Announcement • Jun 30
Hamlet BioPharma Receives European Regulatory Approval For Phase III Study of Alpha1H In Bladder Cancer Hamlet BioPharma announced regulatory approval from the European Medicines Agency (EMA) for its Phase III clinical study of Alpha1H in bladder cancer. The approval represents a milestone crucial for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe. The submission documents including the study protocol were based on the prior scientific dialogue with the Czech State Institute for Drug Control (SÚKL) during the Phase II program and further refined in close collaboration with the U.S. Food and Drug Administration (FDA), supported by regulatory experts at InClino in Europe and Target Health in the USA. The European Phase III study will be conducted in partnership with the group of Professor Marek Babjuk at the Second Faculty of Medicine, Charles University in Prague. The same team recently completed the successful Phase II study of Alpha1H in patients with non-muscle invasive bladder cancer (NMIBC), which demonstrated promising anti-tumor activity and a favorable safety profile. As a result of this approval, patients with low- to intermediate-risk NMIBC will now have access to Alpha1H treatment within the framework of the clinical study. Announcement • Jun 19
Hamlet BioPharma Conducts Pre-Initiation Visit For Phase III Trial Of Alpha1H In Bladder Cancer Hamlet BioPharma AB conducted a pre-initiation visit at the Department of Urology at Charles University, Prague, for the Phase III trial of Alpha1H in bladder cancer. Prague is an important center for bladder cancer research and trials of novel therapies, and the trial technology and collaboration with Hamlet BioPharma and Lund University is established. Professor Babjuk's group conducted the recently completed, successful Phase II study of Alpha1H in patients with non-muscle invasive bladder cancer (NMIBC). The Phase III study strengthens the commercial potential of Alpha1H and the future market opportunities for the drug. Bladder cancer is a significant unmet medical need and the costliest cancer form in the USA, due to high recurrence rates and cancer progression. Despite available treatments, patient remain at risk of recurrence, creating a need for less toxic therapies. The Phase III study is based on an extensive scientific and clinical evaluation of Alpha1H by the FDA (Food and Drug Administration, USA), including reviews of published clinical data and the mechanism of action described in peer-reviewed publications. Announcement • May 20
Hamlet Biopharma Secures New Patents and Allowances Hamlet Biopharma, a company innovating the treatment of cancer and infections, announced the successful granting of new patents in Japan and India and a further patent allowance in Japan. The continued strengthening of Hamlet BioPharma's intellectual property portfolio reaffirms its position at the forefront of technological innovation. The new patents and allowances cover breakthroughs in the HAMLET family of drug candidates, which effectively kill cancer cells and growing tumor tissue with high precision, as well as the company's technology relating to the treatment of bacterial infections, including cystitis. With these latest additions, Hamlet BioPharma now holds about 150 active patents and over 30 pending patent applications across numerous countries, showcasing a robust innovation strategy designed to fuel long-term growth, protect proprietary technologies, and drive value for partners and customers alike. The company plans to integrate these patented technologies with Phase III clinical trial activities and ongoing product development. Board Change • Nov 11
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Elisabeth Parker was the last director to join the board, commencing their role in 2023. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Nov 10
Hamlet BioPharma Receives FDA Pivotal- Study Feedback for Novel Neoadjuvant Therapy in Non-Muscle Invasive Bladder Cancer Hamlet BioPharma announced it has received written feedback from the U.S. Food and Drug Administration (FDA) supporting a pivotal development path for Alpha1H, a first-in-class neoadjuvant therapy for patients with low-risk non-muscle invasive bladder cancer (NMIBC). This latest interaction with the US FDA follows the previous successful face-to-face interaction with the Agency last June 2025. FDA's letter, specific and helpful, evidenced both serious and enthusiastic support for the program. Alpha1H has so far exhibited little to no toxicity in the clinic and offers low-risk NMIBC patients treatment in the neoadjuvant phase of disease, for which currently there are no therapy options available. Helpful in advancing Hamlet's marketing objectives for Alpha1H, the FDA's comments focused on a pivotal clinical design. Next steps for Hamlet BioPharma and their partners will be to put these collaborative fruits to good use with the full protocol development. Highlights from the FDA Interaction: The FDA's written feedback supports the overall pivotal study design framework proposed by Hamlet BioPharma, including patient population, key efficacy endpoints, and statistical approach. The Agency provided guidance on primary and key secondary endpoints appropriate for low-risk NMIBC, including complete response (CR) rate and duration of response and event-free survival, along with the safety database size. FDA aligned on Hamlet's plan to utilize central pathology review, blinded independent review (as applicable), and standardized cystoscopic assessment intervals. Hamlet intends to incorporate the Agency's recommendations and initiate enrollment in the next stage of the clinical program pending completion of routine CMC activities and institutional review board (IRB) approvals. Next Milestones: Finalize protocols and engage first study sites First Quarter - Second Quarter 2026. Complete CMC readiness packages, including process and formulation optimization, stability testing, and pharmaceutical development plans. Evaluate potential expedited-program designations with FDA. Announcement • Sep 24
