Release – Kratos and Clearbox Systems Partner to Develop Advanced Dynamic Satellite Ground and Space Domain Awareness Solutions

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

May 22, 2023 at 8:00 AM EDT

Clearbox’s Foresight Network and Spectrum Monitoring Product Will Become the Latest to Run on Kratos’ OpenSpace® Virtual Ground System

SAN DIEGO and NEW SOUTH WALES, Australia, May 22, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, and Clearbox Systems Pty Ltd, the Australian company that uses technology to provide better approaches and techniques for the operations and management of communications networks and the electromagnetic spectrum, have signed a collaboration agreement to co-develop and co-market solutions to advance the capabilities of software-defined satellite ground systems.

As part of the agreement, Clearbox will integrate its flagship Foresight product to run seamlessly on Kratos’ OpenSpace^® dynamic ground platform. Foresight provides a unified user interface across essential ground functions including equipment monitoring and control, spectrum monitoring and network management. Foresight can be deployed on physical, virtual or cloud infrastructure and, being web-based, can be accessed by users on any workstations connected on the network. It is trusted by militaries, governments, satellite operators and commercial users large and small in Australia and globally in deployments ranging across SATCOM, ISREW, Crypto, OSS and Space Domain Awareness (SDA).

Foresight’s web-based, modular, distributed and open architecture makes it a natural application for running in the software-defined satellite network environments enabled by OpenSpace, the first and only commercially available virtual and orchestrated satellite ground system. OpenSpace enables satellite and network operators to fully support next-generation satellites, dynamically provision services and missions, and integrate far better with the networks used by global terrestrial and cellular communications providers.

“We have been highly successful working with Kratos in the past and are extremely excited to be expanding that relationship moving forward,” said Matthew Collins-Leslie, CEO & Managing Director of Clearbox. “With this agreement we will be working together to develop new, advanced solutions for the global market.”

As part of the agreement, Clearbox will integrate Foresight with OpenSpace and enhance the product to take advantage of OpenSpace’s unique dynamic operating capabilities. In addition, the two companies will work together to co-market each other’s products, Clearbox representing OpenSpace to its Australian customers and Kratos marketing Foresight globally. Clearbox will also become Kratos’ primary representative in Australia for opportunities incorporating systems engineering, installation and support for several of Kratos’ other space networking products. Both companies will also work together to deliver SDA solutions that combine Clearbox’s SpaceAware product and sensors with Kratos’ global RF signal monitoring SDA network.

“Our experience with Clearbox has been extremely productive,” commented Stuart Daughtridge, SVP for Advanced Technologies at Kratos. “Their people and technology are first-class, and we are looking forward to putting our heads together on the cause of advancing virtual ground system technologies to enable systems that are as dynamic, flexible and agile as smart phones are today.”

About Kratos OpenSpace
Kratos’ OpenSpace family of solutions enables the digital transformation of satellite ground systems to become a more dynamic and powerful part of the space network. The family consists of three product lines: OpenSpace SpectralNet for converting satellite RF signals to be used in digital environments; OpenSpace quantum products, which are virtual versions of traditional hardware components; and the OpenSpace Platform, the first commercially available, fully orchestrated, software-defined ground system. These three OpenSpace lines enable satellite operators and other service providers to implement digital operations at their own pace and in ways that meet their unique mission goals and business models. For more information about the OpenSpace family visit http://KratosDefense.com/OpenSpace.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a Technology Company that develops and fields transformative, affordable systems, products and solutions for United States National Security, our allies and global commercial enterprises. At Kratos, Affordability is a Technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with actual products, systems and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being First to Market with our solutions, well in advance of competition. Kratos is the recognized Technology Disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Announces Clinical Proof-of-Concept Study of TNX-1900 (Intranasal Potentiated Oxytocin)

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 22, 2023 7:00am EDT

Intranasal Oxytocin Blocks the Release of CGRP in Animal Models

Intranasal Oxytocin is the Core Technology of TNX-1900 for Migraine

Oxytocin Treatment Affects a Pathway that is Distinct from the Recently Available CGRP Migraine Treatment Drug Class

CHATHAM, N.J., May 22, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has entered into a research collaboration agreement to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on capsaicin- or electrical stimulation-induced forehead dermal blood flow in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, will serve as principal investigator for the study.

