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Release – Permex Petroleum Announces Extension of Warrant Repricing and Exercise Incentive Program

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June 16, 2023 11:22 ET

DALLAS, June 16, 2023 (GLOBE NEWSWIRE) — Permex Petroleum Corporation (CSE: OIL) (OTCQB: OILCF) (FSE: 75P0) (“Permex” or the “Company“), is pleased to announce the extension of its early warrant exercise program (the “Program”), as initially announced by the Company in its news release dated May 18, 2023 (the “Initial News Release”).

The Program was announced with the intention to encourage the exercise of up to 1,015,869 unlisted common share purchase warrants of the Company (the “Eligible Warrants”). Pursuant to the Program, the Company amended the exercise price of the outstanding Eligible Warrants to USD$2.86 per Eligible Warrant, from May 18, 2023, at 9:00 a.m. (Vancouver time) until June 16, 2023 at 5:00 p.m. (Vancouver time). The Company now wishes to extend the Program until June 30, 2023 at 5:00 p.m. (the “Extended Exercise Deadline”).

As part of the Program, the Company will also offer, to each holder of Eligible Warrants (the “Warrant Holders”) who exercises any Eligible Warrants until the Extended Exercise Deadline, the issuance of one additional common share purchase warrant for each such exercised Eligible Warrant (each, an “Incentive Warrant”). Each Incentive Warrant entitles the Warrant Holder to purchase one common share of the Company (each, a “Share”) for a period of 5 years from the date of issuance, at a price of USD$4.50 per Share. The Company may also issue pre-funded common share purchase warrants (each, a “Pre-Funded Warrant”) in lieu of Shares, upon the exercise of Eligible Warrants, to certain Warrant Holders. Each Pre-Funded Warrant will allow the holder thereof to acquire one Share at a nominal exercise price of USD$0.01 and will not expire.

The Eligible Warrants which remain unexercised following the completion of the Extended Early Deadline will continue to be exercisable, on the terms existing immediately prior to the implementation of the Program, and no further Incentive Warrants will be granted on the exercise of the Eligible Warrants following the Extended Exercise Deadline.

For additional information on the Program, please refer to the Initial News Release.

The Incentive Warrants, and any securities issuable on the exercise thereof, will be subject to a four-month hold period from the date of issuance pursuant to applicable Canadian securities laws, in addition to such other restrictions as may apply under applicable securities laws of jurisdictions outside of Canada. None of the securities issued in connection with the Program will be registered upon issuance under the United States Securities Act of 1933, as amended (the “1933 Act“), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission to register the Shares within 30 days of the end of the Extended Exercise Deadline. This news release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

Contact Information

Permex Petroleum Corporation
Mehran Ehsan
President, Chief Executive Officer & Director
469-804-1306

Gregory Montgomery
Chief Financial Officer
469-804-1306

Or for investor relations, please contact:
Renmark Financial Communications Inc.
Steve Hosein: [email protected]
Tel.: (416) 644-2020 or (212)-812-7680
www.renmarkfinancial.com

Forward Looking Statements

This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian and United States securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as “intends” or “anticipates”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should”, “would” or “occur”. This information and these statements, referred to herein as “forward‐looking statements”, are not historical facts, are made as of the date of this news release and include without limitation, statements regarding discussions of future plans, estimates and forecasts and statements as to management’s expectations and intentions with respect to, among other things: the anticipated timing and completion of the Program.

These forward‐looking statements involve numerous risks and uncertainties and actual results might differ materially from results suggested in any forward-looking statements. These risks and uncertainties include, among other things: delays in obtaining or failures to obtain required regulatory approvals for the Program from the CSE; market uncertainty; and the inability of the Company to raise proceeds pursuant to the Program.

In making the forward-looking statements in this news release, the Company has applied several material assumptions, including without limitation, that: the Company will obtain the required CSE approval for the Program; and the Company will be able to raise proceeds under the Program.

Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such 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 forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. We seek safe harbor.

Release – Permex Petroleum Engages Renmark Financial USA Inc. for Investor Relations

Posted on by [email protected]

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June 16, 2023 08:30 ET

DALLAS, June 16, 2023 (GLOBE NEWSWIRE) — Permex Petroleum Corporation (CSE: OIL) (OTCQB: OILCF) (FSE:75P0) (“Permex” or the “Company”) announces that it has retained Renmark Financial Communications USA Inc. (“Renmark”), an arm’s length party to the Company, to provide investor relations services (the “Services”) to the Company.

Renmark was engaged to heighten market and investor awareness for the Company and broaden the Company’s reach within the investment community. In implementing its investor relations program, Renmark employs a number of different communication methods, including live phone calls and emails. To reach new potential investors, for an additional set-up fee, Renmark will organize virtual non-deal roadshows for senior management in zones across the USA, Canada, and Europe. Additionally, Renmark will ensure the timely disclosure of Company information to existing and potential shareholders and electronically send documents and factsheets to prospective shareholders.

