FY 2024 earnings in line with our projections; binding letter of intent signed to acquire SKNY Pharmaceuticals in all-stock transaction; press release light on detail.

MIRA Pharmaceuticals reported financial results for the year ended December 31, 2024. Revenue was $0, on par with our estimate. FY 2024 GAAP EPS of $(0.51) was slightly better than our $(0.52) estimate, mainly due to lower than expected R&D costs during Q4 2024. Common shares outstanding increased from 14.78 million at the end of FY 2023 to 16.56 million onDecember 31, 2024, representing 12.04% dilution.

In our view, for a company of MIRA’s size with two part-time employees–MIRA’s CEO and CFO divide their time between MIRA and Telomir Pharmaceuticals–and one key consultant, FY2024 G&A expenses of over $1 million per quarter are high. Included in the G&A expense category are employee-related expenses, including salaries, benefits, and travel, other administrative functions, as well as fees paid for legal, accounting, and tax services, consulting fees, and facilities costs not included in R&D expense.

MIRA’s cash position declined from $4.60 million at the end of FY 2023 to $2.83 million on December 31, 2024, causing the company’s current ratio to drop from 8.7x to 4.0x. Management stated that existing cash resources are expected to support operations into Q3 2025. In light of MIRA’s FY 2024 net loss of$7.85 million, net cash used in operations of $5.56 million, and advancement of lead asset Ketamir-2 into Phase 1 clinical development during Q1 2025, there is an urgent need to raise additional funds in the near future.

On March 24, 2025, MIRA announced that it had signed a binding letter of intent to acquire SKNY Pharmaceuticals, Inc., a privately-held Delaware corporation, in an all-stock transaction. The announcement said that the SKNY acquisition would provide MIRA with $5 million in cash or cash equivalents, while adding a preclinical-stage oral drug candidate targeting weight loss and smoking cessation to MIRA’s development pipeline.

A $5 million cash infusion would provide MIRA with runway into 2026. However, according to MIRA’s 2024 Form 10K, filed with the SEC on April 28, 2025, the completion of the transaction is contingent upon an independent valuator determining that SKNY’s valuation is at least equal to or greater than that of MIRA. Consequently, the contemplated transaction would result in 100% or greater dilution of MIRA’s existing shareholders via the issuance of shares from the company’s treasury. Closing of the transaction is not assured at present, as the parties must complete a 90-day mutual due diligence period, negotiate deal terms, and obtain the necessary regulatory and board approvals.

Markets responded negatively to the announcement, with the stock losing 30% in value, dropping from a closing price of $1.28 on March 21 (the last trading day before the announcement) to $0.90 on April 3.

We note the numerous uncertainties associated with the proposed transaction given the black boxnature of the target: SKNY has no publicly available business description, website, financial information, or information regarding owners, principals, or management. In addition, purchase price and share exchange ratio have yet to be determined.

MIRA management declined to answer questions raised by its press release announcing the proposed SKNY transaction, referring us to a Form S-4 the company will be filing at an unspecified future date. Our questions sought additional detail on the molecular structure of the SKNY asset, intellectual property protecting it, preclinical data and/or IND-enabling studies that would allow for verification of the asset, and clarification on interrelationships between members of MIRA’s board, executive leadership or major shareholders with the principals or owners of SKNY, among others. While some of these questions were answered in MIRA’s 2024 Form 10K–SKNY, the proposed acquisition target, and MIRA’s largest shareholder, are related parties–other questions remained unaddressed.

SKNY licenses its weight loss and smoking cessation asset from Miralogx, an intellectual property development company owned by the Bay Shore Trust. The Bay Shore Trust is MIRA’s largest shareholder. Miralogx also licenses development and commercialization rights to Ketamir-2 to MIRA. MIRA and Miralogx have the same founder, who is also MIRA’s largest shareholder, and thus Miralogx is considered a related party to both MIRA and SKNY. MIRA’s founding stockholders include the Bay Shore Trust and Miralogx, which collectively own more than 27% of MIRA’s outstanding common stock, as well as outstanding warrants to purchase up to 700,000 shares of MIRA’s common stock at an exercise price of$2.00, expiring on November 15, 2028.

In clinical news, MIRA submitted an Investigational New Drug (IND) application for Ketamir-2 for neuropathic pain indications to the FDA in December 2024. In its response, the agency required the completion of a neurotoxicity study before proceeding with human dosing. This study is currently ongoing and management expects it to be completed by May 2025.

