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Ground-breaking RedEdge-P Green camera to provide revolutionary accuracy for smart farming 

WICHITA, Kan., Aug. 12, 2025 (GLOBE NEWSWIRE) — AgEagle Aerial Systems Inc. (NYSE: UAVS), a leading provider of advanced drone and aerial imaging solutions, proudly announces the launch of the RedEdge-P^™ Green, a groundbreaking multispectral camera designed to revolutionize precision agriculture from planting to harvest.

The new RedEdge-P Green camera delivers high-quality data and modularity, enabling advanced deep learning capabilities in data-rich, cost-effective imaging. The RedEdge-P Green will provide agronomists and researchers with actionable, high-resolution data to optimize crop management and boost productivity.

“The RedEdge-P Green represents a leap forward in precision agriculture, providing unprecedented accuracy and precision in the emerging smart farming vertical,” said Bill Irby, CEO of AgEagle Aerial Systems. “The sensor provides high-resolution multispectral imaging with modular configurations, producing a large volume of detailed, high-resolution multispectral data. We are empowering agronomists and researchers to make data-driven decisions that enhance yields, reduce costs, and help conserve natural resources. This camera will set the new standard in agricultural imaging.”

Key benefits of the new RedEdge-P Green sensor apply to multiple industries:

• Farming: Achieve higher yields through quicker interventions both early on and late in the crop cycle. Operators can reduce fertilizer and irrigation inputs and engage in smart harvesting techniques using optimized indices and targeted indices like the Plant Senescence Reflectance Index (PSRI).
• Researchers: Access a robust toolset of narrow spectral bands for advanced studies and machine learning applications, driving innovation in crop health and environmental monitoring.
• Environmental management: Gain deeper insights into biome health and invasive species across all seasons, in diverse biomes and at varying latitudes.

The unique spectral bands of the RedEdge-P Green offer insights into chlorophyll, carotenoids, and flavonoid content, providing a richer set of data and enhancing tracking capabilities during critical harvest periods. Users can improve yield, taste, and storage life through smarter harvesting decisions.

Available as a standalone camera or in paired configurations with the original RedEdge-P and the RedEdge-P Blue, this flexible family of sensors addresses a wide range of market needs. Users can leverage up to 15 noise-resistant, data-rich spectral bands essential for large-area precision agriculture.

The RedEdge-P Green camera is NDAA-compliant and integrates seamlessly with multiple drone platforms. Each camera kit includes a Calibrated Reflectance Panel (CRP) and a Downwelling Light Sensor (DLS2) for radiometric calibration, ensuring reliable data under varying light conditions to support time-series analysis.

Initial production of the RedEdge-P Green camera has started, and the first units are expected to ship this week. For more information about the RedEdge-P Green and AgEagle’s full suite of UAS solutions, or to schedule a demo, visit www.ageagle.com or contact the AgEagle Media Relations team.

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About AgEagle Aerial Systems Inc.

Through its three Centers of Excellence, AgEagle is actively engaged in designing and delivering best-in-class flight hardware, sensors and software that solve important problems for its customers. Founded in 2010, AgEagle was originally formed to pioneer proprietary, professional-grade, fixed-winged drones and aerial imagery-based data collection and analytics solutions for the agriculture industry. Today, AgEagle is a leading provider of full stack UAS, sensors and software solutions for customers worldwide in the energy, construction, agriculture, and government verticals. For additional information, please visit our website at www.ageagle.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on AgEagle’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the timing and fulfilment of current and future purchase orders relating to AgEagle’s products, the success of new programs and software updates, the ability to implement a new strategic plan and the success of a new strategic plan. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of AgEagle in general, see the risk disclosures in the Annual Report on Form 10-K of AgEagle for the year ended December 31, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by AgEagle. All such forward-looking statements speak only as of the date they are made, and AgEagle undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise.

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Media Contact

Andy Woodward
+1 (469) 451-2344
[email protected]
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Investor Relations

Email: [email protected]

They are achieving efficiencies by pinpointing resources where needed, increasing their sugarcane yields while simultaneously maintaining soil health and conserving natural resources for a sustainable future.

ROCKAWAY, N.J., Aug. 12, 2025 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that Kelly Benning has been hired as the Senior Vice President of Truvaga, effective July 21, 2025.

