SelectImmune: YEAR-END REPORT JULY 2021 - JUNE 2022
SelectImmune Pharma is an innovative biotech company that develops novel immunotherapies against infection.
Excessive innate immune responses to infection cause symptoms and pathology in acute pyelonephritis and acute cystitis. Immunomodulation is therefore a realistic option for treating these conditions as alternatives or complements to antibiotics.
Several of the company's drug candidates have shown protective effects against bacterial infection in animal models, including acute cystitis, severe kidney infection and urosepsis.
One drug candidate, Interleukin-1 receptor antagonist (IL1-RA) has successfully been used in the clinic to treat bladder pain syndrome and is currently being investigated in controlled Phase II trials.
Furthermore, IL1-RA treatment is being investigated in a Phase II trial in patients with recurrent cystitis.
SelectImmune Pharma is research-based and the company has an agreement with Lund University.
The discoveries are protected by four patent families. Patents have been approved in the US, Europe and Australia. Group I includes known immunomodulatory substances and pain inhibitors. Group II includes molecules from ''good'' bacteria that rebalance the immune system and Group III small RNA inhibitors that target excessive inflammation and reduce the risk of sepsis or kidney damage.
The drug candidates address important medical needs in large patient groups. The markets for the treatment of infections are very large, nationally and internationally.
Antibiotic resistance is a global, rapidly growing health issue. The World Health Organization (WHO) has declared antibiotic resistance a major threat to global health.
SUCCESSFUL DEVELOPMENT DURING THE 2021-2022 FISCAL YEAR
SelectImmune Pharma has made significant progress during the 2021-2022 fiscal year. The company went public in 2019 and is already pursuing Phase II clinical trials in two indications with very large medical needs and potential markets. The study of recurrent cystitis is proceeding according to plan and the Swedish Medical Products Agency (Läkemedelsverket) has approved the application to conduct a placebo-controlled clinical study using IL1-RA for the treatment of Bladder Pain Syndrome. An agreement with Sobi (Swedish Orphan Biovitrum) guarantees drug supply for future clinical trials. In addition, the company is taking new drug candidates from discoverytowards the clinic. Critical steps include an agreement with LONZA to develop large scale production methods for our new drug candidate NlpD. Publications in leading medical journals affirm the position of the science behind SelectImmune Pharma and the service agreement with Linnane Pharma ensures the company's access to advanced science and technology.
Clinical trial program
The clinical program is exploring the potential of immunotherapy in two separate patient groups: recurrent cystitis and bladder pain syndrome. The ongoing Phase II study in patients with recurrent cystitis will help define the cystitis disease process and address how immunotherapy affects this patient group, using the Interleukin-1 receptor antagonist (IL-1RA), which neutralizes the biological effects of IL-1α and IL-1β. We have further set the framework for a placebo-controlled study of bladder pain - a patient group where off label IL-1RA treatment has shown promising results. In addition to the approval from the Swedish regulatory authorities, the ethics application has now been approved and the participating centers are ready to start the patient enrollment process. This study will be essential to understand the clinical benefits and market potential of IL-1RA.
Securing Kineret® and placebo for clinical studies
The IL-1RA drug Kineret® has been developed and registered by Sobi since 2002. Kineret® is widely used for hyperinflammatory disorders, such as rheumatoid arthritis, and more recently for the treatment of COVID pneumonia. SelectImmune Pharma has patented IL-1RA for the indications of cystitis and bladder pain and Sobi will provide study drug and placebo material for the controlled clinical trial. An agreement between SelectImmune and Sobi was signed on March 29, 2022.
Continued drug development
Like IL-1RA, the bacterial protein NlpD shows potent effects on human cells, where it reduces the response to infection, including inflammation. Strong protective effects against infection have been observed in animal models of kidney infection and acute cystitis, both common and serious conditions. SelectImmune is therefore working to produce NlpD on a larger scale and to enter into preparations for clinical trials including toxicity studies. This work is performed in collaboration with LONZA, a world leader inthe area for drug production.
