Author: aweinsoff@channelchek.com

Release – CORRECTION: MAIA Biotechnology Announces $1.08 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 05, 2025 11:45pm EDT Download as PDF

This is a correction of the announcement. The initial exercise date and term of the warrants purchased in the private placement have been corrected to one year following issuance and have a term of six years from the initial issuance date. All other aspects of the announcement remain the same.

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 719,999 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.05 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.08 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released May 5, 2025

Release – FreightCar America, Inc. Reports First Quarter 2025 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on RAIL

05/05/2025

Gross Profit Increased 26% with Gross Margin Expanding 780 Basis Points

Generates Quarterly Operating Cash Flow of $13 million and Adjusted Free Cash Flow of $12 million

Strong Order Intake Supports Reaffirmed Full Year Guidance

CHICAGO, May 05, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (“FreightCar America” or the “Company”), a diversified manufacturer and supplier of railroad freight cars, railcar parts and components, today reported results for the first quarter ended March 31, 2025.

First Quarter 2025 Highlights

  • Revenues of $96.3 million, consistent with expectations, decreased 40.2% from $161.1 million in the first quarter of 2024, with planned railcar deliveries of 710 units compared to 1,223 units in the prior-year period
  • Gross margin of 14.9% with gross profit of $14.4 million, compared to gross margin of 7.1% with gross profit of $11.4 million in the first quarter of 2024
  • Net income of $50.4 million, or $1.52 per share and Adjusted net income of $1.6 million, or $0.05 per share, primarily reflecting a $52.9 million non-cash adjustment due to change in warrant liability
  • Adjusted EBITDA of $7.3 million, compared to Adjusted EBITDA of $6.1 million in the first quarter of 2024, up 20.5%
  • Generated Operating Cash Flow of $12.8 million, compared to $25.3 million of cash used in the first quarter of 2024, a $38.1 million increase year over year
  • Generated Adjusted Free Cash Flow of $12.5 million, compared to $30.5 million of cash used in the first quarter of 2024, a $43.0 million increase year over year
  • Ended the quarter with a backlog of 3,337 units valued at $318 million

“We continued to solidify our position as the fastest-growing railcar manufacturer in North America, driven by strong commercial execution and operational discipline. In line with our expectations for the first quarter, we achieved robust margins, once again outperforming our industry peers, reflecting our commitment to differentiated product offerings and exceptional commercial discipline. Order activity remained strong, with 1,250 railcars ordered during the quarter valued at approximately $141 million, underscoring our ongoing momentum and expanding market share,” commented Nick Randall, President and Chief Executive Officer of FreightCar America.

Randall continued, “Looking forward, our healthy backlog and growing inquiry pipeline position us for a meaningful ramp up in deliveries for the remainder of the year. While the industry has experienced some delays in order placements, we have continued to capture significant market share through our agility and superior responsiveness to customer needs. We reaffirm our previously announced full-year guidance and remain confident in our ability to deliver profitable growth and increased market share, further strengthening our long-term competitive position.”

Fiscal Year 2025 Outlook

The Company has reaffirmed outlook for fiscal year 2025 as follows:

 Fiscal 2025 OutlookYear-over-Year
Growth at Midpoint
Railcar Deliveries4,500 – 4,900 Railcars7.7%
Revenue$530 – $595 million0.6%
Adjusted EBITDA1$43 – $49 million7.0%

1. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA guidance due to the inherent difficulty in forecasting and quantifying adjustments necessary to calculate such non-GAAP measure without unreasonable effort. Material changes to such adjustments, including warrant liability and non-core operating items, could affect future GAAP results.

Mike Riordan, Chief Financial Officer of FreightCar America, added, “We remain in a strong financial position, generating consistent operating and free cash flow, marking our fourth consecutive quarter of positive operating cash flow, while ending the quarter with over $50 million in cash on hand. Our disciplined approach continues to drive margin strength and consistent cash generation, reinforcing our balance sheet and providing significant financial flexibility. We are firmly on track to achieve our full year guidance targets and remain committed to sustainable value creation through continued operational efficiency, commercial execution and delivering positive free cash flow for the year.”

