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Release – Conduent Implements Technologies to Help South Carolina EBT Cardholders Protect SNAP and Other Benefits from Fraud

Posted on April 11, 2024April 11, 2024 by aweinsoff@channelchek.com

APRIL 11, 2024

The technologies can help agencies and beneficiaries nationwide prevent EBT fraud targeting nutrition assistance and other cash-aid programs

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, has implemented technologies for the South Carolina Department of Social Services (SCDSS) to help combat fraud and further enhance the security of the state’s Electronic Benefits Transfer (EBT) program. In South Carolina and other states, EBT fraud targeting the Supplemental Nutrition Assistance Program (SNAP) and other cash benefits adds costs to government agencies and causes challenges for the recipients who depend on these benefits.

“Our agency is continually working with Conduent to deploy new strategies and safeguards to prevent our clients from becoming fraud victims.”

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The fraud-reducing technologies are part of a suite of tools Conduent offers that can assist agencies and beneficiaries nationwide in protecting government aid for nutrition assistance, unemployment insurance and other cash-aid programs.

“SNAP beneficiaries rely on benefits to help supplement their monthly food budget to feed their families. When these benefits are stolen from them through fraud, that can result in less food on a family’s dinner table and hungry homes,” said Michael Leach, SCDSS State Director. “Our agency is continually working with Conduent to deploy new strategies and safeguards to prevent our clients from becoming fraud victims.”

Last year, Conduent implemented an advanced interactive voice response (IVR) system technology for South Carolina’s EBT customer service center that automatically identifies suspicious phone call patterns, such as an unusually high number of calls from a single phone number. When threats are identified, the technology can prevent access to EBT account information in real time.

South Carolina has also made an account protection feature available to beneficiaries, allowing them to easily and quickly lock and unlock their benefits card using Conduent’s ConnectEBT mobile app and cardholder portal. This feature, which applies to both in-state and out-of-state purchases, provides cardholders more control and security in managing their accounts and helps prevent perpetrators from gaining access to their benefits. Other states including Iowa, Maryland, New York and Ohio have also implemented this ConnectEBT feature.

In addition, for South Carolina, Conduent implemented the ability for cardholders to receive and manage usage alerts for identifying suspicious transaction activity on their EBT accounts. This feature can help beneficiaries monitor, spot and report the suspicious activity in real-time.

SCDSS says it will never send clients a text message about locking a card and requiring a SNAP recipient to contact a 1-888 number and provide the client’s EBT card number to unlock the benefits. To report suspicious activity or SNAP fraud, the public is encouraged to make a report to the USDA Office of the Inspector General at 1-800-424-9121 or online here.

“We’re proud and excited to bring these enhanced benefit protection features to South Carolina as well as other states,” said Wade Fairey, General Manager, Payments and Child Support Solutions at Conduent. “We’re providing agencies with security tools and technologies that help ensure states can most effectively serve their EBT constituents. These features are designed to help states curb unauthorized access to accounts and ensure that funds go to the intended benefits recipients.”

About Conduent
Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduent, http://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

Trademarks
Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

Media Contacts

NEIL FRANZ

Conduent

neil.franz@conduent.com

+1-240-687-0127

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546

Release – 1-800-FLOWERS.COM, Inc. to Release its Fiscal 2024 Third Quarter Results on Thursday, May 2, 2024

Posted on April 11, 2024April 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on FLWS

Apr 11, 2024

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2024 third quarter on Thursday, May 2, 2024. The press release will be issued prior to market opening and will be followed by a conference call with members of senior management at 8:00 a.m. (ET).

The conference call will be available via live webcast from the Investors section of the Company’s website at www.1800flowersinc.com/investors. A recording of the call will be posted on the website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) on May 2, 2024, through May 9, 2024, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID: #4365463.

Special Note Regarding Forward-Looking Statements:

Some of the statements contained in the Company’s scheduled Thursday, May 2, 2024, press release and conference call regarding its results for its fiscal 2024 third quarter, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.

About 1-800-FLOWERS.COM, Inc.

1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, and Simply Chocolate®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; and Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized among the top 5 on the National Retail Federation’s 2021 Hot 25 Retailers list, which ranks the nation’s fastest-growing retail companies, and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com or follow @1800FLOWERSInc on Twitter.

