Price Target Changed • Mar 31
Price target decreased by 48% to US$46.67 Down from US$90.00, the current price target is an average from 6 analysts. New target price is 6,295% above last closing price of US$0.73. Stock is down 94% over the past year. The company is forecast to post a net loss per share of US$4.14 next year compared to a net loss per share of US$5.48 last year. Breakeven Date Change • Mar 30
No longer forecast to breakeven The 6 analysts covering Reviva Pharmaceuticals Holdings no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$6.03m in 2028. New consensus forecast suggests the company will make a loss of US$60.4m in 2028. Ankündigung • Mar 19
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Series G Common Warrants
Security Type: Equity Warrant
Security Name: Series H Common Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant New Risk • Mar 08
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$23m Forecast net loss in 3 years: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (151% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Market cap is less than US$100m (US$20.9m market cap). Price Target Changed • Feb 09
Price target decreased by 10.0% to US$4.50 Down from US$5.00, the current price target is an average from 7 analysts. New target price is 1,471% above last closing price of US$0.29. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.90 last year. Ankündigung • Jan 24
Reviva Pharmaceuticals Holdings, Inc. Announces Nasdaq Grants Exception for Continued Listing Amid Bid Price Non-Compliance On January 20, 2026, the Nasdaq Hearings Panel (the “Panel”) of the Nasdaq Stock Market LLC (“Nasdaq”) notified Reviva Pharmaceuticals Holdings, Inc. (the “Company”, “we” or “us”) that the Panel has granted the Company’s request for an exception to demonstrate compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”) for continued listing through March 27, 2026 (the “Exception”). Pursuant to the Exception, the Company is required to, and fully intends to, provide the Panel with prompt notification of any significant events that occur during the Exception period that may affect the Company’s compliance with Nasdaq requirements. The Exception is in connection with the previously-disclosed matter originally initiated pursuant to the Nasdaq notice received by the Company on May 13, 2025, indicating that it was not in compliance with the Bid Price Requirement. The Company had been provided a compliance period of 180 calendar days from the date of the notice, or until November 10, 2025, to regain compliance with the Bid Price Requirement. Also as previously disclosed in connection with such matter, on November 11, 2025, the Company had received a letter from Nasdaq indicating that, based upon the Company’s not having regained compliance with the Bid Price Requirement and its ineligibility for a second 180 calendar day compliance period, the Listing Qualifications Staff of Nasdaq had determined to delist the Company’s securities from Nasdaq unless the Company timely requested a hearing before the Panel. The Company timely requested a hearing before the Panel, which was held on January 8, 2026 and following which hearing the Panel determined to grant the above-described Exception. Ankündigung • Jan 08
Reviva Pharmaceuticals Holdings, Inc. Announces Publication on Clinical Vocal Biomarker Data from the Recover Phase 3 Clinical Trial of Brilaroxazine to Treat Negative Symptoms in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced the publication, in the peer-reviewed journal Biological Psychiatry, of an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials that highlights clinical vocal biomarker data from the RECOVER Phase 3 clinical trial and the therapeutic potential of brilaroxazine for the treatment of schizophrenia. The publication is available at revivapharma.com/publications. Highlights of brilaroxazine vocal or speech biomarker data from the pivotal Phase 3 RECOVER trial in schizophrenia include: Speech latencies classified the presence of moderate to severe negative symptoms (VBM-positive) and low negative symptoms (VBM-negative) in patients randomized to the RECOVER trial. A greater percentage of VBM positive patients showed significant treatment response, as measured by clinician assessed efficacy outcomes of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia. VBM-positive patients showed a fast and strong response to brilaroxazine treatment in nearly every outcome measure, especially negative symptoms. Speech latency, an objective measure of verbal response time, is sensitive to cognitive, social, and motivational factors, and can be assayed from psychiatric interviews. Speech latency differentiates patients with moderate-to-severe vs. low negative symptoms across countries and languages. As an enrichment tool, it could reduce sample-size needs and enhance the trial outcomes thereby reducing clinical trial costs and burden. Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the FDA for the treatment of PAH and IPF conditions. Breakeven Date Change • Jan 06
Forecast to breakeven in 2028 The 6 analysts covering Reviva Pharmaceuticals Holdings expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$6.03m in 2028. Average annual earnings growth of 53% is required to achieve expected profit on schedule. Price Target Changed • Dec 24
Price target decreased by 10% to US$4.81 Down from US$5.38, the current price target is an average from 7 analysts. New target price is 1,398% above last closing price of US$0.32. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.90 last year. New Risk • Nov 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$28m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Shareholders have been substantially diluted in the past year (241% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Market cap is less than US$100m (US$57.3m market cap). Ankündigung • Nov 05
Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Dec 18, 2025 Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Dec 18, 2025. Ankündigung • Oct 29
Reviva to Present Negative Symptom Data for Brilaroxazine in Schizophrenia from the Phase 3 Recover Double-Blind and Open-Label Extension Trials At the CNS Summit 2025 Reviva Pharmaceuticals Holdings, Inc. announced that negative symptom data for brilaroxazine from the Phase 3 RECOVER double-blind trial in patients with acute exacerbation of schizophrenia, and from the long-term open-label extension trial in clinically stable schizophrenia patients will be presented as a poster presentation at the CNS Summit 2025, taking place November 2-5, in Boston, Massachusetts. Ankündigung • Oct 18
Reviva Pharmaceuticals Holdings, Inc. Receives Notice of Regained Compliance with Nasdaq Market Value Listing Requirement On October 14, 2025, Reviva Pharmaceuticals Holdings, Inc. received a letter (the “MVLS Compliance Letter”) from the Listing Qualifications Department (the “Nasdaq Staff”) of The Nasdaq Stock Market (“Nasdaq”) formally notifying the Company that it has regained compliance with the minimum Market Value of Listed Securities (“MVLS”) requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”) and that the MVLS Requirement matter is now closed. The MVLS Compliance Letter was pursuant to a previous notice received on August 8, 2025 from Nasdaq Staff indicating, as previously reported, that the Company was not then in compliance with the MVLS Requirement because the Company had failed to maintain a minimum MVLS of $35 million over the previous 30 consecutive business days preceding such previous notice. Since then, Nasdaq Staff has determined that for the last 10 consecutive business days preceding the MVLS Compliance Letter, from September 30, 2025 to October 13, 2025, the Company’s MVLS has been $35 million or greater. As previously disclosed, pursuant to the written notice received from Nasdaq on May 13, 2025 (the “Minimum Bid Price Notice”), the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Minimum Bid Price Requirement”). The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days preceding the Minimum Bid Price Notice, the Company is not currently in compliance with Minimum Bid Price Requirement. As previously reported, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until November 10, 2025, to regain compliance with the Minimum Bid Price Requirement. The Company intends to continue to actively monitor the closing bid price of its common stock and assess potential actions to regain compliance with the Minimum Bid Price Requirement and may, if appropriate, consider and effectuate available options, including implementation of a reverse stock split of the Company’s common stock. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement, or that the Company will be able to maintain compliance with this requirement or with the other Nasdaq continued listing requirements. Ankündigung • Sep 19
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Series E Common Warrants
Security Type: Equity Warrant
Security Name: Series F Common Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Price Target Changed • Aug 18
Price target decreased by 11% to US$8.43 Down from US$9.43, the current price target is an average from 7 analysts. New target price is 1,523% above last closing price of US$0.52. Stock is down 35% over the past year. The company is forecast to post a net loss per share of US$0.46 next year compared to a net loss per share of US$0.90 last year. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Chairman of the Board Parag Saxena was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Jun 26
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Series C Common Warrants
Security Type: Equity Warrant
Security Name: Series D Common Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Ankündigung • Jun 02
Reviva Pharmaceuticals Holdings, Inc. Announces Positive Full Dataset for 1-Year Phase 3 Recover Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced a positive full dataset and successful completion of the Company's Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia. Once daily brilaroxazine led to robust broad-spectrum efficacy that was sustained over 1-year and was generally well tolerated with a discontinuation rate of 35% in this long-term study. Brilaroxazine is a novel serotonin dopamine signaling modulator with multi-faceted direct and indirect activities on critical pathways implicated in schizophrenia. Key safety, efficacy and compliance findings for pooled analysis of brilaroxazine (n = 446) at 15 mg (n = 140), 30 mg (n = 158), and 50 mg (n = 148) include: Dose-dependent, broad spectrum, clinically meaningful and sustained long-term (1-year) efficacy across all major symptom domains of schizophrenia. Clinical safety, tolerability and adherence findings with pooled doses of brilaroxazine (15, 30, and 50 mg) in the OLE trial patients (N=446) support a well-tolerated safety profile: 8.5% of participants reported at least one treatment-emergent adverse event (TEAE), which were mostly mild (6.5%) or moderate (2.0%) in severity and transient in nature; Most common TEAEs 2% were headache (2.7%), insomnia (4.0%), sleep disturbance (2.9%) and mild tremor (3.1%); Brilaroxazine was not associated with any clinically meaningful changes in movement disorder scales used for evaluating motor side effects such as akathisia and extrapyramidal symptoms over 1-year treatment; Mild weight gain (1.52 kg) reported in the pooled brilaroxazine dose group over 1-year treatment. Weight gain was not dose dependent with least weight gain (1.28 kg) at 50 mg dose; No drug related serious adverse events (SAEs) observed or major safety concerns reported for brilaroxazine after 1-year of treatment; 5 serious adverse events were reported, and none were related to brilaroxazine treatment; No incidence of clinically significant cardiac side effects, or gastrointestinal side effects; No incidence of drug induced liver injury (DILI)No significant change in blood glucose levels; Improved lipids levels and endocrine hormone levels (prolactin, and thyroid); and Treatment discontinuation rate of 35% reported in this one-year study primarily due to withdrawal of consent (22%), participant lost to follow up (7%) and treatment related adverse events (1.1%). The RECOVER OLE Study is a global, open-label, multicenter study to assess the safety, tolerability and efficacy of brilaroxazine at flexible doses of 15, 30 or 50 mg, administered once daily for 52-week (1-year) in patients with stable schizophrenia. The OLE study included both rollover participants from the RECOVER double-blind study and de novo participants with stable schizophrenia. Long-term safety data from 100 patients who have completed 1-year of treatment is a requirement for brilaroxazine’s NDA submission to the U.S. Food and Drug Administration (“FDA”). Ankündigung • May 31
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Apr 01
Reviva Pharmaceuticals Holdings, Inc. announced delayed annual 10-K filing On 03/31/2025, Reviva Pharmaceuticals Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. New Risk • Jan 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 67% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Negative equity (-US$10.0m). Shareholders have been substantially diluted in the past year (67% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Market cap is less than US$100m (US$90.4m market cap). Price Target Changed • Jan 10
Price target decreased by 11% to US$13.50 Down from US$15.20, the current price target is an average from 6 analysts. New target price is 618% above last closing price of US$1.88. Stock is down 55% over the past year. The company is forecast to post a net loss per share of US$0.95 next year compared to a net loss per share of US$1.65 last year. Ankündigung • Dec 16
Reviva Pharmaceuticals Holdings, Inc. Announces Positive Preliminary Topline Data for the Long-Term Open Label Extension Portion of the Phase 3 Recover Study Evaluating Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced positive preliminary topline data for the open-label extension (OLE) portion of the Company's ongoing Phase 3 RECOVER study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. Administration of brilaroxazine once daily led to robust broad-spectrum efficacy that was sustained over 1 year. Brilaroxazine was generally well tolerated with no single side effect >5% and favorable compliance, with a discontinuation rate of 35% in the OLE part of this study. All three doses of brilaroxazine (15 mg, 30 mg and 50 mg) tested were efficacious and generally well-tolerated. 3 serious adverse events were reported and none were related to brilaroxazine treatment. Treatment discontinuation rate of 35% reported in this OLE, primarily due to withdrawal of consent (22%), participant lost to follow up (7%), and treatment-related adverse events (1.6%) Collectively, the findings from the OLE (52-week/1-year) portion of the Phase 3 RECOVER study further strengthen the safety, efficacy and treatment adherence findings from the double-blind (4-week) portion of RECOVER. The OLE portion of the RECOVER Study is being conducted globally at multiple centers to assess the safety, and efficacy of brilaroxazine at flexible doses of 15, 30 or 50 mg, administered once daily for 52 weeks (1 year) in patients with stable schizophrenia. The OLE included both rollover participants from the double-blind portion of RECOVER study and de novo participants with stable schizophrenia. Long-term safety data from a minimum of 100 patients who have completed 1 year of treatment is a requirement for brilaroxazine's NDA submission to the FDA. Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains, including reduction in key proinflammatory cytokines implicated in the pathophysiology the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with CYP3A4 inhibitors. Reviva intends to develop brilaroxazine for other neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclini cal activity for inflammatory diseases, such as psoriasis, pulmonary arterial hypertension (PAH) and idiopathIC pulmonary fibrosis (IPF), with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. New Risk • Nov 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$33m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$33m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-US$10.0m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$49m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (US$37.6m market cap). Ankündigung • Nov 13
