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Syra Health Wins Contract Valued At Nearly $6M To Train Indiana Health Workers

Syra Health

By Kyle Anthony, Benzinga Syra Health Corp. (NASDAQ: SYRA), has been awarded a $5.8 million contract to train professionals who deliver healthcare to Indiana residents at home or in a community-based setting under the purview of the Indiana Family and Social Services Administration (FSSA). Headquartered in Carmel, Indiana, Syra Health was founded in 2020 and is focused on improving healthcare through innovative services and technology solutions. At its core, the company is a healthcare technology company powering better health in challenging areas such as behavioral and mental health, digital health, and population health. Syra Health's offerings are centered on prevention, improved access, and affordable care. In securing this new contract, Syra Health says it will deliver curriculum development, competency assessments, a sophisticated learning management system (LMS), a comprehensive training registry, and a dynamic quality improvement plan, all to fulfill FSSA's vision of "ensuring all home and community support professionals serving any population under a home and community-based settings waiver have the same competencies and training." In speaking about being selected for this new contract, Dr. Deepika Vuppalanchi, CEO of Syra Health, stated, “We are proud to have been selected to implement statewide home and community support professionals training as part of this important program administered by FSSA. In recent months, we have seen a surge in demand for our off-the-shelf training services, and we look forward to providing additional health training services across the country.” Syra Health’s curriculum reflects important gold-standard learning models and over 200 years of experience. It has module-specific learning objectives and interactive activities across the foundational, fundamentals, medication administration, and micro-credentials curricula. These areas, aligned with state-defined core competencies, integrate health equity and cultural competency principles aimed at supporting home and community support professionals of all backgrounds. Syra Health’s training registry will track the utilization of the training materials and will be integrated into the LMS. As such, it will be able to provide a snapshot of workforce capacity and competency at any given moment in time. Effective monitoring and reporting will also be a critical aspect of this project. Syra Health says it will be providing regular comprehensive reports to the FSSA and modifying the process to meet any evolving monitoring or reporting needs. Featured photo by Ani Kolleshi on Unsplash. Syra Health is a healthcare technology company addressing some of healthcare's most significant challenges in areas such as behavioral and mental health, digital health, and population health, by providing innovative services and technology solutions. Syra Health’s products and services are centered on prevention, improved access, and affordable care. Syra Health supplies its solutions to payers, providers, life sciences organizations, academic institutions, and government. For more information, please visit www.syrahealth.com. Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to the expected use of proceeds, the Company’s operations and business strategy and the Company’s expected financial results. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained in this press release are based on management's current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Investors should read the risk factors set forth in our registration statement on Form S-1 and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Christine Drury +1 463-345-8950 Christined@syrahealth.com Company Website https://www.syrahealth.com/

July 31, 2024 08:55 AM Eastern Daylight Time

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Mainz Biomed's (NASDAQ: MYNZ) Cutting-Edge Colorectal Cancer Test Applies For FDA Breakthrough Status

Benzinga

By Johnny Rice, Benzinga Mainz Biomed (NASDAQ: MYNZ) has taken a significant step forward in the fight against colorectal cancer with its application to the FDA for breakthrough device designation for its colorectal cancer test. This innovative screening test could revolutionize how we detect one of the most prevalent and deadly cancers worldwide. At its core, the test combines traditional fecal immunochemical testing with cutting-edge mRNA biomarker analysis, all enhanced by advanced AI algorithms. It's a sophisticated approach that aims to dramatically improve early detection rates for both colorectal cancer and precancerous lesions. The numbers coming out of clinical trials are truly promising. In a study involving 295 participants across 21 U.S. gastroenterology centers, the test showed a 97% sensitivity for colorectal cancer and an 88% sensitivity for advanced precancerous lesions. These figures, coupled with a 93% overall specificity, suggest a significant improvement over current screening methods. Mainz Biomed's CEO, Guido Baechler, emphasizes the test's potential impact, stating that the next-generation test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias. This level of accuracy could be game-changing, potentially catching cancer and precancerous growths at much earlier, more treatable stages. However, what sets this test apart isn't just its accuracy but also its accessibility. Mainz Biomed is taking a decentralized approach, partnering with third-party laboratories to make the test more widely available. This strategy could be particularly beneficial for underserved communities where access to high-quality cancer screening has often been limited. If granted breakthrough device designation by the FDA, this test could see an expedited approval process, bringing it to patients sooner. The implications are significant: earlier and more accurate detection could lead to more timely interventions, potentially saving countless lives. Even as the FDA's decision is pending, this test potentially represents a beacon of hope in the ongoing battle against colorectal cancer. By combining innovative biotechnology with AI, Mainz Biomed is pushing the boundaries of what's possible in cancer detection. While it's important to temper excitement with caution until a full FDA review, this development undoubtedly marks a significant step forward. It serves as a powerful reminder of the ongoing progress in medical science and the potential for new technologies to make a real difference in people's lives. Featured photo by Tung Nguyen from 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

