Overview
- TickerRVPH on OTC1
- IndustryPharmaceutical Preparations1
- HeadquartersCupertino, California1
- Incorporated inDE2
- Business address10080 N Wolfe Road, Suite Sw3-200, Cupertino, Ca 950142
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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All references in this report to “Reviva,” the “Company,” “we,” “us,” or “our” mean Reviva Pharmaceuticals Holdings, Inc. and its subsidiaries unless we state otherwise, or the context otherwise indicates.3 From its latest annual report
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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $11.7M | $22.9M |
| General and administrative | $8.5M | $7.9M |
| Total operating expenses | $20.2M | $30.8M |
| Loss from operations | -$20.2M | -$30.8M |
| Gain on remeasurement of warrant liabilities | $89.0K | $717.6K |
| Interest expense | -$13.4K | -$18.5K |
| Interest income | $311.4K | $361.4K |
| Other expense, net | -$33.0K | -$160.9K |
| Total other income, net | $354.0K | $899.6K |
| Loss before provision for income taxes | -$19.8M | -$29.9M |
| Provision for income taxes | $18.9K | $19.5K |
| Net loss | -$19.9M | -$29.9M |
| Basic and diluted (in dollars per share) | -$5.48 | -$17.73 |
| Basic and diluted (in shares) | 3.6M shares | 1.7M 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.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $14.4M | $13.5M | |
| Prepaid clinical trial costs | $0 | $540.6K | |
| Prepaid expenses and other current assets | $664.7K | $666.4K | |
| Total current assets | $15.1M | $14.7M | |
| Non-current prepaid clinical trial costs | $819.7K | $819.7K | |
| Total Assets | $15.9M | $15.5M | |
| Short-term debt | $406.9K | $458.2K | |
| Accounts payable | $3.0M | $6.3M | |
| Accrued clinical expenses | $2.6M | $6.7M | |
| Accrued compensation | $485.9K | $635.6K | |
| Other accrued liabilities | $791.6K | $500.6K | |
| Total current liabilities | $7.3M | $14.6M | |
| Warrant liabilities | $0 | $89.0K | |
| Total Liabilities | $7.3M | $14.7M | |
| Common stock, par value of $0.0001; 515,000,000 and 315,000,000 shares authorized; 5,842,497 and 2,328,960 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $11.7K | $4.7K | |
| Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2025 and 2024 | $0 | $0 | |
| Additional paid-in capital | $192.8M | $165.1M | |
| Accumulated deficit | -$184.1M | -$164.3M | |
| Total stockholders' equity | $8.6M | $812.6K | $5.7M |
| Total Liabilities and Stockholders Equity | $15.9M | $15.5M | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in shares) | 515.0M shares | 315.0M shares | |
| Common Stock, Shares, Outstanding (in shares) | 5.9M shares | 2.4M shares | |
| Common Stock, Shares, Issued (in shares) | 5.9M shares | 2.4M shares | |
| Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $0.00 | $0.00 | |
| Preferred Stock, Shares Authorized (in shares) | 10.0M shares | 10.0M shares | |
| Preferred Stock, Shares Issued (in shares) | 0 shares | 0 shares | |
| Preferred Stock, Shares Outstanding (in shares) | 0 shares | 0 shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $14.4M | $13.5M | |
| Prepaid clinical trial costs | $0 | $540.6K | |
| Prepaid expenses and other current assets | $664.7K | $666.4K | |
| Total current assets | $15.1M | $14.7M | |
| Non-current prepaid clinical trial costs | $819.7K | $819.7K | |
| Total Assets | $15.9M | $15.5M | |
| Short-term debt | $406.9K | $458.2K | |
| Accounts payable | $3.0M | $6.3M | |
| Accrued clinical expenses | $2.6M | $6.7M | |
| Accrued compensation | $485.9K | $635.6K | |
| Other accrued liabilities | $791.6K | $500.6K | |
| Total current liabilities | $7.3M | $14.6M | |
| Warrant liabilities | $0 | $89.0K | |
| Total Liabilities | $7.3M | $14.7M | |
| Common stock, par value of $0.0001; 515,000,000 and 315,000,000 shares authorized; 5,842,497 and 2,328,960 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $11.7K | $4.7K | |
| Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2025 and 2024 | $0 | $0 | |
| Additional paid-in capital | $192.8M | $165.1M | |
| Accumulated deficit | -$184.1M | -$164.3M | |
| Total stockholders' equity | $8.6M | $812.6K | $5.7M |
| Total Liabilities and Stockholders Equity | $15.9M | $15.5M | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in shares) | 515.0M shares | 315.0M shares | |
| Common Stock, Shares, Outstanding (in shares) | 5.9M shares | 2.4M shares | |
| Common Stock, Shares, Issued (in shares) | 5.9M shares | 2.4M shares | |
| Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $0.00 | $0.00 | |
| Preferred Stock, Shares Authorized (in shares) | 10.0M shares | 10.0M shares | |
| Preferred Stock, Shares Issued (in shares) | 0 shares | 0 shares | |
| Preferred Stock, Shares Outstanding (in shares) | 0 shares | 0 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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$19.9M | -$29.9M |
| Change in fair value of warrant liabilities | -$89.0K | -$717.6K |
| Stock-based compensation expense | $2.2M | $1.6M |
| Prepaid clinical trial costs (current and non-current) | $540.6K | -$1.3M |
| Prepaid expenses and other current assets | $1.8K | -$411.8K |
| Accounts payable | -$3.4M | $2.3M |
| Accrued expenses and other current liabilities | -$4.0M | -$5.1M |
| Net cash used in operating activities | -$24.6M | -$33.5M |
| Proceeds from issuance of short-term debt | $406.9K | $976.9K |
| Repayment of short-term debt | -$458.2K | -$518.8K |
| Proceeds from issuance of common stock, common stock warrants, prefunded warrants and from modification of existing warrants, in offerings, net of transaction costs | $17.2M | $23.2M |
| Net cash provided by financing activities | $25.6M | $23.7M |
| Net decrease in cash and cash equivalents | $962.5K | -$9.9M |
| Cash paid for taxes | $3.4K | $3.4K |
| Cash paid for interest | $13.4K | $18.5K |
| Settlement of bonuses in form of stock options | $0 | $330.8K |
| Warrant modification recorded in stockholders' equity | $0 | $1.1M |
| Transaction costs related to offerings included in accounts payable and accrued expenses | $136.3K | $143.1K |
No quarter-by-quarter statement was filed.
Compare REVIVA PHARMACEUTICALS HOLDINGS, INC. with another company
Corporate structure
REVIVA PHARMACEUTICALS HOLDINGS, INC. 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 REVIVA PHARMACEUTICALS HOLDINGS, INC.
- Barclays Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Aug 13, 2026 (2 filings since May 14, 2026)
- INTEGRATED CORE STRATEGIES (US) LLC Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Aug 3, 2026 (4 filings since Aug 14, 2024)
- UBS Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Jul 31, 2026 (2 filings since May 7, 2026)
- CVI Investments, Inc. Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest May 15, 2026 (6 filings since Dec 23, 2024)
- Parag Saxena Filed SCHEDULE 13D/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Mar 24, 2026 (6 filings since Aug 23, 2024)
- 683 Capital Management, LLC Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Feb 17, 2026 (2 filings since Sep 29, 2025)
- Laxminarayan Bhat Filed SCHEDULE 13D/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Sep 24, 2025 (6 filings since May 5, 2023)
- HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Aug 14, 2025
- TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Aug 14, 2025 (2 filings since May 15, 2025)
- Schonfeld Strategic Advisors LLC Filed SCHEDULE 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- VEDANTA PARTNERS, LLC Filed SC 13D/A on REVIVA PHARMACEUTICALS HOLDINGS, INC., latest May 31, 2024 (3 filings since Sep 12, 2022)
- REVIVA PHARMACEUTICALS HOLDINGS, INC. Cupertino, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What REVIVA PHARMACEUTICALS HOLDINGS, INC. 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.
