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-- Presented Updated Data for 5F9 in Four Patient Populations at ASCO and EHA Meetings --
-- Received FDA Feedback Suggesting Single-Arm Pivotal Trials May Support Registration in MDS and DLBCL --
-- Entered Exclusive Licensing Agreement with Ono Pharmaceutical to Develop and Commercialize 5F9 in Japan, South Korea, Taiwan and the ASEAN Countries --
-- Raised $86.3 Million in Follow-On Offering, Extending Cash Runway Through First Quarter of 2021 --
-- Management to Host Conference Call at 4:30 p.m. ET Today --
MENLO PARK, Calif., Aug. 13, 2019 (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 second quarter ended June 30, 2019 and provided a business update.
“In recent months, we continued to make significant progress toward our commitment to maximizing the potential of 5F9 as a novel, first-in-class therapeutic for the treatment of cancer,” said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. “In particular, we were excited to present updated data for 5F9 in four patient populations, which showed consistent clinical activity across a range of tumor types, and enabled us to define potential accelerated pathways to approval in both MDS and DLBCL. In addition, we entered into a collaboration with Ono Pharmaceutical, allowing us to extend our reach into Japan and other South and East Asian countries and accelerate 5F9’s development, while still focusing our internal resources on executing against our path to U.S. registration.”
Dr. McCamish continued, “We enter the second half of 2019 in a strong corporate position, buoyed by our recent follow-on offering, and with clear priorities for the year ahead. We look forward to initiating our first registration-enabling studies in early 2020, while continuing to advance our broader development program for 5F9 toward additional data readouts later this year and preparing FSI-174 and FSI-189 for investigational new drug application filings.”
Second Quarter and Recent Business Highlights:
5F9 Clinical Programs:
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Non-Hodgkin Lymphoma (NHL)
The company expects to achieve the following milestones by the end of 2019:
Second Quarter 2019 Financial Results:
Conference Call Information:
Forty Seven will host a live conference call and webcast at 4:30 p.m. ET today to discuss second quarter 2019 financial results and recent business activities. The conference call may be accessed by (866) 953-0780 (domestic) or (630) 652-5854 (international), and by referring to conference ID 3387853. A webcast of the conference call will be available in the Investors section of the Forty Seven website at https://ir.fortyseveninc.com. The archived webcast will be available on Forty Seven’s website approximately two hours after the conference call and will be available for 30 days following the call.
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 multiple clinical studies in patients with solid tumors, myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian cancer 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 presentation of, timing of and outcome of results from the Phase 1b clinical trial evaluating 5F9 as a monotherapy and in combination with azacitidine for the treatment of MDS and AML, the Phase 1b/2 clinical trial of 5F9 in combination with rituximab for patients with relapsed/refractory (r/r NHL), including diffuse large B-cell lymphoma (DLBCL), the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer, the Phase 1b trial of 5F9 in combination with cetuximab in patients with colorectal cancer, and other ongoing trials of 5F9 for the treatment of solid tumors 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 sufficiency of a single-arm trial evaluating durability, complete responses and partial responses to support the registration of 5F9 in combination with azacitidine in patients with untreated, higher-risk MDS; the sufficiency of a single-arm pivotal study evaluating ORR and durability to support the registration of 5F9 in combination with rituximab in patients with r/r DLBCL; the potential of macrophage activation for the treatment of cancer; the potential of FSI-174 as a potential conditioning regimen for bone marrow transplantation; the safety, tolerability and efficacy of 5F9, FSI-189 and FDI-174; the success of Forty Seven’s collaboration and licensing agreement with Ono Pharmaceutical; Forty Seven’s ability to fund its clinical programs and the sufficiency of its cash and short-term investments; 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 Forty Seven's periodic filings with the Securities and Exchange Commission at www.sec.gov. 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.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||18,829||$||13,596||$||37,955||$||24,749|
|General and administrative||5,057||3,362||9,641||7,205|
|Total operating expenses||23,886||16,958||47,596||31,954|
|Loss from operations||(23,886||)||(16,958||)||(47,596||)||(31,954||)|
|Interest and other income, net||680||236||1374||1374|
|Unrealized gains on available-for-sale securities||41||43||141||16|
|Net loss per share, basic and diluted||$||(0.74||)||$||(2.52||)||$||(1.48||)||$||(4.76||)|
|Shares used in computing net loss per share, basic and diluted||31,355,135||6,636,862||31,261,182||6,618,736|
Forty Seven Inc.
Condensed Balance Sheets
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents and short-term investments||$||99,007||$||139,023|
|Total stockholders’ equity||91,484||133,221|