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USANA Health Sciences Announces Strategic Acquisition of Hiya Health

USANA Health Sciences Announces Strategic Acquisition of Hiya Health

Hiya is a fast-growing, emerging leader of high-quality children’s health & wellness products.

Broadens USANA’s reach into the highly attractive direct-to-consumer channel driven by Hiya’s powerful subscription model with runway for sustainable future growth.

Expected to be immediately accretive to 2025 adjusted EBITDA.

9/30/2024 LTM net sales of $103 million, LTM net income of $19 million, and LTM adjusted EBITDA of $22 million.

The Company will discuss the transaction during a conference call on Monday, December 23, 2024, at 5:00 PM ET.

SALT LAKE CITY–(BUSINESS WIRE)–
USANA Health Sciences, Inc. (NYSE: USNA) (the “Company,” “USANA”), today announced its acquisition of a 78.8% controlling ownership stake in Hiya Health Products, LLC (“Hiya”), a leading direct-to-consumer provider of high-quality children’s health & wellness products. The $205 million cash transaction closed on December 23, 2024 and is anticipated to be accretive to USANA’s 2025 adjusted EBITDA. For the last twelve months ended September 30, 2024 (unaudited), Hiya generated net sales of $103 million, net income of $19 million, and adjusted EBITDA of $22 million. As of September 30, 2024, Hiya had more than 200,000 customers.

“The Hiya brand is a natural fit for USANA and this acquisition represents a key strategic milestone for our business,” said Jim Brown, President and Chief Executive Officer of USANA Health Sciences, Inc. “Hiya’s co-founders, Darren Litt and Adam Gillman, have disrupted the children’s health and wellness market by building a high quality, better-for-you brand that aligns with our vision of creating the healthiest family on Earth. This strategic acquisition adds a diversified layer of growth to USANA’s overall business, while maintaining our commitment to our core direct sales business, where we continue to invest in initiatives to drive growth. Notably, this acquisition will allow USANA to reach a broader audience by diversifying distribution channels through Hiya, which we believe will enhance our ability to generate sustainable long-term growth and deliver value for our stakeholders. Darren and Adam will continue to lead Hiya through its next phase of growth. Their leadership and expertise is instrumental to Hiya’s business, which is now part of USANA’s mission and strategic objectives.”

Darren Litt, co-founder and CEO of Hiya, commented, “Today represents an exciting chapter for Hiya and we are thrilled to join the USANA family. As parents ourselves, we recognized that so many wellness companies did not prioritize our children’s health interests, so we created Hiya to give families the very best in clean, honest nutrition. With the help of USANA’s extensive capabilities, support and international expertise, we can now extend that commitment to create healthy products for more families in more countries. USANA and Hiya share a deep commitment to improving the lives of families everywhere by providing the best nutritional products possible, and we look forward to continuing this exciting journey as part of USANA.”

Strategic Rationale

  • Fast-Growing, Emerging Leader in the Children’s Health and Wellness Market. The acquisition of Hiya provides the opportunity for USANA to expand its presence in the children’s health & wellness market through Hiya. For the last twelve months ended September 30, 2024, Hiya’s net sales of $103 million grew 50% as compared to fiscal year 2023. For fiscal year 2025, the Company currently anticipates Hiya’s net sales growth to approach 30% year-over-year.
  • Strengthens USANA’s Financial Profile. Hiya offers a compelling subscription model with attractive margins, profitability, and cash flow generation, which is expected to enhance the Company’s ability to deliver long-term growth and drive shareholder value. Hiya’s domestic profitability diversifies USANA’s geographic sales mix and is anticipated to lower the Company’s consolidated effective tax rate and create a more tax-efficient structure.
  • Presents Opportunity to Accelerate Growth and Enhance Profitability by Leveraging Synergies. Over the next several years, USANA and Hiya will work together to take advantage of identified synergies, assets and expertise across both companies to create efficiencies, and to accelerate growth and profitability. For example, there are opportunities for Hiya to leverage USANA’s significant manufacturing and international expansion expertise. Similarly, USANA may leverage Hiya’s market data insights, marketing expertise, and children-focused products within its direct sales channel.
  • Channel Expansion into Direct-to-Consumer Wellness Market with a Leading and Proven Brand. Hiya currently holds a leading position in children’s Vitamins, Minerals & Supplements brand sales in the United Statesⁱ and has a clear pathway and strong growth strategy to become the #1 children’s wellness platform through new product introductions, channel expansion, and geographic expansion.Hiya’s commitment to being the most trusted and preferred brand for wellness products in the 0-18 age range is an additive category for the Company and is complimentary to USANA’s vision of the healthiest family on Earth.
  • Expands the Company’s United States Operations. The transaction meaningfully expands and diversifies the Company’s revenue mix as Hiya’s net sales are generated in the United States through their direct-to-consumer subscription model, with plans to enter other sales channels. This will allow USANA to reach a broader audience of health-conscious consumers to grow the enterprise’s overall customer base.

ⁱ Source: Nielsen

Transaction Highlights

  • The Company made an initial cash investment of approximately $205 million (subject to customary closing and post-closing purchase price adjustments) in exchange for a 78.8% ownership stake in Hiya.

  • Transaction structure includes a put/call feature that provides for USANA’s acquisition of the remaining rollover equity at a pre-negotiated valuation scale, which is based on Hiya’s financial performance.

