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Biotech Company Abpro Poised for Growth Through Merger with SPAC

Posted on by slightbourne@noblecapitalmarkets.com

Abpro, an emerging biotechnology company developing novel antibody therapies, has entered into a definitive agreement to go public via a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC). The deal values Abpro at $725 million and will provide capital to advance its drug pipeline.

Abpro specializes in leveraging its proprietary technology platform to create next-generation antibody treatments for cancer, eye diseases, and viral infections. The company aims to develop breakthrough immunotherapies to help patients facing life-threatening conditions.

Though Abpro is still in the preclinical phase, it has made significant progress with its pipeline of antibody therapies. Its lead candidates target HER2+ cancers, which include aggressive forms of breast, gastric, and colorectal cancer. Abpro is also pursuing antibodies for COVID-19 treatment and ophthalmic conditions like wet AMD and DME.

Last year, Abpro announced a partnership with South Korea’s Celltrion to further develop ABP 102, an antibody-based treatment for HER2+ cancers. Under the deal, Abpro received a direct equity investment from Celltrion along with eligibility for up to $1.75 billion in milestone payments.

Abpro leverages its DiversImmune platform to design diverse antibody libraries and identify optimal drug candidates. The technology enables more precise targeting compared to conventional antibodies.

Take a look at Noble Capital Markets Senior Biotechnology Research Analyst Robert LeBoyer’s coverage list.

The merger with Atlantic Coastal will provide capital for Abpro to advance its most promising therapies into clinical studies. Abpro also plans to use the funds for business development activities and expanding its pipeline.

Atlantic Coastal is a SPAC focused on finding and merging with high-potential healthcare companies. The transaction is expected to close in Q2 2024, at which point the combined company will trade publicly.

Commenting on the merger, Abpro CEO Ian Chan stated: “This milestone will accelerate getting our therapies to patients needing life-changing treatments.”

Abpro represents an attractive investment opportunity within biotech. Analysts project the global antibody technology market to reach $272 billion by 2030, driven by rising demand for targeted immunotherapies. With its next-generation platform and infusion of growth capital, Abpro is well-positioned to compete in this thriving sector.

The transaction comes amidst a wave of biotech SPAC deals, as pre-revenue companies aim to access public growth financing. With its proprietary technology and strategic partnership in place, Abpro seems poised to leverage this deal to evolve from an R&D startup into a fully integrated biopharma company.

Explore other SPAC Mergers via Spactrac reports from Noble Capital Markets

FG Merger Corp. (FGMC) – Asymmetric Return Profile Acquisition To Unlock iCoreConnect Saas Potential

Heritage Distilling Co.: Liquor With A Kicker

What Investors Should Know About the Growing Disparity Between Large and Small Cap Returns

Posted on by slightbourne@noblecapitalmarkets.com

Over the past year, large cap stocks have vastly outperformed their small cap counterparts. This widening rift between the biggest and smallest public companies has reached extremes not seen in over 20 years. While large caps continue charging ahead, small caps face mounting challenges that threaten their role in a balanced investment portfolio.

The stark contrast is evident in the returns of two major indices. The S&P 500, comprised of 500 of the largest U.S. companies, has delivered over -15% returns over the past 12 months. Meanwhile the Russell 2000 small cap index plunged over -25% over the same period.

This nearly 10 percentage point gap represents the highest divergence between large and small caps since 2001. The lopsided returns conjure memories of the late 1990s dot-com bubble, when mega cap tech stocks left smaller companies in the dust.

However, the current environment contains even stronger headwinds against small caps. Rampant inflation has battered small companies, which lack the pricing power of large cap brands. Ongoing supply chain difficulties and labor shortages have also taken a heavier toll on small business.

Moreover, the Federal Reserve’s aggressive interest rate hikes to combat inflation have disproportionately impacted small caps. Not only are borrowing costs up, but higher rates dampen economic growth forecasts which small caps rely upon. With the Fed signaling even more hikes ahead, the path ahead looks rocky.

Large caps have also benefitted from a flight to quality. Investors have piled into mega cap stocks like Apple, Microsoft, and Procter & Gamble as safe havens amid volatile markets. These stalwarts deliver steady revenues and dividends that provide shelter from broader economic storms.

The growth versus value dynamic has also disadvantaged small caps. With recession fears looming, investors have favored large cap stocks of mature companies over risky, high-growth small caps. Additionally, large tech names like Amazon and Nvidia dominate future-facing themes like cloud computing, AI, and the metaverse.

Some analysts argue this gap has created a bubble, with popular large caps trading at overextended valuations. However, until inflation shows meaningful declines, small caps will likely continue struggling against their mega cap peers.

