News Hub | News Direct

Hemogenyx Pharmaceuticals achieves breakthrough with HEMO-CAR-T program, CBR platform

HemoGenyx Pharmaceuticals

Hemogenyx Pharmaceuticals PLC CEO Dr Vladislav Sandler and non-executive director Peter Redmond joined Proactive's Stephen Gunnion after the company pioneering breakthrough treatments for life-threatening diseases, including blood and solid cancers, achieved a number of significant milestones. Sandler highlighted the company's significant progress with its HEMO-CAR-T program after it received the green light from the US Food and Drug Administration (FDA) to enter Phase 1 clinical trials for acute myeloid leukaemia, marking its transition to a clinical-stage biopharmaceutical company. This development symbolises a pivotal milestone, offering potential life-changing treatments for patients with limited options. Additionally, Hemogenyx is advancing its proprietary Chimeric Bait Receptor (CBR) platform, announcing that it has demonstrated in vivo that the CBR can be delivered intranasally in the form of messenger RNA (mRNA) for the potential treatment of airborne viral infections. As 2024 unfolds, Hemogenyx anticipates starting clinical trials and advancing its CBR platform towards IND-enabling studies, signaling a landmark year with promising outcomes for investors and patients alike. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 20, 2024 08:09 AM Eastern Standard Time

Video

hVIVO chairman Cathal Friel says he remains committed to hVIVO following share sale

hVIVO PLC

hVIVO chairman Cathal Friel joined Proactive's Stephen Gunnion to discuss the sale of shares in hVIVO PLC by directors, including himself. Friel explained his decision to sell a portion of his shares in hVIVO was to accommodate the high demand from major institutions while emphasising his commitment to remain a long-term, supportive shareholder despite this sale. Friel, who co-founded hVIVO (formerly known as Open Orphan) in 2017, highlighted the company's significant growth and his active involvement in its operations and strategic direction. He mentioned his 25-year experience in mergers and acquisitions (M&A) and his confidence in the company's ability to surpass its medium-term revenue target of £100 million, partly through strategic M&A activities. Additionally, Friel talked about his new role as Executive Chairman at Poolbeg, a company associated with hVIVO, assuring that this would not diminish his involvement with hVIVO. He shared his enthusiasm for the future of both companies, underscoring his role in identifying market opportunities and assembling high-performing teams to capitalize on them. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 20, 2024 04:55 AM Eastern Standard Time

Video

Poolbeg Pharma chair discusses shift to executive role; hVIVO share sale

Poolbeg Pharma PLC

Poolbeg Pharma chairman Cathal Friel joined Proactive's Stephen Gunnion to discuss his new hands-on role at the company. Stepping up as the executive chairman at Poolbeg Pharma, Friel expressed his intention to replicate the success he achieved with hVIVO, another company he founded. With the addition of key former Amryt leadership team members to Poolbeg, Friel said he is optimistic about the company's aggressive growth prospects and is focused on share price appreciation. The chairman also explained the rational for the sale of shares in hVIVO PLC by directors, including himself. Friel, who has a rich background in mergers and acquisitions (M&A) and investment banking, said the decision was driven by strong institutional demand for hVIVO stock. Despite selling a small portion of his stake, he affirmed his long-term commitment to the company, highlighting its robust growth, profitability, and cash generation under current management. He also revealed plans to increase his stake in Poolbeg, indicating confidence in the company's potential and his commitment to driving shareholder value. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 20, 2024 04:40 AM Eastern Standard Time

Video

Roberts & Ryan Inc., America's first Service-Disabled Veteran-Owned (SDVO) broker-dealer, is pleased to welcome Andrew Reynolds as Senior Director of Equity Trading.

Roberts & Ryan, Inc.