  • The transaction was financed with $200 million cash on hand with the balance covered by the Company’s existing credit facility.

BofA Securities acted as exclusive financial advisor to the Company in connection with the transaction. Wilson Sonsini Goodrich & Rosati, P.C. served as the Company’s legal advisor. William Hood & Company, LLC acted as exclusive financial advisor to Hiya. Bodman PLC acted as Hiya’s legal advisor.

Conference Call

The Company will provide a supplemental presentation and discuss the transaction on a conference call on Monday, December 23, 2024 at 5:00 PM Eastern Time. The supplemental presentation and live audio webcast of the conference call will be available on the Company’s investor relations website at http://ir.usana.com.

Non-GAAP Financial Measures

This press release contains the non-GAAP financial measure LTM adjusted EBITDA of Hiya. Adjusted EBITDA is a Non-GAAP financial measure of earnings before interest, taxes, depreciation, and amortization that also excludes certain adjustments as indicated below in the reconciliation from net income.

The Company prepares its financial statements using U.S. generally accepted accounting principles (“GAAP”) and investors should not directly compare with or infer relationship from any of the Company’s operating results presented in accordance with GAAP to the LTM adjusted EBITDA of Hiya. We believe that this non-GAAP financial information of Hiya may be helpful to investors as an indication of future cash flow generation. Non-GAAP financial measures have limitations in their usefulness to investors because they have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles. In addition, other companies, including companies in our industry, may calculate similarly titled non-GAAP financial measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of non-GAAP financial information as a tool for comparison. As a result, the non-GAAP financial information of Hiya is presented for supplemental informational purposes only and should not be considered in isolation from, or as a substitute for financial information presented in accordance with GAAP.

The following is a reconciliation of net income, presented and reported in accordance with GAAP, to Adjusted EBITDA:

(Unaudited)

Last Twelve Months Ended ($000’s)

30-Sep-24
 

Net income

$

19,416

Definitional Adjustments:

Interest expense

 

143

Depreciation and amortization

 

38

Income tax expense

 

80

EBITDA before Adjustments

 

19,677

 

Adjustments to EBITDA:

Transaction expenses and other non-recurring items

 

760

Non-operational costs

 

566

Normalizations

 

321

Timing adjustments

 

212

Management compensation

 

142

Adjusted EBITDA

$

21,678

About USANA

USANA develops and manufactures high-quality nutritional supplements, functional foods and personal care products that are sold directly to Associates and Preferred Customers throughout the United States, Canada, Australia, New Zealand, Hong Kong, China, Japan, Taiwan, South Korea, Singapore, Mexico, Malaysia, the Philippines, the Netherlands, the United Kingdom, Thailand, France, Belgium, Colombia, Indonesia, Germany, Spain, Romania, Italy, and India. More information on USANA can be found at www.usana.com.

About Hiya

Hiya is the leading children’s health brand, re-imagining kids’ wellness with an inspired range of clean-label products. Offering a delicious and high-quality line of powders and chewables, Hiya is at the forefront of wellness with a focused assortment of better-for-you products. Since its founding in 2020, Hiya has established itself as a trusted name in the industry and is loved by both parents and children with adherence to the highest clean nutrition standards, ingredient transparency, and commitment to continuous improvement through ongoing collaborations with experts. More information on Hiya can be found at www.hiyahealth.com.

Safe Harbor

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, including but not limited to statements that: Hiya is fast growing; the Hiya acquisition will be accretive to USANA’s 2025 adjusted EBITDA, experience net sales growth approaching 30% year-over-year in fiscal 2025, allow USANA to reach a broader audience, generate long-term growth, deliver value for USANA stakeholders, scale the Hiya brand, bring better health to children across the country and the world, enhance USANA’s geographic sales mix and income tax efficiency in the near and long-term, take advantage of synergies, create efficiencies, accelerate growth and profitability, expand and diversify USANA’s revenue mix, grow overall customer base, and strengthen USANA’s overall financial profile; Mr. Litt and Mr. Gillman will continue to lead Hiya through its next phase of growth; Hiya will have a clear pathway and growth strategy to become the #1 children’s wellness platform through new product introductions, channel expansion, and geographic expansion; and other forward-looking statements. These forward-looking statements are based on current plans, expectations, estimates, forecasts, and projections as well as the beliefs and assumptions of management. Words such as “expect,” “vision,” “envision,” “evolving,” “drive,” “anticipate,” “intend,” “maintain,” “should,” “believe,” “continue,” “plan,” “goal,” “opportunity,” “estimate,” “predict,” “may,” “will,” “could,” and “would,” and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Our actual results could differ materially from those projected in these forward-looking statements, which involve a number of risks and uncertainties, many of which involve factors or circumstances that are beyond our control, including: risks that the acquisition disrupts each company’s current plans and operations; the diversion of the attention of the management teams of USANA and Hiya from ongoing business operations; the ability of to retain key personnel of Hiya; the ability to realize the benefits of the acquisition, including efficiencies and cost synergies; the ability to successfully integrate Hiya’s business with USANA’s business, at all or in a timely manner; the amount of the costs, fees, expenses and charges related to the acquisition; global economic conditions generally, including continued inflationary pressure around the world and negative impact on our operating costs, consumer demand and consumer behavior in general; reliance upon our network of independent Associates; risk that our Associate compensation plan, or changes that we make to the compensation plan, will not produce desired results, benefit our business or, in some cases, could harm our business; risk associated with governmental regulation of our products, manufacturing and direct selling business model in the United States, China and other key markets; potential negative effects of deteriorating foreign and/or trade relations between or among the United States, China and other key markets; potential negative effects from geopolitical relations and conflicts around the world, including the Russia-Ukraine conflict and the conflict in Israel; compliance with data privacy and security laws and regulations in our markets around the world; potential negative effects of material breaches of our information technology systems to the extent we experience a material breach; material failures of our information technology systems; adverse publicity risks globally; risks associated with commencing operations in India and future international expansion and operations; uncertainty relating to the fluctuation in U.S. and other international currencies; and the potential for a resurgence of COVID-19, or another pandemic, in any of our markets in the future and any related impact on consumer health, domestic and world economies, including any negative impact on discretionary spending, consumer demand, and consumer behavior in general. The contents of this release should be considered in conjunction with the risk factors, warnings, and cautionary statements that are contained in our most recent filings with the Securities and Exchange Commission. The forward-looking statements in this press release set forth our beliefs as of the date hereof. We do not undertake any obligation to update any forward-looking statement after the date hereof or to conform such statements to actual results or changes in the Company’s expectations, except as required by law.

