The Board and Chief Executive Officer of Cereno Scientific AB here present the interim report for Q2 2024 (April 1-June 30).
Summary of the interim report for Q2 2024 (April 1-June 30)
Cereno Scientific Group
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -21,234,039 (-10,686,053)
- Earnings per share was SEK -0.08 (-0.05) before dilution and SEK -0.01 (-0.04) after dilution
- The equity/assets ratio was 76.2% (95.4%)
- Cash and bank balance was SEK 85,596,493 (85,291,722)
Parent company
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -21,229,026 (-10,679,871)
- Earnings per share was SEK -0.08 (-0.05) before dilution and SEK -0.91 (-0.04) after dilution
- The equity/assets ratio was 76.2% (95.4%)
- Cash and bank balance was SEK 85,472,485 (85,219,725)
Significant events during the first quarter
- 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) in Atlanta, 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 trial 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.
- 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.
- On May 23, Cereno published the Interim Report for Q1 2024.
- On May 23, Sten R. Sörensen, CEO, presented the Company at ABGSC Investor Days in Stockholm.
• On June 3, Cereno Scientific announced that the Company will join the PVRI Roundtable (Pulmonary and Vascular Research Institute).
• On June 3-6, Sten R. Sörensen, CEO attended BIO 2024 in San Diego and engaged in partnering activities.
• On June 10, Cereno announced the move to a new office space at GoCo Health Innovation City in Gothenburg during June 2024.
• On June 15, preclinical data for drug candidate CS585, showing high selectivity for the IP receptor, was presented by Dr. Michael Holinstat, Director of Translational Research, at the EHA 2024 Hybrid Congress, in Madrid.
• On June 18, Cereno Scientific announced a granted approval from the European Medicines Agency (EMA) to initiate the first-in-human Phase I trial with novel HDAC inhibitor CS014.
- On June 28, Cereno Scientific announced that the Company had decided to close patient recruitment to the Phase II trial of CS1 in Pulmonary Arterial Hypertension (PAH) per July 1, as the Study Clinical Steering Committee concluded that there was sufficient data for evaluating the next steps in development.
• On June 28, the Company announced the first subject dosed in the first-in-human Phase I trial of novel HDAC inhibitor CS014.
Significant events after the period
- On July 2, Cereno Scientific's Board of Directors and Executive Management entered into a voluntary lock-up agreement for their shares and/or other securities in the Company until topline results for the Phase II trial of the Company's lead asset CS1 in the rare disease Pulmonary Arterial Hypertension (PAH) is presented in Q3, 2024.
- On July 5, the Company announced a final milestone payment to Emeriti Bio for CS014, which Cereno acquired from Emeriti in 2019.
- On July 9, Cereno Scientific announced expanded patent protection for CS1's second and third patent families in New Zealand and the US, respectively.
- On July 10, Cereno Scientific reported acquired warrants by members of the Company's management within the framework of the incentive program resolved at the Annual General Meeting.
- On July 10, the Company announced an extended loan maturity date for a loan of up to 90 MSEK issued by Fenja Capital II A/S (formerly Formue Nord Fokus A/S), from May 14, 2025, until March 31, 2026.
- On August 16, Cereno Scientific reported expanded patent protection for CS1's third patent family in Brazil.
Letter from the CEO
Cereno is on a quest to develop innovative, effective, and safe treatments for patients affected by rare and common cardiovascular diseases and we are currently pursuing this vision with a portfolio of three innovative drug candidates. I am pleased to report that we during the second quarter of 2024 solidified our position as a groundbreaking and innovative biotech company, now with two drug candidates advancing in clinical development. Our novel histone deacetylase (HDAC) inhibitor CS014 has entered Phase I development in Thrombosis prevention, and the first subjects have already been successfully dosed. We are also approaching a significant milestone with our HDAC inhibitor CS1. The Phase II trial of CS1 for the treatment of the rare disease Pulmonary Arterial Hypertension (PAH) was closed for patient recruitment in July based on a recommendation from the Study Clinical Steering Committee, which concluded that sufficient data had been collected for evaluating the next steps in development. We anticipate sharing topline results in Q3, 2024.
CS1 - Phase II trial in PAH is proceeding to topline
PAH is a rare disease and a specific form of high blood pressure in the pulmonary circulation. PAH is a progressive disease that ultimately leads to heart failure and poor lung function. Patients with PAH have a severe prognosis, with inadequate treatment options, and more than 50 percent of patients die within 5 years with a reduced quality of life throughout the course of the disease. There is a very high unmet need for more effective, safe and disease modifying new therapies. Cereno is on a mission to untap the potential of epigenetic modulation through HDAC inhibition to improve quality of life and prolong life for these patients. Indeed, Cereno's lead drug candidate CS1, is an HDACi with epigenetic effects and is being developed as a treatment for PAH with the aim of offering patients an effective, safe and disease-modifying drug.
