Release – Bit Digital, Inc. Announces First Quarter of Fiscal Year 2025 Financial Results

Research News and Market Data on BTBT

NEW YORK, May 15, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City, today announced its financial results for the First Quarter of 2025. The Company will host a conference call on May 16, 2025, at 10:00 AM ET to discuss results (click here for registration information).

Financial Highlights for First Quarter of 2025

  • Total revenue for the First Quarter of 2025 was $25.1 million, a 17% decrease compared to the prior year’s results. The decrease was driven by a decline in Digital asset mining revenue following the April 2024 halving and partially offset by continued growth in Cloud services revenue and the addition of Colocation services revenue.
  • Revenue from bitcoin mining was $7.8 million for the quarter, a 64% decrease compared to the prior year’s quarter. Cloud services revenue was $14.8 million, an 84% increase from the prior year’s quarter. Colocation services revenue was $1.6 million for the quarter as compared to none in the prior year’s quarter. ETH staking revenue was $0.6 million for the quarter, a 72% increase from the prior year’s quarter.
  • Revenue from digital asset mining comprised 31% of total revenue for the first quarter of 2025 compared to 72% for the prior year’s quarter.
  • The Company had cash, cash equivalents and restricted cash of $61.3 million, and total liquidity (defined as cash, cash equivalents and restricted cash, USDC, and the fair market value of digital assets) of approximately $141.4 million, as of March 31, 2025.
  • Total assets were $458.2 million and Shareholders’ Equity amounted to $417.4 million as of March 31, 2025.
  • Adjusted EBITDA1 was $(44.5) million for the First Quarter of 2025 compared to $58.5 million for the first quarter of 2024. Adjusted EBITDA for Q1 2025 includes $49.2 million in mark-to-market losses on digital assets compared to $45.7 million of gains in Q1 2024.
  • GAAP loss per share was $(0.32) on a fully diluted basis for the First Quarter of 2025 compared to earnings per share of $0.43 for the first quarter of 2024.

Operational Highlights for First Quarter of 2025

  • The Company earned 83.3 bitcoins during the First Quarter of 2025, an 80% decrease from the prior year. The decline was driven by a reduction in block rewards following the halving event in April 2024, an increase in network difficulty, and a decrease in the Company’s average operational hash rate following a fleet deployment in connection with the Company’s exit from Coinmint facilities.
  • The Company earned 211.0 ETH in native staking for the three months ended March 31, 2025.
  • Treasury holdings of BTC and ETH were 417.6 and 24,434.2, respectively, with a fair market value of approximately $34.5 million and $44.5 million on March 31, 2025, respectively.
  • As of March 31, 2025, we had 20,854 miners owned or operating (in Iceland) for bitcoin mining with a total maximum hash rate of 2.4 EH/s. The Company’s active hash rate of its bitcoin mining fleet was approximately 1.5 EH/s as of March 31, 2025.
  • The Company had approximately 21,568 ETH actively staked in native staking protocols as of March 31, 2025.
  • As of January 1, 2025, Bit Digital officially transitioned to domestic issuer status under U.S. securities law.
  • In January 2025, the Company entered into a new agreement to supply its first customer for an additional 464 B200 GPUs for a period of eighteen months. This new agreement replaced the prior agreement whereby the Company was to provide the customer with an incremental 2,048 H100 GPUs. The contract represents approximately $15 million of annualized revenue and features a two-month prepayment from the customer. The customer has elected to defer the commencement date until August 20th, 2025, which is the latest allowable date under the agreement.
  • In addition to the above, the Company signed multiple new cloud services agreements during the first quarter totaling more than 200 NVIDIA H200 GPUs, with contract durations ranging from one to twelve months. These deployments supported training and inference workloads and reflect continued momentum and customer diversification across the Company’s GPU cloud platform.
  • In February, the Company officially rebranded its HPC business as WhiteFiber, Inc., encompassing its GPU cloud services and HPC data center platform, Enovum Data Centers.
  • In February, the Company, through its high-performance computing platform WhiteFiber, secured a five-year, 5MW colocation agreement with Cerebras Systems (“Cerebras”), a leader in generative AI. In April, Bit Digital announced the selection of a new data center site in Saint-Jérôme, Québec (“MTL-3“) to fulfill the contract. The facility, being developed by Enovum under a lease-to-own structure, is expected to commence operations in July 2025, with total development costs estimated at approximately CAD $55 million (approximately $40 million USD). Cerebras holds a right of first refusal for additional capacity at the site.
  • In March, the Company announced a strategic partnership between WhiteFiber and Shadeform, a leading multi-cloud GPU marketplace, to deliver on-demand access to NVIDIA B200 GPUs. Bit Digital received its first shipment of B200s during the quarter, comprising 64 servers (512 GPUs), and began phased deployment in April. Through the Shadeform integration, WhiteFiber’s GPU cloud became globally accessible across more than 100 regions, enabling developers and enterprises to access high-performance AI infrastructure without long-term commitments
  • In March 2025, the Company executed two new service orders under its existing agreement with Boosteroid, a global cloud gaming provider. The orders total 701 GPU servers under five-year terms, with deployments scheduled to commence in May and June 2025. These new contracts represent approximately $2.1 million in annualized contract value, bringing total contract value from Boosteroid to approximately $3.6 million annually and over $18 million in total contract value.

Subsequent Events

  • In April 2025, the Company entered into a definitive agreement to acquire a data center property in Madison, North Carolina. Closing of the transaction is subject to customary closing conditions, including receipt of an energy study verifying utility capacity. An earnest money deposit of $2.25 million was deposited in escrow pursuant to the terms of the Purchase Agreement, of which $1.25 million is non-refundable to us.
  • In April 2025, the Company signed two additional cloud services agreements with DNA Fund. The first agreement, commencing in early May 2025, includes 104 NVIDIA H200 GPUs under a 25-month term. The second, expected to commence in May 2025, includes 512 H200 GPUs under a 23-month term. With these additions, DNA Fund’s total contracted deployment increased to 1,192 GPUs. Combined, the agreements represent approximately $20.9 million of annualized revenue.

Management Commentary

“Our first quarter results were affected by mark-to-market losses on digital assets and lower bitcoin mining revenue, both of which reflect industry-wide headwinds and the strategic rebalancing of our business. We continued to make meaningful progress in scaling our infrastructure platform and diversifying our revenue streams.

