Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Reviva's CEO, Laxminarayan Bhat, will participate in the Benchmark Healthcare House Call Virtual Investor Conference on May 29, 2025, at 11:15 a.m. ET [2]. - The company will also present at the Lytham Partners Spring 2025 Investor Conference on the same day at 2:00 p.m. ET [2].

Part I [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The company reported a net loss of $6.4 million for Q1 2025, with a $5.3 million working capital deficit and cash, raising going concern doubts [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $7.1 million, liabilities to $11.5 million, and stockholders' equity shifted to a $4.5 million deficit by March 31, 2025 Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 5,289,404 | 13,476,331 | | Total current assets | 6,257,325 | 14,683,367 | | Total Assets | 7,077,046 | 15,503,088 | | **Liabilities & Equity** | | | | Total current liabilities | 11,509,254 | 14,601,506 | | Total Liabilities | 11,537,070 | 14,690,516 | | Total stockholders' equity (deficit) | (4,460,024) | 812,572 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q1 2025 was $6.4 million ($0.13/share), an improvement from $7.4 million in Q1 2024, driven by reduced R&D expenses Condensed Consolidated Statements of Operations (Unaudited) | Operating Item | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Research and development | 4,113,537 | 5,783,865 | | General and administrative | 2,424,630 | 2,138,241 | | Total operating expenses | 6,538,167 | 7,922,106 | | Loss from operations | (6,538,167) | (7,922,106) | | Net loss | (6,432,840) | (7,433,608) | | Net loss per share (Basic and diluted) | (0.13) | (0.25) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to $8.2 million in Q1 2025, with cash and cash equivalents falling to $5.3 million by quarter-end Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Item | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (8,194,198) | (11,725,809) | | Net cash provided by financing activities | 7,271 | 332,000 | | Net decrease in cash and cash equivalents | (8,186,927) | (11,393,809) | | Cash and cash equivalents, end of period | 5,289,404 | 11,973,647 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail a significant working capital deficit, accumulated deficit, and limited cash, raising substantial doubt about the company's going concern ability - The company is a late-stage pharmaceutical firm focused on developing therapies for central nervous system (CNS), inflammatory, and cardiometabolic diseases[20](index=20&type=chunk) - As of March 31, 2025, the company had a working capital deficit of **$5.3 million**, an accumulated deficit of **$170.7 million**, and cash of **$5.3 million**, raising substantial doubt about its ability to continue as a going concern for one year[25](index=25&type=chunk)[26](index=26&type=chunk) - The company's current cash is only sufficient to cover operations through the end of the **second quarter of 2025**, and it will need to raise additional funds during the **third quarter of 2025**[26](index=26&type=chunk) - For Q1 2025, three vendors accounted for **53%**, **18%**, and **12%** of total research and development expenses, indicating a high concentration of vendor risk[30](index=30&type=chunk) - Stock-based compensation expense increased to approximately **$0.9 million** in Q1 2025 from **$0.4 million** in Q1 2024, with **$2.7 million** of unrecognized stock-based compensation expense as of March 31, 2025[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses positive Phase 3 trial results for brilaroxazine, but highlights precarious financial condition with cash only through Q2 2025 and a $6.4 million net loss [Company Overview and Recent Developments](index=24&type=section&id=Company%20Overview%20and%20Recent%20Developments) Reviva, a late-stage pharma company, achieved positive Phase 3 results for brilaroxazine in schizophrenia and plans a second trial contingent on financing - The company's primary focus is completing the clinical development of brilaroxazine for the treatment of acute and maintenance schizophrenia[80](index=80&type=chunk) Phase 3 RECOVER-1 Trial Topline Results (Brilaroxazine 50mg vs. Placebo at Week 4) | Endpoint | Point Reduction/Improvement | Cohen's d Effect Size | P Value | | :--- | :--- | :--- | :--- | | PANSS Total Score (Primary) | **10.1** | **0.6** | **< 0.001** | | Positive Symptoms | **2.8** | **0.5** | **< 0.001** | | Negative Symptoms (NS) | **2.0** | **0.4** | **0.003** | | Personal & Social Performance | **6.3** | **0.5** | **< 0.001** | - The Open Label Extension (OLE) trial is complete, with the full data set expected in **Q2-2025**, showing sustained efficacy and good tolerability over one year[88](index=88&type=chunk)[89](index=89&type=chunk) - The company plans to initiate the registrational RECOVER-2 Trial in **mid-2025**, with a topline readout anticipated in **Q3 2026**, subject to receiving additional financing[86](index=86&type=chunk) [Financial Overview and Results of Operations](index=28&type=section&id=Financial%20Overview%20and%20Results%20of%20Operations) Q1 2025 net loss was $6.4 million, an improvement from $7.4 million in Q1 2024, primarily due to reduced R&D expenses, with a $5.3 million working capital deficit - As of March 31, 2025, the company had an accumulated deficit of **$170.7 million** and expects to incur significant operating losses for the next several years[101](index=101&type=chunk) Comparison of Results for the Three Months Ended March 31 | Item | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | 4,113,537 | 5,783,865 | (1,670,328) | (28.9)% | | General and administrative | 2,424,630 | 2,138,241 | 286,389 | 13.4% | | Net loss | (6,432,840) | (7,433,608) | 1,000,768 | (13.5)% | - The decrease in R&D expenses was primarily due to a reduction in external clinical research costs as the OLE Trial winds down[114](index=114&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is critically low with $5.3 million cash, sufficient only through Q2 2025, raising substantial doubt about going concern, necessitating Q3 2025 fundraising - The company's existing cash of approximately **$5.3 million** will not be sufficient to complete the development of its product candidates[122](index=122&type=chunk) - Management believes it has adequate cash to cover outlays only through the end of the **second quarter of 2025** and will need additional fundraising during the **third quarter of 2025**[122](index=122&type=chunk) - The company's financial condition and need for additional capital raise substantial doubt about its ability to continue as a going concern[122](index=122&type=chunk) Key Financial Position Data | Balance Sheet Data | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 5,289,404 | 13,476,331 | | Working (deficit) capital | (5,251,929) | 81,861 | | Total stockholders' equity (deficit) | (4,460,024) | 812,572 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Reviva is not required to provide the information called for by this item[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of March 31, 2025, due to material weaknesses in control environment, personnel, and IT general controls, with remediation underway - Management, including the CEO and CFO, concluded that as of **March 31, 2025**, the company's disclosure controls and procedures were **not effective** at the reasonable assurance level[133](index=133&type=chunk) - The company identified several **material weaknesses**, including an ineffective control environment due to an insufficient number of knowledgeable personnel[134](index=134&type=chunk) - Specific material weaknesses include ineffective **IT general controls** related to change management and access controls, and ineffective **process-level controls** affecting substantially all accounts[135](index=135&type=chunk) - The company has started remediation, including hiring a third-party consulting firm to enhance IT general controls and realigning personnel to strengthen financial reporting oversight[137](index=137&type=chunk) Part II [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or aware of any significant pending claims - The company is currently not aware of any legal proceedings or claims that may be, individually or in the aggregate, material to the company[143](index=143&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) New risk factor highlights Nasdaq non-compliance due to minimum bid price, potentially leading to delisting if not resolved by November 10, 2025 - On **May 13, 2025**, the company received a notice from Nasdaq for non-compliance with the minimum bid price requirement of **$1.00 per share**[145](index=145&type=chunk) - The company has an initial period of **180 calendar days** (until **November 10, 2025**) to regain compliance, with failure potentially resulting in the delisting of its common stock from Nasdaq[145](index=145&type=chunk)[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - There were no unregistered sales of equity securities during the quarter ended March 31, 2025[149](index=149&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) Discloses Nasdaq non-compliance notice for minimum bid price, with a November 10, 2025 deadline for compliance, and no Rule 10b5-1 trading plan changes - On **May 13, 2025**, the company received a written notice from Nasdaq because its common stock closing bid price was below **$1.00** for **30 consecutive business days**[152](index=152&type=chunk) - The company has **180 calendar days**, until **November 10, 2025**, to regain compliance with the Nasdaq minimum bid price requirement[153](index=153&type=chunk) - During the quarter ended March 31, 2025, no officers or directors adopted or terminated a Rule **10b5-1** trading arrangement[156](index=156&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with Form 10-Q, including CEO and CFO certifications and Inline XBRL data files

Exhibit 99.1 Reviva Reports First Quarter 2025 Financial Results and Recent Business Highlights – 446 participants completed the brilaroxazine long-term open-label extension (OLE) trial with 156 completing one-year and 301 completing six months of treatment – – Full data set from RECOVER OLE highlighting clinical response, safety, ef icacy, adherence, and biomarker data expected in Q2 2025 – Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Secti ...

Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program towards registration, with significant upcoming milestones including the full dataset from the long-term open-label extension trial expected in Q2 2025 and the initiation of the Phase 3 RECOVER-2 trial anticipated in mid-2025 [2][4]. Clinical Program Highlights - A total of 446 participants completed the long-term open-label extension trial for brilaroxazine, with 156 completing one year and 301 completing six months of treatment [1][5]. - The full data analysis from the RECOVER OLE trial will include clinical response, safety, efficacy, adherence, and biomarker data, expected to be reported in Q2 2025 [1][5]. - The company plans to submit a New Drug Application (NDA) for brilaroxazine in the fourth quarter of 2026, targeting unmet needs in schizophrenia treatment [2][5]. Financial Results - For the first quarter ended March 31, 2025, the company reported a net loss of approximately $6.4 million, or $0.13 per share, compared to a net loss of approximately $7.4 million, or $0.25 per share, for the same period in 2024 [10][12]. - As of March 31, 2025, cash and cash equivalents totaled approximately $5.3 million, down from approximately $13.5 million as of December 31, 2024 [10][11]. Anticipated Milestones and Events - The company will present a late-breaking poster on the RECOVER 12-month OLE trial at the 2025 American Society of Clinical Psychopharmacology annual meeting on May 28, 2025 [5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in mid-2025, contingent on additional financing [5].

CUPERTINO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in a fireside chat at the A.G.P. Healthcare Company Showcase, taking place virtually May ...

Summary of Reviva Pharmaceuticals Holdings (RVPH) Conference Call Company Overview - Reviva Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapies for neuropsychiatric diseases, particularly schizophrenia [3][38]. Pipeline and Development - The company has two molecules in development, with biloroxazine being the most advanced, currently in phase three studies for schizophrenia. Over one thousand patients have been treated [3][38]. - Enrollment for a long-term safety study is expected to complete in the next two to four weeks, with full data readout anticipated [3][38]. Core Insights on Schizophrenia - Schizophrenia is characterized by multiple symptom domains: positive, negative, mood, and cognitive symptoms. Most approved antipsychotics primarily address positive symptoms, leaving a significant unmet need for negative symptom treatment and treatment adherence [5][40]. - Neuroinflammation has gained attention as a contributing factor to schizophrenia, with approximately 30% of patients not responding to current treatments [6][40]. Efficacy and Safety Data - Biloroxazine shows a statistically significant efficacy with a ten-point separation from placebo in phase three trials, outperforming other antipsychotics like olanzapine and CAPLYTA [7][8]. - The drug demonstrates robust activity for negative symptoms, a critical area where most antipsychotics show limited efficacy [8][9]. - The discontinuation rate for biloroxazine is reported at 16%, significantly lower than the 30-45% range seen with other antipsychotics [11][13]. - Safety data indicates a clean profile with no significant movement disorders observed, which is a common side effect of other treatments [12][18]. Mechanism of Action - Biloroxazine modulates dopamine and serotonin receptors and has potent activity against neuroinflammatory targets, differentiating it from other antipsychotics [7][16]. - The drug's unique mechanism may enhance efficacy while mitigating side effects, particularly motor side effects [17][19]. Future Development Plans - Beyond schizophrenia, Reviva plans to explore indications for bipolar disorder, major depressive disorder, and ADHD, leveraging the drug's safety profile and efficacy in treating negative symptoms [34][39]. - The ADHD market is estimated at $28 billion, with no new drugs currently in development, presenting a significant opportunity for Reviva [34]. Market Positioning - The company believes biloroxazine will be a differentiated product in the treatment landscape, especially as it addresses both positive and negative symptoms effectively [32][33]. - The drug's development is positioned against both older generic drugs and newer mechanisms, emphasizing the need for effective treatment of negative symptoms [31][32]. Regulatory Pathway - Reviva has engaged with the FDA regarding the phase three study data and plans to conduct a pre-NDA meeting as full data readout approaches [26][27]. Conclusion - Reviva Pharmaceuticals is optimistic about biloroxazine's potential for NDA approval within the next 18 to 24 months, with a strong focus on addressing unmet needs in schizophrenia and expanding into other neuropsychiatric conditions [14][34].

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will present at the Citizens Life Sciences Conference on May 8, 2025, at 10:30 a.m. ET in New York, NY [1][2].

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][3] - The company will present a late-breaking poster on the RECOVER 12-month open label extension trial for brilaroxazine in schizophrenia at the 2025 ASCP annual meeting [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Clinical Development and Trials - The company announced positive topline results from the Phase 3 RECOVER-1 trial, achieving a statistically significant 10.1-point reduction in PANSS total score for brilaroxazine 50 mg compared to placebo at week 4 (p<0.001) [438]. - Brilaroxazine demonstrated a well-tolerated safety profile with no drug-related serious adverse events reported after 4 weeks of treatment, and a low discontinuation rate of 16% for the 50 mg dose compared to 22% for placebo [442]. - The ongoing Open Label Extension (OLE) trial has enrolled 435 patients, with preliminary results showing a dose-dependent efficacy with PANSS total score reductions of -15.2, -18.6, and -20.8 points for 15 mg, 30 mg, and 50 mg doses respectively after 1 year [449]. - The company plans to initiate the registrational global Phase 3 RECOVER-2 trial in mid-2025, with completion anticipated in Q3 2026, subject to additional financing [441]. - Brilaroxazine's clinical development includes a completed positive Phase 2 REFRESH trial and ongoing long-term safety assessments, with NDA submission planned for Q4 2026 [441]. - Key secondary endpoints in the RECOVER-1 trial also showed statistically significant improvements, including a 2.8-point reduction in positive symptoms and a 2.0-point reduction in negative symptoms at week 4 [439]. - The OLE trial reported a treatment discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up, with no significant adverse events related to brilaroxazine treatment [455]. - The company has completed Phase 1 studies for multiple indications of brilaroxazine, including schizophrenia and bipolar disorder [464]. Financial Performance and Funding - The company raised approximately $2.8 million from the May 2024 Offering and $3.6 million from the August 2024 Offering, after deducting expenses [452][454]. - As of December 31, 2024, the company reported a working capital surplus of approximately $0.1 million and an accumulated deficit of $164.3 million [460]. - The net loss for the years ended December 31, 2024 and 2023 was approximately $29.9 million and $39.3 million, respectively [460]. - The company expects to incur approximately $67 million in clinical costs over the next three years for the development of brilaroxazine for schizophrenia [466]. - The December 2024 Underwritten Offering included the sale of 12,000,000 shares of common stock at a combined public offering price of $1.50 per share, generating net proceeds of approximately $16.5 million [459]. - The company has not generated any revenues from product sales and has incurred losses since inception [460]. - The company plans to raise significant additional capital to fund ongoing operations and development efforts, indicating potential liquidity concerns [489]. - The company completed a registered direct offering in May 2024, raising net proceeds of approximately $2.8 million [493]. - In August 2024, the company completed an underwritten offering, raising approximately $3.6 million in net proceeds [494]. - The company completed an underwritten offering on December 18, 2024, raising net proceeds of $16.5 million from the sale of 12,000,000 shares of common stock and associated warrants [495]. - For the year ended December 31, 2024, net cash used in operating activities was approximately $33.5 million, primarily due to a net loss of approximately $29.9 million [497]. - The company reported a decrease in net operating assets and liabilities of approximately $4.5 million for the year ended December 31, 2024, mainly due to a decrease in accrued clinical expenses [497]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately $23.7 million, primarily from the issuance of common stock and warrants [499]. - The company had a net loss of approximately $39.3 million for the year ended December 31, 2023, with net cash used in operating activities of approximately $28.3 million [498]. - For the year ended December 31, 2023, net cash provided by financing activities was approximately $33.2 million, including proceeds from the issuance of common stock and warrants [500]. - The company does not currently have any committed external sources of capital and may face dilution of stockholder ownership if additional capital is raised [496]. Expenses and Financial Outlook - Research and development expenses are expected to increase significantly as the company advances its development programs and seeks regulatory approval [462]. - The company aims to expand its infrastructure and clinical programs, leading to increased general and administrative expenses [468]. - Research and development expenses decreased from approximately $31.4 million in 2023 to $22.9 million in 2024, a reduction of $8.5 million or 27.1% [480][481]. - General and administrative expenses slightly decreased from approximately $8.1 million in 2023 to $7.9 million in 2024, a reduction of $0.2 million or 2.4% [483]. - The company reported a net loss of approximately $29.9 million for the year ended December 31, 2024, compared to a net loss of approximately $39.3 million in 2023, reflecting an improvement of $9.3 million [477]. - Cash and cash equivalents decreased from approximately $23.4 million in 2023 to $13.5 million in 2024, a decline of $9.9 million or 42.3% [488]. - Total assets decreased from approximately $23.7 million in 2023 to $15.5 million in 2024, a reduction of $8.2 million or 34.6% [488]. - The company expects to incur significant expenses and operating losses as it continues research and clinical development of product candidates, including brilaroxazine [490]. - The company recognized a gain on remeasurement of warrant liabilities of approximately $0.7 million in 2024, compared to a loss of $0.2 million in 2023 [484]. Regulatory and Designation - The company has received Orphan Drug Designation from the FDA for brilaroxazine for the treatment of pulmonary arterial hypertension and idiopathic pulmonary fibrosis [434]. - The company continues to face uncertainties regarding the successful development and marketing approval of its product candidates [466]. - The Series A Common Stock Warrants are exercisable immediately and expire on June 18, 2025, with an exercise price of $1.50 per share [495]. - The Series B Common Stock Warrants are also exercisable immediately, expiring on December 18, 2029, with an exercise price of $1.50 per share [495]. - The company does not have any off-balance sheet arrangements as defined under SEC rules [501].

Financial Performance - Reviva reported a net loss of approximately $29.9 million, or $0.90 per share, for the fiscal year ended December 31, 2024, a decrease from a net loss of approximately $39.3 million, or $1.65 per share, for the fiscal year ended December 31, 2023[6] - Cash and cash equivalents totaled approximately $13.5 million as of December 31, 2024, down from approximately $23.4 million as of December 31, 2023[6] - The company reported a total operating expense of $30.8 million for the fiscal year 2024, down from $39.5 million in 2023[15] - The company completed a public follow-on offering with aggregate gross proceeds of approximately $18.0 million in December 2024[7] Clinical Trials and Efficacy - The ongoing Phase 3 RECOVER study showed a dose-dependent efficacy with decreases in PANSS total scores of -15.2, -18.6, and -20.8 points at the 15, 30, and 50 mg doses respectively, from baseline to end-of-treatment at 52 weeks[3] - The pooled data from the RECOVER study demonstrated a clinically meaningful and sustained long-term efficacy for schizophrenia, with a PANSS total score decrease of 18.6 points (from 71.6 to 53), p ≤ 0.0001[3] - The anticipated registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected to initiate in mid-2025, subject to additional financing[7] - A potential New Drug Application (NDA) submission for brilaroxazine is targeted for the fourth quarter of 2026[7] - The company expects to report the full data set from the RECOVER OLE study, including vocal and blood biomarker data, in the second quarter of 2025[2] Adverse Events - The most common treatment-related adverse events (TRAEs) reported were weight increase (3.2%), insomnia (1.8%), and somnolence (1.6%)[7]