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MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing On Early Clinical Efficacy Demonstration For Neuropathic Pain In 2025

MIRA Pharmaceuticals, Inc.

By Meg Flippin, Benzinga MIRA Pharmaceuticals (NASDAQ: MIRA), the pre-clinical-stage pharmaceutical company focused on transforming the treatment of neuropathic pain and mental health disorders through scientific research and technological advancements, is making progress in its clinical development planning for Ketamir-2, its novel oral ketamine analog. So much so that the company said that, as part of its strategic development plan, it’s prioritizing early demonstration of Ketamir-2’s clinical efficacy. That could come as early as 2025 through innovative phase 1/2 study designs. What’s more, the company said it's on track for Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) in December 2024. "Our primary goal is to demonstrate efficacy in humans as quickly as possible," says MIRA Pharmaceuticals chairperson and CEO Erez Aminov. "By implementing specific study designs and leveraging our ongoing preclinical research, we aim to gather early evidence of clinical benefits, positioning our treatment as a transformative option for neuropathic pain." To bolster its approach to clinical and regulatory approval, MIRA said it brought on a consultant with expertise in navigating academia and regulatory bodies, including the Federal Drug Administration. The company said this addition demonstrates that it is serious about meeting the highest standards in clinical development and regulatory compliance. Ketamir-2’s Approach To Fighting Neuropathic Pain and Depression Ketamir-2 is an oral ketamine analog designed to be taken as a pill. It is being investigated for the treatment of neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDDSI) and PTSD. Unlike traditional ketamine, which requires intravenous administration, posing accessibility and safety challenges, Ketamir-2 could potentially simplify and improve the treatment experience. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression, cancer-related neuropathic pain and diabetic neuropathy. These conditions often have limited treatment options and significant patient populations needing effective therapies. Neuropathic pain alone is a big market, poised to reach over $14 billion by 2034, growing at a CAGR of 5.7% from now until then. Driving demand for drugs to relieve pain is an aging population in the U.S. and an increase in chronic diseases. Collaborating To Speed Time To Market To get testing underway, MIRA Pharmaceuticals said it is collaborating with Formulex, a nano-technology-based drug delivery company, to develop ways to deliver Ketamir-2. The two focus on a spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience. A deterrent to more people using ketamine to treat mental health issues and chronic pain is the delivery. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including requiring intravenous administration under medical supervision, making it less accessible and more costly for patients. In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option. By reducing the need for medical supervision and hospital visits, MIRA Pharmaceuticals says Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Phase I Trial Kicking Off Soon Through the phase I/II study designs MIRA is focused on demonstrating the clinical activity in treating neuropathic pain and potentially other neurologic conditions. The idea is to gather data that can drive faster decision-making and potentially expedite patient access, the company said. The phase 1 clinical trial is slated to kick off in the first quarter of 2025 and will be used to assess safety, tolerability and pharmacokinetics in humans. MIRA says that lays the groundwork for subsequent efficacy studies. MIRA collaborates with international academic research institutes to refine and enhance its clinical development strategy. “We are excited to move smoothly forward with our IND-enabling pre-clinical studies towards Phase I trials, which are designed to provide critical insights into the safety and pharmacokinetic profile of our candidate,” said Dr. Angel, chief scientific advisor at MIRA Pharmaceuticals. “This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards.” Featured photo by Towfiqu barbhuiya on Unsplash. MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”). The statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2 and MIRA-55. Any forward-looking statements are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michelle Yanez +1 305-340-8988 Myanez@mirapharma.com Company Website http://www.mirapharmaceuticals.com/

September 19, 2024 09:00 AM Eastern Daylight Time

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Industry Update: 3 Exciting Precision Oncology Players to Watch Following Summit’s Meteoric Rise: Silexion, Nuvectis, Scorpian

