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-- Presented Preliminary Data from Three Clinical Trials of 5F9 as a Monotherapy and Combination Agent --
-- Granted Fast Track Designation from the U.S. Food and Drug Administration for 5F9 in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma --
-- Dosed First Patient in Phase 1b Clinical Trial Evaluating 5F9 in Combination with PD-L1 Inhibitor in Ovarian Cancer --
-- Strengthened Company Leadership, Appointing Ian T. Clark to Board of Directors and Ann D. Rhoads as Chief Financial Officer --
-- Successfully Completed Initial Public Offering, Raising $129.4 Million in Gross Proceeds --
MENLO PARK, Calif., Aug. 13, 2018 (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 and provided a business update for the second quarter ended June 30, 2018.
“The second quarter was a period of significant growth for Forty Seven, marked by our maturation into a publicly-traded company and the presentation of preliminary data from three clinical trials of 5F9, our leading monoclonal antibody against CD47,” said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. “Based on our early clinical experience with 5F9, we believe that harnessing macrophages in the fight against cancer may offer patients with difficult-to-treat solid and hematological tumors a new therapeutic option, with potential both as a single agent and in combination with approved tumor targeting antibodies and checkpoint inhibitors. We look forward to advancing our six ongoing studies of 5F9 toward multiple data readouts in 2019 and to broadening our investigative reach with the initiation of new trials, which we believe will allow us to fully explore 5F9’s potential across a range of tumor types and treatment modalities.”
Second Quarter and Recent Business Highlights:
Second Quarter 2018 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 based on technology licensed from Stanford University. Forty Seven’s lead program, 5F9, is a monoclonal antibody against the CD47 receptor, a “don’t eat me” signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in six clinical studies in patients with solid tumors, acute myeloid leukemia, non-Hodgkin’s lymphoma and colorectal carcinoma.
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 "may," "will," "expect," "anticipate," "estimate," "intend," 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 of Forty Seven’s clinical trials, the safety, tolerability and efficacy of 5F9 and its other anti-CD47 products, Forty Seven’s ability to fund its clinical programs, Forty Seven’s receipt of clinical data from clinical trials of 5F9 and its other anti-CD47 products, and Forty Seven’s financial outlook. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. 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. In addition, 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. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven's stock price. Additional information concerning these and other risk factors affecting Forty Seven's business can be found in the prospectus dated June 27, 2018 filed with the Securities and Exchange Commission (SEC) on July 28, 2018 and Quarterly Report on Form 10-Q to be filed with the SEC on August 13, 2018. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Forty Seven disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
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Forty Seven, Inc.
Statements of Operations Data
(In thousands, except share and per share data)
Three Months Ended
Six Months Ended
|Research and development||$||13,596||$||9,189||$||24,749||$||18,370|
|General and administrative||3,362||1,697||7,205||3,458|
|Total operating expenses||16,958||10,886||31,954||21,828|
|Loss from operations||(16,958||)||(10,886||)||(31,954||)||(21,828||)|
|Interest and other income, net||236||59||457||93|
|Net loss per share, basic and diluted||$||(2.52||)||$||(1.68||)||$||(4.76||)||$||(3.39||)|
|Shares used in computing net loss per share, basic and diluted (1)||6,636,862||6,431,534||6,618,736||6,404,423|
|(1) The shares outstanding for the three and six months ended June 30, 2018 exclude the common stock issued upon the completion of the Company's Initial Public Offering and the conversion of all outstanding shares of convertible preferred stock into shares of common stock in July 2018.|
Forty Seven, Inc.
Selected Balance Sheet Data
|As of June 30, 2018||As of December 31, 2017|
|Actual||Pro Forma (2)||Actual|
|Cash, cash equivalents and short-term investments||$||58,007||$||174,325||$||88,111|
|Total stockholders’ equity (deficit)||(96,130||)||165,520||83,462|
| (2) Represents the unaudited pro forma Balance Sheet data as of June 30, 2018 and has been prepared assuming (a) the automatic conversion of all outstanding shares of convertible preferred stock into shares of common stock up the completion of the Initial Public Offering, and (b) the issuance of common shares in the Initial Public Offering including the exercise of the underwriter's over-allotment option.