Release – Fatburger and Round Table Pizza Open First Co-Branded Location

Research News and Market Data on FAT

October 25, 2023

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Legendary Chains Merge for the First Time to Serve Up Burgers and Pizzas Under One Roof in Lantana, Texas

LOS ANGELES, Oct. 25, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. , parent company of Fatburger, Round Table Pizza, and 16 other restaurant concepts, announces that it has officially opened its first-ever co-branded Fatburger and Round Table Pizza location in Dallas. Situated in the vibrant Lantana neighborhood, the 3,500 sq. foot restaurant offers a full-service, full-bar casual dining experience great for game day. It is the first of four co-branded Fatburger and Round Table Pizza locations planned for the greater Dallas area operated by SNM Management Group.

“We are beyond thrilled to introduce our first co-branded Fatburger and Round Table Pizza concept to Dallas,” says Taylor Wiederhorn, Chief Development Officer of FAT Brands. “This new restaurant will allow guests to enjoy the best of both brands in one space, creating a seamless experience that caters to a range of tastes. With the success Fatburger has seen co-branding with Buffalo’s Cafe and Express, we’re eager to see this new venture with Round Table Pizza flourish.”

Ever since the first Fatburger opened in Los Angeles 70 years ago, the chain has been known for its delicious, grilled-to-perfection and cooked-to-order burgers. Founder Lovie Yancey believed that a big burger with everything on it is a meal in itself; at Fatburger “everything” is not just the usual roster of toppings. Burgers can be customized with everything from bacon and eggs to chili and onion rings. In addition to its famous burgers, the Fatburger menu also includes Fat and Skinny Fries, sweet potato fries, scratch-made onion rings, Impossible Burgers, turkeyburgers, hand-breaded crispy chicken sandwiches, and hand-scooped milkshakes made from 100 percent real ice cream.

Since its founding, Round Table Pizza has been recognized as “Pizza Royalty” for its homemade dough, signature three-cheese blend, and gold-standard ingredients topped to the edge. Customers can enjoy the chain’s proprietary handmade pizzas, salads, baked-to-perfection Garlic Parmesan Twists, classic and boneless wings, and more.

The new co-branded Fatburger and Round Table Pizza location is located at 3701 FM 407 Suite 600, Bartonville, Texas 76226. It is open Sunday to Thursday, 11 a.m. to 10 p.m., and Fridays and Saturdays 11 a.m. to 12 a.m. – perfect for late-night cravings.

For more information on Fatburger, please visit www.fatburger.com. For more information on Round Table Pizza, please visit www.roundtablepizza.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 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, 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 Fatburger

An all-American, Hollywood favorite, Fatburger is a fast-casual restaurant serving big, juicy, tasty burgers, crafted specifically to each customer’s liking. With a legacy spanning 70 years, Fatburger’s extraordinary quality and taste inspire fierce loyalty amongst its fan base, which includes a number of A-list celebrities and athletes. Featuring a contemporary design and ambiance, Fatburger offers an unparalleled dining experience, demonstrating the same dedication to serving gourmet, homemade, custom-built burgers as it has since 1952 – The Last Great Hamburger Stand. For more information, visit www.fatburger.com.

About Round Table Pizza

Inspired by the honor, valor, and revelry of the Knights of the Round Table, Round Table Pizza’s® superior pizza and commitment to quality and authenticity have earned the reputation of “Pizza Royalty” for over 60 years. With more than 410 restaurants across the United States, Round Table celebrates community, family, and making merry. For more information, visit www.roundtablepizza.com.

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

Source: FAT Brands Inc.

Release – Entravision Announces Board Updates

Research News and Market Data on EVC

October 25, 2023

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Two New Directors Join the Board

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced the following updates to its Board of Directors (“the Board”), effective immediately, as part of the Company’s ongoing commitment to corporate governance practices and enhancing stockholder value:

  • Michael Christenson, Entravision’s Chief Executive Officer, was appointed as a director of the Company.
  • Lara Sweet, currently a director of MediaAlpha, Inc. and previously the Chief People Officer, Interim Chief Financial Officer, and Chief Accounting Officer and Controller of Snap Inc., was appointed as an independent director of the Company. Ms. Sweet will serve on the Audit Committee as a financial expert and on the Compensation Committee.
  • Juan Saldivar von Wuthenau, Entravision’s Chief Digital, Strategy and Accountability Officer, has resigned as a director of the Company. Mr. Saldivar will remain in his current executive role at Entravision which he has held since November 2020.