July 31, 2024 08:30 AM Eastern Daylight Time

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News Release

Acarix announces shares are now being traded on the OTCQB under the ticker ACIXF

Acarix AB

Acarix CEO Aamir Mahmood joined Steve Darling from Proactive to share news the company has begun trading on the OTCQB Market in the United States, under the ticker symbol ACIXF. This listing complements its existing presence on the Nasdaq First North Growth Market in Stockholm. Mahmood expressed that with the US being Acarix's most important commercial market, this development allows for a broader investor base to participate in the company’s growth journey. Acarix specializes in medical devices aimed at rapid assessment of coronary artery disease (CAD) at the point of care. The company's flagship product, the CADScor System, is CE-approved and FDA DeNovo-cleared, offering a non-invasive solution to help healthcare providers rule out CAD in patients experiencing chest pain, potentially reducing the need for costly and invasive diagnostic procedures. The company recently announced a significant reorder of single-use patches for the CADScor System by a primary care clinic in the New Orleans, Louisiana metropolitan area. These patches are integral to the system's operation in evaluating patients suspected of having coronary artery disease. Additionally, Acarix has received a multi-order for the CADScor System from Saving Grace Concierge, which will use it as a diagnostic aid for symptomatic patients in the Oklahoma City and Tulsa metro areas. Looking ahead, Mahmood outlined the company's focus on top-line growth, reimbursement efforts with CMS and private payers, and initiating clinical trials. He emphasized the device's potential to save significant healthcare costs and drive commercial success in the US market. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 30, 2024 10:58 AM Eastern Daylight Time

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Citius Pharmaceuticals Nears Market Breakthrough With Two Leading Products

