Reviva Pharmaceuticals Holdings (RVPH) Update Summary Company Overview - Reviva Pharmaceuticals is a late-stage pharmaceutical company focused on developing next-generation therapies for central nervous system, respiratory, and metabolic diseases using chemical genomics-driven technologies [3][2]. Key Points from the Call Clinical Trials and Drug Development - Reviva is presenting results from the Phase 3 RECOVER trial, which focuses on the long-term safety, tolerability, and efficacy of viloroxazine in treating schizophrenia [11][12]. - The RECOVER trial included nearly 1,000 patients across multiple studies, demonstrating a differentiated clinical profile for viloroxazine [11]. - The drug showed strong efficacy in both acute and stable schizophrenia, with over 50% better adherence outcomes compared to historical data [12][11]. Efficacy Results - The efficacy of viloroxazine was highlighted, showing significant improvements in both positive and negative symptoms of schizophrenia, with effect sizes for PANSS total and positive symptoms being notably large [20][22]. - The drug demonstrated sustained decreases in psychopathology over a one-year period, with substantial improvements in negative symptoms and social cognition [27][30][33]. - The open-label extension trial indicated that patients experienced a 46.1% decrease in symptoms for the 15 mg dose and a 49.6% decrease for the 50 mg dose over the trial period [28]. Safety and Tolerability - The discontinuation rate due to adverse effects was low at 16% for viloroxazine compared to 22% for placebo, indicating good tolerability [20][44]. - Common side effects included somnolence and headache, with no significant extrapyramidal symptoms reported [45][69]. - The drug showed a weight gain of only 1.2 kg over 13 months, indicating a weight-neutral effect, which is a significant improvement over other atypical antipsychotics [52][70]. Metabolic Profile - Viloroxazine demonstrated reductions in cholesterol and LDL levels, suggesting a favorable metabolic profile compared to existing treatments [53][70]. - The drug also showed a significant reduction in prolactin levels, which is often elevated in patients taking other antipsychotics, potentially improving sexual function [57][71]. Neuroinflammation and Biomarkers - The drug's effects on neuroinflammatory markers were noted, with significant reductions in interleukins and TNF-alpha, suggesting a broad anti-inflammatory effect that may contribute to its efficacy in treating schizophrenia [63][65]. - Improvements in brain-derived neurotrophic factor (BDNF) levels were also reported, which is associated with better neuronal signaling and recovery from damage [64]. Additional Insights - The call emphasized the importance of addressing both positive and negative symptoms in schizophrenia treatment, with viloroxazine showing robust efficacy in both areas [74][76]. - The potential for viloroxazine to improve quality of life and functioning in patients with schizophrenia was highlighted, with suggestions that it could be effective in both acute and chronic settings [35][36]. Conclusion - Reviva Pharmaceuticals is advancing its clinical development of viloroxazine, which shows promise as a treatment for schizophrenia with a favorable safety and efficacy profile compared to existing therapies. The drug's ability to address both positive and negative symptoms, along with its favorable metabolic effects, positions it as a potential next-generation antipsychotic [35][71].

Efficacy of Brilaroxazine - Brilaroxazine demonstrated a significant decrease of 18 points in PANSS total score at Week 52 compared to baseline (p ≤ 0.0001) [41] - There was a 5-point decrease in PANSS positive symptoms score at 12 months with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p ≤ 0.001) [47] - Brilaroxazine showed a 4.4-point decrease in PANSS negative symptoms score at 12 months compared to baseline (p ≤ 0.001) [50] - 58.5% of patients showed >1-point improvement on the CGI-S scale at 12 months with brilaroxazine pooled (15, 30, & 50 mg) vs baseline (p ≤ 0.001) [69] Safety and Tolerability of Brilaroxazine - In the 52-week open-label trial, 37.2% of patients experienced any treatment emergent adverse event (TEAE) [84] - The pooled brilaroxazine dose group reported a mild weight gain of 1.52 kg [104] - There was a decrease in cholesterol of -8.3 mg/dL overall (p=0.030) and LDL cholesterol of -8.0 mg/dL overall (p=0.0093) in the 12-month OLE trial [90] - A clinically significant decrease in serum prolactin levels of -12.50 ug/L overall was observed from baseline to week-52/EOT [94] - There was an improvement in thyroid (T3) hormone levels of 0.044 ug/L overall (P ≤ 0.05) [97] Trial Design and Demographics - The RECOVER open-label extension (OLE) trial enrolled 446 patients with stable schizophrenia [37]

