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
1.5 million people (particularly those with compromised immune systems such as cancer patients, diabetes patients, organ transplant recipients and HIV/AIDS patients) die each year due to fungal infections – both in the West and in the rest of the world – even though USD 16.7 billion is spent annually on antifungal drugs. Biosergen is developing an antifungal drug that is significantly more effective and with a significantly better side effect profile than the existing drugs developed 40-70 years ago. Biosergen therefore has blockbuster potential (annual sales of more than USD 1 billion) for its drug, which is expected to be launched in 2026.
The main problems with the existing antifungal drugs for serious (fatal) fungal infections on the market are:
1) They do not kill the fungi, but only inhibit them
2) They cause incurable kidney damage
3) They increase the resistance of the fungi
Biosergens, on the other hand, are 1) fungicidal, 2) do not cause kidney damage and 3) do not give rise to resistance in the fungi. In addition, it is significantly more effective/kills several different types of fungi. Biosergen therefore expects that their product will be used as the primary product (first line), which is why the market potential for Biosergen’s product is large.
In Q1 2023, Biosergen has presented positive topline data in a phase 1 study with the drug BSG005. The study has confirmed that the drug is safe and very important without the same serious side effects as existing medical drugs. Although the results so far indicated that the study would be successful, the results are a significant price trigger event. The next step is discussions with the FDA about the phase 2 study, where the drug BSG005 will show its efficacy in sick patients (rather than healthy patients in the phase 1 study).
Price triggers:
Risks:
The risks of an investment in Biosergen are, like all other biotech companies, related to the development and results of the studies and the authorities’ (in particular the FDA’s) assessment of the products. In addition, Biosergen, like other biotech companies, has a financial risk, as the company has a negative cash flow that requires ongoing financing.
Biosergen’s drug has the potential to save lives – a lot of lives, and very soon
1.5 million people (especially those with compromised immune systems, such as cancer patients, diabetes patients, organ transplant recipients and HIV/AIDS patients) die every year due to fungal infections – both in the West and in the rest of the world – even though USD 16.7 billion is spent annually on antifungal drugs.
The biotech company Biosergen is developing an antifungal drug that is potentially significantly more effective as it kills the fungi instead of just inhibiting the infection, can treat many different fungal infections and has a significantly better side effect profile (does not cause kidney damage/failure) than the existing drugs developed 40-70 years ago.
Approximately 90% of people infected with an aggressive fungal infection die within the first 2 weeks. As the exact type of fungal infection is typically not known, it is essential to treat patients quickly (within 4-5 days) with an agent that kills as many different fungi as possible and does not have significant negative side effects.
Biosergen’s product has been shown to meet these requirements, and it is therefore expected that Biosergen’s product will be used as the primary product and therefore has significant market potential. The market is growing at around 6-7% annually, so there is blockbuster potential (annual sales of more than USD 1 billion) for Biosergen’s drug, which is expected to be launched in 2026.
Paradigm shift from inhibiting to treating dangerous fungal infections
Biosergen is developing BSG005, a breakthrough and innovative antifungal drug for the treatment of invasive fungal infection, an area of very high unmet medical need. Invasive fungal infection of the lungs, liver, kidneys or brain is a serious condition that can be fatal, affecting around 1.5 million people annually. 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.
BSG005 has shown better efficacy and fewer side effects compared to competing antifungal agents and is active against a wider range of fungal spores.
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 fungal infection (fungistatic), BSG005 (fungicide) kills the fungi causing the infection. A 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 general patient population. In contrast, a fungicide 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 that often limit the duration of treatment or the uptake of treatment. Existing treatments with current polyenes lead to renal toxicity (poisoning of the kidneys), potentially causing the patient to stop treatment of their invasive fungal infection. BSG005 does not cause renal toxicity, as shown in toxicology studies.
The fact that BSG005 kills the fungi, is not kidney toxic and is effective against a wide range of fungi may mean that patients with invasive fungal infections will be treated with BSG005 earlier during 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 can lead to increased pressure on healthcare systems worldwide. We therefore believe that BSG005 has the potential for a paradigm shift in the treatment of invasive fungal infections.
Phase 1 top-line data in Q1’2023 has shown positive data – next step is discussions with the FDA on a phase 2 study
Biosergen went public in June 2021 and has followed the plans presented to investors at that time. The first (top-line) results of the Phase 1 study were presented in Q1 2023 with positive results confirming that the drug is safe and very important without the same serious side effects as existing agents. Although the results to date indicated that the study would be successful, the results are a significant price trigger event. The next step is discussions with the FDA about the phase 2 study, where the drug BSG005 will show its efficacy in diseased patients.
The study included Single Ascending Dose (SAD), where the dose was gradually increased for each new group of subjects, and Multiple Ascending Dose (MAS), where the subjects received the drug intravenously every 7 days with a gradually increasing dose. The study showed that SGN005 had no adverse effects on either kidney or liver.
