10-Q 1 clsd-10q_20190630.htm 10-Q clsd-10q_20190630.htm

Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2019

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number: 001-37783

 

Clearside Biomedical, Inc.

 

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

45-2437375

(State or other jurisdiction of

incorporation or organization)

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

900 North Point Parkway, Suite 200

Alpharetta, GA

30005

(Address of principal executive offices)

(Zip Code)

(678) 270-3631

Registrant’s telephone number, including area code

N/A

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

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

CLSD

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  

  

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

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

 

As of August 5, 2019, the registrant had 37,759,781 shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

Page

 

PART I - FINANCIAL INFORMATION

 

Item 1.

Financial Statements

2

 

Balance Sheets as of June 30, 2019 (unaudited) and December 31, 2018

2

 

Statements of Operations for the three and six months ended June 30, 2019 and 2018 (unaudited)

3

 

Statements of Stockholders’ Equity for the three and six months ended June 30, 2019 and 2018 (unaudited)

4

 

Statements of Cash Flows for the six months ended June 30, 2019 and 2018 (unaudited)

5

 

Notes to the Financial Statements

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

23

Item 4.

Controls and Procedures

24

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

25

Item 1A.

Risk Factors

25

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 5.

Other Information

26

Item 6.

Exhibits

27

Signatures

28

 

 

 

 

1


 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

 

CLEARSIDE BIOMEDICAL, INC.

Balance Sheets

(in thousands, except share and per share data)

(unaudited)

 

 

 

June 30,

2019

 

 

December 31,

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,174

 

 

$

8,043

 

Short-term investments

 

 

 

 

 

32,835

 

Prepaid expenses

 

 

1,659

 

 

 

2,049

 

Other current assets

 

 

60

 

 

 

17

 

Total current assets

 

 

27,893

 

 

 

42,944

 

Property and equipment, net

 

 

708

 

 

 

790

 

Operating lease right-of-use asset

 

 

867

 

 

 

 

Restricted cash

 

 

360

 

 

 

360

 

Other assets

 

 

26

 

 

 

26

 

Total assets

 

$

29,854

 

 

$

44,120

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,227

 

 

$

6,869

 

Accrued liabilities

 

 

2,863

 

 

 

2,923

 

Current portion of long-term debt

 

 

2,222

 

 

 

556

 

Current portion of operating lease liabilities

 

 

504

 

 

 

 

Current portion of deferred rent

 

 

 

 

 

128

 

Other current liabilities

 

 

225

 

 

 

 

Total current liabilities

 

 

8,041

 

 

 

10,476

 

Long-term debt

 

 

7,877

 

 

 

9,419

 

Operating lease liabilities

 

 

1,035

 

 

 

 

Deferred rent

 

 

 

 

 

605

 

Total liabilities

 

 

16,953

 

 

 

20,500

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued

   at June 30, 2019 and December 31, 2018

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2019

   and December 31, 2018; 37,746,146 and 32,119,227 shares issued and

   outstanding at June 30, 2019 and December 31, 2018, respectively

 

 

38

 

 

 

32

 

Additional paid-in capital

 

 

240,888

 

 

 

230,475

 

Accumulated deficit

 

 

(228,025

)

 

 

(206,887

)

Total stockholders’ equity

 

 

12,901

 

 

 

23,620

 

Total liabilities and stockholders’ equity

 

$

29,854

 

 

$

44,120

 

 

See accompanying notes to the financial statements

2


 

CLEARSIDE BIOMEDICAL, INC.

Statements of Operations

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Collaboration revenue

 

$

45

 

 

$

 

 

$

90

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

658

 

 

 

17,343

 

 

 

11,625

 

 

 

30,722

 

General and administrative

 

 

5,004

 

 

 

3,561

 

 

 

9,388

 

 

 

6,635

 

Total operating expenses

 

 

5,662

 

 

 

20,904

 

 

 

21,013

 

 

 

37,357

 

Loss from operations

 

 

(5,617

)

 

 

(20,904

)

 

 

(20,923

)

 

 

(37,357

)

Other (expense) income, net

 

 

(117

)

 

 

203

 

 

 

(215

)

 

 

49

 

Net loss

 

$

(5,734

)

 

$

(20,701

)

 

$

(21,138

)

 

$

(37,308

)

Net loss per share of common stock — basic and diluted

 

$

(0.15

)

 

$

(0.65

)

 

$

(0.59

)

 

$

(1.27

)

Weighted average shares outstanding — basic and diluted

 

 

37,636,053

 

 

 

31,979,158

 

 

 

35,899,777

 

 

 

29,412,904

 

 

See accompanying notes to the financial statements.

 


3


 

CLEARSIDE BIOMEDICAL, INC.

Statements of Stockholders’ Equity

(in thousands, except share data)

(unaudited)

 

 

 

 

Six Months Ended June 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Paid-In-Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2018

 

 

32,119,227

 

 

$

32

 

 

$

230,475

 

 

$

(206,887

)

 

$

23,620

 

Issuance of common shares from at-the-market sales

   agreement

 

 

4,660,966

 

 

 

5

 

 

 

6,622

 

 

 

 

 

 

6,627

 

Exercise of stock options

 

 

2,727

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Share-based compensation expense

 

 

 

 

 

 

 

 

1,247

 

 

 

 

 

 

1,247

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(15,404

)

 

 

(15,404

)

Balance at March 31, 2019

 

 

36,782,920

 

 

 

37

 

 

 

238,345

 

 

 

(222,291

)

 

 

16,091

 

Issuance of common shares from at-the-market sales

   agreement

 

 

945,974

 

 

 

1

 

 

 

1,272

 

 

 

 

 

 

1,273

 

Issuance of common shares under employee

   stock purchase plan

 

 

17,252

 

 

 

 

 

 

15

 

 

 

 

 

 

15

 

Share-based compensation expense

 

 

 

 

 

 

 

 

1,256

 

 

 

 

 

 

1,256

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(5,734

)

 

 

(5,734

)

Balance at June 30, 2019

 

 

37,746,146

 

 

$

38

 

 

$

240,888

 

 

$

(228,025

)

 

$

12,901

 

 

 

 

 

Six Months Ended June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

Total

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Paid-In-Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2017

 

 

25,354,651

 

 

$

25

 

 

$

145,618

 

 

$

(124,220

)

 

$

(8

)

 

$

21,415

 

Cumulative effect of accounting change

 

 

 

 

 

 

 

 

 

 

 

151

 

 

 

8

 

 

 

159

 

Issuance of common shares from follow-on

   public offering

 

 

6,538,462

 

 

 

7

 

 

 

79,574

 

 

 

 

 

 

 

 

 

79,581

 

Exercise of stock options

 

 

53,920

 

 

 

 

 

 

237

 

 

 

 

 

 

 

 

 

237

 

Share-based compensation expense

 

 

 

 

 

 

 

 

1,138

 

 

 

 

 

 

 

 

 

1,138

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,607

)

 

 

 

 

 

(16,607

)

Balance at March 31, 2018

 

 

31,947,033

 

 

 

32

 

 

 

226,567

 

 

 

(140,676

)

 

 

 

 

 

85,923

 

Issuance of common shares under employee

   stock purchase plan

 

 

7,386

 

 

 

 

 

 

45

 

 

 

 

 

 

 

 

 

45

 

Exercise of stock options

 

 

69,804

 

 

 

 

 

 

196

 

 

 

 

 

 

 

 

 

196

 

Share-based compensation expense

 

 

 

 

 

 

 

 

1,199

 

 

 

 

 

 

 

 

 

1,199

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(20,701

)

 

 

 

 

 

(20,701

)

Balance at June 30, 2018

 

 

32,024,223

 

 

$

32

 

 

$

228,007

 

 

$

(161,377

)

 

$

 

 

$

66,662

 

 

See accompanying notes to the financial statements.

