Carronade Says Dramatic Change Needed at Cannae Holdings to Halt Persistent Underperformance and Egregious Governance Practices

Nominates Four Director Candidates with Expertise, Independence and Accountability Required to Unlock Shareholder Value

Believes Proposed Initiatives Could Result in Share Price Upside of at Least 50%

DARIEN, Conn., March 20, 2025 (GLOBE NEWSWIRE) — Carronade Capital Management, LP (together with its affiliates, “Carronade Capital”, “our” or “we”), which beneficially owns approximately 2.9 million shares of Common Stock of Cannae Holdings, Inc. (NYSE: CNNE) (“Cannae” or the “Company”) and is one of the Company’s top five shareholders, today announced it has issued the below letter to Cannae’s Board of Directors (the “Board”) and nominated four independent director candidates for the four Board seats up for election at the Company’s 2025 Annual Meeting of Shareholders.

Carronade Capital believes Cannae’s total shareholder return and corporate governance can be meaningfully improved, and significant opportunities exist to unlock substantial value for all shareholders. We believe Cannae can halt persistent underperformance and restore shareholder confidence by improving capital allocation and unlocking portfolio value through spin outs or buybacks, reducing overhead costs and aligning management incentives, and establishing corporate governance and accountability. If decisive action is taken, we believe that Cannae equity could have a share price upside of at least 50% as a result of activities initiated by year end.

Carronade’s four highly qualified nominees are as follows:

Mona Aboelnaga

  • 35 years of experience including at Siguler Guff & Company and Proctor Investment Managers with expertise in investment management and private equity industries.
  • Extensive corporate governance expertise as a board member of both public and private companies including Webster Financial, a financial services company, Perpetual Limited, an Australian-based diversified global financial services company, and Sterling Bancorp, a regional financial services company.

Benjamin Duster

  • 45 years of experience including at Wells Fargo and Salomon Brothers with expertise in working with companies to improve execution effectiveness and create long-term sustainable value.
  • Extensive public and private company board service including Expand Energy, an oil and gas production company, Weatherford International, a global energy services company, Republic First Bancorp, a commercial bank, and Alaska Communications Systems, a broadband and telecommunications service provider.

Dennis Prieto

  • 21 years of experience including at Aurelius Capital Management and Evercore with expertise in financial analysis and restructuring oversight.
  • Significant investment management and board experience including GO Lab, a privately held building products company, Aventiv Technologies, a provider of telecommunications and technology solutions, Mohawk Gaming Enterprises, a gaming company, and Endo International GUC Trust, a trust established to obtain recoveries for creditors of Endo International plc.

Cherie Schaible

  • 24 years of experience including as General Counsel of Ankura Consulting Group and Associate General Counsel of AIG Investments with expertise in complex legal and financial matters.
  • Extensive experience in structuring, negotiating and leading a variety of corporate legal matters in public and private companies.

The full text of the letter is below:

March 20, 2025

Cannae Holdings, Inc.
1701 Village Center Circle
Las Vegas, Nevada 89134
Attn: Board of Directors

Dear Members of the Board of Directors,

Entities managed by Carronade Capital Management, LP (together with its affiliates, “Carronade Capital” or “We” or “Us” or “Our”) beneficially own approximately 2.9 million shares of Common Stock of Cannae Holdings, Inc. (“Cannae” or the “Company” or “You” or “Your”), making us one of your top five investors. We believe Cannae’s total shareholder return (“TSR”) and corporate governance can be meaningfully improved, and significant opportunities exist within the control of both management and the Board of Directors (the “Board”) to unlock substantial value for all shareholders. We are reiterating these previously communicated views to you, and the broader market, to ensure the entire Board is made aware of our discussions to date and to highlight this potential value creation opportunity in the hope of building a consensus for the best path forward.

Our letter today outlines why we believe the status quo at Cannae is untenable and why dramatic change is required to halt persistent underperformance and egregious governance practices for the benefit of all stakeholders. We believe there are numerous ways to drive value creation, and, by extension, shareholder returns, including by reducing costs and aligning incentives, improving capital allocation, unlocking the value of the parts of the portfolio, and establishing corporate governance and accountability by reconstituting the Board with truly independent directors. If Cannae takes decisive action to properly implement these achievable steps and rebuild investor confidence, we believe that the equity could have share price upside of at least 50% as a result of activities initiated by year-end.

The Status Quo is Untenable

In our view, there is an urgent need for changes in strategy and governance based on Cannae’s substantial long-term relative TSR underperformance, persistent discount to intrinsic value, shareholder frustration with corporate strategy, and a pattern of governance deficiencies that we believe have significantly hindered the Company’s ability to create shareholder value. Our concerns are underscored by the high degree of interconnectedness amongst the current directors and Cannae’s classified Board structure which, among other governance concerns, have resulted in repeated adverse voting recommendations from leading proxy advisory firms. We were further shocked by the Board’s egregious actions earlier this week, while we were engaged in active settlement discussions, to accelerate equity vesting for directors if they fail to be re-elected by shareholders and to require the repurchase of half of CEO and Chairman Bill Foley’s shares at a significant premium to market prices. This is on top of his already rich compensation package if he invokes his right to resign because a single director is elected without his consent. That a Board of Directors deemed these actions consistent with their fiduciary duties and in the best interest of shareholders demonstrates a complete lack of independence and an abdication of their duty. We believe such an offensive combination of entrenchment techniques and unfair enrichment are beyond the pale and make it crystal clear that immediate change is necessary in the boardroom.

Management’s stated strategy consists of “improving the performance and valuation of our portfolio companies, making new investments primarily in private companies that will grow NAV, and returning capital to shareholders.”1 Put plainly, management’s plan is not working. Cannae has a valuable collection of assets, but buybacks to date have failed to close the discount due to market concerns around overall strategy and perceived misalignment of interests between management and shareholders. Shareholders have consistently shared concerns that they do not want Cannae to sell public shares to invest in small private positions with no disclosure – such actions we believe would only compound the current problems and Cannae’s persistent value discount. Despite a handful of successful investments in the past, the current portfolio of private investments is consistently marked at cost and the remaining investments in public equities have destroyed approximately $900 million of value.2 Market feedback that we have gathered to date suggests a near unanimous view that numerous shareholders prefer a return of their capital as opposed to management’s stated goal of selling down public positions to invest more in private equity.

Since Ceridian, they have made a bunch of bad capital allocation decisions…We would rather them distribute value than re-invest. They haven’t earned the right to keep that capital.
– Top 10 Shareholder, Nov. 2024
 

Furthermore, a lack of strategic cohesion amongst investments and limited portfolio company disclosure weigh on investor confidence. There has been no clear investment narrative for shareholders to rally behind, as we consistently hear Cannae described simply as the Bill Foley co-investment vehicle. Additionally, we believe the persistent marking of private investments at cost without balance sheet information and absence of third-party valuations, or enough disclosure for investors to determine performance, are significant contributors to the wide NAV discount. As one analyst queried on the Company’s third quarter 2024 earnings call:

If you had your wish how many positions would you have? How large would they be and I just think I kind of look at some of the parts… It’s just kind of all over the place you have things that are worth less than $1 per share and I just don’t see the focus here.
– Oppenheimer Q&A on Q3 2024 Earnings Call
 

As a result of these perceptions in the market, Cannae trades at a much steeper discount to NAV than its disclosed proxy peers and closed end fund peers. The discount widened persistently after the IPO of Dun & Bradstreet in 2019 and the sell down of Dayforce from 2020 through 2023, implying the market lacks confidence in the current leadership’s ability to execute a viable strategy for value creation going forward. Over the past three years, Cannae equity has traded at an average discount to its NAV per share of -40%, which places it in the bottom tenth of US investment firms with assets over $500 million.3 Approximately 90% of Cannae’s market cap is covered by public holdings net of debt, and the market is valuing the remaining nearly $900 million of private NAV at an 85% discount. A well-managed company with a strong asset base should not be trading at such a deep discount. We believe this misalignment points to a failure in capital allocation, strategic planning, and governance oversight.

Shareholders ‘vote with their feet’, and the most objective indication that fundamental change is required is relative TSR underperformance compared to peers over the long term. Even when viewed on an absolute basis, Cannae shareholders have suffered a negative total return since Cannae became an independent public company despite the backdrop of one of the strongest bull markets in history. Despite the readily identifiable value in the Company’s portfolio, Cannae’s stock has significantly underperformed most relevant benchmarks.4Consistent underperformance is the market telling Cannae, “The status quo is unacceptable.”

Dramatic Change is Required Immediately

As discussed previously with Mr. Foley and Mr. Caswell, we believe Cannae can resolve these issues through decisive action in the near term. We believe that Cannae must pursue the following initiatives without delay:

  1. Reduce overhead costs and align management incentives – A history of burdensome fees and non-performance linked compensation paid out to management are out of step with the overall performance of Cannae’s portfolio, are impacting the discount which the market places on the NAV, and need to be streamlined to reflect best-in-class approach. We believe the Company should implement a corporate overhead cost reduction program and convert the termination fee payable to its manager, Trasimene Capital Management, into performance-based, vesting stock compensation.

