Russian Export Ban May Push Crude Oil Higher

Oil prices climbed over 1% Friday after Russia banned diesel and gasoil exports. The move aims to increase Russia’s domestic supply but reduces the global oil market.

West Texas Intermediate crude climbed back above $90 per barrel following the news. Brent futures also gained, topping $94. Energy analysts say the Russian ban will likely sustain upward pressure on oil prices near-term.

Russia is a leading diesel producer globally. How much the export halt affects US fuel prices depends on how long it remains in place, says Angie Gildea, KPMG’s head of energy. But any drop in total global oil supply without lower demand will lift prices.

The ban comes as US gas prices retreat from 2022 highs, now averaging $3.86 nationally. Diesel is around $4.58 per gallon. Diesel powers key transport like trucks and ships. The loss of Russian exports could spur further diesel spikes.

However, gas prices may keep easing for most of the US, says Tom Kloza of OPIS. Western states could see increases.

Kloza believes crude may rise $2 to $3 per barrel in the near-term. But gasoline margins are poised to shrink even if oil nears $100 again. The US transition to cheaper winter fuel could also limit price hikes.

Oil has increased steadily since summer as OPEC+ cuts output. Saudi Arabia and Russia also reduced production. More Wall Street analysts now predict $100 oil in 2023.

Goldman Sachs sees Brent potentially hitting $100 per barrel in the next 12 months. Sharper inventory declines are likely as OPEC supply falls but demand rises, says Goldman’s head of oil research.

The White House has criticized OPEC+ for the production cuts. US gasoline demand recently hit a seasonal record high over 9.5 million barrels per day. Jet fuel use is also rebounding towards pre-pandemic levels.

Strong demand, paired with reduced Russian oil exports, leaves the market more exposed to supply disruptions. Hurricane Ian showed how quickly price spikes can occur.

Take a moment to take a look at other energy companies covered by Noble Capital Markets Senior Research Analyst Michael Heim.

The Biden Administration plans to keep tapping the Strategic Petroleum Reserve into 2023 to restrain cost increases. But further export bans or output reductions could overwhelm these efforts.

While tighter global fuel supplies might not directly translate to the US, Russia’s latest move signals volatility will persist. Energy prices remain sensitive to supply and demand shifts.

More export cuts could accelerate oil’s return to triple-digits. But for US drivers, the road ahead on gas costs seems mixed. Falling margins and seasonal shifts could limit prices, but risks linger.

Release – Snail, Inc. Announces the Launch of the ARKade Ambassador Program

Research News and Market Data on SNAL

September 22, 2023 at 7:52 AM EDT

PDF Version

CULVER CITY, Calif., Sept. 22, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, today announced the launch of ARKade Ambassador Program (the “Program”) in collaboration with the Company’s partners, Noiz and Studio Wildcard. This Program, of limited duration, will continue until the year’s end, and pre-registration will commence on September 21st.

Designed in alignment with the upcoming release of ARK: Survival Ascended, the Program is tailored to offer influencers and streamers a unique and engaging streaming experience. Participants will receive an early access code to the game and can undertake specific activities to earn digital tickets (or points), which can then be redeemed for bespoke rewards including, but not limited to, custom ARK merchandise, streaming equipment, and PC components. In addition, each participant will automatically be enrolled in a grand giveaway and raffle. Detailed information about the ARKade Ambassador Program is available on the official ARKade pre-registration website.

Jim Tsai, Chief Executive Officer of Snail, commented: “Reimagining the classic arcade concept as ARKade offers an innovative approach to connecting with the player community. We expect this initiative bolstering the prominence of ARK: Survival Ascended while enabling content creators to produce unique content and enhance player engagements. Our commitment remains steadfast in exploring fresh strategies to elevate player engagement and deliver unparalleled experiences.”

About Snail, Inc.

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:

investors@snail.com

Release – Ocugen, Inc. Announces Connie Collingsworth Joins Business Advisory Board

Research News and Market Data on OCGN

September 21, 2023

MALVERN, Pa., Sept. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Connie Collingsworth, former Chief Operating Officer of the Bill and Melinda Gates Foundation, will join the Company’s Business Advisory Board (BAB). The BAB was established in June 2023 to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.