“We are pleased to welcome both Mr. Christenson and Ms. Sweet as directors, consistent with our commitment to corporate governance and periodically refreshing the Board with new perspectives, skill sets and experiences,” commented Paul Zevnik, Chair of Entravision’s Board of Directors. “We look forward to benefiting from Mr. Christenson’s extensive experience with high-growth public and private technology companies and, in conjunction with his role as CEO of the Company, building on our strategy to drive growth and stockholder value. In addition, Ms. Sweet has valuable leadership experience in finance and human resources at major technology companies. These updates align with our ongoing Board refreshment and succession planning, which includes the appointment earlier this year of Brad Bender, who brings significant digital advertising industry experience, and Tom Strickler, who added deep knowledge of the media and entertainment industry as well as significant business leadership expertise. I’d also like to thank Mr. Saldivar for his contributions to the Board over the past nine years and for remaining in his executive role as the Company continues to build value with our digital media, advertising and technology platforms.”

Mr. Saldivar added, “It has been an honor to serve as a director since 2014, while helping develop and implement the Company’s digital strategy as an external consultant since 2011 and a member of the executive team for the past three years. I believe Entravision’s future is bright and I look forward to continuing to collaborate with the Board and executive team as we advance our strategy of being a premiere global media, advertising solutions and technology company.”

Ms. Sweet has been a director of MediaAlpha, Inc., a marketing technology company that uses technology and data science to help businesses optimize their customer acquisition efforts, since the completion of its initial public offering in October 2020 and serves as the chair of its Audit Committee. In addition, Ms. Sweet serves as an advisor to private technology companies. From May 2019 to June 2021, Ms. Sweet served as the Chief People Officer at Snap Inc., a social media company and owner of the Snapchat application. Prior to that, Ms. Sweet served as Snap’s Interim Chief Financial Officer from January 2019 to May 2019, and as Chief Accounting Officer and Controller from June 2016 to September 2019. During her tenure in these roles, Ms. Sweet was integrally involved in developing and implementing best practices across Snap’s accounting and financial reporting functions, among other key initiatives. Prior to Snap, Ms. Sweet served as Controller and Chief Accounting Officer at AOL. She has also held the positions of Senior Director, External Reporting at Freddie Mac and Senior Manager, Internal Audit at Marriott International. Ms. Sweet received a B.S. in Accounting from George Mason University.

About Entravision Communications Corporation

Entravision is a global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services in 40 countries. We have commercial partnerships with Meta, X Corp. (formerly known as Twitter), TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

Christopher Young
Chief Financial Officer
Entravision
310-447-3870

Kimberly Orlando
Addo Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – ZyVersa Therapeutics Announces Research Published in the Peer-Reviewed Journal Diabetes Reinforcing IC 100’s Rationale for Inhibiting ASC to Attenuate Damaging Inflammation Associated with Serious Conditions Such as Obesity-related Heart Disease

Research News and Market Data on ZVSA

Oct 25, 2023

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  • Paper reports that obesity exacerbates scarring of the heart’s muscular tissue (myocardial fibrosis) through recruitment of inflammasome ASC to the heart’s mitochondria, facilitating NLRP3 inflammasome assembly and activation leading to damaging inflammation
  • Obesity, which affects over 650 million adults, is a known risk factor for myocardial fibrosis which is associated with almost all heart diseases
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation

WESTON, Fla., Oct. 25, 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 a publication in the peer-reviewed journal, Diabetes, demonstrating the role of ASC in myocardial fibrosis induced by obesity. ASC is an inflammasome adaptor protein that has a critical role in inflammasome activation.