FLWS-COMP
FLWS-FN

View source version on businesswire.com: https://www.businesswire.com/news/home/20240411068070/en/

Investor:

Andy Milevoj

(516) 237-4617

amilevoj@1800flowers.com

Media:

Cherie Gallarello

cgallarello@1800flowers.com

Source: 1-800-FLOWERS.COM, Inc.

Release – Snail Inc. Unveils Release Date for Anticipated Title, Bellwright

Posted on April 11, 2024April 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on SNAL

April 11, 2024 at 9:00 AM EDT

CULVER CITY, Calif., April 11, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, is thrilled to announce its much-anticipated title, “Bellwright” is officially launching into Early Access on Steam, on April 23^rd, 2024, at 12:00 pm UTC.

Bellwright promises to be a groundbreaking addition to Snail’s portfolio, offering an immersive gaming experience that transcends traditional gaming. Bellwright is a city builder, RPG, and survival strategy game where players are the leaders and catalysts of a revolution. Set in a rich and dynamic world filled with intricate storytelling and innovative gameplay mechanics, Bellwright brings something unique to the gaming landscape.

Following the success of Snail Inc.’s recent releases, including ARK Survival Ascended’s “Scorched Earth” map and “Bob’s Tall Tales” DLC, Snail Inc. is set to maintain its momentum entering the second quarter of 2024. ARK: Survival Ascended and Bob’s Tall Tales were both in the top three selling software on Steam at launch. These successes, resulting in an approximately 400% player increase on one of Snail’s biggest titles, serve as a testament to Snail’s dedication to delivering immersive experiences that resonate with players.

Bellwright underwent a sneak peek creator beta test last month, generating overwhelmingly positive feedback from participants. This successful beta test further solidified Snail’s confidence in the game’s potential to resonate with players. “I think we’ll be playing more of it. This first look is good, but … the more we play the better it will get.” -Raptor (Streamer and YouTube Creator)

“We are incredibly excited to unveil Bellwright to the world,” said Jim Tsai, CEO of Snail, Inc. “With its compelling narrative and immersive gameplay, we believe Bellwright has the potential to captivate players and become a long-term success.”

As Bellwright’s official release date approaches, Snail Inc. remains committed to delivering value to shareholders and stakeholders.

For more information, visit Snail Games.

About Snail, Inc.

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

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations, including the scheduled release date of ‘Bellwright’ and the overall acceptance and positive feedback of ‘Bellwright’ by players. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed by the Company with the SEC on April 1, 2024, and other documents filed by the Company from time to time with the SEC. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.

Contacts:

Investors:

investors@snail.com

Press:

media@snail.com

Release – ISG to Announce First-Quarter Financial Results

Posted on April 11, 2024April 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on III

4/10/2024

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, said today it will release its first-quarter financial results on Thursday, May 9, 2024, at approximately 4:15 p.m., U.S. Eastern Time.

The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Friday, May 10. Dial-in details are as follows:

The dial-in number for U.S. participants is +1 (800) 715-9871.
International participants should call +1 (646) 307-1963.
The security code to access the call is 7294332.

Participants are requested to dial in at least five minutes before the scheduled start time.

A recording of the conference call will be accessible on ISG’s investor relations page for approximately four weeks following the call.

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 – NN, Inc. Announces Jeff Tritapoe as Vice President Of Global Operations

Posted on April 11, 2024April 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on NNBR

PDF Version

30 Year Veteran Brings Decades of Manufacturing, Operations, and Business Transformation Expertise to NN, Inc.

CHARLOTTE, N.C., April 10, 2024 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced the appointment of Jeff Tritapoe as Vice President of Global Operations, effective April 10, 2024. In this newly created position, Jeff will be a key leader responsible for driving the company’s operations team of approximately 3,000 employees in six countries and helping generate significant business transformation, margin enhancement and operational excellence. Mr. Tritapoe brings over 30 years of experience in manufacturing, operations and business transformation. He will report directly to Tim French, NN’s Chief Operating Officer.

“Jeff is a proven operational leader with decades of experience in the industrial, vehicle and medical manufacturing markets. His global experience driving productivity, optimizing footprints, launching new programs, and improving quality in highly technical manufacturing environments will add a key element to the NN team and accelerate our ongoing transformation plan – both cost and growth,” said Mr. French. “Harold Bevis and I have both worked with Jeff in similar situations in the past and are excited to bring him to the NN team. Jeff is an expert in driving operational excellence as well as JIT and Pull manufacturing systems, and medical and automotive PPAP processes. He is a footprint expert and has closed high-cost plants and built plants in low-cost countries including Mexico and China. Jeff will be instrumental in NN’s future success.”

