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Surging Biotech M&A Reaffirms Massive Opportunity In Rare Disease Drug Development

RazorPitch CRDL NVO AZN SNY

Compared to their non-orphan counterparts, orphan drugs have consistently outpaced growth and have become a major part of pharma’s mainstream business. The U.S. FDA's orphan drug designation, established under the Orphan Drug Act of 1983, encourages the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. by providing incentives to offset the small market size. Last year, sales from orphan drugs soared to $168 billion, accounting for about 17% of the industry’s total and just shy of the entire oncology therapeutic category at $194 billion. This year, these drugs are on track to generate an impressive $185 billion and are projected to hit around $270 billion by 2028. For such a large cohort of drugs to still be growing at a double-digit pace is impressive and shows that continued investment into the unmet need of rare diseases is warranted. That explains why there has been a surge in M&A activity among orphan drug developers over the past couple of years. For instance, when novel cannabidiol-based drug Epidiolex successfully treated rare forms of child onset epilepsy, GW Pharmaceuticals more than doubled its market value. The 120-patient trial showed patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. GW Pharmaceuticals went on to be acquired by Jazz Pharmaceuticals for $7.2 billion in 2021, representing a premium of approximately 50% over GW's closing stock price at the time. Clearly, there is a significant opportunity in orphan drug development, which is why these four stocks have been generating substantial investor interest. Cardiol Therapeutics (NASDAQ:CRDL) is a Canadian biotech drug developer focused on developing their novel ultrapure cannabidiol formulation, CardiolRx™, for rare inflammatory heart diseases, specifically recurrent pericarditis and acute myocarditis. Pericarditis is characterized as inflammation of the pericardium, layers of tissue that surround the heart, that affects about 165,000 people in the U.S. annually and has no first-line FDA-approved treatment. Among those treated for acute pericarditis, 15% to 30% may experience recurrent pericarditis. Currently, anti-inflammatory drugs such as colchicine are prescribed for pericarditis treatment in cases of chronic or recurrent pericarditis. If the patient with pericarditis disease does not respond to anti-inflammatory medications, corticosteroids such as prednisone are prescribed. More recently, Kiniksa Pharmaceuticals’ ARCALYST® (rilonacept) became the first and only FDA-approved treatment indicated for the treatment of recurrent pericarditis and the reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is a weekly subcutaneous injection, whereas CardiolRx™ is an oral drug taken twice daily which is a major advantage as the idea of weekly injections could not be as appealing to patients. Cardiol Therapeutics’ (NASDAQ:CRDL) pre-clinical models showed that by inhibiting activation of the NLRP3 inflammasome pathway, cannabidiol may help resolve the symptoms of pericarditis. This approach has already demonstrated incredible potential, as the company was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol Therapeutics followed this major achievement with completing enrollment in its Phase 2, open-label MAvERIC-Pilot study investigating the tolerance, safety, and effect of CardiolRx™ in patients with recurrent pericarditis. The primary endpoint of the trial is the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS) from baseline to week 8 with topline results expected in early June. Not only that, Cardiol Therapeutics recently presented its concurrent Phase II ARCHER trial design at the annual congress of the Heart Failure Association of the European Society of Cardiology. This demonstrated the high level of interest from the cardiology community in novel approaches to treat acute myocarditis, for which there are currently no therapies approved by European and US regulatory authorities. The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis, and ARCHER has already exceeded 85% of target enrollment. Cardiol Therapeutics (NASDAQ:CRDL) expects that results from the ARCHER trial will assist in furthering its understanding of the therapeutic potential of CardiolRx™ and will complement the more advanced MAvERIC-Pilot Phase II study in patients with recurrent pericarditis. Just to put the opportunity here in context, Future Market Insights expects that the worldwide pericarditis treatment market is likely to be worth $ 6 billion by 2032. ARCALYST’s sales further reaffirm this considering that the drug’s 2023 net revenue grew 90% year-over-year to $233.1 million. Several analysts have maintained their positive outlook on the company and have high hopes that the June data will further prove CardiolRx™ efficacy in treating recurrent pericarditis. In fact, Joe Gantoss of Chimera Research Group notes, “I won’t be surprised to see the price breaking out the 3-year high at $4.96 if the recurrent-pericarditis data show a clear success and open the path to move to the next stage with Phase-3 trial,” while analysts at H.C Wainwright & Co. issued a $9 price target for the stock. Novo Nordisk (NYSE:NVO) announced that it was buying Phase II-stage heart failure drug developer Cardior Pharmaceuticals (private) for up to $1.11 billion as it moves to strengthen its pipeline of drugs to treat cardiovascular disease and expand into areas outside of its core diabetes and weight-loss markets. The Denmark-based pharmaceutical giant is enjoying blockbuster success for its Wegovy and Ozempic obesity and diabetes treatments, which aren’t only proving highly effective at regulating blood sugar and helping patients lose weight, but are also yielding extra health benefits such as cutting the risk of stroke and heart attacks and slowing the progression of kidney disease. Based on these findings, the company recently unveiled plans to build a portfolio of therapies in areas like cardiovascular diseases and emerging-therapy areas while strengthening its progress in the rare-disease pipeline. CDR132L, Cardior’s lead compound, is designed to halt and reverse detrimental cardiac remodeling following myocardial infarction (MI) as the first-ever ncRNA-based therapy to enter clinical trials in heart disease. It is currently being investigated in the Phase 2 HF-REVERT clinical trial in 280 post-MI patients with cardiac dysfunction at more than 60 locations across Europe. AstraZeneca (NASDAQ:AZN) also announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases for $800 million. The deal also features $250 million in milestones tied to a regulatory event. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase 3 investigational therapeutic peptide with a novel mechanism of action designed to treat hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. It is one of the largest known rare diseases, affecting an estimated 115,000 people in the US and 107,000 people in the EU, approximately 80% of whom are women. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover. Sanofi (NASDAQ:SNY) earlier this year agreed to buy the U.S. biotech Inhibrx Inc. for as much as $2.2 billion, giving the French drugmaker a potential therapy for a genetic disorder that affects the lungs and liver. Inhibrx shareholders will get $30 per share as part of the deal, along with the right to receive $5 in cash if the experimental drug meets a regulatory milestone. “The addition of INBRX-101 as a high potential asset to our rare disease portfolio reinforces our strategy to commit to differentiated and potential best-in-class products,” said Houman Ashrafian, Sanofi’s head of research and development. “With our expertise in rare diseases and growing presence in immune-mediated respiratory conditions, INBRX-101 will complement our approach to deploy R&D efforts in key areas of focus.” 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 Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. 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 Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