First Quarter 2025 Conference Call & Webcast Information

The Company will host a conference call and live webcast on Tuesday, May 6, at 11:00 a.m. (Eastern Time) to discuss its first quarter 2025 financial results. FreightCar America invites shareholders and other interested parties to listen to its financial results conference call.

Teleconference details are as follows:

About FreightCar America

FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.

Forward-Looking Statements

This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

Non-GAAP Financial Measures

This press release includes measures not derived in accordance with generally accepted accounting principles (“GAAP”), such as EBITDA, Adjusted EBITDA, Adjusted net income (loss), Adjusted EPS, Free cash flow and Adjusted free cash flow. These non-GAAP measures should not be considered in isolation or as a substitute for any measure derived in accordance with GAAP and may also be inconsistent with similar measures presented by other companies. Reconciliations of these measures to the applicable most closely comparable GAAP measures, and reasons for the Company’s use of these measures, are presented in the attached pages.

Investor Contact:RAILIR@Riveron.com

View full release here.

Release – V2X Delivers First Quarter Results and Reaffirms Full-Year Guidance

Posted on by aweinsoff@channelchek.com
V2X (PRNewsfoto/V2X, Inc.)

Research News and Market Data on VVX

May 05, 2025

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First Quarter Highlights

  • Revenue of $1.02 billion with +10% y/y growth in Indo-Pacific region
  • Net income of $8.1 million; Adjusted net income1 of $31.5 million, up 10% y/y
  • Adjusted EBITDA1 of $67.0 million, with a margin of 6.6%
  • Diluted EPS of $0.25; Adjusted diluted EPS1 of $0.98, up 9% y/y
  • Enhanced capital structure to generate interest expense savings and cash flow
  • Notable progress on new Foreign Military and International Sales opportunities

RESTON, Va., May 5, 2025 /PRNewswire/ — V2X, Inc. (NYSE:VVX) announced first quarter 2025 financial results.

“The overall trends in our market remain positive and are being driven by customer requirements to improve deterrence, enhance readiness, and strengthen national security,” said Jeremy C. Wensinger, President and Chief Executive Officer. “We are performing well as V2X possesses the unique full lifecycle, mission driven solutions to deliver on these requirements. The V2X value proposition is being recognized by customers and is demonstrated by our recent wins and extensions, which provide substantial visibility for the next several years.”

Mr. Wensinger continued, “V2X is in an enviable position with strong visibility, differentiated capabilities, and a robust geographic footprint. We are capitalizing on this position by increasing bid velocity. Additionally, the foreign military sales and international markets continue to represent a large and growing addressable opportunity to deliver more solutions across locations in which we already operate. These customers know V2X, they trust V2X, and see the benefit of our solutions. Our focused engagement strategy and visible presence is yielding substantial traction on several nearer-term opportunities that align exactly to our core capabilities.”

Mr. Wensinger concluded, “We continue to execute in a dynamic market, bringing the whole of V2X to meet our customers critical mission requirements. It’s our employees that make this possible and I’d like to recognize their commitment and contributions.”

First Quarter 2025 Results

“V2X reported revenue of $1.02 billion in the quarter, with 10% year-over-year growth in the Indo-Pacific region,” said Shawn Mural, Senior Vice President and Chief Financial Officer. “We are pleased with our performance and start to the year, particularly in light of the overall market environment. We remain on track to achieve our commitments and are confident in the strength and resiliency of our business model that generates strong, predictable cash flow.”   

“For the quarter, the Company reported operating income of $34.3 million and adjusted operating income1 of $61.5 million. V2X delivered adjusted EBITDA1 of $67.0 million, with a margin of 6.6%. Net income for the quarter was $8.1 million dollars, up from $1.1 million dollars from the prior year. Adjusted net income1 was $31.5 million dollars, increasing 10% year-over-year. First quarter GAAP diluted EPS was $0.25. Adjusted diluted EPS1 for the quarter was $0.98, increasing 9% year-over-year.”

