On August 26, 2022 The fiscal year 2021/2022 of Hamlet Pharma AB reported that it has been very successful and important milestones have been reached. The company has consolidated its financial position by raising significant capital, competed successfully for continued funding from the EU Horizon 2020 program, produced drug for clinical trials on a large scale, conducted successful clinical trials, added brain tumor therapy as a new indication for drug development and progressed with the BAMLET drug candidate (Press release, HAMLET Pharma, AUG 26, 2022, View Source;utm_medium=rss&utm_campaign=q4-year-end-report-july-2021-june-2022 [SID1234623366]).
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Financing and leadership
The year started with the successful completion of a funding round through a rights issue that provided the company with approximately 50.4 million SEK, before deductions for issue costs. Hamlet Pharma’s rights issue was oversubscribed by 260% for the B units. The company later received approximately SEK 5.8 million for warrants of series TO 3 B.
During the past year Hamlet Pharma received additional financial support from the EIC Accelerator Horizon 2020 fund. The European Union extended the funding after a successful 18-month report. The evaluators concluded that the company had "fully achieved the objectives and milestones for the period" and "remains in line with the objectives". The EU evaluators also noted that these advances were made despite the COVID pandemic, which seriously delayed many companies.
On the 1st of June 2022, Martin Erixon joined Hamlet Pharma as CEO. Martin Erixon combines a scientific background with extensive experience from major corporations. The former CEO Mats Persson will stay on as a senior advisor.
Clinical trial program
The clinical study in patients with bladder cancer continues according to plan. Significantly stronger effects were detected with a higher dose in the dose-escalation part of the study. The tumors were strongly affected in patients treated with five times higher amounts of Alpha1H, without an increase in side effects. Extensive molecular evaluation of the tumor response shows very encouraging results for the continued clinical trial program. Experienced consultant organizations are engaged in the discussions with the European and US regulatory authorities (EMA and FDA).
Hamlet Pharma’s strategy is to broaden the use of Alpha1H for other cancer indications, where tests in animal models already support therapeutic effects. To explore Alpha1H as brain tumor therapy, a collaboration agreement has been signed with a key opinion leader in the field of neurosurgery, Professor Steven Gill at the university of Bristol. Together with Neurochase Limited, founded by Steven Gill, Hamlet Pharma will develop a novel drug delivery technology and methods to treat tumors in the central nervous system with Alpha1H. The goal is to provide adequate materials and data to prepare for clinical trial applications.
Securing Alpha1H production for clinical studies
The external manufacturing partnerships for drug production include the synthesis of the Alpha1 peptide, the formulation of drug substance and clinical supply chain. Drug manufacturing has been successfully transferred to a new multinational commercial partner. During the third quarter, a new batch of Alpha1H was produced and shown to be stable and fully active against cancer cells, securing material for the continued clinical studies in patients with bladder cancer, which we regard as our highest priority.
Business development strategy
Hamlet Pharma and its network of pharmaceutical experts have established an interesting model for effective drug development with an emphasis on problem solving and minimizing risk. Hamlet Pharma has effectively delivered on its promises including positive clinical results and a dynamic technology platform. Hamlet Pharma was one of the few companies in the EU Horizon 2020 program to reach the promised milestones despite the Corona pandemic.
We are grateful for all efforts made by the teams in Sweden and Prague, the invaluable assistance from our committed consultants and for continued confidence and support from our shareholders.
Catharina Svanborg and Martin Erixon
Chairperson of the Board and CMO, and CEO, respectively, of Hamlet Pharma AB
Significant events during the fiscal year
Q1
On July 5, 2021, the Prospect defining Hamlet Pharma’s rights issue was published after approval and registration by the Swedish Financial Supervisory Authority (Finansinspektionen). Västra Hamnen Corporate Finance AB acted as financial advisor during the rights issue and the law firm Vinge as legal advisor.