In the paper titled, “Obesity enables NLRP3 activation and induces myocardial fibrosis via hyperacetylation of HADHa,” the authors performed MRIs on obese and lean people and evaluated their plasma. They also studied an animal model of obesity, with and without induced myocardial injury. Data indicate that:

  • Activated NLRP3 inflammasomes leading to increased levels of proinflammatory IL-1β and IL-18 contribute to obesity-related myocardial fibrosis in obese humans and mice.
  • Inflammasome ASC localized in the heart’s mitochondria participates in NLRP3 inflammasome formation and activation based on mouse data.
  • Inhibition of NLRP3 activation or removal of IL-1β and IL-18 abated the adverse effects on cardiac fibrosis and function in mice.

The authors concluded that these results provide new evidence for the involvement of mitochondria-localized ASC in obesity-induced cardiac fibrosis. To read the article, Click Here.

“Obesity, a well-established risk factor for cardiovascular disease, has reached pandemic proportions, and may affect up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in Diabetes demonstrates that ASC in the heart’s mitochondria facilitates NLRP3 inflammasome assembly and activation leading to damaging inflammation and myocardial fibrosis associated with obesity. This provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate 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

MAIA Biotechnology (MAIA) – THIO-101 Data Update Shows Improved Disease Control Rates


Wednesday, October 25, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

ESMO Data Shows Unusually High Survival Rates. MAIA Biotechnology presented preliminary data from the THIO-101 trial in non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology conference. The disease control rate (DCR) reached 100% in second line patients compared with about 53% to 64%  for standard of care therapies. DCR for third line patients reached 88%, compared with about 30% expected. We see these results as extremely strong, and believe DCR could correlate with overall survival (OS), a primary endpoint of the trial.

Preliminary Data Shows Strong Response. The results showed a disease control rate (DCR, consisting of complete responses, partial responses, or stable disease) of 100% or 19 out of 19 patients in second line therapy and 88% or 14 out of 16 patients in third line. Published data from 74 clinical trials with standard of care therapies show 53% to 64% DCR in second line and about 30% in third line. We see this as a substantial improvement over results from standard of care therapies.


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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. 

Travelzoo (TZOO) – Entering A More Normalized Growth Period


Wednesday, October 25, 2023

Travelzoo® provides its 30 million members with exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Upside surprise. Q3 revenue of $20.6 million, which increased 30.0% year over year, was better than our $18.9 million estimate and reflected strong revenue growth in its Europe operations (+35.5%) and North America (+27.4%). Q3 adj. EBITDA beat expectations, $3.9 million versus our $3.1 million estimate. 

Margin improvement. Adj. EBITDA margins were 18.7%, up significantly from the year earlier margins of 7.1%, reflecting the improved revenue performance and the company’s diligence on keeping costs low and its earlier significant cuts in its infrastructure footprint.    


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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. 

DLH Holdings (DLHC) – Reports Key Metrics for Fiscal 2023 Year End


Wednesday, October 25, 2023

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Key Metrics. Yesterday, DLH Holdings released some key metrics for the fiscal year ended September 30, 2023. The Company expects to release full audited financial results on December 6th. We will update our models following the full release.

Revenue. The preliminary 4Q23 revenue estimate is $100 million, which would be below our $103 million estimate and the $104 million consensus estimate, up from $67.2 million in 4Q22. The increase was driven by the GRSi acquisition. The legacy contract portfolio grew modestly. We believe the slow roll out of work under recently won ID/IQs negatively impacted quarterly revenue growth. 


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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. 

Bond Market Sell-Off: Impact on Markets, Investors, and Consumers

The recent sharp sell-off in the bond market has sent shockwaves through financial markets, impacting investors and consumers alike. This sell-off is characterized by rising yields on U.S. government bonds, particularly the 10-year Treasury note. As we delve into the implications of this development, it’s crucial to consider the historical context and the ripple effects on stock markets, investors, and consumers.