Benzinga

By Meg Flippin, Benzinga From fighting cancer to treating bloodstream infections, Citius Pharmaceuticals Inc. (NASDAQ: CTXR) is busy trying to solve some of the world’s ills. That’s picking up steam with two of its lead products close to commercialization. Take Mino-Lok (MLT), Citius Pharmaceuticals ' novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium to treat patients with catheter-related blood stream infections. Mino-Lok offers hospitals an alternative to removing and replacing a central venous catheter (CVC), and that could reduce the number of serious adverse events like air embolism and bleeding. It could also save hospitals money. Bringing It To The Market Citius Pharmaceuticals CEO and co-founder Leonard Mazur told Benzinga that his company has “extremely positive” topline data from a Phase 3 Trial of Mino-Lok. Now Citius is meeting with the U.S. Food and Drug Administration (FDA) to move ahead with Mino-Lok, he said. Once Mino-Lok is approved, the company says it will be the only FDA-backed product for infected catheters in the market, presenting a big opportunity for the company. “The market potential is about $2 billion,” said Mazur. “Positive announcements will come out of the meeting but I can’t predict that moment.” Then there is LYMPHIR, a recombinant fusion protein designed to treat T-cell lymphomas. The drug agent combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of peripheral T-cell lymphoma (PTCL) and Cutaneous T-cell lymphoma (CTCL). In 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain other parts of Asia. In March this year, the FDA accepted Citius’s Biologics License Application (BLA) for LYMPHIR with a decision expected on August 13, the FDA's assigned Prescription Drug User Fee Act (PDUFA) action date. If approved, Citius is preparing for LYMPHIR commercialization later this year. “We’re very excited about this launching during the fourth quarter,” said Mazur. “We go from no revenue to revenues.” The executive pegged the market opportunity at $300 to $400 million, telling Benzinga LYMPHIR is an additive and won’t take market share from anyone. Shoring Up Shareholder Value Bringing two drug products to market isn't the only way Citius is enhancing shareholder value. The company is also spinning out its wholly-owned oncology unit to form Citius Oncology, a stand-alone publicly traded entity. It is doing it via a SPAC deal with TenX Keane (NASDAQ: TENK). Citius Pharma is getting 67.5 million shares in Citius Oncology at $10 per share, valuing the stake at $675 million and will retain majority ownership of approximately 90%. This transaction is expected to unlock significant value for Citius shareholders by separating the oncology business, potentially leading to increased access to capital markets and further development of new applications and additional intellectual property, reports Citius. It also underscores Citius’s strategy to purchase assets, develop them and bring them to market and then unlock shareholder value. Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies, with LYMPHIR the first to go to market. The company said the deal is expected to provide Citius Oncology with improved access to the public equity markets and thereby facilitate the commercialization of LYMPHIR and position the company to explore additional value-creating opportunities more fully. “The reason we are doing it is we get a Nasdaq listing by having the SPAC acquire the assets and at the same time it enables us to do something to prevent dilution for shareholders,” said Mazur. The CEO counts himself as one of them; he has invested $22.5 million of his own money in the business. “During the first year on the market we will be profitable. All that benefits Citius shareholders.” Featured photo by Nataliya Smirnova 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

July 30, 2024 08:45 AM Eastern Daylight Time

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Pancreatic Cancer Could Overtake Colorectal Cancer To Become Second Leading Cause Of Cancer Death – Oncolytics Is Working On A Promising Treatment

Benzinga

