On August 3, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the quarter ended June 30, 2023 (Press release, IGM Biosciences, AUG 3, 2023, View Source [SID1234633749]).
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"We continued to make good progress in the development of our IgM platform in the second quarter, as reflected in our announcement of encouraging data from the clinical trials of IGM-8444, now known as aplitabart, and in the clearance by the FDA of two Investigational New Drug applications to begin clinical trials of imvotamab, our IgM-based CD20 x CD3 bispecific antibody T cell engager, in severe systemic lupus erythematosus and severe rheumatoid arthritis," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Building on this progress, during the third quarter we expect to initiate these two Phase 1b autoimmune clinical trials and to continue to build enrollment in our randomized clinical trial of aplitabart in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second-line metastatic colorectal cancer patients."
Pipeline Progress
Aplitabart (IGM-8444) (DR5 agonist)
Clinical data with 3 mg/kg of aplitabart plus FOLFIRI from a non-randomized Phase 1 clinical trial. In June 2023, the Company reported Phase 1 data from a cohort of patients treated with aplitabart, the Company’s IgM agonist antibody targeting death receptor 5 (DR5), in combination with FOLFIRI through a data cut-off date of April 12, 2023.
In 51 CRC patients treated with the combination regimens, no drug related clinically significant hepatotoxicity was observed, with only grade 1 and grade 2 transient liver enzyme elevations noted as of the data cut-off date.
In these predominantly third-line metastatic colorectal cancer patients, the combination of aplitabart dosed at 3 mg/kg and FOLFIRI showed promising activity in terms of progression-free survival.
Multiple confirmed partial responses were observed among the patients treated with 3 mg/kg of aplitabart and FOLFIRI, including some patients who had previously progressed on FOLFIRI treatment.
Clinical development of aplitabart advances. The Company continues to advance the clinical development of aplitabart.
Dosing ongoing in the randomized colorectal cancer clinical trial. The Company is currently enrolling patients in an open-label randomized clinical trial of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. This randomized trial will assess the additional benefit of 3 mg/kg of aplitabart with a primary endpoint of progression-free survival (PFS) and secondary endpoints of overall response rate and overall survival as compared to the current standard of care treatment arm of FOLFIRI and bevacizumab. The Company’s goal is to have enrolled approximately 110 patients in the trial by the end of the first quarter of 2024 and to have median PFS data from these patients by the end of 2024.
Dosing at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial. The Company has also begun dosing additional colorectal cancer patients at 10 mg/kg of aplitabart in its single arm FOLFIRI combination clinical trial.
Dosing ongoing in the venetoclax combination. The Company is currently treating patients with acute myeloid leukemia in its aplitabart plus venetoclax and azacytidine Phase 1 combination cohort.
Dosing ongoing in birinapant combination. The Company is also currently treating patients in its aplitabart plus birinapant Phase 1 combination cohort.
Imvotamab (CD20 x CD3)
FDA clearance to begin autoimmune clinical trials. In the second quarter, the Company received clearance of two Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) for imvotamab, an IgM-based CD20 x CD3 bispecific antibody T cell engager, which will enable the initiation of two Phase 1b clinical trials, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA), during third quarter 2023.
IGM-7354 (IL-15 x PD-L1)
Phase 1 trial continues. The Company continues to enroll patients in a Phase 1 clinical trial exploring the safety, efficacy and biomarker activity of IGM-7354, an IgM-targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
IGM-2644 (CD38 x CD3)
Phase 1 trial initiated. The Company has initiated a clinical trial exploring the safety and efficacy of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma.
Financing
Completed underwritten public offering of common stock and concurrent private placement. As previously announced, the Company recently closed a public offering of its voting and non-voting common stock and concurrent private placement of non-voting common stock, with total gross proceeds of $120.0 million and net proceeds of $113.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, of which $68.5 million had been received by the Company as of June 30, 2023 and $45.0 million was received on July 3, 2023.
Second Quarter 2023 Financial Results
Cash and Investments: Cash and investments as of June 30, 2023 were $386.9 million (which amount does not include an additional $45.0 million from the public equity offering received on July 3, 2023), compared to $427.2 million as of December 31, 2022.
Collaboration Revenue: For the second quarter of 2023, collaboration revenues were $0.4 million, compared to $0.4 million for the same period in 2022.
Research and Development (R&D) Expenses: For the second quarter of 2023, R&D expenses were $55.7 million, compared to $47.2 million for the same period in 2022.
General and Administrative (G&A) Expenses: For the second quarter of 2023, G&A expenses were $13.0 million, compared to $12.4 million for the same period in 2022.
Net Loss: For the second quarter of 2023, net loss was $64.4 million, or a loss of $1.43 per share, compared to a net loss of $58.6 million, or a loss of $1.33 per share, for the same period in 2022.
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $45 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with more than $325 million in cash and investments, and the Company expects its existing cash and investments and anticipated collaboration payments to fund operations into the second half of 2025.