Rising Yields and Interest Rates:

Yields on government bonds, especially the 10-year Treasury note, play a pivotal role in shaping interest rates across the financial spectrum. Mortgage rates, credit card rates, and other forms of debt are closely tied to these yields. The yield on the 10-year Treasury note, widely viewed as one of the safest investments globally, recently surged above 5%, a level not seen since 2007.

Drivers of the Sell-Off:

Several factors have fueled this bond market sell-off. Stronger-than-expected economic data has boosted the outlook for the U.S. economy. The government’s deteriorating financial condition, coupled with concerns over mounting debt levels, have also contributed to the sell-off. In 2022, the bond market faced its worst year on record, with the Federal Reserve aggressively raising interest rates to combat high inflation.

Inverse Relationship: Bond Prices and Yields:

The inverse relationship between bond prices and yields is a cornerstone of the bond market. When yields rise, bond prices fall. This dynamic has been particularly pronounced in recent weeks, pushing yields higher.

The Fed’s Role and Economic Implications:

The Federal Reserve, the U.S. central bank, has played a pivotal role in the bond market. During the pandemic, it acquired trillions of dollars’ worth of fixed-income securities to support the economy. However, since 2021, the Fed has been gradually reducing the size of its portfolio. Over the past 18 months, the Fed has hiked benchmark interest rates by over 500 basis points.

Fed Chair Jerome Powell recently indicated that the central bank will approach its monetary-tightening measures carefully. The Fed’s priority is to tame inflation, which may require maintaining higher interest rates for an extended period, further influencing the bond market.

Growing Debt and Downgrades:

Wall Street’s concerns are further compounded by the United States’ escalating debt levels. Fitch Ratings recently downgraded the country’s bond rating from AAA to AA+. The U.S. budget deficit has surged in the latest fiscal year, with the outstanding debt reaching a staggering $33.64 trillion. Notably, the debt has increased by $640 billion in just the past five weeks.

Impact on Stock Markets and Investors:

The bond market’s turbulence can have a pronounced impact on stock markets. The rise in bond yields can make fixed-income investments more attractive, potentially diverting capital from stocks. This shift in investor sentiment has been a factor in the recent decline in U.S. stock markets in the latter half of 2023.

Consumer Implications:

Consumers are not immune to the repercussions of a bond market sell-off. Rising yields tend to result in higher borrowing costs, impacting mortgage rates, credit card rates, and other forms of consumer debt. Consumers may also experience the indirect effects of a less accommodative monetary policy, which can influence overall economic conditions.

In summary, the bond market’s recent sell-off, with surging yields and growing debt concerns, has multifaceted implications. It underscores the intricate interplay between bond markets, stock markets, investors, and consumers. As the Federal Reserve continues to navigate the path of monetary tightening, the financial landscape remains fluid, and stakeholders must adapt to these evolving dynamics.

AMN Healthcare Expands Its Footprint with Acquisition of MSDR

AMN Healthcare (NYSE: AMN), a prominent player in total talent solutions for healthcare organizations across the United States, has announced its plans to acquire MSDR, marking a significant move in the healthcare staffing sector. The definitive agreement, with a purchase price of $300 million, encompasses two healthcare staffing companies, Medical Search International (MSI) and DRW Healthcare Staffing (DRW), both of which specialize in locum tenens and advanced practices.

Meet the Companies:

MSI, established in 2002, is renowned for its services in placing high-quality healthcare professionals specializing in psychiatry, anesthesia, radiology, and surgery, serving healthcare systems throughout the United States. DRW, founded in 2011, boasts expertise in psychiatry, anesthesia, and surgery placements, making it a valued leader in the locum tenens industry. Notably, Chris Wang, the Chief Executive Officer and Managing Partner of DRW, will continue to contribute as the President of MSDR.

Growth Prospects and Financials:

This strategic acquisition positions AMN Healthcare for substantial revenue growth within the locum tenens sector. In 2022, MSDR generated $104 million in revenue, and the annualized revenue for 2023 stands at approximately $155 million. AMN anticipates the deal to be modestly accretive to adjusted earnings per share (EPS) within the first 12 months of integration.