Global Markets News

Summit Therapeutics (NASDAQ: SMMT) recently captured headlines with the release of its Phase 3 data for ivonescimab, a targeted NSCLC therapy that has generated substantial buzz. The results from its trial conducted in China showed a dramatic 49% reduction in the risk of disease progression or death compared to Merck’s Keytruda, signaling a potentially disruptive force in NSCLC treatment. However, the news wasn’t without its concerns—since the trial data originates from China, there are questions about its applicability to broader, global populations. As noted by BMO Capital Markets’ Evan Seigerman: “Results may or may not be generalizable beyond the China-focused patient population initially assessed.” Despite this, Summit’s valuation has risen by over 100%, now approximating $19 billion. With such a high valuation, the company could see limited room for further significant gains, leading many in the industry to explore other emerging opportunities in precision oncology. Alongside Summit, there are quite a few other players in the field. Some if these companies have even already shown promising initial results and could see similar success in the future if they were to report positive results. These emerging players are worth watching for those interested in following precision oncology drug candidates and pipelines. Among them are precision oncology innovators such as Silexion Therapeutics, Nuvectis Pharma, and Scorpion Therapeutics, which we discuss below. Silexion Therapeutics: Disrupting the KRAS-Driven Cancer Space Silexion Therapeutics (NASDAQ: SLXN) is another under-the-radar player in the precision oncology space, with a focus on KRAS-driven cancers—a notoriously difficult target in oncology. While current small-molecule KRAS inhibitors are making progress, they are often limited to specific mutations, such as KRAS G12C, which accounts for a small percentage of cancers. Silexion’s RNA interference (RNAi) approach offers a broader solution, targeting a wider spectrum of KRAS mutations, particularly in pancreatic cancer, one of the deadliest and most treatment-resistant cancers. At the heart of Silexion’s approach is its LODER™ platform, which delivers siRNA directly to the tumor site, silencing KRAS mutations at the genetic level. This localized delivery not only increases efficacy by concentrating the treatment in the tumor, but it also reduces systemic side effects. Silexion’s next-generation candidate, SIL-204, is an optimized siRNA formulation designed to target pan-KRAS G12x mutations, positioning it to treat a broader range of KRAS-driven cancers beyond pancreatic cancer, such as lung and colorectal cancers. In Phase 2 trials for locally advanced pancreatic cancer, Silexion's LODER™ platform showed a 9.3-month improvement in overall survival when combined with standard chemotherapy. Additionally, the objective response rate (ORR) increased from 20% with chemotherapy alone to 55% with the combination, and in some cases, tumors that were initially non-resectable became operable after treatment with LODER™. These results are especially encouraging given the limited options available for pancreatic cancer patients. SIL-204, is expected to enter Phase 2/3 clinical trials in 2025-2026. What makes Silexion particularly intriguing is its current market valuation. Valued at aproximatly just ~$9 million following its SPAC merger, the company’s valuation could be perceived as low when compared to some of its peers, especially given its innovative technology and promising clinical achievements. Some have wondered whether this low valuation has more to do with dynamics post-SPAC companies. If Silexion can report positive results in its later-stage trials, the company’s outlook could dramatically improve, reflecting the potential of its RNAi-based platform. Like NXP900, SIL-204 could potentially have vast applications across multiple KRAS-driven cancer types, making Silexion a company to watch closely as it advances through clinical development. Nuvectis Pharma: Targeting NSCLC and Beyond by Inhibiting SRC/YES1 Kinases Nuvectis Pharma (NASDAQ: NVCT) has been quietly making strides in the precision oncology sector, developing innovative therapies aimed at overcoming treatment resistance in hard-to-treat cancers. Its lead candidate, NXP900, targets NSCLC by inhibiting the SRC/YES1 kinases, which play critical roles in cancer cell survival and resistance to current therapies. This approach positions NXP900 as a potential game-changer in the treatment of NSCLC, particularly in patients who have developed resistance to EGFR and ALK inhibitors, such as AstraZeneca’s Tagrisso and Novartis’ Alecensa. NXP900 is still in the early stages of clinical development, currently undergoing Phase 1 trials. However, preclinical studies have already shown that it has strong anti-tumor activity in resistant NSCLC models. Even more promising is its potential application beyond NSCLC. Like Summit's ivonescimab, NXP900 focuses on resistance, but it also has broader applications due to its ability to target multiple cancer types driven by SRC/YES1 pathways. This versatility makes it a promising asset not just for NSCLC but also for other difficult-to-treat cancers like squamous cell carcinomas. In addition to NXP900, Nuvectis is advancing NXP800, another precision oncology candidate that is further along in the clinical development process. NXP800 is currently in Phase 1b trials, targeting ARID1a-mutated cancers such as ovarian and endometrial cancers. The early clinical data for NXP800 is promising, showing positive responses in patients with platinum-resistant ovarian cancer. With two strong candidates in the pipeline, Nuvectis is positioning itself as a formidable player in the precision oncology landscape. As Summit’s ivonescimab continues to gain attention, Nuvectis’ earlier-stage NXP900, with its NSCLC focus and beyond, could see similar success in the future if clinical results continue to trend positively. Scorpion Therapeutics: Pioneering Mutant-Selective Therapies Scorpion Therapeutics is redefining the frontier of precision oncology with its focus on delivering highly selective small molecules targeting validated and previously undruggable cancer mutations. Its lead candidate, STX-478, is a mutant-selective, allosteric PI3Kα inhibitor