June 11, 2024 06:00 AM Eastern Daylight Time

Elicio Therapeutics Unveils Promising Phase 1a Data For ELI-002 7P In mKRAS Tumors

Benzinga

By Kyle Anthony, Benzinga Elicio Therapeutics (NASDAQ: ELTX) has announced that preliminary data from their AMPLIFY-7P Phase 1a Study of ELI-002 7P in patients with mKRAS-driven solid tumors was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose (“RP2D”). Elicio Therapeutics is a clinical-stage biotechnology company focused on developing innovative lymph node-targeted immunotherapies to treat aggressive cancers. Given the firm’s expertise in materials science, immunology and oncology, it plans to forge a new path forward for cancer treatment by utilizing its diverse capabilities to fulfill its mission of amplifying the potential of immunotherapies, empowering patients to fight cancer with full force. The initial findings from its study are encouraging, given that KRAS mutated cancers are difficult to target in part due to the number of diverse mutations and bypass resistance mechanisms. “We are encouraged by the first data from the ongoing AMPLIFY-7P trial, which demonstrate ELI-002 7P has a favorable safety profile and early antitumor effects that correlate with induction of T cells specific for multiple KRAS mutations potentially providing broader coverage for patients, said Craig E. Devoe, M.D., MHCM., chief of the Division of Medical Oncology & Hematology and the R.J. Zuckerberg Cancer Center, and scientific investigator at Northwell Health. Elicio Therapeutics Pipeline Elicio Therapeutics’ lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (AMP) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene — a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio Therapeutics’ AMP technology, consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy. ELI-002 7P (7 peptide formulation) is being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations(G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. Compelling Results From The Ongoing AMPLIFY-7P Phase 1a Study The company reports that the efficacy of ELI-002 7P as a treatment solution was successful in several instances, demonstrating the versatility of the drug and its ability to provide a strong T cell response. The preliminary data findings from the ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P include: ELI-002 7P administered as a monotherapy was well tolerated and able to generate a ~100x mKRAS-specific expanded T cell response relative to baseline levels ELI-002 7P generated an mKRAS-specific T cell response in 100% of patients including responses targeting all mKRAS mutations enrolled (G12D, V, R and G13D) mKRAS-specific T cells were polyfunctional with 66.7% (4/6) of evaluable patients having both CD8+ and CD4+ responses at the 4.9 mg Phase 2 dose level Tumor biomarker reductions were observed in 5/7 (71%) of evaluable patients at the 4.9 mg Phase 2 dose level ELI-002 7P was shown to induce antigen-spreading with increased T cell responses targeting non-immunizing, personalized tumor neoantigens in 6/6 (100%) of evaluable patients at the 4.9 mg Phase 2 dose level In speaking about these findings, Christopher Haqq, MD, PhD, executive vice president, head of Research and Development and chief medical officer at Elicio Therapeutics, stated, “These early immunogenicity and biomarker response data from ELI-002 7P continue to provide encouraging results showing that our lymph node-targeted approach generates a robust and differentiated T cell response that strongly correlates with tumor biomarker reductions.” “Across two trials, ELI-002 has demonstrated an ability to generate a robust T cell response against all mKRAS mutations of enrolled patients as well as T cell responses against non-immunizing personalized tumor neoantigens. ELI-002’s broader KRAS mutation coverage and higher T cell responses with the 7-peptide vaccine at the Phase 2 dose holds promise for the high unmet need of patients with KRAS-mutated tumors,” Haqq said. The AMPLIFY-7P Phase 1a Study data findings of ELI-002 7P were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, IL. The ASCO Annual Meeting is considered the premier international forum for presenting scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. An Immunotherapeutics Company Founded as a spin-out from the Massachusetts Institute of Technology (MIT), Elicio Therapeutics leverages the research of Professor Darrell Irvine, a Howard Hughes Investigator and expert in biomedical engineering and immunology. The company's main innovation, the Amphiphile (AMP) platform, delivers immunotherapeutics directly to the body’s lymph nodes to enhance the immune system's cancer-fighting mechanisms. By delivering cancer immunotherapies to the center of the immune response, Elicio Therapeutics intends to optimize the natural ability of the lymph nodes to educate, activate, and amplify cancer-specific T cells. Elicio Therapeutics' mission is to give patients battling cancer the best possible outcome. The firm’s leadership and scientific advisory board are composed of determined and experienced individuals who are committed to engineering lymph node–targeted immunomodulators, adjuvants, and vaccines for an array of aggressive cancers. The Path Forward Elicio Therapeutics’ recent findings are encouraging news and a tailwind for the firm’s innovation activities. Given the applicability of ELI-002 7P in treating patients with differing cancers, this is a milestone moment for Elicio Therapeutics and an encouraging step forward in the firm’s research and development and eventual commercialization of its treatment offering. As such, the benefit that Elicio Therapeutics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance. Featured photo by CDC 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