The Phase II trial of CS1 for the treatment of the rare disease PAH was closed for patient recruitment in July based on a recommendation from the Study Clinical Steering Committee, which concluded that sufficient data had been collected for evaluating the next steps in development. We anticipate sharing topline results in Q3, 2024.
Earlier this year we were very pleased to obtain approval for Expanded Access to CS1 from the FDA. The request for Expanded Access was submitted after Cereno was urged to do so by an investigator in the Phase II trial, seeking permission to continue to administer the investigational drug, CS1, to patients post the conclusion of the study treatment. The Expanded Access Program (EAP) enables long-term access to CS1 for patients who have completed the Phase II trial of CS1 in PAH. During the second quarter we have progressed numerous regulatory, contractual and logistical matters related to the EAP. Site-specific contracts and IRB approvals are being finalized and we are positive that we will have the first patient dosed shortly.
The development program for CS1 in PAH is further supported by the Orphan Drug Designation (ODD) granted by the US FDA in March 2020. To further strengthen the orphan drug status for CS1, we are now pursuing Orphan Medicinal Product Designation (OMPD) in the EU and we are expecting an approval during the fall.
Further strengthening our commercial strategy, the patent protection for CS1 has been significantly expanded during Q2, with new patents issued in Canada and New Zealand (second family), as well as in the US (third family).
Novel HDACi CS014 has entered clinical Phase I
CS014 is a new chemical entity and represents a novel approach to antithrombotic treatment without an increased risk of bleeding as documented in preclinical trials.
At the end of June, Cereno Scientific received approval by EMA to initiate a first-in-human Phase I trial of novel HDACi CS014 in healthy volunteers, after dedicated hard work from our team to evaluate and document the preclinical safety and efficacy. Only a few days later, the first subject was dosed, and we are excited that the Phase I trial is now in an active phase. This is a significant milestone for the CS014 program, as well as for Cereno Scientific as a whole, as we now have two of our three drug candidates in clinical phase. This marks the beginning of the next phase in the Company's growth journey, as we now will be advancing two clinical-stage candidates for patients with rare and common cardiovascular diseases
Just after the end of the second quarter, we also announced that the final milestone payment for CS014 was paid to Emeriti Bio, from which the drug candidate was acquired in 2019. The payment of the last milestone was triggered by the PCT patent application for CS014 recently having entered into national phase in more than 20 countries globally. The agreement with Emeriti Bio signed in 2019 transferred all rights for CS014, and the related compound family, from Emeriti Bio to Cereno. This final milestone payment concludes all remuneration under the agreement.
CS585, a promising antithrombotic treatment strategy
During the second quarter of 2024, Cereno secured further patent protection for the drug candidate CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. The new patent expands the patent protection for the Prostacyclin Receptor Agonist program to also include Europe, one of the largest CVD markets, supporting a favorable commercial positioning in future treatments for cardiovascular disease.
During June, Dr. Michael Holinstat presented our new preclinical data for CS585 at the EHA (European Hematology Association) 2024 Hybrid Congress in Madrid, supporting the high selectivity of CS585. We are also very pleased that an abstract on CS585 has been accepted for presentation at the ESC (European Society of Cardiology) Congress in London on August 31. The ESC Congress 2024 is where the world's leading cardiology experts convene to transform patient care and advance the field through ground-breaking research, pioneering technologies, and collaborative initiatives. The congress serves as a catalyst for shaping the future of cardiovascular medicine on a global scale. We are delighted that CS585 is continuing to demonstrate the potential to ameliorate disease mechanisms relevant to cardiovascular diseases, in this case the highly prevalent condition thrombosis, and we look forward to continuing our work to progress CS585 into the clinic and to patients.
