Forty Seven Inc. Reports Second Quarter 2019 Financial Results and Recent Business Highlights
-- Presented Updated Data for 5F9 in Four Patient Populations at
-- Received FDA Feedback Suggesting Single-Arm Pivotal Trials May Support Registration in MDS and DLBCL --
-- Entered Exclusive Licensing Agreement with
-- Management to Host Conference Call at
“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
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)
June 2019, Forty Seven presented updated initial data from its Phase 1b clinical trial evaluating 5F9 as a monotherapy and in combination with azacitidine for the treatment of MDS and AML at the 2019 American Society of Clinical Oncology( ASCO) Annual Meeting in Chicago, Illinoisand at the 24th Congressof the European Hematology Associationin Amsterdam, Netherlands. Among patients treated with the combination regimen, the ORR was 100% in higher-risk MDS and 64% in untreated AML. 5F9 was well-tolerated in combination with azacitidine and AEs were consistent with prior clinical experience. Read the full data here.
- Also in
June 2019, Forty Seven received feedback from the FDAand believes that a single-arm trial evaluating durability, complete responses and partial responses may be sufficient to support the registration of 5F9 in combination with azacitidine in patients with untreated, intermediate to very high-risk MDS. The Company anticipates needing a sample size of approximately 91 patients, with six-month efficacy and 12-month safety follow-up data. Based on this feedback, Forty Seven is expanding its ongoing Phase 1b clinical trial to 91 patients, treated with weekly dosing, to accelerate the acquisition of 12-month safety data. In parallel, the Company will work with the FDAunder a Special Protocol Assessment to finalize key parameters of a second trial of 91 patients, treated with bi-weekly dosing. The Company expects to complete enrollment in its ongoing trial in the third quarter of 2020, to initiate the second clinical trial in the first quarter of 2020 and complete enrollment in the first quarter of 2021, and, if successful, to file a biologics license application (BLA) using combined efficacy and safety data in the fourth quarter of 2021.
Non-Hodgkin Lymphoma (
June 2019, Forty Seven presented updated clinical data from its ongoing 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) and indolent lymphoma at the 24th Congressof the European Hematology Association(EHA) in Amsterdam, Netherlandsand at the 15th International Conference of Malignant Lymphoma(ICML) in Lugano, Switzerland. The overall response rate (ORR) for patients treated in the Phase 1b/2 trial was 45% per Lugano criteria (36% in DLBCL and 61% in indolent lymphoma). Among DLBCL patients treated in the Phase 2 portion of the study, all of whom had either primary refractory disease or were relapsed/refractory to ≥ 2 prior lines of therapy and ineligible for CAR-T therapy, the ORR was 29%. 5F9 was well-tolerated in combination with rituximab and adverse events (AEs) were consistent with prior clinical experience. Read the full data here.
- Also in
June 2019, Forty Seven received feedback from the U.S. Food and Drug Administration( FDA) and believes that a single-arm pivotal study evaluating ORR and durability may be sufficient to support the registration of 5F9 in combination with rituximab in patients with r/r DLBCL who have failed at least two prior lines of therapy, including those who have been deemed CAR-T ineligible. Based on this feedback, Forty Seven plans to initiate a registration-enabling trial evaluating the combination, dosed bi-weekly, in approximately 100 patients. The Company is refining patient eligibility criteria based on clinical and translational data from its Phase 1b/2 trial, and expects to initiate the study in the first quarter of 2020, with interim efficacy data available by the fourth quarter of 2020.
July 2019, Forty Seven entered into an amendment of its agreement with The Leukemia & Lymphoma Society(LLS) to accelerate the development of 5F9 in MDS. Under the collaboration, funded through LLS’s Therapy Acceleration Program® (TAP), Forty Seven is eligible for up to $3.0 millionin milestone payments from LLS upon the achievement of certain clinical or regulatory milestones. This is on top of the prior LLS TAP funding commitment of $4.2 millionto progress 5F9 through clinical development. LLS also recently purchased $3.0 millionof common stock in Forty Seven’s July 2019public offering.
July 2019, Forty Seven announced the closing of an underwritten public offering of 10,781,250 shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of stock. Forty Seven received gross proceeds from the offering of approximately $86.3 million, before deducting underwriting discounts and commissions and estimated offering expenses.
July 2019, Forty Seven entered into an exclusive licensing agreement with Ono Pharmaceutical Co., Ltd. for the development, manufacture and commercialization of 5F9 as a monotherapy or combination agent in Japan, South Korea, Taiwanand the ASEAN countries. Under the terms of the agreement, Forty Seven will receive a one-time upfront payment of approximately $15.7 millionfrom Ono, and is eligible to receive up to an additional approximately $103.3 millionat current exchange rates if specified future development and commercial milestones are achieved by Ono, in addition to tiered percentage royalties, spanning from the mid-teens to the low-twenties, on future net sales of 5F9 in the territory.
The company expects to achieve the following milestones by the end of 2019:
- Report expanded efficacy and durability data from the Phase 1b trial of 5F9 in combination with azacitidine in patients with MDS and AML in the fourth quarter.
- Report data from the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer in the fourth quarter.
- Report data from the Phase 1b trial of 5F9 in combination with cetuximab in patients with colorectal cancer in the fourth quarter.
- Report preclinical data and complete investigational new drug (IND)-enabling studies for FSI-174, an anti-cKIT antibody with potential use as a novel conditioning regimen for bone marrow transplantation, in the second half.
- Complete IND-enabling studies for FSI-189, an anti-SIRPα antibody with therapeutic potential for cancer and other indications, in the second half.
Second Quarter 2019 Financial Results:
- Cash Position: As of
June 30, 2019, cash, cash equivalents and short-term investments were $99.0 million, as compared to $139.0 millionas of December 31, 2018. Cash and cash equivalents as of June 30, 2019do not include aggregate gross proceeds of approximately $86.3 millionfrom the Company’s July 2019public offering, or the approximate $15.7 millionupfront payment received in connection with Forty Seven’s entering into the collaboration with Ono Pharmaceutical. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first quarter of 2021.
- R&D Expenses: R&D expenses were
$18.8 millionfor the second quarter of 2019, as compared to $13.6 millionfor the second quarter of 2018. The increase was primarily due to a $3.2 millionincrease in third-party costs related to advancing Forty Seven’s current clinical programs focused on lead product candidate, 5F9, and associated contract manufacturing costs, a $1.1 millionincrease in preclinical and discovery program costs, and a $0.9 millionincrease in personnel-related costs.
- G&A Expenses: G&A expenses were
$5.1 millionfor the second quarter of 2019, as compared to $3.4 millionfor the second quarter of 2018. The increase was primarily due to a $0.8 millionincrease in personnel-related costs driven by an increase in headcount, a $0.6 millionincrease in accounting and consulting expenses incurred in connection with operating as a public company and business expansion, and a $0.2 millionincrease in directors and officer’s insurance expense.
- Net Loss: Net loss was
$23.2 millionfor the second quarter of 2019, or a net loss per share of $0.74, as compared to $16.7 millionfor the second quarter of 2018, or a net loss per share of $2.52.
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.
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
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
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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||)||$||(4.76||)|
|Shares used in computing net loss per share, basic and diluted||31,355,135||6,636,862||31,261,182||6,618,736|
Condensed Balance Sheets
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents and short-term investments||$||99,007||$||139,023|
|Total stockholders’ equity||91,484||133,221|
Source: Forty Seven, Inc.