Renmark has been engaged by the Company for an initial 7-month period (the “Initial Term”) which commenced on May 1, 2023; the term will automatically continue after the Initial Term on a monthly basis, unless terminated in accordance with the investor relations agreement (the “Agreement”) among the parties.

As consideration for the Services, the Company will pay Renmark a monthly fee of USD$9,000, (the “Monthly Service Fee”) during the Initial Term. The Monthly Service Fee becomes payable on the first day of each month during the Initial Term. Renmark is also entitled to reimbursement for all expenses reasonably incurred, subject to the terms of the Agreement.

The Company and Renmark act at arm’s length, and Renmark has no present interest, directly or indirectly, in the Company or its securities, or any right or present intent to acquire such an interest.

About Permex Petroluem Corporation

Permex Petroleum is a uniquely positioned junior oil & gas company with assets and operations across the Permian Basin of West Texas and the Delaware Sub-Basin of New Mexico. The Company focuses on combining its low-cost development of Held by Production assets for sustainable growth with its current and future Blue-Sky projects for scale growth. The Company, through its wholly owned subsidiary, Permex Petroleum US Corporation, is a licensed operator in both states, and owns and operates on private, state and federal land. For more information, please visit www.permexpetroleum.com.

About Renmark Financial Communications USA Inc.

Renmark Financial Communications is a full-service investor relations firm representing small, medium, and large cap public companies trading on all major North American exchanges. Renmark facilitates connections between their clients and key stakeholders in order to assist their clients in efficiently achieving their milestones. Renmark has offices in Toronto, Montreal, New York, and Atlanta.

Contact Information

Permex Petroleum Corporation
Mehran Ehsan
President, Chief Executive Officer & Director
469-804-1306

Gregory Montgomery
Chief Financial Officer
469-804-1306

Or for Investor Relations, please contact:
Renmark Financial Communications Inc.
121 King Street West
Suite 1140
Toronto ON M5H 3T9

Steve Hosein: [email protected]
Tel.: (416) 644-2020 or (212)-812-7680
www.renmarkfinancial.com

Forward-Looking Statements

This news release contains forward-looking statements relating to Renmark heightening the market and investor awareness of the Company and broadening the Company’s reach within the investment community, fees payable to Renmark, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include those relating to the ability of Renmark to heighten the market and investor awareness of the Company and broaden the Company’s reach within the investment community, and other risks detailed from time to time in the filings made by the Company with securities regulations.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward- looking statements as expressly required by applicable law.

Release – Alvopetro Announces US$0.14 Per Share Q2 2023 Dividend

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Jun 15, 2023

CALGARY, AB, June 15, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces that our Board of Directors has declared a quarterly dividend of US$0.14 per common share, payable in cash on July 14, 2023, to shareholders of record at the close of business on June 30, 2023. This dividend is designated as an “eligible dividend” for Canadian income tax purposes. 

Dividend payments to non-residents of Canada will be subject to withholding taxes at the Canadian statutory rate of 25%.  Shareholders may be entitled to a reduced withholding tax rate under a tax treaty between their country of residence and Canada.  For further information, see Alvopetro’s website at  https://alvopetro.com/Dividends-Non-resident-Shareholders.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation. 

Social Media

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltd

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

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 news release.

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward–looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the Company’s plans for dividends in the future, the timing and amount of such dividends and the expected tax treatment thereof. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic and other significant worldwide events, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest in properties and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. In addition, the declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.

Release – Aurania ShareholdersApprove All Resolutions At Annual And Special Meeting

Posted on by [email protected]

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Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) is pleased to announce that its shareholders have approved all resolutions at the Company’s Annual and Special Meeting (the “Meeting”) which was held on June 14, 2023.   

At the Meeting, shareholders approved the financial statements for the year-ended December 31, 2022, and the report of the auditors thereon, the appointment of auditors, election of directors, amendments to the Company’s restricted stock unit plan and the Company’s incentive stock option plan for the upcoming year.  Details of these matters are disclosed in the Management Information Circular for the Meeting dated May 2, 2023, and posted under the Company’s profile on www.sedar.com and on the Company’s corporate website http://www.aurania.com/investors/annual-general-meeting/.  The formal part of the Meeting was followed by an update from Aurania’s President & CEO, Dr. Keith Barron.  A summary of Keith Barron’s update will be provided in the coming days.

The Company also announces that its Chairman, President and Chief Executive Officer, Dr. Keith Barron (the “Lender”) completed a loan of C$2,000,000 to the Company. The loan is unsecured, bears interest at 2% per annum and matures upon notice of twelve months and one day from the Lender.  The loan will help fund the Company’s working capital and general corporate purposes as well as any exploration expenses in Ecuador.