Investor contact:

Andrew Masuda

Investor Relations

(801) 954-7201

[email protected]

Media contact:

Sarah Searle

(801) 954-7626

[email protected]

KEYWORDS: Utah United States North America

INDUSTRY KEYWORDS: Vitamins/Supplements Health Fitness & Nutrition

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Carlisle Companies to Acquire ThermaFoam, a Texas-Based Manufacturer of Expanded Polystyrene Insulation Products

Carlisle Companies to Acquire ThermaFoam, a Texas-Based Manufacturer of Expanded Polystyrene Insulation Products

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Carlisle Companies Incorporated (NYSE:CSL) today announced that it has entered into a definitive agreement to acquire Texas-based expanded polystyrene insulation manufacturer ThermaFoam. Founded in 1978 and located in the Dallas/Fort Worth area, ThermaFoam serves the commercial, residential, and infrastructure construction markets through both the ThermaFoam and PowerFoam brands.

The purchase of ThermaFoam is consistent with Carlisle’s Vision 2030 strategy and strategic pivot to a pure play building products company with increased investment in innovation and synergistic M&A.

Chris Koch, Chair, President, and Chief Executive Officer, said, “The acquisition of ThermaFoam builds on our recently completed acquisition of Plasti-Fab, and leverages the vertically integrated expanded polystyrene capabilities of our EPS business while adding scale, supporting retail channel growth, and providing valuable geographic coverage in Texas and the South Central United States.”

The acquisition is expected to close in the first quarter of 2025.

Forward-Looking Statements

This press release contains forward-looking statements, including those with respect to the acquisition of ThermaFoam and the anticipated timing of the closing of the transaction. These statements represent only Carlisle’s current belief regarding future events, many of which, by their nature, are inherently uncertain and outside of Carlisle’s control. Actual results could differ materially from those reflected in this press release for various reasons, including the failure of the parties to meet or waive closing conditions. Carlisle disclaims any obligation to update forward-looking statements except as required by law.

About Carlisle Companies Incorporated

Carlisle Companies Incorporated is a leading supplier of innovative building envelope products and solutions for more energy efficient buildings. Through its building products businesses – Carlisle Construction Materials (“CCM”) and Carlisle Weatherproofing Technologies (“CWT”) – and family of leading brands, Carlisle delivers innovative, labor-reducing and environmentally responsible products and solutions to customers through the Carlisle Experience. Carlisle is committed to generating superior shareholder returns and maintaining a balanced capital deployment approach, including investments in our businesses, strategic acquisitions, share repurchases and continued dividend increases. Leveraging its culture of continuous improvement as embodied in the Carlisle Operating System (“COS”), Carlisle has committed to achieving net-zero greenhouse gas emissions by 2050. Learn more about Carlisle at www.carlisle.com.

Mehul Patel

Vice President, Investor Relations

Carlisle Companies Incorporated

(310) 592-9668

[email protected]

KEYWORDS: Texas Arizona United States North America

INDUSTRY KEYWORDS: Commercial Building & Real Estate Construction & Property Other Manufacturing Building Systems Chemicals/Plastics Other Construction & Property Manufacturing Residential Building & Real Estate

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OFG Bancorp to Report 4Q24 Results and Hold Call Wednesday, January 22, 2025

OFG Bancorp to Report 4Q24 Results and Hold Call Wednesday, January 22, 2025

SAN JUAN, Puerto Rico–(BUSINESS WIRE)–
OFG Bancorp (NYSE: OFG) will report fourth quarter 2024 financial results on Wednesday, January 22, 2025, before the market opens and hold its conference call that morning at 10:00 AM ET.

  • Participant Toll-Free Phone Number: (800) 225-9448

  • Participant International Phone Number: (203) 518-9708

  • Conference ID: OFGQ424

The call can also be accessed live on OFG’s website at www.ofgbancorp.com. Webcast replay will be available shortly thereafter. Visit the webcast link in advance to pre-register or download any necessary software.