Investments
Properties, in its own words
Our principal offices are located at 10080 N. Wolfe Road, Suite SW3-200, Cupertino, California 95014. The facility is subject to a lease which was extended through December 31, 2026. The facility is used for office space only, and we believe the facility is adequate for our foreseeable needs. We operate primarily as a virtual company.
Item 2 of the 10-K filed Mar 30, 2026.3
Leadership
Who has led REVIVA PHARMACEUTICALS HOLDINGS, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chair
President
Chief financial officer
- Chief executive officerLaxminarayan Bhat Dec 18, 2020 to now12
- Chief executive officerRahul Nayar Aug 20, 2018 to Sep 4, 201813
- ChairParag Saxena Aug 20, 2018 to Sep 4, 201814
- PresidentLaxminarayan Bhat Dec 18, 2020 to now12
- Chief financial officerNarayan Parbhu Dec 18, 2020 to now15
- Chief financial officerGonzalo Cordova Aug 20, 2018 to Aug 20, 201816
Board members and other officers (10)
- Chief Medical OfficerMarc Cantillon Dec 18, 2020 to Dec 18, 202017
- Vice PresidentAtanuu Agarrwal Aug 20, 2018 to Aug 20, 201818
- Board memberLeslie D. Funtleyder Jun 16, 2021 to now19
- Board memberLaxminarayan Bhat Dec 18, 2020 to now12
- Board memberPurav Patel Dec 18, 2020 to now20
- Board memberRichard A. Margolin Dec 18, 2020 to now21
- Board memberParag Saxena Dec 28, 2020 to now22
- Board memberNina B. Shapiro Aug 20, 2018 to Aug 20, 201823
- Board memberRahul Nayar Aug 20, 2018 to Sep 4, 201813
- Board memberVikas Thapar Aug 20, 2018 to Aug 20, 201824
Named in SEC Form D filings
People the company listed in its private-offering notices.
- Executive OfficerNarayan Prabhu named Sep 19, 202225
Former names
- Tenzing Acquisition Corp.Jun 19, 2018 to Dec 14, 20202
Timeline
- Aug 12, 20268-K Results of operations; Regulation FD disclosure26
- May 13, 20268-K Listing notice or transfer; Other events27
- May 13, 20268-K Results of operations; Regulation FD disclosure28
- Apr 15, 20268-K Regulation FD disclosure; Other events29
- Mar 30, 20268-K Results of operations; Regulation FD disclosure30
- Mar 19, 20268-K Entered a material agreement; Regulation FD disclosure31
- Mar 5, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events32
- Jan 23, 20268-K Listing notice or transfer; Other events33
- Dec 23, 20258-K Bylaws or fiscal year changed; Shareholder vote; Regulation FD disclosure34
- Nov 13, 20258-K Results of operations; Regulation FD disclosure35
- Oct 17, 20258-K Listing notice or transfer36
- Sep 26, 20258-K Bylaws or fiscal year changed37
- Dec 18, 2020New chief executive Laxminarayan Bhat becomes CEO12
- Aug 20, 2018New chief executive Rahul Nayar becomes CEO13
Calendar
Coming up
- Around Nov 11, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.