Dr. Keith Barron is a related party of the Company by virtue of the fact that he is the Chairman, the President and Chief Executive Officer, a promoter and a principal shareholder of the Company, and as a result, each of the Loan constitutes a “related party transaction” for the purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying upon an exemption from the formal valuation and minority shareholder approval requirements under MI 61-101 in respect of the Related Party Transactions, in reliance on Sections5.5(a) and 5.7(1) of MI 61-101, respectively, as the fair market value of the Related Party Transaction, collectively, does not exceed 25% of the Company’s market capitalization, as determined in accordance with MI 61-101. The Company did not file a material change report related to the Loan more than 21 days before the expected closing of the Loan as required by MI 61-101, as the Company required the funds from closing on an expedited basis for sound business reasons.

The Loan and the Insider Participation were approved by the members of the board of directors of the Company who are independent for purposes of the Related Party Transactions, being all directors other than Dr. Barron. No special committee was established in connection with the Loan and the Insider Participation, and no materially contrary view or abstention was expressed or made by any director of the Company in relation thereto.

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America.  Its flagship asset, The Lost Cities – Cutucu Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

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 release.

Click this link to view the full release dated June 14, 2023 on Aurania’s website.

Release – Great American Cookies Continues U.S. Expansion Push with First Alaska Location

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JUNE 15, 2023

Original Cookie Cake Franchise Now Open in Anchorage

LOS ANGELES, June 15, 2023 (GLOBE NEWSWIRE) — Great American Cookies, the Original Cookie Cake franchise, announces its first location in the state of Alaska. Located in Anchorage, the new store serves as the ultimate sweet spot for locals with desserts including Custom Cookie Cakes, fresh, soft-baked cookies, brownies, and more.

“This year, Great American Cookies arrived in Arizona, New Mexico, and Illinois,” said Allison Lauenstein, President of Great American Cookies. “Growing domestically has been a key growth pillar for us so we are pleased to be able to expand our footprint to four new states, including Alaska, in just a few months. We see Anchorage as a great market to make our Alaska debut in, providing a perfect spot for family nights, birthdays, and beyond.”

Since 1977, Great American Cookies has baked up a reputation for not only being the creator of the Original Cookie Cake, but also for its famous chocolate chip cookie recipe. Other crave-able menu items include brownies and Double Doozies™, delectable icing sandwiched between two cookies.

The Anchorage Great American Cookies is located at 800 E Dimond Blvd, Suite 183, Anchorage, AK 99515, and is open Monday through Saturday, 10 a.m. to 9 p.m., and Sunday, 12 p.m. to 7 p.m.

For more information on Great American Cookies, visit www.greatamericancookies.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.

About Great American Cookies
Founded on a family chocolate chip cookie recipe in 1977, Great American Cookies believes that pure, simple delight is part of living a full life. Serving the Original Cookie Cake, fresh baked cookies in a variety of flavors, brownies, and Double Doozies™, we promise to treat you to bites of bliss that prove how sweet life can be. With more than 370 bakeries across the country and internationally in Bahrain, Guam, and Saudi Arabia, and treats available to ship right to your door, the sweet spot is always close to home. For more information, visit www.greatamericancookies.com. 

MEDIA CONTACT:
Erin Mandzik, FAT Brands
[email protected]
860-212-6509

Release – Tonix Pharmaceuticals Announces Publication of Results from Phase 3 RELIEF Trial of TNX-102 SL for the Management of Fibromyalgia

Posted on by [email protected]

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June 15, 2023 7:00am EDT

Previously Disclosed Data Demonstrated that TNX-102 SL Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01) and Was Generally Safe and Well Tolerated

Topline Data from RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL, Expected Fourth Quarter 2023

CHATHAM, N.J., June 15, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that previously disclosed results from the Phase 3 RELIEF study of TNX-102 SL for the management of fibromyalgia have been published in the peer-reviewed journal Arthritis Care & Research, an official journal of the American College of Rheumatology. In RELIEF, treatment with TNX-102 SL was associated with significant reductions in daily pain and was generally safe and well tolerated in patients with fibromyalgia. Secondary results also suggest that treatment with TNX-102 SL can improve sleep and reduce fatigue, which together with pain are recognized as core fibromyalgia symptoms. TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, intended to be taken once daily at bedtime. The paper can be accessed online at https://pubmed.ncbi.nlm.nih.gov/37165930/.

