Q4 Year-end Report July 2020 – June 2021
Opening remarks
The fiscal year 2020/2021 of Hamlet Pharma AB started well, with the payment of 12.6 million SEK from the European Union Research Grant on July 1st. Hamlet Pharma was selected for the Horizon 2020 accelerator grant in competition with hundreds of applicants and this first payment secured the continued development of Alpha1H for the treatment of bladder cancer.
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.
Clinical trial program
The extensive analysis of clinical and molecular data was finalized for the first part of the clinical trial in bladder cancer. The positive results were published in June 2021 in Nature Communication, a leading international journal.
The clinical trial program has been expanded. In January the first patient was included in the dose-escalation of the Alpha1H study and preliminary results were communicated. Based on positive data in an animal model, a clinical study combining Alpha1H with low doses of a chemotherapeutic drug was also initiated. Combination therapy is widely used in cancer patients to enhance treatment outcome and to reduce side effects. Information from the ongoing study program will be essential for the design of the future clinical program and preparations for a Phase III trial.
Securing Alpha1H for future clinical studies
During the fiscal year, the production of the Alpha1 peptide has been accelerated to ensure continued supply for future clinical trials. We have invested heavily in peptide production in collaboration with our partner, Polypeptide Laboratories. The formulation of Alpha1H according to patented procedures has been scaled up and we have initiated new partnerships for drug manufacturing and packaging.
BAMLET
The development of BAMLET (bovine α-lactalbumin made lethal to tumor cells) as a stand alone therapeutic in cancer has progressed, with plans for production and clinical trials. For use as a food supplement, the production methods and charateristics of the BAMLET complex will be modified. To distinguish the BAMLET drug from other products containing similar ingredients, the term ‘’The A Complex’’ will be used for the food supplement area. In November, Hamlet Pharma was granted a patent in Europe for the use of BAMLET as nutraceutical. We have further secured patent protection in Europe for the manufacturing of BAMLET using a simplified process.
Business development
Forming strong partnerships with market leaders of drug development and commercialization is a company priority. In June, Hamlet Pharma and Linnane Pharma signed a Letter of Intent with Tetra Pak for the development of consumer products. This collaboration will explore technical aspects of production and the possibility for a future commercial agreement.
Financing
The financial situation of Hamlet Pharma is very stable. As stated above 12,6 million SEK was paid in July last year from the European Union. A second payment of 6,7 million SEK from EU was made in July this year.
During the last quarter the board decided to issue new shares/warrants with preferential rights for the company's shareholders. Hamlet Pharma's rights issue was significantly oversubscribed, providing the Company with approximately 50.4 million SEK and options for raising additionally 90.7 million SEK, both before deduction of issue costs.
We are proud to summarise these advances, which have been made despite the Covid pandemic. Hamlet Pharma is committed to improving the treatment options for cancer patients, initially patients with bladder cancer, where there is a significant unmet medical need for new therapies. We recognise the extraordinary efforts of the teams in Sweden and Prague and the invaluable assistance from our committed consultants and are grateful to all shareholders for continued confidence and support.
Catharina Svanborg and Mats Persson
Chairperson of the Board and CMO, and CEO, respectively, of Hamlet Pharma AB
Significant events during the fiscal year
On July 1, 2020, the first Grant payment of 12.6 million SEK of a total of approximately 22.4 million SEK was received. The remainder of the grant will be paid incrementally during the project´s 24-month duration. Instructions accompanying the grant specify clinical development, scientific excellence, drug development and business development.
On September 4, 2020, the board of Hamlet Pharma decided to accept a proposal from Linnane Pharma to terminate the patent license agreement of BAMLET from May 12, 2020. The board of Hamlet Pharma accepted the proposal from Linnane Pharma and thus all rights were returned to Hamlet Pharma without any compensation to Linnane Pharma.
On September 25 , 2020, Hamlet Pharma received the permission from the Czech authorities to resume its clinical trial activities. Two investigations will be conducted in parallel; a dose-escalation part, which will examine the efficacy of higher Alpha1H concentrations and a combination part, combining Alpha1H with a currently used chemotherapeutic agent.
