The Company did not generate any revenue from product sales in 2017, and recorded a net loss of approximately $31.9 million ($0.26 per Common Share), compared with approximately $11.6 million ($0.39 per Common Share) in 2016. The increase in net loss in 2017 was primarily due to non-cash, finance related expenses of approximately $7.9 million recorded in the fourth quarter of 2017 in connection with the valuation of the debentures and warrants that the Company issued in its private placement financing in December 2017; non-cash, finance related expenses of approximately $9 million recorded in the fourth quarter of 2017 in connection with the issuance costs of the debentures and warrants that the Company issued in its private placement financing in December 2017; other non-cash, finance related expense of approximately $9.6 million related to the valuation of the Company’s contingent liabilities at December 31, 2017 that were recorded as part of the Talent Biotechs, Ltd. acquisition; and other non-operating expenses of $331,000 recorded in the third quarter of 2017.
Research and development expenses for 2017 were approximately $1.7 million, compared to approximately $1.6 million in 2016. The slight increase in research and development expenses was primarily due to an increase in sponsored research costs as well as costs incurred relating to the invention of the Company’s patent pending CBD prodrugs and start-up costs for the Company’s clinical-trials evaluating CBD in the prevention and treatment of GVHD.
General administration expenses for 2017 were approximately $3.2 million, compared to approximately $3.5 million in 2016. The slight decrease in general administration expenses was primarily due to a decrease in consulting fees paid by the Company in 2017, compared with the amount of consulting fees paid in 2016.
As of December 31, 2017, the Company had cash and cash equivalents of approximately $3.7 million, compared with $673,000 as of December 31, 2016. Subsequent to year-end 2017, the Company’s U.S. patent application for the use of CBD in the treatment of GVHD issued as U.S. Patent No. 9,889,100 B2, and as a result Kalytera is now obligated to make a $2 million payment and to issue 2,883,535 Common Shares to the former shareholders of Talent Biotechs, Ltd. When the second patent is formally issued (expected to occur on or about May 1, 2018), this will trigger an additional contingent payment in the amount of $2 million. The Company does not currently have sufficient working capital to fully fund such obligations or to continue to fund the Company’s operations without raising additional capital in the near term.
The Company plans to raise additional capital through equity financing in the near term to finance the payments to the former Talent shareholders and its working capital requirements and the clinical development of its lead product program, CBD in the treatment and prevention of GVHD. The Company may also seek to enter into an arrangement with former Talent shareholders in order to defer its payment obligations, however, there can be no assurance that such an arrangement will be successfully entered into. If the Company is able to successfully defer its payment obligations to former Talent shareholders, or is able to raise sufficient funds to do so, the Company’s current working capital may be sufficient to fund the Company’s operations through the third quarter of 2018.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. (“Kalytera”) is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.
- Website Home: https://kalytera.co/
- News and Insights: https://kalytera.co/news/
- Investors: https://kalytera.co/investors/
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
Meanwhile, two longstanding cannabis partners ended their relationship.
Trulieve to donate $20,000 in scholarship funding and $15,000 to support leadership development
Trulieve Cannabis Corp . (CSE: TRUL) (OTC: TCNNF), a leading and top-performing cannabis company in the United States today announced a new partnership with the Thurgood Marshall College Fund (TMCF), the nation’s largest organization exclusively representing the Black College Community. Trulieve will donate $20,000 to help fund several college scholarships awarded to students who are attending one of the organization’s member-schools as part of Trulieve’s diversity, equity, and inclusion initiatives. The $15,000 in talent funding is earmarked to support TMCF’s internship program, reaching a diverse talent pool of students and alumni from their 47 member-schools to provide immersive experiences at Trulieve.
The new dispensary expands patient access to Florida’s largest inventory of medical cannabis products
Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) (“Trulieve” or “the Company”), a leading and top-performing cannabis company based in the United States announced today the opening of a brand-new Florida dispensary, the Company’s 80th nationwide. The new location marks the Company’s first in Tamarac and third in Broward County expanding patient access to Florida’s largest and broadest assortment of high-quality medical cannabis products.
Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Planned Completion and Emergency Use Authorization Request
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
With its recent $23 million dollar financing, the Company plans to aggressively expand from 14 clinical sites to up to 50 clinical sites to meet the next enrollment goals for the Study in Q2-2020. The Study is a randomized, double-blinded, placebo-controlled trial and the safety and efficacy data analyzed at each interim analysis timepoint of 210, 400, 600 and 800 completed patients are only made available to the Independent Data and Safety Monitoring Board (“DSMB”) for review and recommendations on continuation, stopping or changes to the conduct of the Study. In the event of any serious safety concerns, the DSMB would be notified to determine any risks and provide its recommendations. To date, in this initial 210 interim point there have been no serious safety concerns that required the DSMB to be notified.
HempFusion Wellness Inc. (TSX:CBD.U) (OTCQX:CBDHF) (FWB:8OO) (“HempFusion” or the “Company”), a leading health and wellness CBD company utilizing the power of whole-food hemp nutrition, is pleased to announce that its common shares have been approved for DTC full-service eligibility in the United States by the Depository Trust Company (“DTC”) and can now be both traded and serviced through DTC’s electronic book-entry system.
DTC is a subsidiary of the Depository Trust & Clearing Corp. (“DTCC”) that provides clearing and settlement services for the financial markets and settles the majority of securities transactions in the United States. This electronic method of clearing securities speeds up the receipt of stock and cash and thus accelerates the settlement process for investors and brokers, enabling the stock to be traded over a much wider selection of brokerage firms.