“There continues to be a pressing need for novel, safe and more tolerable drugs to treat patients with fibromyalgia, a debilitating chronic disease that afflicts an estimated 6 to 12 million adults in the United States, with symptoms including multisite pain and disturbed sleep,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Current fibromyalgia therapies have limited efficacy in alleviating symptoms of sleep disturbance and fatigue. These Phase 3 RELIEF data suggest that treatment with TNX-102 SL may improve sleep quality and fatigue in patients with fibromyalgia, in addition to reducing pain.”

The paper, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo Controlled RELIEF Trial,” includes data demonstrating that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, in an exploratory analysis, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue and fibromyalgia-specific global symptomatic and functional recovery.

Early discontinuation rates were similar for TNX-102 SL and placebo (17.7% and 16.5%, respectively). In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and lead to only one discontinuation.

Tonix is currently enrolling in a potentially confirmatory, registration-enabling Phase 3 study (RESILIENT). Topline results are expected in the fourth quarter of this year.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial is expected to enroll approximately 470 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

For more information, see ClinicalTrials.gov Identifier: NCT05273749.

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-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. 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 first quarter of 2024. 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.

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
[email protected]
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
[email protected]
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released June 15, 2023

Release – Comtech, E-Space Team Up to Make Space-Powered Connectivity Services Available and Actionable Anywhere

Posted on by [email protected]

Research News and Market Data on CMTL

MELVILLE, N.Y. & LOS GATOS, Calif. – June 14, 2023– Comtech (NASDAQ: CMTL) and E-Space, the company bridging Earth and space to enable hyper-scaled deployments of Internet of Things (IoT) solutions and services, today announced a teaming agreement to collaborate, develop and deploy innovative space-based communications solutions and IoT services to support predominantly government and targeted commercial customers.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230613091149/en/

The collaboration will leverage Comtech’s vast portfolio of industry leading technologies and strategic partnerships, coupled with E-Space’s future advanced space system, inclusive of its global low Earth orbit (LEO) constellation and unique device capabilities, to provide customers with secure, resilient global connectivity services. The E-Space space system, optimized with edge Artificial Intelligence (edge AI), will enable the delivery of new smart applications, real-time actionable insights and suggested courses of action.

“Continuous connectivity is a fundamental need in today’s information-driven society that will generate ongoing demand to blend terrestrial, wireless and satellite networks,” said Ken Peterman, President and CEO, Comtech. “By teaming with E-Space, we will provide end users with reliable, global connectivity to enable near real-time predictive insights that will drive efficiency, reduce operator burden and empower individuals by providing access to new technologies.”

Greg Wyler, founder, chairman and CEO of E-Space, added, “Combining the expertise and resources from Comtech and E-Space will help revolutionize the way defense and commercial companies leverage space-powered data to connect, communicate and put intelligence into action. From providing warfighters up-to-the-minute situational awareness to ensuring logistics providers have incredible insights into every asset in a shipment – we will be able to provide unique information sets that will enable smarter operations.”

E-Space is building a satellite infrastructure that will blur the line between satellite and terrestrial communications network capabilities for delivering IoT connectivity. E-Space’s advanced technology will enable a new class of ubiquitous, real-time communications capabilities, which is expected to reduce device costs and increase coverage.

Comtech delivers innovative approaches to automate workflows, enhance safety, improve reliability and reduce system downtime. The Company holds hundreds of patents spanning terrestrial and satellite communications as well as location-based services, and its technologies are currently fielded in over 200 countries. Comtech is expanding its already vast portfolio of solutions and services through EVOKE, Comtech’s Innovation Foundry, as well as through strategic partnerships with world class innovators, like E-Space. These relationships provide customers with unprecedented access to data and insights that deliver meaningful value and uncover a number of new economic growth opportunities in diverse global markets.

About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

About E-Space
E-Space is bridging Earth and space to enable hyper-scaled deployments of Internet of Things (IoT) solutions and services. The Company is fundamentally changing the design, economics, manufacturing, coverage limitations and service delivery of space-powered IoT connectivity. Its advanced, sustainable low Earth orbit (LEO) space infrastructure will blur the line between satellite and terrestrial communications networks, creating a new class of ubiquitous, real-time communications capabilities that enable end-users to connect, track, sense and act on edge AI optimized data, gathered from billions of novel E-Space devices deployed planet-wide. Learn more about E-Space at: e-space.com and follow the Company on LinkedIn and Instagram.

Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

Comtech:
Investor Relations
Robert Samuels
631-962-7102
[email protected]

Media Relations
Jamie Clegg
480-532-2523
[email protected]

E-Space:
PR & Communications
Chris Phillips
917-974-1667
[email protected]

Release – US Navy and Gaming Community Network Host Never Before Seen STEM Competition for High School Students

Posted on by [email protected]

Research, News and Market Data on GAME

06/14/2023

Three talented high school STEM students will win the opportunity to play their custom Fortnite maps with the U.S. Navy’s Goats & Glory Team and the chance at $30,000 in cash prizes.

