 2008 private placement that we were offering, in exchange for such warrants, new warrants to purchase Raptor’s common stock at an exercise price of $0.30 per share, but only to the extent such exchange and exercise, including the delivery of the exercise price, occur prior to or on July 17, 2009. If the exchange and exercise do not occur by that date, then the original, unexercised warrants with an exercise price of $0.90 per share remain in place in accordance with the warrant agreement and such original unexercised warrants will retain their original expiration date of May 21, 2010. This may result in the exercise of a substantial portion of the warrants and the issuance of up to 10 million shares of our common stock in July 2009. These stock issuances and other future issuances of common stock underlying unexpired and unexercised warrants will result in, significant dilution to our stockholders.

 

The issuance of shares of our common stock in a current financing including future issuances of common stock underlying warrants will result in, significant dilution to our stockholders.

 

In connection with other collaborations, joint ventures or license agreements that we may enter into in the future, we may issue additional shares of common stock or other equity securities, and the value of the securities issued may be substantial and create additional dilution to our existing and future common stockholders. 

 

There is no active trading market for our common stock and if a market for our common stock does not develop, our investors will be unable to sell their shares.

 

There is currently no active trading market for our common stock and such a market may not develop or be sustained. Shares of our common stock are eligible for quotation on the Financial Industry Regulatory Authority (“FINRA”) Over-the-Counter Bulletin Board (“OTC Bulletin Board”) but there has been very limited trading of our common stock. We cannot provide our investors with any assurance that a public market will materialize.

 

Further, the OTC Bulletin Board is not a listing service or exchange, but is instead a dealer quotation service for subscribing members. If our common stock is not quoted on the OTC Bulletin Board or if a public market for our common stock does not develop, then investors may not be able to resell the shares of our common stock that they have purchased and may lose all of their investment. If we establish a trading market for our common stock, the market price of our common stock may be significantly affected by factors such as actual or anticipated fluctuations in our operating results, our ability or perceived ability to reach corporate milestones, general market conditions and other factors. In addition, the stock market has from time to time experienced significant price and volume fluctuations that have particularly affected the market prices for the shares of development stage companies. As we are a development stage company such fluctuations may negatively affect the market price of our common stock.

 

Because we do not intend to pay any cash dividends on our common stock, investors seeking dividend income or liquidity should not purchase shares of our common stock.

 

We have not declared or paid any cash dividends on our common stock since our inception, and we do not anticipate paying any such cash dividends for the foreseeable future. Investors seeking dividend income or liquidity should not invest in our common stock.

 

-55-

 

 

 

 

 

Our stock is a penny stock. Trading of our stock may be restricted by the SEC’s penny stock regulations and the FINRA’s sales practice requirements, which may limit a stockholder’s ability to buy and sell our stock.

 

Our common stock is a penny stock. The SEC has adopted Rule 15g-9 which generally defines “penny stock” to be any equity security that has a market price less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and institutional accredited investors. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer’s confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules discourage investor interest in and limit the marketability of our common stock.

 

In addition to the “penny stock” rules promulgated by the SEC, the FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, the FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock.

 

Our stock price may be volatile, and an investment in our stock could suffer a decline in value.

 

If we establish a trading market for our common stock, the market price of that stock is likely to fluctuate due to factors including:

 

        

-    

results of our preclinical studies and clinical trials;

 

-

commencement and progress of our drug product candidates through the regulatory process;

 

-

announcements of technological innovations or new products by us or our competitors;

 

-

government regulatory action affecting our drug product candidates or our competitors’ drug products in both the U.S. and foreign countries;

 

 

-

developments or disputes concerning patent or proprietary rights;

 

-

general market conditions and fluctuations for the emerging growth biotechnology and pharmaceutical market sectors;

 

 

-

economic conditions and broad market fluctuations in the U.S. or abroad; and

 

-

actual or anticipated fluctuations in our operating results.

 

Anti-takeover provisions under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.