Mr. Mural continued, “During the quarter we continued to demonstrate our steadfast commitment to increasing shareholder value by making further enhancements to our capital structure. Our strong fundamental profile and consistent financial performance created a compelling opportunity to reprice and extend both our revolver and Term Loan A.”

Reaffirming 2025 Guidance

Mr. Mural concluded, “The trends and demand signals in our business remain positive and we believe our strategy, visibility, and targeted growth opportunities will yield value creation. Given our performance in the first quarter and current trends, the Company is reaffirming guidance for 2025.”

Guidance is as follows:

$ millions, except for per share amounts2025 Guidance2025 Mid-Point
Revenue$4,375$4,500$4,438
Adjusted EBITDA1$305$320$313
Adjusted Diluted Earnings Per Share1$4.45$4.85$4.65
Adjusted Net Cash Provided by Operating Activities1$150$170$160

The Company is not providing a quantitative reconciliation with respect to the foregoing forward-looking non-GAAP measures in reliance on the “unreasonable efforts” exception set forth in SEC rules because certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. For example, unusual, one-time, non-ordinary, or non-recurring costs, which relate to M&A, integration and related activities cannot be reasonably estimated. Forward-looking statements are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the Safe Harbor Statement below. 

First Quarter Conference Call

Management will conduct a conference call with analysts and investors at 4:30 p.m. ET on Monday, May 5, 2025. U.S.-based participants may dial in to the conference call at 877-300-8521, while international participants may dial 412-317-6026. A live webcast of the conference call as well as an accompanying slide presentation will be available here: https://app.webinar.net/0pq4wxEAbDQ    

A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through May 19, 2025, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10198194. 

Presentation slides that will be used in conjunction with the conference call will also be made available online in advance on the “investors” section of the company’s website at https://gov2x.com. V2X recognizes its website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with its obligations under the U.S. Securities and Exchange Commission (“SEC”) Regulation FD.

1   See “Key Performance Indicators and Non-GAAP Financial Measures” for descriptions and reconciliations.

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

Investor ContactMedia Contact
Mike Smith, CFAAngelica Spanos Deoudes
IR@goV2X.comCommunications@goV2X.com
719-637-5773571-338-5195

Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 (the “Act”): Certain material presented herein includes forward-looking statements intended to qualify for the safe harbor from liability established by the Act.

Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “could,” “potential,” “continue” or similar terminology. These statements are based on the beliefs and assumptions of the management of the Company based on information currently available to management. Forward-looking statements in this press release, include, but are not limited to our future performance and capabilities; all of the statements and items listed under “Reaffirming 2025 Guidance” above and other assumptions contained therein for purposes of such guidance; our belief that prior performance provides substantial visibility for future performance; market trends; our expectations that the foreign military sales and international markets represent a large and growing addressable opportunity; and our belief that our strategy, visibility, and targeted growth opportunities provide substantial opportunities for value creation.

These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside our management’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements.  In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company’s historical experience and our present expectations or projections. For a discussion of some of the risks and uncertainties that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC.

View the full release here.

Release – MAIA Biotechnology Announces $1.08 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 05, 2025 4:05pm EDT Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 719,999 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.05 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.08 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released May 5, 2025

Release – SelectQuote to Release Fiscal Third Quarter 2025 Earnings on May 12

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SLQT

05/05/2025

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its third quarter 2025 financial results before market open on Monday, May 12, 2025. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (May 12, 2025) at 8:30 am ET to discuss the results.

To register for this conference call, please use this link: https://registrations.events/direct/Q4I54780976.

After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

Release – The ONE Group Hospitality, Inc. to Host First Quarter 2025 Earnings Conference Call and Webcast at 4:30 PM ET on May 7, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on STKS

May 05, 2025

 Download as PDF

DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today announced that Emanuel “Manny” Hilario, President and Chief Executive Officer, and Tyler Loy, Chief Financial Officer, will host a conference call and webcast to discuss first quarter 2025 financial results on Wednesday, May 7, 2025 at 4:30 PM ET. A press release containing the first quarter 2025 financial results will be issued after market close that same afternoon.