The successful Phase 1 study supports progression of the pipeline towards a potential approval in 2026/27.
he total global market for all antifungal drugs is USD 16 billion. It is expected that Biosergen will be able to address the part of the market for invasive fungal infections that today includes 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 competing agent Amphotericin B is an old product that is available in cheap copy versions. Assuming good data, Biosergen expects that BSG005 could enter the market at a premium price due to its significantly better efficacy in killing the fungus rather than just inhibiting it and especially if, as expected, there is a better safety profile, particularly in the kidneys.
The US is likely to be the main 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 for new special nano formulations. We therefore see a small risk of competition from copycat producers in the EU and China already 2 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, which could potentially extend patent protection further. The US will probably be Biosergen’s most important 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.
Pipeline
The most advanced formulation of BSG005 is intravenous, similar to the competing products on the market for severe fungal infections. In addition, BSG005 Nano, targeting severe fungal infections of the lungs, and BSG005 Oral, which is pill-based and therefore has a broad use, including as a follow-up treatment after e.g. surgery, are being developed.
Stockholm, September 25, 2023: Biosergen AB (Biosergen) and Alkem Laboratories Ltd. (Alkem) are pleased to announce the signing of a co-development and license agreement for BSG005, an innovative polyene macrolide, through phase II and phase III trials for sale in the Indian market. Biosergen is developing BSG005 for the treatment of severe and difficult-to-treat invasive fungal diseases. After the successful […]
Stockholm, Sweden – August 28, 2023 – Biosergen AB ("Biosergen" or the “Company") today announces the outcome of the exercise of warrants series TO2, which were issued in connection with the Company’s rights issue of units on Nasdaq First North Growth Market in October 2022. In total, 8,258,203 warrants series TO2, corresponding to approximately 96.1 percent of the total number […]
Stockholm, Sweden – August 22, 2023 – Today is the last day of trading in warrants series TO2 in Biosergen AB (“Biosergen” or the “Company”). The exercise period for the warrants series TO2 runs up until August 25, 2023. Each warrant series TO2 gives the owner the right to subscribe for one (1) new share in the Company at an […]
Stockholm, Sweden – August 16 – Biosergen AB ("Biosergen" or the “Company"), a clinical stage biotech company specializing in the development of innovative anti-fungal therapies, is pleased to announce significant guarantees from its largest shareholders and executive management to fully exercise their warrants during the ongoing warrant exercise period. Östersjöstiftelsen and Rosetta Capital, the Company’s largest shareholders, will exercise all […]
Monday, August 14, 2023: Biosergen AB (“Biosergen” or the “Company”) thereby publishes the interim report for the second quarter 2023. The interim report is available as an attached document and on the company website (www.biosergen.net) Summary of the Interim Report for Q2 2023 2023 2022 2023 2022 2022 TSEK April-June April-June Jan-June Jan-June Jan-Dec Profit/loss Other income 2.456 1.409 7.771 […]
Stockholm, Sweden – August 11, 2023 – Biosergen AB ("Biosergen" or the “Company") completed a rights issue of units on Nasdaq First North Growth Market in October 2022 (the “Rights Issue”). The exercise period for warrants series TO2 issued in conjunction with the Rights Issue begins on Monday, August 14, 2023. Each warrant series TO2 entitles to subscription of one […]
Biosergen announces today that the company will publish the quarterly financial report for Q2 2023 ahead of schedule on August 14 instead of August 31 as previously communicated. […]
Stockholm, Sweden – August 7, 2023 – Biosergen AB (“Biosergen” or the “Company”), a clinical stage biotech company specializing in the development of innovative anti-fungal therapies, today announced the acceptance of an abstract for oral presentation by the Company’s Chief Operating Officer Tine Kold Olesen, PhD, MBA, at the 11th Congress on Trends in Medical Mycology (TIMM-11) to take place […]
Biosergens COO Tine Kold Olesen will present the company. The presentation will be i Stockholm June 13 11:45 and can be seen online. It will be possible to ask questionas via e-mail, sms or twitter. Questions can be send in advance, latest 5 minutes before questions are started. Aktiespararna will receive questions via sms 079 347 98 45, e-mail event@aktiespararna.se and via […]
Wednesday, May 31, 2023: Biosergen AB (“Biosergen” or the “Company”) thereby publishes the interim report for the first quarter 2023. The interim report is available as an attached document and on the company website (www.biosergen.net) Summary of the Interim Report for Q1 2023 2023 2022 2022 TSEK Jan-Mar Jan-Mar Jan-Dec Profit/loss Other income 5,315 1,317 5,183 Profit/loss before depreciation (EBITDA […]
Forside > Investment cases > Biosergen
Kapital Partner performs or has within the last 12 months performed corporate finance, market relations, investor relations, Certified Adviser or other advisory activities for the following listed companies: NORD.investments, Biosergen, InterMail, Pila Pharma, Hypefactors, Curasight, Evaxion, Re-Match, Audientes, Mdundo.com, Nexcom.
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