For investors, the uneven returns underscore the importance of diversification between company sizes. While small caps carry higher risks today, they historically deliver long-term outperformance. Once the economy stabilizes, the pendulum could swing back in favor of smaller dynamos. For those with the risk tolerance, small caps trading at multi-year discounts could offer an opportunity.

Looking ahead, economic uncertainty persists. But maintaining exposure across the market cap spectrum remains imperative. Having allocation to both large and small caps allows investors to weather various market cycles. With patience and prudence, this lopsided period will eventually balance out.

Greenfire Shares Drop After SPAC Merger Completes

Posted on by slightbourne@noblecapitalmarkets.com

Greenfire Resources, a Calgary-based oil sands company, began public trading on the New York Stock Exchange on Thursday through a merger with a special purpose acquisition company (SPAC). However, shares of Greenfire fell sharply on its debut, dropping around 11% in morning trading.

Greenfire combined with M3-Brigade Acquisition III Corp, a SPAC sponsored by New York-based private investment firm Brigade Capital Management. The deal, first announced in December 2022, valued Greenfire at $950 million.

The new company, Greenfire Resources Ltd, is now listed on the NYSE under the ticker “GFR”. But investors reacted negatively to the stock early on. After opening at $9.80 per share, GFR declined over 37% to around $6.10 by Friday morning.

SPAC deals have faced increased skepticism from investors amid high market volatility this year. Many companies that went public via SPACs have seen their share prices sink below initial trading levels. This broader SPAC downturn could be contributing to the weak debut for Greenfire.

Greenfire operates steam-assisted gravity drainage (SAGD) facilities in Alberta’s prolific oil sands region. It has a 75% stake in the Hangingstone expansion project, which came online in 2017, and 100% ownership of the adjacent Hangingstone demonstration facility. Both produce bitumen using steam injection to mobilize viscous oil sands deposits.

The company raised approximately $42 million through a private placement that closed concurrently with the SPAC merger on September 20. It also put in place $300 million in new senior secured notes and a $50 million senior secured credit facility to boost liquidity.

According to Greenfire’s management, the company will prioritize debt reduction in the near-term to strengthen its financial position. It also plans to increase production at its existing facilities through techniques like infill drilling and debottlenecking.

For example, Greenfire is currently drilling extended reach “refill” wells at the Hangingstone expansion site. These wells are intended to produce incremental volumes from between existing well pairs. No new drilling has occurred at the project since its commissioning in 2017.

In the long-term, Greenfire aims to generate free cash flow thanks to controlled capex spending and its high quality oil sands reservoirs. The company believes it has a structural cost advantage compared to some other SAGD operators in the Athabasca region.

Greenfire says its assets have long-life reserves and relatively low decline rates versus conventional oil and gas resources. For instance, the Hangingstone demonstration project has maintained steady production for nearly 20 years without new wells. This could support continued output for decades.

The company intends to initiate a shareholder returns policy over time once it has made sufficient progress on debt reduction. It also plans to evaluate potential acquisition opportunities to drive further growth down the line.

But in the short-term, investors seem cautious on the newly public company as oil prices waver. Energy stocks have seen significant volatility in 2022. Greenfire traded down double-digits in its NYSE debut as traders reacted hesitantly.

Its success at boosting production from existing assets through relatively low-cost techniques like infill drilling may dictate whether shares can rebound over the coming months. For now, the market is taking a wait-and-see approach with the SPAC-backed oil sands operator.

Explore other SPAC Mergers via SPACtrac reports from Noble Capital markets

FG Merger Corp. (FGMC) – Asymmetric Return Profile Acquisition To Unlock iCoreConnect Saas Potential

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Release – Bitcoin Depot Announces Share Repurchase Program

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

September 22, 2023 08:30 ET

ATLANTA, Sept. 22, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced that its Board of Directors has authorized a share repurchase program pursuant to which the Company is authorized to repurchase up to $10 million of outstanding shares of its Class A common stock beginning immediately and continuing through and including June 30, 2024.

Pursuant to the authorization, repurchases may be made from time to time using a variety of methods, including open market purchases, privately negotiated transactions or by other means in accordance with U.S. securities laws and regulations, including pursuant to Rule 10b-18 and under plans intended to qualify under Rule 10b5-1 of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”). The timing and total amount of share repurchases will be determined by the Company at its discretion and will depend upon a variety of factors, including business, economic and market conditions, corporate and regulatory requirements, management’s assessment of the intrinsic value of the Company’s Class A common stock, available liquidity, compliance with the Company’s debt and other agreements and prevailing stock prices. The exact dollar amount or number of shares to be repurchased by the Company is not guaranteed, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund repurchases with cash on hand and cash provided by operations.

About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations in 48 U.S. states through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of June 30, 2023. Learn more at www.bitcoindepot.com.

