Reviva expects cash to cover outlays into Q3 2027
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Reviva Pharmaceuticals Holdings, Inc. (RVPH) reported net losses of $2.3 million for the third quarter and $7.9 million for the first nine months of 2026, compared with $4.0 million and $16.5 million in the corresponding 2025 periods. It had $17.5 million in cash and cash equivalents at September 30, 2026, while operating activities used $8.1 million over nine months. The March 2026 public offering provided approximately $8.9 million in net proceeds.
The company said its current cash was insufficient for operating needs over the next 12 months, although it believed cash would cover anticipated outlays into the third quarter of 2027; it expects additional fundraising before then and disclosed substantial doubt about its ability to continue as a going concern for one year after the financial statements’ issuance. RVPH’s common stock was suspended from Nasdaq trading on May 14, 2026, and has been quoted on OTCQB since then. RECOVER-2 enrollment is planned for the first half of 2027, subject to additional financing, with study completion expected in 2028.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNine-month net loss declined to $7.9 million from $16.5 million.
Negative
- Major pointCompany disclosed substantial doubt about one-year going-concern ability.
- Major pointNasdaq trading of RVPH common stock was suspended on May 14, 2026.
- Moderate pointEfforts continue to remediate material weaknesses in financial reporting controls.
Filing Explained
The offering put new shares into circulation and created additional, contingent warrant capacity that could further reduce existing holders’ ownership.
The 10-Q reports that the
The issued shares increase the total share count, and warrant exercise would reduce existing holders’ percentage ownership.
The Series G and H warrants were immediately exercisable at
As of
Key Figures
Key Terms
going concern financial
at-the-market offering financial
pre-funded warrants financial
bioequivalence study medical
Orphan Drug Designation regulatory
Level 3 financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much cash did RVPH have at September 30, 2026?
What was RVPH’s net loss in the third quarter and first nine months of 2026?
When does RVPH plan to start the RECOVER-2 trial?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____ to ____
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
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(Registrant’s telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year,
if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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N/A* |
N/A* |
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*The registrant’s common stock is currently quoted on the OTCQB Venture Market operated by OTC Markets Group Inc. under the symbol “RVPH”, with such OTC quotation having commenced on May 14, 2026 upon the common stock’s suspension from The Nasdaq Capital Market (“Nasdaq”), and Nasdaq filing a Form 25 on July 10, 2026 to effect the delisting of the Company's common stock from Nasdaq.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
As of November 10, 2026 the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was
REVIVA PHARMACEUTICALS HOLDINGS, INC.
FORM 10-Q TABLE OF CONTENTS
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Page |
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Part I |
Financial Information |
F-1 |
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Item 1. |
Financial Statements (unaudited) |
F-1 |
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Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
F-1 |
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Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2026 and 2025 |
F-2 |
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Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2026 and 2025 |
F-3 |
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Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 |
F-5 |
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Notes to Condensed Consolidated Financial Statements |
F-6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
1 |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
15 |
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Item 4. |
Controls and Procedures |
15 |
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Part II |
Other Information |
17 |
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Item 1. |
Legal Proceedings |
17 |
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Item 1A. |
Risk Factors |
17 |
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Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
17 |
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Item 3. |
Defaults Upon Senior Securities |
17 |
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Item 4. |
Mine Safety Disclosures |
17 |
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Item 5. |
Other Information |
17 |
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Item 6. |
Exhibits |
18 |
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Signatures |
19 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
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December 31, |
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2026 |
2025 |
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Assets |
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Cash and cash equivalents |
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Prepaid clinical trial costs |
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Prepaid expenses and other current assets |
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Total current assets |
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Non-current prepaid clinical trial costs |
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Total Assets |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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Short-term debt |
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Accounts payable |
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Accrued clinical expenses |
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Accrued compensation |
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Other accrued liabilities |
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Total current liabilities |
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Total Liabilities |
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Commitments and contingencies (Note 6) |
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Stockholders’ Equity |
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Common stock, par value of $ |
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Preferred Stock, par value of $ |
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Additional paid-in capital |
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Accumulated deficit |
( |
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Total stockholders' equity |
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Total Liabilities and Stockholders’ Equity |
$ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2026 |
2025 |
2026 |
2025 |
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Operating expenses |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expense) |
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(Loss) gain on remeasurement of warrant liabilities |
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Interest expense |
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Interest income |
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Other income (expense), net |
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Total other income, net |
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Loss before provision for income taxes |
( |
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Provision for income taxes |
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Net loss |
$ | ( |
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Net loss per share: |
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Basic and diluted |
$ | ( |
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) | $ | ( |
) | $ | ( |
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Weighted average shares outstanding |
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Basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)
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Common Stock |
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Three Months Ended September 30, 2026 |
Shares |
Amount |
Additional Paid-In Capital |
Accumulated Deficit |
Total
Stockholders' Equity |
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| Balance at June 30, 2026 | $ | $ | $ | ( |
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Stock-based compensation expense |
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Net loss |
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Balance at September 30, 2026 |
$ | $ | $ | ( |
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Common Stock |
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Nine Months Ended September 30, 2026 |
Shares |
Amount |
Additional Paid-In Capital |
Accumulated Deficit |
Total
Stockholders' Equity |
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Balance at December 31, 2025 |
$ | $ | $ | ( |
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Common stock issued in connection with warrant exercises |
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Issuance of common stock in At-The-Market (ATM) offering, net of transaction costs |
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Issuance of common stock in public offerings, net of transaction costs |
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Issuance of common stock warrants in public offerings, net of transaction costs |
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Issuance of pre-funded warrants in public offering, net of transaction costs |
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Stock-based compensation expense |
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Net loss |
— | ( |
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Balance at September 30, 2026 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)
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Common Stock |
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Three Months Ended September 30, 2025 |
Shares |
Amount |
Additional |
Accumulated |
Total Stockholders' (Deficit) Equity |
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Balance at June 30, 2025 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
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Issuance of common stock in At-The-Market (ATM) offering, net of transaction costs |
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Issuance of common stock in June 2025 and September 2025 public offerings, net of transaction costs |
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Issuance of common stock warrants in June 2025 and September 2025 public offerings, net of transaction costs |
— | |||||||||||||||||||
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Vesting of restricted common stock issued to consultant in exchange for services |
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Stock-based compensation expense |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at September 30, 2025 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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Common Stock |
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Nine Months Ended September 30, 2025 |
Shares |
Amount |
Additional |
Accumulated |
Total Stockholders' Equity |
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Balance at December 31, 2024 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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Common stock issued in connection with warrant exercises |
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Issuance of common stock in At-The-Market (ATM) offering, net of transaction costs |
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Issuance of common stock in June 2025 and September 2025 public offerings, net of transaction costs |
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Issuance of common stock warrants in June 2025 and September 2025 public offerings, net of transaction costs |
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Vesting of restricted common stock issued to consultant in exchange for services |
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Stock-based compensation expense |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at September 30, 2025 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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Nine Months Ended September 30, |
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2026 |
2025 |
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Cash flows from operating activities |
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Net loss |
$ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Change in fair value of warrant liabilities |
( |
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Stock-based compensation expense |
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Changes in operating assets and liabilities: |
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Prepaid clinical trial costs (current and non-current) |
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Prepaid expenses and other current assets |
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Accounts payable |
( |
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Accrued expenses and other current liabilities |
( |
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Net cash used in operating activities |
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Cash flows from financing activities |
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Repayment of short-term debt |
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Proceeds from issuance of common stock in ATM offering, net of transaction costs paid |
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Proceeds from issuance of common stock, common stock warrants, and pre-funded warrants in offerings, net of transaction costs paid |
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Proceeds from exercise of common stock warrants |
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Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
( |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period |
$ | $ | ||||||
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Supplemental disclosures of cash flow information: |
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Cash paid for taxes |
$ | $ | ||||||
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Cash paid for interest |
$ | $ | ||||||
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Noncash Investing and Financing Activities: |
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Issuance of common stock warrants |
$ | $ | ||||||
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Issuance of pre-funded warrants |
$ | $ | ||||||
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Transaction costs related to offerings included in accounts payable and accrued expenses |
$ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVIVA PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. ORGANIZATION AND NATURE OF OPERATIONS
Reviva Pharmaceuticals Holdings, Inc. (together with its consolidated subsidiaries, the “Company” or "Reviva") is a late-stage pharmaceutical company developing new therapies that seek to address unmet medical needs in the areas of central nervous system ("CNS"), inflammatory and cardiometabolic diseases.
Reviva Pharmaceuticals, Inc. was originally incorporated in the state of Delaware and commenced operations on May 1, 2006 and its Indian subsidiary, Reviva Pharmaceuticals India Pvt. Ltd. was incorporated in 2014. In these notes to the unaudited condensed consolidated financial statements, unless otherwise specified or the context indicates otherwise, references to the “Company,” “Reviva,” “we,” “us” and “our” refer to Reviva Pharmaceuticals Holdings, Inc. and its consolidated subsidiaries.
Reverse Stock Split
On March 9, 2026, Reviva completed a 1-for-
Nasdaq Delisting & OTC Quotation
Reviva's common stock was previously listed on The Nasdaq Capital Market (“Nasdaq”). As previously disclosed, Reviva's common stock was not in compliance with the requirement under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq (the “Bid Price Requirement”) and the Company had until May 11, 2026 to regain compliance, which was the maximum extent of the discretionary authority of the Nasdaq Hearings Panel (the “Panel”).
Also as previously disclosed, having not regained compliance with the Bid Price Requirement by such date, the Company received a letter from the Panel dated May 12, 2026 indicating that the Panel had determined to delist Reviva's common stock from Nasdaq. Reviva's common stock was suspended from trading on Nasdaq as of the open of trading on May 14, 2026, and Nasdaq filed a Form 25 on July 10, 2026 to effect the delisting of the Company’s common stock from Nasdaq.
Beginning on May 14, 2026, Reviva's common stock has been quoted on the OTCQB Venture Market operated by OTC Markets Group Inc. (the "OTCQB Venture Market") under its existing symbol “RVPH.”
