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MediVera Compounding Pharmacy™ Expands into 18 States Across Five Regions in 2024, Now Offers Dozens of Personalized Medicine Options

MediVera

MediVera Compounding Pharmacy™, a leader in personalized medicine since 1999, announced today that it has officially been licensed to serve residents in 18 new states across the West, Southwest, Southeast, Midwest, and Northeast regions in 2024. The licenses allow MediVera to fill compounding prescriptions—including semaglutide and tirzepatide—throughout these states. This expansion broadens the company’s geographical reach, reflecting its commitment to providing personalized compounding services to prescribers and patients nationwide. The new states include: West Region: Colorado, Idaho, Montana, Utah, Washington, Wyoming Southwest Region: Arizona, New Mexico, Oklahoma Southeast Region: Georgia, North Carolina, South Carolina, Tennessee, Virginia, West Virginia Midwest Region: South Dakota Northeast Region: Connecticut, Maine The licenses were issued between January 24, 2024, and August 13, 2024, by the respective State Boards of Pharmacy following rigorous application and compliance processes that require MediVera to meet or exceed governmental regulations and recommendations. MediVera is PCAB Accredited in both sterile and non-sterile compounding, certifying ethical and quality standards met by only 1% of compounding pharmacies nationwide. Prescribers and patients in these states are now welcome to use MediVera’s services, effective immediately. “We are absolutely thrilled with the opportunity to do business in these new states,” said MediVera CEO Bradley McCloskey, PharmD. “MediVera has been dedicated to changing lives with the industry standard in personalized medicine since it was founded by my father over 20 years ago. Bringing that simple mission to states across the country—and now to these additional 18 states—is a dream come true.” This growth coincides with an increased interest in compounded medications, including hormone replacement therapy and solutions for men’s and women’s health. MediVera has responded with an ongoing nationwide expansion effort, growing its footprint to include 37 states, with more licenses expected before the end of the year. About MediVera Since its inception in 1999, MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy) has been dedicated to providing personalized medicine. With a focus on quality and innovation, MediVera Compounding Pharmacy™ continues to set industry standards, offering tailored solutions to meet the unique needs of healthcare providers and patients. MediVera Compounding Pharmacy™ is currently licensed in and ships to the following 33 states: AZ, CN, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, PA, RI, SC, SD, TN, VA, VT, WA, WI, WY. Contact Details MediVera Compounding Pharmacy™ Laurie Malseed +1 937-242-0430 laurie@mediverarx.com Company Website https://mediverarx.com/

September 26, 2024 09:00 AM Eastern Daylight Time

Independent Living And Safety: How LogicMark's Innovations Are Helping To Address The Needs Of An Aging America

