Psilocybin

-- Aligned with U.S. Food and Drug Administration (FDA) on Registrational Path for RE104 in Postpartum Depression (PPD); On Track to Initiate Phase 3 Trial in 2026 -- -- Enrolling Phase 2 REKINDLE Trial of RE104 in Adjustment Disorder (AjD); Initial Data Expected in 1Q 2027 -- -- On Track to Initiate Phase 2 RECLAIM Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026 -- MORRISTOWN, N.J., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Reunion Neuroscience, Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, today announced program updates and anticipated 2026 milestones. Program Updates and Upcoming Milestones: RE104 is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, which is administered via a single subcutaneous injection. Reunion designed RE104 to deliver a shorter acute psychoactive experience when compared to longer experience duration psychedelics such as psilocybin or LSD. RE104 has potential across a range of mood and anxiety disorders, including in PPD, AjD and GAD, where Reunion is focusing its initial clinical development efforts. Postpartum Depression (PPD) : PPD is the most common complication of pregnancy and childbirth and affects 12.5 percent of new mothers within the first year of giving birth. In December 2025, Reunion completed an End-of-Phase 2 (EOP2) meeting with the FDA regarding its development plans for RE104 for PPD. The EOP2 meeting was supported by results from the multicenter, randomized, double-blind, dose-controlled Phase 2 RECONNECT clinical trial. As previously disclosed , RECONNECT met its primary endpoint, demonstrating a clinically-meaningful reduction in MADRS scores through Day 28, as well as a favorable safety and tolerability profile. Based on feedback from the FDA, Reunion expects that the results from a single additional Phase 3 trial, if successful, would complete the pivotal clinical studies required to support potential registration of RE104 in PPD. Additionally, after review of Reunion’s lactation study, FDA feedback supports the enrollment of women who are actively breastfeeding into the planned Phase 3 trial; these women can expect to return to breastfeeding on the same day of treatment following discharge. Reunion expects to initiate Phase 3 development of RE104 in PPD in 2026. “We are entering 2026 with tremendous momentum across our business,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “Last year, we reported positive topline data from our Phase 2 RECONNECT trial in PPD, demonstrating that a single dose of RE104 can safely deliver clinically meaningful improvements in depression and anxiety scores. These results unlock a blockbuster opportunity in PPD, where we believe we are advancing a best-in-class therapy poised to disrupt a significant and still underserved market. Following a productive End of Phase 2 meeting with the FDA, we look forward to initiating a Phase 3 trial in PPD later this year, which – if successful – could enable us to submit our first new drug application for RE104.” Adjustment Disorder (AjD): AjD, which is defined as a disproportionate reaction to a stressful life event or change that impacts the ability to function, is among the most frequent diagnoses managed by psychiatrists globally. Cancer and other medical illnesses are known to be key precipitants of AjD. RE104 is currently being evaluated in REKINDLE, a randomized, double-blind, parallel-group, dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. Reunion expects to complete patient enrollment by year-end, and to report topline clinical data from the REKINDLE trial in the first quarter of 2027. Generalized Anxiety Disorder (GAD): GAD is a chronic mental health condition, characterized by excessive and uncontrollable worry; a majority of patients fail to achieve remission with currently available therapies. Reunion plans to evaluate RE104 in RECLAIM, a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating the safety and efficacy of RE104 for the treatment of GAD in adult patients. Reunion expects to initiate the RECLAIM trial in the first quarter of 2026. Mr. Mayes continued, “Beyond advancing our PPD program, the RECONNECT data are critical in de-risking our planned indication expansion strategy across other mental health disorders characterized by depression and anxiety. In the near term, we look forward to progressing our efforts in AjD and GAD, and longer term, to exploring the potential of RE104 across a broad range of other acute and chronic mood and anxiety disorders, as we work to deliver the full promise of psychedelic-inspired medicines to patients with mental health conditions.” RE245 is a non-psychedelic serotonergic neuroplastogen designed to deliver 5HT2A-mediated neuroplasticity, resulting in therapeutic mental health benefits without producing hallucinations or cardiotoxicity. Reunion plans to investigational new drug application (or foreign equivalent) in 2026 and commence a Phase 1 clinical trial in 2027. About Reunion Neuroscience, Inc. Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression, adjustment disorder and generalized anxiety disorder and may in the future expand to additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. Reunion has advanced a lead candidate, RE245, from its non-psychedelic discovery program and plans to IND in 2026. To learn more, visit , and follow Reunion on LinkedIn and Bluesky . For further information: IR Inquiries: Hannah Deresiewicz Precision AQ hannah.deresiewicz@precisionaq.com PR Inquiries: Ashley Murphy Precision AQ ashley.murphy@precisionaq.com