 

 

 

 

 


4


 

CLEARSIDE BIOMEDICAL, INC.

Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(21,138

)

 

$

(37,308

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

107

 

 

 

94

 

Share-based compensation expense

 

 

2,503

 

 

 

2,337

 

Non-cash interest expense

 

 

93

 

 

 

60

 

Accretion of debt discount

 

 

31

 

 

 

79

 

Amortization and accretion on available-for-sale investments, net

 

 

(115

)

 

 

(244

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

347

 

 

 

(830

)

Other assets and liabilities

 

 

164

 

 

 

(50

)

Accounts payable and accrued liabilities

 

 

(4,702

)

 

 

640

 

Net cash used in operating activities

 

 

(22,710

)

 

 

(35,222

)

Investing activities

 

 

 

 

 

 

 

 

Maturities of available-for-sale investments

 

 

32,950

 

 

 

31,870

 

Purchase of available-for-sale investments

 

 

 

 

 

(52,446

)

Acquisition of property and equipment

 

 

(25

)

 

 

 

Net cash provided by (used in) investing activities

 

 

32,925

 

 

 

(20,576

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from at-the-market sales agreement, net of issuance costs

 

 

7,900

 

 

 

 

Proceeds from follow-on public offering, net of issuance costs

 

 

 

 

 

79,581

 

Proceeds from exercise of stock options

 

 

1

 

 

 

433

 

Proceeds from shares issued under employee stock purchase plan

 

 

15

 

 

 

45

 

Proceeds from long-term debt

 

 

 

 

 

10,000

 

Payments made on long-term debt

 

 

 

 

 

(8,300

)

Net cash provided by financing activities

 

 

7,916

 

 

 

81,759

 

Net increase in cash, cash equivalents and restricted cash

 

 

18,131

 

 

 

25,961

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

8,403

 

 

 

9,584

 

Cash, cash equivalents and restricted cash, end of period

 

$

26,534

 

 

$

35,545

 

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

June 30,

 

 

 

2019

 

 

2018

 

Cash and cash equivalents

 

$

26,174

 

 

$

35,185

 

Restricted cash

 

 

360

 

 

 

360

 

Cash, cash equivalents and restricted cash at end of period

 

$

26,534

 

 

$

35,545

 

 

See accompanying notes to the financial statements.

 

5


 

CLEARSIDE BIOMEDICAL, INC.

Notes to the Financial Statements

(unaudited)

 

 

1. The Company

 

Clearside Biomedical, Inc. (the “Company”) is a late-stage clinical biopharmaceutical company developing first-in-class pharmacological therapies to restore and preserve vision for people with serious eye diseases. The Company’s current product candidates focus on treatments for diseases affecting the retina and choroid and are injected into the suprachoroidal space (“SCS”) using its proprietary SCS Microinjector™. Incorporated in the State of Delaware on May 26, 2011, the Company has its corporate headquarters in Alpharetta, Georgia.

The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company has no current source of revenue to sustain present activities, and does not expect to generate meaningful revenue until and unless the Company receives regulatory approval of and successfully commercializes its product candidates. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts, regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals.

 

Liquidity

 

The Company has funded its operations primarily through the sale of convertible preferred stock and common stock and the issuance of long-term debt. On June 30, 2017, the Company entered into an at-the-market sales agreement (“the ATM agreement”) with Cowen and Company LLC (“Cowen”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Cowen acting as sales agent. During the six months ended June 30, 2019, the Company sold 5.6 million shares of its common stock for net proceeds of $7.9 million under the ATM agreement. The Company’s registration statement on Form S-3 contemplated under the ATM agreement was declared effective by the SEC on July 13, 2017.  The registration statement on Form S-3 includes a prospectus supplement covering the offering up to $18.5 million of shares of common stock over the 12 months ending March 15, 2020 in accordance with the ATM agreement.

The Company will need to obtain additional financing to fund future operations, including completing the development and commercialization of its primary product candidates. The Company will need to obtain additional financing to conduct additional trials for the regulatory approval of its product candidates if requested by regulatory bodies, and to complete the development of any additional product candidates. If such products were to receive regulatory approval, the Company may need to prepare for the potential commercialization of its product candidates, which could include collaborating with third parties for the commercial launch of the products.

The Company had cash and cash equivalents of $26.2 million as of June 30, 2019. The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can obtain approval from the U.S. Food and Drug Administration (the “FDA”) to market and then generate significant sales of any of its product candidates. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue. The Company will need additional financing to fund its operations and may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements.

Based on its current research and development plans, its plans to reduce certain administrative expenses, its timing expectations related to the approval of its New Drug Application (“NDA”) submission and its intention to seek a licensing or collaboration agreement with one or more partners for the commercialization of its lead product candidate, XIPERE, the Company expects that its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2020. Accordingly, the Company has plans to mitigate its going concern risk by raising additional capital, potentially in a combination of equity or debt financings, or by entering into potential collaborations, partnering and other strategic arrangements. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could exhaust its capital resources sooner than it expects. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date these financial statements are being issued.

The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the

6


 

possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.

 

 

2. Significant Accounting Policies

Basis of Presentation

The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).

Unaudited Interim Financial Information

The accompanying balance sheet as of June 30, 2019, statements of operations for the three and six months ended June 30, 2019 and 2018, statements of stockholders’ equity for the three and six months ended June 30, 2019 and 2018 and statements of cash flows for the six months ended June 30, 2019 and 2018 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2019, its results of its operations for the three and six months ended June 30, 2019 and 2018, its changes in stockholders’ equity for the three and six months ended June 30, 2019 and 2018 and its cash flows for the six months ended June 30, 2019 and 2018. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2019 and 2018 are unaudited. The results for the six months ended June 30, 2019 are not indicative of results to be expected for the year ending December 31, 2019, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the accounting for useful lives to calculate depreciation and amortization, clinical expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates.

Research and Development Costs

Research and development costs are charged to expense as incurred and include:

 

employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel;

 

expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct clinical trials and preclinical studies;

 

costs associated with nonclinical and clinical development activities;

 

costs associated with submitting regulatory approval applications for the Company’s product candidates;

 

costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information;

 

costs associated with technology and intellectual property licenses;

 

costs for the Company’s research and development facility; and

 

depreciation expense for assets used in research and development activities.

7


 

Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expense. In connection with the termination of the Company’s development program for retinal vein occlusion (“RVO”), the research and development expenses related to the RVO program for the second quarter of 2019 reflect a credit of $2.6 million upon reconciliation with the CRO of final trial costs for the RVO program. The adjustments to these estimates have been recorded in these financial statements.

Share-Based Compensation

Compensation cost related to share-based awards granted to employees is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. Compensation expense for options granted to non-employees is determined as the fair value of consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period.

Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date.

All share-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations based upon the underlying employees’ roles within the Company.

Cash Equivalents

Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase.