June 10, 2024 08:30 AM Eastern Daylight Time

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Room to Roam: ‎The Elephant’s Path to Climate Resilience

News Media Group, Inc.

Contact Details Karl Wayne +1 334-440-6397 karl@newsmg.com Company Website https://newsmg.com/

June 10, 2024 07:00 AM Eastern Daylight Time

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Candel Therapeutics’ (NASDAQ: CADL) Lead Candidate CAN-2409 Combats Lung, Pancreatic And Prostate Cancers With Fast Track Designation For Three Cancers

Candel Therapeutics

By Jeremy Golden, Benzinga Immunotherapy has transformed the way cancer is treated, but just 20% to 40% of patients typically respond to FDA-approved immune checkpoint inhibitor (ICI) treatments. Poor ICI treatment response has been linked to the tumor’s ability to disguise antigen presentation and generate an immunosuppressive microenvironment. In addition, most conventional immunotherapies are not designed to educate the patient’s immune system on how to recognize a variety of tumor antigens and neoantigens. Amid this landscape, a clinical-stage biopharmaceutical company has developed a new multimodal biological approach that leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens to the immune system, resulting in vaccination against the tumor while inhibiting the immunosuppressive tumor microenvironment. Candel Therapeutics, Inc. (NASDAQ: CADL) is developing a product candidate that is being studied in lung, pancreatic and prostate cancers. Candel’s most advanced viral immunotherapy candidate, CAN-2409, is an investigational off-the-shelf replication-defective adenovirus designed to induce an individualized, systemic immune response against the patient’s own tumor. Part of the company’s adenovirus platform, CAN-2409 is injected directly into the tumor or target tissue using a localized injection, akin to the standard approach for vaccination. CAN-2409's adenoviral construct serves as a vector to transport the HSV-thymidine kinase gene into tumor cells at the site of injection. These tumor cells can then express HSV-thymidine kinase, which converts generic, FDA-approved anti-herpes drugs – such as ganciclovir, acyclovir and valacyclovir – into a toxic nucleotide analog that blocks DNA synthesis in dividing cells. Cancer cells exposed to the toxic nucleotide analog in the tumor microenvironment have been observed to undergo immunogenic cell death. Simultaneously, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad and systemic anti-tumor activity. CAN-2409 is currently being studied in an open-label, phase 2 clinical trial in non-small cell lung cancer (NSCLC) and in randomized, controlled, blinded phase 2b and phase 3 clinical trials in prostate cancer. The company has recently released very encouraging data for CAN-2409’s ability to improve overall survival in non-metastatic pancreatic cancer, with topline overall survival data in non-small cell lung cancer planned for this quarter (Q2 2024) and results from the prostate clinical trials later this year (Q4 2024). When it comes to NSCLC, the company previously presented data from the phase 2 clinical trial in which patients received two administrations of CAN-2409 plus prodrug. Those patients demonstrated the following: 1) Increased infiltration of CD8+ cytotoxic T cells in the tumor microenvironment, systemic expansion of effector T cells and increased soluble granzyme B levels in peripheral blood; 2) Favorable changes in the trajectory of tumor progression; 3) Decreased tumor size of target lesions in most patients; and 4) Reduced size of uninjected tumor lesions. The CAN-2409 immunotherapy antitumor strategy aims to increase the number of long survivors beyond 10 to 13 months. As previous work has shown that progressive disease could be converted into stable disease in most patients with non-small cell lung cancer after CAN-2409 treatment, the hypothesis is that this will translate into improved survival. When it comes to pancreatic cancer, the company reported notable improvements in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409. The estimated overall survival rate was 71.4% at 24 months in CAN-2409-treated patients versus only 16.7% in the control arm after chemoradiation. In 2023, CAN-2409 received Fast Track Designation for both non-small cell lung cancer and pancreatic cancer, a validation from the FDA on its potential. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC and an inadequate response to anti-PD(L)-1 therapy. In 2024, CAN-2409 also received Orphan Drug Designation from the FDA for CAN-2409 in borderline resectable pancreatic cancer. In the upcoming year, Candel plans to announce data readouts for the following: 1) Phase 2 topline overall survival (OS) data for CAN-2409 in NSCLC, expected in Q2 2024; 2) Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer, expected in Q4 2024; 3) Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer, expected in Q4 2024. Featured photo by National Cancer Institute on Unsplash. Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