“Collaborating with Professor Maassen van den Brink is an exciting opportunity to learn about the potential for TNX-1900 for treating migraine, facial pain and other related conditions,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In animal studies, intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) release from trigeminal neurons.¹ CGRP is released from trigeminal neurons during a migraine attack and several CGRP inhibitors are approved for the treatment of migraine. Both a CGRP inhibitor and a triptan have been successfully tested in the model and have been found to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.^2,3 We look forward to learning the results of TNX-1900 in this proof-of-concept study. Together with other studies, the results will guide future development of this potential non-addictive treatment for migraine and other painful conditions.”

Dr. Maassen van den Brink, the principal investigator of the study said, “The signaling pathways that mediate migraine and facial pain are becoming understood. Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine that is distinct from the recently available CGRP inhibitor migraine treatment drug class.”

In February 2023, Tonix initiated enrollment in its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The Company expects topline results in the fourth quarter of this year.

About Migraine

Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.⁴ Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.⁵ In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).⁵ The current FDA approved drugs for migraine prevention in chronic migraine include Botox^® (onabotulinumtoxin), and the anti-CGRP/CGRP-receptor monoclonal antibodies Aimovig^® (erenumab), Vyepti^® (eptinezumab), Ajovy^® (fremanezumab) and Emgality^® (galcanezumab).

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in migraine. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system⁶ resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.¹ Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding⁷ as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.⁸ Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children⁹. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies¹⁰. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, craniofacial pain conditions, binge eating disorder, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
¹Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
²de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with
erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.
³Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.
⁴The International Classification of Headache Disorders, 3^rd Edition. Cephalalgia. 2018. 38(1):1-211
⁵Burch et al., Migraine: Epidemiology, Burden, and Comorbidity, Neurol Clin 37 (2019):631–649
⁶Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
⁷Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
⁸Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
⁹Yeomans, DC et al. 2017. US patent US2017368095
¹⁰MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 22, 2023

Release – Sandy Breland Named Gray’s Chief Operating Officer

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on GTN

Sandy Breland Named Gray’s Chief Operating Officer

May 22, 2023 07:00 ET|

ATLANTA, May 22, 2023 (GLOBE NEWSWIRE) — Gray Television, Inc. (“Gray”) (NYSE: GTN) promoted Sandy Breland from Senior Managing Vice President to the role of Executive Vice President and Chief Operating Officer, effective today. Sandy succeeded Bob Smith, who recently retired after a long career with Gray in various capacities.

“Sandy has vast talents and experience in leading local news-focused operations that have earned her enormous respect within Gray and throughout our industry,” explained Gray’s Executive Chairman Hilton H. Howell. “She is the natural choice to lead Gray’s unique portfolio of leading television stations, and we are thrilled to announce her promotion as our new Chief Operating Officer.”

In early 2019, Sandy joined Gray as a Senior Vice President of Local Media upon Gray’s acquisition of Raycom Media, where she served as a Group Vice President. In her current role, she has overseen a portfolio of television stations and local digital platforms in 16 markets as well as Gray’s Washington DC News Bureau, its National Investigative Unit, and news support services for all markets. Last year, she assumed oversight of Recruiting and Gray’s new in-house News Research and Consulting operation. Sandy also has oversight of InvestigateTV, a weekly program airing across Gray’s stations.

Sandy has over 30 years of experience in local broadcasting and has received some of the industry’s highest honors. Her career has included General Manager of WVUE-TV (Fox) in New Orleans, Louisiana, and WAFB/WBXH in (CBS/MyNetwork) Baton Rouge, Executive News Director of KTVK-TV (Arizona’s Family TV3) in Phoenix, Arizona, and Executive News Director of WWL-TV (CBS) in New Orleans.

Sandy was honored with a Peabody and an Edward R. Murrow award for her planning and execution of Hurricane Katrina coverage during her time at WWL-TV. She proudly serves on the Board of Directors for the Carole Kneeland Project for Responsible Journalism. Sandy is a recipient of the RTNDF’s First Amendment Award and the Society of Professional Journalists’ Sigma Delta Chi Award for public service. In addition to a Bachelor’s in Journalism from Loyola University-New Orleans, she has attended continuing education sessions at Columbia University’s Sulzberger Leadership Program, Missouri University’s Management Program for Broadcast Professionals, and the Poynter Institute.

About Gray:

Gray Television, Inc. is a multimedia company headquartered in Atlanta, Georgia. Gray is the nation’s largest owner of top-rated local television stations and digital assets in the United States. Its television stations serve 113 television markets that collectively reach approximately 36 percent of US television households. This portfolio includes 80 markets with the top-rated television station and 102 markets with the first and/or second highest rated television station. It also owns video program companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, as well as the studio production facilities Assembly Atlanta and Third Rail Studios. Gray owns a majority interest in Swirl Films. For more information, please visit www.gray.tv.

