M&A - MIRA PHARMACEUTICALS, INC.

Form Type: 8-K

Filing Date: 2025-07-10

Corporate Action: Acquisition

Type: New

Accession Number: 000164117225018595

Filing Summary: On July 10, 2025, MIRA Pharmaceuticals, Inc. announced new preclinical results for SKNY-1, an oral drug candidate for obesity and nicotine addiction, currently under definitive agreement for acquisition. SKNY-1 has demonstrated significant efficacy in reversing anxiety-related behavior induced by a CB1 activator, distinguishing it from earlier CB1-targeting drugs that experienced discontinuation due to severe central nervous system (CNS) side effects. Preclinical studies utilized the light-dark preference test in zebrafish, showcasing that SKNY-1 induced normalized anxiety-related behaviors across various treatment conditions. MIRA is preparing for shareholder approval related to the proposed acquisition of SKNY Pharmaceuticals, Inc., and plans to initiate Investigational New Drug (IND)-enabling studies for SKNY-1 following this approval.

Form Type: 8-K

Filing Date: 2025-07-02

Corporate Action: Acquisition

Type: Update

Accession Number: 000164117225017557

Filing Summary: On July 2, 2025, MIRA Pharmaceuticals, Inc. announced preclinical results for its proprietary drug candidate, Mira-55, which provided morphine-equivalent pain relief without opioid risks in an animal model for inflammatory pain. This synthetic analog of marijuana selectively activates CB2 receptors, avoiding psychoactive effects typically associated with THC. Additionally, the Company confirmed that Mira-55 is not classified as a controlled substance by the DEA, facilitating its clinical development. The announcement also included updates on the acquisition of SKNY Pharmaceuticals, developing SKNY-1 for obesity and nicotine addiction, with positive trial results. The SEC has completed its review of the merger proxy, permitting MIRA to proceed towards shareholder approval and transaction completion. Overall, these developments aim to enhance MIRA’s non-opioid pain management portfolio alongside Ketamir-2, its current NMDA receptor antagonist in Phase 1 trials.

Form Type: 8-K

Filing Date: 2025-06-30

Corporate Action: Acquisition

Type: New

Accession Number: 000164117225017046

Filing Summary: On June 30, 2025, MIRA Pharmaceuticals, Inc. announced significant results from an animal study of SKNY-1, a drug candidate under definitive agreement for acquisition from SKNY Pharmaceuticals, Inc. The study revealed that SKNY-1 achieved approximately 30% weight loss after six days of oral treatment in a zebrafish model that mimics human obesity and craving behaviors. Notably, the weight loss was associated with muscle preservation and no changes in muscle density. Additionally, SKNY-1 enhanced metabolic activity, as indicated by an increased breathing rate. Improvements in liver fat and cholesterol profiles were observed, with fat buildup in the liver decreasing to healthy levels and cholesterol levels returning to normal. The study also showed that SKNY-1 effectively reduced appetite, compulsive eating behaviors, and cravings for nicotine, indicating its potential effectiveness in addressing obesity and smoking addiction. These findings are seen as a strong foundation for MIRA to advance SKNY-1 towards Investigational New Drug (IND)-enabling studies, underscoring the drug's significance to the company's strategic direction following the acquisition.

Form Type: 8-K

Filing Date: 2025-06-24

Corporate Action: Acquisition

Type: Update

Accession Number: 000164117225016285

Filing Summary: MIRA Pharmaceuticals, Inc. is providing an update regarding newly generated preclinical data for SKNY-1, a next-generation oral drug candidate aimed at weight loss and smoking cessation, which is being developed by SKNY Pharmaceuticals, Inc. MIRA has signed a definitive agreement to acquire SKNY, with the transaction pending regulatory review and shareholder approval. The update includes new in vitro pharmacology data demonstrating SKNY-1's selective inhibition of the β-arrestin signaling pathway at the CB1 receptor, distinguishing it from previous treatments by avoiding mental health side effects. Additionally, SKNY-1 shows promise with partial agonist activity at the CB2 receptor and selective inhibition of the MAO-B enzyme, indicating a favorable safety profile. The findings suggest a multi-pathway approach to effectively support weight loss and cessation without adverse emotional effects. Further in vivo studies are being finalized to assess its effects and guide development and regulatory planning.

Form Type: 8-K

Filing Date: 2025-06-17

Corporate Action: Acquisition

Type: Update

Accession Number: 000164117225015401

Filing Summary: On June 17, 2025, MIRA Pharmaceuticals, Inc. announced that its lead drug candidate, Ketamir-2, was accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The article presents scientific validation of Ketamir-2’s unique pharmacological profile and its potential as a differentiated oral alternative to traditional ketamine. Highlights from the publication include selective NMDA antagonism, no significant off-target activity, antidepressant and anxiolytic effects, and improved oral bioavailability. The ongoing Phase 1 trial of Ketamir-2 is advancing with no safety concerns reported, and a Phase 2a trial is expected by the end of 2025. Additionally, MIRA is progressing with the acquisition of SKNY Pharmaceuticals, for a first-in-class oral CB1/CB2 inverse agonist, with regulatory filings submitted to the SEC.

