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Calithera Biosciences (CALA) has initiated a phase 2 clinical trial for its drug sapanisertib (CB-228) targeting NRF2-mutated squamous non-small cell lung cancer (sqNSCLC), a condition lacking effective treatments. This milestone follows the company's acquisition of the drug from Takeda. The trial aims to confirm sapanisertib's selective activity and evaluate its safety and efficacy in patients previously treated with chemotherapy and immunotherapy. Approximately 15% of sqNSCLC patients carry NRF2 mutations, highlighting a significant unmet medical need.
Calithera Biosciences announced the enrollment of the first patient in a multicenter phase 2 trial for its SYK inhibitor, mivavotinib (CB-659), targeting non-germinal center diffuse large B-cell lymphoma (non-GCB DLBCL). This subgroup often has poorer outcomes with current treatments. Previous studies showed a 53% response rate for mivavotinib in non-GCB DLBCL patients. The trial aims to confirm efficacy, particularly in patients with MYD88 or CD79b mutations, and refine treatment schedules. Results are expected by Q1 2023.
Calithera Biosciences (CALA) announced a 1-for-20 reverse stock split effective June 14, 2022, to comply with Nasdaq's $1 minimum bid price requirement. The split will combine every twenty shares into one, resulting in approximately 4,865,000 shares outstanding. The decision follows approval from stockholders at the 2022 Annual Meeting. This action aims to maintain its listing on the Nasdaq Global Select Market. Additional details can be found in the definitive proxy statement filed on April 20, 2022.
Calithera Biosciences (Nasdaq: CALA) announced that Dr. Susan Molineaux, its founder and CEO, will present at the H.C. Wainwright Global Investment Conference from May 23-25, 2022. The presentation will be available on-demand starting May 24 at 7:00 a.m. Eastern Time through Calithera's website, with a replay accessible for 30 days. Calithera focuses on precision oncology, developing targeted therapies for patients with aggressive cancers, emphasizing a biomarker-driven approach.
Calithera Biosciences (CALA) reported its first quarter 2022 financial results, highlighting progress in clinical studies for mivavotinib and sapanisertib. The company aims to enroll patients in both trials by Q2 2022 and expects to present data by Q1 2023. Calithera completed a $10 million public offering, raising $8.5 million in net proceeds. Cash and equivalents totaled $44.7 million as of March 31, 2022, sufficient to fund operations through mid-2023. R&D expenses shrank to $9.6 million from $15.3 million year-over-year, while the net loss was $13.8 million.
Calithera Biosciences (CALA) will release its first quarter 2022 financial results on May 10, 2022. A conference call will follow at 2:00 p.m. PT to discuss these results and recent corporate highlights. Interested parties can access the press release and live audio webcast on Calithera's investor website. The company specializes in precision oncology and is advancing a pipeline of small molecule therapies targeting genetic vulnerabilities in cancer cells. Forward-looking statements indicate potential risks in clinical development and regulatory approvals.
Calithera Biosciences (CALA) presented new findings at the AACR Annual Meeting on their synthetic lethality program targeting VPS4A and VPS4B gene paralogs. This research identifies VPS4A inhibitors as potential cancer therapeutics, particularly for tumors with heterozygous VPS4B loss, which occurs in approximately 60% of certain cancers, including colorectal and pancreatic cancers. The company's discovery is seen as a significant step forward in addressing unmet needs in oncology, with plans for further development of the identified inhibitors.
Calithera Biosciences (CALA) reported its financial results for Q4 and FY 2021, with revenue of $9.8 million, up from $0 in 2020, linked to collaboration agreements. Net loss was $69.2 million for Q4 and $115.1 million for the year. The company acquired two clinical-stage therapies, mivavotinib and sapanisertib, advancing its oncology pipeline, with phase 2 trials expected to start in 2022. Cash reserves were reported at $59.5 million, with an additional $10 million from a public offering. Research expenses decreased, primarily due to the telaglenastat program discontinuation.
Calithera Biosciences (CALA) priced its public offering of 18,518,519 shares at $0.54 each, raising approximately $10 million before expenses. Each share includes two types of warrants, one expiring in 18 months and the other in five years, both with an exercise price of $0.54. The offering, set to close on April 1, 2022, is managed by SVB Leerink and H.C. Wainwright & Co. These funds will be pivotal for ongoing clinical trials and business operations as the company continues its focus on oncology therapeutics.
Calithera Biosciences (CALA) announced plans for an underwritten public offering of common stock and warrants. The offering is contingent on market conditions and requires Nasdaq approval. Joint book-running managers for the offering include SVB Leerink and H.C. Wainwright & Co. A shelf registration statement for the securities was filed with the SEC and has been declared effective, with details to be available in a preliminary prospectus. This announcement does not constitute an offer to sell securities in jurisdictions where lawful registration is required.