Gray Contact

Hilton H. Howell, Jr., Executive Chairman and Chief Executive Officer, 404-266-5513

Pat LaPlatney, President and Co-Chief Executive Officer, 334-206-1400

Jim Ryan, Executive Vice President and Chief Financial Officer, 404-504-9828

Kevin P. Latek, Executive Vice President, Chief Legal and Development Officer, 404-266-8333

# # #

Release – Alliance Resource Partners, L.P.to Participate in the 20th Annual Energy Infrastructure Council CEO & Investor Conference

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ARLP

Company Release – 5/22/2023 7:00 AM ET

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) today announced that Joseph W. Craft III, Chairman, President and Chief Executive Officer, and other members of management will participate in investor meetings at the 20^th Annual Energy Infrastructure Council CEO & Investor Conference in West Palm Beach, Florida on Tuesday, May 23, 2023.

A presentation will also be available May 23, 2023 on ARLP’s website (www.arlp.com) under “Investor Relations” and “Events & Presentations.”

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
918-295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – ZyVersa Therapeutics Announces Changes to ZyVersa’s Board of Directors

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 19, 2023

PDF Version

WESTON, Fla., May 19, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces that two members of the Board of Directors have stepped down due to obligations associated with recent executive opportunities: Katrin Rupalla, PhD and Daniel O’Connor. Dr. Rupalla resigned from ZyVersa’s Board of Directors to pursue an opportunity that precludes her ability to serve on any board of directors. Mr. O’Connor, the former CEO of Larkspur which merged with ZyVersa in December of 2022, has recently taken on the CEO role at Ambrx Biopharma and has resigned to focus on growth of his new company.

“On behalf of the Board of Directors and the team at ZyVersa, I would like to thank Dr. Rupalla and Mr. O’Connor for their impactful leadership during their tenure as Board members at ZyVersa,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “As biopharmaceutical leaders with impeccable credentials and a proven track record of success, their knowledge and perspectives have been invaluable as we progress development of our company and our lead renal and anti-inflammatory assets.”

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the 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 included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Bowlero Corp. Completes First Acquisition in Tennessee

Posted on May 19, 2023May 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BOWL

05/19/2023

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL), the global leader in bowling entertainment, announced today that it has completed the acquisition of Andy B’s, marking the Company’s first center in the state of Tennessee. Andy B’s will be open to the public on May 19^th, under the Bowlero name.

Andy B’s, opening as Bowlero Bartlett, is located in Bartlett, TN, 13 miles outside of Memphis. This 44-lane center is made up of 32 traditional lanes and 12 private lanes featuring state-of-the-art audio and lighting with 50 feet of video displays. Andy B’s is also home to an interactive arcade, a snack bar and grill, and a full-service bar.

“We are pleased with our continued growth, officially expanding our national footprint in 34 states with the acquisition of Andy B’s,” stated Thomas Shannon, Founder and CEO of Bowleo Corp. “This acquisition echos our focus on expansion in new markets, giving us the opportunity to provide new guests with the unique Bowlero experience. We are looking forward to this next chapter while looking ahead to new growth opportunities throughout the year.”

About Bowlero Corp

Bowlero Corp. is the global leader in bowling entertainment, media, and events. With more than 325 bowling centers across North America, Bowlero Corp. serves more than 30 million guests each year through a family of brands that includes Bowlero, Bowlmor Lanes, and AMF. In 2019, Bowlero Corp. acquired the Professional Bowlers Association, the major league of bowling, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com

For Media:
PR@BowleroCorp.com

For Investors:
IRSupport@BowleroCorp.com

Source: Bowlero Corp.

Release – Kelly Elects Board of Directors at Annual Shareholders Meeting, Announces Board Leadership Succession

Posted on May 19, 2023May 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on KELYA

May 19, 2023

TROY, Mich., May 19, 2023 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading specialty talent solutions provider, today announced that at its 2023 Annual Shareholders Meeting held on May 17, 2023, Kelly shareholders elected nine individuals to serve one-year terms on its board of directors.