Balance Sheet and Sharpened Strategy VANCOUVER, BRITISH COLUMBIA / ACCESS Newswire / January 8, 2026 / Lobe Sciences Ltd. (CSE: LOBE)( OTCQB: LOBEF)( Frankfurt: LOBE.F ) (" Lobe " or the " Company "), a biopharmaceutical company advancing programs in diseases with unmet medical needs, today reported audited financial results for the fiscal year ended August 31, 2025 ("FY2025") and provided an update on operational progress achieved since the Company's leadership transition and Board renewal beginning in late 2024. Dr. Frederick D. Sancilio, Chairman and CEO of Lobe Sciences, stated: "Fiscal 2025 was about strengthening Lobe's balance sheet and funding our core assets responsibly. Advancing L-130 through Cynaptec Pharmaceuticals, Inc. allowed us to secure development capital while limiting dilution at Lobe, which we believe better aligns capital with asset value." Financial Highlights: FY2025 In FY2025, Lobe improved its balance sheet position and liquidity profile: Cash increased to $5,854,118 on August 31, 2025, compared to $237,772 on August 31, 2024 Working capital improved to a surplus of $5,163,526, compared to a deficit of $2,008,849 on August 31, 2024 The current portion of the convertible notes were eliminated on August 31, 2025, as compared to $641,374 on August 31, 2024 Derivative liability decreased to $205,105 on August 31, 2025, from $603,724 on August 31, 2024 Short-term investments of $1,686,688 were held on August 31, 2025 (none reported on August 31, 2024) Loss per share was $0.03 for fiscal 2025, compared to $0.04 for fiscal 2024, despite significant balance-sheet restructuring and increased investment in corporate infrastructure and development activities. For FY2025, the Company reported a net loss attributed to the parent company of $4,861,611 (FY2024: $4,420,727). Management believes the strengthened working capital position reduces liquidity risk and improves the Company's ability to pursue business development initiatives. Progress Since Leadership Transition Following the leadership transition and Board renewal in late 2024, Lobe implemented a broad operational and financial stabilization program aimed at strengthening governance and disclosure, reducing legacy balance-sheet complexity, and positioning the Company to pursue disciplined financing and value-focused business development opportunities. In FY2025, this transformation translated into a materially improved liquidity position and a clearer corporate structure focused on two core strategic development programs advanced through subsidiaries, as described below. Product Development Program Summary Lobe is advancing two product development programs through its subsidiaries: Cynaptec Pharmaceuticals, Inc. (64% owned by Lobe) - L-130 for chronic cluster headache (lead program) and substance use disorder, with other indications under strategic review. Altemia, Inc. - S-100, an early-stage drug product candidate for sickle cell disease. In addition to these two ongoing programs, the Company continues to evaluate other strategic opportunities consistent with its business strategy and leverage its development expertise. Cynaptec Pharmaceuticals, Inc.: L-130 - A CNS Therapeutic L-130 is a novel, patented, oral, stable analog of psilocin, the active metabolite of the prodrug psilocybin, designed to enhance bioavailability and therapeutic efficacy. Psilocin has been identified as having therapeutic potential in a variety of neurological conditions. The lead indication for L-130 is chronic cluster headache, a neurological condition with limited treatment options and significant unmet clinical need. As described in the Company's MD&A, a Phase 1a study in healthy volunteers and supporting preclinical work have been completed internationally under applicable standards, and the Company is continuing to advance the development plan and partnership strategy in line with US FDA guidance received in its Pre-IND correspondence. Altemia, Inc.: S-100 - Sickle Cell Disease Drug Product Candidate During FY2025, Lobe refined its sickle cell disease strategy to prioritize S-100 , an early-stage therapeutic candidate intended to address aspects of the underlying pathology of the disease. S-100 is based on a patented drug-delivery platform and comprises a lipid-based formulation primarily containing docosahexaenoic acid and eicosapentaenoic acid in triglyceride form, combined with pharmaceutical-grade surfactants. The Company is also maintaining limited, preliminary commercialization activities related to a proprietary medical food intended to address nutritional deficiencies commonly observed in patients with sickle cell disease. These activities are focused primarily on assessing third-party reimbursement pathways. There can be no assurance that reimbursement will be obtained or that the product will be commercially viable, and the Company may elect to pursue alternative strategies or discontinue commercialization efforts if reimbursement is not achieved. Potential Value-Creation Strategy The Company's strategy is focused on advancing the intrinsic value of its existing research and development assets. During fiscal 2025, Lobe's market capitalization remained below $5.0 million, making parent-level financings highly dilutive. In response, the Company transferred its L-130 program into its wholly owned subsidiary, Cynaptec Pharmaceuticals, Inc., and completed a subsidiary-level financing that raised $8.46 million at a $22.56 million post-money valuation, while retaining a 64% ownership interest. Management believes this approach supports continued development of L-130, limits dilution at the parent level, and preserves long-term shareholder participation. Outlook for FY2026 In FY2026, the Company expects to build on progress made in FY2025 by continuing to strengthen its corporate infrastructure, advance its core development programs through disciplined milestone execution, and evaluate strategic opportunities aligned with shareholder