SAN DIEGO, July 30, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies, today announced that sasineprocel (ANPD001), its lead investigational product, for the treatment of Parkinson’s Disease (PD) was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).

RMAT designation provides increased FDA guidance and expedited development support, including potential eligibility for priority review and accelerated approval pathways for regenerative therapies that are deemed to be transformative. Aspen previously received FDA Fast Track designation for sasineprocel. These designations underscore its clinical promise, innovative iPSC-derived cell therapy platform, and the potential to modify the course of PD.

The RMAT designation for sasineprocel is based on results from the ongoing Phase 1/2a ASPIRO trial*, which has demonstrated encouraging early clinical activity and a favorable safety profile. The ASPIRO study is an open-label, multicohort, multicenter trial evaluating the safety, tolerability and activity of the surgical delivery of autologous dopaminergic neuron precursor cells (DANPCs) into the putamen, the part of the brain where restoration of dopamine signaling is needed.

“This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” said Damien McDevitt, Ph.D., president and chief executive officer of Aspen Neuroscience. “We stand with the Parkinson’s community realizing the urgency around the serious and growing unmet need in PD and are unwavering in our commitment to bring sasineprocel to patients as soon as possible.”

“FDA has created this collaborative regulatory framework to facilitate early and frequent interactions, align on development requirements and potentially support more efficient pathways to approval,” said Ana Sousa, chief regulatory officer. “Our team is working tirelessly to advance this investigational therapy designed to regenerate neural networks and restore lost neuronal function with the vision to potentially improve motor function, enhance quality of life, and reverse disease progression for patients.”

What is RMAT Designation?

The Regenerative Medicine Advanced Therapy (RMAT) designation was established under the 21st Century Cures Act to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious conditions. To qualify, a product must show preliminary clinical evidence indicating its potential to address unmet medical needs. RMAT designation offers sponsors benefits such as early and frequent FDA interactions, potential eligibility for priority review, and potential accelerated approval.

About Aspen Neuroscience

Aspen Neuroscience is a leading, clinical-stage regenerative medicine biotechnology company developing autologous induced pluripotent stem cell-derived (iPSC) therapies beginning with neurodegenerative diseases of high unmet need including PD.

Its lead product candidate is sasineprocel (ANPD001), the most advanced autologous investigational cell therapy in the United States for treating PD.

About Sasineprocel (ANPD001)

Sasineprocel is a single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by replacing a patient’s lost dopaminergic (DA) neurons with DANPCs and aiming to reconstruct the underlying neural circuitry lost in the progression of disease.

Specifically, sasineprocel is created from a patient’s own cells via a small skin punch biopsy, reprogrammed to iPSCs (turning back the biological clock of the cells to a pre-disease state), and differentiated into DANPCs. Our proprietary cell composition is then delivered via image-guided administration to the putamen, the part of the brain where restoration of dopamine signaling is needed.

This approach is designed to establish a biologically active cellular microenvironment that supports engraftment, survival and functional integration of the transplanted cells to achieve durable clinical benefits for PD patients with the goal of slowing or halting disease progression.

Since it is autologous (using a patient’s own cells), immunosuppression, which is required for donor-derived (allogeneic) cell therapies, is not needed.

For more information, visit www.aspenneuroscience.com.

* Funding for Cohorts 1 and 2 provided by the California Institute for Regenerative Medicine (CIRM), a state of California agency that supports regenerative medicine, stem cell, and gene therapy research.

CONTACT:

Sam Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

Advancement of commercial-ready formulation supports scalability and late-stage development

SAN DIEGO, June 30, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies, today announced completion of dosing in Cohort 3 and Cohort 4 of its ongoing Phase 1/2a ASPIRO clinical trial evaluating sasineprocel (ANPD001) for the treatment of Parkinson’s disease (PD).

With the completion of these cohorts, a total of 15 patients have been dosed in the ASPIRO study to date, representing one of the largest clinical experiences reported for an autologous cell therapy in Parkinson’s disease.

Cohorts 3 and 4* utilize Aspen’s commercial-ready formulation of sasineprocel designed to support scalable, reproducible manufacturing and streamlined clinical delivery. This formulation incorporates a cryopreserved “thaw-and-inject” drug product, enabling cells to be administered upon arrival at the clinical site and increasing procedural efficiency.