currently in Phase 1/2 trials for advanced solid tumors. Early data presented at the ESMO Congress 2024 highlighted its potential, with STX-478 demonstrating a 23% overall response rate in breast cancer and a 21% response rate across all tumor types, positioning it as a potentially best-in-class PI3Kα inhibitor. STX-478 is notable for its ability to spare wild-type PI3Kα activity in normal tissues, avoiding the toxicities seen with previous PI3Kα inhibitors, such as hyperglycemia and rash. Tumor reductions were seen in 72% of patients treated with STX-478 as a monotherapy, with circulating tumor DNA levels dropping in 86% of patients. This mutant-selective precision could help overcome the limitations of existing PI3Kα inhibitors, which have struggled with dose-limiting toxicities. In July 2024, Scorpion raised $150 million in a Series C financing round, co-led by Frazier Life Sciences and Lightspeed Venture Partners. The additional funding will support the advancement of STX-478 and other pipeline assets, positioning Scorpion for further clinical success. Scorpion’s pipeline includes a broad range of wholly-owned compounds that target both validated and novel cancer targets, positioning the company for future expansion into larger patient populations. As STX-478 progresses through clinical development, Scorpion is poised to become a significant player in the precision oncology space, making it another company worth watching closely. Optimistic Outlook for Precision Oncology The precision oncology space is experiencing a golden era of innovation, with companies like Summit Therapeutics, Nuvectis Pharma, Silexion Therapeutics, and Scorpion Therapeutics leading the charge. As the focus shifts towards targeted therapies that address resistance mechanisms, the market is increasingly favoring companies with novel approaches and broad applications. Summit’s meteoric rise has shown that there is tremendous potential for companies that can demonstrate efficacy in overcoming cancer resistance. While Summit has already captured much of the current attention, companies like Nuvectis, Silexion, and Scorpion, with their earlier-stage pipelines, offer exciting opportunities for the industry to keep a close eye on. As these companies continue to report clinical data and advance through trials, the potential for breakthroughs in treating some of the most difficult cancers grows stronger. With targeted therapies offering the possibility of overcoming resistance without the need for chemotherapy, the future of cancer treatment looks brighter than ever. For those in the oncology space, keeping a close eye on emerging players like Nuvectis, Silexion, and Scorpion could lead to transformative developments as the field of precision oncology continues to evolve. * * * This update may include speculative forward looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. the BioTech and Pharma industries are volatile and risky and readers are advised to seek out preffesional advice in the relevent feilds from licensed profesionals. This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [ https://justpaste.it/ch2qt/pdf ]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

September 19, 2024 07:45 AM Eastern Daylight Time

Potential Catalyst Right Around The Corner? CMS To Announce Preliminary Medicare Payment For Cardio Diagnostics' Heart Disease Tests

Cardio Diagnostics Holdings, Inc

By James Blacker, Benzinga Cardio Diagnostics (NASDAQ: CDIO), the company leveraging AI to revolutionize cardiovascular disease prevention with precision epigenetics, is awaiting a crucial decision that could be a major factor in the commercial success of its flagship heart disease tests. In June of this year, the company attended an annual meeting hosted by the Centers for Medicare and Medicaid Services (CMS), where healthcare companies presented the prices they think Medicare should pay for their products and the rationale for their recommendation. At this meeting, Cardio Diagnostics submitted information and pricing recommendations for its two cutting-edge tests: Epi+Gen CHD and PrecisionCHD. Now, the company is awaiting the next important step – the CMS is expected to release its proposed payment determinations in September, based on the timeline posted by the CMS on its website. These preliminary determinations are based on the information from said annual meeting, public comments and the recommendations from the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel. The final determinations are expected in November. "Our cutting-edge tests represent a significant advancement in the prevention, detection and management of coronary heart disease, and we are committed to making them accessible to Medicare beneficiaries," stated Meesha Dogan, PhD, CEO and Co-Founder of Cardio Diagnostics. A Trilogy Of AI-Powered Solutions For Heart Disease According to the CMS, heart disease is the leading cause of death among Medicare beneficiaries. Coronary heart disease (CHD) is the most common type of heart disease and the primary cause of heart attacks, killing 371,506 people in the U.S. in 2022. Recognizing the urgent need for advanced diagnostic tools, Cardio Diagnostics has developed state-of-the-art solutions to assess risk for, detect, manage and monitor CHD. Epi+Gen CHD is an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to assess the three-year risk for a symptomatic CHD event, while PrecisionCHD aids in diagnosing the condition. Both tests have already been assigned unique CPT codes by the American Medical Association, 0439U and 0440U, respectively, which became effective in April 2024. Coupled with the Epi+Gen CHD and PrecisionCHD tests is the Actionable Clinical Intelligence (ACI) provider-facing platform, which provides personalized insights by linking the epigenetic and genetic biomarkers evaluated by these tests to the drivers of coronary heart disease. With the crucial decision from the CMS expected this month, Cardio Diagnostics is on the brink of a breakthrough that has the potential to bring its heart disease tests one step closer to being widely accessible to Medicare patients, potentially saving the lives of millions. Click here to find out more about Cardio Diagnostics. Featured photo by Jean-Louis Paulin 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/

