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Cardio Diagnostics Inks Groundbreaking Telehealth Agreement With Navierre And Expands Access To Cardiovascular Tests

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention and early detection more precise, has inked a new deal with an innovative digital health technology platform. Cardio Diagnostics’ strategic partnership with Navierre — which revolutionizes how patients access healthcare by acting as a true health companion for every stage of life — aims to significantly expand access to Cardio Diagnostics' industry-leading, AI-enabled precision cardiovascular diagnostic tests. On April 1, Cardio Diagnostics’ precision heart health solutions, including its flagship AI-powered epigenetic-genetic cardiovascular risk, detection and management tests, became available to thousands of patients and clinicians on Navierre’s platform. Now, Navierre-partnered clinicians across the United States can seamlessly order these tests for their patients. Consumers can easily register for a profile on the platform by filling out a health questionnaire and requesting a test. Those clinical tests, Epi+Gen CHD and PrecisionCHD, only require a blood sample that can be collected in provider settings, at home or via mobile phlebotomy. This ease of collection will enable Cardio Diagnostics’ partnership with Navierre to leverage the growing telehealth market and revolutionize the patient cardiovascular care journey through earlier detection, accessible specialty care and personalized prevention. “We are thrilled to partner with Navierre to make our industry-leading cardiovascular clinical tests more widely available to patients and clinicians nationwide,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “Navierre’s innovative platform aligns with our mission to transform cardiovascular care through AI-driven precision diagnostics and personalized prevention strategies.” Cardiovascular Market Growth Nearly 50% of Americans live with diabetes, obesity, hypertension or another major cardiovascular risk, according to the Centers for Disease Control and Prevention (CDC). Cardiovascular disease is the leading cause of death worldwide, accounting for nearly 19 million deaths annually. This impact on a growing number of people across the world means the demand for cardiovascular diagnostics has never been higher. Companies in the field are in a position to achieve robust growth as they strive to meet the demand. Projections indicate a Compound Annual Growth Rate (CAGR) of 5.1% in the cardiovascular diagnostics market, whose market valuation is expected to reach $9.7 billion by 2033. This surge can be attributed to the escalating demand for sophisticated and accessible diagnostic technologies in the fight against cardiovascular diseases. Following this upward trend, the digital health and telehealth markets are poised for growth that has been fueled by the rapid adoption of telehealth services and the integration of AI technologies. The AI healthcare market, which is also poised for significant growth, had an estimated size of $22.45 billion in 2023, a number that’s expected to accelerate at a CAGR of 36.4%. Finally, the telehealth market, with a valuation of $128.12 billion in 2022, is forecasted to quadruple by 2030 to $504.24 billion. These developments have changed the healthcare landscape and underscore the Cardio Diagnostics-Navierre partnership’s positioning to capitalize on these market shifts. Navierre provides a digital health platform that can integrate Cardio Diagnostics’ tests into a broader telehealth ecosystem, expanding access and facilitating earlier cardiovascular risk detection. That means the flexibility of Cardio Diagnostics’ tests will pave the way for rapid nationwide scaling with minimal infrastructure barriers. Thus, the partnership could make specialty cardiology care more readily available for all communities, including those that are often underserved. By expanding the sites of care to telehealth and remote-enabled provider organizations, this partnership addresses the critical issue of increasing wait times for specialty care while democratizing access to top-tier heart disease services. This collaboration directly responds to current diagnostic methods' limitations, offering a scalable solution that extends to remote zip codes in the U.S. Advances In The Fight Against The Top Cause Of Death The COVID-19 pandemic has accelerated the adoption of digital health solutions, with the CDC reporting that 36% of adults used telehealth services in 2021. McKinsey & Company estimates that up to $250 billion of U.S. healthcare spending could be virtualized, representing about 20% of all Medicare, Medicaid and commercial outpatient, office and home health expenditures. This shift to digital health and AI-driven diagnostics could have a broad impact on the cardiovascular detection, care and management industry. Across the country, there is a need for more accessible and systemic healthcare solutions. This new partnership offers an important response to the goal of combating cardiovascular diseases globally while committing to health equity and access. “Cardio Diagnostics’ groundbreaking testing solutions are an exciting addition to our curated list of products and services we offer to our users,” said Mustafa Dinani, CEO and co-founder of Navierre. “By combining our innovative platform with their AI-driven precision diagnostics, we empower patients and clinicians with the tools they need to identify cardiovascular risk early when it can be most effectively addressed. Together, we are making significant strides in the fight against the world’s leading cause of death,” he said. Featured photo by Ali Hajiluyi on Unsplash 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/