FRISCO, TX / ACCESSWIRE / June 14, 2023 / GameSquare Holdings, Inc. (“GameSquare”, or the “Company”) (NASDAQ:GAME)(TSXV:GAME) announced today that the U.S. Navy, the most highly skilled and technologically advanced military force in the world, with over half of all jobs in STEM fields, has partnered with Gaming Community Network (GCN) to create an exciting new STEM competition for high school students. In this unique competition, students will use their STEM skills to create new and innovative islands in the recently released Unreal Editor for Fortnite.The islands must incorporate a Navy inspired nautical theme where the player experiences and challenges such as scavenger hunts, puzzles or speed runs are happening on, or under, the water.

According to a Naval spokesperson, “This competition offers a first-of-its-kind opportunity for high school students to showcase their STEM skills and creativity in a fun, engaging way. By taking part in the competition, students not only will develop valuable skills, but also gain exposure to potential opportunities in Navy STEM fields.”

The qualifying competition will be judged by four well-known gaming influencers, who also will drive the conversation surrounding the different paths and STEM opportunities available in America’s Navy. These influencers will judge each map submitted by the students and help promote them to the gaming community.

This is the first time GCN will launch a campaign using the Unreal Editor for Fortnite.

According to Epic, this application is created for “designing, developing, and directly publishing games and experiences into Fortnite.” This implementation grants players greater artistic license, as well as access to innovative Unreal Engine 5 tools that will allow for expanded capabilities and more efficient workflow for creators.

The maps will be played and promoted by the Navy’s own Esports team, Goats & Glory. The top three finalists will be invited to a final map judging event by Goats & Glory team members. GCN will award the grand prize winner with $30,000 in scholarships.

“We’re thrilled to partner with America’s Navy and offer this exciting opportunity to high school students,” said Drew Brunson, President at Gaming Community Network. “We believe that this competition will help inspire students to pursue careers in Navy STEM fields and show them the endless possibilities that await them.”

The competition opens today, June 14th and runs until July 31st. To enter, high school students should visit operationoceanodyssey.com.

###

About the U.S. Navy
With more than 330,000 active-duty Sailors, 290 deployable ships, more than 3,700 aircraft and dozens of bases in the U.S. and across the globe, America’s Navy is the largest, most powerful naval force in the world. The opportunities available in today’s Navy are as boundless as the sea itself. You can learn more about these opportunities at Navy.com, and on Facebook, Twitter, Instagram, YouTube, and LinkedIn.

About Gaming Community Network
GCN is the only independent media group completely dedicated to gaming and esports across community sites, content producers, influencers and tournament/event operators. Bridging the gap between traditional media and gaming with a “Gamer First” promise, GCN’s aggregated & integrated proprietary media network reaches 65M+ MAUs in the US and 115M+ MAUs globally, driving scale for premium content designed to provoke and share conversations. GCN builds bespoke strategy solutions from content creation to full-scale tournaments for any endpoint, be it social, broadcast TV or live stream. GCN collaborates with its partners to deliver memorable experiences for gamers and brands. Learn more at GCN.gg or follow on LinkedIn.

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.

SOURCE: GameSquare Holdings, Inc.



View source version on accesswire.com:
https://www.accesswire.com/761123/US-Navy-and-Gaming-Community-Network-Host-Never-Before-Seen-STEM-Competition-for-High-School-Students

Release – Covers Pulled Off Le Mans Ultimate Game at Centenary 24 Hours Of Le Mans

Posted on by [email protected]

Research News and Market Data on MSGM

JUNE 14, 2023

LE MANS, France, June 14, 2023 (GLOBE NEWSWIRE) — Le Mans Ultimate – the official game of the 24 Hours of Le Mans and FIA World Endurance Championship – was announced ahead of the eagerly-anticipated Centenary edition of the 24 Hours of Le Mans (June 10/11), with a first look available for fans to play during the build-up to the ultimate endurance race.

An early version of the game developed by Studio 397 and Motorsport Games Inc. (the “Company” or “Motorsport Games”) was available in the Family Fan Village for race goers of all ages to try an early build preview presented by Thrustmaster. The free to play activation allowed over 3,200 fans to get behind the wheel of either the Porsche 963 Hypercar or Ferrari 488 GTE on full rig set-ups. The session around a virtual Circuit de la Sarthe gave drivers a chance to echo the real-life action taking place race around the legendary venue, using with the latest products from Thrustmaster, including the entry-level T248 wheel or bespoke sim racing Direct Drive T818.

Among those sampling an early version of the PC-based game was factory Porsche Penske Motorsport driver Matt Campbell and Porsche Coanda Esports Racing Team star Joshua Rogers who put the Porsche 963 Hypercar through its paces. Ferrari was also represented, as Scuderia Ferrari Esports drivers Timotej Andonovski and Alex Siebel were on hand to give feedback on the Ferrari 488 GTE machine.