“We are proud to reach this important milestone, which reflects meaningful progress in the sasineprocel program and underscores the growing clinical experience with our personalized, autologous approach,” said Damien McDevitt, Ph.D., President and Chief Executive Officer of Aspen Neuroscience. “Importantly, the use of our commercial formulation in these cohorts represents a critical step toward scalable manufacturing and commercial readiness as we prepare for Phase 3 initiation.”

The ASPIRO study is an open-label Phase 1/2a clinical trial designed to evaluate the safety, tolerability, and potential efficacy of sasineprocel, an autologous induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell (DANPC) therapy. Sasineprocel is designed to replace and restore damaged neural circuitry in patients with Parkinson’s disease without the need for immunosuppressive therapy.

Aspen continues to progress key activities supporting late-stage clinical development, including manufacturing scale-out and process optimization aligned with future pivotal trial requirements.

About Aspen Neuroscience

Aspen Neuroscience is a leading, clinical-stage regenerative medicine biotechnology company developing autologous induced pluripotent stem cell-derived (iPSC) therapies beginning with neurodegenerative diseases of high unmet need including PD.

Its lead product candidate is sasineprocel (ANPD001), the most advanced autologous investigational cell therapy in the United States for treating PD.

About Sasineprocel

Sasineprocel is a single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by replacing a patient’s lost dopaminergic (DA) neurons with DANPCs and aiming to reconstruct the underlying neural circuitry lost in the progression of disease.

Specifically, sasineprocel is created from a patient’s own cells via skin biopsy, reprogrammed to iPSCs (turning back the biological clock of the cells to a pre-disease state), and differentiated into DANPCs. Our proprietary cell composition is then delivered via image-guided administration to the putamen, the part of the brain where restoration of dopamine signaling is needed.

This approach is designed to establish a biologically active cellular microenvironment that supports engraftment, survival and functional integration of the transplanted cells to achieve durable clinical benefits for PD patients with the goal of slowing or halting disease progression.

Since it is autologous (using a patient’s own cells), immunosuppression, which is required for donor-derived (allogeneic) cell therapies, is not needed. Sasineprocel has received Fast Track designation by the U.S. Food and Drug Administration (FDA).

For more information, visit www.aspenneuroscience.com.

* Cohorts 3 and 4 build on funding provided by the California Institute for Regenerative Medicine (CIRM), a state of California agency that supports regenerative medicine, stem cell, and gene therapy research, which enabled Cohorts 1 and 2.

CONTACT:

Sam Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

Experienced biotech legal executive strengthens leadership team as Aspen advances clinical development and prepares for Phase 3 growth   

SAN DIEGO, June 11, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies, today announced the appointment of Jeff Boerneke as General Counsel and Secretary. 

“Jeff joins Aspen at an important time for the company as we advance sasineprocel into Phase 3,” said Damien McDevitt, Ph.D., president and CEO of Aspen Neuroscience. “His experience with other leading biotech companies and distinguished leadership experience across corporate governance, financings, partnerships and compliance will be valuable as we continue to execute on our mission and scale the organization.” 

“I am excited to join Aspen Neuroscience at such a pivotal stage,” said Jeff Boerneke. “The company’s approach to developing personalized therapies for patients with Parkinson’s disease is compelling, and I look forward to supporting its continued growth and advancement.” 

Mr. Boerneke most recently served as Senior Vice President, General Counsel and Secretary at Gossamer Bio, where he was a member of the executive team and led all legal matters spanning corporate governance, public company reporting, financings, licensing and partnerships, intellectual property, and clinical and commercial contracting. He led Gossamer Bio’s 2019 initial public offering and most recently its global partnership with Chiesi.  

Prior to Gossamer Bio, Mr. Boerneke served as Corporate Counsel at Amgen, where he supported debt transactions, public company reporting, global subsidiary management and board governance. Earlier in his career, he was a corporate associate at Latham & Watkins LLP, advising on capital markets transactions, mergers and acquisitions, and licensing and commercial arrangements.  

Mr. Boerneke earned a Juris Doctor from UCLA School of Law and a B.S. in Chemistry from Point Loma Nazarene University.  

About Aspen Neuroscience

Aspen Neuroscience is a leading, clinical-stage regenerative medicine biotechnology company developing autologous induced pluripotent stem cell-derived (iPSC) therapies beginning with neurodegenerative diseases of high unmet need including Parkinson’s disease (PD).   

Its lead product candidate is sasineprocel (ANPD001), the most advanced autologous investigational cell therapy in the United States for treating PD.  