The immunomodulators in SelectImmune Pharma's portfolio also affects pain. Our extensive studies into the molecular basis of pain have shown that bacteria directly activate the pain response in nerve cells and the effects of our different drug candidates on pain is a current focus. The direct links between infection and pain is an essential aspect for characterizing our drug candidates and identifying relevant molecular targets.
The threat posed by infections is a global concern, including bacteria with broad antimicrobial resistance. SelectImmune has an efficient strategy for the development of new drugs against bacterial infections. High rates of resistance have been observed for common bacterial infections, including urinary tract infections and sepsis and finding alternative treatments is a focus of the company. An overview of the immunotherapy approach is given in a recent review, published in NatureReviews Urology (DOI: 10.1038/s41585-022-00602-4.
SelectImmune Pharma and its network of experts and technologies form an efficient drug development organisation, with competence bridging from discovery to clinical trials. SelectImmune Pharma has appointed Gabriela Godaly as acting CEO. Gabriela Godaly is a clinical trials expert and her contributions are extremely valuable for the rapidly evolving clinical trials program of SelectImmune Pharma. Professor Godaly is also a member of the Board of SelectImmune Pharma. The focus in 2022-2023 is to implement and evaluate the two clinical Phase II trials and develop our potent new drug candidates to treat bacterial infections and their sequels. We thank our colleagues, consultants and partners for their contributions and our shareholders for their confidence and continued support.
Catharina Svanborg Chairman
Gabriela Godaly CEO (acting)
SIGNIFICANT EVENTS DURING THE FISCAL YEAR
SelectImmune Pharma will implement reporting in English SelectImmune Pharma is extending its presence on the international pharmaceutical arena, where research & development as well as clinical study results and strategic partnerships are typically reported in English. Hence the company Board of Directors has decided to change the company reporting language to English from 2021/2022 and onwards.
SelectImmune Pharma reports significant patent progress across the project portfolio SelectImmune Pharma is pleased to announce a continued strengthening of its intellectual property portfolio through a number of recent patent grants. Following extensive research into the treatment of cystitis using interleukin-1 receptor antagonists (IL1-RA), patent protection was filed in Europe, the US and Australia. The US and Australian patent offices granted protection in May of 2021 and the European Patent Office recently announced acceptance of the patent claims. Grant of the European patent is therefore expected to follow soon.
Potential treatment breakthrough in patients with severe bladder pain The successful outcome of a new treatment approach is now reported for patients with severe bladder pain. The publication presents data showing that an IL-1 receptor antagonist (IL-1RA) reduces pain and increases the quality of life in this severely handicapped patient group. Preliminary findings were reported in 2020.
Start of the SelectImmune Pharma Phase II trial of targeted immunotherapy in recurrent acute cystitis SelectImmune Pharma is proud to report that the Phase II trial of the IL-1 receptor antagonist (IL-1RA) in patients with recurrent acute cystitis has started. The clinical trial is led by Professor Wagenlehner, an international key opinion leader in the field of urinary tract infection therapy and antibiotic resistance at the center for such studies in Giessen, Germany, in collaboration with scientists at Lund University and SelectImmune.
SelectImmune Pharma held digital investor meeting SelectImmune Pharma offered a digital investors' meeting via Zoom, on Thursday September 23rd at 12.00 CET. We welcomed existing owners, other investors and interested parties to join. The meeting participants were able to hear of the company
SelectImmune Pharma held digital investor meeting
SelectImmune Pharma offered a digital investors' meeting via Zoom, on Tuesday December 7th at 12.00CET, for good dialogue and to follow up from the Annual meeting, which was held virtually due to covid-19 restrictions. We welcomed existing owners, other investors and interested parties to join. The meeting participants were informed of the company developments, which were discussed.
