IGM Biosciences Announces First Quarter 2021 Financial Results and Provides Corporate Update
– Recommended Phase 2 Dose of IGM-2323 Expected in 2021 –
– Initial Data from Phase 1 Trial of IGM-8444 in Solid Cancers Expected in 2021 –
– IND Filing for IGM-7354 Planned in 2021 –
“We are very pleased with the progress we made in the first quarter towards achieving our clinical and pipeline goals for 2021,” said
- Recommended Phase 2 dose expected in 2021. IGM continues to advance the clinical development of IGM-2323, the Company’s IgM-based CD20 x CD3 bispecific antibody, for the treatment of non-Hodgkin’s lymphoma (NHL) and potentially other CD20-expressing hematologic malignancies, including chronic lymphocytic leukemia (CLL). IGM has cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs in the ongoing Phase 1 clinical trial of IGM-2323, and is currently enrolling patients in what is expected to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling patients in the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the dose escalation portion of the Phase 1 clinical trial and select a recommended Phase 2 dose in 2021.
- Phase 1 data expected in the second half of 2021. IGM also continues to advance the clinical development of IGM-8444, the Company’s IgM Death Receptor 5 (DR5) agonist, for the treatment of a potentially broad range of solid tumors and hematologic malignancies. IGM has cleared its second dose escalation dose cohort, 1 mg/kg, in the ongoing Phase 1 trial, and is currently dosing patients in its third dose escalation cohort, 3 mg/kg, with every two week dosing. IGM has also begun dosing patients in its first combination with FOLFIRI dose cohort and its first weekly dosing cohort. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in the second half of 2021.
- Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. As previously announced, during the first quarter of 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 this year.
- Investigational New Drug (IND) application expected to be filed this year. IGM also plans to file an IND application with the
U.S. Food and Drug Administration(FDA) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies.
George Gauthierappointed to the newly created position of Chief Commercial Officer. Mr. Gauthierbrings twenty years of experience in global commercial strategy, marketing and product development. Most recently, Mr. Gauthierwas Vice President of Global Product Strategy for Breast and Gynecological Cancers at Genentech, where he led a global team in the creation and execution of commercial and product development strategies.
First Quarter 2021 Financial Results
- Cash and Investments: Cash and investments as of March 31, 2021 were $331.7 million, compared to
$366.3 millionas of December 31, 2020.
- Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expenses were
$23.6 million, compared to $14.6 millionfor the same period in 2020.
- General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expenses were
$8.1 million, compared to $4.0 millionfor the same period in 2020.
- Net Loss: For the first quarter of 2021, net loss was $31.6 million, or a loss of $0.95 per share, compared to a net loss of
$17.6 million, or a loss of $0.58per share, for the same period in 2020.
2021 Financial Guidance
IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses to be between
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its antibody drug candidates and birinapant; statements regarding IGM’s Phase 1 clinical trials of IGM-2323 and IGM-8444; the anticipated timing of the selection of a recommended Phase 2 dose for IGM-2323, the reporting of initial data from the dose escalation portion of the Phase 1 trial of IGM-8444, the initiation of clinical testing of birinapant in combination with IGM-8444 and an IND filing for IGM-7354; IGM’s expectations regarding its financial position, including operating expenses and cash and investments; and statements by the Chief Executive Officer of IGM. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the risk that all necessary regulatory approvals cannot be obtained; the risk that the potential benefits of combination therapies do not outweigh their costs; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the
|Selected Statement of Operations Data|
|(in thousands, except share and per share data)|
|Three Months Ended|
|Research and development (1)||$||23,572||$||14,583|
|General and administrative (1)||8,134||3,990|
|Total operating expenses||31,706||18,573|
|Loss from operations||(31,706||)||(18,573||)|
|Other income, net||62||949|
|Net loss per share, basic and diluted||$||(0.95||)||$||(0.58||)|
|Weighted-average common shares outstanding, basic and diluted||33,328,994||30,491,463|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$||1,865||$||666|
|General and administrative||3,639||657|
|Total stock-based compensation expense||$||5,504||$||1,323|
|Selected Balance Sheet Data|
|Cash and investments||$||331,674||$||366,269|
|Total stockholders' equity||355,610||381,815|
Source: IGM Biosciences