Based in Sweden, Cereno Scientific is focused on the development of innovative, effective and safe treatments for people with rare cardiovascular and pulmonary diseases. Lead asset CS1, an HDAC inhibitor that acts as an epigenetic modulator, is currently being investigated in a Phase II clinical trial for the treatment of PAH.
EDISON VIEW
Cereno’s Q226 results recapped an active period, with subsequent developments marking a tangible shift towards advanced clinical development. The post-period highlight was the August activation of the first site in the Phase IIb EPIMODE study of CS1, enabling patient screening and recruitment to commence. The focus is now on first-patient randomisation, site activation and recruitment progress. Encouragingly, management continues to guide to Q428 for the top-line data, despite the slight shift from the initial June target for study commencement. CS014 provides a near-term catalyst, with top-line data expected within September following completion of the PK bridging study. Supportive results could enable a direct move into Phase IIb in PH-ILD, now targeted for Q327 (from Q127). The SEK60m directed issue supports headroom into late Q426, although further funding and/or partnering will be required. We keep CS1’s PoS unchanged, with our valuation at SEK7.0bn or SEK21.5/share.
Cereno Scientific is a clinical-stage biotech developing treatments for rare cardiovascular and pulmonary diseases; it has no revenue, so it does not make money yet, and partnering is a major value driver. Its two clinical-stage assets, CS1 and CS014, are histone deacetylase (HDAC) inhibitors that use epigenetic modulation to target the underlying disease biology. CS1 is in development for pulmonary arterial hypertension (PAH) and CS014 for pulmonary hypertension associated with interstitial lung disease (PH-ILD). CS1 has moved into mid-stage development in the global Phase IIb EPIMODE study, and a third asset, CS585, remains preclinical. As a clinical-stage company, Cereno is funded by external capital. Management has been actively engaging with potential partners, while our assumptions build in a post Phase IIb licensing agreement for CS1 in 2029.
Cereno Scientific is valued at SEK7.0bn, or SEK21.5 per share, on our risk-adjusted net present value (rNPV) model of its two clinical-stage programmes, CS1 and CS014. The model uses phase-appropriate probabilities of success and a flat 12.5% discount rate; the preclinical CS585 is excluded. Following Q226, the valuation rose modestly from SEK6.8bn, while the per-share value declined from SEK21.7 because of dilution from the SEK60m raise. At our September 2026 update, we kept a 50% probability of success for CS1 and 15% for CS014. The model assumes a $2bn global licensing deal for CS1 after Phase IIb in 2029, including a $150m upfront payment and a flat 15% royalty rate, and successful EPIMODE execution remains central to realising those partnering economics. An earlier global, regional or local transaction would warrant a revision of our forecasts.
CS1 is the main driver of the Cereno Scientific investment case. At our September 2026 update, we retained a 50% probability of success for CS1 in pulmonary arterial hypertension (PAH), with peak sales potential of $2.8bn; for CS014 in PH-ILD, we maintained c $2.4bn peak sales potential, and we regard our 15% probability of success as relatively conservative. The main risks are the usual clinical, regulatory and financing risks of a biopharma company. We view the EPIMODE Phase IIb study as the first larger, randomised, placebo-controlled test of the preliminary efficacy signals seen in the CS1 Phase IIa study, and recruitment execution remains the primary near-term variable. Strong uptake of Merck's Winrevair (sotatercept) in PAH is validating the commercial opportunity and demand for therapies targeting the underlying disease biology, although we believe these developments raise the efficacy bar for CS1. Financing remains a key consideration, with current funding headroom into late Q426.
The next catalysts for Cereno Scientific centre on recruitment into the EPIMODE Phase IIb study of CS1, where we maintain our expectation of top-line data in Q428. Initial patient randomisation slipped slightly beyond the targeted mid-September start, which we view as manageable given a requirement of c 126 patients across c 68 sites, fewer than two per site on average. For CS014, the full IND package is due to be submitted to the FDA in Q426. We see FDA acceptance as the key near-term de-risking event, because it determines whether CS014 can move directly into Phase IIb, targeted for Q327, without a Phase IIa study. Management has not ruled out a partnering transaction during 2026, although we remain cautious about assigning value to partnering interest ahead of a transaction.
CS1 is the lead asset of Cereno Scientific: an oral, once-daily HDAC inhibitor that acts through epigenetic modulation on disease-driving pathways implicated in vascular remodelling, fibrosis and inflammation in pulmonary arterial hypertension (PAH). It is a patent-protected delayed immediate release formulation of valproic acid. The EPIMODE Phase IIb study plans to enrol c 126 patients across c 68 sites in 12 countries. Patients are randomised 1:1:1 to CS1 320mg once daily, CS1 640mg once daily or placebo for 36 weeks, then re-randomised again for a 16-week extension. The primary endpoint is the change in pulmonary vascular resistance (PVR) after 36 weeks. We believe the 36-week primary assessment, longer than the 24-week timeframe of several other PAH trials, gives structural or remodelling effects more opportunity to emerge, which is particularly relevant to CS1's proposed disease-modifying profile.
As a clinical-stage company, Cereno Scientific is funded by external capital, and we estimate its current funds provide headroom to late Q426, with another c SEK50m needed before year-end. Cereno ended Q226 with gross cash of SEK39.0m and SEK175.0m of outstanding convertible debt; a SEK60m directed issue at SEK5.10 per share at the end of July took pro-forma cash to c SEK99m before issue costs. Drawdown of the SEK175m loan facility agreed with Fenja Capital in November 2025 depends, among other requirements, on conversion and divestment of the outstanding convertibles. The SEK10 per share conversion price was materially above the share price at the time of our Q226 update, so we do not treat the facility as fully secured. We estimate Cereno could need more funding during FY27, and a partnering or licensing deal could substantially reduce the external funding requirement.
In Q226, Cereno Scientific's reported operating loss was relatively contained at SEK19.0m, versus SEK21.9m in Q126, given the higher level of capitalised development spending. External costs rose to SEK63.3m from SEK53.7m in Q126 as preparatory activity for the Phase IIb EPIMODE study stepped up, and capitalised development expenditure rose to SEK52.4m. The net loss increased to SEK30.5m from SEK28.6m, reflecting higher interest expense of SEK11.5m. Free cash outflow remained meaningful at c SEK31.5m, albeit improving from SEK58.7m in Q126. We caution against reading the SEK20.9m operating cash inflow as better underlying cash generation, as it relied on a rise in operating liabilities. We now forecast operating losses of SEK84.6m in FY26 and SEK86.5m in FY27, after raising our R&D expenditure estimates to SEK170m and SEK227.5m respectively.
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Eva Jagenheim
CFO
Jeppe Øvlesen
Chairman
Sten Sörensen
CEO