Overview
- TickerNERV on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersWaltham1
- Websitewww.minervaneurosciences.com
- Incorporated inMA4
- Business address1500 District Avenue, Burlington, Ma 018034
- Filer categoryNon-accelerated filer, Smaller reporting company4
- Legal formCorporation
See how the biggest companies compare on our leaderboards

Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.12
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $5.8M | $11.9M |
| General and administrative | $9.3M | $9.9M |
| Total expenses | $15.1M | $21.8M |
| Loss from operations | -$15.1M | -$21.8M |
| Foreign exchange losses | -$56.6K | -$1.9K |
| Investment income | $948.1K | $1.3M |
| Non-cash interest expense for the sale of future royalties | -$4.6M | |
| Other income | $26.6M | |
| Loss on issuance of convertible preferred stock and warrants | -$321.5M | |
| Warrant issuance cost | -$3.1M | |
| Changes in fair value of the warrant liability | $45.4M | |
| Net (loss) income | -$293.4M | $1.4M |
| Net (loss) income per share, basic | -$34.67 | $0.19 |
| Weighted average shares outstanding, basic | 8.5M shares | 7.6M shares |
| Net (loss) income per share, diluted | -$34.67 | $0.19 |
| Weighted average shares outstanding, diluted | 8.5M shares | 7.6M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.12
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $82.3M | $21.4M | |
| Restricted cash | $100.0K | $100.0K | |
| Prepaid expenses and other current assets | $697.7K | $806.9K | |
| Total current assets | $83.1M | $22.3M | |
| Equipment, net | $0 | $5.4K | |
| Goodwill | $14.9M | $14.9M | |
| Total assets | $98.0M | $37.1M | |
| Accounts payable | $639.7K | $1.6M | |
| Accrued expenses and other current liabilities | $1.7M | $1.2M | |
| Total current liabilities | $2.3M | $2.8M | |
| Warrant liability | $171.5M | $0 | |
| Liability related to the sale of future royalties | $60.0M | $60.0M | |
| Total liabilities | $233.8M | $62.8M | |
| Common stock; $0.0001 par value; 250,000,000 shares authorized; 43,274,398 shares issued and outstanding as of December 31, 2025 and 125,000,000 shares authorized; 6,993,406 shares issued and outstanding as of December 31, 2024 | $4.3K | $699 | |
| Additional paid-in capital | $548.0M | $369.7M | |
| Accumulated deficit | -$688.8M | -$395.4M | |
| Total stockholders' deficit | -$140.7M | -$25.7M | -$28.5M |
| Total liabilities, redeemable preferred stock and stockholders' deficit | $98.0M | $37.1M | |
| Preferred stock, par value (in dollars per share) | $0.00 | ||
| Preferred stock, shares authorized | 100.0M shares | ||
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 250.0M shares | 125.0M shares | |
| Common stock, shares issued | 43.3M shares | 7.0M shares | |
| Common stock, shares outstanding | 43.3M shares | 7.0M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $82.3M | $21.4M | |
| Restricted cash | $100.0K | $100.0K | |
| Prepaid expenses and other current assets | $697.7K | $806.9K | |
| Total current assets | $83.1M | $22.3M | |
| Equipment, net | $0 | $5.4K | |
| Goodwill | $14.9M | $14.9M | |
| Total assets | $98.0M | $37.1M | |
| Accounts payable | $639.7K | $1.6M | |
| Accrued expenses and other current liabilities | $1.7M | $1.2M | |
| Total current liabilities | $2.3M | $2.8M | |
| Warrant liability | $171.5M | $0 | |
| Liability related to the sale of future royalties | $60.0M | $60.0M | |
| Total liabilities | $233.8M | $62.8M | |
| Common stock; $0.0001 par value; 250,000,000 shares authorized; 43,274,398 shares issued and outstanding as of December 31, 2025 and 125,000,000 shares authorized; 6,993,406 shares issued and outstanding as of December 31, 2024 | $4.3K | $699 | |
| Additional paid-in capital | $548.0M | $369.7M | |
| Accumulated deficit | -$688.8M | -$395.4M | |
| Total stockholders' deficit | -$140.7M | -$25.7M | -$28.5M |
| Total liabilities, redeemable preferred stock and stockholders' deficit | $98.0M | $37.1M | |
| Preferred stock, par value (in dollars per share) | $0.00 | ||
| Preferred stock, shares authorized | 100.0M shares | ||