On October 6, 2020, potent therapeutic effects of BAMLET were announced, based on studies in animal models of colon cancer. BAMLET administration indrinking water markedly reduced colon cancer development in susceptible mice. The effect was quantified as a reduction in tumour number and tumour size after 2 weeks. Long-term effects were also found in mice that had been treated for 27 weeks. These mice survived longer than untreated controls, where the disease developed faster. BAMLET was taken up by tumour tissue and was shown to lower the cellular content of several cancer markers. The results suggest that local BAMLET treatment may be effective against colon cancer also in humans, with a therapeutic and prophylactic potential. Large scale production and clinical studies will be required to further define the potential of BAMLET in patients in need of a therapeutic and/or a prophylactic treatment approach.
On October 23, 2020, a kick-off meeting for the European Union funded project was successfully held. The goal of the EU project is to accelerate the development of Alpha1H as a novel treatment for patients suffering from bladder cancer.With the EIC Accelerator funding, Hamlet Pharma has committed to finalize the Phase I/II clinical safety and efficacy study for publication and to advance the development of Alpha1H towards future Phase III trials.
On November 17, 2020, the Company announced discussions regarding BAMLET with major multinational companies. The discussions concern the future commercial use of BAMLET (bovine α-lactalbumin made lethal to tumor cells) in non-prescription and food products.
On November 17, 2020, the Nutraceutical Patent for HAMLET and BAMLET was granted in Europe. Hamlet Pharma AB has secured patent protection in Europe for the manufacturing of BAMLET using a simplified process. The patent is based on results from an extensive academic research and discovery platform and is valid until August 8, 2033.
On November 25, 2020, Hamlet Pharma successfully secured patent protection in Europe for its lead clinical candidate, Alpha1H. The patent is valid until May 14 th, 2038. Alpha1H is currently used in clinical trials in patients with bladder cancer. Hamlet Pharma AB plans to seek equivalent protection in further key countries around the world.
On November 26, 2020, the film "This is Hamlet" was made public. The film was produced by the well-known TV journalists Calle Magnell and Fredrik Kron in collaboration with Jan-Olof Bengtsson. The film tells the story of HAMLET and Alpha1H from discovery to clinical trials in cancer patients. In the film, members of the HAMLET team add their stories about working with Alpha1H research and their thoughts about the process of translation from science to clinical use. The principal investigator Professor Marek Babjuk at the University Hospital in Prague is also interviewed about the ongoing clinical study in patients with bladder cancer carried out together with his team.
On November 26, 2020, the General Annual Meeting of Hamlet Pharma was held in Malmö. Due to the pandemic, shareholders were asked to send in their voting forms in advance. It was decided to appoint Catharina Svanborg, Bengt Westermark, Christer Köhler, Rolf Carlsson and Helena Lomberg as board members for the period until the end of the next Annual General Meeting.
On January 22, 2021, the first patient was included in the dose-escalation part of the ongoing study. The local clinical study team is very experienced and highly motivated to continue the investigations to define the potential of Alpha1H in bladder cancer treatment. The authorities have allowed five times and ten times increase in the dose of Alpha1H compared to the previous part of the trial. The Food and Drug Administration in US has declared bladder cancer a great unmet medical need, and we are determined to fill this gap and improve treatment options.
On January 29, 2021, the Board of Directors of Hamlet Pharma proposed to introduce A and B shares with different voting rights. Each existing share in Hamlet Pharma was split into 2 new A shares and 1 new B share, where each A share will have a voting value of 10 and each B share a voting value of 1. The shares will have the same right to future dividends. An information leaflet was sent to all shareholders to provide a background to this decision and fully explain practical aspects, to facilitate this process.
On January 29, 2021, shareholders were invited to an Extraordinary General Meeting to be held on March 2, 2021. Considering the corona virus pandemic, the meeting was conducted by advance voting with the support of temporary statutory rules. There was no opportunity to attend in person or through a representative.