June 07, 2024 08:30 AM Eastern Daylight Time

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This One Company Is Working On A Breakthrough Approach To Revolutionize Pain Management

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Autonomix Medical (NASDAQ: AMIX) is a medical device company dedicated to transforming the diagnosis and treatment of diseases or disorders related to the nervous system. At the core of Autonomix's innovative approach is a first-in-class technology platform featuring a catheter-based microchip sensing array. This technology boasts an unprecedented ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than existing technologies. This breakthrough has paved the way for transvascular diagnosis and treatment of nervous system diseases virtually anywhere in the body, offering a new horizon of medical possibilities and market opportunities. Clinical Studies In Pancreatic Cancer Pain Autonomix has initiated its first clinical study targeting pancreatic cancer pain, marking a significant milestone in its ongoing medical innovation. Pancreatic cancer represents a considerable unmet medical need, particularly concerning pain management. Effective solutions in this area are critically needed, as current relief options for pancreatic diseases are limited to drugs like opioids. In light of that, the initiation of these clinical studies represents a crucial step toward addressing this substantial healthcare challenge for suffering patients. Market Opportunities In addition to addressing the pain relief needs of patients, Autonomix’s technology presents significant market opportunities across various medical fields. By accurately targeting the nervous system, Autonomix aims to address unmet needs and improve treatments for a wide range of conditions including but not limited to: Pancreatic Cancer Pain: The successful application of Autonomix's technology in pancreatic cancer pain management would not only help pancreatic cancer patients find relief from pain but also unlocks significant market potential. Pancreatic cancer pain management is part of a $2.2 billion market for pancreatic cancer treatment. Chronic Pain: This market presents a significant opportunity estimated at $75 billion. Conditions such as lower back pain, pelvic pain, urinary tract pain, digestive disorders and other tumor-related pain are prevalent and often inadequately managed with current therapies, particularly opioids. Autonomix's technology offers the potential to significantly reduce or eliminate the dependence on opioids, providing a safer and more effective solution for chronic pain management. Cardiovascular Diseases: With a market opportunity estimated at $23 billion, Autonomix's technology could revolutionize the treatment of conditions like hypertension and cardiovascular disease. By targeting the nervous system's role in these diseases, more precise and effective treatments could be developed. Pulmonary Diseases: Chronic obstructive pulmonary disease (COPD) is another area where Autonomix's technology could have a substantial impact. The market for COPD treatments is estimated to be around $18 billion with considerable growth ahead, driven by the need for more effective and less side-effect-prone therapies. Autonomix's approach could provide a new paradigm in managing this debilitating condition. Meeting Unmet Needs with Innovative Solutions Current drug therapies for many of these conditions often come with significant side effects and do not adequately address the underlying issues. Autonomix's technology offers a promising alternative by providing targeted, nerve-based treatments that could improve patient outcomes and quality of life. This innovative approach aligns with Autonomix's mission to dramatically enhance the lives of millions by enabling precise and effective nerve-targeted treatments. In doing so, Autonomix can both detect and ablate malfunctioning nerves in one simple procedure, effectively opening new treatment options in the field of electrophysiology. The Full Opportunity Autonomix Medical sits at the forefront of a potential revolution in medical treatment for diseases driven by the nervous system. The company’s advanced technology platform not only offers hope for better management of pancreatic cancer pain, but also opens the door to addressing numerous other conditions with significant unmet need. By providing physicians with powerful new tools for diagnosis and treatment, Autonomix is poised to make a profound impact on the future of healthcare. Featured photo by Irwan on Unsplash. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

June 06, 2024 09:00 AM Eastern Daylight Time

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Manitoba Woman Beats Stage 4 Cancer with Breakthrough CAR T-Cell Therapy

