SelectImmune Pharma Interim report Q1 2022/2023
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 extensive, both 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.
ONGOING CLINICAL TRIALS DEVELOP ACCORDING TO PLAN
Our focus this quarter has been on the two ongoingclinical Phase II trials. The first study on patients with recurrent acute cystitis is proceeding according to plan, in Giessen Germany. The study organization is highly competent and the collection of clinical data and samples for laboratory test is well controlled, and samples are continuously analyzed. The study is a so-called double-blind study, which means that the company will not be able to know about results until the study is completed. The company will therefore not be able to publish `interim reports' describing the study results. In a press release on October 10, 2022 the company announced that the study is proceeding according to plan, and that we estimate the last patient to be admitted at the end of this year.
The placebo-controlled study of patients with bladder pain has been initiated. The study is based on the finding that this group of severely handicapped patients experience significant improvement when treatment off label with Kineret, an IL-1 receptor antagonist with potent immunotherapeutic effects. A long-term improvement with a significant reduction in symptom score and improved quality of life was seen in the treated patients.
The placebo-controlled trial protocol has now been approved by the Swedish regulatory authorities (Läkemedelsverket), has received ethical approval and the first patients have been recruited.
Kineret has been developed and registered by the international biopharmaceutical company Sobi and is widely used to treat hyperinflammatory disorders, such as rheumatoid arthritis, and more recently treatment of COVID pneumonia. SelectImmune Pharma has patented the treatment with IL-1RA for the indications of cystitis and bladder pain. Sobi will provide the study drug and placebo for the controlled clinical trial in patients with bladder pain. A supply agreement between SelectImmune and Sobi was signed on March 29, 2022.
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 the company focus. An overview of the immunotherapy approach is given in a recent review, published in Nature Reviews Urology (DOI: 10.1038/s41585-022-00602-4). (https://rdcu.be/cP963).
The company has sufficient funding for this fiscal year ending 30 June 2023 and is actively seeking solutions to raise additional funds for the next development phase.
We understand that it is in the interest of all shareholders that the clinical trials are completed as soon as possible and the company is making every effort to run the studies safely and efficiently. We thank our colleagues, consultants and partners for their contributions and our shareholders for their confidence and continued support.
SIGNIFICANT EVENTS DURING THE FIRST QUARTER
The patent protecting the use of IL-1RA (Kineret) in patients with bladder pain was published in the USA
Clinical study ready to start - a new treatment option for patients with bladder pain
SelectImmune Pharma has successfully completed the 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 Interleukin-1 (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.
The development of the new NlpD molecule (Group II) is making significant progress. In addition to the preparations for large-scale production in collaboration with the international manufacturer Lonza, a screen for peptide fragments has been initiated. Fragments that retain key activities of the whole molecule would be of significant interest, to facilitate production by peptide synthesis rather than recombinant technology. Peptides may also be developed for increased activity or tissue specific properties.
Significant events after the period
The Phase II trial of recurrent acute cystitis is proceeding according to plan
SelectImmune Pharma is conducting a randomized single-center Phase II trial in patients with recurrentacute cystitis, investigating the effects of the IL-1 receptor antagonist (IL-1RA). The clinical trial is led by key opinion leaders in the field of urinary tract infection therapy in Giessen, Germany and at Lund University. The efficient study organization includes physicians, monitors, other clinical and laboratory staff. Patient recruitment is proceeding according to plan, and we envisage completion of enrolment by the end of this year (See the WHO registry at https://trialsearch.who.int/ and insert the number 2019-004209-28).
Magnus Nylén was proposed as a new member of SelectImmune Pharma's board
Magnus Nylén has been proposed for election to the board of SelectImmune Pharma at the annual general meeting on 23 November 2022. Magnus Nylén has extensive experience from national and international capital markets including The Royal Bank of Scotland, Alfred Berg Fondkommission, HSBC and Aros Fondkommission. Since 2013, Magnus Nylén is one of the owners of Partner Fondkommission with offices in Gothenburg and Stockholm.
Clinical trial initiated - a new treatment option for patients with bladder pain
As previously announced, SelectImmune Pharma has successfully completed preparations to start a controlled clinical trial in patients with bladder pain syndrome (severe pain in the bladder). We can now announce that the study has started and the first patient has been included in the study. The patients will be treated with the drug Kineret, which is an Interleukin1 (IL-1) receptor antagonist (IL-1RA).Group I
Based on the initial successful off-label study of IL1-RA treatment of patients with bladder pain syndrome, we have initiated the placebo-controlled clinical trial.