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or U.S. GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these unaudited condensed consolidated financial statements have been prepared on the same basis as the Company's annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2026.
The unaudited condensed consolidated balance sheet as of December 31, 2025, has been derived from the Company's audited financial statements at that date but does not include all disclosures and financial information required by U.S. GAAP for complete financial statements. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company's consolidated financial statements and notes thereto for the fiscal year ended December 31, 2025, which were included in the Company's Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (“SEC”) on March 30, 2026.
Principles of consolidation
The accompanying condensed consolidated financial statements include the accounts of Reviva Pharmaceuticals Holdings, Inc. and its wholly-owned subsidiaries Reviva Pharmaceuticals, Inc. and Reviva Pharmaceuticals India Pvt. Ltd. The Company's foreign subsidiary’s functional currency is the U.S. dollar. The Company recognizes a foreign currency gain or loss each reporting period as part of other income (expense), net, on the consolidated statement of operations. Any such foreign currency gain or loss is recognized as part of other income (expense), net, on the condensed consolidated statement of operations. The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. All transactions and balances between the parent and its subsidiaries have been eliminated in consolidation.
Segment information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation and used by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company and the Company’s CODM, the Company’s chief executive officer, view the Company’s operations and manage its business as a single operating segment. See Note 8, Segment Information, for more information.
Liquidity and going concern
The Company has incurred losses since inception and as of September 30, 2026, the Company had a working capital surplus of approximately $
The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2026, the Company raised capital through registered financial offerings, including sales of common stock pursuant to the Company’s May 2025 ATM Sales Agreement (Note 5) and the sale of common stock, common stock warrants, and pre-funded warrants through a public offering (Note 4). The Company believes that it has adequate cash on hand to cover anticipated outlays into the third quarter of 2027, but will need additional fundraising activities and cash on hand prior to such time. The Company has based this estimate, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than it currently expects. The Company will need to raise additional funds to continue funding its development efforts and operations. The Company intends to secure such additional funding, although there are no guarantees or commitments for additional funding. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the consolidated financial statements are issued. The amount and timing of the Company's future funding requirements will depend on many factors, including the pace and results of the Company's clinical development efforts. The Company will seek to fund its operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying, discontinuing certain clinical activities or ceasing operations. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods covered by the condensed consolidated financial statements and accompanying notes. Significant items subject to such estimates and assumptions include clinical trial costs, fair value of stock-based compensation, and fair value of warrants. Actual results could differ materially from such estimates under different assumptions or circumstances.
Concentration of credit risk and other risks and uncertainties
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. Substantially all the Company’s cash and cash equivalents are held in demand deposit and money market funds at three financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. Amounts held in demand deposit in excess of federally insured limits, totaled $
The Company is subject to all of the risks inherent in a clinical-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of the product(s) in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry.
The Company contracts with vendors and consultants to provide services related to the Company’s research and development. Costs and expenses that represented 10% or more of research and development costs for the three and nine months ended September 30, 2026 and 2025 consisted of the following: during the three months ended September 30, 2026, costs from two vendors each represented
The Company’s operating results may be materially affected by the foregoing factors.
Cash and cash equivalents
As of September 30, 2026 and December 31, 2025, the Company’s cash was maintained in demand deposit forms at three financial institutions. The Company considers any highly liquid investments, such as money market funds, with an original maturity of three months or less to be cash and cash equivalents.
The components of cash and cash equivalents were as follows:
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As of September 30, 2026 |
As of December 31, 2025 |
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Cash on deposit |
$ | $ | ||||||
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Money market funds (cash equivalents) |
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Cash and cash equivalents |
$ | $ | ||||||
Fair value measurements
Accounting Standards Codification ("ASC") 820, Fair Value Measurements ("ASC 820"), defines fair value, establishes a framework for measuring fair value in U.S. GAAP and expands disclosures about fair value measurements. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
The three levels of the fair value hierarchy under ASC 820 are described below:
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● |
Level 1 - Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
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Level 2 - Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument. |
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Level 3 - Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions. |
The Company's equity-classified and liability-classified warrants are measured at fair value using significant unobservable inputs and are therefore categorized within Level 3 of the fair value hierarchy. In determining the fair value of equity-classified warrants, the Company utilizes the Black-Scholes-Merton model using assumptions regarding volatility, expected term of the warrants, expected divided rate, and risk-free interest rates. In determining the fair value of liability-classified warrants, the Company utilizes a Lattice model using assumptions regarding volatility, expected term of the warrants, expected dividend, and risk-free interest rates. These assumptions are described as:
|
● |
Expected term: The Company’s expected term represents the period between the valuation date and the expiration date of the warrant; however, if an estimated liquidation event is expected to occur and the warrants are affected by said liquidation event, the period between the valuation date and that event would be used instead. |
|
● |
Expected volatility: Expected volatility for equity-classified awards is based on historical stock volatility data for a peer set of similar public companies with sufficient trading history, over the expected term of the warrant, or Company stock volatility when sufficient trading history exists. Expected volatility for liability-classified warrants is based on the volatility implied by the public warrant market price when sufficient data is available; otherwise it is based on a peer set of similar public companies. |
|
● |
Expected dividend: The Black-Scholes-Merton valuation model calls for a single expected dividend yield as an input. The Company has never paid dividends and has no plans to pay dividends. |
|
● |
Risk-free interest rate: The risk-free interest rate used in the Black-Scholes-Merton valuation method is based on the U.S. Treasury zero-coupon issues in effect at the valuation date for periods corresponding with the expected term of the warrant. |
Due to their short maturities, the carrying amounts for cash and cash equivalents, prepaid expenses and other current assets, prepaid clinical trial costs, accounts payable, accrued clinical expenses, accrued compensation, short-term debt, and other accrued liabilities approximate their fair value.
Clinical trial costs
The Company records clinical trial costs as they are incurred. For any unbilled costs as of each reporting date, the Company determines the amounts to accrue by obtaining reports from its vendors, including the Company's contract research organizations (“CROs”), and communicating with the Company's personnel and suppliers to identify services that have been performed, but not yet billed. The Company further validates the completeness of its accruals by reconciling payments and invoices, and reviewing vendor contracts and purchase orders. As necessary, the Company obtains milestones and percentage completion reports from vendors and will estimate the level of service performed and the associated cost incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual cost.
During the fiscal year ended December 31, 2025, all patient visits related to the ongoing trials concluded due to the completion of the Company's Phase 3 RECOVER-1 trial and completion of its open-label extension trial (the "OLE Trial"), and clinical sites were closed. Clinical trial costs were therefore recorded based on actual costs to date provided by the Company's CROs, as these clinical trials in progress were then deemed to be in the wind-down phase. Previously, the Company's accrued clinical trial costs for patients and sites included the calculation of patient visits incurred, but not yet reported by the vendor. The calculation previously involved the use of key inputs and assumptions such as estimated budget, estimated unreported costs based on historical trending of reported costs to date, and projected costs remaining until the conclusion of the trials which is no longer necessary given the status of the clinical trials.
For all other clinical trial costs the Company's estimated accrued expenses are based on facts and circumstances known to the Company at that time. The Company will confirm the accuracy of its estimates with the service providers and adjust if necessary.
Short-term debt
In December 2025, the Company obtained new financing for the renewal of certain policy premiums related to Director and Officers liability insurance. The governing agreement assigns the lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies.
The total premiums, taxes, and fees financed during 2025 was $
New accounting pronouncements not yet adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to require disclosure, in the notes to the consolidated financial statements, of specified information about certain costs and expenses. This ASU was further clarified by ASU 2025-01, Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses, which was issued in December 2024. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which provides clarity about current interim disclosure requirements and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. ASU 2025-11 will be effective for interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact that the adoption of ASU 2025-11 will have on the consolidated financial statements, but does not expect a material impact upon adoption.
3. NET LOSS PER SHARE
Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common shares and pre-funded warrants outstanding during the period. Diluted net loss per share includes potentially dilutive securities such as stock options, and warrants to purchase common stock (excluding pre-funded warrants that are exercisable for $
The components of basic and diluted net loss per share were as follows:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Numerator: |
||||||||||||||||
|
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
Denominator: |
||||||||||||||||
|
Weighted-average common shares outstanding – basic and diluted |
||||||||||||||||
|
Net loss per share – basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Shares issuable upon exercise of stock options |
||||||||||||||||
|
Shares of unvested restricted common stock issuable to consultant in the future in exchange for services to be provided |
||||||||||||||||
|
Shares issuable upon exercise of warrants to purchase common stock |
||||||||||||||||
The shares issuable upon exercise of warrants to purchase common stock exclude (i)
The diluted net loss per share computation equals basic net loss per share for the three and nine months ended September 30, 2026 and 2025 because the Company had a net loss and the impact of the assumed exercise of stock options and certain warrants would be anti-dilutive.