  2. Improve capital allocation, unlock portfolio value, and provide a clear investment narrative – Management’s current strategy is vague and undifferentiated, and shareholder feedback is that management has lost its mandate from shareholders to allocate capital in this way. We believe a commitment from management and the Board to return shareholder capital tied up in Dun & Bradstreet, Alight and Paysafe shares either via spin outs or substantial buybacks would force a collapse of the discount placed on those assets and result in a re-rating of the remaining portfolio. We appreciate that management has conceded in its last earnings call that a significant return of capital is a priority; however, we believe that Cannae should commit definitively to returning a substantial majority of this capital on an accelerated timeline. Management could then reallocate its time from monitoring small stakes in large public companies where their ability to “improve the performance and valuation” is limited to focusing on improving disclosure and valuation of the remaining private assets.

  3. Establish governance oversight – We believe that market confidence in this new plan would be best supported by new fit-for-purpose directors that will be a voice for shareholders on the Board. To that end, we delivered a formal notice in December nominating a slate of four highly qualified and independent director candidates for election to the Board at the Company’s 2025 Annual Meeting of Stockholders (the “Annual Meeting”). In addition to the four new directors, we believe the Board should refresh leadership of the Affiliate Transaction Committee and the Nomination and Governance Committee chosen from the four new candidates, and the Board should also create a new committee for Value Maximization tasked with the formulation and oversight of successful execution of a plan designed to improve shareholder returns. The need for immediate and significant governance reform is underscored by Cannae’s entrenchment and unfair enrichment actions earlier this week.

Our intent at the time of nomination was, and continues to be, to engage constructively with the Board with the goal of reaching a consensual solution for the benefit of all stakeholders. However, it appears that the current Board fails to recognize the urgency of the situation. We are therefore prepared to take all necessary steps to ensure that shareholders have the opportunity to vote for directors who they believe have the skill sets and experience necessary to drive value creation and ensure accountability in the boardroom.

Management’s Lack of Willingness to Meaningfully Engage

We have sought to engage with management and the Board for several months to convey our views with respect to corporate strategy and governance with the aim of closing the NAV discount and improving relative share price performance. As discussed in our original private letter to the Board dated December 19, 2024, we submitted our nomination notice as required under the Company’s Bylaws despite the nomination deadline of December 27, 2024, nearly six months ahead of the anticipated Annual Meeting date. We did so in order to preserve our rights as shareholders to elect directors at the Annual Meeting, but with the hope that it would serve as a starting point for further positive discussions. Unfortunately, we now believe our sincere efforts to engage constructively have not been meaningfully reciprocated in good faith.

While the Company confirmed receipt of our December letter and nomination notice, it was more than thirty days before we received any further communication. Given the Company’s significant governance failings and chronic underperformance, we have offered to travel to meet in-person with relevant Board members, but Cannae has yet to permit us to speak with any non-management directors. Perhaps as a result, the Board has failed to appreciate the market’s call for urgent, meaningful governance changes. Then on March 17, 2025, we were astounded to learn via a Company 8-K that the Board, in an apparent move to entrench and enrich leadership, determined to further compensate themselves and Mr. Foley at the expense of shareholders. We believe this offensive action trounces shareholder rights and the Board’s fiduciary duties and further disenfranchises the Company’s true owners. It also makes clear to us that Cannae has not been engaging in good faith dialogue despite our persistent and sincere efforts, which necessitated the need to release this letter with the goal of reaching the entire Board and building a market consensus on the best path forward for the Company.

Carronade Has Nominated Four Highly Qualified Director Candidates

The fundamental role of a Board in its fiduciary duty to shareholders is to be an advocate in providing oversight of management and corporate strategy. Shareholders deserve a board that is proactive, transparent, and fully committed to driving long-term value. As evidenced by their backgrounds below, we believe our candidates will bring the expertise, independence and accountability required to correct the chronic underperformance of Cannae and champion its strategic transformation.

  • Mona Aboelnaga

    • 35 years of experience including at Siguler Guff & Company and Proctor Investment Managers with expertise in investment management and private equity industries.
    • Extensive corporate governance expertise as a board member of both public and private companies including Webster Financial, a financial services company, Perpetual Limited, an Australian-based diversified global financial services company, and Sterling Bancorp, a regional financial services company.
  • Benjamin Duster

    • 45 years of experience including at Wells Fargo and Salomon Brothers with expertise in working with companies to improve execution effectiveness and create long-term sustainable value.
    • Extensive public and private company board service including Expand Energy, an oil and gas production company, Weatherford International, a global energy services company, Republic First Bancorp, a commercial bank, and Alaska Communications Systems, a broadband and telecommunications service provider.
  • Dennis Prieto

    • 21 years of experience including at Aurelius Capital Management and Evercore with expertise in financial analysis and restructuring oversight.
    • Significant investment management and board experience including GO Lab, a privately held building products company, Aventiv Technologies, a provider of telecommunications and technology solutions, Mohawk Gaming Enterprises, a gaming company, and Endo International GUC Trust, a trust established to obtain recoveries for creditors of Endo International plc.
  • Cherie Schaible

    • 24 years of experience including as General Counsel of Ankura Consulting Group and Associate General Counsel of AIG Investments with expertise in complex legal and financial matters.
    • Extensive experience in structuring, negotiating and leading a variety of corporate legal matters in public and private companies.

Conclusion

We remain committed, engaged investors in Cannae due to our conviction in the significant opportunity for value creation that will flow from implementing achievable actions to unlock value, outlining a clear corporate strategy, establishing governance and restoring investor confidence. We repeat our request to meet in-person with the Board, including non-management directors, to discuss these proposals in more detail and explore a consensual solution that is in the best interests of all shareholders. If meaningful changes are not enacted, we are prepared to take our case to shareholders so that they have the opportunity to vote for directors who they believe will best prioritize their interests and ensure accountability in the boardroom.

Sincerely,

Dan Gropper
Managing Partner

Andy Taylor
Partner and Head of Research

About Carronade Capital

Carronade Capital is a multi-strategy investment firm based in Connecticut with over $2.2 billion in assets under management that focuses on process driven investments in catalyst-rich situations. Carronade Capital was founded in 2019 by industry veteran Dan Gropper and is based in Darien, Connecticut. The Funds managed by Carronade Capital were launched on July 1, 2020, and the firm employs 15 team members. Dan Gropper brings with him nearly three decades of special situations credit experience serving in senior roles at distinguished investment firms, including Elliott Management Corporation, Fortress Investment Group and Aurelius Capital Management, LP.

Media Contact:

Paul Caminiti / Jacqueline Zuhse
Reevemark
(212) 433-4600
[email protected]

Investor Contact:

Andy Taylor / Win Rollins
Carronade Capital Management, LP
(203) 485-0880
[email protected]

Disclaimers

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein in any state to any person. This press release does not recommend the purchase or sale of a security. There is no assurance or guarantee with respect to the prices at which any securities of Cannae Holdings, Inc. (the “Company”) will trade, and such securities may not trade at prices that may be implied herein. In addition, this press release and the discussions and opinions herein are for general information only, and are not intended to provide financial, legal or investment advice. Each shareholder of the Company should independently evaluate the proxy materials and make a decision that aligns with their own financial interests, consulting with their own advisers, as necessary.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and may include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will be” and similar expressions. Although Carronade Capital and its affiliates believe that the expectations reflected in forward-looking statements contained herein are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties—many of which are difficult to predict and are generally beyond the control of Carronade or the Company—that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. In addition, the foregoing considerations and any other publicly stated risks and uncertainties should be read in conjunction with the risks and cautionary statements discussed or identified in the Company’s public filings with the U.S. Securities and Exchange Commission, including those listed under “Risk Factors” in the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q . The forward-looking statements speak only as of the date hereof and, other than as required by applicable law, Carronade does not undertake any obligation to update or revise any forward-looking information or statements. Certain information included in this press release is based on data obtained from sources considered to be reliable. Any analyses provided herein is intended to assist the reader in evaluating the matters described herein and may be based on subjective assessments and assumptions and may use one among alternative methodologies that produce different results. Accordingly, any analyses should not be viewed as factual and should not be relied upon as an accurate prediction of future results. All figures are estimates and, unless required by law, are subject to revision without notice.

Certain of the funds(s) and/or account(s) managed by Carronade (“Accounts”) currently beneficially own shares of the Company. Carronade in the business of trading (i.e., buying and selling) securities and intends to continue trading in the securities of the Company. You should assume the Accounts will from time to time sell all or a portion of its holdings of the Company in open market transactions or otherwise, buy additional shares (in open market or privately negotiated transactions or otherwise), or trade in options, puts, calls, swaps or other derivative instruments relating to such shares. Consequently, Carronade’s beneficial ownership of shares of, and/or economic interest in, the Company may vary over time depending on various factors, with or without regard to Carronade’s views of the Company’s business, prospects, or valuation (including the market price of the Company’s shares), including, without limitation, other investment opportunities available to Carronade, concentration of positions in the portfolios managed by Carronade, conditions in the securities markets, and general economic and industry conditions. Without limiting the generality of the foregoing, in the event of a change in the Company’s share price on or following the date hereof, Carronade may buy additional shares or sell all or a portion of its Account’s holdings of the Company (including, in each case, by trading in options, puts, calls, swaps, or other derivative instruments relating to the Company’s shares). Carronade also reserves the right to change the opinions expressed herein and its intentions with respect to its investment in the Company, and to take any actions with respect to its investment in the Company as it may deem appropriate, and disclaims any obligation to notify the market or any other party of any such changes or actions, except as required by law.