September 17, 2024 09:00 AM Eastern Daylight Time

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New Immuno-Oncology Research Team in Partnership with Ono Pharmaceutical Starts at BioMed X Institute

BioMed X Institute

BioMed X, a German biomedical research institute, announced the start of a new research team at the BioMed X Institute in Heidelberg, Germany, the institute’s first joint research project with the Japanese company Ono Pharmaceutical Co., Ltd. The scope of this project is to investigate the antitumor effects of neutrophils to develop novel next-generation immunotherapies. The presence of neutrophils in solid tumors has been well-documented, albeit their role in the tumor microenvironment seems paradoxical according to the current data. “We know far more about T cells in the context of immunotherapy than we know about neutrophils, but distinct immune cell types, including neutrophils, seem to have a potential to exert antitumor effect, while their biology remains unclear. By understanding neutrophil biology in depth, we aim to develop a wider range of effective therapies for cancer patients” explains Dr. Stefanie Bärthel, the group leader of the new research team in partnership with Ono Pharmaceutical. Dr. Bärthel, a Klaus Tschira Boost Fund Fellow in 2023, was a senior scientist at the German Cancer Research Center (DKFZ) in Heidelberg and the Center for Translational Cancer Research (TranslaTUM) in Munich before joining BioMed X as a group leader. “We are delighted to form a team of outstanding scientists with unique ideas on neutrophil-based immunotherapy through our innovative partnership with BioMed X. We believe that the research undertaken by this team will pave the way for the development of groundbreaking treatments,” said Dr. Seishi Katsumata, Corporate Officer/Executive Director, Discovery & Research at Ono Pharmaceutical. “This is our first research team in collaboration with a Japanese company. We are honored by the trust placed in us by Ono Pharmaceutical and look forward to extending our network of collaborators in Japan,” added Dr. Christian Tidona, Founder and Managing Director of the BioMed X Institute. The new research team will join nine other research groups at the BioMed X Institute in Heidelberg, Germany, and two research groups overseas, one at the BioMed X Institute in New Haven, CT, and one at XSeed Labs, a new type of innovation accelerator on the campus of the pharmaceutical company Boehringer Ingelheim in Ridgefield, CT. To read more about research and innovation at BioMed X, visit their website: www.bio.mx. About BioMed X BioMed X is an independent research institute with sites in Heidelberg, Germany, New Haven, Connecticut, XSeed Labs in Ridgefield, Connecticut, and a worldwide network of partner locations. Together with our partners, we identify big biomedical research challenges and provide creative solutions by combining global crowdsourcing with local incubation of the world’s brightest early-career research talents. Each of the highly diverse research teams at BioMed X has access to state-of-the-art research infrastructure and is continuously guided by experienced mentors from academia and industry. At BioMed X, we combine the best of two worlds – academia and industry – and enable breakthrough innovation by making biomedical research more efficient, more agile, and more fun. About Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. ONO focuses its research on oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at www.ono-pharma.com/en. Contact Details BioMed X Institute Flavia-Bianca Cristian +49 6221 42611706 fbc@bio.mx Company Website https://www.bio.mx/

September 17, 2024 06:00 AM Eastern Daylight Time

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Join Benchmark International's Exclusive Webinar "Seller Motivation: What Goes Into the Decision to Sell?"

Benchmark International

Are you considering selling your business? Deciding when and why to sell is one of the most significant decisions you’ll ever make as a business owner. While maximizing financial proceeds is often at the forefront of these decisions, it’s essential to recognize that it’s not the only factor. Life circumstances, time with family, and other qualitative considerations can often outweigh financial gain. To help you navigate this complex process, we invite you to join our upcoming webinar: Seller Motivation: What Goes Into The Decision To Sell? Space is filling up fast, so register today! Why You Should Register Selling a business is about more than just crunching the numbers. In this exclusive webinar, you’ll gain valuable insights into the full spectrum of motivations that drive business owners to sell. Understanding these motivations can help you make a well-rounded and informed decision about your business’s future. This webinar is a must-attend for business owners contemplating the sale of their business, particularly in today’s strong but disciplined market. By attending, you’ll be better equipped to evaluate both the financial and personal factors that play a crucial role in this life-changing decision. Whether you’re focused on securing a comfortable financial future or prioritizing time with loved ones, the information presented will help you weigh these considerations effectively. Spots are limited, so don’t miss this opportunity to secure your spot. What You’ll Learn This webinar offers actionable insights into the decision-making process for business owners. Here’s what you can expect to learn: The wide range of reasons why business owners choose to sell, beyond just financial incentives How personal life events, such as family needs and future aspirations, can influence your decision A look at the current M&A market and how buyers are approaching valuations How to balance personal and financial goals using the concept of indifference curves, which help weigh non-monetary values like time with family against financial returns By attending, you’ll gain the tools to make a decision that aligns with your long-term vision—both personally and financially. Spots Are Filling Fast – Register Now! If you’re ready to gain clarity on your motivations for selling and align your decision with both your personal and financial goals, this is the webinar for you. Don’t miss out—register now and take the first step toward making a well-informed, strategic decision about the future of your business. ABOUT BENCHMARK INTERNATIONAL: Benchmark International is a global M&A firm that provides business owners with creative, value-maximizing solutions for growing and exiting their businesses. Benchmark International has handled over $11 billion in transaction value across various industries from offices across the world. With decades of M&A experience, Benchmark International’s transaction teams have assisted business owners with achieving their objectives and ensuring the continued growth of their businesses. The firm has also been named the Investment Banking Firm of the Year by The M&A Advisor and the Global M&A Network as well as the #1 Sell-side Exclusive Privately-held M&A Advisor in the World by Pitchbook and Refinitiv's Global League Tables. Contact Details Brittney Zoeller +1 813-898-2350 zoeller@benchmarkintl.com Company Website https://www.benchmarkintl.com/

