0001437749-16-031704.txt : 20160512 0001437749-16-031704.hdr.sgml : 20160512 20160512172743 ACCESSION NUMBER: 0001437749-16-031704 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160512 DATE AS OF CHANGE: 20160512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CESCA THERAPEUTICS INC. CENTRAL INDEX KEY: 0000811212 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY APPARATUS & FURNITURE [3821] IRS NUMBER: 943018487 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-82900 FILM NUMBER: 161645088 BUSINESS ADDRESS: STREET 1: 2711 CITRUS ROAD CITY: RANCHO CORDOVA STATE: CA ZIP: 95742 BUSINESS PHONE: 9168585100 MAIL ADDRESS: STREET 1: 2711 CITRUS ROAD CITY: RANCHO CORDOVA STATE: CA ZIP: 95742 FORMER COMPANY: FORMER CONFORMED NAME: THERMOGENESIS CORP DATE OF NAME CHANGE: 19951117 FORMER COMPANY: FORMER CONFORMED NAME: INSTA COOL INC OF NORTH AMERICA DATE OF NAME CHANGE: 19920703 8-K 1 kool20160512_8k.htm FORM 8-K kool20160512_8k.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 12, 2016

   

CESCA THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

  

Delaware

 

333-82900

 

94-3018487

(State or other jurisdiction of incorporation or organization)

 

(Commission File Number)

 

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

 

2711 Citrus Road

Rancho Cordova, California 95742

(Address and telephone number of principal executive offices) (Zip Code)

 

(916) 858-5100

(Registrant's telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

[ ]

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ]

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ]

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ]

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 
 

 

  

Item 2.02 Results of Operations and Financial Condition

 

On May 12, 2016, Cesca Therapeutics Inc. issued a press release announcing its results of operations and financial condition for the third quarter of fiscal year 2016. The full text of the press release is set forth in Exhibit 99.1 attached to this report.

 

This press release includes adjusted EBITDA, which is a financial measure that is not determined in accordance with United States generally accepted accounting principles “U.S. GAAP”.  Adjusted EBITDA represents loss from operations excluding amounts for depreciation and amortization, stock-based compensation expense and impairment of intangible asset. Adjusted EBITDA should not be considered in isolation or as a substitute for net loss as a measure of performance.  A reconciliation to the comparable GAAP measure is provided in the accompanying financial summaries.

 

The information contained in this Item 2.02 and in Exhibits 99.1 attached to this Curent Report on Form 8-K is being furnished to the SEC and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Exchange Act or the Securities Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1 Press release dated May 12, 2016, titled “Cesca Therapeutics Reports Third Quarter Fiscal Year 2016 Results and Provides Business Update”.

 

 

 
 

 

 

SIGNATURE

 

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 hereunto duly authorized.

 

 

   

Cesca Therapeutics Inc.

 
   

a Delaware Corporation

 
       
       
 

Dated: May 12, 2016

/s/ Michael Bruch

 
   

Michael Bruch

 
   

Chief Financial Officer

 

 

 

 
 

 

 

Exhibit Index

 

 

Exhibit No.

 

Description

 
 

99.1

 

Press release dated May 12, 2016, titled “Cesca Therapeutics Reports Third Quarter Fiscal Year 2016 Results and Provides Business Update”.

 

 

EX-99.1 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm

Exhibit 99.1

  

cesca therapeutics REPORTS THIRD QUARTER FISCAL 2016 RESULTS AND PROVIDES BUSINESS UPDATE

 

Management to Hold Conference Call Today at 2:00pm Pacific (5:00pm Eastern)

 

Rancho Cordova, CA, May 12, 2016 – Cesca Therapeutics Inc. (NASDAQ: KOOL), an autologous cell-based regenerative medicine company, today reported financial results for the third quarter of fiscal 2016 and provided an update to investors that included the status of clinical initiatives, with a particular emphasis on the Company’s critical limb ischemia (CLI) program. The Company expects to submit an Investigational Device Exemption (IDE) supplement to the FDA at the end of the month detailing a range of changes to the pivotal CLI trial design and amendments to its CLI study protocol. The supplement will touch on, among other things, study end-points, the statistical analysis plan, the required patient enrollment totals for both the treatment arm and the control arm, patient inclusion/exclusion criteria and protocol changes designed to enhance patient enrollment.

 

Cesca had earlier been granted IDE approval by the FDA for a 224 patient, randomized, double blinded, placebo controlled pivotal study at up to 60 sites, for the treatment of Rutherford category 5 CLI patients using the Company’s proprietary SurgWerksTM-CLI system. However Cesca subsequently has deferred the commencement of the trial pending approval by the FDA of the enhancements to be proposed in the supplement.

