Page 214 – Channelchek

Release – V2X Lands $88 Million Contract, Expanding Navy IT and Communications Support in the Pacific Region

Posted on May 2, 2024May 2, 2024 by dburczyk@noblecapitalmarkets.com

MCLEAN, Va., May 2, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) is proud to announce it has been awarded a firm-fixed price contract valued at $88 million, including option periods. This contract supports the operation and maintenance of Navy communication, electronic, and computer systems in support of the Naval Computer and Telecommunications Area Master Station Pacific (NCTAMS PAC).

The NCTAMS PAC serves as the principal Navy hub for communications in the Pacific, providing crucial command, control, communications, computers, and intelligence support to U.S. and allied forces across the Pacific and Indian Oceans.

“This significant award not only enables V2X to continue our crucial support of the Navy’s global communication networks, but it also highlights our expanding footprint and growing solutions in the Pacific region.” said Chuck Prow President and Chief Executive Officer of V2X. “We are grateful for the Navy’s trust in selecting us and look forward to delivering operational excellence while improving the security and efficiency of Navy communications.”

Work under the contract will be primarily performed in Oahu, Hawaii, and Geraldton, Australia and runs through October 2029, including all option periods.

The contract includes a 12-month base period, four 12-month options, and a six-month extension option, as per federal regulations. The full execution of this contract, through October 2029, underscores V2X’s commitment to long-term strategic support for the U.S. Navy’s operational capabilities.

About V2X
V2X builds smart solutions designed to integrate physical and digital infrastructure – by aligning people, actions, and outputs. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.

The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 16,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos
Deoudes Director, Corporate Communications
Angelica.Deoudes@goV2X.com
571-338-5195

Investor Contact
Mike Smith, CFA
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com
719-637-5773

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SOURCE V2X, Inc.

Release – ISG Earns Gender Equality Certification

Posted on May 2, 2024May 2, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on III

ISG Italy recognized by Bureau Veritas for meeting the gender equality guidelines set by Ente Italiano di Normazione (UNI)

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced ISG Italia S.p.A has earned gender equality certification through Bureau Veritas, a world leader in audit and certification services.

The ISG business in Italy has supported the Italian public sector for more than a decade, including a framework contract with Consip, the Italian Public Administration’s central IT purchasing body, to provide governance services for various digital transformation initiatives as part of Italy’s “Three-Year Plan for Information Technology in the Public Administration.”

Bureau Veritas evaluated ISG Italy across six workplace functions―culture and strategy; governance; HR management processes; opportunities for growth and inclusion of women in business; gender pay equity and parental protection, and work-life balance―and determined the firm’s practices comply with the gender equality guidelines defined in the March 2022 UNI/PdR 125:2022 certification issued by UNI (Ente Italiano di Normazione), the Italian standardization body.

“We are delighted to earn this prestigious certification for our gender equality management approach, which aims to promote diversity and equal opportunity in the workplace,” said Michael P. Connors, Chairman and CEO, ISG. “ISG is strongly committed to overcoming the traditional obstacles to women’s success in the workplace, and to supporting fair and equitable workplaces for all.”

ISG established the ISG Women in Digital community in 2018 to provide a platform for exchanging practical advice and innovative ideas on diversity and advancement in the workplace. The community hosts the annual ISG Women in Digital Awards, a LinkedIn page, an ongoing ISG Digital Dish podcast series, and regular events for ISG employees and the greater IT and business services industry.

“ISG is committed to ensuring men and women receive fair wages and have the same opportunities for recruitment, career advancement and leadership,” said Julien Escribe, partner and managing director of ISG Italy. “By advancing our ISG culture of diversity, equity and inclusion and complying with laws and regulations that promote gender and wage equality and address gender-based violence, we believe we help uphold the fundamental values of our firm and of society.”

