Biosergen AB: Biosergen publishes interim report for fourth quarter 2024

2025: STRENGTHENING BIOSERGEN'S POSITION FOR GLOBAL TRIALS
2025 will be the year we expect to initiate substantial discussions with the U.S. FDA on securing an Investigational New Drug (IND) application for BSG005-an essential step toward conducting clinical trials in the U.S. We plan to enter these discussions with strong clinical data from our ongoing trial in India and a clear plan for establishing a production of BSG005 to meet regulatory requirements in India, the U.S., and beyond. We do so with great confidence, following the significant progress made in 2024. At the beginning of the year, the only certainty we had about BSG005 in humans was that it showed no toxicity in healthy volunteers. By the end of 2024, we had demonstrated its potential as a successful treatment for multiple cases of the most difficult-to-treat fungal infections-in patients who had no other options. In parallel, we secured the financial backing necessary to advance our clinical program. With these key elements in place, we are well-positioned to make 2025 a year in which we successfully strengthen Biosergen's position for the future.

HIGHLIGHTS DURING Q4 2024
In October, Biosergen completes first cohort of BSG005 clinical trial, showing promising potential in drug-resistant fungal infections. The cohort consisted of five patients: two completely recovered, two saw significant improvements, and one very sick patient passed away because of unrelated causes to BSG005. Seeing two patients who had suffered from some of the most severe fungal infections existing in the world today fully recover is truly remarkable.

• In November, Biosergen announced safety committee approval to proceed with dose escalation and dose first patients in second cohort of BSG005 clinical trial for life-threatening fungal infections
• In December, Biosergen AB received approximately SEK 44,9 million through warrants of series TO3. In total, 91,701,328 warrants of series TO3 were exercised, corresponding to 100.0 percent of the total number of outstanding warrants. The exercise rate amounted to approximately 93.1 percent, and a top underwriting commitment was utilized for the remaining volume.
• In December, Biosergen agreed to accelerated dosing escalation in the second cohort of the ongoing clinical trial. This decision was made following a request from the Principal Investigator, supported by compelling preliminary data, reflecting the investigator team's expectation that BSG005 will deliver even greater clinical benefits at higher doses with no severe side effects. The independent Data Safety Review Committee reviewed and approved this request.

HIGHLIGHTS AFTER THE PERIOD
On February 4, Biosergen successfully completed the second cohort of BSG005 clinical trial, gaining conclusive proof-of-concept data, and confirming 2025 objectives. With the completion of the second cohort, we now have compelling proof-of-concept data on BSG005, further reinforcing its potential as a life-saving treatment for patients with invasive fungal infections who have no remaining medical treatment options. In short, across cohort 1 and 2, every patient who completed BSG005 treatment experienced clinical benefits, with multiple complete recoveries and significant improvements-all without severe side effects.

Summary of the interim report for Q4 2024

CEO STATEMENT
As we move through the early months of 2025, I want to summarize the important progress Biosergen has made over the past year and into the beginning of this one.

The most significant milestones of 2024 and early 2025 have been the completion of our first and second patient cohorts in our ongoing clinical trial. The trial, conducted in India, is aimed at establishing proof-of-concept for our antifungal drug candidate, BSG005, as an effective and safe treatment for life-threatening fungal infections. These results were achieved in a population that had no other treatment options either due to lack of efficacy or intolerability to current standard of care, the most difficult patient population to treat.

Across the two cohorts, ten patients with life-threatening fungal infections have been enrolled and treated with BSG. Eight patients completed their treatment cycles, with several achieving full recovery, while others showed significant clinical improvement, including patients with otherwise drug-resistant Aspergillus and severe Mucormycosis. One patient passed away due to unrelated causes, and another voluntarily withdrew from treatment.

