INTERIM REPORT OCTOBER 1st 2022 – DECEMBER 31st 2022
SELECTIMMUNE PHARMA IN BRIEF
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 pyelone phritis and acute cystitis. Immunomodulation is therefore a realistic option for treating these condi tions 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 antag onist (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 a research based company with an agreement with LU.
• The discoveries are protected by four patent fami lies. Patents have been approved in the US, Europe and Australia. Group I includes known immunomod ulatory substances and pain inhibitors. Group II includes molecules from ’’good’’ bacteria that rebal ance 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 nation ally and internationally.
• Antibiotic resistance is a global, rapidly growing health concern. The World Health Organization (WHO) has declared antibiotic resistance a major threat to global health.
ONGOING CLINICAL TRIALS DEVELOP ACCORDING TO PLAN
This quarter has seen the continued development of SelectImmune Pharma’s project portfolio. The strategy includes the completion of the ongoing clinical Phase II trial for recurrent acute cystitis and the start of a placebo-controlled Phase II trial in patients with bladder pain syndrome. The first patients have been recruited. In both cases the immunotherapeutic drug Kineret, which is an IL-1 receptor antagonist (IL-1RA), is being used. SelectImmune Pharma owns the patent rights to use Kineret for both of these indications and the potential for helping these patients is significant. Kineret treatment has shown great promise for severely handicapped patients with bladder pain syndrome.
The company is also taking the drug candidate NlpD, through the drug development process, including GMP production and toxicology testing, and planning for clinical trials. NlpD is a protein from ‘’nice’’ bacteria, which is beneficial for different tissues and prevents exaggerated inflammatory responses to infection. The recombinant protein shows potent anti-infective and anti-inflammatory activity in animal models of cystitis and kidney infection. NlpD promotes bacterial clearance and inhibits the inflammatory response that causes disease. In view of these properties, NlpD has the potential to add a new approach to the treatment of infection and potentially a wide range of inflammatory conditions. In addition, structural studies of NlpD may open up for 2nd generation drug candidates or new production methods, in the future.
Additionally, the company will focus on developing IRF7 inhibitors for use primarily in the treatment of kidney infections and urosepsis. IRF7 inhibitors have the potential to significantly add to antibiotic therapy for these indications and the company is exploring novel ways of inhibiting IRF7. Urosepsis is a major cause of death world-wide and treatments is made very difficult by wide-spread antibiotic resistance.
Overall, the company’s continued development strategy is focused on bringing new and innovative drugs to market, and on improving patient outcomes through the use of these new treatments. The engagement in partnership and market access discussions, all play a critical role in achieving this goal.
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.
Catharina Svanborg
Chairman
Gabriela Godaly
CEO (acting)
SIGNIFICANT EVENTS DURING THE SECOND QUARTER
Q2
2022-10-10
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 recurrent acute 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 EudraCT number 2019-004209-28).
2022-11-11
Magnus Nylén proposed as new member of the SelectImmune Pharma board
SelectImmune Pharma has proposed Magnus Nylen for election to the board of SelectImmune Pharma at the Annual General Assembly on November 23rd, 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 Göteborg and Stockholm.
2022-11-14
First patient in – a new treatment option for patients with bladder pain
SelectImmune Pharma has announced the start of a controlled clinical trial for patients with bladder pain syndrome, using the drug Kineret, an Interleukin1 (IL-1) receptor antagonist and the first patient has been included in the study. The study will include a larger number of patients and clinical centers in Sweden, and aims to evaluate the treatment effect with greater precision. The trial will initially take place in two centers in Sweden, which have extensive experience with this patient group, with the goal of reducing pain and improving quality of life for those affected. The company has received permission from the Swedish Medicines Agency and and Swedish Ethical Review Authority, and has established the study organization in Sweden. The possibility of treating this patient group is of great medical interest.
2022-11-24
Communiqué from the Annual General Meeting of SelectImmune Pharma AB
SelectImmune Pharma published a Communiqué from the Annual General Meeting of SelectImmune Pharma AB held November 23rd in Malmö. The board was granted freedom from liability. Catharina Svanborg was elected chairman. It was decided that the board sould consist of the chairman, Carl-Johan Wachtmeister, Helena Lomberg, Magnus Nylén and Gabriela Godaly. All decisions were unanimous.