About OFG Bancorp

Now in its 60th year in business, OFG Bancorp is a diversified financial holding company that operates under U.S., Puerto Rico and U.S. Virgin Islands banking laws and regulations. Its three principal subsidiaries, Oriental Bank, Oriental Financial Services and Oriental Insurance, provide a wide range of retail and commercial banking, lending and wealth management products, services, and technology, primarily in Puerto Rico and U.S. Virgin Islands. Our mission is to make progress possible for our customers, employees, shareholders, and the communities we serve. Visit us at www.ofgbancorp.com.

Puerto Rico & USVI: Lumarie Vega López ([email protected]) and Victoria Maldonado Rodríguez ([email protected]) at (787) 771-6800

US: Gary Fishman ([email protected]) and Steven Anreder ([email protected]) at (212) 532-3232

KEYWORDS: New York Latin America North America United States Puerto Rico Caribbean

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Allied Gaming & Entertainment Announces Postponement of its 2024 Annual Meeting of Stockholders

Allied Gaming & Entertainment Announces Postponement of its 2024 Annual Meeting of Stockholders

NEW YORK–(BUSINESS WIRE)–
Allied Gaming & Entertainment, Inc. (NASDAQ: AGAE) (the “Company” or “AGAE”), a global experiential entertainment company, announced today the postponement of its 2024 Annual Meeting of Stockholders (“Annual Meeting”), originally scheduled for December 30, 2024, due to the previously disclosed lawsuit filed by Knighted Pastures LLC (“Knighted”) against the Company which prevents the Annual Meeting from being held prior to its conclusion. The Company believes that the lawsuit is yet another attempt by Knighted and its Managing Partner, Roy Choi, to pursue their scheme to gain control of the Company at a discounted price below the Company’s cash value to further their own short-term interests, while destroying long-term value for all stockholders of AGAE.

As a result of this pending lawsuit and in accordance with the litigation schedule order, the Company must reschedule its previously scheduled Annual Meeting, along with all related deadlines, until after the lawsuit is resolved. The Company currently is unable to determine the exact date of the Annual Meeting. The Company will provide an update to stockholders as soon as it is able to set the Annual Meeting date.

About Allied Gaming & Entertainment

Allied Gaming & Entertainment Inc. (Nasdaq: AGAE) is a global experiential entertainment company focused on providing a growing world of gamers and concertgoers with unique experiences through renowned assets, products and services. For more information, visit alliedgaming.gg.

Forward Looking Statements

This communication contains certain forward-looking statements under federal securities laws. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of such terms, or other comparable terminology. These statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results to be materially different from those contemplated by the forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside our control, that could cause actual results or outcomes to differ materially from those discussed in these forward-looking statements. The inclusion of such information should not be regarded as a representation by the Company, or any person, that the objectives of the Company will be achieved.

Investor Contact:

Addo Investor Relations

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Entertainment eSports Sports General Entertainment Events/Concerts Electronic Games

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Comtech Provides Update on Quarterly Filing Process

Comtech Provides Update on Quarterly Filing Process

Announces Notification of Delinquency from Nasdaq for Late Filing of Form 10-Q for Period Ended October 31, 2024

CHANDLER, Ariz.–(BUSINESS WIRE)–
December 23, 2024–Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global technology leader, received a letter (the “Letter”) from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that it is not in compliance with periodic requirements for continued listing set forth in Nasdaq Listing Rule 5250(c)(1) (the “Listing Rule”) because the Company’s Quarterly Report on Form 10-Q for the period ended October 31, 2024 (the “Report”) was not filed with the Securities and Exchange Commission (the “SEC”) by the required extended due date of December 16, 2024. This Letter received from Nasdaq has no immediate effect on the listing or trading of the Company’s shares.

The Letter states that the Company has 60 calendar days, or by February 17, 2025, to submit to Nasdaq its plan to regain compliance with the Listing Rule. Pursuant to the Letter, if Nasdaq accepts the plan, Nasdaq can grant an exception of up to 180 calendar days from the Report’s due date, or until June 16, 2025, to regain compliance. If Nasdaq does not accept the plan, the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel.

The Company is diligently working to complete its Report, and the Company expects to complete and file its Report with the SEC to regain compliance with the Listing Rule prior to the expiration of the 60-day period.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing satellite and space communications technologies, terrestrial and wireless network solutions, NG911 emergency services and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages its global presence, technology leadership and decades of experience to create the world’s most innovative communications solutions. For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains, and oral statements made from time to time by our representatives may contain, forward-looking statements. Forward-looking statements include, among others, statements regarding our expectations regarding our response to the Letter, our expectations for our operational initiatives, future performance and financial condition, the plans and objectives of our management and our assumptions regarding such future performance, financial condition, and plans and objectives that involve certain significant known and unknown risks and uncertainties and other factors not under our control which may cause our actual results, future performance and financial condition to be materially different from the results, performance or other expectations implied by these forward-looking statements. Factors that could cause actual results to differ materially from current expectations are described in our filings with the SEC. We urge you to consider all of the risks, uncertainties and factors identified above or discussed in such reports carefully in evaluating the forward-looking statements. The risks described above are not the only risks that we face. We do not intend to update or revise publicly any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.