About Sasineprocel  

Sasineprocel is a single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by replacing a patient’s lost dopaminergic (DA) neurons with dopaminergic neuron precursor cells (DANPCs) and aiming to reconstruct the underlying neural circuitry lost in the progression of disease.    

Specifically, sasineprocel is created from a patient’s own cells via skin biopsy, reprogrammed to iPSCs (turning back the biological clock of the cells to a pre-disease state), and differentiated into DANPCs. Our proprietary cell composition is then delivered via image-guided administration to the putamen, the part of the brain where restoration of dopamine signaling is needed. 

This approach is designed to establish a biologically active cellular microenvironment that supports engraftment, survival and functional integration of the transplanted cells to achieve durable clinical benefits for PD patients with the goal of slowing or halting disease progression. 

Since it is autologous (using a patient’s own cells), immunosuppression, which is required for donor-derived (allogeneic) cell therapies, is not needed. 

Sasineprocel has received Fast Track designation by the U.S. Food and Drug Administration (FDA).    

For more information, visit www.aspenneuroscience.com.   

CONTACT:
Samantha Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

Results Show Continued Safety, Tolerability, and Sustained Clinical Benefit Including Improvements in Function, Physician- and Patient-Reported Outcomes, and Quality-of-Life  

This Personalized Autologous Cell Therapy Aims to Replace and Restore the Damaged Neural Circuitry in Parkinson’s Patients that Underpins Everyday Movement and Function, Without the Need for Immune Suppression 

SAN DIEGO, Mar. 18, 2026 /PRNewswire/ — Aspen Neuroscience, a clinical-stage regenerative medicine company developing autologous induced-pluripotent stem cell (iPSC)-derived therapies to initially address neurodegenerative diseases with high unmet medical need, today announced data from its ongoing Phase 1/2a ASPIRO* clinical trial in a late‑breaking oral presentation at the AD/PD^TM 2026 International Conference on Alzheimer’s and Parkinson’s Diseases, taking place March 17–21, 2026 in Copenhagen, Denmark. 

The presentation highlights 12‑month safety, tolerability, and efficacy data following delivery of Sasineprocel (ANPD001), an autologous induced pluripotent stem cell (iPSC)‑derived dopaminergic neuron precursor cell therapy (DANPC), in patients with Parkinson’s disease without requiring immune suppression or permanent implantable hardware. 

“These data support Aspen’s differentiated autologous approach and underscore the potential for sustained clinical benefit without the need for chronic immunosuppression,” said ASPIRO trial investigator Chad Christine, M.D., Professor of Neurology, University of California at San Francisco. “This regenerative cell therapy approach aims to not only restore dopamine levels in the brain, but also to replace and rebuild the neural circuitry essential for everyday movement and function, with the goal of slowing or halting disease progression.” 

The presentation represents data from the first eight treated patients – four of whom received a low dose and four of whom received a higher dose of the therapy. At twelve months, both dosing cohorts showed numerical improvements in function, physician- and patient-reported outcomes, and quality-of-life, including: mean Good ON time (+2.1 hours in low dose (LD), +2.4 hours in high dose (HD)), mean MDS-UPDRS III OFF scores (-15.5 points in LD, -13.5 points in HD), mean MDS-UPDRS II scores (-5.3 points in LD, -2.3 points in HD), and mean improvement in PDQ-39 scores (51.6% in LD, 28.5% in HD).   

Several patients had these improvements while also demonstrating LEDD (Levodopa equivalent daily dose) reductions. Additionally, FDOPA PET imaging shows cell survival and successful engraftment of Sasineprocel. 

No serious surgical adverse events and no severe graft-induced dyskinesia were observed. No symptomatic hemorrhages or infarctions were observed. Real-time intraoperative imaging confirmed accurate placement of DANPCs into the post-commissural putamen. 

“We’re very encouraged by these data showing improvements in function, physician- and patient-reported outcomes, and quality-of-life, and look forward to advancing Sasineprocel to a Phase 3 study later this year,” said Revati Shreeniwas, M.D., Chief Medical Officer, Aspen. “These findings support our approach of reprogramming a patient’s own cells to wind back the epigenetic clock to a pre‑disease state. Combined with precisely delivering our multi-cell composition to the putamen, we’re starting to see the positive clinical impact of rebuilding the neural networks damaged by this debilitating disease.”  

