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Release – The GEO Group Announces Funding Extension for Adelanto ICE Processing Center Contract

Posted on May 20, 2024May 20, 2024 by dburczyk@noblecapitalmarkets.com

BOCA RATON, Fla.–(BUSINESS WIRE)–May 20, 2024– The GEO Group (NYSE: GEO) (“GEO”) announced today that U.S. Immigration and Customs Enforcement (“ICE”) announced that it plans to issue a task order for the GEO-owned 1,940-bed Adelanto ICE Processing Center in California (the “Adelanto Center”), which provides for continued funding through September 30, 2024.

GEO previously filed motions, on January 4, 2024, with the U.S. District Court, Central District of California, in the case of Roman v. Wolf, to Intervene and to Vacate several injunction orders (collectively the “Orders”) including an intake prohibition order issued more than three years ago, limiting the use of the Adelanto Center based on then-prevailing COVID-19 conditions. GEO was joined in its filings by three unions (collectively the “Unions”) representing over 350 employees at the Adelanto Center. Subsequently, on April 22, 2024, GEO and the Unions filed a renewed motion with the U.S. Court of Appeals for the Ninth Circuit to intervene in the case of Roman v. Wolf, with a proposed motion to stay the Orders. GEO and the Unions will continue to pursue legal action to protect GEO’s and the Unions’ interests, which include the Adelanto Center contract’s annualized revenues and the potential loss of jobs by 350-plus employees.

ICE and GEO entered into a 15-year contract on December 19, 2019, for the provision of secure residential housing and care at the Adelanto Center, consisting of a 5-year base period, ending on December 19, 2024, followed by two 5-year option periods. The Adelanto Center contract generates approximately $85 million in annualized revenues for GEO.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements, including statements regarding GEO’s filings in the case of Roman v. Wolf,statements regarding the Orders, and statements regarding the Adelanto Center contract. Risks and uncertainties that could cause actual results to vary from current expectations and forward-looking statements contained in this press release include, but are not limited to, risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K, 10-Q, and 8-K reports. GEO disclaims any obligation to update or revise any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240517420374/en/

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Snail (SNAL) – Patiently Waiting for the ARK

Posted on May 20, 2024May 20, 2024 by cpereira@noblefcm.com

Monday, May 20, 2024

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

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

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

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

Q1 results. The company reported Q1 revenue of $14.1 million, and adj. EBITDA loss of $1.9 million, both of which were lower than our estimates of $24.0 million and $2.8 million, respectively. Notably, the company deferred $5.5 million of revenue in the quarter, which contributed to the shortfall. We expect revenue deferrals and the technology gap to cause some noise in operating results during 2024.

Technology gap. Importantly, we believe there is a technology gap between ASA and some of the user base’s PC equipment, which dampened sales of the game. We believe the closing of the technology gap could also lead to a more steady sales profile of the game over a longer period of time as users upgrade their hardware and migrate to ASA.

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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) – An Interesting Turn of Events

Posted on May 20, 2024May 20, 2024 by cpereira@noblefcm.com

Monday, May 20, 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.

Location, location. Alliance is the largest coal producer in the eastern U.S. with operations in the Illinois Basin and Appalachia. The partnership produces a diverse range of thermal coals with high heat content and benefits from access to both domestic and export markets. With demand for electricity expected to grow, Alliance is well-positioned to increase its market share despite efforts to curb coal-fired generation and coal’s declining share of the electricity generation market. Closure dates for coal-fired power plants are being delayed due to growing energy demand and reliability concerns.

Trouble brewing in the Powder River Basin (PRB)? Last week the Bureau of Land Management (BLM) proposed ending federal coal leasing in the Powder River Basin. The PRB includes Wyoming and Montana and accounted for 44% of the coal produced in the United States in 2022. The Bureau expects coal production in Wyoming to continue through 2041 under existing leases. While we expect the ruling to be challenged, it underscores the uncertainty and challenges facing coal mining operations on federally leased lands. The BLM manages public land in the western United States. In our view, coal could turn into an increasingly scarce resource in the United States which could be supportive of pricing.

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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).