The acquisition is slated to close in the fourth quarter of 2023, contingent on regulatory approvals and closing conditions. It will be treated as an asset purchase, creating a step-up in the tax basis for the intangible assets acquired.

Expanding Solutions and Expertise:

With the integration of MSDR, AMN Healthcare’s extensive portfolio of solutions is set to expand significantly. Clients will gain access to a larger and more diverse candidate pool, including healthcare professionals specializing in some of the most sought-after and in-demand services.

Moreover, the acquisition brings the wealth of expertise and knowledge of the MSDR team in recruitment, placement, and operations, coupled with candidate matching technology tailored for locum tenens. This move underscores AMN Healthcare’s commitment to delivering high-quality, tailored workforce solutions.

Commentary from Leadership:

AMN Healthcare President and Chief Executive Officer Cary Grace expressed enthusiasm about the acquisition, stating, “We are very excited to welcome the MSDR team into the AMN Healthcare family and expand the workforce solutions available to our clients across the country.” The move signifies a strategic growth opportunity that positions AMN Healthcare as a stronger and more comprehensive player in the healthcare staffing industry, ultimately benefitting both healthcare organizations and the dedicated professionals they serve.

Explore more healthcare and biotechnology stocks covered by Noble Senior Analysts Gregory Aurand and Robert LeBoyer

Release – DLH Reports Key Metrics for Fiscal 2023 Year End

Research News and Market Data on DLHC

October 24, 2023

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Exceeded Debt Reduction Expectations; Facility Rationalization Review Completed

ATLANTA, Oct. 24, 2023 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of digital transformation, science, research and development, and systems engineering and integration, today announced selected key metrics for the fiscal year ended September 30, 2023.

Debt Reduction
Total debt at fiscal year end was $179.4 million compared to $207.6 million following the acquisition of Grove Resource Solutions, Inc. (“GRSi”) in December 2022, outperforming management expectations of $186.4 million. The Company reduced its debt by $28.2 million in total for the post-acquisition period, composed of $14.3 million in mandatory payments and $13.9 million in prepayments.

“DLH has a history of effectively deploying free cashflow to aggressively pay down debt,” said DLH President & CEO Zach Parker. “This track record provides the capacity to make transformative acquisitions, invest in our people, and grow the Company’s footprint within key markets. I am proud that we are once again making tremendous progress towards de-levering the balance sheet and providing additional value to our shareholders.”

Fourth Quarter Revenue
The preliminary estimate of revenue for the fiscal 2023 fourth quarter is approximately $100 million versus $67.2 million in the prior-year period. The increase was primarily driven by contributions from GRSi. The Company’s legacy contract portfolio grew moderately to offset the completion of short-term contracts associated with the COVID-19 pandemic response in fiscal 2022.

Facility Rationalization
During the fourth quarter of fiscal 2023, DLH reduced its leased office space requirement by consolidating underutilized premises as part of an ongoing facility rationalization effort, to accurately reflect the operational needs of the business. As a result, the Company has determined that its Right of Use Assets experienced a reduction in fair value below its associated carrying value. While DLH continues to quantify this reduction, the Company anticipates that its year end audited financial statements will include an impairment in the amount of approximately $8 million. This non-cash charge will decrease operating income for the fourth quarter, but the Company expects to benefit from lower lease expenses by approximately $1 million annually going forward. DLH expects to primarily utilize such savings in strategic initiatives related to organic growth.

As the Company has not completed its year end annual close procedures and the audit of its 2023 financial statements is not complete, the financial information presented in this press release is preliminary, subject to final year end closing adjustments and may change materially. The information presented above has not been audited by the Company’s independent accountants, should not be considered a substitute for audited financial statements, and should not be regarded as a representation by DLH as to the actual financial results for the fiscal year ended September 30, 2023. DLH expects to release full audited financial results for its fiscal fourth quarter and year ended September 30, 2023, on December 6, 2023.

About DLH
DLH (NASDAQ: DLHC) delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit http://www.DLHcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. Forward-looking statements are based only on our current beliefs, expectations and assumptions that may not prove to be accurate and are subject to numerous risks and uncertainties, including the completion of the audit of the Company’s consolidated financial statements for the fiscal year ended September 30, 2023, as well as other risks relating to our business or general economic and market factors. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of our acquisition of GRSi or any other acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations resulting from our recent acquisition; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our increased debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the ability to successfully integrate the operations of GRSi or any future acquisitions; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com

Release – GeoVax Update: Clinical and Operational Progress Toward Transformative Opportunities

Research News and Market Data on GOVX

ATLANTA, GA, October 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced an update on key strategic initiatives.

“The third quarter marked advancements in our next-generation COVID-19 vaccine clinical programs and our cancer therapy program, along with advanced manufacturing developments, and new patents issued for our Ebola, Marburg, Malaria, and HIV vaccines. I look forward to sharing more details about these developments during our upcoming investor/analyst earnings call on November 8,” said David Dodd, GeoVax’s Chairman and CEO.

“We believe this is a defining moment for the Company, as we expand the full potential of a next-generation COVID-19 vaccine (GEO-CM04S1) currently in three Phase 2 clinical trials and the broad application of Gedeptin® against solid tumors. We are gearing up to announce initial data readouts from two of these trials, along with updates from our Gedeptin clinical trial against advanced head and neck cancer as well as other important corporate developments. We believe that these upcoming catalysts will have a profound impact on patients in need and all our stakeholders.”

Recent Company Highlights

GEO-CM04S1

  • Investigator-Initiated Clinical Trial Begins, Randomized Observer-Blinded Phase 2 Trial of COVID-19 Booster with GEO-CM04S1 or Pfizer-BioNtech Bivalent Vaccine in Patients with Chronic Lymphocytic Leukemia.”

    • Trial is rapidly enrolling patients, progressing towards an interim data review.
  • Enrollment Target Completed for Phase 2 Clinical Trial Evaluating GEO-CM04S1 as a Booster for Healthy Patients Who Have Previously Received the Pfizer or Moderna mRNA Vaccine.
    • Initial data readout is expected soon.
  • GeoVax Next-Generation COVID-19 Vaccine (GEO-CM04S1) Demonstrated Potent Antibody and Cellular Immunity in Immunocompromised Patients.
    • The journal, Vaccines, publishes data (GEO-CM04S1 Publication) from GeoVax’s Phase 2 clinical trial evaluating the safety and immunogenicity of GEO-CM04S1 next-generation COVID-19 vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have previously received an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR-T cell therapy.
  • GeoVax Universal COVID-19 Vaccine Data Presented at Keystone Symposia Conference.
    • Abstract Title: MVA-vector multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal modes.
    • Data revealed: GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.

Gedeptin®

  • Gedeptin® Clinical Data presented at the AACR-AHNS Head and Neck Cancer Conference
    • Abstract Title: Phase 1/2 study of Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC).
    • Data revealed: FDA-funded study reveals that administration of Gedeptin® is safe and feasible.

Advanced Vaccine Manufacturing Process

  • GeoVax and ProBioGen announced the signing of a landmark commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.pIX® suspension cell line. The agreement empowers GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio.

Intellectual Property Developments

  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled patent titled “Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).”
  • GeoVax announced that the U.S Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).”

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. 

Company Contact:        Investor Relations Contact:        Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

Release – Vera Bradley Launches First-Ever Toy Story Collection In Collaboration With Disney And Pixar

Research News and Market Data on VRA

Oct 24, 2023

Pixar | Vera Bradley Toy Story Collection Now Available Nationwide

FORT WAYNE, Ind., Oct. 24, 2023 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) today announced that Vera Bradley, its iconic American bag and luggage lifestyle brand, has collaborated with Disney and Pixar to launch its first-ever collection inspired by the beloved Toy Story franchise.

Celebrating the magic of childhood, friendship and adventure with more than 60 lighthearted styles made especially for new adventures with special friends, the Pixar | Vera Bradley Toy Story Collection includes four new patterns—Andy’s Room, Festive Toy Story, Toy Chest, and Toy Story Sketch—featuring Pixar’s Woody, Buzz Lightyear and the entire Pixar Toy Story gang.

