Wednesday August 20, 2024: Biosergen AB ("Biosergen" or the "Company") hereby publishes the interim report for the second quarter 2025. The interim report is available as an attached document and on the company website (www.biosergen.net)
Advancing BSG005 Toward Cohort 3 and Key Appointments
"During the second quarter of 2025, we made solid progress on several key fronts. Manufacturing a new GMP-compliant batch of BSG005 is underway to support the start of Cohort 3 later this year and the phase 2/3 program. At the same time, we continued our regulatory discussions in India and advanced preparations for an IND application in the U.S. We also welcomed new medical leadership with the appointment of Dr. Dora Corzo Leon as Consultant Medical Lead and strengthened our Board of Directors with the addition of Dr. Marco Taglietti.
The company appointed Mark Beveridge as its new Chief Financial Officer. In his ongoing position as Vice President Finance at Moberg Pharma, Mark has contributed to financing, strategic planning, and international commercialization efforts. He will continue in this role alongside his new responsibilities at Biosergen. This part-time CFO arrangement provides Biosergen with experienced financial leadership in a cost-efficient manner, well suited to the company's current phase of development.
These additions ensure we have the right expertise in place to execute our clinical and regulatory plans with the strongest possible foundation for success." -Tine Olesen, CEO Biosergen
CONSOLIDATED FINANCIAL HIGHLIGHTS AND RATIOS
2025 | 2024 | 2025 | 2024 | 2024 | |
TSEK | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Jan-Dec |
Profit/loss | |||||
Other income | 1.671 | 479 | 1.956 | 1.172 | 1.940 |
Profit/loss before depreciation (EBITDA | -11.039 | -5.728 | -16.176 | -12.526 | -19.203 |
Operating profit/loss before net financials | -11.039 | -5.728 | -16.176 | -12.526 | -19.203 |
Net financials | - | - | -10 | -95 | 8 |
Net profit/loss for the period | -11.039 | -5.728 | -16.186 | -12.621 | -19.195 |
Earnings per share (SEK) | -0,05 | -0,04 | -0,07 | -0,18 | -0,08 |
Diluted earnings per share | -0,05 | -0,04 | -0,07 | -0,18 | -0,08 |
Highlights during Q2 2025
- On May 9. Proposal of electing Dr. Marco Taglietti. M.D. as a new member of the Board of Directors ahead of the upcoming Annual General Meeting. Dr. Taglietti has an extensive and successful track record in anti-infective drug development, securing regulatory approvals for multiple therapies, and experience with significant licensing deals.
HIGHLIGHTS AFTER THE PERIOD
- On July 24. appointment of Mark Beveridge as Chief Financial Officer
CEO STATEMENT
As the second quarter of 2025 has ended, I'm pleased to report that Biosergen continues to make steady progress across all key areas throughout the quarter and in recent months. The plans we set out at the beginning of the year are advancing as scheduled.
Following the successful completion of Cohorts 1 and 2 in our ongoing BSG005 proof-of-concept clinical trial, preparations for initiating Cohort 3 later this year remain on track. Most importantly, the manufacturing of a new GMP-compliant drug supply batch is progressing according to plan. Establishing this supply is essential-not only to enable Cohort 3 but also to support our planned Phase 2 trials and future international regulatory activities.
In parallel, our regulatory efforts are moving forward. We remain in ongoing dialogue with the CDSCO in India to define a clear and efficient path toward a Phase 2 trial. At the same time, we are preparing for formal engagement with the U.S. FDA. These preparations are supported by our preclinical data, the completed Phase 1 trial in healthy volunteers, and encouraging results from the first two patient cohorts. These data will form part of the Investigational New Drug (IND) submission, which we aim to file later this year-an essential step for initiating clinical development in the United States. In parallel we are working with EMA in EU to achieve orphan drug status for two indications (Invasive aspergillosis and Mucor mycosis).
We have also strengthened our leadership team. In June, Dr. Dora Corzo Leon joined Biosergen as Consultant Medical Lead, following the resignation of Dr. Peder M. Andersen from his role as Chief Medical Officer after many years of service-first as CEO, and later in his CMO capacity. We are grateful for Peder's contributions throughout the company's history and are pleased that Dr. Corzo Leon has agreed to lead our medical efforts going forward. She is a recognized expert in medical mycology, with deep scientific expertise and a broad international network. Her involvement is already contributing meaningfully to the next stages of our development.
We were also pleased to welcome Dr. Marco Taglietti to our Board of Directors. His proven track record in antifungal drug development and successful licensing deals-including his leadership at SCYNEXIS, where he oversaw the out-licensing of a novel antifungal drug to GSK-is highly relevant to our current stage. His experience will be particularly valuable in the coming years as we work to position BSG005 globally and prepare for potential strategic partnerships.
Dr. Taglietti was formally elected at our Annual General Meeting in June.. We appreciate this support-it enables the forward planning required for success as a focused biotech company.
The company appointed Mark Beveridge as its new Chief Financial Officer. Mark Beveridge brings over 15 years of experience in accounting, auditing, and financial management across both SMEs and publicly listed companies. He is a qualified Chartered Accountant from Sydney, Australia, holding a Bachelor of Commerce and a Graduate Diploma in Chartered Accounting. This part-time CFO arrangement provides Biosergen with experienced financial leadership in a cost-efficient manner, well suited to the company's current phase of development.
Looking ahead, our priorities remain clear: to complete the manufacture and release of the new BSG005 batch; to initiate Cohort 3 as planned; and to continue our regulatory dialogue in both India and the U.S.
I'm proud of the progress made so far this year and grateful for the ongoing commitment of our investigators, partners, and shareholders. With this support, I remain confident in BSG005's potential to become a globally relevant antifungal treatment.
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
Mark Beveridge, CFO Telephone: +46 76 805 8288
Email: mark.beveridge@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.
