Biosergen publishes interim report for third quarter 2024

Friday November 8, 2024: Biosergen AB (“Biosergen” or the “Company”) hereby publishes the interim report for the third quarter 2024. The interim report is available as an attached document and on the company website (www.biosergen.net)

BIOSERGEN HAS COMPLETED FIRST PATIENT COHORT
The most significant recent result for Biosergen is the successful completion of the treatment of the first cohort of patients in our clinical trial for BSG005. The early data are remarkable, with some patients achieving complete recovery at a low dose of BSG005, while others experienced significant improvement in their condition. These results underscore the drug's potential as a powerful rescue therapy for life-threatening fungal infections, bringing us closer to advancing this new life-saving therapy to patients. This was confirmed by the Safety Review Committee who recommend a dosing increase for the second cohort.

• August 30, Biosergen have completed treatment of the first patient with BSG005
• July 12, First Patient in Biosergen Clinical Trial Treating with BSG005 for Life Threatening Fungal Infection treated with promising results.

Highlights after the period

• November 7, Biosergen Announces Safety Committee Approval to Proceed with Dose Escalation in Second Cohort for BSG005 Clinical Trial
• October 31, Biosergen completes first cohort of BSG005 clinical trial, shows promising potential in drug-resistant fungal infections
• October 7, Biosergen Completes Enrollment of First Cohort in BSG005 Proof-of-Concept Trial

Summary of the interim report for Q3 2024

CEO STATEMENT

In the first cohort of our ongoing proof-of-concept clinical trial for BSG005, we enrolled five patients suffering from severe fungal infections, all of whom had limited or no treatment options left due to either drug resistance or safety concerns with existing therapies. The early results from this cohort are both promising and impactful: two patients achieved complete recovery, two showed marked clinical improvement, while one severely ill patient, unfortunately, passed away due to causes unrelated to BSG005. The positive outcomes underscore BSG005's potential as a secure, life-saving rescue therapy. We look forward to gathering further evidence as we progress through the trial. It is difficult to overestimate the significance of these results, as it is rare to see this level of clinical effect so early in the development process of a new drug, we treated longer and at higher doses than anticipated. Remember, the dosing level in this first cohort was lower, and if BSG005 follows typical response patterns, we anticipate even greater impact as the dose is increased in upcoming cohorts.

In October, I had the privilege of visiting our trial sites in India and meeting with the highly skilled investigators leading this study. This visit left me with a strong sense of optimism about both the commitment of our Indian partners and the steady progress of our trial. Occasionally, I am asked why we chose India for this important trial. India was a strategic choice due to its position at the forefront of treating severe fungal infections and as a region significantly impacted by antifungal resistance. My recent visit confirmed this, as I was deeply impressed by our teams’ expertise, their use of novel diagnostic methods, and their dedication to advancing the fight against fungal infections. Having worked with leading life science organizations across Denmark, Sweden, Germany, and the United States, I can confidently attest to the exceptional quality and rigor of our partners’ work in India.

Following the successful completion of our first cohort and promising patient outcomes, we are now focused on progressing to enrolment in the second cohort. An independent Data Safety Review Committee recommended continuing and escalating to 0,8 mg/kg as the starting dose. We expect to initiate the enrolment of an additional five patients soon, with a goal of treating up to 15 patients by January 2025. Alongside this, we are working closely with Alkem Laboratories to prepare for subsequent clinical phases, where we will further evaluate BSG005’s efficacy.

On a global level, I am encouraged by the rising attention to antimicrobial resistance (AMR), with antifungal resistance as a major concern. In September, during the United Nations General Assembly High-Level Meeting on AMR, world leaders adopted a political declaration with ambitious targets, including a 10% reduction in human deaths due to antimicrobial resistance by 2030. The declaration emphasizes the urgency of developing national AMR action plans, which aligns directly with our mission of advancing BSG005 as a new treatment for resistant fungal infections. Our orphan drug designation from the U.S. FDA for aspergillosis further underscores the importance of our work in this vital area.

In closing, I want to extend my gratitude to all our shareholders for your continued support. This quarter has been one of tangible progress, and I believe we are well-positioned to advance BSG005's development further. I look forward to updating you in the coming months as we continue this critical journey to bring much-needed therapies to patients in urgent need.

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.