Hamlet BioPharma Prepares for Next Steps and Secures Drug Manufacturing of Alpha1h At Phase III Quality Hamlet BioPharma announced the successful production of a first batch of Alpha1H, the drug candidate targeting Bladder Cancer, at Phase III quality. The batch is now undergoing final evaluation steps, before release for clinical use. The clinical trial program in patients with bladder cancer has proceeded successfully, showing significant treatment effects and low toxicity in treated patients. Large-scale manufacturing of Alpha1H at Good Manufacturing Practice (GMP) quality has been established since the start of the clinical program, with an increase in volumes and technical adjustments during successive phases of the program. A Phase III trial requires increased production capacity, and advanced technical and drug quality control programs must be in place. Drug production at Phase III quality is therefore costly and extremely demanding. Hamlet BioPharma has completed the production of a first batch ofAlpha1H at Phase III quality. The batches is now undergoing final evaluation steps., before release for clinical use. To meet the increased demand for Phase III-grade material, Hamlet BioPharma is expanding its production of the Alpha1 peptide, which is the first step in the production process. The company has indentified Porton Pharmaceutical Chemicals GmbH as an advanced and cost effective pharmaceutical manufacturing infrastructure. The Alpha1 peptide production technology has been adjusted by Porton to meet the requirements of a Phase III trial and the production site has been extensively audited for alignment with international market requirements. To manufacture the final product, Hamlet BioPharma collaborates with Rechon Life Science AB - a manufacturer approved for pharmaceutical supply worldwide, including the US. Rechon are responsible for the final formulation and release of Alpha1H and have already established large scale processes for Alpha1H production and distribution to clinical trial sites. The timing of Phase III adjusted manufacturing is essential to secure a rapid and robust supply of Alpha1H to the clinic, which benefits Hamlet BioPharma's shareholders and patients, who will receive Alpha1H treatment. Announcement • Aug 24
Hamlet BioPharma Announces the Completion of the Alpha1H Phase II Study in Non-Muscle Invasive Bladder Cancer Hamlet BioPharma announced the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. The final clinical report has been completed and submitted to the FDA (Food and Drug Administration, USA). Summary from the Clinical Study Report: Efficacy was formally confirmed - 80% of tumors responded to Alpha1H, with 59% average tumor size reduction in the high-dose group. Molecular and cellular secondary endpoints. Alpha1H reaches tumor tissue, triggers tumor cell apoptosis, and causes rapid shedding of tumor cells into the urine. Durable effect shown across repeated treatment cycles. Patients who received a second round of instillations maintained clinical benefit, showing continued tumor cell death and reduction -- demonstrating the treatment's lasting efficacy, even with repeated dosing. BCG-like immune activation confirmed - but faster. Cytokine profiling shows Alpha1H activates a broad immune response overlapping with BCG, the current standard of care. However, Alpha1H triggers this response more rapidly and without lasting side effects. Suppression of cancer genes and pathways. Advanced RNA sequencing revealed Alpha1H downregulated over 700 of ~800 cancer-related genes, including key oncogenes like RAS and GJA1. This provides a mechanistic explanation for its unique tumor-killing profile. Strong safety profile confirmed over longer follow-up - no serious side effects. No drug-related serious adverse events occurred, even after higher or repeated dosing. Mild local side effects were comparable to placebo, and no systemic effects were observed, consistent with Alpha1H's local mechanism of action. Announcement • Jul 29
Hamlet BioPharma AB (publ) to Report Fiscal Year 2025 Results on Aug 28, 2025 Hamlet BioPharma AB (publ) announced that they will report fiscal year 2025 results on Aug 28, 2025 New Risk • Jul 28
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 8.2% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr40m free cash flow). Share price has been highly volatile over the past 3 months (8.2% average weekly change). Earnings have declined by 25% per year over the past 5 years. Revenue is less than US$1m (kr178k revenue, or US$19k). Board Change • Jul 28
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Elisabeth Parker was the last director to join the board, commencing their role in 2023. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Jun 19
Hamlet Biopharma Announces Progress in Tuberculosis Therapy Hamlet BioPharma announced progress in Tuberculosis therapy. The group led by Professor Gabriela Godaly, has conducted a study on the antimicrobial peptide NZ2114, which has been accepted for publication in Frontiers in Microbiology. The key findings are summarised below: The study highlights NZ2114, a plectasin variant, as a promising candidate therapeutic against Mycobacterium tuberculosis, capable of overcoming the bacterium's uniquely complex, lipid-rich, and low-permeability membrane. NZ2114 demonstrates potent antimycobacterial activity, synergizes with first-line TB drugs, remains stable in serum, and is non-toxic to human cells, making it a strong candidate for future TB treatment strategies. The antimicrobial effect was also observed against several clinical isolates of Gram-positive bacteria, including Enterococcus facadeecalis, Enterococcus facadeecium, and Methicillin-Resistant Staphylococcus aureus (MRSA). The peptide eliminated M. tuberculosis in a murine TB infection model with a log reduction of 81.14%) after three doses, compared to untreated controls. This study investigated another plectasin variant, NZ2114, known for its effectiveness against Gram-positive bacteria, as a potential anti-mycobacterial peptide both in cellsand disease models. NZ2114 effectively killed bacteria at a minimal inhibitory concentration (MIC99) of 6.1 mM, was non-toxic to primary human cells, and remained resistant to serum degradation while preserving its antimycobacterial capacity. In a checkerboard assay, NZ2114 demonstrated synergy with the first-line TB drugs isoniazid and ethambutol. Announcement • Apr 08
