Form 8-K

8-K — Minerva Neurosciences, Inc.

Accession: 0001193125-26-205129

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0001598646

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — d947378d8k.htm (Primary)

EX-99.1 (d947378dex991.htm)

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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): May 5, 2026

Minerva Neurosciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware

000-36517

26-0784194

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

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 May 5, 2026, Minerva Neurosciences, Inc. (the “Company”) issued a press release regarding its financial results for the quarter ended March 31, 2026. 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 May 5, 2026.

104

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

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: May 5, 2026

MINERVA NEUROSCIENCES, INC.

/s/ Fred Ahlholm

Name: Fred Ahlholm

Title: Chief Financial Officer

EX-99.1

Filename: d947378dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Minerva Neurosciences Provides First Quarter 2026 Financial Results

and Business Updates

Confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia initiated and first patient screened

Previous open label trial data presented at SIRS 2026 showed no safety or drug–drug interaction concerns with roluperidone and

olanzapine

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

BURLINGTON, Mass.– May 5, 2026 (GLOBE NEWSWIRE) – Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage

biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported financial and business updates for the first quarter ended March 31, 2026.

Business Updates

Roluperidone -

potentially the First Treatment for Negative Symptoms of Schizophrenia

•

Minerva initiated its global confirmatory Phase 3 clinical trial of roluperidone for the treatment of negative

symptoms of schizophrenia during the first quarter of 2026 with efficacy topline data expected 2H 2027.

•

The Company screened the first patient in March 2026, marking an important operational milestone for the program.

•

The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including

the United States (US) and multiple European countries.

•

This confirmatory Phase 3 trial 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).

•

The trial will evaluate roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary

negative symptoms at 12 weeks.

•

The trial will also evaluate on an informational basis the longer-term relapse rate of positive symptoms for

roluperidone as compared with several commonly prescribed antipsychotic medications for an additional 40 weeks.

•

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 presentations - further supporting the roluperidone program and reinforcing real world applicability

•

In March 2026, Minerva presented data from its open-label safety trial

evaluating roluperidone co-administered with olanzapine at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress.

•

The data demonstrated no clinically meaningful safety concerns, no significant pharmacokinetic interactions, and

no pharmacodynamic effects when roluperidone was administered with olanzapine. This supports the continued development of roluperidone in patients receiving background antipsychotic therapy.

•

The presentation is available on Minerva’s website under the presentation tab:

https://ir.minervaneurosciences.com/static-files/49dcf8af-fa88-428d-89c7-c35491745374

•

In February 2026, Minerva hosted a live key opinion leader (KOL) webcast, “Roluperidone: From Unmet Need to

Reality,” featuring Greg Strauss, PhD, Franklin Professor of Psychology at the University of Georgia, and Brian Kirkpatrick, MD, MSPH, Peters Professor of Psychiatry at the University of Arkansas for Medical Sciences.

•

The discussion addressed the burden and assessment of negative symptoms, limitations of existing treatment

approaches, and the rationale and design of the ongoing confirmatory Phase 3 trial. The presentation is available at: https://bit.ly/48YzdNK and the replay is also available: https://lifescievents.com/event/pkv02859/

“The initiation of our confirmatory Phase 3 trial and the screening of the first patient represent meaningful milestones for

Minerva that underscore the progress of our lead program,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva Neurosciences. “With no approved treatments for negative symptoms of schizophrenia in the United States or

Europe, roluperidone remains the only late-stage candidate specifically targeting this substantial unmet medical need. Patients often live with persistent negative symptoms such as avolition and anhedonia that

remain even when positive symptoms of schizophrenia are controlled, driving long-term disability and functional impairment. Building directly on consistent late-stage

clinical results, this confirmatory Phase 3 trial is designed to evaluate roluperidone’s potential to improve these core drivers of disability while laying the groundwork for a broader treatment strategy.”

Corporate Updates

•

During the first quarter of 2026, Minerva announced a leadership transition with the appointment of Jim

O’Connor as Chief Business Officer and General Counsel, effective April 21, 2026, as Geoff Race, the Company’s President, elected to leave the company. Mr. Race will continue to be involved with Minerva as a consultant.

•

During the quarter, one investor from the October private placement elected to exercise a portion of their

warrants to purchase Series A preferred stock, resulting in additional proceeds to Minerva of $1.2 million.

First Quarter Financial Results

Research and Development (R&D) Expenses: R&D expenses were $5.3 million, compared to $1.4 million in the prior-year period. The

increase was primarily due to expenses related to the initiation of the C19 trial as well as higher compensation costs.

General and Administrative

(G&A) Expenses: G&A expenses were $11.4 million, compared to $2.5 million in the prior-year period. The increase of $8.9 million was primarily due to non-cash stock compensation

expense of $8.0 million, as well as higher professional service fees and compensation costs. Non-cash stock compensation expense included a one-time charge of

$6.6 million for the modification of the terms of previously granted stock options related to Mr. Race’s settlement agreement.

Change

in Fair Value of Warrant Liability: For the three months ended March 31, 2026, the Company recorded a non-cash expense of $109.4 million for both the change in the fair value of the warrant liability and losses recognized upon the

exercise of warrants during 2026.

Total Liabilities: Under U.S. Generally Accepted Accounting Principles (“GAAP”), for the periods

ended March 31, 2026 and December 31, 2025, total liabilities were $343.1 million and $233.8 million, respectively. Excluding the warrant liability and liability related to the sale of future royalties, non-GAAP total liabilities* were $4.5 million and $2.3 million for the periods ended March 31, 2026 and December 31, 2025, respectively.

Net loss: Under GAAP, Net loss for the three months ended March 31, 2026 was $125.4 million, or $2.86 per basic and diluted share, compared

to a net loss of $3.8 million, or $0.50 per basic and diluted share, for the three months ended March 31, 2025. On a non-GAAP basis, adjusted net loss* was $7.3 million, or an adjusted net loss per share* of $0.17, compared to a non- GAAP adjusted net loss* of $3.5 million, or an adjusted net loss per share* of $0.46 per share, in the prior-year period.

Cash Position: As of March 31, 2026, Minerva had approximately $78.2 million in cash, cash equivalents, marketable securities and restricted

cash, compared to $82.4 million at December 31, 2025.

Definitions of the non-GAAP measures used by Minerva and a

reconciliation of such measures to the related GAAP financial measure can be found under the sections below titled “Non-GAAP Financial Measures” and “Reconciliation of GAAP Financial Measures

to Non-GAAP Financial Measures.”

About the Phase 3 MIN-101C19 Trial

The global Phase 3 MIN-101C19 trial will enroll approximately 380 adults aged 18–55 with moderate to severe

negative symptoms of schizophrenia, confirmed by a Positive and Negative Syndrome Scale (PANSS) negative subscale score greater than 20 and stable positive symptoms for at least six months. The trial utilizes a

two-part design. The overall objective of the study is to confirm the effect of roluperidone on primary negative symptoms at 12 weeks compared to placebo and to evaluate longer-term relapse of positive

symptoms compared with commonly prescribed antipsychotic medications for an additional 40 weeks.

The trial is designed to minimize variability and

maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. Topline data from the 12-week Phase A portion (i.e., primary efficacy endpoint) of the

trial are expected in the second half of 2027. The trial’s operational model includes intensive rater training, real-time monitoring of scoring data, and structured caregiver outreach to support safety tracking, functional assessments, and

adherence.