By Meg Flippin, Benzinga Pancreatic cancer isn’t something that only happens to those who smoke, are overweight, have a family history of the condition, or are older than 55. Increasingly, women and younger adults are getting diagnosed with this deadly form of cancer. It’s alarming, given one study found that in the U.S., the incidence of pancreatic cancer among those under the age of 55 is increasingly more rapidly than in those 55+. While pancreatic cancer is now the third leading cause of cancer deaths, by 2030, it is expected to morph into second place, surpassing colorectal cancer deaths. This year alone, about 66,440 Americans will be diagnosed with pancreatic cancer, a record for this deadly form of cancer. What’s more, about 51,750 Americans are expected to die from the disease this year. Among cancers, pancreatic is a tough one to treat. It’s a highly aggressive form of cancer that attacks the pancreas, an organ needed for digestion. With limited treatment options, the five-year survival rate is just 13%. It doesn’t help that most people are diagnosed with pancreatic cancer in a late stage when it has already spread to other parts of the body. That’s particularly true with pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer that’s created from the cells that line the ducts of the pancreas. It's one of the most lethal forms of pancreatic cancer. A person’s health, lifestyle, diet, age and family history all play a role in whether they will get this lethal disease, and changing lifestyles may be a factor in the rise in the condition’s prevalence. Given the difficulty of treating pancreatic cancer and its increasing incidence, much medical research is directed toward earlier detection and better treatments. As a result, the global pancreatic cancer market is projected to reach $7.4 billion by 2032, growing at a CAGR of 13.7% during the forecast period. Your Immune System Fired Up One area of treatment that holds promise is immunotherapies. Administered as a pill, injection, or intravenously, immunotherapies help the body’s immune system attack cancer cells. On its own, the immune system has difficulty finding and attacking cancer cells but with these therapies, it can be an avid hunter. That’s exactly what Oncolytics Biotech Inc. (NASDAQ: ONCY), the clinical-stage biopharmaceutical company specializing in immunotherapeutics for oncology, is betting will happen with pelareorep, its leading agent to fight pancreatic cancer that has demonstrated promising results in phase 1 and 2 studies. It is an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot.” Pelareorep works by generating, recruiting and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access. When added to existing treatment regimens such as chemotherapy, pelareorep demonstrates the potential to extend survival times in addition to expanding existing and new T cell clones in the blood, the company reports. Testing Under Way Pelareorep is being tested in the GOBLET study, a phase 1/2 multiple-indication study in advanced or metastatic gastrointestinal cancers conducted at 17 centers in Germany. The aim of the study, which kicked off in fall 2021, is to investigate the safety of the drug combination and improvements in tumor size. The GOBLET study was recently expanded to include a new cohort to test pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. mFOLFIRINOX is a chemotherapy treatment for pancreatic cancer that combines several drugs. The new cohort, which is testing the objective response rate (ORR) and safety, is supported by the $5 million Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award. The grant was established to accelerate the development of new treatments for pancreatic cancer patients. Hitting Milestones Oncolytics Biotech recently dosed the first patient in that expanded cohort, marking a major milestone for the company. “We’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration.” The trial is being closely watched because of the promise the treatment holds if it proves successful. mFOLFIRINOX is currently considered one of two primary treatment options for many pancreatic cancer patients. If pelareorep is effective, it could broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies, the company reports. “Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal.” Featured photo by National Cancer Institute 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

