Executives from Contineum Therapeutics (NASDAQ:CTNM) outlined the company’s clinical priorities and upcoming catalysts during a presentation at the Leerink Global Healthcare Conference, emphasizing a shift from a discovery platform to a clinical-stage company with two lead programs and multiple trials underway.
Strategy: From platform to clinical-stage focus
CEO Carmine Stengone described Contineum as a small-molecule company focused on neuroscience, inflammation, and immunology, with a particular emphasis on pulmonary fibrosis. He said the company has transitioned over the past couple of years from a platform-based drug discovery model into an organization advancing two clinical-stage assets and “prosecuting three different clinical trials.”
PIPE-791: Differentiation vs. Bristol Myers Squibb’s LPA1 program
Much of the discussion centered on PIPE-791’s potential positioning relative to Bristol Myers Squibb’s LPA1 receptor antagonist zimilparant, which is expected to report Phase 3 data in idiopathic pulmonary fibrosis (IPF) in Q4, according to Stengone. He cited prior Bristol Myers Squibb readouts in progressive pulmonary fibrosis (PPF) and IPF across two molecules as strong validation of the target, while also arguing that Contineum may be able to address perceived limitations.
Stengone and Chief Medical Officer Tim Watkins highlighted several differentiators they are pursuing:
- Target coverage: Management said Bristol Myers Squibb’s pharmacokinetic profile does not achieve the “highest levels of target coverage,” and Contineum believes full receptor occupancy may translate into benefit on forced vital capacity (FVC). Contineum said PIPE-791 can reach around 90% receptor occupancy at doses as low as 1 mg daily.
- Dosing and convenience: Contineum emphasized PIPE-791 is a once-daily (QD) molecule, which management said could be important for a typically older IPF population.
- Hypotension signal: Executives noted Bristol Myers Squibb has discussed a hypotension signal and is using a dose titration strategy in Phase 3. Contineum said it has not observed a hypotension signal in its studies to date and does not expect titration to be required, while also acknowledging hypotension could still prove to be a class effect.
- Potential pain benefit: If PIPE-791 shows a signal in an exploratory pain study, the company believes it could potentially support quality-of-life differentiation in pulmonary fibrosis populations, including RA-associated interstitial lung disease (RA-ILD) or systemic sclerosis ILD.
Watkins added that if PIPE-791 is well tolerated, Contineum sees it as a potential “foundation” therapy that may be easier to combine with other agents than current marketed IPF drugs, noting that combinations could be important since existing therapies slow disease rather than stop it.
PIPE-791 Phase 2 IPF trial: design and execution focus
Watkins described Contineum’s ongoing Phase 2 IPF study as “phase III-like in rigor,” though not in size. The trial is designed as a 108-subject study with three arms (placebo and two dose arms of PIPE-791) over 26 weeks, and it allows background therapy. He said eligibility criteria are similar to prior IPF studies, but emphasized the company’s focus on execution—particularly investigator training, confirmation of IPF diagnosis against guideline criteria, and ensuring high-quality spirometry and FVC measurement.
Watkins said the study opened at the end of last year and has enrolled its first patients, while acknowledging the operational complexity of launching an IPF trial in an orphan population amid numerous competing studies.
PIPE-307 partnered with J&J: MOONLIGHT 1 in MDD and deal economics
On PIPE-307, Stengone said J&J is running a Phase 2 proof-of-concept study focused on major depressive disorder (MDD). He described the study as enrolling 124 patients with two dosing regimens and a primary endpoint of change in MADRS on day five, which he said aligns with rapid-acting depression agents such as Spravato and prior scopolamine clinical validation. When asked what would constitute a clinically meaningful signal, Watkins said he would rely on J&J to communicate that.
Stengone also referenced prior safety learnings, saying Contineum sought an M1 selective compound to mitigate anticholinergic-related issues and said cognition assessments in healthy volunteer studies showed no impairment across multiple domains. He added that patient exposure in prior work included once-daily dosing for six months, supporting the safety and tolerability profile.
Regarding collaboration terms, Stengone said the 2023 agreement included:
- $50 million upfront payment
- $25 million equity investment in a crossover round, with support into the IPO
- More than $1 billion in milestones across development, regulatory, and commercial events
- Royalties starting in the low teens and ramping to the high teens
- An option for Contineum to participate in co-development/co-funding (less than 50%), which could add “a point or two” to royalties and potentially bring the top royalty rate to 20%
Near-term catalysts and financial position
Management identified three primary catalysts for the year:
- Exploratory chronic pain study with PIPE-791, which executives cautioned should not be the core investment thesis but could provide upside and, importantly, additional safety/tolerability data in patients treated up to a month.
- J&J’s MDD readout from the PIPE-307 program, which Stengone suggested could come in late summer or early fall.
- Bristol Myers Squibb’s Phase 3 IPF data for zimilparant expected in Q4, which Contineum said would be an important external validation event.
On capital allocation, Stengone said Contineum is funded through the “middle of 2029” and is prioritizing the Phase 2 IPF trial. He noted J&J is funding ongoing development for PIPE-307, and said the company continues to run an internal discovery engine, while acknowledging that clinical development will take the “lion’s share” of capital going forward. On additional partnerships, he said the company speaks with strategic partners frequently but does not foresee a near-term deal, preferring to generate more data from PIPE-791 in IPF first.
About Contineum Therapeutics (NASDAQ:CTNM)
Contineum Therapeutics, Inc, a clinical stage biopharmaceutical company, focuses on discovering and developing novel oral small molecule therapies for neuroscience, inflammation, and immunology indications with high unmet need. Its lead asset is PIPE-791, a novel, brain penetrant, small molecule inhibitor of the lysophosphatidic acid 1 receptor (LPA1R) for the treatment of idiopathic pulmonary fibrosis and progressive multiple sclerosis (MS). The company also develops PIPE-307, a novel, small molecule selective inhibitor of the muscarinic type 1 M1 receptor to treat depression and relapse remitting MS; and CTX-343, a peripherally-restricted LPA1R antagonist.
