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MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review

On September 17, 2026 MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, reported that, following review and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution.

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MIRA incorporated the FDA’s feedback into the protocol and is targeting site initiation in the first quarter of 2027, subject to completion of IRB review and other routine site activation requirements. The study represents Ketamir-2’s first clinical evaluation in patients with CIPN and is designed to generate initial efficacy and dose-response data while further characterizing safety and tolerability.

"We are entering an important stage for Ketamir-2 as we prepare to evaluate the drug for the first time in patients with persistent CIPN," said Erez Aminov, CEO of MIRA. "This marks the transition from establishing safety and pharmacokinetics in healthy volunteers to evaluating Ketamir-2’s potential therapeutic effect in patients."

About the Phase 2a Study

The randomized, double-blind, placebo-controlled, three-period crossover study will enroll adults with moderate-to-severe persistent CIPN. Participants will receive Ketamir-2 at 300 mg and 600 mg, as well as placebo, in a defined treatment sequence across three seven-day treatment periods separated by 13-day washout periods, allowing each participant to serve as their own control.

The study will evaluate the safety, tolerability, efficacy, and dose-response relationship of oral Ketamir-2, including its effect on post-chemotherapy neuropathic pain intensity. Additional assessments will evaluate CIPN-related symptoms and functional status, as well as potential central nervous system adverse effects.

The study builds on MIRA’s completed Phase 1 clinical program in healthy volunteers, in which Ketamir-2 demonstrated a favorable safety, tolerability, and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities reported. The Phase 2a study will be conducted under MIRA’s active Investigational New Drug (IND) application.

Addressing a Significant Unmet Need in Neuropathic Pain

CIPN is a painful and potentially persistent complication of certain commonly used chemotherapies that can continue long after cancer treatment has ended. Treatment options remain limited, and there are currently no FDA-approved therapies specifically indicated for CIPN. Existing treatment approaches offer limited options for managing painful CIPN, underscoring the need for new therapies specifically developed for this condition.

Ketamine has demonstrated analgesic activity in neuropathic pain through modulation of the NMDA receptor pathway, supporting the therapeutic relevance of this mechanism. However, its broader use as a chronic treatment can be constrained by intravenous administration, dissociative and other neuropsychiatric effects, monitoring requirements, and its Schedule III controlled-substance status.

Ketamir-2 is being developed as an oral NMDA receptor modulator designed to engage this therapeutically relevant pathway while potentially overcoming key limitations associated with ketamine. Ketamir-2 is orally administered; its Phase 1 pharmacokinetic profile supports once-daily dosing, and it is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

"There is a strong scientific rationale for targeting NMDA receptor signaling in neuropathic pain," said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA. "Ketamine has provided important clinical validation of this pathway, but its properties can limit its practicality for chronic use. Ketamir-2 was designed as an oral NMDA receptor modulator with high selectivity and a differentiated pharmacologic profile, and we believe this Phase 2a study will provide an important first opportunity to determine whether this profile can translate into meaningful pain reduction in patients with persistent CIPN."

While CIPN is the initial patient population being evaluated in Phase 2a, MIRA believes that positive clinical evidence in CIPN could support the evaluation of Ketamir-2 across additional neuropathic pain conditions where NMDA receptor signaling may play a role. The Company views CIPN as a potential clinical entry point into the broader neuropathic pain market.

October Scientific Presentation and BioJapan Participation

MIRA expects to present Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo, Japan, on October 5–6, 2026, where an abstract titled "An Oral Selective NMDA Modulator for Chemotherapy-Induced Peripheral Neuropathy—Phase 1 Safety, Pharmacokinetics, and Clinical Development Update" has been accepted for oral presentation by Dr. Itzchak Angel, MIRA’s Chief Scientific Advisor.

MIRA also expects to participate in BioJapan in October as the Company continues licensing and strategic partnership discussions around Ketamir-2 and its broader pipeline.

About Ketamir-2

Ketamir-2 is MIRA Pharmaceuticals’ proprietary oral NMDA receptor modulator in clinical development for neuropathic pain. The compound is designed to selectively modulate the NMDA receptor PCP binding site with low binding affinity and limited off-target receptor activity.

MIRA holds exclusive worldwide rights to Ketamir-2 and is pursuing intellectual property protection across major global pharmaceutical markets.

