Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill
'According to UNAIDS, 1.3 million people acquired HIV in 2023, highlighting the continued need for new PrEP options like our investigational once-monthly, oral PrEP candidate MK-8527, especially among women in sub-Saharan Africa and men who have sex with men, who experience disproportionately high rates of HIV,' said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. 'Our collaboration with the Gates Foundation will help us explore the potential of MK-8527 to contribute to global efforts to reduce the number of HIV infections and help support opportunities to accelerate access around the world.'
The decision to initiate the Phase 3 clinical trial program was supported by the results of a double-blind, multicenter, Phase 2 trial (MK-8527-007, NCT 06045507) examining the safety and pharmacokinetics of MK-8527. The study enrolled 350 participants, 18–65 years of age, with low likelihood of HIV-1 exposure, who were randomized 2:2:2:1 to receive MK-8527 (3, 6, or 12 mg) or placebo once monthly for six months. In the trial, the rates of adverse events were similar among those in the MK-8527 arms and those in the placebo arm, and no clinically meaningful changes were seen in laboratory tests, including total lymphocyte and CD4 T-cell counts. The pharmacokinetics of MK-8527 and MK-8527-TP, the active form of MK-8527, support the continued development of MK-8527 as an oral, once-monthly option for PrEP. Results from the Phase 2 trial were highlighted in the opening press conference for IAS 2025, the 13th International AIDS Society Conference on HIV Science in Kigali, Rwanda, on Monday, July 14, at 15:30 – 16:30 CAT, titled 'Breakthroughs Amid Crisis: The Future of HIV Innovation.' These research findings will be further detailed in a late-breaker oral session on Wednesday, July 16, at 12:15 – 13:15 CAT.
'Scientific advances against HIV have brought us further than ever imagined and are ushering in a new era in HIV prevention,' said Trevor Mundel, president of global health at the Gates Foundation. 'With only 18% of global PrEP need currently met, there is a clear and urgent need for options like MK-8527 that may offer the ability to prevent infection. These Phase 3 trials are a key step toward translating progress into longer-acting options that could help turn the tide on HIV.'
In the EXPrESSIVE-10 trial, the International Clinical Research Center (ICRC) within the University of Washington Department of Global Health, in partnership with the University of Alabama at Birmingham, will receive grant funding from the Gates Foundation to support ICRC's collaboration with 31 clinical research trial sites in Kenya, South Africa, and Uganda; sites will inform and engage communities and recruit, enroll, and follow women who participate in the EXPrESSIVE-10 trial. Merck will be the trial sponsor, gaining regulatory and customs approvals, and providing operational expertise and resources for management of the trials. The Gates Foundation will also provide support for global community advisory groups, which will offer insight into community perspectives on a monthly PrEP pill, participant recruitment materials and strategies, and cultural considerations for these trials. Separately, the Gates Foundation will provide grant funding for EXPrESSIVE-11 to support the establishment of a community advisory group and the development of recruiting and retention materials only.
About the EXPrESSIVE MK-8527 Phase 3 Clinical Trial Program
The EXPrESSIVE-11 trial (MK-8527-011, NCT 07044297) is a randomized, active-controlled study enrolling 4,390 sexually active people who could benefit from PrEP across trial sites in 16 countries. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The trial will begin enrolling in August 2025.
The EXPrESSIVE-10 trial (MK-8527-010) is a randomized, active-controlled study enrolling 4,580 sexually active women aged 16 to 30 in Kenya, South Africa, and Uganda. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The study will begin enrolling in the next few months.
About MK-8527
MK-8527 is being evaluated as a potential once-monthly oral prevention option for HIV-1. MK-8527 inhibits reverse transcriptase through multiple mechanisms of action, including inhibition of translocation and delayed chain termination. For an overview of Merck's complete HIV treatment and prevention clinical development program, please click here.
Merck's Commitment to HIV
For more than 35 years, Merck has been committed to scientific research and discovery in HIV, leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage their HIV and to help prevent HIV, with the goal of reducing the growing burden of HIV worldwide. We want to ensure people are not defined by HIV, and our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube, and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
15 minutes ago
- Business Wire
Phreesia Sets Release Date for Fiscal Second Quarter 2026 Results
ALL-REMOTE COMPANY/WILMINGTON, Del.--(BUSINESS WIRE)--Phreesia, Inc. (NYSE: PHR) ('Phreesia') today announced that it will release its fiscal second quarter 2026 financial results after the close of market trading on Thursday, Sept. 4, 2025. Phreesia will issue a press release announcing its quarterly results and the company's quarterly stakeholder letter, both of which will be posted on its investor website at Phreesia will then hold a conference call to discuss its fiscal second quarter results starting at 5PM Eastern Time on the same day. To participate in the company's live conference call and webcast, please dial (800) 715-9871, or (646) 307-1963 for international participants, using conference code number 7404611, or visit the 'Events & Presentations' section of A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 90 days. ABOUT PHREESIA Phreesia is a trusted leader in patient activation, giving healthcare providers, life sciences companies and other organizations tools to help patients take a more active role in their care. Founded in 2005, Phreesia enabled approximately 170 million patient visits in 2024—1 in 7 visits across the U.S.—scale that we believe allows us to make meaningful impact. Offering patient-driven digital solutions for intake, outreach, education and more, Phreesia enhances the patient experience, drives efficiency and improves healthcare outcomes. To learn more, visit