Cloud services revenue increased 84% compared to the year-ago period and accounted for the majority of total revenue. Demand was driven by both long-term enterprise contracts and short-term workloads from AI-native developers. Our strategic investments in next-generation hardware and distribution partnerships, including B200 deployments and our integration with Shadeform, helped expand platform reach and customer access.

Colocation services contributed a full quarter of revenue following our acquisition of Enovum in late 2024. We expect this business line to become a major growth engine as we expand our development pipeline to meet growing customer demand.

Bitcoin mining accounted for 31% of total revenue in the quarter, down from 40% in Q4 and 72% a year ago. The decline reflects both the halving event and the ongoing redeployment of miners from Coinmint facilities, which we used as an opportunity to retire less efficient assets and reposition our fleet. While mining remains a component of our platform, we expect its contribution to continue declining over time as our infrastructure businesses grow.

Gross margins improved both sequentially and year-over-year, driven by stronger contribution from Cloud and Colocation segments and ongoing cost discipline. We ended the quarter with approximately $140 million in total liquidity and no debt, giving us the flexibility to invest in high-return initiatives.

We advanced our platform on several fronts, deploying NVIDIA B200 GPUs, expanding key customer relationships, and progressing our datacenter expansion strategy. These milestones support our roadmap and reflect our growing relevance in the AI infrastructure landscape. As we scale our platform, we remain focused on disciplined execution and long-term value creation.”

About Bit Digital

Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. The Company’s HPC business operates under the WhiteFiber Inc. (“WhiteFiber”) brand. Our operations are located in the US, Canada, and Iceland. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice 

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors”  Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. The risk factor in the Form 10-K titled “If we are classified as a passive foreign investment company (“PFIC”) U.S. taxpayers who own our ordinary shares may have adverse United States federal income tax consequences” has been modified to the extent that Management has obtained a third party analysis for 2024 and does not believe that Bit Digital should be classified as a PFIC for 2024. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. See “Safe Harbor Statement” below.

Safe Harbor Statement 

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Release – QuoteMedia Announces Financial Results for Q1 2025

Research News and Market Data on QMCI

PHOENIX, May 15, 2025 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, announced financial results for the quarter ended March 31, 2025.

QuoteMedia provides banks, brokerage firms, private equity firms, financial planners and sophisticated investors with a more economical, higher quality alternative source of stock market data and related research information. We compete with several larger legacy organizations and a modest community of other smaller companies. QuoteMedia provides comprehensive market data services, including streaming data feeds, on-demand request-based data (XML/JSON), web content solutions (financial content for website integration) and applications such as Quotestream Professional desktop and mobile.

Highlights for Q1 2025 include the following:

  • Quarterly revenue increased by $145,156 (3%) to $4,824,356 in Q1 2025 from $4,679,200 in Q1 2024.
  • On an FX-neutral basis (FXN), revenue growth for Q1 2025 vs Q1 2024 was 5% (1) .
  • Adjusted EBITDA (1) for Q1 2025 was $368,269 compared to $676,886 in Q1 2024, a reduction of $308,617.
  • Our net loss for Q1 2025 was $499,811 compared to a net loss of $28,176 in Q1 2024, a decrease in profitability of $471,635.

“This was a successful quarter for QuoteMedia,” said Robert J. Thompson, Chairman of the Board. “As previously forecast, our quarterly revenue was the highest in company history, despite the challenges we faced in 2024. We expect to see continued growth throughout the year, culminating in our highest ever annual revenue.

“And, while we had a significant loss for the quarter and decreased Adjusted EBITDA, this was largely attributable to capitalizing a lower proportion of development costs than were capitalized in previous quarters. While this had no impact on cashflow, it increased development costs expensed in the quarter. This treatment of development costs will continue moving forward, however, we expect to see improvements in profitability in future quarters.

“This has been a good start to 2025, and we are excited about the opportunities ahead.”

QuoteMedia will host a conference call Friday, May 16, 2025, at 2:00 PM Eastern Time to discuss the Q1 2025 financial results and provide a business update.

Conference Call Details:

Date: May 16, 2025

Time: 2:00 PM Eastern Time

Dial-in numbers: 888-999-3182; 848-280-6330
Conference ID: QUOTEMEDIA

Or use the Conference Link below to bypass the operator: https://link.meetingpanel.com/?id=quotemedia_first_quarter_results

An audio rebroadcast of the call will be available later at: www.quotemedia.com

About QuoteMedia

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, The Goldman Sachs Group, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Credential Qtrade Securities, CNW Group, iA Private Wealth, Ally Invest, Inc., Suncor, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Stock-Trak, Mergent, Cision and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com .

Statements about QuoteMedia’s future expectations, including future revenue, earnings, and transactions, as well as all other statements in this press release other than historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. QuoteMedia intends that such forward-looking statements be subject to the safe harbors created thereby. These statements involve risks and uncertainties that are identified from time to time in the Company’s SEC reports and filings and are subject to change at any time. QuoteMedia’s actual results and other corporate developments could differ materially from that which has been anticipated in such statements.

Below are the specific forward-looking statements included in this press release:

  • We expect to see continued growth throughout the year, culminating in our highest ever annual revenue.
  • This treatment of development costs will continue moving forward, however, we expect to see improvements in profitability in future quarters.

QuoteMedia Investor Relations

Dave Shworan
Email: dave@quotemedia.com
Call: (250) 954-3216 ext. 2101

Note 1 on Non-GAAP Financial Measures

We believe that Adjusted EBITDA, as a non-GAAP pro forma financial measure, provides meaningful information to investors in terms of enhancing their understanding of our operating performance and results, as it allows investors to more easily compare our financial performance on a consistent basis compared to the prior year periods. This non-GAAP financial measure also corresponds with the way we expect investment analysts to evaluate and compare our results. Any non-GAAP pro forma financial measures should be considered only as supplements to, and not as substitutes for or in isolation from, or superior to, our other measures of financial information prepared in accordance with GAAP, such as net income attributable to QuoteMedia, Inc.

We define and calculate Adjusted EBITDA as net income attributable to QuoteMedia, Inc., plus: 1) depreciation and amortization, 2) stock compensation expense, 3) interest expense, 4) foreign exchange loss (or minus a foreign exchange gain), and 5) income tax expense. We disclose Adjusted EBITDA because we believe it is a useful metric by which to compare the performance of our business from period to period. We understand that measures similar to Adjusted EBITDA are broadly used by analysts, rating agencies, investors and financial institutions in assessing our performance. Accordingly, we believe that the presentation of Adjusted EBITDA provides useful information to investors. The table below provides a reconciliation of Adjusted EBITDA to net income attributable to QuoteMedia, Inc., the most directly comparable GAAP financial measure.