Ms. Benning, who brings almost three decades of leadership experience across digital health, AI-enabled technologies, and consumer wellness, will lead electroCore’s consumer wellness division.

Kelly Benning, electroCore’s Senior Vice President of Truvaga

“As an ever-increasing number of people are beginning to be more aware of the link between their lifestyle choices and well-being, wellness has evolved from a niche trend to a fundamental part of the daily lives of many, shifting the focus of the wellness market to a more personalized, consumer-centric dynamic,” said Ms. Benning. “It’s important that we meet the demand for consumer-led, lifestyle-based solutions by continuing to innovate and refine our technology, and empowering people to confidently take control of their own well-being. My focus will be on emphasizing electroCore’s commitment to research-based, trustworthy health solutions. I plan to use strategic partnerships to provide more accessibility to those looking to purchase our consumer devices. We’re not just growing a brand; we’re building a movement centered around approachable, personal, and science-backed wellness solutions.”

Ms. Benning has successfully brought pioneering digital health products to market, including the first and only FDA-cleared watch to monitor blood pressure, delivering breakthrough solutions and expertly navigating the commercialization process. Her interest in AI and machine-learning has led her to drive continual innovation and consistent market adoption of technology at the intersection of healthcare, data, and consumer experience.

Throughout her career, Ms. Benning has worked with a multitude of consumer retailers, payors, providers, and healthcare enterprises to bring clinically impactful and commercially successful products to market. She currently serves as Senior Vice President of Truvaga, electroCore’s digital wellness platform, where she leads strategy, operations, and growth. Prior to joining electroCore, Ms. Benning held executive leadership roles including President at LiveMetric, Vice President of Sales at IBM Watson Health, and senior roles at CipherHealth, Savonix, Healthgrades, and National Jewish Health. Ms. Benning holds a Bachelor of Arts in Kinesiology and Exercise Science from the University of Colorado Boulder.

“Bringing a proven and accomplished executive like Kelly to electroCore is the first of several benefits from our accelerating investment to support electroCore’s growth,” commented Dan Goldberger, CEO of electroCore. “I am confident that Kelly has the right skills to expand our direct-to-consumer strategy.”

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company’s two leading prescription products, gammaCore non-invasive vagus nerve stimulation (nVNS) and Quell neurostimulator, treat chronic pain syndromes through non-invasive neuromodulation technology. Additionally, the Company commercializes its Truvaga™ products, handheld, and personal use nVNS products utilizing bioelectronic technologies, to promote general wellness and human performance.

For more information, visit www.electrocore.com.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about the anticipated contributions of a newly appointed executive, the Company’s future business strategies, growth opportunities, prospects, product development, and market expansion, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” and other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to use strategic partnerships to provide more accessibility to those looking to purchase our consumer devices, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize its products, electroCore’s results of operations and financial performance, inflation and currency fluctuations, and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall economic and market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Contact

ECOR Investor Relations
(973) 302-9253
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bd0a2b17-cb17-4c9c-bbed-22f1bca42304

COLUMBUS, Ohio, Aug. 12, 2025 (GLOBE NEWSWIRE) — Core Molding Technologies, Inc. (NYSE American: CMT) (“Core Molding,” “Core” or the “Company”), a leading engineered materials company specializing in molded structural products, principally in building products, industrial and utilities, medium and heavy-duty truck and powersports industries across the United States, Canada and Mexico today announced that management will participate in the 16^th Annual Midwest IDEAS Investor Conference at The InterContinental Chicago Magnificent Mile in Chicago on August 26, 2025.

The Company will host one-on-one investor meetings throughout the day, with their presentation scheduled for 2:45-3:20 PM CT on August 26^th. Dave Duvall, Chief Executive Officer, Alex Panda, Chief Financial Officer, and Eric Palomaki, Chief Operations Officer, will be attending the conference on behalf of Core Molding Technologies, Inc. The presentation will be webcast live and can be accessed through the investor relations section of Core Molding Technologies at https://coremt.com/investor-relations/events-presentations. A replay will be available shortly after the presentation has concluded. To schedule a one-on-one meeting, please contact the Three Part Advisors conference team at (817) 769-2373 or [email protected]

About Core Molding Technologies, Inc.

