Author: aweinsoff@channelchek.com

Release – CVG Reports Fourth Quarter and Full Year 2023 Results

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Research News and Market Data on CVGI

March 4, 2024

Fourth quarter sales of $223 million, record annual sales of $995 million 
Full year adjusted EBITDA margins increased by 140 bps to 6.8% 
Provides outlook and guidance for full year 2024

NEW ALBANY, Ohio, March 04, 2024 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI), a diversified industrial products and services company, today announced financial results for its fourth quarter and full year ended December 31, 2023.

Fourth Quarter 2023 Highlights (Compared with prior-year period, where comparisons are noted)

  • Revenue of $223.1 million, down 5.0% due primarily to the impacts of a strike-related labor stoppage at a customer facility and reduced demand across Vehicle Solutions, Industrial Automation and Aftermarket segments; however, Electrical Systems segment continues to show strong growth with 19.4% increased revenue.
  • Operating income of $5.0 million, up $9.0 million; adjusted operating income of $6.6 million, down $1.8 million. Lower adjusted operating income was driven primarily by lower volumes and increased SG&A.
  • Net income of $23.3 million, or $0.70 per diluted share, compared to net loss of $32.0, or $(0.98) per diluted share; adjusted net income of $2.9 million, or $0.09 per diluted share, versus $1.4 million, or $0.04 per diluted share.
  • Adjusted EBITDA of $10.3 million, down $2.9 million, with an adjusted EBITDA margin of 4.6%, down from 5.7%.

Full Year 2023 Highlights (Compared with prior-year period, where comparisons are noted)

  • Revenue of $994.7 million, driven by pricing and the contribution of new business wins in Electrical Systems, offset by lower sales volume in Industrial Automation, Vehicle Solutions, and Aftermarket segments.
  • New business wins in excess of $150 million when fully ramped; these wins were concentrated in our Electrical Systems segment.
  • Operating income of $48.1 million, up $27.9 million, and adjusted operating income of $51.1 million, up $14.5 million. The increase in operating income was due to improved pricing and business mix.
  • Full-year 2023 debt paydown was $10.9 million, and net debt declined to $103.7 million; leverage ratio declined to 1.5x from 2.2x.

James Ray, President and Chief Executive Officer, said, “We are pleased with our 2023 results as CVG continued winning new business, particularly in Electrical Systems, and made progress on the Company’s transformation plan, driving record annual sales and improved profitability for the year. As we look to fiscal 2024, we are focused on enhancing operational efficiency and quality standards, growing our Electrical Systems segment to be our largest business, as well as facilitating cross-functional collaboration among our various business segments to strengthen our core Vehicle Solutions business and cultivating stronger customer relationships.”

Mr. Ray concluded, “As the new CEO, I am grateful for the hard work of our talented global teams that help drive improvements in our business every day, and I am looking forward to a strong fiscal 2024.”

Andy Cheung, Chief Financial Officer, added, “We delivered another year of record revenue driven by continued price realization and new business wins, despite softer fourth quarter revenues which were impacted by, among other things, a UAW labor strike at one customer facility. Our strong performance resulted in free cash flow of $19 million in 2023, which has helped us further pay down debt and reduce our net leverage to 1.5x. During the quarter, we initiated several restructuring actions to better align our resources with investments in growth product lines, which we expect will further enhance profitability across our underlying core businesses. Despite industry forecasts for a lower Class 8 truck build in 2024, we expect our financial performance in 2024 to be more resilient as we continue our diversification strategy reflecting primarily the success in growing our Electrical Systems business.”

Financial Results
(amounts in millions except per share data and percentages)

 Fourth Quarter  
  2023   2022  Change
Revenues$223.1  $234.9  (5.0)%
Gross profit$26.2  $12.4  111.3%
Gross margin 11.7%  5.3%  
Adjusted gross profit1$26.0  $23.9  8.8%
Adjusted gross margin1 11.7%  10.2%  
Operating income (loss)$5.0  $(4.0) NM2
Operating margin 2.2% (1.7)%  
Adjusted operating income1$6.6  $8.4  (21.4)%
Adjusted operating margin1 2.9%  3.6%  
Net income (loss)$23.3  $(32.0) NM2
Adjusted net income (loss)1$2.9  $1.4  107.1%
Earnings (loss) per share, diluted$0.70  $(0.98) NM2
Adjusted earnings (loss) per share, diluted1$0.09  $0.04  125.0%
Adjusted EBITDA1$10.3  $13.3  (22.6)%
Adjusted EBITDA margin1 4.6%  5.7%  
1See Appendix A for GAAP to Non-GAAP reconciliation  
2Not meaningful  

Consolidated Results

Fourth Quarter 2023 Results

  • Fourth quarter 2023 revenues were $223.1 million compared to $234.9 million in the prior year period, a decline of 5.0%. The decrease in revenues is due primarily to the impact of a strike at a customer facility, previous year benefit from a post-COVID backlog in Asia-Pacific, and reduced demand in Vehicle Solutions, Aftermarket, and Industrial Automation segments, which more than offset an increase in Electrical Systems revenue. Foreign currency translation favorably impacted fourth quarter 2023 revenues by $1.8 million, or by 0.7%.
  • Operating income for the fourth quarter 2023 was $5.0 million compared to operating loss of $4.0 million in the prior year period. Foreign currency translation also favorably impacted fourth quarter 2023 operating income by $0.7 million. Excluding special costs, the fourth quarter of 2023 adjusted operating income was $6.6 million, down 21.4%. The decline in adjusted operating income was driven primarily by lower volumes, strike impact, and higher SG&A.
  • Interest expense was $2.4 million and $2.9 million for the fourth quarter ended December 31, 2023 and 2022, respectively. The decrease in interest expense was due to lower average debt balances, partially offset by higher interest rates on variable debt.
  • Net income was $23.3 million, or $0.70 per diluted share, for the fourth quarter 2023 compared to net loss of $32.0 million, or $(0.98) per diluted share, in the prior year period.

