kool20180813_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): August 13, 2018

 

CESCA THERAPEUTICS INC.

 (Exact Name of Registrant as Specified in Charter)

 

 

 

 

 

 

Delaware

 

333-82900

 

94-3018487

 

 

 

 

 

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

2711 Citrus Road, Rancho Cordova, California

 

95742

 

 

 

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (949) 753-0624

 

N/A
(Former Name or Former Address, if Changed Since Last Report)

 


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:

 

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

          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.  ☐

 



 

 

 

Item 2.02.

Results of Operations and Financial Condition.

 

On August 13, 2018, Cesca Therapeutics Inc. issued a press release announcing its results of operations and financial condition for the second quarter of fiscal year 2018. The full text of the press release is set forth in Exhibit 99.1 attached to this Current Report on Form 8-K.

 

The information contained in this Item 2.02 and in Exhibit 99.1 attached to this Current Report on Form 8-K is being furnished to the Securities and Exchange Commission 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 of 1933, except as shall be expressly set forth in such a filing.

 

 

Item 9.01.

Financial Statements and Exhibits.

 

Exhibit No.

 

Description

     

99.1

 

Press release dated August 13, 2018, titled “Cesca Therapeutics Announces Second Quarter 2018 Financial Results and Provides Corporate Update”.

 

 

 

 

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 hereunto duly authorized.

 

   

CESCA THERAPEUTICS INC.

   

   (Registrant)

     

Dated: August 13, 2018

 

/s/ Vivian Liu

   

Vivian Liu, Chief Operating Officer

 

ex_121661.htm

Exhibit 99.1

 

 

 

 

CESCA THERAPEUTICS ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

 

Conference Call to be Held at 4:30 p.m. ET (1:30 p.m. PT)

 

RANCHO CORDOVA, CA, August 13, 2018 – Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced financial and operating results for the second quarter ended June 30, 2018 and provided a corporate update.

 

Second Quarter and Recent Highlights

 

 

Announced the release of its X-Mini™ cell selection kit for the CAR-T research market.

 

 

Announced the commercial launch of its PXP™ System for the automated processing of bone marrow cells at the point-of-care.

 

 

Completed a public financing, raising gross proceeds of approximately $5.5 million.

 

 

“Since the beginning of the second quarter, we’ve continued to make significant progress toward our goal of becoming the ‘partner of choice’ for CAR-T researchers and developers looking to automate key parts of the complex CAR-T manufacturing process,” said Chris Xu, PhD, chief executive officer of Cesca. “Most notably, the release of our X-Mini cell selection kit for the research market represents a pivotal achievement for our Company, as it is the first component of our proprietary CAR-TXpress™ system to be introduced in a live research setting. We also began formally exhibiting our X-Series™ kits at industry conferences, and these initial product demonstrations resulted in sales of both X-Mini and X-Wash® during the third quarter. We are very encouraged by the progress we made during the second quarter, and the momentum with which we have entered the back half of the year. These activities serve to solidify our strong belief that Cesca can play a key role in streamlining and accelerating the CAR-T manufacturing process, as well as expanding the availability and affordability of these revolutionary cancer treatments, while creating long-term value for our shareholders.”

 

 

 

 

Financial Results for the Second Quarter Ended June 30, 2018

 

Net revenue. Net revenues for the three months ended June 30, 2018 were $2.0 million compared to $3.5 million for the comparable period in 2017. The decline in revenues, year-over-year, was the result of lower AXP sales due to the distributor change in China, lower BioArchive device sales and the termination of a royalty payment agreement in the prior year.

 

Gross profit. Gross profit for the three months ended June 30, 2018 was $363,000, or 18.1 % of net revenue, compared to $1.5 million, or 43.6 % of net revenue, for the comparable period in 2017. The decline in gross profit, year-over-year, was due to lower sales, higher overhead costs resulting from the acquisition of SynGen and inventory scrap expenses due to discontinuing sales of two, low volume products. Additionally, prior year gross profit margin percentage was higher due to the reversal of inventory reserves for products sold.