Core Molding Technologies is a leading engineered materials company specializing in molded structural products, principally in building products, utilities, transportation and powersports industries across North America. The Company operates in one operating segment as a molder of thermoplastic and thermoset structural products. The Company’s operating segment consists of one reporting unit, Core Molding Technologies. The Company offers customers a wide range of manufacturing processes to fit various program volume and investment requirements. These processes include compression molding of sheet molding compound (“SMC”), resin transfer molding (“RTM”), liquid molding of dicyclopentadiene (“DCPD”), spray-up and hand-lay-up, direct long-fiber thermoplastics (“DLFT”) and structural foam and structural web injection molding (“SIM”). Core Molding Technologies serves a wide variety of markets, including the medium and heavy-duty truck, marine, automotive, agriculture, construction, and other commercial products. The demand for Core Molding Technologies’ products is affected by economic conditions in the United States, Mexico, and Canada. Core Molding Technologies’ operations may change proportionately more than revenues from operations.

Company Contact:

Core Molding Technologies, Inc.
Alex Panda
Executive Vice President & Chief Financial Officer
[email protected]

Investor Relations Contact:

Three Part Advisors, LLC
Sandy Martin or Steven Hooser
214-616-2207

FT. LAUDERDALE, Fla., Aug. 12, 2025 (GLOBE NEWSWIRE) — OptimumBank Holdings, Inc. (NYSE American: OPHC), today clarified statements made during its second quarter 2025 earnings webcast on August 7, 2025.

During the question-and-answer session, a member of the audience inquired about the company’s projected total assets at the end of 2026. In their response, both Chairman of the Board Moishe Gubin and Chief Executive Officer Tim Terry mistakenly provided the company’s projection for the end of 2025.

OptimumBank is on track to continue its strong annual growth trajectory, which has consistently been in the range of 25% to 30% per year. With current total assets nearing the $1 billion milestone, the Company reiterates its strategic plan to exceed the $1.2 billion asset mark by the end of 2025. Building on this momentum and sustained annual growth of 25% to 30%, the Company projects total assets will reach between $1.5 billion and $1.6 billion by the end of 2026.

“We want to clear up any confusion caused during the call,” said Moishe Gubin, Chairman of the Board. “Our primary focus is sustaining annual growth of 25% to 30%, which remains the driver behind our projections. That growth rate supports our goal of surpassing $1.2 billion in total assets by the end of 2025 and reaching $1.5 billion to $1.6 billion by the close of 2026. More importantly, that pace of growth reflects the ambition and momentum we intend to carry forward for years to come.”

You may contact Seth Denison at [email protected] for more information.

About OptimumBank Holdings, Inc.

OptimumBank was founded in 2000 in Ft. Lauderdale, Florida. The bank focuses on traditional in-person banking with businesses and consumers residing in South Florida. Our customers found a bank that isn’t charging the exorbitant fees they were experiencing at the larger financial institutions, a bank having unmatched expertise in real estate and commercial lending. OptimumBank has seen explosive growth this decade, and we look to capitalize on our momentum in the coming months and years ahead. The Company is traded on the NYSE American under the symbol “OPHC”.

OptimumBank’s business and financial solutions include: Business Banking, Business Lending, SBA Lending Solutions, Treasury Management, and Personal Banking.

Note Regarding Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the rules and regulations of the Private Securities Litigation and Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. These statements are not guarantees of future results or occurrences and are subject to change, possibly materially. See “Note Regarding Forward-Looking Statements” and the sections entitled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission which are available on OptimumBank’s website (
Investor Relations – OptimumBank
) and on the Securities and Exchange Commission’s website (
www.sec.gov
). Any forward-looking statements made by or on behalf of OptimumBank speak only as to the date they are made, and OptimumBank does not undertake to update forward-looking statements to reflect the impact of circumstances or events that arise after the date the forward-looking statements were made.

SOURCE: OptimumBank Holdings, Inc.