September 16, 2024 09:54 AM Eastern Daylight Time

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Could Nuvectis Pharma be the Next Summit Therapeutics? A New Report Highlights NXP900's Approach to NSCLC Treatment

Global Markets News

A new report by PESG Research highlights Nuvectis Pharma's (NASDAQ: NVCT) drug candidate NXP900 and its potential role in the treatment of Non-Small Cell Lung Cancer (NSCLC). The review focuses on NXP900's unique approach to addressing critical challenges in cancer therapy resistance. NXP900 is positioned as a potential significant player in NSCLC treatment, comparing its approach to Summit Therapeutics' ivonescimab. NXP900's mechanism of action targets SRC/YES1 kinases in EGFR and ALK resistant NSCLC patients, offering a novel approach to overcoming treatment resistance. Preclinical studies, as noted in the report, indicate that NXP900 could enhance the efficacy of existing therapies like AstraZeneca's osimertinib (Tagrisso) when used in combination. The report also mentions NXP900's potential beyond NSCLC, including possible applications in other cancers such as squamous cell carcinoma. Context: The Current NSCLC Treatment Landscape The report comes at a time of significant developments in NSCLC treatment. Recently, Summit Therapeutics (NASDAQ: SMMT) made headlines with its drug ivonescimab, which showed promising results in a Phase 3 trial conducted in China. In this trial, ivonescimab outperformed Merck's Keytruda (NYSE: MRK), a current standard of care in many NSCLC cases. This breakthrough has intensified interest in novel approaches to NSCLC treatment, particularly those addressing resistance mechanisms. The report highlights the different approaches being developed to tackle NSCLC. While Summit's ivonescimab targets PD-L1 expression, Nuvectis' NXP900 focuses on EGFR and ALK mutations. The report suggests that this diversity in treatment approaches could be important in providing comprehensive options for NSCLC patients. Nuvectis Pharma's NXP900: Current Status and Potential NXP900 is currently in Phase 1 clinical trials, with a focus on safety and pharmacokinetics evaluations. The report emphasizes the preclinical data supporting NXP900, noting its activity against NSCLC models resistant to standard treatments and its potential synergistic effects when combined with existing therapies. A key feature of NXP900, as highlighted in the report, is its ability to inhibit both catalytic and scaffolding functions of SRC and YES1, which are described as key drivers of cancer cell survival. Implications for Cancer Treatment The Report underscores a trend in oncology: the focus on overcoming treatment resistance. It notes that as patients face progression despite initial responses to immunotherapies or targeted treatments, there's a growing need for novel approaches. NXP900's approach to targeting SRC/YES1 kinases seems is positioned as a unique strategy strategy compared to other emerging therapies. This diversification of approaches could be important in providing multiple avenues to tackle the complex mechanisms of treatment resistance. Conclusion The report provides an in-depth look at Nuvectis Pharma's NXP900, positioning it as a noteworthy development in the field of NSCLC treatment. While acknowledging the early stage of NXP900's development, the report highlights its unique mechanism of action and potential to address treatment resistance. The report suggests that as the landscape of NSCLC treatment continues to evolve, NXP900 represents one of several innovative approaches aiming to improve outcomes for cancer patients. As with all early-stage drug candidates, the full potential of NXP900 will only become clear as it progresses through clinical trials and further research. Click here to review the full report: https://finance.yahoo.com/news/pesg-releases-report-nuvectis-pharma-111500319.html * Please make sure to refer to the full dislcaimers and disclosures linked in the report itself when reading it. *** This news alert may include speculative forward looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. the BioTech and Pharma industries are volatile and risky and readers are advised to seek out preffesional advice in the relevent feilds from licensed profesionals. *** This news alert is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [https://justpaste.it/fcm9n/pdf]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news related to innovative companies and industries and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