QuoteMedia, Inc. Adjusted EBITDA Reconciliation to Net Income:

Three-months ended March 31,20252024
Net loss$(499,811)$(28,176)
Depreciation and amortization805,504728,678
Stock-based compensation
Interest expense2,387953
Foreign exchange loss(5,962)(25,307)
Income tax expense66,151738
Adjusted EBITDA$368,269$676,886


In addition to the non-GAAP measures discussed above, we also analyze certain measures, including net revenues and operating expenses, on an FX-neutral basis to better measure the comparability of operating results between periods. Management believes that changes in foreign currency exchange rates are not indicative of the company’s operations and evaluating growth in net revenues and operating expenses on an FX-neutral basis provides an additional meaningful and comparable assessment of these measures to both management and investors. FX-neutral results are calculated by translating the current period’s local currency results with the prior period’s exchange rate. FX-neutral growth rates are calculated by comparing the current period’s FX-neutral results by the prior period’s results.

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Release – V2X, Inc. Announces Sale Of 2,000,000 Shares of Common Stock In Secondary Offering By Vertex Aerospace

V2X (PRNewsfoto/V2X, Inc.)

Research News and Market Data on VVX

May 15, 2025

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MCLEAN, Va., May 15, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX) (“V2X”), a leading provider of global mission solutions, announced today the sale of 2 million shares of its common stock on an underwritten basis by Vertex Aerospace Holdco LLC (“Vertex Aerospace”).  In addition, the underwriter will have an option to purchase up to 300,000 additional shares from Vertex Aerospace.  V2X is not selling any shares of common stock in the offering, and V2X will not receive any proceeds from the offering by Vertex Aerospace.  The offering is expected to close on or about May 19, 2025, subject to customary closing conditions.

RBC Capital Markets is acting as the sole underwriter for the offering. RBC Capital Markets proposes to offer the shares of common stock from time to time to purchasers directly or through agents, or through brokers in brokerage transactions on the New York Stock Exchange, or to dealers in negotiated transactions or in a combination of such methods of sale, at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.

Following the offering, Vertex Aerospace will continue to beneficially own 12,167,286 shares, or approximately 38.4%, of V2X’s outstanding common stock after giving effect to the offering (or 11,867,286 shares, or approximately 37.4%, if the underwriter fully exercises its option to purchase additional shares).

A registration statement on Form S-3 (File No. 333-267223) relating to the shares of common stock of V2X to be sold in the offering was declared effective by the Securities and Exchange Commission (the “SEC”) on September 12, 2022 and the offering may only be made by means of the written prospectus contained therein. Before you invest, you should read the prospectus in that registration statement and the other documents V2X has filed with the SEC for more complete information about V2X and this offering. You may get these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, RBC Capital Markets will arrange to send you the prospectus if you request it by writing RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281, Attention: Equity Capital Markets, Facsimile: (212) 428-6260.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, and the Private Securities Litigation Reform Act of 1995 and, as such, may involve risks and uncertainties. All statements included in this press release, other than statements that are purely historical, are forward-looking statements. Forward-looking statements include statements about the offering and 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 our management based on information currently available to management. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements.

These risks and uncertainties include, but are not limited to: V2X’s ability to submit proposals for and/or win all potential opportunities in their pipeline; V2X’s ability to retain and renew existing contracts; the V2X’s ability to compete with other companies in their market; security breaches, cyber-attacks or cyber intrusions, and other disruptions to their information technology and operation; their mix of cost-plus, cost-reimbursable, firm-fixed-price and time-and-materials contracts; maintaining their reputation and relationship with the U.S. government; protests of new awards; economic, political and social conditions in the countries in which they conduct their businesses; changes in U.S. or international government defense budgets, including potential changes from the U.S. president and administration; government regulations and compliance therewith, including changes to the Department of Defense’s procurement process; changes in technology; V2X’s ability to protect their intellectual property rights; governmental investigations, reviews, audits and cost adjustments; contingencies related to actual or alleged environmental contamination, claims and concerns; delays in completion of the U.S. government budget; V2X’s success in extending, deepening, and enhancing their technical capabilities; V2X’s success in expanding their geographic footprint or broadening their customer base; V2X’s ability to realize the full amounts reflected in their backlog; impairment of goodwill; misconduct of V2X’s employees, subcontractors, agents, prime contractors and business partners; V2X’s ability to control costs; the V2X’s level of indebtedness; terms of the V2X’s credit agreements; inflation and interest rate risk; geopolitical risk, including as a result of recent global hostilities and tariffs; the V2X’s subcontractors’ performance; economic and capital markets conditions; the V2X’s ability to maintain safe work sites and equipment; V2X’s ability to retain and recruit qualified personnel; V2X’s ability to maintain good relationships with their workforce and unions; V2X’s teaming relationships with other contractors; changes in V2X’s accounting estimates; the adequacy of V2X’s insurance coverage; volatility in V2X’s stock price; changes in V2X’s tax provisions or exposure to additional income tax liabilities; risks and uncertainties relating to integrating and refining internal control systems, including enterprise resource planning and business systems, post-merger; changes in generally accepted accounting principles; and other factors, including those described under the heading “Risk Factors” in V2X’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC and in the prospectus related to the offering that V2X will file with the SEC. V2X undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

V2X, Inc.
Mike Smith
Vice President, Treasury, Corporate Development and Investor Relations
1-719-637-5773
IR@goV2X.com

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SOURCE V2X, Inc.

Release – Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness

Research News and Market Data on CVKD

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy.

Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway.

“We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,” said Quang X. Pham, Chairman & CEO. “This is a key milestone as we support our clinical development strategy and tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.”

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Corporate and Investor Relations

Paul Sagan

LaVoieHealthScience

(617) 865-0041

psagan@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Release – Bitcoin Depot Reports First Quarter 2025 Financial Results

Research News and Market Data on BTM

May 15, 2025 8:00 AM EDT Download as PDF

Q1 Revenue up 19% Year-Over-Year to $164.2 Million

Q1 Net Income up Significantly to $12.2 Million Compared to a Net Loss of $4.2 Million in the Prior Year Quarter

Q1 Adjusted Gross Profit up 92% Year-Over-Year to $33.1 Million

Q1 Adjusted EBITDA up 315% Year-Over-Year to $20.3 Million

Q1 Cash from Operations of $16.3 Million

ATLANTA, May 15, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (Nasdaq: BTM) (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the first quarter ended March 31, 2025. Bitcoin Depot will host a conference call and webcast at 10:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.

