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Publicerat: 2022-05-24 09:00:00

SelectImmune Pharma AB (publ): SelectImmune Pharma Interim report Q3 2021/2022

 

SELECTIMMUNE PHARMA IN SHORT

  • SelectImmune Pharma is an innovative biotech company, developing novel immunotherapies.
  • 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 will be 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.

 

 

Significant progress in Q3

SelectImmune Pharma has made significant progress during the third quarter of the 2021-2022 fiscal year. The company is focusing on driving key clinical trials through Phase II, to define the cystitis disease process in patients with recurrent disease and the potential of the Interleukin-1 receptor antagonist (IL-1RA) for immunotherapy in this patient group. We have further focused on setting the frame work for a placebo-controlled study of bladder pain; a patient group where IL-1RA treatment has shown promising results. After the end of the period, the Swedish regulatory authorities have approved an application to conduct a placebo-controlled study of IL-1RA in this patient group. This study will be essential to understand the clinical benefits and market potential of this treatment approach.

The IL-1RA substance anakinra has been developed by SOBI (Swedish Orphan Biovitrum) and is registered under the name of Kineret. It is widely used for hyperinflammatory disorders such as rheumatoid arthritis, and more recently for the treatment of COVID pneumonia. SelectImmune Pharma has an ongoing dialogue with SOBI for the development of the new IL-1RA indications cystitis and bladder pain that have been patented by SelectImmune. SOBI also produces placebo material that is essential to conduct controlled clinical trials. The agreement between SelectImmune and SOBI as of March 29 makes this possible.

The immunomodulators in SelectImmune Pharma’s portfolio also affect pain. Extensive studies into the molecular basis of pain have shown that bacteria directly activate the pain response in nerve cells. The molecular basis of pain and the effects of our different drug candidates 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.

Following extensive research at Lund University into new treatment options for acute pyelonephritis, efficient new approaches have now been identified and the therapeutic effects confirmed in animal models, strengthening the commitment to develop these substances for future clinical use.

We look forward to continuing clinical trials and developing our potent new drug candidates to treat bacterial infections and their sequelae. We thank our previous CEO Ann Gidner for her efforts and wish her success in her new position. We also thank our colleagues, consultants and partners for their contributions and our shareholders for their confidence and continued support.

 

Catharina Svanborg                                   Gabriela Godaly

Chairman                                                   CEO (acting)

 

SIGNIFICANT EVENTS

2022-02-01

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 surprising levels 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, mortality is high. Acute pyelonephritis is also common in childhood, and may cause long-term problems by damaging renal tissue.

2022-02-03

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 production technology 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.

2022-02-16

SelectImmune Pharma’s CMO and Board member Gabriela Godaly promoted to Professor at Lund University

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. The group studies the immune response, effects of vaccines and new treatment approaches. Dr. Godaly’s group has successfully developed a peptide-based therapy, characterized its effects in cellular models and performed effect studies in animal models, in collaboration with leading international experts. Dr. Godaly has also played an important role for the development of teaching programs for medical students and as member of different networks and policy committees in the medical faculty. 

Gabriela Godaly is a clinical trials expert, from work at Gambro AB as well as Lund University. This expertise is extremely valuable for SelectImmune Pharmas 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.

2022-03-27

SelectImmune Pharma AB (publ): SelectImmune Pharma’s CEO recruited to new position

SelectImmune Pharma’s CEO Ann Gidner will leave SelectImmune Pharma, having accepted an offer from a non-competing life science company. Ann Gidner will remain in the CEO role during the notice period of one month. The board has initiated the recruitment of a new CEO for the company.

2022-03-29

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.

 

Significant events after the period

2022-04-21

SelectImmune Pharma releases new film about immunotherapy

Today we are proud to present 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.

2022-04-25

SelectImmune Pharma receives approval to conduct a placebo-controlled clinical study of Bladder Pain

SelectImmune Pharma is pleased to announce that 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.

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 fails to provide adequate symptom relief and even after surgical removal of damaged parts of the bladder, the pain often returns.

We have recently 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 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. 

2022-04-26

SelectImmune Pharma appoints acting CEO

Professor Godaly is familiar with all aspects of the company and has been actively involved in 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.

 

Project portfolio overview

For figures, please see attached pdf.                                       

Inflammation and pain caused by infection

  • Based on the initial successful off-label study of IL1-RA treatment of patients with bladder pain syndrome, we are proceeding towards a placebo-controlled clinical trial and partners in Sweden and abroad have been identified.
  • The IL1-RA Phase II clinical trial in recurrent, acute cystitis is being performed in Giessen, Germany, and the patient enrolment 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.