At December 31, 2023, the Company had no outstanding borrowings on its revolving credit facility, $37.8 million of cash and $160.1 million availability from revolving credit facilities, resulting in total liquidity of $197.9 million.

Segment Results

Fourth Quarter 2023 Results (Compared with prior-year period, where comparisons are noted)

Vehicle Solutions Segment

  • Revenues were $128.4 million, a decrease of 10.1% primarily resulting from lower volumes and the impact of a strike at a customer facility during the quarter.
  • Operating income for the fourth quarter 2023 was $3.6 million, a decrease of 1.8%. Excluding special costs, the fourth quarter of 2023 adjusted operating income was $4.0 million, a decrease of 3.9%, as compared to the fourth quarter 2022, primarily due to the impact of lower sales volumes partially offset by pricing improvement and cost controls.

Electrical Systems Segment

  • Revenues were $56.2 million, an increase of 19.4%, primarily resulting from increased pricing and sales volume.
  • Operating income was $6.7 million, an increase of 25.0% primarily attributable to pricing and volume leverage.

Aftermarket and Accessories Segment

  • Revenues were $31.4 million, a decrease of 8.1%, primarily resulting from decreased sales volume.
  • Operating income was $3.4 million, an increase of 7.3%. Excluding special costs, the fourth quarter of 2023 adjusted operating income decreased 6.4%, as compared to the fourth quarter 2022, primarily due to the lower sales volume, partially offset by increased pricing.   

Industrial Automation Segment

  • Revenues were $7.1 million, a decrease of 35.0%, due to lower sales volume from decreased customer demand.
  • Operating income was $0.9 million, compared to operating loss of $11.9 million in the prior year. Fourth quarter of 2023 adjusted operating income increased to $0.3 million, compared to an adjusted operating loss of $0.5 million in the fourth quarter 2022, primarily due to cost controls.

Outlook

CVG is providing the following outlook for the full year 2024:

Metric2024 Outlook ($ millions)
Net Sales$915 – $1,015
Adjusted EBITDA$60 – $73

This outlook reflects, among others, current industry forecasts for North American Class 8 truck builds. According to ACT Research, 2024 North American Class 8 truck production levels are expected to be at 285,000 units. The 2023 actual Class 8 truck builds according to the ACT Research was 340,140 units.

We expect to benefit from growth in Electrical Systems, partially offsetting the projected 16% decline in Class 8 truck builds.

GAAP to Non-GAAP Reconciliation

A reconciliation of GAAP to non-GAAP financial measures referenced in this release is included as Appendix A to this release.

Conference Call

A conference call to discuss this press release is scheduled for Tuesday, March 5, 2024, at 10:00 a.m. ET. Management intends to reference the Q4 2023 Earnings Call Presentation posted on our website during the conference call. To participate, dial (888) 259-6580 using conference code 88986985. International participants dial (416) 764-8624 using conference code 88986985.

This call is being webcast and can be accessed through the “Investors” section of CVG’s website at www.cvgrp.com, where it will be archived for one year.

A telephonic replay of the conference call will be available for a period of two weeks following the call. To access the replay, dial (877) 674-7070 using access code 986985 and international callers can dial (416) 764-8692 using access code 986985.

Company Contact

Andy Cheung
Chief Financial Officer
CVG
IR@cvgrp.com 

Investor Relations Contact

Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com 

About CVG

At CVG we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets, global supply chain constraints, changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction equipment business, the Company’s prospects in the wire harness, industrial automation and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment, including inflation and labor shortages and the Company’s financial position or other financial information. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.

Source: Commercial Vehicle Group, Inc.

View full release here.

Release – Labrador Gold Announces Assays Up to 479.5G/T Au in Surface Samples From Golden Glove

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NKOSF

August 23, 2022 08:00 ET

TORONTO, Aug. 23, 2022 (GLOBE NEWSWIRE) — Labrador Gold Corp. (TSX.V:LAB | OTCQX:NKOSF | FNR: 2N6) (“LabGold” or the “Company”) is pleased to announce assays from six samples containing visible gold recently collected during prospecting in the Golden Glove area at its 100% owned Kingsway Project. The samples were collected as part of the Company’s continuous efforts to generate and upgrade targets for drilling along the 12km strike length of the Appleton Fault Zone covered by the Kingsway Property.

The samples were taken from quartz veins believed to be splays off the original Golden Glove vein. Assays of the six samples ranged from 7.51 g/t to 479.51 g/t Au. The quartz veins are hosted by grey and black shales and are typically vuggy and locally stylolitic with iron carbonate alteration. The four highest grade samples contain visible gold, and all samples contain between 2 and 5% pyrite and arsenopyrite both in the vein and along the contact with the shale wallrock. These results are comparable to assays from the initial samples taken at Golden Glove that ranged from 2.99 to 338.08g/t Au (see news release dated September 21, 2021).