Dow Smashes Through 40,000 as Unstoppable Rally Reaches New Heights

Posted on May 20, 2024May 20, 2024 by slightbourne@noblecapitalmarkets.com

In a feat cementing the relentless momentum of the historic bull market, the Dow Jones Industrial Average has obliterated the 40,000 milestone for the first time ever. The blue-chip index’s new record high represents the culmination of a stupendous 15-month surge, defying fears of an economic downturn while leaving skeptics grasping for explanations.

The Dow’s ascension through 40,000 highlights the astounding resilience fueling U.S. equities. Robust corporate profits, rapidly cooling inflation, and rising optimism over the Federal Reserve’s ability to orchestrate a “soft landing” have emboldened investors. Propelling the rally, expectations have solidified that the central bank is nearing the conclusion of its aggressive rate hiking campaign to subdue elevated prices.

Market pricing now reflects two quarter-point interest rate cuts likely by year-end, with overwhelming odds of the first reduction materializing as soon as September. The dovish pivot aligns with this week’s cooler-than-anticipated consumer price data, relieving pressure on the Fed to maintain its hawkish posture.

The Dow’s remarkable feat has been powered by heroic gains among its elite constituents throughout 2023. Semiconductor titan Nvidia has skyrocketed 94% higher amid the AI frenzy. Industrial titans like 3M, Salesforce, Boeing and Walgreens Boots Alliance have all tacked on over 20%. Even beleaguered First Republic Bank remains up 17% year-to-date despite its recent turmoil.

For investors, the Dow’s breach of 40,000 represents the proverbial pot of gold at the end of the rainbow. The milestone solidifies the “Goldilocks” scenario playing out of moderating inflation and resilient growth, providing a springboard for further gains as concerns over economic overheating fade. While risks remain of a potential inflationary resurgence, excessively tight labor conditions forcing more Fed hawkishness, or a hard landing, the prevailing mood is overwhelmingly bullish.

Stretched valuations, with the S&P 500 trading north of 20x forward earnings, represent a valid concern. But traders and Wall Street strategists remain steadfastly focused on embracing the upside, brushing aside such worries amid a torrent of positive price momentum and fundamentals. The Dow’s coronation at 40,000 is emblematic of this euphoric mindset.

For the record books, the Dow ultimately settled the session at 39,869.38, up over 19% year-to-date after reaching an intraday record of 40,038.87 before paring gains. While symbolic, the new milestone supremely underscores the dynamism and strength across Corporate America’s boardrooms and C-suites. With earnings continuing to impress amid the rate cutting pivot, many on Wall Street expect the stock market’s electrifying run to continue regaling investors.

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Release – GeoVax to Raise Approximately $1.3 Million of Gross Proceeds in Offering Priced At-the-Market

Posted on May 17, 2024May 17, 2024 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, May 17, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 802,844 shares of the Company’s common stock (or common stock equivalents) at a price of $1.68 per share in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 1,605,688 shares of common stock. The warrants have an exercise price of $1.68 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $1.3 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about May 21, 2024, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a ‘shelf’ registration statement on Form S-3 (File No. 277585) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on March 13, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	austin.murtagh@sternir.com	sr@roberts-communications.com
678-384-7220	212-698-8696	202-779-0929

Schwazze (SHWZ) – In for the Long Haul

Posted on May 17, 2024May 17, 2024 by cpereira@noblefcm.com

Friday, May 17, 2024

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, CFA, 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.

1Q24 Results. Revenue of $41.6 million was up 4% y-o-y, driven by new store growth. Gross margin declined to 43.1% from 54.6% due to pricing pressure in New Mexico and a higher mix of lower margined medical sales. Schwazze reported an operating loss of $2.7 million compared to $5.6 million of operating profit in 1Q23. GAAP net loss totaled $18.2 million, or a loss of $0.24/sh, versus essentially breakeven last year. We had estimated revenue of $42.5 million and a net loss of $11.6 million, or a loss of $0.16/sh.

Environment Still Challenging. The Colorado and New Mexico markets remain some of the most competitive cannabis markets in the country. A supply/demand situation still coming into balance and too many retail locations will continue to impact both markets in the near-term.

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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).

Bit Digital (BTBT) – AI Showing its Impact

Posted on May 17, 2024May 17, 2024 by cpereira@noblefcm.com

Friday, May 17, 2024

Joe Gomes, CFA, 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.

