Nasdaq: MIRA · Miami, FL

Developing novel oral therapies for neurologic, inflammatory, and metabolic disease.

Reengineering proven biology into safer, orally available therapies. MIRA Pharmaceuticals is a clinical-stage company advancing three drug candidates: one has completed Phase 1, two are in preclinical development. The Company has also disclosed substantial doubt about its ability to continue as a going concern; read that disclosure alongside the pipeline below.

Pipeline and disclosures Financial position

Ketamir-2 · Phase 1 complete MIRA-55 · Preclinical, IND-enabling SKNY-1 · Preclinical

Read both sides

Three programs advancing. Two disclosures that come with them.

Real preclinical and clinical progress across three programs, and a real going-concern doubt: both stated at the same size, neither buried.

The pipeline

Ketamir-2

Oral NMDA modulator · CIPN neuropathic pain

Phase 1 done

MIRA-55

Oral cannabinoid analog · chronic inflammatory pain

Preclinical

SKNY-1

CB1/CB2 + MAO-B modulator · obesity, nicotine dependence

Preclinical

The disclosures

Going concern 10-Q

"These factors raise substantial doubt about the Company's ability to continue as a going concern for a period of twelve months from the issuance date of this Quarterly Report."

Management states existing resources support operations into 1Q 2027; no financing is committed. 10-Q, acc. 0001493152-26-037366

Nasdaq bid-price notice 8-K

Notice received July 27, 2026 that the Company's common stock did not meet the $1.00 minimum bid price requirement. The stock continues to trade on the Nasdaq Capital Market.

8-K, filed 2026-07-31, acc. 0001493152-26-035665

Pipeline detail

Three oral small-molecule candidates, none a controlled substance

The DEA has completed its scientific review of all three compounds and concluded that none is currently a controlled substance or listed chemical under the CSA.

Ketamir-2

Phase 2a in preparation

An orally bioavailable NMDA receptor modulator that selectively binds the PCP site with low affinity (IC50 ~100 µM), designed to differentiate from ketamine's broader receptor binding. Phase 1 (randomized, double-blind, placebo-controlled SAD/MAD) enrolled 56 healthy volunteers; dosing is complete, with no serious adverse events or dose-limiting toxicities reported to date and no clinically significant dissociative effects observed. The database remains blinded pending final analyses.

Lead indication is chemotherapy-induced peripheral neuropathy (CIPN). A Phase 2a protocol, revised for FDA feedback, was submitted for IRB review at a leading cancer research institution as of September 17, 2026; site initiation is now targeted for 1Q 2027. Worldwide exclusive license (expanded May 2026 from the original US/Canada/Mexico territory), with patent filings across the US, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.

10-K, acc. 0001493152-26-014001; 8-K, acc. 0001493152-26-043051; 8-K, acc. 0001493152-26-025335

MIRA-55

IND targeted 1Q 2027

A non-psychoactive oral cannabinoid analog designed to preferentially engage CB2 receptor activity while minimizing CB1-mediated central nervous system effects. In preclinical models, MIRA-55 produced analgesic and anti-inflammatory activity without the sedation, catalepsy, or anxiogenic responses associated with THC, and in one preclinical assay showed anxiolytic activity that THC does not produce.

Positive 7-day rat and dog toxicology and toxicokinetic studies (Sept 1, 2026) characterized tolerability and informed dose selection for the next phase of IND-enabling work; earlier formulation studies (July 2026) showed favorable oral bioavailability with brain and liver distribution. Worldwide exclusive license as of June 2026.

10-K, acc. 0001493152-26-014001; 8-K, acc. 0001493152-26-040930; 8-K, acc. 0001493152-26-032777; 8-K, acc. 0001493152-26-027202 (worldwide license)

SKNY-1

IND targeted 2026

A CB1/CB2 modulator and selective MAO-B inhibitor targeting energy balance, appetite regulation, and reward/craving pathways, for weight management and nicotine dependence. Acquired via the September 29, 2025 acquisition of SKNY Pharmaceuticals (a related-party transaction; SKNY contributed $5.0 million in marketable securities at closing). In preclinical animal models, oral SKNY-1 was associated with reduced body weight, food intake, and nicotine-seeking behavior, without measurable loss of muscle mass under the conditions evaluated; preclinical findings may not be predictive of clinical outcomes.