April 12, 2024 08:45 AM Eastern Daylight Time

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Select Sector SPDR ETFs: A Strategic Approach to Precision Investing and Customized Portfolios

Select Sector SPDR

In the dynamic world of investing, Exchange-Traded Funds ( ETFs ) have proved to be a powerful tool for investors seeking diversification, flexibility, and potentially a more sector-driven approach. Select Sector SPDR ETFs offer a focused approach to sector investing, enabling investors to specifically target sectors within the broader market. This method of investment strategy is designed to arm investors with greater control and flexibility over their portfolios. Select Sector SPDR ETFs segment the S&P 500 into 11 investable sectors, covering all broad market segments. They provide access to various industries, allowing investors to craft a diversified portfolio that aligns with their unique investment goals. This approach presents an excellent opportunity for both individual and institutional investors to effectively navigate the financial markets. Each ETF comprises well-known, large-cap companies from the S&P 500, ensuring broad exposure and diversification. The transparent nature of ETFs allows for daily disclosure of portfolio holdings and weightings, providing investors with visibility into their investments. The full lineup of Select Sector SPDR ETFs includes: Communication Services Select Sector SPDR Fund (XLC) Consumer Discretionary Select Sector SPDR Fund (XLY) Consumer Staples Select Sector SPDR Fund (XLP) Energy Select Sector SPDR Fund (XLE) Financials Select Sector SPDR Fund (XLF) Health Care Select Sector SPDR Fund (XLV) Industrials Select Sector SPDR Fund (XLI) Materials Select Sector SPDR Fund (XLB) Real Estate Select Sector SPDR Fund (XLRE) Technology Select Sector SPDR Fund (XLK) Utilities Select Sector SPDR Fund (XLU) These ETFs provide flexible, transparent, and low-cost investment options to both retail and institutional investors. The flexibility offered by these ETFs empowers investors to make strategic adjustments in their portfolios as market conditions change. This flexibility, combined with the transparency of daily disclosure of portfolio holdings, allows investors to always be aware of where their money is invested. Select Sector SPDR ETFs offer a unique opportunity to invest in various sectors with precision and flexibility. They provide a simplified approach to sector investing, allowing investors to customize their portfolios to meet their specific investment objectives. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007439 EXP 5/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

April 12, 2024 05:00 AM Eastern Daylight Time

News Release

Most cannabis consumers would vote for pro-cannabis candidates regardless of party, new polling finds

NuggMD

A majority of cannabis consumers who are likely to vote this November would cast their ballot for a pro-cannabis presidential candidate regardless of that candidate’s party, according to a new poll that sheds light on how aligned cannabis consumers are as a voting bloc and what they think about this year's presidential election. When asked whether a presidential candidate’s endorsement of pro-cannabis policies would increase their likelihood of voting for that candidate, 59% of the respondents said: “Yes, this would make me more likely to vote for that candidate regardless of their party.” Just 14% of respondents said they are locked into voting for their party or candidate of choice. The poll was conducted by NuggMD.com, the largest telehealth platform for cannabis, using its own first-party data. The full results are available on the company’s website. It shows President Biden outperforming Donald Trump, 43% to 36%, among those who use cannabis regularly, a population of at least 35 million voting-age people. President Biden also polled well ahead of a generic Republican candidate, while Trump was roughly tied with a generic Democratic candidate. Concerning cannabis policy, the Democratic Party polled better than the GOP among this audience. Fifty-six percent of respondents said Democratic electeds have better ideas for cannabis policy, compared to 16% who said the same of Republicans. But this support is neither universal nor particularly intense. Nearly 40% of respondents indicated that they believe Democrats “want to suppress the legal use of cannabis,” while 68% said the same of Republicans. While 88% of respondents said understanding cannabis culture is a requirement for writing and passing effective cannabis legislation, 73% said elected officials in general currently lack that understanding. “This poll shows that adopting pro-cannabis policies can move more constituents into either party’s camp,” said Deb Tharp, head of legal and policy research at NuggMD. “This is a large voting population we’re talking about, and its demographics are changing quickly.” She continued: “Respondents say they’re motivated by policy commitments and wins, not by grievance politics, outrage, or red meat. The degree to which this emerging constituency is moveable, and how to move them, will probably come as a surprise to insiders of both parties. “To me, it signals that Republicans are shooting themselves in the foot by continuing to embrace the platform of prohibition. Democrats should double down on cannabis and expand their voting base by embracing full decriminalization and expungement for victims of targeted, unjust enforcement.” Methodology NuggMD.com conducted the poll digitally from March 25 to April 3 using a random sample of its first-party data. In total, 53,380 individuals were contacted and 755 completed the survey, resulting in a margin of error of 3.89% at a confidence level of 95%. Six swing states (n=120 in aggregate) were over-indexed. The full data set is available upon request. About NuggMD NuggMD is the nation's leading medical marijuana technology platform, serving patients in Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They've connected over 1,300,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit https://www.nuggmd.com. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

