Peer-reviewed Phase 2 Results Inform Ongoing Phase 3/Pivotal Trial of Celeste® in Parkinson’s Disease

PhotoPharmics, Inc. today announced the peer-reviewed publication of results from its Phase 2 randomized, double-blind, controlled clinical trial evaluating Celeste®, an investigational photo-neuromodulation device, in people living with Parkinson’s disease (PD). The study has been published in the journal Neurotherapeutics. Celeste® has been designated by the U.S. Food and Drug Administration as a Breakthrough Device.

The publication marks an important scientific milestone for the Company and contributes to the growing body of clinical evidence examining circadian-effective photo-neuromodulation in PD. The Phase 2 findings informed the design of the Company’s ongoing Phase 3/Pivotal trial, which is fully enrolled and expected to complete in Q2 2026.

The Phase 2 study evaluated daily photo-neuromodulation delivered via a patented spectral band of light frequencies designed to engage circadian pathways.  The trial assessed both motor and non-motor features in individuals with PD receiving standard-of-care therapies. Celeste was well tolerated over the six-month period, with no serious adverse events reported.

The study’s primary endpoint, change in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score, did not reach statistical significance (p = 0.074). The results nevertheless showed an 8-point between-group difference on the primary endpoint at six months, along with nominal statistical significance on selected secondary measures, including the Parkinson’s Disease Questionnaire-39 (PDQ-39) quality-of-life measure (5.7 points, p=0.038) and the MDS-UPDRS Parts I+II (4.0 points, p=0.037). These findings informed the decision to advance the program into a Phase 3/Pivotal trial.

“The Phase 2 study results provided critical learning that helped refine the design and powering of our Phase 3/Pivotal trial,” said Dan Adams, Chief Science Officer of PhotoPharmics. “That translational step is exactly what this stage of development is intended to accomplish.”

As noted by the study authors, daily photo-neuromodulation was well tolerated by participants, with no serious adverse effects reported, and the findings support further investigation in larger, double-blind studies. The full article is available via Neurotherapeutics at: (https://www.sciencedirect.com/science/article/pii/S1878747925002065).

“This peer-reviewed publication reflects our commitment to scientific rigor and transparent reporting,” said Kent Savage, Chief Executive Officer of PhotoPharmics. “The Phase 2 data provided a critical learning step for the program and directly informed the design of our Phase 3/Pivotal trial, expected to complete in Q2 2026.”

Phase 3 Trial Update

Building on insights from the Phase 2 trial, PhotoPharmics completed enrollment in October 2025 for its Phase 3/Pivotal trial evaluating Celeste®, an investigational photo-neuromodulation device, in people living with Parkinson’s disease. The trial is advancing according to protocol, with anticipated data collection through April 2026 and is designed to further evaluate long-term safety and clinical outcomes aligned with regulatory expectations.

Savage added, “Full enrollment in our Phase 3 trial reflects the strong engagement of the Parkinson’s disease community and our clinical partners. We look forward to sharing trial results when the trial concludes.”

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company advancing investigational technologies for neurodegenerative disorders. The Company is developing Celeste®, an investigational photo-neuromodulation device designated by the U.S. Food and Drug Administration as a Breakthrough Device, which is currently being studied in clinical trials involving people living with Parkinson’s disease.

PhotoPharmics’ clinical program includes a peer-reviewed Phase 2 randomized, controlled clinical trial and an ongoing Phase 3/Pivotal clinical trial expected to complete in Q2 2026. The Company’s approach is grounded in decades of circadian biology research and translational science.

The Company’s founders bring more than 30 years of experience in circadian and light-based therapies and previously developed specialized light solutions widely used for seasonal affective disorder and sleep disorders, which were acquired by Philips-Respironics in 2007.

PhotoPharmics is committed to delivering safe and rigorously evaluated solutions that address unmet needs in neurodegenerative disease. Learn more at www.photopharmics.com.

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Important Disclaimer

Celeste® is an investigational device and has not been authorized for marketing by the U.S. Food and Drug Administration.