Investor Relations Contact

Maria Ceriello

631-962-7102

[email protected]

Media Contacts

Jamie Clegg

480-532-2523

[email protected]

KEYWORDS: Arizona United States North America

INDUSTRY KEYWORDS: Telecommunications Satellite Networks Internet Audio/Video Technology Mobile/Wireless Security

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Palladyne AI Achieves Key Milestone with First Small Drone Autonomous Tracking Flight

Palladyne AI Achieves Key Milestone with First Small Drone Autonomous Tracking Flight

Palladyne Pilot AI Software Platform Enables Third-Party Drone to Identify, Prioritize, and Autonomously Track Terrestrial Targets

SALT LAKE CITY–(BUSINESS WIRE)–Palladyne AI Corp. (NASDAQ: PDYN and PDYNW) (“Palladyne AI”), a developer of artificial intelligence software for robotic and unmanned platforms in the industrial and defense sectors, today announced that its Palladyne™️ Pilot AI software platform has achieved a key developmental milestone with the successful first flight of a third-party small drone that demonstrated the ability to identify and prioritize terrestrial targets of interest and then interface with the drone’s autopilot software to follow the prioritized target autonomously.

Palladyne AI had previously successfully demonstrated the Palladyne Pilot AI platform’s ability to identify and prioritize targets on stationary nodes and with hovering drones. Last week’s test flight was the first to successfully integrate with third-party autopilot software to autonomously control the drone’s navigation while identifying, prioritizing, tracking, and following the desired target.

“Our first autonomous flight with Palladyne Pilot was able to track and follow a target, successfully demonstrating how powerful our AI platform can be by automating those functions where algorithms and machines excel, while still leaving ultimate control in the hands of humans,” said Dr. Denis Garagic, co-founder and CTO, Palladyne AI. “Once we complete commercialization of Palladyne Pilot — which we expect to happen by the end of the first quarter of 2025 — small, economical drones will finally offer some of the same intelligence capabilities that larger, multi-million-dollar unmanned systems have had for years.”

About Palladyne Pilot

The Palladyne Pilot AI Software Platform for UAVs transforms unmanned, tactical systems into highly efficient, autonomous force multipliers capable of persistent target tracking, dynamic collaboration, and enhanced situational awareness. With advanced perception, learning, and autonomous capabilities designed to reduce operational burden while dramatically improving mission effectiveness for military and defense operations, Palladyne Pilot stands ready to support and deliver mission effectiveness and success.

The development and continued advancement of Palladyne Pilot is the result of multiple contracts with the U.S. Air Force. From inception, Pilot was designed to be a collaborative sensing platform for small drone platforms and is one of the pillars, along with Palladyne IQ, of Palladyne AI’s technology offerings.

About Palladyne AI Corp.

Palladyne AI Corp. (NASDAQ: PDYN) has developed an advanced artificial intelligence (AI) and machine learning (ML) software platform poised to revolutionize the capabilities of robots, enabling them to observe, learn, reason, and act in a manner akin to human intelligence. Our AI and ML software platform empowers robots to perceive variations or changes in the real-world environment, enabling them to autonomously maneuver and manipulate objects accurately in response.

The Palladyne AI software solution operates on the edge and dramatically reduces the significant effort required to program and deploy robots enabling industrial robots and collaborative robots (cobots) to quickly achieve autonomous capabilities even in dynamic and or complex environments. Designed to achieve precise results with minimal training time, limited data sets, and lower power requirements, compared to current solutions, Palladyne AI believes its software has wide application, including in industries such as automotive, aviation, construction, defense, general manufacturing, infrastructure inspection, logistics and warehousing. Its applicability extends beyond traditional robotics to include Unmanned Aerial Vehicles (UAVs), Unmanned Ground Vehicles (UGVs), and Remotely Operated Vehicles (ROVs). Palladyne AI’s approach is expected to elevate the return on investment associated with a diverse range of machines that are fixed, fly, float, or roll.

By enabling autonomy, reducing programming complexity, and enhancing efficiency, we are paving the way for a future where machines can excel in tasks that were once considered beyond their reach.

For more information, please visit www.palladyneai.com and connect with us on LinkedIn at www.linkedin.com/company/palladyneaicorp.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the future development and timing of commercialization of Palladyne Pilot, the capabilities or future capabilities of Palladyne AI’s software platform and products generally, the benefits of the software platform and products and the industries that could benefit from them, the impact of the software platform and products on robotics and the applicability of the software platform to different kinds of machines (such as UAVs, UGVs and ROVs and different available industrial robots). Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events, or results of operations, are forward-looking statements. These statements may be preceded by, followed by, or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates,” “intends” or “continue” or similar expressions. Such forward-looking statements involve risks and uncertainties that may cause actual events, results, or performance to differ materially from those indicated by such statements. These forward-looking statements are based on Palladyne AI’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events. However, there can be no assurance that the events, results, or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and Palladyne AI is not under any obligation and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Readers should carefully review the statements set forth in the reports which Palladyne AI has filed or will file from time to time with the Securities and Exchange Commission (the “SEC”), in particular the risks and uncertainties set forth in the sections of those reports entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements,” for a description of risks facing Palladyne AI and that could cause actual events, results or performance to differ from those indicated in the forward-looking statements contained herein. The documents filed by Palladyne AI with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

Palladyne AI Corp PR and Investor Contacts:

Press Contact:

[email protected]

Investor Contact:

[email protected]

KEYWORDS: Utah United States North America

INDUSTRY KEYWORDS: Software Defense Other Defense Military Artificial Intelligence Robotics Technology Drones

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Genasys Provides Calendar Year End Status Report

Genasys Provides Calendar Year End Status Report

Record Bookings & Strong Backlog

Genasys Systems and Solutions in All 50 States

SAN DIEGO–(BUSINESS WIRE)–Genasys Inc. (NASDAQ: GNSS), the global leader in Protective Communications, today provided a recap of the Company’s fiscal year 2024 (FY 2024) business developments that produced record bookings and strong backlog and discussed Genasys’ fiscal year 2025 (FY 2025) outlook.

