UNC School of Medicine

Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025 ~40 million Americans go to emergency department annually after a traumatic experience 1 Second externally funded stress-related trial for BXCL501 NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a collaboration with the University of North Carolina at Chapel Hill (UNC) on a grant awarded by the U.S. Department of Defense (DoD) to evaluate the efficacy and safety of BXCL501 as a potential treatment for acute stress disorder (ASD). The award provides $2.8 million to the UNC Institute for Trauma Recovery from September 15, 2024 through September 14, 2026 to evaluate the potential efficacy of BXCL501 to reduce ASD symptom severity and/or posttraumatic neuropsychiatric symptoms. The double-blind, placebo-controlled trial is expected to enroll 100 patients experiencing ASD resulting from motor vehicle collisions, beginning in the first half of 2025. BioXcel Therapeutics will supply BXCL501 for the trial. ASD symptoms occur in the days and weeks after trauma, and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reaction does not resolve, and include persistent pain, posttraumatic stress, and depressive symptoms. ASD prevalence varies considerably based on the study and nature of the trauma. An estimated 40 million Americans annually go to the emergency department after a traumatic experience.1 “There is an urgent need for effective interventions to prevent the development of these ‘invisible wounds,’” said Principal Investigator Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the UNC School of Medicine. “Fortunately, advances in research methods and biologic understanding have created an opportunity to develop interventions to prevent symptoms associated with ASD. We look forward to initiating this important study of BXCL501, which could potentially be administered to patients in the early aftermath of severe trauma to reduce acute stress symptoms and prevent the emergence of chronic symptoms.” “In addition to our development of PRN dosing treatment with BXCL501 for agitation associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia, BXCL501 may have potential as a precision medicine for short-term treatment of the spectrum of symptoms related to trauma and stress-related disorders,” said Frank Yocca, Ph.D., Chief Scientific Officer of BioXcel Therapeutics. “Our lead neuroscience asset is currently being evaluated by Yale University School of Medicine for the potential short-term treatment of PTSD related to alcohol and substance abuse disorder, and we are pleased that a second externally funded trial will soon commence led by another prominent academic research institution.” The ASD research is supported by the DoD under award number HT9425-24-1-1108. The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the DoD. About BXCL501 Government-Supported Investigator-Initiated Trials In addition to Acute Stress Disorder (ASD), BioXcel Therapeutics has been awarded grant programs for the development of BXCL501 for the potential treatment of post-traumatic stress disorder (PTSD)/alcohol use disorder (AUD) and opioid use disorder (OUD). A PTSD/AUD outpatient trial is being led by clinical researchers and regulatory staff at Yale University Medical School and funded through a cooperative agreement with the DoD’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. An OUD inpatient trial is being led by clinical researchers and regulatory staff at Columbia University and funded through a cooperative agreement with the National Institute on Drug Abuse (NIDA). About BXCL501Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI™ (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting and for the acute treatment of agitation associated with Alzheimer’s dementia. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About BioXcel Therapeutics, Inc.BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the expected funding, timing and outcome of trial of BXCL501 evaluating its ability to potentially treat agitation resulting from acute stress disorder. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to remain listed on the Nasdaq Capital Market and impacts from any potential delisting on the Company and its ability to raise capital; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as such factors may be updated from time to time in its other filings with the SEC, including without limitation its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/InvestorsBioXcel TherapeuticsErik Kopp 1.203.494.7062 MediaRusso PartnersDavid Schull 1.858.717.2310 Source: BioXcel Therapeutics, Inc. References Kessler, R.C., Ressler, K.J., House, S.L. et al. Socio-demographic and trauma-related predictors of PTSD within 8 weeks of a motor vehicle collision in the AURORA study. Mol Psychiatry 26, 3108–3121 (2021). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41380-020-00911-3