Certain Information Concerning the Participants

Carronade Capital Management, LP, together with the other participants named herein (collectively, “Carronade Capital”), intends to file a preliminary proxy statement and accompanying proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of Carronade Capital’s highly-qualified director nominees at the 2025 annual meeting of stockholders of Cannae Holdings, Inc., a Nevada corporation (the “Company”).

CARRONADE CAPITAL STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC’S WEB SITE AT HTTP://WWW.SEC.GOV. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. REQUESTS FOR COPIES SHOULD BE DIRECTED TO THE PARTICIPANTS’ PROXY SOLICITOR.

The participants in the proxy solicitation are anticipated to be Carronade Capital Master, LP (“Carronade”), Carronade Capital, Carronade Capital GP, LLC (“Carronade GP”), Carronade Capital Management GP, LLC (“Carronade Management GP”), Dan Gropper, Mona Aboelnaga, Benjamin C. Duster, IV, Dennis A. Prieto and Chérie L. Schaible.

As of the date hereof, Carronade beneficially owns directly 2,627,877 shares of Common Stock, par value $0.0001 per share, of the Company (the “Common Stock”). Carronade GP, as the general partner of Carronade, may be deemed the beneficial owner of the 2,627,877 shares of Common Stock owned by Carronade. As of the date hereof, 262,770 shares of Common Stock were held in a certain account managed by Carronade Capital (the “Managed Account”). Carronade Capital, as the investment manager of Carronade, may be deemed the beneficial owner of an aggregate of 2,890,647 shares of Common Stock directly owned by Carronade and held in the Managed Account. Carronade Management GP, as the general partner of Carronade Capital, may be deemed the beneficial owner of an aggregate of 2,890,647 shares of Common Stock directly owned by Carronade and held in the Managed Account. As the Managing Member of Carronade Management GP, Mr. Gropper may be deemed the beneficial owner of an aggregate of 2,890,647 shares of Common Stock directly owned by Carronade and held in the Managed Account. As of the date hereof, Ms. Aboelnaga directly beneficially owns 800 shares of Common Stock. As of the date hereof, Mr. Duster directly beneficially owns 1,338.329 shares of Common Stock. As of the date hereof, Mr. Prieto directly beneficially owns 820 shares of Common Stock. As of the date hereof, Ms. Schaible directly beneficially owns 1,360 shares of Common Stock.

____________________________

Note: All analyses performed as of 3/17/2025.
1 Ryan Caswell on Q3 2024 Earnings Call.
2 Current GAV plus realized sales compared to original cost basis of DNB, ALIT, PSFE, and SST.
3 Company published NAV reports.
4 TSR per Bloomberg as of 3/17/2025. Average cumulative shareholder return. TSR Proxy Peers include APO, FSK, GBDC, PSEC, CODI, NMFC. Closed End Fund Peers include UTG, STEW, KYN, CET, GAM, IGR, EOI, MEGI, PEO.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/77496dfe-1ffc-44b7-94dd-bbd69816468b



WhiteFiber and Shadeform Announce Strategic Partnership to deliver on-demand access to NVIDIA B200 GPUs

PR Newswire


NEW YORK
, March 20, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York, announced today that subsidiary WhiteFiber, a leading provider of high-performance GPU cloud infrastructure, and Shadeform, the premier multi-cloud GPU marketplace have entered a strategic partnership to bring on-demand NVIDIA B200 GPUs to customers beginning in April.

This partnership combines WhiteFiber’s next-generation AI/ML optimized GPU cloud with Shadeform’s expansive, multi-cloud management capabilities, and GPU marketplace. Organizations and developers in more than 100 regions worldwide will experience immediate access to cutting-edge high-performance AI infrastructure that was previously out of reach due to up-front costs and long-term commitments.

“The WhiteFiber GPU Cloud is at the forefront of next-generation infrastructure for AI and machine learning,” said Ed Goode, CEO at Shadeform. “Their platform architecture not only delivers the most powerful GPUs available, but optimizes for performance across the entire infrastructure stack to maximize utilization and efficiency. We’re thrilled to offer WhiteFiber’s upcoming NVIDIA B200 GPUs to our customers, unlocking new possibilities for startups and developers who otherwise wouldn’t have access.”

Benjamin Lamson, Head of Revenue at WhiteFiber, added, “We’re excited to partner with Shadeform to deliver cutting-edge GPU technology directly to enterprises and startups. Starting in April, Shadeform customers will have immediate on-demand access to our NVIDIA B200 GPUs, without requiring long-term commitment. This partnership represents a significant step forward in democratizing high-performance AI capabilities, empowering global innovation and accelerating growth for AI developers and organizations alike.”

Organizations interested in exploring how WhiteFiber’s GPU Cloud solutions can accelerate their AI initiatives are encouraged to visit WhiteFiber.com for more information and to receive updates on the upcoming launch of NVIDIA B200 GPUs.

About Bit Digital

Bit Digital (@BitDigital_BTBT), 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 (@WhiteFiber_). Our operations are located in the US, Canada, and Iceland. For additional information, please contact [email protected] 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. 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.

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SOURCE Bit Digital, Inc.

Direct Digital Holdings Launches “Practical Generative AI Use Cases & Tools for DMOs” to Help Break New Ground in Destination Marketing With AI

PR Newswire

New guide provides powerful AI strategies and tools for DMOs to elevate promotion, enhance visitor experiences, and streamline operational efficiency


HOUSTON
, March 20, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of Practical Generative AI Use Cases & Tools for DMOs, the latest addition to its AI education series. This comprehensive guide is designed to help Destination Marketing Organizations (DMOs) understand and implement AI-powered solutions to improve efficiency, enhance marketing efforts, and optimize visitor engagement.

DMOs operate in a fast-paced environment where they are expected to manage strategic initiatives while balancing daily business demands. As AI adoption accelerates, destination marketers are discovering new ways to leverage generative AI to streamline workloads, enhance creative outputs, and drive smarter decision-making. “AI is no longer a futuristic tool—it’s a present-day necessity for DMOs looking to maximize their impact with limited resources,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings. “From developing custom destination guides to optimizing marketing content and data analysis, AI empowers DMOs to work smarter while maintaining the human touch that makes their destinations unique.”

Turning AI Theory into Actionable DMO Solutions

Practical Generative AI Use Cases & Tools for DMOs provides a structured roadmap for integrating AI across essential DMO functions. Through real-world examples the guide demonstrates how AI can be used to enhance workflows, reduce manual tasks, and improve operational efficiency. It reinforces that AI is not a replacement for human expertise but a powerful tool for augmenting strategic planning, creative execution, and data-driven decision-making.

Key topics covered include:

  • AI-powered meeting preparation and stakeholder research – Use AI-driven research to enhance engagement and streamline meeting readiness.
  • Custom destination guides – Develop highly personalized itineraries for travelers and meeting planners at scale.
  • Marketing and social media content creation – Automate content generation for campaigns while maintaining brand voice.
  • Visual content for trade shows – Use AI to create high-quality, customized visual assets for promotional events.
  • Social listening and crisis management – Monitor public sentiment and develop rapid-response communication strategies.
  • Event & RFP optimization – Streamline event planning, proposal responses, and logistical coordination with AI insights.
  • Data analysis and performance reporting – Generate AI-powered insights to track visitor behavior and campaign effectiveness.
  • Website optimization – Enhance website performance by leveraging AI-driven user behavior analysis and smart content recommendations.” DMOs are under increasing pressure to do more with fewer resources,” added Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings. “This guide is designed to provide immediate, practical steps for DMOs to integrate AI effectively, helping them enhance engagement, increase efficiency, and drive economic impact for their destinations.”

In addition to practical use cases, the guide includes a curated list of AI tools that DMOs can implement today and expert insights on AI’s role in tourism marketing, operational efficiency, and future destination strategies.

To download Practical Generative AI Use Cases & Tools for DMOs, please visit our AI Council resource center.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Travel & Tourism, Energy, Healthcare, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.

At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”

For more information, visit www.directdigitalholdings.com.

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SOURCE Direct Digital Holdings

Instacart Launches AI-Powered Universal Campaigns for Advertisers

PR Newswire

New automation tools help brands of all sizes create high-performing ad campaigns on Instacart


SAN FRANCISCO
, March 20, 2025 /PRNewswire/ — Instacart (NASDAQ: CART), the leading grocery technology company in North America, today announced a suite of new AI-powered automation tools designed to drive ad campaign performance and help brands of all sizes achieve their business goals. 

This collection of time-saving tools to drive performance includes AI-powered landing pages, campaign recommendations, product library enhancements, and Universal Campaigns. With Universal Campaigns, advertisers can create one campaign with a single budget that automatically optimizes across multiple ad formats in real-time. This performance-driven approach allows brands to simply select their business objectives while Instacart’s technology handles the complex work of budget allocation and format optimization. Universal Campaigns uses advanced machine learning algorithms to continuously analyze performance data and automatically adjust the mix of formats including sponsored product and shoppable display ads.

