On March 28, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the fourth quarter ended December 31, 2021 and provided a corporate update (Press release, Immunome, MAR 28, 2022, View Source [SID1234611062]).

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"There remains a clear need for safe and efficacious antibody treatments against COVID-19, especially those less susceptible to mutational drift. We believe our three-antibody cocktail, IMM-BCP-01, has strong potential to address that unmet need. We are pleased the FDA has given us a safe-to-proceed notification and lifted the clinical hold for our Investigational New Drug (IND) application," stated Purnanand Sarma, Ph.D., President and CEO of Immunome.

"Additionally, we continue to progress IMM-ONC-01, our novel, IL-38-targeting innate immune checkpoint inhibitor, towards an IND submission in the second half of 2022," Sarma continued. "Our preclinical work is ongoing, and we have analyzed IL-38 expression across nearly 60 tumor subtypes and we have confirmed a high frequency of expression in difficult to treat cancers, such as head and neck squamous cell carcinoma, gastroesophageal squamous carcinoma, and squamous lung carcinoma."

Fourth Quarter and Subsequent Highlights

·Demonstrated In Vitro Efficacy of IMM-BCP-01 Against SARS-CoV-2 Omicron Variant in Live Virus Testing. In February 2022, Immunome announced that IMM-BCP-01 demonstrated effective neutralization of the Omicron variant of COVID-19 in in vitro testing. The combination of two antibodies in Immunome’s antibody cocktail, IMM20253/IMM20184, demonstrated neutralization of the Omicron variant within 3.5-fold potency compared to a preclinical version of sotrovimab in a head-to-head test using live virus samples. Additionally, IMM20253 exhibited a novel mechanism of action not reported in any other EUA antibodies by promoting a proteolytic cleavage of the portion of the spike protein needed for ACE2 binding.

·IMM-BCP-01 IND Application for the Treatment of COVID-19. In March 2022, the FDA communicated that the clinical study can be initiated for our antibody cocktail for the treatment of SARS-CoV-2 following a brief clinical hold. Immunome is continuing its ongoing clinical preparations ahead of the Phase 1b trial.

This investigational work was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

Financial Highlights

•Cash and cash equivalents: As of December 31, 2021, cash and cash equivalents totaled $49.2M.
•Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2021 were $4.4M. R&D expenses for the year ended December 31, 2021 were $14.1M.
•General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2021 were $3.5M. G&A expenses for the year ended December 31, 2021 were $10.6M.
•Net loss: Net loss attributable to common stockholders was $7.9M, or $.65 per share, for the three months ended December 31, 2021. Net loss attributable to common stockholders was $24.7M, or $2.14 per share, for the year ended December 31, 2021.
•As of December 31, 2021, Immunome has 12,110,373 shares of common stock outstanding.