Short-Term Investments

Short-term investments are investments with original maturities of between 90 and 365 days when purchased and are comprised of commercial paper and treasury bills. The Company classifies its short-term investments as available-for-sale securities. Short-term investments are recorded at fair value and unrealized gains and losses are recorded within interest income. In addition, the Company evaluates the short-investments with unrealized losses to determine whether such losses are other-than-temporary.

Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits

The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances.

Recent Accounting Pronouncements

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (ASC 842), and subsequently issued updates as part of ASU 2018-11, Leases, Targeted Improvements. The new guidance requires organizations that lease assets with lease terms of more than 12 months to recognize assets and liabilities for the rights and obligations created by those leases on their balance sheets. The Company adopted the ASC 842 effective January 1, 2019 using the optional transition method, did not restate any prior periods and adopted the package of practical expedients. Under the package of practical expedients permitted by the new standard, the Company does not have to reassess whether contracts are or contain leases, the classification of leases or whether initial direct costs should be capitalized. The adoption of the new standard resulted in the recognition of a right-of use asset of $1.0 million and lease obligations of $1.7 million on the Company’s balance sheet as of January 1, 2019. The adoption did not have a material impact on the Company’s statements of operations or cash flows.

8


 

 

In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation: Improvements to Nonemployee Shared-Based Payment Accounting. The ASU update expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The Company adopted ASU 2018-07 effective January 1, 2019, and the adoption did not have a material impact on its financial statements and related disclosures.

 

3. Property and Equipment, Net

Property and equipment, net consisted of the following (dollar amounts in thousands):

 

 

 

Estimated

Useful Lives

(Years)

 

June 30,

2019

 

 

December 31,

2018

 

Furniture and fixtures

 

5

 

$

400

 

 

$

382

 

Machinery and equipment

 

5

 

 

121

 

 

 

121

 

Computer equipment

 

3

 

 

19

 

 

 

19

 

Leasehold improvements

 

Lesser of

useful life or

remaining

lease term

 

 

684

 

 

 

677

 

 

 

 

 

 

1,224

 

 

 

1,199

 

Less: Accumulated depreciation

 

 

 

 

(516

)

 

 

(409

)

 

 

 

 

$

708

 

 

$

790

 

 

4. Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

Accrued research and development

 

$

777

 

 

$

1,263

 

Accrued employee costs

 

 

1,610

 

 

 

1,191

 

Accrued marketing

 

 

185

 

 

 

47

 

Accrued professional fees

 

 

79

 

 

 

63

 

Accrued interest payable

 

 

 

 

 

76

 

Accrued expense

 

 

212

 

 

 

283

 

 

 

$

2,863

 

 

$

2,923

 

 

5. Long-Term Debt

Loan and Security Agreements

In September 2016, the Company entered into an amended and restated loan and security agreement, which was subsequently amended on October 31, 2017 (as amended, the “1st A&R loan agreement”) with Silicon Valley Bank (“SVB”), MidCap Funding XII Trust and MidCap Financial Trust, which amended and restated in its entirety the Company’s prior loan and security agreement. The 1st A&R loan agreement provided for new term loans of up to $15.0 million, with a floating interest rate equal to 7% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, or (ii) 0.50%.

Under the terms of the 1st A&R loan agreement, an initial tranche of $8.0 million was advanced on September 28, 2016. The draw period for the remaining $7.0 million available under the 1st A&R loan agreement expired on March 31, 2018. The Company was required to pay accrued interest only on the outstanding $8.0 million balance through December 31, 2017, followed by 30 equal payments of principal and accrued interest. The Company had the option to prepay the outstanding balance of the term loans in full, subject to a prepayment fee of 2% of the original principal amount of the aggregate term loans for any prepayments through May 31, 2020. A final payment of $0.5 million was due at maturity of the loan on June 1, 2020, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default, and was being accreted in long-term debt over the life of the loan. Of the $8.0 million borrowed, $5.3 million was used to repay all amounts outstanding under the original loan agreement.

9


 

Closing costs incurred in the refinancing portion of the loan were recorded as expense while the financing costs for the new portion of the loan are recorded in long-term debt and being accreted over the life of the loan. Upon repayment of the original loan agreement, all remaining closing costs associated with the original loan agreement were being accreted to long-term debt over the life of the 1st A&R loan agreement.

On May 14, 2018, the Company entered into a second amended and restated loan and security agreement (the “2nd A&R Loan Agreement”) with SVB, MidCap Funding III Trust and MidCap Financial Trust (together, “MidCap” and collectively with SVB, the “Lenders”), which amended and restated in its entirety the 1st A&R loan agreement. The 2nd A&R Loan Agreement provides for new term loans of up to $20.0 million, with a floating interest rate equal to 6.50% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, or (ii) 1.89%.

The Company borrowed an initial tranche of $10.0 million on May 14, 2018, of which $7.0 million was used to repay all amounts outstanding under the 1st A&R loan agreement, including fees associated with the final payment. The prepayment fees were waived. Of the remaining $10.0 million under the 2nd A&R Loan Agreement, $5.0 million became available for draw but was not drawn by the Company, and the other $5.0 million is not available for draw.

The Company is required to pay accrued interest only on the $10 million borrowed under the 2nd A&R Loan Agreement through October 31, 2019, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. The Company has the option to prepay the outstanding balance in full, subject to a prepayment fee of 2% of the original principal amount for any prepayment prior to October 1, 2022. A final payment of 5.50% of the aggregate borrowed amount is due at maturity of the loan on October 1, 2022, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.

The borrowings under the 2nd A&R Loan Agreement are secured by substantially all of the Company’s assets, except that the collateral does not include any of the Company’s intellectual property. However, pursuant to the terms of a negative pledge arrangement, the Company has agreed not to encumber any of its intellectual property.

Interest expense on the borrowings under the loan agreements described above was $227,000 and $186,000 for the three months ended June 30, 2019 and 2018, respectively, and $452,000 and $346,000 for the six months ended June 30, 2019 and 2018, respectively. Accretion of the scheduled final payment was $47,000 and $11,000 for the three months ended June 30, 2019 and 2018, respectively, and $93,000 and $60,000 for the six months ended June 30, 2019 and 2018, respectively. Accretion of the deferred debt issuance costs was $16,000 and $30,000 for the three months ended June 30, 2019 and 2018, respectively, and $31,000 and $79,000 for the six months ended June 30, 2019 and 2018, respectively.

As of June 30, 2019, the scheduled payments for the 2nd A&R Loan Agreement, including the scheduled final payment in 2022, were as follows (in thousands):

 

Year Ending December 31,

 

Principal

 

 

Interest and

Final Payment

 

 

Total

 

2019

 

$

556

 

 

$

423

 

 

$

979

 

2020

 

 

3,333

 

 

 

651

 

 

 

3,984

 

2021

 

 

3,333

 

 

 

366

 

 

 

3,699

 

2022

 

 

2,778

 

 

 

638

 

 

 

3,416

 

 

 

$

10,000

 

 

$

2,078

 

 

$

12,078

 

 

6. Common Stock

The Company’s amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of $0.001 par value common stock. As of June 30, 2019 and December 31, 2018, there were 37,746,146 and 32,119,227 shares of common stock outstanding, respectively.