Cautionary Note Regarding Forward-Looking Statements

This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services and our proposed share repurchase program and the projected timing, purchase price and number of shares purchased under such program, if at all. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

Contacts:

Investors 
Cody Slach, Alex Kovtun 
Gateway Group, Inc. 
949-574-3860 
BTM@gateway-grp.com

Media 
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
BTM@gateway-grp.com

Release – ZyVersa Therapeutics Announces Research Published in The Journal of Clinical Investigation Reinforcing IC 100’s Rationale for Inhibiting ASC Specks to Attenuate Spread of Inflammation into Surrounding Tissues

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Sep 22, 2023

  • Patients with chronic kidney disease (“CKD”) exhibit chronic systemic inflammation characterized by increased circulating levels of IL-1β, IL-6, and CRP.
  • This study demonstrated that CKD-induced IL-1β activates NLRP3 inflammasomes in the heart’s atria to trigger inflammation promoting the onset and progression of atrial fibrillation (“AF”).  
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit inflammasomes and their associated extracellular ASC specks to attenuate propagation of IL-1β that triggers damaging inflammation and its spread to surrounding tissues.

WESTON, Fla., Sept. 22, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of a paper in the peer-reviewed Journal of Clinical Investigation highlighting how inflammation in the kidneys can trigger inflammation in the heart.

In the paper titled, “Chronic kidney disease promotes atrial fibrillation via inflammasome pathway activation,” the authors conducted a study in mouse models of CKD and in-vitro studies with serum from CKD patients and atrial samples from CKD and other patients undergoing open heart surgery. Data from the research indicate that CKD creates a substrate (IL-1β) that activates NLRP3 inflammasomes in the heart’s atria triggering damaging inflammation associated with adverse atrial remodeling and dysfunction leading to AF.

The authors stated, “Together, these findings support the idea that CKD-induced systemic inflammatory factors activate the atrial NLRP3 inflammasome thereby promoting the onset of AF. This hypothesis is supported by the fact that genetic ablation of NLRP3 protected against abnormal atrial activation, atrial fibrosis and atrial enlargement induced by CKD.” To read the article, Click Here.

ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple inflammasomes, including NLRP3, and their associated ASC specs to attenuate release and perpetuation of circulating IL-1β to control inflammation in various inflammatory diseases.

“The research published in The Journal of Clinical Investigation reinforces the importance of attenuating extracellular propagation of IL-1β to minimize induction and perpetuation of inflammation in surrounding tissues,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade, and to inhibit their associated ASC specks to reduce perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate 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, 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 in 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 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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

Brightline Connects Florida’s Finance Hubs with New Train Line

Posted on by slightbourne@noblecapitalmarkets.com

Brightline, the private passenger rail service in Florida, has began operating its high speed train lines to connect South Florida to Orlando today. This new route will link two major finance hubs in the state and make travel between them faster and easier.

Brightline’s trains have currently been running between Miami, Fort Lauderdale, and West Palm Beach. The expansion to Orlando, which opened on September 22, 2023, stretches the service across the state and connects it to one of Florida’s largest business and tourism centers.

According to Brightline’s president Patrick Goddard, the new route “will transform Central Florida into a connected region” and link its economy even closer with South Florida’s. This enhanced connectivity between the region’s financial sectors will likely lead to increased business deals, partnerships, and investment.

In particular, the new Brightline connection will simplify travel between Palm Beach County and Orlando. Palm Beach is home to a cluster of hedge funds, private equity firms, and other financial companies. Orlando similarly has a thriving financial industry, with investment firms, banks, and financial technology companies based in the metro area.

With a Brightline station at Orlando International Airport, it is now easier than ever for finance professionals to commute between the two cities for meetings and conferences. This will allow greater collaboration within Florida’s finance community.

One major finance event that will benefit is NobleCon19, an investor conference focusing on emerging growth companies. NobleCon19 is scheduled for December 3-5, 2023 in Boca Raton, located in Palm Beach County. The conference attracts finance experts from across the country, including professionals based in the Orlando area.

Once the new Brightline route opened, Orlando-based investors, analysts, and executives interested in attending NobleCon now have a convenient 3.5 hour train trip directly from Orlando International Airport to Boca Raton. This is faster than driving, which takes over 4.5 hours in traffic. It is also quicker than Amtrak’s routes connecting the two cities, which take 5-7 hours.

Brightline’s president Patrick Goddard noted that the train service will “make it easier for all Floridians and visitors to experience the best our state has to offer.” This will certainly include connecting finance pros between hubs like Orlando and Palm Beach County.

Overall, Brightline’s expansion to Orlando has linked key financial centers across Florida. For financial companies and professionals, it will facilitate easier networking, stronger partnerships, and more dealmaking. The launch of the new route in September 2023 is a major plus for Florida’s finance sector.