Investor Relations & Corporate Relations
Contact: Seth Denison
Telephone: (305) 401-4140 / [email protected]

Appendix A: Q2 2025 Earnings Call Transcript

OptimumBank Holdings, Inc. (Q2 Earnings Call)
August 7, 2025

Corporate Speakers

• Seth Denison; OptimumBank Holdings Inc.; Managing Director of Investor Relations
• Moishe Gubin; OptimumBank Holdings Inc.; Chairman of the Board
• Elliot Nunez; OptimumBank Holdings Inc.; Chief Financial Officer
• Tim Terry; OptimumBank Holdings Inc.; Chief Executive Officer

PRESENTATION

Operator: Ladies and gentlemen, thank you for joining us and welcome to the OptimumBank Holdings Inc.’s Second Quarter 2025 Earnings Webcast. After today’s prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please raise your hand. If you have dialed into today’s call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Seth Denison, Managing Director of Investor Relations. Please go ahead.

Seth Denison: Good morning everybody. My name is Seth Denison. I’m the Managing Director of Investor Relations for OptimumBank. And directly to my left of me is Tim Terry, the CEO of OptimumBank; Moishe Gubin, who’s the Chairman of the Board for OptimumBank; and Elliot Nunez, who is our Chief Financial Officer. I want to thank everybody for joining us today for OptimumBank Holdings’ second quarter 2025 earnings webcast. We’re excited to walk you through what has been another exceptional quarter of solid financial performance and meaningful strategic progress. Before we begin, participants should be aware that this call is being recorded and listeners are advised that any forward-looking statements made on today’s call are based on management’s current expectations, assumptions and beliefs about OptimumBank’s business and environment in which it operates. Let me note that this presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions that are subject to risks and uncertainties that may cause actual results to differ materially. We refer you to our filings with the SEC, including our most recent 10-Q, for more information. Additionally, references will be made during this call to non-GAAP financial results and investors are encouraged to review these non-GAAP financial measures as identified in the presentation deck. Let me now turn it over to Moishe to kick off today’s discussion.

Moishe Gubin: Thanks, Seth. Good morning, everyone. It’s a privilege to open today’s call by highlighting the strength of our results this quarter. In an environment with ongoing industry challenges, the OptimumBank team has once again demonstrated its ability to generate strong core earnings. This was achieved through our strategic focus on smart deposit pricing, disciplined growth in our consumer and multifamily loan portfolios, and a sharp eye on operational efficiency. Our company’s momentum is stronger than ever. For those who have been following our journey, you know this is part of a consistent pattern of profitable performance. We generated net earnings of $3.6 million for the quarter, and while slightly lower than our first quarter, it represents a continued demonstration of our strategic execution. We believe our assets now at $999.13 million have us on the verge of crossing the $1 billion milestone and we are prepared for the new responsibilities and opportunities that will bring. This significant growth equates to a compound annual growth rate of 34.74% since 2021 and reflects our strategic initiatives, positioning us for even greater opportunities and responsibilities in the future. We are confident in our ability to manage this growth effectively. We believe this momentum is a direct result of our focused approach and deep understanding of the South Florida market, our ability to adapt to evolving economic conditions, coupled with our unwavering commitment to our clients who have been the cornerstone of our success. We’re not just growing, we’re growing strategically, ensuring that each step we take builds a more resilient and profitable institution. This means continuing to refine our lending practices, optimizing our deposit mix, and consistently evaluating operational efficiencies. The strength of our local relationships and our agile business model truly differentiates us, allowing us to capture opportunities and navigate challenges more effectively than many of our peers. This is a great time to be a part of OptimumBank. We have a clear vision, strong execution, and most importantly, a team that cares deeply about what we’re building. With that, let me hand it off to Elliot to take you through the financials in detail.

