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No concerns raised regarding presented non-clinical or clinical safety data Meeting provides clear path forward for filing an IND for conducting a Phase 2 trial in depression patients responding inadequately to standard of care RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat central nervous system disorders—today announced the completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) Division of Psychiatry, Office of Neuroscience, Center for Drug Evaluation and Research. FDA Feedback & Guidance The focus of the pre-IND meeting was to receive FDA feedback and guidance on the non-clinical data, clinical data, and Phase 2 trial design for EVX-101, a novel adjunctive antidepressant candidate for depression patients responding inadequately to first-line serotonin reuptake inhibitor monotherapy. The pre-IND meeting was completed through written responses. The FDA expressed no concerns regarding the three months GLP non-clinical safety data presented and provided useful guidance on further non-clinical development of EVX-101, including on elements that can be omitted, given the favorable historical safety record on 5‑hydroxytryptophan (5‑HTP), the key active pharmaceutical ingredient in EVX-101. The FDA expressed no concerns regarding the safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase 1 trial of adjunctive EVX-101 in healthy volunteers, in terms of supporting a subsequent Phase 2 trial. The pre-IND meeting enabled alignment with the FDA regarding submission of an IND to conduct a Phase 2 trial of EVX-101 in depression. “We are delighted with the outcome of the pre-IND meeting written responses from the FDA,” said Jacob Jacobsen, CEO of Evecxia Therapeutics. “The positive and helpful feedback from the FDA is a significant milestone for our development program to develop EVX-101 as a potentially safer and more effective option for the millions of mood disorder patients not responding adequately to first-line serotonin reuptake inhibitors.” About EVX-101 EVX-101 is a first-in-class, proprietary gastro-retentive, sustained-release tablet formulation of 5‑hydroxytryptophan (5-HTP), the immediate precursor to serotonin, and low-dose carbidopa (multiplies 5-HTP’s bioavailability). EVX-101 is in development for next-line adjunctive therapy in depression and obsessive compulsive disorder. Adjunctive EVX-101 is intended to elevate brain serotonin activity beyond the effect of first-line serotonin reuptake inhibitor monotherapy. Multiple published clinical studies support this serotonin augmentation pharmacology is safe and effective in treating depression patients responding inadequately to serotonin reuptake inhibitors (1-4); but, it is not used in any marketed antidepressants. Hence, EVX-101 for depression is risk-mitigated, as based in clinical evidence, yet novel. All marketed antidepressants are based in clinical evidence. EVX-101 appears safe and devoid of abuse potential and could be scalable to broad outpatient mood disorder care. About 5-HTP 5-HTP is the immediate precursor of the neurotransmitter serotonin. Decades of clinical reports support a consensus that 5-HTP has demonstrated therapeutic potential in mood and others central nervous system disorders (5-7). 5-HTP has a benign human safety record (6, 8). 5-HTP’s putative therapeutic action is via Serotonin Synthesis Amplification, creating a stronger, more resilient brain serotonin system, a pharmacology distinct from available serotonin drugs, e.g., serotonin reuptake inhibitors and psychedelics. But the 5-HTP molecule is impractical for clinical practice, as 5-HTP is minimally absorbed by the body and very short-acting (9). No FDA-approved 5-HTP drug exists. Evecxia deploys pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP in the body, thus enabling practical Serotonin Synthesis Amplification therapy. About Evecxia Therapeutics Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat central nervous system disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder when first-line serotonin reuptake inhibitor antidepressants alone are inadequate. EVX-301 is being developed as rescue therapy for patients hospitalized for acute suicidal crisis. For additional information about Evecxia, please visit . References 1. van Praag HM (1982): Adv Biochem Psychopharmacol. 34:259-286. 2 Nardini M, et al. (1983): Int J Clin Pharmacol Res. 3:239-250. 3. Walinder J, et al. (1976): Arch Gen Psychiatry. 33:1384-1389. 4. Papakostas GI, et al. (2012): Am J Psychiatry. 169:1267-1274. 5. Shaw K, et al. (2002): Cochrane Database Syst Rev.CD003198. 6. Turner EH, et al. (2006): Pharmacol Ther. 109:325-338. 7. Levy A, et al. (2016): Curr Treat Options Neurol. 18:21. 8. Das YT, et al. (2004): Toxicol Lett. 150:111-122. 9. Evecxia (2024): Data on file. Contacts Jacob Jacobsen, CEO Evecxia Therapeutics, Inc. Info@evecxia.com

The comprehensive cancer center’s experts will spotlight scientific data on how dietary choices, psychosocial support, massage therapy and mind-body calming practices can improve outcomes and the quality of life of people touched by cancer LOS ANGELES--(BUSINESS WIRE)--Researchers from City of Hope ® , one of the largest and most advanced cancer research and treatment organizations in the United States, ranked among the nation’s top 5 cancer centers by U.S. News & World Report and a national leader in providing cancer patients with best-in-class, integrated supportive care programs, will present new data on integrative oncology research and clinical trials at the 21st International Conference of the Society for Integrative Oncology taking place Oct. 25 to 27. Integrative oncology is a patient-centered field of cancer care that combines conventional cancer treatments with complementary, evidence-based therapies to improve outcomes and quality of life. The hybrid conference hosted by City of Hope in Costa Mesa, California, will include more than 170 oral and poster abstracts evaluating supplements and herbal therapies, traditional medicine such as acupuncture, lifestyle choices like diet and exercise, mind-body practices, and use of artificial intelligence and machine learning in integrative oncology. “City of Hope and other experts will share the best science that’s occurring in the field of integrative oncology, which aims to optimize health, quality of life and clinical outcomes,” said Richard T. Lee , M.D., Cherng Family Director’s Chair for the Center for Integrative Oncology at City of Hope, medical director of supportive and integrative medicine at City of Hope Orange County and co-chair of the SIO conference. “City of Hope is leading a national effort to make evidence-based integrative oncology a routine and interwoven part of optimal cancer care and survivorship. City of Hope is bringing together leaders in the field to create the most holistic approach to cancer care.” A $100 million gift from Panda Express Co-CEOs Andrew and Peggy Cherng has enabled City of Hope to lead efforts to accelerate research, therapeutic development and clinical trials for the advancement of evidence-based integrative oncology practices so that cancer patients nationwide and their doctors have access to safe, proven approaches. Some of the leading-edge data City of Hope will present include the following oral abstracts. Massage therapy during infusion lessens the side effects of chemotherapy in a pilot study Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m. Christy DiCristofano, a City of Hope massage therapist, led a pilot study assessing the therapeutic effects of massage on cancer patients. The research team surveyed 232 individuals who collectively received 500 hand and/or foot massages while undergoing an infusion. They found that massage therapy is a beneficial additional treatment for symptoms induced by chemotherapy. The therapy had no reported side effects and proved useful in managing symptoms, such as anxiety, pain, shortness of breath, nausea and neuropathy, which is marked by shooting pain, numbness or tingling. Further research is needed to comprehensively evaluate the benefits of this intervention during infusion. Increasing white button mushroom intake could slow the progression of prostate cancer Presentation time and location: Sunday, Oct. 27 in the Lido Room from 10:45 a.m. to noon Bidirectional translational research led by Xiaoqiang Wang, M.D., Ph.D., City of Hope staff scientist, and Shiuan Chen , Ph.D., professor and chair of City of Hope’s Department of Cancer Biology and Molecular Medicine and the Lester M. and Irene C. Finkelstein Chair in Biology, revealed that consuming white button mushrooms can alter androgen levels and boost anti-cancer immunity. The comprehensive research included preclinical experiments, mouse models and prostate cancer patients participating in an ongoing phase 2 clinical trial. The physician-scientists collected blood samples from both mouse models and humans, analyzing myeloid-derived suppressor cells that are responsible for squelching immune responses and assisting tumor growth. They found that consuming white button mushrooms enhances anti-tumor immunity and slows prostate cancer progression. They expect to learn more once the phase 2 clinical trial is completed. Can intermittent fasting decrease the side effects of radiotherapy and enhance its efficacy? Presentation time and location: Friday, Oct. 25 in the Mesa Verde Room from 2:30 to 3:45 p.m. Several clinical and preclinical studies suggest that time-restricted eating, more commonly called intermittent fasting, may enhance anti-tumor response, decrease side effects and improve quality of life during systemic therapy. Ziyi Huang, M.D., City of Hope research fellow, and Yun Rose Li , M.D., Ph.D., assistant professor of radiation oncology at City of Hope, are leading an ongoing randomized phase 2 trial testing whether patients with pelvic malignancies who practice time-restricted eating could experience reduced levels of radiotherapy-induced side effects and enhanced radiotherapy efficacy. The time-restricted eating group are asked to fast for 12 to 14 hours on radiotherapy days. Researchers collect diet logs, stool, urine and blood samples alongside patient- and clinician-reported toxicities. Thus far, the results are encouraging and support the tolerability and feasibility of intermittent fasting during pelvic radiotherapy, especially among patients with prostate cancer. Enrollment in the trial is expected to be completed in spring 2025. Nurses can videoconference cancer patients to provide supportive care and improve quality of life Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m. Psychosocial support services can be limited in small urban and rural areas. Up to 70% of patients with advanced cancer experience elevated levels of fear of cancer progression characterized by intrusive thoughts, distress and difficulty making future plans. Anne Reb , Ph.D. N.P., assistant professor of nursing research and education at City of Hope, and Betty Ferrell , Ph.D., M.S.N., CHPN, City of Hope director and professor of nursing research and education, led a pilot study to assess the feasibility and preliminary effects of a nurse-guided videoconferencing intervention to manage fear of cancer progression levels in patients with Stage 3 or 4 gynecologic or lung cancer. Some 82% of the 30 study participants completed all five nurse-led videoconferencing sessions and reported using the tools the nurses introduced like attention training and detached mindfulness to focus, connect with what is most important to them and gain control over daily life stressors. The intervention showed improvement in fear and other quality-of-life outcomes. Feasibility and acceptability was established in this small sample size and suggestions for improvement were established. The potential risk of drug interactions with cannabis use Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 11:30 a.m. to 12:45 p.m. In one of the first studies to assess cannabis-related drug interactions in patients receiving cancer treatment, Elyssa Kim, B.S., former City of Hope research assistant, and Richard T. Lee , M.D., City of Hope clinical professor of supportive and integrative medicine, found that a significant proportion of cannabis users are at risk of moderate to major potential medication interactions. Of the 313 participants, 61 were actively using a form of cannabis to address insomnia (46%), pain (41%) and mood (39%). The most common medications whose effectiveness could be compromised due to cannabis use were noted to be medications for pain or inflammation (acetaminophen, dexamethasone), anti-nausea (ondansetron) and even chemotherapy (paclitaxel, doxorubicin). Researchers say that more states are legalizing cannabis and more cancer patients turn to cannabis to alleviate cancer symptoms, but we need more data on the therapeutic effects and pitfalls of cannabis use during cancer treatment. A mix of mindfulness meditation, gentle exercise and spirituality is linked to improved emotional well-being among breast cancer survivors Presentation time and location: Saturday, Oct. 26 in the Lido Room from 11:30 a.m. to 12:45 p.m. Breast cancer survivors often report experiencing anxiety, depression, poor sleep and cognitive impairment. Frank Munoz, a City of Hope chaplain, conducted a pilot study of meditative movement effects on this patient population, taking blood samples to measure serotonin-related (HTR1F and SLC6A4) and mood/cognitive function-related (BDNF, IL6 and IL1b) gene expression levels. The intervention resulted in a biological change in scores of anxiety, depression, sleep quality and cognitive function. This small study, which demonstrated changes in gene expression, suggests that meditative movement such as tai chi and meditation may help breast cancer survivors recover from persistent mental and emotional symptoms. About City of Hope City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn . Contacts Zen Logsdon 626-409-9367 zlogsdon@coh.org

RESEARCH TRIANGLE PARK, N.C.--( BUSINESS WIRE )--Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders—today announced Dr. Jacob Pade Ramsøe Jacobsen , the Co-Founder & Chief Executive Officer of Evecxia Therapeutics, Inc. , will be presenting at the ACCESS CHINA Partnering Forum – Autumn Virtual Showcase during September 24th to 25th, and 27th, 2024. Link to ACCESS CHINA. About Evecxia Therapeutics Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder (OCD) when first-line serotonin reuptake inhibitor (SSRI/SNRI) antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients hospitalized for acute suicidal crisis. For additional information about Evecxia, please visit www.evecxia.com .