AI Adding to Growth. Total revenue for the first quarter was $30.3 million compared to $8.3 million in the prior year. This surpassed our $23.5 million estimate, as a higher bitcoin price and the Company’s inclusion of AI revenue led to the increase. The AI revenue comes from the Company’s anchor AI contract with expected annualized revenue of $50 million. We believe the AI contract provides an alternative revenue stream non-correlated to the cryptocurrency market.

Potential for More Soon. Although the $50 million contract is in place, earlier in the year Bit Digital received a proposal for an expansion of its contract. With the expansion, the proposal calls for an additional 2,048 GPUs on top of the 2,048 GPUs already in the contract, effectively doubling revenue to $100 million. The Company is currently in talks with the client on the terms of the expansion and we expect an announcement in the coming weeks.

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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).

Crescent Shells Out $2.1 Billion for Massive Eagle Ford Upgrade

Posted on May 17, 2024May 20, 2024 by slightbourne@noblecapitalmarkets.com

In a transformative transaction for the U.S. shale industry, Crescent Energy Company has agreed to acquire rival Eagle Ford producer SilverBow Resources in an all-stock deal valued at $2.1 billion. The combination solidifies Crescent’s position as a leading player in the prolific Eagle Ford basin of South Texas, creating the second largest operator in the region.

The deal significantly bolsters Crescent’s scale and low-cost inventory. SilverBow shareholders can elect to receive 3.125 Crescent shares for each SilverBow share owned, or opt for $38 per share in cash up to a $400 million cap. Post-closing, expected in Q3 2024, existing Crescent investors will own between 69-79% of the combined entity.

The merged company boasts imposing production of around 250,000 boe/d from a complementary portfolio of high-quality, long-life assets spanning the Eagle Ford and Uinta basins. This large-scale, high-margin asset base underpins robust free cash flow generation backed by a deep inventory of high-return drilling locations to drive compelling growth.

For Crescent, the deal achieves increased scale and premiumization of its portfolio through SilverBow’s attractive Eagle Ford position assembled over 30 years in the region. The combination enhances corporate returns through $65-$100 million of expected annual synergies from combined operating efficiencies and cost of capital benefits.

Crescent characterizes the transaction as highly accretive on all key per share metrics. It aligns with the company’s proven strategy of pursuing disciplined acquisitions at attractive valuations to augment its free cash flow, production, and inventory depth. Maintaining a fortress investment-grade balance sheet post-merger affords financial flexibility to further consolidate the fragmented shale landscape.

The deal represents a compelling value proposition for SilverBow shareholders. They gain exposure to Crescent’s larger-scale diversified assets while participating in the upside from performance improvements, synergy realization, and further consolidation. Alternatively, investors can opt for immediate cash consideration at a premium.

Crescent’s leadership expressed high confidence in the strategic merits of the transaction. Chairman John Goff labeled it “a compelling transaction…creating a premier growth platform”, while CEO David Rockecharlie highlighted SilverBow’s “complementary and high-quality” Eagle Ford position enhancing Crescent’s “unique value proposition.”

The merger exemplifies the accelerating consolidation across the U.S. shale patch as producers pursue scale, streamlining, and consistent shareholder returns. Crescent emerges exceptionally well-positioned to lead this rationalization as a serial acquirer given its sector-leading free cash flow generation, returns philosophy, and strong balance sheet.

Investors evaluating opportunities in the energizing energy and natural resources space may be interested in Noble Capital Markets’ upcoming Emerging Growth Equity Conference in September, offering insights into prospective investments.

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This $850M Biotech Deal Could Disrupt the Atopic Dermatitis Market

Posted on May 17, 2024May 17, 2024 by slightbourne@noblecapitalmarkets.com

In a strategic move to strengthen its dermatology portfolio, pharmaceutical giant Johnson & Johnson has agreed to acquire Proteologix, a privately-held biotech developing bispecific antibody therapies for inflammatory skin diseases like atopic dermatitis. The $850 million all-cash deal gives J&J access to promising clinical and preclinical stage assets.