“At Instacart, we’re motivated to use the latest technology to help our brand partners succeed in an increasingly complex advertising landscape,” said Ali Miller, VP of Ads Product at Instacart. “As the retail media space continues to mature, brands face more choices than ever about where and how to reach consumers. We’re investing in AI-powered automation that can cut through some of that complexity – reducing manual setup and allowing advertisers to maximize performance aligned with their business objectives through automatic optimization across formats and placements. Ultimately, these innovations benefit consumers too, creating more personalized discovery experiences that help them find new products they’ll love. We’ve developed these tools hand-in-hand with our advertising partners, and we’re excited to see them drive meaningful growth for brands across the Instacart Ads ecosystem.”

Brands have begun to test this approach to campaign management. Rescue Dog Wines drove an increase in new-to-brand sales while piloting Universal Campaigns, compared to their single-format campaign approach.

“Universal campaigns are particularly useful for new customer acquisition,” said Blair Lott, CEO, Rescue Dog Wines. “As a mission-driven brand, we value solutions that allow us to focus on what matters most – creating great wines that support the placement of rescue dogs into loving homes. We’ve seen an increase in first-time purchases since implementing Instacart’s new capability, allowing us to introduce more customers to our wines while furthering our mission. The automation handles complex campaign decisions in real-time, giving our team the freedom to concentrate on strategic growth and brand storytelling rather than managing tactical campaign adjustments.”

“Instacart Universal Campaigns have been a game-changer for our brand,” said Mike Zirngibl, Marketing Director, 1st Phorm. “The ability to seamlessly target high-intent consumers across the platform has driven significant sales lift and solid ROAS while keeping our products top-of-mind at the moment of purchase. The automation and optimization features make campaign management effortless. If you’re looking to maximize retail media impact, Instacart Universal Campaigns are a must.”

Instacart is also rolling out AI-Powered Landing Pages, which enable brands to quickly create engaging, shoppable brand destinations using AI to generate product showcases and custom copy. Early adopter Celsius has already seen a 20% increase in campaign-attributed sales using this new tool.

Instacart continues to invest in automation tools that transform campaign management. The new suite includes:

  • Universal Campaigns: One campaign that works across multiple ad formats with a single budget, optimizing in real-time for specific objectives like sales maximization.
  • AI-Powered Landing Pages: Creates shoppable brand destinations in minutes using AI to generate product showcases and custom copy.
  • Recommendations in Ads Manager: Provides actionable, data-driven insights that can be implemented with a single click to drive campaign performance.
  • Enhanced Product Library: Streamlined tools for managing product information at scale.

Today’s announcement builds on Instacart’s continued investment in emerging brands. With reach across more than 100,000 retail partner stores in North America, Instacart has become a launchpad for brands, driving consumer discovery.

AI-generated landing pages are available for all CPG advertisers today. Additional products in the new automation suite are currently in pilot with select brands, with plans for broader availability in the coming months.

About Instacart
Instacart, the leading grocery technology company in North America, works with grocers and retailers to transform how people shop. The company partners with more than 1,800 national, regional, and local retail banners to facilitate online shopping, delivery and pickup services from more than 100,000 stores across North America on the Instacart Marketplace. Instacart makes it possible for millions of people to get the groceries they need from the retailers they love, and for approximately 600,000 Instacart shoppers to earn by picking, packing and delivering orders on their own flexible schedule. The Instacart Platform offers retailers a suite of enterprise-grade technology products and services to power their e-commerce experiences, fulfill orders, digitize brick-and-mortar stores, provide advertising services, and glean insights. With Instacart Ads, thousands of CPG brands – from category leaders to emerging brands – partner with the company to connect directly with consumers online, right at the point of purchase. With Instacart Health, the company is providing tools to increase nutrition security, make healthy choices easier for consumers, and expand the role that food can play in improving health outcomes. For more information, visit www.instacart.com/company, and to start shopping, visit www.instacart.com. Maplebear Inc. is the registered corporate name of Instacart.

Instacart does not guarantee specific results from using any of the tools or products featured in this release.

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SOURCE Maplebear Inc. dba Instacart

Solventum to Present Value Creation Formula and Long-Range Plan at 2025 Investor Day

PR Newswire

Provides 2028 Targets for Revenue Growth, Margin Expansion, and Free Cash Flow


ST. PAUL, Minn.
, March 20, 2025 /PRNewswire/ — Solventum (NYSE: SOLV) today hosts its 2025 Investor Day and will outline strategic priorities for the Company, its business segments, and its long-range plan (LRP) to drive growth and value creation.

“Solventum has tremendous potential, with attractive businesses, large and growing markets, and highly regarded brands. We have undertaken a significant transformation to unlock the potential of our Medical Surgical, Dental Solutions, and Health Information Systems businesses, positioning the company to drive accelerated growth and create shareholder value,” said Bryan Hanson, Chief Executive Officer of Solventum.

“Solventum has entered 2025 as a more focused company with an improving innovation engine and a purpose-built leadership team committed to realizing our mission of enabling better, smarter, safer healthcare to improve lives. The recently announced sale of our Purification & Filtration (P&F) business is a major milestone and will allow us to accelerate our plans and deliver for customers and shareholders. Our long-range plan demonstrates the progress we made in the last year and reflects our confidence in our ability to accelerate sales growth, expand margins, deliver EPS growth, and improve free cash flow,” Hanson concluded.


Long-Range Plan and Financial Targets
Solventum today reaffirmed its fiscal year 2025 guidance, originally provided in connection with its Q4 earnings, and announced its LRP for 2025 through 2028:

  • Accelerate organic sales growth of 4% to 5% in 2028
  • Expand operating margins to be 23% to 25% in 2028 (inclusive of ~200bps 3M COGS increase)
  • Generate EPS CAGR of 10% over the 3-year period ending 2028
  • Drive free cash flow conversion of 80%+

The Company is also focused on delivering attractive ROIC and a solid investment grade credit rating and intends to use the proceeds from the P&F transaction primarily to pay down debt. Solventum will consider share repurchases and dividends over time.

Three-Phased Transformation Plan
The Company has been executing a three-phased transformation plan, and the LRP reflects the foundational improvements implemented over the last year to position the Company for success.

  • Capture hearts and minds and stabilize the business: The Company has taken action to drive mission and culture, refresh talent and harmonize the executive team, and enhance execution with a focus on relevant metrics for its business.

  • Enhance strategic focus: Solventum is executing a clear strategic plan to drive revenue growth, margin expansion, and cash flow improvement with a focus on high-potential markets where the Company has a path to leadership. Over the past year, the Company has carefully analyzed its markets to select key growth driver areas that will propel growth across the business segments.

  • Portfolio optimization: Solventum has identified organic and inorganic growth opportunities to maximize value and optimize its portfolio, including the recent sale of the P&F business, which frees up significant capital to invest for growth through M&A. The Company will continue to evaluate opportunities to enter or increase scale within the most attractive markets and submarkets, as well as invest in R&D and CapEx to support innovation and top-line growth.

2025 Investor Day Webcast 
Solventum will host its 2025 Investor Day in New York City today starting at 1 p.m. Eastern Daylight Time. The event will also be accessible via webcast and can be found on the Company’s investor relations site. A replay of the webcast and the presentation slides used will be available on the same site following the event.

Forward-Looking Statements

This news release contains forward-looking information about Solventum’s financial results and estimates and business prospects, including guidance for 2025 and its long-range plan for 2025 through 2028, that contain or incorporate by reference statements that relate to future events and expectations and, as such, constitute forward-looking statements that involve risk and uncertainties. Forward-looking statements include those containing such words as “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “guidance,” “intends,” “may,” “outlook,” “plans,” “projects,” “seeks,” “sees,” “should,” “targets,” “will,” “would,” or other words of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum’s control; (2) operational execution risks; (3) damage to Solventum’s reputation or its brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum’s business dealings involving third-party partners in various markets; (6) Solventum’s ability to access the capital and credit markets and changes in Solventum’s credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers’ research budgets or government funding; (10) the timing and market acceptance of Solventum’s new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum’s ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, FCPA and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, product liability claims, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to per-and polyfluoroalkyl substances; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum’s failure to obtain, maintain, protect, or effectively enforce its intellectual property rights; (21) pension and postretirement obligation liabilities; (22) any failure by 3M Company (“3M“) to perform any of its obligations under the various separation agreements entered into in connection with the separation of Solventum from 3M and distribution (the “Spin-Off”); (23) any failure to realize the expected benefits of the Spin-Off; (24) a determination by the IRS or other tax authorities that the Separation or certain related transactions should be treated as taxable transactions; (25) indebtedness incurred in the financing transactions undertaken in connection with the Separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the Spin-Off will exceed Solventum’s estimates; and (27) the impact of the Spin-Off on Solventum’s businesses and the risk that the separation from 3M may be more difficult, time-consuming or costly than expected, including the impact on Solventum’s resources, systems, procedures and controls, diversion of management’s attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in Solventum’s periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

Non-GAAP Financial Measures
In addition to reporting financial results in accordance with U.S. GAAP, Solventum also provides non-GAAP measures that we use, and plan to continue using, when monitoring and evaluating operating performance and measuring cash available to invest in our business. The adjusted measures are not in accordance with, nor are they a substitute for, GAAP measures. These non-GAAP financial measures are supplemental measures of our performance and our liquidity that we believe help investors understand our underlying business performance and Solventum uses these measures as an indication of the strength of Solventum and its ability to generate cash.

