Investors

Cereno Scientific — CS1 takes another step towards Phase IIb

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Cereno Scientific — CS014 completes Phase I, path clears for Phase II

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Cereno Scientific — Poised for active year in CVD and rare diseases

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Cereno Scientific — CS014 achieves another Phase I milestone

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Cereno Scientific – executive interview

Cereno Scientific (OMX: CRNO-B) is a clinical-stage biotech focused on developing innovative, effective and safe treatments for cardiovascular diseases (CVD) and pulmonary diseases. The company has an exciting pipeline targeting unmet needs in CVD, with two clinical programmes and one preclinical programme. Lead candidate CS1 is a histone deacetylase inhibitor (HDACi) with epigenetic modulation properties, showing promise as a potentially disease-modifying treatment for pulmonary arterial hypertension (PAH), a rare, debilitating and progressive condition with no curative therapies. The Phase IIa data for CS1 in PAH were positive, and management is gearing up for discussions with regulators on a potential Phase IIb or pivotal Phase IIb/III study. The potential of Cereno’s HDACi programme to reverse disease progression in PAH was also highlighted in preclinical data reported for CS014, the company’s other HDACi programme. Second asset CS014 is currently in Phase I and Cereno recently announced that idiopathic pulmonary fibrosis will be the target indication for the candidate as part of a strategic pivot to strengthen the company’s focus on rare diseases. The third, preclinical, asset CS585 is a novel prostacyclin receptor agonist and is currently under evaluation for CVD, backed by encouraging preclinical data. Management hopes to start Phase I studies for CS585 in 2026, likely targeting a rare disease.

In this video, we talk to Sten Sörensen, CEO of Cereno Scientific, about the company’s strategic pivot to focus on rare diseases, how the recent SEK250m fundraise will be used to advance Cereno’s pipeline activities, as well as key milestones and catalysts that investors should watch out for as we move into 2025.

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Cereno Scientific — A productive period with plenty more to come

Update

Cereno Scientific has released its Q324 results, marking a productive and strategically significant period. Following the positive top-line data from the Phase IIa safety study of CS1 in pulmonary arterial hypertension (PAH), Cereno decided to concentrate its development programmes on rare diseases. Key developments included the selection of idiopathic pulmonary fibrosis (IPF) as the target indication for second asset, CS014, and the positioning of its preclinical asset, CS585, towards rare disease indications. In November 2024, Cereno announced a SEK250m capital raise, extending its cash runway into 2026. This funding secures financial resources to advance several key milestones, including FDA acceptance of the CS1 Phase IIb/III study and completion of the Phase I trial for CS014. We believe these developments de-risk Cereno’s clinical pathway and strengthen its position for potential partnering opportunities. We adjust our estimates for the Q3 results, with the increased debt servicing costs and higher net debt offsetting roll-forward benefits, resulting in our valuation remaining unchanged at SEK4.0bn or SEK14.3/share.

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Cereno Scientific — New SEK250m financing secures runway into 2026

Flash note

Cereno Scientific has announced a new financing arrangement of at least SEK250m, with net proceeds expected to extend the runway into 2026, past several key clinical milestones. Secured from Fenja Capital and Arena Investors, the new financing includes a cash loan of SEK175m across two tranches and SEK75m in convertible debt. While the first cash tranche of SEK125m will be paid out on signing, the second SEK50m payout is conditional on lead asset CS1 receiving FDA approval for the next clinical phase. Tranche 1 will be partially used to repay the outstanding c SEK91m loan from Fenja Capital, raised in November 2023, and comes with a 3.87% set-up fee. Following the debt repayment and set-up fee, management expects net proceeds from Tranche 1 and the convertible debt of c SEK99m. The financing agreement will extend the cash runway into 2026, past key milestones such as FDA approval of the next CS1 study and completion of the Phase I trial and Phase II regulatory approval for CS014. We will present our updated estimates following the Q324 results.

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Cereno Scientific — CMD highlights a ‘rare’ portfolio refocus

Update

Cereno Scientific recently held a capital markets day (CMD), providing greater insight on its development pipeline and strategic objectives. The key takeaway was its decision to focus on the rare disease space across its three programmes, a move we believe was strategically driven to maximise potential clinical and commercial success, and to appeal to future partners. While lead asset CS1 is targeting pulmonary arterial hypertension (PAH), supported by Fluidda and CardioMEMS (pivotal studies expected in 2026), CS014, the second HDAC inhibitor in Cereno’s portfolio, will now be evaluated in idiopathic pulmonary fibrosis (IPF), another rare indication with a three- to five-year average survival and no curative treatments. Management also highlighted the potential for CS585, its preclinical-stage asset in rare indications such as antiphospholipid syndrome (APS), an autoimmune disorder. We update our estimates to reflect the new target indication for CS014 and increase our valuation to SEK14.3/share, from SEK13.9/share previously.

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Cereno Scientific – executive interview

Cereno Scientific (OMX: CRNO-B) is a clinical-stage biotech focused on developing treatments for cardiovascular diseases (CVD) using novel approaches. The company has an exciting pipeline of differentiated assets targeting unmet needs in CVD, with two clinical programmes and one preclinical programme. Lead candidate CS1 has an interesting mechanism of action (a histone deacetylase inhibitor (HDACi) showing epigenetic modulation properties) and promises disease-modifying properties in pulmonary arterial hypertension (PAH), a rare, debilitating and progressive condition with no curative therapies. The company recently presented positive Phase IIa data for CS1 and is gearing up for discussions with regulators on a potential Phase IIB/III pivotal study. The potential of Cereno’s HDACi programme to reverse disease progression in PAH was also highlighted in the preclinical data reported recently for CS014, the company’s other HDACi programme, which entered the clinic in June 2024 and is in a Phase I trial for thrombosis prevention (the leading cause of morbidity in CVD), but without the increased risk of bleeding associated with currently available antithrombotics. The preclinical asset CS585, a novel prostacyclin (IP) receptor agonist, is currently under evaluation for different CVD indications, backed by encouraging preclinical data.

In this video, we talk to Sten Sörensen, CEO of Cereno Scientific, about the exciting clinical data for CS1 and what the results mean for the company’s near-term development plans. We also discuss Cereno’s other pipeline assets as well as key upcoming catalysts.

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Cereno Scientific — CS1 shines in Phase IIa PAH trial

Update

Cereno Scientific has reported positive top-line results for the Phase IIa CS1-003 trial, which evaluated the HDAC inhibitor CS1 in pulmonary arterial hypertension (PAH). The primary endpoint of safety and tolerability was met and, importantly, CS1 delivered encouraging results on exploratory efficacy measures, creating a strong foundation for the next steps of clinical development, in our view. The recently signed agreement with medical technology company Fluidda to visualise the impact of CS1 on the reverse remodelling of pulmonary vessels is another positive step and could bolster the data package for the candidate. With the recent preclinical data on CS014, Cereno now has two HDAC inhibitors in its portfolio with disease-modifying potential and we expect this to influence discussions with regulators, as well as potential partners. As management is planning a potentially pivotal Phase IIb/III trial, we raise our probability of success for CS1 to 40% (from 25%), resulting in our valuation for Cereno upgrading to SEK13.9/share from SEK9.1/share.

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