Halia Therapeutics, Inc.

– Completion of SAD/MAD trial marks advancement toward further clinical development of HT-4253 in Alzheimer's and other neurodegenerative diseases – LEHI, Utah, June 16, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company redefining treatment paradigms through inflammation-targeted and resilience-driven therapies, today announced the successful completion of its first-in-human Phase 1 clinical trial evaluating HT-4253 in healthy adult volunteers. The randomized, double-blind, placebo-controlled single- and multiple-ascending-dose (SAD/MAD) trial (ClinicalTrials.gov Identifier: NCT06537817) was conducted at CMAX Clinical Research in Adelaide, Australia. A total of 80 participants were dosed across 10 cohorts. The primary objectives of the trial were safety and tolerability, with secondary endpoints assessing pharmacokinetics (PK) and pharmacodynamics (PD. HT-4253 was generally well tolerated across all dose levels, with no serious adverse events reported. A comprehensive Clinical Study Report (CSR) is anticipated in Q4 2025. "The successful completion of this first-in-human study marks a significant milestone for Halia and provides compelling validation of HT-4253's safety, tolerability, and its potential to address a critical unmet need in neurodegenerative diseases, where dysregulated immune responses play a central role," said Dr. David Bearss, Chief Executive Officer of Halia Therapeutics. "These results show that HT-4253 can be safely administered at pharmacologically active doses, positioning us to move forward into patient populations with confidence. Backed by robust preclinical data and a mechanism inspired by naturally resilient individuals, HT-4253 represents a potentially transformative approach to modulating neuroinflammation in diseases such as Alzheimer's. Our team is now focused on preparing for the next phase of clinical development and identifying strategic opportunities to accelerate the program. Ultimately, our goal is to harness the protective biology observed in genetically resilient individuals and translate it into medicines that can delay or prevent disease in at-risk populations." About HT-4253 HT-4253 is a selective, orally administered LRRK2 kinase inhibitor that pharmacologically reduces phosphorylated Rab10 (pRab10), a biomarker associated with neuroinflammatory processes. Preclinical, genetic findings have suggested that some individuals who carry the high-risk APOE4 allele for Alzheimer's disease, but exhibit naturally reduced Rab10 activity, may correlate with cognitive resilience, highlighting the potential therapeutic rationale for targeting this pathway. This natural resilience suggests that dampening the LRRK2–Rab10 pathway may protect against the progression of neurodegeneration. By pharmacologically inhibiting LRRK2, HT-4253 reduces pRab10 levels, helping to suppress innate immune overactivation and lysosomal dysfunction. The therapeutic goal is to replicate the resilience seen in genetically protected individuals and apply it to patients at risk of Alzheimer's and other chronic neuroinflammatory conditions. About Halia Therapeutics Halia Therapeutics focuses on harnessing the biology of naturally resilient individuals to redefine treatment paradigms, aiming to restore immune balance in inflammatory and neurodegenerative conditions. Founded on breakthrough research identifying protective mutations in individuals genetically predisposed to severe diseases, Halia's therapies aim to restore immune balance in inflammatory and neurodegenerative conditions. The company's expanding pipeline includes: HT-6184 (Ofirnoflast): currently in a Phase 2a trial for Myelodysplastic Syndrome (MDS); enrollment is complete, with the study expected to conclude in late 2025. For more details, visit the clinical trial record: CTRI/2023/11/059758) HT-6184+Semaglutide: planned Phase 2a trial in patients with Obesity and Type 2 diabetes (T2D), expected to initiate in Q3 2025; HT-4253: neuroinflammation-targeted candidate now completed Phase 1, with a CSR expected in Q4 2025. For more information about HT-4253, Ofirnoflast (HT-6184), or ongoing clinical trials, please visit . Media Contact Taylor Avei Director of Business Development Halia Therapeutics [email protected] SOURCE Halia Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Selected biotechs will receive 12 months of lab and office space at Altitude Lab’s “rapidly-expanding life science hub in Salt Lake City.”\n Salt Lake City-based accelerator Altitude Lab is hoping it can entice biotechs impacted by the uncertainty surrounding federal grants.Altitude has secured a fund of “at least” $2.5 million sourced from private individuals, which the accelerator is planning to dole out to “promising” biotechs in parcels of between $100,000 and $250,000 of pre-seed investment capital. Selected companies will also get access to mentorship and 12 months of lab and office space at Altitude’s “rapidly-expanding life science hub in Salt Lake City.”The accelerator is designed to be a \"stopgap\" for companies needing immediate assistance, an Altitude spokesperson told Fierce Biotech over email. To take advantage of the opportunity, biotechs will need to have previously requested funding under the National Institutes of Health\'s (NIH’s) Small Business Innovation Research (SBIR) program and received an impact score of 20 or less.SBIR and the NIH’s Small Business Technology Transfer (SBTT) program account for a total of around $4.5 billion in annual funding obligations, making them “a cornerstone for biotech innovation,” Altitude said in a Feb. 19 release.Salt Lake City-based biotech Recursion founded Altitude in 2020, and Chris Gibson, Ph.D., co-founder and CEO of Recursion and chair of Altitude’s board, is one of the private individuals contributing to the fund. He\'s joined by Halia Therapeutics CEO and co-founder David Bearss, Ph.D. “Earning our early SBIRs was a pivotal moment for Recursion,” Gibson said in a statement. “The few million dollars that came in via the SBIR mechanism in our early years allowed us to build the fundamentals of our platform.” However, Altitude alluded to recent SIBR-related policy changes as placing “an estimated 1,500 health-related startups in limbo, jeopardizing critical advancements in medicine, drug development and diagnostics.”The fund announced today is designed to “help bridge this gap, while continuing to grow the rapidly-expanding life science hub in Salt Lake City by offering capital and infrastructure to high-potential startups currently at risk,” Altitude explained.“Federal funding disruptions are stalling groundbreaking biotech research,” Altitude’s executive director Chandana Haque said in the same release. “With this fund, we are doing our small part to help secure the future of biotech innovation in America, to build the ecosystem of life science companies around Recursion in Salt Lake City, and also ensuring that the best female and underrepresented founders—who receive only 15% of SBIR funding and 3% of venture capital—have an opportunity to build the next great biotech,” Haque added.Fierce Biotech asked the NIH for clarity on the future of SIBR and SBTT funding but had not received a response at time of publication.

Before biopharmaceutical companies raise money from venture capital firms, their early funding often comes from the U.S. government in the form National Institutes of Health grants. That was the case for Recursion Pharmaceuticals, a now publicly traded company that applies artificial intelligence to drug discovery and development. With layoffs at the NIH underway and its grant funding programs in limbo, Recursion is stepping in to fill in some of the funding gap for biotech startups. Altitude Lab, a biotech accelerator formed by Recursion, on Wednesday announced the launch of a pre-seed venture fund to support early-stage startups affected by the changes in federal funding policy. Altitude Lab Fund will provide pre-seed investments of $100,000 to $250,000 as well as 12 months of lab and office space at the Altitude Lab facility in Salt Lake City. Funding awards also come with admission to the Altitude accelerator program, which provides mentorship from industry executives and connections to national funds that could be sources of future investment. According to Altitude Labs, startups incubating there have collectively raised $154 million in early-stage funding since the accelerator’s launch. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient “Recursion founded Altitude Lab in 2020 to fuel more founders and enable more audacious companies in our industry,” Chris Gibson, Recursion CEO and Altitude Lab board chairperson said in a prepared statement. “This fund is Altitude Lab’s way of supporting and accelerating the science on which our industry stands.” Recursion Pharmaceuticals formed in 2013, co-founded by Gibson. Three years later, the young company raised its Series A round of funding. Gibson said NIH small business innovation research (SBIR) grants in Recursion’s early years allowed the young company to build the fundamentals of its technology platform. The company was able to go on to raise more than $1 billion in private investment. Recursion currently has eight drug candidates in clinical development. In 2019, Recursion established the Recursion Foundation, a vehicle for charitable and philanthropic efforts. Altitude Lab was the first effort of the foundation. According to Recursion regulatory filings, the biotech’s board of directors has committed to putting 1% of the company’s equity into the foundation “to help demonstrate the strong commitment we have to social responsibility and to ensure a sustainable future for our work in this arena.” Altitude Lab was conceived with an emphasis on working with underrepresented founders. One key goal is for their startups to grow permanently in Utah. The accelerator has since become part of a larger regional economic development vision in partnership with the University of Utah. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The Altitude Lab Fund will be led by Gibson alongside David Bearss, the CEO of Lehi, Utah-based Halia Therapeutics, and Altitude Executive Director Chandana Haque. Startups seeking NIH funding have their applications go through two levels of review. Applications are scored on a scale that assesses the potential impact of a technology. The scale ranges from 10 to 90, with 10 being the best score. Altitude Lab said its new fund is open to startups that have received an impact score of 20 or less. Applications may be submitted here.