The newly elected directors are Gerald S. Adolph, retired senior partner, strategy and M&A, Booz & Co.; George S. Corona, retired president and chief executive officer, Kelly; Robert S. Cubbin, retired president and chief executive officer, Meadowbrook Insurance Group, Inc.; Amala Duggirala, executive vice president and chief information officer, United Services Automobile Association (USAA); InaMarie Felix Johnson, former chief people and diversity officer, Zendesk, Inc.; Terrence B. Larkin, retired executive vice president, business development, general counsel and corporate secretary, Lear Corporation; Leslie A. Murphy, CPA, president and chief executive officer, Murphy Consulting, Inc.; Donald R. Parfet, managing director, Apjohn Group, LLC; and Peter W. Quigley, president and chief executive officer, Kelly.

Following the election of the board of directors, the board appointed Mr. Larkin to the position of chairman of the board, effective immediately. An attorney with 28 years of experience in business law, Mr. Larkin has served as an independent director on Kelly’s board since 2010 and brings a valuable combination of complex problem-solving skills, legal and governance expertise, and global experience. He succeeds Mr. Parfet, who has elected to step down as chairman of the board, a position in which he has served since 2018. Mr. Parfet will continue his service on Kelly’s board as an independent director.

“On behalf of the entire board of directors, I would like to thank Don for his distinguished leadership during the last five years. Kelly has benefited immensely from his guidance and insights as the Company has executed its specialty strategy and transformed its portfolio,” said Mr. Larkin. “I am grateful for the opportunity to serve as Kelly’s next chairman, and I look forward to continuing to work with Don and the rest of the board to carry out our responsibility to Kelly’s shareholders as the Company embarks on the next phase of its growth journey.”

About Kelly®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.

KLYA-FIN

ANALYST CONTACT:	MEDIA CONTACT:
James Polehna	Jane Stehney
(248) 244-4586	(248) 765-6864
james.polehna@kellyservices.com	stehnja@kellyservices.com

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SOURCE Kelly Services, Inc.

Release – GameSquare Holdings Reports Standalone First Quarter 2023 Results for GameSquare Esports and Provides First Quarter Pro-Forma Income Statement

Posted on May 19, 2023May 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on GAME

05/18/2023

Record pipeline and recent contract wins expected to accelerate revenue growth in second half of 2023

Merger integration underway with $8 million of annualized cost savings expected in 2023

Company initiates 2023 guidance reflecting pro-forma sales of $75 to $80 million, and annual gross margins of 30% – 35%

TORONTO, ON / ACCESSWIRE / May 18, 2023 / GameSquare Holdings, Inc. (“GameSquare“, or the “Company“) (NASDAQ:GAME)(TSXV:GAME) announced that GameSquare Esports, Inc. has filed its standalone financial results for its first quarter ended March 31, 2023. As a result of the April 11, 2023 merger of GameSquare Esports and Engine Gaming and Media, Inc. (“Engine Gaming”), GameSquare provided a pro-forma income statement for the 2023 first quarter. The Company expects to file its second quarter 2023 consolidated financial statements for the combined entity, in August of 2023. The Company also provided 2023 guidance as a consolidated company.

“With the merger now behind us, our business momentum is accelerating, driven by a record pipeline, increasing ad spend, and the benefits of the merger. In addition, we believe advertising partners are already recognizing the value of our combined company’s assets. We recently have signed several significant brand deals across numerous verticals, including healthcare, automotive, and CPG, with average expected contract values north of seven figures. We believe that our record pipeline and recent wins indicate that global brands see the value of GameSquare’s leading end-to-end media platform and our success helping companies connect with gaming and youth audiences. As a result of the merger, GameSquare now serves approximately 350 brands, 1,500 creators, and has an aggregate audience reach over 500 million,” said Justin Kenna, CEO of GameSquare.

“Since our inception in late 2020, we have invested heavily in our business to build industry leading capabilities, create new and innovative revenue opportunities, complete a transformational merger, and assemble a team of experienced, motivated, and passionate leaders, talent, and influencers. With a solid foundation, we are focused on successfully integrating the merger, scaling our business, and pursuing a path to profitability. As we look forward, we believe pro-forma annual sales of the combined company in 2023 will be between $75 and $80 million. In addition, we have identified approximately $8 million of annualized cost savings and other opportunities to streamline and optimize the combined company. We expect annual gross margin in 2023 will range between 30% and 35%. As a result, we believe we will see significant improving trends towards profitability starting in the second half of 2023,” continued Mr. Kenna.

“I am encouraged by the growing momentum underway, as we focus over the near-term on integrating the merger, growing sales, and accelerating our path to profitability. I am excited by the direction we are headed, and I look forward to updating you on the progress we are making as we convert our growing pipeline into profitable sales,” concluded Mr. Kenna.