The conference call can be accessed live over the phone by dialing 412-542-4186. A replay will be available after the call and can be accessed by dialing 412-317-6671; the passcode is 10198138. The replay will be available until Wednesday, May 21, 2025.

The webcast can be accessed from the Investor Relations tab of The ONE Group’s website at www.togrp.com under “News / Events”.

About The ONE Group

The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:

  • STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
  • Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
  • Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
  • RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
  • Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
  • Samurai, an interactive dining experience located in sunny Miami, FL and soon to be in Westwood, CA, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki, anywhere from two to twenty tables, right before your eyes along with a robust selection of steak offerings.
  • ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.

Additional information about The ONE Group can be found at www.togrp.com.

Investors:
ICR
Michelle Michalski or Raphael Gross
(646) 277-1224
Michelle.Michalski@icrinc.com

Media:
ICR
Seth Grugle
(646) 277-1272
seth.grugle@icrinc.com

Source: The ONE Group Hospitality, Inc.

Released May 5, 2025

Release – GoHealth to Announce First Quarter 2025 Results on May 13, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

May 05, 2025 at 9:00 AM EDT

CHICAGO, May 05, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its first quarter 2025 financial results on the morning of May 13, 2025.

Chief Executive Officer, Vijay Kotte, and Chief Financial Officer, Brendan Shanahan, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – FAT Brands Announces Drew Martin as Chief Information Officer

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Research News and Market Data on FAT

05/05/2025

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Global Restaurant Franchising Company Hires Seasoned Global IT Executive

LOS ANGELES, May 05, 2025 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., announces the hiring of Drew Martin as Chief Information Officer. Martin joins FAT Brands with over 35 years of IT experience, delivering impactful results for a wide range of companies—from Fortune 500 companies to high-growth start-ups. Martin will be focused on delivering scalable technological solutions to progress the growth of FAT Brands.

Martin’s diverse background includes serving as Senior Vice President and CIO for Jack in the Box and Senior Vice President and CIO for Sony Electronics. Other previous ventures include PepsiCo, leading the digital transformation/supporting the sale of Jenny Craig, and serving as Executive Vice President and CIO of high-growth software start-up Lytx Inc., where Martin led the development of AI product features.

“Drew’s vast experience across the consumer landscape will provide great value to FAT Brands as we continue to enhance and strengthen our technology platforms,” said Thayer Wiederhorn, Chief Operating Officer of FAT Brands. “His deep understanding of digital innovation will be instrumental as we work to elevate our guest experience, streamline operations, and drive long-term growth across our portfolio of brands.”

“FAT Brands continues to cement itself as a leader in the restaurant space with its dynamic, growing restaurant portfolio,” said Drew Martin, CIO of FAT Brands. “I look forward to identifying new technology opportunities that provide strategic value across our brands and position the company as an innovator within the industry.”

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

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

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

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Source: FAT Brands Inc.

Release – ACCO Brands Corporation Declares Quarterly Dividend

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Research News and Market Data on ACCO

04/25/2025

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that its board of directors has declared a quarterly cash dividend of $0.075 per share. The dividend will be paid on June 18, 2025 to stockholders of record as of the close of business on May 23, 2025.

About ACCO Brands Corporation

ACCO Brands is the leader in branded consumer products that enable productivity, confidence and enjoyment while working, when learning and while playing. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

For further information:

Chris McGinnis
Investor Relations
(847) 796-4320

Kori Reed
Media Relations
(224) 501-0406

Source: ACCO Brands Corporation

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Release – Aurania Appoints Corporate Secretary and Provides Highlights from Year End Financial Statements

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Research News and Market Data on AUIAF

April 25, 2025 7:51 AM EDT

Toronto, Ontario–(Newsfile Corp. – April 25, 2025) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) is pleased to announce the appointment of Ms. Carolyn Muir as Corporate Secretary of the Company, in addition to her role as Vice President, Corporate Development & Investor Relations. The Company also reports that its Financial Statements and Management’s Discussion and Analysis for the year ended December 31, 2024, are available under Aurania’s public filings on SEDAR+ at www.sedarplus.com and on the Company’s website. Highlights are described below.