When it reported results
- Aug 12, 2026Reported quarterly or annual results26
- May 13, 2026Reported quarterly or annual results28
- Mar 30, 2026Reported quarterly or annual results30
- Nov 13, 2025Reported quarterly or annual results35
- Aug 14, 2025Reported quarterly or annual results38
- May 15, 2025Reported quarterly or annual results39
- Mar 31, 2025Reported quarterly or annual results40
- Nov 14, 2024Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
222 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 64 major events, 33 insider forms, 41 large holders, 1 private raises, 63 other. The latest 20:
- Aug 13, 2026SCHEDULE 13G/A EDGAR
- Aug 12, 202610-Q EDGAR
- Aug 12, 20268-K EDGAR
- Aug 3, 2026SCHEDULE 13G/A EDGAR
- Jul 31, 2026SCHEDULE 13G/A EDGAR
- Jul 10, 202625-NSE EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 14, 2026SCHEDULE 13G EDGAR
- May 13, 202610-Q EDGAR
- May 13, 20268-K EDGAR
- May 13, 20268-K EDGAR
- May 7, 2026SCHEDULE 13G EDGAR
- Apr 15, 20268-K EDGAR
- Mar 30, 2026S-8 EDGAR
- Mar 30, 20268-K EDGAR
- Mar 30, 202610-K EDGAR
- Mar 30, 2026SCHEDULE 13G EDGAR
- Mar 25, 2026SCHEDULE 13G EDGAR
- Mar 24, 2026SCHEDULE 13D/A EDGAR
- Mar 20, 20264 EDGAR
The 222 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
3 open-market trades by officers, directors and large owners since October 2021: 3 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 18, 2022 | Patel PuravDirector | Buy | 3,000 | $4.69 | $14.1K | Form 4 |
| Sep 30, 2022 | Narayan PrabhuChief Financial Officer | Buy | 50,000 | $1.66 | $83.0K | Form 4 |
| Jun 30, 2022 | Narayan PrabhuChief Financial Officer | Buy | 50,000 | $1.21 | $60.5K | 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.
- BarclaysSCHEDULE 13G/A, 2 filings May 14, 2026 to Aug 13, 202642
- INTEGRATED CORE STRATEGIES (US) LLCSCHEDULE 13G/A, 4 filings Aug 14, 2024 to Aug 3, 202643
- UBSSCHEDULE 13G/A, 2 filings May 7, 2026 to Jul 31, 202644
- CVI Investments, Inc.SCHEDULE 13G/A, 6 filings Dec 23, 2024 to May 15, 202645
- Parag SaxenaSCHEDULE 13D/A, 6 filings Aug 23, 2024 to Mar 24, 202646
- 683 Capital Management, LLCSCHEDULE 13G/A, 2 filings Sep 29, 2025 to Feb 17, 202647
- Laxminarayan BhatSCHEDULE 13D/A, 6 filings May 5, 2023 to Sep 24, 202548
- HIGHBRIDGE CAPITAL MANAGEMENT LLCSCHEDULE 13G, 1 filing Aug 14, 202549
- TANG CAPITAL MANAGEMENT LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202550
- Schonfeld Strategic Advisors LLCSCHEDULE 13G/A, 2 filings Nov 14, 2024 to Feb 14, 202551
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202452
- VEDANTA PARTNERS, LLCSC 13D/A, 3 filings Sep 12, 2022 to May 31, 202453
- TANG CAPITAL PARTNERS LPSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202454
- SABBY MANAGEMENT, LLCSC 13G/A, 1 filing Jan 5, 202255
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 |
|---|---|---|---|---|
| 2024 | Laxminarayan BhatPhD | 60 | $450.0K | $607.5K56 |
| 2024 | Narayan Prabhu | 54 | $325.0K | $404.9K56 |
| 2023 | Chief Executive Officer and President | $450.0K | $2.8M56 | |
| 2023 | Chief Financial Officer | $325.0K | $1.2M56 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Sep 8, 2022Filed a private offering of equity Form D: 3 investors so far Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| TD Waterhouse Canada Inc. | 625 | $412 | 0.0% | No change |
| Purpose Unlimited Inc. | 405 | $259 | 0.0% | No change |
| Mosley Wealth Management | 1 | $1 | 0.0% | New |
| Miller Global Investments, LLC | 1 | $1 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How REVIVA PHARMACEUTICALS HOLDINGS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARREVIVA PHARMACEUTICALS HOLDINGS, INC.1
- CIK0001742927
- Employer ID (EIN)85-43065263
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address10080 N Wolfe Road, Suite Sw3-200, Cupertino, CA 950141
- Phone40850188811
- Shares outstanding13,110,377 as of Aug 13, 202611
- Public float$21.4M as of Jun 30, 20253
- AuditorBaker Tilly US, LLP, San Francisco, CA PCAOB ID 23; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJun 19, 20181
- Filings412 in all: 8-K (94), 4 (63), 10-Q (25), 3 (19), 424B3 (14), 424B5 (13), CORRESP (13), EFFECT (12)1
All 40 form types