Release – Direct Digital Holdings Announces Extension of the Expiration of the Previously Commenced Offer to Purchase and Consent Solicitation Relating to its Warrants

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

September 21, 2023 5:00pm EDTDownload as PDF

HOUSTON, Sept. 21, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company has extended the expiration date of its previously commenced offer to purchase (the “Offer”) all of its outstanding publicly traded warrants (the “Warrants”) to purchase shares of its Class A common stock, par value $0.001 per share, at a purchase price of $1.20 in cash, without interest, to one minute after 11:59 p.m., Eastern Time, on September 28, 2023, unless the Company, in its discretion, extends the period of time during which the Offer will remain open.

As of September 21, 2023, approximately 95 Warrants have been validly tendered and not validly withdrawn from the Offer, representing 0.003% of the outstanding Warrants. Warrant holders who have validly tendered and not withdrawn their Warrants do not need to re-tender their Warrants or take any other action in response to the extension of the tender offer.

Direct Digital Holdings is also soliciting consents (the “Consent Solicitation”) to amend the Warrant Agent Agreement, dated as of February 15, 2022 (the “Warrant Agreement”), by and between Direct Digital Holdings and Equiniti Trust Company, LLC (formerly American Stock Transfer & Trust Company, LLC (the “Transfer Agent”), which governs all of the Warrants, to permit Direct Digital Holdings to redeem each outstanding Warrant for $0.35 in cash, without interest, which is approximately 71% less than the price applicable to the Offer (such amendment, the “Warrant Amendment”). Pursuant to the terms of the Warrant Agreement, the adoption of the Warrant Amendment will require the consent of holders of at least 50.1% of the outstanding Warrants. In order to tender the Warrants in the Offer and receive $1.20 in cash for each of their Warrants, holders of the Warrants are required to consent to the Warrant Amendment. Tendered Warrants may be withdrawn by holders at any time prior to the Expiration Date. The Company’s obligation to complete the Offer is conditioned on the tender of at least 50.1% of the outstanding Warrants.

The Offer and Consent Solicitation are being made pursuant to a Second Amended and Restated Offer to Purchase dated September 21, 2023, and Schedule TO, originally filed on August 29, 2023, as amended and supplemented, each of which has been filed with the SEC and more fully set forth the terms and conditions of the Offer and Consent Solicitation.

The Company’s Class A common stock and Warrants are listed on The Nasdaq Stock Market LLC under the symbols “DRCT” and “DRCTW,” respectively. As of August 29. 2023, a total of 3,217,800 Warrants were outstanding.

Stifel, Nicolaus & Company, Incorporated has been appointed as the Dealer Manager for the Offer and Consent Solicitation, D.F. King, Co., Inc. (“D.F. King”) has been appointed as the Information Agent for the Offer and Consent Solicitation, and Equiniti Trust Company, LLC has been appointed as the Depositary for the Offer and Consent Solicitation. All questions concerning tender procedures and requests for additional copies of the offer materials, including the letter of transmittal and consent should be directed to D.F. King.

Important Additional Information Has Been Filed with the SEC

Copies of the Schedule TO and Offer to Purchase will be available free of charge at the website of the SEC at www.sec.gov. Requests for documents may also be directed to D.F. King at (866) 796-1290 (toll-free) or drct@dfking.com.

This announcement is for informational purposes only and shall not constitute an offer to purchase or a solicitation of an offer to sell the Warrants. The Offer and Consent Solicitation are being made only through the Schedule TO and Offer to Purchase, and the complete terms and conditions of the Offer and Consent Solicitation are set forth in the Schedule TO and Offer to Purchase.

Holders of the Warrants are urged to read the Schedule TO and Offer to Purchase carefully before making any decision with respect to the Offer and Consent Solicitation because they contain important information, including the various terms of, and conditions to, the Offer and Consent Solicitation.

None of Direct Digital Holdings, any of its management or its board of directors, or the Dealer Manager or the Information Agent or Depositary or any other person makes any recommendation as to whether or not Warrant holders should tender Warrants for exchange in the Offer or consent to the Warrant Amendment in the Consent Solicitation. Warrant holders must make their own decision as to whether to tender their Warrants and, if so, how many Warrants to tender.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 136,000 clients monthly, generating approximately 250 billion impressions per month across display, CTV, in-app and other media channels. 

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to the Company. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; the satisfaction of the conditions to the Offer, including the minimum tender condition; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts:

Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com 

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SOURCE Direct Digital Holdings

Released September 21, 2023

Russian Export Ban May Push Crude Oil Higher

Posted on by slightbourne@noblecapitalmarkets.com

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

Posted on by aweinsoff@channelchek.com

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

Posted on by aweinsoff@channelchek.com

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

Posted on by aweinsoff@channelchek.com

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

Posted on by aweinsoff@channelchek.com

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

Posted on by slightbourne@noblecapitalmarkets.com

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.