Business Wire
15 minutes ago
- Business Wire
Concentra Group Holdings Parent, Inc. Announces Results For Its Second Quarter Ended June 30, 2025, Cash Dividend, and Raised FY 2025 Guidance
ADDISON, Texas--(BUSINESS WIRE)--Concentra Group Holdings Parent, Inc. ('Concentra,' the 'Company,' 'we,' 'us,' or 'our') (NYSE: CON), the nation's largest provider of occupational health services, today announced results for its second quarter ended June 30, 2025, the declaration of a cash dividend, and raised guidance for FY 2025. 'Concentra delivered strong results in the second quarter, building on our solid start to 2025,' said Keith Newton, Chief Executive Officer of Concentra. 'Our results reflected strength across several key measures, including growth in patient visits, rate, revenue, and Adjusted EBITDA. We are well-positioned for continued momentum driven by the disciplined execution of our strategy by our outstanding colleagues.' Matt DiCanio, Concentra's President and Chief Financial Officer, added, 'We are progressing well on the integration of our recent acquisitions of Nova Medical Centers and Pivot Onsite Innovations, enabling Concentra to deliver our high-quality workplace health services from over 1,000 combined occupational health center and onsite health clinic locations across the country. In addition to our organic visit growth, these acquisitions and our broader development efforts will contribute to Concentra's performance through increased top line growth and operational efficiencies.' Second Quarter 2025 Highlights Second Quarter 2025 Financial Overview For the second quarter ended June 30, 2025, revenue increased 15.2% to $550.8 million, compared to $477.9 million for the same quarter, prior year. Income from operations increased 6.7% to $89.5 million for the second quarter ended June 30, 2025, compared to $83.9 million for the same quarter, prior year. Net income was $46.2 million, earnings per share was $0.35, and Adjusted Earnings per Share was $0.37 for the second quarter ended June 30, 2025 compared to net income of $53.1 million, earnings per share of $0.50 and Adjusted Earnings per Share of $0.49, for the same quarter, prior year. Net income decreased due to higher interest expense from the IPO recapitalization. Adjusted EBITDA increased 13.2% to $115.0 million for the second quarter ended June 30, 2025, compared to $101.6 million for the same quarter, prior year. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table X of this release. The definition of Adjusted Earnings per Share and a reconciliation of net income attributable to the Company and earnings per share on a fully diluted basis to Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share on a fully diluted basis are presented in table XI of this release. Year to Date June 30, 2025 Financial Overview For the six months ended June 30, 2025, revenue increased 11.2% to $1,051.5 million, compared to $945.5 million for the same period, prior year. Income from operations increased 6.5% to $169.9 million for the six months ended June 30, 2025, compared to $159.4 million for the same period, prior year. Net income was $86.8 million, earnings per share was $0.65 and Adjusted Earnings per Share was $0.70 for the six months ended June 30, 2025, compared to net income of $103.3 million, earnings per share of $0.97, and Adjusted Earnings per Share of $0.98 for the same quarter, prior year. Adjusted EBITDA increased 10.1% to $217.7 million for the six months ended June 30, 2025, compared to $197.7 million for the same period, prior year. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table X of this release. The definition of Adjusted Earnings per Share and a reconciliation of net income attributable to the Company and earnings per share on a fully diluted basis to Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share on a fully diluted basis are presented in table XI of this release. Balance Sheet As of June 30, 2025, our balance sheet reflected cash of $73.9 million, total debt of $1,665.9 million and total assets of $2,841.6 million. Concentra's net leverage ratio as of June 30, 2025 is 3.8x, which was in compliance with the financial covenant under our credit agreement. The Company is targeting a net leverage ratio of approximately 3.5x by the end of 2025 and less than 3.0x by the end of 2026. Cash Flow Cash flows provided by operating activities in the second quarter ended June 30, 2025 totaled $88.4 million compared to $70.4 million for the same quarter, prior year. The increase in year over year cash flow from operations is driven primarily by the higher income from operations and also due to the timing of payroll and other payables at quarter end. During the second quarter ended June 30, 2025, cash flow from investing activity resulted in cash used of $79.5 million, including capital expenditures of $25.2 million, with $7.4 million of one-time capital expenditures associated with our Nova integration and rebranding, and acquisition-related spend of $54.3 million. Cash flow from operations less cash flow from investing activity resulted in cash provided of $8.9 million for the quarter. Cash flow from financing activity generated $12.9 million for the quarter, resulting in an increase in cash of $21.8 million. Pivot Onsite Innovations Acquisition Closing Effective June 1, 2025, the Company acquired Onsite Innovations, LLC ('Pivot Onsite Innovations') for a purchase price of $54.4 million, subject to adjustment in accordance with the terms and conditions set forth in the equity purchase agreement. Pivot Onsite Innovations operates over 240 onsite health clinics at employer locations in over 40 states, providing occupational health, wellness, prevention and performance services. The acquisition enabled the Company to expand to over 400 onsite health clinics at employer locations. The transaction was financed using a combination of $35.0 million of available borrowing capacity under our existing Revolving Credit Facility and the remaining with cash on hand. Dividend On August 6, 2025, the Board of Directors declared a cash dividend of $0.0625 per share. The dividend will be payable August 28, 2025, to stockholders of record as of the close of business on August 21, 2025. There is no assurance that future dividends will be declared. The declaration and payment of dividends in the future are at the discretion of the Board of Directors after taking into account various factors, including, but not limited to, the Company's financial condition, operating results, available cash and current and anticipated cash needs, the terms of indebtedness, and other factors the Board of Directors may deem to be relevant. 