On November 12, 2019 Forty Seven, Inc. (Nasdaq:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Forty Seven, NOV 12, 2019, View Source [SID1234551042]).
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"In the third quarter, we continued to enroll patients in our Phase 1b clinical trial of magrolimab in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), while preparing to initiate potential registration-enabling trials in MDS and diffuse large B cell lymphoma (DLBCL) in the first quarter of 2020," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven. "We have plans in place for both programs that we believe could enable us to pursue accelerated paths to approval and to address the unmet needs of substantial patient populations in need of safe, well-tolerated and effective new options."
Dr. McCamish continued, "We also made important progress with our preclinical candidates, FSI-174 and FSI-189, and remain on track to advance both into clinical testing next year. This morning, we announced a new collaboration with bluebird bio to evaluate our antibody-based conditioning regimen, comprised of magrolimab and FSI-174, in combination with LentiGlobin. We believe this partnership will allow us to accelerate and expand our efforts to provide an alternative, antibody-only conditioning regimen that avoids chemotherapy/radiation exposure for patients undergoing hematopoietic stem cell (HSC) transplantation. We are excited to work with the bluebird team as we continue our efforts to fully exploit the CD47 pathway as a novel therapeutic target."
Third Quarter and Recent Business Highlights:
Magrolimab Clinical Programs:
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Forty Seven continues to enroll patients in its ongoing, single-arm trial evaluating magrolimab in combination with azacitidine in approximately 90 patients with untreated, intermediate to very high risk MDS, treated with weekly dosing. The primary endpoint of the trial is overall response rate (ORR) with durability of response. The company expects to complete enrollment in the third quarter of 2020. In parallel, Forty Seven continues to engage with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) to finalize key parameters of a second clinical trial, evaluating every two week dosing, which may support a potential accelerated approval. The company is moving forward in parallel with chemistry, manufacturing and controls (CMC) activities to support an expected filing of a biologics license application (BLA) in the fourth quarter of 2021, consistent with prior guidance.
In September 2019, Forty Seven announced that the FDA granted Fast Track designation to magrolimab for the treatment of MDS and AML.
Non-Hodgkin Lymphoma (NHL)
Forty Seven has finalized the patient eligibility criteria for its planned registration-enabling trial evaluating magrolimab in combination with rituximab in approximately 100 patients with diffuse large B-cell lymphoma (DLBCL). The company plans to enroll patients who have failed at least two prior lines of therapy. The primary endpoint of the trial will evaluate ORR and durability of response. Forty Seven expects to initiate the study in the first quarter of 2020, and to report interim efficacy data by the fourth quarter of 2020. In parallel, the company continues to evaluate biomarkers for potential predictive value, which could enable advancement into earlier lines of treatment.
O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States
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Solid Tumors
Forty Seven recently submitted abstracts including data from its ongoing Phase 1b trial of magrolimab in combination with avelumab in patients with ovarian cancer, and its Phase 1b trial of magrolimab in combination with cetuximab in patients with colorectal cancer, to major medical meetings which will occur in the first quarter of 2020. The company plans to announce initial data from both studies at the time of those presentations.
FSI-174:
In November 2019, Forty Seven entered into a collaboration with bluebird bio to evaluate Forty Seven’s antibody-based conditioning regimen, which is comprised of FSI-174 and magrolimab, with bluebird’s LentiGlobin gene therapy platform for the treatment of beta thalassemia and sickle cell disease. The companies expect to initiate a Phase 1b trial in 2020.
oming Milestones:
Forty Seven will present expanded efficacy and durability data from the Phase 1b trial of magrolimab in combination with azacitidine in patients with MDS and AML in an oral presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held December 7-10, 2019 in Orlando, Florida. Also at ASH (Free ASH Whitepaper), Forty Seven will present a poster detailing preclinical data for FSI-174.
Additionally, the company expects to complete investigational new drug (IND)-enabling studies for both FSI-174 and FSI-189 before year-end.
Third Quarter 2019 Financial Results:
Cash Position: As of September 30, 2019, cash, cash equivalents and short-term investments were $166.7 million, as compared to $139.0 million as of December 31, 2018. This increase reflects aggregate gross proceeds of approximately $86.3 million from Forty Seven’s underwritten public offering of common stock that closed in July 2019, as well as an approximately $15.7 million upfront license payment from Forty Seven’s entry into its 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.
Revenue: Revenues were $15.7 million for the third quarter of 2019, due to the license granted under the Ono agreement. Forty Seven did not record revenues in the third quarter of 2018.
R&D Expenses: R&D expenses were $27.1 million for the third quarter of 2019, as compared to $18.0 million for the third quarter of 2018. The increase was primarily due to a $9.2 million increase in advancing Forty Seven’s current clinical programs focused on lead product candidate, magrolimab, and associated contract manufacturing costs for BLA enabling studies, a $3.2 million increase in preclinical program costs, a $1.5 million decrease in funding recognition under the California Institute for Regenerative Medicine (CIRM) and Leukemia and Lymphoma Society (LLS) grants, and a $1.1 million increase in personnel-related costs, partially offset by a $5.9 million decrease in license fees, primarily due to the non-recurring license fees paid under the BliNK asset purchase and the Synthon license agreements in 2018.
G&A Expenses: G&A expenses were $5.0 million for the third quarter of 2019, as compared to $4.4 million for the third quarter of 2018. The increase was primarily due to a $0.4 million increase in personnel and corporate related costs driven by an increase in headcount.
Net Loss: Net loss was $15.1 million for the third quarter of 2019, or a net loss per share of $0.38, as compared to $21.7 million for the third quarter of 2018, or a net loss per share of $0.71.
O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States
Helping Patients Defeat Their Cancer
Conference Call Information:
Forty Seven will host a live conference call and webcast at 8:00 a.m. ET today to discuss third 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 7667736. A webcast of the conference call will be available in the Investors section of the Forty Seven website at View Source 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.