“I am excited to be joining the NN team and getting back together with Harold and Tim. We all share the same commitment to speed and accountability,” said Mr. Tritapoe. “NN possesses tremendous potential. Their precision engineering experience and global manufacturing footprint are perfectly suited to grow above market rates in their chosen markets. I am looking forward to adding my experience to the NN team and help continue the transformation already underway.”

Mr. Tritapoe, a native of South Carolina, is a results-driven executive with over 30 years of experience in streamlining operations, optimizing productivity and driving business growth. He brings proven expertise in implementing strategic initiatives, managing cross-functional teams and ensuring operational excellence, and a commitment to delivering exceptional results through effective leadership and collaboration. Mr. Tritapoe’s focused expertise includes oversight of all aspects of manufacturing operations, including production planning, quality control, supply chain management, and cost/capacity/operational optimization.

Jeff has served as Chief Operating Officer and SVP Global Operations, as well as other senior operational leadership positions for both public and private companies. He most recently worked at Commercial Vehicle Group. He holds a BS in Mechanical Engineering from the University of Tennessee and an MS in Industrial Engineering from the University of Tennessee Space Institute. He has extensive experience in lean manufacturing, Kaizen and 6 Sigma processes having attained Black Belt and DFSS Certifications.

About NN, Inc.
NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.

FORWARD-LOOKING STATEMENTS
Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises, including the COVID-19 pandemic, on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, and the availability of labor; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; unanticipated difficulties integrating acquisitions; new laws and governmental regulations; the impact of climate change on our operations; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Contact:
Tim Peters
Media Contact
+1 312 445 2874
tim.peters@alphaadvgroup.com

Joseph Caminiti, CFA
Investor Relations Contact
joseph.caminiti@alpha-ir.com
+1 312 445 2864

Source: NN, Inc.

Tonix Pharmaceuticals (TNXP) – Increasing The Focus on Fibromyalgia

Posted on April 11, 2024April 11, 2024 by cpereira@noblefcm.com

Thursday, April 11, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

We Expect Tonmya To Drive TNXP Forward. Since announcing successful Phase 3 RESILIENT trial data in late December, Tonix has been shifting its development and financial strategy to focus on filing the NDA for Tonmya approval during 2H24. The company has raised capital and plans lower R&D expenses to preserve cash. We have revised our earnings estimates and price target while maintaining our Outperform rating.

Tonix Will Focus On Products For CNS Disorders and Reduce Expenses. Tonix has developed broad pipeline of products in infectious disease, biodefense, and immunology that grew from its original work in neurology and immunology. In the coming year, it will focus on the NDA filing and premarketing activities for Tonmya. We have reduced our clinical expenses estimates, since the large trials have been completed and no late-stage trials are scheduled.

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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.

Alliance Resource Partners (ARLP) – Lowering Near-Term Estimates to Reflect More Conservative Pricing and Cost Assumptions

Posted on April 11, 2024April 11, 2024 by cpereira@noblefcm.com

Thursday, April 11, 2024

ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.

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.

Updating estimates. We have lowered our 2024 EBITDA and EPU estimates to $841.1 million and $3.90 from $846.9 million and $3.98, respectively. Among our revisions, we have lowered our coal price assumptions, increased our expense estimates, and made minor changes in our unit count. Our estimates remain within the partnership’s guidance ranges and are summarized within this report.

New officer appointment. Mr. Steven Schnitzer recently joined the general partner of ARLP as Senior Vice President, General Counsel and Secretary. Mr. Schnitzer was involved in the 1996 leveraged buy-out of MAPCO Coal, now Alliance Resource Partners, and regularly represented the partnership until 2014 when he left private practice. His experience working with companies in the natural resources and energy transition fields will be helpful as Alliance pursues growth opportunities within and outside its traditional businesses. Most recently, Mr. Schnitzer served as Chief Legal Officer and Secretary of a commercial and industrial solar generation and battery storage developer.

Get the Full Report

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

Century Therapeutics Makes Bold Move in Autoimmune Disease and Cell Therapy

Posted on April 11, 2024April 11, 2024 by slightbourne@noblecapitalmarkets.com

Century Therapeutics, a pioneering biotech company developing induced pluripotent stem cell (iPSC)-derived cell therapies, announced a transformative set of initiatives that could reshape the landscape of cell therapy in cancer and autoimmune diseases.