Elliot Nunez: Great. Thank you Moishe. And I want to thank everyone that’s joining us today on this call. The second quarter of 2025 was a quarter of a strategic repositioning and continued momentum and the numbers tell a very good story. Now, when we look at our net earnings for the second quarter, they reached $3.6 million compared to $3.8 million in the first quarter of 2025. And looking back, $3.5 million in the second quarter of 2024. This second quarter 2025 did have a credit loss of almost a million dollars as compared to reversal or provision of $165,000 in Q1. The second quarter provision is primarily due to one single specific reserve on a commercial loan. Now, when we look at the full year-to-date net earnings for the first six months of the year, they amounted to $7.4 million compared to $5.8 million a year ago. As we look at our earnings composition, starting with net interest income, it increased $816,000 to $10.2 million, up from $9.4 million in the prior quarter and it also increased $1.5 million from $8.7 million in the second quarter of 2024. The increase in net interest income was aided with the growth in our average loan portfolio combined with increasing loan yields and also in conjunction with deposit portfolio repricing with reductions. Our net interest margin expanded to 4.32% for the quarter and 4.19% for the year. On a quarter-over-quarter basis, we saw a 26 (technical difficulty) the repayment of all of our FHOB borrowings that we had as of December 2024. Our team is also growing alongside our assets. Our employee count has increased significantly from 38 in 2021 to 88 as of June 30, 2025. The expansion in our team supports our increasing operational scale past the $1 billion threshold. It strengthens our ability to serve our growing customer base and is vital to our continued success and market penetration.

Operator: Please stand by as we are having some technical difficulties.

Elliot Nunez: The cost of our interest-bearing liabilities improved to 3.49%. On a quarter-over-quarter basis, we saw a 10-basis-point decrease. On a year-over-year basis, we saw 50 basis point decrease. We continue to see benefit from the repricing of our deposit portfolio on CDs with rates paid of 4.34% which is 18 bps lower quarter-over-quarter and compared to 5.22% or 88 bps lower than the prior quarter year. We’re continuing to strategically reduce rates in our other interest-bearing deposit accounts as we monitor the competitive landscape. Looking at the funding side, we added over $26 million in deposits ending with $878 million in total deposits for the quarter. A significant portion of this growth came from non-interest-bearing demand deposits which increased to $259 million. Our average non-interest-bearing deposits increased $22 million over the prior quarter. Now, when we look at our loan portfolio, our gross loans total $784 million which is a slight decrease of $15 million quarter-over-quarter, primarily from loan payoffs during the quarter and the resolution of one non-performing loan that we had as of Q1. This will allow us to redeploy the capital into higher return opportunities in the coming quarters. On a year-over-year basis, the loan portfolio increased by more than $23 million which is more representative of our expectations for the remainder of the year. Asset quality remains well managed. Non-accrual loans decreased to $3.2 million from $7.5 million in the prior quarter, primarily due to the resolution of the loan that I mentioned previously. And we recorded also during this Q2, a $19,000 net recovery on our allowance. Our allowance recorded losses stands at $9.34 million, which amounts to a total of the portfolio 1.19%. This includes a specific reserve for the one loan that I mentioned previously. Finally, on capital, total equity rose to $111 million. Our fully diluted tangible book value per share climbed to $4.76 and up $0.14 per fully diluted share from the end of the first quarter and $0.33 or $14.9 annualized from year end. This increase reflects strong earnings retention and solid overall capital strength. The bottom line is this was a clean, high-quality quarter, defined by strategic discipline. Our capital is strong, our balance sheet, including liquidity, is well managed and we are well positioned to continue to deliver durable, long-term value. Moishe, back to you.

Moishe Gubin: Thank you, Elliot. There’s something special happening at OptimumBank and it goes beyond the numbers. It’s cultural, it’s strategic, it’s operational. We’ve built a bank that punches far above its weight. We are focused on using our capital and team to continue driving shareholder value. We are continuing to invest in technology, talent and growth strategies that reinforce our position as one of the most dynamic and rapidly growing community banks in South Florida. We are doing it while staying true to our roots as a relationship-driven community bank. With that, I’ll hand it back to Seth to open up Q&A.

Seth Denison: Thank you, Moishe. Before we open it up for questions, I’d like to thank Moishe, Tim and Elliot for their insights today. OptimumBank continues to deliver strong financial performance and we appreciate everybody’s time. We’re going to open it up for questions in a moment, but for anybody that would prefer to email a question in, please feel free to do so to my email address at [email protected]. That’s spelled S-D-E-N-I-S-O-N @optimumbank.com. We’re happy to answer those questions now or at any point in the future. Now, let’s open it up for Q&A.