(Press release, Mira Pharmaceuticals, SEP 17, 2026, View Source [SID1234670943])

Calidi Biotherapeutics Announces $1.2 Million Registered Direct Offering

On September 17, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it has entered into a definitive stock purchase agreement with certain accredited investors and/or qualified institutional buyers for the purchase and sale of 1,025,640 shares of the Company’s common stock, in a registered direct offering, at a per share purchase price of $1.17.

The closing of the registered direct offering is expected to occur on or about September 18, 2026, subject to the satisfaction of customary closing conditions.

The gross proceeds to Calidi from the registered direct offering, before deducting offering expenses payable by the Company, are expected to be approximately $1.2 million. Calidi intends to use the net proceeds from the offering for working capital and for general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-282456), which was declared effective by the United States Securities and Exchange Commission ("SEC") on October 10, 2024. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, which is part of the effective registration statement, that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described therein, nor shall there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Calidi Biotherapeutics, SEP 17, 2026, View Source [SID1234670942])

Lisata Therapeutics Announces Acquisition of Marea Therapeutics and $225 Million Concurrent Private Placement

On September 17, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata"), a clinical-stage pharmaceutical company, reported that it has acquired Marea Therapeutics, Inc. ("Marea"), a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases.

Concurrent with the acquisition, Lisata entered into a definitive purchase agreement for the sale of Series C non-voting convertible preferred stock in a private placement financing, which is expected to result in gross proceeds to Lisata of approximately $225 million before deducting placement agent and other offering expenses. The oversubscribed financing included participation from leading life sciences investors including RA Capital Management, Forbion, Third Rock Ventures, Alpha Wave, Perceptive Advisors, Sofinnova Investments, Omega Funds, Surveyor Capital (a Citadel company), Columbia Threadneedle Investments, Nantahala Capital, Affinity Asset Advisors, LLC, venBio, Rock Springs Capital and other institutional investors.

Lisata plans to use the net proceeds primarily to advance MAR001/005 and MAR002 through key clinical milestones, including the completion of an ongoing Phase 2b trial in patients with severe hypertriglyceridemia, as well as a Phase 2 trial in patients with acromegaly. Both studies are expected to report topline data in the fourth quarter of 2027. Remaining proceeds will be used for general corporate purposes.

"After a thorough review of strategic alternatives, the acquisition of Marea marks a significant milestone for Lisata as we broaden our focus toward advancing Marea’s product candidate portfolio, which addresses significant unmet need across a range of cardioendocrine diseases," said Dr. David J. Mazzo, CEO of Lisata. "This pipeline, led by MAR001, is designed to overcome the limitations of current treatment paradigms and has the potential to establish a new standard of care in the treatment of severe hypertriglyceridemia (sHTG). With a strong balance sheet, we believe that we are well-positioned to drive these programs through their next stages of development and ultimately deliver meaningful benefit to patients. We believe that this acquisition, in combination with our parallel efforts to evaluate possible next steps in the development of certepetide, can provide long-term value to our shareholders."

"This transaction provides the combined company with the resources to advance our two clinical stage drug candidates through pivotal milestones, including MAR001 topline Phase 2b data in severe hypertriglyceridemia and MAR002 Phase 2 proof of concept data in patients with acromegaly next year, as well as initiation of Phase 3 registrational studies for both programs," said Dr. Josh Lehrer, newly appointed Chief Operating Officer and President of Lisata Therapeutics and Chief Executive Officer of Marea. "Joining with Lisata gives our first-in-class antibody programs a faster path to patients who today have limited options for these serious cardioendocrine diseases, and we’re grateful for the continued confidence of our new and existing investors."

About the Transactions
The acquisition of Marea was structured as a stock-for-stock transaction pursuant to which all of Marea’s outstanding equity interests were exchanged based on a fixed exchange ratio for a combination of 1,793,129 shares of Lisata common stock and 211,365.213 shares of Series C non-voting convertible preferred stock (representing in the aggregate 213,158,342 shares of Lisata common stock on an as-converted-to-common stock basis), in each case, calculated on a fully-diluted basis (and without giving effect to any beneficial ownership limitations). Concurrently with the acquisition of Marea, Lisata entered into a definitive purchase agreement for a private placement financing with leading life sciences investors and other institutional investors to raise $225 million in which the investors will be issued an aggregate of 150,867.995 shares of Series C non-voting convertible preferred stock (or 150,867,995 shares of Lisata common stock on an as-converted-to-common stock basis and without giving effect to any beneficial ownership limitations) at a price of approximately $1,491.37 per share (or approximately $1.4914 per share of common stock on an as-converted-to-common stock basis). Subject to Lisata stockholder approval, each share of Series C non-voting convertible preferred stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. As a result of the transactions, equity holders of Lisata immediately prior to the acquisition will own approximately 2.39% of Lisata’s common stock, equity holders of Marea immediately prior to the acquisition will own approximately 59.54% of Lisata’s common stock and investors in the private placement financing will own approximately 38.07% of Lisata’s common stock, in each case, calculated on a fully-diluted, as-converted-to-common-basis (and without giving effect to any beneficial ownership limitations) using the treasury stock method and based on the implied equity values of Lisata and Marea.