Benzinga

By Gerelyn Terzo, Benzinga Check out LogicMark’s investment deck here. In America, more than 10,000 Baby Boomers reach the milestone age of 65 each day. By 2040, 25% of the American population will be over the age of 65. Meanwhile, senior citizens are choosing to live life independently more than ever before, a shift that has gained momentum in the wake of the pandemic. These days, nearly three-quarters (70%) of Americans shudder at the thought of being admitted into a nursing home, a Gallup poll revealed. Additionally, almost two-thirds of families would hesitate to admit a loved one to a nursing home facility. However, living independently introduces a host of other challenges that must be overcome. While emergency and safety needs have evolved over the past several decades, personal safety solutions often lag behind and don’t keep pace with modern technological standards. This has an impact on vulnerable communities, as well as the “sandwich generation” – many of whom are caring both for their own children as well as their aging parents. Why Seniors Are Vulnerable To Falling In reality, the leading cause of injury and death for senior citizens over the age of 65 is falling, and with more of the aging population living independently, the trend is only getting worse, according to the U.S. Centers for Disease Control and Prevention (CDC). In fact, of the roughly 58 million Americans age 65 or older, one in four report experiencing a fall, based on historical data from the CDC, a growing problem they admit can be prevented. Dr. Esiquio Casillas, Senior Vice President and Chief Medical Officer for the AltaMed Health Services Program of All-Inclusive Care for the Elderly, explained the cause, saying, “That’s because aging affects our muscle strength and flexibility, making it more challenging to maintain balance and stability. Older adults are also more likely to have chronic conditions that can affect their mobility, coordination and overall stability. Plus, age-related vision changes and hearing loss can make it harder to navigate and identify potential hazards.” Recognizing these concerns, LogicMark (NASDAQ: LGMK), with nearly two decades in the personal safety products market, has developed an entire suite of solutions, including personal emergency response systems (PERS), health communications devices and internet-of-things (IoT) technologies for a connected care platform. LogicMark says its technology harnesses data to identify risks while anticipating needs and protecting data privacy. It carries the potential to reverse a troubling and dangerous trend of death from accidental falls. Considering the growth that the senior medical alerts/PERS market is set to experience, with the market opportunity projected to reach $17.26 billion by 2028 – reflecting a compound annual growth rate of 10.6% – LogicMark could be strategically positioned to capitalize on this trend. LogicMark’s Business Evolution Since its founding in 2006, LogicMark has become a leader in personal safety. Early in its inception, the company relied heavily on reactive medical alert hardware, products that generated one-time revenue and were predominantly targeting the business-to-government (B2G) market, which LogicMark says it has not only penetrated but is strong in despite fierce barriers to entry. Since 2021, the company’s transformation has been in full gear, coinciding with the appointment of CEO Chia-Lin Simmons, who remains at the helm. LogicMark reports that it has since expanded from a one-time revenue model to one that includes recurring subscription revenue with a very good lifetime value. Its latest products exist in white-hot areas such as AI, software-as-a-service and mobile applications, while it has also broadened its reach to include business-to-business (B2B) and business-to-consumer (B2C) channels. The LogicMark ecosystem integrates proprietary AI and machine learning technologies, facilitating ongoing connectivity and scalability. How LogicMark’s Products Can Be A Lifeline In Distress LogicMark has no shortage of products and solutions from which senior citizens and others can choose that could serve as a lifeline in times of distress. While LogicMark offers numerous products and services, here are a couple that are uniquely fit for seniors: Freedom Alert Mini: The newest in its line of mobile medical alert devices, Freedom Alert Mini brings revolutionary technology to medical alert devices. 24/7 monitoring means this device will always reach help and ensure wearers receive critical assistance. Fall detection will alert emergency services even when the fallen can't speak. GPS location services allow caregivers to monitor device location at all times. Caregivers can set geofencing boundaries to receive alerts when those under their care may wander. The Care Village app provides ultimate reassurance as a hub for emergency alerts, device status and geofencing boundary management. Guardian Alert 911 Plus: Guardian Alert 911 Plus is a 4G LTE technology that gives wearers peace of mind to travel anywhere within range of a cellular network. An industry-leading battery life means Guardian Alert 911 Plus only needs to be charged every 3-6 months, based on battery monitoring settings. LogicMark brought two-way voice communication to medical alert device technology. Guardian Alert 911 Plus can be worn on a lanyard, in a belt clip or on a wrist strap. This device is a one-time purchase, requiring no monthly monitoring fees. Aster: For aging adults who have a cell phone and are not ready for a traditional medical alert device, LogicMark offers Aster, a personal safety app that connects directly to a monitoring service to ensure the user's safety. In an emergency, a swipe will immediately connect them to monitoring professionals who will stay on the line and dispatch emergency services to help. A press and hold will allow all aging adults to arm the app when they don't feel safe and call help when they release. The follow me feature allows users to schedule events or appointments that they would like a check-in after, to make sure they have left safely. The Bluetooth button can be clipped to a keychain or purse to call emergency services immediately when help is needed. Freedom Alert Plus: Freedom Alert Plus is an in-home, Wi-Fi-powered medical alert device. LogicMark reports that it is the first of its kind with a touch screen and fall detection, making the device the ultimate safety companion for around the home and yard. 24/7 monitoring means emergency professionals are always available to dispatch help when wearers need it. Care Village provides caregivers with peace of mind, knowing they will always receive alerts when their loved one needs assistance. They can monitor device battery life and Wi-Fi connection to make sure Freedom Alert Plus will connect to emergency services. The issues around personal safety and independence are not going to disappear by themselves. Investors who are interested in participating in this digitization of the personal safety market can check out LogicMark’s investment deck here. Featured photo by Oppo Find X5 Pro on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 24, 2024 08:45 AM Eastern Daylight Time

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CompleCure Partners with AGC Biologics’ Chiba Site to Develop Advanced Anti-Cancer Therapeutic Using Pioneering AMDC Technology

