PALM BEACH, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - Worldwide, there is a rising demand for neuropsychiatric disorder treatments which is expected to fuel the global markets for years to come. With expanding research and development efforts and a robust pipeline of novel medications, the neuropsychiatric disorders treatment landscape is evolving rapidly. Pharmaceutical companies are focusing on innovative drug therapies to meet the growing need for effective and affordable treatments. The market is primarily driven by the high incidence of mental illnesses, including depression and anxiety, and the rising awareness of these conditions. As a result, new treatment options are being developed, and drug-related activities such as clinical trials and drug approvals are intensifying. Recently an article on the 4th European Congress of Neurology and Neuropsychiatry website said that: “The global neuropsychiatric disorders and treatment market is on an upward trajectory, with a significant increase in demand for innovative solutions that cater to the growing burden of mental health conditions. In 2024, the market was valued at USD 130.5 billion, and by 2032, it is projected to reach USD 166.3 billion, growing at a compound annual growth rate (CAGR) of 10.20% from 2023 to 2032. This growth is fueled by continuous research, advancements in treatment, and heightened awareness of neuropsychiatric disorders.”   Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Sage Therapeutics, Inc. (NASDAQ: SAGE), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), atai Life Sciences (NASDAQ: ATAI).

The article continued: “The growing global burden of neuropsychiatric disorders is a critical driver for the treatment market. With over 9.1 million annual deaths attributed to neurological diseases and an additional 8 million caused by neuropsychiatric conditions, this category represents a substantial public health challenge. These disorders contribute significantly to disability globally, with an estimated 461 million disability-adjusted life years (DALYs) lost each year. Moreover, rising awareness through public education, media coverage, and advocacy organizations is encouraging more individuals to seek early diagnosis and treatment, ultimately improving outcomes for patients. Social media and celebrity-led campaigns have also played a pivotal role in removing the stigma surrounding mental health, further boosting the demand for treatments. Drug treatments continue to be the fastest-growing segment in the neuropsychiatric disorders market, driven by ongoing advancements in pharmacology. New medications are being developed with fewer side effects and increased efficacy in managing conditions like depression, schizophrenia, and Alzheimer’s disease.”

Cybin Inc. (NYSE AMERICAN: CYBN) (Cboe Canada: CYBN) Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures - Funding agreement contemplates a conversion formula with a potential 30% premium upon conversion and positions the Company for growth, and accelerated advancement of its clinical pipeline programs, CYB003 and CYB004 -   Cybin Inc. (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce the Company has entered into a securities purchase agreement (the “Securities Purchase Agreement”) with High Trail Special Situations LLC (“High Trail”), pursuant to which the Company agreed to sell and issue to High Trail up to US$500,000,000 in aggregate principal amount of unsecured convertible debentures (the “Convertible Debentures”). The sale and issue of US$50,000,000 principal amount of Convertible Debentures was completed on June 30, 2025 (the “Private Placement”). The sale and issue of US$450,000,000 of the principal amount of Convertible Debentures will be determined at a future date, upon mutual agreement of the parties.

“This financing represents a major inflection point for Cybin and supports our position as a leader within our sector,” said Doug Drysdale, Chief Executive Officer of Cybin. "High Trail Capital is an experienced investor, and its confidence and appreciation of our breakthrough clinical data and intellectual property portfolio recognize the potential of the Company. This financing comes at an opportune time for Cybin, as we advance our lead programs, CYB003 and CYB004, in Phase 3 and Phase 2, respectively. CYB003 demonstrated over 70% remission rates and continued durability over 12 months for patients with uncontrolled depression. We await the conclusion of our CYB004 Phase 2 proof-of-concept study, in patients with generalized anxiety disorder,” said Drysdale.

Joseph Gunnar & Co., LLC acted as the sole placement agent in connection with this transaction.