Bureau Veritas is accredited to certify organizations under the Italian Gender Equality Certification System. Gender equality certification is voluntary, available to companies of all sizes, and determined by the UNI/PdR 125:2022 guidelines and key performance indicators for gender equality within an organization.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including AI and automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

Release – FAT Brands Foundation Raises Over $130,000 at 2024 FAT Brands Summit

Posted on May 2, 2024May 2, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on FAT

FAT Brands’ Charitable Organization Fuels Impact at 2024 Conference

LOS ANGELES, May 02, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., a leading global franchising company that owns restaurant brands including Johnny Rockets, Fatburger, Round Table Pizza, Twin Peaks, Fazoli’s and 13 other concepts, is pleased to announce the FAT Brands Foundation has raised over $130,000 via donations and committed funds at FAT Brands’ bi-annual Summit in Las Vegas, Nevada. The Foundation team surpassed its $75,000 fundraising goal, which was then matched with an additional $50,000 donation by FAT Brands Inc., bringing the grand total to over $130,000.

Along with on-site fundraising, including a silent auction and raffle, the FAT Brands Foundation hosted its first-ever giving back event at the 2024 FAT Brands Summit to bring to life its mission of partnering with local non-profit organizations. In partnership with Las Vegas non-profit, Three Square, Southern Nevada’s only food bank and the area’s largest hunger-relief organization, FAT Brands Summit attendees helped pack nearly 6,000 meals for families. To further their commitment to the cause, the Foundation also presented a $10,000 check to Three Square to fund an additional 30,000 meals for the greater Las Vegas community.

“The Foundation has made remarkable strides since we announced its inception at the last FAT Brands Summit in 2022,” said Jessica Wiederhorn, President of FAT Brands Foundation. “To date, we have aided the work of over 50 causes in FAT Brands’ communities across the country. The pinnacle of this year’s Summit was celebrating with our key supporters, who have provided valuable donations, silent auction items and their time. We couldn’t be more grateful.”

For non-profits interested in applying for a grant or for those interested in donating to the Foundation, please visit www.fatbrands.com/foundation.

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

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 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, Smokey Bones, 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.

About FAT Brands Foundation

Founded in 2022, the FAT Brands Foundation was created to uplift and unite the communities in which FAT Brands operates. While the company’s 18-brand portfolio is deeply rooted in charitable initiatives both locally and nationally, FAT Brands, as an organization, is seeking to magnify those efforts further. The 501(c)(3) organization is aimed at partnering with local non-profit organizations to provide essential programs to help families and communities thrive.

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

Release – FAT Brands Expands Partnership with Six Flags, Brings Third Restaurant Brand to Iconic Parks

Posted on May 2, 2024May 2, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on FAT

LOS ANGELES, May 02, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Hurricane Grill & Wings and 17 other restaurant concepts, announces their latest brand to enter the legendary Six Flags properties. Hurricane Grill & Wings, the Florida-born wing brand known for its laid-back environment and award-winning wings, will debut at Six Flags Great Escape Lodge in Queensbury, New York this summer.

The latest opening underscores FAT Brands and Six Flags’ dynamic partnership and the global franchising company’s commitment to growth in non-traditional venues. The new Hurricane Grill & Wings will expand the wing brand’s presence in New York state, marking its first location in the upstate region. Hurricane Grill & Wings is FAT Brands’ third brand to appear in Six Flags properties, joining sister brands Fatburger and Johnny Rockets.

“Since we began our relationship with Six Flags following our acquisition of Johnny Rockets in 2020, they have been a tremendous partner of ours,” said FAT Brands Chief Development Officer, Taylor Wiederhorn. “Our brands have a one-of-a-kind, fun environment, so it is only natural to grow FAT Brands’ footprint in theme parks with a likeminded industry leader like Six Flags. We look forward to continued expansion in the years to come.”

“The addition of the first Hurricane Grill & Wings at a Six Flags property is an exciting expansion of our commitment to making good food fun,” said Six Flags Chief Marketing Officer, Edithann Ramey. “Just like our theme and water parks, Hurricane Grill & Wings provides a fun and casual environment where family and friends can gather and make memories.”

For more information or to find a Hurricane Grill & Wings near you, visit hurricanewings.com.

###

About FAT (Fresh. Authentic. Tasty.) Brands

Fragranzi(NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, casual and polished casual dining restaurant 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, Native Grill & Wings, Pretzelmaker, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit http://www.fatbrands.com.

About Hurricane Grill & Wings

With almost 50 restaurants located across the United States, Hurricane Grill & Wings^® is known for its jumbo, fresh wings, more than 35 signature sauces, and rubs, and tropical, laid-back vibe. Hurricane Grill & Wings’ menu includes wings, tacos, burgers, and seafood. The original Hurricane Grill & Wings opened in Fort Pierce, Fla., in 1995 and has expanded to locations throughout the United States. For more information visit www.hurricanewings.com.