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 250.0M shares | 125.0M shares | |
| Common stock, shares issued | 43.3M shares | 7.0M shares | |
| Common stock, shares outstanding | 43.3M shares | 7.0M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.12
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net (loss) income | -$293.4M | $1.4M |
| Depreciation and amortization | $5.4K | $5.4K |
| Amortization of capitalized software | $17.0K | |
| Stock-based compensation expense | $1.3M | $1.3M |
| Loss on issuance of convertible preferred stock and warrants | $321.5M | |
| Warrant issuance cost | $3.1M | |
| Changes in fair value of the warrant liability | -$45.4M | |
| Non-cash interest expense associated with the sale of future royalties | $4.6M | |
| Remeasurement of liability related to sale of future royalties | -$26.6M | |
| Prepaid expenses and other current assets | $109.2K | $183.0K |
| Accounts payable | -$1.1M | -$197.5K |
| Accrued expenses and other current liabilities | $317.4K | -$306.1K |
| Net cash used in operating activities | -$13.5M | -$19.6M |
| Net cash provided by investing activities | $0 | $0 |
| Proceeds from sales of common stock and warrants in private placement | $80.0M | |
| Costs paid in connection with private placement | -$5.4M | |
| Payment of deferred offering costs | -$155.9K | |
| Net cash provided by (used in) financing activities | $74.5M | |
| Net increase (decrease) in cash, cash equivalents and restricted cash | $60.9M | -$19.6M |
| Initial recognition of warrant liability at fair value | $216.9M | |
| Deferred issuance costs included in accounts payable and accrued expenses | $195.2K |
No quarter-by-quarter statement was filed.
Compare Minerva Neurosciences (United States) with another company
Corporate structure
Minerva Neurosciences (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Minerva Neurosciences (United States)
- BALYASNY ASSET MANAGEMENT L.P. Filed SCHEDULE 13G/A on Minerva Neurosciences (United States), latest Aug 14, 2026 (3 filings since Feb 17, 2026)
- FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G/A on Minerva Neurosciences (United States), latest Aug 13, 2026
- Janus Henderson Group Ltd. Filed SCHEDULE 13G on Minerva Neurosciences (United States), latest May 15, 2026
- Coastlands Capital LP Filed SCHEDULE 13G on Minerva Neurosciences (United States), latest Feb 20, 2026
- Logos Global Management LP Filed SCHEDULE 13G on Minerva Neurosciences (United States), latest Feb 17, 2026
- Adage Capital Management, L.P. Filed SCHEDULE 13G on Minerva Neurosciences (United States), latest Feb 12, 2026
- Farallon Capital Partners, L.P. Filed SCHEDULE 13G/A on Minerva Neurosciences (United States), latest Feb 5, 2026 (2 filings since Dec 29, 2025)
- Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G on Minerva Neurosciences (United States), latest Dec 31, 2025
- Boehringer AG Filed SCHEDULE 13D/A on Minerva Neurosciences (United States), latest Dec 30, 2025 (2 filings since Jul 7, 2023)
- FMR LLC Filed SC 13G/A on Minerva Neurosciences (United States), latest Nov 12, 2024 (2 filings since Feb 9, 2024)
- Point72 Asset Management, L.P. Filed SC 13G/A on Minerva Neurosciences (United States), latest Feb 14, 2023 (2 filings since Aug 23, 2022)
- VANGUARD GROUP INC Filed SC 13G/A on Minerva Neurosciences (United States), latest Feb 9, 2023 (2 filings since Feb 10, 2022)
- Minerva Neurosciences (United States) Waltham
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Minerva Neurosciences (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $012 Dec 31, 2025 | $5.4K12 Dec 31, 2024 | −100.0% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $82.3M12 Dec 31, 2025 | $21.4M12 Dec 31, 2024 | +285.3% |
Intangibles and goodwill
Properties, in its own words
Our principal executive offices are located at 1500 District Avenue, Burlington, MA 01803. We lease this facility, which consists of approximately 88 square feet of office space. The lease is on a month-to-month basis, with the renewed agreement commencing on February 1, 2026. We believe that our existing facility is sufficient for our current needs for the foreseeable future.