Further to the presence in the fan zone, the traditional pre-event press conference organised by the Automobile Club de l’Ouest (ACO) saw the premiere of the first teaser video for the game [LINK], alongside the news of the 2024 FIA World Endurance Championship calendar and Hydrogen prototype plans from Toyota, the first manufacturer to announce plans for the new-for-2026 category.

In conjunction with the week-long activation, the Le Mans Ultimate Steam store went live. This will enable PC gamers to add the title to their Wishlist, so they can be kept up to date with the latest developments ahead of the expected release in December 2023 – bit.ly/LeMansUltimateOnSteam

Stephen Hood, CEO Motorsport Games commented, “After months of planning, it was fantastic to see the reaction for Le Mans Ultimate, from not only the gaming, but the motorsport community – a welcome surprise for many during the build-up to the 100th anniversary of the 24 Hours of Le Mans. We were able to show the public an early version of the game as well as listening to their stories of the iconic event, and gather feedback for the game; its vitally important we do that as often as we can in the run up to release. We want to make this experience as realistic and enjoyable as possible and we will be taking feedback onboard from the public as well as working closely with the manufacturers, FIA WEC and the ACO to bring the ultimate experience to the game.”

More information, news and updates on Le Mans Ultimate can be found on the website, lemansultimate.com or @LeMansUltimate on social media channels.

About Motorsport Games:

Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.

Forward-Looking Statements:

Certain statements in this press release which are not historical facts are forward- looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are provided pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected Le Mans Ultimate and/or Studio 397’s attributes, performance, benefits and features, the benefits and positive attributes of competing or playing Le Mans Ultimate game, that Motorsport Games will be successful in bringing the ultimate experience to Le Mans Ultimate game. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Motorsport Games and are difficult to predict. Examples of such risks and uncertainties include, without limitation: difficulties, delays in or unanticipated events that may impact the timing and expected benefits of the new Le Mans Ultimate game and/or related products and features, such as due to unexpected release delays, whether the reveal of Le Mans Ultimate will be well received and/or successful, whether the final product will meet the expectations of the fans, users and spectators and/or whether Studio 397 and Motorsport Games will produce the positive experience for gamers and motorsport fans. Factors other than those referred to above could also cause Motorsport Games’ results to differ materially from expected results. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in Motorsport Games’ filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, its Quarterly Reports on Form 10-Q filed with the SEC during 2023, as well as in its subsequent filings with the SEC. Motorsport Games anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Motorsport Games assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing Motorsport Games’ plans and expectations as of any subsequent date. Additionally, the business and financial materials and any other statement or disclosure on, or made available through, Motorsport Games’ website or other websites referenced or linked to this press release shall not be incorporated by reference into this press release.

Website and Social Media Disclosure:

Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):

WebsitesSocial Media
   motorsportgames.comTwitter: @msportgames & @traxiongg
   traxion.ggInstagram: msportgames & traxiongg
   motorsport.comFacebook: Motorsport Games & traxiongg
 LinkedIn: Motorsport Games
 Twitch: traxiongg
 Reddit: traxiongg

The contents of these websites and social media channels are not part of, nor will they be incorporated by reference into, this press release.

Contacts:

Investors:

[email protected]

Media:

[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83b2a5eb-afd0-447e-b9cb-6e31ffd20445

Release – PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

Posted on by [email protected]

Research News and Market Data on PDSB

  • 14 patients in the immune checkpoint inhibitor naïve arm of VERSATILE-002 have experienced either a complete response or partial response on two consecutive scans, thus constituting a confirmed objective response
  • Efficacy and safety continue to be monitored as additional patients have yet to undergo imaging evaluation

FLORHAM PARK, N.J., June 14, 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, announced today the Company achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023. The threshold for efficacy, as defined in the clinical protocol, was achieved when 14 out of the 54 immune checkpoint inhibitor (ICI) naïve patients enrolled achieved a confirmed objective response. Additional patients in the trial have yet to undergo imaging evaluation. 

Per RECIST 1.1, the standard to classify oncologic imaging outcomes in clinical trials, patients are considered to have achieved an objective response when imaging studies document tumor shrinkage of 30% or more. In VERSATILE-002, the primary endpoint requires two consecutive scans 9 to 12 weeks apart, rather than one, to be considered a confirmed objective response. Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1.