“The discovery of more veins containing high-grade gold at surface is encouraging as it gives us additional information on the structural context of the mineralization at Golden Glove and will allow more efficient drill targeting.” said Roger Moss, President and CEO. “Drilling to date has been following up recent high-grade intersections of 20.07 g/t Au over 1m in Hole K-22-154 and 6.22 g/t Au over 4m in hole K-22-150 located approximately 160m south of the discovery outcrop. Given the high-grade nature of these veins we will certainly look to specifically target them in our ongoing drilling at Golden Glove.”

Sample
ID		Sample
type		Rock TypeAu (g/t)
853601*GrabQuartz Vein 479.51
853602*GrabQuartz Vein 81.49
853603*GrabQuartz Vein 114.72
853604*GrabQuartz Vein 34.90
853605GrabQuartz Vein 7.51
853606GrabQuartz Vein 12.25

* Sample contains visible gold. Note that grab samples are select samples and
are not necessarily representative of gold mineralization found on the property.

Figure 1. Portion of Sample 853601 showing visible gold grains in quartz and country rock.
https://www.globenewswire.com/NewsRoom/AttachmentNg/535e38c4-278d-4f70-8798-e2338a3eae1a

Figure 2. Location map of Kingsway gold occurrences showing recent results at Golden Glove.
https://www.globenewswire.com/NewsRoom/AttachmentNg/fea783dc-89b0-40f2-9eb0-46afd5858897

QA/QC

All samples are securely stored prior to shipping to Eastern Analytical Laboratory in Springdale, Newfoundland for assay. Eastern Analytical is an ISO/IEC17025 accredited laboratory. Samples were assayed by metallic screen/fire assay. The whole sample is crushed to -10mesh and pulverized to 95% -150mesh. The total sample is then weighed and screened through 150mesh. Both the +150mesh fraction and a 30g subsample of the -150mesh fraction are fire assayed for Au and a calculated weighted average of total Au in the sample is reported. The company routinely submits blanks and certified reference standards at a rate of approximately 5% of the total samples in each batch.

Qualified Person

Roger Moss, PhD., P.Geo., President and CEO of LabGold, a Qualified Person in accordance with Canadian regulatory requirements as set out in NI 43-101, has read and approved the scientific and technical information that forms the basis for the disclosure contained in this release.

The Company gratefully acknowledges the Newfoundland and Labrador Ministry of Natural Resources’ Junior Exploration Assistance (JEA) Program for its financial support for exploration of the Kingsway property.

About Labrador Gold
Labrador Gold is a Canadian based mineral exploration company focused on the acquisition and exploration of prospective gold projects in Eastern Canada.

Labrador Gold’s flagship property is the 100% owned Kingsway project in the Gander area of Newfoundland. The three licenses comprising the Kingsway project cover approximately 12km of the Appleton Fault Zone which is associated with gold occurrences in the region, including those of New Found Gold immediately to the south of Kingsway. Infrastructure in the area is excellent located just 18km from the town of Gander with road access to the project, nearby electricity and abundant local water. LabGold is drilling a projected 100,000 metres targeting high-grade epizonal gold mineralization along the Appleton Fault Zone with encouraging results. The Company has approximately $25 million in working capital and is well funded to carry out the planned program.

The Hopedale property covers much of the Florence Lake greenstone belt that stretches over 60 km. The belt is typical of greenstone belts around the world but has been underexplored by comparison. Work to date by Labrador Gold show gold anomalies in rocks, soils and lake sediments over a 3 kilometre section of the northern portion of the Florence Lake greenstone belt in the vicinity of the known Thurber Dog gold showing where grab samples assayed up to 7.8g/t gold. In addition, anomalous gold in soil and lake sediment samples occur over approximately 40 km along the southern section of the greenstone belt (see news release dated January 25th 2018 for more details). Labrador Gold now controls approximately 40km strike length of the Florence Lake Greenstone Belt.

The Company has 169,189,979 common shares issued and outstanding and trades on the TSX Venture Exchange under the symbol LAB and on the OTCQX under the symbol NKOSF.

For more information please contact:             

Roger Moss, President and CEO      Tel: 416-704-8291

Or visit our website at: www.labradorgold.com

Twitter: @LabGoldCorp

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements: This news release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.

Release – Kratos Awarded a $499 Million Multiple Award, Indefinite-Delivery/Indefinite-Quantity Contract for the Design, Build, Test, and Delivery of Functioning Anti-Tamper Solutions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

March 4, 2024 at 8:00 AM EST

SAN DIEGO, March 04, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in Defense, National Security and Global Markets, announced today that it has been awarded a $499,000,000 multiple award, indefinite-delivery/indefinite-quantity contract for the design, build, test, and delivery of functioning anti-tamper solutions that will be ready for follow-on production to be integrated into a broad range of Department of Defense programs. The development of these solutions enables the necessary protection of critical program information from adversarial tamper efforts. Work will be performed in the continental United States and is expected to be completed February 28, 2030. This contract was a competitive acquisition, and twenty offers were received. The Air Force Life Cycle Management, Wright Patterson Air Force Base, Ohio, is the contracting activity.

Kratos SRE is a technology business focused on strategic deterrence systems, missiles, space and satellite communications, exotic material test and analysis, intelligence, surveillance and reconnaissance, hypersonic platforms, trusted and assured microelectronics, anti–tamper technology and other platforms and systems.

