Main menu button

Equity Research Biosergen: Stable quarter with exciting news around the corner

23 maj 2025

On 21 May, Biosergen announced the financial report for the first quarter of 2025 and reported on the current status of the proof-of-concept study as well as preparations for an IND-discussion in the USA.

Financial development in line with our expectations

The report was not a surprise when it came to the financials, nor did it deviate significantly compared to our estimates. Other external expenses amounted to minus SEK 3.8 million, with personnel costs of minus SEK 1 million and other operating expenses of minus SEK 570 thousand. These figures compare to our estimates of minus SEK 3.7 million, 1.4 million and 300 thousand respectively. With a cash balance of just under SEK 45 million per the end of Q1, should the burn rate remain on the same level as in Q1, Biosergen should have a cash runway extending until late 2026 at least. That being said, we expect expenditure to increase in coming quarters, as activities in the USA start to develop.

Increased activity around the corner

As was discussed in the report, there are three main objectives that Biosergen wants to complete during 2025. First, as we have discussed in our previous research update, Biosergen is currently preparing a new batch of BSG005 for use in coming clinical trials. The newly produced batch will be manufactured to meet the regulatory GMP standards required by relevant agencies, namely the FDA, the EMA, as well as India’s CDSCO. The process is necessary to complete before Biosergen can continue the study with the third cohort, slated for Q3 or Q4 in 2025. Secondly, in parallel, the company is continuing discussions with the CDSCO for the initiation of the coming phase II clinical trial. The CDSCO is not known to be fast, but the company states that the successes seen in the two first cohorts might be aiding these discussions. Lastly, Biosergen is preparing for the initiation of formal discussions with the FDA later this year. More exactly, the plan is to initiate discussions with the FDA for securing an Investigational New Drug (IND) application. This will later be used to conduct a clinical trial in the USA, one of the target markets for Biosergen. The data collected in India, as well as previous data from the phase I and pre-clinical data, can and will be used as a basis for the discussions.

Taken together, we leave our base case valuation unchanged at SEK 1.5 pending more updates on progress in India and the USA.
Read our latest Research update here.


Disclaimer

Carlsquare AB, www.carlsquare.se, hereinafter referred to as Carlsquare, conducts business with regard to Corporate Finance and Equity Research in which areas it, among other things, publishes information about companies, including analyzes. The information has been compiled from sources that Carlsquare considers to be reliable. However, Carlsquare cannot guarantee the accuracy of the information. Nothing written in the analysis should be regarded as a recommendation or invitation to invest in any financial instrument, option, or the like. Opinions and conclusions expressed in the analysis are intended only for the recipient.

The content may not be copied, reproduced, or distributed to another person without the written approval of Carlsquare. Carlsquare shall not be held responsible for any direct or indirect damage caused by decisions made on the basis of information contained in this analysis. Investments in financial instruments provide opportunities for value increases and profits. All such investments are also subject to risks. Risks vary between different types of financial instruments and combinations of these. Historical returns should not be considered as an indication of future returns.

The analysis is not directed to U.S. persons (as defined in Regulation S of the United States Securities Act and interpreted in the United States Investment Company Act 1940), nor may it be disseminated to such persons. The analysis is also not directed to such natural and legal persons where the distribution of the analysis to such persons would result in or entail a risk of a violation of Swedish or foreign law or constitution.

The analysis is a so-called Commissioned Research Report where the analyzed Company has signed an agreement with Carlsquare for analysis coverage. The analyses are published ongoing during the contract period and for a usually fixed remuneration.

Carlsquare may or may not have a financial interest in the subject of this analysis. Carlsquare values the assurance of objectivity and independence and has established procedures for managing conflicts of interest for this purpose.

The analysts Herman Kuntscher and Niklas Elmhammer do not own and are not allowed to own shares in the Company analyzed.

Equity Research Biosergen: Stable quarter with exciting news around the corner