2022-11-29
SelectImmune Pharma held a digital investor meeting
SelectImmune Pharma held a digital investors’ meeting via Zoom on Tuesday November 29th for existing shareholders, other investors, and interested parties. The purpose of the meeting was to provide updates on the company’s developments and to allow for a question-and-answer session.
Significant events after the period
2023-01-23
SelectImmune Pharma AB publishes video from digital investor meeting
SelectImmune Pharma AB has published a video from the digital investors’ meeting held in conjunction with the company’s Annual General Meeting in November 2022. The video is available on the company’s website.
Group I
• Based on the initial successful off-label study of IL1-RA treatment of patients with bladder pain syndrome, we have initiated a 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
Group II
• 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. Select-Immune Pharma is testing small-scale quantities for further development work.
• SelectImmune Pharma has filed patent applications for further indications of this interesting active protein.
Group III
• 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 PERIOD IN SUMMARY
Amounts in parentheses indicate the corresponding value in the preceding year.
SECOND QUARTER 2022-10-01–2022-12-31
• Net sales totaled kSEK 0 (0)
• Loss before tax amounted to kSEK -1 338 (-4 498)
• Loss after tax amounted to kSEK -1 338 (-4 498)
• Loss per share* was SEK -0,0766 (-0,2576)
FIRST HALF 2022-07-01–2022-12-31
• Net sales totaled kSEK 0 (0)
• Loss before tax amounted to kSEK -2 750 (-7 630)
• Loss after tax amounted to kSEK -2 750 (-7 630)
• Loss per share* was SEK -0,1575 (-0,437)
• On december 31, 2022, the equity/assets ratio** was 88 (86)%
* 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 December 31, 2022. The comparative figure in parentheses was the number of shares on December 31, 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. The company is developing new drug candidates for the treatment of bacterial infections.
The technology agreement between SelectImmune Pharma and Linnane Pharma from 2021 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.
Revenue and earnings
As SelectImmune Pharma is a development company in life science, future income will primarily consist of various forms of royalty income such as advance payments, milestone-based payments and ongoing royalties. 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.
Net sales during the second quarter amounted to kSEK 0 (0), and the profit after tax amounted to kSEK -1,338 (-4,498). The lower negative result is explained by an uneven distribution of costs between the quarters and specifically lower costs for the clinical trials during this quarter.
Financial position
At the end of the quarter, the equity/assets ratio was 88 (86) %, and the company’s cash and cash equivalents were kSEK 9 158 (19 411). The equity at the same time amounted to kSEK 9 035 (18 237).
Cash flow and investments
During the period July 1 2022 to December 31 2022, cash flow amounted to kSEK -2 033 (-7 158). 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.
Depreciation
During the quarter, depreciation of equipment amounted to kSEK 100 (100), and during the first half, depreciation of equipment amounted to kSEK 200 (199).
Employees
The company had the corresponding of 2 (2) full-time employees during the quarter.
The share
The number of registered shares as of December 31, 2022 amounted 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. The share is traded under the short name “SELECT B” with ISIN code SE0012622785.
Transactions with related parties
During the first half, there were costs to Linnane Pharma AB of kSEK 750 (750) for the technology platform and kSEK 240 (240) for license costs . The corresponding amounts for the quarter are kSEK 375 (375) for the technology platform and kSEK 120 (120) for license costs. Furthermore, 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, SelectImmune Pharma needs access to current and innovative cutting-edge expertise. Linnane Pharma offers a collaboration to solve these needs. A 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, etc.
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.
Review
This interim report has not been audited.
Financial calendar
Interim report for Q3, 2022/2023 2023-05-25
Interim report for Q4, 2022/2023 2023-08-29
Year end report 2022/2023 2023-11-01
Interim report for Q1, 2023/2024 2023-11-16
Annual General Meeting 2022/2023 2023-11-22