Centhaquine Citrate

The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA. Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India. Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial. WILLOWBROOK, IL, USA I July 29, 2025 I Pharmazz, Inc. (“Pharmazz” or the “Company”), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function. “There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.” “There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,” said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. “Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.” Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor (ETBR) agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients. Pharmazz has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. About Sovateltide and Stroke Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 65 1 . Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78). 2 About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company’s website, www.pharmazz.com . SOURCE: Pharmazz

Funding supports pivotal Phase 3 trial for sovateltide, a potential first-in-class therapy that could transform the treatment of acute cerebral ischemic strokeWILLOWBROOK, Ill., June 11, 2025 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, has announced a $25 million equity investment from Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies), one of the world’s leading pharmaceutical companies. This strategic investment brings Sun Pharma’s total commitment in Pharmazz to $40 million (including a previous $15 million equity investment). “We believe sovateltide has the potential to redefine the treatment of ischemic stroke, which has not seen a new FDA approved non-thrombolytic therapy in over 30 years. This investment means we are now fully funded to complete our pivotal Phase 3 study and execute on our mission to make this first in class therapy available to stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We deeply value Sun Pharma’s continued partnership, which strengthens our ability to bring our therapies to patients worldwide.” The new funding will provide Pharmazz with the capital required to complete the pivotal U.S. Phase 3 clinical trial of sovateltide (known as Tycamzzi® and Tyvalzi™ in international markets), its lead drug candidate for treating acute cerebral ischemic stroke. Dr. Neil Marwah, President of Pharmazz, added, “This investment gives us the operational runway to execute a complex, multi-country clinical trial and scale the company responsibly as we prepare for a potential public offering. We are thrilled to strengthen our partnership with Sun Pharma, whose continued support reflects deep confidence in our platform and our ability to execute.” Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients. Pharmazz is initiating the Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial at 65 sites in the US, Germany, Spain, and the UK, designed to enroll 514 stroke patients. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. Commercially Approved in India: Early Validation from 60,000+ patients Sovateltide was approved in 2023 in India and marketed by Sun Pharma under the brand name Tyvalzi™, offering compelling proof of concept for global commercialization. In a randomized, placebo-controlled, multicenter clinical trial conducted in 158 cerebral ischemic stroke patients conducted in India, the product was shown to be well tolerated and effective in improving neurological outcomes when administered within 24 hours of stroke symptoms. Patients on Sovateltide were 22.7% more likely to achieve functional independence at 90 days (as measured by mRS score 0–2; p=0.0045)Sovateltide delivered a 17.1% higher rate of favorable National Institutes of Health Stroke Scale (NIHSS) scores (p=0.0024)The ordinal shift in mRS and NIHSS score between control and sovateltide groups was favorable towards sovateltide across the entire range.Results represent the first statistically significant clinical data in stroke in 30 years, since the introduction of alteplase (tPA)Over 60,000 patients treated to date since commercial launch in India Targeting a Multibillion-Dollar Market with a Broader Therapeutic Window Stroke remains one of the leading causes of disability and death globally, with over 7 million ischemic strokes annually. Today, fewer than 15% of patients receive approved interventions, largely due to their narrow treatment window and strict eligibility criteria. Sovateltide’s 24-hour dosing window and broader eligibility could expand access—particularly for underserved populations—and position it as a major advance in acute stroke care. If successful in Phase 3 and subsequently approved, sovateltide has strong commercial potential and is expected to be a foundational product in the Pharmazz emerging neurology franchise. About Sovateltide Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, www.pharmazz.com. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. and global emerging markets. Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology and accounts for over 18% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com. Disclaimer: Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors Kabir MarwahMediaShruti Gulati Tel+1 630 780 6087 Tel+1 630 780 6087E mailkabir.marwah@pharmazz.com E mailshruti.gulati@pharmazz.com