The crown jewel of the acquisition is Proteologix’s lead candidate PX128, a Phase 1-ready bispecific antibody targeting two key drivers of atopic dermatitis and asthma – interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP). By simultaneously blocking these complementary inflammatory pathways, PX128 could provide a substantial efficacy boost over current monospecific antibody treatments.

Proteologix’s second asset, the preclinical bispecific PX130, goes after IL-13 and IL-22 for the treatment of moderate to severe atopic dermatitis. J&J cited the differentiated design of these dual-acting antibodies, highlighting their potential for infrequent, convenient dosing that could improve adherence.

The acquisition aligns with J&J’s strategic focus on building an immunology pipeline centered around bispecific antibodies for improved disease control across a range of inflammatory conditions.

Atopic dermatitis, a chronic inflammatory skin disease, impacts over 100 million adults worldwide, representing a massive market opportunity. However, up to 70% of patients fail to achieve remission on standard systemic treatments, underscoring a significant unmet need.

“We see an opportunity for best-in-disease efficacy for both PX128 and PX130,” said David Lee, global immunology therapeutic area head at J&J. The company believes the bispecifics could be game-changers for underserved patient subgroups by more comprehensively targeting the heterogenous drivers of atopic dermatitis.

The deal comes on the heels of positive Phase 3 data from Eli Lilly’s IL-13 antibody lebrikizumab in atopic dermatitis. After manufacturing setbacks, Lilly resubmitted its lebrikizumab filing in April and anticipates a decision later this year, setting up a potential commercial clash with J&J’s dual-acting antibodies down the road.

Proteologix, based in California, will be eligible for additional milestone payments on top of the $850 million upfront cash paid by J&J. The transaction, expected to close in mid-2024 pending regulatory approval, will fold in Proteologix’s other preclinical bispecific antibody programs focused on autoimmune diseases and cancer.

For J&J, the deal provides a promising path toward next-generation, differentiated therapies for the significant population of atopic dermatitis patients struggling with existing treatment options. Proteologix’s dual-acting bispecific antibodies represent potentially transformative medicines for a disease area that has proven stubbornly difficult to treat.

The acquisition reinforces J&J’s commitment to immunology and dermatology while bolstering its pipeline with innovative, clinically advanced assets that could drive future growth. As the atopic dermatitis market heats up, J&J has made a preemptive strike to secure a competitive edge through its newest biotech addition.

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Release – Traws Pharma Reports First Quarter 2024 Financial Results And Provides Business Update

Posted on May 16, 2024May 17, 2024 by aweinsoff@channelchek.com

May 16, 2024

PDF Version

Completed acquisition of Trawsfynydd and concurrent $14 million Capital Raise

Excellent pipeline progress, led by candidates for COVID 19, influenza, and oncology programs

Poised to initiate Phase 2 studies in H2 2024 for our influenza candidate and
ritonavir-free COVID 19 protease inhibitor

NEWTOWN, Pa., May 16, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced financial results for the first quarter of 2024, and provided a business update.

“2024 has already been a transformative year for Traws Pharma to advance our portfolio of novel treatments for serious respiratory infections and oncology programs. We completed the acquisition of Trawsfynydd and concluded a concurrent $14 million private placement financing. In addition, we initiated first-in-human dosing for our COVID 19 product candidate, including completion of the first cohort dosing group. Furthermore, we completed the last dose escalation cohort for our CDK4+ inhibitor, narazaciclib,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. “We believe that we are poised to make even more meaningful progress in the second half of 2024, as we advance our influenza treatment and ritonavir-free protease inhibitor for COVID 19 into expanded Phase 1 dose escalation studies and begin Phase 2 development.”

“Based on the preclinical profile and early clinical data from our infectious disease candidates and narazaciclib, I am optimistic about the outlook for Traws’ portfolio and look forward to updating our investors with our progress through the year,” concluded Dr. Cautreels.