“Connie brings value-added expertise in all aspects of strategic growth and organizational governance—across a variety of industries—that will offer unique insights to the BAB,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “Connie’s deep financial background at a global level will provide meaningful counsel to Ocugen as we pursue new business development opportunities to support and evolve our clinical programs.”

Ms. Collingsworth has been a primary advisor to Bill Gates, Melinda French Gates, and Warren Buffett regarding governance. During her tenure with the Bill and Melinda Gates Foundation, she designed and implemented the core operational infrastructure and created the intellectual property strategy known as “Global Access,” as well as advising on the creation of a $2.5 billion strategic investment fund.

“I am inspired by Ocugen’s commitment to not only developing novel therapies that address unmet medical needs for patients with serious conditions, but their passion to ensure access to all patients around the world,” said Ms. Collingsworth. “I look forward to sharing my diverse experiences as an executive and a board member so that patients can potentially benefit.”

Ms. Collingsworth joins Senator Pat Toomey, Ambassador Joseph W. Westphal, Ph.D., and Dennis Carey, Ph.D. on the BAB. These advisors will work alongside the Executive Leadership Team to offer guidance to enable the Company to fulfill its mission and achieve its short- and long-term strategy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com

Source: Ocugen

Release – Great American Cookies And Marble Slab Creamery Announce March Of Dimes Partnership Spotlighting NICU Awareness Month

Research News and Market Data on FAT

09/21/2023

Milestones Matter! Cookie and Ice Cream Franchises Announce Partnership to Support Mom and Baby Nonprofit

LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) — Great American Cookies, the Original Cookie Cake franchise, and Marble Slab Creamery, the imaginative small-batch ice cream brand, proudly announce their partnership with March of Dimes, the leading nonprofit fighting for the health of moms and babies. Tapping into the brands’ synergies of celebrating family milestones, the three organizations will join forces to honor Neonatal Intensive Care Unit (NICU) patients, their families, and the healthcare professionals caring for them.

To celebrate heroic NICU employees on Sept. 28, NICU Staff Appreciation Day, Great American Cookies and Marble Slab Creamery will provide a sweet surprise to select NICU teams around the country by delivering Original Cookie Cakes and Ice Cream Cakes. In honor of NICU Awareness Day on Sept. 30, Great American Cookies and Marble Slab Creamery will donate $1 to March of Dimes for every purchase made in-store or online. Additionally, customers who order Cookie Cakes or Ice Cream Cakes online on Sept. 30 (and pick up no later than Oct. 7) receive $3 off their Cookie Cake or IceCream Cake with code.

Many babies will spend their earliest days in the NICU due to preterm birth, birth defects, surgical or genetic conditions, or other diagnosis. This time can be stressful and overwhelming for families. The funds raised will help further March of Dimes’ critical support for families through programs like the NICU Family Support® program, which offers family education, staff training on family-centered care and an improved patient experience.

“With 1 in 10 babies born preterm each year, many of whom will spend time in the NICU, we appreciate the remarkable impact NICU staff have on families,” said Jenn Johnston, Chief Marketing Officer at FAT Brands, Inc. “At Marble Slab Creamery and Great American Cookies, we love sharing milestone moments with families, whether it’s a birthday or first steps – every milestone is worth celebrating. We have the perfect Cookie Cakes and Ice Cream Cakes to do just that! We are proud to raise funds to further the March of Dimes mission to improve the health of all moms and babies.”

“For more than 20 years, March of Dimes has been there for families with a baby in the NICU and as they transition home, offering the support and education they need, right when they need it,” said Kelly Ernst, March of Dimes Senior Vice President, Chief Revenue and Impact Officer. “This NICU Awareness Month, we are inspired by Great American Cookies and Marble Slab Creamery’s commitment to celebrate the dedicated staff that work so hard to take care of thousands of families each year with support from our hospital partners across the country as part of their exciting Milestones Matter initiative.”

For nearly 40 years, Marble Slab Creamery has been an innovator in the ice cream space, dreaming up the frozen slab technique and offering homemade, small-batch ice cream with free unlimited mix-ins, shakes in a variety of flavors, and ice cream cakes.