“The Vera Bradley brand came to life more than 40 years ago thanks to the friendship of co-founders Barbara Bradley Baekgaard and Patricia R. Miller, so we are especially excited to celebrate the power of friendship with our new Pixar | Vera Bradley Toy Story Collection,” noted Alison Hiatt, CMO of Vera Bradley, Inc. “Fans of the Disney and Pixar Toy Story franchise are sure to love the colorful, fun and festive patterns and embroidered motifs featuring their favorite Toy Story characters.”

Pixar | Vera Bradley Toy Story Collection styles range in price from $15 to $160 and are perfect for holiday gift-giving. Shop the collection now in Vera Bradley Full Line Stores, participating Vera Bradley retailers and online at www.verabradley.com/disney. Follow @verabradley for updates and to learn more.

ABOUT VERA BRADLEY

Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace. Visit www.verabradley.com and follow @verabradley to learn more.

CONTACTS 
877-708-VERA (8372)
Mediacontact@verabradley.com
Hunter PR for Vera Bradley
verabradley@hunterpr.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/75381a18-3e7f-4352-809d-ca5fca8580cd

https://www.globenewswire.com/NewsRoom/AttachmentNg/21038911-95b1-49fd-86e1-613d24b9f69c

Release – Harte Hanks Names Kelly Waller as Senior Vice President of Sales and Marketing

Research News and Market Data on HHS

CHELMSFORD, MA / ACCESSWIRE / October 24, 2023 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced that Kelly Waller, a proven executive with a diverse and successful career in global marketing/demand generation, field/inside sales, client retention and sales enablement, has agreed to join Harte Hanks as Senior Vice President of Sales and Marketing. Ms. Waller is relocating to Boston, working in close proximity to Kirk Davis, Chief Executive Officer, as part of the Harte Hanks senior leadership team.

For the past seven years, Ms. Waller has served as Global Vice President, Mid-Market (Marketing Demand Generation, GTM & Sales) for Finastra, a global provider of financial software applications and marketplaces with $1.85 billion in revenue. In this role, she managed the revenue generating function for Mid-Market for Finastra, consisting of over 120 global employees. Previously, she served as Inside Sales Director for Extreme Networks managing inside sales account managers, new logo sales, and services sales team across EMEA and APAC. Previous sales leadership roles include tenures at SunGard, Kantar Media and Durrants.

Kirk Davis, Chief Executive Officer, commented: “Kelly brings robust experience and a significant track record of success in lead generation, sales organization leadership and client retention, with particular expertise in selling marketing solutions, making her the ideal executive to lead our sales organization going forward. Her experience is especially well-aligned with Harte Hanks’ future, leveraging data assets and technology to drive modern solutions for our customers. I welcome her to the Harte Hanks leadership team.”

“Harte Hanks is a company with decades of history, but a modern approach to delivering innovative solutions, and I am excited to pursue new logo growth, customer retention, and process excellence to drive long-term growth,” commented Ms. Waller. “Global organizations are seeking new ways to identify and target customers, harnessing technology to deliver customized solutions, and Harte Hanks is well-positioned to meet this growing need.”

About Harte Hanks:

Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.

Release – Onconova Expands Leadership Team With Two Key Appointments

Research News and Market Data on ONTX

Oct 24, 2023

PDF Version

Dr. Victor Moyo named Chief Medical Officer
Meena Arora joins as Vice President Global Medical Affairs and R&D

NEWTOWN, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company expanded its leadership team with the naming of Dr. Victor Moyo as Chief Medical Officer (CMO), and the addition of Meena Arora as Vice President, Global Medical Affairs and Research and Development (R&D).