Richard Danforth, Chief Executive Officer of Genasys Inc., said, “In FY 2024, we won a $75 million Puerto Rico dams project award and secured significant orders from Los Angeles County and the states of Oregon and New Hampshire. We also reported record domestic law enforcement orders and a substantial rebound in international LRAD business. These, and other FY 2024 business wins, resulted in $111 million in new bookings and a 12-month backlog of more than $40 million at the September fiscal year end.

“Our software business starts fiscal 2025 with an ARR of $8.3 million,” continued Mr. Danforth. “Since our early FY 2024 acquisition of Evertel Technologies and its subsequent rebranding, we have continued to grow Genasys CONNECT to surpass 250 clients with more than 31,000 active users. These agencies are using CONNECT to protect more than 50 million people in the U.S.”

Michael Smith, Senior Vice President of Genasys Protect, said, “Our Genasys Protect suite of ACOUSTICS, ALERT, CONNECT, and EVAC are proliferating in the U.S. and generating material pipeline and ARR growth. Of note, the recent use of EVAC by Los Angeles County first responders and emergency managers was instrumental in keeping people safe during the Franklin Fire that ravaged Malibu earlier this month.”

David Schnell, Vice President of Global Hardware Sales, added, ”Renewed LRAD demand from international naval customers and defense and law enforcement agencies in Africa, the Middle East, and our APAC region led to an 86% year-over-year increase in international hardware bookings in FY 2024. Both domestic and international hardware pipeline and bookings are growing at a steady pace as we enter calendar 2025.”

Mr. Danforth concluded, “Exiting calendar 2024 with record bookings and robust backlog, Genasys is incredibly well positioned. Genasys systems and solutions are now in use in all 50 states. We have received the $8.0 million deposit for the first group of dams in Puerto Rico, invoiced to receive the second deposit, and are aggressively moving to procure, build, and install the ACOUSTICS-based Early Warning System across all 37 dams for the PREPA project.

“I want to thank our entire Genasys team for their steadfast commitment to delivering and supporting world-class Protective Communications systems and solutions that provide proactive preparedness, data-driven decision making, secure, inter-agency collaboration, and multichannel communication that speed emergency responses and save lives.”

We include in this press release Non-GAAP operational metrics of backlog and bookings, which we believe provide helpful information to investors with respect to evaluating the Company’s performance. Bookings is an internal, operational metric that measures the total dollar value of customer purchase orders executed in a period, regardless of the timing of the related revenue recognition. Backlog is a measure of purchase orders received that are planned to ship within the next 12 months.

About Genasys Inc.

Genasys Inc. (NASDAQ: GNSS) is the global leader in Protective Communications. Incorporating the most comprehensive portfolio of preparedness, response, and analytics software and systems, as well as the Company’s Long Range Acoustic Devices (LRAD®), the Genasys Protect platform is designed around one premise: ensuring organizations and public safety agencies are “Ready when it matters™.” Protecting people and saving lives for over 40 years, Genasys covers more than 155 million people in all 50 states and in over 100 countries worldwide. For more information, visit genasys.com.

Forward-Looking Statements

Except for historical information contained herein, the matters discussed are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance on these statements. We base these statements on particular assumptions that we have made in light of our industry experience, the stage of product and market development as well as our perception of historical trends, current market conditions, current economic data, expected future developments and other factors that we believe are appropriate under the circumstances. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those suggested in any forward-looking statement. The risks and uncertainties in these forward-looking statements include without limitation the business impact of geopolitical conflicts and other causes that may affect our supply chain, and other risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. Risks and uncertainties are identified and discussed in our filings with the Securities and Exchange Commission. These forward-looking statements are based on information and management’s expectations as of the date hereof. Future results may differ materially from our current expectations. For more information regarding other potential risks and uncertainties, see the “Risk Factors” section of the Company’s Form 10-K for the fiscal year ended September 30, 2024. Genasys Inc. disclaims any intent or obligation to publicly update or revise forward-looking statements, except as otherwise specifically stated.

Investor Relations Contact

Brian Alger, CFA

SVP, IR and Corporate Development

[email protected]

(858) 676-0582

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Technology Data Analytics Professional Services

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Graco Publishes Latest Environmental, Social and Governance Report

Graco Publishes Latest Environmental, Social and Governance Report

MINNEAPOLIS–(BUSINESS WIRE)–
Graco Inc. (NYSE:GGG), a leading manufacturer of fluid handling equipment, released today its third environmental, social and governance (ESG) report. The report underscores Graco’s commitment to transparency, accountability and continuous progress in product innovation, operational practices, workplace culture and community impact.

The report highlights information about Graco’s introduction of an increasing number of electrically powered products. In addition, the company continues to support electric vehicle (EV) battery manufacturing, as well as work on precision dispense to decrease waste and reduce the release of volatile organic compounds (VOCs) into the environment.

The full 2023 ESG report is available on the company’s website at www.graco.com.

