On August 8, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the second quarter ended June 30, 2022 and provided an update on recent developments (Press release, IGM Biosciences, AUG 8, 2022, View Source [SID1234617785]).

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"We continued to make good progress in the second quarter in our two Phase 2 clinical trials of our IgM T cell bispecific antibody, imvotamab, and in our Phase 1 clinical trial of our IgM Death Receptor 5 (DR5) agonist, IGM-8444, in multiple combination treatment regimens. We also made good progress across our preclinical pipeline in the second quarter, and we continue to expect to file INDs for our targeted IL-15 IgM antibody, IGM-7354, and our CD38 x CD3 bispecific IgM antibody, IGM-2644, this year," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "In the second quarter, we also initiated our research collaboration with Sanofi for the development of agonist IgM antibodies against three oncology targets and three autoimmune/inflammation targets."

Pipeline Updates

Imvotamab (CD20 x CD3)

Clinical development of imvotamab (IGM-2323) advances. IGM continues to advance the clinical development of imvotamab, the Company’s novel IgM T cell engaging bispecific antibody, and continues to enroll patients in two Phase 2 clinical trials to assess the safety and efficacy of two doses, 100 mg and 300 mg, in patients with relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. IGM expects to provide an initial Phase 2 efficacy and safety update later this year or in the first quarter of 2023.
IGM-8444 (DR5)

Clinical development of IGM-8444. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase 1 clinical trial in multiple combination treatment regimens in subjects with relapsed and/or refractory solid and hematologic cancers.

Three initial patients dosed in the fourth FOLFIRI dose cohort. IGM announced that it has successfully dosed the initial three patients in the fourth and final planned FOLFIRI combination dose escalation cohort (10 mg/kg Q2W) with no dose limiting toxicities (DLTs) and no clinically significant liver toxicity observed to date. IGM plans to continue to enroll patients in the fourth FOLFIRI dose cohort and expects to provide an initial efficacy and safety update on the FOLFIRI combination later this year or in the first quarter of 2023.

Third birinapant dose cohort successfully completed. IGM also announced that it has cleared the third 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 fourth planned birinapant combination dose escalation cohort.
IGM-7354 (IL-15 x PD-L1)

IND application expected to be filed this year. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s targeted IL-15 IgM antibody, in solid tumors this year.
IGM-2644 (CD38 x CD3)

IND application expected to be filed this year. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma this year.
Corporate Updates

Collaboration agreement with Sanofi. In connection with the closing of the previously-announced collaboration agreement, IGM received a $150 million upfront payment from Sanofi in the second quarter. The agreement is for the creation, development, manufacture, and commercialization of IgM antibody agonists against three oncology targets and three immunology/inflammation targets. In addition to the $150 million upfront payment, IGM is eligible to receive potentially over $6 billion in aggregate development, regulatory and commercial milestones, a 50:50 profit share in certain major market countries and tiered royalties on net sales in the rest of world for oncology targets, and tiered royalties on global net sales for autoimmune/inflammation targets.

Umesh Muchhal, Ph.D., appointed Senior Vice President of Antibody Sciences. Dr. Muchhal brings over 24 years of biotech experience to IGM and is an industry leader in the design and development of novel antibody-based therapeutics. He has co-authored 24 publications and is an inventor on more than 15 granted U.S. patents. Prior to joining IGM, he led the Protein Sciences and Technology teams at Xencor. Dr. Muchhal received a Ph.D. in Molecular Biology from the University of Nebraska-Lincoln and an M.S. in Microbiology from the Maharaja Sayajirao University of Baroda.

Steven Weber appointed Senior Vice President, Corporate Controller and Principal Accounting Officer. Mr. Weber has over 20 years of experience leading financial operations. Most recently, Mr. Weber served as Vice President and Principal Accounting Officer at Aeglea BioTherapeutics, where he held several positions of increasing responsibility. Mr. Weber received an M.P.A. and a B.B.A. in Accounting from the University of Texas at Austin.
Second Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of June 30, 2022 were $513.2 million, compared to $229.5 million as of December 31, 2021.
Collaboration Revenue: For the second quarter of 2022, collaboration revenue was $0.4 million, compared to no revenue for the same period in 2021.
Research and Development (R&D) Expenses: For the second quarter of 2022, R&D expenses were $47.2 million, compared to $30.1 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the second quarter of 2022, G&A expenses were $12.4 million, compared to $8.6 million for the same period in 2021.
Net Loss: For the second quarter of 2022, net loss was $58.6 million, or a loss of $1.33 per share, compared to a net loss of $38.7 million, or a loss of $1.16 per share, for the same period in 2021. The net loss included non-cash stock-based compensation expense of $11.3 million and $5.6 million for the second quarter of 2022 and 2021, respectively.
2022 Financial Guidance
IGM expects to end 2022 with a balance of approximately $400 million in cash and investments. IGM estimates full year collaboration revenue of approximately $1 million related to the Sanofi agreement. IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses of $250 million to $260 million including estimated non-cash stock-based compensation expense of approximately $50 million.