“Bitcoin Depot delivered a remarkable first quarter, with 19% year-over-year revenue growth and a more than threefold increase in Adjusted EBITDA to $20 million,” said Brandon Mintz, Founder and CEO of Bitcoin Depot. “This performance demonstrates the strength of our operating model, the success of our kiosk optimization strategy, and the powerful cash flow we can generate once fixed costs are covered. In fact, with the cash generated in Q1, we strengthened our balance sheet by increasing our bitcoin holdings and building our cash balance, positioning us for continued growth and flexibility. Looking ahead, we remain focused on scaling responsibly, both domestically and internationally, while delivering sustained value to both our customers and shareholders.”

First Quarter 2025 Financial Results

Revenue in the first quarter of 2025 increased 19% to $164.2 million compared to $138.5 million in the first quarter of 2024. This increase was driven by increased kiosk deployment and higher median transaction size. 

Total operating expenses declined 7% to $15.3 million for the first quarter of 2025 compared to $16.6 million for the first quarter of 2024 due to lower depreciation expense and insurance costs as the Company continues to optimize its cost structure as a steady-state public company.

Net income for the first quarter of 2025 increased significantly to $12.2 million, compared to a net loss of $4.2 million for the first quarter of 2024. Net income attributable to common shareholders increased to $4.2 million, or $0.20 per share, from a net loss of $1.5 million, or ($0.25) per share, in last year’s first quarter. The increase was due to higher revenue and gross profit in 2025.

Adjusted gross profit, a non-GAAP measure, in the first quarter of 2025 increased 92% to $33.1 million from $17.3 million for the first quarter of 2024. Adjusted gross profit margin, a non-GAAP measure, in the first quarter of 2025 increased approximately 770 basis points to 20.2% compared to 12.5% in the first quarter of 2024. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Adjusted EBITDA, a non-GAAP measure, in the first quarter of 2025 increased 315% to $20.3 million compared to $4.9 million for the first quarter of 2024. The increase was primarily due to the higher revenue and gross profit. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Cash, cash equivalents, and cryptocurrencies as of March 31, 2025, were $43.3 million compared to $31.0 million at the end of 2024. The company used $7.8 million in the first quarter of 2025 to acquire 83 more Bitcoin, bringing the total held for investment to 94.35 BTC.

Net cash flows provided by operations in the first quarter of 2025 were up significantly to $16.3 million compared to $1.3 million in the first quarter of 2024.

Outlook

The Company expects revenue in the second quarter of 2025 to grow low-to-mid-single digits on a percentage basis from the second quarter of 2024.

Conference Call

Bitcoin Depot will hold a conference call at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) today to discuss its financial results for the first quarter ended March 31, 2025.

Call Date: Thursday, May 15, 2025 
Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time) 

Phone Instructions
U.S. and Canada (toll-free): 888-596-4144
U.S. (toll): 646-968-2525
Conference ID: 4520708

Webcast Instructions
Webcast link: https://edge.media-server.com/mmc/p/akdxpm7o

A replay of the call will be available beginning after 2:00 p.m. Eastern time through May 22, 2025.

U.S. & Canada (toll-free) replay number: 800-770-2030
U.S. toll number: 609-800-9909
Conference ID: 4520708

If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

About Bitcoin Depot

Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with over 8,400 kiosk locations as of February 25, 2025.  Learn more at www.bitcoindepot.com

Cautionary Statement Regarding Forward-Looking Statements

This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

View full release here.

Contacts:

Investors 
Cody Slach,
Gateway Group, Inc. 
949-574-3860 
BTM@gateway-grp.com

Media 
Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
BTM@gateway-grp.com

Primary Logo

Source: Bitcoin Depot Inc.

Released May 15, 2025

Release – Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Research News and Market Data on COCP

May 15, 2025

In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants

BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus’ core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We’re preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide.

“Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.”

Antiviral Product Pipeline Overview

We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

Influenza Programs
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deathsOn average, about 8% of the U.S. population contracts influenza each seasonIn addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

  • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
    • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
  • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
    • Dry powder inhalation formulation development and toxicology studies have been completed.
  • Influenza A/B program
    • Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing.

Norovirus Program
Norovirus is a common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. Norovirus outbreaks occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites and military settings.

In the U.S. alone, noroviruses are responsible for an estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
    • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
    • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy subjects.
    • In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and European countries in 2024-2025.
    • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.
    • We plan to initiate a human challenge study in the U.S. in the coming months to evaluate CDI-988 as a norovirus treatment and prophylaxis.

SARS-CoV-2 and Other Coronavirus Program
By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.

First Quarter Financial Results

Research and development (R&D) expenses for the first quarter of 2025 were $1.4 million, compared with $3.0 million for the first quarter of 2024, with the decrease primarily due to a reduction in personnel costs and the timing of clinical study costs. General and administrative (G&A) expenses for the first three months of 2025 were $1.0 million, compared with $1.2 million for the first three months of 2024, with the decrease primarily due to a reduction in insurance costs and other expenses.

Net loss for the first quarter of 2025 was $2.3 million, or $0.23 per share, compared with net loss for the first quarter of 2024 of $4.0 million, or $0.39 per share.

Cocrystal reported unrestricted cash as of March 31, 2025 of $6.9 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first quarter of 2025 was $2.9 million, compared with $4.5 million for the first quarter of 2024. The Company had working capital of $6.9 million and 10.2 million common shares outstanding as of March 31, 2025.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344 The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

View full release here.

Release – MAIA Biotechnology Accepted for Poster Presentation at American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

Research News and Market Data on MAIA

May 15, 2025 11:05am EDT Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that an abstract about the efficacy data from the Phase 2 THIO-101 clinical trial was accepted for poster presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3, 2025, in Chicago, Illinois. The poster is scheduled for presentation on May 31, 2025, from 01:30pm to 04:30pm CDT in the Lung Cancer track.

“We continue to believe that our telomere targeting agent ateganosine (THIO) could become a best-in-class anticancer treatment with the potential to challenge the standard of care for NSCLC,” said MAIA CEO Vlad Vitoc, M.D. “Treatment with ateganosine has shown excellent efficacy in third-line NSCLC to date and we look forward to presenting our findings at ASCO 2025 on May 31st.”