Late‑Breaking ASPIRO Data at AD/PD 2026 

Abstract Title: “Twelve-Month Safety, Tolerability, and Efficacy of Intracranial Delivery of Autologous iPSC‑Derived Dopaminergic Precursors (Sasineprocel) in Parkinson’s Disease”  

Date/Time: March 18, 2026, 3:45-4:00 p.m. CET 

Session Name: MODULATING NEUROINFLAMMATION, Α-SYNUCLEIN, LRRK2, AND DOPAMINERGIC REPAIR: EARLY HUMAN DATA  

About the ASPIRO Trial 

ASPIRO is a first-in-human, multi-patient, multi-center clinical trial of an autologous cell therapy for Parkinson’s disease. This Phase 1/2a open-label trial is evaluating safety, tolerability and preliminary efficacy of Sasineprocel (ANPD001) in PD patients aged 50–70.   

The study’s primary aim is to assess safety and tolerability of bilateral intracranial administration of autologous iPSC DANPCs into the post-commissural putamen. 

The study’s secondary aim is to evaluate change in clinician- and patient-reported PD-specific clinical outcomes.  

The product was derived from skin fibroblasts which were converted into iPSCs and then differentiated into DANPCs. Four patients received 5 million cells per hemisphere, and four patients received 5 million to 10 million cells per hemisphere, all under MRI guidance via occipital surgical approach. Clinical outcomes were assessed every six months after transplantation. 

More information about the Phase 1/2a trial is available at clinicaltrials.gov (NCT06344026). 

About Sasineprocel (ANPD001)  

Sasineprocel (ANPD001) is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease. Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against the foreign cells used in allogeneic cell therapy. This approach will eliminate IS-associated adverse events, IS drug-monitoring requirements and enable dosing for those with contraindications to IS therapies.  In addition, this approach will not require implanted permanent hardware. 

Aspen’s manufacturing process starts from a small biopsy of the patient’s own skin cells, followed by reprogramming to iPSCs, which rejuvenates the cells by turning back their biological clock to a pre-disease state. The iPSCs are then differentiated into DANPCs, which are transplanted into the posterior putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine-learning-based genomics tests.   

With this novel therapeutic approach, it is Aspen’s vision to address the core challenge of Parkinson’s disease: to not only restore dopamine levels in the brain but to also replace and restore the damaged neural circuitry that supports everyday movement and function—without the requirement of  immune suppression. Our investigational autologous cell therapy is designed to rebuild these neural networks with the goal to potentially slow or halt disease progression.  

Sasineprocel has received Fast Track designation by the U.S. Food and Drug Administration (FDA).  

For more information, visit www.aspenneuroscience.com.  

* The study was made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research (Grant Number CLIN2-15547). 

CONTACT:
Samantha Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

Approved for Use By both the World Health Organization’s International Nonproprietary Names (WHO-INN) and the American Medical Association’s United States Adopted Names (AMA-USAN) Council

SAN DIEGO, Mar. 12, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical‑stage biotechnology company pioneering autologous regenerative therapies, today announced that the World Health Organization (WHO) has published Sasineprocel as the International Nonproprietary Name (INN) for Aspen’s investigational therapy ANPD001, with clearance also from the American Medical Association’s United States Adopted Names (AMA-USAN) Council, pending publication.

Sasineprocel (ANPD001) is Aspen’s investigational autologous dopaminergic neuron precursor cell (DANPC) therapy derived from a patient’s own induced pluripotent stem cells (iPSCs) generated from a skin biopsy. It is designed as a neuron replacement approach for Parkinson’s disease and is delivered via image-guided intracranial administration to the putamen, without the need for immune suppression. Sasineprocel is being evaluated in Aspen’s Phase 1/2a ASPIRO study for moderate to advanced Parkinson’s disease.

“Earning global nonproprietary naming rights is an important milestone for Aspen’s  Parkinson’s disease program, marking our continued clinical and regulatory progress as we move toward planned commercialization. We are committed to bringing Sasineprocel to the people living with Parkinson’s disease who are awaiting transformative therapies with the potential to slow or stop the progression of this devastating disease,” said Damien McDevitt, Chief Executive Officer, Aspen.

The USAN program and WHO’s INN Expert Group assigns simple, informative and unique nonproprietary names for drugs to identify chemical/pharmacological relationships and ensure clarity in medical communication. 