About Six Flags Entertainment Corporation

Six Flags Entertainment Corporation is the world’s largest regional theme park company with 27 parks across the United States, Mexico and Canada. For 63 years, Six Flags has entertained hundreds of millions of guests with world-class coasters, themed rides, thrilling water parks and unique attractions. Six Flags is committed to creating an inclusive environment that fully embraces the diversity of our team members and guests. For more information, visit www.sixflags.com.

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

Release – PDS Biotech Appoints Stephan Toutain as Chief Operating Officer

Posted on May 2, 2024May 2, 2024 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., May 02, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced the appointment of Stephan Toutain, MS, MBA, as Chief Operating Officer (COO), effective as of May 1, 2024.

“We are thrilled to welcome Stephan to the PDS Biotech team as Chief Operating Officer. His invaluable experience spans many aspects of the life sciences industry, from drug development to commercialization, providing a wealth of knowledge to our team,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Stephan’s strategic vision, proven ability to drive operational excellence, and distinguished track record, particularly in oncology, will be instrumental as we advance our lead program into a pivotal clinical trial.”

Mr. Toutain brings more than 30 years of operational experience in the pharmaceutical industry from drug development, general management, operations, commercial development, market access and sales and marketing leadership with prior global expertise in the oncology and orphan drugs markets. Before joining PDS Biotech, he served as COO at Anavex Life Sciences from May 2018 to April 2024 and Chief Commercial Officer at Interleukin Genetics from July 2016 to August 2017. Mr. Toutain also worked with Alnylam Pharmaceuticals to build its early access program. In addition, he led Global Commercial Development for Sarepta Therapeutics and served as General Manager for Alexion Pharmaceuticals in Europe. Mr. Toutain has also held various U.S. commercial, marketing and product management positions with Celgene Corporation and Johnson & Johnson. He received a Master of Business Administration from the University of North Carolina Kenan-Flagler Business School and a Master of Engineering in Biotechnology from the University of Nancy II in France.

“I am excited to join the PDS Biotech team during this pivotal time as the company hones its late-stage clinical strategy on the novel triple combination,” said Mr. Toutain. “I am eager to contribute my experience and insights to drive forward our mission of transforming how the immune system targets and fights cancer.”

The Company also announced today that on May 1, 2024, PDS Biotech granted a nonstatutory stock option to Mr. Toutain to purchase 200,000 shares of PDS Biotech common stock as a material inducement to Mr. Toutain’s employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

The stock option has an exercise price of $3.61, the closing price of PDS Biotech’s common stock on May 1, 2024. The stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the Company through the applicable vesting dates.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune^® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune^® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Our Infectimune^® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – Ocugen Announces CSO To Present On Modifier Gene Therapy At Retina World Congress

Posted on May 2, 2024May 2, 2024 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 2, 2024

MALVERN, Pa., May 02, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the Retina World Congress (RWC) being held May 9-12, 2024 in Ft. Lauderdale, FL.

“This is a terrific opportunity to share the most recent developments in modifier gene therapy with my peers and learn more about their discoveries to fight retinal disease,” said Dr. Upadhyay. “Opportunities like these are critical as we work together to address unmet medical needs for patients with blindness diseases.”

RWC is one of the largest retina meetings in the world and is leading the advancement of science in retina. This annual meeting brings together retina specialists from every continent to achieve a global scientific and clinical exchange in retinal health.

Details on Dr. Upadhyay’s presentation are as follows:

RWC Unplugged Panel Session: Gene Therapy, Pharmacotherapy and Optogenetics for IRD
Date: Thursday, May 9, 2024
Time: 9:05 – 9:35 a.m. (ET)
Location: Marriott Harbor Beach Resort

Additionally, Ocugen’s abstract, “Safety and Efficacy Results from a Phase 1/2 Clinical Trial of OCU400 Modifier Gene Therapy for Treatment of Retinitis Pigmentosa,” has been accepted as an e-poster/video presentation and will be showcased in a video display during the conference.