SelectImmune Pharma files important patent application for acute pyelonephritis
SelectImmune Pharma AB has filed for patent protection over a range of new agents that show surprisinglevels of activity in the treatment of acute pyelonephritis. This new patent application adds to SelectImmune Pharma's expanding range of intellectual property rights in the pharmaceutical sector, specifically for treating bacterial infections. Acute pyelonephritis (kidney infection) is the most severe form of urinary tract infection, caused by bacteria that directly infect the kidneys. In about 30% of adults with acute pyelonephritis, bacteria invade the blood stream, causing urosepsis, and without appropriate treatment, the mortality is high. Acute pyelonephritis is also common in childhood, and may cause long-term problems by damaging renal tissue.
Successful technology transfer for production of drug candidate NlpD
The protein drug candidate NlpD, which is being developed by SelectImmune Pharma, needs adequate, large-scale production technology for continued development towards clinical trials. To achieve this goal, SelectImmune Pharma collaborates with the leading international manufacturer Lonza. The productiontechnology has now successfully been transferred as a first step towards larger scale production.The collaboration agreement has allowed the successful transfer of our laboratory scale vector design and expression technology to Lonza, and the production method has been reproduced in their facilities. The collaboration with an established producer is essential for developing the drug candidate further towards clinical trials. The produced quantity will be tested for biological activity and structural characteristics.
SelectImmune Pharma's CMO and Board member Gabriela Godaly promoted to Professor at
Dr. Godaly received her PhD in 2000 and has since developed a successful, well-funded research group, focusing on the area of tuberculosis and the development of new alternatives to antibiotics for treating these infections. Gabriela Godaly is a clinical trials expert, from work at Gambro AB as well as Lund University. This expertise is extremely valuable for SelectImmune Pharma's clinical trial program and Dr. Godaly was appointed Chief Medical Officer of SelectImmune Pharma in 2020. Dr. Gabriela Godaly has served on the Board of Directors of SelectImmune Pharma since 2019.
SelectImmune Pharma AB (publ): SelectImmune Pharma's CEO recruited to new position
SelectImmune Pharma's CEO Ann Gidner left SelectImmune Pharma, having accepted an offer from a non-competing life science company. The board initiated the recruitment of a new CEO for the company.
SelectImmune Pharma AB to conduct clinical trials in cystitis and bladder pain syndrome
On March 29th it was reported that SelectImmune Pharma was signing an agreement with Swedish Orphan Biovitrum (Sobi) to buy Kineret® (anakinra) and placebo, to investigate anakinra as a potential treatment of patients with cystitis and bladder pain syndrome. Kineret® (anakinra) is a trademark of Sobi, who markets the drug for various inflammatory conditions. SelectImmune Pharma's patents cover the use of anakinra for the treatment of cystitis and bladder pain syndrome. The agreement defines that SelectImmune Pharma will conduct clinical trials in these areas with Sobi as a provider of drug and placebo. The parties have the intention to discuss a potential commercialization agreement for the indications protected by SelectImmune Pharma's patent rights.
SelectImmune Pharma releases new film about immunotherapy
SelectImmune Pharma proudly presented a new film entitled "Immunotherapy - a complement to antibiotics''. The film tells the story about SelectImmune Pharma's drug development program and the scientific discoveries that have defined new and exciting tools for treating infections.
SelectImmune Pharma receives approval to conduct a placebo-controlled clinical study of Bladder Pain
SelectImmune Pharma announced that the Swedish Medical Products Agency (Läkemedelsverket) hasapproved the application to conduct a placebo-controlled clinical study using IL1-RA for the treatment of Bladder Pain Syndrome. Bladder pain syndrome is a highly painful chronic condition that severely impairs the quality of life of affected patients. Numerous therapeutic approaches have been tested, but currently, no specific therapies are available. Regular painkillers, or even morphine fail to provide adequate symptom relief, and even after surgical removal of damaged parts of the bladder, the pain often returns. SelectImmune has previously reported positive treatment effects in this patient group using the IL1-α and β receptor antagonist (IL1-RA) anakinra, reducing patient symptoms and increasing quality of life. The study also reported positive long-term effects in patients with bladder pain who continued their treatment. SelectImmune Pharma is now proceeding with a randomized, placebo-controlled study of IL1-RA in patients with bladder pain syndrome. The company has received clinical trial authorization from the Swedish Medical Products Agency (Läkemedelsverket). The study is planned to involve several clinical sites.