In further developments, Mira received approval from the Israeli Ministry of Health and Institutional Review Board to initiate a Phase I clinical trial, which is now being conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel. On April 1, 2025, MIRA announced the enrollment of the first volunteer study subjects, along with expected completion of the study by Q4 2025.

In our view, the scientific rationale underlying MIRA’s developmental assets, Ketamir-2 and MIRA-55, isbacked by compelling preclinical data. In its 2024 Form 10K, MIRA confirmed its plan to sell or license both assets after the completion of Phase 2 development. However, even if Ketamir-2 were to move directly from Phase 1 to Phase 2 clinical trials at the end of 2025, we believe that a sale of the asset or a licensing transaction of a scope that would allow MIRA to finance the development of follow-on assets cannot reasonably be completed before 2027.

Further, even if MIRA manages to secure $5 million of development capital in a potential acquisition of SKNY Pharmaceuticals in Q3 2025, the company would still need to raise additional capital in 2026 in what has been and we expect will continue to be a very challenging market for micro and nano cap companies.

With MIRA’s share price under pressure, we caution investors that in addition to the potential dilution associated with the proposed SKNY acquisition, there will likely be the pain of a potential reverse stock split to maintain compliance with Nasdaq listing requirements before the market rewards any clinical successes.

We maintain our HOLD rating on the stock for the time being, until more information on the proposed SKNY acquisition becomes available to permit a more in-depth assessment of MIRA’s prospects.

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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.

Achieving a long-awaited milestone, MIRA prepares to become a clinical-stage company in early 2025.

On December 19, 2024, MIRA Pharmaceuticals announced the filing of its first investigational new drug (IND) application with the FDA for Ketamir-2, its oral ketamine analog, for the treatment of neuropathic pain.

The IND application includes data from preclinical pharmacology, pharmacokinetics, and toxicology studies of Ketamir-2 along with results from in vitro and in vivo studies, including neuropathic pain models. In parallel with the submission, MIRA is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the company’s pre-IND documentation.

Preclinical studies using Ketamir-2 have shown full pain reversal in animals, including the normalization of pain thresholds invalidated neuropathic pain models, along with an encouraging safety profile. Ketamir-2 was designed to address the limitations of existing neuropathic pain treatments through its selective targeting of the N-methyl-D-aspartate (NMDA) receptor, an ion channel in the central nervous system that plays a key role in synaptic function and is involved in many neurological and psychiatric disorders.

Unlike ketamine, Ketamir-2 does not cause sedation or hyperactivity side effects often associated with psychiatric conditions such as schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder (ADHD).

Ketamir-2 is being developed as a non-addictive, non opioid pain therapy. MIRA now enters a 30-day waiting period, during which the FDA examines the IND filing for safety guidelines to ensure that research subjects are not at an unreasonable risk, before it can initiate its Phase I clinical trial in healthy human volunteers. The IND application will go into effect on January 18, 2025, unless the FDA notifies MIRA otherwise.

We anticipate results from MIRA’s Phase I trial will be available by mid-2025 and will give investors an initial indication whether the safety, tolerability, pharmacokinetics, and pharmacodynamics signals observed in animals may translate to humans.

Beyond neuropathic pain, MIRA is targeting major depressive disorder (MDD), major depressive disorder with suicidal ideation (MDD-SI), treatment resistant depression (TDI), and post-traumatic stress disorder (PTSD) as potential additional indications for Ketamir-2.

We reiterate our BUY rating and 12-month price target of $7.50.

MIRA Pharmaceuticals reported financial results for the third quarter ended September 30, 2024. As is typical for a preclinical-stage company, revenue was $0, on par with our estimates. GAAP EPS of $(0.14) was a slight miss on our $(0.13)estimate, mainly due to higher-than-forecast general and administrative expenses. Common shares outstanding increased from 14.78 million at the end of Q2 2024 to 16.27 million on September 30, 2024, representing a dilution of 10.05%.

MIRA’s cash position improved from $2.82 million at the end of Q2 2024 to $4.14 million on September 30, 2024, causing the company’s current ratio to rise from 3.7x to 6.1x. With current cash on hand, management expects to be able to fund operations through Q4 2025; however, as MIRA advances its Ketamir-2 asset into human clinical trials in early 2025, the need to raise significant additional external capital in the near term remains pressing.

