Interim Report First Quarter 2023 January 1 – March 31 2023 Kancera AB (publ.), org.no. 556806-8851
The period in brief
January – March
Financial summary for the first quarter
• Net sales amounted to SEK 0 million (SEK 0).
• R&D expenses amounted to SEK 15,2 million (SEK10,6 million).
• Operating profit for the first quarter amounted to SEK -17.2 million (SEK -11.9 million).
• The loss after financial items for the first quarter amounted to SEK -17.5 million (SEK -12.0 million
• Earnings per share, before and after dilution, for the first quarter amounted to SEK -0.22 (SEK -0.21).
• Cash flow from operating activities for the first quarter amounted to SEK -19.0 million (SEK -9.8 million).
• As of 31 March 2023, equity amounted to SEK 89.4 million (SEK 110.5 million) or SEK 1.12 (SEK 1.97) per share.
• The equity/assets ratio on 31 March 2023 was 8.5 percent (90 percent).
• Cash and cash equivalents on 31 March 2023 amounted to SEK 76.1 million (SEK 96.8 million).
Significant events during the first quarter
• Kancera reported that the US Patent Office has granted a patent protecting the production method of KAND567 and KAND145. The patent is owned by Kancera and is valid until 2039.
• Kancera reported that the Swedish Medical Products Agency has approved the company's application to conduct the KANDOVA study.
• Kancera announced the appointment of Hanjing Xie as its new Chief Medical Officer.
• Kancera reported that the recruitment of patients to the FRACTAL study has been completed and that a total of 71 patients have been recruited to the study.
• Kancera reported that an in-depth analysis of data from the phase IIa study in COVID patients shows that short-term treatment with KAND567 has a long-term pharmacological effect on certain pro-inflammatory and tumor-stimulating immune cells.
• Kancera reported that applications to conduct the KANDOVA study have been submitted to the regulatory authorities in Denmark and Norway.
Important events after the end of the period
• Kancera reports that the regulatory application to conduct a phase I study of KAND145 in healthy subjects has been submitted.
• Kancera reports that the Danish and Norwegian Medicines Agencies have approved the company's application to conduct the KANDOVA study.
• Kancera reports that screening of patients for the KANDOVA study has started at Karolinska University Hospital in Solna.
• Kancera reports that the exercise period for warrants of series TO6 started on May 3 and was completed on May 17, 2023.
CEO statement
Recruitment of myocardial infarction patients to the FRACTAL study completed
The KANDOVA study in ovarian cancer starts 2023 will be an important and eventful year for Kancera with three projects in clinical development phase:
• The FRACTAL study: a phase IIa study of KAND567 in myocardial infarction
• The KANDOVA study: a combined phase Ib/IIa study of KAND567 in ovarian cancer
• Phase I / First-In-Human Study of KAND145
Kancera's business strategy is based on the development of innovative drug candidates with strong IP protection and robust study data that reach the market and provide benefits for patients through commercially attractive collaboration agreements with internationally established pharmaceutical companies. During the first quarter of the year, several important results were delivered in line with this strategy and important steps were taken towards the goal of establishing a strong clinical development portfolio with significant value potential for Kancera's share holders.
In the FRACTAL study, we completed recruitment by reaching a total of 71 treated patients, which exceeds the target of 60 patients originally set for the study. Analysis of the data is now ongoing, and we plan to report the study's overall results in the third quarter of this year.
Prior to the start of the KANDOVA study, we received regulatory approval in Sweden and after the period we have also received approval in Norway and Denmark. Karolinska University Hospital in Solna was then the first to start screening of patients who will participate in the study.
During the period, Kancera finalized the extensive documentation required to submit the regulatory application to conduct the first study of KAND145 in human, our second clinical drug candidate within the Fractalkine program. After the period Kancera has reported that the application has been submitted.
During the period, Kancera also reported important results from in-depth analyses conducted on data from the previously conducted phase IIa study of KAND567 in COVID patients. These analyses show that KAND567 has the ability to regulate certain types of immune cells over a long period of time. These immune cells, so-called non-classical monocytes, have been shown by several different research groups to be strongly correlate to several forms of serious medical conditions, including hyperinflammation, cancer and autoimmune diseases. What makes the findings unique is that the effect persists for several months after the end of treatment with KAND567. The discovery indicates that a short-term treatment with KAND567 may have a long-term effect on certain pro-inflammatory and tumor-stimulating immune cells, which strengthens our conviction of the potential to show efficacy in the FRACTAL and KANDOVA studies.
During the period, Kancera reported that the company's applications for patent protection of the manufacturing processes for KAND567 and KAND145 were approved in the US and Japan, which constitute two major markets for pharmaceuticals. These are important milestones as strong IP protection is the basis for entering in attractive commercial partnerships. The processing of these patent applications continues in Europe and other territories.
In parallel with the company's research and development work, we put great effort into business development activities aimed at positioning ourselves for partnerships with internationally established pharmaceutical companies. These activities are ongoing but will be further intensified in connection with reporting the results from the FRACTAL study.
The financial result for the period is in line with the company's plan. The macroeconomic environment, including high inflation, higher interest rates and higher energy prices, is not expected to affect the implementation of our business plan and the capital raised by Kancera at the end of 2022 has secured financing for the completion of all three ongoing clinical development projects.
As mentioned, the year has started very positively for Kancera and we look forward with confidence to an eventful year, and expect a strong news flow:
• Second quarter: continuous patient recruitment to the KANDOVA study
• Third quarter: approval and start of the First-In-Human study of KAND145 and reporting of results from the FRACTAL study
• Fourth quarter: transition from phase Ib to IIa in the KANDOVA study and reporting of results from the First-In-Human study.
Solna, May 19 2023
Kancera AB
Thomas Olin, CEO