Lobe Sciences Moves Forward with Development of Conjugated Psilocin(TM) Following April 14 Agreement to Spin Out Compound to Cynaptec Pharmaceuticals

Rhea-AI Summary

Lobe Sciences (LOBEF) has spun out its Conjugated Psilocin™ compound to newly created Cynaptec Pharmaceuticals, securing a $6M investment with an option for additional $20M for Phase 3 trials. Cynaptec will advance the development of this novel psilocin analog, designed to treat chronic cluster headaches without hallucinations. Lobe retains 64% ownership in Cynaptec post-investment. The compound targets an orphan disease affecting 60,000+ US patients with no FDA-approved treatments. Additionally, Lobe is launching Altemia® Medical Food for Sickle Cell Disease, which affects 100,000 people in the US and 10M worldwide, particularly impacting African American children.

Positive

• Secured $6M investment for clinical trials with option for additional $20M
• Retains significant 64% ownership in Cynaptec Pharmaceuticals after spinout
• Targeting orphan disease market with 60,000+ US patients and limited competition
• Compound designed to work without hallucinations, improving safety profile
• Diversified portfolio with Altemia Medical Food targeting large SCD market of 10M patients globally

Negative

• Early-stage development with significant clinical trials ahead
• Faces competition from existing off-label treatments for cluster headaches
• Will require substantial additional funding for Phase 3 trials

• New subsidiary, Cynaptec Pharmaceuticals, established to hold global rights to Conjugated Psilocin™

• $6 million investment in Cynaptec Pharmaceuticals secured to advance research and early-stage clinical trials for chronic cluster headaches and addiction

• Option for an additional $20 million investment in Cynaptec Pharmaceuticals to support Phase 3 clinical development

VANCOUVER, BRITISH COLUMBIA / ACCESS Newswire / June 17, 2025 / Lobe Sciences Ltd., (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) a leading biopharmaceutical company focused on breakthrough treatments for rare diseases, is advancing the development of its novel compound, Conjugated Psilocin™, following the April 14, 2025 spinout of the compound to the newly created Delaware corporation Cynaptec Pharmaceuticals, Inc. and signing of a key US$6 million investment non-brokered private placement agreement for preferred shares in Cynaptec Pharmaceuticals.

This funding supports preclinical research, Phase 1, and Phase 2a clinical trials as Lobe Sciences Ltd., via Cynaptec Pharmaceuticals, progresses toward new treatment options for chronic cluster headaches, one of the most painful neurological conditions and considered an Orphan Disease. In addition, an option for a further US$20 million investment remains available, which would support the Phase 3 clinical program. Chronic cluster headache affects over 60,000 people in the United States. Currently, there is no FDA-approved drug specifically for chronic cluster headaches. The only FDA-approved medication for clusterheadaches is Emgality (galcanezumab-glnm), but it is indicated only for episodic cluster headaches, not the chronic form. For chronic cluster headaches, treatment typically involves off-label use of medications such as verapamil at very high and potentially dangerous doses, lithium, corticosteroids, and oxygen therapy.

As part of this strategy, Lobe launched Cynaptec Pharmaceuticals, Inc., a Delaware-based private subsidiary now holding the worldwide rights and intellectual property for Conjugated Psilocin™. Lobe transferred all relevant IP and commercial agreements to Cynaptec while retaining a 64% ownership stake after the initial $6 million investment.

Conjugated Psilocin™ is a stable, oral analog of psilocin (the active component of psilocybin) designed to deliver enhanced bioavailability and effectiveness without hallucinations. While the primary focus is treating chronic cluster headaches, ongoing research is also exploring its potential for substance use disorders, expanding its impact.

Lobe Sciences Ltd. is also advancing the introduction of Altemia® Medical Food, a specially formulated oral emulsion designed to address long-chain fatty acid deficiencies commonly seen in Sickle Cell Disease (SCD). SCD affects approximately 100,000 people in the United States and an estimated 10 million worldwide. African American children are disproportionately impacted, with 1 in every 365 African American births affected by the disease. Middle Eastern and South Asian populations also face a heightened risk. Altemia Medical Food has undergone clinical testing, demonstrating its ability to positively impact fatty acid imbalances in patients with SCD, potentially improving overall health. Currently, few treatment options exist for hematologists managing this condition, making Altemia® a promising new approach. This first-of-its-kind medical food is available only under physician supervision, ensuring proper dietary management for those in need. Lobe Sciences Ltd. remains committed to expanding access to innovative solutions for underserved patient populations.