4. WARRANTS
The following is a summary of the Company’s warrant activity (number of common stock shares underlying the warrants) for the nine months ended September 30, 2026:
|
Warrant Issuance |
Issuance Date |
Exercise |
Outstanding, |
Warrant |
Warrant |
Warrant |
Outstanding, September 30, |
Expiration |
||||||||||||||||||||||
|
June 2021 Common Stock Warrants |
June 2021 |
$ | ( |
) |
May 2026 |
|||||||||||||||||||||||||
|
June 2021 Common Stock Warrants (August 2024 Amended) |
June 2021 |
$ |
August 2029 |
|||||||||||||||||||||||||||
|
September 2022 Private Pre-Funded Warrants |
September 2022 |
$ |
September 2027 |
|||||||||||||||||||||||||||
|
September 2022 Common Stock Warrants |
September 2022 |
$ |
September 2027 |
|||||||||||||||||||||||||||
|
November 2023 Common Stock Warrants |
November 2023 |
$ |
November, 2028 |
|||||||||||||||||||||||||||
|
November 2023 Common Stock Warrants (May 2024 Amended) |
November 2023 |
$ |
May 2029 |
|||||||||||||||||||||||||||
|
November 2023 Common Stock Warrants (August 2024 Amended) |
November 2023 |
$ |
August 2029 |
|||||||||||||||||||||||||||
|
November 2023 Pre-Funded Warrants |
November 2023 |
$ |
November 2028 |
|||||||||||||||||||||||||||
|
May 2024 Common Stock Warrants |
May 2024 |
$ |
May 2029 |
|||||||||||||||||||||||||||
|
August 2024 Common Stock Warrants |
August 2024 |
$ |
August 2029 |
|||||||||||||||||||||||||||
|
August 2024 Underwriter Warrants |
August 2024 |
$ |
August 2029 |
|||||||||||||||||||||||||||
|
December 2024 Series B Common Stock Warrants |
December 2024 |
$ |
December 2029 |
|||||||||||||||||||||||||||
|
June 2025 Series C Common Stock Warrants |
June 2025 |
$ |
June 2030 |
|||||||||||||||||||||||||||
|
June 2025 Series D Common Stock Warrants |
June 2025 |
$ | ( |
) |
June 2026 |
|||||||||||||||||||||||||
|
September 2025 Series E Common Stock Warrants |
September 2025 |
$ |
September 2030 |
|||||||||||||||||||||||||||
|
September 2025 Series F Common Stock Warrants |
September 2025 |
$ | ( |
) |
September 2026 |
|||||||||||||||||||||||||
|
March 2026 Pre-Funded Warrants |
March 2026 |
$ | ( |
) | n/a | |||||||||||||||||||||||||
|
March 2026 Series G Warrants |
March 2026 |
$ |
March 2031 |
|||||||||||||||||||||||||||
|
March 2026 Series H Warrants |
March 2026 |
$ |
March 2027 |
|||||||||||||||||||||||||||
| ( |
) | ( |
) | |||||||||||||||||||||||||||
March 2026 Public Offering
On March 20, 2026, the Company closed a public offering (the “March 2026 Public Offering”) pursuant to a placement agency agreement and securities purchase agreements with certain investors participating in the offering, pursuant to which the Company issued and sold (i) an aggregate of
The Company evaluated the March 2026 Common Stock Warrants and March 2026 Pre-Funded Warrants in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging, and determined that they should be classified as equity instruments, with no recurring fair value measurement required. The March 2026 Common Stock Warrants and March 2026 Pre-Funded Warrants are indexed to the Company’s common stock and require settlement through physical settlement or in certain circumstances if permitted net share settlement, if exercised. Accordingly, the March 2026 Common Stock Warrants and March 2026 Pre-Funded Warrants were recorded at their grant date fair value with no subsequent remeasurement.
The fair value of the March 2026 Common Stock Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance. Refer to Note 2, Summary of Significant Accounting Policies and Basis of Presentation, for further detail regarding how these assumptions were determined. Due to the nominal exercise price, the fair value of the March 2026 Pre-Funded Warrants approximated the fair value of the Company’s common stock on the issuance date. The grant date relative fair value of the Series G Warrants, Series H Warrants, and March 2026 Pre-Funded Warrants was estimated to be $
The following assumptions and key inputs were used to value the March 2026 Common Stock Warrants at the date of issuance:
|
Series G Warrants |
Series H Warrants |
|||||||
|
Risk-free interest rate |
% | % | ||||||
|
Expected term (years) |
||||||||
|
Expected volatility |
% | % | ||||||
|
Stock price on valuation date |
$ | $ | ||||||
|
Exercise price |
$ | $ | ||||||
|
Expected dividend |
% | % | ||||||
5. STOCKHOLDERS' EQUITY (DEFICIT), EQUITY INCENTIVE PLANS, AND STOCK-BASED COMPENSATION
The Company's authorized capital stock consists of:
|
● |
|
|
● |
|
On December 18, 2025, the Company's stockholders approved an amendment to the Company's Amended and Restated Certificate of Incorporation, as amended, to increase the Company’s authorized shares of common stock, par value $
As of September 30, 2026 there were
Equity Offering Activity
On March 20, 2026, the Company closed the sale of
As of September 30, 2026, the Company has shares of common stock reserved for future issuance as follows:
|
Shares underlying outstanding warrants |
||||
|
Shares reserved for future grants under the 2020 Equity Incentive Plan |
||||
|
Shares underlying outstanding stock options |
||||
|
Total common stock reserved for future issuance |
May 2025 ATM Sales Agreement
On May 30, 2025, the Company entered into an at market issuance sales agreement (the “May 2025 ATM Sales Agreement”) with B. Riley Securities, Inc. and Alliance Global Partners serving as agents (the “Agents”), with respect to an at-the-market ("ATM") offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $
2020 Equity Incentive Plan
During the nine months ended September 30, 2026, in accordance with the “evergreen” provision of the Company’s 2020 Equity Incentive Plan, an additional
Stock-based Compensation Expense
The Company records stock-based compensation expense based on the fair value of stock options and shares of restricted common stock granted to employees, non-employee consultants and non-employee directors. As of September 30, 2026, the Company had unrecognized stock-based compensation expense of $
Determining Fair Value
Valuation and Recognition – The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes pricing model utilizes assumptions regarding volatility of the Company's common share price, expected term, expected divided rate, and risk-free interest rates as described below:
|
● |
Expected term: The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding and is determined using the simplified method. |
|
● |
Expected volatility: Expected volatility is based on historical stock volatility data for a peer set of similar public companies with sufficient trading history, over the expected term of the awards, or Company stock volatility when sufficient trading history exists. |
|
● |
Expected dividend: The Black-Scholes-Merton valuation model calls for a single expected dividend yield as an input. The Company has never paid dividends and has no plans to pay dividends. |
|
● |
Risk-free interest rate: The risk-free interest rate used in the Black-Scholes-Merton valuation method is based on the U.S. Treasury zero-coupon issues in effect at the time of grant for periods corresponding with the expected term of the option. |
The fair value of options granted during the nine months ended September 30, 2026 and 2025 used the following assumptions and key inputs:
Black-Scholes-Merton Inputs
|
Nine Months Ended September 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Risk-free interest rate |
% | % | ||||||
|
Expected term (in years) |
||||||||
|
Expected volatility |
% | % | ||||||
|
Expected dividend yield |
% | % | ||||||
The weighted average fair value of stock options granted during the nine months ended September 30, 2026 was $
Activity under the Company's equity compensation plan for the nine months ended September 30, 2026 is as follows:
|
Number of |
Weighted |
Weighted |
Aggregate |
|||||||||||||
|
Balance, December 31, 2025 |
$ | $ | ||||||||||||||
|
Granted |
— | — | ||||||||||||||
|
Expired/Cancelled |
( |
) | — | — | ||||||||||||
|
Balance, September 30, 2026 |
$ | $ | ||||||||||||||
|
Options vested and exercisable at September 30, 2026 |
$ | $ | ||||||||||||||
For the three months ended September 30, 2026 and 2025, the amount of stock-based compensation expense included within research and development and general and administrative expenses was as follows:
|
Three Months Ended September 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Research and development |
$ | $ | ||||||
|
General and administrative |
||||||||
|
Total stock-based compensation expense |
$ | $ | ||||||
For the nine months ended September 30, 2026 and 2025, the amount of stock-based compensation expense included within research and development and general and administrative expenses was as follows:
|
Nine Months Ended September 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Research and development |
$ | $ | ||||||
|
General and administrative |
||||||||
|
Total stock-based compensation expense |
$ | $ | ||||||
6. COMMITMENTS AND CONTINGENCIES
Clinical trials
Since 2010, the Company has entered into multiple clinical trial agreements with medical institutions in the United States, Europe and Asia for the purpose of enrolling patients into various clinical trials. The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, how much will be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions. The clinical trial services provided by each site generally include the screening of prospective patients and, for those patients to be enrolled in the study, administration of the Company’s investigation drug according to the trial protocol, any required hospitalization, ancillary medical supplies, and patient follow-up. Further, each agreement requires the Company to indemnify each respective clinical site against any and all liability, loss, or damage it may suffer as a result of third-party claims; the Company maintains product liability insurance in conjunction with this indemnification. The agreements may be terminated upon 30 days’ written notice, subject to conditions of paying all liabilities incurred through the date of termination. Additionally, with each screened patient, the Company incurs expense with other entities engaged to provide independent review of patient medical records.
Indemnification
From time to time, in its normal course of business, the Company may indemnify other parties, with whom it enters into contractual relationships, including lessors and parties to other transactions with the Company. The Company may agree to hold other parties harmless against specific losses, such as those that could arise from a breach of representation, covenant or third-party infringement claims. It may not be possible to determine the maximum potential amount of liability under such indemnification obligations due to the unique facts and circumstances that are likely to be involved in each particular claim and indemnification provision. Historically, there have been no such indemnification claims. The Company has also indemnified its directors and executive officers, to the extent legally permissible, against all liabilities reasonably incurred in connection with any action in which such individual may be involved by reason of such individual being or having been a director or executive officer. To date, no such indemnification payments have been made by the Company.
Operating Leases
The Company leases a corporate office located at 10080 N. Wolfe Road, Suite SW3-200, Cupertino, CA 95014. The lease has a
Litigation
The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened claims. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities.
7. FAIR VALUE MEASUREMENTS
The following tables provide a summary of the assets and liabilities that are required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of September 30, 2026 and December 31, 2025:
|
September 30, 2026 |
||||||||||||||||
|
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Money market funds (cash equivalents) |
$ | $ | $ | $ | ||||||||||||
|
Total assets measured and recorded at fair value |
$ | $ | $ | $ | ||||||||||||
|
December 31, 2025 |
||||||||||||||||
|
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Money market funds (cash equivalents) |
$ | $ | $ | $ | ||||||||||||
|
Total assets measured and recorded at fair value |
$ | $ | $ | $ | ||||||||||||
The following table summarizes the changes in the fair value of the warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Balance, beginning of period |
$ | $ | $ | $ | ||||||||||||
|
Change in fair value of warrant liabilities |
( |
) | ||||||||||||||
|
Balance, end of period |
$ | $ | $ | $ | ||||||||||||
No liabilities were measured at fair value as of September 30, 2026 and December 31, 2025.
