HOPE Therapeutics, Inc., an NRx Pharmaceuticals Subsidiary, Announces First-in-Florida Initiation of One Day (ONE-D) Depression Treatment in Partnership with Ampa Health

Rhea-AI Summary

HOPE Therapeutics (NASDAQ: NRXP) began offering the Ampa ONE-D protocol for treatment‑resistant depression in Florida on Nov 10, 2025, deploying the FDA‑cleared Ampa device at clinics in Sarasota, Naples and Fort Myers with six Florida locations planned by year‑end 2025.

The ONE‑D protocol reports 87% response and 72% remission at 6 weeks in nonrandomized results when single‑day TMS is combined with physician‑prescribed D‑cycloserine and lisdexamfetamine; D‑cycloserine is also a component of investigational NRX‑101, which has Breakthrough Therapy designation and expanded access availability.

Positive

• FDA‑cleared Ampa device deployed at HOPE clinics
• 87% response rate reported at 6 weeks in nonrandomized results
• 72% remission rate reported at 6 weeks in nonrandomized results
• Six Florida locations planned by year‑end 2025

Negative

• Key clinical results are from nonrandomized trials, limiting strength of evidence
• D‑cycloserine and lisdexamfetamine are not FDA‑approved for this depression indication
• Randomized prospective data demonstrating benefit with D‑cycloserine are described as not yet available for ONE‑D

Insights

Clinical and Commercial Analyst

HOPE's Florida roll‑out of Ampa ONE‑D is operationally notable but evidence remains nonrandomized and preliminary.

HOPE has deployed the Ampa FDA‑cleared device at multiple Florida clinics and plans six locations by year-end 2025, offering a single‑day (ONE‑D) protocol for treatment‑resistant depression. Published, nonrandomized results report 87% response and 72% remission at 6 weeks when the device is combined with physician‑prescribed D‑cycloserine and lisdexamfetamine; the device itself is FDA‑cleared and NRx’s investigational drug NRX‑101 contains D‑cycloserine and is available under an expanded access identifier NCT05779267.

The business mechanism is straightforward: faster treatment courses could raise throughput and patient demand versus traditional 90‑day TMS, improving clinic utilization and service differentiation. Key dependencies include broader, randomized evidence to validate the reported effect sizes, regulatory clarity over off‑label drug combinations, and successful operational scaling to the planned six Florida locations by year-end 2025.

Risks and watch items are concrete: the core efficacy figures derive from nonrandomized data and one randomized trial is cited only for D‑cycloserine’s enhancement effect; therefore confirmatory randomized, prospective results are necessary before judging clinical benefit as established. Monitor for publication or release of randomized trial outcomes, regulatory communications about combined device‑drug protocols, and actual patient throughput and reimbursement trends over the next 6–12 months.

• ONE-D is the first reported protocol to achieve remission from treatment-resistant depression with a single day of treatment, using an FDA-cleared device.
• HOPE is one of the first Ampa deployments nationwide and is now deployed at multiple HOPE locations in Florida, including Naples, Fort Myers, and Sarasota, with six locations planned by year-end 2025.
• HOPE Medical Director, Rebecca Cohen, MD, is first Ampa-certified psychiatrist in Florida.
• Ampa Health has reported nonrandomized results indicating 87% response and 72% remission from treatment resistant depression at 6 weeks with its FDA-cleared device combined with physician-prescribed D-cycloserine and lisdexamfetamine.

SARASOTA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- HOPE Therapeutics™, Inc. ("HOPE"), an interventional psychiatry network owned by NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) today announced initiation of patient care with for treatment-resistant depression with the Ampa one day (ONE-D) protocol. HOPE is the first to deploy the Ampa technology in Florida and one of the first deployments nationwide. The Ampa device differs from other Transcranial Magnetic Stimulation (TMS) treatments in that the peer-reviewed literature has reported a high rate of success (87% response and 72% remission) in nonrandomized trials when a single day of TMS treatment is combined with physician-prescribed D-cycloserine and lisdexamfetamine (note that neither of the drugs reported in the published results is FDA-approved for the stated indication).¹ D-cycloserine was previously reported to substantially enhance the effectiveness of TMS in reducing depression and suicidality by more than two-fold in a placebo-controlled trial using a traditional TMS protocol.²   Additional supportive findings documenting the effect of D-cycloserine in enhancing the effect of TMS were recently published by a team of researchers led by Prof. Joshua Brown at Harvard’s McLean hospital.³ Dr. Brown additionally serves as the President of the Clinical TMS Society.

The Ampa device is initially deployed at multiple HOPE clinic locations in Florida including Sarasota, Naples and Fort Myers, under the direction of Rebecca Cohen, MD, HOPE’s Medical Director, with six locations in Florida planned by year-end 2025. The ONE-D protocol offers a new treatment paradigm to patients with severe depression who previously were required to undergo 90 days of TMS. D-cycloserine is an active component of NRX-101, a Breakthrough Therapy designated investigational drug that is available under an expanded access protocol (www.clinicaltrials.gov NCT05779267) and Federal and State Right to Try regulations.

“I am thrilled to be assuming a leadership role in HOPE Therapeutics at a moment when TMS is suddenly demonstrating dramatic results for patients with potential to heal the brain in depression in weeks, rather than months, based on a one-day treatment protocol. Although the results reported by multiple leaders in the field of short-term TMS combined with neuroplastic drugs are not yet based on randomized, prospective data, they are promising and have the potential to change the paradigm of TMS therapy from a three month course of treatment to a far shorter and rapidly effective modality of care. The randomized prospective data demonstrating a greater than two-fold enhancement of the TMS effect when D-cycloserine is added represents a dramatic enhancement. We at HOPE aim to remain on the cutting edge of life transforming therapy for depression and PTSD and to rapidly expand to change the lives of the 13 million Americans who tragically contemplate suicide each year,” said Dr. Cohen.

About HOPE Therapeutics, Inc.

HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetics stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. HOPE is the first network in Florida to offer the AMPA One Day (ONE-D) treatment that combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine to achieve remission from treatment resistant depression.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently re-filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

About Ampa

Ampa is a neurotechnology company using breakthroughs in neuroscience to create practical tools that help people recover their mental health. Its FDA-cleared Ampa One system and emerging Ampa One Day protocol advance the mission of one billion remissions from mental and neurological disorders. Learn more at www.ampahealth.com

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:
Matthew Duffy Chief Business Officer, NRx Pharmaceuticals mduffy@nrxpharma.com	Brian Korb Investor Relations, ASTR Partners 917-653-5122 brian.korb@astrpartners.com
PATIENT and PHYSICIAN INQUIRIES 1-(833)-4HOPETMS www.hopetherapeutics.com

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1} Vaughn DA, Marino B, Engelbertson A, et al. Real-world effectiveness of a single day regimen for transcranial magnetic stimulation using Optimized, Neuroplasticity-enhanced techniques in Depression (ONE-D): An open-label case series. Transcranial Magnetic Stimulation November 4, 2025, https://www.sciencedirect.com/science/article/pii/S3050529125001163
² Cole J, Sohn MN, Harris AD, et al, Efficacy of Adjunctive D-cycloserine to intermittent theta-burst stimulation for major depressive disorder: A randomized clinical trial. JAMA Psychiatry 2022 79(12):1153-1161
³ Kim H, Ganesh P, Kweon J, et. al., Effects of D-cycloserine and accelerated TMS on TMS-evoked potentials in the left DLPFC. Brain Stimulation 2025;18:470

FAQ

What is the ONE‑D depression treatment announced by HOPE Therapeutics (NRXP) on Nov 10, 2025?

ONE‑D is a single‑day TMS protocol using the FDA‑cleared Ampa device combined with physician‑prescribed D‑cycloserine and lisdexamfetamine for treatment‑resistant depression.

What clinical results did Ampa report for the ONE‑D protocol referenced by HOPE (NRXP)?

Ampa reported nonrandomized results of 87% response and 72% remission at 6 weeks when ONE‑D was combined with the specified medications.

Where and when did HOPE Therapeutics (NRXP) deploy the Ampa ONE‑D treatment in Florida?

HOPE deployed Ampa at clinics in Sarasota, Naples, and Fort Myers and plans six Florida locations by year‑end 2025.

Is D‑cycloserine approved for treating depression as used in the ONE‑D protocol (NRXP)?

No; the press release notes that the drugs used in the published results are not FDA‑approved for that indication.

How does ONE‑D compare to traditional TMS treatment durations mentioned by HOPE (NRXP)?

ONE‑D is presented as a single‑day protocol versus a typical ~90‑day course of traditional TMS therapy.