The centerpiece is an ambitious expansion of Century’s lead program CNTY-101, a novel CD19-targeting immune cell therapy, into multiple autoimmune indications beyond the previously planned systemic lupus erythematosus (SLE) trial. This strategic pivot is backed by a $60 million private financing round and bolstered by the acquisition of Clade Therapeutics.

CNTY-101 is an allogeneic, iPSC-derived natural killer (iNK) cell therapy that has shown promising potential in eradicating cancerous B-cells in early clinical trials. Century believes its unique design, including gene edits to enable repeat dosing without lymphodepletion, could make it an ideal therapy for autoimmune diseases driven by B-cell dysregulation.

“We’ve seen compelling translational data pointing to CNTY-101’s potential in diseases like lupus,” said Century CEO Brent Pfeiffenberger. “This financing allows us to aggressively pursue that opportunity across multiple autoimmune indications with high unmet need.”

While the SLE trial remains on track for 2024, Century plans additional regulatory filings for CNTY-101 in autoimmune diseases in the second half of this year, supported by the $60 million raise from investors like Bain Capital Life Sciences and Adage Capital.

But the company didn’t stop there. Century also acquired Clade Therapeutics and its innovative iPSC-derived alpha beta T-cell platform for $35 million upfront, with potential future milestones. The deal adds three promising preclinical cancer and autoimmune programs to Century’s pipeline.

More importantly, it provides Century with next-generation capabilities to manufacture highly-functional, engineered T-cell therapies from iPSCs, something the field has long sought after.

“Clade’s groundbreaking platform replicates the natural T-cell development process, overcoming key limitations of current therapies,” said Century R&D President Hy Levitsky, M.D. “Combined with our iPSC-derived NK and gamma delta T-cells, this gives us unparalleled ability to create potential cures across a wide range of diseases.”

The move establishes Century as a preeminent player in allogeneic, off-the-shelf iPSC cell therapy, with an arsenal of NK cells, alpha beta T-cells, and gamma delta T-cells for oncology and autoimmune diseases. It diversifies the pipeline with complementary assets while providing a renewable cell source to manufacture consistent, high-quality therapies.

While still in early stages, some analysts view this as an aggressive and smart play by Century to stay ahead of the competition in this rapidly evolving space. By expanding into autoimmune diseases, acquiring transformative technology, and putting significant capital behind it all, Century is cementing its position as an iPSC cell therapy leader looking to deliver on the modality’s long-awaited promise.

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Biotech Buzz: Adial and Skye Bioscience Deliver Promising Updates Amid Sector Momentum

Posted on April 10, 2024April 10, 2024 by slightbourne@noblecapitalmarkets.com

The biotech and healthcare sectors have seen a flurry of activity in recent weeks, with companies making strides through drug developments, clinical trials, and corporate milestones. Two firms generating buzz today are Adial Pharmaceuticals (ADIL) and Skye Bioscience (SKYE), both reporting encouraging news that has fueled investor interest.

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing addiction therapies, announced the publication of a peer-reviewed article highlighting the promising safety data and high patient compliance observed with its lead investigational drug AD04 in a Phase 3 clinical trial for alcohol use disorder (AUD).

The study, published in the European Journal of Internal Medicine, comprehensively analyzed the liver safety profile of low-dose AD04 compared to a placebo in patients with AUD and a specific genetic profile. Notably, AD04 did not significantly impact biochemical markers of liver injury like ALT, AST, and bilirubin levels, underscoring its potential to address AUD while mitigating liver damage risks.

Moreover, AD04 demonstrated an impressive safety and tolerability profile, with low adverse event occurrence, high medication adherence, and minimal dropout rates – a rarity for AUD treatments. Adial’s CEO, Cary Claiborne, expressed enthusiasm about providing a precision treatment tailored to individuals with AUD, potentially offering a novel approach to managing alcohol consumption and liver harm.

Separately, Skye Bioscience (SKYE), a clinical-stage biotech focused on the endocannabinoid system, achieved a significant milestone by uplisting its common stock to the Nasdaq Global Market. Trading under the ticker “SKYE” is expected to commence on April 11th.

The Nasdaq uplisting is a testament to Skye’s recent accomplishments, including advancing its Phase 2 clinical programs, strengthening its financial position, and broadening its shareholder base. As CFO Kaitlyn Arsenault noted, the move aims to enhance visibility, liquidity, and ultimately drive long-term shareholder value.