Cereno actively participating in medical and investor events, and pursuing external collaborations
Cereno has been active at several medical and investor events during the second quarter. We started the quarter by attending ACC.24 in Atlanta, hosted by the American College of Cardiology, raising awareness about our portfolio of innovative drug candidates, learning about the most recent advances and expanding our network among academic and industry actors. We also took the opportunity while in Atlanta, to meet with members of our Scientific Advisory Board as well as members of the Clinical Steering Committee for our Phase II trial of CS1. A few days later, Dr. Rahul Agrawal, CMO and Head of R&D, and Dr. Björn Dahlöf, CSO, attended The ISHLT 44th Annual meeting and Scientific sessions, organized by The International Society for Heart and Lung Transplantation, in Prague. At ISHLT, we learned more about the advances in the care of patients with advanced heart or lung disease, extended the Company's network within academia and industry and met with investigators to discuss the finalization of the Phase II study of CS1 in PAH and the Expanded Access Program for CS1. In May, I represented Cereno at BioEquity in San Sebastian, networking with fellow biotech leaders and investors looking to drive a paradigm shift in the treatment of rare and common CVD. I presented the Company's pipeline at ABGSC Investor Days in Stockholm in May and met with engaged shareholders and potential investors. I also participated at BIO International in San Diego in June, where I had many discussions with potential partners. In mid-June, Dr. Michael Holinstat attended EHA 2024 Hybrid Congress in Madrid, where he presented preclinical data for CS585.
In June, Cereno Scientific joined the PVRI Roundtable (Pulmonary and Vascular Research Institute), by exclusive invitation from the organization. We look forward to participating in PVRI's Innovative Drug Development Initiative (IDDI), addressing the most challenging issues faced by pharma, researchers, regulators, and clinicians and join a task force to stimulate awareness of new research in Pulmonary Hypertension.
During the period Cereno also initiated a collaboration with Rx Securities, to raise further awareness on the Company's portfolio of innovative drug candidates among institutional investors. This collaboration extends the analytical coverage in addition to the earlier initiated collaboration for analytical coverage by Edison.
Future outlook
The second quarter of 2024 has been transformational for Cereno, with CS014 entering into clinical development and the closing of patient recruitment to the Phase II trial of CS1 in PAH, now proceeding to topline results. We expect the coming months to be just as defining.
Looking ahead into the third quarter, we look forward to report topline results of the Phase II trial of CS1 in the rare disease PAH, report on the progress of the EAP for CS1, pursuing the progress of the Phase I trial of CS014, continue engaging in high-level partnering activities and continue positioning Cereno Scientific to optimize the advancement of our pipeline within rare and common cardiovascular diseases.
To strengthen our financial position going into Q3 we, shortly after end of Q2, announced that we drew down the second payment of 45 MSEK of the loan issued by Fenja Capital II A/S (Formerly Formue Nord Fokus A/S) and simultaneously extended the maturity date of the loan of 90 MSEK from May 2025 to March 2026.
As this Q2 report reaches you, our team is preparing for optimal business impact at the ESC Congress 2024 in London, where I, together with our CMO and Head of R&D Dr. Rahul Agrawal and CSO Dr. Björn Dahlöf, will be meeting with leaders within the global cardiovascular community to continue raising awareness about our portfolio of innovative drug candidates, learn about the most recent advances in the cardiovascular field and expand our network among academic and industry actors. With important milestones having been reached and others soon to be reported, the interest in Cereno Scientific and our pipeline has increased considerably lately. We are eager to discuss our progress and future plans with current and potential future collaborators.
We continue to see a high level of engagement from interested and knowledgeable shareholders, which we very much appreciate. At Cereno we take great pride in our work, which we pursue through passion for our vision, high level competence and relentless grit. I am proud to say that our entire Cereno Team is fully dedicated to return your support by advancing our pipeline programs towards the milestones set for each of them.
Thank you for your continued support in our efforts to bring life-changing treatments to patients with great unmet need.
August 2024
Sten R. Sörensen
Chief Executive Officer
Cereno Scientific
Financial calendar
Interim Report, Q3 2024........................ 21 November 2024
End-Of-Year Report, Q4 2024................ 25 February 2025
Annual Report 2024………………………………Week 20, 2025
Interim Report, Q1 2025………………….……22 May 2025
Annual General Meeting ……….……………..17 June, 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 an 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 trial is ongoing (patient recruitment closed on July 1st, 2024) 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 trial. Two initiatives performed during the Phase II trial 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 trial 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's pipeline comprises two additional programs in development through research collaborations with the University of Michigan. Investigational drug CS014 is an HDAC inhibitor in Phase I development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment. 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 an increased risk of bleeding as documented in preclinical trials. On 28th of June, 2024, Cereno initiated a first-in-human Phase I trial of CS014. Preclinical candidate CS585 is an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Pulmonary Hypertension and thrombosis prevention without increased risk of bleeding. CS585 was in-licensed from the University of Michigan in 2023. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. Based in Kendall Square, Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). The Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information is on www.cerenoscientific.com.