Item 2 of the 10-K filed Mar 11, 2026.15
Leadership
Who has led Minerva Neurosciences (United States), and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerRemy Luthringer Apr 16, 2015 to now16
- Chief executive officerCoelho Rogerio Vivaldi Jun 30, 2014 to Sep 26, 201417
- PresidentGeoff Race Feb 18, 2022 to now18
- PresidentRichard E. Russell Dec 12, 2017 to Aug 17, 202019
- PresidentRemy Luthringer Apr 16, 2015 to Feb 7, 201716
- PresidentCoelho Rogerio Vivaldi Jun 30, 2014 to Sep 26, 201417
- Chief financial officerFrederick W. Ahlholm Feb 18, 2022 to now20
- Chief financial officerGeoff Race Jun 30, 2014 to Dec 16, 202021
- Chief operating officerJoseph H. Reilly Apr 16, 2015 to now22
Board members and other officers (19)
- Chief Accounting OfficerAnthony Aliquo Aug 20, 2026 to now23
- SVP and Head of R&DJay Saoud Sep 5, 2017 to Oct 14, 202024
- Chief Accounting OfficerFrederick W. Ahlholm Jun 30, 2014 to Dec 16, 202025
- Chief Business OfficerJoseph H. Reilly Jun 30, 2014 to Jul 9, 201426
- EVP and Head of R&DRemy Luthringer Jun 30, 2014 to Jul 11, 201427
- Board memberInderjit Kaul Nov 18, 2025 to now28
- Board memberJeryl L. Hilleman Jul 17, 2018 to Sep 29, 202329
- Board memberHans Peter Hasler Dec 12, 2017 to now30
- Board memberRemy Luthringer Apr 16, 2015 to now16
- Board memberFouzia Laghrissi-Thode May 18, 2015 to now31
- Board memberDavid Kupfer Nov 3, 2015 to now32
- Board memberCoelho Rogerio Vivaldi Jun 30, 2014 to Sep 26, 201417
- Board memberHeek G. Jan Van Jun 30, 2014 to now33
- Board memberLorenzo Pellegrini Jun 30, 2014 to Jul 9, 201434
- Board memberMarc D. Beer Jun 30, 2014 to Feb 2, 201835
- Board memberMichele Ollier Jun 30, 2014 to Dec 14, 201636
- Board memberRubertis Francesco De Jun 30, 2014 to Dec 14, 201637
- Board memberNico Vandervelpen Sep 3, 2014 to Jul 26, 201738
- General counselDevin Whittemore Smith Aug 2, 2018 to Oct 14, 202039
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorJan Peter van Heek named Jul 3, 202340
Timeline
- Aug 12, 20268-K Executive or director change41
- Aug 7, 20268-K Results of operations42
- Jun 4, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Shareholder vote43
- May 27, 20268-K Entered a material agreement; Other events44
- May 5, 20268-K Results of operations45
- Apr 6, 20268-K Other events46
- Apr 2, 20268-K Executive or director change; Regulation FD disclosure; Other events47
- Mar 11, 20268-K Results of operations48
- Feb 3, 20268-K Regulation FD disclosure; Other events49
- Dec 22, 20258-K Executive or director change; Shareholder vote50
- Nov 19, 20258-K Executive or director change; Regulation FD disclosure51
- Oct 22, 20258-K Entered a material agreement; Unregistered sale of shares; Bylaws or fiscal year changed52
- Apr 16, 2015New chief executive Remy Luthringer becomes CEO16
- Jun 30, 2014New chief executive Coelho Rogerio Vivaldi becomes CEO17
- 2007Founded Founded1
Calendar
Coming up
- Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.36) a share, on Nov 5, 2025.53
When it reported results
- Aug 7, 2026Reported quarterly or annual results42
- May 5, 2026Reported quarterly or annual results45
- Mar 11, 2026Reported quarterly or annual results48
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
