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Just one single dose of ‘magic mushrooms' could relieve depression for 5 years, researchers find

Just one single dose of ‘magic mushrooms' could relieve depression for 5 years, researchers find

New York Post24-06-2025
Psilocybin, the main psychoactive ingredient in magic mushrooms, could alleviate depression for at least five years after just one dose, according to a new study.
The research, presented June 18 at the Psychedelic Science 2025 conference in Denver, followed up with patients who had been diagnosed with clinical depression — also known as major depressive disorder (MDD) — and had participated in a previous psilocybin treatment study in 2020.
'Most people who participated in our trial reported improvements in depression symptom intensity or in the ways in which they experienced depression in their life, lasting up to five years after the trial,' study co-author Alan Davis, director of the Center for Psychedelic Drug Research and Education at The Ohio State University, told Fox News Digital.
Doug Drysdale, CEO of the Canadian pharmaceutical company Cybin in Toronto, Ontario, told Fox News Digital that the outcome speaks to the 'exciting' potential of psilocybin and other psychedelic-based treatments in treating MDD and other mental health conditions.
'The results of the study are certainly very encouraging,' said Drysdale, who was not involved in the study.
Earlier studies pointed toward the possibility of psilocybin as a potential antidepressant, prompting researchers to conduct the first-ever randomized clinical trial.
4 Earlier studies pointed toward the possibility of psilocybin as a potential antidepressant.
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The initial 2020 trial, published in JAMA Psychiatry, included 24 patients with major depressive disorder.
Half received psilocybin at the beginning of the trial, and the other half received the treatment eight weeks later.
Each patient also underwent 11 hours of psychotherapy.
One month after treatment, 17 patients reported experiencing symptom relief.
Fourteen of those reported full remission from depression, according to the published study.
4 The initial 2020 trial, published in JAMA Psychiatry, included 24 patients with major depressive disorder.
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'The effectiveness of psilocybin therapy after a single or only a few administrations represents another substantial advantage over commonly used antidepressants that require daily administration,' the researchers wrote.
The new study aimed to explore the longer-term effects of this treatment on 21 of the original trial participants.
Sixty-seven percent reported being in remission from depression five years after treatment, and they also had less anxiety and easier daily functioning.
For those whose depression came back, many still reported lasting benefits in their attitudes, perspectives and ability to pursue things that were meaningful to them, Davis told Fox News Digital.
'Certainly, more controlled and rigorous study is required, but at least anecdotally, these findings are very interesting, and I am cautiously optimistic about the potential for extended efficacy provided by these types of treatments,' Drysdale added.
Other factors may have also played a role in the participants' long-term mental health benefits, such as psychotherapy sessions or other antidepressants, experts agreed.
4 The new study aimed to explore the longer-term effects of this treatment on 21 of the original trial participants.
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'The study doesn't account for naturalistic changes that could have affected their depression in the five years since the main trial, and the sample is not representative of the population of people suffering with depression,' Davis told Fox News Digital.
Psilocybin has also been explored as a potential treatment for post-partum depression (PPD), which affects as many as one in seven new mothers.
A 2022 study outlined the potential role of psychedelics in PPD cases, finding that psilocybin has been shown to catalyze a sense of 'reconnection' in new mothers.
'This effect in PPD, by fostering a sense of 'reconnection' for the mother, may allow for improved mood and maternal sensitivity toward the infant, which can positively impact maternal role gratification and the mother-infant relationship,' the researchers stated.
In February, Cleveland Clinic reported on an upcoming study that explores single-dosing psilocybin as a way to treat PPD.
The trial, now in its second phase, focuses on RE104, a proprietary drug similar to psilocybin.
Study participants will undergo multiple physical and mental health tests.
Potential risks and limitations
Ryan Moss, chief science officer at Filament Health, a clinical-stage natural psychedelic drug development company in Canada, has emphasized the importance of administering psychedelics in a safe setting when treating mental health conditions.
'Psychedelic experiences can sometimes feature anxiety, hallucinations and paranoia,' Moss previously told Fox News Digital.
'Some patients using traditional psychedelics have reported experiencing adverse cardiovascular events during clinical trials.'
4 The trial, now in its second phase, focuses on RE104, a proprietary drug similar to psilocybin.
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To mitigate these risks, Moss recommended clinical trial participants receive thorough preparation and monitoring by trained professionals during sessions.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and Fox News' senior medical analyst, previously interviewed two of the country's top researchers on psychedelics: Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone.
'They agree there is therapeutic potential if very carefully studied under very strict medical guidance, but there is a huge downside in terms of unregulated recreational uses,' Siegel told Fox News Digital at the time.
'Both doctors see likely therapeutic value to psychedelics if carefully managed by medical experts ,' Siegel added.
Melissa Rudy and Angelica Stabile, both of Fox News Digital, contributed reporting.
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WELL Health Reports Record Revenue, Adjusted EBITDA, and Adjusted Net Profit in Q2-2025, Upgrades Guidance, and Delivers First-Ever Quarter With More Than 1 Million Patient Visits in Canada
WELL Health Reports Record Revenue, Adjusted EBITDA, and Adjusted Net Profit in Q2-2025, Upgrades Guidance, and Delivers First-Ever Quarter With More Than 1 Million Patient Visits in Canada

