Forside > Investment cases > Biosergen
Biosergen AB is a biopharmaceutical company that was listed on Nasdaq First North Sweden in June 2021. The company develops innovative antifungal drugs based on the latest biopharmaceutical research and development from laboratory facilities in Trondheim, Norway and several other locations around the world.
The company is developing BSG005, a potential antifungal drug that has demonstrated significant safety data and potency advantages over competing antifungal agents. BSG005, which is in clinical phase I (the first of three phases of development towards the market), could potentially reach the market as early as 2026/27
Biosergen is developing an innovative drug that kills fungal infections – unlike most of the existing products on the market that can only inhibit the fungal infection. With a market size of USD 16 billion, Biosergen is an opportunity for investors who want to invest in a biotech company with blockbuster potential (sales of over USD 1 billion) with a breakthrough and innovative treatment targeting some poorly treated patient groups with a high need for new effective treatments that can save human lives.
Price triggers:
– BSG005: Phase I top-line results from SAD (single dose) (Q3 2022)
– BSG005: Phase I top-line results from MAD (multiple dose) (Q4 2022)
– Pipeline: Progression of new formulation development projects
Risks:
– BSG005: Poor Phase I top-line results from SAD (single dose) (Q3’2022)
– BSG005: Poor Phase I top-line results from MAD (multiple dose) (Q4’2022)
– Future financing of operations
Biosergen is developing BSG005, a pioneering and innovative antifungal drug for the treatment of invasive fungal infections, an area of very high medical need. Invasive fungal infection of the lungs, liver, kidneys or brain is a serious condition that can lead to death. The infection mainly affects people who have a weakened immune system for various reasons, such as transplant recipients, people with HIV or diabetes, or patients undergoing treatment for cancer. The mortality rate is 20-80% depending on the fungus causing the infection, and during the COVID pandemic there has been a resurgence of invasive fungal infections.
BSG005 has shown better efficacy and fewer side effects compared to competing antifungals and is also effective against a wider range of fungal spores.
The market for antifungals in general is USD 16 billion and growing at 6-7% per year. Biosergen is an opportunity for investors looking to invest in a biotech company with blockbuster potential (sales of over USD 1 billion) with a breakthrough and innovative treatment targeting resistant or difficult to treat invasive fungal infections that often cause death.
BSG005 has the potential for a paradigm shift in the treatment of invasive fungal infections
Unlike most existing products on the market that only inhibit the fungal infection (fungistatic), BSG005 (fungicide) kills the fungi that cause the infection. Fungistatic treatment allows for the development of resistance and thus increases the risk of lack of efficacy, not only in the individual patient but also in the patient population in general. In contrast, fungicidal treatment does not lead to the development of resistance and is therefore a more effective long-term treatment option for all these patients.
Unlike BSG005, other drugs in the same class (polyenes) have serious side effects which often limit the duration of treatment or the extension of treatment. Existing treatments with current polyenes lead to renal toxicity (poisoning of the kidneys), which could potentially lead to patients having to stop treatment of their invasive fungal infection. BSG005 does not cause renal toxicity, as shown in the toxicology studies.
The fact that BSG005 kills the fungi, is not renally (kidney) toxic and has efficacy on a wide range of fungi may mean that patients with invasive fungal infections will be treated with BSG005 earlier in the course of treatment. Not only as an alternative to other antifungal agents, but also as a substitute for antifungal agents to avoid the spread of resistant fungal spores which in turn may put increased pressure on healthcare systems worldwide. We therefore believe that BSG005 has the potential to be a paradigm shift in the treatment of invasive fungal infections.
Phase 1 top-line data expected in Q4’2022 – good data will be a price trigger
Phase 1 data from the ongoing study is expected in Q4 2022. The aim of the study is to evaluate the safety and tolerability of BSG005 in healthy subjects. Good data will, in our view, firstly reduce the uncertainty in Biosergen because polyene antifungals kill the fungi and therefore it is expected that if safety is good there is very little doubt about the efficacy of BSG005, and secondly it will ensure safe progression of the pipeline towards potential approval in 2026/27.
The total global market for all antifungals is USD 16 billion. It is expected that Biosergen will be able to address the part of the market for invasive fungal infections that currently counts the treatment categories: Polyenes (10%), Azoles (42%) and Echinocandins (32%). With a market size of USD 16 billion, this is a very lucrative market where only a small market share is required to be commercially attractive.