About Sasineprocel (ANPD001)
Sasineprocel (ANPD001) is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease. Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against foreign cells. This approach will eliminate IS-associated adverse events, IS drug-monitoring requirements, and enable dosing for those with contraindications to IS therapies. 

Aspen’s manufacturing process starts from a small biopsy of the patient’s own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the posterior putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine-learning-based genomics tests. 

Sasineprocel has received Fast Track designation by the U.S. Food and Drug Administration (FDA).

For more information, visit www.aspenneuroscience.com. 

CONTACT:
Samantha Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

Facility Enters Qualification to Support Late‑Stage Pivotal Manufacturing and Commercial Readiness 

SAN DIEGO, Jan. 8, 2026 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical‑stage biotechnology company pioneering autologous regenerative therapies, today announced completion of Cohort Three* dosing in the company’s ASPIRO Phase 1/2a trial of ANPD001, a personalized dopaminergic neuronal precursor cell (DANPC) therapy for moderate to advanced Parkinson’s disease (PD). The company also announced the completion of construction of its current GMP manufacturing build‑out in San Diego. 

“Cohort Three dosing marks a meaningful inflection point for Aspen. With dosing complete and our facility build‑out finished and entering qualification, we are positioned to move decisively into late‑stage development while preserving the personalized quality that defines autologous medicine,” said Damien McDevitt, Ph.D., President & Chief Executive Officer.  

Cohort Three: Commercial‑Ready Formulation and Streamlined Clinical Workflow 
Cohort Three used Aspen’s commercial formulation of ANPD001, designed to support scalable, reproducible manufacturing and a cryopreserved “thaw‑and‑inject” drug product that enables cells to be ready for dosing upon arrival at the institution—streamlining surgical procedures and minimizing impact on hospital cell processing labs. 

Manufacturing Build‑Out Completed 
The North Torrey Pines manufacturing facility expansion project brings the total facility size to nearly 22,000 sq. ft. The facility’s new state-of-the-art ISO 7 automated manufacturing cleanroom suites and ISO 8 support areas provide advanced environmental controls essential for high-quality cell therapy production, ensuring product integrity and supporting Aspen’s late-stage clinical and commercial manufacturing needs. These new cleanroom suites serve as a template for future automated facility build-outs and support increased manufacturing capacity.

“Guided by Aspen’s vision to transform the lives of people living with Parkinson’s disease, this world-class facility represents a bold step forward in delivering personalized, life-changing therapies,” said Kim Raineri, Chief Technology Officer. “This facility also serves as our template for future scale-out. By building a model for automation, we gain valuable insight into the additional technological advances that will be used to further increase efficiency and scalability in our state-of-the-art manufacturing process.”  

Building on Cohort One & Two Progress 
Data reported from earlier cohorts at six months have demonstrated safety and tolerability, with clinician‑ and patient‑reported improvements, achieved without the need for immunosuppression, consistent with Aspen’s autologous approach.  

In January 2025, Aspen announced completion of the first two cohorts and dose escalation, confirming continued progress of the ASPIRO study and the transition toward the commercial formulation employed in Cohort Three. 

About ANPD001 
ANPD001 is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease.  

Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against foreign cells. This approach will eliminate IS-associated adverse events, IS drug-monitoring requirements, and enable dosing for those with contraindications to IS therapies. 

Aspen’s manufacturing process starts from a small biopsy of the patient’s own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the posterior putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine-learning-based genomics tests. 

ANPD001 has received Fast Track designation by the U.S. Food and Drug Administration (FDA).  

About the ASPIRO Trial 
ASPIRO is the first multi-patient, multi-center clinical trial of an autologous cell therapy for Parkinson’s disease. It is evaluating safety, tolerability, and preliminary efficacy of ANPD001 in levodopa-responsive patients aged 50–70. Primary endpoints will be reported at 12 months, with long-term follow-up extending to 15 years.

More information about the Phase 1/2a trial is available at clinicaltrials.gov (NCT06344026) 

For more information, visit www.aspenneuroscience.com. 

* Cohort Three builds on funding provided by the California Institute for Regenerative Medicine (CIRM), a state of California agency that supports regenerative medicine, stem cell, and gene therapy research, which enabled Cohorts 1 and 2. 