199 filings to the SEC since October 2021: 10 annual reports, 15 quarterly reports, 43 major events, 57 insider forms, 28 large holders, 1 private raises, 45 other. The latest 20:
- Aug 20, 20263 EDGAR
- Aug 20, 20263 EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 13, 2026SCHEDULE 13G/A EDGAR
- Aug 12, 20268-K EDGAR
- Aug 7, 202610-Q EDGAR
- Aug 7, 20268-K EDGAR
- Aug 3, 20264 EDGAR
- Jul 8, 2026SCHEDULE 13G/A EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 5, 20264 EDGAR
- Jun 4, 20268-K EDGAR
- May 27, 20268-K EDGAR
- May 27, 2026424B5 EDGAR
- May 15, 2026SCHEDULE 13G EDGAR
The 199 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
5 open-market trades by officers, directors and large owners since October 2021: 0 buys and 5 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| May 2, 2023 | Luthringer RemyCEO | Sale | 3,641 | $3.76 | $13.7K | Form 4 |
| May 1, 2023 | Luthringer RemyCEO | Sale | 23,753 | $3.85 | $91.4K | Form 4 |
| May 1, 2023 | Race GeoffPresident | Sale | 22,082 | $3.85 | $85.0K | Form 4 |
| May 1, 2023 | Ahlholm Frederick WSVP, CFO and Secretary | Sale | 3,580 | $4.48 | $16.0K | Form 4 |
| Dec 1, 2021 | Kupfer DavidDirector | Sale | 55,635 | $0.88 | $49.0K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- BALYASNY ASSET MANAGEMENT L.P.SCHEDULE 13G/A, 3 filings Feb 17, 2026 to Aug 14, 202654
- FARALLON CAPITAL MANAGEMENT, L.L.C.SCHEDULE 13G/A, 1 filing Aug 13, 202655
- Janus Henderson Group Ltd.SCHEDULE 13G, 1 filing May 15, 202656
- Coastlands Capital LPSCHEDULE 13G, 1 filing Feb 20, 202657
- Logos Global Management LPSCHEDULE 13G, 1 filing Feb 17, 202658
- Adage Capital Management, L.P.SCHEDULE 13G, 1 filing Feb 12, 202659
- Farallon Capital Partners, L.P.SCHEDULE 13G/A, 2 filings Dec 29, 2025 to Feb 5, 202660
- Vivo Opportunity Fund Holdings, L.P.SCHEDULE 13G, 1 filing Dec 31, 202561
- Boehringer AGSCHEDULE 13D/A, 2 filings Jul 7, 2023 to Dec 30, 202562
- FMR LLCSC 13G/A, 2 filings Feb 9, 2024 to Nov 12, 202463
- Point72 Asset Management, L.P.SC 13G/A, 2 filings Aug 23, 2022 to Feb 14, 202364
- VANGUARD GROUP INCSC 13G/A, 2 filings Feb 10, 2022 to Feb 9, 202365
- Remy LuthringerSC 13G/A, 1 filing Feb 11, 202266
- Assenagon Asset Management S.A.SC 13G, 2 filings Nov 24, 202167
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Dr. Remy Luthringer | 65 | $675.0K | $9.4M68 |
| 2025 | Geoffrey Race | $511.7K | $6.3M68 | |
| 2025 | Frederick Ahlholm | 60 | $467.5K | $2.5M68 |
| 2024 | Chief Executive Officer | $649.1K | $1.2M68 | |
| 2024 | Former President | $492.0K | $919.7K68 | |
| 2024 | Chief Financial Officer | $449.5K | $754.2K68 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Jun 30, 2023Filed a private offering of equity Form D: $20 million offered in all Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 58. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Federated Hermes, Inc. | 4,670,426 | $25.9M | 0.0% | −442,798 |
| Jupiter Topco LLC | 4,386,027 | $24.3M | 0.0% | New |
| Vivo Capital, LLC | 4,322,747 | $24.0M | 2.2% | No change |
| Balyasny Asset Management L.P. | 4,257,000 | $23.6M | 0.0% | −1,600 |
| Logos Global Management LP | 3,288,777 | $18.3M | 0.8% | +73,777 |
| Farallon Capital Management, L.l.c. | 2,365,000 | $13.1M | 0.1% | No change |