Andrew Reynolds joins Roberts & Ryan as Senior Director of Equity Trading and has more than 30 years of experience in equity trading, capital markets, portfolio management, options & derivatives, sales & business development, investor relations, and corporate compliance. Prior to joining Roberts & Ryan, Mr. Reynolds was Head of Equity Trading and a Registered Principal at Tullett Prebon and KCCI Ltd. Before that, he was Head Trader and Floor Broker at Tradition North America and R.J. Murphy & Associates. Prior to that, he was Head Trader at Preferred Technology. Mr. Reynolds began his career as an Options Clerk at Pershing, LLC. “Andrew brings extensive experience in equity trading and represents Roberts & Ryan’s commitment to providing best in class service and execution,” said James McDevitt, Roberts & Ryan’s Senior Director of Equity Sales and Trading, Capital Markets. “He will be a tremendous advocate for our social mission of supporting veterans and their families. I’m very excited to have him join our team.” Mr. Reynolds is a member of the Securities Traders Association (STA), the Securities Traders Association of New York (STANY), Philadelphia Traders (ITAP), and the National Investor Relations Institute (NIRI). He holds SIE and FINRA Series 7, 24, 25, 55, 57 & 63 licenses. Mr. Reynolds served as a Technical Warfare Specialist, Team Leader, and Group Leader in the 25 th Infantry Division of the United States Army and is a graduate of Archbishop Ryan in Philadelphia. About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $1.8 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, focusing primarily on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com

February 19, 2024 09:00 AM Eastern Standard Time

Image

Gates Ventures, Mayo Clinic Back Tiny Robot Created By $400M Apple Face ID Inventors To Treat Brain Disease