SelectImmune Pharma appoints acting CEO
Professor Gabriela Godaly has been appointed acting CEO of SelectImmune Pharma. Professor Godaly has been actively involved with the company and its development for several years. She was appointed Chief Medical Officer of SelectImmune Pharma in 2020 and has served on the Board of Directors since 2019. Gabriela Godaly is a clinical trials expert and her contributions are extremely valuable for the rapidly evolving clinical trials program of SelectImmune Pharma.
A publication in Nature Reviews Urology summarizes the scientific basis for SelectImmune's drug development strategy "Immunomodulation therapy offers new molecular strategies to treat urinary tract bacterial infections" in Nature Reviews Urology summarizes the scientific basis behind SelectImmune's drug development strategy. The review also describes successful examples of innate immunomodulation therapy.Butler, D., Ambite, I., et al. Immunomodulation therapy offers new molecular strategies to treat UTI. Nature Reviews Urology (2022). DOI: 10.1038/s41585-022-00602-4. (https://rdcu.be/cP963)
Significant events after the period
Clinical study ready to start - a new treatment option for patients with bladder pain
SelectImmune Pharma has successfully completed all preparations to start a controlled clinical trial in patients with bladder pain syndrome (severe pain in the bladder). The patients will be treated with the drug Kineret, which is an Interleukin1 (IL-1) receptor antagonist (IL-1RA). The company can now announce that all permits are in place and that the recruitment of patients can start.
PROJECT PORTFOLIO OVERVIEW
Please see full report in attachment.
PATENT PORTFOLIO OVERVIEW
Please see full report in attachment.
THE COVID-19 PANDEMIC
The Covid pandemic has affected the infrastructure for clinical trials world-wide. The pandemic caused certain delays in the early part of the clinical study in Germany, but patient enrollment is now proceeding according to plan.
THE PERIOD IN SUMMARYFOURTH QUARTER 2022-04-01-2022-06-30
Net sales for the quarter totaled kSEK 0 (0)
Loss before tax amounted to kSEK -2,963 (-5,064)
Loss after tax amounted to kSEK -2,963 (-5,064)
Loss per share* was SEK -0.1697 (-0.2901)
Net sales for full year totaled kSEK 0 (0)
Loss before tax amounted to kSEK -14,081 (-12,643)
Loss after tax amounted to kSEK -14,081 (-12,643)
Loss per share* was SEK -0.8065 (-0.7242)
On June 30, 2022, the equity/assets ratio** was 91 (90)%
* Profit/loss after tax for the period divided by 17,459,225 (17,459,225) shares, where 17,459,225 is the number of shares outstanding on June 30, 2022. The comparative figure in parentheses was the number of shares on June 30, 2021.** Equity divided by total capital. Amounts in parentheses indicate the corresponding value in the preceding year.
SelectImmune Pharma AB
SelectImmune Pharma AB is a drug development company that works to offer effective alternatives to antibiotics for the treatment of bacterial infections. Instead of killing the bacteria directly, the body's immune system is strengthened and balanced to reduce symptoms and improve bacterial clearance.
Revenue and earnings
As SelectImmune Pharma is a life science development company, future income will primarily consist of various forms of royalty income such as advance payments, milestone-based payments, and royalties. The company has assessed that continued development under its own auspices will increase value and improve bargaining power during business negotiations with potential future partners. The company has entered into an agreement with Sobi regarding clinical trials, but this agreement does not at present provide revenue to SelectImmune Pharma.
