Forty Seven Inc. Reports Second Quarter 2018 Financial Results and Recent Business Highlights
-- Presented Preliminary Data from Three Clinical Trials of 5F9 as a Monotherapy and Combination Agent --
-- Granted Fast Track Designation from the
-- 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
-- Successfully Completed Initial Public Offering, Raising
“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
Second Quarter and Recent Business Highlights:
June 2018, Forty Seven presented preliminary data from three separate clinical trials evaluating 5F9 in patients with solid and hematological tumors. In these trials, 5F9 was safe and generally well-tolerated at all doses, with on-target anemia successfully mitigated by Forty Seven’s proprietary priming and maintenance dose regimen:
- At the 2018
American Society of Clinical Oncology( ASCO) Annual Meeting in Chicago, Illinois, Forty Seven presented proof-of-concept data from the first 22 patients in an ongoing Phase 1/2b trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL), including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Forty Seven subsequently shared updated data from 30 patients in this trial, which showed an objective response rate of 47% and a complete response rate of 33%. Median duration of response was not reached with over six and eight months median follow-up in DLBCL and FL, respectively.
- Also at
ASCO, Forty Seven presented data from a Phase 1 pharmacokinetic and pharmacodynamic trial of single-agent 5F9 in patients with advanced solid tumors. Data demonstrated preliminary evidence of anti-tumor activity, including two confirmed partial responses in patients with ovarian cancer.
- At the 23rd
Congressof the European Hematology Association(EHA) in Stockholm, Sweden, Forty Seven presented preliminary data from an ongoing Phase 1 clinical trial of monotherapy 5F9 in patients with relapsed/refractory acute myeloid leukemia. The data showed encouraging biologic activity, which supports continued evaluation of 5F9 in combination studies with azacitidine and atezolizumab.
- At the 2018
June 2018, Forty Seven and its partner, Merck KGaA, dosed the first patient in a Phase 1b clinical trial evaluating 5F9 in combination with avelumab, Merck KGaA’s PD-L1 checkpoint inhibitor. The open-label, multicenter trial is designed to determine safety, tolerability and anti-tumor activity of the combination of 5F9 and avelumab in patients with ovarian cancer.
May 2018, Forty Seven announced that the U.S. Food and Drug Administrationgranted two Fast Track designations to 5F9 for the treatment of r/r DLBCL and FL, two forms of B-cell NHL.
July 2018, Forty Seven signed a settlement and license agreement with Synthon Biopharmaceuticals B.V., resolving the ongoing patent litigation and granting Forty Seven a sublicense that covers 5F9 for the treatment of cancer in combination with other antibodies. Under the terms of the agreement, Forty Seven will pay Synthon an aggregate of up to approximately $47 million, comprising an upfront payment upon grant of the sublicense and subsequent payments upon the achievement of future regulatory and commercial milestones, which comprise the significant majority of the aggregate payments. In addition, Forty Seven will pay Synthon an annual license fee and a royalty of a tiered, low single digit percentage on net sales of any approved licensed products.
July 2018, Forty Seven closed its initial public offering of 8,090,250 shares of common stock at a price to the public of $16.00per share, which includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. The aggregate net proceeds to Forty Seven from the offering were $116.3 million.
June 2018, Forty Seven entered into an asset purchase agreement with BliNK Biomedical SAS, through which the Company acquired all assets related to BliNK’s research and development program for antibodies directed against CD47. These assets consist of an anti-CD47 monoclonal antibody for potential use in non-oncology indications, in addition to certain patents and patent applications.
April 2018, Forty Seven announced the appointment of Ian T. Clarkto its board of directors.
April 2018, Forty Seven announced the appointment of Ann D. Rhoadsas chief financial officer.
Second Quarter 2018 Financial Results:
- Cash Position: As of
June 30, 2018, cash, cash equivalents and short-term investments were $58.0 million, as compared to $88.1 millionas of December 31, 2017. Cash and cash equivalents as of June 30, 2018do not include the proceeds from the Company’s initial public offering of common stock, which closed in July 2018. The Company expects that the proceeds from its initial public offering, together with its cash, cash equivalents and short-term investments as of June 30, 2018, will fund operating expenses and capital expenditure requirements into 2020.
- R&D Expenses: R&D expenses were
$13.6 millionfor the second quarter ended June 30, 2018, as compared to $9.2 millionfor the same period in 2017. This increase was primarily due to continued advancement of the Company’s current clinical programs and the expansion of the Company’s preclinical and discovery efforts, partially offset by the receipt of $1.4 millionin grant funding recognized under the Company’s grants from the California Institute of Regenerative Medicineand the Leukemia & Lymphoma Society
- G&A Expenses: G&A expenses were
$3.4 millionfor the second quarter ended June 30, 2018, as compared to $1.7 millionfor the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in preparation for the Company’s initial public offering.
- Net Loss: Net loss was
$16.7 millionfor the second quarter ended June 30, 2018, or $2.52per basic and diluted share, as compared to a net loss of $10.8 million, or $1.68per basic and diluted share, for the same period in 2017.
Forward Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the timing of Forty Seven’s clinical trials, the safety, tolerability and efficacy of 5F9 and its other anti-CD47 products, Forty Seven’s ability to fund its clinical programs, Forty Seven’s receipt of clinical data from clinical trials of 5F9 and its other anti-CD47 products, and Forty Seven’s financial outlook. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven's stock price. Additional information concerning these and other risk factors affecting Forty Seven's business can be found in the prospectus dated
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Statements of Operations Data
(In thousands, except share and per share data)
|Three Months Ended
|Six Months Ended
|Research and development||$||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||)||$||(3.39||)|
|Shares used in computing net loss per share, basic and diluted (1)||6,636,862||6,431,534||6,618,736||6,404,423|
|(1) The shares outstanding for the three and six months ended June 30, 2018 exclude the common stock issued upon the completion of the Company's Initial Public Offering and the conversion of all outstanding shares of convertible preferred stock into shares of common stock in July 2018.|
Selected Balance Sheet Data
|As of June 30, 2018||As of December 31, 2017|
|Actual||Pro Forma (2)||Actual|
|Cash, cash equivalents and short-term investments||$||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.
Source: Forty Seven, Inc.