Highlights from Management’s Discussion and Analysis

During the fourth quarter of 2024, the Company advanced drill target definition at its Kuri-Yawi gold target through detailed geophysical surveys and geological mapping. Preliminary results show a large vertical conductive corridor aligned with thallium-rich chalcedony veins, sinters and hydrothermal alterations, key indicators of epithermal systems. Two main chargeability structures were identified, interpreted as potential mineralized zones. Ongoing data integration will guide preparations for a future drill campaign.

The Anaconda mapping program at the Awacha porphyry copper target area was completed during 2024. Initial geological reconnaissance has confirmed an area of interest through the observation of porphyric intrusive showing potassic and sericite alteration with the presence of quartz veins with chalcopyrite traces. Next steps will consist of an interpretation of all the data collected with the realization of thematic maps to define the most prospective area of interest.

During 2024, Aurania’s CSR activities supported clean water access, education, and women’s entrepreneurship across the communities in its areas of influence in Ecuador, including the launch of a micro-business program, school and library construction, and community-based training initiatives.

The Swiss challenge and public consultation phases associated with the application for a 51 km² exploration permit-located immediately adjacent to the South Armorican Shear (cisaillement sud-armoricain) in the Brittany Peninsula of northwestern France-have now been completed, and the Company continues to advance through the progress of the application.

The Company signed non-binding memoranda of understanding with the Communes of Ogliastro and Nonza in Cap Corse, Northern Corsica, France, for the exploitation of heavy mineral beach placers that are highly enriched in nickel (Ni) and other metals. The nickel-bearing mineral in the black magnetic sand is awaruite, a naturally occurring nickel-iron alloy, which is both of high specific gravity (dense) and of high magnetic susceptibility (magnetic).

AuroVallis, the wholly owned Swiss subsidiary of Aurania, completed the liquidation process initiated several years on June 30, 2024, with no impact on the Company’s consolidated financial figures.

On September 23, 2024, Palamina Corp. (“Palamina”), completed the acquisition of 100% of the shares of Aurania’s Peruvian subsidiary in exchange of 350,000 common shares of Palamina Corp. (TSXV: PA) (OTCQB: PLMNF) and a 1% Net Smelter Return (“NSR”) royalty over certain mining claims located in Peru and held by the Company’s subsidiary. Palamina has the option to buy back half of the NSR for $1,000,000 at any time.

During 2024, the Company completed two non-brokered private placements totaling $5,429,481 in gross proceeds, with units priced at $0.20 and $0.45, each including one common share and one warrant. Proceeds were used to advance exploration activities and working capital. To preserve cash and improve the balance sheet, the Company settled $3,812,781 in debt owed to Dr. Keith Barron through the issuance of common shares. Additionally, the Company received a $1,000,000 unsecured loan from Dr. Barron to support ongoing operations.

The Company reached an agreement with the corresponding Ecuadorian authorities for the payment of the annual concession fees of its 42 mineral exploration concessions in Ecuador for the year 2024. Subsequent to year end, the Company filed all the appropriate documentation for the renewal of its 42 mineral exploration concessions in Ecuador for the year 2025 and filed a request to enter into a new agreement for payment of the associated annual concession fees. Its property in Ecuador remains in good standing while an agreement is being finalized.

Subsequent to year end, on April 3, 2025, the Company announced its intention to complete a non-brokered private placement financing of up to 5,000,000 units of the Company at a price of $0.30 per unit for total gross proceeds of up to $1,500,000. On April 17, 2025, the Company announced the closure of the first tranche. An aggregate of 3,182,899 units were sold under the first tranche for total gross proceeds of $954,870. Each unit consisting of one common share of the Company and one common share purchase warrant, the warrant having and exercise price of $0.55 per common share and an expiry date of two years after closing of the first tranche. Dr. Keith Barron subscribed for 1,000,000 Units of this offering.