The OCU400 Phase 3 liMeliGhT clinical trial is currently underway and on track to meet the Company’s 2026 BLA and MAA approval targets. OCU400 is the first gene therapy program to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on nuclear hormone receptor (NHR) gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with RP. Between the U.S. and EU, nearly 300,000 people are affected by RP.

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, Leber congenital amaurosis and Stargardt disease, as well as multifactorial diseases like dry age-related macular degeneration (dAMD). Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently, Ocugen has three modifier gene therapy programs in the clinic: OCU400, OCU410, and OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease are currently underway. GA affects approximately two to three million people between the U.S. and EU and Stargardt disease affects nearly 100,000 people between the U.S. and EU.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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 Communications
Tiffany.Hamilton@ocugen.com

The Rise of PIPEs in the Biotech World

Posted on May 2, 2024May 2, 2024 by slightbourne@noblecapitalmarkets.com

For biotech companies operating in the small and micro-cap arena, access to capital can often be the difference between make or break. Developing cutting-edge therapies is an expensive endeavor, with clinical trials alone costing millions. When equity markets turn volatile, these small players can find themselves in a funding crunch that stalls or derails their most promising innovations.

This dilemma has led to a surge in an alternative financing technique known as the PIPE – a private investment in public equity. PIPEs allow select investors to directly purchase shares or convertible securities from a public biotech company at a discounted price in a private placement. In exchange, these investors gain access to highly coveted non-public information like interim clinical trial data or study results before they hit the mainstream.

The allure is obvious – getting an early peek under the hood allows “PIPE investors” to make educated bets on a company’s prospects ahead of any market-moving news releases. If the confidential data looks promising, they can stock up on discounted shares before the positive study results send the share price shooting upwards.

For the issuing biotech, a PIPE deal solves a dire cash crunch while attracting buy-in from reputable healthcare funds who often have existing holdings. It’s a win-win that has fueled a PIPE boom, with U.S. biotechs raising a record $5.7 billion through these private placements in Q1 2024 alone according to Jefferies data.

However, this lucrative trend is also igniting a raging controversy. The investing community is deeply divided between those with a rarefied seat at the PIPE table, and those feeling deprived of a chance at the same insight and opportunities.

On one side are specialist healthcare funds like Adage Capital, Logos Capital, and EcoR1 which have made PIPEs their bread-and-butter. They argue the confidential data access merely levels the playing field, as professional biotech investors already do rigorous public-sourced analyses that give them an edge over casual investors.

“You have companies spending years running clinical trials, taking huge risks to develop these drugs for patients. PIPEs give them a fighting chance to meet funding needs when equity markets turn hostile,” says Oleg Nodelman of EcoR1. “It’s better than watching all that work disintegrate.”

Opposing them are generalist investors and even some biotech CEOs who decry PIPEs as sanctioned insider trading that unfairly favors an elite group. Sounding the loudest alarms are those burned by buying into hyped PIPEs only to see outsized stock gains instantly materialize for PIPE investors.

“There are instances where stocks rallied over 40% the day positive PIPE data was announced,” notes Daphne Zohar, CEO of Seaport Therapeutics, who avoids PIPEs. “These lopsided deals make generalist investors feel the deck is stacked against them.”

The controversy deepened when an investor sued Taysha Gene Therapies in April, alleging company leaders strategically timed disclosures alongside a $150 million PIPE to maximize profits for an inner circle before share prices spiked.

As PIPEs proliferate from niche deals into a $5 billion-plus financing pipeline, stakes are rising for all sides. Furious retail investors have even conjectured PIPEs could enable “shadow trading” – using confidential data about one company’s study to invest in an unrelated competitor ahead of public releases.

While merely allegations now, any concrete evidence of foul play could precipitate a harsh regulatory crackdown to ensure fair markets. Already some PIPEs have seen muted stock bounces as news travels faster about these non-public data disclosures.

For now, cash-strapped biotechs seem willing to accept the criticism as a worthwhile price to pay for crucial growth capital. PIPE defenders argue if disclosure rules are followed, there’s no meaningful distinction between benefiting from non-public information as an investor versus as a biotech executive or regulator with early trial data access.

Only time will tell if the alluring but contentious PIPE well runs dry from overuse and regulatory scrutiny. But in today’s turbulent climate, it offers a vital lifeline to biotech innovators facing turbulent public capital currents. Just be prepared to defend your stake in this high-stakes game of data-driven musical chairs.

