University of Southern California

- Findings underscore that the combination of onvansertib with FOLFIRI and bevacizumab demonstrates clinical activity and is well tolerated in second-line KRAS-mutant mCRC - - Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77% compared to 10% in bev-exposed patients - - Results from this trial, along with translational studies, supported the transition of clinical development of onvansertib to first-line RAS-mutant mCRC - - Initial readout from first-line RAS-mutant mCRC CRDF-004 trial expected in H2 2024 - SAN DIEGO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the publication of data from our Phase 2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab (bev) for the second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC) in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO). “It is exciting to see novel therapies in development that are well tolerated and demonstrate clinical activity in KRAS mutant mCRC, a cancer indication that has lacked new treatment options for decades,” said Heinz-Josef Lenz, MD, Professor of Medicine, J. Terrence Lanni Chair in Cancer Research, Deputy Cancer Center Director USC Norris Comprehensive Cancer Center, USC Keck School of Medicine and the national principal investigator on this trial. “The 77% objective response rate observed with onvansertib in combination with standard of care in bev-naïve patients is remarkable, and we look forward to determining the impact that onvansertib can make in the first-line setting.” “We are proud to be recognized by this prestigious oncology journal for our groundbreaking clinical and preclinical findings observed when adding onvansertib to the standard of care for KRAS mutant mCRC,” added Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. We are highly encouraged by the clinical results demonstrating a 7.7x higher objective response rate (ORR) in patients who were not previously exposed to bev, and our subsequent discovery of a novel mechanism for onvansertib through our translational work. Collectively, these findings and the support of the FDA led us to shift our clinical development program for onvansertib to the first-line setting where all patients are bev-naïve.” The results of the published Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and revealed a greater clinical benefit in bev-naïve patients (ORR of 77%, mPFS of 14.9 months) compared to bev-exposed patients (ORR of 10%, mPFS of 6.6 months). In addition, the company showed the underpinnings of this clinical finding using preclinical models which demonstrated onvansertib inhibited the hypoxia pathway and exhibited robust antitumor activity in combination with bev through the inhibition of angiogenesis. Based on these findings, Cardiff Oncology initiated CRDF-004, a Phase 2 randomized clinical trial of onvansertib in combination with SoC (FOLFIRI and bev or FOLFOX and bev) for the first-line treatment of patients with RAS mutant mCRC. The company anticipates releasing initial data from the CRDF-004 trial in the second half of 2024. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. For more information, please visit https://www.cardiffoncology.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of an epidemic or pandemic such as the COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact:James LevineChief Financial Officer858-952-7670jlevine@cardiffoncology.com Investor Contact:Kiki Patel, PharmDGilmartin Group332-895-3225Kiki@gilmartinir.com Media Contact:Grace SpencerTaft Communications609-583-1151grace@taftcommunications.com

VADUZ, Liechtenstein, Oct. 10, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, is pleased to report an impressive level of support from a large number of U.S. doctors who are interested to start with RefluxStop®* after launch, pending FDA approval, driven by the very solid clinical results from the 5-year CE-study and real world outcomes from multiple centers that mirror these excellent results. Over 600 of the world's top anti-reflux surgeons, gastroenterologists, and other experts met to discuss treatment innovations in foregut diseases at the American Foregut Society (AFS) Annual Meeting in Colorado, where RefluxStop® dominated the discussions. Implantica is actively working on the FDA approval process to bring RefluxStop® to the US market with the PMA filing of the second module (of three) expected in the near-term. The RefluxStop® procedure was at the forefront of the new innovation discussions at the AFS meeting. The meeting was revved up with a power-packed panel about RefluxStop including the leading US Surgeons and Gastroenterologists, moderated by Dr. John Lipham, Chief of the Division of Upper GI and General Surgery and Professor at the Keck School of Medicine of the University of Southern California and AFS Past President. Dr. Lipham opened the meeting by announcing the 5-year long-term outcomes data from the CE mark study that further reinforces the already published 1-year and 4-year results that are largely consistent with the published real-world data from Europe, including the latest safety and quality-of-life outcomes from over 200 patients in Switzerland and Germany, presented at the AFS meeting. Dr. Lipham shared the following: "RefluxStop's CE mark data and reported real-world data show highly consistent outcomes, which is quite impressive. It is also very interesting to see how closely the RefluxStop procedure's mechanism of action matches the white paper on the ARB released by AFS in November 2022. Seeing the impact of treating all three aspects of the anti-reflux barrier to resolve acid reflux is confirming much of our learning experience. RefluxStop's unique mechanism of action is what truly differentiates it from the traditional methods. I hope we will be able to offer this promising procedure to US patients in the near future, pending US FDA approval." Panelist Dr. Felice Schnoll-Sussman of Weill Cornell Medicine and President of AFS offered insights from a gastroenterologist's perspective, "I was encouraged to see such long-term outcomes after the RefluxStop® procedure. It could have the potential to be a great solution for many patients, including those that might not have qualified for traditional surgical options, as it does not encircle the food passageway. The fact that the current data shows