On May 7, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the first quarter ended March 31, 2020 and provided an update on recent developments (Press release, IGM Biosciences, MAY 7, 2020, View Source [SID1234557270]).

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"While these unprecedented times have presented many unique challenges, thanks to the hard work and dedication of the entire IGM team, we continue to make good progress," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Notably, we recently announced a collaboration with Atreca and BeiGene which will allow us to evaluate the potential of our novel IgM and IgA antibodies for the treatment of COVID-19. Beyond this exciting new program, we continue to expect initial data from our Phase 1 trial of IGM-2323 in relapsed/ refractory NHL in the second half of 2020, as well as the filing of an IND for IGM-8444 later this year."

Recent Highlights and Pipeline Updates:

Collaboration with Atreca and BeiGene for COVID-19: In April 2020, IGM, Atreca, Inc., and BeiGene, Ltd. announced plans to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise in an effort to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. If research, manufacturing, and regulatory activities proceed very well, then the companies believe that an antibody may be ready to begin clinical testing in the first half of 2021.

IGM-2323

Phase 1 data expected in the second half of 2020: IGM continues to expect to report initial data from the Phase 1 trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL, the first-in-human application of IGM’s engineered IgM antibody technology, in the second half of 2020.
IGM-8444

IGM-8444 data to be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. The poster, titled "IGM-8444 as a potent agonistic Death Receptor 5 (DR5) IgM antibody: Induction of tumor cytotoxicity, combination with chemotherapy and in vitro safety profile," will be made available online via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29, at 8:00 a.m. ET.
IND filing in 2020: IGM continues to expect to file an IND 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

IND filing in 2021: IGM continues to expect to file an IND with the FDA for IGM-7354, the Company’s third clinical candidate, in 2021. 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.
First Quarter 2020 Financial Results:

Cash and Investments: Cash and investments as of March 31, 2020 were $219.0 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the first quarter of 2020, R&D expenses were $14.6 million, compared to $5.9 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the first quarter of 2020, G&A expenses were $4.0 million, compared to $1.4 million for the same period in 2019.
Net Loss: For the first quarter of 2020, net loss was $17.6 million, or a loss of $0.58 per share, compared with a net loss of $7.5 million, or a loss of $16.86 per share, for the same period in 2019.
Shares Outstanding: Weighted-average shares outstanding for the first quarter of 2020 were 30.5 million, compared to 0.4 million for the same period in 2019.
2020 Financial Guidance:

IGM reiterates its previously issued financial guidance which consisted of non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.