At the recent 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, we presented data showing 9 confirmed responses among 34 evaluable patients.  Median progression-free survival (PFS) of 10.4 months was also presented at the 2023 ASCO Annual Meeting along with a 12-month overall survival (OS) rate of 87.1% for patients with a CPS≥1. Additional patients have been assessed since data was presented at the 2023 ASCO Annual Meeting. With these additional data, a total of 14 patients have now achieved a confirmed response to date.   The achievement of this endpoint suggests an additive effect of PDS0101 over published results with ICI monotherapy and is based on statistical calculations using the appropriate power and alpha.

The primary endpoint in the VERSATILE-002 study is the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1. The key secondary endpoints are progression-free survival (PFS), OS at 12 and 24 months, safety, and tolerability. The study utilizes a Simon’s 2-stage optimum design.

“We are highly encouraged by the growing set of PDS0101 efficacy and safety data being generated in multiple independent trials by leading experts in the field,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “The consistency in PDS0101 induced HPV16-specific immune responses, the response rates and survival benefit observed in multiple types of HPV cancer and at different stages of disease, aligns with both the preclinical and Phase 1 monotherapy results. Multiple studies have demonstrated the induction of high levels of active and potent, HPV16-specific CD4 and CD8 T cells, as well as long-lasting memory CD8 T cells by PDS0101.” 

“Achieving the efficacy threshold in VERSATILE-002 is an important milestone for the Company, especially as it has been achieved ahead of the full efficacy evaluation for this cohort,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “With our Phase 2 trial near completion, and our planned global Phase 3 confirmatory randomized, controlled trial, VERSATILE-003, actively advancing, we believe we are closer to our goal of providing a well-tolerated, safe and effective therapy for those who suffer from head and neck cancer, a critical unmet medical need.”

PDS Biotech plans to initiate the VERSATILE-003 as a result of the successful completion of an End-of-Phase 2 meeting in the third quarter of 2022 with the FDA, during which PDS Biotech received guidance on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). The planned primary endpoints for VERSATILE-003 are OS and PFS. In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in the third quarter of 2023.

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.   

Interim efficacy and safety data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients (PR link). Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.

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

 About VERSATILE-003 

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve 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.  

About Versamune®
Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

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. 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: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
[email protected]

Bill Borden 
Phone: +1 (732) 910-1620 
[email protected]

Release – CoreCivic Enters Into New Lease Agreement With the State of Oklahoma for the Davis Correctional Facility

Posted on by [email protected]

Research News and Market Data on CXW

June 14, 2023

BRENTWOOD, Tenn., June 14, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (CoreCivic or the Company) announced today it has entered into a lease agreement with the Oklahoma Department of Corrections (ODOC) for the company-owned, 1,670-bed Davis Correctional Facility (DCF), which the Company currently operates under a management contract with ODOC that is currently scheduled to expire on June 30, 2023. CoreCivic expects to enter into a 90-day contract extension for the current management contract, after which time operations will transfer from CoreCivic to ODOC in accordance with the new lease agreement. The new lease agreement includes a base term commencing October 1, 2023, with a scheduled expiration date of June 30, 2029, and unlimited two-year renewal options.

Terms of the 90-day contract extension are expected to remain consistent with the existing management contract at the DCF. Annual rental revenue generated from the ODOC at the DCF under the new lease agreement will be $7.5 million during the base term and will be reported in the CoreCivic Properties business segment upon lease commencement.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. CoreCivic provides a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. CoreCivic is the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. CoreCivic has been a flexible and dependable partner for government for 40 years. CoreCivic’s employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Forward-Looking Statements

This press release contains statements as to CoreCivic’s beliefs and expectations of the outcome of future events that 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, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with executing a contract extension of the current management contract under substantially the same terms as the existing management contract, the successful transition of operations from CoreCivic to ODOC, and the financial impact of the new lease agreement.

CoreCivic takes no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

Contact:  Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
  Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204

Release – Onconova Therapeutics Presents Preclinical Data On Narazaciclib At The 17th International Conference On Malignant Lymphoma

Posted on by [email protected]

Research News and Market Data on ONTX

Jun 14, 2023

Narazaciclib demonstrated significant synergistic anti-cancer activity in multiple in vivo models of mantle cell lymphoma (MCL) when combined with ibrutinib, the current standard-of-care

NEWTOWN, Pa., June 14, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today presented preclinical data on narazaciclib at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17, 2023.