CONTACT:
Samantha Murphy
SVP, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

SAN DIEGO, Jan.7, 2025 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical‑stage biotechnology company pioneering autologous regenerative therapies, today announced two executive leadership appointments: Revati Shreeniwas, M.D., FCCP has joined Aspen as Chief Medical Officer (CMO), and Lisa Johnson‑Pratt, M.D., who has been leading Aspen’s therapeutic program strategy for ANPD001, will transition into the role of Chief Commercial Officer (CCO). These moves strengthen Aspen’s late‑stage development and commercial readiness for its autologous iPSC‑derived cell therapy for Parkinson’s disease. 

“These leadership updates underscore Aspen’s evolution. Filling both the Chief Medical Officer and Chief Commercial Officer roles now is about one thing: patients,” said Damien McDevitt, Ph.D., President & Chief Executive Officer. “We’re bringing together seasoned leaders who know how to move programs from the clinic to the market with integrity and purpose. Revati’s late‑stage clinical development expertise and Lisa’s end‑to‑end clinical and commercial track record position Aspen for commercial readiness to deliver on our mission for people living with Parkinson’s.” 

Proven leadership focused on patient impact 
Dr. Shreeniwas brings more than 20 years of experience in global clinical development, with leadership across 40+ clinical trials and multiple registrational programs where she has advanced assets from early stage/IND through global approvals. Her experience spans neurology and neurodegeneration in the CNS arena and includes contribution to the approval and commercialization of therapies such as RYTARY® (Parkinson’s disease), SUNOSI®, Esbriet®, and TRACLEER®.

Dr. Johnson‑Pratt is an industry leader with more than two decades of experience across the full product life cycle. She has led clinical development, medical affairs, new product strategy, and in-line commercialization including global launch teams at top companies including Merck, GSK, Akcea, and Ionis. Her record includes leading commercial activities in the U.S., globally and in international markets. In her roles she has shaped the value strategy and supported best-in-class market development for innovative therapeutics including IMITREX®, FOSAMAX®, GARDASIL®, SINGULAIR®, BLENREP, and WAINUA®.

Her contributions have led to significant corporate advancements to create employee, shareholder and patient value.  

Keeping patients at the center 
“As ANPD001 progresses toward late‑stage development, we are building a commercialization framework that keeps patients at the center—preparing the market, engaging stakeholders, and ensuring the infrastructure is ready to bring our personalized, regenerative cell therapy to the patients and families who are waiting,” said Lisa Johnson‑Pratt, M.D., Chief Commercial Officer.

“Aspen’s autologous iPSC‑derived approach is redefining what’s possible in neurodegenerative disease. I’m excited to help deliver a rigorous registrational program for Parkinson’s patients, partnering across clinical, regulatory, technical operations, and medical affairs,” said Revati Shreeniwas, M.D., FCCP, Chief Medical Officer.  

About ANPD001 
ANPD001 is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease. More information about the Phase 1/2a trial is available at clinicaltrials.gov (NCT06344026). 

Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against foreign cells. This approach will eliminate IS-associated adverse events, IS drug-monitoring requirements, and enable dosing for those with contraindications to IS therapies. 

Aspen’s manufacturing process starts from a small biopsy of the patient’s own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the posterior putamen, replacing cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine-learning-based genomics tests. 

ANPD001 has received Fast Track designation by the U.S. Food and Drug Administration (FDA).  

About the ASPIRO Trial 
ASPIRO is the first multi-patient, multi-center clinical trial of an autologous cell therapy for Parkinson’s disease. It is evaluating safety, tolerability, and preliminary efficacy of ANPD001 in levodopa-responsive patients aged 50–70. Primary endpoints will be reported at 12 months, with long-term follow-up extending to 15 years

For more information, visit www.aspenneuroscience.com.

CONTACT:
Samantha Murphy
Vice President, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.

SAN DIEGO, Nov. 20, 2025 /PRNewswire/ — Aspen Neuroscience, Inc., a clinical-stage biotechnology company pioneering autologous regenerative therapies, today announced the closing of a $115 million Series C financing round. This significant investment will fuel the continued clinical development of Aspen’s lead program, ANPD001, for moderate to advanced Parkinson’s disease.

The Series C round was co-led by OrbiMed, ARCH Venture Partners, Frazier Life Sciences, and Revelation Partners, with participation from existing investors including Medical Excellence Capital, S32, Axon Ventures, LYFE Capital, and LifeForce Capital, among others. New investorsinclude Kite, a Gilead Company (Nasdaq:GILD), Balyasny Asset Management, Cormorant Asset Management, Prebys Ventures, and others. This latest funding brings Aspen’s total capital raised to date to over $340 million, including an $8 million grant from California Institute for Regenerative Medicine (CIRM).