The company had net sales of kSEK 0 (0) during the full year. Profit after tax for the corresponding period amounted to kSEK -14,081 (-12,643) kSEK. The costs have mainly been related to staff, continued development of clinical trial technology and regulatory approval, production issues, patent costs and collaboration with the research group at Lund University. Net sales during the fourth quarter amounted to of kSEK 0 (0), and the loss after tax amounted to kSEK -2,963 (-5,064).
At the end of the quarter, the equity/assets ratio was 91 (90) %, and the company's cash and cash equivalents were kSEK 11,191 (26,569). The equity at the same time amounted to kSEK 11,785 (25,866).SelectImmune Pharma's financial position is well controlled. According to the board's assessment, a need for further capital will arise in the first half of 2023 to secure the development, including the clinical trials.
Cash flow and investments
During the period July 1, 2021 to June 30, 2022, cash flow amounted to kSEK -15, 378 (3,599). No intangible assets were capitalized during the period, since the company is at 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 quarter.
During the 12 months, depreciation of equipment amounted to kSEK 399 (399), where the Q4 represented kSEK 100 (100).
The company had the corresponding of 2 (2) full-time employees during the full fiscal year.
The number of registered shares as of June 30, 2022 amounted to 17,459,225 (17,459,225), of which 2,000,000 (2,000,000) Series A shares and 15,459,225 (15,459,225) Series B shares. Each Series A share entitles to ten votes and Series B shares to one vote. SelectImmune Pharma's Series B shares have been admitted to trading on Spotlight Stock Market since June 26, 2019. Spotlight Stock Market is the secondary name of ATS Finans AB, a securities company under supervision by the Swedish Financial Supervisory Authority (Finansinspektionen).
Transactions with related parties
During the fiscal year, costs for the technology platform (Linnane Pharma AB) amounted to kSEK 1,500 (375), license costs for patents of kSEK 480 (480) and kSEK 0 (374) for consulting fees. The corresponding amounts for the quarter are kSEK 375 (375) for the technology platform, kSEK 120 (120) for license costs and kSEK 0 (0) for consulting fees. Linnane Pharma AB is the parent company of SelectImmune Pharma AB. Professor Catharina Svanborg is the main shareholder of Linnane Pharma, representing the interests of the scientists. Salaries and remuneration to the board and management were paid during the period. Transactions with related parties are on market terms.
In addition to the collaboration with Lund University, SelectImmunePharma needs access to current and innovative cutting-edge expertise. The Linnane Pharma Technology Platform provides access to a unique combination of cutting-edge expertise, large-scale analysis methods such as proteomics, RNA and DNA sequencing, methods for analysis of clinical materials and animal models for the design of clinical studies for drug development, as well as patenting and drug development expertise. The technology agreement between SelectImmune Pharma and Linnane Pharma ensures the company's access to advanced science and technology. The agreement runs for two years and the technology platform is available to SelectImmune Pharma on a subscription basis. This is an effective way to gain access to cuttingedge expertise and new technology at low cost. The agreement does not contain any further financial commitments to Linnane Pharma.
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 (2021-06-30).
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 (Bokföringsnämnden).The company's accounting principles are unchanged compared with the most recent financial year and are described in the most recent published annual report (2021-06-30).
This interim report has not been audited.The AGM and the annual report
The Annual General Meeting for 2021/2022 is planned to be held in Malmö on November 23, 2022.
The Annual Report for 2021/2022 will be available on November 2, 2022, at the Company office, Klinikgatan 32, Lund. The documents are also published on the company's website (www.selectimmune.com) and will be distributed to those shareholders who request it and provide their postal address.
The Board proposes that no dividends be paid for the 2021/2022 fiscal year.
Annual Report for 2021/2022 November 2, 2022
Interim report for Q1, 2022/2023 November 16, 2022
Annual General Meeting for 2021/2022 November 23, 2022