Michael Johns, President of Kratos SRE, said, “This recent award provides Kratos access to a new contractual channel and new customers for certain of our most sophisticated technology and products, specifically related to the protection of mission critical national security programs and systems from tampering efforts.”  

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets.  Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements.  At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions.  We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers.  Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter.  For more information, visit www.KratosDefense.com

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Kratos Press Contact:
Yolanda White
858-812-7302 Direct

Kratos Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Defense Metals Ships Mixed Rare Earth Carbonate Samples to two major REE companies

Posted on by aweinsoff@channelchek.com

Research News an Market Data on DFMTF

04 Mar, 2024, 07:00 ET

VANCOUVER, BC, March 4, 2024 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“; (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that samples of mixed rare earth carbonate (“MREC“) have been shipped to two major Rare Earth Element (“REE“) companies. Samples generated by SGS Canada Inc. in Lakefield, Ontario during 2023 hydrometallurgical piloting test work performed on concentrate produced by earlier flotation pilot plant testing of a 26-tonne bulk sample taken from the Company’s wholly-owned Wicheeda deposit have now been sent to almost every REE separator in the world.

MREC samples shipped to the recipients are independently verifying the high-quality of the REE product from the Wicheeda deposit, and further establishing Defense Metals’ Wicheeda REE Project as a critically important, future North American source of rare earths.

Craig Taylor, CEO of Defense Metals, commented:

“Defense Metals continues to advance the Wicheeda Project, establishing it as one of the few western world REE projects that has the key characteristics required for a viable REE project including: (1) location and  superior logistics, (2) minerology, metallurgy, and grade, (3) the ability to produce a REE product as established by pilot plant operations , (4) significant potential mine life, and (5) social licence and support of the McLeod Lake Indian Band. Defense Metals believes strongly that Wicheeda will play a key role in establishing North American REE supply chains; first and foremost, with respect to mining and hydrometallurgical processing, and ultimately with respect to the onshoring of downstream REE separation, refining and metallizing capabilities. Defense Metals is positioned as one of the very few North American REE companies having true ability to achieve this vision.” 

Defense Metals to Attend the Prospectors & Developers Association of Canada Convention  

Defense Metals will be attending the Prospectors & Developers Association of Canada (PDAC) Convention in Toronto, Canada from March 3 to March 6, 2024, and invites interested parties to visit the Company at Booth #2500 and at Discovery Group’s Booth #2630.

Qualified Person

This news release has been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), a Principal of APEX Geoscience Ltd., of Edmonton, Alberta, a technical consultant to the Company, and a “Qualified Person” as defined in NI 43-101.

About Defense Metals Corp. and its Wicheeda Rare Earth Element Project

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned, 8,301-hectare (~20,534-acre) Wicheeda REE Project that is located on the traditional territory of the McLeod Lake Indian Band in British Columbia, Canada.

The Wicheeda REE Project, approximately 80 kilometres (~50 miles) northeast of the city of Prince George, is readily accessible by a paved highway and all-weather gravel roads and is close to infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.

Defense Metals is a proud member of Discovery Group. For more information please visit: www.discoverygroup.ca.

For further information, please visit www.defensemetals.com or contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Cautionary Statement Regarding “Forward-Looking” Information

This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to attending PDAC and related meetings, advancing the Wicheeda REE Project, the expectations and plans for the Wicheeda REE Project, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR+ (www.sedarplus.com). While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain or obtain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical, engineering and pricing assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, restriction on labour and international travel and supply chains, loss of key employees, consultants, officers or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–loo

Release – Unicycive Therapeutics Announces Orphan Drug Designation Granted For UNI-494 By the U.S. Food and Drug Administration For The Prevention Of Delayed Graft Function In Kidney Transplant Patients

Posted on by aweinsoff@channelchek.com

Research news and Market Data on UNCY

March 04, 2024 7:03am EST Download as PDF

LOS ALTOS, Calif., March 04, 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 the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.

“We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. DGF is one of the most serious complications resulting from kidney transplantation, and we believe that the mechanism of action of UNI-494 is ideally suited for the prevention of this orphan condition.”

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to agents that have the potential to offer a safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 individuals in the United States.

As previously announced, on March 12, 2024, Unicycive will present data on the efficacy of UNI-494 in animal models of DGF and a poster describing the ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.

About Delayed Graft Function

Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.

Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.

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.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Released March 4, 2024

Release – GeoVax Reports 2023 Year-End Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Progress across the pipeline in multiple clinical trials, including

Phase 2 program of GEO-CM04S1, next-generation Covid-19 vaccine, and

multicenter Phase 1/2 study of Gedeptin®, targeting advanced head and neck cancer

Catalyst-rich 2024 with data readouts planned throughout the year

Company to host conference call and webcast today at 4:30 p.m. ET

ATLANTA, GA, February 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

 “2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our next-generation Covid-19 vaccine, and for Gedeptin® in cancer therapy,” stated David Dodd, GeoVax’s Chairman and CEO. “This past year, we completed enrollment for the Phase 2 clinical trial assessing GEO-CM04S1 as a universal booster for the mRNA Covid vaccines, while expanding to multiple sites for our Phase 2 trial among immunocompromised/stem cell transplant patients, evaluating GEO-CM04S1 as a primary vaccine, in direct comparison to mRNA vaccines.  In addition, the third Phase 2 trial of GEO-CM04S1 was initiated, evaluating our vaccine among immunocompromised/Chronic Lymphocytic Leukemia patients as a booster for such patients having initially received a mRNA vaccine, also in a direct comparison to a mRNA vaccine.