Skye’s pipeline includes SBI-100 Ophthalmic Emulsion, a CB1 agonist being studied in a Phase 2 trial for glaucoma and ocular hypertension, with top-line data expected this quarter. Additionally, the company plans to launch a Phase 2 clinical trial in Q3 2024 for nimacimab, a peripheral CB1 inhibitor, targeting obesity through monotherapy and combination arms with a GLP-1R agonist.

These developments from Adial and Skye underscore the vibrant activity within the biotech and healthcare sectors, where companies are continuously striving to advance innovative therapies and achieve corporate milestones.

Contributing to the sector’s momentum is the upcoming Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference, taking place on April 17-18. This premier event will bring together industry leaders, investors, and emerging companies, providing a platform to showcase groundbreaking research, discuss market trends, and explore potential partnerships and collaborations.

With the biotech and healthcare industries consistently evolving, such conferences play a crucial role in fostering collaboration, facilitating knowledge-sharing, and driving progress towards improving patient outcomes and advancing healthcare solutions.

As companies like Adial and Skye continue to make strides, the broader biotech and healthcare sectors remain vibrant and poised for growth, fueled by scientific advancements, regulatory approvals, and investor confidence. The upcoming Noble Capital Markets Virtual Healthcare Conference promises to further catalyze innovation and propel the industry forward.

Click here to register for the Emerging Growth Virtual Healthcare Equity Conference.

Hotter Inflation Pushes Back Expected Fed Rate Cuts

Posted on April 10, 2024April 10, 2024 by slightbourne@noblecapitalmarkets.com

Inflation picked up speed in March, with consumer prices rising at a faster pace than anticipated. The higher-than-expected inflation data throw cold water on hopes that the Federal Reserve will be able to start cutting interest rates anytime soon.

The Consumer Price Index (CPI), which measures the costs of a broad basket of goods and services across the economy, rose 0.4% in March from the previous month. That pushed the 12-month inflation rate up to 3.5% compared to 3.2% in the year through February.

Economists had forecast the CPI would rise 0.3% on a monthly basis and 3.4% annually.

The acceleration in inflation was driven primarily by two major categories – shelter and energy costs.

Housing costs, which make up about one-third of the CPI’s weighting, climbed 0.4% from February and are now up 5.7% over the past 12 months. Rising rents and home prices get reflected in the shelter component.

Energy prices increased 1.1% in March after already jumping 2.3% in February. Gasoline costs have remained elevated despite recent pullbacks.

Stripping out the volatile food and energy components, core CPI also rose 0.4% for the month and 3.8% annually – both higher than expected.

The stronger-than-expected inflation readings make it more challenging for the Fed to start lowering interest rates in the coming months as financial markets had anticipated. Traders had priced in expectations that the first rate cut would occur by June based on Chairman Jerome Powell’s comments that inflation was headed lower.

However, following the hot March data, markets now project the Fed’s first rate reduction won’t come until September at the earliest. Some economists believe even a July rate cut now looks unlikely.

The acceleration in inflation puts the Fed in a difficult position as it tries to navigate bringing stubbornly high price pressures under control without crashing the economy. Policymakers have emphasized the need to see more concrete evidence that inflation is cooling in a sustained way before easing up on rate hikes.

Fed officials have pointed to an expected deceleration in housing costs, which tend to be sticky, as a key reason inflation should slow in the coming months. But the March data showed rents continuing to increase at an elevated pace.

The services inflation component excluding energy picked up to a 5.4% annual rate. The Fed views services prices as a better indicator of more durable inflationary pressures in the economy.

Some bright spots in the report included lower used vehicle prices, which declined 1.1%. Food costs only increased 0.1% with lower prices for butter, cereal and baked goods offsetting a big 4.6% jump in egg prices.

Overall, the March CPI report suggests the Fed still has more work to do in taming inflation back to its 2% target. Traders are now pricing in higher terminal interest rates and little chance of rate cuts in 2023 following the inflation surprise.

Persistently elevated inflation could ultimately force the Fed to hike rates higher than expected, raising risks of a harder economic slowdown. The central bank will provide more clues on its policy outlook when it releases minutes from its March meeting on Wednesday afternoon.

For consumers feeling the pinch of high prices, the March CPI data means little relief is likely coming anytime soon on the inflation front. The big question is how long stubbornly high inflation will persist and exacerbate the already difficult trade-offs facing the Federal Reserve.