On July 6, 2021, the successful outcome of the bladder cancer clinical trial was featured in South China Morning Post’s Health & Wellness section. South China Morning Post is Hong Kong-based and has a circulation of 105,000 with 197 million page views per month.
On July 9, 2021, Hamlet Pharma invited investors to take part in on-line meetings to give participants the opportunity to ask questions and discuss the latest developments and future plans for the company.
On July 9, 2021, Hamlet Pharma’s achievements were highlighted during an EU evaluation. Despite the COVID pandemic, the company has fully achieved its milestones. After this successful evaluation, Hamlet Pharma received the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6.7 million SEK.
The EU evaluators state that: "All required milestones and deliverables to date are without any significant deviations. This is particularly impressive considering the global Corona virus pan- demic. To date, the beneficiary has succeeded in manufacturing the Investigational Medicinal Product (IMP) Alpha1H. The company has demonstrated non-clinical improvement of therapeutic efficacy of other cancer drugs like Mitomycin C and Epirubicin, when combined with Alpha1H and successfully continued with the Phase I/II study of Alpha1H in bladder cancer patients. There is evidence of good financial management in this project. The number of financial re- sources utilized to date is proportionate to the achievements of the project to date".
On July 23, 2021, it was announced that Hamlet Pharma’s rights issue was significantly oversubscribed, B units by 260%. The issue guarantees were not used. The rights issue provides the company with approximately 50.4 million SEK, before deductions for issue costs of approximately SEK 4.1 million. Future warranties (TO3 and TO4) will potentially raise an additional SEK 90.7 million SEK before deduction of issue costs of approximately SEK 2.3 million SEK.
On August 27, 2021, the Year-end Report for the fiscal year 2020 – 2021 was published. The focus during the past 12 months has been on i) finishing the evaluation and publication of the first part of the phase I/II trial ii) expanding the clinical trial program to include a dose-escalation part and combination therapy iii) securing the production of Alpha1H for future clinical trials, iv) developing business strategies and identifying partners for Alpha1H and BAMLET and v) securing continued funding of the company.
On September 3, 2021, it was announced that Hamlet Pharma’s conversion of BTU B into shares and warrants of series TO3 B and TO4 B was on September 9, 2021.The first day for trading in warrants of series TO3 B and TO4 B will be September 10, 2021.
Q2
On October 28, 2021, the shareholders of Hamlet Pharma were summoned to the Annual General Meeting on November 25, 2021.
On October 29, 2021, Hamlet Pharma announced that it had secured the production of larger quantities of Alpha1H, using a stable, large scale manufacturing process. Larger amounts of drug will be needed for the continued clinical trial program, which involves larger study populations. Hamlet Pharma is collaborating with Rechon Life Science for the production and formulation of the drug candidate Alpha1H. Rechon is a well-recognized contract manufacturing organization based in Malmö and offers a complete pharmaceutical service including preparation, packaging, and distribution of Clinical Trial Supplies for clinical studies phases I-IV. Production is carried out in accordance with GMP and Rechon is approved for pharmaceutical supply worldwide (including the US).
On November 2, 2021, Hamlet Pharma’s Board of Directors proposed two new members for election to the company’s Board of Directors. Ulla Trägårdh is a lawyer with broad experience in the area of business law. She has been involved in the development of both a major Swedish law firm, as well as a local niche law firm that she established 2003. Lars Hedbys has many years’ experience from the pharmaceutical industry and has founded and listed several life science companies.
On November 4, 2021, the annual report for the fiscal year 2020/2021 was published. It can be found on our website or on Spotlight Stock Market’s webpage.
On November 11, 2021, Q1 for the fiscal year 2021/2022 was published. It can be found on our website or on Spotlight Stock Market’s webpage.