First Quarter 2023 GameSquare Esports Standalone Highlights (Comparisons are to Prior Year Period)

Revenue of $5,050,713, compared to $5,040,074
Gross margin increased to 40.2%, compared to 32.6%
Net loss of $4,258,273, compared to a net loss of $3,993,629
Adjusted EBITDA loss of $2,255,835, compared to a loss of $2,742,172

First Quarter 2023 Pro-Forma Highlights

Revenue of $13,843,347, compared to $12,897,929 in the prior year period
Gross margin of $4,267,983 or 30.8% in Q1 23
Net loss of $12,150,604 in Q1 23
Adjusted EBITDA loss of $5,045,947, compared to loss of $7,333,281 in the prior year period

Conference Call Details

Justin Kenna, CEO, Lou Schwartz, President, Paul Bozoki, former CFO of GameSquare Esports, and Mike Munoz CFO of GameSquare Holdings, are scheduled to host a conference call with the investment community. Analysts and interested investors can join the call via the details below:

Date: Thursday, May 18, 2023
Time: 5:00 pm ET
Webcast: http://services.choruscall.ca/links/gamesquare2023q1.html

Media and Investor Relations

Andrew Berger
Phone: (216) 464-6400
Email: IR@gamesquare.com

About GameSquare Holdings, Inc.

GameSquare Holdings, Inc. (NASDAQ:GAME | TSXV:GAME) is a vertically integrated, digital media, entertainment and technology company that connects global brands with gaming and youth culture audiences. GameSquare’s end-to-end platform includes GCN, a digital media company focused on gaming and esports audiences, Cut+Sew (Zoned), a gaming and lifestyle marketing agency, USA, Code Red Esports Ltd., a UK based esports talent agency, Complexity Gaming, a leading esports organization, Fourth Frame Studios, a creative production studio, Mission Supply, a merchandise and consumer products business, Frankly Media, programmatic advertising, Stream Hatchet, live streaming analytics, and Sideqik a social influencer marketing platform. www.gamesquare.com

Forward-Looking Information

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the Company’s future performance and revenue; continued growth and profitability; the Company’s ability to execute its business plan; and the proposed use of net proceeds of the Offering. These forward-looking statements are provided only to provide information currently available to us and are not intended to serve as and must not be relied on by any investor as a guarantee, assurance or definitive statement of fact or probability. Forward-looking statements are necessarily based upon a number of estimates and assumptions which include, but are not limited to: the Company being able to grow its business and being able to execute on its business plan, the Company being able to complete and successfully integrate acquisitions, the Company being able to recognize and capitalize on opportunities and the Company continuing to attract qualified personnel to supports its development requirements. These assumptions, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: the Company’s ability to achieve its objectives, the Company successfully executing its growth strategy, the ability of the Company to obtain future financings or complete offerings on acceptable terms, failure to leverage the Company’s portfolio across entertainment and media platforms, dependence on the Company’s key personnel and general business, economic, competitive, political and social uncertainties including impact of the COVID-19 pandemic and any variants. These risk factors are not intended to represent a complete list of the factors that could affect the Company which are discussed in the Company’s most recent MD&A. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. GameSquare assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: GameSquare Holdings, Inc.

View source version on accesswire.com:
https://www.accesswire.com/755906/GameSquare-Holdings-Reports-Standalone-First-Quarter-2023-Results-for-GameSquare-Esports-and-Provides-First-Quarter-Pro-Forma-Income-Statement

Release – Salem Media to Present at the Singular Research Spring Select Webinar

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SALM

May 18, 2023 4:06pm EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM), announced today that it will present virtually at the Singular Research Spring Select Webinar on Wednesday, May 24^th at 3:45 PM Central Time. The presentation will be available on the investor relations portion of the company’s website www.salemmedia.com prior to the company’s presentation.

ABOUT SINGULAR RESEARCH

Singular Research aims to be the most trusted supplier of independent, trusted, single-sources research on small-to-micro cap companies to the small-to-medium sized Hedge Fund manager. Singular Research provides quarterly updates for 40 to 70 companies and makes recommendations.

Singular strives to achieve goals by finding undercovered and undervalued securities. Singular’s goal is to provide initiation reports and quarterly updates for approximately 50 micro-to-small cap companies. In most cases, Singular analysts research companies that are not covered by any other firms.

Singular provides honest advice. Independent analysts have no financial interest in the stocks covered. Analysts are compensated based on the accuracy of their research calls not through trading commissions or potential deal flow.