Release – Comtech Partners with Arizona to Complete Transition to Statewide Next Generation 911 Services

Posted on April 10, 2024April 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CMTL

BY THE COMTECH EDITORIAL TEAM – APR 10, 2024 | 2 MIN READ

CHANDLER, Ariz. – April 10, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, in partnership with the Arizona Department of Administrations (“ADOA”), today announced the successful completion of a statewide transition to Comtech’s Next Generation 911 (“NG911”) services. Arizona’s new statewide NG911 infrastructure is designed to significantly enhance the ability of first responders and public safety answering points (“PSAPs”) to respond faster to emergencies and provide more comprehensive and reliable 911 services to Arizona residents.

In less than two years, Comtech and the ADOA successfully migrated the state’s legacy 911 system to the new infrastructure. The Arizona NG911 program modernizes the state’s emergency response capabilities and enhances the efficiency, effectiveness and reliability of 911 services, while enabling new capabilities such as geospatial location routing and improved redundancy, as well as the implementation of a new Emergency Service IP Network (“ESiNET”).

“We are honored to partner with the State of Arizona to deploy one of the nation’s most robust NG911 infrastructures,” said John Ratigan, Interim CEO of Comtech. “With this statewide deployment, Arizona residents benefit from a much higher rate of call reliability and new multi-media and location services, which can save critical time during emergencies. Comtech has worked closely with the ADOA and state leaders to integrate multiple legacy networks to create a new unified NG911 infrastructure, and we are confident this transition helps ensure residents get the help they need when seconds matter most.”

“The efficiency of this deployment can serve as a model for the rest of the United States, and we are pleased to work with Comtech to roll out these lifesaving NG911 services to better protect Arizona residents,” said Travis Jensen, Program Administrator of the ADOA 911 Program. “We look forward to continuing our partnership and bringing new capabilities to residents as they become available.”

The Arizona NG911 statewide transition involved upgrading and integrating a wide range of 911 technologies, including call handling, dispatch, mapping and database systems. It also required implementing new protocols and standards to ensure interoperability and compatibility with other systems and networks.

As one of the most trusted providers of public safety technologies, Comtech is continuing to expand its NG911 offerings for governments and emergency response providers around the world. The Company’s NG911 systems are designed to adapt and continuously evolve over time to meet the needs of emerging use cases as well as future applications.

About Comtech

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

Forward-Looking Statements

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

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20240409404955/en/

Investor Relations

Maria Ceriello

631-962-7102

investors@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Ocugen, Inc. Announces Positive Scientific Advice From The European Medicines Agency Related To The Approval Pathway For OCU400—Modifier Gene Therapy For Broad Retinitis Pigmentosa Indication

Posted on April 10, 2024April 10, 2024 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 10, 2024

MALVERN, Pa., April 10, 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 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the pivotal OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and provided acceptability of the U.S.-based trial for submission of a Marketing Authorization Application (MAA).

EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study. The Phase 3 liMeliGhT study will have a sample size of 150 participants primarily in the U.S.—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic (representing multiple gene mutations associated with RP). In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 10¹⁰ vg/eye of OCU400) and untreated control group, respectively.

The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400. OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication. Previously, OCU400 received broad Orphan Drug Designation for RP and Leber congenital amaurosis in the EU.

“We are very grateful to EMA for their collaborative discussions and support in providing a gene-agnostic therapeutic option to RP patients with severe unmet medical need,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “This positive opinion is a critical step in providing our game-changing modifier gene therapies to patients globally.”

The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. With this milestone, OCU400 remains on track for 2026 BLA and MAA approval targets.

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on 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 inherited retinal diseases.

About RP
RP is a group of rare, genetic disorders that involve a breakdown and loss of cells in the retina, leading to vision loss and blindness. Currently, RP is associated with mutations in more than 100 genes.

There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene-replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene-replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retina degeneration. Therefore, the development of gene-specific replacement therapy is highly challenging, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting broader RP disease in a gene agnostic manner offer greater hope for patients.

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

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

Release – Unicycive Therapeutics to Present At The Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

Posted on April 10, 2024April 10, 2024 by aweinsoff@channelchek.com

Research News and Market Data on UNCY

April 10, 2024 7:03am EDT

LOS ALTOS, Calif., April 10, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer will present a company update at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on Thursday April 18, 2024 at 11:00 a.m. ET.

A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Released April 10, 2024