Forty Seven Inc. Reports Third Quarter 2018 Financial Results and Recent Business Highlights
-- Advanced Oncology Pipeline with FSI-189, an Anti-SIRPα Antibody; Investigational New Drug (IND) Application-Enabling Studies Expected to Begin in 2019 –
-- Enhanced Corporate Position,
-- Plan to Present New Preclinical Data Supporting Priming Dose and Azacitidine Combination Strategies for 5F9 at
“Our recent accomplishments reflect our commitment to establishing Forty Seven as a pioneer in the development of a new class of checkpoint therapies, which harness the innate immune system to help patients more effectively defeat their disease,” said
“In addition to progressing our ongoing clinical trials of 5F9 toward data readouts in 2019, we advanced our pipeline in the third quarter with additional efforts on FSI-189 as our next development candidate,” continued Dr. McCamish. “FSI-189 is an anti-SIRPα antibody, designed to interfere with CD47 activity through a distinct modality, which enables us to more fully exploit the potential of the CD47/SIRPα pathway as a novel oncology target. We look forward to building on this momentum in the coming months, as we work together with our newly appointed SAB to advance our pipeline and maximize our impact.”
- Forty Seven plans to present preclinical data providing new insights into the mechanism of action of its priming and maintenance dose strategy for 5F9 in a poster session at the 60th ASH Annual Meeting, which will be held
December 1-4, 2018in San Diego, California. Also at ASH, Forty Seven will present a poster detailing new preclinical data that supports the combination of 5F9 and azacitidine for the treatment of acute myeloid leukemia (AML). Patients with AML have already been dosed with this combination based on these promising preclinical results.
Third Quarter and Recent Business Highlights:
October 2018, Forty Seven advanced FSI-189, an anti-SIRPα antibody, as its second product candidate for the treatment of cancer. SIRPα is the cognate receptor of CD47 and, in preclinical models, FSI-189 blocked SIRPα binding to CD47 and enhanced macrophage phagocytosis of cancer cells. SIRPα is only expressed on certain cells types, including macrophages. As a result, Forty Seven believes that FSI-189 may be effective at low doses. FSI-189 is currently in preclinical development, and Forty Seven plans to initiate IND-enabling studies in 2019.
October 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory NHLwere published in the New England Journal of Medicine. In the Phase 1b portion of the study, 5F9 demonstrated signs of clinical efficacy, and was safe and well-tolerated in the patients treated.
October 2018, Forty Seven announced the formation of its SAB, including the appointment of four leading scientists in the fields of immunotherapy and oncology: 2018 Nobel Laureate for Medicine, James Allison, Ph.D.; Ronald Levy, M.D.; Padmanee Sharma, M.D., Ph.D.; and Louis Weiner, M.D.
August 2018, the European Patent Office Opposition Division ruled in favor of Forty Seven, rejecting challenges to the company’s licensed European patent, EP ‘512, which covers the use of CD47 antibodies designed to treat cancer through phagocytosis. This decision strengthens Forty Seven’s patent protection for 5F9 in Europe.
Third Quarter 2018 Financial Results:
- Cash Position: As of
September 30, 2018, cash, cash equivalents and short-term investments were $154.0 million, as compared to $88.1 millionas of December 31, 2017. This increase reflects net proceeds of $116.3 millionfrom Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into 2020.
- R&D Expenses: R&D expenses were
$18.0 millionfor the third quarter ended September 30, 2018, as compared to $8.8 millionfor the same period in 2017. This increase was primarily due to non-recurring upfront payments on two licensing deals of $6.3 million, as well as the continued advancement of the company’s clinical development efforts and preclinical and discovery programs. This increase was partially offset by $1.7 millionin grant and cost-share funding recognized under the company’s grants from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Societyand Merck KGaA.
- G&A Expenses: G&A expenses were
$4.4 millionfor the third quarter ended September 30, 2018, as compared to $2.1 millionfor the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in connection with operating as a public company.
- Net Loss: Net loss was
$21.7 millionfor the third quarter ended September 30, 2018, or $0.71per basic and diluted share, as compared to a net loss of $10.8 million, or $1.67per basic and diluted share, for the same period in 2017.
Forward Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential of macrophage activation for the treatment of cancer, the potential of FSI-189 as a treatment of cancer and the potential for a
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|Forty Seven, Inc.
Statement of Operations Data
(In thousands, except share and per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||$||17,984||$||8,842||$||42,733||$||27,212|
|General and administrative||4,383||2,051||11,588||5,509|
|Total operating expenses||22,367||10,893||54,321||32,721|
|Loss from operations||(22,367||)||(10,893||)||(54,321||)||(32,721||)|
|Interest and other income, net||708||60||1,165||153|
|Net loss per share, basic and diluted||$||(0.71||)||$||(1.67||)||$||(3.63||)||$||(5.06||)|
|Shares used in computing net loss per share, basic and diluted||30,430,898||6,504,467||14,643,348||6,438,138|
|Forty Seven, Inc.
Selected Balance Sheet Data
|As of September 30, 2018||As of December 31, 2017|
|Cash, cash equivalents and short-term investments||$||154,018||$||88,111|
|Total stockholders’ equity (deficit)||149,235||83,462|
Source: Forty Seven, Inc.