Business Wire

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WELL Health Reports Record Revenue, Adjusted EBITDA, and Adjusted Net Profit in Q2-2025, Upgrades Guidance, and Delivers First-Ever Quarter With More Than 1 Million Patient Visits in Canada

VANCOUVER, British Columbia--(BUSINESS WIRE)--WELL Health Technologies Corp. (TSX: WELL, OTCQX: WHTCF) (the ' Company ' or ' WELL '), a digital healthcare company focused on positively impacting health outcomes by leveraging technology to empower healthcare practitioners and their patients globally, is pleased to announce its interim consolidated financial results for the quarter ended June 30, 2025. Hamed Shahbazi, Chairman and CEO of WELL commented, 'I am very proud of our performance this quarter as it reflects a very significant milestone in our history with best-ever performances across most of our key financial metrics. We delivered record performances across Revenue, Adjusted EBITDA, Adjusted Net Income, and patient visits. Furthermore, we would have reported best-ever Free Cash Flow Available to Shareholders had we not had elevated cash taxes and capital expenditures due to new investments made in our Canadian clinics, executive health and longevity health portfolios, which have historically delivered excellent returns on capital invested (ROIC). Importantly, we also delivered $17M in IFRS net profit for the quarter demonstrating our ability to deliver on all key adjusted and non-adjusted metrics. I'm also very pleased to commemorate that we delivered more than 1 million patient visits in Canada during the quarter for the first time ever reflecting 38% YoY growth; approximately a third of which came from organic growth. It's important to remember the significance of each of those visits and how vital it can be to a person's health and wellness. This awareness, along with our growing scale and relevance in the healthcare ecosystem, is top of mind for us. We think about it every day as we are committed to making the investments that are designed to help healthcare providers deliver the best care and patient outcomes possible. One positive by-product of our investments is the growing productivity of our providers. The average provider at WELL grew its number of patient visits by 22%. While there are many contributors to this improvement, we believe improved tooling and technology to be one of those key reasons.' Mr. Shahbazi further added, "We are also very pleased to report our first quarter with the inclusion of HEALWELL AI, a company that we helped launch and incubate almost two years ago and in which we took a majority voting control position this past April. 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Year to date, we have completed fourteen transactions and are pleased to report fifteen signed LOIs representing approximately $134 million in revenues. Our high-quality pipeline of acquisition opportunities mostly includes targets across Canadian Clinics and WELLSTAR. Also, notably our WELLSTAR platform delivered another strong 'Rule of 40' performance with strong organic revenue growth and healthy Adjusted EBITDA margins, while executing on its M&A pipeline. WELLSTAR's goal is to exceed $100 million in revenues next year with continued strong margins and growth metrics. Overall, we remain committed to improving margin profile and operating leverage across the organization, while evaluating strategic opportunities to streamline and optimize our portfolio. With a strong balance sheet and increasing cash generation, we are well-positioned to support long-term growth and return value to shareholders.' 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The increase in Adjusted Gross Margin percentage was primarily driven by revenue mix and the addition of higher margin HEALWELL revenue, while being offset by the addition of lower margin Provider Staffing revenue from the acquisition of Harmony in January 2025. Adjusted EBITDA (1) was $49.7 million in Q2-2025, an increase of 231% compared to Adjusted EBITDA of $15.0 million in Q2-2024. Excluding the impact of CM Deferrals, Adjusted EBITDA would have reached $40.0 million, representing a 166% increase compared to the previous year. Adjusted EBITDA Attributable to WELL shareholders was $37.5 million in Q2-2025, an increase of 215% compared to Adjusted EBITDA Attributable to WELL shareholders of $11.9 million in Q2-2024. Adjusted Net Income (1) was $25.8 million, or $0.10 per share in Q2-2025, compared to Adjusted Net Income of $4.1 million, or $0.02 per share in Q2-2024. Free Cash Flow Available to Shareholders (or FCFA2S) was $11.7 million in Q2-2025 an increase of 34% compared to FCFA2S of $8.7 million in Q2-2024. Note that FCFA2S was impacted by elevated cash taxes and capital expenditures which were focused on investments in upgrading our clinical portfolio. Segmented Revenue: Canadian Patient Services revenue was $114.5 million in Q2-2025, an increase of 49% compared to $76.7 million in Q2-2024. U.S. Patient Services revenue was $184.8 million in Q2-2025, an increase of 38% compared to $133.7 million in Q2-2024. WELLSTAR, the Company's pure-play SaaS technology subsidiary, achieved revenue of $15.2 million in Q2-2025, an increase of 49% compared to $10.2 million in Q2-2024. WELLSTAR's growth was driven by healthy organic growth and acquisitions. Second Quarter 2025 Patient Visit Metrics: WELL achieved a total of 1.7 million patient visits in Q2-2025, an increase of 21% compared to 1.4 million patient visits in Q2-2024. 