MarketJar

Disseminated on behalf of CERo Therapeutics Holdings, Inc. Cancer treatments have come a long way over the years, but there is a newer treatment that is providing even stage four cancer patients with a new lease on life. The first CAR T-cell therapy was only approved in 2017, but it’s already having a significant impact in the cancer treatment market. The latest success story comes from Sandra Hajlo, who just became the first person in Manitoba to be declared cancer-free following CAR T-cell therapy. 1 Initially diagnosed with stage four B-cell lymphoma in 2015, Hajlo underwent successful chemotherapy. However, eight years later, her cancer returned, leading to another battle with the disease. After a misdiagnosis of scoliosis, a CT scan revealed her cancer had come back. Her oncologist recommended CAR T-cell therapy, a new treatment where T-cells are modified to target cancer cells, making her the first recipient of this therapy at CancerCare Manitoba. Dr. David Szwajcer, Manitoba Blood & Marrow Transplant Director at CancerCare Manitoba, explained that the CAR T-cells are collected, sent to a U.S. facility for modification, and then reintroduced to the patient. Hajlo described the procedure as quick and straightforward, taking only 20 minutes. After undergoing CAR T-cell therapy in December 2023, Hajlo learned in April 2024 that the treatment was successful, and she is cancer-free once again, expressing her gratitude for the second chance at life. CAR T-cell therapy does not guarantee survival, with about half of the patients not responding,but it has shown promising results in many cases. CERo Therapeutics Holdings (NASDAQ:CERO) is an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics. CERo Therapeutics is unrelated to CancerCare Manitoba and had no role in the CAR T-cell therapy described above. Nevertheless, CERo Therapeutics believes that the success of the CAR T-cell therapy in Manitoba may provide an indication of the potential for its proprietary CER-T (chimeric engulfment receptor) cell therapy. CAR-T cell treatment has a steep price tag and some potential serious side effects including secondary cancer developing 2 as well as cytokine release syndrome (CRS), 3 which causes your immune system to go into overdrive and is potentially life threatening. CER-T cell therapy may provide a more cost-effective alternative with fewer side effects. CERo Advances Innovative Cancer Immunotherapy CERo Therapeutics (NASDAQ:CERO) developed CER-T cells to enhance efficiency and reduce side effects compared to traditional therapies by leveraging the body's natural tumor-fighting mechanisms. CER-T cells achieve this through direct tumor killing and by amplifying the body's anti-tumor immune response, and additionally by presenting cancer cell fragments to other immune cells, drawing these cells to attack the tumor. Peer-reviewed data shows that CER-T cells have at least eight anticancer functions, offering potent, durable, and low-toxicity therapeutic benefits, with the capability to completely eliminate tumors. The company has validated these findings in 10 animal experiments, including a study on Acute Myeloid Leukemia (AML) published in March 2024. CERo Therapeutics believes CER-T cells offer greater therapeutic potential than currently approved chimeric antigen receptor (CAR-T) cell therapy, potentially targeting both hematological malignancies and solid tumors. The company plans to begin clinical trials for its lead product candidate, CER-1236, in 2024 for treating hematological malignancies. CERo has been diligently completing pre-clinical studies and documentation necessary to initiate clinical trials after gaining approval from the FDA for its Investigational New Drug (IND) Application. CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) has successfully completed toxicity studies for CER-1236, a critical step before applying to the FDA for approval to begin human trials. With these studies showing that CER-1236 can be safely administered, the company is now focusing on ensuring safe manufacturing and finalizing its FDA application. Upon FDA acceptance, the company would be able to commence Phase 1 clinical trials, marking the start of the journey toward US approval and addressing unmet medical needs. CERo plans to update shareholders on their progress, including presentations at investor conferences, potential growth of their intellectual property portfolio, and advancements in other programs beyond AML. Click here for more information CERo Therapeutics Holdings, Inc., (NASDAQ:CERO). Footnotes: [1] https://globalnews.ca/news/10428035/manitobas-first-car-t-cell-therapy-patient-declared-cancer-free/ [2] https://jamanetwork.com/journals/jama/article-abstract/2815500 [3] https://www.pennmedicine.org/cancer/navigating-cancer-care/treatment-types/immunotherapy/what-is-car-t-therapy Disclosure: 1) The author of the Article, or members of the author’s immediate household or family, do not own any securities of the companies outlined in this Article. The author determined which companies would be included in this article based on research and understanding of the sector. 2) The Article was issued on behalf of and sponsored by, CERo Therapeutics Holdings, Inc. Market Jar Media Inc. was paid $1,500 USD for the production and publishing of this article by CERo Therapeutics Holdings, Inc.’s Digital Marketing Agency of Record (Native Ads Inc.). Additional details relating to Market Jar Media Inc.’s engagement by CERo Therapeutics Holdings, Inc.’s Digital Marketing Agency of Record (Native Ads Inc.) are set out in https://pressreach.com/disclaimer-cero. 3) Statements and opinions expressed are the opinions of the author and not Market Jar Media Inc., its directors or officers. The author is wholly responsible for the validity of the statements. The author was not paid by Market Jar Media Inc. for this Article. Market Jar Media Inc. was not paid by the author to publish or syndicate this Article. Market Jar has not independently verified or otherwise investigated all such information. None of Market Jar or any of their respective affiliates, guarantee the accuracy or completeness of any such information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Market Jar Media Inc. requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Market Jar Media Inc. relies upon the authors to accurately provide this information and Market Jar Media Inc. has no means of verifying its accuracy. 4) The Article does not constitute investment advice. All investments carry risk and each reader is encouraged to consult with his or her individual financial professional. Any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Market Jar Media Inc.'s terms of use and full legal disclaimer as set forth here. This Article is not a solicitation for investment. Market Jar Media Inc. does not render general or specific investment advice and the information on PressReach.com should not be considered a recommendation to buy or sell any security. Market Jar Media Inc. does not endorse or recommend the business, products, services or securities of any company mentioned on PressReach.com. 5) Market Jar Media Inc. and its respective directors, officers and employees hold no shares for any company mentioned in the Article. 6) This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of CERo Therapeutics Holdings, Inc. or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of CERo Therapeutics Holdings, Inc. or such entities and are not necessarily indicative of future performance of CERo Therapeutics Holdings, Inc. or such entities. 8) Investing is risky. The information provided in this article should not be considered as a substitute for professional financial consultation. Users should be aware that investing in any form carries inherent risks, and as such, there is a possibility of losing some or all of their investment. The value of investments can fluctuate significantly within a short period, and investors must understand that past performance is not indicative of future results. Additionally, users should exercise caution as transactions involving investments may be irreversible, even in cases of fraud or accidental actions. It is crucial to acknowledge that rapidly evolving laws and technical issues can have adverse effects on the usability, transferability, exchangeability, and value of investments. Furthermore, users must be cognizant of potential security risks associated with their investment activities. Individuals are strongly encouraged to conduct thorough research, seek professional advice, and carefully evaluate their risk tolerance before engaging in any investment endeavors. Market Jar Media Inc. is neither an investment adviser nor a broker-dealer. The information presented on the website is provided for informative purposes only and is not to be treated as a recommendation to make any specific investment. No such information on PressReach.com constitutes advice or a recommendation. Contact Details James Young +1 800-340-9767 campaigns@pressreach.com Company Website https://pressreach.com