On March 2, 2021, the Extraordinary General Meeting was held. It was decided, in accordance with the Board’s proposal, to amend the Articles of Association, whereby the possibility of issuing shares in two series, series A and series B, was introduced. Following the completion of the division, the total number of shares in the company will increase from 33,624,899 to 100,874,697 shares, of which 67,249,798 shares will be series A shares and 33,624,899 shares will be Series B shares.
It was also decided to elect Professor Bill Hansson to the board of Hamlet Pharma. Bill Hansson is an internationally recognized scientist in the field of biology and his extensive academic leadership includes his directorship at the Max Planck Institute for Chemical Ecology in Jena. Bill Hansson was recently awarded the Federal Cross of Merit 1st Class by the President of Germany.
On March 9, 2021, the Board of Directors decided that the recording date for the division of shares shall be Tuesday, March 16, 2021. The first day for trading of the divided shares was set to Monday, March 15, 2021. In connection with the share split, the B share took over the existing trading venue on Spotlight Stock Market. The A share will remain unlisted. Further information on the introduction of A and B shares and the procedure for conversion from A shares to B shares was found in the information brochure sent out to all shareholders and was published on the Hamlet Pharma homepage.
On March 10, an information leaflet was sent to all shareholders with the background information to the decision as well as instructions on the practical aspects, to facilitate this conversion process.
On March 18, 2021, the company announced new treatment advances in an experimental animal model of bladder cancer. Repeated Alpha1H treatment prevented tumor growth and upon visual/microscopic inspection the bladders remained similar to the control group without tumors in mice. In contrast, mice treated with placebo showed rapid tumor progression and severe disease after 12 days. The first round of Alpha1H treatment prevented tumor development for 4 weeks and long-term protection was achieved when treatment was repeated at 4-week intervals, as evidenced by marked differences in tumor size, pathology score, biomarkers, and gene expression.
On April 7, 2021, Hamlet Pharma signed a contract with Rechon Life Science AB for the manufacture of clinical batches of Alpha1H. The batches will be used for continued phase II and future phase III clinical trials in patients with bladder cancer. 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). The production will be preceded by technology transfer from our laboratory as well as from previous suppliers.
On April 21, 2021, the report of the phase I/II bladder cancer trial was accepted for publication in Nature Communications: a leading international journal. The paper is entitled "Bladder cancer therapy using a conformationally fluid tumoricidal peptide complex". The Nature journals are very competitive and only accept innovative science of highest quality and with significant interest for a discerning audience. The paper analyses the structure of the Alpha1H complex, characterizes its tumor killing effects and describes the successful clinical trial of Alpha1H in patients with bladder cancer. A detailed analysis of primary and secondary end points is provided and differences between the Alpha1H treated patients and the placebo group are described for several crucial efficacy variables.
On May 10, 2021, the company announced the successful outcome of treatment with higher amounts of Alpha1H in patients with bladder cancer. The preliminary analysis of the data revealed a potent increase in several effect variables and without any evidence of serious adverse events.
On June 2, 2021, shareholders were summoned to an Extraordinary General Meeting to ask for authorization for the Board of Directors to, on one or more occasions, during the period leading up to the next Annual General Meeting, decide on the issue of shares and / or warrants, with preferential rights for the company's shareholders. Considering the coronavirus, the meeting was conducted by advance voting with the support of temporary statutory rules.
On June 4, 2021, Hamlet Pharma invited investors to a series of meetings, arranged to facilitate the dialogue with shareholders and to inform them about the latest developments, including the expanded clinical study program.
On June 7, 2021, a Letter of Intent (LoI) was signed between Tetra Pak, Hamlet Pharma and Linnane Pharma. regarding the development of consumer products. The objective is to allow Tetra Pak´s customers or other producers of products to include The A Complex as an ingredient, enabling potential future claims on benefits generated by the complex. The processing technology and solutions will be sourced from Tetra Pak with the patent rights from Hamlet Pharma. The parties will explore the possibility for a commercial agreement during the product validation process.