ABOUT GRACO

Graco Inc. supplies technology and expertise for the management of fluids and coatings in both industrial and commercial applications. It designs, manufactures and markets systems and equipment to move, measure, control, dispense and spray fluid and powder materials. A recognized leader in its specialties, Minneapolis-based Graco serves customers around the world in the manufacturing, processing, construction, and maintenance industries. For additional information about Graco Inc., please visit us at www.graco.com.

Investors: David M. Lowe, 612-623-6456

Media: Sadie O. Moen, 612-623-6545

[email protected]

KEYWORDS: Minnesota United States North America

INDUSTRY KEYWORDS: EV/Electric Vehicles Machinery Professional Services Machine Tools, Metalworking & Metallurgy Automotive Other Manufacturing Environment Green Technology Engineering Chemicals/Plastics Climate Change Environmental, Social and Governance (ESG) Manufacturing

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ICE First Look at Mortgage Performance: Delinquencies Hit Highest Level in Nearly Three Years; Prepayments Drop on Higher Rates

ICE First Look at Mortgage Performance: Delinquencies Hit Highest Level in Nearly Three Years; Prepayments Drop on Higher Rates

  • The national delinquency rate jumped 29 basis points (bps) in November to 3.74%, its highest level in almost three years, marking six consecutive months of year-over-year increases

  • While much of November’s spike was driven by seasonality, post-hurricane distress, and a late-in-the-month Thanksgiving, delinquencies more broadly continue to rise from recent year lows

  • Early-, mid- and late-stage defaults all rose in November, with seriously delinquent loans – 90 or more days past due but not in active foreclosure – now at the highest level since February 2023

  • Both foreclosure starts and completions dropped in November and remain well below pre-pandemic levels, leaving 31K fewer loans in active foreclosure than at the same time last year

  • Prepayment activity fell -25.0% month over month on October’s higher interest rates, and remains nearly 30% off last year’s levels

ATLANTA & NEW YORK–(BUSINESS WIRE)–
Intercontinental Exchange, Inc. (NYSE:ICE), a leading global provider of technology and data, reports the following “first look” at November 2024 month-end mortgage performance statistics derived from its loan-level database representing the majority of the national mortgage market.

Data as of Nov. 30, 2024

Total U.S. loan delinquency rate (loans 30 or more days past due, but not in foreclosure): 3.74%

Month-over-month change: 8.38%

Year-over-year change: 10.46%

Total U.S. foreclosure pre-sale inventory rate: 0.34%

Month-over-month change: -2.09%

Year-over-year change: -15.96%

Total U.S. foreclosure starts: 21,000

Month-over-month change -29.15%

Year-over-year change: -29.22%

Monthly prepayment rate (SMM): 0.63%

Month-over-month change: -25.02%

Year-over-year change: 71.20%

Foreclosure sales: 5,300

Month-over-month change: -8.43%

Year-over-year change: -17.65%

Number of properties that are 30 or more days past due, but not in foreclosure: ​ 2,027,000

Month-over-month change: 159,000

Year-over-year change: 224,000

Number of properties that are 90 or more days past due, but not in foreclosure: 512,000

Month-over-month change: 32,000

Year-over-year change: 53,000

Number of properties in foreclosure pre-sale inventory: 185,000

Month-over-month change: -4,000

Year-over-year change: -31,000

Number of properties that are 30 or more days past due or in foreclosure: 2,213,000

Month-over-month change: 155,000

Year-over-year change: 192,000

Top 5 States by Non-Current* Percentage

Louisiana:

8.60

%

  

Mississippi:

8.48

%

  

Alabama:

6.23

%

  

Indiana:

5.68

%

  

Arkansas:

5.55

%

  

 

 

  

Bottom 5 States by Non-Current* Percentage

Washington:

2.16

%

  

Idaho:

2.19

%

  

Colorado:

2.21

%

  

Montana:

2.25

%

  

California:

2.30

%

  

 

  

Top 5 States by 90+ Days Delinquent Percentage

Mississippi:

2.30

%

  

Louisiana:

2.26

%

  

Alabama:

1.63

%

  

Arkansas:

1.42

%

  

Georgia:

1.35

%

  
 

Top 5 States by 12-Month Change in Non-Current* Percentage

Hawaii:

-9.59

%

  

New York:

-5.86

%

  

Massachusetts:

-2.24

%

  

Rhode Island:

-0.80

%

  

Pennsylvania:

0.05

%

  

 

  
Bottom 5 States by 12-Month Change in Non-Current* Percentage

Florida

28.13

%

  

North Carolina:

20.39

%

  

South Carolina:

17.59

%

  

Arizona:

15.65

%

  
Georgia:

12.76

 %  

*Non-current totals combine foreclosures and delinquencies as a percent of active loans in that state.

Notes:

1)

Totals are extrapolated based on ICE’s loan-level mortgage and property records databases.

2)

All whole numbers are rounded to the nearest thousand, except foreclosure starts and sales, which are rounded to the nearest hundred.

NOTE: Due to the holidays ICE Mortgage Monitor will not publish a report in January. Reports for previous months are available online at mortgagetech.ice.com/resources/data-reports. The next ICE Mortgage Monitor will publish February 3, 2025.

For more information about gaining access to ICE’s loan-level database, please send an email to [email protected].