Multidisciplinary board members bring expertise in drug discovery, clinical development, computational life science, GPCRs and drug formulationBOSTON, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Superluminal Medicines, Inc., “The Membrane Company” using generative biology, chemistry and machine learning approaches to revolutionize the speed and accuracy of how medicines are created, today announced the formation of its Scientific Advisory Board (SAB). Comprised of renowned experts whose skillsets span drug discovery, computational life science, translational research, GCPRs, clinical trials and commercialization, the newly formed SAB has a deep understanding of Superluminal Medicines and its strategic priorities and will play a crucial role in advising the Company as it progresses its lead program into clinical development and increases the number of small molecule drug discovery programs focused on high-value G protein-coupled receptor (GPCR) targets. “The members of our new Scientific Advisory Board are world-renowned experts in their fields who have pushed the boundaries of science, established new areas of research and have brought new therapeutics to market,” said Cony D'Cruz, CEO of Superluminal Medicines. “I can think of no better set of advisors to help Superluminal Medicines take our lead program into clinical development, advance six small molecule programs and build our discovery platform to quickly and efficiently generate therapeutics for any membrane drug target.” Inaugural members of Superluminal Medicine’s Scientific Advisory Board include: Morris J. Birnbaum MD, PhD, SAB Chairman, is a physician-scientist who has led research teams in academic and pharmaceutical settings, investigating fundamental problems in metabolic regulation and their relevance to chronic disease. Dr. Birnbaum was Senior Vice President and Chief Scientific Officer, at Pfizer Inc., initially of the Cardiometabolic and later the Internal Medicine Research Unit, where he was responsible for the discovery and early clinical development of drugs designed to treat metabolic diseases. Under his leadership, Pfizer brought seven novel potential medicines into clinical development. Dr. Birnbaum has held faculty positions at Harvard Medical School, the Perelman School of Medicine at the University of Pennsylvania, and the Howard Hughes Medical Institute. Dr. Birnbaum received his AB, PhD and MD from Brown University and completed an Internal Medicine residency at Barnes Hospital at Washington University in St. Louis, followed by postdoctoral training at the University of California, San Francisco, and Sloan-Kettering Institute in New York. John Griffin, PhD, is an entrepreneur and advisor to science-driven organizations. With more than 30 years of R&D leadership experience, he is the Co-Founder and former Chief Scientific Officer of Theravance, Inc. Dr. Griffin was Chief Scientific Officer of Numerate, a startup that sought to overcome major challenges in drug discovery by applying novel machine-learning algorithms to drug design at cloud scale which was acquired by Valo Health. After the acquisition, he was Vice President at Valo Health—a technology company focused on utilizing large-scale data and AI-driven computation to discover and develop therapeutics. Dr. Griffin was also an Assistant Professor of Chemistry at Stanford University, has authored 40 publications and is co-inventor of 29 patents. He received his BS in Chemistry from Hope College, a PhD in Chemistry from the California Institute of Technology and was a National Science Foundation Postdoctoral Fellow at Harvard Medical School. Carrie Haskell-Luevano, PhD, conducts research focused on GPCRs, the neuroendocrine regulation of pain (opioid receptors), food intake and energy homeostasis (melanocortin receptors). She is the Philip S. Portoghese Endowed Chair in Chemical Neuroscience at the University of Minnesota’s Department of Medicinal Chemistry. The Haskell-Luevano laboratory uses a variety of multidisciplinary techniques and research approaches including peptide, small molecule and combinatorial chemistry synthesis; cell-based assays; chemical biology; neuromolecular pharmacology; developing knock-out mice and neuroscience. The Haskell Luevano laboratory has published over 130 peer-reviewed manuscripts, reviews, book chapters and conference proceedings. Dr. Haskell-Luevano completed her postdoctoral studies and started an independent research program at the University of Florida Department of Medicinal Chemistry, where she was promoted through the ranks of Assistant, Associate, and Full Professor. Dr. Haskell-Luevano received her BS degree in Chemistry from the California State University of Fresno and her PhD in Chemistry at the University of Arizona. Terrence Kenakin, PhD, is a leader in the use of pharmacologic tools and concepts to characterize the activity of molecules in biological systems using quantified molecular properties so that their activity can be predicted in therapeutic and other systems. Currently, Dr. Kenakin is Professor of Pharmacology at the University of North Carolina School of Medicine in Chapel Hill, where he optimizes the design of drug activity assay systems, discovery and testing of allosteric molecules for therapeutic application and quantitative modeling of drug effects. He joined Burroughs-Wellcome as an associate scientist following a postdoctoral fellowship at University College London, UK . Dr. Kenakin worked in drug discovery for 25 years at Glaxo, Inc., Glaxo Wellcome and GlaxoSmithKline’s Research and Development laboratories. He has authored numerous articles and 10 books on Pharmacology. Dr. Kenakin received his BSc in Organic Chemistry and PhD in Pharmacology from the University of Alberta in Canada. Georgia McGaughey, PhD, is a veteran scientific leader with more than 30 years of corporate experience in drug discovery and digital transformation earned at Pfizer, Merck and Vertex Pharmaceuticals. In 2024, she retired from Vertex Pharmaceuticals where she was Vice President of the global Data and Computational Sciences (DCS) group and a member of the Research Leadership Team, which is responsible for the scientific strategy and direction for the entire Vertex drug discovery portfolio. Under her leadership, the DCS group was responsible for leveraging data and advanced analytics with impact from research to FDA approval and played a central role in the approval of CASGEVY®, a gene-editing CRISPR therapy. Dr. McGaughey spent 13 years at Merck in a variety of roles in infectious diseases, CNS and other therapeutic areas, contributing directly to Belsomra®, Filorexant, MK-8189 and MK-8193, a PET-tracer used to measure target engagement for PDE10. Upon her departure from Vertex, Dr. McGaughey founded Trilligant to continue lending her expertise in digital transformation for a wide variety of businesses from sports analytics to drug discovery. Dr. McGaughey completed her PhD studies at the University of Georgia and has published over 100 peer-reviewed scientific publications and contributed to numerous patents. Sandeep Menon, MD, PhD, MPH, MS, is the Chief Development Officer at Alnylam Pharmaceuticals, where he leads a multifunctional global team and oversees end-to-end development. Before, Dr. Menon was Senior Vice President and head of Early Clinical Development at Pfizer. He oversaw Pfizer’s early clinical pipeline of assets from IND through Phase 2b across all therapeutic areas, playing a critical leadership role in increasing Pfizer’s R&D productivity resulting in a Phase II success rate of over 50%. In 2021, his team co-led the early clinical development of Paxlovid, which went from first-in-human to emergency use authorization in nine months. He also served as Chief Scientific Officer for AI and Digital Sciences, overseeing the cutting-edge Pfizer Innovation and Research Lab (PfIRE Lab), responsible for using state-of-the-art technology to develop meaningful novel quantitative digital endpoints through dynamic and remote monitoring of human behaviors. Prior to Pfizer, Dr. Menon was at Biogen where he worked on Tecfidera and Tysabri; prior to that he was a Research fellow at Harvard Clinical Research Institute. Dr. Menon received his medical degree from Karnataka University, India, his Master’s in Public Health and PhD in Biostatistics at Boston University and his MS in Translational Pharmacology from Ohio State University. He has published over 70 peer-reviewed scientific publications and book chapters and co-authored / co-edited 9 books. About Superluminal Medicines Inc. Superluminal Medicines is a generative biology and chemistry company developing a differentiated pipeline and revolutionizing the speed and accuracy of how medicine is created. The company’s platform creates candidate-ready compounds with unprecedented speed using a comprehensive combination of deep biology and chemistry expertise, machine learning, and proprietary big data infrastructure. The predict-design-test architecture accurately models protein shapes and designs highly selective compounds to target the precise structural change for therapeutic effect. Its discovery engine is powered by an industry-leading, pharmacokinetic and toxicology in silico prediction capability. The company’s proprietary pipeline validates its platform with initial programs focused on high-value GPCR targets. Based in Boston, the company is backed by a strong network of investors including RA Capital Management, Insight Partners, NVentures, Catalio Capital Management, Eli Lilly and Company, Gaingels, and Cooley LLP. For more, visit www.superluminalrx.com. Media ContactJanine McCargo6 Degreesjmccargo@6degreespr.com

Consistent improvement in patient reported outcomes with 10 of 11 evaluable patients in the first four cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks The fourth cohort showed the greatest percentage change in histology (EoEHSS2) scores of any cohort to date The RESOLVE Phase 1b/2a trial is progressing as anticipated with no serious adverse events reported in all four fully-dosed cohorts VICTORIA, BC, Sept. 11, 2024 /PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology to optimize drug delivery for applications with significant unmet need, today announced additional positive clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis ("EoE"). New Clinical Data from the Fourth Cohort of the RESOLVE Trial The results announced today from the fourth cohort of the RESOLVE trial, using Eupraxia's DiffuSphere™ technology for EoE, are derived from twelve 2.5 mg injections of EP-104GI (total dose of 30 mg) administered to less than two-thirds of each patient's lower esophagus. The data show: Straumann Dysphagia Index ("SDI")1, a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to four points (67% from baseline). At 12 weeks post-administration, SDI was reduced by a mean of 45% or 3.3 points – a level comparable with currently approved therapies. Eosinophilic Esophagitis Histology Scoring System ("EoEHSS")2 scores, which evaluate the severity and extent of EoE, showed the largest percent reduction of any cohort to date, with a mean 39% reduction in Composite Stage and a mean 37% reduction in Composite Grade at 12 weeks – a level comparable with currently approved therapies. Using data from four biopsy sites, which is consistent with the U.S. Food and Drug Administration ("FDA") Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in Peak Eosinophil Counts ("PEC")3 was 67% at 12 weeks. Notes "The RESOLVE trial is progressing rapidly and we continue to observe positive data on efficacy and safety outcomes with EP-104GI, with the fifth cohort expected to read out in November 2024," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "Overall, we are encouraged by the data that we have seen across a number of key metrics and remain optimistic that we'll see further improvements in patient response as the trial progresses towards an optimal dosing level." The RESOLVE trial is a Phase 1b/2a, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed, active EoE. EP-104GI is administered as a single dose via 4 to 20 injections into the esophageal wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts will be assessed for up to 24 weeks. Patients in cohorts five and above will be assessed for 52 weeks. Dr. Helliwell added, "In each of the trial's successive cohorts, patients are injected with EP-104GI at either higher doses or across a greater number of injection sites. We anticipate that the dose-escalating cohorts will allow us to evaluate the trial's emerging dose-response relationship. In addition, biopsies measuring tissue health have demonstrated a correlation between the dose of drug and the response on histology. This is exactly the outcome we hope to see in a dose-escalation trial such as this." Dr. Evan S. Dellon, MD, MPH (University of North Carolina School of Medicine) and Chairman of the Company's Gastrointestinal Clinical Advisory Board, commented, "I'm encouraged to see the positive trends in the SDI1, EoEHSS2 and PEC3 scores as the trial continues. These metrics have emerged as key data points to help clinicians better understand a patient's esophageal health and will be important in informing the design of the Company's late-stage clinical trials. We believe that EP-104GI has the potential to contribute to improved overall esophageal health in patients, in part, because it is being injected into the deeper areas of the esophagus versus coating the surface of the tissues, which may help to improve esophageal remodeling." The Company intends to continue to periodically disclose additional data from the trial. New Clinical Data from the Third Cohort in the RESOLVE Trial The results announced today from the third cohort of the RESOLVE trial, using Eupraxia's DiffuSphere™ technology for EoE, are derived from eight 2.5mg injections of EP-104GI (total dose of 20 mg) administered to a portion of each patient's lower esophagus. The data show: SDI1 was 50% lower in one of two evaluable patients at 24 weeks. A third patient in this cohort discontinued evaluation for reasons unrelated to the study. EoEHSS2 Composite Stage and Composite Grade scores were both lower than baseline at 12 weeks post-administration, showing an average reduction of 7% and 15%, respectively. Using data from four biopsy sites, which is consistent with the FDA Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in PEC3 was 55% at 12 weeks. About EoE EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the healthcare system and the individual. About Eupraxia Pharmaceuticals Inc. Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: . Notice Regarding Forward-looking Statements and Information This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "suggests", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the Company's product candidates, including expected benefits to patients with respect to safety, efficacy, duration and tolerability; additional clinical data from the RESOLVE trial of EP-104GI in EoE, including the Company's intention to periodically disclose such data and timing thereof; the Company's expectations regarding dose-escalating cohorts; the Company's product candidates, including expected benefits to patients; the results gathered from studies and trials of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; potential market opportunity for the Company's products, and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise. SOURCE Eupraxia Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED