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Phase 1 results demonstrate that SUL-238, a first-in-class, orally administered, mitochondria-directed drug candidate, is safe and well-tolerated in healthy elderly volunteers, showing a favourable pharmacokinetic profile and high brain penetration. These findings support the advancement of SUL-238 into further clinical development for Alzheimer’s and other neurodegenerative diseases.

ANKARA, TR / ACCESS Newswire / July 28, 2025 / GEN Pharmaceuticals (GENIL.IS), Türkiye’s leading specialty pharmaceutical company, announced positive results from its Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of first-in-class and novel orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were presented at the Alzheimer’s Association International Conference 2025 (AAIC^®) in Toronto.

This single oral ascending dose (SAD) Phase 1, first-in-human, randomized, double-blind, placebo-controlled study was conducted in three parts, involving a total of 53 healthy elderly adults. Part 1 included 6 cohorts (50, 100, 250, 500, 1000, and 2000 mg orally, n=23). In Part 2, the PK of a single 1000 mg oral dose was investigated in 10 healthy elderly adults. In Part 2B, the food effect was assessed using a randomized, single oral 2000 mg dose, two-treatment, two-period, crossover design (n=20).

The trial results showed that single oral doses of 50-2000 mg of SUL-238 were safe and well-tolerated, while demonstrating a favourable PK profile and high cerebrospinal fluid (CSF) penetration. These findings make SUL-238 a promising candidate for further clinical development in neurodegenerative diseases, including Alzheimer’s disease.

No adverse effects (AEs) limited dose escalation, AE rates were comparable between SUL-238 and placebo, and all AEs were mild or moderate. The mean terminal elimination half-life was 0.86-3.80 hours, and the time to maximum plasma concentration was 0.50-1.39 hours. Under fed conditions, maximum plasma concentration (C_max) and area under the plasma concentration-time curve (AUC_0-∞) decreased by 50% and 60%, respectively. CSF-to-plasma percentages at 2 and 8 hours post-dose were 21.1% (±6.6%) and 74.2% (±46.0%).

Abidin Gülmüş, Chairman of GEN, stated:
“We are very encouraged by these promising first-in-human results, marking an important step forward in our mission to address the underlying biology of Alzheimer’s disease.”

Nadir Ulu, MD, PhD, Vice President of R&D at GEN, added:
“With its excellent safety and PK profile in this Phase 1 trial, combined with robust preclinical data, SUL-238 represents a strong candidate for further clinical development to meet the critical unmet needs in neurodegenerative diseases, including Alzheimer’s disease.”

About SUL-238
SUL-238 is a novel, first-in-class, hibernation-derived small molecule that targets mitochondria, the cell’s “powerhouse.” It supports mitochondrial bioenergetics via complex I/IV activation and has improved mitochondrial function in rodent models of neurodegenerative, cardiovascular, and renal diseases, as well as aging. SUL-238 crosses the blood-brain barrier and has undergone extensive safety evaluation in preclinical and Phase 1 studies. GEN licenses SUL-238 from Sulfateq BV for neurodegenerative disease applications.

About GEN:
Founded in 1998, GEN is Türkiye’s leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas. GEN manufactures high-quality, competitive products at its GMP-certified facility and pursues original drug development through two dedicated R&D centers and investments.

About Sulfateq:
Sulfateq B.V. is an early-stage Dutch biotech company that fosters strategic collaborations with academic and industrial research centers to accelerate the development of innovative new medicines. It has developed a novel class of small molecules, the SUL-compounds, that maintain mitochondrial health.

For more information:
www.genilac.com.tr
www.sulfateqbv.com

SOURCE: GEN İlaç ve Sağlık Ürünleri A.Ş.

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Conversation will feature visionary crypto leaders  Ryan Zurrer of Dialectic, Robert Leshner of Superstate, and Rhydon Lee of Goff Capital

FRISCO, TEXAS / ACCESS Newswire / July 28, 2025 / GameSquare Holdings, Inc. (NASDAQ:GAME) provides a link for its previously announced livestream on July 29, 2025 at 12:00 p.m. ET. The livestream will feature Justin Kenna, CEO of GameSquare, alongside its newest advisors and investors, a collective of the most forward-thinking leaders in decentralized finance:. Ryan Zurrer, Founder of Dialectic AG, Robert Leshner, CEO of Superstate, and Rhydon Lee of Goff Capital.