 

7. Stock Purchase Warrants

In September 2016, in connection with the 1st A&R loan agreement (see Note 5), the Company issued warrants to purchase up to 29,796 shares of common stock at a price per share of $10.74. The warrants expire in September 2026, or earlier upon the occurrence of specified mergers or acquisitions of the Company, and are immediately exercisable. The warrants were recorded in equity and had a weighted average remaining life of 7.25 years as of June 30, 2019.

10


 

8. Share-Based Compensation

Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation.

Stock Options

The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards.

Share-based compensation expense for options granted under the 2011 Plan and the 2016 Plan is reflected in the statements of operations as follows (in thousands):

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Research and development

 

$

361

 

 

$

443

 

 

$

823

 

 

$

873

 

General and administrative

 

 

848

 

 

 

753

 

 

 

1,623

 

 

 

1,456

 

Total

 

$

1,209

 

 

$

1,196

 

 

$

2,446

 

 

$

2,329

 

 

The following table summarizes the activity related to stock options during the six months ended June 30, 2019:

 

 

 

 

 

 

 

Weighted

 

 

 

Number of

 

 

Average

 

 

 

Shares

 

 

Exercise Price

 

Options outstanding at December 31, 2018

 

 

3,463,096

 

 

$

6.62

 

Granted

 

 

1,882,600

 

 

 

1.26

 

Exercised

 

 

(2,727

)

 

 

0.40

 

Forfeited

 

 

(760,999

)

 

 

4.38

 

Options outstanding at June 30, 2019

 

 

4,581,970

 

 

 

4.79

 

 

 

 

 

 

 

 

 

 

Options exercisable at December 31, 2018

 

 

1,583,749

 

 

 

5.63

 

 

 

 

 

 

 

 

 

 

Options exercisable at June 30, 2019

 

 

2,092,661

 

 

 

5.84

 

 

As of June 30, 2019, the Company had $6.6 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.6 years.

 

Employee Stock Purchase Plan

 

In January 2016, the Company’s board of directors adopted and approved, and in January 2016 the Company’s stockholders approved, the Clearside Biomedical, Inc. 2016 Employee Stock Purchase Plan (the “2016 ESPP”) which became effective on June 1, 2016. The first offering period for the 2016 ESPP commenced January 1, 2017. The 2016 ESPP is considered a compensatory plan and the fair value of the discount and the look-back period are estimated using the Black-Scholes option pricing model and expense is recognized over the six month withholding period prior to the purchase date. The Company has issued a total of 39,539 shares of common stock purchased under the 2016 ESPP. The Company has recorded $3,000 of share-based compensation expense for each of the three months ended June 30, 2019 and 2018, and $12,000 and $8,000 for the six months ended June 30, 2019 and 2018, respectively, in the statements of operations for the estimated number of shares to be purchased on the next purchase date following the conclusion of the applicable reporting period.

 

Restricted Stock Units

 

The Company has granted 485,900 restricted stock units (“RSUs”) to employees from its 2016 Plan at a fair value of $1.09 per share. The shares underlying the RSU awards will vest in full one year from the date of grant subject to the employees’ continuous service and subject to accelerated vesting in specified circumstances. The Company recorded $45,000 of share-based compensation expense for both the three months and six months ended June 30, 2019 for the RSUs. As of June 30, 2019, the Company had $0.5

11


 

million of unrecognized compensation expense related to the RSUs, which is expected to be recognized over a weighted average period of 0.9 years.

 

9. Commitments and Contingencies

Lease Commitment Summary

 

In November 2016, the Company signed an office lease agreement to lease approximately 20,000 square feet of office space in Alpharetta, Georgia for its corporate headquarters. The lease agreement is for a 6.5 year term with a renewal option for one additional five-year term. Rental payments are $35,145 per month subject to an increase of 3% per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. In addition, the lease agreement requires payment of the pro-rata share of the annual operating expenses associated with the premises. The Company relocated to this space in March 2017.

 

In August 2018, the Company signed an office lease agreement to lease approximately 3,500 square feet of office space in Berkeley, California for its commercial operations. The lease agreement is for a two-year term with a renewal option for an additional one-year term. Rental payments are $12,775 per month subject to a 3% increase per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. The Company will pay a pro-rata share of the annual operating expenses associated with the premises.

 

The Company’s operating leases included on the balance sheet are as follows (in thousands):

 

 

 

June 30,

2019

 

Operating lease right-of-use asset

 

$

867

 

 

 

 

 

 

Liabilities

 

 

 

 

   Current portion of operating lease liabilities

 

$

504

 

   Operating lease liabilities

 

 

1,035

 

      Total operating lease liabilities

 

$

1,539

 

The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term. The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the leases will be renewed. The present value of the lease payments is calculated using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. At June 30, 2019, the Company’s weighted average discount rate was 5.3% and the weighted average lease term was 2.6 years.

Total future undiscounted minimum lease payments were as follows at June 30, 2019 (in thousands):

 

Year Ending December 31,

 

 

 

 

2019

 

$

314

 

2020

 

 

574

 

2021

 

 

496

 

2022

 

 

511

 

2023

 

 

393

 

Total minimum lease payments

 

$

2,288

 

 

Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial.

 

Rent expense was $100,000 and $58,000 for the three months ended June 30, 2019 and 2018, respectively, and $200,000 and $116,000 for the six months ended June 30, 2019 and 2018, respectively. Cash payments included in operating activities on the statement of cash flows for operating lease liabilities were $257,000 for the six months ended June 30, 2019.

12


 

Contract Service Providers

In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis.

 

10. Collaboration Agreements

 

The Company has periodically entered into other short-term collaboration agreements, generally with performance obligations of one to two months, to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these collaboration agreements are recognized as revenue over the term of the agreement. The Company recorded $45,000 and $90,000 of revenue from these collaboration agreements during the three and six months ended June 30, 2019, respectively. In addition, the Company recorded $0.2 million of deferred revenue in other current liabilities from these collaboration agreements during the three and six months ended June 30, 2019.

 

 

11. Fair Value Measurements

The Company records certain financial assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, on fair value measurements. As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value.

 

Level 1—Unadjusted quoted prices in active, accessible markets for identical assets or liabilities.

 

Level 2—Other inputs that are directly or indirectly observable in the marketplace.

 

Level 3—Unobservable inputs that are supported by little or no market activity.

The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

The Company’s material financial instruments at June 30, 2019 and December 31, 2018 consisted primarily of cash and cash equivalents, short-term investments and long-term debt. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of long-term debt approximates the carrying value due to variable interest rates that correspond to market rates and is classified as Level 1 in the fair value hierarchy. The Company has determined its short-term investments, comprised of commercial paper, to be Level 2 in the fair value hierarchy. The fair value was determined using a market approach, based on prices and other relevant information generated by market transactions involving similar assets. The short-term investments consist of investments with original maturity dates from date of acquisition of 90 to 365 days and are classified as available-for-sale.

There were no significant transfers between Levels 1, 2 and 3 during the six months ended June 30, 2019 and the year ended December 31, 2018.