 

We are incorporated in Delaware. Certain anti-takeover provisions of Delaware law as currently in effect may make a change in control of our Company more difficult, even if a change in control would be beneficial to the stockholders. In December 2008, we entered into a stockholder rights plan with Nevada Agency and Transfer Company, as Rights Agent. The terms of the stockholder rights plan provide for a dividend distribution, as authorized and declared by our board of directors, of one preferred stock purchase right for each outstanding share of our common stock to stockholders of record on and after the close of business on December 19, 2008. Each such

 

-56-

 

 

 

 

 

right entitles the registered holder to purchase from the Company one one-thousandth of one share of Series A junior participating preferred stock, par value $0.001 per share, of the Company, at a purchase price equal to $5.50 per right, subject to adjustment. The rights will, subject to certain exceptions, cause substantial dilution to a person or group that acquires 20% or more of our common stock on terms not approved by our board of directors. However, the rights may have the effect of making an acquisition of us, which may be beneficial to our stockholders, more difficult, and the existence of such rights may prevent or reduce the likelihood of a third-party making an offer for an acquisition of us. In connection with the stockholder rights plan, our board of directors designated 1,000,000 shares of preferred stock as Series A junior participating preferred stock, as set forth in the Certificate of Designation of Series A Junior Participating Preferred Stock. The Certificate of Designation, which amended our Certificate of Incorporation, was filed with the Secretary of State of the State of Delaware on December 9, 2008.

 

Our board of directors has the authority to issue up to 10,000,000 shares of preferred stock, none of which are issued or outstanding and to determine without any further action by our stockholders the terms of 9,000,000 shares of such preferred stock. The rights of holders of our common stock are subject to the rights of the holders of any preferred stock that may be issued. The issuance of preferred stock could make it more difficult for a third-party to acquire a majority of our outstanding voting stock. Our charter contains provisions that may enable our management to resist an unwelcome takeover attempt by a third party, including: a prohibition on actions by written consent of our stockholders; the fact that stockholder meetings must be called by our Board of Directors; and provisions requiring stockholders to provide advance notice of proposals. Delaware law also prohibits corporations from engaging in a business combination with any holders of 15% or more of their capital stock until the holder has held the stock for three years unless, among other possibilities, the board of directors approves the transaction. Our board of directors may use these provisions to prevent changes in the management and control of our Company. Also, under applicable Delaware law, our board of directors may adopt additional anti-takeover measures in the future.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

 

During the three month period ended May 31, 2009, we entered into a stock option agreement under our 2006 Equity Incentive Plan, as amended, to issue the following stock options to purchase a total of 150,000 shares of our common stock:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of stock

 

 

 

 

 

 

 

Grant date / type of stock option(1)

 

Type of optionee

 

options

 

 

Exercise price

 

 

Vesting

 

April 16, 2009 / ISO

 

Employee

 

 

150,000

 

 

$

0.20

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)

 

ISO - incentive stock option. Stock option expires ten years from grant date.

 

 

 

(2)

 

Options vest 6/48ths upon the six-month anniversary of grant date and 1/48th per month thereafter. These issuances were exempt from registration under the Securities Act of 1933 pursuant to an exemption under Section 4(2) thereof as a sale of securities not involving any public offering.

 

The forms of stock option agreements for our 2006 Equity Incentive Plan were filed as Exhibits 10.1 and 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on August 25, 2006.

 

 

 

 

 

 

 

-57-

 

 

 

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Submission Of Matters To A Vote Of Security Holders.

 

None.

 

Item 5. Other Information.

 

None.

 

Item 6.

Exhibits.

(31)

Section 302 Certification

31.1

Certification of Christopher M. Starr, Ph.D., Chief Executive Officer and Director

31.2

Certification of Kim R. Tsuchimoto, Chief Financial Officer, Secretary and Treasurer

(32)

Section 906 Certification

32.1

Certification of Christopher M. Starr, Ph.D., Chief Executive Officer and Director, and of Kim R. Tsuchimoto, Chief Financial Officer, Secretary and Treasurer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-58-

 

 

 

 

 

 

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

RAPTOR PHARMACEUTICALS CORP.

 

By: /s/ Christopher M. Starr

Christopher M. Starr, Ph.D.

Chief Executive Officer and Director

(Principal Executive Officer)

Date: July 15, 2009

By: /s/ Kim R. Tsuchimoto

Kim R. Tsuchimoto

Chief Financial Officer, Secretary and Treasurer

(Principal Financial Officer and Principal Accounting Officer)

Date: July 15, 2009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-59-

 

Exhibit Index

(31)

Section 302 Certification

31.1

Certification of Christopher M. Starr, Ph.D., Chief Executive Officer and Director

31.2

Certification of Kim R. Tsuchimoto, Chief Financial Officer, Secretary and Treasurer

(32)

Section 906 Certification

32.1

Certification of Christopher M. Starr, Ph.D., Chief Executive Officer and Director, and of Kim R. Tsuchimoto, Chief Financial Officer, Secretary and Treasurer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-60-