The acquisition was approved by the Board of Directors of Lisata and the Board of Directors and stockholders of Marea. The acquisition and private placement financing were not subject to the approval of Lisata’s stockholders. The approval of Lisata’s stockholders is required under the terms of the Series C non-voting convertible preferred stock in order for the Series C non-voting convertible preferred stock to be converted into shares of Lisata common stock, and Lisata is required to hold a stockholder meeting for such vote. On an as-converted basis and after accounting for these transactions (and without giving effect to any beneficial ownership limitations), the total number of shares of Lisata common stock (including shares underlying the Series C non-voting convertible preferred stock) will be approximately 396,315,542.

H.C. Wainwright is serving as financial advisor to Lisata. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Lisata. Leerink Partners is serving as financial advisor to Marea. Jefferies, Leerink Partners, Guggenheim Securities, Cantor and LifeSci Capital are acting as placement agents for the concurrent private placement financing. Goodwin Procter LLP is serving as legal counsel to Marea. Cooley LLP is serving as legal counsel to the placement agents.

(Press release, Lisata Therapeutics, SEP 17, 2026, View Source [SID1234670941])

Electra Therapeutics Announces Pricing of Upsized $350.0 Million Initial Public Offering

On September 17, 2026 Electra Therapeutics, Inc., a late clinical-stage biopharmaceutical company focused on pioneering a new class of precision medicines for the treatment of immune-mediated diseases and cancer, reported the pricing of its upsized initial public offering of 23,333,334 shares of common stock at a price to the public of $15.00 per share. The gross proceeds to Electra from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Electra, are expected to be approximately $350.0 million. In addition, Electra has granted the underwriters a 30-day option to purchase up to an additional 3,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Electra.

The shares are expected to begin trading on The Nasdaq Global Select Market on September 18, 2026, under the ticker symbol "ETRA." The offering is expected to close on September 21, 2026, subject to the satisfaction of customary closing conditions.
Jefferies, TD Cowen, Evercore ISI and Cantor are acting as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 17, 2026. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. When available, copies of the final prospectus relating to the initial public offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; Evercore Group L.L.C., 55 East 52nd Street, 35th Floor, New York, New York 10055, Attention: Equity Capital Markets, or by email at [email protected] or by telephone at (888) 474-0200; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].
This press release does not constitute an offer to sell, or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations of offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, Electra Therapeutics, SEP 17, 2026, View Source [SID1234670940])

NeOnc Technologies Redeems All Outstanding Series A Convertible Preferred Stock and Eliminates Related Potential Dilution

On September 17, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported that it has redeemed for cash all 6,000 outstanding shares of its Series A Convertible Preferred Stock (the "Series A Preferred Stock") at their aggregate stated value of $6.0 million. Following the redemption, no shares of Series A Preferred Stock remain outstanding.

The redemption was funded with a portion of the net proceeds from the Company’s $15 million registered direct offering announced on September 9, 2026, consistent with the use of proceeds disclosed for that offering.

"We made a deliberate decision to redeem the Series A Preferred Stock in cash and eliminate the potential dilution these securities represented for our shareholders," said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc. "Our recent financing enabled us to retire all outstanding Series A Preferred Stock before its discounted conversion feature became available, simplifying our capital structure without issuing common shares in the redemption. As we advance NEO100 and NEO212, disciplined management of shareholder capital remains central to our strategy. We are focused on translating clinical progress into lasting value for patients and shareholders."

NeOnc issued the Series A Preferred Stock in June 2026 in a private placement for gross proceeds of $5.0 million. Under its terms, the Company had the right to redeem all outstanding shares for cash at stated value within four months of issuance. Had the Company elected not to redeem, the stated value would have increased by $166.67 per share, and the shares would have become convertible, at the holders’ option, into NeOnc common stock at a conversion price equal to 80% of the lowest closing price during the five trading days prior to conversion, subject to a $1.00 floor price.

(Press release, Neonc, SEP 17, 2026, View Source [SID1234670939])