The Board and Chief Executive Officer of Cereno Scientific AB here present the interim report for Q1 2024 (January 1-March 31).
Summary of the interim report for Q1 2024 (January 1-March 31)
Cereno Scientific Group
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -15,437,724 (-4,409,588)
- Earnings per share was SEK -0.07 (-0.03) before dilution and SEK -0.05 (-0.03) after dilution
- The equity/assets ratio was 74.5% (94.3%)
- Cash and bank balance was SEK 49,178,602 SEK (44,622,145)
Parent company
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -15,233,285 (-4,469,970)
- Earnings per share was SEK -0.07 (-0.03) before dilution and SEK -0.05 (-0.03) after dilution
- The equity/assets ratio was 74.5% (95.8%)
- Cash and bank balance was SEK 49,110,483 (41,281,024)
Significant events during the first quarter
• On January 3, Cereno submitted a request to the FDA for Expanded Access, also called "Compassionate Use", to use CS1 in an extension of the ongoing Phase II trial evaluating CS1 in the rare disease Pulmonary Arterial Hypertension (PAH). The Expanded Access Program (EAP) will initially be limited to patients who have completed the Phase II study in PAH.
• On January 5, the Company announced that a research article on the innovative study design of the ongoing Phase II study of drug candidate CS1 in PAH had been published in the renowned medical journal Pulmonary Circulation. The research article concludes that CS1 represents a potential novel disease-modifying treatment for PAH.1]
• On January 11, Cereno signed an agreement with CordenPharma, a Contract Development and Manufacturing Organization (CDMO). CordenPharma is contracted to perform a feasibility and then manufacture drug candidate CS1.
• On January 12, the Company announced that Tatiane Abreu Dall'Agnol had joined the Company as Medical Director. She will be part of the Company's R&D team and report to Dr. Björn Dahlöf.
• On January 17, Cereno announced that drug candidate CS014, a novel histone deacetylase inhibitor (HDACi), had obtained an issued patent in the UK. This is the drug candidate's first patent, which strengthens the positioning of CS014.
• On January 22, Cereno announced that equity research company Edison Investment Research had been engaged by Cereno to produce regular, in-depth research for the Company. The intention is to raise the visibility of the Company and enable investors and stakeholders to develop an improved understanding of the business.
• On January 30, Cereno was granted approval by the FDA for Expanded Access, to investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in PAH.
• On January 31-February 3, CEO Sten R. Sörensen, Dr. Raymond Benza, Network Director of Pulmonary Hypertension at Mount Sinai Icahn School of Medicine, New York City, Principal Investigator of the Phase II study of CS1, and member of Cereno's Scientific Advisory Board as well as CMO Dr. Björn Dahlöf, attended the PVRI 2024 Annual Congress organized by the Pulmonary Vascular Research Institute. The PVRI 2024 Annual Congress: "The next 50 years of pulmonary hypertension - a global view" is a top pulmonary vascular congress globally.
• On February 1, Megha Ranjan joined the Company as Project Director. She will be part of the Company's business and operational team and report to Sten R. Sörensen, Chief Executive Officer (CEO).
• On February 2, Julia Fransson joined the Company as Director of Business Development. Julia will develop value leverage to our BD strategies as well as work across functions to coordinate our commercial business focus.
• On February 13, the Company announced that Dr. Rahul Agrawal, with a background in leading and/or co-designing close to 30 clinical trials with over 200,000 patients, had been appointed as Chief Medical Officer and Head of R&D.
• On February 13, Cereno announced an expansion of the Executive Management Team, with CEO Sten R. Sörensen, CSO Dr. Björn Dahlöf, Head of Preclinical Development Nicholas Oakes and Chief Financial Officer Eva Jagenheim, to include the newly appointed Chief Medical Officer & Head of Research & Development Dr. Rahul Agrawal and the Business Development Director Julia Fransson, to strengthen focus on the strategic priorities in the development programs.