Poster Presentation Details

Poster title: “Phase 2 Study of Telomere-Targeting Agent THIO Sequenced With Cemiplimab in Third-Line Immune Checkpoint Inhibitor–Resistant Advanced NSCLC: Evaluation of Overall Survival”

Session date and time: May 31, 2025, 01:30pm to 04:30pm CDT

Presenter: Tomasz Jankowski, M.D.

MAIA’s poster will be available on the Publications page of MAIA’s website on the day of the presentation.

About ASCO 2025

The 2025 ASCO Annual Meeting will feature over 200 sessions and more than 5,000 posters complementing the theme, “Driving Knowledge to Action: Building a Better Future,” reflecting the meeting’s tradition of inspiring and advancing the oncology field with the power of the latest knowledge in cancer care.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using overall response rate (ORR) as the primary clinical endpoint. The expansion of the study will assess ORR in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase 2 trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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, 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 15, 2025

Release – SKYX Reports Record First Quarter 2025 of $20.1 Million Compared to $18.9 Million for First Quarter 2024 as it Continues to Grow its Market Penetration of its Advanced and Smart Platform Products in the U.S and Canadian Markets

Research News and Market Data on SKYX

May 14, 2025 16:05 ET

Company expects its products to be in 30,000 U.S. and Canadian homes by the end of the Second quarter of 2025.

Company is Progressing with Significant Projects and Orders that will Enable it to Become Cash Flow Positive in Second Half of 2025

General and Administrative Expenses Decreased by 17% as Compared to the First Quarter of 2024 and Gross Margin and Gross Profit Improvement by 4.8% and 2% in the First Quarter of 2025 Sequentially from the Fourth Quarter of 2024

SKYX Announces Additional $4 million in Recent Preferred Stock Funding Representing $2 Per Share from Strategic Investors in a Round Totaling $15 million Led by Global Marriott Hotels Chain Owner, The Shaner Group

SKYX’s Safety Code Standardization Team is Receiving Support from a New Significant Prominent Leader with its Government Safety Organization Process for a Safety Mandatory Standardization of its Electrical Ceiling Outlet/Receptacle Technology

MIAMI, May 14, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 97 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the First quarter ended March 31, 2025.

First Quarter 2025 Highlights and Recent Events

  • Generated record First quarter 2025 revenues of 20.1 million compared to $18.9 million for the First quarter of 2024.
  • As of March 31, 2024, Company reported $12.3 million in cash, cash equivalents, and restricted cash, as compared to $15.5 million as of March 31, 2024.
  • SKYX has recently secured approximately $4 million in additional equity, mainly through preferred stock investment representing $2.00 per share of common stock with no warrants part of a broader financing round totaling approximately $15 million to date, led by The Shaner Group, owner, and developer of more than 70 hotels worldwide.
  • The $15 million broader round included substantial participation from company insiders, including SKYX President Steve Schmidt and Co-CEOs Lenny Sokolow and John Campi, underscoring their continued confidence in SKYX’s strategic vision and growth trajectory.
  • As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company leverages its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
  • Management emphasizes that it has sufficient cash to achieve its goals including being cash flow positive in 2025.
  • Company reported a reduction in General and Administrative expenses of 17% by $1.3 million to $6.6 million in the First quarter of 2025 from $7.9 million in the First quarter of 2024.
  • Company’s gross margin and gross profit for the First quarter ending March 31, 2025, increased sequentially by 4.8% and 2% to $5.7 million compared to the quarter ending December 31, 2024.
  • Net loss per share decreased by $0.01 to ($0.09) per share in the first quarter of 2025 compared to ($0.10) in the first quarter of 2024. Adjusted EBITDA loss per share, a non-GAAP measure, decreased to $(0.04) per share in the first quarter of 2025, as compared to $(0.05) per share, in the first quarter of 2024.
  • The Company continues to grow its market penetration of its advanced and smart plug & play products and expects its products to be in 30,000 U.S. and Canadian homes by the end of the Second quarter of 2025.
  • Company expects its products to be in tens of thousands additional homes in the second half 2025.
  • Company expects to continue increasing units and grow its revenue to pro and builder segments.
  • The Company announced a U.S. strategic manufacturing partnership with Profab Electronics, a premier electronic contract manufacturer based in Pompano Beach, Florida. This collaboration marks a significant step forward in SKYX’s commitment to building a resilient, efficient, and localized supply chain for its innovative product lines. This in addition to manufacturing collaborations in Vietnam, Taiwan, China and Cambodia.
  • Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe plug & play products it will start being recommended by insurance companies.
  • SKYX’s technologies provide opportunities for recurring revenues through interchangeability, upgrades, monitoring, and subscriptions. Company is focused on the “Razor & Blades” model and its product range includes its advanced ceiling electrical outlet (Razor) and its advance and smart home plug & play products (Blades) including its advance and smart home plug & play platform products, lighting, recessed lights, down lights, EXIT signs, emergency lights, ceiling fans, chandeliers/pendants, holiday/kids/themes lights, indoor/outdoor wall lights among other. Company’s plug & play technology enables an installation of lighting, fans, and smart home products in high-rise buildings and hotels within days rather than months.
  • Company’s total addressable market (TAM) in the U.S. is roughly $500 billion with over 4.2 billion ceiling applications in the U.S. alone. Expected revenue streams from retail and professional segments include product sales, royalties, licensing, subscription, monitoring, and sale of global country rights.
  • Company continues to utilize its e-commerce platform of over 60 websites for lighting and home décor to educate and enhance its market penetration to both retail and professional segments.