The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy (in thousands):

 

 

 

June 30, 2019

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Recorded

Value

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and money markets

 

$

26,174

 

 

$

 

 

$

 

 

$

26,174

 

Restricted cash money market

 

 

360

 

 

 

 

 

 

 

 

 

360

 

Total financial assets

 

$

26,534

 

 

$

 

 

$

 

 

$

26,534

 

13


 

 

 

 

December 31, 2018

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Recorded

Value

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and money markets

 

$

8,042

 

 

$

 

 

$

 

 

$

8,042

 

Restricted cash money market

 

 

360

 

 

 

 

 

 

 

 

 

360

 

Treasury bills

 

 

7,490

 

 

 

 

 

 

 

 

 

7,490

 

Commercial paper

 

 

 

 

 

25,346

 

 

 

 

 

 

25,346

 

Total financial assets

 

$

15,892

 

 

$

25,346

 

 

$

 

 

$

41,238

 

 

 

12. Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented. The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following:

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Outstanding stock options

 

 

4,581,970

 

 

 

3,220,500

 

 

 

4,581,970

 

 

 

3,220,500

 

Non-vested restricted stock units

 

 

485,900

 

 

 

 

 

 

485,900

 

 

 

 

Stock purchase warrants

 

 

29,796

 

 

 

29,796

 

 

 

29,796

 

 

 

29,796

 

 

 

 

5,097,666

 

 

 

3,250,296

 

 

 

5,097,666

 

 

 

3,250,296

 

 

 

 

 

 


14


 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, particularly in Part II – Item 1A, “Risk Factors”. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, 2018 appearing in our Annual Report on Form 10-K filed with the SEC on March 15, 2019.

Overview

We are a late-stage clinical biopharmaceutical company developing first-in-class pharmacological therapies to restore and preserve vision for people with serious eye diseases. Our current product candidates focus on diseases affecting the retina, which is the tissue that lines the inside of the eye and is primarily responsible for vision; and the choroid, which is the layer adjacent to the retina that supplies the retina with blood, oxygen and nourishment.

 

Our suprachoroidal injection platform is a novel, patented non-surgical approach for delivering pharmacotherapy to the back of the eye in the anatomic structure known as the suprachoroidal space, or SCS. The elasticity of the SCS allows for migration when fluid is injected between the choroid and sclera and allows the fluid to spread spherically toward the posterior regions of the eye where it is absorbed into adjacent tissue. We are able to precisely administer drugs into the SCS with our proprietary microinjector that utilizes a needle that is approximately 1 millimeter in length.

 

Our suprachoroidal injection technology is used in conjunction with our proprietary formulations of existing drugs and novel therapies to create a therapeutic platform of product candidates to treat several serious eye diseases. Our lead product candidate, XIPERE, is a proprietary, preservative-free suspension of the corticosteroid triamcinolone acetonide formulated for administration via suprachoroidal injection. Based in part on the positive results from our Phase 3 PEACHTREE clinical trial, in December 2018, we submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for XIPERE for the treatment of macular edema associated with uveitis. On February 19, 2019 we received notification from the FDA that it had accepted the XIPERE NDA for review and had determined that the application was sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act, or PDUFA, goal date has been assigned for October 19, 2019. If it is approved for marketing, we intend to pursue collaborations with third parties to commercialize XIPERE in the United States and internationally.

 

In May 2018, we completed a Phase 2 clinical trial, which we refer to as TYBEE, evaluating the safety and efficacy of administering XIPERE in combination with intravitreal EYLEA® (aflibercept), an anti-VEGF agent, in patients with diabetic macular edema, or DME. Based upon a review of our Phase 2 TYBEE clinical trial data, we have decided to cease clinical development of XIPERE in combination with an anti-VEGF therapy for the treatment of DME. We believe there is a path forward with XIPERE in DME and are evaluating options for clinical trials that can demonstrate the potential benefit from XIPERE as a monotherapy. We intend to discuss this strategy with appropriate regulatory authorities and, subject to the availability of additional funding, to pursue the development of XIPERE as monotherapy in DME and other potential indications outside of uveitis either alone or with a partner. We are also evaluating the potential to develop therapeutic candidates based on the administration of gene therapy and novel small molecules through the SCS using our SCS Microinjector.

We have incurred net losses since our inception in May 2011. Our operations to date have been limited to organizing and staffing our company, raising capital, undertaking preclinical studies and other research and development initiatives, conducting clinical trials of our most advanced product candidates and preparing to commercialize XIPERE for the treatment of macular edema associated with uveitis, if it is approved by the FDA. To date, we have not generated any revenue, other than license and collaboration

15


 

revenue, and we have primarily financed our operations through public offerings and private placements of our equity securities, issuances of convertible promissory notes and loan agreements. As of June 30, 2019, we had an accumulated deficit of $228.0 million. We recorded net losses of $5.7 million and $20.7 million for the three months ended June 30, 2019 and 2018, respectively, and net losses of $21.1 million and $37.3 million for the six months ended June 30, 2019 and 2018, respectively. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the necessary clinical development of, and obtaining regulatory approval and preparing for potential commercialization of, our product candidates, including commercializing XIPERE for the treatment of macular edema associated with uveitis, if approved, in collaboration with third parties.

We expect to continue to incur significant operating losses at least for the next several years. We do not expect to generate product revenue unless and until we successfully complete necessary development of, and obtain regulatory approval for, one or more of our product candidates. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials and our expenditures on other research and development activities. Our clinical trial expenses have decreased significantly following our decision to discontinue late-stage clinical trials of XIPERE for indications other than uveitis. However, we will continue our efforts to seek to discover, research and develop additional product candidates and seek regulatory approvals in additional regions for XIPERE for the treatment of macular edema associated with uveitis.

 

Business Strategy Update

 

We have decided not to commercialize XIPERE on our own but instead to seek a licensing or collaboration agreement with one or more partners for its commercialization. We have completed pre-launch preparations, including branding, injection training development, distribution reimbursement support and pricing evaluations, but we do not intend to spend significant additional amounts on commercialization preparations.

 

We are currently in discussions with multiple potential partners for XIPERE in the United States and internationally. While there can be no guarantee that we will be successful in partnering XIPERE, or as to the structure of any such transaction, we expect that any partnering agreement could provide for upfront payments and milestone payments, as well as royalties on product sales if XIPERE receives regulatory approval and has a successful commercial launch.  

 

Based on our current plans and forecasted expenses, and our decision not to commercialize XIPERE ourselves, we expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2020. This expectation does not give effect to any payments we might receive in connection with a license or collaboration agreement for XIPERE or any other potential license agreement.

 

Components of Operating Results

Revenue

We have not generated any revenue from the sale of any drugs, and we do not expect to generate any revenue unless or until we obtain regulatory approval of and commercialize our product candidates, or successfully enter into licensing or collaboration arrangements with third parties to commercialize our product candidates.

We have periodically entered into short-term collaboration agreements, generally with performance obligations of one to two months, to evaluate the potential use of our proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these collaboration agreements are recognized as revenue over the term of the agreement.

Research and Development

Since our inception, we have focused on our development programs. Research and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical product candidates, which include:

 

employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel;

 

expenses incurred under agreements with contract research organizations, or CROs, as well as contract manufacturing organizations and consultants that conduct clinical trials and preclinical studies;

 

costs associated with nonclinical activities and development activities;

 

costs associated with submitting regulatory approval applications for our product candidates;

 

costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information;

16


 

 

costs associated with technology and intellectual property licenses;

 

costs for our research and development facility; and

 

depreciation expense for assets used in research and development activities.

We expense research and development costs to operations as incurred. The costs for some of our development activities, such as clinical trials, are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs occurred.