• On February 21, Cereno updated the Phase II study progress of CS1 in PAH. Investigators noted that most patients would like continued access to CS1 after the study. They expressed substantial interest in the FDA-approved EAP for patients who completed the study. The Company reported significant progress in the study, however, a slower recruitment pace than estimated during the last months and a longer start-up phase for two new clinics have affected the study timeline and topline results are expected in Q3 2024.
• On February 22, equity research Company Edison Investment Research published its first, in-depth research on Cereno Scientific, with a valuation of 2.32 BSEK and a price of 9.90 SEK per share.
• February 29, Cereno shared further developments in the Phase II study of drug candidate CS1 in PAH.
• On March 4, Cereno announced that the exercise price for the warrants of series TO3 had been determined to 1.60 SEK per share of series B.
• On March 6, Cereno shared details on the study design for the EAP for its lead candidate drug, the HDACi CS1, in the rare disease PAH.
• On March 14, the Company sent out a notice to attend the Annual General Meeting, and an updated timeline bringing forward the AGM to April 16, and the Annual Report to March 26, 2024.
• On March 14, the Nomination Committee proposed Dr. Gunnar Olsson and CEO Sten R. Sörensen as new members of the Board of Directors.
• On March 14, Cereno announced that Don de Bethizy had been engaged as Senior Advisor to the Executive Management and Board of Directors of the Company.
• On March 18-20 CEO Sten R. Sörensen attended the partnering event BIO-Europe Spring.
• On March 19, the Company announced a new patent issued in Mexico for CS1.
• On March 21, Cereno announced that the TO3 warrants had been subscribed at 99.6 %, bringing in an additional 73.6 MSEK to the Company.
• On March 22, the Company announced that the drug candidate CS1's third patent family had been issued in 25 European countries following a completed validation and registration process.
• On March 26, Cereno published the Annual Report for 2023.
Significant events after the period
- On April 6-8, Sten R. Sörensen, CEO, Dr. Rahul Agrawal, CMO and Head of R&D, Dr. Björn Dahlöf, CSO and Fredrik Frick, Head of Clinical Operations, attended ACC's 73rd Annual Scientific Session & Expo (ACC.24) organized by the American College of Cardiology.
- On April 9, Cereno announced that a patent had been approved (Notice of Allowance) in Europe, in the first patent family for the preclinical Prostacyclin Receptor Agonist program, which includes drug candidate CS585.
- On April 10, the Company announced the submission of a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a First-In-Human, Phase I study of novel histone deacetylase inhibitor (HDACi) drug candidate CS014.
- On April 10-13, Dr. Rahul Agrawal, CMO and Head of R&D, and Dr. Björn Dahlöf, CSO, attended ISHLT 44th Annual meeting and Scientific sessions, organized by The International Society for Heart and Lung Transplantation, in Prague to meet global experts in the field of Pulmonary Hypertension.
- On April 11, Cereno announced that the Canadian authorities issued a patent for the drug candidate CS1:s second patent family on Tuesday April 9.
- On April 16, the Annual General Meeting for the Company was held in Gothenburg.
- On May 2, Cereno announced the new Nomination Committee ahead of the Annual General Meeting 2025.
CEO letter
The first quarter of 2024 has seen Cereno accomplish several important milestones on our mission to develop innovative, effective, and safe treatments to meet high unmet needs for patients suffering from rare and common cardiovascular diseases. CS1 was granted Expanded Access ("Compassionate Use") by the FDA, enabling patients with the rare and lethal disease Pulmonary Arterial Hypertension (PAH), who have completed our Phase II study, continued access to this potentially disease modifying drug. A successful TO3 financing brought 73.6 MSEK to the Company, further strengthening our ability to deliver on our development and commercial plans for our portfolio. Since the beginning of the year, several patents have been issued for the three drug candidates CS1, CS014 and CS585, bolstering their commercial potential. A few days after end of Q1, a Clinical Trial Application (CTA) for a first-in-human Phase I study of CS014 was sent to EMA, notably the most important milestone of the CS014 program so far. During the first months of the year, we have also substantially strengthened the Cereno team with several strategic recruitments with extensive experience in pharmaceutical development to help propel our pipeline and leverage our company's commercial position further.