Hamlet BioPharma Announces the Publication of New Scientific Advances Important for the Mechanism of Action of Alpha1H in the Treatment of Bladder Cancer Hamlet BioPharma announced the publication of new scientific advances important for the mechanism of action of Alpha1H in the treatment of bladder cancer, in collaboration with scientists at Lund University. The study shows that Alpha1H targets a major membrane system (ER) in tumor cells that stretches from the cell border all the way to the nuclei. This continuous membrane structure defines many aspects of cellular life. It is the largest membrane-bound organelle and accounts for more than 50% of the total membrane area in eukaryotic cells. Organized like a 'fishing net' the network plays a critical role as a scaffold for many different cellular functions, including cell death. The membrane structure is rigorously controlled to fulfil these different cellular needs. The scientists discovered that Alpha1H changes the structure of the network and triggers a process similar to the tightening of fishing nets around their content of fish. The paper proposes that this process allows dying cells to contain toxic components and avoid leakage to the surrounding tissue during the cell death process. This mechanism could be an essential explanation for the low toxicity of the Alpha1H complex, which has been seen in cells, animal models and patients. These insights into the mechanism of action of Alpha 1H were made possible by combining high resolution imaging technology with advanced microcopy, cellular and molecular techniques, available to Hamlet BioPharma through the collaboration with Lund University. Announcement • Apr 07
Hamlet Biopharma's Drug Candidate Alpha1H Shows Potent Treatment Effects in Patients with Cancer of the Urinary Bladder Hamlet BioPharma announced that Hamlet BioPharma's drug candidate Alpha1H has shown potent treatment effects in patients with cancer of the urinary bladder. The final analysis of the placebo-controlled, dose-escalation and repeated treatment study parts, confirmed the strong treatment effects compared to placebo. The Clinical study report is being completed for submission to the FDA. Clinical effects: Clinical effects of alpha1-oleate were quantified in patients with non-muscle invasive bladder cancer, using a randomized, placebo-controlled study protocol. Patients were treated by six intra-vesical instillations of alpha1-oleate (Alpha1H) and the treatment response was defined relative to the placebo group. Responding patients were offered a second round of treatment, consisting of six intravesical instillations. A complete or partial tumor response was detected in >80% of the tumors in patients treated with 8.5 mM of Alpha1H. Intravesical Alpha1H administrations triggered rapid, dose-dependent tumor cell shedding and tumor fragmentation, consistent with the reduction in tumor size. Alpha1H was taken up by tumor tissue and treatment triggered rapid tumor cell apoptosis, during both treatment rounds. Immune response confirmed: Alpha1H treatment has previously been shown to activate an immune response with strong anti-tumor characteristics. This was confirmed in the study, with similar effects as BCG treatment, underlining the potential of Alpha1H as a broadly acting anti-tumor molecule. Alpha1H treatment further inhibited the expression of cancer gene networks, including bladder cancer genes and became more similar to healthy tissue. Drug-related side effects were not recorded, except for local irritation at the site of instillation. Clinical study report is being completed for submission to the FDA: These anti-tumor effects strongly support Alpha1H's potential in patients, initially as a neoadjuvant, targeting newly diagnosed tumors or recurrences, acknowledged by the FDA (Food and Drug Administration, USA), by awarding Alpha1H Fast Track status as a neoadjuvant for the treatment of bladder cancer. The broad collaborative clinical network required for these studies is maintained through long-standing collegial interactions. Technology for genome-wide analyses of clinical samples is maintained by the scientists at Lund University. Announcement • Feb 18
Hamlet BioPharma AB (publ) Announces CEO Changes The Board of Hamlet BioPharma has decided to appoint Catharina Svanborg as CEO. Catharina immediately assumes the CEO role and continues as a Board member. Martin Erixon leaves the CEO role and will be at the company's disposal during his notice period. New Risk • Feb 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr42m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr42m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 21% per year over the past 5 years. Shareholders have been substantially diluted in the past year (41% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€59.3m market cap, or US$62.3m). New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 33% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 17% per year over the past 5 years. Shareholders have been substantially diluted in the past year (33% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€48.7m market cap, or US$50.1m). Announcement • Dec 11
Hamlet BioPharma AB (publ) to Report Q1, 2026 Results on Nov 14, 2025 Hamlet BioPharma AB (publ) announced that they will report Q1, 2026 results on Nov 14, 2025 Announcement • Dec 04
Hamlet BioPharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 26.790008 million. Hamlet BioPharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 26.790008 million.
Security Name: B Shares
Security Type: Common Stock
Securities Offered: 9,922,225
Price\Range: SEK 2.7
Transaction Features: Subsequent Direct Listing Board Change • Jun 06
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. No independent directors (6 non-independent directors). Director Bill Hansson was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment.