Mirna Therapeutics, Inc.

HOUSTON--(BUSINESS WIRE)-- Diakonos Oncology Corp. (“Diakonos”), a clinical stage immuno-oncology company, announced today that Paul Lammers, M.D., M.Sc., a distinguished executive with over 35 years of experience in the biotech and pharmaceutical industries, has been named to its Board of Directors. "Dr. Lammers' success in leading both private and public biopharma companies, combined with his extensive experience in fundraising, will provide critical experience in guiding our clinical development and commercialization of Diakonos’ unique cancer immunotherapies," said Mike Wicks, Chief Executive Officer of Diakonos. "His pivotal role in advancing cell therapies for cancer perfectly aligns with our mission to revolutionize the treatment landscape for patients facing the most challenging cancers." Dr. Lammers is recognized for his strategic leadership and successful fundraising efforts, notably as President and CEO of Triumvira Immunologics, where he raised substantial venture funding focusing on CAR T-cell therapies for solid tumors. Before Triumvira, he led Mirna Therapeutics as President and CEO, taking the company public on NASDAQ in 2015. His earlier roles include Chief Medical Officer and Head of US Product Development at EMD Serono, where he oversaw a large team of professionals, and various executive positions that showcased his expertise in clinical development, medical, and regulatory affairs across the pharmaceutical and biotech sectors. “I am deeply honored to join the Diakonos team and contribute to their groundbreaking work in developing dendritic cell vaccines. This technology represents a significant leap forward in cancer treatment, promising a new era of personalized and effective immunotherapies for patients in dire need," Dr. Lammers said. About Diakonos Oncology Corp. Based out of Houston, TX, Diakonos Oncology is at the forefront of developing dendritic cell vaccines that leverage a patient's immune system to target and eliminate cancer cells, mimicking the body's natural response to viral infections. Initiating a natural immune response without any genetic modification of the patient’s immune cells, Diakonos has seen both encouraging efficacy and safety in its clinical trials to date. With its leading candidate, DOC1021, Diakonos recently completed its Phase 1 trial for glioblastoma (NCT04552886) at MD Anderson Cooper and UTHealth Houston. Diakonos is underway with additional trials for pancreatic cancer at Baylor College of Medicine (NCT04157127) and angiosarcoma at MD Anderson (NCT05799612). View source version on businesswire.com: Contacts Jay Hartenbach pr@diakonosoncology.com Source: Diakonos Oncology Corp. View this news release online at:

Vincent J. O’Neill, M.D., promoted to Executive Vice President, Chief of Product Development and Medical Officer Rajiv Patni, M.D., appointed Strategic Clinical Advisor to CEO and Board of Directors NEW HAVEN, Conn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced a key executive promotion and a clinical advisor appointment as part of the Company’s strategic reprioritization focused on the advancement of its late-stage clinical programs and emerging pipeline candidates. Vincent J. O’Neill, M.D., Senior Vice President and Chief Research & Development Officer of OnkosXcel Therapeutics, has been promoted to Executive Vice President, Chief of Product Development and Medical Officer of BioXcel Therapeutics. He will lead clinical, regulatory and medical affairs to provide a fully integrated approach to product development. Additionally, Rajiv Patni, M.D., has been appointed to the newly created position of Strategic Clinical Advisor to the BioXcel Therapeutics Chief Executive Officer and Board of Directors. “Our strategic focus has shifted to expanding the market opportunities for our lead program BXCL501 in the at-home setting, which we believe represent key value drivers for the Company. We are adding to the strength of our existing team and expanding our clinical leadership in line with our prioritization of late-stage TRANQUILITY and SERENITY III programs for BXCL501’s potential use to treat Alzheimer’s, bipolar disorder, and schizophrenia-related agitation,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We are also excited to advance development candidates identified through our AI-driven approach as part of our efforts to build a sustainable R&D pipeline. The promotion of Vince and the appointment of Rajiv are in support of our clinical execution, and we welcome their strong leadership as we look to progress in 2024.” Vincent J. O’Neill, M.D.: Executive Vice President, Chief of Product Development and Medical Officer Dr. O’Neill has significant expertise in therapeutic and diagnostic product development. He joined BioXcel Therapeutics in 2017 as Vice President and Chief Medical Officer, later Senior Vice President and Chief Medical Officer, and played an instrumental role in the Company’s SERENITY I and II trials of BXCL501, which contributed to the FDA approval of IGALMI™ (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults. He also led the Company’s immuno-oncology program and the successful human proof of concept trials for BXCL701, an investigational, orally administered systemic innate immune activator for the treatment of refractory forms of prostate cancer. In 2022, he became Senior Vice President and Chief Research & Development Officer of the Company’s wholly owned OnkosXcel Therapeutics subsidiary. Prior to joining BioXcel Therapeutics, Dr. O’Neill held senior leadership roles at several leading global pharmaceutical companies, including Sanofi, Genentech, and GlaxoSmithKline. Most recently, he served as Chief Medical Officer at Mirna Therapeutics and Exosome Diagnostics. He was instrumental in the expanded approvals of Genentech’s oncology therapeutics, Avastin® and Tarceva®. At GSK, he oversaw the signal transduction discovery unit and led the first IND application and clinical trial of the MEK inhibitor, MEKINIST®. Dr. O’Neill has authored several peer-reviewed publications and conference presentations. He received his M.D. and B.Sc. in Molecular Pathology from the University of Glasgow, Scotland, and is a member of the Royal College of Physicians. Rajiv Patni, M.D.: Strategic Clinical Advisor to the BioXcel Therapeutics CEO and Board of Directors Dr. Patni was Chief Research and Development Officer at Reata Pharmaceuticals, a commercial-stage company recently acquired by Biogen. Previously, he was a successful Chief Medical Officer at several public, small-cap, commercial-stage biopharmaceutical companies: Adamas, Portola, and Global Blood Therapeutics. He joined these companies at an inflection point in their R&D growth trajectories and contributed to their acquisition by larger companies. Earlier in his career, Dr. Patni had roles of increasing responsibility at Pfizer, Roche, and Actelion. Over his 23-year industry tenure in global product development, Dr. Patni has contributed to the development of 21 NCEs for both common and, most recently, rare diseases. His experience in fostering successful team efforts at these different companies contributed to the approval of 10 medicines, from the U.S. FDA, EMA, and other regulatory agencies. Dr. Patni received his M.D. degree from the Mount Sinai School of Medicine in New York City as part of an accelerated B.S. /M.D. program. He completed his internal medicine residency and adult cardiology fellowship at the Albert Einstein College of Medicine, also in New York City, where he continued as an attending physician-scientist before joining the biopharmaceutical industry. “I have been impressed by the Company’s AI-based discovery and development of BXCL501, which was approved as IGALMI, and their continued development of this asset for potential at-home treatment of agitation associated with Alzheimer’s dementia, bipolar disorders, and schizophrenia,” said Dr. Patni. “I look forward to working with the BioXcel leadership team in continuing to address the unmet medical needs of patients and caregivers and advance the Company’s product-development goals.” About IGALMI™ (dexmedetomidine) sublingual film INDICATION IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@bioxceltherapeutics.com. Please see full Prescribing Information at igalmi.com. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and 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 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, its expectations regarding its development programs and anticipated contributions of Drs. O’Neill and Patni. 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, the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as such factors may be updated from time to time in its other filings with the SEC, 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 BioXcel TherapeuticsErik Kopp1.203.494.7062ekopp@bioxceltherapeutics.com Investor Relations BioXcel TherapeuticsBrennan Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com Media Russo PartnersDavid SchullT: 858-717-2310David.Schull@russopartnersllc.comScott StachowiakT: 646-942-5630Scott.Stachowiak@russopartnersllc.com Source: BioXcel Therapeutics, Inc. *IGALMI is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc.All other trademarks are the properties of their respective owners.Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved.

- Neil Leatherbury Appointed Senior Vice President, Head of CMC – - Derek Jantz, Ph.D., to Assume Advisory Position of Co-Founder and Chief Science Advisor – - Jeff Smith, Ph.D., Co-Founder and Chief Research Officer Continues to Lead Research Strategy and Day-to-Day Execution of the Research Function – DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced a promotion and organizational changes within the Company’s Senior Leadership Team (SLT). The company announced the promotion of Neil Leatherbury to Senior Vice President, Head of Chemistry, Manufacturing and Controls (CMC) reporting directly to Michael Amoroso, President and Chief Executive Officer. Mr. Leatherbury leads Precision’s teams responsible for gene delivery, analytical development, process development, manufacturing, supply chain and manufacturing science and technology. “I’m pleased to announce the promotion of Neil to lead our CMC teams as member of the SLT. He has done an excellent job leading his team through a successful allogeneic CAR T manufacturing optimization process that improved our cell manufacturing platform resulting in enhanced CAR T attributes that are associated with efficacy and safety,” said Michael Amoroso. “This work was instrumental in achieving favorable Type C feedback from the FDA on the company’s CMC processes and analytical methods in support of late-stage development for azercabtagene zapreleucel (azer-cel), our lead clinical stage allogeneic CAR T cell candidate. We look forward to building on this success with our CAR T programs in 2023.” In addition, the company announced that Derek Jantz, Ph.D., Co-Founder and Chief Scientific Officer, has announced his intentions to gradually step away from his current day-to-day responsibilities at the Company to pursue other personal and professional interests while continuing to support the Company’s external relationships, including existing and potential business development partners. He will assume an advisory role as Co-Founder, Chief Science Advisor. In this capacity, Dr. Jantz is expected to provide ongoing platform advice and support to the Company’s executive team, as well as the Board of Directors' Science and Technology Committee, while also providing continuity to ongoing collaborations and assisting with development of new partnerships. Co-founder Jeff Smith, Ph.D. continues to lead the Company’s research strategy and day-to day management of the research function in his role as Chief Research Officer, reporting directly to the CEO, as previously announced in September 2022. In addition to these ongoing responsibilities, Jeff will assume primary leadership of the company’s joint steering committees with Lilly and Novartis and will serve as the primary scientific lead for potential new business development partners. “Derek has been instrumental to Precision since its founding in 2006. Jeff and Derek began the Company and have built it from the ground up on the basis of the ARCUS gene editing platform, scaling up research and development, advancing programs into the clinic and pushing new in vivo gene editing programs toward first clinical programs,” said Michael Amoroso. “For 17 years, they have put Precision’s interests first to reach our current stage of development. Jeff and Derek have recruited, trained and developed our new generation of scientists who are leading many of our research functions. As a result of their work to develop our bench strength and secure partnerships with Lilly and Novartis, we are now in a position where Derek will have more time to explore his other personal and professional interests, while providing welcome advice on the ARCUS platform to support our future business needs. I’m thankful for all Derek has accomplished for Precision and very pleased that Jeff will continue to lead our research scientists to advance our ARCUS platform.” “At this time in our company life cycle, I believe Precision BioSciences has the right leadership team in place and is poised to continue taking important steps toward becoming a commercial stage company. I’m very enthusiastic about the opportunities ahead for Precision and me,” said Dr. Jantz. “I look forward to continuing to work closely with the company in achieving continued success for ARCUS. As a co-developer of the technology and a significant shareholder, I derive great personal satisfaction from making strides towards bringing ARCUS-based therapies to patients in need. As such, I’m very much looking forward to the day when the first ARCUS-based in vivo gene editing program enters the clinic. At the same time, I’m eagerly watching as our lead CAR T program moves steadily toward a clinical inflection point.” "I deeply appreciate Derek's friendship and partnership over the last 17 years as we sought to develop and advance a gene editing tool that elegantly mimics a natural homing endonuclease for therapeutic gene editing. We now have preclinical and clinical data supporting the ARCUS platform," said Dr. Jeff Smith, Chief Research Officer. "As we developed the technology, we also built a top-notch and deep scientific team that has achieved major learnings with ARCUS and is propelling current programs and future applications of the technology into new disease areas. I am excited to continue leading this team that is equally passionate about our ultimate goal of bringing new potential cures to patients." Mr. Leatherbury joined Precision BioSciences in 2017 and has served in a variety of roles within Precision BioSciences’ CMC organization, including his most recent role as the Vice President of CMC. Neil brings more than 25 years of life science experience to this role with experience in CMC operations, pharmaceutical development and product development. Prior to joining Precision BioSciences, Neil worked at Mirna Therapeutics, Azaya Therapeutics, Smith & Nephew and Procter & Gamble. Dr. Smith is one of the true pioneers in genome editing and has made some of the key observations that led to the first successful engineered editing nucleases. Jeff received his graduate degree from Johns Hopkins University, where he developed and characterized custom nucleases for genome engineering. Continuing his work in protein engineering at Duke University, Jeff helped create the foundation for Precision’s ARCUS genome editing technology. He is an inventor on more than 75 foundational, issued patents involving the production and use of genome editing tools. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the company’s pipeline consists of multiple ex vivo “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected efficacy and benefit of Precision’s product candidates, the development and potential benefits and application of ARCUS and planned personnel changes. The words “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “promise,” “pursue,” “should,” “target,” “will,” “would,” and other similar words or expressions, or the negative of these words or similar words or expressions, are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical studies and clinical trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of COVID-19 pandemic and variants thereof, or any pandemic, epidemic or outbreak of an infectious disease; effects of sustained inflation, supply chain disruptions and major central bank policy actions; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com. All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, Precision has no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.