significantly reduced undesirable post-surgical side effects is especially exciting." Founder and CEO of Implantica, Dr. Peter Forsell, says, "It's truly humbling to see the amazing interest, energy, and excitement coming from the 2024 AFS meeting. It could not be clearer that there is an urgent need for an innovative surgical treatment to offer GERD patients in the US, where an estimated 20% of adults suffer from the disease. We are confident that RefluxStop® can help address this enormous treatment gap in GERD management for millions of patients when we launch in the US, pending FDA approval." Additional Panelists included: Dr. med. Reginald Bell, Past-President and Chair, American Foregut Society, Colorado, US Prof. Dr. Peter Kahrilas, Gilbert H. Marquardt Professor of Medicine, Professor, Fienberg School of Medicine, Northwestern University, Chicago, US Dr. med. Tripp Buckley, Associate professor in the Department of Surgery and Perioperative Care and chief of the Division of Elective General Surgery, University of Texas at Austin Dell Medical School, Texas, US Dr. med. FSIE Christy Dunst, Esophageal Surgical Specialist, Center for Advanced Surgery, The Oregon Clinic, Portland, OR, US Prof. Dr. Sebastian F. Schoppmann, MD, FACS, Professor of Surgical Oncology, Medical University of Vienna, Upper-GI-Service, Department of General Surgery, Division of Visceral Surgery, Vienna, Austria Prof. Dr. Sheraz Markar, Professor of Upper Gastrointestinal Surgery & Director of the Surgical Interventional Trials Unit Nuffield Department of Surgical Sciences, Oxford University, UK Dr. med. Moustafa Elshafei, Senior Consultant Nordwest Hospital Frankfurt Department of Metabolic and Bariatric Surgery, Frankfurt, Germany * Registered Trademark in US For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)79 335 09 49 [email protected] Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] The information was sent for publication, through the agency of the contact person set out above, on October 10, 2024, at 08:30 a.m. (CET). About Implantica Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop®, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit for further information. About RefluxStop® RefluxStop® is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GERD involve encircling the food passageway to support the lower oesophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. In contrast, the RefluxStop® device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower oesophageal sphincter in its original, natural position. The RefluxStop® mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux. Newsroom Community Media Contact: Implantica AG Juanita Eberhart, VP Marketing & Advocacy M: +1 925-381-4581 [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Novel oncolytic immunotherapy being evaluated via IV and intratumoral delivery, both as monotherapy and in combination with checkpoint inhibitors PITTSBURGH, PA, USA I October 08, 2024 I KaliVir Immunotherapeutics, Inc. , a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy therapeutics, today announced that the first patient has been dosed in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors. VET3-TGI is a novel oncolytic immunotherapy which is designed to target and selectively kill tumor cells while also expressing an immuno-stimulatory transgene payload consisting of interleukin-12 and a TGFbeta inhibitor. “The dosing of our first patient in the STEALTH-001 study marks a significant milestone for KaliVir and our innovative VET3-TGI program,” said James Burke, M.D., Chief Medical Officer of KaliVir Immunotherapeutics. “The unique engineering of this platform to selectively target the tumor even in the face of anti-viral immunity holds great promise in delivering potent immune stimulatory cargo intravenously in patients with advanced solid tumors. Both VET3-TGI monotherapy and combination with checkpoint inhibition will be explored in this initial study.” About the STEALTH-001 Clinical Trial STEALTH-001 (ClinicalTrials.gov No. NCT06444815) is a dose escalation and expansion study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation will determine the highest tolerated dose of VET3-TGI when injected directly into the tumor(s), given intravenously and when combined with the checkpoint blockade. Once the maximum tolerated dose is found for each of these groups, expansion cohorts will be initiated to further evaluate the safety and efficacy of VET3-TGI. The study is enrolling patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. “VET3-TGI has the potential to reshape our approach to treating advanced tumors and provide a new path forward for patients who urgently need better treatment options,” said Jorge Nieva, M.D., Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Section Head of Lung and Head/Neck Tumors at the Norris Comprehensive Cancer Center and a member of KaliVir’s Medical Advisory Board. “This is a pivotal milestone and I look forward to seeing the continued progress of VET3-TGI as a monotherapy and in combination with checkpoint inhibitor therapy.” About KaliVir Immunotherapeutics, Inc. KaliVir Immunotherapeutics is a clinical-stage biotechnology company at the forefront of developing next-generation oncolytic immunotherapies. By harnessing the unique advantages of the vaccinia platform, KaliVir engineers optimized viral backbones to create innovative candidates for cancer treatment. The Company’s proprietary Vaccinia Enhanced Template (VET™) platform integrates multiple genetic modifications, allowing for the systemic delivery of oncolytic vaccinia candidates and the targeted expression of therapeutic transgenes within tumors. The Company is actively expanding its pipeline using the VET™ platform, with its capabilities validated through strategic global partnerships with Astellas Pharma and Roche. Currently, the Company has two product candidates in Phase 1 clinical trials: ASP1012, exclusively licensed and led by Astellas Pharma, and its internal lead candidate, VET3-TGI. With multiple therapeutic candidates progressing through clinical development, KaliVir is positioned as a leader in innovative cancer therapies. Headquartered in Pittsburgh, Pennsylvania, KaliVir is committed to revolutionizing cancer treatment. For more information, visit kalivir.com . SOURCE: KaliVir Immunotherapeutics