2025 Business Outlook Concentra raised its financial guidance for 2025. We now expect to deliver the following results: Revenue in the range of $2.13 billion to $2.16 billion Adjusted EBITDA in the range of $420 million to $430 million Capital expenditures in the range of $80 million to $90 million (no change) Net leverage ratio of approximately 3.5x (no change) A reconciliation of full year 2025 Adjusted EBITDA expectations to net income is presented in table XII of this release. Company Overview Concentra is the largest provider of occupational health services in the United States by number of locations, with the mission of improving the health of America's workforce, one patient at a time. Our approximately 13,000 colleagues and affiliated physicians and clinicians support the delivery of an extensive suite of services, including occupational and consumer health services and other direct-to-employer care. We support the care of over 50,000 patients each day on average across 47 states at our 628 occupational health centers, 406 onsite health clinics at employer worksites, and Concentra Telemed as of June 30, 2025. Conference Call Concentra will host a conference call regarding its second quarter financial results and business outlook on Friday August 8, 2025, at 9 a.m. Eastern Time. The conference call will be a live webcast and can be accessed via this Earnings Call Webcast Link or via Concentra's website at A replay of the webcast will be available shortly after the call at the same locations. Participants may join the audio-only version of the webcast or participate in the question-and-answer session by calling: Toll Free: 888-506-0062 International: 973-528-0011 Participant Access: All dial-in participants should ask to join the Concentra call. Certain statements contained herein that are not descriptions of historical facts are 'forward-looking' statements (as such term is defined in the Private Securities Litigation Reform Act of 1995), including statements related to Concentra's 2025 and long-term business outlook. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following: The frequency of work-related injuries and illnesses; The adverse changes to our relationships with employer customers, third-party payors, workers' compensation provider networks or employer services networks; Changes to regulations, new interpretations of existing regulations, or violations of regulations; State fee schedule changes undertaken by state workers' compensation boards or commissions and other third-party payors; Our ability to realize reimbursement increases at rates sufficient to keep pace with the inflation of our costs; Labor shortages, increased employee turnover or costs, and union activity could significantly increase our operating costs; Our ability to compete effectively with other occupational health centers, onsite health clinics at employer worksites, and healthcare providers; A security breach of our, or our third-party vendors', information technology systems which may cause a violation of HIPAA and subject us to potential legal and reputational harm; Negative publicity which can result in increased governmental and regulatory scrutiny and possibly adverse regulatory changes; Significant legal actions could subject us to substantial uninsured liabilities; Litigation and other legal and regulatory proceedings in the course of our business that could adversely affect our business and financial statements; Insurance coverage may not be sufficient to cover losses we may incur; Acquisitions may use significant resources, may be unsuccessful, and could expose us to unforeseen liabilities; Our exposure to additional risk due to our reliance on third parties in many aspects of our business; Compliance with applicable laws regarding the corporate practice of medicine and therapy and fee-splitting; Our facilities are subject to extensive federal and state laws and regulations relating to the privacy of individually identifiable information; Compliance with applicable data interoperability and information blocking rule; Facility licensure requirements in some states are costly and time-consuming, limiting or delaying our operations; Our ability to adequately protect and enforce our intellectual property and other proprietary rights; Adverse economic conditions in the U.S. or globally; Any negative impact on the global economy and capital markets resulting from other geopolitical tensions; The impact of impairment of our goodwill and other intangible assets; Our ability to maintain satisfactory credit ratings; The effects of the Separation on our business; Our ability to achieve the expected benefits of and successfully execute the Separation and related transactions; Restrictions on our business, potential tax and indemnification liabilities and substantial charges in connection with the Separation and related transactions; The negative impact of public threats such as a global pandemic or widespread outbreak of an infectious disease similar to the COVID-19 pandemic; The loss of key members of our management team; Our ability to attract and retain talented, highly skilled employees and a diverse workforce, and on the succession of our senior management; Climate change, or legal, regulatory or market measures to address climate change; Increasing scrutiny and rapidly evolving expectations from stakeholders regarding ESG matters; Changes in tax laws or exposures to additional tax liabilities; and Changes to United States tariff and import/export regulations and the impact on global economic conditions may have a negative effect on our business, financial condition and results of operations. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, or otherwise. You should not place undue reliance on our forward-looking statements. Although we believe that the expectations reflected in forward-looking statements are reasonable, we cannot guarantee future results or performance. _____________________________________________ (1) Includes transition services agreement fees of $3.5 million for the three months ended June 30, 2025, and shared service fees from a related party of $3.8 million for the three months ended June 30, 2024. (2) Refer to table III for calculation of earnings per common share. N/M Not meaningful Expand II. Condensed Consolidated Statements of Operations For the Six Months Ended June 30, 2025 and 2024 (In thousands, except per share amounts, unaudited) Six Months Ended June 30, 2025 2024 % Change Revenue $ 1,051,537 $ 945,513 11.2 % Costs and expenses: Cost of services, exclusive of depreciation and amortization 746,435 676,263 10.4 General and administrative, exclusive of depreciation and amortization (1) 99,644 73,737 35.1 Depreciation and amortization 35,617 36,355 (2.0 ) Total costs and expenses 881,696 786,355 12.1 Other operating income 20 284 (93.0 ) Income from operations 169,861 159,442 6.5 Other income and expense: Loss on early retirement of debt (875 ) — N/M Equity in losses of unconsolidated subsidiaries — (3,676 ) N/M Interest (expense) income (53,741 ) 94 N/M Interest expense on related party debt — (19,289 ) N/M Income before income taxes 115,245 136,571 (15.6 ) Income tax expense 28,409 33,233 (14.5 ) Net income 86,836 103,338 (16.0 ) Less: net income attributable to non-controlling interests 3,365 2,645 27.2 Net income attributable to the Company $ 83,471 $ 100,693 (17.1 )% Basic and diluted earnings per common share (2) $ 0.65 $ 0.97 Expand _____________________________________________ (1) Includes transition services agreement fees of $7.2 million for the six months ended June 30, 2025, and shared service fees from a related party of $7.7 million for the six months ended June 30, 2024. (2) Refer to table III for calculation of earnings per common share. N/M Not meaningful Expand III. Earnings per Share For the Three and Six Months Ended June 30, 2025 and 2024 (In thousands, except per share amounts, unaudited) As of June 30, 2025, the Company's capital structure consists of common stock and unvested restricted stock. To calculate earnings per share ('EPS') for the three and six months ended June 30, 2025, the Company applied the two-class method because its unvested restricted shares were participating securities. As of June 30, 2024, the Company's capital structure consists of common stock. There were no participating shares or securities outstanding during the three and six months ended June 30, 2024. The following table sets forth the net income attributable to the Company, its shares, and its participating shares: Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net income $ 46,194 $ 53,059 $ 86,836 $ 103,338 Less: net income attributable to non-controlling interests 1,634 1,322 3,365 2,645 Net income attributable to the Company 44,560 51,737 83,471 100,693 Less: distributed and undistributed net income attributable to participating securities 530 — 985 — Distributed and undistributed net income attributable to common shares $ 44,030 $ 51,737 $ 82,486 $ 100,693 Expand The following table sets forth the computation of EPS. The Company applied the two-class method for the three and six months ended June 30, 2025. Three Months Ended June 30, 2025 Three Months Ended June 30, 2024 Common shares $ 44,030 126,647 $ 0.35 $ 51,737 104,094 $ 0.50 Participating securities 530 1,524 $ 0.35 — — $ — Total Company $ 44,560 128,171 $ 0.35 $ 51,737 104,094 $ 0.50 Expand _____________________________________________ (1) Represents the weighted average shares outstanding during the period. Expand IV. Condensed Consolidated Balance Sheets (In thousands, unaudited) December 31, 2024 ASSETS Current assets: Cash $ 73,872 $ 183,255 Accounts receivable 271,752 217,719 Prepaid income taxes 5,280 1,544 Other current assets 44,263 34,689 Total current assets 395,167 437,207 Operating lease right-of-use assets 473,334 435,595 Property and equipment, net 220,278 197,930 Goodwill 1,480,653 1,234,707 Other Identifiable intangible assets, net 257,261 204,725 Other assets 14,891 11,000 Total assets $ 2,841,584 $ 2,521,164 LIABILITIES AND EQUITY Current liabilities: Current operating lease liabilities $ 83,279 $ 75,442 Current portion of long-term debt and notes payable 13,921 10,093 Accounts payable 38,877 19,752 Accrued and other liabilities 198,992 201,899 Total current liabilities 335,069 307,186 Non-current operating lease liabilities 430,439 396,914 Long-term debt, net of current portion 1,652,003 1,468,917 Non-current deferred tax liability 24,362 25,380 Other non-current liabilities 32,331 24,043 Total liabilities 2,474,204 2,222,440 Redeemable non-controlling interests 19,560 18,013 Stockholders' equity: Common stock, $0.01 par value, 700,000,000 shares authorized, 128,170,952 and 128,125,952 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 1,282 1,281 Capital in excess of par 265,390 260,837 Retained earnings 79,827 13,553 Accumulated other comprehensive loss (3,863 ) — Total stockholders' equity 342,636 275,671 Non-controlling interests 5,184 5,040 Total equity 347,820 280,711 Total liabilities and equity $ 2,841,584 $ 2,521,164 Expand V. Condensed Consolidated Statements of Cash Flows For the Three Months Ended June 30, 2025 and 2024 (In thousands, unaudited) Three Months Ended June 30, 2025 2024 Operating activities Net income $ 46,194 $ 53,059 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 18,998 17,870 Equity in losses of unconsolidated subsidiaries — 3,676 Loss (gain) on sale of assets 1 (1 ) Stock compensation expense 2,285 166 Amortization of debt discount and issuance costs 995 — Deferred income taxes (1,177 ) 903 Other 1,096 47 Changes in operating assets and liabilities, net of effects of business combinations: Accounts receivable (5,106 ) 676 Other current assets (5,028 ) 8,539 Other assets 1,401 (4,939 ) Accounts payable and accrued liabilities 28,720 (9,563 ) Net cash provided by operating activities 88,379 70,433 Investing activities Business combinations, net of cash acquired (54,282 ) — Purchases of property and equipment (25,226 ) (15,263 ) Proceeds from sale of assets — 1 Net cash used in investing activities (79,508 ) (15,262 ) Financing activities Borrowings on revolving facilities 35,000 — Payments on related party revolving promissory note — (50,000 ) Payments on term loans (2,375 ) — Borrowings of other debt 107 — Principal payments on other debt (1,810 ) (2,102 ) Dividends paid to common stockholders (16,021 ) — Distributions to and purchases of non-controlling interests (2,009 ) (1,100 ) Distribution to Select — (852 ) Net cash provided by (used in) financing activities 12,892 (54,054 ) Net increase in cash and cash equivalents 21,763 1,117 Cash and cash equivalents at beginning of period 52,109 49,552 Cash and cash equivalents at end of period $ 73,872 $ 50,669 Supplemental information Cash paid for interest $ 16,295 $ 9,554 Cash paid for taxes $ 35,616 $ 33,975 Expand VI. Condensed Consolidated Statements of Cash Flows For the Six Months Ended June 30, 2025 and 2024 (In thousands, unaudited) Six Months Ended June 30, 2025 2024 Operating activities Net income $ 86,836 $ 103,338 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 35,617 36,355 Equity in losses of unconsolidated subsidiaries — 3,676 Loss on extinguishment of debt 51 — Loss on sale of assets — 42 Stock compensation expense 4,554 332 Amortization of debt discount and issuance costs 1,971 — Deferred income taxes (2,205 ) (1,618 ) Other 1,107 59 Changes in operating assets and liabilities, net of effects of business combinations: Accounts receivable (26,251 ) (12,829 ) Other current assets (7,781 ) 1,224 Other assets 2,303 (4,217 ) Accounts payable and accrued liabilities 3,876 (11,307 ) Net cash provided by operating activities 100,078 115,055 Investing activities Business combinations, net of cash acquired (333,300 ) (5,144 ) Purchases of property and equipment (40,958 ) (32,494 ) Proceeds from sale of assets 1 23 Net cash used in investing activities (374,257 ) (37,615 ) Financing activities Borrowings on revolving facilities 85,000 — Borrowings from related party revolving promissory note — 10,000 Payments on related party revolving promissory note — (60,000 ) Proceeds from term loans, net of issuance costs 948,848 — Payments on term loans (850,250 ) — Borrowings of other debt 6,575 6,618 Principal payments on other debt (6,505 ) (4,378 ) Dividends paid to common stockholders (16,021 ) — Distributions to and purchases of non-controlling interests (2,851 ) (2,643 ) Distribution to Select — (7,742 ) Net cash provided by (used in) financing activities 164,796 (58,145 ) Net (decrease) increase in cash (109,383 ) 19,295 Cash at beginning of period 183,255 31,374 Cash at end of period $ 73,872 $ 50,669 Supplemental information Cash paid for interest $ 54,432 $ 19,512 Cash paid for taxes $ 35,568 $ 34,009 Expand VII. Disaggregated Revenue For the Three and Six Months Ended June 30, 2025 and 2024 (In thousands, unaudited) The following table disaggregates the Company's revenue for the three and six months ended June 30, 2025 and 2024: Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Occupational health centers: Workers' compensation $ 332,191 $ 288,405 $ 634,298 $ 568,271 Employer services 174,318 153,305 334,458 304,040 Consumer health 7,177 7,669 15,788 15,995 Other occupational health center revenue 2,452 1,861 4,516 4,006 Total occupational health center revenue 516,138 451,240 989,060 892,312 Onsite health clinics 22,569 15,539 39,119 31,396 Other 12,078 11,136 23,358 21,805 Total revenue $ 550,785 $ 477,915 $ 1,051,537 $ 945,513 Expand VIII. Key Statistics For the Second Quarter Ended June 30, 2025 and 2024 (unaudited) Three Months Ended June 30, 2025 2024 Facility Count Number of occupational health centers—start of period 627 547 Number of occupational health centers acquired — — Number of occupational health centers de novos 1 1 Number of occupational health centers closed/sold — (1 ) Number of occupational health centers—end of period 628 547 Number of onsite health clinics operated—end of period 406 154 The following table sets forth operating statistics for our occupational health centers operating segment for the periods presented: Three Months Ended June 30, Number of patient visits 2025 2024 % Change Workers' compensation 1,589,981 1,455,254 9.3 % Employer services 1,877,383 1,702,399 10.3 % Consumer health 52,956 56,602 (6.4 )% Total 3,520,320 3,214,255 9.5 % Visits per day volume Workers' compensation 24,843 22,739 9.3 % Employer services 29,334 26,600 10.3 % Consumer health 827 884 (6.4 )% Total 55,005 (3) 50,223 9.5 % Revenue per visit (1) Workers' compensation $ 208.93 $ 198.18 5.4 % Employer services 92.85 90.05 3.1 % Consumer health 135.52 135.49 — % Total $ 145.92 $ 139.81 4.4 % Business Days (2) 64 64 Expand _____________________________________________ (1) Represents the average amount of revenue recognized for each patient visit. Revenue per visit is calculated as total patient revenue divided by total patient visits. Revenue per visit as reported includes only the revenue and patient visits in our occupational health centers segment and does not include our onsite health clinics or other businesses segments. (2) Represents the number of days in which normal business operations were conducted during the periods presented. (3) Does not total due to rounding Expand IX. Key Statistics For the Six Months Ended June 30, 2025 and 2024 (unaudited) Six Months Ended June 30, 2025 2024 Facility Count Number of occupational health centers—start of period 552 544 Number of occupational health centers acquired 72 2 Number of occupational health centers de novos 4 2 Number of occupational health centers closed/sold — (1 ) Number of occupational health centers—end of period 628 547 Number of onsite health clinics operated—end of period 406 154 The following table sets forth operating statistics for our occupational health centers operating segment for the periods presented: Six Months Ended June 30, 2025 2024 % Change Number of patient visits Workers' compensation 3,034,861 2,888,338 5.1 % Employer services 3,573,795 3,361,690 6.3 % Consumer health 116,032 119,882 (3.2 )% Total 6,724,688 6,369,910 5.6 % Visits per day volume Workers' compensation 23,897 22,565 5.9 % Employer services 28,140 26,263 7.1 % Consumer health 914 937 (2.5 )% Total 52,950 (3) 49,765 6.4 % Revenue per visit (1) Workers' compensation $ 209.00 $ 196.75 6.2 % Employer services 93.59 90.44 3.5 % Consumer health 136.06 133.42 2.0 % Total $ 146.41 $ 139.45 5.0 % Business days (2) 127 128 Expand _____________________________________________ (1) Represents the average amount of revenue recognized for each patient visit. Revenue per visit is calculated as total patient revenue divided by total patient visits. Revenue per visit as reported includes only the revenue and patient visits in our occupational health centers segment and does not include our onsite health clinics or other businesses segments. (2) Represents the number of days in which normal business operations were conducted during the periods presented. (3) Does not total due to rounding. Expand X. Net Income to Adjusted EBITDA Reconciliation For the Three and Six Months Ended June 30, 2025 and 2024 (In thousands, unaudited) Adjusted EBITDA and Adjusted EBITDA Margin are non-GAAP measures that we believe provide useful insight into the underlying performance of our business by excluding items that may obscure trends in our core operating results. These metrics are not intended to be substitutes for GAAP measures such as net income and may differ from similarly titled metrics supported by other companies. We use these non-GAAP measures internally for budgeting, forecasting, and evaluating performance. Investors should consider these measures in addition to, and not as a replacement for, GAAP results reported in our financial statements. Adjusted EBITDA is a supplemental measure that we believe offers a clearer view of business performance by excluding items that do not reflect the core operations of the Company. We define adjusted EBITDA as net income before interest, income taxes, depreciation and amortization, stock-based compensation expense, acquisition related costs, gains or losses on early retirement of debt, separation transaction costs, gains or losses on the sale of businesses, and equity in earnings or losses from unconsolidated subsidiaries. Adjusted EBITDA Margin is calculated by dividing Adjusted EBITDA by total revenue. This margin helps assess the efficiency of our operations on a normalized basis. The following table reconciles net income to Adjusted EBITDA and net income margin to Adjusted EBITDA margin and should be referenced when we discuss Adjusted EBITDA and Adjusted EBITDA margin. Reconciliation of Adjusted EBITDA: Net income $ 46,194 8.4 % $ 53,059 11.1 % $ 86,836 8.3 % $ 103,338 10.9 % Add (Subtract): Income tax expense 15,155 2.8 18,096 3.8 28,409 2.7 33,233 3.5 Interest expense (income) 28,193 5.1 (205 ) 0.0 53,741 5.1 (94 ) 0.0 Interest expense on related party debt — — 9,318 1.9 — — 19,289 2.0 Equity in losses of unconsolidated subsidiaries — — 3,676 0.8 — — 3,676 0.4 Loss on early retirement of debt — — — — 875 0.1 — — Stock compensation expense 2,285 0.4 166 0.0 4,554 0.4 332 0.0 Depreciation and amortization 18,998 3.4 17,870 3.7 35,617 3.4 36,355 3.8 Separation transaction costs (1) 1,360 0.2 (380 ) (0.1 ) 1,675 0.2 1,613 0.2 Nova and Pivot Onsite Innovations acquisition costs 2,833 0.5 — — 5,970 0.6 — — Adjusted EBITDA $ 115,018 20.9 % $ 101,600 21.3 % $ 217,677 20.7 % $ 197,742 20.9 % Expand _____________________________________________ (1) Separation transaction costs represent non-recurring incremental consulting, legal, audit-related fees, system implementation, and software disposal costs incurred in connection with the Company's separation into a new, publicly traded company and are included within general and administrative expenses on the condensed consolidated statements of operations. (2) Does not total due to rounding. Expand XI. Reconciliation of Earnings per Share to Adjusted Earnings per Share For the Three and Six Months Ended June 30, 2025 and 2024 (In thousands, except per share amounts, unaudited) Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share are used by management to provide useful insight into the underlying performance of our business. Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share are not measures of financial performance under U.S. GAAP and are not intended to be substitutes for U.S. GAAP measures such as net income or earnings per share. These metrics may differ from similarly titled metrics supported by other companies. Concentra believes that the presentation of Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share are important to investors because they are reflective of the financial performance of Concentra's ongoing operations and provide better comparability of its results of operations between periods. Investors should consider these measures in addition to, and not as a replacement for, U.S. GAAP results reported in our financial statements. We define Adjusted Net Income Attributable to the Company as net income attributable to the Company, excluding gain (loss) on early retirement of debt, separation transaction costs, acquisition costs, gain (loss) on sale of businesses, and other non-recurring costs not directly tied to operating performance, all on an after tax basis. We define Adjusted Earnings per Share as the Adjusted Net Income Attributable to the Company divided by the diluted weighted average shares outstanding. The following table reconciles net income attributable to the Company and earnings per share on a fully diluted basis to Adjusted Net Income Attributable to the Company and Adjusted Earnings per Share on a fully diluted basis. Reconciliation of Adjusted Net Income Attributable to the Company: (1) Net income attributable to the Company $ 44,560 $ 0.35 $ 51,737 $ 0.50 $ 83,471 $ 0.65 $ 100,693 $ 0.97 Adjustments: Loss on early retirement of debt — — — — 875 0.01 — — Separation transaction costs (2) 1,360 0.01 (380 ) 0.00 1,675 0.01 1,613 0.02 Nova and Pivot Onsite Innovations acquisition costs 2,833 0.02 — — 5,970 0.05 — — Total additions, net $ 4,193 $ 0.03 $ (380 ) $ 0.00 $ 8,520 $ 0.07 $ 1,613 $ 0.02 Less: tax effect of adjustments (3) (1,036 ) (0.01 ) 97 0.00 (2,100 ) (0.02 ) (392 ) 0.00 Adjusted Net Income Attributable to the Company $ 47,717 $ 0.37 $ 51,454 $ 0.49 $ 89,891 $ 0.70 $ 101,914 $ 0.98 Expand _____________________________________________ (1) As of June 30, 2025, we updated the schedule for all periods presented to include Net Income Attributable to the Company. Management believes this measure will provide an improved insight into the performance of our business. (2) Separation transaction costs represent non-recurring incremental consulting, legal, audit-related fees, system implementation, and