“Results released during 2023 demonstrated the safety and efficacy of GEO-CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection,” Dodd continued. “Perhaps of most importance, the results to date have demonstrated potential protective immunity of GEO-CM04S1 against multiple strains of SARS-CoV-2, from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5, without the need for vaccine reconfiguration.  This critically important potential feature appears unique to our Covid-19 vaccine.”

Dodd concluded, “Relative to our oncology progress, GeoVax completed enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.  During first half 2024, we anticipate reporting additional results from the Gedeptin Phase 1/2 clinical trial, as well as our plans for an expanded Phase 2 clinical trial.  Overall, these achievements can be attributed to the successful execution of our long-term strategy, with an end goal to bring unique, patented products to market, addressing unmet medical needs. We look forward to reporting further progress in these studies and are encouraged to be entering into a data-rich 2024.”

 2023 Clinical Trial Progress and Operational Developments

 GEO-CM04S1

  • Enrollment completed for the Phase 2 clinical trial assessing GEO-CM04S1 as a potential universal booster for patients previously vaccinated with Pfizer or Moderna vaccines. The data presented during this period showcased promising results, indicating the potential of GEO-CM04S1 as a versatile Covid-19 vaccine capable of providing immunity against various strains, including the Wuhan, Delta, and Omicron variants. The trial involves 63 healthy adults who previously received mRNA vaccines as their primary vaccine. The data showed no serious adverse events and significant increases in neutralizing antibody, as well as cellular immune responses against multiple SARS-CoV-2 variants. Final results from this trial are anticipated during the fourth quarter of 2024.
  • Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia (CLL), who typically have reduced immune responses to mRNA vaccines due to their medical condition. This investigator-initiated trial expects to enroll 80 patients and directly compare GEO-CM04S1 with the Pfizer/BioNTech Bivalent vaccine. Results from an interim analysis are anticipated during the first half of 2024.
  • Data presentations from the immunocompromised/stem cell transplant patient Phase 2 trial of GEO-CM04S1 at the World Vaccine Congress, as well as initial results published in the peer-reviewed journal, Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine’s ability to induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of GEO-CM04S1 providing protective immune levels from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5 variant. This study has been expanded to a multi-site trial, with further results anticipated throughout 2024.

Gedeptin®

  • Completion of patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. The data presented at the AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. During 2024, we expect to announce plans relative to an expanded Phase 2 study among advanced head and cancer patients, following discussions with regulatory authorities. In addition, we plan to outline plans for further Gedeptin clinical development, both in additional monotherapy and in combination-therapy (e.g., Gedeptin + immune-checkpoint inhibitor) indications. 

Advanced Vaccine Manufacturing Process

  • Significant advancements made in MVA manufacturing capabilities focused on implementing a transformative manufacturing process in support of MVA-based vaccines and immunotherapies. The multi-product license with ProBioGen involving the AGE1.CR.PIX® suspension cell line enhances GeoVax’s capacity to produce MVA-based vaccines and immunotherapies at an unprecedented scale. Additionally, the agreement with Advanced Bioscience Laboratories, Inc. (ABL) secures cGMP production capabilities in support of GeoVax transitioning to worldwide commercialization capability. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.  Our intent is to successfully develop our products for worldwide commercialization and distribution, in conjunction with partnering and collaborative relationships.

Corporate and Intellectual Property Developments

  •  Achieved notable milestones in intellectual property development, securing multiple patents covering a range of vaccine candidates. The expanded rights under the NIH Covid-19 license to include Mpox and smallpox further diversify GeoVax’s vaccine portfolio, potentially offering broader protection against infectious diseases. Additionally, the issuance of patents for Ebola, Marburg, Malaria, and HIV vaccines underscores GeoVax’s innovative approach to vaccine development and its dedication to advancing global health initiatives. As of February 2024, the following actions were taken by global patent offices, further strengthening the Company’s intellectual property assets:
  • The Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company’s Patent Application No. 2022-153352 titled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax’s MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims.
  • The U.S. Patent and Trademark Office issued Patent No. 11,896,657 to GeoVax, pursuant to the Company’s patent application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
  • The U.S. Patent and Trademark Office issued Patent No. 11,897,919 pursuant to the Company’s patent application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
  • Appointed J. Marc Pipas, M.D., as Executive Medical Director, Oncology. Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center. He brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.

 2023 Full Year Financial Results

Net Loss: Net loss for the year ended December 31, 2023, was $26.0 million, as compared to $14.0 million for the year ended December 31, 2022.

R&D Expenses: Research and development expenses were $20.7 million for 2023, compared to $9.1 million in 2022, with the increase primarily due to the costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs.

G&A Expenses: General and administrative expenses were $6.0 million for 2023, compared to $5.0 million in 2022, with the increase primarily attributable to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses.

Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.

Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.

Conference Call Details

Management will host a conference call scheduled to begin at 4:30 p.m. ET today, February 29, 2024, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.