Phase A is a12-week, randomized, double-blind, placebo-controlled phase during which

patients will receive 64 mg of roluperidone or placebo to evaluate the primary endpoint: change from baseline in the Marder Negative Symptoms Factor Score (NSFS), which is a factor-analytic composite created from selected PANSS items. The sole key

secondary endpoint is the change from baseline in the Personal and Social Performance (PSP) total score. Other secondary endpoints include a broad set of additional clinical measures, including PANSS subscales, Clinical Global Impression –

Severity (CGI-S), Clinical Global Impression – Improvement (CGI-I), the Calgary Depression Scale, avolition-specific analyses, and patient and caregiver

treatment-satisfaction ratings.

Phase B extends the trial for 40 weeks using a double-dummy, active-controlled, randomized design comparing

continued roluperidone with three commonly prescribed antipsychotic medications (risperidone, aripiprazole, or olanzapine). This phase is designed to compare relapse rates between treatment groups. Relapses of positive symptoms will be evaluated

using a rigorous, multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior.

About Minerva Neurosciences

Minerva

Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva is initiating a confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia. For more

information, please visit the Company’s website.

Non-GAAP Financial Measures

In addition to the financial information presented in this release in accordance with accounting principles generally accepted in the United States of America

(GAAP), Minerva also presents adjusted non- GAAP financial measures.

Non-GAAP financial measures are included with the intent of providing investors with an understanding of

Minerva’s historical financial results and trends and to facilitate comparisons between periods. In addition, these non-GAAP financial measures are among the indicators that Minerva’s management

uses for planning and forecasting purposes and measuring Minerva’s performance. Minerva believes that these non - GAAP financial measures, when considered together with U.S. GAAP measures, can enhance

the understanding of its financial and operating performance. Non - GAAP financial measures have no standardized meaning and investors are cautioned that, unlike financial measures prepared in accordance with

U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. The limitations of using non-GAAP financial measures as

performance measures are that they provide a view of Minerva’s results of operations without including all events during a period and may not provide a comparable view of Minerva’s performance to other companies in the biopharmaceutical

industry. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not

to rely on any single financial measure to evaluate the business.

Non-GAAP total liabilities is defined as

GAAP total liabilities, excluding warrant liability and liability related to the sale of future royalties.

Non-GAAP adjusted net loss is defined as GAAP net loss, adjusted to exclude

non-cash items related to: (i) stock-based compensation expense and (ii) changes in fair value of the warrant liability.

Non-GAAP adjusted net loss per share, basic and diluted, is defined as GAAP net loss per share, basic and

diluted, adjusted to exclude non-cash items related to: (i) stock-based compensation expense and (ii) changes in fair value of the warrant liability.

Forward-Looking Safe Harbor Statement

This

press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect

management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to implied or express statements regarding

the expected timeline, design and conduct of Minerva’s confirmatory Phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia, including the timing of its results; the therapeutic and regulatory potential of

roluperidone in the United States and Europe; market opportunities; and Minerva’s plans and objectives with respect to the

roluperidone program. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without

limitation, the inability to predict with certainty the level of expenditures and resources required for the confirmatory Phase 3 trial for roluperidone and other operational matters following Minerva’s plans to refocus efforts on the

successful execution of the Phase 3 trial; Minerva’s future financial performance and position may not improve, resulting in difficulties in implementing Minerva’s business strategy, and plans and objectives for future operations; the

expected sufficiency of Minerva’s existing cash resources and runway may not be accurate resulting in the need for additional financing sooner than anticipated or unexpected liquidity constraints; the internal and external costs required for

Minerva’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause Minerva to use cash more quickly than expected or to change or curtail some of Minerva’s plans or

both; trials and studies may be delayed and may not have satisfactory outcomes, and earlier trials and studies may not be predictive of later trials and studies; the design and rate of enrollment for clinical trials, including the current design of

the Phase 3 confirmatory trial evaluating roluperidone may not enable successful completion of the trial(s); the commercial opportunity for roluperidone in negative symptoms of Schizophrenia may be smaller than anticipated; Minerva may be unable to

obtain and maintain regulatory approvals, including uncertainties associated with the development and timing of Minerva’s interactions with the FDA; Minerva may experience uncertainties inherent in the initiation and completion of clinical

trials and clinical development; the need to align with collaborators or partners may hamper or delay development and regulatory efforts or increase costs; uncertainties of patent protection and litigation; general economic conditions; and other

factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year

ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2026, as supplemented by Minerva’s Form 10-Q for the quarter ended

March 31, 2026, filed with the SEC on May 5, 2026. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are

based on information available to Minerva as of the date hereof, and Minerva disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Frederick Ahlholm

Chief Financial Officer

Minerva Neurosciences, Inc.

fahlholm@minervaneurosciences.com

Corey Davis, Ph.D.