September 16, 2024 08:45 AM Eastern Daylight Time

UNOS fires back at defamatory statements that it has acted unlawfully

United Network for Organ Sharing

The United Network for Organ Sharing (UNOS) is a private non-profit organization focused on saving lives. Its mission is to help patients and their families who are in desperate need of organ donation. But some members of the donation and transplant community continue to malign and defame UNOS, accusing our organization of unlawful behavior. It must stop. At a hearing of the House Energy and Commerce Committee’s Oversight Subcommittee on Sept. 11 to discuss HRSA’s implementation of the Organ Procurement and Transplantation Network (OPTN) reform law, several witnesses made false statements under oath alleging violations of the law by UNOS while the non-profit served as OPTN. These individuals were able to produce no evidence of their claims, because it does not exist. To be clear: UNOS has never engaged in any unlawful behavior. Any statement to the contrary is outrageous and actionable in court. UNOS has been the international leader in organ donation and transplant for decades, and anyone who questions our motivations or accuses UNOS of unlawful activity is just plain wrong. Here are some of the statements that imply or outright accuse UNOS of criminal behavior, and here’s our responses: Statement: UNOS is a monopoly, and that monopoly has meant that patients don’t receive the care they need, and that the donation and transplantation system is corrupt. (Greg Segal, co-founder of Organize, and Dr. Seth Karp, former OPTN Board Member and OPTN Membership and Professional Standards Committee (MPSC) Member) False. While witnesses used the term “monopoly” to characterize UNOS’ contract role, the characterization is false. The fact that there has only ever been a single OPTN contractor is because the law –not UNOS — said there could only be one OPTN contractor. Since the OPTN’s inception, HRSA has issued requests for proposals for a single organization to operate the network. UNOS submitted a bid proposal at each opportunity to compete. HRSA awarded the OPTN contract to UNOS in 1986, 1987, 1990, 1993, 1996, 2000, 2005, and 2018 HRSA, not UNOS, structures the OPTN contract and the bid process. Use of the term “monopoly” suggests that there is (or should be) a “market” for organ donation and transplant in America – a position with which UNOS strongly disagrees. Statement: UNOS retaliates against whistleblowers, and engaged in rewarding and incentivizing whistleblower retaliation. (Greg Segal) False. The individual who recited these false facts, while declining to produce any evidence in support, has never served on or volunteered with the OPTN, never worked within an OPTN member transplant program, and never worked within an organ procurement organization. He has, further, never served in any transplant and donation oversight role with HHS. Nonetheless, he stated under oath that whistleblower complaints were repeatedly and inexplicably brought to him regarding UNOS (while in its capacity as OPTN) because all complainants were afraid to report to OPTN, and that he promptly referred the complaints to law enforcement and government authorities to conduct further investigations.<p>There is no record of any such complaints, no record of any allegations against UNOS (whistleblower or otherwise) that were referred to law enforcement by Greg Segal, nor any follow-up investigation of UNOS/OPTN by law enforcement or government authorities, nor any request for UNOS’ cooperation in investigation of an OPTN member because of whistleblower complaints brought forth by Segal to law enforcement or HHS. UNOS is aware of no such record, complaint, or incident in the past four decades it has held the OPTN contract. UNOS adheres to whistleblower protection laws and does not tolerate, or engage in, retaliation against whistleblowers. Let’s also take a look at some key assertions from the subcommittee hearing - and what the real story is. The following are among statements made on Sept. 11, 2024, at the House Energy and Commerce Committee’s Oversight Subcommittee hearing titled “A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation.” The United Network for Organ Sharing (UNOS), whose leadership was not invited to participate in the hearing, has been the sole contractor for the OPTN for decades. To set the record straight and correct some false information, UNOS is fact-checking statements made during the hearing. Statement: Instead of reporting serious allegations of Medicare fraud, patient safety concerns, and bribery to the OPTN, whistleblowers reported these allegations to a private citizen who does not have oversight authority or the capacity to investigate these claims. (Greg Segal, co-founder of Organize) If true, such allegations must be reported to applicable government authorities and law enforcement for further investigation. Statement: The OPTN contract has recently been opened for competitive bidding “for the first time since the enactment of the OPTN.” (Opening statement of the hearing) False. Every OPTN contract bid, including the initial solicitation in 1986, has been competitive. In each prior bid, UNOS was selected by HRSA to serve as the OPTN contractor after submitting responsive proposals. Until 2024, the OPTN contracts issued by HRSA were always single-vendor contracts. Starting in 2024, the government’s new model involves a multi-vendor approach, where the work of the OPTN is divided across multiple vendors. UNOS welcomes this new arrangement by which the OPTN contracting process includes more competition. Statement: The OPTN, and/or individual OPOs, have been complicit or negligent in circumstances where potential donors have shown signs of life. (Segal) False. In any situation involving deceased donation, the medical staff of the hospital make independent clinical determinations as to whether death has occurred or is imminent, according with the hospital’s own policy and applicable state laws or regulation. Organ recovery will not occur until death has been declared by the medical staff at the hospital. Neither OPO staff nor transplant professionals are involved in the determination of death. In the rare occasion that the clinical situation of a potential donor changes prior to a death declaration, all involved donation and transplant clinicians will immediately cease their activity and allow the hospital to provide supportive care as appropriate. OPOs must adhere to a complex framework of rules and regulations generated by CMS, the OPTN, and the states in which they operate. Any potential violations of OPTN policies or bylaws that are reported to the OPTN are investigated by the OPTN’s Membership & Professional Standards Committee (MPSC), a committee on which HRSA representatives serve. Statement: Previous OPTN Boards of Directors were “selected” by UNOS in a non-transparent process. (Dr. Seth Karp, surgeon-in-chief of Vanderbilt University Medical Center) False. UNOS’s role, as the OPTN Contractor, is to administer the OPTN’s nomination process for the Board. UNOS does not select the board members. Rather, each OPTN board member is elected by the entire OPTN membership, via a process that is described in a detailed plan posted to the OPTN website and overseen by HRSA. In February 2024, reflecting the HRSA modernization principles, the current OPTN Board, whose terms began July 1, was elected by the OPTN membership, and not a single person who was elected to the OPTN Board simultaneously serves on the UNOS Board. Furthermore, the OPTN Board of Directors is now independent of the OPTN contractor and will be supported in the future by a new contractor that will manage future nomination processes and will not have any responsibility for OPTN operations. Statement: Board and committee volunteers are “industry insiders” and have inherent conflicts of interest with their institution or professional organization. (Karp and Segal) More context needed. This year alone, there are more than 1,000 distinct unpaid volunteers serving on the OPTN board and committees. Any individual bringing clinical or professional expertise to volunteer service on the Board or a committee will likely have relationships with a transplant hospital, an OPO, a histocompatibility lab, and/or clinical or professional societies relating to their discipline. This expertise is in fact key to making informed decisions that affect the national donation and transplant system, and it is specifically required by federal law and regulation regarding the OPTN Board composition. Notably, when Congress amended NOTA in 2023, it did not remove the composition provisions for the board, thus retaining the requirement that the OPTN Board be comprised of “representatives of organ procurement organizations…transplant centers, voluntary health associations, and the general public.” If Congress did not intend for these so-called “industry professionals” to be on the OPTN Board, it would have stricken that requirement from NOTA when it were amending other aspects of the law. The OPTN has had in place for many years a conflict of interest policy to allow its volunteer leaders to disclose potential conflicts and recuse themselves from making decisions that pose a direct conflict. OPTN Board members are also required to sign an attestation at the beginning of each term, confirming that “My advice and opinions will be the result of my own independent judgment, and I will not take into consideration any responsibilities I have to any other organization while I fulfill my responsibilities as a director on the OPTN Board.” Additional steps taken under the HRSA modernization initiative, such as having a separate OPTN Board and a new code of conduct, should further strengthen the measures already in place to enable these volunteers to contribute in a fair and transparent manner. Statement: UNOS has lobbied aggressively against reform and has made contract transitions as difficult as possible. (Segal) False. UNOS has led efforts to improve the system, which are identified in the UNOS Action Agenda. In collaboration with stakeholders and government officials, UNOS established its independent corporate Board of Directors on March 30, secured language in the Federal Aviation Administration (FAA) reauthorization to ensure organs can travel above wing instead of as cargo to ensure safe handling and care, and educated policymakers about the need to ensure OPTN has the authority to collect pre-waitlist data on patients to understand and address barriers to transplantation. UNOS has called for a federal tracking system for organs, increased patient empowerment tools to support patients’ choices regarding their transplantation care, and improvements to hospitals’ donor referral processes to organ procurement organizations. UNOS performs this advocacy consistent with our mission and outside of our work or funding as the OPTN contractor. UNOS has repeatedly stated its support for HRSA’s OPTN Modernization Initiative and has actively lobbied for Congress to fully fund the President’s Fiscal Year (FY) 2025 budget request to support implementation. As there has never been a transition of OPTN work to a new contractor, it is categorically untrue that UNOS has made contract transitions as difficult as possible. UNOS will work collaboratively with other OPTN contractors and transition work as determined by HRSA’s contract awards. Statement: UNOS and the federal government lose organs that have been donated for transplant. (several speakers) False. There are many organizations involved in transporting organs. Organ procurement organizations (OPOs) and transplant programs handle arrangements, scheduling, and coordination. The Organ Center, operated by UNOS for the OPTN, assists OPOs and transplant hospitals in making arrangements for the transportation of donated organs if requested. UNOS is not primarily responsible for transporting organs and HRSA has not required a federal tracking system, although UNOS has requested HRSA implement one. Further, outside of the requirements and funding of the OPTN contract, UNOS has developed an organ tracking system to assist in tackling this problem. Furthermore, the OPTN only has purview for whole organs for transplant. The heart example shared at the hearing was about a research organ which is under FDA’s authority. Statement: Some members of the UNOS board also sit on the OPTN board. (Chair Morgan Griffith) False. UNOS established a new seven-person board effective on March 30, 2024. There is no overlap in the membership of the UNOS board and the OPTN board. Statement: The OPTN Board President had something more important to do than testify (Greg Segal, in response to following statement from Rep. Armstrong: “[Rich Formica] refused to testify today, right?” during questioning on new OPTN whistleblower policy) More context needed. The OPTN Board President is a practicing physician who was informed of the hearing with little notice. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