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 craveable menu items include brownies and Double Doozies™, made with delectable icing sandwiched between two cookies.

To donate directly to the cause, please visit the brands’ Milestones Matter website. For more information on Great American Cookies, visit www.greatamericancookies.com. For more information on Marble Slab Creamery, visit www.marbleslab.com. The brands are thankful to partners Southern Champion Tray and Specialty Box & PACKING CO. for enabling this partnership and donation.

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 400 bakeries across the country and internationally in Bahrain, Guam, 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.

About Marble Slab Creamery
Since dreaming up the frozen slab technique and serving fresh homemade, small-batch Ice Cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite Ice Cream possibilities to feed your curiosity and capture cravings. With our always free mix-in philosophy, delicious Ice Cream and Shakes in a variety of flavors, hand-rolled waffle cones, and Ice Cream Cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Canada, Kuwait, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.

About March of Dimes
March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs, and provide education and advocacy so that every family can have the best possible start. Building on a successful 85-year legacy, we support every pregnant person and every family. To learn more about March of Dimes, please visit marchofdimes.org.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Source: FAT Brands Inc.

Release – Tonix Pharmaceuticals Presents New Preclinical Data at Seventh International Cancer Immunotherapy Conference 2023

Research News and Market Data on TNXP

September 21, 2023 7:00am EDT

mTNX-1700 (mTFF2-MSA) suppresses tumor growth and increases survival rates in preclinical colorectal cancer models

mTNX-1700 shows single agent activity and additive effects in combination with anti-PD-1

mTNX-1700 targets myeloid-derived suppressor cells (MDSCs) in a novel mechanism to treat cancer

CHATHAM, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation showing research results for mTNX-1700 (murine trefoil factor family member 2- murine serum albumin, or mTFF2-MSA) at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival, being held September 20-23, 2023, in Milan, Italy. The poster is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The poster presentation, titled, “mTFF2-MSA (mTNX-1700) Suppresses Tumor Growth and Increases Survival in Anti-PD-1 Treated CT26.WT Subcutaneous and CT26-Luciferase Orthotopic Syngeneic Colorectal Cancer Models by Targeting MDSCs in BALB/C Mice,” includes data demonstrating that the novel fusion protein, mTNX-1700 has single agent activity and can improve on the therapeutic effects of anti-PD-1 in treating syngeneic mouse models of advanced colorectal cancer. In two models, mTNX-1700 increases survival rates and suppresses tumor growth. Additive tumor growth suppression effects were observed when mTNX-1700 and anti-PD-1 were used in combination.

“mTNX-1700 is a novel fusion protein that has single agent activity and augments PD-1 blockade therapy in combination therapy in advanced and metastatic syngeneic mouse models of colorectal and gastric cancer,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Certain cancers are unresponsive to anti-PD-1 therapy. Despite the significance of PD-1 checkpoint blockade in treating many types of cancer, there’s a need to better understand why some cancers don’t respond and how to make them responsive. We believe these data show the potential of TNX-1700 in treating cancer both as a single agent and in combination with other immuno-oncology drugs, particularly anti-PD-1, and highlight how mTNX-1700 targets MDSCs as a novel mechanism to treat cancer.”

About Trefoil Factor Family Member 2 (TFF2)

Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 (rTFF2-HSA) for the treatment of gastric and colon cancers under a license from Columbia University. The inventor of the core technology at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8+ T cells.1 He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth.2 Dr. Wang proposed the concept of employing rTFF2 in combination with other therapies in cancer prevention and early treatment. Dr. Wang presented data at the American Association for Cancer Research (AACR) conference as a collaboration between Tonix and Columbia University in 2020 that includes data from a preclinical study which investigated the role of PD-L1 in colorectal tumorigenesis and evaluated the utility of targeting myeloid-derived suppressor cells (MDSCs) in combination with PD-1 blockade in mouse models of colorectal cancer. The data show that anti-PD-1 monotherapy was unable to evoke anti-tumor immunity in this model of colorectal cancer, but mTFF2-CTP augmented the efficacy of anti-PD-1 therapy. Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice.