Domestic: (800) 715-9871

International: +1 (646) 307-1963

Conference ID: 3926207

Webcast: https://edge.media-server.com/mmc/p/uo7z87mz

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

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

Forward-Looking Statements

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

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

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

FINANCIAL TABLES

Release – Direct Digital Holdings to Report Fourth Quarter & Full Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

February 29, 2024 4:01 pm EST

HOUSTON, Feb. 29, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company will report financial results for the fourth quarter and fiscal year 2023 ended December 31, 2023 on Thursday, March 21, 2024 after the U.S. stock market closes.

Management will host a conference call and webcast on the same day at 5:00 PM ET to discuss the results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.

Contacts:
Brett Milotte, ICR
investors@directdigitalholdings.com

 View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-to-report-fourth-quarter–full-year-2023-financial-results-302076387.html

SOURCE Direct Digital Holdings

Released February 29, 2024

Release – ZyVersa Therapeutics Generated Approximately $2.7 Million From Exercise of Warrants Following Excitement Around News That Inflammasome Inhibitors Have Potential to Effectively Treat Obesity

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Feb 29, 2024

PDF Version

  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which is designed to inhibit formation of multiple types of inflammasomes, including NLRP3, and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation associated with obesity and numerous other conditions.

WESTON, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of inflammatory and renal diseases with high unmet medical needs, announces that on February 26, 2024, the company generated approximately $2.7 Million from existing investors’ exercise of previously issued warrants. This was following excitement around news issued by NodThera on February 19, 2024, that their NLRP3 inflammasome inhibitors have potential to treat obesity with weight loss efficacy similar to the GLP-1 receptor agonist, Wegovy, but with added cardiovascular benefits. This news became viral among financial reporters, driving high volume trading and increased stock prices for companies developing inflammasome inhibitors, including ZyVersa.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP3, and AIM2, to address inflammatory diseases in which multiple inflammasome pathways are activated. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the spread and perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

Release – Codere Online Reports Financial Results for the Fourth Quarter and Full Year 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CDRO

02/29/2024

Download(opens in new window)

  • Total revenue was €46.9 mm in Q4 2023, while net gaming revenue1 was €50.1 mm in the period, 32% and 33% above those from Q4 2022, respectively.
  • Mexico revenue was €22.6 mm in Q4 2023, while net gaming revenue1 was €25.1 mm in the period, 54% above Q4 2022.
  • Spain revenue (and net gaming revenue) reached €20.8 mm in Q4 2023, 17% above Q4 2022.
  • Net loss was €1.0 mm in Q4 2023 versus a net loss of €17.4 mm in Q4 2022.
  • Total cash position of €41 mm as of December 31, 2023.
    • Providing full year 2024 net gaming revenue outlook of €185-200 mm and expect to generate positive Adjusted. EBITDA and cash flow.

Madrid, Spain and Tel Aviv, Israel, February 29, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited2 financial results for the fourth quarter and year ended December 31, 2023.

Below are the main financial and operating metrics of the period.

        
 Quarter ended December 31 Year ended December 31
 20222023Chg. % 20222023Chg. %
        
Net Gaming Revenue (EUR mm)1       
Spain17.820.817% 60.075.726%
Mexico16.325.154% 51.181.760%
Colombia2.32.3– 7.98.58%
Other1.31.838% 3.96.054%
Total37.750.133% 122.9171.940%
        
Avg. Monthly Active Players (000s)3       
Spain41.347.415% 38.142.311%
Mexico50.859.116% 38.552.537%
Colombia38.523.0(40%) 28.724.3(15%)
Other11.29.6(14%) 7.99.217%
Total141.8139.2(2%) 113.1128.313%

Aviv Sher, CEO of Codere Online, stated, “In Q4 2023 we delivered an impressive 33% growth in net gaming revenue to €50 million, our highest ever quarterly figure, despite a tough comp with the World Cup in the prior year period. Our strategic focus on Mexico and Spain, where we are seeing a strong return on marketing investment, has proven successful, with significant increases in both our active customer base and spend per customer. Casino continued to exceed our expectations with a second consecutive quarter contributing 58% of total net gaming revenue in the period.”

Mr. Sher further added, “Our net gaming revenue in Mexico grew by 54% in the fourth quarter, reaching more than €25 million, whereas net gaming revenue in Spain, grew by 17%, to nearly €21 million. We were able to grow our active customer base by more than 15% in both markets in the quarter which we believe is impressive considering the similar level of marketing investment in these countries in 2023 versus the prior year.”

Oscar Iglesias, CFO of Codere Online, stated, “Our fourth quarter results have allowed us to reach nearly €172 million of net gaming revenue for the full year, 19% above the midpoint of the initial €140-150 mm outlook we provided early last year. This outperformance, combined with the overall lower level of marketing investment, also allowed us to deliver a better than expected negative €12mm in Adjusted EBITDA versus the initial outlook of negative €20-30mm.”

Mr. Iglesias further added, “We are very encouraged by our performance in 2023 which further supports our expectation that we will generate positive Adjusted EBITDA and cash flow for the full year in 2024, a year in which we expect net gaming revenue of €185-200 mm. In short, we expect to deliver upon our original commitment to investors to be a profitable company in the third year after de-SPAC and are more committed than ever to creating meaningful value for our shareholders.”


Conference Call Information

Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, February 29, 2024. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.