On June 10, 2021, the results of the controlled clinical trial in bladder cancer patients were published in Nature Communications. In the paper, therapeutic efficacy of the complex is demonstrated in patients with non-muscle invasive bladder cancer (NMIBC). The complex induced rapid shedding of tumour cells and tumour fragments into the urine and a significant reduction in tumour size, compared to the placebo group. The Alpha1-oleate complex is readily internalized by cancer cells, which end up being killed. Healthy cells are less responsive and extensive toxicity studies have failed to detect adverse effects in the bladder. This low toxicity was confirmed in the clinical study, as no severe drug-related side effects were observed in patients in the treatment group. Alpha1H triggered apoptotic cell death in the tumour and by gene expression analysis, a massive reduction in cancer gene expression was observed.
On June 17, 2021, an Extraordinary General Meeting (EGM) was held, which in the light of the coronavirus was conducted only by advance voting. The EGM resolved, in accordance with the Board's proposal, to authorize the Board to, on one or more occasions, during the period until the next Annual General Meeting, decide on the issue of shares and/or warrants, with preferential rights for the company's shareholders. The number of shares and/or warrants that entitle to new subscriptions of shares issued with the support of the authorization may amount to a maximum of 20,000,000, corresponding to a dilution of approximately 17 percent calculated on the number of outstanding shares in the company after full exercise of the authorization.
On June 18, 2021, it was announced that the Company's parent company, Linnane Pharma AB, has declared itself ready to subscribe for the part of the issue that corresponds to Linnane Pharma's ownership in the company in a future rights issue of shares/warrants.
On June 24, 2021, the Board of Directors decided to, with the support of authorization from the Extraordinary General Meeting on June 17, 2021, carry out an issue of shares and warrants ("Units") with preferential rights for the company's shareholders totalling approximately SEK 50.4 million (the "Rights Issue"). The Rights Issue enables continued and accelerated development of the Company's drug candidates Alpha1H and BAMLET. The company has entered into a subscription and guarantee agreement regarding the Rights Issue of SEK 37.9 million, corresponding to approximately 75% of the Rights Issue.
Significant events after the end of the fiscal year
On July 5, 2021, the brochure regarding Hamlet Pharma’s rights issue was published. The brochure had received prior approval and was registered by the Swedish Financial Supervisory Authority (Finansinspektionen). Västra Hamnen Corporate Finance AB is the financial advisor and Advokatfirman Vinge is the legal advisor in connection with the Rights Issue.
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 possibility 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 of the project. Despite the COVID pandemic, the company has fully achieved its milestones and secured the second payment of the grant from the EIC Accelerator Horizon 2020 fund. 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 pandemic. 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 resources utilized to date is proportionate to the achievements of the project to date”. After this evaluation, Hamlet Pharma received the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6.7 million SEK.
On July 23, 2021, it was announced that Hamlet Pharma's rights issue was significantly oversubscribed. The new funding will allow us to pursue our vision to develop new cancer drugs for the benefit of large patient groups. The issue guarantees was not used. The rights issue provides the Company with approximately SEK 50.4 million, before deductions for issue costs of approximately SEK 4.1 million. Future warrants (TO3 and TO4) will give the company a possibility to provide additionay SEK 90.7 million before deduction of issue costs of approximately SEK 2.3 million.
Impact of the COVID 19 pandemic
The COVID-19 pandemic has significantly affected drug development, not least the clinical trials. The European Medicines Agency (EMA) has acknowledged this and advised keeping activities on clinical trials to a level not impacting the priorities in the clinic. HAMLET Pharma has continued the clinical trials and the Czech authority has approved our applications. Moreover, the clinical team in Prague has done their utmost to recruit patients and support the study. Despite this, some delays are inevitable.