 

Sales and marketing expenses. Sales and marketing expenses for the three months ended June 30, 2018 were $359,000 compared to $421,000 for the comparable period in 2017. The decrease was due to reduced headcount and bad debt expenses in the Company’s Totipotent RX clinical subsidiary in India. Sales and marketing expenses in the Company’s ThermoGenesis device segment were generally flat compared to the same period in 2017.

 

Research and development expenses. Research and development expenses for the three months ended June 30, 2018 were $908,000, compared to $566,000 for the comparable period in 2017. The increase was due to additional headcount and expenses related to the development of the Company’s CAR-TXpress platform, and a shift in existing personnel from the clinical development segment to the device segment as the Company is minimally funding clinical development projects unless and until a strategic partner is identified.

 

General and administrative expenses. General and administrative expenses for the three months ended June 30, 2018 were $2.4 million compared to $2.0 million for the comparable period in 2017. The increase was driven by severance expenses and a legal settlement in a dispute with a broker-dealer.

 

Impairment Charge. During the second quarter ended June 30, 2018, the Company incurred impairment charges of $27,202,000 as compared to impairment charges of $310,000 during the three months ended June 30, 2017. The Company performed a quantitative assessment which determined that the carrying amount for the Company’s goodwill and indefinite lived intangible assets relating to its clinical protocols exceeded their estimated fair value. As a result, impairment charges of $12,695,000 to goodwill and $14,507,000 to intangible assets were recorded during the period.

 

Net loss attributable to common stockholders. For the three months ended June 30, 2018, the Company reported a comprehensive loss attributable to common stockholders of ($26.6) million, or ($1.73) per share, based on approximately 15.4 million weighted average basic and diluted common shares outstanding. This compares to a net loss of ($1.2) million, or ($0.12) per share, based on approximately 9.9 million weighted average basic and diluted common shares outstanding for the three months ended June 30, 2017. This net loss is attributable primarily to the above-described impairment charges.

 

 

 

 

Conference Call and Webcast Information

Cesca will host a conference call and audio webcast today at 4:30 p.m. EDT (1:30 p.m. PDT). Participants may access the call by dialing 1-844-889-4331 within the U.S. or 1-412-380-7406 outside the U.S. and referencing “Cesca.” To access a live webcast of the call, please visit: https://services.choruscall.com/links/kool180813.html. A replay of the call can be accessed approximately one hour after completion of the call and will be available until September 13, 2019. To listen to the replay, dial 1-877-344-7529 within the U.S. or 1-412-317-0088 outside the U.S. and reference access code 10122202.

 

About Cesca Therapeutics Inc.

Cesca Therapeutics develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. Its device division, ThermoGenesis, provides a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. The Company is developing an automated, functionally-closed CAR-TXpress™ platform that addresses the critical unmet need for better cellular manufacturing and controls (CMC) for the emerging CAR-T immunotherapy market. Cesca is an affiliated company of China-based Boyalife Group.

 

Forward-Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially 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 Cesca Therapeutics’ forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics’ annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

 

Company Contact:

Cesca Therapeutics Inc.

Wendy Samford

916-858-5191

ir@cescatherapeutics.com

 

Investor Contact:

Rx Communications

Paula Schwartz

917-322-2216

pschwartz@rxir.com

 

 

 

 

Financials

 

Cesca Therapeutics Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

   

June 30,

2018

   

December 31,

2017

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 3,071,000     $ 3,513,000  

Accounts receivable, net

    1,844,000       2,549,000  

Inventories

    5,156,000       4,798,000  

Prepaid expenses and other current assets

    335,000       594,000  
                 

Total current assets

    10,406,000       11,454,000  
                 

Restricted cash

    1,000,000       1,000,000  

Equipment, net

    3,466,000       2,996,000  

Goodwill

    1,281,000       13,976,000  

Intangible assets, net

    7,039,000       21,629,000  

Other assets

    51,000       56,000  
                 

Total assets

  $ 23,243,000     $ 51,111,000  
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY

               

Current liabilities:

               

Accounts payable

  $ 2,048,000     $ 2,079,000  

Other current liabilities

    3,352,000       3,385,000  

Total current liabilities

    5,400,000       5,464,000  
                 

Long-term liabilities

    8,880,000       12,435,000  

Total liabilities

  $ 14,280,000     $ 17,899,000  
                 

Cesca Therapeutics Inc. stockholders' equity

    10,363,000       33,699,000  
                 

Noncontrolling interests

    (1,400,000 )     (487,000 )
                 

Total liabilities and stockholders’ equity

  $ 23,243,000     $ 51,111,000  

 

 

 

 

Cesca Therapeutics Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   

Three Months Ended
June 30,

   

Six Months Ended

June 30,

 
   

2018

   

2017

   

2018

   

2017

 

Net revenues

  $ 2,004,000     $ 3,501,000     $ 3,871,000     $ 6,753,000  
                                 

Cost of revenues

    1,641,000       1,973,000       3,156,000       3,848,000  
                                 

Gross profit

    363,000       1,528,000       715,000       2,905,000  
                                 

Expenses:

                               

Sales and marketing

    359,000       421,000       685,000       756,000  
                                 

Research and development

    908,000       566,000       1,949,000       1,133,000  
                                 

General and administration

    2,399,000       1,963,000       4,641,000       4,601,000  
                                 

Impairment Charges

    27,202,000       310,000       27,202,000       310,000  
                                 

Total operating expenses

    30,868,000       3,260,000       34,477,000       6,800,000  
                                 

Loss from operations

    (30,505,000 )     (1,732,000 )     (33,762,000 )     (3,895,000 )
                                 

Fair value change of derivative instruments

    308,000       44,000       567,000       113,000  

Interest expense

    (383,000 )     (112,000 )     (743,000 )     (131,000 )

Other (expenses)

    (32,000 )     (27,000 )     (44,000 )     (11,000 )

Total other expenses

    (107,000 )     (95,000 )     (220,000 )     (29,000 )
                                 

Loss before benefit for income taxes

    (30,612,000 )     (1,827,000 )     (33,982,000 )     (3,924,000 )

Benefit for income taxes

    3,451,000       673,000       3,451,000       673,000  

Net loss

    (27,161,000 )     (1,154,000 )     (30,531,000 )     (3,251,000 )
                                 

Loss attributable to noncontrolling interests

    (503,000 )     --       (913,000 )     --  
                                 

Net loss attributable to common stockholders

  $ (26,658,000 )   $ (1,154,000 )   $ (29,618,000 )   $ (3,251,000 )

 

 

 

 

Cesca Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   

Six Months Ended

June 30,

 
   

2018

   

2017

 

Cash flows from operating activities:

               

Net cash used in operating activities

  $ (6,102,000 )   $ (4,645,000 )
                 

Cash flows from investing activities:

               

Capital expenditures

    (850,000 )     (99,000 )
                 

Cash flows from financing activities:

               

Payments on capital lease obligations

    (19,000 )     (24,000 )

Proceeds from issuance of common stock, net

    6,032,000       --  

Proceeds from long-term debt-related party

    500,000       3,500,000  

Payment of financing cost

    --       (13,000 )
                 

Net cash provided by financing activities

    6,513,000       3,463,000  
                 

Effects of foreign currency rate changes on cash and cash equivalents

    (3,000 )     5,000  

Net decrease in cash, cash equivalents and restricted cash

    (442,000 )     (1,276,000 )
                 

Cash and cash equivalents at beginning of period

    3,513,000       4,899,000  

Cash and cash equivalents at end of period

  $ 3,071,000     $ 3,623,000