Take a moment to take a look at some emerging growth biotech companies, by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

Great Lakes Dredge & Dock (GLDD) – New Credit Facility Provides Flexibility and Optionality

Posted on May 2, 2024May 2, 2024 by cpereira@noblefcm.com

Thursday, May 02, 2024

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

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.

New Credit Agreement. Last week, Great Lakes entered into an $150 million 5-year, senior secured second-lien credit agreement with Guggenheim Credit Funding, LLC. The new agreement provides the Company with flexibility to fund its new vessel build out program as well as optionality on borrowing, although the interest rate is higher than the existing debt.

Use of Funds. The Company borrowed $100 million under the agreement on the closing date, which was used to repay amounts outstanding under the existing ABL. Great Lakes has the option to draw an additional $50 million for a period of 12 months following the closing date of the initial loan. The optional $50 million, if drawn, will be used to fund future new build payments, ongoing working capital, and other general corporate purposes.

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

FAT Brands (FAT) – Mixed 1Q Results but Growth Trends Remain Positive

Posted on May 2, 2024May 2, 2024 by cpereira@noblefcm.com

Thursday, May 02, 2024

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.

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

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

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1Q24 Results. FAT Brands reported 1Q24 revenue of $152 million, up 43.8% y-o-y, driven by the Smokey Bones acquisition. FAT reported adjusted EBITDA of $18.2 million in the quarter, compared to $19.2 million in 1Q23. Net loss for the quarter was $40.2 million, or $2.37/sh, compared to a net loss of $23.6 million, or $2.05/sh last year. Adjusted net loss for the quarter was $32.9 million, or $2.05/sh, compared to a net loss of $23.5 million, or a loss of $1.53/sh, last year. We had projected revenue of $163 million and a net loss of $23.2 million, or a loss of $1.39/sh.

Economy/Weather Impacted 1Q24 Results. While System-wide sales growth was 4.8% y-o-y, same store sales declined 4% y-o-y, as consumers traded down and weather conditions impacted traffic. Weather conditions also impacted new store openings, which came in at 16 for 1Q24, although management expects to increase to over 40 new openings in 2Q and for 125-150 new openings for all of 2024.

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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) – A Look into the Second Quarter

Posted on May 2, 2024May 2, 2024 by cpereira@noblefcm.com

Thursday, May 02, 2024

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.

Past the Continuing Resolution. With the Continuing Resolution in the rear view mirror and building momentum in government decision making, DLH is positioned to realize any opportunities for awards throughout 2024, in our view. With the more positive environment, DLH already experienced an increase in its backlog, up $80 million sequentially, and we believe there is still more to come.

2Q Results. Revenue for the second quarter was $101.0 million, an increase from $99.4 million last year and above our estimate of $99 million. Net income totaled $1.8 million, or $0.12 per diluted share, versus $0.8 million, or $0.06 per diluted share, for 2Q23 and in-line with our estimate. EBITDA for 2Q24 was approximately $10.2 million versus $10.5 million in the prior year, or a margin of 10.1% and 10.5%, respectively, slightly below our $11.3 million projection.

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

Conduent Inc. (CNDT) – A Good Start on its Transitional Journey

Posted on May 2, 2024May 2, 2024 by cpereira@noblefcm.com

Thursday, May 02, 2024

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

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

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

Q1 beat. Conduent is in a period of transition, given that it is in the process of monetizing non-core assets. While year-over-year comparisons will be difficult to make, the company reported Q1 revenue and adj. EBITDA that were better than our expectations.

Positive commercial trends. Management noted that business activity in its Commercial segment (50% of total revenue) is improving in 2024 as client companies seek ways to restore projects while reducing costs. This could benefit Conduent, particularly for its outsourcing services.

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

Comstock Inc. (LODE) – Concerns About Near-Term Liquidity; Rating Lowered to Market Perform

Posted on May 2, 2024May 2, 2024 by cpereira@noblefcm.com

Thursday, May 02, 2024

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Rating changed to a Market Perform. We have lowered our investment rating to Market Perform from Outperform pending significant improvement in the company’s liquidity position and a visible path toward net income and cash flow growth from operations. Outside of its mining assets, the company operates much as a start-up within its Fuels and Metals businesses. We think those segments may require significant capital investment and we would like to see a clearer funding path. Additionally, we would like more details such as the components that drive the economics of the business models for each segment (i.e. terms of licensing agreements, royalties, and fees for engineering services).