Reviva Pharmaceuticals Holdings, Inc. Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. RECOVER Trial OLE Enrollment Status Update as of November 12, 2024: Global trial progressing well; 108 patients have completed 1-year (12-month) of treatment; Over 250 patients have completed 6-months of treatment; Blood and digital biomarkers designed to independently support efficacy; Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA and 12 months long-term safety study to complete in First Quarter 2025. The RECOVER Trial OLE is a randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of brilaroxazine at fixed doses of 15 mg or 50 mg, administered once daily for 28 days in subjects with an acute exacerbation of schizophrenia, followed by the long-term safety assessment of brilaroxazine at flexible doses of either 15, 30 or 50 mg administered once daily for 52 weeks in subjects with stable schizophrenia. The OLE study will include both double-blind rollover and de novo subjects with stable schizophrenia. About Brilaroxazine: Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. Ankündigung • Oct 18
Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Dec 10, 2024 Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Dec 10, 2024. New Risk • Sep 24
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$36m Forecast net loss in 3 years: US$21m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-US$6.0m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Shareholders have been diluted in the past year (46% increase in shares outstanding). Market cap is less than US$100m (US$41.0m market cap). Ankündigung • Aug 22
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $4.999852 million. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $4.999852 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,276,262
Price\Range: $1.05
Discount Per Security: $0.084
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,485,643
Price\Range: $1.0499
Discount Per Security: $0.084
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 4,761,905
Transaction Features: Registered Direct Offering New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$35m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$35m free cash flow). Negative equity (-US$6.0m). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (32% increase in shares outstanding). Market cap is less than US$100m (US$21.4m market cap). New Risk • Jul 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-US$1.3m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Shareholders have been diluted in the past year (32% increase in shares outstanding). Market cap is less than US$100m (US$37.3m market cap). Board Change • Jul 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 1 highly experienced director. Independent Chairman of the Board Parag Saxena was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • May 16
Reviva Pharmaceuticals Holdings, Inc. Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. RECOVER Trial OLE Enrollment Status Update As of May 15, 2024: Trial progressing as expected in the USA, Europe (Bulgaria) and Asia (India); 358 patients enrolled in the study; 223 patients currently on treatment in the study; Over 130 patients currently in the study have completed 1-6 months of treatment; Over 90 patients currently in the study have completed 6-9 months of treatment; 23 patients have completed 12 months of treatment; Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA; Reviva is on track to complete the 12 months long-term safety study in fourth quarter 2024. The RECOVER Trial OLE is a randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of brilaroxazine at fixed doses of 15 mg or 50 mg, administered once daily for 28 days in subjects with an acute exacerbation of schizophrenia, followed by the long-term safety assessment of brilaroxazine at flexible doses of either 15, 30 or 50 mg administered once daily for 52 weeks in subjects with stable schizophrenia. The OLE study will include both double-blind rollover and de novo subjects with stable schizophrenia. About Brilaroxazine: Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications. Ankündigung • May 15
Reviva Pharmaceuticals Holdings, Inc. to Present New Preclinical Efficacy Data on Brilaroxazine in Idiopathic Pulmonary Fibrosis at 2024 ATS International Conference Reviva Pharmaceuticals Holdings, Inc. will present new efficacy data on brilaroxazine in an animal model of idiopathic pulmonary fibrosis as part of a late-breaking poster presentation at the 2024 American Thoracic Society (ATS) International Conference, to be held in San Diego, CA, May 17-22, 2024. Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. Ankündigung • Apr 16
Reviva Pharmaceuticals Holdings, Inc. Gains Alignment with U.S. Food and Drug Administration on its Registrational Phase 3 Program for Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced that it has gained alignment with the U.S. Food and Drug Administration (FDA) on its registrational Phase 3 program for brilaroxazine in schizophrenia. The FDA accepted a 4-week RECOVER-2 study for brilaroxazine in schizophrenia. Notably, the FDA also indicated that two positive Phase 3 studies showing efficacy at week 4 that are accompanied by long-term safety data of at least 12 months could be supportive of an NDA submission for the acute treatment of schizophrenia. In addition, FDA indicated that it will require a long-term randomized withdrawal study post-approval to support maintenance of effect. RECOVER-2 is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter, 4-week study designed to assess the safety and efficacy of brilaroxazine in approximately 450 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 30 mg or 50 mg once daily for 28-days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning, and cognition, and key biomarkers implicated in neuroinflammation. Reviva plans to initiate the first clinical site in the Q2-2024. Ankündigung • Apr 03