LifeSci Advisors, LLC

212-915-2577

cdavis@lifesciadvisors.com

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited)

March 31,

2026

December 31,

2025

(in thousands)

ASSETS

Current assets:

Cash and cash equivalents

32,660

82,302

Marketable securities

45,405

—

Restricted cash

100

Prepaid expenses and other current assets

942

698

Total current assets

79,107

83,100

Goodwill

14,869

Deferred offering costs

—

Total assets

94,027

97,969

LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’

DEFICIT

Current liabilities:

Accounts payable

2,118

639

Accrued expenses and other current liabilities

2,364

1,651

Total current liabilities

4,482

2,290

Long-term liabilities:

Warrant liability

278,597

171,465

Liability related to the sale of future royalties

60,000

Total liabilities

343,079

233,755

Redeemable preferred stock:

Series A convertible preferred stock

4,962

Stockholders’ deficit:

Common stock

Additional paid-in capital

560,186

548,047

Accumulated deficit

(814,204

)

(688,799

)

Total stockholders’ deficit

(254,014

)

(140,748

)

Total liabilities, redeemable preferred stock and stockholders’ deficit

94,027

97,969

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended March 31,

(in thousands, except per share amounts)

2026

2025

Operating expenses:

Research and development

5,255

1,362

General and administrative

11,417

2,541

Total operating expenses

16,672

3,903

Loss from operations

(16,672

)

(3,903

)

Foreign exchange losses

)

Investment income

630

158

Changes in fair value of the warrant liability

(109,360

)

—

Net loss

(125,404

)

(3,753

)

Net loss per share, basic and diluted

(2.86

)

(0.50

)

Weighted average shares outstanding, basic and diluted

43,900

7,569

Reconciliation of GAAP Financial Measures to Non-GAAP Financial

Measures

RECONCILIATION OF TOTAL LIABILITIES — NON-GAAP

(Unaudited)

March 31,

2026

December 31,

2025

(in thousands)

Current liabilities:

Accounts payable

2,118

639

Accrued expenses and other current liabilities

2,364

1,651

Total current liabilities

4,482

2,290

Long-term liabilities:

Warrant liability

278,597

171,465

Liability related to the sale of future royalties

60,000

Total liabilities - GAAP

343,079

233,755

Reconciling items:

Warrant liability

(278,597

)

(171,465

)

Liability related to the sale of future royalties

(60,000

)

(60,000

)

Total liabilities - non-GAAP

4,482

2,290

RECONCILIATION OF ADJUSTED NET LOSS -

NON-GAAP

(Unaudited)

Three Months Ended March 31,

(in thousands, except per share amounts)

2026

2025

Net loss – GAAP

(125,404

)

(3,753

)

Reconciling items:

Stock-based compensation expense

8,710

297

Changes in fair value of the warrant liability

109,360

—

Adjusted net loss – non-GAAP

(7,334

)

(3,456

)

Net loss per share, basic and diluted – GAAP

(2.86

)

(0.50

)

Weighted average shares outstanding, basic and diluted

43,900

7,569

Reconciling items:

Stock-based compensation expense

0.20

0.04

Changes in fair value of the warrant liability

2.49

—

Net loss per share, basic and diluted –

non-GAAP

(0.17

)

(0.46

)

Weighted average shares outstanding, basic and diluted

43,900

7,569

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

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No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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