Data from the Josep Carreras Leukaemia Research Institute expanded on a prior presentation at the recent American Association for Cancer Research (AACR) Annual Meeting, showing that narazaciclib’s antitumor activity against mantle cell lymphoma (MCL) cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Combining narazaciclib with the FDA-approved Bruton’s tyrosine kinase inhibitor ibrutinib led to synergistic increases in antitumor activity against both ibrutinib-sensitive and ibrutinib-resistant MCL cell lines. In addition, treatment with narazaciclib combined with ibrutinib led to significant inhibition of tumor growth and significant reductions in malignant B cell infiltration into the bone marrow in multiple chicken embryo chorioallantoic membrane xenograft models of MCL.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “The data being presented at ICML provide further evidence of narazaciclib’s potential to combine synergistically with a wide range of therapeutic classes, derived from its ability to inhibit CDK 4, 6, and additional kinases involved in cancer cell survival and metastasis. This differentiated kinase inhibitory profile also confers expansive therapeutic potential across a variety of indications and may enable narazaciclib to overcome the efficacy limitations and safety concerns of currently marketed CDK 4/6 inhibitors. Given ibrutinib is the standard-of-care in mantle cell lymphoma, the preclinical results showing narazaciclib improving antitumor responses in combination represents a promising development that speaks to its potential therapeutic utility in this high unmet need indication. We look forward to discussing our data throughout ICML as we continue to evaluate additional opportunities for clinical studies with narazaciclib and advance our ongoing Phase 1/2a combination trial of narazaciclib plus estrogen blockade in endometrial cancer.”

The ICML poster, titled, “Prolonged cell cycle arrest by the CDK 4/6 antagonist narazaciclib restores ibrutinib response in preclinical models of BTKi-resistant mantle cell lymphoma,” is currently available to registered attendees of ICML via the conference’s e-poster gallery. The poster will also be displayed during the in-person poster sessions being held throughout the conference. A copy of the poster will be available on the “Scientific Presentations” section of the Onconova website following the conclusion of the conference.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

For more information, please visit www.onconova.com.

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Release – ZyVersa Therapeutics Publishes New White Paper Detailing the Critical Role of Inflammasome ASC in Inflammatory Diseases, and Its Potential as a Therapeutic Target

Posted on by [email protected]

Research News and Market Data on ZVSA

Jun 13, 2023

PDF Version

  • White paper summarizes the research of leading inflammasome experts, Drs. Helen Bramlett, Juan Pablo de Rivero Vaccari, W. Dalton Dietrich, and Robert W. Keane, University of Miami Miller School of Medicine
  • ASC, in monomeric form or as ASC specks, is central to initiation, amplification, and perpetuation of damaging inflammation leading to progressive tissue injury and chronic inflammatory diseases
  • The World Health Organization reports that chronic inflammatory diseases (heart disease, cancer, chronic respiratory disease, and diabetes) significantly threaten human health (led to death in over 33 million people worldwide in 2019)

WESTON, Fla., June 13, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with inflammatory and renal diseases who have significant unmet medical needs, announces availability of a new white paper on the critical role of inflammasome ASC in the development and progression of a wide-range of inflammatory diseases. Data suggest that drugs targeting ASC may provide the best opportunity to control damaging inflammation associated with diseases affecting millions of people worldwide. The white paper titled, “Inflammasome ASC: A Promising Therapeutic Target,” can be accessed by Clicking Here.  

The white paper highlights groundbreaking research from the labs of Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane, pioneers in the field of inflammasomes and members of ZyVersa’s Scientific Advisory Board. To read their biographies, Click Here.

“After 15 years of research to develop an understanding of how inflammasomes contribute to so many diverse diseases and conditions, we discovered the critical role of the ASC component and developed a monoclonal antibody, known as Inflammasome ASC Inhibitor IC 100,” stated Dr. Keane. “ASC is central to formation and activation of multiple inflammasome complexes associated with numerous diseases. ASC forms a large filamentous structure, the ASC speck, which is released from cells, amplifying and perpetuating inflammation. We believe that targeting ASC provides the best opportunity to control damaging inflammation.”

Dr. de Rivero Vaccari added, “We have studied IC 100 in animal models of diverse diseases and injuries including multiple sclerosis, age-related inflammation associated with neurodegenerative diseases, Alzheimer’s disease, acute respiratory distress syndrome, traumatic brain injury, and spinal cord injury. Each of these conditions demonstrated that IC 100 inhibited inflammasome activation, which resulted in improved histopathology and/or improved functional outcomes. We are continuing our research in other diseases, including Parkinson’s disease, for which we were awarded a grant from the Michael J. Fox Foundation.”

“ZyVersa, which obtained a worldwide license for Inflammasome ASC Inhibitor IC 100, is honored to collaborate with Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane to advance development of IC 100 into human trials,” said Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa. “We have progressed manufacturing of IC 100 through GMP production, and our IND-enabling preclinical program has progressed through demonstration of IC 100 safety in dose-ranging toxicology studies in mice and monkeys.”

Mr. Glover continued, “We expect to complete the preclinical program for IC 100 by year’s end, and file an IND to initiate a Phase 1 trial in early 2024. We are excited about our progress, as we believe Inflammasome ASC Inhibitor IC 100 has potential to transform treatment of debilitating inflammatory diseases.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

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
[email protected]
786-251-9641        

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325