ABOUT SALEM MEDIA GROUP

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230518005691/en/

Company Contact:
Evan D. Masyr
Executive Vice President and Chief
Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released May 18, 2023

Release – FAT Brands Strengthens Leadership Team with C-Suite Appointment and Two New Brand Presidents

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FAT

MAY 18, 2023

Jenn Johnston Assumes Chief Marketing Officer Role , New Brand Presidents to Lead Round Table Pizza , Great American Cookies, Marble Slab Creamery, and Pretzelmaker Concepts

LOS ANGELES, May 18, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc . announces the elevation of Jenn Johnston to the role of Chief Marketing Officer. Since the acquisition of Global Franchise Group in July 2021, Ms. Johnston has held the role of President of the Quick-Service Division at FAT Brands, overseeing brands including Round Table Pizza, Great American Cookies, Marble Slab Creamery, and Pretzelmaker. With Ms. Johnston’s promotion to Chief Marketing Officer, Allison Lauenstein and David Pear will assume Brand President roles.

Ms. Lauenstein will serve as Brand President of Great American Cookies, Marble Slab Creamery, and Pretzelmaker. Ms. Lauenstein brings over a decade of experience working with the respective brands, having previously served as Executive Vice President of Brand Operations and Marketing at Global Franchise Group. Ms. Lauenstein successfully launched several initiatives during her tenure, including the unlimited mix-ins platform at Marble Slab Creamery, the co-branded model of Great American Cookies and Marble Slab Creamery, and the Fresh Twist menu concept for Pretzelmaker. Prior to joining Global Franchise Group, Ms. Lauenstein spent 13 years at Dunkin’ and Baskin-Robbins Brands in various leadership positions.

With over 20 years of strategic and operational restaurant leadership experience, Mr. Pear will assume the role of Brand President at Round Table Pizza. Mr. Pear most recently served as Vice President of Strategic Initiatives at Desert De Oro Foods, a multi-unit franchise organization with 360 restaurants, including Taco Bell, KFC, Pizza Hut, Whataburger, Dickey’s Barbecue Pit, and Dave’s Hot Chicken. Prior to that, Mr. Pear served as Senior Vice President of Operations at Del Taco, where he played a key role in consistently increasing same-store sales and driving overall unit growth. Mr. Pear also brings experience from his time at Yum! Brands’ Taco Bell and Domino’s Pizza, where he led operational transformation through a combination of key initiatives focused on culture, continuous improvement of operational elements, and elevation of the guest experience.

“As FAT Brands continues to evolve and grow, we saw an opportunity to expand Jenn’s role to impact the larger organization,” said Thayer Wiederhorn, Chief Operating Officer of FAT Brands. “Her unique marketing and operations background will enable us to develop impactful campaigns that increase brand visibility and drive profitable sales across our 17 concepts. We are also pleased to welcome Allison and David to the team. Allison has a great track record with Great American Cookies, Marble Slab Creamery, and Pretzelmaker. We expect a seamless integration into her new role and immediate value to the brands. On the other hand, David brings exciting insights from his outside experience, which we also expect will bring immediate results. We are fortunate to have them both join our talented management team.”

For more information on FAT Brands, visit www.fatbrands.com.

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

MEDIA CONTACT:
Erin Mandzik, FAT Brands
emandzik@fatbrands.com
860-212-6509

Release – PDS Biotech Completes Enrollment in Immune Checkpoint Inhibitor Naïve Arm of VERSATILE-002 Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Company plans to initiate VERSATILE-003 Phase 3 clinical trial in late 2023

FLORHAM PARK, N.J., May 18, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the completion of enrollment in the immune checkpoint inhibitor naïve group (ICI naïve) of its VERSATILE-002 Phase 2 trial for the treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.

VERSATILE-002 (NCT04260126) is a Phase 2, open-label, multicenter trial of the efficacy and safety of PDS0101 administered in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in adults with HPV16-positive, unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations with HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with an ICI, also known as the ICI naïve cohort, and is PD-L1 positive. The second group of patients has failed treatments, including ICI therapy (ICI refractory). In December 2022, PDS Biotech announced the completion of enrollment in the first stage of the ICI refractory group.

PDS Biotech recently announced that updated data from the ICI naïve group will be the subject of a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The abstract was also selected as one of the featured posters to be reviewed by an expert panel in the Head and Neck Cancer discussion session. The data will build upon previously announced preliminary efficacy data reported at ASCO 2022 from 17 ICI naïve VERSATILE-002 patients, which demonstrated an objective response rate of 41% (confirmed and unconfirmed responses), clinical benefit rate of 77%, and an overall survival rate of 87% at nine months.

