IGM Biosciences Announces Second 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 –
– Expansion of IgM Platform into Infectious Diseases –
“We continue to make steady progress in the development of our innovative product pipeline, including the successful completion of the initial dose escalation portion of our IGM-2323 Phase 1 clinical trial,” said
- Phase 1 dose escalation completed; dose expansion continues. 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). The Company cleared its highest planned dose escalation cohort, a top dose of 1000 mg, without a dose limiting toxicity, and is currently treating additional patients in four Phase 1 dose cohorts with top doses of 100 mg, 300 mg, 600 mg and 1000 mg, respectively. IGM expects to select a recommended Phase 2 dose in 2021.
- Additional dose cohorts cleared in Phase 1. IGM 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 third dose cohort (3 mg/kg) of the single-agent portion of its Phase 1 clinical study and is currently treating patients in its highest dose escalation cohort (10 mg/kg) with every two-week single agent dosing. IGM has also cleared the first dose cohort of the FOLFIRI combination portion of the Phase 1 study and is currently treating patients in the second of four planned FOLFIRI combination dose escalation cohorts. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in 2021.
- Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 in 2021.
- New pipeline candidate for the treatment and prevention of COVID-19 expected to advance into the clinic this year. In
June 2021, IGM announced IGM-6268, which represents the expansion of the Company’s IgM platform into infectious diseases. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody and is being developed as an intranasally administered agent for the treatment and prevention of COVID-19. IGM expects to initiate a Phase 1 clinical trial of IGM-6268 in 2021.
- Nature manuscript published. In
June 2021, Nature published an article entitled “Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants”. The article describes results from preclinical studies demonstrating significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all evaluated mutant Variants of Concern and Variants of Interest, and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The article was co-authored by researchers at IGM, The University of Texas Medical Branch at Galvestonand The University of Texas Health Science Center at Houston.
- Investigational New Drug (IND) application expected to be filed this year. IGM 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.
Chris Takimotoappointed Chief Medical Officer. Dr. Takimotobrings 30 years of experience in cancer research and development. Most recently, Dr. Takimotowas Senior Vice President, Oncology at Gilead Sciences, Inc. Prior to Gilead, he served as Chief Medical Officer of Forty Seven, Inc., a biotechnology company formed out of Stanford Universityand acquired by Gilead Sciences in 2020.
Second Quarter 2021 Financial Results
- Cash and Investments: Cash and investments as of June 30, 2021 were $301.8 million, compared to
$366.3 millionas of December 31, 2020.
- Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expenses were
$30.1 million, compared to $15.0 millionfor the same period in 2020.
- General and Administrative (G&A) Expenses: For the second quarter of 2021, G&A expenses were
$8.6 million, compared to $4.4 millionfor the same period in 2020.
- Net Loss: For the second quarter of 2021, net loss was $38.7 million, or a loss of $1.16 per share, compared to a net loss of
$18.8 million, or a loss of $0.62per 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, the initiation of a Phase 1 trial for IGM-6268 and an IND filing for IGM-7354; IGM’s expectations regarding its financial position, including operating expenses, cash and investments and non-cash stock-based compensation; 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||Six Months Ended|
|Research and development (1)||$||30,089||$||15,019||$||53,661||$||29,602|
|General and administrative (1)||8,649||4,388||16,783||8,378|
|Total operating expenses||38,738||19,407||70,444||37,980|
|Loss from operations||(38,738||)||(19,407||)||(70,444||)||(37,980||)|
|Other income, net||24||568||86||1,517|
|Net loss per share, basic and diluted||$||(1.16||)||$||(0.62||)||$||(2.11||)||$||(1.19||)|
|Weighted-average common shares outstanding, basic and diluted||33,371,753||30,551,736||33,350,492||30,521,600|
|(1)Amounts include stock-based compensation expense as follows:|
|Research and development||$||2,645||$||1,047||$||4,510||$||1,713|
|General and administrative||2,964||908||6,603||1,565|
|Total stock-based compensation expense||$||5,609||$||1,955||$||11,113||$||3,278|
|Selected Balance Sheet Data|
|Cash and investments||$||301,834||$||366,269|
|Total stockholders' equity||322,456||381,815|
Source: IGM Biosciences, Inc.