June 06, 2024 08:30 AM Eastern Daylight Time

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OncoCyte's Innovative Approach: Potential in Precision Diagnostics

RazorPitch OCX

Chronic conditions such as organ transplant rejection and cancer represent significant challenges in modern healthcare, demanding precise diagnostic tools for effective management and treatment. For organ transplant patients, the risk of graft rejection remains a persistent threat, necessitating continuous monitoring to ensure long-term success. Similarly, the complexity of cancer requires advanced diagnostics to tailor treatments to individual patients, optimizing therapeutic efficacy while minimizing adverse effects. Amidst these challenges, OncoCyte Corporation (NASDAQ: OCX ) has emerged as an innovative player in the precision diagnostics market. The company's tests enhance clinical outcomes for patients undergoing organ transplants and cancer treatments. With recent strategic partnerships and regulatory advancements, OncoCyte has spearheaded transformative advancements in the field. OCX’s product portfolio includes VitaGraft, a clinical blood-based test for monitoring solid organ transplants, and GraftAssure, a research-use-only test for the same purpose. Additionally, DetermaIO and DetermaCNI are designed for oncology applications, predicting responses to immunotherapies and monitoring therapeutic efficacy, respectively. Partnerships In April 2024, OCX partnered with Bio-Rad Laboratories (NYSE: BIO) to commercialize the GraftAssure assay. This agreement leverages Bio-Rad's extensive reach and expertise in the life sciences sector, facilitating the co-marketing of GraftAssure in the U.S. and Germany. Bio-Rad holds exclusive global distribution rights outside these regions. This collaboration is pivotal for scaling OncoCyte's operations and meeting the growing demand for transplant diagnostics. The partnership also includes an option for Bio-Rad to acquire IVD commercial rights upon FDA clearance, subject to specific milestones. This option comes with a second equity investment into OncoCyte, reflecting Bio-Rad's confidence in the product's market potential. Riggs noted, "The QX600 ddPCR platform, along with their expertise in the life science market, makes Bio-Rad a natural partner for our transplant technology." Financial Performance OncoCyte's Q1 2024 financial results indicate a strategic focus on commercialization and cost-efficiency. The company reported gross proceeds of $15.8 million from an equity private placement, including a significant investment from Bio-Rad. This funding is crucial for advancing OncoCyte's product pipeline and expanding its market presence. Operational efficiency is evident, with OncoCyte reducing its cash burn to $3.9 million, reflecting a capital-efficient business model. The collaboration with Bio-Rad and the anticipated commercial launch of GraftAssure RUO test kits in Asia, the U.S., and the EU are expected to drive revenue growth and broaden the company's market reach. Riggs remarked, "The collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing accessible point-of-care diagnostics and continuous innovation in transplant rejection monitoring." Publication in New England Journal of Medicine OCX announced a significant milestone on May 30, 2024, with the publication of promising data on VitaGraft Kidney in the New England Journal of Medicine. This phase 2 study highlights VitaGraft Kidney’s potential to revolutionize kidney transplant care by accurately monitoring graft health through measuring donor-derived cell-free DNA (dd-cfDNA). For investors, this development signals substantial market potential. VitaGraft Kidney's ability to monitor therapeutic efficacy and detect disease recurrence opens new revenue streams. This test could become a standard in post-transplant care, driving repeated testing and long-term revenue. VitaGraft Kidney addresses a critical unmet need. Up to 20.2% of kidney transplant patients develop antibody-mediated rejection (AMR) within 10 years, with no FDA-approved drugs currently available for AMR management. The combination of VitaGraft testing and felzartamab therapy offers a promising solution, potentially improving patient outcomes and healthcare efficiency. OCX CEO Josh Riggs emphasized the breakthrough nature of this study, stating, “This positions VitaGraft Kidney as a crucial tool in managing transplant health. Our recent partnership with Bio-Rad expands our capacity to deliver these innovative solutions globally.” Riggs highlighted the test’s competitive edge in detecting AMR up to 10 months earlier than current protocols, enhancing patient care, and strengthening OncoCyte’s market position. The findings will be presented at the 2024 American Transplant Congress on June 3, 2024. This presentation is expected to further validate VitaGraft Kidney’s clinical value and could act as a catalyst for broader market adoption. OncoCyte’s latest publication not only validates VitaGraft Kidney’s clinical potential but also strengthens the company’s market position. As OCX continues to innovate and expand its market reach, investors can anticipate significant growth opportunities in the precision diagnostics sector. 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 PCG Advisory Inc. 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 Inc Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