 Market Acceptance and Recent Events:

  • In addition to selling product on it its 60 websites, SKYX collaborates with Home Depot for its Advanced and Smart Plug & Play Products for both retail and professional segments. SKYX’s product offering will include a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and more.
  • Company collaborates with Wayfair for Its Advanced and Smart Plug & Play Products for both retail and professional segments. SKYX’s product offering will include a variety of its advanced and Smart Plug & Play products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and more.
  • SKYX collaborates with U.S. and world leading lighting companies including Kichler Quoizel, European leading company, EGLO, and worlding lighting manufacturer Ruee.
  • Collaborated with Cavco Homes, a leading U.S. prefabricated home manufacturer, for integrating our advanced and smart plug & play technologies into Cavco’s high-end premium homes shown at the builder show. Cavco is a public company that has sold nearly one million homes and continues to deliver close to 20,000 annually.
  • Three luxury developments by Forte Developments, including an 80-story high-rise in Miami’s Brickell District and projects in Clearwater Beach and Jupiter, Florida, will feature SKYX’s technology. More than 12,000 smart plug & play products, including ceiling outlets, lighting, fans, and emergency fixtures, will be supplied across 400+ units. A 1,000-unit mixed-use development by Jeremiah Baron Companies will incorporate smart plug & play technologies, with 140 units receiving initial product supply. This product rollout will include ceiling outlets, lighting, fans, and emergency fixtures, with deliveries continuing throughout construction.
  • A strategic partnership with JIT Electrical Supply, a leading builder supplier, will expand SKYX’s footprint in electrical, lighting, and ceiling fan markets. JIT, which has supplied over 100,000 U.S. homes, will distribute SKYX’s lighting solutions, ceiling fans, recessed lights, emergency lights, exit signs, and indoor/outdoor wall lights beginning early 2025.
  • Huey Long, former Amazon E-Commerce Director and executive at Walmart and Ashley Furniture, has joined as head of SKYX’s e-commerce platform. He will collaborate with the existing team to expand market penetration across 60 lighting and home décor websites and other key e-commerce channels in the U.S. and Canada.
  • Greg St. John, former Home Depot lighting head and CEO of Eglo and Cordelia Lighting, has been appointed President of Lighting, Fans, and Smart Home Products. With 30+ years of industry experience, he will lead expansion efforts in retail, homebuilder, and commercial markets, overseeing partnerships with Home Depot, Wayfair, and other major retailers.

Safety Standardization Mandatory Code / Insurance Specification and Recommendation

  • SKYX’s Safety Code Standardization Team is receiving support from a new significant prominent leader with its government safety organization process for a safety mandatory standardization of its electrical ceiling outlet/receptacle technology.
  • SKYX’s code team, led by industry veterans Mark Earley, former head of the National Electrical Code (NEC), and Eric Jacobson, former President and CEO of the American Lighting Association (ALA). Company’s safety Code Standardization team believes it will achieve assistance from additional safety organizations with its code mandatory safety standardization efforts based on the product’s significant safety aspects. Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries. Both strongly believe that, in light of the Company’s standardization progress including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturers Association) and being voted into 10 segments in the NEC Code Book, it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings.
  • With respect to insurance companies, the Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe advanced plug & play products it will start being recommended by insurance companies.

Select First Quarter 2025 Financial Results

Revenue in the First quarter of 2025 increased 6% to a $20.1million, including E-commerce sales as well as smart and standard plug and play products, as compared to $18.9 million in the First quarter of 2024.

The gross margin and gross profit for the First quarter ending March 31, 2025, increased sequentially by 4.8 % and 2% to $5.7 million compared to the fourth quarter ending December 31, 2024.

Net cash used in operating activities for the First quarter ending March 31, 2025, decreased sequentially by 29% to $4 million compared to $6.1 million in the Fourth quarter of 2024.

Reported $12.3million in cash, cash equivalents, and restricted cash, as of March 31, 2025, as compared to $15.5 million as of March 31, 2024. As common with companies such as ours when their sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, we leverage our trades payable to finance our operations to enhance our cash position and lower our cost of capital.

Recently secured $4 million in additional equity, mainly through preferred stock investment representing $2.00 per share of common stock with no warrants. This part of broader financing round totaling approximately $15 million to date, led by The Shaner Group, owner and developer of more than 70 hotels worldwide as well as SKYX’s President Steve Schmidt and Co-CEOs Lenny Sokolow and John Campi, underscoring their continued confidence in SKYX’s strategic vision and growth trajectory.

For the First quarter of 2025 Adjusted EBITDA loss, which is the loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments, a non-GAAP measure, decreased to $3.6 million, or $(.04) per share, as compared to $4.5 million, or $(.05) per share, in the First quarter of 2024.

The Company’s financial statements for the quarter ended March 31, 2025, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/.

Management Commentary

Company’s Management, Board members, and Senior Advisors include former CEO’s and executives from Fortune 100 companies including Nielsen, Microsoft, Disney, GE, Home Depot, Office Depot, Chrysler, among others.

Although the First quarter of 2025 reflected expected tempered revenues following traditionally stronger calendar fourth-quarter sales, the Company generated record First quarter 2025 revenues of $20.1 million as compared to $18.9 million for the First quarter of 2024.

The First quarter of 2025 was highlighted by our continued market acceptance and positioning that includes our previously announced collaboration with Home Depot and Wayfair which we believe can be significant for our growth to both retail and professional markets. Additionally, the Ruee Appliances collaboration will assist us with product variety, gross margins, future distribution channels, and sales and marketing programs with key stakeholders in such channels. We believe we have accelerated our cadence of sales, notably managing our cash burn, while our e-commerce platform with over 60 websites is providing additional cash flow to the Company, which, when combined with our existing cash enhanced by our approximately $15 Million equity raises between in October 2024 and May 2025, enhances our cash position to continue executing our business plan. We believe we will be cash flow positive during 2025.

We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.

Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, licensing and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies.

 We believe we have accelerated our pace of sales with a robust gross margin profile, notably managing the cash burn of SKYX. Our e-commerce platform with over 60 websites is expected to continue providing additional cash flow to the Company.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with First-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions, including recent measures adopted by the federal government, on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Snail, Inc. Reports First Quarter 2025 Financial Results

Research News and Market Data on SNAL

May 14, 2025 at 4:05 PM EDT

PDF Version

CULVER CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) —  Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, today announced financial results for its first quarter ended March 31, 2025.