QUESTIONS AND ANSWERS

Operator: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please raise your hand now. If you have dialed into today’s call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. As we currently have no questions in queue, I will hand over to Seth Denison, Managing Director of Investor Relations.
Seth Denison: Thank you, Aiden. Appreciate that. Let’s see, I’m looking at three questions. So I’m going to read the questions to our management team and hopefully they can provide some further insights for the audience. So gentlemen, the first question that I have has to do with the $1.04 million provision in the commercial loan. And the question is, you noted the provision was related to a single commercial loan. Was this an isolated credit event or does it reflect broader stress within the segment or this particular borrower? Could you please provide more details?

Moishe Gubin: So I mean, any of us can answer that. I guess I’ll just answer it. So our provision that we have on our balance sheet today is more than adequate. Our segments of our loan portfolio have had zero, minimal to zero loss year-over-year. Most of our bad debt that we have in our books refer to the LendingClub and Marlette relationships that we have there, which is consumer lending. This specific reserve that we took in second quarter is on a credit we expect to have complete payment on. We don’t expect to lose a penny on it. We took the easier side of caution and we took a specific allowance against the whole receivable. This happens to be against the accounts receivable, nursing home division, not any of our regular real estate book that’s in South Florida. This program is expected over the years to have minimal loss as the receivable. It’s all backed by government receivables. It’s a program that the bank administers through a separate team that runs it. And historically, myself and other board members who have experience in the healthcare world help refer the business and help bring in borrowers that we believe will pay us in full and run a good business. This happens to be a business that’s struggling one facility and we have full guarantees from wealthy guarantors. And again, we expected to get paid in full. But we thought it was the prudent idea, the prudent choice to record a specific reserve in the second quarter. Second quarter was a good quarter for us. You would add back that million dollars. We beat first quarter. We beat the quarter year-over-year numbers. And so, we don’t expect that to be recurring at all. We don’t expect third quarter to have anything in bad debt at all other than, like we said, a consumer loan portfolio.

Seth Denison: Great. Thank you. Moishe. We have another question. It says can you expand on underwriting standards and borrower quality for new originations, especially as you approach the $1 billion in assets and new regulatory thresholds?

Moishe Gubin: Well, I can answer that one as well. But in this case, Tim is our chief lender aside being CEO. So we can let Tim talk about how we do our lending today and what’s changed the fact that we’re a billion-dollar bank.

Tim Terry: Simply stated, we have not changed our underwriting standards at all. We have excellent asset quality. That’s really a result of the way we do underwrite loans. And we intend to continue doing it the same way going forward.

Moishe Gubin: Yes, I would just add to that, like as in previous quarters when we — I guess, we didn’t do it like this. This is really the first time we’re doing earnings like this. But majority of our loans are in South Florida. The South Florida market is still a great market. It’s probably one of the best markets in the country. Our borrowers are all known to the bank. They’re not simply a transaction of a loan that we got somehow. They’re usually borrowers that also have bank accounts and they’re part of our world in some form or another and they have relationships with management as well as maybe the board of directors or maybe myself. And so actually this topic actually turns into a bigger topic because when you think about how the bank has to evolve as a company in the long term, the fight of not growing a certain way is that we have such good, strong business doing exactly what we do, exactly the way we do it. And anything else that we potentially do is a distraction from our core business that we have. And so the debate that we have often is, well, do we want to go and do this, that or something else that would enhance our bank, make it bigger, grow the footprint? And the debate ends up being, well, we have something so good in what we’re doing and we haven’t changed it, like Tim said, as far as how we lend, what our credit criteria is, where we lend and who we lend to. And so that’s where we are as a company. But again, back to what we talked about, we have a strong loan portfolio like Tim said, and our credit administration has been strong doing exactly the same thing for many, many years. And proven, if you look at our financials, what our losses have been on our loan portfolio has been basically zero, except for the consumer lending division, which was expected in the model that we had, which is there’s a higher interest consumer loan and it was expected at a certain default rate. And the GAAP accounting, we’re forced to put that, that bad debt expense below the line where I would have taken it as a contra account against the revenue, the top line income. But anyway, yes, I think that answers your question.

Seth Denison: Gentlemen, we have two more emailed questions and then we’ll see if the audience has anything further and otherwise we’ll wrap up. Elliot, you mentioned that the loan portfolio saw a quarter-over-quarter decrease of $15.6 million partly due to the resolution of a $5.6 million non-performing loan. Could you elaborate on how this resolution was achieved and what impact it had on the bank’s asset quality?