During the second cohort, the independent safety board increased the maximum dose from 1.5 to 2.0 mg/kg/day exceeding the original recommended dose. Even at this higher dose, BSG005 continued to demonstrate a strong safety profile, with no severe side effects. However, while this is very positive, it also delayed the immediate initiation of  Cohort 3. We run Biosergen as efficiently as possible, and the higher-than-expected drug consumption in Cohort 2, combined with the newly increased  dosing in Cohort 3, requires us to replenish our drug supply before proceeding. In clinical development, it is essential to ensure sufficient stock of the drug candidate before starting a new cohort to guarantee the completion of all planned treatments.

It is important to emphasize that the delay in Cohort 3 will not affect any of the planned activities outside of India for 2025. The key factors for discussions with the FDA remain the manufacturing process, in vitro and in vivo data, and Phase 1 data in healthy subjects conducted in Australia. Additionally, we can incorporate data from the first two cohorts as supplementary information.

A key priority in 2024 was to ensure stable funding for our ongoing development efforts. It was therefore very positive that we raised SEK 26 million through a rights issue in March, followed by the full subscription of TO3 warrants in November, which secured an additional SEK 45 million. With this funding, we are now able to prepare for our Phase 2 trial activities and produce new BSG supply. We are thankful to all investors who participated in these financing rounds.

In general, we will have three main priorities in 2025: First, the already-mentioned manufacturing of additional BSG005 to support further clinical development. We have already started procuring this new batch of drug supply, which will be manufactured to meet the requirements of all relevant international agencies, such as the FDA in the US, EMA in the EU, and others. We expect to complete this process so that we can initiate Cohort 3 in Q4 2025.

Secondly, We will initiate regulatory discussions with the CDSCO in India to determine how we can move most smoothly toward the initiation of a Phase 2 trial in India.

Thirdly, We will be advancing toward an Investigational New Drug (IND) application with the U.S. FDA, paving the way for later-stage U.S.-based trials.

I want to highlight a potentially overlooked aspect of the investigators' interest in maximizing both the dose and treatment duration of BSG005. The fact that longer treatment periods are being explored strongly indicates the drug's favorable safety profile, which bodes well for its market potential. First, a drug that can be administered for an extended period without toxicity concerns is inherently more competitive. Second, in some markets, reimbursement is tied to drug consumption, meaning longer treatments can have a positive financial impact. Therefore, the investigators' inclination to extend BSG005 treatment should further enhance its appeal to potential commercial partners-encouraging news for all of you supporting its development.

Before concluding, we are also planning for the long-term future, where we will continue to seek additional funding through partnerships and grants . The promising data generated from our clinical study strengthens the evidence supporting BSG005 as a unique treatment for invasive fungal infections. Meanwhile, the growing global focus on Antimicrobial Resistance (AMR), driven by increased awareness and funding, presents an opportunity for us to contribute to addressing these challenges. For instance, Swedish health authorities have recommended screening for Candida auris, a multidrug-resistant fungal strain. Notably, BSG005 has demonstrated efficacy against this strain in both in vitro and animal studies, reinforcing its potential impact in combating this global health threat

I would like to thank our shareholders, partners, and employees for their support over the past year. We will continue to focus on the work ahead and look forward to sharing further updates as we make progress in 2025.

Sincerely,

Tine Olesen
CEO Biosergen

For further information about Biosergen, please contact:

Tine Kold Olesen, CEO

Telephone: +45 3135 5707
E-mail: tine.olesen@biosergen.net

Niels Laursen, CFO

Telephone: +45 4014 5059

Email: niels.laursen@biosergen.net

The Company's Certified Adviser is Carnegie Investment Bank AB (publ).

ABOUT BIOSERGEN

Biosergen is a biotechnology company in the clinical stage within the therapeutic field of life-threatening fungal diseases. Biosergen' s mission is to develop the drug candidate BSG005, into a new first line treatment choice for resistant and/or difficult to treat invasive fungal infections, to save thousands of lives of immune-compromised cancer- transplant- and AIDS patients every year.