The Company had previously issued formerly-outstanding warrants to purchase
|
Risk-free interest rate |
% | |||
|
Remaining expected term of Private Warrants (years) |
||||
|
Expected volatility(1) |
% | |||
|
Stock price on valuation date |
$ | |||
|
Exercise price |
$ | |||
|
Expected dividend |
% |
|
(1) |
|
8. SEGMENT INFORMATION
The Company views its operations and manages its business as one operating and reportable segment focused on developing new therapies that seek to address unmet medical needs in the areas of central nervous system ("CNS"), inflammatory and cardiometabolic diseases. The CODM, the Company's Chief Executive Officer, manages and allocates resources to the operations of the Company on a consolidated basis, considering primarily research and development expenditures and net loss. This enables the Chief Executive Officer to assess the Company's overall level of available resources and determine how best to deploy these resources in line with long-term company-wide strategic goals.
Consistent with the Company's management reporting, results of operations are reported on a consolidated basis for purposes of segment reporting. Net loss and research and development expenses are used to allocate resources and are reported on the condensed consolidated statements of operations. The measure of segment assets is reported on the condensed consolidated balance sheets as cash and cash equivalents.
The CODM does not review any measure of significant segment expenses or segment loss which differ from the level of reporting as reflected on the condensed consolidated statement of operations.
9. SUBSEQUENT EVENTS
The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the filing date of this Quarterly Report on Form 10-Q, the date that the condensed consolidated financial statements were issued. Based on this review, the Company did not identify any subsequent events that would have required adjustment or disclosure in the condensed consolidated financial statements.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The information in this Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with the Company’s unaudited condensed consolidated financial statements and the related notes set forth in Item 1 of Part I of this Quarterly Report on Form 10-Q, our MD&A set forth in Item 7 of Part II of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and the Company’s consolidated financial statements and related notes set forth in Item 8 of Part II of such Annual Report on Form 10-K. See Part II, Item 1A, “Risk Factors,” below and “Cautionary Note Regarding Forward-Looking Statements,” and the information referenced therein, for a description of risks that we face and important factors that we believe could cause actual results to differ materially from those in our forward-looking statements. All amounts and percentages are approximate due to rounding and all dollars in the text are in millions, except per share amounts or where otherwise noted. When we cross-reference to a “Note,” we are referring to our “Notes to Condensed Consolidated Financial Statements (Unaudited)” included in Part I, Item 1, of this Quarterly Report on Form 10-Q, unless the context indicates otherwise.
All statements other than statements of historical fact included in this section regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. When used in this section, words such as “anticipate,” “believe,” “estimate,” "project," “expect,” “intend,” “target,” “plan,” “potential,” “assume” and similar expressions, as they relate to our management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those contemplated by the forward- looking statements as a result of certain factors detailed herein. All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
|
● |
the success of our current or planned clinical trials through all phases of clinical development, including our ability to conduct and complete clinical trials in accordance with projected timelines, our ability to achieve the desired results, and our ability to successfully complete requisite regulatory review and approval processes; |
|
● |
our ability to obtain the necessary financing to continue to conduct our business operations as planned, and to conduct our ongoing and planned trials, and continue and complete the planned development and commercialization of our product candidates; |
|
● |
our ability to successfully achieve and realize our plans and intentions for extending the long-term value of the brilaroxazine program and preparing for the next phase of development, including with respect to extending patent life and commercial exclusivity, and our plans for switching to a new formulation of brilaroxazine in our planned RECOVER-2 Phase 3 trial and our potential New Drug Application (“NDA”) submission, U.S. Food and Drug Administration ("FDA") feedback and our ability to align with FDA, and our plans for, and our ability to successfully complete, our planned bioequivalence study to confirm comparability of the new formulation, as well as our planned RECOVER-2 Phase 3 trial, as well as the results of each of the foregoing, and the expected timing, results and benefits of the Company’s business plans and strategy; |
|
● |
our ability to maintain compliance with the continued listing requirements of the OTCQB Venture Market tier of the OTC Markets Group (“OTCQB Venture Market”); |
|
● |
our ability to raise additional capital while trading on the OTCQB Venture Market may be adversely impacted; |
|
● |
our ability to successfully apply and attain approval for relisting on Nasdaq as intended, including the projected timing thereof, which is associated with corresponding risks including that our application and associated listing process may be delayed and/or unsuccessful, and that there can be no assurances that it will occur on any particular timing or at all; |
|
● |
our ability to grow and manage growth economically; |
|
● |
our ability to retain key executives and medical and science personnel; |
|
● |
the possibility that our products in development succeed in or fail clinical trials or are not approved by the FDA or other applicable authorities; |
|
● |
the possibility that we could be forced to delay, reduce or eliminate our planned clinical trials or development programs; |
|
● |
our ability to obtain approval from regulatory agents in different jurisdictions for our current or future product candidates; |
|
● |
changes in applicable laws or regulations; |
|
● |
changes to our relationships within the pharmaceutical ecosystem; |
|
● |
the performance of third-party suppliers and manufacturers and our ability to find additional suppliers and manufacturers and obtain alternative sources of raw materials; |
|
● |
our current and future capital requirements to support our development and commercialization efforts and our ability to satisfy our capital needs; |
|
● |
our ability to access capital on acceptable terms in a rising interest rate and tighter credit environment; |
|
● |
expectations regarding our ability to continue as a going concern; |
|
● |
the accuracy of our estimates regarding expenses and capital requirements, including estimated costs of our clinical studies, and our estimates about our forecasted cash runway, together with our efforts to manage our capital resources; |
|
● |
our limited operating history; |
|
● |
our history of operating losses in each year since inception and expectation that we will continue to incur operating losses for the foreseeable future; |
|
● |
changes in the markets that we target; |
|
● |
our ability to maintain or protect the validity of our patents and other intellectual property; |
|
● |
our exposure to any liability, protracted and costly litigation or reputational damage relating to data security; |
|
● |
the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; |
|
● |
any disruption to our business that may occur on a longer-term basis should we be unable to remediate the material weaknesses we have identified in our internal controls; and |
|
● |
the possibility that we may be adversely affected by other economic, business, and/or competitive factors. |
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Part II-Item 1A-Risk Factors” for additional risks which could adversely impact our business and financial performance.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.
Company Overview
We are a late-stage pharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing significant unmet medical needs and burdens to society, patients, and their families. Our current pipeline focuses on the central nervous system, inflammatory, and cardiometabolic diseases. We use a chemical genomics driven technology platform and proprietary chemistry to develop new medicines. Our pipeline currently has two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. We have been granted composition of matter patents for both brilaroxazine and RP1208 in the United States (U.S.), Europe, and several other countries.
Our lead drug candidate, brilaroxazine, is in clinical development and is intended to treat multiple neuropsychiatric indications. These include schizophrenia, bipolar disorder (“BD”), major depressive disorder (“MDD”), attention-deficit/hyperactivity disorder (“ADHD”), behavioral and psychotic symptoms of dementia and Alzheimer’s disease (“BPSD”), and Parkinson’s disease psychosis (“PDP”). Furthermore, brilaroxazine is also ready for clinical development for two respiratory indications — pulmonary arterial hypertension (“PAH”) and idiopathic pulmonary fibrosis (“IPF”). The U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to brilaroxazine for the treatment of PAH in November 2016 and IPF in April 2018. Brilaroxazine also is in pre-clinical development for the treatment of psoriasis.
Our primary focus is to complete the clinical development of brilaroxazine for the treatment of acute and maintenance schizophrenia.
Recent Developments
Nasdaq Delisting & OTC Quotation
Our common stock was previously listed on The Nasdaq Capital Market (“Nasdaq”). As previously disclosed, our common stock was not in compliance with the requirement under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq (the “Bid Price Requirement”), and we had until May 11, 2026, which was the maximum extent of the discretionary authority of the Nasdaq Hearings Panel (the “Panel”).
Also as previously disclosed, having not regained compliance with the Bid Price Requirement by such date, we received a letter from the Panel dated May 12, 2026 indicating that the Panel had determined to delist our common stock from Nasdaq. Our common stock was suspended from trading on Nasdaq as of the open of trading on May 14, 2026, and Nasdaq filed a Form 25 on July 10, 2026 to effect the delisting of our common stock from Nasdaq.
Beginning on May 14, 2026, our common stock has been quoted on the OTCQB Venture Market operated by OTC Markets Group Inc. under its existing symbol “RVPH.”
Reverse Stock Split
As previously announced, effective March 9, 2026, we implemented a reverse stock split of our issued and outstanding common stock at a ratio of one-for-twenty (1:20) (the “Reverse Split”). In connection with the Reverse Split, our common stock is designated under a new CUSIP number, 76152G209. All share, common stock warrant, pre-funded warrant, restricted common stock and common stock option amounts, and per share, per common stock warrant, per pre-funded warrant, per restricted common stock and per common stock option amounts, in this Quarterly Report on Form 10-Q, have been retrospectively adjusted as appropriate to reflect the Reverse Split.
FDA Pre-NDA Meeting Feedback on Brilaroxazine Development for Schizophrenia Indication
In November 2025, we met with FDA regarding the potential submission of a new drug application ("NDA") for brilaroxazine for the treatment of schizophrenia in adults and the associated data, and patient enrollment requirements. We received written feedback from FDA in December 2025. FDA informed us that it strongly encouraged us to conduct, prior to submission of an NDA, an additional Phase 3 trial that will be similar in design to the successfully completed RECOVER Phase 3 trial of brilaroxazine utilizing 30 mg and 50 mg doses of brilaroxazine. We indicated to FDA that we will conduct a Phase 3 study incorporating this feedback before submitting an NDA.