Figures
FOURTH QUARTER (APR 1, 2021-JUN 30, 2021)
– Net sales for the quarter totaled KSEK 0 (0)
– Other operating income totaled KSEK 3,310 (448)
– Loss before tax amounted to KSEK -705 (-6,471)
– Loss after tax amounted to KSEK -705 (-6,471)
– Loss per share* was SEK -0.0070 (-0.0642), and SEK -0.0060 after dilution
FULL-YEAR (JUL 1, 2020-JUN 30, 2021)
– Net sales totaled KSEK 0 (0)
– Other operating income totaled KSEK 9,340 (448)
– Loss before tax amounted to KSEK -7,722 (-23,432)
– Loss after tax amounted to KSEK -7,722 (-23,432)
– Loss per share* was SEK -0.0765 (-0.2323), and SEK -0.0662 after dilution
– On June 30, 2021, the equity/assets ratio** was 21.6 (72.0) %
Amounts in parentheses above and below indicate the corresponding value in the preceding year.
* Profit/loss after tax for the period divided by 100,874,697 (3*33,624,899=100,874,697) and 116 647 661, respectively, where 100,874,697 is the number of shares outstanding on June 30, 2021, and 116 647 661 will be the number of shares after the completed emissions in July and if the subscription warrants issued by the Company are exercised. The comparative figure in parentheses was the number of shares on June 30, 2020 - considering the split that was registered at the Swedish Companies Registration Office (Bolagsverket) by April 14, 2021. The shares were splitted in the relation 3:1. Thus, the number of shares totals 100,874,697. Read more in the section “The share” below.
** Equity divided by total capital.
Hamlet Pharma AB
Hamlet Pharma, whose shares are traded on Spotlight Stock Market, is part of a Group and is a subsidiary company of Linnane Pharma AB, which owns 50.19% of Hamlet Pharma AB. Linnane Pharma is wholly owned by Catharina Svanborg, Chairman of Hamlet Pharma. Hamlet Pharma is engaged in drug development based on the tumoricidal protein-lipid complex, HAMLET, formed by two generally regarded as safe (GRAS) molecules present in human milk. The novel therapeutic entity HAMLET is formed when alpha-lactalbumin (the primary protein component of human milk) undergoes a conformational change and binds to oleic acid. The aim is to develop drugs that can primarily be used for the treatment and prevention of cancers. HAMLET selects and removes tumour cells efficiently and has not shown toxicity in two proof-of-concept studies in humans. The agent has shown a therapeutic effect on skin papillomas in a placebo-controlled clinical trial and induces shedding of dead cancer cells after injection into the bladder of patients with bladder cancer.
Alpha1H is a synthetic variant of HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a severe and costly form of cancer. The Company intends to expand its activities into other types of cancer. The ongoing clinical study shows no side effects of Alpha1H, indicating that the treatment is safe and well tolerated. Alpha1H demonstrated clinical efficacy compared with patients who received placebo.
The company’s operations are based on R&D. The Company has therefore concluded an agreement with Lund University to ensure that Hamlet Pharma gains access to the research findings underlying the continued development of its research portfolio. The protein-lipid complex HAMLET is formed when alpha-lactalbumin (a human milk protein) binds to oleic acid (a fatty acid), which is also present in milk. The Company has also identified the active components of the HAMLET molecule that are responsible for the tumoricidal activity and developed large-scale production of these components. The peptide complex named Alpha1H has demonstrated efficacy on bladder cancer. Alpha1H has been granted numerous patents in both Europe, Asia and the US.
Revenue and earnings
During the fourth quarter, Hamlet Pharma’s net sales amounted to KSEK 0 (0). Other operating income amounted to KSEK 3,310 (448). Read more in the section “Horizon 2020 EIC Accelerator Fund” below. Costs were related to the continued R&D activities of the research team at Lund University, and for securing future funding. The team at Lund University is also responsible for the development of manufacturing methods, stability testing and chemical and functional characterization of existing and new drug substances, and plays a key role in the coordination of laboratory testing in the clinical trial. Costs were also related to manufacturing of the Alpha1H drug candidate, for use in ongoing and forthcoming clinical trials.
