Magrolimab – Other Programs
Forty Seven will expand enrollment in its ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine to include additional untreated TP53 mutant AML patients who are ineligible for induction chemotherapy to inform a potential registrational path. Updated data from this trial will be presentedmid-year.
Additionally, Forty Seven is evaluating magrolimab for the treatment of colorectal (CRC) and ovarian cancer. Clinical data in patients with CRC and ovarian cancer will be presented at the ASCO Gastrointestinal Cancers Symposium(ASCO-GI), held January23-25, 2020 in San Francisco, and the ASCO-SITC Clinical Immuno-Oncology Symposium, held February6-8, 2020 in Orlando, respectively. While data from these studies do not support a path to registration, Forty Seven intends to use these results and learnings to identify its next steps in solid tumors.
Additional Pipeline Programs
Forty Seven is developing a broad pipeline of additional programs, which take advantage of the CD47/SIRPα pathway as a rich target for engaging macrophages.FSI-174, an anti-cKIT antibody, is being developed in combination with magrolimab as a novel,all-antibody conditioning regimen to address the limitations of current stem cell transplantation conditioning regimens.FSI-189, an anti-SIRPα antibody, is being developed for the treatment of cancer, as well as certainnon-oncology conditions including transplantation conditioning.
The company expects to achieve the following milestones in 2020:
| • | | Initiate a Phase 1 clinical trial evaluating the safety and tolerability ofFSI-174 in healthy volunteers in the first quarter; |
| • | | File an investigational new drug application with the FDA forFSI-189 in the first quarter; and |
| • | | Initiate a Phase 1 clinical trial evaluating the safety and tolerability ofFSI-189 for the treatment of cancer in the second quarter. |
Cash Position and Financial Guidance:
Based on preliminary estimates, Forty Seven had cash, cash equivalents and short-term investments of $329.1 million at December 31, 2019. Based on its current operating plans, Forty Seven expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the first quarter of 2022.
About Forty Seven, Inc.
Forty Seven, Inc. is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways and specific cell targeting approaches based on technology licensed from Stanford University. Forty Seven’s lead program, magrolimab, 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 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 “potential,” “believe,” “expect,” “will,” “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 the innate immune system in the fight against disease, Forty Seven’s potential-registration enabling programs for magrolimab in MDS and DLBCL, Forty Seven’s success in advancing and