July 30, 2024 08:35 AM Eastern Daylight Time

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MIRA Pharmaceuticals (NASDAQ: MIRA) Reports Promising Pre-Clinical Trial Results For Mental Health Treatment, To Submit Investigational New Drug Application By End Of Year

MIRA Pharmaceuticals, Inc.

By Meg Flippin, Benzinga From cognitive impairments to depression-related illnesses, the current treatments aren’t doing enough. Sure, some may bring relief to the millions of people worldwide affected by neurological and neuropsychiatric disorders, but they come with a lot of side effects and accessibility challenges that can render them less than ideal. That leaves a gap in effective, safe and affordable solutions. MIRA Pharmaceuticals (NASDAQ: MIRA) may have the answer. This preclinical-stage pharmaceutical company is focused on transforming the treatment of mental health disorders through scientific research and technological advancements. It's betting that its two compounds, MIRA-55 and Ketamir-2, will revolutionize mental health care. Take MIRA-55 for starters. The novel compound aims to deliver the therapeutic benefits of THC and CBD without their associated side effects, such as increased appetite, paranoia and cognitive decline. It’s currently under investigation for treating neuropathic pain, anxiety and cognitive enhancements without the impurities of marijuana. In preclinical studies, MIRA-55 has shown the ability to double the memory of mice, in contrast to THC, which is known to impair memory, reports MIRA. MIRA-55 could be particularly beneficial for patients seeking cognitive enhancements and anxiety relief without the downside of impaired memory or other side effects. Meanwhile, Ketamir-2, an oral ketamine analog designed to be taken as a pill, is being investigated for its potential antidepressant effects, particularly for treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation. Unlike traditional ketamine, which requires intravenous administration – posing accessibility and safety challenges – Ketamir-2 aims to simplify and improve the treatment experience. The Science Behind Ketamir-2 Recent preclinical data reveals that Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site, avoiding interactions with opioid receptors, dopamine, serotonin transporters, and acetylcholine receptors. This unique selectivity may reduce side effects typically associated with traditional ketamine. Ketamir-2 has a 30- to 50-fold lower affinity to the PCP site compared to ketamine, which itself has about 10-fold lower affinity than PCP (Phencyclidine, Angel Dust). This is significant because ketamine was developed to be similar to PCP but with lower affinity, thereby reducing the risk of psychoactive side effects. In this respect, advocates consider Ketamir-2 a third-generation drug. Moreover, Ketamir-2 is optimized for brain delivery. It is not a substrate for P-glycoprotein (P-gp), a membrane protein that pumps drugs out of cells, including those in the brain. This characteristic could allow Ketamir-2 to have better oral absorption and penetrate the blood-brain barrier more effectively than traditional ketamine, enhancing its therapeutic potential and bioavailability. Ketamir-2's oral bioavailability is predicted to be around 80%, which is significantly higher than traditional ketamine's 30%. Preclinical studies have shown that oral Ketamir-2 is safe at high doses and effective in several antidepressant and anxiolytic models. It does not appear to induce hyper-locomotor activity – a common side effect of traditional ketamine – and has shown no interaction with the mu-opioid receptor. MIRA says this could potentially mean a reduced risk of opioid-related side effects and dependency. Recent studies further highlight Ketamir-2's anti-depressive and anxiolytic effects in a mouse model, with significant improvements in behavioral tests compared to traditional ketamine. A Step Toward Improved Patient Care If MIRA is right about Ketamir-2, it has the potential to significantly positively impact mental health care, potentially helping millions of people through improved access and affordability. 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 the need for 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, with the ease of taking a pill at home potentially leading to better adherence to treatment regimens compared to frequent hospital visits for IV infusions. By reducing the need for medical supervision and hospital visits, Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Furthermore, MIRA reports that the U.S. Drug Enforcement Administration (DEA) has conducted a scientific review of both MIRA-55 and Ketamir-2 and determined that neither compound is classified as a controlled substance – significantly easing their regulatory pathway. Exploring New Frontiers: Orphan Drug Indications MIRA's journey doesn't stop at common mental health disorders. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. These conditions often have limited treatment options and significant patient populations in need of effective therapies. Moreover, due to its novel chemical profile, MIRA is investigating options for orphan drug indications such as multiple sclerosis-induced depression and Huntington's disease-induced depression. The company believes these rare conditions could benefit from innovative treatments like Ketamir-2. Market Potential And Patient Population The market potential for MIRA Pharmaceuticals' compounds is substantial. Cognitive impairments, including conditions like Alzheimer's disease and dementia, affect millions of individuals. Close to seven million Americans are currently living with Alzheimer's, a number expected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association. Meanwhile, anxiety disorders affect over 40 million adults in the United States, according to the National Alliance on Mental Illness. For depression, particularly treatment-resistant depression, the numbers are equally staggering. Approximately 17.6 million Americans are diagnosed with major depressive disorder, with 5.5 million reporting suicidal ideation and about 2 million having suicidal ideation with intent. The annual burden of medication-treated major depressive disorder in the United States is estimated at $92.7 billion, with $43.8 billion attributable to treatment-resistant depression. Looking Ahead: The Path To Regulatory Approval MIRA Pharmaceuticals reports that it is on track to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of this year. If granted, this would pave the way for human clinical trials, bringing Ketamir-2 closer to becoming a new standard of care for neurological and neuropsychiatric disorders. The company's commitment to advancing these compounds underscores its mission to address the unmet needs of patients suffering from debilitating conditions like depression, TRD and PTSD. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals. Featured photo by Yuris Alhumaydy 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 Myanez@mirapharma.com Company Website http://www.mirapharmaceuticals.com/

July 29, 2024 11:30 AM Eastern Daylight Time

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AGC Biologics’ Seattle Site Achieves Successful Multi-Product Inspection by U.S. Food and Drug Administration for Biologics License Applications