The company maintains an effective shelf registration statement, filed with the SEC on August 12, 2024 and amended on September 24, 2024, for the issuance of common stock under various types of equity offerings. The shelf registration statement includes an At The Market (ATM) Offering Agreement with Rodman & Renshaw LLC, under which MIRA may sell shares of its common stock up to an aggregate amount of $75 million. As of September 30, 2024, MIRA had sold 1,485,263 shares of common stock at an average price per share of $1.61, receiving net proceeds of $3.1 million after commissions and fees. Between October 1 and November 12, 2024, MIRA sold 294,704 shares of common stock under the ATM Agreement at an average price per share of $1.84, for net proceeds of $0.5 million.

While the ATM Agreement is a convenient way for the company to meet its liquidity needs, it will lead to ongoing dilution of existing shareholders. MIRA remains on track to submit an Investigational New Drug application for neuropathic pain indications in December 2024 and begin Phase I clinical trials in humans during the first quarter of 2025.

We reiterate our BUY rating and 13-month price target of $7.50.

MIRA Pharmaceuticals’s stock experienced significant price and volume increases following the company’s announcement that its Ketamir-2 product candidate induced near-complete normalization of pain sensitivity in a mouse model of chemotherapy-induced neuropathy, under experimental conditions where gabapentin provided only moderate relief. Neuropathic pain was induced in mice through administration of four doses of paclitaxel, a common chemotherapy drug. Pain sensitivity was measured using the Von Frey filament test, a mechanical sensitivity test that measures an animal's experience of pain in response to stimuli. To perform the test, animals are placed on a wire mesh surface and calibrated filaments of varying stiffness are applied through the underside of the mesh to the animal’s hind paw, to determine the minimum amount of force required to make the animal withdraw its paw. The force exerted by the filament is inversely proportional to its length and directly proportional to its width. MIRA’s results build on earlier successes across various pain models, further validating Ketamir-2's potential as an effective pain management drug with fewer side effects than gabapentin and pregabalin. Besides chemotherapy-induced pain, MIRA is planning to advance Ketamir-2 for the treatment of diabetic neuropathy.

Neuropathic pain is a expanding health indication, with increasing prevalence linked to conditions like diabetes, chemotherapy-induced nerve damage, and post-herpetic neuralgia. Chronic pain markets are large and growing, with gabapentin (Neurontin) expected to reach $4.95 billion in sales by 2033 and pregabalin (Lyrica) expected to reach $2.20 billion in sales by 2032.

MIRA is on track to submit an Investigational New Drug application for neuropathic pain indications in December 2024 and begin Phase I clinical trials in humans during the first quarter of 2025. MIRA has completed the design of its Phase I clinical trial, which will assess safety, tolerability, and pharmacokinetics in humans. The company’s primary goal is to demonstrate efficacy in humans as early as possible in subsequent Phase II studies.

Looking ahead, MIRA aims to broaden Ketamir-2’s therapeutic applications to include major depressive disorder with suicidal ideation, treatment-resistant depression, and post-traumatic stress disorder, potentially leading to additional IND filings in 2025.

We reiterate our BUY rating and 14-month price target of $7.50.

MIRA Pharmaceuticals reported financial results for the second quarter ended June 30, 2024. As is typical for a preclinical-stage company, revenue was $0, on par with our estimates. GAAP EPS of $(0.11) missed our earnings expectations of $(0.08), mainly due to higher-than-forecast general and administrative expenses. Common shares outstanding remained unchanged at 14,780,885.

MIRA’s cash position decreased from $4.6 million on December 31, 2023 to $2.9 million on June 30, 2024, causing the company’s current ratio to deteriorate from 8.7x to 3.7x. We note that while current cash is expected to support operations through year-end 2024, MIRA expects to generate losses for the foreseeable future and will need to secure significant external funding in the near-term to continue the development of its two preclinical assets.

We update our FY 2024 earnings estimate to $(0.52) to account for higher than previously modeled G&A costs. We also lower our year-end 2025 price target to $7.50, in light of the pressure MIRA is experiencing to secure additional funding by year-end, the associated likely dilution of existing shareholders, and the uncertainty around MIRA’s ability to continue as a going concern.

We further note that MIRA’s CEO, Erez Aminov, was named Chairman of the Board and CEO of Telomir Pharmaceuticals, following the passing of Telomir’s previous CEO, Christopher Chapman, Jr., MD. Telomir Pharmaceuticals is a preclinical-stage pharmaceutical company focused on the development and commercialization of Telomir-1 for the treatment of age-related conditions. Having Mr. Aminov dividing his time and attention between two preclinical-stage companies further increases the risk profiles of both.

Notwithstanding MIRA’s financial pressures, we remain optimistic about the prospects of the company’s preclinical assets.

