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Delivra Health Brands achieves positive EBITDA results for second consecutive quarter

Delivra Health Brands Inc.

Delivra Health Brands President and CEO Gord Davey joins Natalie Stoberman from the Proactive studios to share the how the company's 3Q financial and operational results have been able to repeat positive EBITDA for the second straight quarter. Davey says the company's focus on increasing revenue, reducing costs, and improving margins has been the driver in steady growth and recording a positive EBITDA performance. Davey adds Delivra continues to execute its strategies by expanding its business in the U.S. and international markets, introducing new products in both Dream Water and LivRelief lines, and investing in marketing efforts and ongoing innovation. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

May 24, 2023 02:00 PM Eastern Daylight Time

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Inhibikase Therapeutics: A Novel And Promising Approach To Neurodegeneration And Oncology

TalkMarkets on IKT

Inhibikase Therapeutics ( IKT ) is a small capitalization company working in both neurology and oncology. Their principal focus is a small molecule inhibitor of c-Abl for the treatment of a number of neurodegenerative disorders with an initial focus on Parkinson’s Disease. The lead asset (IkT-148009) is a selective, brain penetrant inhibitor of c-Abl1 and Abl2/ARG. The drug is designed to minimize the toxicity commonly associated with the cancer drugs of this class, while maximizing efficacy against neurological diseases. Neurodegeneration has multiple causes, but the aggregation of misfolded proteins is often associated with these diseases and in the case of Parkinson’s Disease it is the aggregation of alpha-synuclein. Given that these aggregates are clearly associated with the disease, a common tactic to drug development is to find treatments that eliminate the protein bundles, but these approaches have generally had quite modest effects. Inhibikase approaches the disease from a different perspective in that the core issue is when those aggregates become internalized in neurons (in the case of PD). When this occurs, c-Abl triggers a cascade of responses that ultimately leads to neurodegeneration. Inhibiting c-Abl stops these reactions and saves the neurons. (The details of this approach can be seen in the recent article in Neurodegenerative Disease ). One of the difficulties of inhibiting c-Abl in neurodegenerative diseases, however, is the potential toxicity. Gleevec is a commonly used inhibitor of c-Abl in oncology, where it has an acceptable toxicity profile, but it would be too toxic for neurological indications. Developing a drug that can inhibit c-Abl in the brain but without the common toxicities is the fundamental breakthrough of IkT-148009. It is the selectivity of the inhibition that is key. The corporate presentation clearly shows a differentiated inhibition profile ( source ). This selective inhibition of IkT-148009leads to a very clean toxicity profile ( see graphic ). This safety is not simply theoretical as their phase I, Ib, and 2a trials confirm the lack of significant toxicity. There was a grand total of 14 reported adverse events among 113 treated patients and only one was moderate; the rest were mild ( see graphic ). It cannot be stressed enough that safety is absolutely crucial in neurological indications, and it seems that the design of the drug, the preclinical and early clinical results all point to low toxicity, which is exactly what you want to see from these early looks. Inhibikase currently has an ongoing double-blind enrollment trial across three doses for the treatment of Parkinson’s disease. The trial includes a 3-month treatment period followed by a 12-month open label extension. The primary endpoint is safety, which is appropriate for a dose ranging phase II trial and expectations should be a clear confirmation of the established safety profile. That being said, there is a robust set of secondary endpoints that will provide important information as to the efficacy profile. The preclinical work in a Parkinson disease animal model demonstrated a consistent efficacy where treatment lowered alpha-synuclein back to baseline levels, preserved as much as 85% of neurons, restored as much as 90% of motor function, and suppressed neuroinflammation back to near baseline levels. Obviously, a replication of those results in the phase II trial would be spectacular but a clear win would also be a confirmation of the safety profile, a strong signal of efficacy, and a clear move forward dosing level. Given that the PK profile seen in the animal models is similar to the PK shown in the phase I trials, the chosen dosing levels in the phase II trial should lead to a go forward dosing as well as a demonstration of efficacy. The company has guided to a robust set of progress in 2023, where the continued enrollment of the phase II trial is perhaps the most important. Open up to thirty-five 201 trial sites by close of 2Q23 Active screening of commercial formulation Implement 12-month open-label safety extension study into 201 trial Characterize novel compounds as follow-ons to IKT-148009 I noted earlier that Inhibikase Therapeutics is both a neurology and oncology company. In terms of oncology, the company has an improved version of Gleevec that is designed to minimize GI toxicity. This asset is undergoing a bioequivalence trial, which could accelerate the pathway to approval, but I think the key valuation inflection point will be the 201 trial in Parkinson’s disease. The 201 trial has the potential to confirm the safety profile, identify a go-forward dose, and establish efficacy. The current valuation of the company does not reflect any of that potential. It does not even properly reflect the safety profile seen in the phase I trials let alone a potential success in the 201 trial. The heavily discounted valuation provides a compelling risk/reward given the ability to establish both safety and efficacy in Parkinson’s disease let alone any progress in oncology. Originally published at TalkMarkets. More By This Author: The FTC, Amgen, And Horizon: A New Hurdle For Biotech Deal Making Or Regulatory Overreach? Coya Therapeutics: Another Success Sarepta: The AdCom Documents Enter The Discussion Disclosure: This article is part of a new “UnderCovered” series of exclusive articles featuring companies with limited coverage. Authors are compensated by TalkMarkets for their time, and otherwise represent their own assessments and opinions. Authors are not compensated by the subject companies in any way. This article is also part of our IR Insights Initiative in which articles about participating companies can receive greater visibility. To learn more click here.​ Contact Details TalkMarkets ir@talkmarkets.com