Expenses related to activities, such as manufacturing and stability and toxicology studies, that are supportive of a product candidate itself, are classified as direct preclinical costs. Expenses related to clinical trials and similar activities, including costs associated with CROs, are classified as direct clinical costs. Unallocated costs are expenses related to preclinical activities and activities that support more than one development program such as salaries, share-based compensation and depreciation.

For the three and six months ended June 30, 2019 and 2018, substantially all of our research and development expenses were related to the clinical development of our product candidates.

The following table shows our research and development expenses by program, including those that have been discontinued, for the three and six months ended June 30, 2019 and 2018 (in thousands).

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

XIPERE (uveitis program)

 

$

519

 

 

$

2,008

 

 

$

1,702

 

 

$

4,581

 

XIPERE (RVO program)

 

 

(2,622

)

 

 

11,477

 

 

 

4,180

 

 

 

18,853

 

XIPERE (DME program)

 

 

(139

)

 

 

1,079

 

 

 

(136

)

 

 

2,256

 

Total

 

 

(2,242

)

 

 

14,564

 

 

 

5,746

 

 

 

25,690

 

Unallocated

 

 

2,900

 

 

 

2,779

 

 

 

5,879

 

 

 

5,032

 

Total research and development expense

 

$

658

 

 

$

17,343

 

 

$

11,625

 

 

$

30,722

 

 

17


 

Our expenses related to clinical trials are based on estimates of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended under contracts with research institutions, consultants and CROs that conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity according to the protocol. If future timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. Historically, any such modifications have not been material.

 

During the first quarter of 2019, we recorded all remaining accrued expenses reported by our CRO in connection with the termination of our development program for retinal vein occlusion, or RVO. Our research and development expenses related to the RVO program for the second quarter of 2019 reflect a credit of $2.6 million upon reconciliation with our CRO of final trial costs for the RVO program.

 

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. It is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that may include the following:

 

the costs associated with process development, scale-up and manufacturing of XIPERE and the SCS Microinjector in support of filings for regulatory approval;

 

the number of trials required for approval and any requirement for extension trials;

 

per patient trial costs;

 

the number of patients that participate in the trials;

 

the number of sites included in the trials;

 

the countries in which the trials are conducted;

 

the length of time required to enroll eligible patients;

 

the number of doses that patients receive;

 

the drop-out or discontinuation rates of patients;

 

potential additional safety monitoring or other studies requested by regulatory agencies;

 

the duration of patient follow-up; and

 

the efficacy and safety profiles of the product candidates.

In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and Administrative

General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative costs include commercial pre-launch preparation for XIPERE, facility related costs not otherwise included in research and development expenses, professional fees for legal, patent, consulting, and accounting and audit services.

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Other Income (Expense)

Other income consists of interest income earned on our cash and cash equivalents and short-term investments. Interest income is not considered significant to our financial statements.

Other expense primarily consists of interest expense under our loan agreements for the three and six months ended June 30, 2019 and 2018.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include assumptions used in the determination of share-based compensation and some of our research and development expenses. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting policies as those accounting principles generally accepted in the United States of America that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the six months ended June 30, 2019, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2018, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 15, 2019, other than our adoption of ASU 2016-02, Leases, as described in Note 2 to our financial statements included in this report.

Results of Operations for the Three Months Ended June 30, 2019 and 2018

The following table sets forth our results of operations for the three months ended June 30, 2019 and 2018.

 

 

 

Three Months Ended

June 30,

 

 

Period-to-Period

 

 

 

2019

 

 

2018

 

 

Change

 

 

 

(in thousands)

 

Collaboration revenue

 

$

45

 

 

$

 

 

$

45

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

658

 

 

 

17,343

 

 

 

(16,685

)

General and administrative

 

 

5,004

 

 

 

3,561

 

 

 

1,443

 

Total operating expenses

 

 

5,662

 

 

 

20,904

 

 

 

(15,242

)

Loss from operations

 

 

(5,617

)

 

 

(20,904

)

 

 

15,287

 

Other (expense) income, net

 

 

(117

)

 

 

203

 

 

 

(320

)

Net loss

 

$

(5,734

)

 

$

(20,701

)

 

$

14,967

 

Revenue. In the three months ended June 30, 2019, we recognized $45,000 of revenue associated with collaboration agreements to evaluate the potential use of our proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases.

Research and development. Research and development expense decreased by $16.7 million, from $17.3 million for the three months ended June 30, 2018 to $0.7 million for the three months ended June 30, 2019. This was primarily attributable to a $14.1 million decrease due to closing down two late-stage clinical trials, SAPPHIRE and TOPAZ, that were part of our RVO program. Research and development expenses for the three months ended June 30, 2019 reflect the one-time credit of $2.6 million upon reconciliation of final trial costs for the RVO program. Additionally, there was a $1.6 million decrease due to the completion of the PEACHTREE trial during the first quarter of 2018, a $1.2 million decrease in costs related to our DME program, as the TYBEE trial was completed in the second quarter of 2018, and a $0.3 million decrease in regulatory expenses as the NDA submission for XIPERE was completed in the fourth quarter of 2018. These decreases were partially offset by a $0.3 million increase in employee-related costs and a $0.7 million increase in nonclinical activities.

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General and administrative. General and administrative expenses increased by $1.4 million, from $3.6 million for the three months ended June 30, 2018 to $5.0 million for the three months ended June 30, 2019. The increase was primarily attributable to a $1.2 million increase in employee-related costs, including accrued expenses related to the resignation of our former CEO, and an increase of $0.2 million in marketing-related expenses as we prepared for potential commercialization of XIPERE.

Other (expense) income, net. Other (expense) income, net for each of the three-month periods ended June 30, 2019 and 2018 primarily consisted of interest on long-term debt, the amortization of financing costs, the accretion of warrants and the final payment related to our loan agreements, offset in part by interest income from our short-term investments. The decline from 2018 to 2019 was the result of higher interest income on short-term investment balances following our public offering of common stock in the first quarter of 2018, which balances decreased over time.

 

Results of Operations for the Six Months Ended June 30, 2019 and 2018

The following table sets forth our results of operations for the six months ended June 30, 2019 and 2018.

 

 

 

Six Months Ended

June 30,

 

 

Period-to-Period

 

 

 

2019

 

 

2018

 

 

Change

 

 

 

(in thousands)

 

Collaboration revenue

 

$

90

 

 

$

 

 

$

90

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

11,625

 

 

 

30,722

 

 

 

(19,097

)

General and administrative

 

 

9,388

 

 

 

6,635

 

 

 

2,753

 

Total operating expenses

 

 

21,013

 

 

 

37,357

 

 

 

(16,344

)

Loss from operations

 

 

(20,923

)

 

 

(37,357

)

 

 

16,434

 

Other (expense) income, net

 

 

(215

)

 

 

49

 

 

 

(264

)

Net loss

 

$

(21,138

)

 

$

(37,308

)

 

$

16,170

 

Revenue. In the six months ended June 30, 2019, we recognized $90,000 of revenue associated with collaboration agreements to evaluate the potential use of our proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases.