Solventum calculates forward-looking non-GAAP financial measures, including organic sales growth, adjusted earnings per share, and free cash flow based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. Solventum does not provide reconciliations of these forward-looking non-GAAP financial measures to the respective GAAP metrics as it is unable to predict with reasonable certainty and without unreasonable effort certain items such as the impact of changes in currency exchange rates, impacts associated with business acquisitions or divestitures, and the timing and magnitude of restructuring activities, among other items. The timing and amounts of these items are uncertain and could have a material impact on Solventum’s results in accordance with GAAP.

About Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients’ lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com.           

 

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SOURCE Solventum

Get Your Game On! The Global Candy Crush All Stars Tournament Returns with $1M Prize Pool Up for Grabs

PR Newswire

  • Candy Crush All Stars
    ®
    2025 kicks off worldwide on March 20, 2025, following last year’s tournament where over 15 million players competed for victory
  • The massive $1M prize pool is back, and the stakes are just as sweet as ever.
  • From millions of Crushers to just 10 finalists, only the top Crushers will advance to the live Los Angeles final – where they’ll battle for the coveted Candy Crush All Stars title.


NEW YORK
, March 20, 2025 /PRNewswire/ — BIGGER. BOLDER. SWEETER. King’s Candy Crush All Stars is back for its fifth consecutive year, and the tournament is taking the competition to legendary heights. The stakes? A place to compete in the live final and a chance to win a monumental $1M prize pool. Think you’ve got what it takes to claim the crown? It’s time to put your skills to the test and crush the competition!

Kicking off on March 20, 2025, Candy Crush All Stars 2025 is open to players around the world, from newcomers to seasoned Crushers. The global tournament builds on last year’s epic showdown, where more than 15 million players competed for victory. This year, Crushers around the world are invited to join the action in a thrilling battle of skill, strategy, and sweet triumph. The two-month, free-to-enter competition features qualifiers, knockout rounds, and second-chance opportunities – all leading up to a live final in Los Angeles, where in-game winners will compete for the Candy Crush All Stars title. Only the best will make it to the ultimate showdown for a chance to claim their share of the $1M prize pool – matching the largest in Candy Crush history!

Last year alone, a staggering 15 million players joined the battle (that’s more than the populations of New York City, Los Angeles, and Chicago combined!) – swiping their way through 2.2 billion levels and collecting an astonishing 11.4 trillion All Stars Candies. 2024’s reigning champion, Ben, rose to the top, outplaying the competition to claim the crown in a thrilling live final. Now, in 2025, the competition is fiercer than ever. Who will rise to the challenge and etch their name in Candy Crush history?

This year, Candy Crush is cranking up the nostalgia with Smash Mouth’s iconic hit, ‘All Star’ – a song that’s been hyping up champions for decades. “This legendary track sets the perfect tone for the campaign,” says Luken Aragon, VP of Marketing for Candy Crush Saga, King. “In a tournament where skill meets fun, and anyone can go from casual Crusher to world champion, we’re proudly reminding our community that every player can be an All Star.”

Think you have what it takes to be an All Star? Get your game on, press play! The action kicks off with qualifiers running until March 27th, giving all players the chance to compete. This will be followed by knockout rounds, leading up to the high-stakes live final event where the top 10 in-game winners will compete for their share of the $1M prize pool and the coveted Candy Crush All Stars title.

The Candy Crush All Stars tournament is available in 23 markets worldwide and open to players 18 and older on selected level 5+ accounts. Candy Crush Saga® is free to download and play on iOS and Android. Ready to prove you’re a Candy Crush All Star? The countdown to the sweetest competition in gaming starts now! For more information about the mobile game and global tournament, please visit: www.candycrushsaga.com.

About Candy Crush Saga
Candy Crush Saga® is one of the world’s most popular mobile games. Millions of players around the globe match colorful candies in combinations of three or more to win points, defeat obstacles and progress through more than 18,000 levels. In November 2022, Candy Crush Saga celebrated its 10-year anniversary. Candy Crush Saga is available to download for free from the Apple App Store, Google Play, Amazon App store, Windows App Store and Facebook.

About King
With a mission of Making the World Playful, King® is a leading interactive entertainment company for the mobile world with more than 20 years of history of delivering some of the world’s most iconic games in the mobile gaming industry, including the world-famous Candy Crush franchise, as well as other mobile game hits such as Farm Heroes Saga®. Candy Crush has been the top-grossing franchise in U.S. app stores for six years, and King games are played by more than 200 million monthly active users. King, a part of Activision Blizzard which was acquired by Microsoft (NASDAQ: MSFT), has game studios in Stockholm, Malmö, London, Barcelona and Berlin and offices in Dublin, San Francisco, New York, Los Angeles and Malta. More information can be found at King.com or by following us on LinkedIn, @lifeatking on Instagram, or @king_games on X.

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SOURCE Candy Crush Saga

XTI Aerospace Provides TriFan Engine Air Inlet / Exhaust Update

PR Newswire

New Engine Air Inlet / Exhaust Design Meets a Key Product and Engineering Q1 Milestone


ENGLEWOOD, Colo.
, March 18, 2025 /PRNewswire/ — XTI Aerospace, Inc. (NASDAQ: XTIA) (“XTI” or the “Company”), a pioneer in VTOL and powered-lift aircraft solutions, today announced the successful update of its engine air inlet and exhaust system design, achieving a key Q1 product and engineering milestone announced in a prior press release.

The updated engine air inlet and exhaust design significantly improves the air intake, particularly in conventional flight, to ensure the air is not hampered by the air flow boundary layer on the upper fuselage. The design team has successfully created a smooth air flow sufficient for the two turboshaft engines to optimize their performance in both vertical and conventional flight.  For the engine exhaust, the design provides for a smooth engine exhaust flow, while enabling some forward thrust advantage and a minimized drag footprint. Figure 1 depicts the TriFan 600 engine inlet and exhaust for the two turboshaft engines, and Figure 2 illustrates the engine inlet flow optimization around the high-speed shaft to minimize distortion and maximize pressure recovery.

“Earlier versions of the TriFan 600 reflected notional concepts of the engine inlets and exhaust manifolds. This latest update reflects a design that supports the needs of the twin turboshaft engines while addressing the aerodynamic performance of the vehicle in CTOL, VTOL, and cruise flight modes,” said Dave Ambrose, VP of Engineering at XTI Aircraft. “I believe our aero team has done a fantastic job in meeting the requirements for the engines while leveraging our DMU (digital mock-up) and CFD (computational fluid dynamics) analysis to optimize the design and performance.”

Scott Pomeroy, Chairman and CEO of XTI Aerospace, added, “This is yet another step in the design evolution process to bring science and art together – not only does it look great, but the aerodynamics are excellent in our CFD analysis. While these changes would likely be missed by a casual observer, our culture of innovation and customer focus is what will make the TriFan 600 a market leader.”

In a previous update, the Company outlined six core product and engineering milestones for Q1, listed below, beginning with the downwash/outwash study and leading up to the launch of the “Sparrow” subscale working model in early Q2.


Completed:

  • Downwash / Outwash Study – Analyze airflows generated by the aircraft during vertical takeoff and landing to evaluate safety and performance
  • Type Certification Application – Formally apply to the FAA for type certification of the TriFan 600
  • Engine Air Inlets and Exhaust – Optimize air intake and exhaust design to enhance performance and efficiency of the propulsion system


To be Completed:

  • Fuel System Design – Optimize fuel system design to reduce unusable fuel and increase fuel capacity
  • Flight Deck Mockup – Develop a flight deck human factors mockup to design and evaluate and optimize ergonomics, pilot controls, and vision polar
  • Global Finite Element Model (GFEM) of the latest configuration – Update the comprehensive structural model to evaluate and optimize the aircraft’s strength and load paths under various loading conditions

About XTI Aerospace, Inc. 

XTI Aerospace (XTIAerospace.com) (Nasdaq: XTIA) is the parent company of XTI Aircraft Company, an aviation business based near Denver, Colorado, currently developing the TriFan 600, a fixed-wing business aircraft designed to have the vertical takeoff and landing (VTOL) capability of a helicopter, speeds of 345 mph and a range of 700 miles, creating an entirely new category – the vertical lift crossover airplane (VLCA). Additionally, the Inpixon (inpixon.com) business unit of XTI Aerospace is a leader in real-time location systems (RTLS) technology with customers around the world who use the Company’s location intelligence solutions in factories and other industrial facilities to help optimize operations, increase productivity, and enhance safety. For more information about XTI Aerospace, please visit XTIAerospace.com and HangerXStudios.com (aviation innovation podcast), and follow the company on LinkedIn, Instagram, X, and YouTube.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. All statements other than statements of historical fact contained in this press release, including without limitation, statements about the products under development by XTI, the advantages of XTI’s technology, and XTI’s customers, plans and strategies are forward-looking statements.

Some of these forward-looking statements can be identified by the use of forward-looking words, including “believe,” “continue,” “could,” “would,” “will,” “estimate,” “expect,” “intend,” “plan,” “target,” “projects,” or the negatives of these terms or variations of them or similar expressions. All forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. All forward-looking statements are based upon estimates, forecasts, and assumptions that, while considered reasonable by XTI Aerospace and its management, are inherently uncertain, and many factors may cause the actual results to differ materially from current expectations. XTI undertakes no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Readers are urged to carefully review and consider the risk factors discussed from time to time in XTI’s filings with the SEC, including those factors discussed under the caption “Risk Factors” in its most recent annual report on Form 10-K, filed with the SEC on April 16, 2024, and in subsequent reports filed with or furnished to the SEC.

