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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

September 12, 2024 06:00 AM Eastern Daylight Time

Tesla BioHealing and Cell Biotechnology Co., Ltd. Forge Strategic Partnership to Transform Stem Cell Therapies

Pinion Newswire

Tesla BioHealing-PA, LLC, a leader in biophoton life force technology, and Cell Biotechnology Co., Ltd, an innovator in stem cell transplantation, have entered a strategic collaboration to revolutionize the development and delivery of stem cell therapies. This partnership, effective September 9, 2024, unites the companies’ groundbreaking technologies to significantly enhance patient outcomes by empowering autologous stem cell amplification and ensuring immediate availability of large numbers of stem cells. A Revolutionary Alliance Tesla BioHealing, known for its pioneering biophoton technology that boosts life force energy to empower autologous stem cell production, will work alongside Cell Biotechnology, an industry leader in stem cell transplantation, to create integrated stem cell therapy solutions. This collaboration will blend Tesla BioHealing’s proprietary technology with Cell Biotechnology’s expertise, aiming to deliver cutting-edge, more effective, and accessible treatments to patients globally. Pooling Expertise to Improve Patient Outcomes The partnership will focus on joint research, development, and commercialization of enhanced autologous stem cell amplification and transplantation solutions. By sharing proprietary information, research data, and technological expertise, both companies aim to expedite product development, clinical trials, regulatory approvals, and ultimately improve patient outcomes through more effective stem cell therapies. “Tesla BioHealing is thrilled to collaborate with Cell Biotechnology to combine our innovative biophoton technology with their advanced stem cell transplantation techniques,” said Dr. James Liu, CEO of Tesla BioHealing. “This partnership will enable us to broaden the reach of our technology, significantly impacting our R&D and transforming the future of stem cell treatments.” Dr. Taihua Wang, president of Cell Biotechnology, echoed this sentiment, saying, “We are excited to join forces with Tesla BioHealing in this groundbreaking initiative. Combining our stem cell expertise with their cutting-edge biophoton technology opens up new possibilities for advancing stem cell therapies, bringing life-changing treatments to more patients in the near future.” Commercialization and Global Impact Under the agreement, both companies will collaborate on clinical development and commercialization initiatives, including joint research, co-marketing, co-branding, and sales strategies. This strategic partnership has the potential to reshape the stem cell therapy landscape, making advanced, effective treatments more widely available to patients around the world. With a shared vision for transforming stem cell therapies, Tesla BioHealing and Cell Biotechnology Co., Ltd. are positioned to make a lasting impact on the future of regenerative medicine. Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. These statements include, but are not limited to, the potential benefits of Tesla BioHealing® and Cell Biotechnology products. Factors that could cause actual results to differ materially include risks that clinical development activities may be delayed or unsuccessful, that products may not be approved or commercially viable and that regulatory decisions may be unfavourable. Tesla BioHealing Inc. and Cell Biotechnology disclaim any obligation to update these statements after the date hereof except as required by law. About Tesla BioHealing-PA, LLC Based in Butler, PA, Tesla BioHealing is a leader in biophoton technology, developing innovative solutions to enhance life force energy. The company’s technologies are designed to provide safe, effective, and easy-to-use therapies, including stem cell empowerment and other health-promoting solutions. About Cell Biotechnology Co., Ltd. Headquartered in Vaughan, Ontario with several branches in Southeast Asia, Cell Biotechnology Co., Ltd. specializes in advanced stem cell transplantation technology. With a focus on improving patient outcomes through innovative cellular therapies, the company is dedicated to advancing the field of regenerative medicine. For media inquiries, please contact: Tesla BioHealing-PA, LLC Suzanne Street, MBA Director, Public Relations Email: Suzanne.street@teslabiohealing.com Phone: 302-265-2213 Cell Biotechnology Co., Ltd. Xenia Wang, MS, MBA Manager, Public Relations Email: xeniawang@icloud.com Phone: 647-929-6315 Contact Details Tesla BioHealing-PA, LLC Suzanne Street +1 302-265-2213 Suzanne.street@teslabiohealing.com Company Website https://www.teslabiohealing.com/

September 11, 2024 07:14 PM Eastern Daylight Time

MAIA Biotechnology's Phase 2 Study Of THIO In Non-Small Cell Lung Cancer Shows Positive Interim Survival Benefits

