On December 9, 2019, Forty Seven announced preclinical proof-of-concept data for its novel all antibody conditioning regimen, comprised of FSI-174, its anti-cKIT antibody, and magrolimab, its anti-CD47 antibody. Preclinical studies in a non-human primate model showed that the combination of FSI-174 and magrolimab significantly depleted hematopoietic stem cells from the bone marrow, with no dose limiting toxicities. The data will be presented in a poster session at the 61st American Society of Hematology Annual Meeting.
“We are excited to report these preclinical data, which reflect our deep understanding of macrophage biology and our ability to build targeted antibody combinations to better facilitate phagocytosis. These results demonstrate for the first time the utility of our approach in the transplant setting, and the potential of our all antibody-based conditioning regimen to successfully deplete HSCs without relying on chemotherapy or radiation. We are excited to advance FSI-174 into the clinic early next year, and to work internally and with partners to deliver a novel, non-toxic conditioning regimen for patients undergoing transplantation,” said Jens-Peter Volkmer, Co-Founder and Vice President of Research and Early Development at Forty Seven.
Morgan Stanley analyst Matthew Harrison said he believes the additional data presented today by Forty Seven at the ASH meeting “are strong” and suggest robust and durable efficacy with favorable tolerability. The previous level of efficacy reported at the ASCO meeting was maintained for both MDS and AML and the safety observations are consistent with prior clinical experience, noted Harrison. He has an Overweight rating on Forty Seven shares, which are up $13.34, or 92%, to $27.78 in afternoon trading. Matthew Harrison said data presented by Forty Seven at the ASH meeting support the potential for magrolimab to be superior to azacitadine in myelodysplastic syndrome, or MDS, and potentially also acute myeloid leukemia, or AML. In addition, Harrison notes that Forty Seven management finalized a regulatory plan that provides two paths to accelerated approval. Given the new data and approval path details, Harrison lowered his discount rate and also increased his peak sales estimate for the MDS indication to about $800M from $600M, leading him to increase his price target on Forty Seven shares to $45 from $17. He maintains an Overweight rating on the stock.
Credit Suisse analyst Martin Auster raised his price target for Forty Seven to $38 from $18 and maintained an Outperform rating, saying the company’s ASH presentation was a “fairy tale,” providing incremental details on the registration plan in MDS, and presenting data that showed FSI-174 was well-tolerated in preclinical animal models, and that the combo of FSI-174+magrolimab depletes hematopoietic stem cells in non-human primates without depletion of mature immune cells. Auster says he thinks ASH clinical updates are de-risking for the MDS opportunity, and suggest potential upside opportunities for magrolimab in additional settings over time.
Mizuho analyst Mara Goldstein raised her price target for Forty Seven to $37 from $18 following presentation of what she believes to be competitive magrolimab data in myelodysplastic syndrome. While the shares rallied significantly already, the data update, particularly when compared to other candidates, is a “meaningful change” to its potential and probability of success, Goldstein tells investors in a research note. Further, while the analyst does not value Forty Seven on a potential takeout, she feels it is “meaningful to consider” given the recent acquisition activity of other oncology-focused Phase I companies. This provides a “valuation benchmark” for the shares, says Goldstein. She reiterates a Buy rating on Forty Seven shares.
H.C. Wainwright analyst Swayampakula Ramakanth raised his price target for Forty Seven to $36 from $21 saying the company presented a “strong” clinical update from its ongoing Phase 1b clinical study of magrolimab in combination with azacitidine for the treatment of higher-risk myelodysplastic syndrome. The analyst reiterates a Buy rating on the shares.
BTIG analyst Robert Hazlett raised his price target on Forty Seven to $40 and kept his Buy rating afer its ASH presentation of Phase 1b study that showed “solid results” for Magrolimab in untreated MDS and AML patients. The analyst notes that the findings highlighted “deep, durable responses” in both settings, paving the way toward “rapid progress” of Magrolimab in both instances.
Oppenheimer analyst Mark Breidenbach raised his price target for Forty Seven to $35 from $20 after the company presented “impressive” clinical data from its ongoing study evaluating magrolimab in combination with azacitidine in front-line myelodysplastic syndrome and acute myeloid leukemia. Breidenbach, who maintains an Outperform rating, tells investors in a research note that the combination therapy stood out from the pack at ASH in higher-risk MDS, with a maturing clinical profile that could potentially lead to Breakthrough Therapy Designation and accelerated approval.
Roth Capital analyst Tony Butler raised his price target for Forty Seven to $35 from $28 after the company provided an update of data on the anti-CD47 mAb magrolimab in patients with high-risk MDS and AML at the ASH meeting. Of 46 evaluable patients, Butler says the overall response was 92% and 64%, respectively, and the complete response/complete response with incomplete hematological recovery was 50% in MDS, and 55% in AML. Butler maintains a Buy rating on the shares.