Traws Proprietary Portfolio Highlights:

TRX100 (tivoxavir marboxil): a cap-dependent endonuclease inhibitor for influenza: Phase 1

Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains
First Phase 1 study demonstrated safety and tolerability in healthy volunteers with pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose for treatment or prophylaxis
We plan to initiate Phase 1 dose extension to evaluate one additional, higher dose prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025

TRX01 (ratutrelvir): a ritonavir-free Mpro protease inhibitor for COVID19: Phase 1

Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, that does not require co-administration with ritonavir, reducing the risk of drug-drug interactions. Preclinical data support once-daily dosing for 10days which could overcome viral rebound seen with other agents.
We are in the process of conducting a Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers. The second dosing cohort is underway and topline data are expected H2 2024. A Phase 2 study is also planned to begin in H2 2024 in patients with moderate to severe COVID19. Topline data are expected H1 2025

Narazaciclib: CDK 4+ to treat solid tumors: Phase 1/2

Available preclinical and clinical data suggest that narazaciclib is active in numerous tumor types, inhibiting CDK 2/4/6, CSF1R and ARK 5/NUAK1. Preclinical studies also showed reduced neutropenia, as compared to palbociclib, and inhibition of palbociclib resistant cancer cells.
A dose escalation study to define the recommended Phase 2 dose (RP2D) recently enrolled the last cohort. A review of the clinical and PK/PD data is underway. We intend to utilize these data to define the clinical strategy, including selection of a lead indication and next steps in its development.

First Quarter 2024 Financial Results

Cash and cash equivalents as of March 31, 2024, were $16.4 million, compared with $20.8 million as of December 31, 2023.

In April 2024, the Company raised gross proceeds of $14 million from the sale of common and preferred stock to TPAV, LLC, an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP, an affiliate of OrbiMed Advisors.

The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the fourth quarter of 2024.

Revenue was fifty-six thousand dollars for the first quarter of 2024, consistent with the same period in 2023.

General and administrative (G&A) expenses were $3.4 million for the first quarter of 2024, compared with $2.1 million for the same period in 2023. The increase in G&A expenses was caused by higher legal and professional fees related to the Trawsfynydd acquisition on April 1, 2024, partially offset by lower bonus accrual as well as lower insurance, meeting, and public company expenses.

Research and development (R&D) expenses were $1.9 million for the first quarter of 2024, compared with $4.1 million for the same period in 2023. The decrease was primarily caused by lower costs related to narazaciclib drug substance and drug product manufacturing, a reduction in clinical development and consulting costs and lower personnel expenses due to lower bonus accrual.

Net loss for the first quarter of 2024 was $5.0 million, or $0.24 per share on 20.8 million weighted average shares outstanding, compared with a net loss of $5.8 million, or $0.28 per share for the same period in 2023, based on 20.8 million weighted average shares outstanding.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease), ratutrelvir, and tivoxavir marboxil, a new oral antiviral drug candidate for influenza which targets the influenza cap-dependent endonuclease and has shown activity in cell-based assays against drug resistant viruses as well as against avian flu.

In the cancer program, Traws is developing the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib potentially for refractory endometrial cancer and other solid tumor cancers. Narazaciclib targets pathways involved in the development of resistance to CDK inhibitors.

Traws Pharma is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we build solutions for important medical challenges, aiming to alleviate the burden of viral infections and cancer.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Phase 1 study of ratutrelvir in Australia and its design, timing and potential results and the timing of a planned Phase 2 study. Traws has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma, Inc. Contact:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

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

Release – Xcel Brands To Host First Quarter 2024 Earnings Call On May 20

Posted on May 16, 2024May 16, 2024 by aweinsoff@channelchek.com

Research News and Market Data on XELB

May 16, 2024 at 8:01 AM EDT

PDF Version

NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), today announced that it will report its first quarter 2024 financial results on May 20, 2024. The Company will hold a conference call with the investment community on May 20, 2024, at 5:00 p.m. ET.

A webcast of the conference call will be available live on the Investor Relations section of Xcel’s website at https://xcelbrands.co/pages/events-and-presentations or directly at https://edge.media-server.com/mmc/p/r52mtx59.

Interested parties unable to access the conference call via the webcast may dial 800-715-9871 or 646-307-1963 and use the Conference ID 3975904. A replay of the webcast will be available on Xcel’s website.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, marketing, live streaming, social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder by Christian Siriano brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC and a 50% interest in a JV in TWRHLL (“Tower Hill”) by Christie Brinkley. Also Xcel owns a 30% interest in Orme, a short-form video market place. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customer’s shop. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.