On November 25, 2021, the Annual General Meeting was held. Due to the corona virus pandemic, the meeting was conducted by advance voting with the support of temporary statutory rules. It was decided to appoint Catharina Svanborg, Bengt Westermark, Bill Hansson, Ulla Trägårdh, Lars Hedbys and Helena Lomberg as board members for the period until the end of the next Annual General Meeting. The AGM resolved to approve the income statement and balance sheet as included in the annual report. The AGM resolved to dispose the company’s results in accordance with the Board’s proposal in the annual report. Furthermore, it was decided that no dividend will be paid for the financial year 2020/2021. It was also resolved to grant the members of the Board of Directors and the CEO discharge from liability for the period covered by the annual report presented at the meeting. The relevant members of the Board of Directors or the CEO did not participate in this decision.
On November 30, 2021, the company invited investors to an on-line meeting to summarize the information normally presented at the Annual General Meeting and to provide a forum for a dialogue with the shareholders. About 80 participants took part and the discussions were lively and constructive.
On November 30, 2021, Hamlet Pharma signed a contract with Galenica AB. Hamlet Pharma is proceeding with the development of BAMLET for pharmaceutical use and a necessary first step is to establish technology for large-scale production of BAMLET. A new production method has been developed and patented and will be used as a basis for scaling up the production process together with Galenica AB. The parties have agreed on a development plan, including production technology transfer, testing of biological activity of the product and development of suitable formulations. Galenica AB is a contract research organisation (CRO) providing services in the field of pharmaceutical technology. The company has broad skills and experience in formulation, production and quality control of pharmaceuticals.
On December 7, 2021, Hamlet Pharma announced the new website and recruitment of a new media strategist. Hamlet Pharma increase focus on the company’s digital channels to provide easier access for shareholders and the public. An updated website and digital meetings with shareholders are examples already implemented.
Q3
On January 14, 2022, Strategic recruits to the Hamlet Pharma Think Tank were announced. The company has formed the Think Tank as a forum for strategic discussions important to the company’s future. In addition to the competence that exists in the company, leading experts have been recruited in the areas of drug development, business development, finance, and clinical strategy. The Think Tank will provide a forum for creative discussions and networking, a place where experience and expertise within the company’s major strategic areas will be shared to reach innovative solutions.
On January 17, 2022, the successful completion of the dose-escalation extension of the Phase I/II study was announced. More potent effects of Alpha1H for key study parameters were seen for higher doses. 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. The results are very encouraging for our continued work towards Phase III trials.
On January 31, 2022, a newsletter was published to describe data from the dose-escalation study in greater detail. The correlation between dose and effect strongly indicates that Alpha1H has great potential as a drug against bladder cancer.
On February 25, 2022, Hamlet Pharma published the Interim report Q2 for the period October-December 2021.
On March 2. 2022, Hamlet Pharma presented the company on Stockholm Corporate Finance 14th Life Science Capital Market days.
On March 4, 2022, A Successful review of HAMLET Pharma’s EU Horizon 2020 program was announced. Hamlet Pharma has delivered its 18-month report to the European Union’s Horizon 2020 program. The EU reviewer stated that the project has "fully achieved its objectives and milestones for the period" and "remains in line with the objectives". It was mentioned that Hamlet Pharma was one of very few companies that achieved all milestones on time, during the pandemic.
On March 8, 2022 Hamlet Pharma presented at Stockholm Corporate Finance’s 14th Life Science Capital Market days. View Source
Q4
On April 5, 2022, Hamlet Pharma announced that Martin Erixon joins Hamlet Pharma as new CEO. Martin has extensive experience from the Medical/ Pharmaceutical industry as well as from the Food Processing industry. He is a highly motivated team player and negotiator, who strives to find the best solutions in business relationships. In his previous role as advisor to Hamlet Pharma, Martin Erixon has facilitated the discussions with external partners in recent years.
On April 25, 2022, Hamlet Pharma presented at Aktiespararna in Helsingborg.
