Onconova Therapeutics (ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2021 and provided a business update.
Highlights for the first quarter of 2021 and subsequent weeks include:
- The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
- The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
- The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
- The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
- The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.
Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.
Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.
General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.
Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.