Form Type: PREM14A

Filing Date: 2025-06-17

Corporate Action: Merger

Type: New

Accession Number: 000164117225015340

Filing Summary: MIRA Pharmaceuticals, Inc. has proposed a merger with SKNY Pharmaceuticals, Inc. as part of a strategic plan to enhance their focus on biopharmaceutical product development. The merger agreement, dated June 16, 2025, stipulates that MIRA's wholly owned subsidiary will merge with SKNY with SKNY surviving as a subsidiary. The key terms include a significant equity interest where SKNY shareholders will hold approximately 50% of the combined company's shares. A virtual special meeting is scheduled for stockholders to approve the issuance of shares exceeding 20% of MIRA common stock and to discuss potential adjournments for additional proxy solicitation. The board unanimously recommends stockholders vote in favor of the merger proposals, emphasizing its alignment with MIRA's strategic growth in various pharmaceutical domains, including smoking cessation, obesity, and PTSD. Risk factors associated with the merger are outlined in the document, urging stockholders to consider these factors prior to voting.

Form Type: 8-K

Filing Date: 2025-05-28

Corporate Action: Acquisition

Type: New

Accession Number: 000164117225012603

Filing Summary: On May 28, 2025, MIRA Pharmaceuticals, Inc. announced its participation in the BIO International Convention 2025 in Boston, scheduled for June 16–19, 2025. The company will be engaging in BIO One-on-One Partnering meetings to explore potential licensing, strategic collaborations, and M&A opportunities. Additionally, the company provided updates on its clinical and preclinical programs, including the progress of its lead candidate, Ketamir-2, which is in an ongoing Phase 1 clinical trial and is set to begin Phase IIa trials in neuropathic pain by the end of 2025. MIRA is also advancing preclinical studies for Ketamir-2 focusing on PTSD and is finalizing regulatory filings concerning its acquisition of SKNY Pharmaceuticals, Inc., which is developing SKNY-1, an oral therapeutic aimed at smoking cessation and obesity.

Form Type: 10-Q

Filing Date: 2025-05-14

Corporate Action: Acquisition

Type: Update

Accession Number: 000164117225010301

Filing Summary: MIRA Pharmaceuticals, Inc. reported financial results for the quarter ending March 31, 2025, showing a net loss of approximately $1.78 million, a slight increase in loss compared to the previous year. The company has faced significant operational expenses, including $1.49 million in general and administrative expenses and $314,404 in research and development. There has been a significant acquisition development as MIRA entered a binding letter of intent on March 19, 2025, with SKNY Pharmaceuticals, Inc. to conduct a stock exchange transaction aimed at acquiring SKNY. This acquisition will potentially enhance MIRA's drug pipeline with SKNY-1, a compound aimed at obesity and smoking cessation, alongside an infusion of $5 million from SKNY. MIRA has also reported a decrease in its cash reserves from $2.83 million at the end of the previous year to $1.21 million by March 31, 2025, indicating a high cash burn rate. There’s a continued focus on raising additional capital needed to support operations and ongoing clinical trials, along with substantial doubt noted regarding the company’s ability to continue as a going concern.

Form Type: 8-K

Filing Date: 2025-05-08

Corporate Action: Acquisition

Type: New

Accession Number: 000164117225009155

Filing Summary: On April 30, 2025, MIRA Pharmaceuticals, Inc. approved a definitive agreement to acquire SKNY Pharmaceuticals, Inc., a biotechnology company focusing on therapies for obesity and nicotine dependence. The acquisition value, based on independent valuations, is approximately $30.5 million for SKNY and around $30 million for MIRA. At the closing of the transaction, SKNY will contribute $5 million in assets or cash to MIRA, which is expected to bolster MIRA's balance sheet and support future initiatives. This merger will create a combined enterprise value exceeding $60 million, enhancing MIRA's market position and pipeline. MIRA intends to file a preliminary proxy statement on Form 14A to seek shareholder approval for this acquisition.

Form Type: 8-K

Filing Date: 2025-04-11

Corporate Action: Acquisition

Type: Update

Accession Number: 000164117225003889

Filing Summary: MIRA Pharmaceuticals, Inc. received a notification from the Nasdaq Listing Qualifications Staff on April 8, 2025, regarding its failure to meet the minimum stockholders' equity requirement of $2.5 million, as its equity was reported at $2,199,750 as of December 31, 2024. While this notice does not affect the company's listing status or the trading of its stock on the Nasdaq under the symbol 'MIRA', the company has 45 days to submit a plan to regain compliance, with a potential extension of up to 180 days. MIRA Pharmaceuticals is in the process of preparing this compliance plan. A significant aspect of the company's strategy is the anticipated acquisition of SKNY Pharmaceuticals, Inc., which includes a $5 million capital infusion that will strengthen the company's balance sheet. The company is also working on its Phase 1 clinical trial for Ketamir-2, a next-generation oral ketamine analog, and has shown promising early data in its topical formulation. Furthermore, the company is exploring partnerships with strategic investors to enhance its capital position and maintain a focus on advancing its neuroscience pipeline and regulatory milestones.

Form Type: 8-K

Filing Date: 2025-03-24

Corporate Action: Acquisition

Type: New

Accession Number: 000164117225000199

Filing Summary: On March 19, 2025, MIRA Pharmaceuticals, Inc. entered into a binding letter of intent with SKNY Pharmaceuticals, Inc. to acquire SKNY through a stock exchange transaction. This acquisition is significant as it will allow MIRA to include SKNY-1, a novel drug candidate aimed at weight loss and smoking cessation, in its product pipeline. As part of the agreement, SKNY will contribute a $5 million capital infusion, enhancing MIRA's financial position. The acquisition conditions include an independent valuation to ensure SKNY's valuation is at least equal to or greater than MIRA's. This merger will require shareholder approvals from both companies, and a 90-day due diligence period has been initiated to finalize the definitive stock purchase agreement and other documents.