First Quarter 2025 and Recent Operational Highlights

ARK Franchise Updates:

  • ARK: Survival Evolved (“ASE”):
    • Units sold were approximately 690,775 for the first quarter 2025
    • Revealed teaser trailer for ARK: Aquatica, a new in-house developed downloadable content (“DLC”) expansion map for ASE
  • ARK: Survival Ascended (“ASA”):
    • Units sold were approximately 751,960 for the first quarter 2025
    • Launched the Astraeos Map as an Official Partner DLC for ASA
    • Revealed the official trailer for ARK: Lost Colony, the next DLC for ASA produced by Studio Wildcard
  • ARK: Ultimate Mobile Edition (“ARK Mobile”) :
    • Surpassed 4.8 million downloads as of March 31, 2025
    • Launched the Ragnarok expansion map and the Extinction map
    • In the three months ended March 31, 2025, average DAUs totaled 143,976

Game Portfolio Updates:

  • Debuted teaser trailers for two in-house developed projects, Nine Yin Sutra: Wushu and Nine Yin Sutra: Immortal
  • Launched new trailers for upcoming games: For The StarsHoneycomb: The World BeyondRobots at Midnight, and Echoes of Elysium
  • Celebrated Bellwright’s one-year Early Access anniversary in April 2025 and introduced major update with significant content and player-requested features. Bellwright will be making its way to Xbox
  • Launched The Cecil: The Journey Begins and Chasmal Fear
  • Company indie publishing label, Wandering Wizards, acquired publishing rights to Whispers of West Grove

Business Updates:

  • Company subsidiary Interactive Films LLC (“Interactive Films”) signed a Memorandum of Understanding (“MoU”) with Mega Matrix Inc. (“MPU”) for the joint development, production, and global distribution of short dramas

Management Commentary

Company co-Chief Executive Officer Tony Tian commented: “The first quarter saw sustained growth and strong engagement across our ARK franchise. Our ARK franchise had an increase in daily active users in the first quarter of 2025 of approximately 16%, up to 243,000 on the Steam and Epic platforms, when compared to the same period in 2024. We unveiled and released new maps and DLCs for ASE, ASA, and our mobile title, delivering fresh, immersive experiences that continue to expand the ARK universe and deepen player engagement. ARK: Ultimate Mobile Edition maintained strong momentum since launch last quarter, a promising indicator of our ongoing efforts to broaden ARK’s audience. The mobile platform removes hardware barriers, opening the franchise to a new and growing player base. In February, we participated in GDC, where we unveiled a series of new trailers, announcements, and upcoming content for the ARK franchise and our broader game portfolio.”

“Next month marks a major milestone: the 10-year anniversary of ASE. This pivotal moment for Snail Games offers an opportunity to celebrate the franchise’s legacy and community. Beyond gaming, we also signed a MoU with Mega Matrix to co-develop at least 10 short dramas. In support of this initiative, we soft-launched Salty TV, our mobile short film platform, last quarter, which currently hosts 49 short dramas. We look forward to finalizing the agreement and working closely with the MPU team to deliver high-quality entertainment content. As we look to the remainder of 2025, our focus remains on expanding global reach, investing in scalable growth, commemorating ARK’s 10-year journey, and continuing to deliver innovative experiences that engage players and audiences across multiple platforms and genres.”

First Quarter 2025 Financial Highlights

Net revenues for the three months ended March 31, 2025, increased 42.5% to $20.1 million compared to $14.1 million in the same period last year. The increase was primarily due to an increase in total ARK sales of $2.7 million, an increase in ARK Mobile sales of $1.3 million that was driven by the release of ARK: Ultimate Mobile Edition, and the Company deferring $3.3 million less of its sales during the three months ended March 31, 2025 than it deferred in the same period last year, partially offset by a decrease in revenues related to other games of $1.6 million.

Net loss for the three months ended March 31, 2025, was $(1.9) million compared to $(1.8) million in the same period last year; as a result of the aforementioned increase in net revenue offset by increases in the costs of revenues and operating expenses – a result of the Company’s increased headcount, research and development, and marketing expenses.

Bookings for the three months ended March 31, 2025, increased 13.6% to $22.2 million compared to $19.6 million in the same period last year. The increase was primarily due to the releases of ARK: Survival Ascended DLC Astraeos in the first quarter of 2025, the releases of Bobs Tall Tales, and Bellwright in the latter quarters of 2024.

Earnings before interest, taxes, depreciation and amortization (“EBITDA”) for the three months ended March 31, 2025, was $(3.2) million compared to $(1.9) million in the same period last year. The decrease was primarily due to an increase in benefit from income taxes of $1.0 million, a decrease in interest expense of $0.3 million, and an increase in net loss of $0.1 million, partially offset by a decrease in interest income and interest income – related parties of $0.1 million.

As of March 31, 2025, unrestricted cash was $9.4 million compared to $7.3 million as of December 31, 2024.

Use of Non-GAAP Financial Measures

In addition to the financial results determined in accordance with U.S. generally accepted accounting principles, or GAAP, Snail believes Bookings and EBITDA, as non-GAAP measures, are useful in evaluating its operating performance. Bookings and EBITDA are non-GAAP financial measures that are presented as supplemental disclosures and should not be construed as alternatives to net income (loss) or revenue as indicators of operating performance, nor as alternatives to cash flow provided by operating activities as measures of liquidity, both as determined in accordance with GAAP. Snail supplementally presents Bookings and EBITDA because they are key operating measures used by management to assess financial performance. Bookings adjusts for the impact of deferrals and, Snail believes, provides a useful indicator of sales in a given period. EBITDA adjusts for items that Snail believes do not reflect the ongoing operating performance of its business, such as certain non-cash items, unusual or infrequent items or items that change from period to period without any material relevance to its operating performance. Management believes Bookings and EBITDA are useful to investors and analysts in highlighting trends in Snail’s operating performance, while other measures can differ significantly depending on long-term strategic decisions regarding capital structure, the tax jurisdictions in which Snail operates and capital investments.

Bookings is defined as the net amount of products and services sold digitally or physically in the period. Bookings is equal to revenues, excluding the impact from deferrals. Below is a reconciliation of total net revenue to Bookings, the closest GAAP financial measure.

Webcast Details

The Company will host a webcast at 4:30 PM ET today to discuss the first quarter 2025 financial results. Participants may access the live webcast and replay via the link here or on the Company’s investor relations website at https://investor.snail.com/.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other casual game developers and publishers and both large and small, public and private Internet companies; its ability to attract and retain a qualified management team and other team members while controlling its labor costs; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, My Nintendo Store, the Apple App Store, the Google Play Store and the Amazon Appstore; the size of addressable markets, market share and market trends; its ability to successfully enter new markets and manage international expansion; protecting and developing its brand and intellectual property portfolio; costs associated with defending intellectual property infringement and other claims; future business development, results of operations and financial condition; the ongoing conflicts involving Russia and Ukraine, and Israel and Hamas, on its business and the global economy generally; actions in various countries, particularly in China and the United States, have created uncertainty with respect to tariff impacts on the costs of our merchandise and costs of development; rulings by courts or other governmental authorities; the Company’s current program to repurchase shares of its Class A common stock, including expectations regarding the timing and manner of repurchases made under this share repurchase program; its plans to pursue and successfully integrate strategic acquisitions; and assumptions underlying any of the foregoing.