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today that its Seattle Campus completed a new commercial milestone for regulatory compliance in 2024. The site supported a multi-product inspection in March 2024 with the Food and Drug Administration (FDA) to support Biologics License Applications (BLA) for new products seeking commercial approval in the U.S., two of which are now approved for commercial production at the facility. The two approved products include a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration. AGC Biologics Seattle predicts delivering multiple batches per year for the biopharma partners that received the approvals and accommodating increases in future demand. “This achievement is significant for this site, our team members and our partners in the pharmaceutical industry seeking to bring products from clinical stages to commercial approval,” notes Michael Tranmer, General Manager of AGC Biologics Seattle. “Inspections for multiple products at one time is not easy. This accomplishment is a true testament to our commitment to quality and regulatory compliance and helping developers reach their goals as fast and efficiently as possible.” This is the latest achievement for the Seattle-based CDMO manufacturing site, which has produced six commercial products for AGC Biologics. This includes three commercial approvals in the last two years. AGC Biologics Seattle is active in helping clients navigate clinical milestones, as well. The site team is working with several clinical-stage companies and predicts more commercial license application submissions in the coming 18 to 24 months. AGC Biologics runs multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle site. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. Over the last year, AGC Biologics Seattle has also expanded. This work includes a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site. To learn more about AGC Biologics’ protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services in the U.S., Europe, and Japan visit www.agcbio.com. 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 more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

July 29, 2024 05:30 AM Pacific Daylight Time

News Release

KindlyMD, Inc. (NASDAQ: KDLY): Advancing the $11.6 Billion Medical Cannabis Market in Chronic Pain Treatment

RazorPitch KDLY

Amidst the ongoing opioid crisis, which has prompted increasing scrutiny of traditional pain treatments, there is a growing recognition of the need for comprehensive and effective approaches to pain relief. This shift is creating a market for innovative solutions that integrate conventional medical practices with alternative therapies, such as medical cannabis. As more patients and providers seek to navigate the complexities of pain management, the landscape is evolving rapidly, paving the way for new opportunities in healthcare delivery. KindlyMD, Inc. (NASDAQ: KDLY) has emerged as a pioneer in integrating traditional primary care with alternative pain management strategies. Founded on a patient-first philosophy, KindlyMD operates four centers, including the largest alternative pain treatment center in Utah. The company combines primary care, pain management, behavioral therapy, and alternative treatments, including medical cannabis recommendations, to offer comprehensive care and reduce opioid dependency. Financial Milestones and Market Presence KDLY announced the closing of its IPO of 1,240,910 units at $5.50 per unit, raising approximately $6.8 million in gross proceeds back in early June. This financial boost positions KindlyMD to execute its growth strategy effectively. Additionally, KindlyMD has made significant strides in becoming the first alternative medical treatment company in Utah to contract with the state's top insurance payors, including Select Health, Medicare, Medicaid, and Blue Cross Blue Shield, covering nearly 80% of Utah's population. "This is a major milestone for KindlyMD," said Tim Pickett, PA-C, founder and CEO of KindlyMD. "Now, the scope of services we provide at our Company-branded clinics, including behavioral healthcare and medical interventions incorporating alternative medicine, are covered by and reimbursable by the largest insurance providers across the state." Addressing the Opioid Crisis Provisional data from the CDC's National Center for Health Statistics indicates that in 2021, nearly 108,000 people died of drug overdose in the U.S., with over 80,000 of these deaths attributed to opioids. The government has responded with the largest opioid treatment grant funding ever. Despite widespread use of prescription medication among Americans aged 45-64, many of these prescriptions are insufficient and carry significant long-term side effects. KindlyMD is addressing this crisis head-on by offering non-opioid treatment options like medical cannabis, which have become more widespread in recent years. However, these options are often excluded from clinical recommendations and guidelines, creating an unmet need that KindlyMD aims to fill. To date, the company has seen over 60,000 patient visits in its clinics, providing comprehensive care plans that ensure safe use, appropriate dosing, and behavioral health support for those who need opioids. Strategic Collaborations and Community Outreach On June 10, KDLY announced a collaboration with Curaleaf Holdings, Inc., a leading international provider of cannabis products. The two companies are working together to provide educational resources on holistic pain management and treatment options, including medical cannabis. This partnership includes community care events throughout the summer, aiming to enhance patients understanding of holistic pain management "Our innovative collaboration with Curaleaf will provide more patients with access to pain management treatment options and alternative therapies," said Tim Pickett. "As the U.S. government moves toward rescheduling cannabis as a legitimate medicine, this collaboration will help more patients find sustainable, safer, and more affordable healthcare treatment options." KDLY recently submitted a comment to the U.S. Department of Justice regarding the proposed reclassification of cannabis from Schedule I to Schedule III of the Controlled Substances Act. This reclassification is expected to have several positive impacts on the medical cannabis industry, including reducing patient costs and enabling businesses to deduct standard operating expenses. "Reclassification underscores the continued relevance and importance of our integrated healthcare model," said Tim Pickett. "It will likely lead to increased access and utilization of medical cannabis among our patients, benefiting KindlyMD through improved patient outcomes, new educational opportunities, and enhanced financial stability." Federal Funding Initiatives KindlyMD's successful registration on SAM.gov, the official U.S. federal funding platform, marks a significant milestone for the company. This registration enables KindlyMD to obtain federal grants and contracts, including those with the Department of Veterans Affairs, to support its mission of providing comprehensive healthcare solutions. Following its registration, KindlyMD submitted its first grant application for the USDA Rural Utilities Service Distance Learning and Telemedicine Grant Program, seeking $1,000,000 to expand its Complete Care telehealth program in rural communities in Utah. This program aims to deliver effective healthcare through an interconnected network of telemedicine clinics, addressing the unique challenges faced by rural populations. Financial Performance For the quarter ended March 31, 2024, KDLY reported revenues of $829,029, a decrease compared to the previous year, primarily due to a shift towards insurance billing. However, the company began receiving reimbursements from insurance payors for the first time in its history during this period, amounting to $34,722. Operating expenses decreased by 21.9%, and the company reported a net loss per share decrease of 50%. The capital raised from the IPO will enable KindlyMD to invest in growth opportunities, including mergers and acquisitions of additional clinics in Utah. With over 16% of the medical cannabis patient population in Utah already under its care, KindlyMD is well-positioned to expand its reach and enhance patient outcomes. KindlyMD, Inc.'s (NASDAQ: KDLY) innovative approach and industry expertise position it uniquely to continue providing unique healthcare services. As the regulatory landscape evolves, KDLY remains a crucial partner for patients seeking alternative and integrative healthcare solutions, particularly in the ongoing battle against the opioid epidemic. 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 Cambridge Consulting 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