A positive 7-day toxicokinetic study in Beagle dogs (Aug 6, 2026) showed dose-dependent systemic exposure supporting dose selection for GLP toxicology work. Worldwide exclusive license as of June 2026.

10-K, acc. 0001493152-26-014001; 8-K, acc. 0001493152-25-016168; 8-K, acc. 0001493152-26-036262; 8-K, acc. 0001493152-26-027202 (worldwide license)

Governance

Where the pipeline's IP comes from

What the record shows

Four things that are true regardless of the going-concern doubt

Lead program already through Phase 1

Ketamir-2 completed dosing in 56 healthy volunteers with no serious adverse events or dose-limiting toxicities reported to date.

None are controlled substances

The DEA has completed scientific review of all three compounds and concluded none is currently a controlled substance under the CSA.

Worldwide IP, not regional

All three programs now carry worldwide exclusive licenses, with Ketamir-2 patent filings across ten major markets.

Two independent positive tox reads

Both preclinical programs (MIRA-55, SKNY-1) reported positive 7-day dog toxicology results in the same quarter, ahead of GLP studies.

Healthy volunteers dosed in Ketamir-2's Phase 1 trial, zero SAEs reported to date

Major markets with Ketamir-2 patent filings (US, Europe, China, Japan, Canada & more)

3 / 3

Pipeline compounds confirmed by the DEA as not controlled substances

Positive 7-day dog toxicology reads reported in Q3 2026 alone

Source: 10-K, acc. 0001493152-26-014001; 8-K filings acc. 0001493152-26-043051, 0001493152-26-025335, 0001493152-26-040930, 0001493152-26-036262.

Financials

A pre-revenue balance sheet, stated plainly

MIRA has not generated revenue. Every figure below is as reported to the SEC, labelled by the period it covers.

Cash, 2026-06-30

$3.61M

down from $6.35M at 2025-12-31

10-Q, acc. 0001493152-26-037366

Net loss, FY2025

$(10.44)M

vs $(7.85)M FY2024

10-K, acc. 0001493152-26-014001

Shares outstanding

42.02M

as of 2026-08-10

10-Q, acc. 0001493152-26-037366

FY2025 financing raised

$8.2M

$7.0M stock sales, $0.9M options, $0.6M related-party

10-K, acc. 0001493152-26-014001

Annual net loss and cash, fiscal years ended December 31, from each year's own annual report
Fiscal year	Net loss	Cash, year end
2022	$(7.06)M	n/a
2023	$(11.98)M	n/a
2024	$(7.85)M	$2.83M
2025	$(10.44)M	$6.35M
2026 (10-Q, six months)	n/a	$3.61M

FY2022 net loss: 10-K, acc. 0001493152-24-012141. FY2023 net loss: 10-K, acc. 0001641172-25-001183. FY2024-2025 net loss and cash: 10-K, acc. 0001493152-26-014001. 2026 six-month cash: 10-Q, acc. 0001493152-26-037366. Cash figures for FY2022-2023 were not separately disclosed in the sources reviewed and are marked n/a rather than estimated.

Going concern, in full

Substantial doubt, in the Company's own words

"As of the date of filing this Quarterly Report on Form 10-Q, the Company has not generated revenues, continued to generate losses, and has insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date these unaudited condensed financial statements are issued. These factors raise substantial doubt about the Company's ability to continue as a going concern... Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or raise additional debt and/or equity capital."

10-Q, acc. 0001493152-26-037366

Runway: existing resources are stated to support operations into the first quarter of 2027.

Plan: "secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions... none of these alternatives are committed at this time."

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