April 11, 2024 12:28 PM Eastern Daylight Time

Autonomix Medical (NASDAQ: AMIX) Is Cracking the Code Of The Peripheral Nervous System With Its Breakthrough Technology To Treat Diseases

Autonomix Medical, Inc.

By Faith Ashmore, Benzinga The peripheral nervous system (PNS) is the network of nerves that extend from the brain and spinal cord to all parts of the body. Its main function is to facilitate communication between the central nervous system (CNS) and the rest of the body. The PNS is divided into two components: the somatic nervous system, which controls voluntary movements and senses, and the autonomic nervous system, which controls involuntary bodily functions like heart rate and digestion. Simply put, the PNS plays a crucial role in nearly every disease because it is responsible for transmitting signals and information throughout the body. Overactive nerves, disruption, or dysfunction in the PNS can lead to a variety of health issues, including conditions like pain, cardiovascular disease, such as hypertension, as well as gastrointestinal disorders. While many biotechnology companies are looking to treat symptoms for various conditions, Autonomix Medical Inc. (NASDAQ: AMIX) is targeting the root of the issue, which they associate with the PNS. The company’s first-in-class technology platform includes a catheter-based microchip sensing array that can detect and differentiate neural signals and perform nerve ablations, killing the nerve. This technology has the ability to sense individual neural signals with up to 3,000 times greater sensitivity than currently available technologies. The company says this breakthrough technology opens new possibilities in electrophysiology and pain management. Autonomix Medical aims to provide a comprehensive solution that combines the detection and treatment of nerve-related disorders in a single procedure, streamlining the process and potentially improving patient outcomes. Unlike the conventional ablation approaches, Autonomix Medical reports that its technology works like a GPS, allowing doctors to identify, treat and verify the right nerves causing the issue. The company is initially evaluating pancreatic cancer pain to demonstrate the ability of its technology. With current treatment options, pancreatic cancer-related pain can be particularly challenging to manage because it is located near critical nerves and vessels, leading to severe and treatment resistant pain. Traditional pain treatments can often prove inadequate, leaving patients in need of more effective solutions; some patients turn to opioids for relief. If Autonomix Medical’s ongoing trial is successful, it could pave the way for the company to target larger disease markets and expand the total opportunity for their technology, which they estimate exceeds $100 billion. Additionally, Autonomix believes it has the potential to decrease nationwide reliance on opioids, which could be a win for patients and physicians alike. Featured photo by Stefano Bucciarelli on Unsplash Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

April 11, 2024 08:55 AM Eastern Daylight Time

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NRX’s (NASDAQ: NRXP) NMDA Modification Therapy And Its Multiple Applications From Mental Health To Chronic Pain