Further information on risks, uncertainties and other factors that could affect Snail’s financial results are included in its filings with the Securities and Exchange Commission (the “SEC”) from time to time, including its annual reports on Form 10-K and quarterly reports on Form 10-Q filed, or to be filed, with the SEC. You should not rely on these forward-looking statements, as actual outcomes and results may differ materially from those expressed or implied in the forward-looking statements as a result of such risks and uncertainties. All forward-looking statements in this press release are based on management’s beliefs and assumptions and on information currently available to Snail, and Snail does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

About Snail, Inc.

Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.

Investor Contact:

John Yi and Steven Shinmachi
Gateway Group, Inc.
949-574-3860
SNAL@gateway-grp.com

Release – Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations

Research News and Market Data on TNXP

May 14, 2025 7:00am EDT Download as PDF

Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene

Served on Celgene’s Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla® to Amgen

Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyalgia next quarter

CHATHAM, N.J., May 14, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations, effective immediately. Mr. Hand brings significant leadership experience across multiple functions, including legal, business development, human resources and information technology operations.   

“Joe’s strong track record of delivering company growth, driving transformative initiatives, and negotiating complex transactions makes him an important strategic addition to the Tonix team at a pivotal inflection point in the Company’s history,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The breadth of Joe’s expertise and his focus on operational excellence will serve our mission as we prepare for the launch of TNX-102 SL for the management of fibromyalgia, upon receiving FDA marketing authorization.”

Prior to joining Tonix, Mr. Hand’s experience includes nearly a decade at Celgene Corporation, concluding his tenure as Executive Vice President, Global Human Resources and Corporate Services and a member of the Executive Committee. In that capacity, Mr. Hand was responsible for all employee-related activities including talent development, recruiting, and compensation and benefits. He was also responsible for the management of Celgene’s global facilities footprint and played a key strategic role in various transactions, including the $74 billion acquisition of Celgene by Bristol Myers Squibb and subsequent integration, and the $13.4 billion divestiture of Otezla® to Amgen. Subsequent to Celgene, Mr. Hand was Chief Administrative Officer at Phathom Pharmaceuticals, responsible for recruiting over 300 employees into various functions, including the build-out of the company’s commercial sales force. Mr. Hand has previously practiced as a litigation attorney at the international law firm of Jones Day. Mr. Hand holds a BBA from the University of Notre Dame and a JD from New York University School of Law.

“I’m honored to join Tonix at such an exciting time and grateful for the opportunity to work alongside an incredibly talented and dedicated leadership team and group of employees,” said Mr. Hand. “I look forward to contributing to the Company’s momentum and helping to position Tonix for long-term growth while advancing our mission to deliver meaningful therapies to patients.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland. 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; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

About Zembrace SymTouch and Tosymra

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Source: Tonix Pharmaceuticals Holding Corp.

Released May 14, 2025

Release – Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update

Research News and Market Data on UNCY

May 14, 2025 7:15am EDT Download as PDF

– Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025

– New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC

LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update.

“We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.”

Key Highlights & Upcoming Milestones

  • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access.
  • Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings.
    • Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills.
    • New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction.  

Financial Results for the Quarter Ended March 31, 2025

Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs.

General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation.

In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025.

Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability.

Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability.

As of March 31, 2025, cash and cash equivalents totaled $19.8 million.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.

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; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. 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, 2024, 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 Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

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Release – MAIA Biotechnology Announces Director Participation in Recent Private Placement

Research News and Market Data on MAIA

May 14, 2025 10:15am EDT

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CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that two of the Company’s independent directors, Stan V. Smith, Ph.D. and Ramiro Guerrero, JD, LL.M., purchased common stock and warrants in the Company’s private placement offering which closed on May 8, 2025. Gross proceeds from the offering across all investors totaled $1.08 million.

Dr. Smith purchased a total of 66,666 shares and 66,666 warrants for an aggregate purchase price of approximately $100,000. Mr. Guerrero purchased a total of 20,000 shares and 20,000 warrants for an aggregate purchase price of $30,000.

“Stan, Ramiro and our other independent directors have been consistent investors in the Company’s financings, which I believe signals the Board’s confidence in our strategic direction and future market prospects for our novel cancer immunotherapies,” said MAIA Chairman and CEO Vlad Vitoc, M.D.

Dr. Smith commented, “I have participated in nearly all of MAIA’s financings since its founding, and my conviction in the Company is stronger than ever. In my opinion, the clinical and regulatory strategies are thorough, and, as a potential first-in-class cancer telomere targeting treatment, the commercial opportunity for ateganosine is substantial.”

“Based on ateganosine’s clinical results to date, I continue to believe that MAIA’s telomere targeting science could eventually become the standard of care for several high-mortality cancer types,” said Mr. Guerrero.

Additional details on the private placement can be found in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 6, 2025, at www.sec.gov.

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 Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

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 14, 2025

Release – V2X Takes Off with Bell Helicopter to Train the Army’s Next Generation of Aviators

Research News and Market Data on VVX

May 14, 2025

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RESTON, Va., May 14, 2025 /PRNewswire/ — V2X Inc. (NYSE: VVX) is pleased to announce its collaboration with Bell Textron Inc., a Textron company (NYSE: TXT), to begin strategic planning for the U.S. Army’s Flight School Next program. As part of this effort, V2X is collaborating with Bell, DigiFlight, Delaware Resource Group, and TRU Simulation to pursue this critical training initiative.

V2X (PRNewsfoto/V2X, Inc.)

Flight School Next is an advanced rotary-wing training program designed to modernize and enhance how Army aviators are trained. Based at Fort Novosel, Alabama, the program trains every Army aviator, making it a foundational element of Army aviation readiness. Under this collaboration, V2X will provide essential maintenance and readiness support to ensure mission success.

“V2X is proud to support the next generation of Army aviators by preparing them for complex and demanding environments alongside Bell and our other valued partners,” said Vinny Caputo, Senior Vice President of Aerospace Systems at V2X.

“Collaborating with Bell on this effort reflects our shared commitment to Army aviation and national security,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “Together, we will deliver a next-generation training solution that strengthens operational readiness.”

As part of the initiative, V2X will provide maintenance and readiness support for the Bell 505 helicopter, a modern, five-seat training aircraft designed for efficiency and reliability. Equipped with the latest avionics and flight technologies, the Bell 505 is ideally suited to meet the rigorous and evolving demands of Army flight training.

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 16,100 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

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

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

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SOURCE V2X, Inc.