Loss before tax for the fully-year was KSEK -7,722 (-23,432). Loss before tax for the fourth quarter was KSEK -705 (-6,471).
Financial position
During July 2021, the company carried out a rights issue. The issue will provide the Company with approximately 50.4 MSEK, before deductions for issue costs of approximately 4.1 MSEK. Read more in the section “New share issue and subscription warrants” below. Furthermore, a second payment of 6.7 MSEK was received from the EU in July 2021. Read more in the section “Horizon 2020 EIC Accelerator Fund” below.
At the end of the fourth quarter, the equity/assets ratio was 21.6 (72.0) %, and the Company’s cash and cash equivalents were KSEK 7,473 (13,240).
The company is sufficiently equipped in terms of liquidity for the next fiscal year.
Horizon 2020 EIC Accelerator Fund
In March 2020 Hamlet Pharma (together with Linnane Pharma) was awarded a grant of 2.2 MEUR (approx. 22.4 MSEK) (of which 252 KEUR belongs to Linnane Pharma) from the EU’s prestigious Horizon 2020 EIC Accelerator Fund. The funds will be paid incrementally during the project’s 24-month duration. The first payment of 12.6 MSEK was done in July 2020, and the second payment of 6.7 MSEK was done in July 2021. Grants received from Horizon 2020 will be reported as other income as performance within the framework of the agreement is performed. During the fourth quarter 3,248 KSEK was used from the fund, and 9,696 KSEK has been used accumulated from the fund.
Investments
No intangible assets were capitalized during the period, since the Company is in an R&D stage. R&D costs are therefore recognized as operating expenses in the income statement. No new investments in tangible assets were capitalized during the fourth quarter.
Depreciation
During the quarter, depreciation of equipment amounted to KSEK 9 (9), and during the fully-year, depreciation of equipment amounted to KSEK 36 (36).
Employees
The company had the corresponding 5 (2) full-time employees during the fully-year.
The share
The Company’s shares have been traded on Spotlight Stock Market since October 23, 2015. Spotlight Stock Market is the secondary name of ATS Finans AB, a securities company under the Swedish Financial Supervisory Authority’s supervision.
At the extraordinary general meeting in Hamlet Pharma AB on March 2, 2021, it was decided that the company’s common shares would undergo a split with relation 3:1 and would be reclassified as A- and B-shares. The B-shares will be traded on Spotlight Stock Market. The A-shares will not be listed. Each A-share entitles to ten votes and B-shares entitles to one vote. Furthermore, it is possible for shareholders to convert A-shares to B-shares, which can be traded on Spotlight Stock Market. This conversion program is ongoing with no current deadline. This means that the ratio between A- and B-shares will change over time. The split was registered at the Swedish Companies Registration Office (Bolagsverket) by April 14, 2021.
On June 30, 2021, the number of shares registered at the Swedish Companies Registration Office (Bolagsverket) totaled 100,874,697. On August 6, 2021, the registered current ratio of shares was 37,968,210 A-shares and 62,906,487 B-shares.
New share issue and subscription warrants
After the financial year, in July 2021, the Company carried out a rights issue (“Rights Issue”). This has provided the Company with approximately 50.4 MSEK, before deductions for issue costs of approximately 4.1 MSEK.
A total of 3,870,495 units were issued. A unit consists of two shares (A or B shares depending on previous ownership), a warrant in series TO3 and a warrant in series TO4. The warrants were issued free of charge. A warrant of series TO3 entitles the holder to subscribe for a new B share in the Company during the period 17 - 31 May 2022, and a warrant of series TO 4 entitles the holder to subscribe for a new B share in the Company during the period 17 - 31 May 2023. The subscription prices amount to 75% of the volume-weighted average prices for the Company's share in the ten trading days immediately preceding the start of the respective exercise period. However, a maximum of SEK 10 per share for TO3 and a maximum of SEK 13 per share for TO4.