Reviva Pharmaceuticals Holdings, Inc. announced delayed annual 10-K filing On 04/02/2024, Reviva Pharmaceuticals Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. New Risk • Mar 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$97.7m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$8.5m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$29m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (37% increase in shares outstanding). Market cap is less than US$100m (US$97.7m market cap). New Risk • Feb 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: US$38m Forecast net loss in 2 years: US$29m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$8.5m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$29m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (37% increase in shares outstanding). Board Change • Jan 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 1 highly experienced director. Independent Chairman of the Board Parag Saxena was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 5 analysts covering Reviva Pharmaceuticals Holdings expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$104.6m in 2026. Average annual earnings growth of 52% is required to achieve expected profit on schedule. Ankündigung • Nov 22
Reviva Pharmaceuticals Holdings, Inc. has completed a Follow-on Equity Offering in the amount of $30.000008 million. Reviva Pharmaceuticals Holdings, Inc. has completed a Follow-on Equity Offering in the amount of $30.000008 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,853,660
Price\Range: $5.125
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 5,853,660
Transaction Features: Registered Direct Offering Ankündigung • Nov 18
Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $30.000008 million. Reviva Pharmaceuticals Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $30.000008 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,853,660
Price\Range: $5.125
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 5,853,660
Transaction Features: Registered Direct Offering New Risk • Nov 17
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$8.5m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-US$8.5m). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (11% increase in shares outstanding). Ankündigung • Oct 31
Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia. The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints. Key clinical safety and tolerability findings of brilaroxazine support a well-tolerated safety profile: No drug related serious adverse events (SAEs) or treatment-emergent SAEs (TESAEs) observed or major safety concerns reported for brilaroxazine after 4 weeks of treatment, No incidence of suicidal ideation, No significant change in bodyweight, blood glucose levels, lipids levels, or endocrine hormones (prolactin, thyroid hormone) compared to placebo, Akathisia and extrapyramidal symptoms <1% reported for brilaroxazine 50 mg and none for 15 mg, Low discontinuation rates with brilaroxazine that were less than placebo (16% in brilaroxazine 50mg and 19% in brilaroxazine 15mg vs. 22% placebo). The brilaroxazine program consists of the completed positive Phase 2 REFRESH and Phase 3 RECOVER trials, as well as an ongoing 1-year OLE trial evaluating the long-term safety and tolerability, and soon to be initiated confirmatory global, randomized 6-week Phase 3 RECOVER-2 trial. The Company expects to report topline data from the OLE trial in Fourth Quarter 2024 and initiate the registrational Phase 3 RECOVER-2 trial in First Quarter 2024, with completion anticipated in early 2025. These data from the brilaroxazine program will potentially support the planned NDA submission to the FDA in 2025. Conference Call and Webcast Information Reviva management will hold a conference call and webcast at 8:30 a.m. ET to discuss topline results from its Phase 3 RECOVER trial evaluating brilaroxazine for adults with schizophrenia. Dial In: The dial-in number for the conference call is 1-877-704-4453 (U.S./Canada) or 1-201-389-0920 (international). Conference ID: The conference ID for all callers is 13742204. Call me™: Click here. Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to scheduled start time. Live Webcast: The live webcast can be accessed here. The live webcast and replay may also be accessed by visiting Reviva’s website at https://revivapharma.com/events/. An archived version of the webcast will be available on the website for 30 days. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 412 patients with acute schizophrenia compared to placebo. Brilaroxazine was administered at fixed doses of 15 mg or 50 mg once daily for 28 days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning and cognition. New Risk • Oct 20
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.2m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). New Risk • Oct 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$94.5m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.2m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Market cap is less than US$100m (US$94.5m market cap). Ankündigung • Oct 05
Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Nov 13, 2023 Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Nov 13, 2023, at 11:00 Pacific Standard Time. Agenda: To elect five director nominees to serve as directors until the next annual meeting of stockholders; to ratify the appointment of Moss Adams LLP as the Company’s independent registered public accounting firm for the year ending December 31, 2023; and to consider any other matters that may properly come before the Annual Meeting. New Risk • Sep 20
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$31m Forecast net loss in 3 years: US$9.2m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.2m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Ankündigung • Aug 18
Reviva Pharmaceuticals Holdings, Inc. Announces Enrollment Completion for Pivotal Phase 3 Recover Study for Brilaroxazine in Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced that enrollment is complete in the pivotal Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia, with 402 patients enrolled at multiple sites in the United States (~60%), Europe (~10%), and Asia (~30%). RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 402 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression rating scale, positive and negative symptoms, social functioning and cognition. A 1-year open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Over 50% of patients are currently enrolled in the OLE, with completion of the required 100 patients treated with brilaroxazine for 1-year expected in Third Quarter 2024. Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. In a multinational, multicenter, double-blind Phase 2 study in 234 patients with acute schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, reducing Positive and Negative Syndrome Scale (PANSS) total score and demonstrating statistically significant improvement of overall drug treatment outcomes using Clinical Global Impression scale and for secondary endpoints evaluating social functioning, and positive and negative symptoms, and directional improvements for depression and cognition. In this completed Phase 2 study, brilaroxazine met all safety endpoints with no weight gain, no increase in blood sugar and lipids, and no cardiac or endocrine adverse effects compared to placebo. Positive data from a clinical drug-drug interaction study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. A full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. The U.S. Food and Drug Administration has agreed to consider a potential superior safety label claim if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 study in patients with schizophrenia. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder and attention-deficit/hyperactivity disorder. Additionally, brilaroxazine has shown promising efficacy for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. New Risk • Jul 26
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.1m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.6m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (50% increase in shares outstanding). Market cap is less than US$100m (US$95.1m market cap). Ankündigung • Jun 23
Reviva Pharmaceuticals Holdings, Inc. Announces 80% Global Enrollment Update for Pivotal Phase 3 RECOVER Study Evaluating Brilaroxazine for Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced over 80% of patients have been enrolled in the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia. Enrollment is ongoing at multiple sites in the United States, Europe, and Asia. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Reviva continues to make progress and is on expected pace with patient enrollment and site initiation in geographically diverse centers across this global clinical study. Ankündigung • Dec 17
Reviva Pharmaceuticals Holdings, Inc. Announces Positive Safety Data from Drug-Drug Interaction Clinical Study of Brilaroxazine Reviva Pharmaceuticals Holdings, Inc. announced positive data from its recently completed clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects. The CYP3A4 enzyme plays a pivotal role in helping the body metabolize and remove small foreign molecules and is primarily found in the liver and intestine. DDI evaluation is a critical clinical pharmacology study required by theU.S. Food and Drug Administration (FDA) and other regulatory agencies globally for approving a new drug to market. Brilaroxazine is a serotonin/dopamine modulator in late-stage clinical development for the treatment of schizophrenia. Following FDA guidelines, the DDI clinical study was designed to evaluate the drug interaction effect of a strong CYP3A4 inhibitor or inducer when co-administered with brilaroxazine in healthy volunteers. A strong CYP3A4 inhibitor, itraconazole, slightly increased brilaroxazine C(max), AUC(last) and AUC(inf) by 6, 16 and 13%, respectively, in healthy volunteers (N=11). Similarly, a strong CYP3A4 inducer, phenytoin, in healthy volunteers (N=16) decreased brilaroxazine C(max), AUC(last) and AUC(inf) by 33, 56 and 53%, respectively. Reviva believes that brilaroxazine'sclinical safety is further reinforced with the positive results of this DDI study, which found no clinically significant double-blind, placebo- controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term expected in mid-2023. About DDI Clinical Studies Drug-drug interaction (DDI) clinical studies are an imperative step in the new drug approval process. DDI studies help identify potential adverse reactions that may be caused by interactions between multiple drugs, leading to unintended reactions, toxic side effects, or in some cases, a lack of therapeutic efficacy. With the rise in polypharmacy to treat comorbidities, alongside prevalent substance abuse, drug-drug interactions have become a critical factor to consider when treating schizophrenia. Approximately 50% of prescribed drugs and over 25% of antipsychotics currently on the market are known to cause drug interactions with CYP3A4 inhibitors and can lead to side effects. Findings from DDI studies help to inform drug labeling that is then used by healthcare providers to aid in therapeutic decision-making. About Brilaroxazine Brilaroxazine (RP5063) is a new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Price Target Changed • Nov 16