Contacts

General inquiries:

Email: [email protected] 
Web: https://xtiaerospace.com/contact/ 

Investor Relations:

Crescendo Communications
Tel: +1 212-671-1020
Email: [email protected]

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SOURCE XTI Aerospace, Inc.

OneStream Achieves the Highest Level of Federal Security Compliance with FedRAMP High Authorization

PR Newswire

OneStream’s government community cloud now meets one of the most rigorous and strictest safety standards for all levels of government


BIRMINGHAM, Mich.
, March 20, 2025 /PRNewswire/ — OneStream, Inc. (NASDAQ:OS), the leading enterprise Finance management platform that modernizes the Office of the CFO by unifying core finance and operational functions – including financial close, consolidation, reporting, planning and forecasting, today announced that it has achieved Federal Risk and Authorization Management Program (FedRAMP) High authorization status. This authorization certifies that OneStream’s government community cloud meets the federal government’s strictest safety standards and is authorized for use by federal entities that require the highest level of security for the government’s most sensitive, unclassified data in cloud computing environments.

FedRAMP® is a U.S. government-wide program that provides a standardized approach to security assessment, authorization and continuous monitoring for cloud products and services. It enables federal agencies to transition from outdated legacy IT systems to secure cloud-based solutions. FedRAMP High is the program’s most rigorous authorization, accounting for the government’s most sensitive, unclassified data.

“Finance teams across government are under increasing pressure to deliver greater efficiencies amid rapid organizational changes,” said Tom Shea, CEO at OneStream.  “Our FedRAMP High Authorization status positions us as the gold standard for security and compliance in this space, allowing Finance leaders to streamline operations, enhance transparency and unify data to navigate the complexity that comes with legacy systems and evolving processes and budget changes. We are committed to ensuring that Finance leaders across this sector have the technology they need to become more strategic.”

This authorization comes at a pivotal time as federal finance leaders take on increasingly strategic roles in a rapidly evolving landscape. According to OneStream’s Finance 2035 research, nearly three-quarters (73%) of public sector finance leaders report that expectations on CFOs have multiplied in the last three to give years. Additionally, risk management is at the top of their agenda, with 73% of all public sector leaders believing that in 2035, risk mitigation will be a higher priority for other organizations than growth or efficiency.

The OneStream platform has been FedRAMP authorized since 2018, initially achieving FedRAMP Moderate authorization. In January 2025, it advanced to FedRAMP High authorization. Additionally, OneStream completed System and Organization (SOC) 1 Type II and SOC 2 Type II reports, demonstrating its commitment to platform security and compliance.

For more information about OneStream and its FedRAMP High authorization, visit the FedRAMP Marketplace.

To learn more about how OneStream empowers agencies to streamline financial management, budget and reporting, click here.

About OneStream

OneStream is how today’s Finance teams can go beyond just reporting on the past and Take Finance Further by steering the business to the future. It’s the leading enterprise finance platform that unifies financial and operational data, embeds AI for better decisions and productivity, and empowers the CFO to become a critical driver of business strategy and execution.

We deliver a comprehensive cloud-based platform to modernize the Office of the CFO. Our Digital Finance Cloud unifies core financial and broader operational data and processes and embeds AI for better planning and forecasting, with an extensible architecture, so customers can adopt and develop new solutions, achieving greater value as their business needs evolve.

With over 1,600 customers, including 17% of the Fortune 500, more than 300 go-to-market, implementation, and development partners and over 1,500 employees, our vision is to be the operating system for modern finance. To learn more, visit onestream.com.

MEDIA CONTACT

Jaclyn Proctor

Media Relations Contact
OneStream
[email protected]

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SOURCE OneStream, Inc.

Osmose and Neara Partner to Help Utilities Strengthen Transmission and Distribution Infrastructure with AI-Powered Data Insights

PR Newswire

Osmose and Neara are teaming up to enable utilities like CenterPoint Energy to evaluate asset risk with greater precision and improve underlying network data quality and utilization.


ATLANTA
, March 20, 2025 /PRNewswire/ — Osmose, the leading provider of utility infrastructure asset assessment, restoration, and life extension solutions, and Neara, an AI-powered predictive modeling platform for utility networks, have announced a strategic partnership to help utilities better assess risk, improve data accuracy, and strengthen power grids. This collaboration will enable utilities like CenterPoint Energy to prioritize asset upgrades with greater precision and efficiency.

By combining Osmose’s deep expertise in field data collection, structural analysis, and restoration solutions with Neara’s advanced AI modeling, the partnership will address longstanding data quality challenges that often limit effective decision-making. Many utilities struggle with incomplete or outdated network data, leading to premature replacements or missed opportunities for cost-effective reinforcement. This joint solution enhances data accuracy, helping utilities optimize restoration efforts, reduce costs, and improve resiliency.

“By integrating Neara’s AI-driven modeling with our industry-leading field services, we’re giving utilities a powerful tool to make smarter, more data-driven decisions,” said Mike Adams, CEO of Osmose. “Accurate asset data is the foundation for a resilient grid, and this partnership provides the precision needed to maximize reliability and performance.”

The collaboration will focus on several key challenges in utility infrastructure management:

  • Enhancing data accuracy – Osmose’s field teams collect and verify asset conditions on-site, ensuring utilities have the most reliable and precise structural data available. Neara’s AI platform then processes and refines this data, automatically correcting and enhancing GIS records. By combining Osmose’s hands-on expertise with Neara’s AI-driven insights, utilities gain a clearer and more actionable understanding of their network.

  • Improving risk-based decision-making – Osmose’s structural analysis and degradation models provide deep insights into asset condition and performance. Neara enhances these insights by applying predictive analytics, helping utilities quantify risk and prioritize action. Together, they enable utilities to determine which assets require immediate restoration, which can be reinforced or upgraded, and which should be replaced—eliminating costly guesswork.

  • Optimizing restoration strategies – Osmose’s field-verified assessments allow utilities to target restoration and reinforcement efforts with precision. Neara’s modeling further refines this process by force-ranking risk-adjusted priorities across the network. This ensures that utilities make the most cost-effective and impactful restoration decisions, strengthening infrastructure while minimizing unnecessary replacements.

“Restoration, reinforcement, and structure replacement all play key roles in strengthening distribution infrastructure,” said Jack Curtis, Chief Commercial Officer at Neara. “But the most effective decision-making starts with clean, accurate data. By integrating Osmose’s field expertise into our platform, we’re helping utilities like CenterPoint Energy improve resiliency while optimizing costs.”

CenterPoint Energy is already using the partnership’s tools to enhance its storm preparedness and improve network reliability.

“At CenterPoint Energy, we are focused every day on building the most resilient coastal grid in the nation and increasing the resiliency of the communities we are privileged to serve,” said Eric Easton, VP of Grid Transformation at CenterPoint Energy. “As we work to leverage technology to deliver better outcomes for our customers, we’re continuing to enhance our advanced modeling capabilities, which includes collaborating with cutting-edge technology providers like Neara and Osmose to leverage data from both site-specific field analysis and LiDAR-based modeling to optimize the accuracy of individual asset analysis as well as the efficiency of our whole system modeling.”

This partnership helps utilities move beyond traditional inspection cycles and embrace a more proactive, data-driven approach. The benefits include:

  • Up to 70% cost savings by reinforcing rather than replacing high-risk assets;
  • Up to 80% faster restoration, minimizing disruptions and improving reliability; and
  • 25% more accurate asset prioritization, ensuring the most critical upgrades happen first

By continuously updating asset data through field inspections and AI-driven modeling, utilities can stay ahead of potential failures and ensure their networks are stronger, safer, and more reliable.

About Osmose Utilities Services, Inc.
Founded in 1934, Osmose is the market-leading provider of critical above-grade and below-grade electric transmission and distribution asset assessment, evaluation, and restoration for electric utilities, telecommunications companies, and renewable energy generators in the United States, Canada, Europe, Australia, and New Zealand.  Headquartered in Atlanta, Georgia, the company employs more than 4,000 people. Osmose’s field technicians, professional engineers, scientists, and corrosion experts utilize their expertise to identify and solve issues to make utility infrastructure safer, longer lasting, and more resilient while lowering the total cost of ownership. Osmose is a portfolio company of EQT Infrastructure. Learn more at https://www.osmose.com/.

About Neara
Neara’s AI-assisted predictive modeling software helps infrastructure owners drive critical proactive decisions by conducting precise analyses in hours and days that would otherwise take months or years in the field. Network-wide simulation analyses reveal how assets behave in real-world environments during any scenario — empowering better, faster, more cost-effective decisions. The model supports end-to-end network governance, from routine operational decisions to emergency scenarios and major grid-hardening investments — without verification from manual surveys. Neara’s technology has modeled >1.5 million square miles of global network territory featuring ~10 million assets, across four continents from California to Ireland and Australia. Neara’s utility customers identify outage risks 9x faster, restore power 3x faster, and save thousands of field visits per year. More information is available at www.neara.com.

About CenterPoint Energy
As the only investor-owned electric and gas utility based in Texas, CenterPoint Energy, Inc. (NYSE: CNP) is an energy delivery company with electric transmission and distribution, power generation and natural gas distribution operations that serve more than 7 million metered customers in Indiana, Louisiana, Minnesota, Mississippi, Ohio and Texas. With approximately 9,000 employees, CenterPoint Energy and its predecessor companies have been in business for more than 150 years. For more information, visit CenterPointEnergy.com.