For further information please contact:
Seth Burroughs
Xcel Brands
sburroughs@xcelbrands.com

Source:

Release – SEPTA Launches 3D Fare Gates Pilot Program with Conduent Transportation to Detect and Deter Fare Evasion

Posted on May 16, 2024May 16, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CNDT

MAY 16, 2024

TRANSPORTATION

SEPTA pilots Conduent’s solution with plans to expand the number of fare gates in the future

Conduent’s 3D Fare Gate Solution is designed to detect, deter and quantify fare evasion, benefiting both agencies and riders

FLORHAM PARK, N.J. — Conduent Transportation, a global provider of smart mobility technology solutions and business unit of Conduent Incorporated (Nasdaq: CNDT), today announced a pilot program by the Southeastern Pennsylvania Transportation Authority (SEPTA) using Conduent’s 3D Fare Gate Solution at a Philadelphia area transit station. The pilot aims to track and curb incidents of fare evasion, which costs SEPTA an estimated $30 million to $40 million annually.

SEPTA selected the 69th Street station in Upper Darby as its test location for riders traveling on the Market-Frankford and Norristown High Speed lines. The gates, each measuring 7 feet, 8 inches tall, began operating in April. Following the three-month pilot program, the agency plans to expand the fare gates’ availability to other stations, including those with high reported incidents of fare evasion.

“We’re excited to be part of this important pilot for SEPTA to help detect, deter and quantify fare evasion, while simultaneously offering both the agency and riders increased security and convenience,” said Adam Appleby, President, Transportation Solutions at Conduent. “As transit agencies across the country and around the world grapple with how to curb fare evasion, Conduent is poised and ready to deliver our solution, which has shown to deliver meaningful results and helps ensure riders pay their fares.”

Conduent’s 3D Fare Gate Solution uses innovative 3D detection optical sensors, allowing travelers fast and convenient access while detecting and deterring ticketing fraud. The gates also provide transit authorities quick access to reporting and analytics, aiding in enforcement decisions by identifying precisely when and where fare evasion occurs.

The gates, which were also implemented in Paris by Transilien SNCF in 2019, are designed to detect the most common types of fare evasion using advanced, sensor-based feedback mechanisms. The solution, which is ADA-compliant and adaptable to meet agency needs, improves equity in transportation by improving accessibility for all riders as well as helping to ensure passengers pay their share.

SEPTA is one of the largest transit systems in the country, serving five counties in the Greater Philadelphia area and connecting to Delaware and New Jersey transit systems. It operates across six transportation modes and has 2,800 vehicles in service, 285 subway and rail stations, plus 13,000 bus and trolley stops.

Conduent Transportation is a leading provider of streamlined, high-volume mobility services and solutions, spanning road usage charging and advanced transit systems, that enhance the services provided by transportation agencies to benefit the citizens who use them. For over 50 years, the company has helped clients advance transportation solutions in more than 20 countries.

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 – MAIA Biotechnology Abstract Accepted For Poster Presentation At American Society Of Clinical Oncology (ASCO) 2024 Annual Meeting

Posted on May 16, 2024May 16, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 16, 2024 8:37am EDT

Poster to present new efficacy data from Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC)

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract about its Phase 2 THIO-101 clinical trial named “A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Updated results” was accepted for poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, to take place May 31-June 4, 2024, in Chicago, Illinois. The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST.

“We are proud to accept ASCO’s invitation to present at its 2024 Annual Meeting, the most significant gathering of oncology professionals worldwide,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We look forward to revealing the newest efficacy results from THIO-101 and discussing our pioneering telomere targeting science underlying THIO, the first and only cancer treatment of its kind in clinical development.”

MAIA’s abstract will be available online at the ASCO Annual Meeting 2024 website during the week prior to the conference start date, and the poster will be published on maiabiotech.com on the day of the presentation, June 3, 2024.

The 2024 ASCO Annual Meeting will feature more than 200 sessions and 5,000 posters complementing the theme, “The Art and Science of Cancer Care: From Comfort to Cure.”

About ASCO

Founded in 1964, the American Society of Clinical Oncology is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. Its mission is to conquer cancer through research, education, and promotion of the highest quality, equitable patient care. ASCO’s vision is a world where cancer is prevented or cured, and every survivor is healthy. asco.org

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516196926/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released May 16, 2024