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Second Quarter 2025 Business Highlights: On April 1, 2025, the Company and the pre-HEALWELL founders amended the terms of the conditional call option held by the Company to acquire up to 30.8 million Class A Subordinate Voting Shares of HEALWELL at $0.125 per share and 30.8 million Class B Multiple Voting shares of HEALWELL at $0.0001 per share such that it became exercisable, and the Company exercised the call option to acquire such shares for total consideration of $3.9 million. On April 1, 2025, the release conditions were satisfied related to the Company's January 21, 2025, subscription for HEALWELL shares and the Company received 0.5 million Class A voting shares and 0.25 million share purchase warrants with each warrant exercisable into one Class A Subordinate Voting share at $2.50 per share for a period of 36 months in accordance with the terms of the subscription agreement. As of April 1, 2025, the Company held 97.2 million Class A Subordinate Shares and 30.8 million Class B Multiple Voting shares of HEALWELL, representing approximately 37% of the economic interest and approximately 69% of the voting rights in HEALWELL on a non-diluted basis. As a result, the Company obtained control of HEALWELL under IFRS, and accordingly, began to consolidate the financial results of HEALWELL as a subsidiary of the Company effective April 1, 2025. On May 6, 2025, the Company announced the rebranding of its cybersecurity division as CYBERWELL and the appointment of Jeffrey Engle as CEO. CYBERWELL consolidates four firms: Source44, SeekIntoo, Cycura, and Proack Security into a unified cybersecurity company. The division will focus on recurring revenue, acquisitions, and international expansion. WELL noted plans for CYBERWELL to potentially be spun out in the future and serve as a key growth engine. On May 7, 2025, WELLSTAR announced the launch of Nexus AI, a new AI-powered clinical documentation solution available across Canada. The product is initially focused on AI scribing and will expand through partnerships across the WELL ecosystem. Nexus AI is supported by government funding for up to 10,000 providers through Canada Health Infoway's AI Scribe pilot program. On May 28, 2025, the Company announced that subsidiaries of HEALWELL and WELLSTAR, Intrahealth, Pentavere, and OceanMD, were selected as recipients of Canada Health Infoway's 2025 Vendor Innovation Program. The program supports the development and implementation of real-world interoperability solutions aligned with national digital health priorities. The selected projects aim to enhance data quality, care coordination, and access to standardized health information across Canada, with deployments planned in five provinces. Three of the eight recipients are affiliated with the WELL and HEALWELL group. 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('Pentavere'), by exercising a call option that it had previously negotiated at the time of its original acquisition of a majority interest in Pentavere in 2023. Pursuant to the call option, HEALWELL acquired all of the remaining issued and outstanding shares of Pentavere for an aggregate purchase price of $13,978 which was satisfied with the issuance of 10,161,562 HEALWELL Class A Subordinate Voting Shares. With 100% ownership of Pentavere, HEALWELL intends to deepen integration between its AI businesses and accelerate commercialization of AI products across healthcare offerings. Outlook: WELL intends to continue its focus on maintaining strong performance, while strategically enhancing operations in the pursuit of organic growth and profitability. WELL is expecting its momentum to continue in the second half of the year across its key business units. WELL's objective is to invest in and achieve significant growth while effectively managing its costs and delivering cash flow to shareholders. Management is pleased to reaffirm its 2025 annual guidance for revenue to be between $1.40 billion to $1.45 billion, representing 52% to 58% annual growth compared to 2024. Excluding the impact of the CM Deferrals, the Company's annual revenue guidance would be between $1.35 billion to $1.40 billion. This annual revenue guidance only includes announced acquisitions; however, WELL expects to be in the upper half of this guidance range with the inclusion of planned acquisitions in the second half of the year. Furthermore, management is pleased to increase its guidance for annual Adjusted EBITDA to be in the upper half of its previously provided guidance of $190 million to $210 million. Excluding the impact of CM Deferrals, the Company is similarly improving its guidance for annual Adjusted EBITDA to be in the upper half of its previously provided guidance of $140 million to $160 million. This improvement of the Company's annual Adjusted EBITDA guidance only includes announced acquisitions. WELL continues to allocate capital thoughtfully in order to activate both organic and inorganic growth. The Company