FDA also provided us with guidance on, among other topics, methods of data analysis, methods of data presentation, and data requirements for studies of animal pharmacokinetics, human abuse potential, and renal and hepatic impairment.
We plan to initiate patient enrollment in the RECOVER-2 Phase 3 study for brilaroxazine in schizophrenia (the “RECOVER-2 Trial”) in the first half of 2027, subject to additional financing. As previously reported, the FDA has already cleared the protocol for the RECOVER-2 Trial, and we currently expect study completion in 2028. The RECOVER-2 Trial will be similar in design to our completed RECOVER Phase 3 trial of brilaroxazine.
Brilaroxazine Program and Intellectual Property Updates
On April 15, 2026, we announced certain business updates, including in connection with our program for the development of brilaroxazine for the treatment of schizophrenia and regarding our intellectual property strategy.
We announced certain efforts centered on extending the long-term value of the brilaroxazine program and preparing for the next phase of development. A component of that strategy is our effort to extend patent life and commercial exclusivity for brilaroxazine, potentially through 2046. To support this objective, on August 11, 2026, we filed a composition of matter patent application on a new formulation of brilaroxazine internationally in PCT (Patent Cooperation Treaty) and filed an accelerated application in the United States through the United States Patent and Trademark Office (USPTO) Track One Program.
Based on the pre-clinical development package for this new formulation of brilaroxazine, we are seeking FDA alignment on using this new formulation of brilaroxazine product in our potential future NDA submission. This would include switching the drug substance of brilaroxazine and its formulation in the second Phase 3 trial in schizophrenia (RECOVER-2). We believe this type of change is not uncommon in the pharmaceutical industry during late-stage development and prior to NDA filing, particularly when it may strengthen lifecycle management and long-term intellectual property. We are expecting FDA feedback in Q4-2026 on the potential incorporation of the new formulation of brilaroxazine into both our RECOVER-2 Trial and our potential future NDA submission for brilaroxazine for the treatment of schizophrenia. After FDA feedback, we plan to initiate a bioequivalence study to confirm comparability of the new formulation.
If successful, this initiative has the potential to meaningfully extend the commercial exclusivity of brilaroxazine and strengthen our ability to realize the full value of the program over time. Importantly, a longer exclusivity runway could enhance the opportunity to develop brilaroxazine not only in schizophrenia, but also in bipolar disorder, major depressive disorder, and other potential high-value indications. We believe this strategy could materially increase the long-term value of the asset and further improve its attractiveness in future investment and strategic partnering discussions.
May 2025 ATM Sales Agreement
On May 30, 2025, we entered into an at market issuance sales agreement (the “May 2025 ATM Sales Agreement”) with B. Riley Securities, Inc. and Alliance Global Partners serving as agents (the “Agents”), with respect to an at-the-market (ATM) offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50 million through the Agents. The Company does not expect to utilize the May 2025 ATM Sales Agreement while the Company’s common stock is quoted on the OTC Markets Group, and the underlying Form S-3 “shelf” Registration Statement currently covering the offering of the shares pursuant to the May 2025 ATM Sales Agreement (including the prospectus supplement forming a part thereof related to the ATM offering), expires on February 13, 2027 pursuant to SEC rules. During the nine months ended September 30, 2026, we sold 570,845 shares of common stock pursuant to the May 2025 ATM Sales Agreement, for net proceeds of $2.5 million, after deducting sales agent commissions and other offering expenses of approximately $0.1 million. There were no sales pursuant to the May 2025 ATM Sales Agreement during the three months ended September 30, 2026.
March 2026 Public Offering
On March 20, 2026, we closed a public offering (the “March 2026 Public Offering”) pursuant to a placement agency agreement and securities purchase agreements with certain investors participating in the offering, pursuant to which we issued and sold (i) an aggregate of 6,283,334 shares of our common stock, (ii) pre-funded warrants (the “March 2026 Pre-Funded Warrants”) exercisable for an aggregate of up to 383,333 shares of our common stock, (iii) Series G warrants (the “Series G Warrants”) exercisable for an aggregate of up to 6,666,667 shares of our common stock and (iv) Series H warrants (the “Series H Warrants” and together with the Series G Warrants, the “March 2026 Common Stock Warrants”) exercisable for an aggregate of up to 6,666,667 shares of our common stock, for aggregate gross proceeds of $10.0 million. Each share of common stock (or March 2026 Pre-Funded Warrant in lieu thereof) was sold together with (i) a Series G Warrant to purchase one share of common stock and (ii) a Series H Warrant to purchase one share of common stock, at a combined public offering price of $1.50 per share of common stock and accompanying March 2026 Common Stock Warrants (or a combined public offering price of $1.4999 per March 2026 Pre-Funded Warrant and accompanying March 2026 Common Stock Warrants). The March 2026 Pre-Funded Warrants had an exercise price of $0.0001 per share and expired upon their full exercise. The Series G Warrants are exercisable immediately, have a term of five years from the date of issuance and have an exercise price of $1.50 per share. The Series H Warrants are exercisable immediately, have a term of twelve months and have an exercise price of $1.50 per share. The net proceeds to us from the March 2026 Public Offering were approximately $8.9 million, after deducting placement agent fees and expenses and other offering expenses payable by us.
Intellectual Property Overview
We are the sole owner of our patent portfolio that includes issued patents and pending patent applications covering compositions of matter and methods of use of our product candidates RP5063 (brilaroxazine) and RP1208, as well as related compounds. As of September 30, 2026, our portfolio of intellectual property consists of 76 granted patents and 24 pending patent applications in the United States and in over 26 foreign countries.
Brilaroxazine is our first intended commercial product. The original brilaroxazine patents include composition of matter, and methods of use in treating acute mania, autism, BD, depression, psychosis, and schizophrenia. One brilaroxazine original patent (U.S. Patent No. 8,188,076) and its 7 divisional/continuation patents have been granted in the U.S. The original brilaroxazine patents have also been granted in the following foreign countries: Australia, Brazil, Canada, Germany, Spain, France, Great Britain, Hong Kong, Israel, India, Italy, Japan, South Korea, Liechtenstein, Mexico, Russia, Slovakia, and Thailand. We believe that our patent portfolio provides good protection of brilaroxazine. All the U.S. and foreign original brilaroxazine granted patents and pending patent applications will expire or are expected to expire in 2030, if a patent term extension is not obtained. If and when brilaroxazine receives regulatory approval, we intend to apply for patent term extensions on patents covering brilaroxazine in any jurisdiction where patent term extension is available. For example, the expiration date of the first U.S. original brilaroxazine patent may be extendable up to 2035.
We also own additional brilaroxazine granted patents and pending patent applications for additional indications. We own attention hyperactivity disorder patents in the U.S., which will expire in 2035. We own pulmonary arterial hypertension patents in the U.S., Europe, China, Japan, and Hong Kong; all of which will expire in 2036. We own pulmonary fibrosis patents in the U.S., China, Europe, Japan, and Hong Kong, and pending applications in Brazil, which are all expected to expire in 2038.
We have one family of pending applications directed to a formulation of brilaroxazine, which are filed in Brazil, Canada, China, Europe, India, Japan, Korea, Mexico, and the U.S.
We have one family of pending applications directed to a method of using brilaroxazine for treating psoriasis, which are filed in Brazil, Canada, China, Europe, Japan, Korea, Mexico, and the U.S.
In addition, we have two U.S. pending applications each directed to a brilaroxazine composition.
We have two international applications pending; one directed to a method of using brilaroxazine for treating a specific symptom, and one directed to a new formulation of brilaroxazine.
All information regarding our patents and applications in this “Intellectual Property Overview” section is furnished as of September 30, 2026.
Financial Overview
We are a clinical-stage biopharmaceutical company and have not generated any revenues from the sale of products. We have never been profitable and have incurred losses since inception. As of September 30, 2026, we had a working capital surplus of approximately $13.1 million, an accumulated deficit of approximately $192.1 million and cash and cash equivalents on hand of approximately $17.5 million. Our net loss for the three months ended September 30, 2026 and 2025, was approximately $2.3 million and $4.0 million, respectively. Our net loss for the nine months ended September 30, 2026 and 2025, was approximately $7.9 million and $16.5 million, respectively. We expect our expenses to increase in connection with our ongoing activities to research, develop and commercialize our product candidates. Furthermore, we continue to expect to incur additional costs associated with operating as a public company, which may increase as we continue our efforts to remediate the material weaknesses in our internal control over financial reporting that we identified as more particularly described in Part II, Item 9A of our fiscal year 2025 Annual Report on Form 10-K, and in this Quarterly Report on Form 10-Q below in the section of Part I captioned "Item 4. Controls and Procedures." We will need to generate significant revenues to achieve profitability, and we may never do so.
We expect our expenses will increase in connection with our ongoing activities, as we:
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invest significantly to further research and develop, through clinical trials for brilaroxazine, including completion of remaining open-label extension trial ("OLE Trial") activities, initiating and conducting our planned bioequivalence study to confirm comparability of the new formulation of brilaroxazine, initiating and conducting our planned Phase 3 RECOVER-2 Trial, and pre-clinical research for RP1208, and seek regulatory approval for our product candidates brilaroxazine and RP1208; |
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identify and develop additional product candidates; |
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hire additional clinical, scientific and management personnel; |
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seek regulatory and marketing approvals for any product candidates that we may develop; |
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ultimately establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval; |
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maintain, expand and protect our intellectual property portfolio; |
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acquire or in-license other drugs and technologies; and |
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continue to incur costs and expenses associated with operating as a public company, including without limitation additional costs and expenses associated with our planned application and related processes to relist on Nasdaq; |
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add operational, financial and management information systems and personnel, including personnel to support our product candidate development, and any future commercialization efforts, and our ongoing compliance with and maintenance of public company controls, procedures and regulatory requirements and standards. and including in connection with our continuing efforts to remediate the material weaknesses in our internal control over financial reporting that we identified as more particularly described in Part I, Item 4 of this Quarterly Report on form 10-Q, "Controls and Procedures." |
Research and Development Expenses
We focus our resources on research and development activities, including the conduct of pre-clinical and clinical studies and product development and expense such costs as they are incurred. We have not historically tracked or recorded research and development expenses on a project-by-project basis, primarily because we use our employee and infrastructure resources across multiple research and development projects, and it is not practical for us to allocate such costs on a project-by-project basis. Our research and development expenses primarily consist of clinical trial expenses and employee-related expenses, including deferred salaries, salaries, benefits and taxes for personnel in research and development functions.