Reconciliation of Revenue (IFRS) to Net Gaming Revenue (non-IFRS)

 Quarter ended December 31 Year ended December 31
Figures in EUR mm20222023Chg. % 20222023Chg. %
        
Total       
        
Revenue35.646.932% 115.7162.641%
(+) Accounting Adjustments42.13.148% 7.29.228%
Net Gaming Revenue37.750.133% 122.9171.940%
        
Spain       
        
Revenue17.820.817% 60.075.726%
(+) Accounting Adjustments4––n.m. ––n.m.
Net Gaming Revenue17.820.817% 60.075.726%
        
Mexico       
        
Revenue14.522.656% 45.573.361%
(+) Accounting Adjustments41.82.539% 5.68.450%
Net Gaming Revenue16.325.154% 51.181.760%
        
Colombia       
        
Revenue2.42.817% 7.09.333%
(+) Accounting Adjustments4(0.1)(0.5)n.m. 0.9(0.8)n.m.
Net Gaming Revenue2.32.3– 7.98.58%
        
Other       
        
Revenue0.90.7(22%) 3.24.438%
(+) Accounting Adjustments40.41.1n.m. 0.71.6129%
Net Gaming Revenue1.31.838% 3.96.054%

About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

About Codere Group
Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.

Forward-Looking Statements
Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans.

These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, and (xii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

Financial Information and Non-GAAP Financial Measures
Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).

This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue and Adjusted EBITDA. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.

Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.

This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.

Use of Projections
This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.

For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.

Preliminary Information
This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.

No Offer or Solicitation
This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Trademarks
This document may contain trademarks, service marks, trade names and copyrights of Codere Online or other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this document may be listed without the TM, SM, © or ® symbols, but Codere Online will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.

Industry and Market Data
In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
Guillermo.Lancha@codere.com
(+34)-628-928-152

1 Net Gaming Revenue is a non-IFRS measure. Please see reconciliation of Net Gaming Revenue to Revenue at the end of the report.
2 See “Preliminary Information” below.
3 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives.
4 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia, VAT impact from entry fees in Mexico and the impact from the application of inflation accounting (IAS 29) in Argentina.


Primary Logo

Source: Codere Online Luxembourg, S.A.

Release – ISG Announces 2024 ISG Paragon Awards™ ANZ Winners

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

2/28/2024

Program recognizes innovative and impactful sourcing industry partnerships

SYDNEY–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, has announced the winners of the 2024 ISG Paragon Awards™ ANZ, which celebrate the ongoing transformation of sourcing industry partnerships with new solutions and technologies.

A total of 50 nominations were submitted for the annual ANZ program. Winners in each category were selected by an experienced independent expert and announced at a gala awards dinner on Wednesday, February 28, 2024, at the Fullerton Hotel Sydney.

The winners of the 2024 awards are:

Excellence: Outstanding delivery by a service provider

  • Gold: PWC Australia with Levande
  • Silver: Tech Mahindra with One New Zealand

Innovation: Imagination and entrepreneurial spirit in helping organizations future-proof their businesses and better serve clients

  • Gold: AC3 with Southern Cross Austereo
  • Silver: Tech Mahindra with Dnata
  • Silver: Tata Consultancy Services, Ltd. with NSW Government

Transformation: The successful transformation of an organization or key business function

  • Gold: Infosys with Team Global Express
  • Silver: Capgemini with Cochlear

High-Performing Partnerships: Successful partners that demonstrate seamless collaboration, leverage each other’s strengths and adapt together to achieve shared objectives

  • Gold: Ramco with a leading New Zealand telecommunications provider

Infosys and Westpac won the Excellence in Diversity award and Transurban and Blue Connections Pty Ltd. received the People’s Choice Award for an outstanding relationship identified by a client.

“Technology and business services providers make critical contributions to enterprise success,” said Michael Gale, partner and regional leader, ISG Asia Pacific. “We are honored to recognize the winners of the 2024 ISG Paragon Awards ANZ for finding powerful new ways to support their clients’ IT goals and achieve outstanding results.”

The 2024 ISG ANZ Paragon Awards celebrate the evolution of the sourcing industry through the application of new sourcing approaches, automation and digital technology. Full details are available here.

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 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 – Entravision Schedules Fourth Quarter and Full Year 2023 Earnings Release and Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on EVC

February 28, 2024

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, announced that it will release its fourth quarter and full year 2023 financial results after market close on Tuesday, March 5, 2024. The Company will host a conference call that day at 5:00 p.m. Eastern Time to discuss the fourth quarter and full year 2023 results.

To access the conference call, please dial (844) 836-8739 (U.S.) or (412) 317-5440 (International) ten minutes prior to the start time. The call will also be available via live webcast on the investor relations portion of the Company’s website located at www.entravision.com.

If you cannot listen to the conference call at its scheduled time, there will be a replay available through Tuesday, March 19, 2024 which can be accessed by dialing (844) 512-2921 (U.S.) or (412) 317-6671 (International) and entering the passcode 10186277. The webcast will also be archived on the Company’s website.

About Entravision

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

Christopher T. Young

Chief Financial Officer

Entravision

310-447-3870

Kimberly Orlando

Addo Investor Relations

310-829-5400

evc@addo.com

Source: Entravision

Release – Direct Digital Holdings Partners with FreeWheel

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

February 28, 2024 9:00 am EST

Integration Between Holding Group’s Colossus SSP and FreeWheel to Provide Enhanced Connections to Demand to Increase Ability for Advertisers to Reach Audiences at Scale on CTV

HOUSTON and NEW YORK, Feb. 28, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange 142, LLC (“Orange 142”), announced a new partnership with FreeWheel, a global technology platform for the television advertising industry.