About Intercontinental Exchange

Intercontinental Exchange, Inc. (NYSE: ICE) is a Fortune 500 company that designs, builds and operates digital networks that connect people to opportunity. We provide financial technology and data services across major asset classes helping our customers access mission-critical workflow tools that increase transparency and efficiency. ICE’s futures, equity, and options exchanges – including the New York Stock Exchange – and clearing houses help people invest, raise capital and manage risk. We offer some of the world’s largest markets to trade and clear energy and environmental products. Our fixed income, data services and execution capabilities provide information, analytics and platforms that help our customers streamline processes and capitalize on opportunities. At ICE Mortgage Technology, we are transforming U.S. housing finance, from initial consumer engagement through loan production, closing, registration and the long-term servicing relationship. Together, ICE transforms, streamlines and automates industries to connect our customers to opportunity.

Trademarks of ICE and/or its affiliates include Intercontinental Exchange, ICE, ICE block design, NYSE and New York Stock Exchange. Information regarding additional trademarks and intellectual property rights of Intercontinental Exchange, Inc. and/or its affiliates is located here. Key Information Documents for certain products covered by the EU Packaged Retail and Insurance-based Investment Products Regulation can be accessed on the relevant exchange website under the heading “Key Information Documents (KIDS).”

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 – Statements in this press release regarding ICE’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see ICE’s Securities and Exchange Commission (SEC) filings, including, but not limited to, the risk factors in ICE’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 8, 2024.

Category: Mortgage Technology

ICE-CORP

Source: Intercontinental Exchange

ICE Media Contact

Mitch Cohen

[email protected]

+1 704-890-8158

ICE Investor Contact:

Katia Gonzalez

[email protected]

+1 (678) 981-3882

KEYWORDS: New York Georgia United States North America

INDUSTRY KEYWORDS: Commercial Building & Real Estate Construction & Property Finance Asset Management Banking Professional Services REIT Residential Building & Real Estate

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Sixty Degrees Pharmaceuticals and Tufts Medical Center Announce Patent License Agreement to Advance Development of Tafenoquine for Babesiosis Treatment and Prevention

WASHINGTON, Dec. 23, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company, and Tufts Medical Center (“Tufts MC”), a leading academic medical center, today announced the signing of a Patent License Agreement to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.

Tafenoquine is not currently approved by the U.S. Food and Drug Administration (“FDA”) for the treatment and prevention of babesiosis.

The agreement follows initiation of collaboration between researchers from both organizations to study the activity of tafenoquine against babesiosis, a serious tick-borne disease caused by microscopic parasites that infect red blood cells. The study formed the basis of U.S. Provisional Patent Application No. 63/461,060, and related U.S. utility and PCT applications, granting the parties shared intellectual property rights to tafenoquine’s potential future use for babesiosis.

Key Highlights of the Agreement:

  • Joint Patent Ownership: 60 Degrees and Tufts MC will co-own patent applications related to tafenoquine for babesiosis, with the Company leading prosecution and maintenance activities worldwide.
  • Commercialization Rights: 60 Degrees holds exclusive global rights to commercialize tafenoquine for babesiosis, including sublicensing to third parties for product development and sales.
  • Research Collaboration: Tufts MC retains a royalty-free, global license for research purposes, further advancing innovation in this area.
  • Royalties and Revenue Sharing: Tufts MC will receive royalties on net sales of tafenoquine-based products labeled for babesiosis treatment or prevention.
  • Commitment to Development: 60 Degrees has committed to using commercially reasonable efforts to bring tafenoquine products to market (beyond ARAKODA) and to expanding access to innovative therapies for babesiosis.

“This agreement demonstrates the growing confidence Tufts Medical Center and 60 Degrees Pharmaceuticals have in tafenoquine’s potential as a next-generation therapeutic for babesiosis,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Inc., Geoff Dow, PhD. “Today, those whose disease has progressed past the initial stages of mild symptoms may have limited treatment options. We believe tafenoquine, if approved, has the potential to meet this growing unmet need. Tafenoquine also has the potential to become the first prophylaxis available for babesiosis.”

About Babesiosis and the Study of Tafenoquine for Patients Hospitalized with Babesiosis

Babesiosis is a steadily emerging, infectious disease that is caused by a microscopic parasite, Babesia, and is transmitted through the bite of the black-legged (deer) tick, the vector that also spreads Lyme disease. Babesiosis, an orphan disease, may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections each year may be coinfected with Babesia. Cases reported in the medical literature suggest that tafenoquine is a promising therapeutic for patients with relapsing babesiosis. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, are well documented.

60 Degrees Pharmaceuticals is the sponsor of a clinical trial evaluating the efficacy and safety of tafenoquine in treating severe babesiosis in humans. The trial is now enrolling and is being conducted at multiple sites in the U.S., including at Tufts Medical Center, Rhode Island Hospital, Yale University and Brigham and Women’s Hospital. The study is a randomized, double-blind, placebo-controlled trial that compares the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis and treated with standard-of-care. The two main study endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by an FDA-approved nucleic acid test. At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. The interim analysis will include both a test of significance, as well as size re-estimation to allow additional recruitment if required.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.

About ARAKODA
®
(tafenoquine)

Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA® (tafenoquine) Important Safety Information

ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.

Contraindications

ARAKODA® should not be administered to:

  • Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
  • Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
  • G6PD status is unknown;
  • Patients with a history of psychotic disorders or current psychotic symptoms; or
  • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.

To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA® is located here.

About 60 Degrees Pharmaceuticals, Inc.

60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non- malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
[email protected]
(484) 667-6330

Investor Contact:
Patrick Gaynes
[email protected]
(310) 989-5666