Cereno Scientific publishes the interim report for Q3 2024 (July 1–September 30)

The Board and Chief Executive Officer of Cereno Scientific AB here present the interim report for Q3 2024 (July 1–September 30).

Summary of the interim report for Q3 2024 (July 1–September 30)

Cereno Scientific Group

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -22,718,087 (-11,076,974)
• Earnings per share was SEK -0.08 (-0.05) before dilution and SEK -0.07 (-0.05) after dilution
• The equity/assets ratio was 66.8% (95.4%)
• Cash and bank balance was SEK 73,841,665 (68,455,542)

Parent company

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -22,718,087 (-11,076,973)
• Earnings per share was SEK -0.08 (-0.05) before dilution and SEK -0.07 (-0.05) after dilution
• The equity/assets ratio was 66.8% (95.4%)
• Cash and bank balance was SEK 73,791,605 (68,381,544)

Significant events during the third quarter

• 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 IIa trial of the Company’s lead asset CS1 in the rare disease Pulmonary Arterial Hypertension (PAH) was 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 the 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.
• On August 30, the first patient was dosed in Cereno Scientific’s Expanded Access Program (EAP) with CS1 in PAH.
• August 30–September 2, Cereno Scientific participated at ESC Congress 2024, to continue building presence in the global cardiovascular community.
• On August 31, Cereno Scientific’s Director of Translational Research, Prof. Michael Holinstat, presented new preclinical data at the ESC, indicating that drug candidate CS585, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration.
• On September 3, Cereno Scientific announced that CS1 had been granted Orphan Medicinal Product Designation (OMPD) in the EU for the treatment of PAH.
• On September 5, the Company announced expanded patent protection for novel IP Receptor Agonist CS585 through issued patent in China.
• On September 18, Cereno Scientific’s nomination committee composition for the Annual General Meeting 2025 was changed, with Andreas Ejlegård as new member of the nomination committee, representing the Company’s largest group of shareholders.
• On September 25, Cereno Scientific communicated new preclinical data demonstrating dose dependent positive impact on reversal of pulmonary vascular remodeling by novel HDACi CS014.
• On September 27, Cereno Scientific shared positive topline results of Phase IIa trial with lead candidate CS1 in PAH.
• On September 30, the Company announced a collaboration agreement with Fluidda, to evaluate the impact of HDAC inhibitor CS1 on reverse remodeling of pulmonary vessels in patients with PAH.

Significant events after the period

• On October 2, Edison Investment Research increased their valuation of Cereno Scientific to 3.9 BSEK or SEK 13.9 SEK/share after positive topline data.
• On October 17, the Company announced a pivot to rare disease Idiopathic Pulmonary Fibrosis (IPF) as the initial target indication for novel HDAC inhibitor CS014, and a strengthening of the Company’s focus on rare diseases.
• On October 17, Cereno Scientific hosted a Capital Markets Day in Stockholm, presenting the Company’s strategic focus and pipeline to investors and shareholders.
• On October 25, Edison Investment Research increased their valuation of Cereno Scientific to 4.05 BSEK or SEK 14.3 SEK/share after IPF selected as initial target indication for CS014.
• On November 4-6 Cereno Scientific attended BioEurope, in Stockholm, the largest partnering event in Europe with over 5000 attendees.
• On November 11, Cereno Scientific secured minimum 250 MSEK loan financing to reach set milestones into 2026.
• On November 14 the initiation of Multiple Ascending Dose (MAD) part of Phase I trial of the novel HDAC inhibitor CS014 was announced.
• On November 16, new preclinical data for CS585 was presented at the American Heart Association (AHA) Scientific Sessions 2024, indicating that drug candidate, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration.
• On November 20, CEO Sten R. Sörensen presented the Company to investors and potential partners at BioStock Life Science Summit 2024, in Lund, Sweden.

Letter from the CEO

The third quarter of 2024 has been a defining period for Cereno Scientific, as we continue our commitment to enhancing and extending life for people with high unmet medical needs. Our dedication has translated into meaningful progress, most notably with our CS1 program, which targets Pulmonary Arterial Hypertension (PAH), a rare and debilitating disease. We reported positive results from the Phase IIa trial of CS1 demonstrating that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. This quarter, our momentum was further strengthened by the European Union granting Orphan Medicinal Product Designation (OMPD) for CS1, a significant milestone that adds further value and recognition to the CS1 PAH program. We also dosed the first patient under the FDA approved Expanded Access Program (EAP) for CS1 in PAH. Since the end of Q3, we have made significant progress with CS014, our novel histone deacetylase inhibitor (HDACi) progressing well in its clinical Phase I trial. In addition, on the heels of reporting impactful preclinical data, we selected the rare disease Idiopathic Pulmonary Fibrosis (IPF) as the initial target indication for CS014. This selection further strengthens Cereno’s focus on rare diseases. Our third development program, the preclinical program with the potent and selective IP receptor agonist CS585 is also advancing well with reported new data that the drug candidate inhibits platelet activation and clot formation up to 24 hours post-administration. In early November, we announced a new financing agreement with our long-term partner, Fenja Capital, and a new US investor, Arena Investors. This agreement secures a minimum of 250 MSEK loan financing to reach set milestones into 2026. With these recent advancements across our development programs and a strengthened financial foundation, we are well positioned to work towards key program milestones and to progress to explore optimal strategic financial and pharma partnerships for the Company.