Core Insights - Reviva Pharmaceuticals announced positive results from the Phase 3 RECOVER open-label extension study of brilaroxazine for schizophrenia, demonstrating sustained efficacy and a well-tolerated safety profile over one year [1][2][5] Efficacy and Safety - Brilaroxazine showed robust broad-spectrum efficacy across all major symptom domains of schizophrenia, with a statistically significant reduction in PANSS total score of -18.1 at 12 months [3][4] - The treatment was generally well-tolerated, with a discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up [1][9] - Improvements in multiple neuroinflammatory markers were observed, suggesting enhanced efficacy and reduced side effects [1][2][9] Clinical Data - The study included a pooled analysis of 446 patients receiving doses of 15 mg, 30 mg, and 50 mg, showing dose-dependent efficacy [2][4] - Key findings included a reduction in negative symptoms by -4.4 at 12 months and significant improvements in personal and social performance scores [3][4] - The treatment also demonstrated a low incidence of treatment-emergent adverse events, with most being mild or moderate in severity [9][10] Future Development - Reviva aims to advance brilaroxazine towards regulatory submission, with plans to explore its use in other neuropsychiatric conditions such as bipolar disorder and major depressive disorder [10][11] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension and idiopathic pulmonary fibrosis [11][12]

Summary of Reviva Pharmaceuticals Holdings (RVPH) Conference Call Company Overview - **Company**: Reviva Pharmaceuticals Holdings (RVPH) - **Industry**: Pharmaceuticals, specifically focused on neuropsychiatric disorders - **Key Product**: Duloxazine, currently in phase three development for schizophrenia Core Points and Arguments 1. **Pipeline Development**: Reviva is developing next-generation therapies for neuro dysfunction, with Duloxazine being the most advanced molecule aimed at treating schizophrenia and potentially other psychiatric conditions such as bipolar disorder, major depressive disorder, and ADHD [4][5] 2. **Market Potential**: The indications targeted by Reviva represent a multibillion-dollar market, with over 24 million people suffering from schizophrenia globally, and around 4 million in the US alone [7][8] 3. **Unmet Needs**: Approximately 30% of schizophrenia patients do not respond to current treatments, highlighting the need for better options that address negative symptoms and treatment adherence [8][10] 4. **Efficacy and Safety**: Duloxazine has shown a 12-16% discontinuation rate in trials, significantly lower than the 30-70% seen with existing antipsychotics, indicating better treatment adherence [12][26] 5. **Neuroinflammation**: The drug also targets neuroinflammation, which is a significant factor in disease progression and comorbidities in psychiatric patients [9][21] 6. **Phase Three Data**: The pivotal phase three study involved 411 patients and demonstrated a statistically significant outcome with a 10-point separation from placebo, indicating robust efficacy [14][15] 7. **Negative Symptoms**: Duloxazine showed a 2-point separation in negative symptoms, a chronic condition that is difficult to treat, with only a few existing drugs demonstrating significant outcomes [17][20] 8. **Biomarkers**: The use of digital biomarkers, such as speech patterns, has confirmed the drug's efficacy in patients with severe negative symptoms [19][24] 9. **Safety Profile**: The safety profile of Duloxazine is comparable to placebo, with minimal motor side effects and manageable weight gain, which is often a concern with antipsychotics [26][27] 10. **Future Development**: Reviva plans to initiate a second phase three study (RECOVER 2) to further support the NDA submission, expected by the end of next year [34][43] Additional Important Content - **Mechanism of Action**: Duloxazine directly modulates dopamine and serotonin receptors, addressing both behavioral symptoms and inflammatory cascades, which differentiates it from existing treatments [39][40] - **Long-term Efficacy**: Data from long-term studies indicate sustained efficacy and safety, with dropout rates significantly lower than those of other antipsychotics [31][32] - **Regulatory Pathway**: The company is on track to meet the requirements for NDA submission, having completed necessary trials and safety studies [42][43] This summary encapsulates the key points discussed during the conference call, highlighting Reviva Pharmaceuticals' strategic focus on addressing significant unmet needs in the treatment of schizophrenia and related disorders.

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].