Biosergen’s CEO: “The first patient regained his health”
In Biosergen’s Q2 report, the company highlights the successful start of the phase Ib study with BSG005. The first patient with invasive fungal disease recovered and preserved both his lungs by avoiding surgery after being treated with BSG005, something the company describes as “very remarkable.” BioStock reached out to CEO Tine Olesen to learn more about this success and the company’s financial status.
Biosergen is developing BSG005 with the goal of offering a treatment for patients with invasive fungal infections, which pose a life-threatening risk. The company, in collaboration with its partner Alkem Laboratories Limited, is conducting a phase Ib study with the primary aim of evaluating the potential of BSG005 as a rescue treatment for patients that have failed other treatment options. This open-label phase Ib study with dose escalation will evaluate the safety, tolerability, and efficacy of BSG005 in 15 patients in intensive care units in India.
In the company’s Q2 report, CEO Tine Olesen particularly emphasises the company’s efforts in the study. During the quarter, the company has worked diligently to get this first patient study in place, and in July, the company announced that the first patient had been included.
First patient treated – a success
In connection with the report, the company also announced that it had successfully completed the treatment of this first patient. The patient was critically ill with Mucormycosis – one of the most difficult fungal infections to treat. He had fever, hemoptysis, and moderately impaired kidney function. After being treated with BSG005 for 28 days, with the dose escalated from a total of 0.1 mg/kg to 1 mg/kg, the patient recovered, and kidney function stabilised. Additionally, no significant safety issues were observed despite the high dose. Typically, patients with Mucormycosis need to undergo surgery to remove the infected tissue and avoid spreading of the disease. In this particular case, the location of the fungus would suggest the removal of one lung, but thanks to the successful treatment outcome, both lungs could be preserved. “It is a very remarkable case,” writes Tine Olesen.
Recruitment to accelerate
Patient recruitment for the study is a challenging factor, given the strict criteria that BSG005 can only be given to patients that have failed previous attempt of treatment or have impaired kidney function. It is to be given as rescue therapy. Currently five private clinics are involved and ready to recruit patients. Biosergen believes that once approval from the ethics committees to recruit from public hospitals are granted, they will have access to many more patients, which will likely increase recruitment numbers. The company expects to have all approvals in November. Biosergen estimates the last patient’s last visit will occur in January 2025 but will provide ongoing updates from the study before that.
Financial overview
The Q2 report shows that the company had a loss of SEK 5.7 million during the quarter, an improvement compared to the same period last year (SEK -8.0 million). The company’s cash balance amounted to SEK 12.2 million at the end of the period. Importantly, through the company’s warrants TO3, which can be exercised in November 2024, the company could strengthen its cash position by up to SEK 43.9 million with full subscription.
CEO’s comments
BioStock contacted CEO Tine Olesen regarding the positive news from the phase Ib study and to gain a further insight into the company’s financial status.
Tine, in connection with the Q2 report, you announced that the first patient treated with BSG005 was, to say the least, a success. Would you like to comment further on this?
– In this study we are treating patients that have limited treatment options, either because they have formed resistance or are intolerant to current treatments or they have kidney impairment which indeed again limits the treatment options. The patient treated had kidney impairment and at the same time he had an infection with one of the most difficult to treat fungal strains. Treating with BSG005, his disease came under control, his kidney impairment improved and we preserved his lungs. This patient regained his health and improved his overall well-being. It gives hope that we can actually make a difference for these severe sick patients.
What is the next milestone in the study and moving forward?
– The next milestone is to show that we will have excellent results not only in one patient but more patients. We will report on the study on an ongoing basis, the first reporting will be trends and by the end of the study we will see a more clear safety and efficacy profile of BSG005. This will guide us in the next clinical studies. Also based on the data we collect in this study, we can start a compassionate use program, which is individual rescue treatments.
The company had a cash balance of SEK 12.2 million at the end of the period. Can you comment on the company’s financial status for the coming months?
– That is right, the cash balance at the end of the period was SEK 12.2 million. In the rights issue in March this year, the investors besides shares in Biosergen also received warrants. These warrants called TO3 and traded at First North Growth Market in Stockholm, can be exercised in November this year. If fully subscribed at the highest exercise price which is SEK 0.50, Biosergen will receive approximately SEK 45 million which will bring us well through 2025 and to the point where Alkem will fund the patients in India in our phase 2/3 studies. The subscription period for the warrant is from November 18 to November 29 and we hope to see good support.
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