CS1 – Positive Phase IIa trial results – preparations for Phase IIb or pivotal Phase IIb/III trial are ongoing

Cereno Scientific’s lead drug candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for PAH.

At the end of Q3, we were delighted to share the topline data from the Phase IIa trial of CS1 in PAH. Key results from the study demonstrate both that the primary endpoint was met with good safety and tolerability of CS1 in patients with PAH, and, in addition, we also showed a positive impact already after 12 weeks on clinical parameters meaningful to patients and regulatory authorities. These results, together with our foundation of preclinical data, strengthen our conviction that CS1 is a disease-modifying therapy for PAH.

In early September, we received the excellent news that CS1 had received Orphan Medicinal Product Designation (OMPD) in the EU, granting significant advantages such as a 10-year market exclusivity period post-authorization and various benefits during the development process. This milestone facilitates our efforts to bring CS1 to the patients with PAH in Europe. The EU OMPD complements the Orphan Drug Designation (ODD) granted by the US FDA in 2020, enhancing the protection and value of CS1 in these major markets. These market exclusivities, alongside our robust patent portfolio, are integral to our commercial strategy for CS1.

We are also investing further in understanding the long-term effects of CS1 use as well as gaining more insights into CS1’s disease modifying properties and impact on pathological vascular remodeling of small pulmonary arteries. We will achieve this via the EAP, where we recently dosed the first patient, and a planned Investigator Initiated Trial (IIT). The IIT will employ innovative, non-invasive technology developed by our collaborator Fluidda to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This work will give us a deeper understanding of our lead candidate CS1 and further support us in optimizing the road to approval of CS1, and subsequently into the clinic, for the benefit of patients suffering from PAH.

Further strengthening our commercial strategy, the patent protection for CS1 has been significantly expanded during Q3, with new patents issued in the US (third family), Brazil (third family) and New Zealand (second family).

We are excited to now be able to move forward with the next development phase with CS1. Preparations for a Phase IIb or pivotal Phase IIb/III trial are ongoing, with the aim to initiate a trial in 2026.

CS014 – Initial target indication IPF selected

HDACi CS014 is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with Idiopathic Pulmonary Fibrosis (IPF).

We started Q3 with announcing the final milestone payment to Emeriti Bio, from whom we acquired CS014 in March 2019, concluding all remuneration under the agreement. We are very pleased with the fruitful collaboration with Emeriti.

In late Q3, we presented new preclinical data that demonstrates dose dependent reversal of pulmonary vascular remodeling by CS014. Overall, these preclinical data provide the most compelling evidence to date that CS014 offers a disease modifying approach to PAH and related pulmonary vascular diseases by robustly reversing pulmonary pathological vascular remodeling and fibrosis. This data is significant not only for CS014, but also for the HDACi program comprising both CS1 and CS014. 

Driven by our ambition to enhance patient outcomes we, shortly after the end of Q3, announced the selection of IPF as the initial target indication for CS014. Our goal is to provide a disease-modifying treatment for patients suffering from this rare and progressive disease, which currently has no cure. The scientific rationale for evaluating CS014 in IPF is supported by several preclinical studies, which have demonstrated that HDACi can effectively reverse fibrosis in models of IPF. The rationale is further strengthened by our recently published preclinical data of CS014 mentioned above, showing that CS014 has an effect on reversal of fibrosis and a dose-dependent beneficial effect on pathological vascular remodeling. Together, these findings indicate that CS014 has the potential to address the underlying pathophysiology behind the development of IPF and can address unmet needs experienced by IPF patients.

After end of Q3, the CS014 first-in-man Phase I trial in healthy volunteers proceeded into a Multiple Ascending Dose (MAD) phase. We are excited to continue the development of CS014, towards the rare indication IPF. The trial is progressing according to plan and our aim is to conclude the Phase I trial by mid-2025, and advance CS014 into Phase II during 2026.

CS585 – a promising antithrombotic strategy

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. Cereno Scientific pursues its preclinical research for this drug candidate in collaboration with University of Michigan. During Q3, we have presented new preclinical data at the European Society of Cardiology (ESC) indicating that CS585 inhibits platelet activation and clot formation up to 24 hours post-administration. This new data adds to the growing body of evidence supporting CS585 as a viable option for targeting the IP-receptor on platelets for inhibition of thrombosis with a reduced risk of bleeding. A target indication for CS585 is currently being evaluated and rare diseases with high unmet medical needs are being considered.

