Cereno Scientific releases Biostock interview with CEO Sten R. Sörensen on Expanded Access being approved by the FDA

Cereno Scientific (Nasdaq First North: CRNO B) today announced that a video interview by Biostock has been released with CEO Sten R. Sörensen, commenting on the approval by the FDA of an Expanded Access Program, sometimes called “Compassionate Use”, to Cereno’s investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in the rare disease pulmonary arterial hypertension (PAH).

Watch here: Cereno Scientific's PAH drug candidate granted "Compassionate Use" (youtube.com)

“This is an important milestone on our path toward making a difference for patients with the deadly rare disease PAH. I am very pleased that we now have received FDA’s approval for the Expanded Access Program (EAP) to CS1 and delighted for the patients who will now be able to continue receiving CS1 as drug therapy providing potential clinical benefits. As reported recently, we have secured the long-term supply of CS1 by entering a scale-up manufacturing agreement with CordenPharma that will ensure that patients in the EAP have access to CS1 and that we have CS1 for the next clinical study,” said Sten R. Sörensen, CEO, Cereno Scientific.

The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the phase II study. In July, an investigator highlighted a notable case of patient improvement with CS1. Subsequently, positive outcomes were observed during a midway study readout in October. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment. Cereno promptly submitted the request on January 3rd, and it has now been successfully granted by the FDA.

The video is available on Cereno’s website, LinkedIn, YouTube, and on BioStock.

For further information, please contact:

Henrik Westdahl, Director IR & Communications

Email: henrik.westdahl@cerenoscientific.com

Phone: +46 708 17 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 common and rare 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 Q2 2024. Since January 2024, CS1 has been available under FDA’s Expanded Access Program (“compassionate use”) for continued CS1 treatment in patients who have completed the Phase II study. 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. 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). More information on www.cerenoscientific.com.