About Lobe Sciences, Ltd. (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) - Lobe Sciences is a biopharmaceutical company focused on using lipid technology to develop innovative treatments for orphan and rare diseases. Lobe Sciences commercializes Altemia® MF, a medical food designed to manage deficiencies commonly found in sickle cell disease. Additionally, through Cynaptec, Lobe Sciences retains an interest in developing Conjugated Psilocin^TM in neurology and psychiatric indications. Alera Pharma, Inc. remains a wholly owned subsidiary of the Company that Lobe Sciences may elect to utilize for future activity unrelated to Conjugated Psilocin^TM.

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 Conjugated Psilocin^TM 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.

About Conjugated Psilocin^TM- Conjugated Psilocin^TM is a novel, patented, oral, stable analog of psilocin, the active metabolite of the prodrug psilocybin, 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, Conjugated Psilocin's™ 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.

About Altemia® Medical Food - Altemia Medical Food is a specially formulated emulsified blend of long-chain polyunsaturated fatty acids designed for oral administration in patients with Sickle Cell Disease. As a medical food, Altemia must be prescribed under the care of a physician to ensure appropriate dietary management. Its formulation includes natural emulsifying agents such as egg yolk and Vitamin E, which aid in restoring red blood cell membrane fatty acids. Clinical studies have demonstrated that Altemia Medical Food can help address the fatty acid imbalance frequently observed in Sickle Cell Disease, potentially improving patient health outcomes. With limited treatment options available to hematologists for managing this condition, Altemia provides a promising new approach to supporting individuals affected by this debilitating disease.

For further information:

Dr. Fred D. Sancilio, CEO
Lobe Sciences Ltd.
Investor and Media
Info@Lobesciences.com
Phone: +1 (949) 505-5623

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 intention to raise funds for clinical trials, the innovativeness of Conjugated Psilocin^TM. the anticipated focus and timing or efficiency of the Company's research and development activities; the potential for the Company's products to meet unmet medical needs, the anticipated use of proceeds from the offering, the intended development plans for Cynaptec, the intention of Lobe Sciences to provide certain services to Cynaptec, the potential exercise of the option and intended use of proceeds therefrom and the potential ability to raise funds for clinical development 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: the Company's planned activities will be able to create shareholder value and address serious unmet medical needs; the Company will continue to pursue its planned research and development activities, and that the Company will be able to raise funds 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: the Company's planned activities will be unable to create shareholder value or address the targeted unmet medical needs; the Company is unable to obtain the desired results from its current research and development activities; and the Company is unable to raise funds or to 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.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS NEWS RELEASE.

SOURCE: Lobe Sciences Ltd.

View the original press release on ACCESS Newswire

FAQ

What is the purpose of LOBEF's Conjugated Psilocin compound?

Conjugated Psilocin is designed to treat chronic cluster headaches without hallucinations, targeting an orphan disease affecting over 60,000 people in the US with no FDA-approved treatments.

How much funding did Lobe Sciences secure for Cynaptec Pharmaceuticals?

Lobe Sciences secured $6 million in initial investment with an option for an additional $20 million to support Phase 3 clinical development.

What percentage of Cynaptec does Lobe Sciences (LOBEF) retain after the spinout?

Lobe Sciences retains a 64% ownership stake in Cynaptec Pharmaceuticals after the initial $6 million investment.

What is Lobe Sciences' Altemia Medical Food designed to treat?

Altemia Medical Food is designed to address long-chain fatty acid deficiencies in Sickle Cell Disease, affecting 100,000 people in the US and 10 million worldwide.

What are the current treatment options for chronic cluster headaches?

Current treatments include off-label use of medications like verapamil, lithium, corticosteroids, and oxygen therapy, with Emgality approved only for episodic cluster headaches.