SelectImmune Pharma Interim report Q2 2021/2022
SIGNIFICANT EVENTS
On November 2nd, The SelectImmune Pharma Annual Report for the fiscal year of 2020/2021 was published. It may be found on the company homepage.
On November 24th, The SelectImmune Pharma Annual General Meeting was held. Considering the covid pandemic situation, the AGM was held through mail voting as per temporary Swedish law.
On December 7th, a virtual investors’ meeting was given via link and was well attended. A company presentation was given to follow up from the Annual General Meeting, and an active Q&A session followed. A recording of the meeting is available on the company homepage.
SIGNIFICANT EVENTS AFTER THE PERIOD
On February 1st, it was announced that SelectImmune Pharma filed a patent application for the treatment of acute pyelonephritis. Acute pyelonephritis or kidney infection, is a severe and common form of urinary tract infection, caused by bacteria that directly infect the kidneys. Efficient new approaches have now been identified and the therapeutic effects confirmed in animal models as a basis for the patent application, strengthening the commitment to develop these substances for future clinical use.
On February 3rd, SelectImmune Pharma reported the successful technology transfer for production of the drug candidate NlpD in its Group II. The protein drug candidate 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.
On February 16th, the company announced the appointment of its Chief Medical Officer and Board member, Dr. Gabriela Godaly, 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. In addition, Dr. Godaly is a clinical trials expert, from work at Gambro AB as well as Lund University. Dr. Godaly was appointed Chief Medical Officer of SelectImmune Pharma in 2020 and has served on the Board of Directors since 2019.
THE PERIOD IN SUMMARY
Second quarter 2021-10-01–2021-12-31
• Net sales for the quarter totaled kSEK 0 (0)
• Loss before tax amounted to kSEK -4,498 (-3,054)
• Loss after tax amounted to kSEK -4,498 (-3,054)
• Loss per share* was SEK -0,2576 (-0,1749)
First half year 2021-07-01–2021-12-31
• Net sales for the half totaled kSEK 0 (0)
• Loss before tax amounted to kSEK -7,630 (-5,218)
• Loss after tax amounted to kSEK -7,630 (-5,218)
• Loss per share* was SEK -0,4370 (-0,2989)
• On December 31, 2021, the equity/assets ratio** was 86 (97)%
Amounts in parentheses indicate the corresponding value in the preceding year.
WORD FROM THE CHAIRMAN AND CEO
During the second quarter, SelectImmune Pharma has made significant progress in the areas of clinical trial planning and execution, patent protection and drug development. The planning of further clinical trials in patients with Bladder Pain syndrome is under way. In parallel, the Phase II study in patients with recurrent, acute cystitis is progressing at the Giessen site in Germany. As the study is blinded, updates will not be available until the study is concluded.
In addition, SelectImmune Pharma’s patent portfolio was significantly strengthened with a series of patent approvals during the autumn. A new application was filed just after the reporting period regarding therapeutic use of active ingredients to treat pyelonephritis. These serious kidney infections may lead to urosepsis and securing intellectual property here is important.
The immunomodulators in SelectImmune Pharma’s portfolio also affect pain, as shown in the off-label study of bladder pain. The molecular basis of the effects on pain are a current focus. Our research has confirmed direct links between infection and pain responses, identifying relevant molecular targets.
The process of establishing an efficient manufacturing process for the drug candidate NlpD was pursued during the quarter, resulting in successful technology transfer to our development partner, Lonza Corporation and we are now able to proceed further with steps to scale up production and develop the drug candidate for clinical trials.
SelectImmune Pharma is actively seeking partners for the different drug candidates. During the second quarter the company participated in the international partnering conference Bio-Europe and received interest from Big Pharma and international service providers, resulting in specific invitations to present the company at the JP Morgan conference in January.
We look forward to continued clinical trials and developing our potent new drug candidates to treat bacterial infections and their sequelae. We thank our colleagues, consultants and partners for their contributions and our shareholders for their confidence and continued support.
Catharina Svanborg, Chairman
Ann Gidner, CEO
PROJECT PORTFOLIO OVERVIEW
Please see full report in attachment.
PATENT PORTFOLIO OVERVIEW
Please see full report in attachment.
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.
The company had net sales of kSEK 0 (0) during the first half year. Profit after tax for the corresponding period amounted to kSEK -7,630 (-5,218). The costs have mainly been related to continued development in collaboration with the research group at Lund University. Net sales during the second quarter amounted to of kSEK 0 (0), and the profit after tax amounted to kSEK -4,498 (-3,054).
Financial position
At the end of the first half year, the equity/assets ratio was 86 (97) %, and the company’s cash and cash equivalents were kSEK 19,411 (32,269). The equity at the same time amounted to kSEK 18,237 (33,292).
Cash flow and investments
During the period July 1 2021 to December 31 2021, cash flow amounted to kSEK -7,158 (9,300).
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 half year, depreciation of equipment amounted to kSEK 199 (200), while the quarter represented kSEK 100 (100).
Employees
The company had the correspondence of 2 (2) full-time employees during the period.
The share
The number of registered shares as of December 31, 2021 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 half year, there were costs to Linnane Pharma AB of kSEK 750 (0) for the technology platform, kSEK 240 (240) for license costs for patents and kSEK 0 (358) 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 (182) 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
Interim report Q3 2021/2022 May 24, 2022
Year-end report 2021/2022 August 30, 2022
Annual Report 2021/2022 November 2, 2022
Interim report Q1 2022/2023 November 16, 2022
Annual General Meeting 2021/2022 November 23, 2022
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
Ann Gidner
CEO SelectImmune Pharma AB
Phone: +46 768 17 14 14
E-mail: ann.gidner@selectImmune.com
SelectImmune Pharma is a pharmaceutical company whose shares are traded on the Spotlight Stock Market. The company 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.