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Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements regarding the design, conduct, timing, and expected results of PhotoPharmics’ clinical trials, including the ongoing Phase 3/Pivotal trial; future regulatory interactions; and continued clinical development activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those described. PhotoPharmics undertakes no obligation to update or revise any forward-looking statements, except as required by law.

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PR260120

PhotoPharmics, a clinical-stage medical device company developing photo-neuromodulation therapies for neurodegenerative diseases today announced the addition of two widely respected industry leaders to its Board of Directors: W. James W. Tozer, Jr. and Albert Agro, PhD. These appointments strengthen the company’s governance as it prepares for the data readout of its FDA pivotal study, regulatory clearances, global commercialization and industry partnerships.

New Board Members

• James W. Tozer, Jr., Series B Director, is a seasoned investor, banker, real estate developer, and corporate advisor with more than 30 years of operational and board experience. He is Managing Director and co-owner of Vectra Management Group, which he co-founded in 1993. Mr. Tozer is PhotoPharmics’ largest Series B investor and its second-largest investor overall, and brings extensive leadership across capital markets, governance, and organizational growth.
• Albert Agro, PhD, Independent Director, is the CEO of Jocasta Neuroscience Inc., advancing Klotho-based therapeutics for Alzheimer’s and Parkinson’s disease. He previously led clinical development at Cynapsus, co-running the M&A auction that resulted in Sunovion’s $850 million acquisition of sublingual apomorphine. His executive roles—including Sublimity Therapeutics, GRI Bio, Ironshore Pharma, Trillium Therapeutics, and others—span clinical development, regulatory leadership, fundraising, and strategic transactions.

Recognizing Prior Board Leadership

The company also acknowledges and thanks three continuing board members—Gavin Christensen, Kent Savage, and Dan Adams—for their foundational contributions during PhotoPharmics’ formative stages and vision for the future.

• Gavin Christensen — Kickstart Ventures, is Founder of Kickstart Ventures, a leading early-stage investor in the Mountain West with deep expertise in company formation, financing strategy, and operational scaling. Gavin is the Chair-elect of the National Venture Capital Association. His early guidance and governance has supported PhotoPharmics successful capital formation and execution across all areas of the business.
• Kent Savage — CEO and Co-Founder, is an inventor and successful serial entrepreneur who has led the company through early research, device development, regulatory strategy, and its transition towards commercialization. His vision has been instrumental shaping the Celeste® platform and organizing the world class teams to execute the company’s successes.
• Dan Adams — CSO and Co-Founder, is an experienced scientist and entrepreneur who guides the company’s scientific and clinical research strategy and execution. His decades of experience in field of specialized light and its effects on the human neuroendocrine system is the underpinning of the company’s successful IP and clinical programs and provides the vision for continued innovation.

“These board additions align perfectly with our upcoming milestones,” said Kent Savage, PhotoPharmics CEO. “Jim and Albert bring decades of experience in clinical development, corporate strategy, operational execution and international partnering —giving the company precisely the guidance it needs as we prepare for the results of our FDA pivotal study of our breakthrough device and the next phase of PhotoPharmics’ growth. We are equally grateful for our existing board members for building the foundation we stand on today and lighting our way to the future.”

Positioned for a Landmark Year

PhotoPharmics recently reported major milestones in its update to investors, including:

• 350 participants enrolled in the FDA pivotal, Light for PD trial
• Top-line results expected May 2026; FDA submission July 2026
• Engagement of top investment banks ahead of strategic partnering discussions
• A growing IP portfolio including 67 issued patents in 29 territories

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patient’s lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements regarding the design, conduct, timing, and expected results of the Light for PD clinical trial; the potential safety, efficacy, and benefits of the Celeste® device; and future regulatory submissions or approvals. These statements are based on current expectations, assumptions, and estimates and are subject to risks and uncertainties that could cause actual results to differ materially from those described. Such risks include, among others, the inherent uncertainties of clinical development, trial outcomes, regulatory review, and commercialization efforts. PhotoPharmics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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PR20251204

Renowned leaders in neurology, movement disorders, and commercialization join to shape Celeste® market strategy

PhotoPharmics, the leader in specialized phototherapy for neurodegenerative diseases, announced the formation of its Commercial Advisory Board (CAB), uniting top experts in neurology, movement disorders, pharmaceutical and medtech commercialization. The board will provide strategic guidance as the company advances toward regulatory submission and market introduction of Celeste®, its FDA Breakthrough device for Parkinson’s disease.

“We’re entering a decisive stage where market readiness is as critical as clinical success,” said Kent Savage, CEO of PhotoPharmics. “This board brings unmatched expertise to help us navigate pricing, access, and adoption strategies that will get Celeste to the people who need it most.”

“Celeste has the potential to fill a critical gap in Parkinson’s care by addressing symptoms in a completely new way,” said Jordan Dubow, MD, Chair of this new board. “Our role on the Commercial Advisory Board is to ensure that people with Parkinson’s, know the therapeutic device is available and have access to the device when FDA grants market authorization.”

The CAB brings together a multidisciplinary team of leaders with deep experience in clinical practice, research, regulatory strategy, market access, and product commercialization. Their combined expertise spans movement disorders, neurology, health economics, and the launch of innovative therapies worldwide. Together, they will help ensure Celeste’s transition from clinical breakthrough to market is both efficient and impactful.

• Jordan Dubow, MD – Chair, PhotoPharmics Commercial Advisory Board; Managing Principal, Clintrex Research, LLC (a division of BlueRidge Life Sciences). Fellowship-trained movement disorders and vascular neurologist with more than 20 years of clinical trial and industry leadership experience; served as chief medical officer for over a dozen companies, contributed to 20+ new drug applications, and helped raise over $1 billion through investor engagement.
• Jill Giordano Farmer, DO, MPH, FCPP, DipABLM – Founder & Owner Boro Neurology, Assistant Professor of Neurology Drexel College of Medicine. Board-certified neurologist who established a comprehensive movement disorders and lifestyle medicine program, integrating medical, surgical, and rehabilitation care, creating a multidisciplinary clinic without walls.
• Drew Falconer, MD, FAAN – Director, Inova Parkinson’s and Movement Disorders Center; Associate Professor of Neurology, UVA School of Medicine – Inova campus. Specializes in the diagnosis and management of Parkinson’s disease and related disorders, with expertise in deep brain stimulation and botulinum toxin therapy. Speaks nationally on various topics in Movement Disorders and is a respected national educator in Parkinson’s Disease and DBS.
• Robert A. Hauser, MD, MBA, FAAN – Professor of Neurology, University of South Florida; Chair, PhotoPharmics Clinical and Scientific Advisory Board. Internationally recognized researcher and Director of the USF Parkinson’s Disease & Movement Disorders Center; authored over 300 publications and is a leader in developing novel Parkinson’s therapies.
• Rajesh Pahwa, MD, FAAN – Laverne and Joyce Rider Professor of Neurology; Chief, Parkinson’s and Movement Disorder Division; Director, Parkinson Foundation Center of Excellence, University of Kansas Medical Center. Board-certified neurologist who has led numerous clinical trials advancing Parkinson’s disease care.
• Philip Cyr, MPH – Senior Vice President, Pharmaceutical Commercialization Practice, BlueRidge LifeSciences. More than 30 years of experience in clinical development, market access, and health economics; leads commercialization strategies for pharmaceuticals, biologics, cell and gene therapies and digital therapeutics worldwide.
• Michael Soileau, MD, FAAN – Founder, Texas Movement Disorder Specialists; Clinical Asst Professor, Texas A&M School of Medicine, Director, Huntington’s Disease Society of America Center of Excellence Partner Site. Frequent principal investigator in clinical trials for Parkinson’s disease, essential tremor, and other movement disorders, leading a multidisciplinary care team in central Texas.

“The formation of this board ensures our commercialization pathway is informed by leaders who understand the science, the market, and the patients whom we aim to serve,” Savage added.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation therapies for treating neurodegenerative disorders through the eyes. Company founders individually have 30+ years of research and experience in this field. They previously developed specialized light solutions, now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

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PR250828