Hamlet BioPharma AB has announced a productive first quarter for the fiscal year 2024-2025, marked by significant clinical progress in bladder cancer, recurrent acute cystitis, and bladder pain treatments. The company's investigational new drug, Alpha1H, has advanced from discovery to clinical trials, and new clinical indications for the IL-1 receptor antagonist anakinra have been identified.
Clinical Trial Highlights
In bladder cancer therapeutics, the final analysis published in Cancer Medicine demonstrated a strong clinical tumor response in patients treated with Alpha1H. The company also reported significant clinical progress in a randomized Phase II study of immunotherapy against bacterial infection, where anakinra showed therapeutic efficacy comparable to antibiotics. Promising results have also been reported for patients with bladder pain syndrome.
Catharina Svanborg, Chairman of the Board, stated, "This is an important recognition of our results and reinforces the relevance of our approach to developing new cancer treatments."
Alpha1H: Bladder Cancer Therapy
Alpha1H, a synthetic peptide designed for the treatment of non-muscle invasive bladder cancer (NMIBC), received FDA Investigational New Drug (IND) approval and Fast Track designation. Phase II clinical trials revealed impressive anti-tumor activity, with 88% of patients treated with the higher dose experiencing partial or complete tumor responses. Alpha1H also induced a positive immune response in patients, underscoring its potential as both a tumor-targeting agent and an immunotherapeutic.
IL-1RA Immunotherapy: Addressing Infections and Inflammation
Hamlet BioPharma's immunotherapy, using the IL-1 receptor antagonist anakinra, has emerged as a potential alternative to traditional antibiotic treatment for recurrent cystitis. Phase II trials in Germany showed IL-1RA to be as effective as antibiotics in reducing symptoms and improving quality of life for patients with recurrent urinary tract infections. IL-1RA treatment helps preserve the beneficial bacterial flora, reducing the risk of resistance and preserving long-term health outcomes.
Strategic Alliances and Commercial Partnerships
Hamlet BioPharma is actively pursuing strategic collaborations with leading international advisory firms to identify partners for the commercialization of company assets. These partnership strategies have broadened the company's network within the industry, both nationally and internationally. While discussions focus on Alpha1H, recent positive Phase II data put renewed emphasis on the immunotherapy projects and the portfolio of preclinical projects.
Financial Overview
For the first quarter, Hamlet BioPharma reported net sales of KSEK 0 (0) and a loss before tax of KSEK -9,766 (-8,329) for the parent company. The Group reported a loss before tax of KSEK -10,264 (-8,828). The company's cash and cash equivalents were KSEK 16,516 (13,166) at the end of the quarter. The company assesses that there will be a need to raise capital during the financial year in order to secure continued operations.