“Completing enrollment in the ICI naïve arm is an important milestone in the VERSATILE-002 Phase 2 trial and the ongoing development of PDS0101 in combination with KEYTRUDA^® as a potential treatment for recurrent and/or metastatic HPV16-positive head and neck cancer,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “HPV-driven HNSCC is a growing problem, and there is a large unmet medical need to develop an HPV-targeted immunotherapy. Preliminary data reported at ASCO 2022 and highlighted at our October 2022 Head and Neck Cancer KOL Roundtable suggest that PDS0101 in combination with KEYTRUDA^® may lead to improved outcomes in ICI naïve, recurrent or metastatic HNSCC patients. We now look forward to reporting updated data from the VERSATILE-002 trial at ASCO 2023 as the next step towards a planned global confirmatory randomized, controlled trial investigating the combination of PDS0101 and KEYTRUDA^® in this same patient population.”

90% of HPV-associated head and neck cancers in the U.S. are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine (J Clin Med 2018 Sep;7(9):241). The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of PDS0101 and KEYTRUDA^® for the treatment of HPV16-positive HNSCC.

About PDS0101

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune^® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

Preliminary efficacy and safety data were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI naïve patients (PR link). Preliminary data from the first 19 patients demonstrated that 77% of the patients with available imaging (17 of 19) had either disease stabilization or tumor shrinkage. Additionally, the overall survival rate of these patients at 9 months was 87%.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune™ T cell-activating platforms and PDS0301 tumor targeting immunocytokine. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Maple Gold Outlines VMS-Focused Exploration Targeting and Summer Field Program

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on MGMLF

Vancouver, British Columbia–(Newsfile Corp. – May 18, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to provide an update regarding property-wide volcanogenic massive sulfide (“VMS”) targeting and plans for a summer field program at the Douay and Joutel Gold Projects (“Douay” and “Joutel”, respectively) located in Québec, Canada, which are held by a 50/50 joint venture (the “JV”) between the Company and Agnico Eagle Mines Limited. The Company is also planning VMS exploration work at its 100%-owned Morris Project (“Morris”) located approximately 30 kilometres (“km”) east of the town of Matagami in Morris Township, Québec.

The JV’s primary focus remains on testing resource expansion targets at Douay and testing prospective near-mine extension targets in the Telbel mine area at Joutel. However, the Douay and Joutel projects each have demonstrated potential for gold and base metals VMS mineralization, as is illustrated by a series of targets previously defined by field mapping and geophysical surveying across the combined 400 km² property package (see news from July 19, 2022). Under the terms of the JV agreement, the partners agreed to jointly fund C$500,000 in exploration on VMS targets on the western portion of Douay (see news from February 3, 2021).

Summary of VMS-focused exploration and corporate initiatives:

The Company’s mapping, sampling and top of bedrock drilling during 2018 identified six (6) priority target areas for potential base metals and gold-rich VMS mineralization (see press release November 14, 2018).
The Company subsequently appointed Dr. Gérald Riverin, a recognized VMS expert with 40+ years of experience in the Abitibi Greenstone belt, to its board of directors and Technical Advisory Committee (see news from June 9, 2020).
In late 2021, the JV consolidated two (2) inlier claim blocks covering 22 claims and 12.3 km² of ground in the central portion of Douay in an area deemed prospective for zinc and copper mineralization (see news from October 19, 2021).
Also in 2021, the Company acquired 100% of Morris and completed preliminary ground geophysics and lithogeochemical sampling. In 2022 and 2023, the Company completed deep penetrating pulse electromagnetic (“PEM”) surveys that outlined a 3 km long conductive zone adjacent to a favorable rhyolite unit.
In 2022, the JV completed a regional airborne magnetic and electromagnetic (“Mag-EM”) survey to support exploration drill targeting, which identified 55 targets within four (4) primary target areas prospective for pyritic gold and VMS mineralization (see news from July 19, 2022). After geophysical review, sixteen (16) of these targets were selected for priority follow-up (see Figure 1).
In 2023, the Company appointed Paul Harbidge, CEO of Faraday Copper Corp., an emerging U.S. copper developer, to its Technical Advisory Committee to further strengthen the Company’s technical group and support gold and base metals exploration (see news from February 7, 2023).
The JV has recently hired Dr. Marina Schofield, an expert in volcanology, structural geology and VMS systems, to lead the Company’s VMS exploration efforts.