Media Contact

[email protected]

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BioMarin Presents New Data Demonstrating Favorable Safety and Strong Adherence in Real-World Clinical Practice with VOXZOGO® (vosoritide) in Children Under 3 with Achondroplasia at 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting

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New data also to be presented for PALYNZIQ® (pegvaliaise-pqpz), reinforcing its value in sustaining blood Phe level reduction and improving health-related quality of life for adults with phenylketonuria


SAN RAFAEL, Calif.
, March 20, 2025 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced positive new data from studies of VOXZOGO® (vosoritide) in children with achondroplasia and in ongoing clinical trials investigating other skeletal conditions, as well as PALYNZIQ® (pegvaliase-pqpz) in adults with phenylketonuria (PKU). The latest findings further validate the long-term benefit and established safety profiles of both medicines, which continue to play a pivotal role for people living with these genetically defined conditions.

The data will be presented at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Los Angeles.

Data Highlight VOXZOGO Treatment Adherence and Favorable Safety Profile in Infants

New data from a study in Japan showed strong treatment adherence with VOXZOGO in children with achondroplasia under the age of 3, with no reported treatment-related adverse events nor any dose interruptions among 63 children followed for up to 23.7 months. These real-world findings validate VOXZOGO’s established safety profile and reinforce the therapeutic benefit seen in clinical studies. The study’s safety results, including in infants as young as 1 month old, add to the growing body of evidence supporting early treatment initiation.

“VOXZOGO is the first and only approved treatment for children with achondroplasia, and it is encouraging to see favorable safety and strong adherence in very young children receiving the medicine in real-world clinical practice. As the effects of restricted growth are apparent from birth in children with achondroplasia, we expect that earlier treatment should translate to greater benefits,” said Greg Friberg, M.D., executive vice president and chief research & development officer at BioMarin. “In addition to data in achondroplasia, scientific research at ACMG furthers our genetic understanding of skeletal conditions like hypochondroplasia, in which we hope to complete enrollment for our pivotal study with VOXZOGO in the first half of 2025.”

PALYNZIQ Data Show Importance of Sustained Blood Phe Level Reduction and Improvement in Quality of Life in Adults with PKU

New data from the OPAL study, a post-marketing observational trial to assess the real-world safety and efficacy of PALYNZIQ, showed lowered blood Phe levels following treatment and positive health-related quality of life (HRQoL) outcomes. Mean blood Phe level was 1029 μmol/L at baseline (n=51) and lowered to 293 μmol/L at week 96 (n=16), representing a 67.8% reduction. Improvements in HRQoL were also observed, as measured by the PKU quality of life questionnaire (PKU-QOL) and the PKU Symptom Severity and Impacts Scale (PKU-SSIS), which use a scale of 1-100, with lower scores indicating better HRQoL. Mean change from baseline of -12.4 and -11.8 respectively were observed over the same time period.

Additionally, secondary data analyses from the Phase 3 PRISM clinical trial program demonstrated that sustaining lowered blood Phe levels with PALYNZIQ led to improvements in attention and mood. Most notably, scores for sustained Phe levels ≤120 were significantly better than those at sustained levels of ≤600 or ≤360, suggesting blood Phe in the normal range may provide additional benefit for adults living with PKU.

Real-world data from the Assessment of the Treatment and management LAndScape of PKU (ATLAS) study also highlighted a shift in the treatment landscape in part attributable to PALYNZIQ, with an increased proportion of people with PKU treated across 19 U.S. clinics achieving blood Phe levels ≤360 μmol/L and a reduction in the proportion of individuals with blood Phe levels >1200 μmol/L.

These findings demonstrate PALYNZIQ’s efficacy in treating PKU, as the company works to advance this option for younger people living with the genetically defined condition, with results from a Phase 3 study in adolescents expected later this year.

Below are BioMarin’s key presentations at ACMG, all listed in Pacific Time:

Interdisciplinary Variant Re-Classification: FGFR3 as an Example of Genotypic Investigation in Suspected Skeletal Dysplasia Population
Poster #P213
Thursday, March 20, 10:30 – 11:30 a.m.

How Helpful are Sleep Studies in Determining Surgical Need in Infants with Achondroplasia?
Poster #P313
Thursday, March 20, 10:30 – 11:30 a.m.

Beyond Boundaries: The Continuous Spectrum in FGFR3-Related Conditions
Poster #P373
Thursday, March 20, 10:30 – 11:30 a.m.

Index of Sustained Phe Response and Improvements in PKU Clinical Outcome Assessments in Patients Receiving Pegvaliase
Poster #P009
Thursday, March 20, 10:30 – 11:30 a.m.

Initial Psychometric Evaluation of the Adult Symptom Severity and Impacts Scale (PKU-SSIS) Using Interim Data from the OPAL Study
Poster #P029
Thursday, March 20, 10:30 – 11:30 a.m. 

The Assessment of the Treatment and Management Landscape of Phenylketonuria Survey Study: Findings from 19 Clinics in the United States
Poster #P045
Thursday, March 20, 10:30 – 11:30 a.m.

Safety Profile and Adherence of Vosoritide in Young Children with Achondroplasia in Japan
Poster #P208
Friday, March 21, 10:30 – 11:30 a.m.

Vosoritide as a Targeted Therapy for FGFR3-Related Thanatophoric Dysplasia
Poster #P354
Friday, March 21, 10:30 – 11:30 a.m.

Improvements in Blood Phenylalanine and Health-Related Quality of Life Outcomes Among Adults with PKU Receiving Pegvaliase in the OPAL Study
Poster #P002
Friday, March 21, 10:30 – 11:30 a.m.

Occurrence of Anaphylaxis in Adult Incident Pegvaliase-Treated PKU Patients in a Post-Marketing Safety Analysis in the United States
Poster #P046
Friday, March 21, 10:30 – 11:30 a.m.

About Achondroplasia

Achondroplasia, the most common form of skeletal dysplasia leading to disproportionate short stature in humans, is characterized by slowing of endochondral ossification, which results in disproportionate short stature and disordered architecture in the long bones, spine, face and base of the skull. This condition is caused by a change in the FGFR3 gene, a negative regulator of bone growth.

More than 80% of children with achondroplasia have parents of average stature and have the condition as the result of a spontaneous gene mutation. The worldwide incidence rate of achondroplasia is about one in 25,000 live births. VOXZOGO is being tested in children whose growth plates are still “open,” typically those under 18 years of age. Approximately 25% of people with achondroplasia fall into this category.

About Phenylketonuria

PKU, or phenylalanine hydroxylase (PAH) deficiency, is a genetic condition affecting approximately 70,000 people in the regions of the world where BioMarin operates. This enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If functional enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms.

As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU born after this period in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after.

PKU can be managed with a severe Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, it is difficult for most individuals to adhere to the lifelong strict diet to the extent needed to achieve adequate control of blood Phe levels. Dietary control of Phe in childhood can prevent major developmental neurological toxicities, but poor control of Phe in adolescence and adulthood is associated with a range of neurocognitive disabilities with significant functional impact.

About VOXZOGO

In children with achondroplasia, endochondral bone growth, an essential process by which bone tissue is created, is negatively regulated due to a gain of function mutation in FGFR3. VOXZOGO, a C-type natriuretic peptide (CNP) analog, acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.

VOXZOGO is approved in the U.S., Japan and Australia to increase linear growth in children of all ages with achondroplasia with open epiphyses, and VOXZOGO is indicated in the EU for the treatment of achondroplasia in children 4 months of age and older whose epiphyses are not closed, as confirmed by appropriate genetic testing. In the U.S., this indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trial(s). To fulfill this post-marketing requirement, BioMarin intends to use the ongoing open-label extension studies compared to available natural history.

Patient Support Accessing VOXZOGO

To reach a BioMarin RareConnections® Case Manager, please call, toll-free, 1-833-VOXZOGO (1-833-869-9646) or e-mail [email protected]. For more information about VOXZOGO, please visit www.voxzogo.com. For additional information regarding this product, please contact BioMarin Medical Information at [email protected].

About PALYNZIQ

PALYNZIQ substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with a PEGylated version of the enzyme phenylalanine ammonia lyase to break down Phe. PALYNZIQ is administered using a dosing regimen designed to facilitate tolerability; PALYNZIQ’s safety profile consists primarily of immune-mediated responses, which can include anaphylaxis, for which robust risk management measures effective in clinical trials are in place.

PALYNZIQ is approved to reduce blood Phe concentrations for adults in the U.S., for people 16 and older in the EU, Canada and Brazil, and for people 15 and older in Japan to reduce blood Phe concentrations in individuals with PKU who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management.

Patient Support Accessing PALYNZIQ

To reach a BioMarin RareConnections® Case Manager, please call, toll-free, 1-866-906-6100 or e-mail [email protected]. For more information about PALYNZIQ, please visit www.palynziq.com. For additional information regarding this product, please contact BioMarin Medical Information at [email protected].

VOXZOGO U.S. Important Safety Information


What is VOXZOGO used for?

  • VOXZOGO is a prescription medicine used to increase linear growth in children with achondroplasia and open growth plates (epiphyses).
  • VOXZOGO is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.


