Sovateltide

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

In a decisive move to bolster its presence in the biopharmaceutical sector, Sun Pharmaceutical Industries Ltd has announced an increased investment in U.S.-based Pharmazz Inc., raising its total commitment to $25 million and expanding its ownership stake to 22.7%.   This strategic investment, structured in multiple tranches, is set to be completed by November 30, 2025. The initial tranche includes $10 million, along with the remaining $7.5 million from a prior SAFE (Simple Agreement for Future Equity) arrangement, to be invested by May 31, 2025. A subsequent $15 million tranche is scheduled for investment by November 30, 2025, or another mutually agreed date.    Pharmazz is at the forefront of developing innovative treatments for critical care, with two leading drug candidates: Sovateltide, aimed at treating acute cerebral ischemic stroke, and Centhaquine, designed for hypovolemic shock. Both drugs have received approval in India and are marketed under the brand names Tyvalzi and Lyfaquin, respectively. These therapies are currently undergoing development for the U.S. and other international markets.    With this enhanced investment, Sun Pharma secures an option to negotiate licensing rights for Sovateltide in certain developed markets, expanding upon its existing exclusive rights in select emerging markets.    This move underscores Sun Pharma’s commitment to advancing its portfolio in critical care therapeutics and strengthening its global footprint in the pharmaceutical industry.