Research and development. Research and development expense decreased by $19.1 million, from $30.7 million for the six months ended June 30, 2018 to $11.6 million for the six months ended June 30, 2019. This was primarily attributable to a $14.7 million decrease due to closing down the SAPPHIRE and TOPAZ trials, including the one-time credit of $2.6 million upon reconciliation of final trial costs. Additionally, there was a $3.5 million decrease due to the completion of the PEACHTREE trial during the first quarter of 2018, a $2.4 million decrease in costs related to our DME program, as the TYBEE trial was completed in the second quarter of 2018, and a $0.3 million decrease in regulatory expenses as the NDA submission for XIPERE was completed in the fourth quarter of 2018. These decreases were partially offset by $0.6 million increase in costs related to device and drug manufacturing, a $1.0 million increase in employee-related costs and a $0.7 million increase in nonclinical activities.

General and administrative. General and administrative expenses increased by $2.8 million, from $6.6 million for the six months ended June 30, 2018 to $9.4 million for the six months ended June 30, 2019. The increase was primarily attributable to a $1.8 million increase in employee-related costs, including accrued expenses related to the resignation of our former CEO, and an increase of $0.8 million in marketing-related expenses as we prepared for the potential commercialization of XIPERE.

Other (expense) income, net. Other (expense) income, net for each of the six-month periods ended June 30, 2019 and 2018 primarily consisted of interest on long-term debt, the amortization of financing costs, the accretion of warrants and the final payment related to our loan agreements, offset in part by interest income from our short-term investments. The decline from 2018 to 2019 was the result of higher interest income on short-term investment balances following our public offering of common stock in the first quarter of 2018, which balances decreased over time.

 

 

Liquidity and Capital Resources

Sources of Liquidity

We have funded our operations primarily through the proceeds of public offerings of our common stock, sales of convertible preferred stock and the issuance of long-term debt. As of June 30, 2019, we had cash and cash equivalents of $26.2 million. We invest

20


 

any cash in excess of our immediate requirements primarily with a view to liquidity and capital preservation. As of June 30, 2019, our funds were held in cash and money market funds.

On June 30, 2017, we entered into an at-the-market sales agreement, or the ATM agreement, with Cowen and Company LLC, or Cowen, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Cowen acting as our sales agent. During the six months ended June 30, 2019, we sold 5.6 million shares of our common stock for net proceeds of $7.9 million under the ATM agreement. Our registration statement on Form S-3 contemplated under the ATM agreement was declared effective by the SEC on July 13, 2017. The registration statement on Form S-3 includes a prospectus supplement covering the offering up to $18.5 million of shares of common stock over the 12 months ending March 15, 2020 in accordance with the ATM agreement.

On September 28, 2016, we entered into an amended and restated loan and security agreement with Silicon Valley Bank, or SVB, and entities affiliated with MidCap Financial Services, which we refer to collectively with SVB as the Lenders. The amended and restated loan and security agreement provided for new term loans of up to $15.0 million, with a floating interest rate equal to 7% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest was to accrue, or (ii) 0.50%. We borrowed an initial tranche of $8.0 million on September 28, 2016, of which $5.3 million was used to repay all amounts outstanding under our prior loan agreement with SVB. The draw period for the remaining $7.0 million available under the amended and restated loan and security agreement expired on March 31, 2018. In connection with the amended and restated loan and security agreement, we issued warrants to the Lenders to purchase up to 29,796 shares of common stock at a price per share of $10.74. The warrants expire in September 2026, or earlier upon the occurrence of specified mergers or acquisitions of our company, and are immediately exercisable.

On May 14, 2018, we entered into a second amended and restated loan and security agreement with the Lenders, or the Loan Agreement, which amended and restated in its entirety the prior amended and restated loan and security agreement with the Lenders. The Loan Agreement provides for new term loans of up to $20.0 million, with a floating interest rate equal to 6.5% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue or (ii) 1.89%.

We borrowed an initial tranche of $10.0 million on May 14, 2018, of which $7.0 million was used to repay all amounts outstanding under the amended and restated loan and security agreement, including the fees payable in connection with the final payment. The prepayment fees were waived. Of the remaining $10.0 million, $5.0 million became available but we elected not to draw it, and the other $5.0 million did not become available for draw.

We are required to pay accrued interest only on the $10.0 million outstanding balance through October 31, 2019, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. We have the option to prepay the outstanding balance in full, subject to a prepayment fee of 2% of the original principal amount for any prepayment prior to October 1, 2022. A final payment of 5.50% of the aggregate borrowed amount is due at maturity of the loan on October 1, 2022, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.

The amounts due under the Loan Agreement are secured by substantially all of our assets, except that the collateral does not include any of our intellectual property. However, pursuant to the terms of a negative pledge arrangement, we have agreed not to encumber any of our intellectual property.

Funding Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, costs related to our NDA submission, research and development costs to build our product candidate pipeline, legal and other regulatory expenses and general overhead costs.

The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of XIPERE or any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from product sales. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

 

successful enrollment in, and completion of, clinical trials;

 

receipt of marketing approvals from applicable regulatory authorities;

 

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

21


 

 

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; and

 

launching commercial sales of the products, if and when approved, whether alone or in collaboration with others.

A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that candidate.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license and development agreements. We do not currently have any committed external source of funds, and, as described above, we may also be able to sell our common stock under the ATM agreement with Cowen subject to the terms of that agreement and depending on market conditions. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, including any collaboration or licensing arrangement for XIPERE, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We also incur costs as a public company, including costs and expenses for fees to members of our board of directors, accounting and finance personnel costs, directors and officers insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.

Outlook

We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can obtain FDA approval to market and then generate significant sales of XIPERE. We will need additional financing to fund our operations. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date of this report. We have plans to mitigate this going concern risk, which primarily consist of raising additional capital, potentially in a combination of equity or debt financings, or entering into potential collaborations, partnerships and other strategic arrangements.

Based on our current plans and forecasted expenses, and our decision not to commercialize XIPERE ourselves, we expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2020. This expectation does not give effect to any payments we might receive in connection with a license or collaboration agreement for XIPERE or any other potential license or collaboration agreement for any future product candidates. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect.

Our financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.

Cash Flows

The following is a summary of the net cash flows provided by (used in) our operating, investing and financing activities (in thousands):

 

 

 

Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

Net cash (used in) provided by:

 

 

 

 

 

 

 

 

Operating activities

 

$

(22,710

)

 

$

(35,222

)

Investing activities

 

 

32,925

 

 

 

(20,576

)

Financing activities

 

 

7,916

 

 

 

81,759

 

Net change in cash and cash equivalents

 

$

18,131

 

 

$

25,961

 

22


 

 

During the six months ended June 30, 2019 and 2018, our operating activities used net cash of $22.7 million and $35.2 million, respectively. The use of cash in each period primarily resulted from our net losses, offset in part by non-cash share-based compensation expense. The decrease in net loss for the six months ended June 30, 2019 as compared to the six months ended June 30, 2018 was primarily attributable to the lower research and development expenses as a result of the completion of the PEACHTREE and TYBEE trials in the prior year and the shut-down of the SAPPHIRE and TOPAZ trials, partially offset by commercialization activities described above.  The six months ended June 30, 2019 also included a net cash outflow of $4.6 million from the decrease in our accounts payable balance, which was the result of payments for the winding down of the clinical trials.

During the six months ended June 30, 2019, our net cash provided by investing activities was $32.9 million and was due to maturities of short-term, available-for-sale investments. During the six months ended June 30, 2018, our net cash used in investing activities was $20.6 million and was due to the net amount of purchases and sales of short-term, available-for-sale investments.