SC 13D/A (12), SC 13G (11), SCHEDULE 13G/A (11), UPLOAD (11), 425 (10), SC 13G/A (9), 10-K (8), DEF 14A (8), SCHEDULE 13D/A (8), SCHEDULE 13G (8), 424B4 (7), S-1/A (6), POS AM (5), PRE 14A (5), S-8 (5), S-1 (4), 25-NSE (3), 8-K/A (3), ARS (3), DEFA14A (3), S-4/A (3), 10-K/A (2), NT 10-K (2), S-1MEF (2), S-3 (2), SC 13D (2), 8-A12B (1), CERT (1), D (1), DRS (1), POS EX (1), S-4 (1)
- Latest filingsAnnual report (10-K) Mar 30, 2026
Quarterly report (10-Q) Aug 12, 2026
Proxy statement (DEF 14A) Nov 4, 2025
Latest 8-K (8-K) Aug 12, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | RVPH | Nasdaq |
From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks REVIVA PHARMACEUTICALS HOLDINGS, INC. names in Item 1A of its 10-K filed Mar 30, 2026: 60 risks under these headings, as written.3
- Risks Related to Our Business, Financial Position and Capital Requirements
- We have never generated any product revenues.
- We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
- Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern.
- We are heavily dependent on the success of brilaroxazine, our only advanced product candidate, which is still under clinical development, and if brilaroxazine does not receive regulatory approval or is not successfully commercialized, our business will be harmed.
- We face risks related to health epidemics and outbreaks, including any future health crises, pandemics or other widespread health crises or similar events, which could adversely impact our business, including our clinical trials.
- We will require substantial additional capital to finance operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may not be able to complete the development and commercialization of brilaroxazine or RP1208 and we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations, or make changes to our operating plan, or curtail or cease operations.
- Raising additional funds by issuing securities may cause dilution to existing stockholders, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
- Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
- If we seek to enter into strategic alliances for the development of brilaroxazine or RP1208 but fail to enter into and maintain successful strategic alliances, our development costs may increase and our ability to develop brilaroxazine or RP1208 may be significantly delayed.
- To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.
The other 49 risks
- Our business and operations would suffer in the event our computer systems and networks fail.
- Computer system interruptions, cyber-attacks or security breaches could significantly disrupt our product development programs and our ability to operate our business.
- Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
- We have identified material weaknesses in our internal control over financial reporting as of December 31, 2025. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
- If the interpretations, estimates or judgments we use to prepare our financial statements prove to be incorrect, we may be required to restate our financial results, which could have a number of material adverse effects on us.
- Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock price.
- Risks Related to Development, Regulatory Approval and Commercialization
- Drug development is a very expensive, lengthy and uncertain process.
- Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome.
- The results of our clinical trials may not support our brilaroxazine, RP1208 and any future product candidate claims.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside of our control.
- The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- The results of pre-clinical testing are not necessarily predictive of future results, and RP1208 and other product candidates may not have favorable results in our planned clinical trials.
- Changes in product candidate manufacturing or formulation may result in additional costs, delay or non-approval.
- We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
- Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
- Any breakthrough therapy designation granted by the FDA for our product candidate may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidate will receive marketing approval.
- Even if we obtain FDA approval for brilaroxazine, RP1208 or any future product candidate in the United States, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.