“We have methodically built a pipeline of prospective gold and base metals VMS targets across the large >400 km² Douay-Joutel property package and have expanded our technical expertise in order to systematically evaluate and advance a VMS-focused exploration program,” statedMatthew Hornor, President and CEO of Maple Gold. “The past-producing high-grade Estrades zinc-gold mine is located just over 11 km to the west of Douay-Joutel and the same geologic horizon that hosted that mine appears to continue onto the western portion of the Douay property. Further to the southeast, historical regional exploration drilling along the Joutel Deformation Zone, east of the historical Eagle-Telbel deposits, has also returned anomalous zinc and gold values. We look forward to completing further cost-effective field work this summer to bring the highest priority VMS discovery targets to a drill-ready stage.”

VMS Targets and Associated 2023 Summer Exploration Plans:

Figure 1: Geology base map highlighting VMS and VMS-like base metal mines and deposits in the region and copper-zinc showings.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/3077/166582_final%20fig%201%20may%2018.png

The Douay-Joutel property straddles the Casa Berardi Deformation Zone, which is geologically underlain, from south to north, by predominantly intermediate to felsic tuffs of the Joutel-Raymond Grp, the basinal sediments of the Harricana Grp and the predominantly mafic volcanic sequence forming the Cartwright Hills Grp, followed by further basinal sediments of the Taïbi Grp. Although the geological model for Eagle-Telbel is still evolving, gold mineralization was associated with mixed sedimentary and pyroclastic horizons hosting abundant iron carbonate and semi-massive sulfide (pyrite) at the top of the volcanic package that hosts the past-producing Joutel/Poirier VMS mining camp. The main VMS target horizons occur laterally along the Eagle-Telbel Mine Horizon, as well as along multiple interflow horizons within The Cartwright Hills Grp, which include the interpreted eastern extension of the Estrades horizons.

Figure 2: Gold, VMS and base metal target areas in the greater Joutel area (same legend as Fig 1).

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/3077/166582_final%20fig%202%20may%2018.png

The Joutel Targets (see Figure 2 above) include several EM anomalies within ~2-5 km of the historical Eagle, Telbel and Eagle West deposits that have very limited drilling. These deposits are associated with the Harricana and Joutel Deformation Zones and appear as discrete conductive zones aligned along a well-defined northwest trend. The Mag-EM survey indicates possible similar structures extending more than 9 km further to the east in this area where historical drilling intersected anomalous gold (“Au”) and zinc (“Zn”) in several holes. Hole M-94-078 (also known as McClure 93-2 showing) intersected 0.81% Zn over 0.6 metres (“m”); hole JO-12-05 intersected 6.1 g/t Au over 1.5 m, as well as 0.55% Zn over 4 m further downhole, including 0.88% Zn over 1m.

Planned work to advance VMS targets at Douay and Joutel is expected to include compilation of existing data, including review of historical drill logs, followed by field work including lithogeochemistry and initial follow-up ground EM surveys to support bringing highest priority VMS target areas towards a drill ready stage.

Separately, planned work at Morris is expected to include detailed lithogeochemical sampling to establish the full extent of strong VMS related hydrothermal alteration identified in 2021 and identify promising portions of the 3 km long conductor identified by ground geophysics in 2022 and 2023 (see Figure 3). Morris is located approximately 30 km east of the Matagami VMS mining camp and hosts the Watson Lake rhyolite unit which forms the footwall of all the VMS mines at Matagami.

Figure 3: 100% owned Morris claims with geology and geophysics compilation. Favorable alteration is highlighted by higher Riverindex values.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/3077/166582_a96d77c1043a2814_003full.jpg

Qualified Person

The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km² of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.

The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Matthew Hornor”

B. Matthew Hornor, President & CEO

For Further Information Please Contact:

Mr. Joness Lang
Executive Vice-President
Cell: 778.686.6836
Email: jlang@maplegoldmines.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.

Forward Looking Statements:

This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.com. The Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Release – Tonix Pharmaceuticals to Participate in the A.G.P. Virtual Healthcare Conference

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 18, 2023 7:00am EDTDownload as PDF

CHATHAM, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate in the A.G.P. Virtual Healthcare Conference and host investor meetings. The conference is being held May 23-24, 2023.

In addition, Seth Lederman, M.D., Chief Executive Officer of Tonix, will participate in a panel discussion titled, “New Approaches to Depression,” scheduled from 12:00 p.m. – 1:00 p.m. ET, Tuesday, May 23, 2023.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the conference coordinator or Ian Frost at ian.frost@westwicke.com.

Tonix Pharmaceuticals Holding Corp.^*

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 18, 2023