Biosergen is pleased to announce its plans to initiate its first Phase 2 clinical trial towards the end of Q2 2023. The multi-indication, open-label, single-center trial will be conducted at a site in India and enrol 15 patients suffering from invasive fungal infections, expected to include the infectious diseases the Company has previously highlighted as the main candidates for its Phase 2 programs; mucormycosis ("Black Fungus"), aspergillosis, and later febrile, neutropenic patients with symptoms of invasive fungal disease. The key enrolment criteria for the first phase 2 trial is, that the patients are, or have been, undergoing treatment with an Amphotericin B antifungal product but, due to intolerability or toxicity of Amphotericin B, have been taken off this last resort treatment, and are left without any effective treatment options. A top-line data readout is expected approximately six months after the dosing of the first patient, expected in early Q3 2023.

Study rationale
The trial design serves several purposes, including demonstrating that BSG005 could become a rescue treatment for a large group of patients with no treatment options due to the well-known severe side effects of Amphotericin B treatment, a global patient population with a high unmet medical need. In addition, the trial will serve to significantly de-risk the further Phase 2 development of BSG005, and to increase the probability of attracting future non-dilutive funding.

The primary endpoint of the trial has been designed to show that BSG005 has the potential to challenge Amphotericin B's role as a last resort treatment in difficult-to-treat invasive fungal infections. The choice to focus on this endpoint was prompted by the recent positive outcome of the Company's Phase I trial, as announced on March 13 (https://mb.cision.com/Main/20568/3732376/1907335.pdf), where no serious adverse events were observed. Importantly, there were no signs in all laboratory assessments of any influence from BSG005 on kidney and liver function. This is significant because currently, 20 - 40% of patients receiving an Amphotericin B product have to be taken off the treatment due to organ intolerance or toxicity, mainly kidney damage. For the vast majority of such seriously ill patients, where Amphotericin B is not a viable treatment option, there are no real effective alternative treatments, and the invasive fungal infection may, for example in the case of mucormycosis, severely injure patients' organs, and develop into a life-threatening condition or major disability.

Since Biosergen became a listed company in June 2021, the general market conditions for biotech companies' access to capital have deteriorated due to macroeconomic changes. Therefore, it is currently highly important to de-risk clinical development and plan as thoroughly as possible for maximal clinical impact for patients in the first single-indication registration trial. With the data from the multi-indication Phase 2 trial announced today, Biosergen will be able to identify any significant indicative differences in the potency of BSG005 for the treatment of various invasive fungal infectious diseases. In addition, the Company will gain important data on needed dosing size, treatment cycle time, and more. Such data will be valuable in qualifying the decision on what disease to initiate the Company's first subsequent registration-oriented single-indication Phase 2 trial and ensure an optimized trial design.

Additionally, having data from a human clinical trial verifying that BSG005 shows potency as a valuable treatment for specific patient populations, which globally currently does not have any real treatment options, will increase Biosergen's chances of securing non-dilutive soft-money funding of the further development of BSG005, as the Company has successfully done in the past.

The Company's two main targets for registration-oriented Phase 2 trials remain to be mucormycosis and, of course, the Aspergillosis indication for which Biosergen has Orphan Drug Designation in the US.

Biosergen does not anticipate that this trial will prompt a need for additional equity financing.

Biosergen's CEO Peder M. Andersen comments:
"With the data from this trial, we will be able to challenge Amphotericin B's role as `the only last resort antifungal product', as we expect that it will provide data showing that BSG005 works in situations where no real alternative is currently available," said Biosergen CEO Peder M. Andersen, and added: "I can't wait to learn more about the degree of potency BSG005 shows in different invasive fungal diseases. In preclinical trials, we saw cases of up to six times higher potency when compared to the existing standard-of-care. So, we have justified, high hopes for developing a new antifungal drug that is superior across-the-board. Our ambition with this multi-indication trial, is to quickly and cost-efficiently show that BSG005 actually works in humans with invasive fungal disease and use this information to de-risk our further development so that our shareholders can rest assured they are supporting a company, that have very strong odds for getting BSG005 approved."