Price target increased to US$14.00 Up from US$9.50, the current price target is an average from 3 analysts. New target price is 253% above last closing price of US$3.97. Stock is up 6.4% over the past year. The company is forecast to post a net loss per share of US$1.25 next year compared to a net loss per share of US$0.58 last year. Ankündigung • Nov 01
Reviva Pharmaceuticals Announces Global Enrollment Update for Pivotal Phase 3 Recover Study Evaluating Brilaroxazine for Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced over 30% enrollment in the United States, and initiation and ongoing enrollment across sites in Europe for the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia. The Company has received regulatory approval for initiating the study in Asia (India), with enrollment at multiple sites in India expected in 2022. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Since Reviva initiated its first clinical site at the end of January in the United States, the Company continues to make progress and is on pace with patient enrollment and site initiation in geographically diverse centers across this global clinical study. Ankündigung • Oct 12
Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Nov 10, 2022 Reviva Pharmaceuticals Holdings, Inc., Annual General Meeting, Nov 10, 2022, at 11:00 Pacific Standard Time. Agenda: To elect five director nominees to serve as directors until the next annual meeting of stockholders; to ratify the appointment of Armanino LLP as independent registered public accounting firm for the year ending December 31, 2022; and to consider any other matters that may properly come before the Annual Meeting. Recent Insider Transactions • Oct 04
Chief Financial Officer recently bought US$83k worth of stock On the 30th of September, Narayan Prabhu bought around 50k shares on-market at roughly US$1.66 per share. This transaction increased Narayan's direct individual holding by 1x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Narayan has been a buyer over the last 12 months, purchasing a net total of US$144k worth in shares. Ankündigung • Jul 28
Reviva Pharmaceuticals Holdings, Inc. Provides Update on Clinical Development Pipeline Reviva Pharmaceuticals Holdings, Inc. provided an update on key milestones related to its clinical development pipeline. Phase 3 RECOVER Study:- Reviva's pivotal Phase 3 study and a long-term safety trial to assess Reviva's new chemical entity brilaroxazine for the treatment of subjects with an acute exacerbation of schizophrenia is actively enrolling patients across all sites in the US and remains on schedule to begin enrollment at trial sites in Europe and India during the third quarter of 2022. The global Phase 3 trial, known as RECOVER, is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine over 4 weeks in approximately 400 patients with acute schizophrenia compared to placebo and a 52-week open-label study will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 4 weeks in the double-blind part of the study and 15 mg to 50 mg flexible dose once daily for 52 weeks in the open-label part of the study. Since Reviva initiated its first clinical site in Bentonville, Arkansas, led by principal investigator Dr. Fayz A. Hudefi, M.D., at the end of January, the team has initiated 15 geographically diverse sites across the US. In its randomized, double-blind, placebo-controlled, multicenter Phase 2 trial to assess the safety and efficacy of brilaroxazine in 234 subjects with acute exacerbation of schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, which was reduction in total Positive and Negative Syndrome Scale (PANSS) at the end of the treatment from baseline versus placebo. The drug candidate also met all safety endpoints including clinical, labs, body weight, prolactin, lipids, fasting glucose, and EKG. The PANSS total score was reduced by 20 points, a statistically significant treatment difference from the placebo. Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition. Importantly, the FDA has agreed to consider a potential 'Superior Safety' label claim, if there is a positive outcome on a relevant endpoint in the pivotal Phase 3 clinical study in schizophrenia currently underway. Recent Insider Transactions • Jul 01
Chief Financial Officer recently bought US$61k worth of stock On the 30th of June, Narayan Prabhu bought around 50k shares on-market at roughly US$1.21 per share. This was the largest purchase by an insider in the last 3 months. This was Narayan's only on-market trade for the last 12 months. Ankündigung • Jun 28