Anti-inflammatory treatment from good bacteria

  • 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 at its 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 protein active.

Bacterial infection / Sepsis

  • 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.
  • SelectImmune Pharma was recently granted patent protection in Australia for IRF-7 Inhibitors for treatment of antibiotic resistant Enterobacteriaceae. This adds to patents already granted in Europe and the US for this invention.

 

Patent portfolio overview

For figures, please see attached pdf.    

It includes the recent patent application for the treatment of acute pyelonephritis, where efficient new approaches have been identified and the therapeutic effects confirmed in animal models as a basis for the patent application. Patent protection has also been granted in Australia for IRF-7 Inhibitors for treatment of Enterobacteriaceae infections. This patent was previously granted in Europe and the US. In addition, SelectImmune has been seeking protection for modulators of the IL-1 pathway for treatment of chronic inflammatory conditions in the lower urinary tract and chronic pelvic pain syndrome and has recently extended the geographical scope for this invention by filing for patent protection in Europe, the US, Australia, China and Japan.

 

The period in summary

Amounts in parentheses indicate the corresponding value in the preceding year.

Third quarter 2022-01-01--2022-03-31

– Net sales for the quarter totaled kSEK 0 (0)

– Loss before tax amounted to kSEK -3 488 (-2 361)

– Loss after tax amounted to kSEK -3 488 (-2 361)

– Loss per share* was SEK -0,1998 (-0,1353)

 

Nine Months 2021-07-01--2022-03-31

– Net sales totaled to kSEK 0 (0)

– Loss before tax amounted to kSEK -11 118 (-7 579)

– Loss after tax amounted to kSEK -11 118 (-7 579)

– Loss per share* was SEK -0,6368 (-0,4341)

– On March 31, 2022, the equity/assets ratio** was 88 (95)%

 

* 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 March 31, 2022. The comparative figure in parentheses was the number of shares on March 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.

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.

This means that the company had net sales of kSEK 0 (0) during the first nine months. Profit after tax for the corresponding period amounted to kSEK -11,118 (-7,579). The costs have mainly been related to continued development in collaboration with the research group at Lund University. Net sales during the third quarter amounted to of kSEK 0 (0), and the profit after tax amounted to kSEK -3,488 (-2,361).

Financial position

At the end of the quarter, the equity/assets ratio was 88 (95) %, and the company’s cash and cash equivalents were kSEK 15,334 (30,710). The equity at the same time amounted to kSEK 14,749 (30,931).

Cash flow and investments

During the period July 1 2021 to March 31 2022, cash flow amounted to kSEK -11,234 (7,741).

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 first nine months, depreciation of equipment amounted to kSEK 299 (299), while the quarter represented kSEK 100 (99).

Employees

The company had the corresponding of 2 (2) full-time employees during the period.

The share

The number of registered shares as of March 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. 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 first nine months, there were costs to Linnane Pharma AB of kSEK 1,125 (0) for the technology platform, kSEK 360 (360) for license costs for patents and kSEK 0 (374) for consulting fees. The corresponding amounts for the quarter are kSEK 375 (0) for the technology platform, kSEK 120 (120) for license costs and kSEK 0 (41) for consulting fees.

Linnane Pharma AB is the parent company of SelectImmune Pharma AB. Linnane Pharma is owned by Professor Catharina Svanborg. 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.

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 (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).

Review

This interim report has not been audited.

Financial calendar

Year-end report for 2021/2022                                August 30, 2022

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

 

For income statement, Balance sheet, Cash flow statement and Equity, please see attached pdf.   

       

                                                                                                                             

For more information, please contact:

Catharina Svanborg

Chairman of the board SelectImmune Pharma AB

Phone: +46 709 42 65 49

E-mail: catharina.svanborg@med.lu.se

Gabriela Godaly

CEO, Board member SelectImmune Pharma AB

Phone: +46 73 338 13 14

E-mail: gabriela.godaly@selectImmune.com

 

SelectImmune Pharma is a pharmaceutical company whose shares are traded on the Spotlight Stock Market. The company's goal is to develop new immunotherapies, which act as immune enhancers and offer alternatives to antibiotics.

Bacterial infections affect large parts of the population and are becoming increasingly difficult to treat due to increasing antibiotic resistance. SelectImmune Pharma develops immunotherapies that can supplement or replace antibiotics. Urinary tract infections (UVI) are one of the world’s most common infectious diseases, affecting about 150 million people each year. The need for alternative treatments for bacterial infections is currently very large as are potential markets.

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