BSG005 is expected to be priced at a premium
The main competitor Amphotericin B is an old product which is available in cheap generic versions. Assuming good data, Biosergen expects that BSG005 could come to market at a premium price due to a significantly better effect that kills the fungus and not just inhibits it and especially if there is a better safety profile as expected on the kidneys in particular.
US likely to be primary market
BSG005 has patent protection until 2033 in the US and Japan, and until 2028 in the EU and China, but is working on several new patents on the base molecule BSG005’s production and formulation processes. Patent applications have already been filed on new special nano formulations. We therefore see a small risk of competition from coproducers in the EU and China already two years after the potential launch of the initial finished product, and thus a good opportunity for Biosergen in these markets to maintain a premium price after 2028. Biosergen is also developing other formulations of BSG005 and new production processes that could potentially extend patent protection further. The US is likely to be Biosergen’s main market but with the effect on resistant and difficult to treat indications, other parts of the world (China, India, South America) will also be interesting markets.
January 16, 2023: Biosegen AB (“Biosergen” or the “Company”) today announced that the Safety Review Committee has approved escalation to the next 6-volunteer cohort in the Multiple Ascending Dose (MAD) part of BSG005’s phase I trial. BSG005 is Biosergen’s lead development compound. It is a novel anti-fungal molecule from the group of polyene macrolides known for their broad anti-fungal and… […]
December 12, 2022: Biosergen AB (“Biosergen” or the “Company”) today announced that the first volunteer in the MAD part of the Phase I study has been dosed with the Company’s proprietary antifungal drug candidate BSG005. Biosergen has enrolled the first subjects into the MAD part of the Phase I trial of BSG005. The subjects will be part of a first… […]
Wednesday, November 30, 2022: Biosergen AB (“Biosergen” or the “Company”) thereby publishes the interim report for the third quarter 2022. The interim report is available as an attached document and on the company website (www.biosergen.net Summary of the Interim Report for Q3 2022 2022 2021 2022 2021 2021 TSEK July-Sep July-Sep Jan-Sep Jan-Sep Jan-Dec Other income 493 2.652 3.219 4.653… […]
Biosergen AB (publ) (“Biosergen” or the “Company”) has appointed Mangold Fondkommission to act as a liquidity provider for the company's share. The liquidity providing will begin on Wednesday, October 5[th], 2022. Mangold Fondkommission will fulfil its mandate as a liquidity provider to continuously place trading posts on each buy and sell side in the Biosergen share booklet and ensure that… […]
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, NEW ZEALAND, SOUTH AFRICA, SOUTH AFRICA, CANADA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. Biosergen AB (publ) (“Biosergen” or the “Company”) announces that CEO Peder Andersen, CFO Niels Laursen and board members Mattias… […]
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, NEW ZEALAND, SOUTH AFRICA, SOUTH AFRICA, CANADA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. Today, September 15, 2022, the subscription period for Biosergen AB’s (publ) (“Biosergen” or the “Company”) upcoming rights issue of… […]
The ISIN code for unit rights in the forthcoming rights issue that was communicated in the prospectus has been noted to be incorrectly stated. The correct ISIN code for the unit rights is SE0018588238. Advisors Mangold Fondkommission AB is the financial advisor to Biosergen in connection with the Rights Issue. Advokatfirman Lindahl KB is the legal advisor to the Company… […]
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, NEW ZEALAND, SOUTH AFRICA, SOUTH AFRICA, CANADA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. Biosergen AB (publ) (“Biosergen” or the “Company”) has prepared an EU growth prospectus (the “Prospectus”) for the forthcoming issue… […]
September 8, 2022: Biosegen AB (“Biosergen” or the “Company”) today announced that the phase I study in Australia will now move into the MAD part of the study after testing 4 cohorts in the SAD part of the study. It was expected that infusion reactions would appear in the healthy volunteers and limit further dose escalations. There were no impact… […]
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED KINGDOM, THE UNITED STATES, CANADA, JAPAN, AUSTRALIA, HONG KONG, NEW ZEALAND, SWITZERLAND, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. The Board of Directors of Biosergen… […]
Forside > Investment cases > Biosergen
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