expects to continue to fund its acquisitions from its own cash flow as well as planned divestitures ensuring compounding gains over time on a per share basis. The Company also continues to focus most of its M&A and capital allocation activity in Canada where it is experiencing its strongest returns. Conference Call: WELL will release its Second Quarter 2025 financial results for the period ended June 30, 2025, on Thursday, August 14, 2025. The Company will hold a conference call and simultaneous webcast to discuss its results on the same day at 1:00 pm ET (10:00 am PT). Please use the following dial-in numbers: 1-800-717-1738 (Toll Free) or 1-289-514-5100 (International). The conference call will also be simultaneously webcast and can be accessed at the following audience URL: Selected Unaudited Financial Highlights: Please see SEDAR for complete copies of the Company's condensed interim consolidated financial statements and interim MD&A for the quarter ended June 30, 2025. Footnotes: Non-GAAP financial measures and ratios. In addition to results reported in accordance with IFRS, the Company uses certain non-GAAP financial measures as supplemental indicators of its financial and operating performance. These non-GAAP financial measures include Adjusted Net Income, Adjusted Net Income Per Share, Adjusted EBITDA, Adjusted Gross Profit, Adjusted Gross Margin, and Adjusted Free Cash Flow. The Company believes these supplementary financial measures reflect the Company's ongoing business in a manner that allows for meaningful period-to-period comparisons and analysis of trends in its business. Adjusted Net Income and Adjusted Net Income per Share The Company defines Adjusted Net Income as net income (loss), after excluding the effects of share-based payments, amortization of acquired intangible assets, time-based earnout expense, change in fair value of investments, change in fair value of derivative liability, non-controlling interests, and revenue precluded from recognition under IFRS 15 that relates to certain patient services revenue that the Company believes should be recognized as revenue based on its contractual relationships. Adjusted Net Income Per Share is Adjusted Net Income divided by weighted average number of shares outstanding. The Company believes that these non-GAAP financial measures provide useful information to analyze our results, enhance a reader's understanding of past financial performance and allow for greater understanding with respect to key metrics used by management in decision making. More specifically, the Company believes Adjusted Net Income is a financial metric that tracks the earning power of the business that is available to WELL shareholders. EBITDA and Adjusted EBITDA EBITDA and Adjusted EBITDA are non-GAAP measures. EBITDA represents net income (loss) before interest, taxes, depreciation, and amortization. The Company defines Adjusted EBITDA as EBITDA (i) less net rent expense on premise leases considered to be finance leases under IFRS and (ii) before transaction, restructuring, and integration costs, time-based earn-out expense, change in fair value of investments, change in fair value of derivative liability, share of loss of associates, foreign exchange gain/loss, and share-based payments, (iii) revenue precluded from recognition under IFRS 15 that relates to certain patient services revenue that the Company believes should be recognized as revenue based on its contractual relationships, and (iv) gains/losses that are not reflective of ongoing operating performance. The Company considers Adjusted EBITDA a financial metric that measures cash that the Company can use to fund working capital requirements, service future interest and principal debt repayments and fund future growth initiatives. EBITDA and Adjusted EBITDA should not be considered alternatives to net income (loss), cash flow from operating activities or other measures of financial performance in accordance with IFRS. Adjusted Gross Profit and Adjusted Gross Margin The Company defines Adjusted Gross Profit as revenue less cost of sales (excluding depreciation and amortization) and Adjusted Gross Margin as adjusted gross profit as a percentage of revenue. Adjusted gross profit and adjusted gross margin should not be construed as an alternative for revenue or net income (loss) determined in accordance with IFRS. The Company does not present gross profit in its consolidated financial statements as it is a non-GAAP financial measure. The Company believes that adjusted gross profit and adjusted gross margin are meaningful metrics that are often used by readers to measure the Company's efficiency of selling its products and services. Adjusted Free Cash Flow The Company defines Adjusted Free Cash Flow Attributable to Shareholders as Adjusted EBITDA Attributable to Shareholders, less cash interest, less cash taxes and less capital expenditures. Adjusted Net income, Adjusted Net Income per Share, Adjusted EBITDA, Adjusted Gross Profit, Adjusted Gross Margin, and Adjusted Free Cash Flow are not recognized measures for financial statement presentation under IFRS and do not have standardized meanings. As such, these measures may not be comparable to similar measures presented by other companies and