 

“The upcoming submission of our IDE Supplement will mark a significant milestone in our SurgWerks™-CLI development program,” said Cesca Therapeutics’ CEO, Robin Stracey. “Over the last several months we have re-evaluated all elements of the previously-approved IDE and have now modified it in a way that we believe enhances the prospects for a successful pivotal trial outcome and ultimately a compelling commercial product. We look forward to initiating the supplement review process with the FDA and sharing additional details about anticipated changes to our program in the coming weeks.”

 

Third Quarter Fiscal 2016 Financial Results

 

The Company reported revenues for the quarter ended March 31, 2016 of $2.8 million, compared to $4.0 million for the quarter ended March 31, 2015, a decrease of $1.2 million. Primary contributors to the decline were AXP consumables as a result of an offset in the timing of scheduled orders between quarters this year compared to the corresponding quarters of the prior year from one of the Company’s major distributors in Asia, and Res-Q BMC, as a result of reductions in purchases by the Company’s largest distributor following Cesca’s decision in June 2015 to withdraw the product from the United States market on or before May 31, 2016.

 

 

 
1

 

   

Gross profit was $0.4 million or 14% of net revenues for the quarter ended March 31, 2016, compared to $1.1 million or 28% for the corresponding quarter in 2015. The decline in gross profit between the reporting periods was primarily attributable to changes in the mix of products sold and the establishment of a provision for losses on non-cancelable purchase commitments to a vendor.

 

Operating expenses for the quarter ended March 31, 2016 were $3.1 million, compared to $6.0 million for the corresponding quarter in 2015. General and Administrative expenses decreased by nearly $1.6 million, attributable primarily to a reduction in legal expenses of approximately $1.0 million linked to the 2015 settlement of certain patent litigation cases. Research and development expenses decreased by just over $1.0 million, primarily as a result of lower personnel costs following the Company’s September 2015 restructuring initiative and reduced spending associated with its clinical programs.

 

The net loss from operations for the quarter ended March 31, 2016 was $2.7 million compared to $4.8 million for the quarter ended March 31, 2015, an improvement of over $2 million. However, reported net loss for the quarter ended March 31, 2016 was $10.9 million, compared to $4.8 million for the same prior year period, an increase of $6.1 million. The difference between net loss from operations and the reported net loss is attributable to the inclusion of one-time charges of almost $7.0 million associated with the refinancing of the Company’s $5.5 million, thirty-year debentures and a loss on the cashless exercise of warrants.

 

Adjusted EBITDA loss was $2.3 million for the quarter ended March 31, 2016 compared to $4.1 million for the corresponding quarter in 2015. The decrease in the adjusted EBITDA loss was the result of the decreased loss from operations as already described.

 

Cash and cash equivalents were $7.2 million as of March 31, 2016, which the Company believes is sufficient to sustain its operations for at least the next 12 months.

 

Conference Call and Webcast

 

Management will hold a conference call today at 2:00pm Pacific (5:00pm Eastern) to review the third quarter fiscal 2016 financial results and provide a business update.

 

Conference call details:

 

Dial-in (U.S.):

 

1-800-860-2442

 

Dial-in (Internationally):

 

1-412-858-4600

 

Conference Name:

 

“Cesca”

 

 

To listen to the audio webcast of the call during or after the event, please visit http://services.choruscall.com/links/kool160512

 

An audio replay of the conference call will be available beginning approximately two hours after completion of the call for the following five business days.

 

To access the replay:

 

Access number (U.S.):

 

1-877-344-7529

 

Access number (Internationally)

 

1-412-317-0088

 

Conference ID#:

 

10084329

 

 

 

 
2

 

 

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:

 

 

The SurgWerks™ System (in development) - a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure Kits for use in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.

 

The CellWerks™ System (in development) - a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.

 

The AutoXpress® System (AXP®) - a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.

 

The MarrowXpress™ System (MXP™) - a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.

 

The BioArchive® System - an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.

 

Manual bag sets for use in the processing and cryogenic storage of cord blood.