The IL1-RA Phase II clinical trial in recurrent, acute cystitis is being performed in Giessen, Germany, and the patient enrollment continues as foreseen.
SelectImmune Pharma has been seeking patent protection for modulators of the IL-1 pathway for treatment of chronic inflammatory conditions in the lower urinary tract and chronic pelvic/bladder pain syndrome. The company has recently extended the geographical scope by filing for patent protection in Europe, the US, Australia, China, and Japan.
While the IL1-RA compound is effective against pain, the company is also pursuing the pain inhibitor NK1-RA, neurokinin receptor antagonist, which is efficient in animal models.
Dialogues for potential project partnering are pursued internationally.
The polymerase inhibitor NlpD is a potent drug candidate. The protective properties of this molecule have been confirmed and extended in cellular assays and animal models.
Technology transfer and small-scale production of the NlpD protein have been successfully completed at the pharmaceutical manufacturing partner Lonza corporation's UK site. SelectImmune Pharma is testing small-scale quantities for further development work.
SelectImmune Pharma has filed patent applications for further indications of this interesting active protein.
- Continued studies in animal models are performed for the IRF7 inhibitor to support and develop the obtained results. Additional molecules are being explored for this indication.
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 Q1 PERIOD IN SUMMARY
Amounts in parentheses indicate the corresponding value
in the preceding year.FIRST QUARTER 2022-07-01--2022-09-30
Net sales for the quarter totaled kSEK 0 (0)
Loss before tax amounted to kSEK -1 412 (-3 132)
Loss after tax amounted to kSEK -1 412 (-3 132)
Loss per share* was SEK -0.0809 (-0.1794)
On September 30, 2022, the equity/assets ratio** was 93 (83)%
* 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 September 30, 2022.
The comparative figure in parentheses was the number of shares on September 30, 2021.
** Equity divided by total capital.
SelectImmune Pharma AB
SelectImmune Pharma AB is a company that performs drug development. The company's development aims to offer effective alternatives to antibiotics. Instead of killing the bacteria directly, the body's immune system is strengthened and balanced to kill the bacteria itself. The company is developing new drug candidates for the treatment of bacterial infections.
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 ongoingroyalties. The longer the company runs its projects under its own auspices, the better bargaining power the company will have in business negotiations with potential future partners. The company has assessed that continued development under its own auspices will increase value and has therefore chosen not to enter into any cooperation agreements yet. This means that the company had net sales of kSEK 0 (0) duringthis quarter. Profit after tax for the corresponding period amounted to kSEK -1 412 (-3 132) kSEK.
At the end of the quarter, the equity/assets ratio was 93 (83) %, and the company's cash and cash equivalents were kSEK 7 873 (24 997). The equity at the same time amounted to kSEK 10 373 (22 735).
Cash flow and investments
During the period July 1, 2022 to September 30, 2022, cash flowamounted to kSEK -3 318 (-1 572). 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 quarter.
During the quarter depreciation of equipment amounted to kSEK 100 (99).
The company had the corresponding of 2 (2) full-time employees during the quarter.
The number of registered shares as of September 30, 2022 amounted17,459,225 (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 SeriesA 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 securitiescompany under supervision by the Swedish Financial Supervisory Authority (Finansinspektionen).
Transactions with related parties
Salaries and remuneration to the Board and management were paid during the period. Transactions with related parties are on market terms. Catharina Svanborg does not receive remuneration as Chairman of the board. In addition to the collaboration with Lund University, SelectImmune Pharma needs access to current and innovative cutting-edge expertise. The R&D company Linnane Pharma offers access to a technology platform, which provides 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, etc. During the quarter, there were costs to Linnane Pharma AB of kSEK 375 (375) for the technology platform and kSEK 120 (120) for license costs for patents. 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 cutting-edge 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 (2022-06-30).
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 2021-2022.
This interim report has not been audited.
Annual General Meeting for 2021/2022 November 23, 2022
Interim report for Q2 (half-year), 2022/2023 February 23, 2023
Interim report for Q3, 2022/2023 May 25, 2023