Announcement • 1h
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. Board Change • May 20
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. 4 non-independent directors. Chairman of the Board Gabriela Godaly was the last director to join the board, commencing their role in 2025. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 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. 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 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 Announcement • May 06
Hamlet BioPharma AB Completes the First Part of A Controlled Clinical Trial in Patients with Bladder Pain Syndrome (Severe Pain in the Urinary Bladder) Hamlet BioPharma AB has successfully completed the first part of a controlled clinical trial in patients with bladder pain syndrome (severe pain in the urinary bladder). The patients have been treated with anakinra, which is an Interleukin1 (IL-1) receptor antagonist (IL-1RA). The company can now announce that a significant proportion of the treated patients have responded positively to the treatment. Patients with bladder pain syndrome have severe pain, which is socially debilitating. Broadly used pain killers are not effective. Some patients are helped by morphine or surgery, but often without lasting effects. Hamlet BioPharma has patented the use of anakinra for bladder pain and is conducting a placebo-controlled study to evaluate the treatment effect in patients with bladder pain syndrome. The pro-inflammatory cytokine IL-1 increases pain in the bladder and blocking of the IL-1 effect with anakinra treatment reduces the pain response in animal models. Anakinra is an IL-1 receptor antagonist that neutralizes the biological activity of the two potent pro-inflammatory molecules IL-1a and IL-1b. In the initial part of the clinical study, the recruited patients were treated with anakinra to define the responder group for the later placebo-controlled part of the trial. Significant effects were detected in the majority of the treated patients. The pain score was reduced after treatment and the quality of life increased in this severely disabled patient group. In addition, laboratory tests showed a convincing reduction in pain molecules after treatment, suggesting a direct effect of treatment at the molecular level. Announcement • Jan 25
Hamlet Biopharma Announces New Analyses of Clinical Data from Alpha1h Treated Patients with Bladder Cancer Detect A Strong Immune Response with Known Anti-Tumor Effects Hamlet BioPharma's drug candidate Alpha1H has been shown to affect a majority of tumors in treated patients with cancer of the urinary bladder. A new analysis now provides a further explanation for this strong effect, based on an immune response in the treated patients with known anti-tumor effects. Thus, in addition to killing tumor cells and inducing tumor cell shedding, Alpha1H activates a broad immune response, which adds a strong protective potential against cancer. Alpha1H complex kills several types of cancer cells in vivo. In clinical studies, the complex has shown therapeutic effects in a randomized, placebo-controlled study of patients with non-muscle invasive bladder cancer and increased effects in patients treated with higher doses, with almost no toxicity. Alpha1H-instillations in the bladder of the patients triggered a rapid tumor response, quantified as the shedding of tumor cells into the urine within two hours of treatment. Tumor cell death was accompanied by a strong apoptosis-like response in the tumor and shed cells contained large amounts of Alpha1H, identifying potential effects of the peptide-lipid complexes on bladder cancer tissue. The new analysis detected an unexpected but very encouraging immune response in patients treated with Alpha1H, with strong anti-tumor potential. The company found that this immune response was activated by Alpha1H immediately after the first treatment, and was sustained during the treatment period of one month. The immune response also increased with the treatment dose. The activation of the immune system adds power to the anti-tumor effects of Alpha1H and an additional way in which the tumor can be attacked and neutralized, as Alpha1H creates a multifunctional therapeutic environment. Alpha1H treatment activates the immune response directly in the tumor area, resulting in a predominantly local effect. A further advantage of Alpha1H treatment is the lack of severe side effects in the treated patients, except for local irritation at the site of injection, which often accompanies local therapies. The new analysis further shows that the immune response profile in Alpha1H treated patients with early tumors is rapid and at least as strong as that reported in of patients treated with BCG, which is the drug of choice for many patients with more severe bladder cancer. Ongoing shortage of BCG supply in the USA and many countries, reported by the Food and Drug Administration, is expected to continue for years resulting in patients not getting full treatments, emphasizing the need for new alternative treatments. The publication will be evaluated during a review process before being considered for publication. Announcement • Dec 20
Hamlet Biopharma AB (Publ) Announces Antimicrobial Peptide Therapy for Tuberculosis Infections Hamlet BioPharma announced the company currently advancing several phase II trials targeting infectious diseases and cancer, along with an extensive project and patent portfolio,is delighted to announce progress for the tuberculosis project. Tuberculosis is a major cause of mortality in all parts of the world, not least in patients whose immune system is compromised as in HIV infected individuals. The treatment options are becoming more limited, due to escalating antibiotic resistance. The group of Professor G. Godaly are developing a novel antimicrobial peptide, NZX, as a potential drug for pulmonary tuberculosis treatment, in collaboration with Hamlet BioPharma. The new, peptide-based drug has shown promising treatment effects against lung tuberculosis in animal models, both against antibiotic sensitive and antibiotic resistant bacteria. The bacteria causing tuberculosis, Mycobacterium tuberculosis, have a unique, thick cell wall, which is difficult for anti-bacterial compounds to penetrate. The effect of the peptide NZX on the bacterial cell was studied to understand NZX's membrane interaction in live bacteria. NZX displayed a pull-and-aggregate mechanism on the inner membrane of mycobacteria, disrupting cell integrity. In drug interaction studies, NZX showed an additive effect with traditional tuberculosis therapies such as isoniazid and ethambutol, which may be essential for defining future clinical protocols. In addition, the peptide NZX demonstrated broad-spectrum activity against non-tuberculosis mycobacteria and drug-resistant Staphylococcus aureus. These findings emphasize NZX's potent effects against mycobacteria, with a notable absence of antibiotic resistant mutants in resistance development studies. Announcement • Dec 07
