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REDWOOD CITY, Calif. - Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biopharmaceutical company with a market capitalization of $14.4 million, announced favorable results from its Phase 1 dose-escalation clinical study of BDC-3042, an immunotherapy treatment for various cancers, at the American Association for Cancer Research (AACR) Annual Meeting held in Chicago. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.2x.
The trial evaluated BDC-3042 in patients with metastatic or unresectable cancers, including triple-negative breast cancer, renal cell carcinoma, colorectal cancer, melanoma, non-small cell lung cancer, and ovarian cancer. The study enrolled seventeen patients who had previously undergone an average of four lines of therapy.
As of April 7, 2025, BDC-3042 was well tolerated at doses up to 10 mg/kg every two weeks, with no dose-limiting toxicities or serious adverse events related to the drug. The most common drug-related adverse events were fatigue, flatulence, and nausea, each reported in 12% of patients.
The treatment showed biological activity, with increases in proinflammatory cytokines and chemokines, and evidence of anti-tumor activity. Notably, all non-small cell lung cancer patients (3/3) experienced stable disease for at least 12 weeks, and two out of three patients at the highest dose also showed stable disease. One non-small cell lung cancer patient had an unconfirmed partial response and remained in the study beyond 18 weeks.
The study’s results support the selection of 10 mg/kg every two weeks as the recommended Phase 2 dose. The drug demonstrated favorable pharmacokinetics, providing sufficient exposure to potentially extend the dosing interval.
Bolt Biotherapeutics is seeking a development partner to further advance BDC-3042, citing its commercial potential. The company’s pipeline includes other immunotherapy candidates, with activities underway to initiate clinical trials for BDC-4182 in the second quarter of 2025.
The press release statement provided the information for this news article. Bolt Biotherapeutics is developing additional immunotherapies and has strategic collaborations with leading biopharmaceutical companies. The company’s focus on myeloid biology and cancer drug development continues to drive its research and development efforts. InvestingPro analysis shows the stock has gained over 11% in the past week, though it remains significantly below its 52-week high of $1.33. With the company’s next earnings report due on May 8, 2025, investors seeking deeper insights into Bolt’s financial health and growth prospects can access 8 additional exclusive ProTips and comprehensive financial metrics through InvestingPro.
In other recent news, Bolt Biotherapeutics has announced changes to its corporate bylaws, specifically adjusting the quorum requirements for stockholder meetings. The amendment, effective immediately, reduces the quorum from a majority to one-third of outstanding shares. This change aims to facilitate decision-making during meetings with fewer shareholders present. Meanwhile, analysts at H.C. Wainwright have reiterated a Neutral rating on Bolt Biotherapeutics, following a review of their clinical candidate, BDC-4182. This candidate, targeting Claudin 18.2, is being developed as a next-generation immune-stimulating antibody conjugate and is set to enter human trials in Australia by the second quarter of 2025.
Stifel analysts have adjusted their outlook on Bolt Biotherapeutics, reducing the stock price target to $1.25 while maintaining a Hold rating. The company recently completed patient enrollment for its Phase 1 BDC-3042 trial, with results expected in the second quarter of 2025. Stifel notes the competitive landscape for CLDN18.2 drug development and highlights the importance of strategic partnerships for further progress. These developments reflect Bolt Biotherapeutics’ ongoing efforts in clinical trials and corporate governance adjustments.
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