Proceeds support first-in-class development program through key clinical and regulatory milestones, including completion of the Phase 2 STAR trial in HIE, top-line data readout, and End-of-Phase 2 meeting with the FDA
Company has raised more than $150 million since its formation
NORFOLK, Va.--(BUSINESS WIRE)--ReAlta Life Sciences Inc. (“ReAlta” or the “Company”), a clinical-stage biopharmaceutical company focused on safely targeting neutrophils and central components of the complement system to potentially revolutionize the treatment of inflammatory disorders, today announced the closing of an oversubscribed $40 million financing. This brings the total capital raised to date to more than $150 million.
The Company will use the proceeds to advance pegtarazimod through key clinical and regulatory milestones as the first potential treatment for Hypoxic Ischemic Encephalopathy (HIE.) Upcoming milestones for this first-in-class program include completion of the Phase 2 STAR trial in HIE (currently underway at 13 sites across the United States), the study’s top-line data readout, and an End-of-Phase 2 meeting with the FDA.
Howard Berman, Ph.D., the Company’s Chief Executive Officer, said, “Every year, thousands of newborns suffer devastating brain injury from HIE with no approved drug therapy to offer them. Rarely in a career does one have the opportunity to work on a program with this level of both scientific rigor and human urgency. This financing reflects strong conviction in pegtarazimod’s potential to change that reality. By targeting both complement activation and neutrophil-driven inflammation, which are the upstream drivers of brain injury in HIE, pegtarazimod represents a fundamentally different and potentially transformative approach. We believe that we are well-positioned to deliver on the key milestones ahead.”
Kia Motesharei, Ph.D., ReAlta’s President and Chief Operating Officer, added, “This financing allows us to execute against key value-inflection points with a disciplined and focused strategy. We are committed to deploying this capital efficiently to generate meaningful clinical and strategic milestones. Our team is creating a new category of medicine for HIE patients where currently no drug therapeutic option is available. The financing enables us to accelerate our work toward realizing that vision. The goal here is not to provide incremental improvement, but to fundamentally change how doctors treat newborn babies who develop HIE.”
About ReAlta Life Sciences
ReAlta Life Sciences is a clinical-stage biopharmaceutical company redefining the treatment possibilities for patients with devastating and historically untreatable inflammation-driven diseases by developing first-in-class tailored peptides designed to achieve life-changing outcomes with unprecedented safety. The company’s lead candidate, pegtarazimod (RLS-0071), is a next-generation dual-targeting intervention that represents a solution that rebalances the body’s inflammatory response and prevents tissue damage by selectively blocking both complement- and neutrophil-mediated pathways at the outset, disrupting inflammation at the core. To learn more about ReAlta, visit https://realtalifesciences.com and follow us on LinkedIn.
About RLS-0071 (pegtarazimod)
Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation and is the Company’s lead therapeutic candidate. The peptide works by inhibiting complement activation at C1, as well as myeloperoxidase activity and neutrophil extracellular trap (NET) formation—key mechanisms implicated in the inflammatory cascade underlying a broad range of diseases driven by dysregulated neutrophils and complement activity. Pegtarazimod was derived from a mechanistic discovery of the human astrovirus HAstV-1, a virus known to cause non-inflammatory gastroenteritis, which provided a novel scaffold for innate immune modulation. Across multiple clinical studies in healthy volunteers and patients with life-threatening inflammatory conditions, pegtarazimod has demonstrated a favorable tolerability profile and encouraging clinical signals, supporting its development in acute inflammatory diseases with significant unmet medical need. Pegtarazimod has received FDA Orphan Drug and Fast Track Designations for Hypoxic Ischemic Encephalopathy (HIE) and EMA Orphan Drug Designation for HIE.
About Hypoxic Ischemic Encephalopathy (HIE)
Hypoxic Ischemic Encephalopathy (HIE) is a serious and often devastating form of neonatal brain injury caused by a lack of oxygen and blood flow to the brain during or around the time of birth. HIE affects thousands of newborns each year in the United States and globally and remains a leading cause of neonatal mortality and long-term neurological disability, including cerebral palsy, epilepsy, and cognitive impairment. Therapeutic hypothermia is currently the standard of care and has been shown to provide modest benefit in some infants; however, there are currently no approved drug therapies that directly target the underlying inflammatory injury that contributes to brain damage following hypoxic ischemic events. As a result, there remains a significant unmet medical need and a potentially multi-billion-dollar global market opportunity for therapies that can meaningfully improve neurological outcomes in affected infants.
About the STAR Trial
The STAR trial (NCT05778188) is a two-stage, randomized, double-blind, placebo-controlled study currently enrolling patients across 13 NICUs in the United States, evaluating RLS-0071 (pegtarazimod) in newborns with moderate or severe HIE undergoing therapeutic hypothermia.
Forward-Looking Statements
This press release contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts
Investor Contact:
John Rickman
Chief Financial Officer
jrickman@realtals.com
Media Contact:
David Schull or Rachelle Babb, Ph.D.
Russo Partners
david.schull@russopartnersllc.com
rachelle.babb@russopartnersllc.com