May 24, 2023 12:04 PM Eastern Daylight Time

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ImmuPharma "looking forward with quiet confidence" to FDA response

ImmuPharma PLC

Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 24, 2023 11:08 AM Eastern Daylight Time

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Voyager Life "now capable of dealing with multinational customers"

Voyager Life PLC

Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 24, 2023 11:03 AM Eastern Daylight Time

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Oxford Cannabinoid Technologies: Phase 1 approval for lead chronic pain drug

Oxford Cannabinoid Technologies Holdings PLC

Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 24, 2023 10:59 AM Eastern Daylight Time

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Intus Care Announces Data Partnership with North Carolina PACE Association

Intus Care

Intus Care, a pioneer in advanced software and data-driven solutions for geriatric healthcare, announced today its collaboration with the North Carolina PACE Association. NC PACE advocates for PACE (Programs of All-Inclusive Care for the Elderly) and strives to broaden its reach and success across the state. Intus Care contributes an innovative blend of automated software and Integrated Care Services (ICS) to this partnership. Already partnering with the majority of North Carolina PACE programs, Intus Care will now automate all benchmark reporting for partnered programs, while assuming responsibility for submissions from non-partnered programs. Utilizing this data, the Intus Care team will collaborate with the NC PACE Association to develop benchmarking reports, conduct data analysis, and present insights to the Association and its members. “We are pleased for this opportunity to work with such an innovative Association as they consistently find creative ways to empower their membership and facilitate the model’s success throughout the state,” said Intus Care Chief Strategy Officer Laura Ferrara. The NC PACE Association will collaborate with Intus Care's team of PACE specialists, led by Laura, to structure benchmarking reporting procedures and analyze data at the organizational, state, and national levels. Through quarterly presentations to the NC PACE Association and its members, Laura and the ICS team will showcase the benchmarking analysis, pinpoint areas of achievement and potential, and propose best practice interventions to empower performance. “The NC PACE Association, along with our NC PACE organizations, believes that reliable data leads to informed decisions. This, in turn, assists us with our mission: providing integrated managed care for the elderly and expanding PACE services statewide,” said Liz Bradsher, Executive Director of the NC PACE Association. "Intus Care shares our mission and we are eager to see the impact of this relationship within our NC PACE organizations, as well as within the state.” About Intus Care Intus Care empowers PACE organizations nationwide through automated software and PACE expert consulting. Our PACE-focused analytics platform improves clinical decision making and data accessibility, while our Integrated Care Service experts collaborate with programs to improve Compliance, Quality, Utilization, and more through a hands-on, data-driven approach. Intus Care currently works with over 40 PACE programs across 16 states and closed a $14.1M Series A in Q4 of 2022. Visit our website to learn more and to sign up for our newsletter intuscare.com. Contact Details SVM Public Relations Jordan Bouclin and Alison Matthiessen +1 401-490-9700 intuscare@svmpr.com Company Website https://www.intuscare.com/

May 24, 2023 10:00 AM Eastern Daylight Time

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BioNTech's mRNA Vaccine Shows Early Potential Against Pancreatic Cancer