The largest recurring component of our total operating expenses has historically been research and development activities. We expect our research and development expenses will increase for the next several years as we advance our development programs, pursue regulatory approval of our product candidates in the U.S. and other jurisdictions and prepare for potential commercialization, which would require a significant investment in costs related to contract manufacturing and inventory buildup.
Our primary product candidates and their current status are as follows:
|
Drug Candidate |
Indication |
Status |
|
Brilaroxazine (RP5063) |
Schizophrenia |
- Conducted pivotal Phase 3 RECOVER-1 and long-term safety studies. Topline data for the RECOVER-1 Trial double-blind part announced October 30, 2023 - OLE positive preliminary topline data readout reported in December 2024, with full data-set and successful completion of the OLE announced in June 2025 - Feedback from FDA on potential incorporation of a new formulation of brilaroxazine into the RECOVER-2 Trial and potential NDA expected in Q4-2026* - After FDA feedback, we plan to initiate in Q1 2027 a bioequivalence study to confirm comparability of the new formulation* - We plan to initiate patient enrollment in our RECOVER-2 Trial in 1H-2027* |
|
Brilaroxazine |
Bipolar Disorder |
Phase 1 complete** |
|
Brilaroxazine |
Depression-MDD |
Phase 1 complete** |
|
Brilaroxazine |
Alzheimer’s (AD-Psychosis/Behavior) |
Phase 1 complete** |
|
Brilaroxazine |
Parkinson’s |
Phase 1 complete** |
|
Brilaroxazine |
ADHD/ADD |
Phase 1 complete** |
|
Brilaroxazine |
PAH |
Phase 1 complete** |
|
Brilaroxazine |
IPF |
Phase 1 complete** |
|
Brilaroxazine |
Psoriasis |
In pre-clinical development |
|
RP1208 |
Depression |
In pre-clinical development. Completed studies including in vitro receptor binding studies, animal efficacy studies, and PK studies. Compound ready for IND enabling studies. |
|
RP1208 |
Obesity |
In pre-clinical development. Completed studies, including in vitro receptor binding studies and PK studies. Compound ready for animal efficacy studies. |
* We plan to initiate patient enrollment in the RECOVER-2 Phase 3 study for brilaroxazine in schizophrenia (the “RECOVER-2 Trial”) in the first half of 2027, subject to additional financing. As previously reported, the FDA has already cleared the protocol for the RECOVER-2 Trial, and we currently expect study completion in 2028. We anticipate that the RECOVER-2 Trial will be similar in design to our completed RECOVER Phase 3 trial of brilaroxazine. We announced certain efforts centered on extending the long-term value of the brilaroxazine program and preparing for the next phase of development. As described above, in connection with our effort to extend patent life and commercial exclusivity for brilaroxazine potentially through 2046, we have filed a composition of matter patent application on a new formulation of brilaroxazine internationally in PCT (Patent Cooperation Treaty) and filed an accelerated application in the United States through the United States Patent and Trademark Office (USPTO) Track One Program. Based on the pre-clinical development package for this new formulation of brilaroxazine, we are seeking FDA alignment on using this new formulation of brilaroxazine product in our future new drug application (“NDA”) submission. This would include switching the drug substance of brilaroxazine and its formulation in the RECOVER-2 Trial. We expect FDA feedback on this strategy in Q4-2026. After FDA feedback, we plan to initiate a bioequivalence study in Q1 2027 to confirm comparability of the new formulation.
** We completed the Phase 1 clinical study for brilaroxazine prior to starting the Phase 2 study in schizophrenia and schizoaffective disorder, and completed our RECOVER-1 Trial double-blind part in acute schizophrenia patients for which we announced topline data in October 2023. In these three studies, we collected safety data for brilaroxazine in over 800 patients, including healthy subjects and patients with stable schizophrenia, acute schizophrenia and schizoaffective disorder. Generally, no separate Phase 1 study is required for conducting a Phase 2 study for an additional indication, provided the treatment doses in the Phase 2 study for an additional indication are within the range of doses tested in the previously completed Phase 1 study.
General Administrative Expenses
General and administrative expenses primarily consist of payroll and related costs for employees in executive, business development, finance, and administrative functions. Other significant general and administrative expenses include professional fees for accounting and legal services.
We expect general and administrative expenses to increase as we expand infrastructure and continue the development of our clinical programs. Other increases could potentially include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel, and increased fees for directors, outside consultants, lawyers, and accountants. We expect to incur significant costs to comply with corporate governance, internal controls, and similar requirements applicable to public companies.
Critical Accounting Estimates
Our critical accounting estimates are disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 30, 2026. Since the date of such Annual Report, there have been no material changes in our critical accounting estimates
Results of Operations
Comparison of the three months ended September 30, 2026 and 2025:
The following table summarizes our results of operations for the three months ended September 30, 2026 and 2025:
|
Three Months Ended September 30, |
Change |
Change |
||||||||||||||
|
2026 |
2025 |
Amount |
Percentage |
|||||||||||||
|
Operating expenses |
||||||||||||||||
|
Research and development |
$ | 1,198,460 | $ | 2,131,444 | $ | (932,984 | ) | (43.8 | )% | |||||||
|
General and administrative |
1,234,058 | 1,898,397 | (664,339 | ) | (35.0 | )% | ||||||||||
|
Total operating expenses |
2,432,518 | 4,029,841 | ||||||||||||||
|
Loss from operations |
(2,432,518 | ) | (4,029,841 | ) | ||||||||||||
|
Loss on remeasurement of warrant liabilities |
— | (27,816 | ) | 27,816 | 100.0 | % | ||||||||||
|
Interest expense |
(1,174 | ) | (2,605 | ) | 1,431 | 54.9 | % | |||||||||
|
Interest income |
135,329 | 59,103 | 76,226 | 129.0 | % | |||||||||||
|
Other income (expense), net |
1,392 | (6,774 | ) | 8,166 | 120.5 | % | ||||||||||
|
Total other income, net |
135,547 | 21,908 | ||||||||||||||
|
Loss before provision for income taxes |
(2,296,971 | ) | (4,007,933 | ) | ||||||||||||
|
Provision for income taxes |
1,934 | 2,840 | (906 | ) | (31.9 | )% | ||||||||||
|
Net loss |
$ | (2,298,905 | ) | $ | (4,010,773 | ) | ||||||||||
Research and Development Expenses
Research and development costs are expensed as incurred. These expenses represent both internal and external costs.
For the three months ended September 30, 2026 and 2025, research and development expenses were approximately $1.2 million and $2.1 million, respectively. Specifically, during the three months ended September 30, 2026 and 2025, our research and development costs consisted primarily of the following costs associated with our key research and development projects for advancing the clinical development of brilaroxazine during the reporting periods, which during such periods consisted primarily of our OLE Trial for our Phase 3 clinical study for brilaroxazine: (i) internal salaries, wages and other payroll related costs for employees involved in research and development activities, of approximately $0.4 million and $0.5 million in each period, respectively; (ii) internal stock-based compensation expenses with respect to employees involved in research and development activities, of approximately $0.1 million and $0.2 million, respectively; and (iii) external research and development expenses of approximately $0.7 million and $1.4 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $0.5 million and $1.2 million, respectively, non-clinical safety related costs of an insignificant amount and $0.1 million, respectively, non-clinical manufacturing related costs of approximately $0.1 million in each period and non-clinical consulting costs of $0.1 million and an insignificant amount, respectively).
The decrease in research and development expenses for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025 was primarily attributed to a decrease in external clinical research and development costs, partially attributed to a decrease in costs associated with patient visits as the OLE Trial proceeded toward completion during 2025 with the remaining OLE activities thereafter consisting of post-data readout activities and trial wind-down costs.
We expect our research and development activities to substantially increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with our ongoing operations, including expenses associated with activities required to complete the development of brilaroxazine in schizophrenia including expenses associated with our planned bioequivalence study and our planned Phase 3 RECOVER-2 Trial, and other expenses to take us through the submission of the planned NDA for brilaroxazine, together with additional costs post-NDA submission in preparation of potential commercialization if approved. For additional information, please see the discussion appearing above in the introductory section of this Part I-Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations.
General and Administrative Expenses
For the three months ended September 30, 2026 and 2025, general and administrative expenses were approximately $1.2 million and $1.9 million, respectively. Specifically, during the three months ended September 30, 2026 and 2025, our general and administrative expenses consisted primarily of: (i) stock-based compensation expense of approximately $0.1 million and $0.3 million, respectively; (ii) consultant and professional expenses of approximately $0.3 million and $0.4 million, respectively; (iii) legal expenses of approximately $0.2 million and $0.5 million, respectively; (iv) employee-related expenses of approximately $0.5 million in each period; (v) Directors and Officers insurance expenses of approximately $0.1 million in each period; and (vi) other general and administrative expenses of an insignificant amount and $0.1 million, respectively.
Loss on Remeasurement of Warrant Liabilities
We recognized a remeasurement of warrant liabilities loss of approximately $27.8 thousand for the three months ended September 30, 2025 resulting from the increase in the calculated fair value of the warrants attributed to an increase in volatility offset by a marginal decrease in stock price. Our previously outstanding liability-classified warrants expired in December 2025; accordingly, no gain or loss was recognized for the three months ended September 30, 2026.
Interest Expense
We incurred interest expense of approximately $1.2 thousand and $2.6 thousand for the three months ended September 30, 2026 and 2025, respectively. The decrease in interest expense is attributed to the reduced interest rate on short term debt obtained by us related to Directors and Officers liability insurance policy premiums.