What is the most important safety information about VOXZOGO?

  • VOXZOGO may cause serious side effects including a temporary decrease in blood pressure in some patients. To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, feeling tired, or nausea), patients should eat a meal and drink 8 to 10 ounces of fluid within 1 hour before receiving VOXZOGO.


What are the most common side effects of VOXZOGO?

  • The most common side effects of VOXZOGO include injection site reactions (including redness, itching, swelling, bruising, rash, hives, and injection site pain), high levels of blood alkaline phosphatase shown in blood tests, vomiting, joint pain, decreased blood pressure, and stomachache. These are not all the possible side effects of VOXZOGO. Ask your healthcare provider for medical advice about side effects, and about any side effects that bother the patient or that do not go away.


How is VOXZOGO taken?

  • VOXZOGO is taken daily as an injection given under the skin, administered by a caregiver after a healthcare provider determines the caregiver is able to administer VOXZOGO. Do not try to inject VOXZOGO until you have been shown the right way by your healthcare provider. VOXZOGO is supplied with Instructions for Use that describe the steps for preparing, injecting, and disposing VOXZOGO. Caregivers should review the Instructions for Use for guidance and any time they receive a refill of VOXZOGO in case any changes have been made.
  • Inject VOXZOGO 1 time every day, at about the same time each day. If a dose of VOXZOGO is missed, it can be given within 12 hours from the missed dose. After 12 hours, skip the missed dose and administer the next daily dose as usual.
  • The dose of VOXZOGO is based on body weight. Your healthcare provider will adjust the dose based on changes in weight following regular check-ups.
  • Your healthcare provider will monitor the patient’s growth and tell you when to stop taking VOXZOGO if they determine the patient is no longer able to grow. Stop administering VOXZOGO if instructed by your healthcare provider.


What should you tell the doctor before or during taking VOXZOGO?

  • Tell your doctor about all of the patient’s medical conditions including
    • If the patient has heart disease (cardiac or vascular disease), or if the patient is on blood pressure medicine (anti-hypertensive medicine).
    • If the patient has kidney problems or renal impairment.
    • If the patient is pregnant or plans to become pregnant. It is not known if VOXZOGO will harm the unborn baby.
    • If the patient is breastfeeding or plans to breastfeed. It is not known if VOXZOGO passes into breast milk.
  • Tell your doctor about all of the medicines the patient takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You may report side effects to BioMarin at 1-866-906-6100. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see additional safety information in the full Prescribing Information and Patient Information.

PALYNZIQ U.S. Indication and Important Safety Information

PALYNZIQ® (pegvaliase-pqpz) is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood Phe levels in adult patients with phenylketonuria who have uncontrolled blood Phe levels greater than 600 micromol/L on existing management.

BOXED WARNING: RISK OF ANAPHYLAXIS

  • Anaphylaxis has been reported after administration of PALYNZIQ and may occur at any time during treatment
  • Administer the initial dose of PALYNZIQ under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient’s and observer’s (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed
  • Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use
  • Prescribe auto-injectable epinephrine. Prior to the first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment
  • PALYNZIQ is available only through a restricted program called PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Further information, including a list of qualified pharmacies, is available at www.PALYNZIQREMS.com or by telephone at 1-855-758-REMS (1-855-758-7367)

WARNINGS AND PRECAUTIONS

Anaphylaxis

  • Signs and symptoms of anaphylaxis reported include syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat tightness, skin flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea)
  • Anaphylaxis generally occurred within 1 hour after injection; however, delayed episodes occurred up to 48 hours after PALYNZIQ administration
  • Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use
  • Anaphylaxis requires immediate treatment with auto-injectable epinephrine. Prescribe auto-injectable epinephrine to all patients receiving PALYNZIQ and instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment. Prior to the first dose, instruct the patient and observer (if applicable) on how to recognize the signs and symptoms of anaphylaxis, how to properly administer auto-injectable epinephrine, and to seek immediate medical care upon its use. Consider the risks associated with auto-injectable epinephrine use when prescribing PALYNZIQ. Refer to the auto-injectable epinephrine prescribing information for complete information
  • Consider the risks and benefits of readministering PALYNZIQ following an episode of anaphylaxis. If the decision is made to readminister PALYNZIQ, administer the first dose under the supervision of a healthcare provider equipped to manage anaphylaxis and closely observe the patient for at least 60 minutes following the dose. Subsequent PALYNZIQ dose titration should be based on patient tolerability and therapeutic response
  • Consider premedication with an H1-receptor antagonist, H2-receptor antagonist, and/or antipyretic prior to PALYNZIQ administration based upon individual patient tolerability

Other Hypersensitivity Reactions

  • Hypersensitivity reactions other than anaphylaxis have been reported in 204 of 285 (72%) patients treated with PALYNZIQ in clinical trials
  • Management of hypersensitivity reactions should be based on the severity of the reaction, recurrence of the reaction, and the clinical judgment of the healthcare provider, and may include dosage adjustment, temporary drug interruption, or treatment with antihistamines, antipyretics, and/or corticosteroids

ADVERSE REACTIONS

  • The most common adverse reactions (at least 20% of patients in either treatment phase) were injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety
  • Of the 285 patients exposed to PALYNZIQ in an induction/titration/maintenance regimen in clinical trials, 44 (15%) patients discontinued treatment due to adverse reactions. The most common adverse reactions leading to treatment discontinuation were hypersensitivity reactions (6% of patients) including anaphylaxis (3% of patients), angioedema (1% of patients), arthralgia (4% of patients), generalized skin reactions lasting at least 14 days (2% of patients), and injection site reactions (1% of patients)
  • The most common adverse reactions leading to dosage reduction were arthralgia (15% of patients), hypersensitivity reactions (9% of patients), injection site reactions (4% of patients), alopecia (3% of patients), and generalized skin reactions lasting at least 14 days (2% of patients)
  • The most common adverse reactions leading to temporary drug interruption were hypersensitivity reactions (14% of patients), arthralgia (13% of patients), anaphylaxis (4% of patients), and injection site reactions (4% of patients)
  • Angioedema and serum sickness: In clinical trials, 22 out of 285 (8%) patients experienced 45 episodes of angioedema (symptoms included: pharyngeal edema, swollen tongue, lip swelling, mouth swelling, eyelid edema, and face edema) occurring independent of anaphylaxis. In clinical trials, serum sickness was reported in 7 out of 285 (2%) patients

Blood Phenylalanine Monitoring and Diet

  • Obtain blood Phe levels every 4 weeks until a maintenance dosage is established. Periodically monitor blood Phe levels during maintenance therapy
  • Counsel patients to monitor dietary protein and Phe intake, and adjust as directed by their healthcare provider

DRUG INTERACTIONS

Effect of PALYNZIQ on Other PEGylated Products

  • In a single-dose study of PALYNZIQ in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced a hypersensitivity reaction. One of the two patients experienced anaphylaxis
  • The clinical effects of concomitant treatment with different PEGylated products is unknown. Monitor patients treated with PALYNZIQ and concomitantly with other PEGylated products for hypersensitivity reactions including anaphylaxis

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

  • PALYNZIQ may cause fetal harm when administered to a pregnant woman
  • Advise women who are exposed to PALYNZIQ during pregnancy or who become pregnant within one month following the last dose of PALYNZIQ that there is a pregnancy surveillance program that monitors pregnancy outcomes. Healthcare providers should report PALYNZIQ exposure and encourage these patients to report their pregnancy to BioMarin (1-866-906-6100)
  • Monitor blood Phe levels in breastfeeding women treated with PALYNZIQ

Pediatric Use

  • The safety and effectiveness of PALYNZIQ in pediatric patients have not been established

Geriatric Use

  • Clinical studies of PALYNZIQ did not include patients aged 65 years and older

You are encouraged to report suspected adverse reactions to BioMarin at 1-866-906-6100, or to FDA at 1-800-FDA-1088 or 

www.fda.gov/medwatch

.

Please see accompanying full Prescribing Information, including Boxed Warning.

About BioMarin

BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The San Rafael, California-based company, founded in 1997, has a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world. To learn more, please visit www.biomarin.com.

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: data to be presented at the 2025 American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting, including the ten poster presentations; the development of BioMarin’s VOXZOGO program generally, including expectation to complete enrollment of the pivotal study with VOXZOGO in hypochondroplasia in the first half of 2025; the safety profile and potential benefits of VOXZOGO for children with achondroplasia, including the expectation that earlier treatment should lead to potentially greater benefits; the development of BioMarin’s PALYNZIQ program generally; BioMarin’s plans to advance PALYNZIQ for the treatment of adolescents with phenylketonuria (PKU), including expectation that results from a Phase 3 study will be available later this year; the benefits of PALYNZIQ for adults with PKU, including potential improvement in health-related quality of life; and the continued clinical development of VOXZOGO and PALYNZIQ. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of VOXZOGO and PALYNZIQ; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the U.S. Food and Drug Administration, the European Medicines Agency, the European Commission and other regulatory authorities; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin®, BioMarin RareConnections®, VOXZOGO® and PALYNZIQ® are registered trademarks of BioMarin Pharmaceutical Inc.


Contacts:    

Investors

Media


Traci McCarty


Andrew Villani


BioMarin Pharmaceutical Inc.


BioMarin Pharmaceutical Inc.


(415) 455-7558


(628) 269-7393

 

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