Reviva Pharmaceuticals Holdings, Inc. Announces Resignation of Marc Cantillon as Chief Medical Officer, Effective July 5, 2022 Reviva Pharmaceuticals Holdings, Inc. announced on June 23, 2022, Marc Cantillon, the Chief Medical Officer of company, notified the Company that he will resign as Chief Medical Officer of the Company effective as of July 5, 2022 to pursue additional opportunities. The Company has commenced a search for new personnel to manage the Company’s clinical trials and intends to utilize independent consultants to support the Company’s clinical trials in the interim period. Dr. Cantillon’s resignation was not due to any disagreements with respect to the Company’s operations, policies or practices. Ankündigung • May 04
Reviva Pharmaceuticals Holdings, Inc. Announces Update on RECOVER, a Pivotal Phase 3 Global Study Evaluating Brilaroxazine for the Treatment of Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced that the RECOVER study is progressing well and all sites in the United States (U.S.) have been initiated. Global sites in Europe and India remain on track to initiate in mid-2022. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Since Reviva initiated its first clinical site in Bentonville, Arkansas, led by principal investigator Dr. Fayz A. Hudefi, M.D. at the end of January, the team has initiated 15 geographically diverse sites across the United States. The ex-US sites in Europe and India remain on track to initiate in mid-2022. Price Target Changed • Apr 27
Price target decreased to US$10.33 Down from US$12.00, the current price target is an average from 3 analysts. New target price is 387% above last closing price of US$2.12. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$0.76 next year compared to a net loss per share of US$0.58 last year. Ankündigung • Feb 02
Reviva Pharmaceuticals Holdings, Inc. Announces First Patients Dosed in Pivotal Phase 3 Study and Long-Term Safety Trial Evaluating Brilaroxazine for the Treatment of Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced that the first patients have been dosed in a pivotal Phase 3 study and long-term safety trial to assess Reviva’s new chemical entity brilaroxazine for the treatment of subjects with an acute exacerbation of schizophrenia. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Reviva initiated the first clinical site in Bentonville, Arkansas with two patients dosed at the Pillar Clinical trial site led by its principal investigator, Dr. Fayz A. Hudefi, M.D. Ankündigung • Jan 12
Reviva Pharmaceuticals Holdings, Inc. Receives FDA May Proceed Letter for Pivotal Phase 3 Clinical Trial and Long-Term Safety Trial Evaluating Brilaroxazine for the Treatment of Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with Phase 3 clinical investigation of its lead candidate, brilaroxazine, a novel serotonin and dopamine receptor modulator for the treatment of schizophrenia. Schizophrenia is a complex and debilitating neuropsychiatric disorder that affects 1% of the world’s population, and approximately 3.5 million people in the United States alone. Characterized by multiple symptoms, patients with schizophrenia often suffer from cognitive impairment, delusions, hallucinations and disorganized speech or behavior. Despite its high prevalence, there are no therapies that adequately address the complex mix of positive and negative symptoms, mood, and cognitive impairment associated with schizophrenia. Limitations of current treatments include suboptimal efficacy, poor tolerability and low patient adherence rates. Price Target Changed • Nov 17
Price target decreased to US$13.00 Down from US$15.00, the current price target is an average from 2 analysts. New target price is 249% above last closing price of US$3.73. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$0.67 next year compared to a net loss per share of US$1.24 last year. Ankündigung • Apr 27
Reviva Pharmaceuticals Holdings, Inc. Announces Full Details of Positive Phase 2 Clinical Trial Results for Acute Schizophrenia Reviva Pharmaceuticals Holdings, Inc. announced the full details of its Phase 2 clinical trial for its lead drug candidate, RP5063 (brilaroxazine) for Acute Schizophrenia. Brilaroxazine has a unique pharmacology profile against key serotonin (5-HT) and dopamine (D) receptors, which Reviva believes can modulate and stabilize the D/5-HT system. Brilaroxazine demonstrated high affinity and selectivity for key serotonin receptors (5-HT1A/2A/2B/7), as it is pharmacologically different from other antipsychotics through its combination of potent affinity and selectivity for target receptors implicated for schizophrenia and its comorbid symptoms. In its randomized, double-blind, placebo-controlled, multicenter Phase 2 trial to assess the safety and efficacy of brilaroxazine in 234 subjects with acute exacerbation of schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, which was reduction in total Positive and Negative Syndrome Scale (PANSS) at the end of the treatment from baseline versus placebo. The drug candidate also met all safety endpoints including clinical, labs, body weight, prolactin, lipids, fasting glucose, and EKG. The PANSS total score was reduced by 20 points, a statistically significant treatment difference from the placebo. Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition. Importantly, the FDA has agreed to consider a potential ‘Superior Safety’ label claim, if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 clinical study in schizophrenia. Ankündigung • Dec 20
Reviva Pharmaceuticals Holdings, Inc. Announces Management Changes Reviva Pharmaceuticals Holdings, Inc. announced the Rahul Nayar resigned as Chief Executive Officer. The appointment of Laxminarayan Bhat, as Chief Executive Officer.