should be considered as supplements to, and not as substitutes for, or superior to, the corresponding measures calculated in accordance with IFRS. Total Care Interactions are defined as Total Patient Visits plus Technology Interactions plus Billed Provider Hours. WELL HEALTH TECHNOLOGIES CORP. Per: 'Hamed Shahbazi' Hamed Shahbazi Chief Executive Officer, Chairman and Director About WELL Health Technologies Corp. WELL's mission is to tech-enable healthcare providers. We do this by developing the best technologies, services, and support available, which ensures healthcare providers are empowered to positively impact patient outcomes. WELL's comprehensive healthcare and digital platform includes extensive front and back-office management software applications that help physicians run and secure their practices. WELL's solutions enable more than 34,000 healthcare providers between the US and Canada and power the largest owned and operated healthcare ecosystem in Canada with more than 165 clinics supporting primary care, specialized care, and diagnostic services. In the United States WELL's solutions are focused on specialized markets such as the gastrointestinal market, women's health, primary care, and mental health. WELL is publicly traded on the Toronto Stock Exchange under the symbol 'WELL' and on the OTC Exchange under the symbol 'WHTCF'. To learn more about WELL, please visit: Forward-Looking Statements This news release may contain 'Forward-Looking Information' within the meaning of applicable Canadian securities laws, including, without limitation: information regarding the Company's goals, strategies and growth plans, including expected acquisitions and divestitures Company and HEALWELL; expectations regarding continued revenue and EBITDA growth; the Company's expectations pertaining to annual guidance for annual revenue and Adjusted EBITDA; the expected benefits and synergies of completed acquisitions; capital allocation plans in the form of more acquisitions or share repurchases; expected patient visits; and the expected financial performance as well as information in the 'Outlook' section herein. Forward-Looking Information are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies. Forward-Looking Information generally can be identified by the use of forward-looking words such as 'may', 'should', 'will', 'could', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-Looking Information involve known and unknown risks, uncertainties and other factors that may cause future results, performance, or achievements to be materially different from the estimated future results, performance or achievements expressed or implied by the Forward-Looking Information and the Forward-Looking Information are not guarantees of future performance. WELL's comments expressed or implied by such Forward-Looking Information are subject to a number of risks, uncertainties, and conditions, many of which are outside of WELL 's control, and undue reliance should not be placed on such information. Forward-Looking Information are qualified in their entirety by inherent risks and uncertainties, including: risks regarding the timing and amount of recognition or revenue and earnings; direct and indirect material adverse effects from adverse market conditions; risks inherent in the primary healthcare sector in general; regulatory and legislative changes; that future results may vary from historical results; inability to obtain any requisite future financing on suitable terms; any inability to realize the expected benefits and synergies of acquisitions; that market competition may affect the business, results and financial condition of WELL and other risk factors identified in documents filed by WELL under its profile at including its most recent Annual Information Form and its Management, Discussion and Analysis. Except as required by securities law, WELL does not assume any obligation to update or revise any forward-looking information, whether as a result of new information, events or otherwise. This news release contains future-oriented financial information and financial outlook information (collectively, 'FOFI') about estimated annual run-rate revenue and Adjusted EBITDA, all of which are subject to the same assumptions, risk factors, limitations, and qualifications as set out in the above paragraph. The actual financial results of WELL may vary from the amounts set out herein and such variation may be material. WELL and its management believe that the FOFI has been prepared on a reasonable basis, reflecting management's best estimates and judgments. However, because this information is subjective and subject to numerous risks, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, WELL undertakes no obligation to update such FOFI. FOFI contained in this news release was made as of the date hereof and was provided for the purpose of providing further information about WELL's anticipated future business operations on an annual basis. Readers are cautioned that the FOFI contained in this news release should not be used for purposes other than for which it is disclosed herein. Neither the TSX nor its Regulation Services Provider (as that term is defined in policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