Hamlet Biopharma's Continued Development of Brain Tumor Therapy Hamlet BioPharma AB (publ) update about the development of brain tumor therapy based on the investigational new drug Alpha1H. Hamlet BioPharma together with its partner Neurochase Ltd. are making progress with the early pre-clinical work for the treatment of brain tumors. Important milestones have been reached during the preclinical assessment. Hamlet BioPharma is developing a new class of anti-cancer therapeutics for multiple cancer indications based on the discovery of its proprietary drug complex HAMLET ('Human Alpha-lactalbumin Made Lethal to Tumor cells'). HAMLET has shown great promise for the treatment of brain tumors, killing brain tumor cells of different origins and significantly delaying brain tumor growth. The cellular effects are reproduced by Hamlet BioPharma's lead anti-cancer compound Alpha1H, which efficiently kills different brain tumor cells in the laboratory. The brain and spinal cord constitute the central nervous system (CNS), where vital functions are controlled. Due to a lack of efficient drugs that are suitable for delivery into the central nervous system, brain tumor treatment presents a significant challenge. Unlike other organs, the brain does not easily tolerate invasive procedures, making surgical removal of tumors particularly difficult. In many cases, the location of tumors within the brain may render them inoperable without causing severe damage to vital neural structures. New Risk • Sep 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 14% This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-kr30m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 2.3% per year over the past 5 years. Revenue is less than US$1m (kr2.4m revenue, or US$217k). Minor Risks Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (€26.4m market cap, or US$28.2m). Announcement • Jun 30
Hamlet Pharma Announces CEO Changes Hamlet Pharma announced the appointment of Petter Segelman Lindqvistas new CEO, starting October 1st 2023. The recruitment of Petter Segelman Lindqvist marks a new phase in the development of Hamlet BioPharma's groundbreaking technologies for cancer and infection therapy. Petter Segelman Lindqvist's extensive experience from the global pharmaceutical Industry will increase the emphasis on partnering, commercialization and future market approval. The board wishes to thank Martin Erixon, who will stay as CEO until Petter Segelman Lindqvist joins the company in the fall of 2023. Petter Segelman Lindqvist, with a background at pharmaceutical companies such as GlaxoSmithKline, Abbott and AbbVie, is currently holding a position as Portfolio Strategy Lead at Sobi (Swedish Orphan Biovitrum AB). He brings significant experience from the Global Strategy and Corporate Development functions, as well as from roles in global commercial operations and product strategy. Petter Segelman Lindqvist holds an MSc in Economics and Business Administration from the Stockholm School of Economics and EM Lyon, France. New Risk • Jun 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.0% This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-kr23m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 1.7% per year over the past 5 years. Revenue is less than US$1m (kr223k revenue, or US$21k). Minor Risks Shareholders have been diluted in the past year (3.0% increase in shares outstanding). Market cap is less than US$100m (€25.8m market cap, or US$28.2m). Board Change • May 10
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. 4 non-independent directors. Director Bill Hansson was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Nov 16
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 Bill Hansson was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Aug 03
Hamlet Pharma Adapts the Clinical Trial Program for Stand-Alone Use Hamlet Pharma develops new drug candidates to treat cancer without causing significant side effects. The drug candidate Alpha1H shows specificity for tumor tissue, where it accumulates and triggers cancer cell death. The anti-tumor effects of Alpha1H have been documented in a placebo-controlled clinical trial of bladder cancer and the effects on the tumor increased with a higher dose of the drug, as demonstrated in a dose-escalation study. There were no drug-related side effects in the treated patients; a very unusual result of cancer therapy. Hamlet Pharma is now taking one more step towards the design of the Phase III clinical trial protocol. The positive effects on the tumor and the lack of side effects of the higher dose make it possible to add a second treatment round after the completion of the first round of treatment in the ongoing study. The aim is to optimise the tumor response by introducing repeated treatments; a likely reality in a future clinical scenario. This approach will be tested in a limited number of patients and will not delay the regulatory process. Preliminary results from the combination study have suggested that Alpha1H is suitable for development as a stand-alone drug candidate. Patients in the combination study, who received Alpha1H in combination with the chemotherapeutic drug epirubicin, showed evidence of side effects, even though a low dose of epirubicin was used. There was no evidence of improved efficacy of the combination treatment compared to Alpha1H alone. For ethical and clinical reasons, Hamlet Pharma has therefore decided not to continue the combination study and instead continue the clinical program with the repeated treatment protocol. These decisions strengthen Hamlet Pharma's position as a company developing drug candidates with a more beneficial profile than traditional chemotherapeutic drugs. Board Change • Apr 27