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today the company entered into a strategic service agreement with CompleCure. The partnership focuses on developing the manufacturing process for a novel anti-cancer therapeutic, which uses Antibody Mimetics Drug Conjugate (AMDC) technology—a groundbreaking advancement in cancer treatment. AGC Biologics is developing the manufacturing process for the protein component of this new therapeutic at its facility in Chiba, Japan. The AMDC technology represents a significant evolution of Antibody Drug Conjugate (ADC) therapy, offering a potentially promising new approach to cancer treatment by combining a mimetic protein structure with a chemically synthesized drug specifically designed to target and destroy cancer cells. The therapeutic being developed by CompleCure aims to revolutionize breast cancer treatment. It is designed to achieve complete remission with minimal side effects, significantly improving patient outcomes. The protein component, which is the focus of AGC Biologics' efforts, features a complex tetrameric structure that demands advanced technologies in microbial expression for successful process development and manufacturing—an area where AGC Biologics Chiba has unparalleled expertise. “AGC Biologics Chiba and our scientists are experts in working with complex proteins and the latest technologies. For this reason, we are an ideal CDMO site to partner with CompleCure on this innovative treatment,” said Jun Takami, General Manager, AGC Biologics Chiba Facility. “We look forward to working side by side with the CompleCure team to develop this new therapeutic that could have a revolutionary impact on breast cancer patients across the globe.” CompleCure selected AGC Biologics as its partner based on the company’s 30-year track record as a leading CDMO, its ability to rapidly propose innovative development solutions, and its flexible production capabilities. The two companies plan to continue manufacturing the protein component at AGC Biologics' Chiba site, ensuring a seamless transition to production for further steps once the process development is completed. This collaboration marks a significant milestone in the path toward the commercialization of AMDC-based therapeutics. By combining AGC Biologics’ development and manufacturing capabilities with CompleCure's innovative therapeutic approach, the two companies hope to bring this promising treatment to market, ultimately contributing to the improvement of quality of life (QOL) for cancer patients worldwide. For more information about AGC Biologics Chiba, visit www.agcbio.com/facilities/chiba. To learn more about AGC Biologics’ global CDMO services go to www.agcbio.com. About CompleCure CompleCure is a start-up developing innovative pharmaceuticals by utilizing cutting-edge biotechnology. We own the intellectual property rights to the “Cupid-Psyche System,” utilizing the high affinity and strong binding of proteins and vitamins. Cupid-Psyche System is one of the outcomes of the “Molecularly Designed Antibody Project,” a cutting-edge R&D support program led by the Cabinet Office and involving Japan Bioindustry Association, the University of Tokyo, Osaka University, Chugai Pharmaceutical Co., Ltd. and Fujifilm Corporation. The new breast cancer treatment for which AGC would develop manufacturing process under the announced strategic service agreement is the most advanced in development among the AMDC based therapeutics utilizing the Cupid-Psyche system. This therapeutics is being developed in cooperation with the University of Tokyo, Tohoku University, and Chiba University. We will open up new possibilities for fundamental treatment of cancer. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

September 23, 2024 04:58 PM Pacific Daylight Time

SBC Medical Group Holdings (Nasdaq: SBC) Claims First-Mover Advantage In Medical Services Franchise Model, Debuts On Nasdaq

Benzinga

By Gerelyn Terzo, Benzinga While it’s hard to put a price tag on time, it’s one of those commodities that healthcare professionals value highly. And yet, many physicians, including surgeons, are mired in administrative work, costing them valuable time that they could otherwise be spending on patient care. Fortunately, the medical field continues to see new innovations such as AI-powered diagnostics, surgery robots, wearables — and the rise of service organizations that shoulder the weight of otherwise mundane administrative tasks. As a result, healthcare professionals across medical segments have more options than ever to keep their operations running smoothly while optimizing performance. One company in the vanguard of this trend is SBC Medical Group Holdings (NASDAQ: SBC), a Tokyo-based medical services healthcare company with a history in the aesthetics space that specializes in solving the problems of medical care providers. SBC has its roots in providing management services to cosmetic treatment centers in Japan, an industry where demand is on the rise, fueled by procedures such as dermal fillers, botulinum toxin (botox) and eyelid surgery and more. Bringing A New Business Model To The Aesthetic Medical Industry SBC Medical’s business model brings the franchisee-franchisor model to a new industry. This model is one that is appreciated by many investors for its proven success in sectors like restaurants and now in healthcare, including medical clinics. SBC believes that as the pioneer of the franchise model in the global aesthetics medical industry, it enjoys a first-mover advantage. The company boasts a No. 1 leading position in Japan’s growing aesthetics medical industry, reporting that it generates stable and high-profit margins owing to the collection of ongoing franchise fees. This model involves franchisor-franchisee contracts or agreements between any of SBC ’s Japanese subsidiaries and medical corporations serving as the umbrella for a total of 218 clinic treatment centers in Japan, with 2 additional clinics located outside of the country. These beauty clinics, which operate under the Shonan Beauty Clinic brand, specialize in services ranging from breast augmentation and laser hair removal to cosmetic dental procedures and beyond. The administrative tasks associated with providing these kinds of medical services can be burdensome without proper support. Supporting Healthcare Professionals Through Management Services The comprehensive management services that SBC provides to franchise clinics run the gamut. Depending on the practice’s needs, SBC might handle its IT requirements, advertising and marketing needs (such as operating social media channels), hiring, payroll, reservations, staff housing and other such requirements. Additionally, SBC supports franchisee clinics in other ways, extending to the construction and design of clinics, procurement and resale of medical equipment and consumables, the provision of cosmetic products to patients, licensure/IP, customer loyalty programs and more. A common thread across these services is that they represent time-consuming activities that can take a toll on practice owners, interfering with their ability to give 100% of their attention to providing high-quality care to their patients. While the services may vary, the end goal is the same - to create greater efficiencies for the medical practice while saving healthcare professionals valuable time and streamlining their operations. As a result, the doctors can focus on what they do best - caring for patients. Importantly, SBC is not limited to any single medical specialization or jurisdiction. Since its inception, the company has expanded its footprint to provide high-quality services to medical corporations overseas, including its first clinic in Vietnam and the United States, respectively. SBC has just made its debut as a publicly traded company on the Nasdaq, giving investors an opportunity to participate in its growing total addressable market. Company And Market Dynamics SBC specializes in providing comprehensive management services to franchisee healthcare clinics. Incorporated in 2023, SBC believes it is well-respected in the industry, owing to the SBC management team’s two decades-plus of industry experience. For more than two decades, SBC CEO and Chairman Dr. Yoshiyuki Aikawa has been at the helm of Aikawa Medical Group, now known as SBC. He also served as president and director of the Japanese Society of Aesthetic Plastic Surgery, Harvard Medical School, PGA. SBC Chief Operating Officer Yuya Yoshida is a seasoned capital markets executive, with former stints at Rakuten Group Co, where he specialized in M&A at Mitsubishi UFJ Financial Group. With a combined 166 franchise clinics, SBC has already claimed the title of Japan’s biggest aesthetic medical group. While the company is in the midst of an expansion push, Japan is its maiden market, where it reports it has a demonstrated track record of success. It plans to continue to grow in Japan while pursuing new growth opportunities in the U.S. and Southeast Asia. Japan’s cosmetic surgery market has experienced steady growth. It is predicted to expand at a compound annual growth rate (CAGR) of 8.1% in the decade leading up to 2033 for a value of $41.6 billion, up from $19 billion in 2023. Meanwhile, the country’s medical aesthetics market was worth $2.6 billion as of last year and is growing at a CAGR of 13% in the current decade for a value of $9 billion by 2033. SBC’s Balance Sheet Investors who are interested in participating in the company’s growth story may find SBC ’s fundamentals interesting. For the fiscal year ended December 31, 2023, SBC’s revenues increased 11% to $193 million with EBITDA of $82 million and net income of $39 million. Revenues increased 27.72% to approximately $54.8 million with a net income of approximately $18.7 million for the three months ended March 31, 2024. The company has a balance sheet to help support its growth, with approximately $96 million in cash and cash equivalents as of March 31, 2024. SBC is not only providing quality comprehensive management services to medical corporations and expanding its Shonan Beauty Clinic brand but doing so profitably. SBC Medical Group Holdings began trading on the Nasdaq under the ticker symbol SBC on September 18 following a business combination with Pono Capital Two (Nasdaq: PTWO), a special purpose acquisition company (SPAC). Investors who would like to participate in SBC’s growth story now have the unique opportunity to do so in the stock’s early days of trading on the Nasdaq market. Featured photo by Bru-nO 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 20, 2024 08:25 AM Eastern Daylight Time

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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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