OurCrowd

By Matthew Kalman PrimeSense, the previous company founded by Michael Shpigelmacher, Aviad Maizels and Alex Shpunt, was acquired in 2013 by Apple (NASDAQ: AAPL) for around $400 million. It was a world leader in 3D sensors that helped power the Microsoft (NASDAQ: MSFT) Kinect for Xbox 360 and provided the technology behind Apple’s Face ID. Bionaut Labs, the medical startup founded by the trio, is on a very different journey – into the deepest recesses of the human brain. But the company is already making waves. This month, Bill Gates’ Gates Ventures joined its early funders, extending investment to $70 million from a blue-chip roster including the Mayo Clinic, Khosla Ventures, Upfront Ventures and OurCrowd, Fortune magazine reported. The company’s Bionaut, a tiny micro-robot smaller than a grain of rice, is guided through a patient’s central nervous system into a targeted spot in the brain where it can perform minor surgery, deliver therapeutic drugs or return with tissue for a biopsy. Not since Raquel Welch was shrunk and inserted into a patient’s bloodstream in the 1966 movie “Fantastic Voyage” have doctors come so close to targeting life-saving medication so precisely to reach the inaccessible recesses of the human body. The company is testing its technology at a Mayo Clinic facility and is poised to begin clinical trials with five top-tier U.S. medical centers as it applies for FDA approval. Investors can still join the Bionaut Labs funding round via the OurCrowd investment platform. Shpigelmacher, CEO of Bionaut Labs, says he realized that treatments for disease occurring at a specific point in the body – especially the brain – were not being accurately targeted. He likens the effect of existing treatments to “carpet bombing a patient’s body with drugs,” creating “widespread undesired side effects or damage to surrounding tissue and organs.” “There we were, flooding the whole body. It was like having one dirty dish in the sink and bringing out a fire hose that floods the whole house just to wash that single dish,” he says. The Bionaut, guided by a physician using a powerful magnet, can release a payload of targeted therapy directly into a tumor or any other localized target – even deep inside the brain – and head for home. “Surgeries to get to the brain tend to be relatively aggressive and fairly in depth and carry a lot of risks associated with them and a lot of recovery time,” says Dr Bill Loudon, VP of Neuroscience at Bionaut Labs. The blood-brain barrier creates “very significant problems to try to get drugs to where we want it to go. On the surgical side it’s hard to get into the brain and on the drug side it’s hard to get into the tissues.” “The Bionaut has specific advantages that circumvent these problems. It truly represents a whole new level,” Dr Loudon says. The company has developed several micro-robot prototypes, each designed for a different purpose. There is a capsule-shaped Bionaut designed to move through fluid, a corkscrew-shaped Bionaut designed to burrow through tissue and a sharp-pointed Bionaut that can perform microsurgery by slicing through the kind of cyst in the brain that causes hydrocephalus, or Dandy-Walker Syndrome. A Bionaut can carry a therapeutic payload and deliver it directly to the targeted area, which avoids flooding the entire central nervous system. Instead of drilling through several centimeters of brain tissue, the Bionaut can be guided through internal fluids to within millimeters of its target. “We minimize tissue penetration, doing it only for the safest and shortest distance possible. It opens a completely new way of treating brain diseases,” Shpigelmacher says. Each tiny Bionaut contains a powerful magnet that allows it to be remotely controlled from outside the body. The patient has an MRI or CT scan, which the physician uses to plan the safest route to the affected area and then loads the route onto a computer. The patient is sedated and the Bionaut is injected into the central nervous system at the entry point worked out in advance. Then, the computer takes over, guiding the probe to its destination while causing the least possible damage to surrounding tissue as the physician monitors its progress via X-ray. $130 Billion Market “The market for brain and CNS therapeutics is massive – over $130 billion today and estimated to grow to over $200 billion. Most of it is drugs,” Shpigelmacher says. Pharma giants are targeting a wide range of neuro-degenerative conditions including Parkinson’s, Huntington’s, Alzheimer’s, epilepsy, glioblastoma and many more, but they all face the challenge of getting the drugs to the point where they are needed