Milestone marks MIRA’s transition from pre-clinical to clinical stage company. Downgrade from BUY to HOLD based on delays in MIRA’s clinical development timeline and a more challenging competitive landscape.
On March 4, 2025, MIRA Pharmaceuticals announced the upcoming initiation of its first Phase 1 clinical trial testing Ketamir-2, its oral ketamine analog, for the treatment of neuropathic pain. The study will be conducted at Hadassah Medical Center in Jerusalem, Israel, with subject recruitment scheduled to commence this month.
The study, designed to evaluate the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adults, will proceed in two parts: a single ascending dose portion enrolling 32 healthy volunteers and a multiple ascending dose portion enrolling an additional 24 participants. Areas of assessment will include severity of adverse and serious adverse events, ketamine-related behavioral side effects, as well as Ketamir-2’s pharmacological profile.
Mira expects to complete the Phase 1 study by Q4 2025, giving investors an initial indication whether the safety, tolerability, pharmacokinetics, and pharmacodynamics signals observed in animals may translate to humans. The company expects to initiate a follow-on Phase 2a study by year-end 2025.
Beyond the neuropathic pain indication, MIRA is targeting post-traumatic stress disorder (PTSD) as a potential additional indication for Ketamir-2. The company is also exploring a topical formulation of Ketamir-2 for localized pain relief.
We believe that while the advancement of MIRA’s lead product candidate into the clinic represents an important milestone for the company, its competitive landscape has become more challenging with the January 2025 FDA approval and market entry of Vertex Pharmaceutical’s JOURNAVX (suzetrigine), a first in-class, non-opioid, oral therapy to treat moderate to severe acute pain in adults.
Vertex’s pivotal program assessing suzetrigine in painful diabetic peripheral neuropathy, a type of peripheral neuropathic pain, is ongoing. In Phase 2 development, suzetrigine demonstrated significant pain reduction in various neuropathic pain populations, and Vertex is said to be aiming for a broad label covering a wide range of neuropathic pain conditions when the company applies for FDA approval. We anticipate that even prior to FDA evaluation and potential approval of suzetrigine for chronic pain indications, we can expect off-label use of the new therapy outside of acute pain.
Other companies with non-opioid pain drugs in mid-to-late-stage development include Tris Pharma, Algiax Pharmaceuticals, Levicept, and Latigo Biotherapeutics, among others. In this dynamic environment, MIRA is lagging behind a number of larger players with deeper pockets and is highly unlikely to be able to capitalize on a first-mover advantage in bringing its product candidates to market or to a stage of development that would support a lucrative asset sale.
We also note that MIRA has continued to stretch previously announced development timelines for both of its current product candidates, pointing to greater than anticipated challenges or unrealistic expectations regarding developmental execution. As a result, we believe that the expectation of an asset sale in 2026, post Phase 2 proof-of-concept, which formed the basis of our initial valuation model, is no longer realistic.
Finally, with MIRA’s stock price having dropped below $1.00 per share, the risk of delisting from the Nasdaq once again rears its ugly head and warrants investor concern.