Interest Income
Interest income was approximately $135.3 thousand for the three months ended September 30, 2026 and $59.1 thousand for the three months ended September 30, 2025. The interest income increase of approximately $76.2 thousand was primarily due to an increase in average cash balances during the three months ended September 30, 2026 compared to the three months ended September 30, 2025.
Other Income (Expense), net
Other income, net was approximately $1.4 thousand for the three months ended September 30, 2026 and other expense, net was approximately $6.8 thousand for the three months ended September 30, 2025. The approximately $8.2 thousand change in the positive direction for the three-month period ended September 30, 2026 as compared to the corresponding 2025 period, was primarily attributable to a lower period-over-period foreign currency transaction loss from foreign currency fluctuations related to the consolidation of our Indian subsidiary for the 2026 period as compared to the 2025 period.
Comparison of the nine months ended September 30, 2026 and 2025:
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
|
Nine Months Ended September 30, |
Change |
Change |
||||||||||||||
|
2026 |
2025 |
Amount |
Percentage |
|||||||||||||
|
Operating expenses |
||||||||||||||||
|
Research and development |
$ | 4,028,164 | $ | 9,969,736 | $ | (5,941,572 | ) | (59.6 | )% | |||||||
|
General and administrative |
4,293,849 | 6,671,254 | (2,377,405 | ) | (35.6 | )% | ||||||||||
|
Total operating expenses |
8,322,013 | 16,640,990 | ||||||||||||||
|
Loss from operations |
(8,322,013 | ) | (16,640,990 | ) | ||||||||||||
|
Gain on remeasurement of warrant liabilities |
— | 44,504 | (44,504 | ) | (100.0 | )% | ||||||||||
|
Interest expense |
(10,762 | ) | (19,022 | ) | 8,260 | 43.4 | % | |||||||||
|
Interest income |
401,002 | 168,061 | 232,941 | 138.6 | % | |||||||||||
|
Other expense, net |
(3,038 | ) | (33,769 | ) | 30,731 | 91.0 | % | |||||||||
|
Total other income, net |
387,202 | 159,774 | ||||||||||||||
|
Loss before provision for income taxes |
(7,934,811 | ) | (16,481,216 | ) | ||||||||||||
|
Provision for income taxes |
7,912 | 16,007 | (8,095 | ) | (50.6 | )% | ||||||||||
|
Net loss |
$ | (7,942,723 | ) | $ | (16,497,223 | ) | ||||||||||
Research and Development Expenses
Research and development costs are expensed as incurred. These expenses represent both internal and external costs.
For the nine months ended September 30, 2026 and 2025, research and development expenses were approximately $4.0 million and $10.0 million, respectively. Specifically, during the nine months ended September 30, 2026 and 2025, our research and development costs consisted primarily of the following costs associated with our key research and development projects for advancing the clinical development of brilaroxazine during the reporting periods, which during such periods consisted primarily of our OLE Trial for our Phase 3 clinical study for brilaroxazine: (i) internal salaries, wages and other payroll related costs for employees involved in research and development activities, of approximately $1.3 million and $2.0 million in each period, respectively; (ii) internal stock-based compensation expenses with respect to employees involved in research and development activities, of approximately $0.5 million and $0.7 million, respectively; and (iii) external research and development expenses of approximately $2.2 million and $7.3 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $1.5 million and $6.0 million, respectively, non-clinical safety related costs of an insignificant amount and approximately $0.7 million, respectively, non-clinical manufacturing related costs of approximately $0.2 million and $0.5 million, respectively, and non-clinical consulting and other related costs of approximately $0.5 million and $0.1 million, respectively).
The decrease in research and development expenses for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025 was primarily attributed to a decrease in external clinical research and development costs, partially attributed to a decrease in costs associated with patient visits as the OLE Trial proceeded toward completion during 2025 with the remaining OLE activities thereafter consisting of post-data readout activities and trial wind-down costs.
We expect our research and development activities to substantially increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with our ongoing operations, including expenses associated with activities required to complete the development of brilaroxazine in schizophrenia including expenses associated with our planned bioequivalence study and our planned Phase 3 RECOVER-2 Trial, and other expenses to take us through the submission of the planned NDA for brilaroxazine, together with additional costs post-NDA submission in preparation of potential commercialization if approved. For additional information, please see the discussion appearing above in the introductory section of this Part I-Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations.
General and Administrative Expenses
For the nine months ended September 30, 2026 and 2025, general and administrative expenses were approximately $4.3 million and $6.7 million, respectively. Specifically, during the nine months ended September 30, 2026 and 2025, our general and administrative expenses consisted primarily of: (i) stock-based compensation expense of approximately $0.5 million and $1.1 million, respectively; (ii) consultant and professional expenses of approximately $1.2 million and $2.3 million, respectively; (iii) legal expenses of approximately $0.7 million and $1.2 million, respectively; (iv) employee-related expenses of approximately $1.5 million in each period; (v) Directors and Officers insurance expenses of approximately $0.3 million in each period; and (vi) other general and administrative expenses of approximately $0.1 million and $0.3 million, respectively.
Gain on Remeasurement of Warrant Liabilities
We recognized a remeasurement of warrant liabilities gain of approximately $44.5 thousand for the nine months ended September 30, 2025 resulting from a decrease in the calculated fair value of the warrants, principally as a result of the decrease in our stock price. Our previously outstanding liability-classified warrants expired in December 2025; accordingly, no gain or loss was recognized for the nine months ended September 30, 2026.
Interest Expense
We incurred interest expense of approximately $10.8 thousand and $19.0 thousand for the nine months ended September 30, 2026 and 2025, respectively. The decrease in interest expense is attributed to the reduced interest rate on short term debt obtained by us related to Directors and Officers liability insurance policy premiums.
Interest Income
Interest income was approximately $0.4 million and $0.2 million for the nine months ended September 30, 2026 and 2025, respectively. The interest income increase of approximately $0.2 million was primarily due to an increase in average cash balances during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.
Other Expense, net
Other expense, net was approximately $3.0 thousand for the nine months ended September 30, 2026 and approximately $33.8 thousand for the nine months ended September 30, 2025. The decrease of approximately $30.8 thousand for the nine months ended September 30, 2026 as compared to the corresponding 2025 period, was primarily attributable to a lower period-over-period foreign currency transaction loss from foreign currency fluctuations for the relevant 2026 period as compared to the 2025 period related to the consolidation of our Indian subsidiary.
Liquidity and Capital Resources
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Change |
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September 30, 2026 |
December 31, 2025 |
Amount |
Percentage |
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Balance Sheet Data: |
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Cash and cash equivalents |
$ | 17,458,418 | $ | 14,438,792 | 3,019,626 | 20.9 | % | |||||||||
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Working capital surplus |
$ | 13,079,361 | $ | 7,827,924 | 5,251,437 | 67.1 | % | |||||||||
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Total assets |
$ | 18,557,325 | $ | 15,923,198 | 2,634,127 | 16.5 | % | |||||||||
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Total stockholders' equity |
$ | 13,079,361 | $ | 8,647,645 | 4,431,716 | 51.2 | % | |||||||||
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Nine Months Ended September 30, |
Change |
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Statement of Cash Flow Data: |
2026 |
2025 |
Amount |
Percentage |
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|
Net cash used in operating activities |
$ | (8,101,051 | ) | $ | (18,796,432 | ) | 10,695,381 | 56.9 | % | |||||||
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Net cash provided by financing activities |
11,120,677 | 18,503,360 | (7,382,683 | ) | (39.9 | )% | ||||||||||
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Net increase (decrease) in cash and cash equivalents |
$ | 3,019,626 | $ | (293,072 | ) | 3,312,698 | 1130.3 | % | ||||||||
Capital Resources
We have funded our operations to date primarily from the issuance and sale of our equity and equity-linked securities, such as warrants. As of September 30, 2026, we had cash and cash equivalents of approximately $17.5 million. To fund our current operating plans, we will need to raise significant additional capital. Our existing cash and cash equivalents will not be sufficient for us to complete development of our product candidates and, if applicable, to prepare for commercializing any product candidate that may receive approval. Accordingly, we will continue to require substantial additional capital beyond our existing cash to continue our clinical development and potential commercialization activities. We believe that we have adequate cash on hand to cover anticipated outlays into the third quarter of 2027, but will need additional fundraising activities and cash on hand prior to such time. We have based this estimate, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. We will need to raise additional funds to continue funding our development efforts and operations. We intend to secure such additional funding, although there are no guarantees or commitments for additional funding. These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date the consolidated financial statements are issued. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition, and our ability to pursue our business strategy, and our ability to continue as a going concern. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue our research and pre-clinical and clinical development of our product candidates including our planned bioequivalence study to confirm comparability of the new formulation of brilaroxazine, our planned RECOVER-2 Phase 3 Trial for brilaroxazine in schizophrenia and other activities to continue development of our brilaroxazine program; expand the scope of our current studies for our product candidates; initiate additional pre-clinical, clinical or other studies for our product candidates; change or add additional manufacturers or suppliers; seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies; seek to identify, evaluate and validate additional product candidates; acquire or in-license other product candidates and technologies; maintain, protect and expand our intellectual property portfolio; attract and retain skilled personnel; add operational, financial and management information systems and personnel, including personnel to support our product candidate development, and any future commercialization efforts, and our ongoing compliance with and maintenance of public company controls, procedures and regulatory requirements and standards, including in connection with our ongoing remediation efforts regarding the material weaknesses in our internal controls as disclosed in Part I, Item 4, "Controls and Procedures," of this Quarterly Report on Form 10-Q; and experience any delays or encounter issues with any of the above. See also the discussion set forth under the caption “Financial Overview” appearing in this Management’s Discussion and Analysis of Financial Condition and Results of Operation section above.