Elliot Nunez: So overall this one loan, it was $5.6 million and the resolution was a very positive one. We were able to sell the loan at full book value and we took no loss on that loan. So that decreased our NPAs, it made it lower and it also helped us with the overall quality of the allowance portfolio.

Seth Denison: Okay. And the last one that I’ve got, it says you’ve highlighted approaching the $1 billion milestone, what incremental investments or hires are underway to prepare for FDICIA or FDICIA compliance, internal audit enhancement or stress testing.

Tim Terry: You can speak to that perfectly because we’re making a big investment.

Seth Denison: Elliot?

Elliot Nunez: That’s fine. So a couple of things now. So for FDICIA point 363 of the rules deals with internal controls over financial reporting as the majority of that rule. So to that endeavor we are already fully underway this year we contracted with an outside firm to help us build those controls. So by the time we begin 2026 and we are made to comply with the rule, if the rule stands, we’ll be fully ready. So that goes through each department of the bank. We will be documenting workflows, documenting all the key controls and we will be doing management testing of all those key controls to enhance financial reporting. that will allow us to have a clean opinion. Once we get to 1231, 26, we will have two opinions on the financial statements, one the regular audit opinion and the other one on management’s assessments or internal control. And by doing this, we will make sure we get clean opinion on both sides. Now, in terms of staffing, it’s yet to be seen. We have more professional services as we conclude our side goals of the full documentation process, we’ll see where some of the gaps are and if those gaps could be filled with outside staff or over current staffing. But we’re well underway. It’s three phases of implementation. We completed very successfully Phase 1, Phase 2. We’re about to complete Phase 3 now at the end of Q3, Q4 beginning and I think we’re going to be in excellent shape to meet the regulations and the expectations of the regulators.

Moishe Gubin: I would add to what Elliot said just by saying that 15 years ago, I think I joined the board maybe 16 years ago at this point. I think we had 17 employees. And today, and at some point, I think our loan portfolio got down to about $88 million or so. And now 16 years later, we’re at 86 employees or right about. And about $850 million of a loan portfolio. So moving along, and I think that compared to our peers, where we beat them in most metrics, another one we beat them in is efficiency ratio, where we’re right around 50% today. And I think our original numbers that we wanted to be under was like under 70. So to be under 50 or right around 50 is positive. And we’re able to run our bank real well where — I told us when we first started 16 years ago, like I said, the one thing we have is the bones is good, meaning, I’m a turnaround guy in my regular life. And so we came here and we’re like, at the end of the day, people are getting their statements, customer-facing people are all friendly. And we had the bones to make something big. And now at a billion dollars, which is still not big, it’s big comparatively to below a billion dollars, but we’re all the way down the bottom. When you’re $998 million, you’re like, oh, we’re at the top of the list, below a billion. Then you get to a billion or one and you’re like, we’re like the lowest of the lowest. Now, we have to crawl out of the basement of the billion to $5 billion. And God willing, at this point, similar to other examples in life where you got to get that first mark done, when you get to that one mark, you’re then able to exponentially grow that mark. So to get to a billion was a lot of years of scratching and crawling and scraping our way and getting through what we had to get through with the regulators and everything else. And now that we’re there now, it seems like it should be easy enough to get from a billion to 2 billion and more over the next five years. And we’ll see where it goes.

Seth Denison: Gentlemen, while you’re giving such excellent answers, we got one more email that rolled in just a moment ago. The question is, is the bank using any AI software for loan approvals that will enhance profit margins for the firm?

Tim Terry: The answer is no.

Moishe Gubin: No. Now, (inaudible) the computer guy is Elliot.

Tim Terry: We are not using AI software to approve loans. While AI arguably could improve efficiency, at this point in time, we’re not so sure that AI would render the same quality results that we get by doing our analysis the traditional way.

Moishe Gubin: Yes, I mean, I would –

Tim Terry: Not to say AI doesn’t have a place in the future, but just not right now, we don’t.

