On January 10, 2020 Forty Seven, Inc. (Nasdaq:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported its strategic plan and expected milestones for 2020 (Press release, Forty Seven, JAN 10, 2020, View Source [SID1234552973]).

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"Our vision is to deliver groundbreaking therapies to patients by harnessing the potential of the innate immune system in the fight against disease," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven. "As we enter the new year, we are executing against this strategy with full force. Our potential-registration enabling programs for magrolimab in MDS and DLBCL are underway, and we are pleased to have recently received FDA Orphan Drug designation for magrolimab in MDS. In parallel, we are preparing to advance FSI-174 and FSI-189 into the clinic, where we believe we can leverage our deep understanding of the CD47/SIRPα pathway to engage previously unexploited phagocytic pathways."

Dr. McCamish continued, "Following our successful follow-on offering in December 2019, we are well financed, with sufficient resources to advance our pipeline through key milestones, including the potential submission of our first biologics license application for magrolimab, while scaling our CMC activities to support future product launches. We expect 2020 to be a year of notable progress across our portfolio, as we read out data for each of our magrolimab programs and accelerate ongoing efforts to offer magrolimab to genomically-defined patient populations, like TP53-mutant AML, where we believe our approach can offer targeted benefit. We will simultaneously progress our earlier-stage assets, FSI-174 and FSI-189, in hopes of delivering on the full potential of macrophage biology for people living with cancer and other serious diseases."

Magrolimab – Registration-Enabling Programs

Forty Seven is focused on advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome (MDS) and heavily-pretreated, relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Magrolimab has previously been granted Fast Track designation by the FDA for the treatment of MDS and acute myeloid leukemia (AML), and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, as well as Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency for the treatment of AML. In December 2019, the FDA granted Orphan Drug designation to magrolimab for the treatment of MDS.

The company expects to achieve the following milestones in 2020:

Myelodysplastic Syndrome:

Initiate Phase 3 ENHANCE trial evaluating the combination of magrolimab and azacitidine compared to azacitidine alone in patients with untreated, higher risk-MDS in the second quarter;

Present updated data from the ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine in untreated patients with higher risk MDS mid-year;

Complete enrollment in the ongoing Phase 1b clinical trial in the third quarter.

Diffuse Large B-Cell Lymphoma:

Initiate single-arm, registration-enabling trial evaluating the combination of magrolimab and rituximab in heavily pre-treated relapsed or refractory DLBCL patients who have failed at least two prior lines of therapy in the first quarter;

Present initial data from the registration-enabling trial in the fourth quarter.

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 presented mid-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 (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI), held January 23-25, 2020 in San Francisco, and the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, held February 6-8, 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 certain non-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 of FSI-174 in healthy volunteers in the first quarter;

File an investigational new drug application with the FDA for FSI-189 in the first quarter; and

Initiate a Phase 1 clinical trial evaluating the safety and tolerability of FSI-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.