LTS and Nualtis sign Business Development Term Sheet to Advance Montelukast Oral Thin Film for Parkinson’s and Alzheimer’s Disease

DATE

October 8, 2025

Transforming a Proven Molecule for New Therapeutic Applications

The development programs for the two indications repurpose Montelukast, a well-established anti-inflammatory medication, using Nualtis’ proprietary VersaFilm® oral thin film technology. This innovative delivery approach offers significant advantages for patients with neurological conditions/disease, including ease of administration, rapid dissolution, and improved medication adherence, particularly important for patients experiencing swallowing difficulties or cognitive impairment.

The two distinct development programs are currently advancing through Phase 2 clinical trials:

Montelukast PD targets neuroinflammation in Parkinson’s disease patients, with the potential to become the first disease-modifying therapy delivered via oral thin film. The program is evaluating the drug’s ability to slow disease progression while improving motor and non-motor symptoms.
Montelukast AD is being developed for Alzheimer’s disease, where preclinical and early clinical data suggest Montelukast may help preserve cognitive function and reduce neuroinflammatory markers associated with disease progression.

With over 10 million people worldwide living with Parkinson’s disease and more than 55 million affected by Alzheimer’s disease, the market opportunity for effective treatments is substantial and growing. Nualtis and LTS are actively seeking a commercial partner to maximize global patient access.

“This expanded collaboration with LTS represents a pivotal milestone in our mission to transform how neurological diseases are treated,” said Dr. Michael Raven, CEO of Nualtis. Jeremy Ordemann, SVP Strategy & Commercial Excellence at LTS, added: “We are excited to deepen our partnership with Nualtis on these groundbreaking programs. The potential of delivering Montelukast through advanced oral film technology exemplifies the type of innovation that can make a real difference in patients’ lives.”

About LTS Lohmann Therapie-Systeme AG
We CARE. We CREATE. We DELIVER. The driving philosophy behind LTS. As a trusted technology partner for the pharmaceutical industry, we develop and manufacture innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) as well as wearable drug delivery devices (“OBDS”). LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Microneedle Array Patches (“MAP”) for the transdermal delivery of small and large molecules, biological actives and vaccines. With its SorrelTM wearable drug delivery platform LTS offers patient friendly solutions for complex drugs delivery at home. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS has also a representative office in Shanghai, China.

About Nualtis Corp.
Nualtis is a specialty pharmaceutical company advancing innovative drug delivery technologies with a focus on oral thin film (OTF) pharmaceutical products. Nualtis’ superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. Nualtis’ innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. Building on more than a decade of formulation and manufacturing expertise, Nualtis supports pharmaceutical partners in extending product lifecycles and accelerating development timelines. Headquartered in Montreal, the company offers a fully integrated platform that includes research and development, analytical services, regulatory support, and scalable manufacturing from lab to market. With a patient centered approach and a focus on execution excellence, Nualtis delivers smart solutions that meet real world therapeutic needs. Nualtis is a wholly owned subsidiary of atai Life Sciences. For more information, visit www.nualtis.com or connect with us on LinkedIn and X.