AI Analyst Predicts 50% Upside for HIMS Stock While Wall Street Stays Cautious
AI Analyst Predicts 50% Upside for HIMS Stock While Wall Street Stays Cautious

Business Insider

time4 hours ago

  • Business Insider

AI Analyst Predicts 50% Upside for HIMS Stock While Wall Street Stays Cautious

While Wall Street analysts remain cautious on Hims & Hers Health (HIMS), TipRanks' A.I. Stock Analysis tool shows strong confidence in the telehealth company's growth. Notably, TipRanks' AI sets a price target of $72 for HIMS stock, implying a 50% upside from current levels, compared with the Wall Street average of $49.11, which indicates only about 2.4% potential growth. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. For context, TipRanks' A.I. Stock Analysis delivers automated, data-driven evaluations of stocks based on key performance metrics, giving investors a clear and concise snapshot of a stock's potential. Notably, HIMS earns a strong score of 74 out of 100 on the tool. AI Analyst Highlights Earnings and Positive Outlook Hims & Hers Health's A.I. score highlights recent Q2 financials and an overall positive outlook. The earnings call showcased solid revenue and subscriber growth, along with expansion into new markets and healthcare services. Notably, Hims & Hers Health saw its subscriber count rise 31% to 2.4 million in Q2. Meanwhile, adjusted EBITDA more than doubled, reaching $82.2 million. On the downside, the company faced challenges, including a drop in GLP‑1 revenue, negative free cash flow, and rising G&A and technology expenses. Specifically, the company's free cash flow took a significant hit, dropping to a negative $69.4 million as of June 30, 2025, compared with a positive $47.6 million a year earlier. The A.I. tool also provides a summary of the company's recent earnings, highlighting both positive and negative updates. A screenshot is shown below for reference. Overall, the A.I. tool sees past the recent short-term volatility. With a growing customer base, new offerings, and market expansion, the current dip could be a buying opportunity for investors focused on the bigger picture. Wall Street Remains Cautious on HIMS Stock After the earnings release, Wall Street remains cautious on HIMS stock. Needham's four-star-rated analyst Ryan MacDonald maintained his Hold rating. He noted that the company's upcoming hormonal health launch and Canadian expansion in 2026 offer growth potential. However, he is concerned that the near-term performance is still heavily tied to weight-loss products, which face regulatory uncertainty. Meanwhile, BofA's top-rated analyst Allen Lutz maintained his Sell rating on HIMS at a price target of $28, predicting a downside of over 40%. Lutz stated that the company is dealing with several short-term challenges, including slow growth in its core business, which could put additional pressure on the GLP-1 segment. He believes that the second half of the year may be even tougher, and near-term cash flow is expected to remain limited as investments continue. Is HIMS Stock a Good Buy? Overall, Wall Street analysts have a Hold consensus rating on HIMS stock based on two Buys, seven Holds, and two Sells assigned in the last three months. The average HIMS stock price target of $49.11 implies an upside of 2.4% from the current trading level.

Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results
Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results

Business Wire

time14 hours ago

  • Business Wire

Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results

TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported unaudited financial results for its first quarter ended June 30, 2025, and is pleased to provide an update on key business milestones. 'With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder. PARADIGM is a significantly larger program than the completed Phase 2 study, with anticipated combined enrollment of approximately 550 participants. Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, and whose symptoms are uncontrolled with existing antidepressant treatment. Our Phase 2 study evaluating CYB004 in generalized anxiety disorder is expected to complete patient enrollment this month.' 'Cybin is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector - both from a clinical and regulatory perspective,' concluded Drysdale. Recent Business and Pipeline Highlights: Received European approval and MHRA approval for EMBRACE, the second Phase 3 study within the PARADIGM program evaluating CYB003 for the adjunctive treatment of MDD, on schedule. The Company has received CTA approval from the Irish Medicines Board for the EMBRACE study in Ireland, Poland, and Greece, as well as approval from the MHRA. EMBRACE is a 12-week, randomized, double-blind, placebo-controlled study in 330 participants with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but with inadequate response. EMBRACE will evaluate two doses of CYB003 (8 mg, 16 mg) three weeks apart, compared to an inactive placebo. The primary endpoint is change in depressive symptoms as measured by the change in MADRS from baseline six weeks after the first dose. Making strong progress on CYB003 development through the APPROACH and EXTEND studies. Dosing is currently ongoing in the first pivotal study, APPROACH, which is expected to enroll 220 patients across 45 U.S. clinical sites. We are pleased to report that patient rollovers continue into EXTEND, the long-term extension study. Clinical Program Summary CYB003: Deuterated psilocin program Phase 3 PARADIGM program is underway, with topline data from first pivotal study, APPROACH, expected in 2026 1. CYB003 program accomplishments: Received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD. A completed Phase 2 study of CYB003 in MDD demonstrated durability of effect at 12 months: 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two 16 mg doses. CYB004: Deuterated dimethyltryptamine program The Phase 2 CYB004 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with generalized anxiety disorder, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. Patient enrollment is expected to be completed this month 1. Change in Presentation Currency Effective April 1, 2025, the Company changed its presentation currency from the Canadian dollar to the United States dollar (' USD '). The change in presentation currency was made to better reflect the Company's operations, align with the currency in which the majority of cash-based expenses are denominated, and improve comparability of its financial results with other publicly traded businesses in the industry. As a result, all amounts presented in this press release are in USD unless otherwise stated. First-Quarter Financial Highlights Cash totaled $118.7 million as of June 30, 2025. Net loss was $24.6 million for the quarter ended June 30, 2025, compared to a net loss of $10.8 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled $23.9 million for the quarter ended June 30, 2025, compared to $11.9 million, in the same period last year. Cash flows used in operating activities were $29.5 million for the quarter ended June 30, 2025, compared to $19.9 million in the same period last year. About Cybin Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Note: There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See 'Cautionary Notes and Forward-Looking Statements'. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, 'forward-looking statements') and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the EMBRACE study to enroll 330 participants at approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia; the Company's expectation to enroll 220 participants at approximately 45 clinical sites across the United States for the APPROACH study; the Company's expectation to complete enrollment in CYB004 Phase 2 study in August 2025; the Company's expectation to receive topline data from APPROACH in 2026; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2025, and the Company's annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.

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