MarketJar

One of the most stubborn, deadly cancers is pancreatic cancer. What if individualized mRNA vaccinations could support the immune system's defense? One of the deadliest forms of cancer around, pancreatic cancer is estimated to kill 88% of patients. It’s also one of the most recurrent cancers, with roughly 90% of patients experiencing a relapse within seven to nine months after surgery. Fortunately, a recent study of an mRNA vaccine for pancreatic cancer patients has provided a glimpse of hope. Scientists at Memorial Sloan Kettering (MSK) Cancer Center in New York just published the results of a small study that the group conducted in partnership with Germany’s BioNTech on pancreatic cancer patients over several years. The study used a pancreatic cancer mRNA vaccine tailored to each patient’s tumor to potentially help provoke an immune response. What’s revolutionary about the vaccines is that the German scientists tailored them to the mutated proteins on the surface of cancer cells instead of a mix of tumor and normal cells, which has been the method tried for decades. The cells were extracted from patients’ tumors by researchers at Memorial Sloan and sent to BioNTech, the company that created the highly-effective COVID-19 vaccine alongside Pfizer. Among the participants in the study, half of the patients’ immune systems learned how to recognize and fight off the cancer cells and showed no signs of relapse during the 18 months they were tracked. While promising, personalized mRNA cancer vaccines are still in their infancy and are too costly to be broadly used. Right now, regular cancer screening remains the best method for detecting cancers, however there are currently no screening tests for pancreatic cancer. Fortunately, that could soon change thanks to Mainz Biomed (NASDAQ:MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer Developing Early Screening Tests for Colon and Pancreatic Cancers On May 10, Mainz Biomed announced a partnership with Microba Life Sciences for the creation of PancAlert in addition to early colon cancer diagnostics. The technical characteristics of a novel pancreatic cancer screening test with DNA and microbiota indications should be enhanced. As part of the agreement, the two companies will conduct a pilot research project utilizing Microba’s proprietary metagenomic sequencing technology and bioinformatic tools in an effort to discover novel microbiome biomarkers to detect pancreatic cancer. The project, which is expected to run until late 2023, will use Microba's Community Profiler (MCP), a proprietary metagenomic platform technology that has proven to be a best-in-class research tool that can produce comprehensive and accurate species profiles of gastrointestinal samples. Mainz Biomed (NASDAQ:MYNZ) is also focused on commercializing its flagship product ColoAlert, a highly efficacious and simple-to-use detection test for colorectal cancer (CRC) that is already available in select international territories. In Q1 2023, the company also launched a corporate health program in Germany by integrating into BGM, a well-established corporate health program that provides services to employees at 48 of the 50 largest companies in Germany. On May 24, Mainz Biomed announced initial results from its colorectal cancer screening campaign with Zöller-Kipper GmbH through its BGM partnership. In April 2023, Zöller-Kipper selected ColoAlert for its corporate health program, which includes over 2,500 employees. According to the results, employees found the online patient portal easy-to-use and convenient and were able to readily access the portal, request a kit and securely receive results within five days. In order to process the ColoAlert PCR test kit, Mainz Biomed has added Eurofins GeLaMed to its network of lab partners. Eurofins GeLaMed is a division of the global laboratory company Eurofins Scientific, which conducts 450 million tests annually and has over 61,000 employees in 61 nations. Germany is home to four of its locations. Advancing Towards FDA Approval to Bring ColoAlert to the US Market Over the last few months, Mainz Biomed has continued to prepare for patient enrollment in its pivotal clinical trial for ColoAlert after successfully completing its pre-submission process with the FDA. ColoAlert will be examined in the FDA-registered trial "ReconAAsense" in order to obtain commercial approval in the United States. The company's business objective is to create scalable distribution across the nation once it receives approval through a cooperative partner program with regional and national laboratory service providers. Learn more about Mainz Biomed (NASDAQ:MYNZ) and its activities by clicking on this link. Disclaimer 1) The author of the Article, or members of the author’s immediate household or family, do not own any securities of the companies set forth 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, Mainz Biomed NV. Market Jar Media Inc. has or expects to receive from Mainz Biomed NV’s Digital Marketing Agency of Record (Native Ads Inc.) eighty nine thousand seven hundred sixty four USD for 12 days (9 business days). 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 document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management's expectations regarding Mainz Biomed NV’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Mainz Biomed NV’s industry; (b) market opportunity; (c) Mainz Biomed NV’s business plans and strategies; (d) services that Mainz Biomed NV intends to offer; (e) Mainz Biomed NV’s milestone projections and targets; (f) Mainz Biomed NV’s expectations regarding receipt of approval for regulatory applications; (g) Mainz Biomed NV’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Mainz Biomed NV’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Mainz Biomed NV’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Mainz Biomed NV’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Mainz Biomed NV’s ability to enter into contractual arrangements with additional Pharmacies; (e) the accuracy of budgeted costs and expenditures; (f) Mainz Biomed NV’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Mainz Biomed NV to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Mainz Biomed NV’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Mainz Biomed NV’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Mainz Biomed NV’s business operations (e) Mainz Biomed NV may be unable to implement its growth strategy; and (f) increased competition. Except as required by law, Mainz Biomed NV undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Mainz Biomed NV nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Mainz Biomed NV nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document. 7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of Mainz Biomed NV or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of Mainz Biomed NV or such entities and are not necessarily indicative of future performance of Mainz Biomed NV or such entities. Contact Details James Young +1 800-340-9767 campaigns@pressreach.com Company Website https://pressreach.com