During Q3, we were also delighted to have obtained further patent protection covering CS585 in China, one of the largest pharmaceutical markets, globally. Cereno has now secured immaterial rights for CS585 on three continents. This expanded IP protection complements the growing preclinical evidence supporting the potential of CS585.

After the end of Q3, additional data was presented at American Heart Association (AHA) Scientific Sessions 2024 of CS585 decreasing platelet adhesion and blood clot formation under arterial shear conditions up to 24 hours post administration.

Strengthened focus on rare diseases

With IPF now as the chosen initial target indication for CS014, we have further strengthened our focus on rare diseases, and reinforced our commitment to addressing the significant unmet needs of patients affected by these conditions. Cereno has the potential to deliver high treatment value to patients leveraging our pioneering portfolio and disease-modifying approach to address the root mechansim of rare and fatal diseases. The strategic focus on rare diseases also provides an attractive business model for biotech companies due to relatively shorter development timelines and less capital needed to reach market authorization as well as attractive incentives offered to companies developing orphan drugs. These include the possibility to obtain market exclusivity for 7 and 10 years in US and EU, respectively, through orphan drug status.

Cereno actively participating in medical and investor events, and expanding collaborations

During the eventful past months, we have been participating and presented preclinical data for CS585 at European Society of Cardiology Congress (ESC) and American Heart Association (AHA) Scientific Sessions as well as engaged in networking and discussions with investors and potential partners at BIO Europe in Stockholm and at Biostock Life Science Summit in Lund.

We have also hosted two well-attended company events; a Cereno webinar presenting the topline data (länk) and a Cereno Capital Markets Day (länk) where we shared current company strategy and upcoming milestones. We are always happy to have the opportunity to meet and engage with our shareholders and other stakeholders, and were delighted to see a good turnout at our online webinar and our Capital Markets Day, both in Stockholm and online. The video of the CMD event has this far reached over ten thousand views on YouTube.

Secured financial runway into 2026

Early November, we were pleased to share news on a new financing agreement with our long-term partner Fenja Capital, and our new US partner Arena Investors. With the new financing agreement, Cereno Scientific secures minimum 250 MSEK loan financing to reach set milestones into 2026. The Financing Agreement is divided into three components: a cash loan in two tranches totaling 175 MSEK (Tranche 2 consists of a cash loan of 50 MSEK and is conditional upon the approval by the FDA for a Phase IIb trial or a pivotal trial for Phase III of CS1 as well as certain additional financial conditions being fulfilled), the issue of convertible loans of 75 MSEK to the Financiers and the issue without consideration of warrants to the Financiers. Parts of the loan will be used to repay the outstanding loan to Fenja of approximately 91 MSEK and the total net cash proceeds from the loan (Tranche 1) and the Convertibles to Cereno Scientific will amount to approximately 99 MSEK. This strengthened capital foundation provides us with ample time to establish optimal strategic partnerships for the company and our current shareholders. For our shareholders, this development reinforces our financial stability and positions us to pursue key milestones with full momentum ahead and minimal dilution.

Future outlook

The third quarter of this year and the following post period months have indeed been pivotal for Cereno Scientific. We have reported positive topline data for our Phase IIa trial of lead program CS1 in PAH. We also have reported new key preclinical data and a selection of the target indication IPF for CS014. Further we have sealed a financing agreement extending the Company’s financial runway into 2026 providing a good foundation to reach key milestones and in parallel increase our ability to explore optimal strategic financial and pharma partnerships for the Company.

We look forward to advancing all our innovative programs towards new milestones. We will prepare for regulatory discussions regarding the next trial in the CS1 program as well as enable recruitment of additional patients into the EAP for CS1. We will continue to progress the Phase I trial of CS014 towards the readout during mid-2025. Business development activities, aiming to secure partners for our development programs, propelled by active discussions at recent conferences, will be intensified.

Cereno Scientific is a company with a vision to provide valuable new drug therapies to patients with high unmet needs. The Company has a strong and growing base of shareholders who have chosen to be part of our dedicated journey to serving patients. Your engagement and confidence in our work is invaluable. Thank you for your continued support and for joining us on our path to aid and empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full.

November 2024

Sten R. Sörensen

Chief Executive Officer

Cereno Scientific

 

Financial calendar

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

Interim Report, Q2 2025…………….……...........27 August, 2025

Interim Report, Q3 2025…………….........…27 November, 2025

End-Of-Year Report, Q4 2025………............27 February, 2026

 

For further information, please contact:

Henrik Westdahl, Director IR & Communications

Email: [email protected]

Phone: +46 70-817 59 96

 

Sten R. Sörensen, CEO

Email: [email protected]

Phone: +46 73-374 03 74

 

About Cereno Scientific AB

Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full.

Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease Idiopathic Pulmonary Fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. 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 thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension.

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 Scientific is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, [email protected]. More information is on www.cerenoscientific.com.