| BlackRock, Inc. | 2,240,578 | $12.4M | 0.0% | +1,615,721 |
| Ally Bridge Group (NY) LLC | 2,175,802 | $12.1M | 15.6% | +520,302 |
| Foresite Capital Management VI LLC | 1,985,584 | $11.0M | 1.7% | −1,016 |
| Vanguard Capital Management LLC | 1,892,807 | $10.5M | 0.0% | +46,976 |
| Spruce Street Capital LP | 1,655,500 | $9.2M | 1.8% | No change |
| Adage Capital Partners Gp, L.l.c. | 1,419,000 | $7.9M | 0.0% | No change |
| Trails Edge Capital Partners, LP | 1,419,000 | $7.9M | 1.3% | No change |
| Seven Fleet Capital Management LP | 1,001,373 | $5.6M | 0.9% | +752,897 |
| Geode Capital Management, LLC | 974,236 | $5.4M | 0.0% | +635,501 |
| Dv Equities, LLC | 754,397 | $4.2M | 0.6% | New |
| Acuta Capital Partners, LLC | 709,500 | $3.9M | 2.7% | No change |
| Millennium Management LLC | 533,602 | $3.0M | 0.0% | −174,689 |
| State Street Corp | 424,915 | $2.4M | 0.0% | +368,566 |
| Vanguard Fiduciary Trust Co | 302,604 | $1.7M | 0.0% | +38,557 |
| Northern Trust Corp | 292,117 | $1.6M | 0.0% | +198,809 |
| Vanguard Portfolio Management LLC | 234,754 | $1.3M | 0.0% | New |
| Goldman Sachs Group Inc | 143,954 | $798.9K | 0.0% | +111,942 |
| Charles Schwab Investment Management Inc | 113,625 | $630.6K | 0.0% | +82,625 |
| Bank of New York Mellon Corp | 75,580 | $419.5K | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Minerva Neurosciences (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARMinerva Neurosciences, Inc.2
- CIK0001598646
- Employer ID (EIN)26-078419415
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company15
- Incorporated inDelaware15
- Fiscal year endsDecember 312
- Industry code (SIC)2834 Pharmaceutical Preparations2
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
- Business address1500 District Avenue, Burlington, MA 018032
- Phone617-600-73732
- Shares outstanding47,747,559 as of Aug 4, 202614
- Public float$7.0M as of Jun 30, 202515
- AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; no auditor attestation of internal control over financial reporting15
- On EDGAR sinceFeb 14, 20142
- Filings643 in all: 4 (228), 8-K (129), 10-Q (37), SC 13G/A (36), 3 (31), CORRESP (14), SC 13G (13), 10-K (12)2
All 45 form types
DEF 14A (12), DEFA14A (11), UPLOAD (10), S-8 (9), SC 13D/A (9), EFFECT (8), SCHEDULE 13G (8), 424B3 (7), 144 (6), S-3 (6), 10-K/A (5), 424B5 (5), SCHEDULE 13G/A (5), ARS (4), PRE 14A (4), S-1/A (4), SC 13D (4), D (3), 3/A (2), 424B4 (2), S-1 (2), SC TO-I/A (2), 4/A (1), 5 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), CT ORDER (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), POS AM (1), RW (1), SC TO-I (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 11, 2026
Quarterly report (10-Q) Aug 7, 2026
Proxy statement (DEF 14A) Apr 23, 2026
Latest 8-K (8-K) Aug 12, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value per share | NERV | Nasdaq |
From the cover page of the 10-K filed Mar 11, 2026 (Section 12(b) of the Exchange Act).15
Risk factors and legal proceedings
The risks Minerva Neurosciences (United States) names in Item 1A of its 10-K filed Mar 11, 2026: 75 risks under these headings, as written.15
- Risks Related to Our Financial Position and Capital Requirements
- We have incurred significant losses since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.