September 13, 2024 04:54 PM Eastern Daylight Time

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News Release

Transforming Cancer Therapy Stocks to Watch In The Oncology Sector

OSTX ATNM PBYI CRBP

In oncology, the relentless drive for innovation is forging new paths in cancer treatment. The field is rapidly evolving with advances in targeted therapies, immunotherapies, and novel technologies, each promising to reshape patient outcomes. Let’s explore some standout stocks that are leading the charge in this transformative era of cancer care with their cutting-edge approaches and pioneering therapies. OS Therapies Inc. (NYSEAmerican: OSTX) is gaining attention in the biotech space for its cutting-edge approaches to treating osteosarcoma and other solid tumors through immunotherapy and antibody drug conjugate (ADC) platforms. The company’s focus on developing next-generation therapeutics and its recent positive data make it a compelling candidate for investors seeking exposure to innovative cancer treatments. Advancing Immunotherapy with OST-HER2 The company's lead asset, OST-HER2, is a novel immunotherapy designed to treat resected, recurrent osteosarcoma. This treatment utilizes Listeria bacteria to stimulate the immune system to target the HER2 protein. OS Therapies has recently completed enrollment for its Phase 2b clinical trial involving 41 patients, with results expected in the fourth quarter of 2024. OST-HER2 aims to prevent metastasis, delay recurrence, and increase overall survival, representing a potential breakthrough for a disease that has not seen significant advancements in decades. If successful, this treatment could address the unmet need for effective adjuvant therapies in osteosarcoma, offering hope to patients with recurrent disease. Innovative Antibody Drug Conjugate Platform OS Therapies is also making strides with its tunable ADC (tADC) platform, leveraging its proprietary SiLinker technology. The platform incorporates pH-sensitive silicon-based linkers capable of releasing multiple therapeutic agents selectively within the tumor microenvironment. Recent preclinical data on their ovarian cancer therapeutic candidate, OST-tADC-FRA-H, showcased strong antitumor activity in mouse models and a favorable safety profile with no significant loss of body weight among treated animals. This preclinical success demonstrates the potential of OS Therapies' technology to enhance the efficacy and safety of ADCs, paving the way for multiple new therapeutic candidates. The company's SiLinker technology is not just about delivering payloads; it also holds the promise of improving existing ADC combinations or creating entirely new intellectual properties. This flexibility could position OS Therapies as a key player in the growing ADC market, which is projected to reach $20.9 billion by 2030, according to Grandview Research. Strategic Collaborations and Industry Recognition OS Therapies' potential is further underscored by its acceptance into Johnson & Johnson Innovation (JLABS), which provides access to resources that could accelerate the development of its tADC platform. This membership could facilitate critical partnerships and collaborations, enhancing the company’s ability to bring its innovative therapies to market. Additionally, OS Therapies has formed both a Patient Advocacy Advisory Board (PAAB) and a Scientific and Medical Advisory Board (SMAB), drawing expertise from leading institutions such as Texas Children’s Hospital, the Cleveland Clinic, and the University of California, San Francisco. These boards will guide the company as it engages with the FDA and prepares for a potential Biologics License Authorization (BLA) for OST-HER2. This strategic alignment with top medical professionals and patient advocates strengthens OS Therapies’ position in navigating the regulatory landscape and underscores its commitment to addressing patient needs. Promising Market Opportunity With its innovative pipeline, strategic collaborations, and strong leadership, OS Therapies is well-positioned to capitalize on the expanding oncology market. The ongoing development of OST-HER2 and the tADC platform could lead to significant milestones, including potential FDA approvals that would not only validate its scientific approach but also create substantial market opportunities. As a clinical-stage company with promising technologies and strategic industry support, OS Therapies represents a compelling investment opportunity in the biopharmaceutical sector. Actinium Pharmaceuticals, Inc. (NYSEAmerican: ATNM) is developing targeted radiotherapies to improve treatment outcomes for patients with blood cancers and other serious conditions. Their lead candidate, Iomab-B, is in late-stage development as a conditioning agent for bone marrow transplants, with potential U.S. and European regulatory submissions on the horizon. Actimab-A, another promising candidate, is targeting relapsed and refractory acute myeloid leukemia (AML) and is developed in partnership with the National Cancer Institute. The company recently advanced Iomab-ACT, designed for conditioning before bone marrow transplants in sickle cell disease patients, with the potential to offer a safer, non-chemotherapy alternative. This targeted approach aims to minimize the toxicities typically seen with traditional conditioning methods, positioning Iomab-ACT as a unique option in a growing market driven by expanding cell and gene therapy applications. Actinium’s strategy is bolstered by a strong intellectual property portfolio with over 230 patents, including new protections for Iomab-ACT in gene therapy conditioning for non-malignant conditions. However, the company faces a regulatory hurdle as the FDA has requested an additional clinical trial for Iomab-B after a mixed outcome in its Phase 3 trial. Actinium is now seeking a partner to help advance Iomab-B while focusing on its broader pipeline. With a unique technology platform and a growing addressable market in cell and gene therapies, Actinium Pharmaceuticals holds potential as an emerging player in the targeted radiotherapy space. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is positioning itself as a key player in precision oncology, with promising advancements in its clinical pipeline. The company's leading asset, CRB-701, a next-generation antibody-drug conjugate (ADC), targets Nectin-4, a well-validated cancer marker. Recent clinical data from the ASCO 2024 conference show encouraging results in both metastatic urothelial cancer and cervical cancer. CRB-701 delivered an overall response rate (ORR) of 44% in mUC and 43% in cervical cancer, with strong disease control rates (DCR) of 78% and 86%, respectively. Importantly, no major toxicities have been observed at higher doses, positioning CRB-701 as a potentially safer option in its class. Corbus expects to complete the Phase 1 dose escalation study for CRB-701 by Q4 2024, with data presentation planned for early 2025. This upcoming milestone could serve as a major catalyst for the stock, particularly if the safety and efficacy data continue to align with the results seen so far. Additionally, Corbus is advancing its other assets, including CRB-601, which targets the tumor microenvironment, and CRB-913, a treatment for obesity. Both programs are expected to enter clinical trials by early 2025, broadening the company’s pipeline and increasing its potential value. Financially, Corbus is in a strong position, with $147 million in cash and investments as of June 30, 2024. This provides the company with a cash runway through Q3 2027, allowing it to advance its key programs without the immediate need for additional capital raises. Recent fundraising efforts, including $35.6 million raised through its ATM program, further strengthen the company's financial foundation. For investors, Corbus represents a high-potential opportunity, particularly with multiple clinical milestones on the horizon. The company’s focus on innovative, targeted therapies in oncology, combined with its solid financial standing, makes it a stock to watch in the biotech sector. Puma Biotechnology, Inc. (NASDAQ: PBYI) is a biopharmaceutical company focused on developing and commercializing treatments to enhance cancer care. Puma licensed the global rights to PB272 in 2011, and in 2017, the U.S. FDA approved neratinib for extended adjuvant treatment of early-stage HER2-positive breast cancer following trastuzumab-based therapy. Marketed under the name NERLYNX in the U.S., the drug received further FDA approval in 2020 for combination use with capecitabine to treat advanced or metastatic HER2-positive breast cancer after two or more prior anti-HER2-based regimens. NERLYNX also gained marketing authorization in the EU in 2018 for the extended adjuvant treatment of hormone receptor-positive, HER2-overexpressed breast cancer patients within a year of completing trastuzumab therapy. In September 2022, Puma entered into an exclusive license agreement for alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A, initially targeting small-cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung1, a Phase II trial of alisertib monotherapy for extensive stage small cell lung cancer. In June 2024, data on alisertib's use in advanced osimertinib-resistant EGFR-mutated non-small cell lung cancer was presented at the ASCO Annual Meeting. The Phase I/Ib study evaluated 21 patients who progressed on osimertinib monotherapy, with alisertib doses of 30 mg and 40 mg twice daily in combination with osimertinib 80 mg daily. The 30 mg dose was identified as the maximum tolerated dose and recommended Phase II dose. The study reported an overall response rate of 9.5% and a disease control rate of 81%. Median progression-free survival (PFS) was 5.5 months, with median overall survival (OS) of 23.5 months. Subgroup analysis showed differences in outcomes based on TP53 mutation status, with patients who were TP53 wild-type experiencing a higher overall response rate and longer PFS compared to those with TP53 mutations. Based on these findings, Puma is modifying the trial protocol to focus on the TP53 wild-type cohort. For the second quarter of 2024, Puma reported revenue of $47.1 million, down 14% from the previous year but still exceeding analyst estimates by 5.4%. Earnings per share also beat estimates by 9.1%. Despite these beats, the company posted a net loss of $4.53 million, a significant drop from a $2.13 million profit in the same quarter last year. Looking ahead, Puma’s revenue is projected to decline by 2% annually over the next three years, contrasting with the 18% growth expected in the U.S. biotech sector. Additionally, on August 5, 2024, Puma granted a restricted stock unit award covering 3,500 shares to a new non-executive employee under its 2017 Employment Inducement Incentive Award Plan. The award vests over three years and serves as an inducement for employment in line with Nasdaq rules. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by OS Therapies Inc. to assist in the production and distribution of content related to OSTX. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

