On March 29, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on recent developments (Press release, IGM Biosciences, MAR 29, 2022, View Source [SID1234611089]).
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"IGM continues to make progress in creating a new class of antibody medicines, which strengthens our commitment to use our expertise to develop and improve upon the inherent qualities of IgM antibodies," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Notably, our exclusive collaboration agreement with Sanofi, announced today, will accelerate the development of our IgM antibody platform across multiple areas of high unmet need beyond our current pipeline efforts. This partnership is a significant step towards exploring and validating our platform in multiple therapeutic areas, and we look forward to working with Sanofi’s impressive team. Simultaneously, our pipeline continues to progress with considerable speed. Namely, the initiation of two Phase 2 studies for our T cell bispecific antibody IGM-2323 and the continued progress in our DR5 agonist IGM-8444 Phase 1 combination treatment regimens. We look forward to sharing information on these efforts later this year."
Global R&D Collaboration with Sanofi
An exclusive worldwide collaboration agreement with Sanofi for multiple oncology, autoimmune and inflammation targets was announced.
IGM and Sanofi will leverage IGM’s proprietary IgM antibody technology platform to discover IgM antibody agonists against three oncology targets and three autoimmune/inflammation targets.
IGM will receive a $150 million upfront payment and potentially over $6 billion in aggregate development, regulatory and commercial milestones. A 50:50 profit share in certain major market countries and tiered royalties in the rest of world is planned for oncology targets, and IGM will receive tiered royalties for autoimmune/inflammation targets. Sanofi has also expressed an interest in purchasing up to $100 million of IGM non-voting common stock in a public financing.
Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.
Pipeline Updates
IGM-2323 (CD20 x CD3)
Phase 2 studies initiated. IGM announced the initiation of two Phase 2 studies to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). If supportive, the data from this Phase 2 multicenter, open-label study could potentially be used as the basis for accelerated review and approval of IGM-2323.
Presented Phase 1 clinical results: In December 2021, IGM presented clinical results from its Phase 1 trial evaluating IGM-2323 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The data was featured in an oral presentation titled "A Phase 1 Dose Escalation Study of IGM-2323, a Novel Anti-CD20 x Anti-CD3 IgM T Cell Engager (TCE) in Patients with Advanced B-Cell Malignancies".
IGM-8444 (DR5)
Clinical development of IGM-8444 advances. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase I study of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid and hematologic cancers. IGM expects to report initial monotherapy and combination data in solid tumors from the dose escalation portion of this Phase 1 trial in 2022.
Third FOLFIRI dose cohort successfully completed. IGM announced that it has cleared the third of four planned FOLFIRI combination dose escalation cohorts (3.0 mg/kg Q2W) with no dose limiting toxicities (DLTs) and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the final planned FOLFIRI combination dose escalation cohort (10.0 mg/kg Q2W).
First birinapant dose cohort successfully completed. IGM also announced that it has cleared the first of four planned birinapant combination dose escalation cohorts with no DLTs and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the second planned birinapant combination dose escalation cohort.
IGM-7354 (IL-15 x PD-L1)
IND filing expected in 2022. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, in solid tumors in 2022.
IGM-2644 (CD38 x CD3)
IND filing expected in 2022. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma in 2022.
Corporate Updates
Announced grant agreement with the Bill & Melinda Gates Foundation. The agreement aims to leverage IGM’s engineered IgM and IgA antibodies for the potential prevention of malaria, a significant driver of morbidity and mortality in low- and middle-income countries.
Carrie Brodmerkel, Ph.D., appointed Chief Scientific Officer of IGM Autoimmunity and Inflammation. Dr. Brodmerkel brings extensive experience across a broad range of disciplines to this role. Most recently, she served as Vice President and Global Head of Exploratory Biology and Scientific Strategy at Janssen R&D, a division of Johnson & Johnson, where she was responsible for scientific and strategic leadership of the biotherapeutics portfolio, functional planning and execution, computational sciences, and exploratory biology across therapeutic areas including immunology, hematology, and oncology.
Fourth Quarter and Full Year 2021 Financial Results
Cash and Investments: Cash and investments as of December 31, 2021 were $229.5 million, compared to $366.3 million as of December 31, 2020.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2021, R&D expenses were $39.2 million and $127.0 million, respectively, compared to $19.6 million and $65.0 million for the fourth quarter and year ended 2020, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2021, G&A expenses were $11.5 million and $38.3 million, respectively, compared to $5.1 million and $18.3 million for the fourth quarter and year ended 2020, respectively.
Net Loss: For the fourth quarter of 2021, net loss was $50.6 million, or a loss of $1.50 per share, compared to a net loss of $24.6 million, or a loss of $0.79 per share, for the fourth quarter of 2020. For the year ended 2021, net loss was $165.2 million, or a loss of $4.93 per share, compared to a net loss of $81.4 million, or a loss of $2.65 per share, for the year ended 2020.
2022 Financial Guidance:
IGM expects full year GAAP operating expenses of $250 million to $260 million including estimated non-cash stock-based compensation expense of approximately $50 million. Concurrent with the Company’s first quarter 2022 financial results expected in May, IGM anticipates providing full year collaboration and license revenue guidance as well as ending 2022 cash and investments guidance.
Conference Call and Webcast
IGM will host a conference call and webcast to discuss the Sanofi R&D collaboration announcement today, March 29, at 8:00 a.m. ET. The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 4983742. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.