Due to the issue guarantors being entitled to receive guarantee compensation in the form of newly issued units in the Company, the Board, with the support of authorization from the Extraordinary General Meeting held on 17 June 2021, decided on a set-off issue ("Offset Issue"), which comprises a total of 72,746 B-units, consisting of 145,492 new B shares and 72,746 new warrants of series TO3 and 72,746 new warrants of series TO4 on the same terms as in the Rights Issue.
Upon full exercise of all warrants, the Company will receive an additional maximum of SEK 39.4 million for TO3 and a maximum of approximately SEK 51.3 million for TO4, before deduction of issue costs of approximately total SEK 2.3 million.
The share capital after the Rights Issue and the Offsetting Issue will after registration amount to SEK 1,087,611.79, divided into a total of 108,761,179 shares.
The warrants TO3 and TO4 will be admitted to trading on the Spotlight Stock Market after the Rights Issue has been registered with the Swedish Companies Registration Office (Bolagsverket).
Transactions with related parties
A science and technology platform support agreement has been signed between Linnane Pharma and Hamlet Pharma, securing access to an advanced science and technologies. During the quarter, KSEK 230 (131) was paid to Linnane Pharma AB regarding consulting fees and technology platform. KSEK 200 (125) was paid to Fridsbo Pharma AB (partly owned by CEO Mats Persson). During the full-year, KSEK 900 (472) was paid to Linnane Pharma AB and KSEK 520 (252) to Fridsbo Pharma AB. Furthermore, salaries and allowances to board and management were paid during the period. Transactions with related parties is on market terms.
Significant risks and uncertainties
The Board's assessment of significant risks and uncertainties is unchanged compared with the most recent financial year and is described in the most recently published annual report (2020-06-30).
Basis of preparation for the interim report
The Company prepares its accounts in accordance with the Swedish Annual Accounts Act and the K3 framework (BFNAR 2012:1) of the Swedish Accounting Standards Board.
The company's accounting principles are unchanged compared with most recent financial year and are described in the most recent published annual report (2020-06-30).
Review
This interim report has not been audited.
The AGM and the annual report
- The Annual General Meeting for 2020/2021 is planned to be held at Malmö Börshus, in Malmö on November 25, 2021. Due to COVID-19, further information will be given in a press release closer to the AGM.
- Annual Report for 2020/2021 will be available on November 4, 2021, on the Company’s office at Klinikgatan 32, Lund. The documents are also published on the company's website (www.hamletpharma.com) and are then sent to the shareholders who request it and state their postal address.
- The Board proposes that no dividends be paid for the 2020/2021 fiscal year.
Financial calendar
Annual Report for 2020/2021 November 4, 2021
Interim report for Q1, 2021/2022 November 11, 2021
Annual General Meeting for 2020/2021 November 25, 2021
Income statement, Balance sheet, Cash flow statement and Equity, please see attached pdf copy.
The Board of Directors and the Chief Executive Officer assure that the interim report provides a true and fair view of the Company's operations, position and results.
Malmö, August 27, 2021
Catharina Svanborg Bengt Westermark
Chairperson of the Board Board member
Christer Köhler Helena Lomberg
Board Member Board member
Bill Hansson Mats Persson
Board member CEO
For more information, please contact
Catharina Svanborg, Chairperson of the board, Hamlet Pharma, +46 709 42 65 49
Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57
About HAMLET Pharma
HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses primarily on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and has proven safe in proof-of-concept studies in animal models. Alpha1H is the synthetic variant of HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a costly form of cancer that is difficult to treat, and intends to expand its activities into other types of cancer. The first results from the ongoing clinical Phase I/II study shows no side effects of Alpha1H, indicating that the treatment is safe and well tolerated. Alpha1H also demonstrated clinical efficacy compared with patients who received placebo. In addition, Hamlet Pharma develops BAMLET, which is a molecular complex formed by bovine α-lactalbumin and oleic acid. Data from animal models suggest that local BAMLET treatment may be effective against colon cancer.