In connection with the upcoming financial interim report for the first quarter 2025, Kancera AB (publ) (Kancera) provides an update on the ongoing collaboration with Recardio Inc. and the company's clinical development program and reports that Kancera:
- conducts joint investor meetings with Recardio Inc. aiming to secure financing of the combined business' long term business plan
- expects to receive pre-IND feedback from FDA concerning the planned phase IIb study in acute myocardial infarction
- is conducting the final activities to complete the phase Ib/IIa study in ovarian cancer and that top-line results are expected to be presented during the third quarter
- is planning to implement the new company name Novakand Pharma in September
Collaboration with Recardio Inc. aiming to create a specialty care company in the field of cardiovascular diseases
In March 2025, Kancera signed a letter of intent with the US private biotech company Recardio Inc. (Recardio) aiming to combine the companies' assets and create a cardiovascular disease focused specialty care company. According to the terms of the letter of intent, Recardio intends to license the candidate drugs KAND567 and KAND145 from Kancera.
Since the letter of intent was signed, the companies have developed a joint business plan, including high-level development plans for the companies' two clinical-stage programs and a joint long-term financial plan. Meetings with potential US investors have been held jointly with Recardio, with the objective to secure financing of the combined business' long-term business plan. Based on the investor meetings held, Kancera is making the assessment that the current macro environment and situation on the financial markets imply that the targeted capital raise will take longer time than what was anticipated when the letter of intent was signed. The investor activities are however proceeding with unchanged pace, primarily focusing on US investors.
Preparations for FRACTIVE - a planned clinical phase IIb study in acute myocardial infarction
FRACTIVE is a planned two-armed, double-blinded, multi-center phase IIb study with KAND567 in acute myocardial infarction, building on the positive results from the phase IIa FRACTAL study. In collaboration with a scientific committee, the company has developed a clinical study protocol synopsis. The company has also submitted a pre-IND application with the US regulatory agency FDA, with the objective to receive formal feedback on the planned phase IIb study design and the overall clinical development plan up until market approval. The company expects to present the FDA feedback before the end of the second quarter 2025.
Completion of KANDOVA - an ongoing phase Ib/IIa study in ovarian cancer
KANDOVA is an ongoing one-arm, open-label, multi-center phase Ib/IIa study with KAND567 in combination with carboplatin in ovarian cancer patients with relapse from platinum therapy. The study is being conducted at five university hospitals in Sweden, Norway and Denmark. In total, 18 patients have been recruited to the study and the last patient has conducted the last visit. Currently, work is ongoing to compile all study data for statistical analysis, as well as to finalize analyses and secondary and exploratory endpoints in order to evaluate KAND576's anti-tumor effect. The top-line results are expected to be presented during the third quarter 2025.
Planned change of company name to Novakand Pharma
In March 2025, the company announced its intention to change company name to Novakand Pharma, a change in line with the company's decision to focus on cardiovascular diseases. The formal decision will be taken at the annual general meeting on May 26, 2025. The company has applied for a trademark to the European Union Intellectual Property Office (EU IPO). An objection has been filed by Novavax, an US vaccine company, but the company makes the assessment that this objection can be mitigated and does not motivate a change of the decision to change the company name to Novakand Pharma. Subject to a decision at the annual general meeting, the new company name is planned to be implemented in September 2025.
About Kancera AB (publ)
Kancera is a clinical stage biotech developing a new class of small molecule drugs with an immune cell modulating mode-of-action with focus on cardiovascular diseases. The stock is traded on the Nasdaq First North Premier Growth Market. Redeye AB is the company's Certified Adviser and can be contacted at certifiedadviser@redeye.se.
For further information:
Visit Kancera's website: www.kancera.com
or contact:
ir@kancera.com or phone: +46 (0)8-5012 60 80