- We will require additional capital to finance our operations, which may not be available to us on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
- Raising additional funds by issuing equity securities will cause dilution to existing stockholders. Raising additional funds through debt financings may involve restrictive covenants and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- Our ability to use net operating losses (“NOL”) carryforwards may be limited.
- Changes in tax laws or tax rulings could materially affect our financial position, results of operations, and cash flows.
- Risks Related to Our Business and Industry
- Our business is highly dependent on the success of roluperidone, as well as any other potential future product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, roluperidone or any other potential future product candidates, or if we experience delays in doing so, our business will be materially harmed.
- We cannot give any assurance that any of our product candidates will receive regulatory approval in a timely manner or at all, which is necessary before they can be commercialized.
- Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.
- The results of clinical trials conducted at sites outside the United States may not be accepted by the FDA and the results of clinical trials conducted at sites in the United States may not be accepted by comparable foreign regulatory authorities.
- If we experience delays in clinical testing, we will be delayed in commercializing our product candidates, our costs may increase and our business may be harmed.
The other 65 risks
- Disruptions at the FDA and other government agencies or foreign regulatory authorities caused by funding shortages or global health concerns could negatively impact our business.
- We have no experience in advancing product candidates beyond Phase 3, which makes it difficult to assess our ability to develop and commercialize our product candidates.
- If we are unable to enroll subjects in clinical trials, we will be unable to complete these trials on a timely basis or at all.
- Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization, and also increase costs.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Even if we complete the necessary clinical trials, we cannot predict when or if we will obtain regulatory approval to commercialize a product candidate or the approval may be for a narrower indication than we expect.
- Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties, including ongoing regulatory obligations and continued regulatory review. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to administrative sanctions or penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
- If the market opportunities for any product that we or our collaborators develop are smaller than we believe, our revenue may be adversely affected and our business may suffer.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- Our failure to obtain regulatory approval in additional international jurisdictions would prevent us from marketing our product candidates outside the European Union and the United States.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
- Even if any of our drug candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- We currently have no marketing and sales organization. If we are unable to establish greater marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.
- Even if we commercialize any of our product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
- Recently enacted and future legislation may increase the difficulty and cost for us to commercialize our product candidates and affect the prices we may obtain.
- Our international operations are subject to foreign currency and exchange rate risks.
- A variety of risks associated with international operations could materially adversely affect our business.
- If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
- Future acquisitions, mergers or joint ventures could disrupt our business and otherwise harm our business.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- Our business and operations would suffer in the event of system failures.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Our employees, independent contractors, principal investigators, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- We are subject to the Foreign Corrupt Practices Act.
- We are subject to stringent and evolving U.S. and foreign laws, regulations and rules, contractual obligations, policies, industry standards, and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- If our information technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
- Risks Related to Our Dependence on Third Parties
- We currently rely and continue to expect to rely on third parties to conduct our future clinical trials. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could substantially harm our business because we may not obtain regulatory approval for or commercialize our product candidates in a timely manner or at all.
- We contract with third parties for the manufacturing of our product candidates for pre-clinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
- We may engage third party collaborators to market and commercialize our product candidates, who may fail to effectively commercialize our product candidates.
- We depend on our collaboration with Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation) (“Tanabe Pharma”) , and could be seriously harmed if our license agreement with Tanabe Pharma was terminated.
- Substantial potential future milestone payments from Royalty Pharma depend on the development and commercialization of seltorexant. We may be obligated to make payments to Royalty Pharma even if Janssen breaches its obligations to pay us.
- We may not be successful in establishing new collaborations which could adversely affect our ability to develop future product candidates and commercialize future products.