On March 20, 2026, we closed a public offering (the “March 2026 Public Offering”) conducted pursuant to a placement agency agreement (the “March 2026 Placement Agency Agreement”) and securities purchase agreements with certain investors participating in the offering, pursuant to which we issued and sold (i) an aggregate of 6,283,334 shares of common stock, (ii) pre-funded warrants (the “March 2026 Pre-Funded Warrants”) exercisable for an aggregate of up to 383,333 shares of common stock (the “March 2026 Pre-Funded Warrant Shares”), (iii) Series G warrants (the “Series G Warrants”) exercisable for an aggregate of up to 6,666,667 shares of common stock (the “Series G Warrant Shares”) and (iv) Series H warrants (the “Series H Warrants” and together with the Series G Warrants, the “March 2026 Common Stock Warrants”) exercisable for an aggregate of up to 6,666,667 shares of common stock (the “Series H Warrant Shares” and together with the March 2026 Pre-Funded Warrant Shares and Series G Warrant Shares, the “March 2026 Warrant Shares”), for aggregate gross proceeds of $10.0 million. Each share of common stock (or March 2026 Pre-Funded Warrant in lieu thereof) was sold together with (i) a Series G Warrant to purchase one share of common stock and (ii) a Series H Warrant to purchase one share of common stock, at a combined public offering price of $1.50 per share of common stock and accompanying March 2026 Common Stock Warrants (or a combined public offering price of $1.4999 per March 2026 Pre-Funded Warrant and accompanying March 2026 Common Stock Warrants). The March 2026 Pre-Funded Warrants had an exercise price of $0.0001 per share and expired upon their full exercise. The Series G Warrants are exercisable immediately, have a term of five years from the date of issuance and have an exercise price of $1.50 per share. The Series H Warrants are exercisable immediately, have a term of twelve months and have an exercise price of $1.50 per share. The net proceeds to us from the March 2026 Public Offering were approximately $8.9 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.
During the nine months ended September 30, 2026 , we sold 570,845 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of $2.5 million after deducting sales agent commissions and other offering expenses of approximately $0.1 million. During the three months ended September 30, 2026, and through the filing date of this Quarterly Report on Form 10-Q, we have not sold any shares of common stock pursuant to the May 2025 ATM Sales Agreement. The Company does not expect to utilize the May 2025 ATM Sales Agreement while the Company’s common stock is quoted on the OTC Markets Group, and the underlying Form S-3 “shelf” Registration Statement currently covering the offering of the shares pursuant to the May 2025 ATM Sales Agreement (including the prospectus supplement forming a part thereof related to the ATM offering), expires on February 13, 2027 pursuant to SEC rules.
Until such time as we can generate substantial product revenue, if ever, we expect to finance our cash needs through a combination of equity or debt financings and collaboration agreements. We do not currently have any committed external sources of capital. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we raise additional funds through collaboration agreements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, or curtail or cease operations. We will need to generate significant revenues to achieve profitability, and we may never do so.
Cash Flows
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2026 was approximately $8.1 million, consisting primarily of a net loss of approximately $7.9 million, adjusted for non-cash items, including stock-based compensation expense of approximately $1.0 million, coupled with a decrease in our operating assets and liabilities totaling approximately $1.2 million. The $1.2 million decrease in net operating assets and liabilities was primarily due to a decrease in accounts payable as well as accrued expenses and other current liabilities, net with a decrease in prepaid expenses and other current assets.
Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $18.8 million, consisting primarily of a net loss of approximately $16.5 million, adjusted for non-cash items, including stock-based compensation expense of approximately $1.8 million, coupled with a decrease in our operating assets and liabilities totaling approximately $4.0 million. The $4.0 million decrease in net operating assets and liabilities was primarily due to a decrease in accrued clinical expenses, other accrued expenses and accounts payable, net with a decrease in prepaid expenses, other current assets, and prepaid clinical trial costs.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2026 was approximately $11.1 million. Cash provided by financing activities during the nine months ended September 30, 2026 was attributable to approximately $9.0 million in proceeds from issuance of common stock, common stock warrants, and pre-funded warrants, net of transaction costs paid, and $2.5 million in net proceeds from the issuance of common stock pursuant to the May 2025 ATM Sales Agreement, which was offset by the repayments of short-term debt of approximately $0.4 million.
Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $18.5 million. Cash provided by financing activities during the nine months ended September 30, 2025 was attributable to (i) $19.0 million in gross proceeds from the sale of common stock, Series C Common Warrants and Series D Common Warrants in our June 2025 Public Offering and Series E Common Warrants and Series F Common Warrants in our September 2025 Public Offering, partially offset by transaction costs of approximately $1.9 million, approximately $0.4 million of which was not yet paid as of September 30, 2025; (ii) gross proceeds of approximately $1.6 million from the sale of common stock under our May 2025 ATM Sales Agreement, partially offset by transaction costs of approximately $0.4 million, approximately $0.1 million of which was not yet paid as of September 30, 2025; and (iii) approximately $0.2 million in proceeds from the exercise of common stock warrants. The foregoing were partially offset by repayments on the short-term debt of approximately $0.5 million.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined under SEC rules.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide the information called for by this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and implementation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2026. Based on that evaluation, management concluded that as of September 30, 2026, the Company did not maintain effective disclosure controls and procedures because of the material weaknesses in internal control over financial reporting described below.
We identified the following entity-level material weaknesses. We have an ineffective control environment, including an insufficient number of personnel with an appropriate level of knowledge and experience to create the proper environment for effective internal control over financial reporting, and did not maintain the other components of the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), including appropriate risk assessment, control activities, information and communication, and monitoring activities components relating to (i) sufficiency of processes related to identifying and analyzing risks to the achievement of objectives, including technology, across the entity, (ii) developing general control activities over technology to support the achievement of objectives across the entity, (iii) sufficiency of selecting and developing control activities that contribute to the mitigation of risks to the achievement of objectives to acceptable levels and (iv) sufficiency of monitoring activities to ascertain whether the components of internal control are present and functioning.
The entity-level material weaknesses contributed to other material weaknesses within our system of internal control over financial reporting as follows:
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● |
We did not design and maintain effective information technology (IT) general controls for certain information systems supporting our key financial reporting processes. Specifically, we did not design and maintain (a) change management controls to ensure that program and data changes affecting financial applications and underlying accounting records are identified, tested, authorized and implemented appropriately, (b) access controls to ensure appropriate IT segregation of duties are maintained that adequately restrict and segregate privileged access between environments which support development and production, (c) controls to monitor on an on-going basis for the proper segregation of privileged access between environments which support development and production and (d) operations controls to ensure appropriate interfacing between systems. As a result, IT application controls and business process controls (automated and manual) that are dependent on the ineffective IT general controls, or that rely on data produced from systems impacted by the ineffective IT general controls, are also deemed ineffective. |
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● |
We did not design and maintain effective process-level controls, which affects substantially all account balances and disclosures. |
These material weaknesses have a pervasive impact and consequently, impact control activities over all financial statement account balances, classes of transactions, and disclosures.
Management’s Remediation Measures
We are committed to continuing to improve our internal control over financial reporting, and also our IT general controls. As of the date hereof, we have commenced procedures to remediate the material weaknesses, including the hiring of an additional internal accounting resource, engaging a third-party consulting firm to assist with the enhancement of IT general controls over information systems relevant to financial reporting, including privileged access and segregation of duties; and with continued realignment of existing personnel to strengthen management’s review and documentation over internal control over financial reporting.
We will continue to monitor the design and effectiveness of these procedures and controls and make any further changes we determine appropriate.
Notwithstanding the existence of the material weaknesses as described above, we believe that the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of operations, and cash flows as of the dates, and for the periods presented, in conformity with U.S. GAAP.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Changes in Internal Control Over Financial Reporting
Except as discussed above, there was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by the Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II OTHER INFORMATION
ITEM 1. 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 previously disclosed in our 10-K for the fiscal year ended December 31, 2025, we are currently not aware of any other legal proceedings or claims that may be, individually or in the aggregate, material to us.
ITEM 1A. RISK FACTORS.
Our business is subject to substantial risks and uncertainties. An investment in our securities involves a high degree of risk. In addition to the other information set forth in this report and in our other SEC filings from time to time, you should carefully consider the factors discussed in "Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 30, 2026, as supplemented by the information set forth in “Part II, Item 1A. Risk Factors” in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2026 and June 30, 2026, as filed with the SEC on May 13, 2026 and August 12, 2026, respectively, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as supplemented by the risks described in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2026 and June 30, 2026, may not be the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Except as required by the federal securities law, we undertake no obligation to update or revise any risk factor, whether as a result of new information, future events or otherwise.
There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 30, 2026, as supplemented by the risk factors previously disclosed in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2026 and June 30, 2026, as filed with the SEC on May 13, 2026 and August 12, 2026, respectively.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
There were no unregistered sales of equity securities during the period covered by this report.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION.
Rule 10b5-1 Trading Arrangements and Non-Rule 10b5-1 Trading Arrangements
During the fiscal quarter ended September 30, 2026, none of our officers or directors, as those terms are defined in Rule 16a-1(f), adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," as those terms are defined in Item 408 of Regulation S-K.
ITEM 6. EXHIBITS
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Exhibit No. |
Exhibit |
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10.1* |
Form of Notice of Option Exercise under the registrant's 2020 Equity Incentive Plan |
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31.1* |
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) |
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31.2* |
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) |
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32.1** |
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 |
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101.INS* |
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
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101.SCH* |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL* |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF* |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB* |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE* |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104* |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* Filed herewith.
** The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and will not be deemed to be incorporated by reference into any filing under such Act or the Securities Act of 1933, as amended, except to the extent that the registrant specifically incorporates such certifications by reference.
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 thereunto duly authorized.
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Reviva Pharmaceuticals Holdings, Inc. (Registrant) |
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Date: November 12, 2026 |
By: /s/ Laxminarayan Bhat |
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Laxminarayan Bhat |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 12, 2026 |
By: /s/ Narayan Prabhu |
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Narayan Prabhu |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |