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].

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] - The company will participate in a fireside chat at the A.G.P. Healthcare Company Showcase on May 21, 2025, at 2:00 p.m. EST [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 [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]

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]