In general, the patients in Cohort 2 were in an even worse condition at the time of enrollment compared to those in Cohort 1. The cohort consisted of five patients with life-threatening fungal infections: one completely recovered, three showed significant improvements, and one patient voluntarily withdrew from the trial due to discomfort. The trial is evaluating BSG005 as a rescue therapy for patients who have either failed previous standard-of-care antifungal treatments due to lack of efficacy or safety, or patients with mild to moderate kidney impairment.

"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. It is also important to note that the data supports BSG005 as a broad-spectrum antifungal, as we have observed clinical improvements in patients with varying infections, including a case of co-infection. These results are incredibly encouraging. Our primary goal for this trial was to assess the safety, tolerability, and efficacy of BSG005, and we have now achieved more than what we set out to do, allowing us to advance to the next phase of our development plans," said Tine K. Olesen, CEO of Biosergen, and continued:

"However, what we did not anticipate was the investigators' request to extend both the dosing period and increase the dosing level beyond our original trial plans. This request was driven by strong clinical rationale-the patients receiving BSG005 needed extended treatment to fully recover and prevent possible immediate relapse. Given the promising outcomes and urgent patient needs, we approved the expansion. However, this also resulted in higher-than-planned usage of BSG005 in the second cohort, meaning we now need to replenish our drug supply before we can initiate the third cohort Q4 year."

Second Cohort Patient Cases

Patients in this second cohort received daily doses of up to 2.0 mg/kg/day of BSG005.

One Mucormycosis patient had a severe fungal infection that had spread across multiple lobes in both lungs. Surgical treatment was not an option, as removing the affected lung tissue would have been fatal. After treatment with BSG005, this patient fully recovered. It is worth noting that a similar case in Cohort 1 also fully recovered, making this the second consecutive Mucormycosis patient to achieve complete recovery with BSG005. For pulmonary Mucormycosis patients not treated with BSG005, the mortality rate is estimated to be between 52-63%¹.

Two Aspergillus patients had previously undergone standard-of-care antifungal treatments but failed therapy, likely due to drug-resistant infections. After receiving BSG005, both patients showed significant improvement. It is important to note that drug-resistant Aspergillus infections typically have mortality rates between 50-80%¹, depending on the patient's underlying health conditions. Furthermore, three similar cases, also with significant improvement, occurred in Cohort 1, making these observations highly remarkable.

One patient suffered from a co-infection with both invasive Mucormycosis and Aspergillus but showed significant improvement after treatment with BSG005. Standard treatment options are extremely limited for such dual infections, as patients face an exceptionally poor survival prognosis due to the combined mortality risks of both diseases. The patient's recovery with BSG005 highlights its potential as a broad-spectrum antifungal capable of addressing complex, high-risk infections.

One patient voluntarily withdrew from the trial after experiencing shortness of breath (dyspnea) and a drop in blood pressure during dosing. These events were not classified as severe side effects..

For the three patients who experienced significant improvements, the clinical benefit was substantial, as their improved conditions will now allow for continued medical care or, in some cases, make surgical intervention possible.

Promising Results Across Both Cohorts

Summing up results from cohorts 1 and 2, all treated patients responded well to BSG005, demonstrating clear clinical benefits:

• Two patients completely recovered
• Six patients showed significant improvements
• One patient voluntarily withdrew
• One patient, unfortunately, passed away due to causes unrelated to BSG005

No severe side effects were observed in either cohort. Across all successfully treated patients key blood parameters-including creatinine (kidney function), potassium (cardiac health), and magnesium (electrolyte balance)-remained stable. This represents a notable advantage over Amphotericin B, the current last-resort antifungal treatment, which is associated with significant toxicity. Of the eight patients who completed treatment with positive outcomes, four were estimated to be infected with drug-resistant fungal infections.

2025 Objectives

These results position Biosergen to advance its key strategic objectives for 2025, including:

• Producing new stock of BSG005
• Initiating consultation with the CDSCO on initiation of a Phase 2 trial in India
• Advancing toward an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) before year-end

Procuring New BSG005 Drug Supply

Biosergen has already initiated the process of procuring additional BSG005 supply, with production adjustments underway to meet the requirements for a Phase 2 clinical trial. The financing for this expansion was secured through the successful warrant exercise completed in December 2024.

Initiating Consultation with the CDSCO

Biosergen will assemble a clinical report summarizing Phase 1 and proof-of-concept trial data to consult with the Central Drugs Standard Control Organisation (CDSCO) of India. The goal is to define the most efficient path forward for a Phase 2 clinical trial, aligning with regulatory expectations.

Planning for an Investigational New Drug (IND) Application

An IND is a regulatory submission that allows a biotech company to initiate clinical trials in the United States under FDA oversight. In 2025, Biosergen plans to Engage in a Pre-IND consultation with the FDA, where it will receive regulatory guidance on clinical trial design and data requirements, and submit a full IND application before year-end, paving the way for FDA authorization to begin U.S.-based clinical trials.

¹ https://www.sciencedirect.com/science/article/pii/S1198743X2100001X