EX-99.1

2 d22348dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Minerva Neurosciences Provides Second Quarter 2026 Financial Results and Business Updates

Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected

2H 2027

Scientific Advisory Board of leading experts in psychiatry and neuroscience established to guide the confirmatory Phase 3 trial of roluperidone

Roluperidone remains the only late-stage drug candidate for this high-need population

BURLINGTON, Mass.– August 7, 2026 (GLOBE NEWSWIRE) – Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported financial and business updates for the second quarter ended June 30, 2026.

“The psychiatry field has increasingly recognized negative symptoms as a distinct, undertreated driver of disability in schizophrenia, separate from the positive symptoms that current antipsychotics are designed to address,” said Remy Luthringer, Ph.D., Chief Executive Officer of Minerva Neurosciences. “Roluperidone is the only late-stage candidate targeting negative symptoms directly. The C19 study, our ongoing confirmatory Phase 3 trial, is designed to confirm the effect we saw in our prior studies. We remain focused on execution and on track for topline efficacy data in the second half of 2027.”

Corporate Updates

Roluperidone - potentially the First Treatment for Negative Symptoms of Schizophrenia

•

Minerva’s global confirmatory Phase 3 clinical trial of roluperidone for the treatment of negative symptoms of schizophrenia (the C19 Study) is designed to enroll 380 patients across approximately 40 clinical sites worldwide, including the United States (US) and multiple European countries.

•

The C19 Study follows productive discussions with the FDA on the overall design and efficacy assessments and builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07).

•

Phase A of the C19 Study will evaluate roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks.

•

Phase B of the C19 Study will evaluate longer-term relapse of positive symptoms for roluperidone versus commonly prescribed antipsychotic medications for an additional 52-week period. The topline data from Phase B is expected in 2H 2028.

•

See “About the Phase 3 MIN-101C19 Trial” below for more information.

•

Roluperidone remains the only late-stage drug candidate for this high-need population.

Scientific Advisory Board

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Minerva previously announced the formation of its Scientific Advisory Board (SAB) on June 1, 2026, comprising eight members with significant experience in psychiatry and neuroscience research, who will advise on the ongoing Phase 3 confirmatory trial of roluperidone as well as potential future pipeline programs.

•

Minerva recently added three additional members to its SAB, bringing the total to eleven members:

Christoph Correll, MD – Clinical Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra University;

Stefan Leucht, MD – Head of the Section for Evidence-Based Medicine in Psychiatry and Psychotherapy at the Department of Psychiatry and Psychotherapy, Technical University of Munich; and

Michael Sand, PhD, MPH – S2 Consulting LLC; formerly a board observer on the Minerva board of directors representing Boehringer Ingelheim.

Scientific Publication – Minerva team advancing thought leadership in schizophrenia research

•

Remy Luthringer, Ph.D. (Chief Executive Officer), Michael Davidson, MD (Chief Medical Officer) and Jonathan Rabinowitz, PhD (biostatistical consultant) continue to advance thought leadership in schizophrenia research through coauthoring findings from a longitudinal analysis of 1,139 patients enrolled in the CATIE trial, one of the largest and most influential studies conducted in schizophrenia (Speyer et al., 2026). The analysis found that patients with greater negative symptom severity experienced a lower likelihood of short-term worsening of positive symptoms.

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The findings suggest a relatively stable illness course among individuals with more severe negative symptoms. These results have implications for prognosis and treatment planning, while underscoring the persistent functional burden imposed by negative symptoms despite lower exacerbation risk.

Second Quarter and Six Months 2026 Financial Results

Research and development (R&D) expense: For the three months ended June 30, 2026 and 2025, R&D expense was $7.2 million and $1.3 million, respectively. For the six months ended June 30, 2026 and 2025, R&D expense was $12.4 million and $2.7 million, respectively. R&D expense was higher versus the prior year period in both the three and six months ended June 30 primarily due to expenses related to the C19 trial as well as higher compensation co

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8-K

NASDAQ false 0001598646 0001598646 2026-03-11 2026-03-11

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 11, 2026

Minerva Neurosciences, Inc. (Exact name of registrant as specified in its charter)

Delaware

000-36517

26-0784194

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

Identification No.)

1500 District Avenue, Burlington, MA 01803

(Address of principal executive offices) (Zip Code) (617) 600-7373 (Registrant’s telephone number, including area code) Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

NERV

The Nasdaq Capital Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On March 11, 2026, Minerva Neurosciences, Inc. (the “Company”) issued a press release regarding its financial results for the quarter and year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in Item 2.02 of this Current Report on Form 8-K, including the accompanying Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number

Description

99.1

Press release issued by Minerva Neurosciences, Inc. dated March 11, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: March 11, 2026

MINERVA NEUROSCIENCES, INC.

/s/ Fred Ahlholm

Name:

Fred Ahlholm

Title:

Chief Financial Officer

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