MENLO PARK, Calif., March 20, 2020 (GLOBE NEWSWIRE) -- Forty Seven Inc., (Nasdaq:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a business update.
In 2019, Forty Seven transformed into a multi-asset, late-stage development company with clear paths to registration in two distinct, underserved patient populations. In parallel, we entered into several new partnerships designed to accelerate the development of magrolimab and FSI-174, and allow us to evaluate both compounds more rapidly across a range of indications and combination paradigms, said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven. Following the recently announced acquisition by Gilead, and with the benefit of their resources and capabilities, we are even better positioned to build on this momentum and deliver on our foundational vision of developing novel immunotherapies that help patients defeat their cancers.
Dr. McCamish continued, Like so many others, we are closely monitoring COVID-19, and have recently instituted a number of proactive measures to mitigate the spread of the virus and protect the safety, health and well-being of the patients, families and healthcare professionals involved in our clinical development programs, as well as our employees. While we are working diligently to limit the impact of COVID-19 on our ongoing clinical trials, we, together with our contract research organization, decided to delay the initiation of our Phase 1 trial of FSI-174 in healthy volunteers in order to support physicians and hospitals in devoting their resources to treating COVID-19 patients, and avoid exposing healthy volunteers to unnecessary risk. We will continue to evaluate the pandemic and expect to re-visit the timing of potential trial initiation in the second quarter.
Fourth Quarter and Recent Business Highlights:
Magrolimab Clinical Programs:Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Diffuse Large B Cell Lymphoma (DLBCL)
Solid Tumors
FSI-174:
FSI-189:
Corporate:
Fourth Quarter and Full Year 2019 Financial Results:
About Forty Seven, Inc.Forty Seven, Inc.is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways and specific cell targeting approaches based on technology licensed fromStanford University. Forty Sevens lead program, magrolimab, is a monoclonal antibody against the CD47 receptor, a dont eat me signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in multiple clinical studies in patients with myelodysplastic syndrome, acute myeloid leukemia and non-Hodgkins lymphoma. In March 2020, Forty Seven entered into a definitive agreement to be acquired by Gilead Sciences, Inc., which is expected to close during the second quarter of 2020.
Additional Information and Where to Find It
This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Forty Seven, nor is it a substitute for any tender offer materials that Gilead, its acquisition company or Forty Seven has or will file with the SEC. A solicitation and an offer to buy shares of Forty Seven will be made only pursuant to an offer to purchase and related materials that Gilead has filed with the SEC. At the time the tender offer was commenced, Gilead filed a Tender Offer Statement on Schedule TO with the SEC, and Forty Seven filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. FORTY SEVENS STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, has been sent to all stockholders of Forty Seven at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement are available for free at the SEC's web site at http://www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Forty Seven. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Forty Seven will be available free of charge under the Investors section of Forty Sevens internet website at ir.fortyseveninc.com.
Forward-Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expect, potential, plans, will, believe, and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the timing and outcome of results from the Phase 1b trial evaluating magrolimab in combination with azacitidine for the treatment of MDS and AML, the potentially-registration enabling clinical development program for magrolimab in higher-risk MDS, the single-arm, registration enabling trial evaluating the combination of magrolimab and rituximab in heavily pre-treated relapsed or refractory DLBCL patients, and other ongoing trials of 5F9 for the treatment of ovarian and colorectal cancer; the timing of and quality of results from investigational new drug-application enabling studies for FSI-189 and FSI-174 and their respective potential for approval by the FDA; the timing and success of research and development plans for Rockets and Forty Sevens respective platforms, product candidates and collaboration; the timing and success of research and development plans for bluebirds and Forty Sevens respective platforms, product candidates and collaboration; the business combination with Gilead and related matter; post-closing operations and the outlook for the companies respective businesses, including, without limitation, the ability of Gilead to advance Forty Sevens product pipeline, including magrolimab, FSI-174 and FSI-189; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; Forty Sevens ability to fund its clinical programs and the sufficiency of its cash and short-term investments, and Forty Sevens financial outlook; and any assumptions underlying any of the foregoing.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by such forward-looking statements include: the potential product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or successfully commercialized; uncertainties as to the timing of the business combination with Gilead; the possibility that various closing conditions for the business combination may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the business combination on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies periodic reports filed with the U.S. Securities and Exchange Commission (the SEC), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 filed by Forty Seven and the Schedule TO and related tender offer documents filed by Gilead and Toro Merger Sub, Inc., a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead and Forty Seven, and Gilead and Forty Seven assume no obligation and disclaim any intent to update any such forward-looking statements.
For more information please visit http://www.fortyseveninc.com or contactinfo@fortyseveninc.com.
For journalist enquiries please contact Sarah Plumridge atfortyseven@hdmz.comor phone (312) 506-5218.
For investor enquiries please contact Hannah Deresiewicz at Stern Investor Relations Inc. athannah.deresiewicz@sternir.comor phone (212) 362-1200.
Forty Seven Inc.Statements of Operations and Comprehensive Loss Data(In thousands, except share and per share data)
Forty Seven Inc.Selected Balance Sheet Data(in thousands)
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Forty Seven, Inc. Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights - BioSpace
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