Benzinga

By Meg Flippin, Benzinga MAIA Biotechnology Inc. (NYSE: MAIA), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted immunotherapies for cancer, reported positive interim survival benefits in a phase 2 study of THIO, its lead therapy to fight advanced non-small cell lung cancer (NSCLC). NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%. In the phase 2 clinical trial dubbed THIO-101, MAIA is evaluating THIO sequenced with Regeneron Pharmaceuticals Inc.’s (NASDAQ: REGN) immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced NSCLC who failed two or more standard-of-care therapy regimens. As of August, 16 patients had survival follow-ups surpassing 12 months, including 9 patients in their third line of treatment. Interim median survival follow-up in third-line patients was 10.6 months. Three of the trials' earliest patients enrolled are nearing 17-month survival benefits. “THIO is showing a survival benefit for patients with advanced NSCLC. We’re on track to achieve our survival goals in third-line therapy,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “THIO’s outperformance to date supports our thesis that our telomere targeting agent could become a treatment option for people suffering from advanced NSCLC.” Attacking Cancer Spreading Telomeres THIO targets and attacks telomeres which play a key role in helping cancer cells live and spread. Telomerase is made from DNA sequences and proteins and sits at the end of chromosomes, capping and protecting them. Telomerase expression most often occurs in the early stages of growth and development in humans and in a few cells of adults. But in nearly all cancers, telomerase is present, allowing cancer cells to divide and spread. More than 80% of NSCLC tumors have telomerase expression. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death. All The Data Coming Together The 12-month survival data corresponds to MAIA’s most recent data from THIO-101 demonstrating favorable disease control and overall response rates. In June, the company presented new efficacy data that showed a favorable overall response rate (ORR) of 38%, a disease control rate (DCR) of 85% and a median progression-free survival (PFS) of 5.5 months from THIO + CPI in third-line treatment. The data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024. The primary objectives of the THIO-101 phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer and to examine the clinical efficacy of THIO in the form of ORR. “All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vitoc when the data was released. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.” THIO seems to be showing promise in fighting one of the most common forms of lung cancer, but that’s not all. If this treatment proves effective, as the company believes, MAIA plans to use THIO in treating other forms of cancer, such as hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and malignant gliomas – indications to which THIO has been granted Orphan Drug Designation by the U.S. FDA. With the size of the cancer treatment market poised to hit $521 billion by 2033, growing at a CAGR of 8.9% over 2023-2033, MAIA may be one company to pay attention to. Featured photo by motorolka on Shutterstock. 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 11, 2024 08:45 AM Eastern Daylight Time

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Armed With Its Patent Portfolio, BioRestorative Therapies Has Success In The Laboratory And At The Negotiating Table: Is Profitability Close Behind?

Benzinga

By Anthony Termini BioRestorative Therapies (NASDAQ: BRTX) is a clinical-stage biotechnology company involved in various clinical trials involving its patented approach for using stem cell therapy to treat a number of disorders. The company has, in recent months, issued updates on its earnings and operations, and it is developing a promising treatment program to treat diabetes and obesity. Quarterly Report Highlights The company issued its second quarter 2024 business update in August, and a number of announcements accompanied their reported financials. BioRestorative announced that preliminary clinical data related to its “Disc/Spine Program” showed meaningful signals and no notable safety markers in patients enrolled in a clinical study of BRTX-100 as a treatment for chronic lumbar disc disease. Also, following manufacturing/clinical process enhancements made by BioRestorative that tripled its monthly trial capacity, it guided that it was targeting completion of patient enrollment in the phase 2 BRTX-100 study in chronic lumbar disc disease (cLDD) by the end of 2024. The company also plans to provide additional preliminary data updates by then. Furthermore, BioRestorative said that it has also laid the foundation for the commercialization of its BioCosmeceuticals business, which could begin generating significant revenues this year. The company noted that it inked an agreement to supply its proprietary cell-based biologic serum to Cartessa Aesthetics, LLC. An analysis of the company’s June 30, 2024 Form 10-Q revealed a 19% improvement in year-over-year operations, with net loss narrowed to $2.5 million compared to a $3.1 million loss in the prior period. BioRestorative’s balance sheet showed some $14.7 million on hand at the end of June. Lance Alstodt, BioRestorative’s Chief Executive Officer, noted that these accomplishments “will provide additional financial flexibility” and bolster the company’s strategy to execute and accomplish important long-term goals. The quarterly report also discussed BioRestorative’s expansion of its core preclinical program for ThermoStem®. “Metabolic Program” Addresses Important And Lucrative Markets One of the more significant opportunities that BioRestorative is pursuing is related to its ThermoStem platform. Currently in preclinical testing, the intended therapy is to target obesity and metabolic disorders (like diabetes) using stem cells to generate a type of body fat that regulates metabolic homeostasis. A recent report from the Centers for Disease Control and Prevention demonstrates that nearly 42% of adults in the United States suffer from obesity. Those diagnosed with severe obesity were just over 9%. Furthermore, research conducted at Harvard University and George Washington University concluded that “adults with obesity spend an average of $1,861 more a year on medical costs than someone who doesn’t have obesity. People with severe obesity spend an average of $3,097 more.” According to investment firm Goldman Sachs, the worldwide market for obesity drugs could be $100 billion by 2030. And there is a link between obesity and diabetes. The American Heart Association says that obesity contributes to up to half of new diabetes cases annually in the United States. Treating this disease also represents a significant market opportunity for BioRestorative. Precedence Research expects the global diabetes drug market to reach about $132 billion by 2034. The combined market for obesity and diabetes drugs creates a significant opportunity for BioRestorative’s ThermoStem over the next decade. It is important to note that ThermoStem is not restricted to being only a standalone treatment. It may be used with drugs like Novo Nordisk’s (NYSE: NVO) Ozempic or Wegovy, or Eli Lilly’s (NYSE: LLY) Mounjaro, which are already approved for use to treat both obesity and diabetes. “We believe that ThermoStem has immense potential to develop both best-in-class and first-in-class therapies,” said Alstodt. Other Developments Related To BioRestorative’s Intellectual Property Portfolio Also accompanying BioRestorative’s business update announcement were comments related to its broad intellectual property portfolio. Previously published data from a study conducted at the University of Utah School of Medicine showed significant reductions in weight, triglyceride, and blood glucose levels compared to controls. The study also demonstrated that BioRestorative’s 3D scaffold was capable of retaining viable transplanted cells for at least five weeks post-implantation. In June, BioRestorative published a press release announcing that it had received notice of allowance from the Japanese Patent Office for a patent application related to ThermoStem. This is the fifth Japanese patent issued for the ThermoStem technology platform. “We are proactively expanding the already formidable ThermoStem intellectual property estate to help ensure long-term market exclusivity…” and “…this is demonstrated by this new patent allowance,” Alstodt remarked. The company also announced that it is currently involved in substantive discussions with at least one (undisclosed) regenerative medicine company regarding ThermoStem licensing. This, along with the Cartessa agreement, is why the company said that it “is poised to potentially enter into a stage of anticipated rapid growth.” Featured photo by qimono on Pixabay. 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