Benzinga

By Meg Flippin, Benzinga The nation may be in a mental health crisis, with many people from the young to the old suffering from depression, anxiety, PTSD and suicidal ideation. The latter is particularly true for patients with bipolar depression. The disease, which afflicts 2.8% of the U.S. population, is marked by high highs and low lows. Thoughts of suicide accompany the depressive lows for nearly half of sufferers. Devastatingly, between 4% to 19% will commit suicide. There are medicines available to help manage the highs and lows of bipolar disorder, but not a single-dose treatment. Typically, it requires one to manage mania and another for depression. They may not work for everyone and come with their own set of side effects. Modifying The NMDA Receptor NRx Pharmaceuticals Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, believes it has the answer with NRX-101. It’s the biopharmaceutical company’s FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company is targeting life-threatening diseases that often go untreated with NRX-101, which is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist. Combined, the drugs target the NMDA receptor which is critical for memory function and the formation of new thoughts in the brain. At excessive rates of NMDA activity, ideas including the creation of new ones are slowed down. People with bipolar disorder tend to ruminate on fewer and more negative thoughts in that state. When the NMDA channel is blocked, thoughts can flow rapidly and incoherently, leading to hallucinations and psychosis. The challenge is to strike a healthy balance between the two. By modulating the NMDA, NRx believes it can improve the function of the thought-forming cells in the brain and thus reduce suicidal ideation. If approved by the U.S. Food and Drug Administration (FDA) and other health regulatory agencies, the company says it would be the first medicine regimen targeted to treat severe bipolar depression in patients with both acute and sub-acute suicidal ideation or behavior (ASIB and SSIB). Trial Over-Enrolled The company is taking steps to make that a reality, recently completing enrollment of a phase 2b/3 study of NRX-101 for 74 patients suffering from bipolar disorder. Enrollment exceeded the original target of 70 patients, to enhance the statistical power of the study, NRx said. Top-line data is expected later this month. "To our knowledge, NRX-101 is the first and only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression,” said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. “On the basis of our previous trial, it was awarded Breakthrough Therapy Designation by the FDA and we aim to confirm its effect on depression and suicidal ideation in this trial.” NRX teamed up with Alvogen Pharmaceuticals for the development and marketing of the combined therapy. During its fourth quarter, NRx said Alvogen advanced its first $5.1 million milestone payment. A successful readout from the phase 2b trial and FDA interaction will trigger an additional $4 million milestone payment together with the transfer of future development costs to Alvogen. The partnership provides for potential milestones of $329 million and a royalty reaching 15% on net sales, according to NRx. Beyond Bipolar Disorder It’s not just bipolar disorder that NRx is aiming to treat with its NMDA therapy platform. The company is making inroads in using its lead compound in chronic pain, betting results of a 200-person efficacy trial conducted by Northwestern University could create a multibillion-dollar opportunity for NRx. Chronic pain is another condition that plagues more than 50 million Americans in which the available treatments have mixed results. Then there’s its new drug application for IV ketamine in acute suicidality. NRx said it is building a specialty pharmaceutical business around ketamine it expects to yield positive cash flow by the end of 2024. Called HOPE Therapeutics, NRx plans to submit a new drug application with the FDA this year. In advance of FDA approval, HOPE partnered with national 503b and 503a pharmacies to address the ketamine shortage reported by the FDA since 2018. The goal is to spin HOPE out into a stand-alone company owned by NRx, current NRx shareholders via a tax-free dividend and new investors. NRx said prospective anchor investors offered $60 million in new investment dollars once HOPE is publicly listed. NRx said HOPE is presenting data from four randomized, prospective trials demonstrating safety and efficacy in 800 patients as the clinical basis for its new drug application (NDA) for HTX-100 (IV Ketamine). And if that’s not enough, NRx recently received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. It's a condition the company says affects 3 million people in the U.S. resulting in over 15,000 deaths annually. NRx is currently seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101. "2023 was a pivotal year for NRx in which we advanced from a single clinical trial in a single indication to a dramatically streamlining operation with a 50% reduction in overhead costs, a 25% reduction in overall costs and a $0.20 per share improvement in negative earnings, while completing our clinical trial objectives,” says Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. ‘We expect data from two key trials this month and predict our first commercial revenue by the end of 2024.” Featured photo by Fernando @cferdophotography on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 11, 2024 08:40 AM Eastern Daylight Time

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Elicio Therapeutics (NASDAQ: ELTX) Makes Strides In Growing Cancer Vaccination Industry