First quarter 2024 achievements. Comstock achieved significant milestones during the first quarter, including securing all required operating permits and the commencement of production at its photovoltaic recycling facility in Nevada. Comstock Fuels commenced sample production of commercially available hydro-deoxygenated bioleum oil (HBO) and executed agreements for up to a $3 million investment in RenFuel K2B AB. Lastly, Comstock Mining updated its internal Dayton-Spring Valley economic assessment and expects to complete a mine plan by year-end 2024.

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

Fed Keeps Interest Rates at Historic 23-Year High

Posted on May 2, 2024May 2, 2024 by slightbourne@noblecapitalmarkets.com

In a widely anticipated move, the Federal Reserve held its benchmark interest rate steady at a towering 5.25%-5.5% range, the highest level since 2001. The decision reinforces the central bank’s steadfast commitment to quashing stubbornly high inflation, even at the risk of delivering further blows to economic growth.

The lack of a rate hike provides a temporary reprieve for consumers and businesses already grappling with the sharpest lending rate increases since the Volcker era of the early 1980s. However, this pause in rate hikes could prove fleeting if inflationary pressures do not begin to subside in the coming months. The Fed made clear its willingness to resume raising rates if inflation remains persistently elevated.

In its latest policy statement, the Fed bluntly stated there has been “a lack of further progress toward the committee’s 2% inflation objective.” This frank admission indicates the central bank is digging in for what could be an extended trek back to its elusive 2% inflation goal.

During the subsequent press conference, Fed Chair Jerome Powell struck a hawkish tone, emphasizing that policymakers require “greater confidence” that inflation is headed sustainably lower before contemplating any rate cuts. This stance contrasts with the Fed’s projections just two months ago that suggested multiple rate reductions could materialize in 2024.

“I don’t know how long it will take, but when we get that confidence rate cuts will be in scope,” Powell stated, adding “there are paths to not cutting and there are paths to cutting.”

The Fed’s preferred core PCE inflation gauge continues to defy its efforts thus far. In March, the index measuring consumer prices excluding food and energy surged 4.4% on an annualized three-month basis, more than double the 2% target.

These stubbornly high readings have effectively forced the Fed to rip up its previous rate projections and adopt a more data-dependent, improvised policy approach. Powell acknowledged the path forward is shrouded in uncertainty.

“If inflation remains sticky and the labor market remains strong, that would be a case where it would be appropriate to hold off on rate cuts,” the Fed Chair warned. Conversely, if inflation miraculously reverses course or the labor market unexpectedly weakens, rate cuts could eventually follow.

For now, the Fed appears willing to hold rates at peak levels and allow its cumulative 5 percentage points of rate increases since March 2022 to further soak into the economy and job market. Doing so risks propelling the United States into a recession as borrowing costs for mortgages, auto loans, credit cards and business investments remain severely elevated.

Underscoring the challenging economic crosswinds, the policy statement acknowledged that “risks to achieving the Fed’s employment and inflation goals have moved toward better balance over the past year.” In other words, the once-overheated labor market may be gradually cooling, while goods price inflation remains problematic.

The only minor adjustment announced was a further slowing of the Fed’s balance sheet reduction program beginning in June. The monthly caps on runoff will be lowered to $25 billion for Treasuries and $35 billion for mortgage-backed securities.

While seemingly a sideshow compared to the main event of interest rate policy, this technical adjustment could help alleviate some recent stresses and volatility in the Treasury market that threatened to drive up borrowing costs for consumers and businesses.

Overall, the Fed’s latest decision exemplifies its unyielding battle against inflation, even at the cost of potential economic pain and a recession. Having surged the policy rate higher at the fastest pace in decades, returning to a 2% inflation environment has proven far trickier than battling the disinflationary forces that characterized most of the post-1980s era.

For investors, the combination of extended high rates and economic uncertainty poses a challenging environment requiring deft navigation of both equity and fixed income markets. Staying nimble and diversified appears prudent as the ferocious inflation fight by the Fed rages on.