July 29, 2024 06:00 AM Eastern Daylight Time

BestGrowthStocks.Com Issues a Comprehensive Analysis of Tivic Health Systems Potential Catalysts

Tivic Health Systems Inc.

NEW YORK, NY / NewsDirect / July 29, 2024 / Best Growth Stocks, a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing exclusive ai-assisted research recently issued a comprehensive analysis on Tivic Health Systems Inc. a health tech company that develops and commercializes bioelectronic medicine. Tivic Health Systems Inc. (NASDAQ: TIVC) recently announced the expansion of its intellectual property portfolio with three new patents granted in the US and Europe. Best Growth Stocks full report breaks through the noise and offers an extensive comprehensive analysis of Tivic Health Systems operations, potential catalysts, pipeline, patents, share structure, recent news events, growth strategy, financials, chart support and resistance zones, and more. Access this full analysis free here: https://bestgrowthstocks.com/access-tivc-analysis/ Access the full analysis free here: https://bestgrowthstocks.com/access-tivc-analysis/ About Tivic Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com. About Best Growth Stocks Best Growth Stocks is a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing our exclusive ai-assisted research. BGS is also a financial news provider, focused on giving investors direct access to CEOs of promising, publicly-traded companies, and market experts. Our CEO interviews aim to answer the questions that rest on the minds of current and future shareholders. This is not to be construed as financial advice. Please consult with a licensed financial advisor before making any investment decisions. Media Contact Best Growth Stocks Senior Editor: Steve Macalbry Editor@BestGrowthStocks.com Contact Details Best Growth Stocks Steve Macalbry Editor@bestgrowthstocks.com

July 29, 2024 04:25 AM Eastern Daylight Time

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BestGrowthStocks.Com Issues a Comprehensive Analysis of Tivic Health Systems Potential Catalysts