Benzinga

By Jeremy Golden, Benzinga Founded in 2011, Elicio Therapeutics Inc. (NASDAQ: ELTX) has made several significant strides in the last 13 years. The immunotherapy company has completed multiple successful preclinical trials and has been featured in publications like Nature Medicine and Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR). With promising potential treatments in its pipeline, Elicio Therapeutics’ future seems even brighter than the achievements it made in its past. AMP Platform For Cancer Immunotherapies Elicio Therapeutics is working to re-engineer the body’s immune response to defeat cancer and infectious diseases with potent lymph node-targeted immunotherapies and vaccines. This approach differentiates Elicio from its competitors and could be highly promising for enhancing anti-tumor immune responses and improving therapeutic efficacy. Elicio’s proprietary Amphiphile or “AMP” platform is being used in the development of cancer immunotherapies for patients facing limited treatment options and often poor outcomes. The platform combines expertise in materials science and immunology to develop novel immunotherapies, including cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. Key immune cells are located in the lymph nodes – critical sites that are not engaged by conventional immunotherapies. AMP is built for targeted delivery of payloads to the lymph nodes, guiding the payloads into the lymphatics. This approach is intended to harness the natural ability of the lymph nodes to enhance the magnitude, potency and durability of immune responses to drive antitumor activity. Through this platform, Elicio Therapeutics has developed an innovative pipeline of cancer immunotherapies with the potential to address critical unmet needs, with three vaccine candidates currently in its pipeline: ELI-002, ELI-007 and ELI-008. ELI-002 is Elicio’s lead investigational asset, targeting Kirsten rat sarcoma (KRAS) driven cancers caused by a mutation of the KRAS gene designed to stimulate an immune response against the seven KRAS mutations driving 25% of solid tumors. While early mKRAS-targeting efforts in the clinical setting show promise, there remains a considerable unmet need for the development of effective therapies. Many traditional vaccines and immunotherapies do not target the lymph nodes. Small molecule-based immunomodulators easily pass through the blood vessel walls at the injection site. As a result, they are rapidly flushed away into the systemic circulation, limiting access to the lymph nodes. Often, this results in a failure to realize the full potential of the immune response. Worse yet, it can lead to the development of dangerous toxicities at other sites in the body. This is where ELI-002 stands out from previous methods. A structurally novel AMP therapeutic vaccine, ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and AMP-modified immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph nodes to enhance the action of key immune cells and educate T cells on how to recognize and eliminate cancer cells. Early clinical studies have shown encouraging results. In a preliminary phase 1 ( AMPLIFY-201 ) study involving patients with pancreatic and colorectal cancers, the vaccine elicited strong T cell responses, with most patients having reduced tumor biomarkers and some having complete clearance following treatment with ELI-002 monotherapy. Increased Awareness Of Cancer Vaccines Is Leading To Market Growth The global cancer vaccine market size was estimated at $7.31 billion in 2022, Grand View Research reports. It’s expected to grow at a compound annual growth rate (CAGR) of 11.04% by 2030. With the rising prevalence of cancer and increased awareness about cancer vaccination, the market is growing amid a rise in government funding and investments. In January, Elicio presented a Trial in Progress poster on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium in San Francisco, California. The poster describes the phase 1 and randomized phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”). In addition, the company announced that the first patient had been dosed as part of the randomized phase 2 ( AMPLIFY-7P ) study of ELI-002 7P. Initial interim data on ELI-002 7P monotherapy from the phase 1A arm is expected to be shared in the second quarter of 2024, the company said. Featured photo by Louis Reed on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 11, 2024 08:30 AM Eastern Daylight Time

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Futura Medical targets global expansion with Eroxon, eyeing profitability in 2024

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder tells Proactive's Stephen Gunnion about a strategic shift and refresh for the company in 2023, marked by the successful launch of Eroxon in the UK and Belgium, generating £3.1 million in revenues, FDA marketing authorisation in the US, and an exclusive marketing rights deal with Haleon for Eroxon in America. These achievements have broadened Futura's global distribution network to approximately 80%, excluding China. The company aims to establish a new sexual health category within the OTC market, leveraging Futura's R&D expertise. The specific launch date in the US with Haleon remains undisclosed due to competitive sensitivities, targeted within a year from the end of February. Pre-launch processes involve ensuring manufacturing capacity, engaging key opinion leaders, product positioning considering cultural sensitivities, and aligning with retailer schedules. Objectives for this year include expanding into at least 14 new countries in the first half, exploring opportunities in Asia, particularly China, and extending Eroxon's product range while focusing on cost management. Barder, reflecting on Futura's transition from a loss-making R&D firm to a pathway towards profitability, expresses optimism for continued progress in 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 11, 2024 07:10 AM Eastern Daylight Time

