RANCHO CORDOVA, Calif., May 14, 2018 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced financial and operating results for the first quarter ended March 31, 2018, and provided a corporate update.
First Quarter and Recent Highlights
- Announced first two evaluation agreements with leading academic research institutions for the Company’s X-Series™ products for automated, closed system cellular processing.
- Presented two posters pertaining to the Company’s X-BACS™ and X-Wash™ cellular processing systems at the International Society for Cellular Therapy (ISCT) 2018 Annual Meeting in Montreal, Québec.
- Announced the release of the X-Mini™ cell selection kit for the CAR-T research market.
- Filed a new patent application with the US Patent and Trademark Office (USPTO) for an innovation to Cesca’s CAR-TXpress™ technology, which will allow for the simultaneous purification and activation of T-cells, thereby simplifying the CAR-TXpress workflow and tangibly accelerating the CAR-T cell manufacturing process.
- Initiated entry into the contract development and manufacturing (CDMO) space with signing of an exclusive license agreement with China-based IncoCell Tianjin Ltd. for CAR-T related CDMO services covering the Asia Pacific region.
- Launched the second-generation AXP® II system for advanced cord blood and peripheral blood processing.
“Since our acquisition of SynGen in July of last year, we have made substantial progress advancing our novel CAR-TXpress solution, and related X-Series kits, toward commercialization,” said Dr. Chris Xu, chief executive officer of Cesca. “Notably, we introduced our first X-Series kit, the X-Mini, which targets the large and growing CAR-T research market, and subsequently entered into our first evaluation agreements with two leading academic research institutions focused on cell therapies. In addition, we continued to execute on our strategy to become a diversified CAR-T service provider with the signing of the CDMO agreement with IncoCell, the first of several CDMO collaborations that we are pursuing in key markets, including the U.S. Finally, we bolstered our intellectual property estate with the filing of an additional patent that further differentiates our proprietary CAR-TXpress workflow. We remain very optimistic about the numerous opportunities within the rapidly-emerging immuno-oncology field and are positioning the Company to respond to unmet market needs. Our goal is to maintain our current momentum, and we believe we have set the stage for 2018 to be a truly transformational year for our company.”
Financial Results for the First Quarter Ended March 31, 2018
Net revenue. Net revenues for the three months ended March 31, 2018 were $1.9 million compared to $3.3 million for the comparable period in 2017. The decline was driven by decreased AXP disposable sales in China.
Gross profit. Gross profit for the three months ended March 31, 2018 was $352,000, or 19.0% of net revenue, compared to $1.4 million, or 42.0% of net revenue for the comparable period in 2017. The decrease in gross profit margin percentage was primarily due to decreased overhead absorption and higher costs as a result of the merger with SynGen, which was completed in July 2017.
Sales and marketing expenses. Sales and marketing expenses for the three months ended March 31, 2018 were $325,000 compared to $335,000 for the comparable period in 2017.
Research and development expenses. Research and development (R&D) expenses for the three months ended March 31, 2018 were $1.0 million, compared to $567,000 for the comparable period in 2017. The increase is primarily due to additional headcount and expenses relating to the ongoing development of the Company’s X-Series products and CAR-TXpress platform.
General and administrative expenses. General and administrative expenses for the three months ended March 31, 2018 were $2.2 million compared to $2.6 million for the comparable period in 2017. The decrease was driven by a reduction in legal expenses due to the settlement of the SynGen litigation.
Net loss attributable to common stockholders. For the three months ended March 31, 2018, the Company reported a net loss attributable to common stockholders of $3.0 million, or ($0.27) per share, based on approximately 11.1 million weighted average basic and diluted common shares outstanding. This compares to a net loss of $2.1 million, or ($0.21) per share, based on approximately 9.9 million weighted average basic and diluted common shares outstanding for the three months ended March 31, 2017.
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 1-800-860-2442 within the U.S. or 1-412-858-4600 outside the U.S. and referencing “Cesca.” To access a live webcast of the call, please visit: http://services.choruscall.com/links/kool180514.html. A replay of the call can be accessed approximately one hour after completion of the call and will be available until June 14, 2018. 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 10119918.
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 its automated, functionally-closed CAR-TXpress™ platform to streamline the manufacturing process for the emerging CAR-T immunotherapy market.
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.
Cesca Therapeutics Inc.
|Cesca Therapeutics Inc. |
Condensed Consolidated Balance Sheets
|March 31, |
|December 31, |
|Cash and cash equivalents||$2,872,000||$3,513,000|
|Accounts receivable, net||1,649,000||2,549,000|
|Prepaid expenses and other current assets||557,000||594,000|
|Total current assets||10,299,000||11,454,000|
|Intangible assets, net||21,590,000||21,629,000|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Other current liabilities||3,980,000||3,385,000|
|Total current liabilities||6,395,000||5,464,000|
|Cesca Therapeutics Inc. stockholders' equity||32,017,000||33,699,000|
|Total liabilities and stockholders’ equity||$50,181,000||$51,111,000|
|Cesca Therapeutics Inc. |
Condensed Consolidated Statements of Operations
|Three Months Ended |
|Cost of revenues||1,515,000||1,875,000|
|Sales and marketing||325,000||335,000|
|Research and development||1,041,000||567,000|
|General and administration||2,242,000||2,591,000|
|Total operating expenses||3,608,000||3,493,000|
|Loss from operations||(3,256,000)||(2,116,000)|
|Fair value change of derivative instruments||259,000||69,000|
|Loss attributable to noncontrolling interests||(410,000)||--|
|Net loss attributable to common stockholders||$(2,960,000)||$(2,097,000)|
|Cesca Therapeutics Inc. |
Condensed Consolidated Statements of Cash Flows
|Three Months Ended |
|Cash flows from operating activities:|
|Net cash used in operating activities||(2,054,000)||(2,543,000)|
|Cash flows from investing activities:|
|Cash flows from financing activities:|
|Payments on capital lease obligations||(9,000)||(23,000)|
|Proceeds from issuance of common stock, net||1,213,000||--|
|Proceeds from long-term debt-related party||500,000||1,500,000|
|Payment of financing cost||--||(13,000)|
|Net cash provided by financing activities||1,704,000||1,464,000|
|Effects of foreign currency rate changes on cash and cash equivalents||(1,000)||4,000|
|Net decrease in cash, cash equivalents and restricted cash||(641,000)||(1,108,000)|
|Cash and cash equivalents at beginning of period||4,513,000||4,899,000|
|Cash and cash equivalents at end of period||$3,872,000||$3,791,000|