Pipeline Acceleration Drives Multiple Value Creation Catalysts

The funding will accelerate Cybin’s clinical-stage programs across multiple high-value indications:

CYB003 Program Achievements:

• Breakthrough Clinical Results: Unprecedented 71% remission rate in major depressive disorder at 12 months after two 16 mg doses in Phase 2 study
• Durability advantage: 12-month sustained efficacy demonstrating long-term therapeutic benefit
• FDA Recognition: Breakthrough Therapy Designation received, expediting regulatory pathway
• Multinational Phase 3 PARADIGM program underway

CYB004 Program Momentum:

• Dual Indication Strategy: Expanding addressable market opportunity
• Phase 2 GAD study expected to complete around mid-year 2025 ¹

Commercialization Infrastructure:

• Manufacturing Scale-Up: Finalizing production capabilities for market launch
• IP Portfolio Expansion: Strengthening competitive moat with more than 90 patents issued and over 230 applications pending
• Strategic Partnerships: Developing market access and pre-commercialization alliances
  

Value Catalysts Drive Sustained Momentum

Near-Term Catalysts:

• CYB004 Phase 2 GAD study expected to complete around mid-2025 ¹
• Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025 ¹
• EXTEND study initiation imminent ¹
  

Medium-Term Catalysts (2025-2026):

• Phase 3 top line readout for CYB003 2H 2026 ¹
• Regulatory submission preparations
• Commercial manufacturing readiness
• International market expansion planning

CONTINUED… Read the Transaction Terms and full Press Release for Cybin at: https://www.financialnewsmedia.com/news-cybn/      NOTES: 1.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 in the Full Press Release”.

In other active company biotech news in the markets:

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, and Beckley Psytech Limited (“Beckley”), a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, recently announced a definitive agreement under which atai and Beckley plan to combine in an all-share transaction subject to pre-agreed BPL-003 (mebufotenin benzoate) Phase 2b success criteria.

“The strategic combination marks a transformational moment, solidifying us as a leader in rapid-acting and accessible psychedelic treatments for mental health conditions with a pipeline of potential first-in-class and best-in-class assets,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of atai. “With a unified vision and a synergistic pipeline, we believe we are well-positioned to unlock the strategic value of our clinical development programs for both patients and shareholders. Together, we plan to move confidently towards our goal of bringing innovative interventional psychiatry therapies to patients in need of new treatments.”

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, recently announced the issuance of inducement grants to four newly hired non-executive employees consisting of options to purchase an aggregate of 128,750 common shares of the Company (the "Options"), with effective grant dates of June 2, 2025 and June 9, 2025, depending on the applicable employee’s respective start date. The Options have an exercise price equal to the closing price of MindMed’s common shares on the last trading day on which MindMed’s common shares traded prior to the date of the respective grant, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in substantially equal monthly increments over the three-year period thereafter, subject to each employee’s continued employment.

Supernus Pharmaceuticals, Inc. (SUPN) and Sage Therapeutics, Inc. (NASDAQ: SAGE) recently announced a definitive agreement for Supernus to acquire Sage through a tender offer for $8.50 per share in cash (or an aggregate of approximately $561 million), payable at closing, plus one non-tradable contingent value right (CVR) collectively worth up to $3.50 per share in cash (or an aggregate of approximately $234 million), for total consideration of $12.00 per share in cash (or an aggregate of up to approximately $795 million). The CVR is payable upon achieving certain net sales and commercial milestones. The transaction is expected to close in the third quarter of 2025.

The transaction will provide Supernus with an innovative marketed product: ZURZUVAE^® (zuranolone) capsules CIV, the first and only U.S. Food and Drug Administration (FDA)-approved oral medicine indicated for the treatment of adults with postpartum depression. Through a collaboration agreement with Biogen, Inc., Supernus will report collaboration revenue that is 50% of total net revenue Biogen records for ZURZUVAE in the U.S.

Compass Pathways plc (NASDAQ: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, recently announced the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The Company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data.

The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD.

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