Tomorrow’s discussion comes at a pivotal moment for GameSquare, as the company accelerates its push into crypto with a series of bold, strategic moves. In just a matter of weeks, GameSquare has partnered with Dialectic, announced plans to scale its ETH treasury to $250 million, and acquired the Cowboy Ape, one of the most iconic CryptoPunks in a headline-grabbing deal that underscored the company’s belief in the long-term cultural and financial value of digital assets. These decisions aren’t isolated plays; they reflect GameSquare’s broader commitment to bringing digital-native fluency to public markets, with an approach rooted in culture, credibility, and strategic execution.Kenna, Zurrer, Leshner and Lee will provide a transparent, front-row look at the Company’s strategy, unpack the thinking behind these latest moves and explain what sets GameSquare apart from other public companies deploying ETH treasury strategies.

One of the key messages that the team will relay in tomorrow’s livestream is that GameSquare isn’t just another ETH treasury company. Since its inception in 2020, it’s created a core business that was built by connecting mainstream players to digital native audiences and educating the traditional marketplace on internet culture. A true market leading digital company, GameSquare provides services across advanced technology and data solutions, internet-first creative and production agencies, and the development and execution of authentic content and live experiences that uniquely serve internet-native audiences. The reason GameSquare has progressed their financial strategy into crypto is because it is a natural expansion of the Company’s current ecosystem that is truly authentic.

The livestream can be accessed at https://event.choruscall.com/mediaframe/webcast.html?webcastid=1zuS67xu and is also available at https://investors.gamesquare.com/events-and-presentations/events/default.aspx.

About GameSquare Holdings, Inc.

GameSquare (NASDAQ:GAME) is a cutting-edge media, entertainment, and technology company transforming how brands and publishers connect with Gen Z, Gen Alpha, and Millennial audiences. With a platform that spans award-winning creative services, advanced analytics, and FaZe Clan, one of the most iconic gaming organizations, we operate one of the largest gaming media networks in North America. Complementing our operating strategy, GameSquare operates a blockchain-native Ethereum treasury management program designed to generate onchain yield and enhance capital efficiency, reinforcing our commitment to building a dynamic, high-performing media company at the intersection of culture, technology, and next-generation financial innovation.

To learn more, visit www.gamesquare.com.

Forward-Looking Statements:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the Company’s future performance, revenue, growth and profitability; and the Company’s ability to execute on its current and future business plans. These forward-looking statements are provided only to provide information currently available to us and are not intended to serve as and must not be relied on by any investor as, a guarantee, assurance or definitive statement of fact or probability. Forward-looking statements are necessarily based upon a number of estimates and assumptions which include, but are not limited to: the Company’s ability to grow its business and being able to execute on its business plans, the success of Company’s vendors and partners in their provision of services to the Company, the Company being able to recognize and capitalize on opportunities and the Company continuing to attract qualified personnel to supports its development requirements. These assumptions, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: the Company’s ability to achieve its objectives, the Company successfully executing its growth strategy, the ability of the Company to obtain future financings or complete offerings on acceptable terms, failure to leverage the Company’s portfolio across entertainment and media platforms, dependence on the Company’s key personnel and general business, economic, competitive, political and social uncertainties. These risk factors are not intended to represent a complete list of the factors that could affect the Company which are discussed in the Company’s most recent MD&A. There can be no assurance that forward-looking 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 the forward-looking statements and information contained in this news release. GameSquare assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

GameSquare Corporate Contact
Lou Schwartz, President
Phone: (216) 464-6400
Email: ir@gamesquare.com

GameSquare Investor Relations
Andrew Berger
Phone: (216) 464-6400
Email: ir@gamesquare.com

GameSquare Media Relations
Chelsey Northern / The Untold
Phone: (254) 855-4028
Email: pr@gamesquare.com

SOURCE: GameSquare Holdings, Inc.

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