1Dubeykovskaya ZA et al, Nat Commun 2016
2Kim W et al, Gastroenterology 2021

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourthquarter of 2023. Tonix’s rare disease development 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 development 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 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released September 21, 2023

MGM Hack Highlights Casino Cyber Risks

Casino and hotel operator MGM Resorts tumbled last week after revealing it was hit by a data breach impacting over 10 million former guests. The hack showcases the cyber risks facing hospitality firms and dragged down related stocks as investors weighed the potential fallout.

MGM shares dropped over 4% following its disclosure of the breach as investors reacted to the cyberattack. The stock slide reflected concerns over potential costs from lawsuits, technical remedies, and reputational damage.

The attack also stoked fears of similar incidents across the broader hospitality sector. Airline, cruise, and casino stocks all declined as analysts noted cyber threats facing the industry. Leisure companies handle vast customer data and suffer from downtime, making them prime hacker targets.

Take a look at Travelzoo, a company providing members with travel, entertainment and lifestyle experiences.

Broader equity markets proved resilient to the MGM incident. But cybersecurity stocks rallied on expectations companies may now invest more in protecting data and systems going forward. Top gainers included cyber firms Palo Alto Networks and CrowdStrike.

The MGM breach follows several recent high-profile hacks of casinos and gaming firms. The frequency of attacks has put the industry on notice. New Nevada regulations now require prompt breach disclosures from casinos. Once inside a network, hackers can often access customer financial data. Small casinos have paid millions in ransoms to regain control of systems.

While the MGM breach didn’t significantly sway major indexes, it highlights the dangers posed by cyber criminals. A larger incident paralyzing critical infrastructure could certainly roil markets. This incident is an important reminder of the growing cyber threats facing corporations and customers alike in today’s digitally connected world.

QuantaSing Group Limited (QSG) – A Favorable Course For Revenue and Cash Flow Growth


Thursday, September 21, 2023

QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners under a variety of brands, including QiNiu, JiangZhen and QianChi, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services, the Company has also expanded its services to corporate clients including, among others, marketing services and enterprise talent management services.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating coverage with an Outperform rating and a $10 price target. QuantaSing is the largest online individual learning service provider in China, by revenue. It launched in 2019 with a focus on adult financial literacy courses, before expanding to personal interest courses. Additionally, the company operates an e-commerce platform focused on liquor, which could expand product offerings in the future. Our favorable rating is based on the company’s positive cash flow growth outlook.

Scalable business model. The company acquires customers at a low cost by offering free introductory courses advertised through online sources, providing a large audience to which it can sell its premium courses, Currently, the company has over 94 million total registered users on its free course offerings. Notably, the company can quickly develop new courses tailored to customer needs, which provides flexible monetization opportunities. 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

FedEx Gains Market Share Amid Rival Struggles

Shares of FedEx jumped over 5% on Thursday after the shipping giant reported better-than-expected fiscal first quarter results. The stock rally comes amid a broader market selloff, with investors cheering FedEx’s improved profitability and outlook.

FedEx earned $4.55 per share last quarter, handily beating analyst forecasts of $3.70. Though revenue declined 6.5% year-over-year to $21.7 billion, the company boosted its operating margin to 7.3%, surpassing expectations.

The strong quarter was driven by effective cost-cutting under CEO Raj Subramaniam and higher shipping volumes as key rivals dealt with challenges. FedEx gained U.S. market share in recent months which it expects to retain.

Management raised full-year EPS guidance to a range of $17.00 to $18.50, up from prior outlook of $16.50 to $18.50. The company also announced new demand surcharges for the holiday peak season and a January rate increase.

FedEx continued benefiting from its DRIVE cost savings program which seeks $1.8 billion in total reductions. Steps like reducing flights, realigning staff and shifting to one daily delivery wave boosted efficiency.

The Ground segment was a standout with a 59% jump in operating income as volumes improved. The Express unit grew operating income 18% despite lower revenue. But the Freight division saw income drop 26% on reduced shipments.

The outperformance comes as labor negotiations weighed on service levels at rival UPS. UPS disclosed it lost 1 million packages daily to other carriers, which FedEx said it captured 400,000 of. The bankruptcy of trucking company Yellow also benefited FedEx.

