IGM Biosciences Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
- Initial data from Phase 1 trial of IGM-2323 in relapsed/refractory non-Hodgkin’s lymphoma expected in the second half of 2020 -
- IND filing for IGM-8444 planned in 2020 -
- Company to host conference call today at 4:30 p.m. ET -
“2019 was a transformational year for IGM. The many highlights of the year included our successful initial public offering and the initiation of our first-in-human trial for our lead product candidate, IGM-2323, a CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL),” said
Recent Highlights and Pipeline Updates
IGM-2323 – Phase 1 trial initiated: In
IGM-8444 – IND filing planned: IGM expects to file an IND application with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.
IGM-7354 – Next candidate announced: IGM nominated IGM-7354 as its third clinical candidate. 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 displayed on 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. IGM expects to file an IND with the FDA for IGM-7354 in 2021.
Fourth Quarter and Full Year 2019 Financial Results
- Cash and Investments: Cash and investments as of December 31, 2019 were $236.6 million.
- Research and Development (R&D) Expenses: For the fourth quarter and year ended 2019, R&D expenses were
$12.8 millionand $35.3 million, respectively.
- General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2019, G&A expenses were
$3.2 millionand $9.2 million, respectively.
- Net Loss: For the fourth quarter of 2019, net loss was $14.8 million, or a loss of $0.49 per share. For the year ended 2019, net loss was
$43.1 million, or a loss of $4.80per share.
- Shares Outstanding: Weighted-average shares outstanding for the fourth quarter of 2019 were 30.5 million and for the full year of 2019 were 9.0 million shares.
2020 Financial Guidance
IGM estimates non-GAAP operating expenses for 2020 of approximately
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, the Company’s IgM technology platform, statements regarding the Company’s Phase 1 clinical trial of IGM-2323, including the timing of reporting initial data from the clinical trial, the timing of filing an IND for IGM-8444, the Company’s future financial and operating performance, including its guidance for the full year 2020 and year end 2020 cash and investments balance, and statements by IGM’s Chief Executive Officer. 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 coronavirus 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 current clinical trials, and enrollment in its current and future clinical trials; 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 advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s ability to accurately forecast future financial results in the current environment; 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; 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||Year Ended|
|Research and development (1)||$||12,763||$||7,814||$||35,257||$||18,962|
|General and administrative (1)||3,174||1,232||9,241||3,829|
|Total operating expenses||15,937||9,046||44,498||22,791|
|Loss from operations||(15,937||)||(9,046||)||(44,498||)||(22,791||)|
|Other income (expense), net||1,122||(7||)||1,365||80|
|Net loss per share, basic and diluted||$||(0.49||)||$||(20.67||)||$||(4.80||)||$||(51.84||)|
|Weighted-average common shares outstanding, basic and diluted||30,478,980||438,074||8,995,410||438,074|
|(1)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||192||$||25||$||522||$||51|
|General and administrative||208||94||492||132|
|Total stock-based compensation expense||$||400||$||119||$||1,014||$||183|
|Selected Balance Sheet Data|
|Cash and investments||$||236,607||$||1,887|
|Convertible preferred stock||-||60,917|
|Total stockholders' equity (deficit)||240,231||(65,828||)|
Source: IGM Biosciences