interests. The timing and outcome of these initiatives will depend on market conditions, financing availability, regulatory considerations, and other factors described under "Forward-Looking Statements." NEITHER THE CANADIANSECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWEDOR ACCEPT RESPONSIBILITY FOR THE ACCURACYOR ADEQUACY OF THIS NEWS RELEASE. About Lobe Sciences Ltd. (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) Lobe Sciences Ltd. is a biopharmaceutical company advancing programs in rare and orphan diseases with unmet medical needs. The Company is pursuing development through its subsidiaries, including a majority interest in Cynaptec Pharmaceuticals, Inc. and wholly owned subsidiary Altemia, Inc. Lobe utilizes a global network of contract pharmaceutical service providers to conduct research and development activities under Lobe's direct supervision. About Cynaptec Pharmaceuticals, Inc . Cynaptec is a biopharmaceutical company dedicated to developing innovative therapies for neurological and psychiatric disorders. Cynaptec's initial development program is focused on the use of its proprietary L-130 (psilocin mucate) compound for treatment of the significant unmet medical needs of patients with Chronic Cluster Headache, with an additional preliminary proof-of-concept to assess potential utility for substance use disorders. Cynaptec is 64% owned by Lobe. About L-130 (psilocin mucate) L-130 is a novel, patented, oral, stable analog of psilocin, the active metabolite of the prodrugpsilocybin, designed to enhance bioavailability and therapeutic efficacy, which has been identified as having therapeutic potential in a variety of neurological conditions. Whereas conventional psilocin is an unstable compound that has been challenging for the industry to develop as a standalone pharmaceutical, L-130 stability and bioavailability profile, and associated safety and efficacy signals, suggest the potential for prescription drug development in a variety of neurological and psychiatric indications. For Further Information Dr. Frederick D. Sancilio Chief Executive Officer Lobe Sciences Ltd. Email: info@lobesciences.com Phone: +1 (949) 505-5623 Website: Cautionary Statement Regarding "Forward-Looking" Information This news release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, including statements regarding future estimates, plans, objectives, timing, assumptions or expectations of future performance, including, without limitation: the Company's belief that its strengthened working capital position will reduce liquidity risk and enhance the Company's ability to execute on its business development initiatives; the Company's belief that its operational and financial stabilization program will position the Company to pursue value-accretive transactions and financing alternatives aligned with shareholder interests; the Company's belief that L-130 will have therapeutic use at sub-hallucinogenic doses and that in addition to the treatment of Chronic Cluster Headaches, L-130 may have additional therapeutic uses; the Company's intention to evaluate other strategic opportunities consistent with its business strategy; the Company's expectation that it will further strengthen its corporate infrastructure and advance its core development programs through disciplined milestone execution are forward-looking statements and contain forward-looking information. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should" or "would" or occur. Forward-looking statements are based on certain material assumptions and analysis made by the Company and the opinions and estimates of management as of the date of this press release, including, among other things, that: a strengthened working capital position will reduce liquidity risk and enhance the Company's ability to execute on its business development initiatives; the Company's operational and financial stabilization program will position the Company to pursue value-accretive transactions and financing alternatives aligned with shareholder interests; L-130 will have therapeutic use at sub-hallucinogenic doses and that in addition to the treatment of Chronic Cluster Headaches, L-130 may have additional therapeutic uses; the Company will have the financial and operational resources to evaluate other strategic opportunities consistent with its business strategy; the Company will be able to further strengthen its corporate infrastructure and achieve its business milestones on the timelines anticipated, among others. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. Important risks that may cause actual results to vary, include, without limitation, the risk that: a strengthened working capital position will not reduce liquidity risk or enhance the Company's ability to execute on its business development initiatives; the Company's operational and financial stabilization program will be insufficient to allow the Company to pursue value-accretive transactions and financing alternatives aligned with shareholder interests; the Company may not have the financial and operational resources to evaluate other strategic opportunities consistent with its business strategy; L-130 fails to demonstrate therapeutic use at sub-hallucinogenic doses, fails to effectively treat Chronic Cluster Headaches or demonstrate other therapeutic uses; the Company will have the financial and operational resources to evaluate other strategic opportunities consistent with its business strategy; the Company will be unable to further strengthen its corporate infrastructure or achieve its business milestones or do so on the timelines anticipated. Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. SOURCE: Lobe Sciences Ltd. View the original press release on ACCESS Newswire