Demand for logistics and shipping services remains resilient despite economic uncertainty. And challenges at competitors created an opening for FedEx to flex its network strength and snatch market share. It expects to maintain most new volumes.

Take a moment to take a look at a few shipping and logistics companies covered by Noble Capital Markets Senior Analyst Michael Heim.

The results suggest FedEx has turned a corner after recent struggles with costs and service issues. The company’s turnaround plan is clearly bearing fruit. And investors have taken notice, bidding the stock price higher after the earnings beat.

FedEx shares have now rebounded nearly 20% from 52-week lows hit in June. The stock remains down 25% year-to-date amid broader market volatility. But it has outpaced the S&P 500 recently.

Thursday’s post-earnings pop provides encouragement that FedEx may sustain its momentum if execution remains solid. But the company still faces macro uncertainty and must continue improving productivity.

The holiday quarter is crucial for delivery firms like FedEx. The company aims to avoid last year’s service shortfalls. Management expressed confidence its initiatives will enable strong peak season performance.

While risks remain, FedEx has proactively adapted its network for holiday demand spikes. And it should reap continued benefits from rival struggles if recent market share gains stick.

Ongoing cost discipline also remains key. As higher rates kick in, boosting revenue, FedEx must maintain focus on trimming unnecessary expenses. Investors want to see margins continue expanding.

The quarterly beat suggests the shipping titan is making strides in its turnaround bid under new leadership. If FedEx sustains stronger operational execution, its stock price could continue recovering lost ground.

But the company must keep innovating and finding efficiency gains in the rapidly evolving logistics arena. Satisfying customers and shareholders means continually improving services and profitability, even in a weakened economic climate.

Cisco to Acquire Cybersecurity Firm Splunk in $28 Billion Cash Deal

Cisco Systems announced Thursday it will acquire cybersecurity company Splunk in an all-cash deal valued at around $28 billion. The acquisition, Cisco’s largest ever, aims to expand its presence in the security software market and boost recurring revenue streams.

Under the agreement, Cisco will pay $157 per share to buy Splunk, representing a premium of over 20% to Splunk’s recent stock price. Splunk shares jumped 21% on the news, while Cisco stock slipped nearly 5%.

The network gear giant has been on an acquisition spree lately to grow its software offerings. Splunk provides data analytics software and services focused on security, internet of things and infrastructure monitoring.

Take a look at One Stop Systems Inc., a company that designs and manufactures innovative AI Transportable edge computing modules and systems, and data recording software for AI workflows.

Cisco CEO Chuck Robbins said Splunk’s data capabilities combined with Cisco’s network telemetry presents an opportunity for more AI-enabled security solutions. The deal is expected to close in late 2024 after clearing regulatory approvals.

Cisco aims to leverage Splunk’s analytics tools to improve threat detection and better predict cyber risks. Splunk’s software is used by over 9,000 customers including over 90 of the Fortune 100. The acquisition provides Cisco an avenue into more subscription-based software sales.

The company said it expects the deal to be cash flow positive and accretive to gross margins within the first year post-closing. Cisco forecasts the acquisition boosting adjusted earnings per share starting in the second year.

Splunk CEO Gary Steele will join Cisco’s executive leadership team once the merger is finalized and report directly to Robbins. Together the companies aim to become a leading force in security infrastructure.

The acquisition reflects Cisco’s ongoing shift toward software and subscription revenue. It provides both an expanded customer base and advanced analytics capabilities around security, core focuses for Cisco. The company will fund the sizable purchase through cash reserves and new debt financing.

Fed Keeping Rates Higher Despite Pausing Hikes For Now

The Federal Reserve left interest rates unchanged on Wednesday but projected keeping them at historically high levels into 2024 and 2025 to ensure inflation continues falling from four-decade highs.

The Fed held its benchmark rate steady in a target range of 5.25-5.5% following four straight 0.75 percentage point hikes earlier this year. But officials forecast rates potentially peaking around 5.6% by year-end before only gradually declining to 5.1% in 2024 and 4.6% in 2025.