The agreement builds on Direct Digital Holdings’ buy- and sell-side relationship with Beeswax, FreeWheel’s programmatic buying platform.

This new deal will allow the holding group’s Colossus SSP to directly connect to FreeWheel’s premium CTV inventory and server technology. Colossus SSP provides brands with access to a truly inclusive audience, tapping into a range of multicultural/diverse publishers and general market media – and this partnership will open pathways to top-tier CTV inventory for both. The partnership will bring together expertise, resources, cutting-edge technology, and robust content to drive demand from top advertisers.

“This agreement will significantly grow the high-quality CTV inventory available through Colossus SSP,” said Mark D. Walker, Co-Founder, CEO, and Chairman at Direct Digital Holdings. “FreeWheel is able to unify all demand channels into one optimal ad decision to maximize the end-viewer experience. Their capabilities complement the performance, efficiencies and transparency that brands and media buyers have come to value at Colossus SSP.”

“Today’s TV ad marketplace is very fragmented and complex, and so, one of our key focus areas is to continually find new ways to simplify and streamline the ad buying process,” said Katy Loria, Chief Revenue Officer, FreeWheel. “We recognize today’s consumers increasingly gravitate towards CTV and our audiences are becoming more diverse. It is our hope that, by teaming up with Colossus SSP, we can help connect publishers to multicultural audiences – at scale – on premium content.”  

“We have worked collaboratively with both Colossus SSP and FreeWheel, and we’re excited to tap into their new partnership as they continue to diversify and scale their collective offerings,” said Michael Piner, EVP, Advanced Advertising, Mediahub. “High-quality CTV inventory is a top priority for our clients, and this partnership will deliver that while expanding our ability to reach robust, diverse audiences through a diverse-owned partner.”

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.

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

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, of receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

About FreeWheel
FreeWheel empowers all segments of The New TV Ecosystem. We are structured to provide the full breadth of solutions the advertising industry needs to achieve their goals. We provide the technology, data enablement and convergent marketplaces required to ensure buyers and sellers can transact across all screens, across all data types, and all sales channels, in order to ensure the ultimate goal – results for marketers. With offices in New York, San Francisco, Chicago, London, Paris, Beijing, and across the globe, FreeWheel, A Comcast Company, stands to advocate for the entire industry through the FreeWheel Council for Premium Video. For more information, please visit freewheel.com, and follow us on X and LinkedIn. 

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.

Media Contacts:

Direct Digital Holdings:
press@directdigitalholdings.com

FreeWheel:
Elaine Wong
elaine_wong@comcast.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-partners-with-freewheel-302073592.html

SOURCE Direct Digital Holdings

Released February 28, 2024

Release – Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 28, 2024 8:00am ESTDownload as PDF

Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection

Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product

Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal of Medicine1

CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.

“Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Anti-CD40L modulates T cell function and has the potential to promote tolerance of transplanted organs. We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated with first-generation anti-CD40L mAbs. Preclinical studies in non-human primates did not result in any thrombotic complications, suggesting that the protein engineering of TNX-1500’s Fc region has achieved its design goals.”

Dr. Lederman continued, “Recently, positive clinical data with other CD40L blockers have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in treating relapsing multiple sclerosis.2 Eledon Pharmaceuticals is developing tegoprubart, a non-covalent dimer antibody with no heavy-light or heavy-heavy interchain disulfide bridges for the prevention of rejection of kidney transplants3.”

Dr. Lederman concluded, “We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden of current immunosuppressive regimens. In addition, TNX-1500 has the potential to address multiple other indications, including several autoimmune diseases. We look forward to the results of this Phase 1 trial, which are expected in the third quarter of this year, and to continuing the development of TNX-1500 as a promising candidate in an important therapeutic space.”

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 trial of TNX-1500 was initiated in the third quarter of 2023. The primary objective of the Phase 1 trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. This first-in-human trial is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts.4,5

About anti-CD40L Therapeutics in Development

No anti-CD40L mAb has been approved in any jurisdiction. In addition to TNX-1500, frexalimab and tegoprubart, tn03 fusion protein dazodalibep is being developed by Amgen (formerly Horizon Therapeutics Public Limited Company) for the treatment of Sjögren’s Syndrome .6,7 Dapirolizumab pegol, an anti-CD40L pegylated Fab, is being developed by UCB for the treatment of systemic lupus erythematosus.8

*TNX-1500 is an investigational new biologic and is not approved for any indication

  1. Vermersch P., et al. N Engl J Med. 2024. 390(7):589-600 https://doi.org/10.1056/nejmoa2309439
  2. Sanofi press release. May 31, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991 (accessed August 2023)
  3. Eledon press release. November 2, 2023. https://ir.eledon.com/news-releases/news-release-details/eledon-reports-updated-data-ongoing-phase-1b-trial-evaluating (accessed February 2024)
  4. Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
  5. Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
  6. BioSpace. September 12, 2022. https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-sjoegren-s-syndrome-meets-primary-endpoint (accessed February 2024)
  7. BioSpace. January 18, 2023. https://www.biospace.com/article/horizon-bags-second-phase-ii-win-in-sjoegren-s-syndrome (accessed February 2024)
  8. https://www.ucb.com/our-science/pipeline (accessed August 2023)

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released February 28, 2024