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LightPath Technologies announces commercialization for BlackDiamond-NRL Based New Infrared Glass

LightPath Technologies Inc

LightPath Technologies CEO Sam Rubin joined Steve Darling from Proactive to announce the commercial release of the company's newest BlackDiamond-NRL infrared glass, BDNL-4. This material represents a significant advancement and is a crucial component of the chalcogenide glass series licensed from the US Naval Research Laboratories (NRL), serving as a substitute for Germanium. Rubin explained to Proactive that BDNL-4 possesses a negative thermo-optic coefficient, a critical characteristic for creating athermalized systems. This feature enables the design of devices that remain unaffected by temperature changes. Furthermore, BDNL-4 is a genuine multi-spectral material suitable for use across short-wave infrared (SWIR), mid-wave infrared (MWIR), and long-wave infrared (LWIR) imaging bands. LightPath offers antireflective and protective DLC coatings for all its Chalcogenide materials, including BDNL-4. After years of development at NRL, BDNL-4 is exclusively licensed to LightPath. The company anticipates that BDNL-4 could become a pivotal material for thermal cameras used in drones and other systems requiring operation across a wide range of temperatures. This launch is particularly significant in light of export restrictions imposed on Germanium and Gallium by China, underscoring the strategic importance of BDNL-4 as a viable alternative. Contact Details Proactive North America Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

April 10, 2024 09:32 AM Pacific Daylight Time

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With Rise In Pancreatic Cancer, Oncotelic Therapeutics (OTCQB: OTLC) Opens Up Enrollment For STOP-PC Clinical Trial

Benzinga

By Faith Ashmore, Benzinga Unfortunately, an increase in early-onset pancreatic cancer has garnered significant media attention lately. From 2010-2019, gastrointestinal cancer rates jumped almost 15% for people under 50, alarming doctors around the globe. With only a 12% five-year survival rate, pancreatic cancer is anticipated to become the second leading cause of cancer-related deaths in the U.S. by 2030. It is projected that 64,440 Americans will receive a pancreatic cancer diagnosis in 2024. In 2022, the global market for pancreatic cancer was valued at $2.22 billion, and it is projected to reach approximately $7.91 billion by 2032. This highlights a crucial need for more therapeutic options for pancreatic cancer. Oncotelic Therapeutics (OTCQB: OTLC), a therapeutics company with a focus on cancer and viral infection treatments, is attempting to provide more hope for Americans who are facing a pancreatic cancer diagnosis. The company’s lead immuno-oncology drug candidate is OT-101. Oncotelic Therapeutics says it is showing promise in the treatment of deadly cancers like pancreatic cancer. It is a first-in-class anti-TGF-β RNA therapeutic that inhibits a protein called Transforming Growth Factor Beta (TGF-β). TGF-β is known to suppress the immune system, help cancer cells evade the immune system and increase the growth and spread of cancer cells. Clinical Trial For OT-101 Phase 2 studies of OT-101 have shown promising results in treating pancreatic cancer, melanoma and glioblastoma, with strong efficacy and safety outcomes among treated patients. Pancreatic cancer is one of the most highly aggressive types of cancer that can be difficult to treat and has a high unmet need. Oncotelic Therapeutics is now seeking participants for its upcoming STOP-PC clinical trial. The trial aims to evaluate the effectiveness of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in combination with mFOLFIRINOX compared to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. Previous data has shown that OT-101 has significant activity as a standalone treatment, with reported overall survival rates surpassing existing drug outcomes. In this phase 2/3 trial, participants will be assigned to either receive OT-101 plus mFOLFIRINOX or mFOLFIRINOX alone as second-line therapy after their cancer has progressed. "STOP-PC trial is the combination of mFOLFIRINOX and OT-101 based on our demonstration that reduced TGF- β2 resulted in outstanding improvement in survival among patients treated with Irinotecan with survival beyond 34 months for the low TGF-β2 expression cohort. The mFOLFIRINOX was chosen as the most well tolerated combination of choice through discussion with regulatory authorities and key opinion leaders. We believe this trial will deliver the decisive win against pancreatic cancer," said Dr. Vuong Trieu, CEO of Oncotelic. To learn more about participation in STOP-PC Clinical Trial click here or watch this explainer video here. Featured photo by Alexander Grey on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 10, 2024 08:30 AM Eastern Daylight Time

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