inside the brain. “The problem is, even if you have the best drug how are you going to get it to the target?” Shpigelmacher says. “This is where Bionaut steps in. Bionaut does not aim to replace these drugs or replace these payloads. It aims to provide a way for the drug manufacturer to get their payload to the target. So even if we just focus on neuro-degeneration, brain cancer and epilepsy – that alone is over a $70 billion market today.” “We’re already in discussions with the FDA to take this to the clinic next year. The idea is that by the end of 2024 we will have early human data for the device, and in 2025 we will license it out for broader neurological indications,” Shpigelmacher says. The company hopes to emulate the success of other companies specializing in robotic surgery and the treatment of neurodegenerative diseases. Intuitive Surgical (NASDAQ: ISRG), a leader in surgical robotics, is worth more than $100 billion. Halozyme (NASDAQ: HALO), which partners with major pharma companies to reformulate drugs for precision use, earns millions of dollars each year and is valued at almost $5 billion. “When we started this research, many of the physicians we spoke to, specialists in cardiology, gastroenterology, ophthalmology and more, simply asked, ‘When can we sign up?’” Shpigelmacher says. For more information about joining Bionaut Labs’ extension round via the OurCrowd platform, click HERE. Featured photo courtesy of Bionaut Labs. OurCrowd was started in 2013, driven by the idea that the business of building startups grows bigger and better when the global ‘crowd’ gains access to VC-level investment opportunities.Today, OurCrowd is a global venture and alternative investing platform that empowers institutions and individuals to invest and engage in emerging companies. OurCrowd vets and selects companies, invests its capital, and provides its global network with unparalleled access to co-invest and contribute connections, talent and deal flow. OurCrowd builds value for its portfolio companies throughout their lifecycles, providing mentorship, recruiting industry advisors, navigating follow-on rounds and creating growth opportunities through its network of multinational partnerships. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Lisa Graston lisa.graston@ourcrowd.com Company Website http://www.ourcrowd.com

February 16, 2024 08:35 AM Eastern Standard Time

Video Image

Kadimastem advances towards Nasdaq: Company Signs a Memorandum of Understanding to Merge with a Company traded on the Nasdaq

Kadimastem

Kadimastem Ltd. (TASE: KDST), a leading cell therapy company in the clinical development stages of breakthrough products for the treatment of ALS and diabetes, announces that the company has signed a non-binding agreement in principle (“MOU”) for a merger with a public company traded on the NASDAQ. pursuant to the MOU Kadimastem shareholders are expected to hold 88% of the shares of the combined company post -merger upon which Kadimastem will no longer be trading on the Tel Aviv Stock Exchange. The MOU is in line with the company's strategic plan, to approach the target markets of its field of activity and the US capital markets. As part of the terms of the MOU, Kadimastem undertook to have approximately $5 million in funds, including capital raised simultaneously with the completion of the transaction and the commencement of trading from existing shareholders and additional investors. Ronen Twito, Executive Chairman of the Board said, "Listing Kadimastem on the NASDAQ is an important and necessary goal for Kadimastem’s development and its progress to the company's target markets in the U.S., as we have stated in the past. The MOU is an important step in that direction. It follows the Company's report of receipt of FDA approval for a Phase IIa multi-site clinical trial in the US for the treatment of ALS, and the joint development agreement signed with iTolerance Inc., a Florida based company with a product in the field of diabetes which we recently reported to have a successful joint INTERCT meeting with the FDA.” We believe that the exposure to the U.S. capital markets will assist Kadimastem in the development of the company's clinical assets and preparations for the planned multi-site clinical trial for the US, and as a result will create value for the company's shareholders." About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). Social Media: LinkedIn, Twitter, Facebook Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science. Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Ltd. Asaf Shiloni +972 73-797-1613 s.bazak@kadimastem.com Company Website https://www.kadimastem.com/