 

Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change. Forward-looking statements can often be identified by words such as “will”, “may,” “could,” “expects,” and similar expressions and include, but are not limited to, statements regarding research, regulatory submissions and regulatory approvals. These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption "Risk Factors" in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

 

Company Contact: Cesca Therapeutics Inc.

ir@cescatherapeutics.com

 

Investor Contact: The Ruth Group

Lee Roth / Tram Bui

646-536-7012 / 7035

lroth@theruthgroup.com / tbui@theruthgroup.com

 

 

 
3

 

   

Financials

 

Cesca Therapeutics Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

(in thousands)

 

March 31,

2016

   

June 30,

2015

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 7,247     $ 3,357  

Accounts receivable, net

    4,038       5,133  

Inventories

    3,524       4,598  

Prepaid expenses and other current assets

    262       163  
                 

Total current assets

    15,071       13,251  
                 

Equipment, net

    3,102       2,937  

Goodwill

    13,195       13,195  

Intangible assets, net

    20,932       21,295  

Other assets

    79       79  
                 

Total assets

  $ 52,379     $ 50,757  
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY

               

Current liabilities:

               

Accounts payable

  $ 3,341     $ 5,079  

Other current liabilities

    2,567       2,867  
                 

Total current liabilities

    5,908       7,946  
                 

Long-term liabilities

    10,688       7,909  
                 

Stockholders' equity

    35,783       34,902  
                 

Total liabilities and stockholders’ equity

  $ 52,379     $ 50,757  

 

 

 
4

 

 

Cesca Therapeutics Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

  

(in thousands)

 

Three Months Ended
March 31,

   

Nine Months Ended

March 31,

 
   

2016

   

2015

   

2016

   

2015

 
                                 

Net revenues

  $ 2,832     $ 4,042     $ 8,949     $ 12,340  
                                 

Cost of revenues

    2,424       2,899       7,146       8,470  
                                 

Gross profit

    408       1,143       1,803       3,870  
                                 

Expenses:

                               
                                 

Sales and marketing

    537       787       1,696       2,315  
                                 

Research and development

    708       1,712       2,451       4,731  
                                 

General and administrative

    1,904       3,480       6,279       9,300  
                                 

Total operating expenses

    3,149       5,979       10,426       16,346  
                                 

Loss from operations

    (2,741 )     (4,836 )     (8,623 )     (12,476 )
                                 

Amortization of debt discount

    (5,137 )     --       (5,189 )     --  

Fair value change of derivative instruments

    (454 )     --       3,152       --  

Registration rights liquidated damages

    --       --       (1,100 )     --  

Loss on cashless exercise of warrants

    (475 )     --       (1,039 )     --  

Loss on extinguishment of debt

    (795 )     --       (795 )     --  

Loss on modification of Series A warrants

    (149 )     --       (149 )     --  

Interest and other

    (1,122 )     25       (1,151 )     (2 )

Net loss

  $ (10,873 )   $ (4,811 )   $ (14,894 )   $ (12,478 )
                                 

COMPREHENSIVE LOSS

                               

Net loss

  $ (10,873 )   $ (4,811 )   $ (14,894 )   $ (12,478 )

Other comprehensive income:

                               

Foreign currency translation adjustments

    (3 )     21       (27 )     (48 )

Comprehensive loss

  $ (10,876 )   $ (4,790 )   $ (14,921 )   $ (12,526 )

 

 

 
5

 

 

Cesca Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

(in thousands)

 

Nine Months Ended

March 31,

 
   

2016

   

2015

 

Cash flows from operating activities:

               

Net cash used in operating activities

  $ (8,349 )   $ (9,315 )
                 

Cash flows from investing activities:

               

Capital expenditures

    (602 )     (544 )
                 

Cash flows from financing activities:

               

Gross proceeds from convertible debentures

    18,000       --  

Payment of financing cost-convertible debentures

    (961 )     --  

Repayment of convertible debentures

    (6,444 )     --  

Payment to extinguish derivative obligations

    (159 )     --  

Payments on capital lease obligations

    (46 )     (39 )

Proceeds from issuance of common stock, net

    2,463       --  

Repurchase of common stock

    (5 )     (97 )
                 

Net cash provided by (used in) financing activities

    12,848       (136 )
                 

Effects of foreign currency rate changes on cash and cash equivalents

    (7 )     (24 )

Net increase (decrease) in cash and cash equivalents

    3,890       (10,019 )
                 

Cash and cash equivalents at beginning of period

    3,357       14,811  

Cash and cash equivalents at end of period

  $ 7,247     $ 4,792  

 

 

 
6

 

 

Cesca Therapeutics Inc.

Adjusted EBITDA

(Unaudited)

 

(in thousands)

 

Three Months Ended
March 31,

   

Nine Months Ended
March 31,

 
   

2016

   

2015

   

2016

   

2015

 

Loss from operations

  $ (2,741 )   $ (4,836 )   $ (8,623 )   $ (12,476 )
                                 

Add:

                               
                                 

Depreciation and amortization

    217       346       876       1,013  
                                 

Stock-based compensation expense

    247       290       551       966  
                                 

Impairment of intangible asset

    --       117       --       117  
                                 

Adjusted EBITDA loss

  $ (2,277 )   $ (4,083 )   $ (7,196 )   $ (10,380 )

 

 

7

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