June 05, 2024 07:00 AM Eastern Daylight Time

Novus Reports Q1 Results And Key Success Factors Following DEA Rescheduling

Novus Acquisition & Development Corp

Miami, Florida - ( ThriveNewsWire ) - Novus Acquisition & Development Corp d/b/a Novus Cannabis MedPlan (OTC Markets: ( NDEV ) is a leading national supplemental health insurance carrier and pioneer in offering cannabis in health plans for recreational and medicinal users. It released its update on its Q1 2024 results, Rx Dispensing Platform, and Key Elements that fuel its success after the Drug Enforcement Agency (DEA) announced that cannabis will be rescheduled. Novus Cannabis MedPlan (Novus) has been integrating cannabis into health plans since 2015. With a network of over 1,200 agents, brokers, and dispensaries, Novus aims to make cannabis-based treatments more affordable and accessible through insurance plans, benefitting a wider range of consumers. Here are three key highlights that contribute to Novus' success. 1) Financial Snapshot: The company utilizes a receivable-based business model with minimal overhead and no convertible debt, demonstrating consistent organic growth year over year. No Dilution: No common stock has been issued after June 15, 2021. No Sales of Insider Shares: For close to 3 years Gross Revenue Increase: During this reporting period, Gross Revenue increased by 6.8% compared to March 31, 2024 and 2023, respectively, Net Revenue Increase: During this reporting period, EBITDA increased by 19.47% compared to March 31, 2024, and 2023. Profit Margin: During the reporting period, the company experienced a gradual increase in gross profit margins, with margins of 43.14% in 2023 and 45.2% in 2024 Cash and Cash Equivalents: There was an increase of 1.8% compared to the financial reporting periods on March 31, 2024, and December 31, 2023. This is in contrast to the higher increase of 6.84% in the period from March 31, 2023, to 2024. Debt Transparency: Frank Labrozzi, the CEO, is owed $158,061. He has no plans to exercise the call provision, and this debt instrument has no equity conversion provision. Leak Out Vendor Shares: All vendors who received treasury-issued stock must gradually sell their shares. The selling amount is determined based on 15% of the average daily trading volume over the past 30 days. 2) Introducing the Rx Dispensing Platform Novus is strategically positioning its cannabis health plans to become a prominent player in mainstream healthcare insurance by acquiring an Rx Dispensing Platform tech stack. Frank Labrozzi, CEO of Novus, stated, "This advancement will significantly impact cannabis in health plans. By promoting collaboration between brands and dispensaries, we aim to empower policyholders with more choices, enabling them to purchase the brands they prefer at any dispensary. Cannabis brands can use the platform to connect directly with dispensaries and showcase their products at no cost. This will improve product distribution efficiency, increase brand visibility, provide real-time inventory data, and facilitate product research for the policyholder. An added bonus to For Rec Users: This platform serves recreational users who prefer not to disclose personal information like their policyholder status to access plan benefits. Instead, users can discreetly order services for a small subscription or transaction fee. 3) Key Success Factors Midwest Expansion: Novus has partnered with Heya Wellness, a prominent cannabis company in Missouri, to offer MedPlans to 4.3 million potential policyholders in the Midwest. By leveraging Missouri's favorable reciprocity laws, Novus aims to maximize the benefits for our sales hub based in St. Louis. Health Carrier Alliances Integration with Traditional Healthcare: By treating cannabis as a traditional pharmaceutical product and including it in insurance plans, Novus could help normalize cannabis use for medical, recreational, and non-users. Now that there is federal approval, Novus bridges traditional healthcare and the cannabis industry, enhancing major healthcare carriers who have expressed interest in integrating Novus' cannabis-based prescription plans into their benefits packages, establishing a connection between the two industries. Compassionate Care Act (CCA): The CCAs, which the Supreme Court sanctions, typically focus on making medical marijuana accessible to workplace patients with specific conditions. Human Resources departments are revising workplace policies to allow employees to access medical marijuana through employer-sponsored health plans. Novus plans to cover some costs through tax-deductible health savings and health reimbursement accounts. Opioid Settlement Framework: The opioid settlement framework is a legal agreement aimed at resolving litigation against pharmaceutical companies and health carriers accused of contributing to the opioid crisis. It includes $50 billion for prevention, treatment, and recovery programs with the goal of mitigating the crisis' impact and preventing future misuse. Novus is playing a crucial role in reducing opioid use by offering states and private organizations alternative treatment options through our developed health plans that help patients transition from opioids to medical cannabis. Compliance with the Veteran’s Affairs (VA): Veterans are increasingly interested in utilizing cannabis for treatment—over 88% support medical cannabis programs. Novus has developed health plans following VA guidelines to integrate cannabis benefits for veterans. In closing: As Novus adjusts to the positive changes in federal cannabis regulation, we are prepared to utilize our niche approach to cannabis in health plans, which utilizes a receivables-based business model. This approach strategically enables us to organically invest in critical areas such as marketing, improving engagement with policyholders and providers, and establishing a reliable cash flow management system. This positions Novus as a significant player in the fast-evolving cannabis integrated into health insurance plans. Do your research on our company to understand our potential in shaping the future of healthcare. Visit our Investor Relations page to see for yourself. About Novus Further Research: Financial Filings: Click Here Quote: Click Here Website Click Here Investor's Page Click Here Video Of Investment Highlights: Click Here Novus Acquisition & Development Corp. (NDEV) operates through its subsidiary, WCIG Insurance Services, Inc., offering health insurance and related insurance solutions in states with legal medical marijuana programs. With a robust infrastructure covering various insurance lines, including health, life, and fixed annuities, Novus is a leading health insurance carrier, using two key indicators to gauge value and performance. The Benefit Monetization Ratio measures the annual total of monetized policies, offset by the operating cost ratio, a Balance Sheet line item derived from Net Asset Value and calculated to the Price Book Value. Novus' medical cannabis benefits package operates as an outside developer. It does not engage in any activities related to the cultivation, handling, transportation, growth, extraction, dispensing, sale, marketing, vending, delivery, supply, circulation, or trade of cannabis or any substances violating United States law or the Controlled Substances Act. The company adheres strictly to state and federal laws and has no intentions to violate them in the future. It is important to note that statements regarding specific products have not been evaluated by the United States Food and Drug Administration (FDA) and should not be interpreted as intended to diagnose, treat, cure, or prevent disease. The information provided in press releases and product labels is for informational purposes only and should not be considered a substitute for advice from qualified healthcare professionals. Novus respects the individual transactions involving cannabis, which are solely between state-licensed dispensaries and registered patients. However, it's worth noting that state laws may conflict with the federal Controlled Substances Act. The current administration has indicated that federal law enforcement agencies will not prioritize prosecuting those complying with state-designated laws concerning medical marijuana usage and distribution. Nevertheless, changes in government policies and consolidation could impact the provider network, and there is no assurance that future administrations will not alter this stance. While Novus does not engage in the harvest, distribution, or sale of cannabis or cannabis-related products, the company could be affected if there were any shifts in enforcement by federal or state governments concerning existing laws. Such changes could result in significant financial implications for Novus and other industry players. Forward-Looking Statements This release includes forward-looking statements, which are based on certain assumptions and reflect management's current expectations. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Some of these factors include general global economic conditions; general industry and market conditions and growth rates; uncertainty as to whether our strategies and business plans will yield the expected benefits; increasing competition; availability and cost of capital; the ability to identify and develop and achieve commercial success; the level of expenditures necessary to maintain and improve the quality of services; changes in the economy; changes in laws and regulations, includes codes and standards, intellectual property rights, and tax matters; or other matters not anticipated; our ability to secure and maintain strategic relationships and distribution agreements. Dilution, if any, would be for the purposes of management taking stock in lieu of cash salary. Novus disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Additionally, this press release that is not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the near future. Investor Contact Information Investor Website 855-228-7355 Email: pr@getnovusnow.com Contact Details Novus Acquisition Frank Labrozzi +1 305-467-6699 frank@ndev.biz Company Website https://getnovusnow.com/