September 12, 2024 07:59 AM Eastern Daylight Time

News Release

Transforming Oncology: Stocks to Watch in the Oncology Sector

ACON

In oncology, the drive for innovation is forging new paths in cancer treatment. The field is rapidly evolving with advances in targeted therapies, immunotherapies, and novel technologies, each promising to reshape patient outcomes. Let’s explore some standout companies that are leading the charge in this transformative era of cancer care with their cutting-edge approaches and pioneering therapies. OS Therapies Inc. (NYSEAmerican: OSTX) is gaining attention in the biotech space for its cutting-edge approaches to treating osteosarcoma and other solid tumors through immunotherapy and antibody drug conjugate (ADC) platforms. The company’s focus on developing next-generation therapeutics and its recent positive data make it a compelling candidate for investors seeking exposure to innovative cancer treatments. Advancing Immunotherapy with OST-HER2 The company's lead asset, OST-HER2, is a novel immunotherapy designed to treat resected, recurrent osteosarcoma. This treatment utilizes Listeria bacteria to stimulate the immune system to target the HER2 protein. OSTX has recently completed enrollment for its Phase 2b clinical trial involving 41 patients, with results expected in the fourth quarter of 2024. OST-HER2 aims to prevent metastasis, delay recurrence, and increase overall survival, representing a potential breakthrough for a disease that has not seen significant advancements in decades. If successful, this treatment could address the unmet need for effective adjuvant therapies in osteosarcoma, offering hope to patients with recurrent disease. Innovative Antibody Drug Conjugate Platform OSTX is also making strides with its tunable ADC (tADC) platform, leveraging its proprietary SiLinker technology. The platform incorporates pH-sensitive silicon-based linkers capable of releasing multiple therapeutic agents selectively within the tumor microenvironment. Recent preclinical data on their ovarian cancer therapeutic candidate, OST-tADC-FRA-H, showcased strong antitumor activity in mouse models and a favorable safety profile with no significant loss of body weight among treated animals. This preclinical success demonstrates the potential of OS Therapies' technology to enhance the efficacy and safety of ADCs, paving the way for multiple new therapeutic candidates. The company's SiLinker technology is not just about delivering payloads; it also holds the promise of improving existing ADC combinations or creating entirely new intellectual properties. This flexibility could position OS Therapies as a key player in the growing ADC market, which is projected to reach $20.9 billion by 2030, according to Grandview Research. Strategic Collaborations and Industry Recognition OS Therapies' potential is further underscored by its acceptance into Johnson & Johnson Innovation (JLABS), which provides access to resources that could accelerate the development of its tADC platform. This membership could facilitate critical partnerships and collaborations, enhancing the company’s ability to bring its innovative therapies to market. Additionally, OSTX has formed both a Patient Advocacy Advisory Board (PAAB) and a Scientific and Medical Advisory Board (SMAB), drawing expertise from leading institutions such as Texas Children’s Hospital, the Cleveland Clinic, and the University of California, San Francisco. These boards will guide the company as it engages with the FDA and prepares for a potential Biologics License Authorization (BLA) for OST-HER2. This strategic alignment with top medical professionals and patient advocates strengthens OS Therapies’ position in navigating the regulatory landscape and underscores its commitment to addressing patient needs. With its innovative pipeline, strategic collaborations, and strong leadership, OSTX is well-positioned to capitalize on the expanding oncology market. The ongoing development of OST-HER2 and the tADC platform could lead to significant milestones, including potential FDA approvals that would not only validate its scientific approach but also create substantial market opportunities. As a clinical-stage company with promising technologies and strategic industry support, OS Therapies represents a compelling opportunity in the biopharmaceutical sector. Actinium Pharmaceuticals, Inc. (NYSEAmerican: ATNM) is developing targeted radiotherapies to improve treatment outcomes for patients with blood cancers and other serious conditions. Their lead candidate, Iomab-B, is in late-stage development as a conditioning agent for bone marrow transplants, with potential U.S. and European regulatory submissions on the horizon. Actimab-A, another promising candidate, is targeting relapsed and refractory acute myeloid leukemia (AML) and is developed in partnership with the National Cancer Institute. The company recently advanced Iomab-ACT, designed for conditioning before bone marrow transplants in sickle cell disease patients, with the potential to offer a safer, non-chemotherapy alternative. This targeted approach aims to minimize the toxicities typically seen with traditional conditioning methods, positioning Iomab-ACT as a unique option in a growing market driven by expanding cell and gene therapy applications. Actinium’s strategy is bolstered by a strong intellectual property portfolio with over 230 patents, including new protections for Iomab-ACT in gene therapy conditioning for non-malignant conditions. However, the company faces a regulatory hurdle as the FDA has requested an additional clinical trial for Iomab-B after a mixed outcome in its Phase 3 trial. Actinium is now seeking a partner to help advance Iomab-B while focusing on its broader pipeline. With a unique technology platform and a growing addressable market in cell and gene therapies, Actinium Pharmaceuticals holds potential as an emerging player in the targeted radiotherapy space. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is positioning itself as a key player in precision oncology, with promising advancements in its clinical pipeline. The company's leading asset, CRB-701, a next-generation antibody-drug conjugate (ADC), targets Nectin-4, a well-validated cancer marker. Recent clinical data from the ASCO 2024 conference show encouraging results in both metastatic urothelial cancer and cervical cancer. CRB-701 delivered an overall response rate (ORR) of 44% in mUC and 43% in cervical cancer, with strong disease control rates (DCR) of 78% and 86%, respectively. Importantly, no major toxicities have been observed at higher doses, positioning CRB-701 as a potentially safer option in its class. Corbus expects to complete the Phase 1 dose escalation study for CRB-701 by Q4 2024, with data presentation planned for early 2025. This upcoming milestone could serve as a major catalyst for the stock, particularly if the safety and efficacy data continue to align with the results seen so far. Additionally, Corbus is advancing its other assets, including CRB-601, which targets the tumor microenvironment, and CRB-913, a treatment for obesity. Both programs are expected to enter clinical trials by early 2025, broadening the company’s pipeline and increasing its potential value. Financially, Corbus is in a strong position, with $147 million in cash and investments as of June 30, 2024. This provides the company with a cash runway through Q3 2027, allowing it to advance its key programs without the immediate need for additional capital raises. Recent fundraising efforts, including $35.6 million raised through its ATM program, further strengthen the company's financial foundation. For investors, Corbus represents a high-potential opportunity, particularly with multiple clinical milestones on the horizon. The company’s focus on innovative, targeted therapies in oncology, combined with its solid financial standing, makes it a stock to watch in the biotech sector. Puma Biotechnology, Inc. (NASDAQ: PBYI) is a biopharmaceutical company focused on developing and commercializing treatments to enhance cancer care. Puma licensed the global rights to PB272 in 2011, and in 2017, the U.S. FDA approved neratinib for extended adjuvant treatment of early-stage HER2-positive breast cancer following trastuzumab-based therapy. Marketed under the name NERLYNX in the U.S., the drug received further FDA approval in 2020 for combination use with capecitabine to treat advanced or metastatic HER2-positive breast cancer after two or more prior anti-HER2-based regimens. NERLYNX also gained marketing authorization in the EU in 2018 for the extended adjuvant treatment of hormone receptor-positive, HER2-overexpressed breast cancer patients within a year of completing trastuzumab therapy. In September 2022, Puma entered into an exclusive license agreement for alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A, initially targeting small-cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung1, a Phase II trial of alisertib monotherapy for extensive stage small cell lung cancer. In June 2024, data on alisertib's use in advanced osimertinib-resistant EGFR-mutated non-small cell lung cancer was presented at the ASCO Annual Meeting. The Phase I/Ib study evaluated 21 patients who progressed on osimertinib monotherapy, with alisertib doses of 30 mg and 40 mg twice daily in combination with osimertinib 80 mg daily. The 30 mg dose was identified as the maximum tolerated dose and recommended Phase II dose. The study reported an overall response rate of 9.5% and a disease control rate of 81%. Median progression-free survival (PFS) was 5.5 months, with median overall survival (OS) of 23.5 months. Subgroup analysis showed differences in outcomes based on TP53 mutation status, with patients who were TP53 wild-type experiencing a higher overall response rate and longer PFS compared to those with TP53 mutations. Based on these findings, Puma is modifying the trial protocol to focus on the TP53 wild-type cohort. For the second quarter of 2024, Puma reported revenue of $47.1 million, down 14% from the previous year but still exceeding analyst estimates by 5.4%. Earnings per share also beat estimates by 9.1%. Despite these beats, the company posted a net loss of $4.53 million, a significant drop from a $2.13 million profit in the same quarter last year. Looking ahead, Puma’s revenue is projected to decline by 2% annually over the next three years, contrasting with the 18% growth expected in the U.S. biotech sector. Additionally, on August 5, 2024, Puma granted a restricted stock unit award covering 3,500 shares to a new non-executive employee under its 2017 Employment Inducement Incentive Award Plan. The award vests over three years and serves as an inducement for employment in line with Nasdaq rules. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

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