During the six months ended June 30, 2019 and 2018, our net cash provided by financing activities was $7.9 million and $81.8 million, respectively. The net cash provided by financing activities for the six months ended June 30, 2019 was comprised of net proceeds from the sales of shares of common stock under the ATM agreement. The net cash provided by financing activities for the six months ended June 30, 2018 was comprised of the net proceeds of $79.6 million received from our March 2018 public offering of common stock, the net proceeds of $10.0 million from the second amended and restated loan and security agreement, offset by $8.3 million paid to satisfy our obligations under the prior loan agreement, and $0.4 million of proceeds from the exercise of stock options.

Contractual Obligations 

As of June 30, 2019, there were no significant changes to our contractual obligations from those presented as of December 31, 2018 in our Annual Report on Form 10-K.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Recent Accounting Pronouncements

See Item 1, “Financial Statements – Note 2, Significant Accounting Policies” for a discussion of recent accounting pronouncements and their effect on us.

JOBS Act

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of June 30, 2019 and December 31, 2018, we had cash and cash equivalents of $26.2 million and $8.0 million, respectively. We generally hold our cash in interest-bearing money market accounts. As of June 30, 2019, we had no short-term investments and as of December 31, 2018, we had short-term investments of $32.8 million. The short-term investments included commercial paper and treasury bills. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and short-term investments and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents and short-term investments.

We do not engage in any hedging activities against changes in interest rates. Our outstanding debt instruments carried a floating interest rate that is 6.5% plus the greater of (i) the 30-day U.S. LIBOR, reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue or (ii) 1.89%. We estimate that a one percentage point increase in the applicable interest rate under our loan agreements would have resulted in a $50,000 and $100,000 increase in interest expense for the six months ended June 30, 2019 and the year ended December 31, 2018, respectively.

23


 

We do not have any foreign currency or other material derivative financial instruments.

 

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report at the reasonable assurance level.

Changes in Internal Controls over Financial Reporting

There has been no change in our internal control over financial reporting during the quarter ended June 30, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

24


 

PART II – OTHER INFORMATION

 

 

Item 1. Legal Proceedings

 

From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.

 

Item 1A. Risk Factors

 

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described below and in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the Securities and Exchange Commission on March 15, 2019. Except as described below, there have been no material changes to the risk factors described in that report.

We intend to seek one or more partners for the commercialization of XIPERE in the United States and internationally. If we are unable to secure commercialization partners, or if those partners fail to successfully commercialize XIPERE in their respective markets, our business and prospects will be materially harmed.

 

As a result of our intention to enter into arrangements with third parties to perform sales, marketing and distribution services for XIPERE in the United States and internationally, our business prospects and our ability to generate product revenue related to XIPERE, if any, will be heavily dependent on the efforts of such third parties. We may be unsuccessful in entering into the necessary commercialization arrangements with third parties or may be unable to do so on terms that are favorable to us. Our product revenue related to XIPERE, if any, or the profitability of such product revenue, may be lower, perhaps substantially lower, than if we were to directly market and sell XIPERE. Such revenue will be heavily dependent on the commercialization efforts of our partners, and we may have little or no control over such third parties. Any disputes with our commercialization partners concerning the adequacy of their efforts will substantially divert the attention of our senior management from other business activities and will require us to incur substantial legal costs to fund litigation or arbitration proceedings. If we are unable to establish licensing or collaboration arrangements with partners or if our future partners fail to exercise commercially reasonable efforts to market and sell XIPERE in their respective licensed jurisdictions or are otherwise ineffective in doing so, our business will be materially harmed, and we may not be able to adequately remedy the harm through negotiation, litigation, arbitration or termination of the commercialization agreements.

 

If we fail to maintain compliance with the listing requirements of The Nasdaq Global Market, we may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

 

Our common stock is currently listed on The Nasdaq Global Market. To maintain the listing of our common stock on The Nasdaq Global Market, we are required to meet certain listing requirements, including, among others, either: (i) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $5 million and stockholders’ equity of at least $10 million; or (ii) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors, affiliates and 10% or more stockholders) of at least $15 million and a total market value of listed securities of at least $50.0 million.

 

We may fail to satisfy one or more Nasdaq Global Market requirements for continued listing of our common stock in the future. There can be no assurance that we will be successful in maintaining the listing of our common stock on the Nasdaq Global Market, or, if transferred, on the Nasdaq Capital Market. This could impair the liquidity and market price of our common stock. In addition, the delisting of our common stock from a national exchange could have a material adverse effect on our access to capital markets, and any limitation on market liquidity or reduction in the price of our common stock as a result of that delisting could adversely affect our ability to raise capital on terms acceptable to us, or at all.

 


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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

(a)

Sales of Unregistered Securities

None.

 

Item 5. Other Information

On August 6, 2019, we entered into an amendment to the offer letter agreement with George Lasezkay, originally dated April 16, 2019, setting forth the terms of Dr. Lasezkay’s employment as our Chief Executive Officer.  Pursuant to the amendment, we and Dr. Lasezkay agreed to extend the initial term of the offer letter agreement to March 31, 2020.  Other than as set forth in the amendment, the other terms and conditions of the offer letter agreement continued in full force and effect.

The foregoing description of the amendment to the offer letter agreement is not complete and is qualified in its entirety by reference to the amendment to the offer letter agreement, which is filed as an exhibit to this Quarterly Report on Form 10-Q and is incorporated herein by reference.

In connection with entering into the amendment extending the initial term of the offer letter agreement, we granted Dr. Lasezkay a restricted stock unit for 100,000 shares of our common stock. The shares underlying this restricted stock unit will vest in full on March 31, 2020, subject to Dr. Lasezkay’s continuous service through such date. In addition, all of the then unvested shares underlying the restricted stock unit will vest upon the earliest of (i) immediately prior to a change in control, (ii) Dr. Lasezkay’s termination by us without cause, (iii) upon request by us that Dr. Lasezkay resign without cause following the receipt of any indication of interest from a third party for a change in control or (iv) upon commencement of employment of a new Chief Executive Officer of our company.

 

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Item 6. Exhibits

 

Exhibit No.

 

Description

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016).

 

 

 

3.2

 

Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016).

 

 

 

10.1*#

 

Third Amendment to License Agreement, by and among the Registrant, Emory University and Georgia Tech Research Corporation, dated April 1, 2018.

 

 

 

10.2*#

 

Consent and First Amendment to Second Amended and Restated Loan and Security Agreement, by and between the Registrant and Silicon Valley Bank, dated as of July 3, 2019.

 

 

 

10.3*

 

Amendment to offer letter agreement, by and between the Registrant and George Lasezkay, dated as of August 6, 2019.

 

 

 

31.1*

 

Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.

 

 

 

31.2*

 

Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.

 

 

 

32.1**

 

Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.

 

 

 

101.INS

 

XBRL Instance Document

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

*

Filed herewith.

**

These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

#

The schedules and exhibits to this agreement have been omitted, but will be furnished to the Securities and Exchange Commission upon request.

 

 

27


 

SIGNATURES

Pursuant to the requirements 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.

 

 

 

Clearside Biomedical, Inc.

 

 

 

 

Date: August 8, 2019

 

By:

/s/ Charles A. Deignan

 

 

 

Charles A. Deignan

 

 

 

Chief Financial Officer

 

 

 

(On behalf of the Registrant and as
Principal Financial Officer)

 

 

 

 

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