software disposal costs incurred in connection with the Company's separation into a new, publicly traded company and are included within general and administrative expenses on the condensed consolidated statements of operations. (3) Tax impact is calculated using the annual effective tax rate, excluding discrete costs and benefits. (4) Does not total due to rounding. Expand XII. 2025 Net Income to Adjusted EBITDA Reconciliation Business Outlook for the Year Ending December 31, 2025 (In millions, unaudited) The following is a reconciliation of full year 2025 Adjusted EBITDA expectations as computed at the low and high points of the range to the closest comparable GAAP financial measure. Refer to tables X for discussion of Concentra's use of Adjusted EBITDA in evaluating financial performance and for the definition of Adjusted EBITDA. Each item presented in the below table is an estimation of full year 2025 expectations. Range Low High Net income attributable to the Company $ 157 $ 164 Net income attributable to non-controlling interests 6 7 Net income $ 163 $ 171 Loss on early retirement of debt 1 1 Income tax expense 54 56 Interest expense 109 109 Income from operations 327 337 Stock compensation expense 10 10 Depreciation and amortization 74 74 Separation transaction costs 3 3 Nova and Pivot Onsite Innovations acquisition costs 6 6 Adjusted EBITDA $ 420 $ 430 Adjusted Net Income Attributable to the Company (1) $ 165 $ 172 Expand _____________________________________________ (1) Represents net income attributable to the Company plus the tax effective adjustments for loss on early retirement of debt, separation transaction costs, and Nova and Pivot Onsite Innovations acquisition costs. Expand
Business Wire
15 minutes ago
- Business Wire
Vistagen Reports Fiscal Year 2026 First Quarter Financial Results and Corporate Update
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today reported financial results for its fiscal year 2026 first quarter ended June 30, 2025, and provided a corporate update. 'We had another productive quarter, advancing key programs across our pipeline,' said Shawn Singh, President and Chief Executive Officer of Vistagen. 'Our lead program, fasedienol, for acute treatment of social anxiety disorder, continues to progress, with topline results from our PALISADE-3 Phase 3 trial anticipated later this year, and topline results from our PALISADE-4 Phase 3 trial expected in the first half of 2026. With no FDA-approved acute treatment, we remain optimistic about fasedienol's potential to impact the lives of over 30 million U.S. adults affected by social anxiety disorder. As the PALISADE trials near completion, we're encouraged by growing support for our pherine platform, including itruvone for MDD and PH80 for hot flashes, from patients, clinicians, and key opinion leaders. With multiple near-term catalysts and a differentiated pipeline, we remain focused on delivering long-term impact for patients and value for stockholders.' Clinical-stage Neuroscience Product Candidates Vistagen is developing a broad and diverse pipeline of five clinical-stage intranasal pherine product candidates spanning three key therapeutic areas: psychiatry, women's health, and cancer supportive care. Lead Program Highlights Fasedienol for the Acute Treatment of Social Anxiety Disorder Vistagen's lead clinical development program – the U.S. registration-directed PALISADE Program evaluating intranasal fasedienol for the acute treatment of Social Anxiety Disorder (SAD) – is moving closer to key milestones. The PALISADE-3 Phase 3 trial is expected to provide topline data in the fourth quarter of this year. Topline results for the PALISADE-4 Phase 3 trial are expected in the first half of 2026. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the acute treatment of social anxiety in adults. There is no FDA-approved acute treatment for SAD, a serious and potentially life-threatening mental health disorder often associated with co-morbidities such as major depressive disorder and suicidal ideation. SAD affects more than 30 million U.S. adults, with rising prevalence, especially among those aged 18-22. PH80 for Menopausal Hot Flashes and Other Women's Health Indications Following positive results from exploratory Phase 2A studies in women's health conditions, including vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder (PMDD), Vistagen is preparing its U.S. Investigational New Drug Application (IND) to facilitate further Phase 2 clinical development of PH80 for treatment of vasomotor symptoms (VMS), also known as hot flashes, due to menopause. An estimated 60% - 80% of menopausal women in the U.S. experience VMS, according to SWAN (Study of Women Across the Nation) and other published studies. Itruvone for Major Depressive Disorder Following positive results from an exploratory Phase 2A, Vistagen is also planning for further Phase 2 development of itruvone for Major Depressive Disorder (MDD) under its U.S. IND in MDD. Depression is a serious medical condition and a global public health concern that can arise at any time during a person's life. According to the World Health Organization (WHO), depression is the leading cause of disability worldwide, affecting over 250 million people. Statistics reported by the U.S. National Institute of Mental Health (NIMH) indicate that approximately 21 million adults in the U.S., or approximately 8.4% of all adults in the U.S., experienced at least one major depressive episode in 2020. Corporate Updates In June, Vistagen announced the appointment of Elissa Cote as its Chief Corporate Development Officer, responsible for overseeing strategic, commercial, and business development functions. Financial Results for Fiscal Year 2026 First Quarter Ended June 30, 2025 Research and development (R&D) expense R&D expense was $11.7 million for the three months ended June 30, 2025, as compared to $7.6 million for the three months ended June 30, 2024. The increase in R&D expense was primarily due to an increase in research, development, contract manufacturing expenses, and headcount related to the U.S. registration-directed PALISADE Program for fasedienol in SAD. General and administrative (G&A) expense G&A expense was $4.4 million for the three months ended June 30, 2025, as compared to $4.6 million for the three months ended June 30, 2024. Net loss Net loss was $15.1 million for the three months ended June 30, 2025, as compared to $10.7 million for the three months ended June 30, 2024. Other financial highlights Cash, cash equivalents, and marketable securities were $63.2 million as of June 30, 2025. Conference Call and Webcast Vistagen will host a conference call and live audio webcast today, August 7, 2025, at 5:00 p.m. Eastern Time to provide a corporate update of the Company's progress. The conference call is being webcast live, and a link can be found under 'Events' in the Investors section of Vistagen's website. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes before the call. The webcast will be archived on Vistagen's website shortly after the call and will be available for at least 90 days. For participants interested in participating in the call via dial-in, please follow the link below to pre-register. After registering, you will be provided with access details via email. About Pherines Vistagen's neuroscience pipeline currently consists of five investigational pherine product candidates, each with a novel mechanism of action (MOA) and positive clinical data in their targeted indications. Pherines activate peripheral receptors in human nasal chemosensory neurons and are designed to rapidly activate nose-to-brain neurocircuits, believed to modulate brain areas, without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits and differentiated safety. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines. Pherines specifically and selectively activate peripheral receptors on human nasal chemosensory neurons and are designed to rapidly trigger olfactory bulb-to-brain neurocircuits believed to regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options if successfully developed and approved. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and multiple women's health conditions, including vasomotor symptoms (hot flashes) associated with menopause. Connect at Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as 'may,' 'could,' 'expect,' 'project,' 'outlook,' 'strategy,' 'intend,' 'plan,' 'seek,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'strive,' 'goal,' 'continue,' 'likely,' 'will,' 'would' and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen's product candidates will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful, or that Vistagen will be able to successfully replicate the results of past studies of any of its product candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including PALISADE-3, PALISADE-4 and/or any other clinical trial conducted by Vistagen as a part of its PALISADE program, as currently expected or at all; completing IND-enabling programs for applicable product candidates, including itruvone and/or PH80; submission of a NDA to the FDA for any of Vistagen's product candidates, including fasedienol; the ability of any clinical trial information from the PALISADE program or otherwise submitted by Vistagen to the FDA to support a NDA; Vistagen's dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, which are outside of Vistagen's full control; risks and uncertainties resulting from disruptions and personnel turnover, staff reductions or otherwise, at the FDA, other government agencies and comparable foreign regulatory authorities; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen's patents, including patents related to Vistagen's pherine product candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct Vistagen's ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen's product candidates. These risks are more fully discussed in the section entitled 'Risk Factors' in Vistagen's Annual Report on Form 10-K for the fiscal year ended March 31, 2025, and Quarterly Report on Form 10-Q for the period ended June 30, 2025, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen's SEC filings are available on the SEC's website at You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen's views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements. VISTAGEN THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value amounts) June 30, 2025 March 31, 2025 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 48,985 $ 67,131 Marketable securities 14,195 13,351 Prepaid expenses and other current assets 3,536 1,594 Total current assets 66,716 82,076 Property and equipment, net 530 476 Right-of-use asset - operating lease 1,206 1,335 Other assets 472 454 Total assets $ 68,924 $ 84,341 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 486 $ 653 Accrued expenses 6,582 8,810 Note payable 933 — Deferred revenue - current portion 2,514 2,588 Operating lease obligation - current portion 640 561 Total current liabilities 11,155 12,612 Deferred revenue - non-current portion 221 391 Operating lease obligation - non-current portion 783 948 Total liabilities 12,159 13,951 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2025 and March 31, 2025; no shares outstanding at June 30, 2025 and March 31, 2025 - - Common stock, $0.001 par value; 325,000,000 shares authorized at June 30, 2025 and March 31, 2025; 29,286,585 and 29,001,481 shares issued at June 30, 2025 and March 31, 2025, respectively 29 29 Additional paid-in capital 483,430 481,956 Treasury stock, at cost, 4,522 shares of common stock held at June 30, 2025 and March 31, 2025 (3,968 ) (3,968 ) Accumulated other comprehensive income 1 5 Accumulated deficit (422,727 ) (407,632 ) Total stockholders' equity 56,765 70,390 Total liabilities and stockholders' equity $ 68,924 $ 84,341 Expand VISTAGEN THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share data) Three Months Ended June 30, 2025 2024 Revenues: Sublicense and other revenue $ 244 $ 84 Total revenues 244 84 Operating expenses: Research and development 11,678 7,648 General and administrative 4,370 4,567 Total operating expenses 16,048 12,215 Loss from operations (15,804 ) (12,131 ) Other income, net: Interest income, net 711 1,398 Other expense (2 ) — Loss before income taxes (15,095 ) (10,733 ) Income taxes — — Net loss $ (15,095 ) $ (10,733 ) Unrealized gain (loss) on marketable securities (4 ) 2,000 Comprehensive loss $ (15,099 ) $ (10,731 ) Basic and diluted net loss per common share $ (0.47 ) $ (0.35 ) Weighted average common shares outstanding, basic and diluted 31,930,665 30,603,435 Expand