CS1 in Phase II study in PAH nearing conclusion
The CS1 program, our histone deacetylase inhibitor (HDACi) with epigenetic effects being developed in the rare and lethal disease PAH, kicked off 2024 with the approval of an Expanded Access Program (EAP) by the FDA on 30 January. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. This initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 documentation for regulatory discussions and Phase IIb/III pivotal study design planning. We continue to see a high level of interest in the EAP from patients and investigators and are working with the study sites to complete central and local approvals needed to start dosing patients. We are working towards finalizing the Phase II study of CS1 in PAH and we expect to share results in Q3 of 2024.
We are also happy to have extended the patent protection for CS1 with new patents approved in Mexico, Europe and Canada. These are all important pharmaceutical markets, and these patents play a significant role in building and strengthening the commercial potential of CS1.
The latest developments on CS1 comes on the heels of positive findings reported over the last months, suggesting potential clinical benefit of CS1 in patients. A previously reported Patient Case Study showed 30% reduction in pulmonary arterial pressure and 20% increase in cardiac output after 12 weeks of treatment, with an overall functional status improvement from NYHA/WHO functional class II to I at the end of the treatment period. Furthermore, a Data Quality Control Review (DQCR) during last autumn, of data obtained by the CardioMEMS HF System from the first 16 patients, showed a clinically meaningful reduction of pulmonary arterial pressure in several patients of a similar, or greater, magnitude as in the patient case.
CS014 soon to be a clinical candidate, first-in-human Phase I study pending approval
CS014, an HDAC inhibitor with epigenetic effects, represents a novel approach to effectively prevent arterial and venous thrombosis without the associated increased risk of bleeding in humans.
In the first quarter of 2024 the first patent for CS014 was granted. The patent was issued in the UK. This is a significant milestone for our CS014 project, as it builds the foundation for strong intellectual property rights around CS014, which will favorably support the drug candidate's position in the eyes of partners and investors.
Preparations for initiating a clinical first-in-human Phase I study, to primarily evaluate the safety and tolerability of CS014 in healthy volunteers, are on track, building on the successful completion of the preclinical safety program for CS014 in December 2023. A Clinical Trial Application (CTA) was sent to EMA on April 10, 2024. Once approved, the CTA will enable us to commence the first human trial with CS014, representing a significant advancement in our endeavor to prevent thrombosis in patients without causing bleeding in the future. The Phase I study will be conducted in Sweden in partnership with the contract research organization (CRO) Clinical Trial Consultants (CTC) and is targeted to start in Q2.
CS585, a promising antithrombotic treatment strategy
Cereno continues to secure a strong patent protection for our preclinical programs to support a favorable commercial positioning in future treatments for cardiovascular diseases. Our preclinical drug candidate CS585 has during the first months of 2024 been awarded an approved patent (Notice of Allowance) in Europe, in the first patent family for the preclinical Prostacyclin Receptor Agonist program.
We are eager to build on the momentum created in the scientific community following the article and commentary in the top-tier journal Blood in late 2023, concluding that CS585 could be a significant milestone to improve anti-thrombotic treatment strategies whilst minimizing the risk of bleeding. In 2024 new data will be presented on CS585, starting with an oral presentation at the prestigious EHA conference in Madrid 15th of June. With a growing body of evidence, we are methodically laying a solid foundation for a future selection of a clinical indication for CS585.
New Cereno team working seamlessly to reach our strategic goals
Cereno has made great advances towards our vision to provide valuable, more effective, and safer drug therapies to patients in need with rare and common cardiovascular diseases, in a challenging investment and market climate. The Cereno team, with several key recruits in the past months, have synched up well and are now working seamlessly to reach our set future milestones and to further propel our pipeline and strategic positioning of the Company. Shortly after Q1, we were happy to announce a strategic change of the Board of Directors, Cereno's Scientific's Advisory Board Member Dr. Gunnar Olsson and I joined the Board. The Nomination Committee's rationale for the new board composition, later approved at the Annual General Meeting, was to ensure that the board has competencies, experience and operational capacity well aligned with the Company's current development phase and growth strategy. We simultaneously announced that Don deBethizy, PhD, with more than 30 years of experience in managing and financing life science-related technologies and having played a key role in building and advising several life sciences companies, joined Cereno as Senior Advisor to the Executive Management Team and Board of Directors.