September 11, 2024 08:35 AM Eastern Daylight Time

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News Release

Aclarion, Inc.’s (NASDAQ: ACON) Emerging Role in the Back Pain Management Sector

ACON

As the healthcare technology sector advances, companies are making significant strides in addressing widespread health challenges. One area experiencing notable innovation is the diagnosis and management of chronic low back pain (cLBP), a condition that affects millions globally and incurs substantial healthcare costs. Aclarion, Inc. (NASDAQ: ACON) is emerging as a key player in this field with its groundbreaking Nociscan platform. Nociscan is an advanced diagnostic tool designed to address the global challenge of chronic low back pain, which impacts approximately 266 million people worldwide. This condition is a major driver of healthcare expenditures, with U.S. costs alone reaching up to $134.5 billion annually. Aclarion’s Nociscan platform stands out as the first evidence-supported software-as-a-service (SaaS) solution that uses Magnetic Resonance spectroscopy (MRS), proprietary signal processing techniques, and augmented intelligence algorithms to noninvasively differentiate between painful and nonpainful discs in the lumbar spine. The Nociscan system operates through a cloud-based platform that processes MRI data to quantify chemical biomarkers associated with disc pain. This data is then analyzed using proprietary algorithms to provide physicians with crucial insights into the potential sources of pain. By integrating Nociscan with traditional diagnostic methods, healthcare providers can achieve greater diagnostic precision and enhance treatment planning, leading to improved patient care. Aclarion, Inc. (NASDAQ: ACON) has recently achieved a significant milestone with its Nociscan platform, announcing the completion of the first Nociscan exams in the LIFEHAB trial. This randomized control trial, conducted in Norway, is pivotal in comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation for chronic low back pain. The trial involves 202 patients and utilized Nociscan’s advanced diagnostic technology to assess how MRS biomarkers can correlate with treatment responses. The LIFEHAB trial began enrollment in Q2 of 2024, and as of late August, six patients have completed their Nociscan exams. Brett Ness, Aclarion’s CEO, highlighted the significance of this development: ““We are excited to see the LIFEHAB Trial progressing on schedule and look forward to the results of the study and to the role we expect Nociscan data to play in not only helping physicians determine which discs to treat but in potentially helping to predict which treatment option is optimal for a particular patient.” This latest achievement showcases ACON’s commitment to advancing chronic low back pain management and demonstrates the growing adoption of Nociscan in research settings. The LIFEHAB trial’s integrations of Nociscan tech represent a crucial step in validating its effectiveness and aligning with Aclarions broader goals of enhaving treatment and outcomes. As ACON continues to make strides, the company has also expended presence in the US market. On August 14, 2024, the company announced a key commercial agreement with Sheridan Community Hospital in Michigan. This partnership marks Aclarion’s entry into central Michigan and involves collaboration with Dr. John Keller, a leading neurosurgeon. This agreement aims to further validate Nociscan’s clinical effectiveness and demonstrates the platform's potential to advance noninvasive, cost-effective diagnostics for disc pain. Building on its success in the UK, where ACON has secured insurance coverage, the company is now focused on achieving similar coverage in the U.S. This is a critical step towards increasing Nociscan’s accessibility and adoption within the American healthcare system. Further expanding its reach, ACON has introduced Nociscan to the personal injury and workers’ compensation markets in New Jersey. Announced on August 29, 2024, this initiative involves Dr. Justin Kubeck, an orthopedic spine surgeon, working to enhance the evaluation of chronic low back pain in these complex legal and insurance settings. This effort aims to provide objective data to support treatment decisions and compensation claims, leveraging Nociscan’s ability to measure biomarkers correlated with pain and structural integrity. In addition to its commercial agreements, Aclarion has launched two major clinical trials to substantiate Nociscan’s benefits. The Clinical Utility and Economic (CLUE) Trial, announced on August 21, 2024, aims to assess how Nociscan’s AI-generated biomarker data impacts surgical treatment decisions. By comparing surgeons’ initial treatment plans with those adjusted after reviewing Nociscan data, the trial seeks to provide valuable real-world evidence of the platform’s effectiveness in improving surgical outcomes. Complementing this, the CLARITY trial—a gold-standard, multicenter, prospective randomized study—will provide definitive evidence on the advantages of incorporating Nociscan data into surgical decision-making processes. Aclarion’s innovative approach has recently garnered industry recognition. On September 5, 2024, ACON was added to the PRISM Emerging Medical Devices Index. This inclusion highlights Aclarion’s position as a leading innovator in the medtech sector. Being part of the PRISM Index validates Aclarion’s technological advancements and can increase its market visibility, credibility, and attractiveness to investors. As the U.S. medical devices market is projected to grow to nearly $315 billion by 2032, Aclarion’s Nociscan is well-positioned to capture a portion of the $40 billion lumbar spine diagnostics and treatment market. ACON’s efforts to address chronic low back pain through innovative, noninvasive technology underscore its potential to make a significant impact in the healthcare sector. With its expanding clinical partnerships, ongoing trials, and recent industry recognition, ACON is positioning itself strongly within the healthcare technology market. 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

September 11, 2024 06:00 AM Eastern Daylight Time

PathAI Launches MET Predict on AISight to Enhance NSCLC Assessments

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced the launch of MET Predict † on the AISight Ⓡ † Image management system (IMS). MET Predict is an AI-powered algorithm designed to help pathologists identify non-small cell lung cancer (NSCLC) tumors that may be more likely to have MET exon 14 skipping (METex14) or MET amplification, directly from an H&E whole slide image. NSCLC accounts for approximately 85% of lung cancers 1, with 3–4% of these cases involving METex14 2. Today, approved targeted therapies are available for patients with NSCLC who harbor METex14 mutations. Additionally, MET amplification occurs in 1–6% of NSCLC cases 3 and is emerging as a potential biomarker in lung cancer. Traditional molecular testing for MET alterations such as exon 14 skipping or amplification is often hindered by high costs, time- and tissue-consuming procedures, and the need for specialized equipment and trained personnel. These factors limit its accessibility and scalability, prompting the need for more efficient and cost-effective methods to assess MET alterations. “The integration of MET Predict into AISight marks a significant leap forward in utilizing AI to enhance the efficiency of NSCLC tumor assessments, particularly in identifying those with potential genetic alterations,” said Andy Beck, MD, PhD, co-founder and CEO of PathAI. “By providing rapid and precise biomarker insights directly from H&E images, MET Predict equips pathologists with the essential information needed to drive timely and accurate NSCLC evaluations.” MET Predict has the potential to significantly improve the efficiency of biomarker evaluation and molecular testing paradigms. The algorithm identifies >90% of MET altered tumors while additionally providing insights that may preserve tissue in 30% of cases where the likelihood of MET alteration is low. With the addition of MET Predict, AISight expands its toolset with the latest technology to assist pathologists in lung cancer assessments. This innovation addresses a crucial gap in pathology labs — the need for accessible, rapid, and comprehensive molecular tools that provide actionable insights from biopsy samples. †:MET Predict and AISight are for Research Use Only. Not for use in diagnostic procedures. References: 1 American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/lung-cancer/about/what-is.html 2 Frampton, G. M., et al. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer discovery, 5(8), 850-859. 3 Wolf J., et al. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787. PMID: 32877583 About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions, dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

September 10, 2024 10:00 AM Eastern Daylight Time

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