February 16, 2024 07:00 AM Eastern Standard Time

Image

RapidClaims uses AI to help US healthcare providers address $250b in denied claims

RapidClaims

Healthcare organizations are turning to automation with “revenue cycle management” to protect operating margins and the increasing claim denials from the payors. Every year, close to $265B in claims made by US healthcare organizations are denied because of the way claims are coded on payor documentation and delayed submissions are two chief reasons for the denials. Coding errors account for over 40% of claim denials, while untimely submissions contribute to 35% of denials; eligibility and prior authorization being some of the other aspects playing a significant role. Addressing this pain point, RapidClaims has today emerged from stealth with a $3.1 million funding round to tackle the claims denial problem head-on with its medical coding automation module. The seed round was led by Together Fund, a $250 million global SaaS fund, with participation from Better Capital, Neon Fund, Peercheque, DeVC with angels and advisors coming from prominent US healthcare organizations including Oscar Benavidez (Executive Director, Mass General), Ankit Jain (Founder & CEO of Infinitus), and Sachin Jain (President & CEO of Scan Health) among others. RapidClaims is led by Dushyant Mishra (CEO), Jot Sarup Sahni (CPTO), and Abhinay Vyas (CDO), each bringing a nuanced understanding of healthcare, data science, and scaling tech products. The idea for RapidClaims originated in 2018 during Dushyant Mishra’s tenure at Abbott Healthcare when he observed the challenges faced by hospitals while interacting with multiple hospital owners and physicians. Since then, he has closely monitored the space, which gained significant momentum in 2022 as two key trends emerged: an increase in claim denial rates across the US and the effective demonstration of large language models (LLMs) as a solution to these challenges. RapidClaims recognizes the diverse challenges inherent in revenue cycle management. With a strategic focus on tackling medical coding initially, the company aims to simplify the rising complexity of coding processes and leverage the potential for AI to drive efficiencies over time. In recent years, coding complexity has surged significantly with diagnosis codes like ICD codes rising from 19,000 (ICD 9) to nearly 120,000 (ICD 11). Adherence to guidelines is becoming increasingly challenging due to rapid changes encompassing NCCI edits, NCD/LCD guidelines, Medicare policies, payor rule sets, among others. RapidClaims has achieved success with six pilots within two months of its beta product launch in June 2023 and is poised to enhance product robustness even further with an additional five pilots already in the pipeline. Dushyant Mishra, Founder & CEO of RapidClaims commented: "We are just beginning to witness tangible benefits in terms of cost savings, speed, and revenue enhancement through AI utilization. While automation is pivotal, we recognize the indispensable role of coders with their nuanced understanding of intricate rules and edge cases. This is the driving force behind our significant investment in the RapidAssist product, which has the transformative potential to elevate medical coding operations for coder-managing teams." AI holds immense potential for introducing exceptional efficiencies into this domain. Beyond identifying the right code, AI's current state allows for precise context interpretation, adding a layer of sophistication to the coding process. RapidClaims has unveiled three multi-specialty products aimed at alleviating coding administrative overload: RapidCode: Fully autonomous medical coding, streamlining the process with end-to-end automation. RapidAssist: A tailored tool for medical coders designed to improve productivity by auditing charts and identifying documentation gaps, which includes a query builder and rule-set engine. RapidRisk: Advanced AI for risk-adjusted coding that calculates HCC and RAF scores while pinpointing opportunities for documentation improvement based on a comprehensive rule set developed in collaboration with prominent CDI leaders. More healthcare organizations are recognizing the need for revenue cycle automation to overcome workforce challenges, handle increasing claim volumes, mitigate revenue losses, and navigate the complexities of healthcare administration. This urgency is further fueled by the rise in claim denials from payors, which puts significant pressure on healthcare providers and exacerbates the already high administrative costs. A recent study conducted by Bain & Company and KLAS reveals that 80% of U.S. healthcare providers are increasing their investment in IT and software, with a specific focus on prioritizing AI technologies. Revenue cycle transformation and automation are the top areas of focus for healthcare executives. Manav Garg, Co-founder of Together Fund added: "We are thrilled about the transformative potential of AI in optimizing administrative processes within the revenue cycle. We are confident that the RapidClaims team embodies the perfect blend of expertise, showcasing an in-depth understanding of the complexities within the U.S. healthcare system coupled with exceptional proficiency in artificial intelligence." About RapidClaims RapidClaims is automating medical coding to help health organizations reduce claim denials from payors. About Together Fund Together Fund is an enterprise software-focused, operator-led fund started by Girish Mathrubootham (Founder, Freshworks ), Manav Garg (Founder, Eka ) and Shubham Gupta (ex Matrix Partners). Together invests in Seed and Series A opportunities across AI, Devtools, Cloud Infra, Security, Horizontal & Vertical SaaS applications. With a “for-founders, by-founders” DNA, Together is joined by 150+ global founders & operators in this endeavor to help build global products. Contact Details RapidClaims Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.rapidclaims.ai/

February 16, 2024 06:00 AM Eastern Standard Time

Image

Candel Therapeutics Sets Stage For Success With Cancer-Fighting Immunotherapies

Candel Therapeutics

By Jeremy Golden, Benzinga A clinical-stage biopharmaceutical company looks forward to the year ahead with several promising developments in motion. Focused on the development of multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) is innovating a new frontier in the field of immunotherapy. By leveraging a data-driven approach, the company seems poised to advance next-generation immunotherapies in its pipeline as well as create new product candidates. Following up on promising initial clinical and biomarker data in hard-to-treat cancers, Candel is moving forward with a focus on strategic key value drivers and catalysts. Lead Candidates Based in Needham, Massachusetts, Candel is developing two off-the-shelf clinical-stage investigational viral immunotherapies. Designed to elicit an individualized anti-cancer response, they are based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform. It’s in the midst of ongoing late-stage clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2) and localized, non-metastatic prostate cancer (phase 2 and 3). CAN-3110 is the lead product candidate from the HSV platform. A phase 1 clinical trial in recurrent high-grade glioma (HGG) is currently ongoing. Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform that leverages human biology and advanced analytics to create new viral immunotherapies for solid tumors. The year 2023 was a productive one for Candel. The company received Fast Track Designation from the FDA based on encouraging clinical activity and biomarker data from the phase 2 clinical trial of CAN-2409 in NSCLC, was also granted Fast Track Designation based on the positive interim data from the ongoing randomized phase 2 clinical trial in borderline resectable pancreatic cancer, published the activity of CAN-3110 in recurrent high-grade glioma in Nature and presented data on the first molecule that was discovered based on the enLIGHTEN TM Discovery Platform at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC). In NSCLC, the phase 2 clinical trial showed that experimental therapy with CAN-2409 achieved disease control in most of the patients who had an inadequate response to immune checkpoint inhibitor treatment. Importantly, there was an abscopal effect (improvement of uninjected lesions) in most patients with metastatic disease. There was an increase in effector/cytotoxic T cells and natural killer cells in peripheral blood after the second CAN-2409 administration (the booster), which was linked with subsequent improved survival. Candel reports that it has observed an encouraging number of long survivors, which the company believes demonstrates that CAN-2409 may induce a new state of functional immunosurveillance and durable disease control. The gold standard endpoint in this population is overall survival. Based on the currently available treatments, median overall survival ≥ 14 months will be considered a significant improvement compared to standard of care. Candel also reported positive interim data from a randomized, controlled clinical trial that revealed a notable increase in survival in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409 plus standard-of-care treatment compared to standard-of-care control treatment alone. The estimated overall survival rate was 71.4% at 24 months in CAN-2409 treated patients versus 16.7% in the control arm after chemoradiation. In patients with progressive disease, there was both a CA19-9 (tumor biomarker) and a survival response to salvage chemotherapy in the CAN-2409 arm but not in the control arm. Dense aggregates of immune cells were observed in PDAC tissue after CAN-2409 treatment, confirming the activation of a robust antitumoral immune response in this immunosuppressive form of cancer. “In 2023, we received Fast Track Designation for both NSCLC and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, our most advanced product candidate,to address these unmet medical need cancers,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. “Clinical data from the ongoing phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma have recently been published in Nature, serving as further recognition of the scientific and clinical excellence of Candel’s programs.” Candel and collaborators at the Brigham and Women’s Hospital published in the high-impact journal Nature that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival after just a single injection of CAN-3110 when compared to expected survival in patients treated with current chemotherapeutic standards of care. Positive HSV-1 serology was a predictor of response and was associated with improved survival. Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were associated with improved survival. Importantly, these results were seen after a single injection of CAN-3110; Candel and its collaborators are currently evaluating a multiple-injection regimen, supported by the Break Through Cancer foundation. “The data generated with CAN-3110 in recurrent high-grade glioma represents a significant step forward in the development of groundbreaking therapeutic candidates for this difficult-to-treat disease,” said Francesca Barone, M.D. PhD, CSO, at Candel Therapeutics. “At the same time, they provide proof of concept for the expansion of CAN-3110 in other Nestin positive tumors, which include a diverse spectrum from triple negative breast cancer to melanoma to soft tissue sarcoma.” What’s To Come Backed by promising clinical and biomarker data in hard-to-treat indications, the company expects six data readouts across three platforms this year, including overall survival data in NSCLC and topline data of the potentially registrational phase 3 clinical trial in prostate cancer. Those data readouts include: Topline overall survival (OS) data for CAN-2409 in a phase 2 topline trial for NSCLC in Q2 2024 Updated overall survival data for CAN-2409 in a phase 2 trial for borderline resectable pancreatic cancer in Q2 2024 New data on the second drug candidate from the enLIGHTEN Discovery Platform by Q3 2024 Phase 1 data for CAN-3110 in recurrent high-grade glioma in 2H 2024 for the multiple injection cohort Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer in Q4 2024 Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer in Q4 2024 During the SITC Annual Meeting and the International Oncolytic Virus Conference (both in 2023), Candel presented the first experimental candidate from enLIGHTEN Discovery Platform Alpha 201-macro-1, an investigational, locally-delivered biological oncolytic therapeutic designed to interfere with the CD47/SIRP1a pathway which demonstrated better inhibition of tumor growth when compared to systemic anti-CD47 antibody therapy in a mouse model of breast cancer. Francesca Barone, M.D. PhD, said “With the enLIGHTEN Discovery Platform, we are leveraging our internal capabilities in advanced analytics, cancer biology and vectorology to design a new class of multimodal therapeutics that can overcome mechanisms of resistance present in the tumor microenvironment.s “This platform is open for collaborations with external partners as illustrated by our collaboration with U Penn aimed at designing a viral gene construct able to support the therapeutic efficacy of CAR-T therapy in pancreatic cancer.” Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

February 15, 2024 08:25 AM Eastern Standard Time

Cardio Diagnostics (NASDAQ: CDIO) Expands Partnership With Family Medicine Specialists To Bring Specialty Cardiology Tests To Select Walmart Supercenters