Expanding awareness of Cereno at Medical and Investor Events
During Q1, CMO & Head of R&D Dr. Rahul Agrawal, CSO Dr. Björn Dahlöf, Dr. Raymond Benza and I represented the Company at several medical conferences, investor and industry partnering events, such as PVRI 2024 Annual Congress in London, Life Science Day in Gothenburg, and BIO-Europe Spring in Barcelona. Post Q1, I was also present at the BioEquity Conference in San Sebastian in May meeting numerous key members of the Life Science investment community. These events have given us valuable insights into the current CVD research landscape as well as the opportunity to have fruitful discussions with potential partners, investors, and study investigators.
Future outlook
The warrants of series TO3 were exercised at approximately 99.6% in late March, injecting a total of 73.6 MSEK into Cereno. This high utilization rate of the warrants demonstrates the continued strong confidence that shareholders have in Cereno, in our vision and ability to develop innovative treatments for rare and common cardiovascular diseases.
During Q1, we received an in-depth analysis by the equity research company Edison, that values Cereno Scientific at 2.32 BSEK with a price of 9.90 SEK per share, pre CS014 first-in-human initiation and pre-Phase II topline results of our leading program CS1 in PAH. This valuation highlights the potential that lies within Cereno's pioneering and innovative pipeline of cardiovascular drug candidates.
We are grateful for the strong support shown by our highly engaged shareholders. The entire Cereno team, remain dedicated to enhancing value for our shareholders by advancing our pipeline programs towards the future milestones set for each of them.
Looking ahead into the second quarter and into the summer, we have our focus set on our most important milestones so far, the launch of a first-in-human Phase I study for CS014 and advancing the Phase II study of CS1 in PAH towards completion and reporting the results.
Thank you for your support and for enabling us to break new ground in supporting patients with rare and common cardiovascular diseases.
May 2024
Sten R. Sörensen
Chief Executive Officer
Cereno Scientific
Financial calendar
Interim Report, Q2 2024..................29 August 2024
Interim Report, Q3 2024..................21 November 2024
End-Of-Year Report, Q4 2024..........25 February 2025
Interim Report, Q1 2025..................22 May 2025
For further information, please contact:
Henrik Westdahl, Director IR & Communications
Email: henrik.westdahl@cerenoscientific.com
Phone: +46 70-817 59 96
Sten R. Sörensen, CEO
Email: sten.sorensen@cerenoscientific.com
Phone: +46 73-374 03 74
About Cereno Scientific AB
Cereno Scientific develops innovative treatments for rare and common cardiovascular disease. The lead drug candidate, CS1, is a HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II study is ongoing to evaluate CS1's safety, tolerability, and efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Two initiatives performed during the ongoing Phase II study have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final study results that are expected in Q3 2024. Since January 2024, we are delighted that the FDA's Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is a HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment potentially without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-fold mechanism of action as an epigenetic modulator - regulating platelet activity, fibrinolysis, and clot stability for the prevention of thrombosis without increased risk of bleeding as documented in preclinical studies. In April 2024, Cereno submitted a Clinical Trial Application (CTA) for a Phase I First-in-Human-Study, expected to start during Q2 2024. Drug candidate CS585 is a prostacyclin receptor agonist that has been documented in several preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding, which also has been recognized in the medical community. CS585 was in-licensed from the University of Michigan in 2023. The company is headquartered in Gothenburg, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information on www.cerenoscientific.com.
[1] Benza RL, Adamson PB, Bhatt DL, Frick F, Olsson G, Bergh N, Dahlöf B. CS1, a controlled-release formulation of valproic acid, for the treatment of patients with pulmonary arterial hypertension: Rationale and design of a Phase 2 clinical trial. Pulm Circ. 2024; 14:e12323. https://doi.org/10.1002/pul2.12323