In conjunction with the financing, Cindy Perettie, Executive Vice President and Global Head of Kite, a Gilead Company, will join Aspen’s board of directors.

“This financing marks a pivotal moment for Aspen as we accelerate our mission to deliver personalized regenerative therapies for people with Parkinson’s disease and beyond,” said Damien McDevitt, Ph.D, President and Chief Executive Officer of Aspen Neuroscience. “We are grateful for the confidence our investors have shown in our science, team, vision, and market opportunity. The significant experience and deep capital resources our investor syndicate brings will be instrumental in advancing Aspen’s next phases of clinical development and commercial readiness. Their strategic guidance and financial support empower us to scale our operations, expand our pipeline, and bring transformative therapies closer to those in need.”

Advancing Clinical Innovation and Commercial Readiness

The Series C financing will be used to:

• Support ongoing clinical trials of ANPD001, Aspen’s lead autologous cell therapy candidate for Parkinson’s disease.
• Scale manufacturing capabilities to meet clinical and future commercial demand.
• Advance Aspen’s pipeline of autologous iPSC-derived therapies for additional neurological indications.

Aspen’s proprietary manufacturing platform leverages machine learning and advanced genomics to produce the highest quality personalized cells for each patient, setting a new benchmark for consistency and scalability in cell therapy.

This financing follows initiation of dosing for the Phase 1/2a Cohort 3 commercial formulation and presentation of promising safety and efficacy data at six months post-procedure for Cohort 1.

“It is significant to see a private financing of this quality. Securing this round is a testament to how this team is rising above with innovation in product characterization, manufacturing automation, and positive clinical results,” said Faheem Hasnain, Board Chairman of Aspen Neuroscience. “Aspen is poised to deliver the first potentially disease-modifying therapy for the millions of patients waiting for these advancements.”

About ANPD001
ANPD001 is the most advanced autologous investigational cell therapy in the United States for treating Parkinson’s disease. More information about the Phase 1/2a trial is available at clinicaltrials.gov (NCT06344026).

Aspen’s personalized approach means that patients do not require immunosuppressive (IS) drugs to dampen the body’s immune response against foreign cells. This approach is intended to avoid IS‑associated adverse events, eliminate IS drug‑monitoring requirements, and enable dosing for those with contraindications to IS therapies.

ANPD001 has received Fast Track designation by the U.S. Food & Drug Administration (FDA).

Recent progress on Cohort 3: Aspen has initiated Cohort 3 in the ASPIRO Phase 1/2a trial, marking the first administration of the commercial formulation of ANPD001, which was deemed preclinically comparable to the formulation used in the first two cohorts. Earlier cohort six‑month data reported at IAPRD demonstrated strong safety and tolerability with clinician‑ and patient‑reported improvements, achieved without immunosuppression. The cryopreserved, ready‑to‑dose formulation is designed to streamline surgical workflows and reduce demands on hospital cell processing labs.

Three pillars that differentiate ANPD001 and Aspen’s platform:

• Manufacturing Platform: A proprietary, high‑tech process converts a small biopsy of the patient’s own skin cells into induced pluripotent stem cells (iPSCs) and then into dopaminergic neuronal precursor cells (DANPCs), with machine‑learning–based genomics tests assessing quality at each stage to deliver high‑quality personalized cells.
• Therapeutic Platform: Autologous iPSC‑derived DANPC therapy that uses each patient’s own cells, designed to avoid immune rejection and eliminate the need for long‑term immunosuppression, while preserving the personalized nature of treatment.
• Proprietary Device for Cell Transplantation: A precision delivery system that combines a metered‑dosing syringe with MRI guidance for sub‑millimeter accuracy, enabling minimally invasive surgery and a streamlined clinical workflow.

About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical-stage private biotechnology company focused on autologous regenerative medicine. Aspen’s patient-derived iPSC platform enables the development of personalized therapies for diseases with high unmet medical needs. The company’s pipeline includes ANPD001 and additional programs targeting neurodegenerative disorders.

For more information, visit www.aspenneuroscience.com.

CONTACT:
Samantha Murphy
Vice President, Corporate Development
smurphy@aspenneuro.com

Kerry Beth Daly
Corporate Communications
Kbdaly@aspenneuro.com

SOURCE Aspen Neuroscience, Inc.