- Risks Related to Intellectual Property
- If we are unable to obtain or protect intellectual property rights, we may not be able to compete effectively in our market.
- One or more of our owned or licensed patents directed to our proprietary products or technologies may expire or have limited commercial life before the proprietary product or technology is approved for marketing in a relevant jurisdiction.
- We have in-licensed or acquired a portion of our intellectual property necessary to develop our product candidates, and if we fail to comply with our obligations under any of these arrangements, we could lose such intellectual property rights.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
- We may need to license or acquire additional patents and intellectual property rights.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
- Restrictions on our patent rights relating to our product candidates may limit our ability to prevent third parties from competing against us.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may not be able to protect our intellectual property rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Risks Related to Ownership of Our Common Stock
- We cannot predict what the market price of our common stock will be and, as a result, it may be difficult for you to sell your shares of our common stock.
- The market price of our stock may be volatile, and you could lose all or part of your investment.
- There is no public market for our Series A Preferred Stock.
- Stockholders will be diluted by any conversions of outstanding Series A Preferred Stock and exercises of outstanding warrants.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
- Our management will continue to have broad discretion over the use of the proceeds we received in our public offerings, private placements, warrant exercises and loans and might not apply the proceeds in ways that increase the value of your investment.
- Future sales and issuances of equity and debt securities could result in additional dilution to our stockholders and could place restrictions on our operations and assets, and such securities could have rights, preferences and privileges senior to those of our common stock.
- We incur increased costs and demands upon management as a result of being a public company.
- We are a “smaller reporting company” and, because we have opted to use the reduced reporting requirements available to us, certain investors may find investing in our securities less attractive.
- Securities litigation could result in substantial damages and may divert management’s time and attention from our business.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- If securities or industry analysts cease publishing research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
- We have never paid dividends on our capital stock, and because we do not anticipate paying any cash dividends in the foreseeable future, capital appreciation, if any, of our common stock will be your sole source of gain on an investment in our common stock.
- Our common stock may be delisted from The Nasdaq Capital Market which could negatively impact the price of our common stock, liquidity and our ability to access the capital markets.
Legal proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of the date of this Form 10-K, we do not believe we are party to any claim or litigation, the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
The opening of Item 3, Legal Proceedings.15
Links
- Websitewww.minervaneurosciences.com1
- WikidataQ43896252
- SEC EDGARCIK 1598646
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1
- 2
- 3Company websiteMinerva Neurosciences (United States) logo
- 4
- 5Company websiteMinerva Neurosciences (United States) photo
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18SEC EDGARGeoff Race, President
- 19SEC EDGARRichard E. Russell, President
- 20
- 21SEC EDGARGeoff Race, Chief financial officer
- 22
- 23
- 24SEC EDGARJay Saoud, SVP and Head of R&D
- 25
- 26
- 27SEC EDGARRemy Luthringer, EVP and Head of R&D
- 28SEC EDGARInderjit Kaul, Board member
- 29SEC EDGARJeryl L. Hilleman, Board member
- 30SEC EDGARHans Peter Hasler, Board member
- 31SEC EDGARFouzia Laghrissi-Thode, Board member
- 32SEC EDGARDavid Kupfer, Board member
- 33SEC EDGARHeek G. Jan Van, Board member
- 34SEC EDGARLorenzo Pellegrini, Board member
- 35SEC EDGARMarc D. Beer, Board member
- 36SEC EDGARMichele Ollier, Board member
- 37SEC EDGARRubertis Francesco De, Board member
- 38SEC EDGARNico Vandervelpen, Board member
- 39
- 40
- 41SEC EDGARExecutive or director change
- 42SEC EDGARResults of operations
- 43
- 44
- 45SEC EDGARResults of operations
- 46SEC EDGAROther events
- 47
- 48SEC EDGARResults of operations
- 49
- 50
- 51
- 52
- 53NasdaqNasdaq calendar
- 54
- 55
- 56
- 57
- 58
- 59
- 60
- 61
- 62
- 63
- 64
- 65
- 66
- 67
- 68