- Even if we obtain regulatory approval for brilaroxazine, RP1208 or any future product candidate, we will still face extensive regulatory requirements and our products may face future development and regulatory difficulties.
- Even if brilaroxazine, RP1208 or any future product candidate receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third-parties, we may not be successful in commercializing brilaroxazine, RP1208 or any future product candidate, if approved.
- If we obtain approval to commercialize any products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
- Our subsidiary may not be in compliance with the laws of foreign countries, and it may face penalties and fines imposed by the Indian government.
- We are subject to U.S. foreign investment regulations, which may impose additional burdens on or may limit certain investors’ ability to purchase shares of our common stock in amounts deemed by the U.S. government to confer control, potentially making our common stock less attractive to investors, and may also impact our ability to generate revenues outside of the U.S.
- Our current and future relationships with foreign actors such as, health care and administrative professionals at foreign state owned hospitals or foreign government healthcare regulators will be subject to applicable anti-corruption laws regulatory laws, which could expose us to penalties.
- Our current and future relationships with investigators, health care professionals, consultants, third-party payors, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
- Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize brilaroxazine, RP1208 or any future product candidate and affect the prices we may obtain.
- Coverage and adequate reimbursement may not be available for brilaroxazine, RP1208 or any future product candidate, which could make it difficult for us to sell our products profitably.
- Risks Related to Our Dependence on Third Parties
- We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of brilaroxazine, RP1208 and any future product candidate.
- We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Changes in the U.S. political and regulatory environment could affect availability of government funding that we or our third-party collaborators may rely on, which could negatively impact the development of our product candidates.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
- 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.
- Third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of brilaroxazine, RP1208 and any future product candidate.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
- We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- Risks Related to Our Securities
- We are currently listed on The Nasdaq Capital Market. If we fail to regain and maintain compliance with the requirements of The Nasdaq Capital Market for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
- An active trading market for our common stock may not be sustained.
- Our officers, directors, and principal stockholders exercise significant voting power and influence with respect to matters impacting our Company, including with respect to the outcome of matters requiring stockholder approval.
- A sale of a substantial number of shares of our common stock or warrants in the public market could cause the market price of our common stock to drop significantly, even if our business is doing well.
- If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our common stock, the price of our common stock could decline.
- The price of our common stock may be volatile, which could subject us to securities class action litigation and our stockholders could incur substantial losses.
- Certain of our warrants are accounted for as liabilities and the changes in value of such warrants could have a material effect on our financial results.
- We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, any gains from an investment in our common stock will likely depend on appreciation in the price of our common stock.
- Upon our dissolution, the stockholders may not recoup all or any portion of their investment.
- Our certificate of incorporation, as amended and restated, allows for our board of directors to create new series of preferred stock without further approval by the stockholders, which could adversely affect the rights of the holders of our common stock.
- Delaware law and our certificate of incorporation, as amended and restated, and our bylaws contain certain provisions, including anti-takeover provisions that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable.
- Our certificate of incorporation, as amended and restated, designates a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or employees.
Legal proceedings
We may from time to time, become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. Except as described above, we are currently not aware of any other legal proceedings or claims that may be, individually or in the aggregate, material to us.
The opening of Item 3, Legal Proceedings.3
Sources
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- 13SEC EDGARRahul Nayar, Chief executive officer
- 14SEC EDGARParag Saxena, Chair
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- 18SEC EDGARAtanuu Agarrwal, Vice President
- 19SEC EDGARLeslie D. Funtleyder, Board member
- 20SEC EDGARPurav Patel, Board member
- 21SEC EDGARRichard A. Margolin, Board member
- 22SEC EDGARParag Saxena, Board member
- 23SEC EDGARNina B. Shapiro, Board member
- 24SEC EDGARVikas Thapar, Board member
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- 36SEC EDGARListing notice or transfer
- 37SEC EDGARBylaws or fiscal year changed
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