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga A precision cardiovascular medicine company’s innovative AI-driven epigenetic-genetic blood tests will soon be available in one of the nation’s largest retailers. Beginning Q2 2024, Cardio Diagnostics (NASDAQ: CDIO) will bring its advanced blood-based epigenetic-genetic tests, Epi+Gen CHD and PrecisionCHD, to the Walmart Supercenter in Round Lake Beach, Illinois. The northern suburb of Chicago has been chosen as the strategic starting point for a new retail healthcare initiative, the company said. The initiative is an expansion of the ongoing Heart Attack Prevention Initiative, a partnership with Family Medicine Specialists (FMS). With the launch of the Heart Attack Prevention Initiative, FMS started deploying Epi+Gen CHD in at least 1,200 patients with coronary heart disease (CHD) risk factors across its BlueCross BlueShield Medicare, Medicaid, HMO and PPO health plans. According to the company, this partnership benefits both patients and providers through early heart attack risk prevention, in addition to offering significant value to health plans. By leveraging Cardio Diagnostics’ technology, FMS is increasing the accessibility of clinical cardiovascular diagnostic solutions, moving them beyond traditional provider settings and into the more accessible realm of retail healthcare for hundreds of additional patients in Lake County, Illinois. “Our partnership with FMS to bring our tests to their Walmart locations is a game-changer in the field of cardiovascular health management,” said Meesha Dogan, Ph.D., Co-Founder and CEO of Cardio Diagnostics. “By integrating Cardio Diagnostics’ state-of-the-art clinical tests within FMS’s expansive retail network, we are shifting the paradigm from a model that relies on specialty care infrastructure to one that meets American communities in their backyard. This strategic alliance not only democratizes access to top-tier heart disease services but also propels Cardio Diagnostics as a leader in cardiovascular retail healthcare innovation. Our ultimate goal is to meet patients where they are, weaving advanced medical services seamlessly into the fabric of their everyday lives.” Accessibility The retail healthcare footprint and market share continue to grow as more Americans embrace the convenience and accessibility of high-quality healthcare services. In their most recent report, AMN Healthcare reported that 30.3% (79.6 million) Americans received care at a retail clinic. About 32.8% of Americans are forecasted to do so in 2024. At the Round Lake Beach Walmart location of FMS, walk-ins will have access to both of Cardio Diagnostics’ clinical blood tests. The company’s epigenetic-genetic cardiovascular clinical blood tests, Epi+Gen CHD and PrecisionCHD detect heart attack risk and coronary heart disease status, respectively. These tests are easy to administer in the retail healthcare setting because they only require a simple blood draw, bringing this vital service closer to patients. “At Family Medicine Specialists, we have multiple retail healthcare partnerships and are particularly excited about our unique and innovative partnership with Cardio Diagnostics, a leader in clinical cardiovascular diagnostic solutions. This collaboration will enable us to bring advanced cardiac diagnostic tools directly into our retail healthcare clinic locations, enhancing our ability to provide more advanced patient care without the need for additional infrastructure,” Jason Bellucci, MBA, President of Family Medicine Specialists, said. “We believe that this partnership will empower our clinicians with additional resources to better serve our patients’ needs.” Bringing Precision Cardiovascular Testing To Each Neighborhood Heart attacks and coronary heart disease pose significant health risks, and earlier detection and intervention remain crucial for prevention. In the current healthcare paradigm, accessing specialized tests for assessing heart attack risk or diagnosing coronary heart disease means having to navigate complex schedules and significant wait times. While primary care and family medicine practices have managed to maintain relatively shorter waits, specialty areas like cardiology have seen a significant rise, with the average wait time now extending to about 26.6 days. This delay particularly impacts cardiology patients, where timely intervention can be crucial. With 45% of Americans projected to have some form of cardiovascular disease by 2035, the key question is: how can Americans and their providers quickly gain clarity about a patient’s heart disease without weeks of waiting for a specialist appointment? One answer is that cardiology specialty tests must be routinely and readily available in community settings, such as retail healthcare stores. With the deployment of Cardio Diagnostics’ advanced blood tests across select Walmart locations, the company strives to alleviate the critical issue of increasing wait times for specialty care. Beginning with the Round Lake Beach location, expansion to other Walmarts is a key opportunity to reduce wait times for cardiac assessments and care, furthering community-based access to heart disease solutions. The company intends to continue its pursuit of providing organizations with a strong retail healthcare presence and desire to enhance their existing heart disease-related services with precision cardiovascular diagnostic and risk assessment technologies. Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com. Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Gene Mannheimer - Investor Relations +1 855-226-9991 investors@cardiodiagnosticsinc.com Company Website https://cardiodiagnosticsinc.com/

February 15, 2024 08:20 AM Eastern Standard Time