June 04, 2024 08:00 AM Eastern Daylight Time

AGC Biologics Completes Copenhagen Campus Expansion, Doubling Single-use Mammalian Bioreactor Capacity at Site

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced at BIO International the completion of its new manufacturing building at the AGC Biologics Copenhagen campus. The completed work doubles the site’s single-use bioreactor capacity for mammalian services and allows it to produce 150 more batches of drug product each year. The expansion adds 19,000 m2 of space in an ultramodern building that houses a large manufacturing floor, expanded quality control and process development lab space, utilities to support all operations and prevent outages caused by natural disasters, and a fully dedicated warehouse to serve the entire AGC Biologics Copenhagen campus. The new AGC Biologics Copenhagen manufacturing building is already in production with its first customer, a phase II/III clinical product. AGC Biologics announced the planned expansion in November 2020, investing roughly $200 million into the work. One-of-a-kind single-use manufacturing offering The new manufacturing area offers 8 x 2,000 L single-use bioreactors with two seed trains, as well as two independent downstream suites – [CW1] more than doubling the existing capacity offered at this site for mammalian-based projects. AGC Biologics Copenhagen is now one of the only sites in the world with multiple single-use bioreactor systems of this magnitude capable of producing batches at high-levels of clinical and commercial production. Further, for developers needing to transfer in an existing process, AGC Biologics Copenhagen’s multiple single-use suites give the site greater flexibility to take on technical transfers and perform like-for-like process and knowledge activities for products entering the facility, eliminating lag time associated with onboarding a new CDMO. AGC Biologics has been a leader in single-use technology over the last decade, and it is one of the largest CDMO networks in the industry offering flexible and scalable single-use bioreactors systems. The news comes after AGC Biologics announced an end-to-end protein biologics drug product partnership with Dutch-based BioConnection in late May. The alliance provides a secure and full-service “gene-to-vial” offering for biopharma developers with drug substance development, manufacturing and aseptic fill and finish capabilities for drug products. “AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals – FDA, EMA, HCA, PMDA, ANVISA etc. – and we are more than happy to offer the capacity and capabilities our current and future customers will look for with this completed expansion,” said Christoph Winterhalter, CBO, AGC Biologics. “The expansion, combined with our new drug product alliance, demonstrates AGC Biologics’ agility to meet all the needs developers may have, from pre-clinical through commercial.” AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems. It has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices. “I am extremely proud of the work and collaboration of everyone at our site over the last several years, it is truly remarkable to see what we can accomplish by working together. We are eager to offer more of the important capabilities the industry is looking for to support patients in need,” said Andrea C. Porchia, General Manager, AGC Biologics Copenhagen. To learn more about AGC Biologics Copenhagen, visit www.agcbio.com/facilities/copenhagen. For more information about AGC Biologics’ global CDMO services go to 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/

June 04, 2024 12:00 AM Pacific Daylight Time

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