Option Grant

On April 24, 2025, Ms. Carolyn Muir was granted 130,000 stock options exercisable at C$0.27 each in connection with her appointment as Corporate Secretary and her existing roles as VP Corporate Development and Investor Relations of the Corporation. The options have a 5-year expiry term and shall vest one-third immediately, one-third one year from the date of grant, and one-third vesting two years after the date of grant.

Qualified Person

The technical information contained in this news release has been verified and approved by Jean-Paul Pallier, MSc. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and is a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucu Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Information on Aurania and technical reports are available at www.aurania.com and www.sedarplus.ca, as well as on Facebook at https://www.facebook.com/auranialtd/, Twitter at https://twitter.com/auranialtd, and LinkedIn at https://www.linkedin.com/company/aurania-resources-ltd-.

For further information, please contact:

Carolyn Muir
VP Corporate Development & Investor Relations
Aurania Resources Ltd.
(416) 367-3200
carolyn.muir@aurania.com

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

Forward-Looking Statements
This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the Company’s teams being on track ahead of any drill program, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.

info

SOURCE: Aurania Resources Ltd.

Release – FreightCar America, Inc. Announces Orders of 1,250 Railcars Valued at $141 Million

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04/24/2025

Orders Highlight Continued Strength Across Diverse Product Offerings

CHICAGO, April 24, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (“FreightCar America” or the “Company”), a diversified manufacturer and supplier of railroad freight cars, railcar parts, and components, today announced that it received total orders valued at approximately $141 million, representing a total of 1,250 railcars, during the quarter ended March 31, 2025. These orders underscore ongoing demand for FreightCar America’s railcar offerings and reflect continued market share gains.

FreightCar America continues to gain share within its core railcar markets, driven by strategic initiatives aimed at increasing operational efficiency, product innovation, and commercial excellence. The orders represent approximately 25% of all new railcars ordered in the quarter, and 36% in our addressable market, marking the largest new railcar market share quarter intake in 15 years.

Nick Randall, President and Chief Executive Officer of FreightCar America, commented, “We are pleased to see sustained customer interest across our product portfolio, particularly in gondolas, open-top hoppers and covered hopper cars, which remain an integral part of our diverse portfolio of railcar types. Our manufacturing agility and ability to capture these opportunities highlights our competitive strengths.”

Randall continued, “We have been monitoring recent tariff developments and based on our current understanding, railcars sold by FreightCar America in North America are not subject to tariffs due to their compliance with the United States-Mexico-Canada Agreement. We continue to monitor any tariff developments. With our supply chain strategy, operational excellence initiatives at our manufacturing facility and continued commercial momentum, we remain confident in our forward trajectory.”

Certain orders referenced in this release are subject to customary documentation and completion of terms.

About FreightCar America

FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.

Forward-Looking Statements

This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These potential risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

Investor ContactRAILIR@Riveron.com


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Source: FreightCar America, Inc.View all news

Release – Lucky Strike Entertainment to Report Third Quarter 2025 Financial Results on May 8, 2025

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Research News and Market Data on LUCK

04/24/2025

RICHMOND, Va.–(BUSINESS WIRE)– Lucky Strike Entertainment (NYSE: LUCK), one of the world’s premier operators of location-based entertainment, will report financial results for the third quarter of fiscal 2025 on Thursday, May 8, 2025, before the U.S. stock market opens. Management will discuss the results via webcast at 9:00 AM ET on the same day.

The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Lucky Strike Entertainment Investor Relations website at IR.LuckyStrikeEnt.com.

About Lucky Strike Entertainment

Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit IR.LuckyStrikeEnt.com.