“We are delighted to have Dr. Moyo and Ms. Arora as integral members of our team at Onconova as we prepare to enter the next phase of development for narazaciclib and rigosertib, our novel and proprietary cell pathway inhibitors for oncology,” said Dr. Steven Fruchtman, President and Chief Executive Officer (CEO). Both are accomplished experts in their fields and bring significant and wide expertise in drug development. I believe Victor’s extensive track record as a clinical researcher and drug developer in oncology and Meena’s unique medical affairs expertise in rare diseases and oncology will be instrumental to the Company’s success as we advance the clinical plan and regulatory strategy for each program.”

Victor Moyo commented, “I am very pleased to be named as Onconova’s Chief Medical Officer. Working with the team over the last quarter has given me the opportunity to appreciate the potential for Onconova’s product pipeline, especially the excellent work that the Company has done differentiating narazaciclib from other CDK4/6 inhibitors. I believe narazaciclib holds the promise of prolonging progression in patients with endometrial and other gynecological cancers as well as hematologic malignancies in indications where there is still an unmet medical need. I look forward to working with my colleagues at Onconova and our clinical collaborators to contribute to our mission of bringing narazaciclib and rigosertib to patients with cancer.

Meena Arora shared, “I am excited to join Onconova’s talented and experienced group of professionals and look forward to beginning my tenure as Vice President Global Medical Affairs and Research and Development to execute on Onconova’s vision. I joined the Company because I believe that our oncology programs are based on impressive science and preliminary clinical results and are focused on important indications where there is a need for improved clinical outcomes. I am excited to couple my expertise in rare disease and oncology with my dedicated experience in medical and regulatory affairs and research and development strategy to help advance Onconova’s potential priority therapies for people with cancer.”

Dr. Moyo is a highly experienced physician researcher and drug developer, with extensive clinical research pharmaceutical industry experience. He has held a variety of senior leadership positions with responsibility for a number of clinical development plans, IND filings, NDA filings, post-market development plans, notably including his work on such programs as Onivyde® for metastatic pancreatic cancer, epoetin alpha trial in myelodysplastic syndrome, and the Doxil® trial in advanced ovarian cancer. He is also a named inventor on numerous granted patents and patent applications.

Dr. Moyo joined Onconova as Consulting Chief Medical Officer in August, 2023. He has also held various leadership roles as Vice President of Clinical Investigations at Merrimack Pharmaceuticals and the Centocor Ortho Biotech Services, LLC division of Johnson & Johnson.

Dr. Moyo earned his M.D. from the University of Zimbabwe. Following his move to the U.S., he went on to complete his internship and residency in Internal Medicine at the George Washington School of Medicine and Health Sciences and his fellowship in Hematology and Oncology at the Johns Hopkins University School of Medicine

Meena Arora is a highly credentialed executive with experience in both pharmaceutical and emerging biotechnology companies, working in roles of increasing responsibility in medical affairs, regulatory strategy and scientific leadership in oncology, rare disease immunology, and inflammation. Over the course of her career, she has worked on development programs for notable products including Filsuvez®, Revlimid®, Imnovid®, Abraxane®, Vidaza® and CAR-T cell therapy (Breyanzi® and Abecma®).

Most recently, Ms. Arora served as Vice President/Head of Global Medical Affairs – Epidermolysis Bullosa (EB) for Amryt Pharma. Prior to that, she held various leadership roles as Medical Director or Associate Medical Director, as well as roles in Investigator Research and Medical Affairs at Celgene International. Ms. Arora has also held multiple advancing roles in medical and commercial development at GlaxoSmithKline and SmithKline Beecham.

Ms Arora earned degrees in Pharmaceutical Science, Pharmaceutical Medicine and Biomedical Science with a Master of Science in Drug Development Science with studies in Biotechnology and Advanced Therapeutics from Kings College London and a Post Graduate Diploma in Pharmaceutical Medicine/Clinical Research from the University of Surrey. Ms. Arora received a Chartered Institute of Marketing Advanced Diploma from Cambridge Marketing College and earned a Post Graduate Diploma in Pharmaceutical Science and Bachelor of Science (Hons) in Biomedical Science from the Nottingham Trent University. Ms Arora is the recipient of multiple industry awards and publication co-author.

About Onconova Therapeutics, Inc.

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

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

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

Forward Looking Statements

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

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com