IGM Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
– Recommended Phase 2 Dose for 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 –
– Company to Host Conference Call Today at 4:30 p.m. ET –
“IGM reached a number of important milestones in 2020, including the presentation of encouraging initial results from our Phase 1 trial of IGM-2323 at the 2020 ASH Annual Meeting and the initiation of our Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and non-Hodgkin’s lymphoma,” said
- Recommended Phase 2 dose expected in 2021. IGM has now cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs and is currently open to enrollment to what is planned to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling to the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the Phase 1 dose escalation study and establish a recommended Phase 2 dose in 2021.
- Additional dose cohorts cleared. IGM has now cleared the first two dose cohorts of the single-agent portion of its Phase 1 clinical study and is currently open to enrollment to the third (3 mg/kg) of four single-agent biweekly dose escalation cohorts. IGM is also currently open to enrollment to its first chemotherapy combination dose cohort and its first single-agent weekly dose cohort. IGM expects to report initial data in solid tumors from the dose escalation portion of this Phase 1 trial in the second half of 2021.
- Entered into exclusive licensing agreement with Medivir for birinapant. In
January 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. IGM plans to begin clinical testing of birinapant in combination with IGM-8444 this year.
- File Investigational New Drug (IND) application. IGM expects to file an IND application with the
U.S. Food and Drug Administration(FDA) in 2021 for IGM-7354 in order to begin clinical testing. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is attached to the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.
- Completed manufacturing facility. Construction of IGM’s new cGMP manufacturing facility in
Mountain View, Californiahas been completed. IGM expects that cGMP manufacturing at this facility will begin in 2021.
- Completed upsized underwritten public offering of common stock. In
December 2020, IGM closed a public offering of its common stock and prefunded warrants, with gross proceeds of $230.0 million, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM.
Fourth Quarter and Full Year 2020 Financial Results
- Cash and Investments: Cash and investments as of December 31, 2020 were $366.3 million, compared to
$236.6 millionas of December 31, 2019.
- Research and Development (R&D) Expenses: For the fourth quarter and year ended 2020, R&D expenses were
$19.6 millionand $65.0 million, respectively, compared to $12.8 millionand $35.3 millionfor the fourth quarter and year ended 2019, respectively.
- General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2020, G&A expenses were
$5.1 millionand $18.3 million, respectively, compared to $3.2 millionand $9.2 millionfor the fourth quarter and year ended 2019, respectively.
- Net Loss: For the fourth quarter of 2020, net loss was $24.6 million, or a loss of $0.79 per share, compared to a net loss of
$14.8 million, or a loss of $0.49per share, for the fourth quarter of 2019. For the year ended 2020, net loss was $81.4 million, or a loss of $2.65per share, compared to a net loss of $43.1 million, or a loss of $4.80per share, for the year ended 2019.
2021 Financial Guidance
IGM expects full year GAAP operating expenses to be between
Conference Call and Webcast
IGM will host a conference call and webcast to discuss this announcement today,
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its antibody drug candidates and birinapant; statements regarding IGM’s Phase 1 clinical trials of IGM-2323 and IGM-8444; the anticipated timing of an IND filing for IGM-7354, the initiation of clinical testing of birinapant in combination with IGM-8444 and the commencement of cGMP manufacturing at IGM’s
|Selected Statement of Operations Data|
|(unaudited; in thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|Research and development (1)||$||19,599||$||12,763||$||65,030||$||35,257|
|General and administrative (1)||5,140||3,174||18,250||9,241|
|Total operating expenses||24,739||15,937||83,280||44,498|
|Loss from operations||(24,739||)||(15,937||)||(83,280||)||(44,498||)|
|Other income, net||117||1,122||1,925||1,365|
|Net loss per share, basic and diluted||$||(0.79||)||$||(0.49||)||$||(2.65||)||$||(4.80||)|
|Weighted-average common shares outstanding, basic and diluted||31,298,264||30,478,980||30,748,280||8,995,410|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$||1,203||$||192||$||4,160||$||522|
|General and administrative||1,379||208||4,294||492|
|Total stock-based compensation expense||$||2,582||$||400||$||8,454||$||1,014|
|Selected Balance Sheet Data|
|(unaudited; in thousands)|
|Cash and investments||$||366,269||$||236,607|
|Total stockholders' equity||381,815||240,231|
Source: IGM Biosciences