IR@LSEnt.com

Source: Lucky Strike Entertainment Corporation

Release – GeoVax Highlights Strong Clinical Results Following Presentation of Multi-Antigen COVID-19 Vaccine at the 25th Annual World Vaccine Congress

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Research News and Market Data on GOVX

GEO-CM04S1 Demonstrates Durable T Cell and Antibody Responses in Healthy and Immunocompromised Populations

ATLANTA, GA, April 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today recapped the successful presentation of new clinical data on its multi-antigen SARS-CoV-2 vaccine candidate, GEO-CM04S1, delivered at the 25th Annual World Vaccine Congress in Washington, D.C.

The presentation, titled “Phase 2b Study Results That Evaluated and Compared GeoVax’s Multi-Antigen Vaccine Candidate (GEO-CM04S1) to an Approved Vaccine Against COVID-19,” was given by Don J. Diamond, Ph.D. on April 24, 2025. It highlighted results across several Phase 1 and 2 clinical trials, including studies involving healthy volunteers as well as immunocompromised patients such as stem cell transplant recipients and those with chronic lymphocytic leukemia (CLL).

GEO-CM04S1, based on the synthetic Modified Vaccinia Ankara (MVA) vector platform, uniquely expresses both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2—resulting in broad and durable immune responses even in populations that have historically responded poorly to mRNA vaccines.

Key Highlights from the Clinical Data Presented

Robust Immune Response in Healthy Adults

  • In a Phase 1 trial, 100% of participants (34/34) seroconverted (i.e., produced antibodies) for Spike IgG, and 94% (32/34) for Nucleocapsid IgG.
  • 98% (48/49) demonstrated a T cell response to either antigen following vaccination.
  • No serious safety concerns were reported across varying dose levels.

Comparable Immunogenicity at Lower Doses (Phase 2 Booster Trial)

  • Healthy volunteers who had previously received mRNA or protein-based COVID-19 vaccines were boosted with GEO-CM04S1 at two dose levels (10⁷ vs 10⁸ pfu).
  • Spike, RBD, and Nucleocapsid IgG antibody responses, as well as neutralization titers against multiple COVID-19 variants (including XBB.1.5), increased significantly at both dose levels with no meaningful differences between them.
  • T cell responses increased significantly post-vaccination, regardless of baseline immunity.

Superior Performance in Immunocompromised Populations

  • In stem cell transplant recipients, GEO-CM04S1 induced ELISA antibody titers and T cell responses that exceeded those observed in healthy volunteers.
  • In a randomized Phase 2 trial comparing GEO-CM04S1 to the Pfizer-BioNTech (Comirnaty®) vaccine in patients with Chronic Lymphocytic Leukemia, GEO-CM04S1 demonstrated a significantly higher T cell response rate.
    • At Day 56 of the study: 6 of 15 patients in the GEO-CM04S1 arm achieved ≥3-fold increases in Spike or Nucleocapsid-specific T cells versus 2 of 14 in the Comirnaty arm.
    • The Data and Safety Monitoring Board (DSMB) recommended halting enrollment in the Pfizer arm due to underperformance, while continuing enrollment of the GEO-CM04S1 arm.

“We were pleased to share these promising results with global leaders in vaccinology,” said Don J. Diamond, Ph.D. “The data underscore the value of our dual-antigen approach, particularly for patients underserved by existing single-antigen vaccines. GEO-CM04S1 not only drives strong antibody and T cell immunity in healthy adults, but also in the immunocompromised—a population historically underserved by single-antigen mRNA vaccines.”

David A. Dodd, Chairman, President, and CEO of GeoVax, added: “The clinical performance of GEO-CM04S1 across diverse and high-risk populations supports our mission to deliver broad and lasting protection through next-generation vaccines. Our data continues to demonstrate strong, durable immune responses in both healthy and immunocompromised populations—a critical feature of our vaccine for public health preparedness. As we continue to advance this program, these results reinforce our confidence in the MVA platform as a foundation for addressing future public health threats.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on the Modified Vaccinia Ankara (MVA) vector originally developed at City of Hope. Its multi-antigen design expresses both Spike and Nucleocapsid proteins of SARS-CoV-2, promoting broad, cross-reactive immunity. The vaccine is being evaluated in three ongoing Phase 2 clinical trials.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, 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:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696