On May 10, 2022, Hamlet Pharma presented at Naventus Corporate Finance & Partners Healthcare Summit. View Source
On May 13, 2022, Hamlet Pharma presented at the 3rd International Donor Milk Research Congress in Milan. View Source
On May 17, 2022, the subscription price for the exercise of warrants of series TO 3 B was set at 3.28 SEK per share. Upon full exercise of all warrants, the Company will receive an additional maximum of 12.9 MSEK.
On May 18, 2022, Hamlet Pharma published a newsletter highlighting the recent presentations of the company. Hamlet Pharma has participated in a number of recent events, presenting highlights from the promising clinical studies and future strategy. With this newsletter, you are invited to see these presentations by following the links in the text.
On May 20, 2022, Hamlet Pharma published the Interim report Q3 for the period January – March 2022.
On May 27, 2022, Hamlet Pharma published last day for trading in warrants of series TO 3 B is 27th of May.
On June 1, 2022, Hamlet Pharma published an interview with Martin Erixon, the new CEO of Hamlet Pharma. He firmly believes in the company and is full of enthusiasm for a promising future.
On June 2, 2022, Hamlet Pharma published warrants of series TO 3 B were subscribed for approximately 45% and Hamlet Pharma AB (publ) will receive approximately SEK 5.8 million.
On June 13, 2022, Hamlet Pharma published "Brain tumor therapy – A new indication for Hamlet Pharma". A joint development agreement with Neurochase Limited, founded by Professor Steven Gill, a world leading expert in the area of neurosurgery, to develop novel technology and methods to treat Central Nervous System (CNS) tumors with Alpha1H.
Significant events after the fiscal year
On August 2, 2022, Hamlet Pharma published "Full speed ahead! – Hamlet Pharma adapts the clinical trial program for stand-alone use". Hamlet Pharma highlights the development of the clinical protocol in bladder cancer. The company has decided to interrupt the combination study where Alpha1H was used together with a chemotherapy drug. There was no evidence of a therapeutic advantage and the patients experienced side effects, which are not seen with Aloha1H alone. It was also announced that Hamlet Pharma is taking one more step towards the design of the Phase III clinical trial protocol by adding a second treatment round after the completion of the first round of treatment in the ongoing study. These decisions strengthen Hamlet Pharma’s position as a company developing drug candidates with a more beneficial profile than traditional chemotherapeutic drugs.
On August 9, 2022, Hamlet Pharma published "Hamlet Pharma receives a new rapid approval in the Czech Republic". Hamlet pharma announced the rapid approval of Hamlet Pharma’s application to amend the clinical trial of Alpha1H in bladder cancer by the Czech regulatory authorities. This important new part of the ongoing study is now ready to start.
The period in summary
FOURTH QUARTER (APR 1, 2022-JUN 30, 2022)
– Net sales for the quarter totaled KSEK 0 (0)
– Other operating income totaled KSEK 241 (3,310)
– Loss before tax amounted to KSEK -7,851 (-705)
– Loss after tax amounted to KSEK -7,851 (-705)
– Loss per share* was SEK -0.0710 (-0.0070), and SEK -0.0686 after dilution
FULL-YEAR (JUL 1, 2021-JUN 30, 2022)
– Net sales totaled KSEK 0 (0)
– Other operating income totaled KSEK 9,979 (9,340)
– Loss before tax amounted to KSEK -17,197 (-7,722)
– Loss after tax amounted to KSEK -17,197 (-7,722)
– Loss per share* was SEK -0.1556 (-0.0765), and SEK -0.1502 after dilution
– On June 30, 2022, the equity/assets ratio*** was 91.1 (21.6) %
Amounts in parentheses above and below indicate the corresponding value in the preceding year.
* Profit/loss after tax for the period divided by 110,529,666 (100,874,697) and 114,472,907, respectively, where 110,529,666 is the number of shares outstanding on June 30, 2022, and 114,472,907 will be the number of shares if the subscription warrants issued by the Company are exercised. The comparative figure in parentheses was the number of shares on June 30, 2021.