MIRA recently revealed that Nor-Ketamir-2, the principal metabolite of its lead asset, Ketamir-2, demonstrated superior selectivity and bioavailability, as well as extended therapeutic efficacy.

A new formulation brings Nor-Ketamir-2’s bioavailability close to 100%, a significant improvement over traditional ketamine’s bioavailability of less than 30%. Taken together with Ketamir-2’s ability to passthrough the blood-brain barrier, this may allow for higher efficacy at lower doses or dosing frequencies.

The extended half-life and elevated levels of Nor-Ketamir-2 imply prolonged therapeutic effects, and the higher receptor binding site specificity of Ketamir-2 and Nor-Ketamir-2 suggest a reduced risk of adverse effects such as dissociation and hallucinations, enhancing the drug’s safety profile.

If validated in clinical trials, Ketamir-2 has the potential to offer effective treatment for neurological and neuropsychiatric disorders such as depression, treatment-resistant depression, and post-traumatic stress disorder, with a more convenient oral administration route than current marketed therapies.

In pursuit of its goal to file an Investigational New Drug (IND) application by year-end, MIRA has begun IND-enabling regulatory safety studies and is progressing with Good Manufacturing Practice (GMP)-compliant drug scale-up, devising a manufacturing process that allows large-scale, low-variability synthesis. The company is also completing Chemistry, Manufacturing, and Controls (CMC)documentation for Ketamir-2.

We will revisit and potentially revise our financial forecast during the fourth quarter of 2024, once additional information is available regarding the size and scale of MIRA’s upcoming financing round.

Shares of MIRA Pharmaceuticals nearly tripled in value since July 19 on news about the continued preclinical success of its investigational drug candidate, Ketamir-2. The newly released data from in vitro studies elucidates a potential mechanism underlying Ketamir-2’s superior oral absorption and ability to penetrate the blood-brain barrier more effectively than traditional ketamine. Improved penetration into target tissues would allow for lower doses of Ketamir-2 to achieve therapeutic effects.
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MIRA Pharmaceuticals has advanced its two preclinical assets, Ketamir-2 and MIRA-55, through preclinical testing, generating encouraging results. We summarize recent company news below.

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We re-initiate coverage on MIRA Pharmaceuticals with a Buy rating and a DCF-based 21-month price target of $10.00. MIRA isa preclinical development-stage life sciences company with two neuroscience programs, MIRA-55 and Ketamir-2, targeting a broad range of neurologic diseases and neuropsychiatric disorders.

Our rating is based on our view that the innovative potential of MIRA-55 and Ketamir-2 and their promising mechanisms of action warrant a higher valuation than the market is currently assigning to the company’s shares. However, MIRA represents a high-risk investment as the company has numerous hurdles to clear before bringing its product candidates to market. Many of the numerous hurdles MIRA will face along the product development timeline are binary events, and each could reduce the value of an asset to zero or, at a minimum, represent a significant setback. Further, MIRA competes in crowded target markets and may therefore face impediments to developing market traction against better-established competitors even after successful clinical development.

We expect MIRA to realize a sizable cash inflow from the sale of the Ketamir-2 and MIRA-55 assets in 2026 and begin generating product revenue in 2027.

That Ketamir-2 is not considered a controlled substance according to United States Drug Enforcement Administration (DEA) schedules, helps MIRA Pharmaceuticals avoid certain legal and regulatory requirements, elevated production costs, and manufacturing/transportation restrictions. A DEA classification of MIRA-55 is currently pending. If successfully developed, price and insurance coverage will be key considerations for patients and providers, influencing market penetration. Proper marketing strategy and sales tactics will be crucial in raising awareness about the drugs’ new mechanisms of action and to inform prescribers of potential use cases.

Our main concerns focus on the current entrenchment of low-cost generics across the target indications, a market condition expected to be more pronounced in three to five years when MIRA Pharmaceuticals expects its product candidates to be market ready. In addition, there are branded prescription drug candidates being developed by competitors with deeper pockets than MIRA Pharmaceuticals, which have a probability of coming to market before MIRA’s products, thus gaining a first-mover advantage in areas of unmet need. Finally, when compared to larger firms with established brands and sales channels, it is difficult for companies of MIRA’s size to conduct effective product awareness campaigns.

We expect MIRA’s stock to exhibit volatility that is typical of early-stage, biotech microcap companies. With the stock currently hovering in the one-dollar vicinity, a prolonged slump in the stock price carries the risk of delisting from the Nasdaq, which could result in further devaluation. On the upside, once proof-of-concept for its technologies has been established, MIRA could become an attractive acquisition target for larger competitors in the field.