May 24, 2023 09:00 AM Eastern Daylight Time

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‘Ready for Ron’ Now ‘Ready to Win’

Ready for Ron

For more than a year, Ready for Ron, an independent group working to Draft Florida Governor Ron DeSantis to run for President, actively built support for his candidacy. A petition with more than 250,000 signatures (and a lawsuit against the Federal Election Commission to share it) tens of thousands of TV and online ads, along with millions of phone calls, mail pieces, and emails, and a grassroots and coalitions program has done its job - Governor Ron DeSantis is expected to soon announce he’s running for President. With Governor DeSantis about to become an official candidate, Ready for Ron is changing its name to ‘Ready to Win’ to reflect its singular mission to nominate and elect Ron DeSantis to win in 2024. “We spent an entire year running thousands of TV ads, millions of mailings, and tens of millions of online, email, and social connections to drive the narrative – Ron DeSantis will be our next President,” stated Ed Rollins, Ready to Win’s Chief Political Strategist. “We built an infrastructure. We completely changed the discussion. With a quarter million petition signers calling for him to run we are thrilled that we see our goal achieved - Ron DeSantis entering the Presidential race. He may well be the only leader who can defeat Joe Biden.” In addition to its outreach and engagement initiatives, Ready for Ron worked with Impact Social to analyze the online and social media discussion in relation to Ron DeSantis and Donald Trump among swing voters. The data clearly and consistently shows Ron DeSantis can beat Joe Biden, and Donald Trump simply can’t. Additional data research with multiple vendors covering more than 19 million voters affirms these findings. “Winning the nomination and the general election requires us all to work together to build this movement and save our nation,” stated Ready to Win Counsel, Dan Backer. “Our groundbreaking research debunked the bad polling plaguing Republicans for more than eight years. Using cutting edge massive data monitoring proves what everyone already knows - Donald Trump’s supporters are loyal and loud, but confined to only a sliver of the population that cannot grow. Moderate, swing, and independent voters are not coming back to Trump, ever, and he cannot possibly win the general Election – Ron DeSantis can.” “Voters young and old both know Governor DeSantis has a proven track record of standing up for America’s values. He is committed to defending the rights of parents, getting inflation and government spending under control, and solving the problems the radical left is causing. He dares to say no to the bullies, no matter how powerful they may seem. He can deliver safe streets, sane schools, and a soaring economy,” stated Gabriel Llanes, Executive Director of Ready to Win. “DeSantis is much more than a politician with savvy instincts; he is a public servant through and through. No ego to get in the way because he is about results.” “We will continue our ground-up grassroots efforts in key primary states, doing the hard work to train and mobilize a volunteer army to nominate, and elect, our next great American president,” Rollins continued. We feel DeSantis is well prepared to be the candidate to win the Republican nomination and beat President Biden. We are officially, Ready to Win!” ### For more information or to schedule an interview with a Ready to Win spokesperson, please contact Dan Rene at 202-329-8357 or dan@readyforron.com. Contact Details Ready to Win Dan Rene +1 202-329-8357 dan@readyforron.com Company Website https://www.readyforron.com/

May 23, 2023 02:50 PM Eastern Daylight Time

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Creo Medical Group "gaining a level of acceptance" in endoscopy

Creo Medical Group PLC

Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 23, 2023 11:15 AM Eastern Daylight Time

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