This extended timeframe for higher rates contrasts with prior projections for more significant cuts starting next year. The outlook underscores the Fed’s intent to keep monetary policy restrictive until inflation shows clearer and more persistent signs of cooling toward its 2% target.

“We still have some ways to go,” said Fed Chair Jerome Powell in a press conference, explaining why rates must remain elevated amid still-uncertain inflation risks. He noted the Fed has hiked rates to restrictive levels more rapidly than any period in modern history.

The Fed tweaked its economic forecasts slightly higher but remains cautious on additional tightening until more data arrives. The latest projections foresee economic growth slowing to 1.5% next year with unemployment ticking up to 4.1%.

Core inflation, which excludes food and energy, is expected to fall from 4.9% currently to 2.6% by late 2023. But officials emphasized inflation remains “elevated” and “unacceptably high” despite moderating from 40-year highs earlier this year.

Consumer prices rose 8.3% in August on an annual basis, down from the 9.1% peak in June but well above the Fed’s 2% comfort zone. Further cooling is needed before the Fed can declare victory in its battle against inflation.

The central bank is proceeding carefully, pausing rate hikes to assess the cumulative impact of its rapid tightening this year while weighing risks. Additional increases are likely but the Fed emphasized future moves are data-dependent.

“In coming months policy will depend on the incoming data and evolving outlook for the economy,” Powell said. “At some point it will become appropriate to slow the pace of increases” as the Fed approaches peak rates.

For now, the Fed appears poised to hold rates around current levels absent a dramatic deterioration in inflation. Keeping rates higher for longer indicates the Fed’s determination to avoid loosening prematurely before prices are fully under control.

Powell has reiterated the Fed is willing to overtighten to avoid mistakes of the 1970s and see inflation fully tamed. Officials continue weighing risks between high inflation and slower economic growth.

“Restoring price stability while achieving a relatively modest increase in unemployment and a soft landing will be challenging,” Powell conceded. “No one knows whether this process will lead to a recession.”

Nonetheless, the Fed chief expressed optimism that a severe downturn can still be avoided amid resilient household and business spending. The labor market also remains strong with unemployment at 3.7%.

But the housing market continues to soften under the weight of higher rates, a key channel through which Fed tightening slows the economy. And risks remain tilted to the downside until inflation demonstrably falls closer to target.

For markets, clarity that rates will stay elevated through 2024 reduces uncertainty. Stocks bounced around after the Fed’s announcement as investors processed the guidance. The path forward depends on incoming data, but the Fed appears determined to keep rates higher for longer.

Release – GeoVax Next-Generation COVID-19 Vaccine Data Presented at Keystone Symposia Conference

Research News ad Market Data on GOVX

 

Preclinical Data for GEO-CM02 Demonstrates Single-Dose Protection

Against Multiple SARS-CoV-2 Variants

Atlanta, GA, September 20, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen SARS-CoV-2 vaccine. The new unpublished data were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, being held in Atlanta, Georgia on September 17-20, 2023.

Presentation Details & Summary:

Abstract Title:            MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models

Abstract Authors:      Shannon Stone1, Amany Elsharkawy1, Janhavi Natekar1, Sreenivasa Rao Oruganti2, Mary Hauser2, Arban Domi2, Pratima Kumari2, Anchala Guglani1, Mark Newman2, and Mukesh Kumar1

1 Georgia State University   2 GeoVax Labs, Inc.

Presenting Author:     Shannon Stone, Georgia State University

First-generation SARS-CoV-2 vaccines based on the spike (S) protein induce neutralizing antibodies provide significant levels of protection. However, vaccine efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring updating and booster doses. To address this limitation, GeoVax has designed multi-antigen SARS-CoV-2 vaccines based on the S, membrane (M), and envelope (E) proteins, which are designed to engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity. Efficacy of the vaccine, designated GEO-CM02, was tested using the industry standard, lethal hACE2 transgenic mouse model.

The poster presentation (viewed here), highlighted the following data:

  • The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
  • Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
  • GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.

Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant.

Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer, commented, “As noted in this presentation, the first-generation SARS-CoV-2 vaccines were designed based on the S protein of the SARS-CoV-2 virus with the goal of inducing neutralizing antibodies. While this approach was successful, the limitations in the face of continually emerging variants are now well documented. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. The multi-antigen, MVA-vectored vaccine design is currently being evaluated by GeoVax in three Phase 2 clinical trials using a similar vaccine (GEO-CM04S1).”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Release – Fazoli’s Opens Second Little Rock Location

Research News and Market Data on FAT

09/20/2023

 Download(opens in new window)

Hot and Fresh Breadsticks Now Cooking on the West Side

LOS ANGELES, Sept. 20, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, has opened its second location in Little Rock. Located at 11410 W. Markham St., the location is now serving up its beloved hot and buttery breadsticks and signature Italian dishes including pastasubs, salads and pizzas. 

“We have loved serving the Little Rock community and look forward to making our fast and fresh Italian offerings more convenient to the west side of town,” said Doug Bostick, President at Fazoli’s. “Our second location in Little Rock is just the beginning of our commitment to growth in Arkansas, so stay tuned for more updates.” 

Since 1988, Fazoli’s has been committed to serving quality Italian food, fast, fresh, and friendly. From unlimited signature breadsticks to freshly prepared pasta entrees, the chain prides itself on serving high-quality menu offerings, all at an affordable price. 

The Little Rock Fazoli’s is located at 11410 W. Markham St. Little Rock, AR 72212. Drive-thru and dine-in are open 10:30 a.m. to 10 p.m., seven days a week. 

For more information, visit Fazolis.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 fatbrands.com

About Fazoli’s

Fast. Fresh. Italian. Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, sub sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. For more information, visit www.Fazolis.com.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Release – PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

Research News and Market Data on PDSB

  • PDS0202 (Infectimune® + COBRA influenza antigens) vaccination also prevented illness/weight loss
  • Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
  • Data from Cleveland Clinic’s Ted Ross Lab presented at the 9th ESWI Influenza Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

“We are encouraged that PDS0202 has demonstrated activity in generating protective hemagglutination inhibition assay (HAI) antibody responses in pre-immune ferret studies, which are the gold standard in influenza vaccine testing. In addition to active neutralization of various influenza strains, the data demonstrated that PDS0202 prevented illness, weight loss and importantly protected the lungs of vaccinated animals from H1N1,” said Dr. Ross. “In humans, we expect PDS0202 to elicit a similar or more broadly reactive antibody profile due to humans having broader exposure to influenza and thus the recall of a more diverse population of memory B cells than the animals evaluated in our preclinical studies.”

H3N2 HAI Response


Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins.  Similar results were demonstrated against multiple strains of the H1N1 virus.
Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.

H1N1 Infection Results: D3 Nasal Wash Viral Titers

PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL).  The quantity of H1N1 virus stays below the detection limits.  The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.
PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.

PDS0202 combines PDS Biotech’s Infectimune® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens. The COBRA antigens developed in the laboratory of Dr. Ted Ross were designed using an in-silico layered consensus building approach, which utilizes HA sequence data from influenza surveillance databases. PDS0202’s ability to generate broad, robust antibody and T cell responses position the vaccine to potentially provide durable protection against seasonal and pandemic strains of influenza. PDS0202 is administered through intramuscular injection in a single dose.

“We are pleased that the PDS0202 data presented at the ESWI Influenza Conference are consistent with our previously reported preclinical studies in murine models, marking encouraging progress toward a potential universal influenza vaccine,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “We look forward to our continued discussions with the National Institute of Allergy and Infectious Diseases to advance PDS0202 into clinical trials with the goal of creating a universal vaccine that provides broad protection against multiple strains of influenza.”

In previous preclinical studies, PDS0202 demonstrated the ability to promote robust induction of broadly neutralizing influenza-specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T cells, as well as long-lasting memory T cells. This robust immune response to the COBRA antigens suggests strong potential for PDS0202 as a broad and long-term protecting universal influenza vaccine.

About Infectimune®
Infectimune® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

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® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. 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 Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/322b8fdb-bf6b-4c74-96c9-81b581f74513

https://www.globenewswire.com/NewsRoom/AttachmentNg/f7fe4fb9-3936-4f2b-9673-f571604ed43