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 Bill Hansson was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 06
Hamlet Pharma Announces Executive Changes Martin Erixon joins Hamlet Pharma as new CEO. Hamlet Pharma enters a new business development phase involving multiple cancer indications and markets. Martin Erixon has extensive experience from the Medical/Pharmaceutical industry as well as from the Food Processing industry. Based on a Ph.D. in Chemistry from the University of Lund and a Master of Science, Martin Erixon has developed a successful career in large corporations such as Gambro (Baxter) and Tetra Pak. He combines strong leadership with excellent communication skills and has successfully built relationships with different stakeholders both in Gambro (Baxter) and Tetra Pak. Martin Erixon is a highly motivated team player and negotiator, who strives to find the best solutions in business relationships. In his capacity as advisor to Hamlet Pharma, Martin Erixon has facilitated the discussions with external partners in recent years. The current CEO Mats Persson will stay in the company and continue to support the clinical trial program. Mats Persson has made invaluable contributions to the development of the company and of Alpha1H into a strong drug candidate for bladder cancer. Announcement • Feb 01
Hamlet Pharma AB (Publ) Has Announces Clinical Dose Escalation Study with the Hamlet Peptide Drug Alpha in Patients with Bladder Cancer Hamlet Pharma AB (publ) has announced that clinical dose escalation study with the Hamlet peptide drug Alpha in patients with bladder cancer was successfully completed in December 2021. The data analysis is ongoing but the preliminary results communicated are very promising indeed. Despite the pandemic, company have completed the study on time, emphasizing commitment to patients and shareholders. This important step on the journey from discovery to a drug puts company closer to the final stages of drug development, before Phase III and FDA approval. Each year around 500 000 patients worldwide are diagnosed with bladder cancer, which results in around 165 000 annual deaths. Bladder cancer has the highest recurrence rate of all cancer indications. This means that more than 80% recur after complete surgical removal of the first tumor and 15% progress to muscle invasive disease. Patients have now been treated with Alpha1H, a synthetic drug candidate derived from HAMLET; the first in a family of cancer killing compounds with astonishing properties. A dose escalation study like this is a fairly advanced step in a clinical trial program for a new drug. Drug development usually starts with a Phase I study, which is performed to ensure that the drug candidate is not too toxic for further development. Alpha1H has been extensively tested in animal models and found not to be toxic for the bladder. In the Phase I/II trial, there was no evidence of toxicity compared to the placebo group. In addition, positive effects on the tumor were documented, including cell shedding, a loss of cancer geneexpression, apoptosis and a reduction in tumor size. The purpose of a dose escalation study is to see if treatment with an increased dose of the drug candidate, results in increased effects in the patients. This is precisely what happened. The tumors were more strongly affected than in patients treated with the lower dose and compared to the placebo group. This correlation between dose and effect strongly indicate that the substance is behaving like a "real drug", and that it may be possible in the future to administer Alpha 1H according to the special needs of the individual patient. Alpha1H has also the potential to be used to treat other cancer types as well. HAMLET kills more than 40 different types of tumor cells in the test tube, including those, which are difficult to treat with available drugs. Announcement • Jan 18
Hamlet Pharma AB (Publ) Announces Successful Completion of the Dose Escalation Study in Patients with Bladder Cancer Hamlet Pharma has previously reported the successful completion of a Phase I/II study using a 1.7 mM dose of Alpha1H. now excited to report the successful completion of the dose escalation extension of the Phase I/II trial, demonstrating more potent effects of Alpha1H for key study parameters. The results are very encouraging for continued work towards Phase III trials. The tumors were more strongly affected by Alpha1H at higher doses than in patients treated with the lower dose, as shown by more extensive shedding of tumor cells and tumor fragments into patient urine. As shown earlier, significant cell shedding or apoptosis did not occur in the placebo group, confirming the treatment effect. Tissue analysis detected tumor fragmentation and shedding of tumor fragments from the remaining tumor, with large affected areas. In addition to the changes in the tumors, a pronounced apoptotic response was detected in cells and tumor fragments shed by the treated patients, confirming that Alpha1H accelerates cell death in the tumor. Apoptosis is a beneficial, non-toxic form of cell death, and therapies inducing apoptosis in growing tumors are highly desirable to limit the side effects of cancer therapy. Furthermore, the tumor fragments in urine were shown to contain large amounts of Alpha1H, confirming the efficiency with which the higher doses of Alpha1H reach tumor tissue. The results suggest that the uptake of Alpha1H by tumor cells is a direct trigger of apoptosis, tumor fragmentation and release of the affected tumor fragments into the urine. Dose-finding studies are essential to understand the potential of new drugs and define the optimal therapeutic window. The dose-dependent increase in therapeutic efficacy further emphasizes the potential of Alpha1-oleate for use as a drug in bladder cancer. 