Moishe Gubin: I would add that one of our secret sauces of what we got going on, what we have going on here is our personal relationships that we have with our borrowers and our customers. And I met with a guy who wanted us to merge or do something, and they had a whole AI system. And we started talking about culture and he’s like, we don’t talk to our customers. We want nothing to do with our customers. We want the AI to manage the whole thing. And they get a lot of drop off. They’re only doing 25% of the connections that are made through the technology. And for me, I actually said to the guy, why don’t you give me the 75% that drops off that you guys don’t do because you don’t want to give in customer service? And the guy said, well, I’m not going to do that for free. So I basically told him to cancel and get out of my house. But the thing is, instead, from our point of view, we have a direct connection. We don’t do every deal. We probably only do — probably only get in front of loan committee, maybe 30%, 40% of what’s brought to us, but we still meet with everybody, talk to them, and that turns into a future piece of business. And the people appreciate that. They know that they’re being spoken to professionally and in a way that we care, that they know that they could come back to us and that we’re trying to find a way to help them if we can. And we recognize that it’s not just us helping them. It’s a win-win. We need the customer just as much as the customer needs us to be their vendor. And we recognize the responsibility of taking care of their banking needs, know they could bank. It’s like, I feel like the airlines, you can fly with any airline. Over here, you can bank anywhere. Then we’re happy that they choose us and we appreciate them and we’re going to continue to appreciate them, continue doing what we’re doing.

Seth Denison: Okay. Gentlemen, I appreciate the time. Those are all the emailed questions that I’ve got. And I understand from our conference organizer that we have no further questions in queue. So with that, I think we’ll wrap up for the most part unless — an email just came. I’m sorry, pause that one second. I apologize. I do have one more final thought here. What do you think total assets will be at the end of 2026?

Moishe Gubin: That’s a good question. At this point I was what, I — I think our original strategic plan and we were hoping to get to about a billion two. If we exceeded that, I’d be super happy. But I think our budget has us close to a billion two. I think…

Tim Terry: That’s a good number. I would agree.

Moishe Gubin: Okay. And I think we have right now in our pipeline easily between $100 million, $200 million of good solid vanilla deals that we do. And God willing, next quarter we won’t be as bashful as far as talking about our loan, our loan growth as it’ll be a good loan growth quarter. And we’ll be able to say look at what we did and help catch up to make the year-over-year growth closer to 20% to 30% growth, which is what our real target is.

Seth Denison: Okay. And if I say that is one more time, then we’re going to end up getting 15 more emailed questions. So Aiden, I think we’re ready to wrap up whenever you guys are.

Operator: Thank you very much.

The celebration marks a major milestone for the patent-pending, next-generation, rapid, compact, and hand-held Daxor BVA

^™

.

Oak Ridge, TN, Aug. 12, 2025 (GLOBE NEWSWIRE) —

Daxor Corporation
(NASDAQ: DXR), the global leader in blood volume measurement technology, today announces that the official replay of its Nasdaq Closing Bell Ceremony is now available. The ceremony, which took place on August 8, 2025, commemorated the FDA 510(k) clearance for its patent-pending, next-generation, rapid, compact, hand-held, lab-based new Daxor BVA^™ (Blood Volume Analyzer).

You can watch the full replay of the event here: Closing Ceremony.

For more information, visit daxor.com.

Sign up to receive news on Daxor’s innovative technologyHERE.

About Daxor Corporation

Daxor Corporation (NASDAQ: DXR) is tackling healthcare’s “multi-billion-dollar silent crisis”, the inability to precisely measure blood volume. This often results in suboptimal care, prolonged hospital stays, and increased readmissions for many high-cost medical conditions like heart failure and those requiring ICU care. With 50 years of experience and innovation, Daxor’s patented, FDA-cleared Blood Volume Analysis (BVA) diagnostic offers unmatched, real-time, precise data via its rapid, hand-held, lab-based system. This empowers clinicians to make individualized treatment decisions that significantly improve patient outcomes and deliver substantial efficiencies in value-based healthcare. Daxor is ISO certified and operates a U.S.-based, 20,000-square-foot state-of-the-art manufacturing facility, positioning the company for accelerated market expansion.

Forward-Looking Statements

Certain statements in this release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the impact of hiring sales staff and expansion of our distribution channels. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, FDA regulatory actions, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and additional other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Daxor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

Investor Relations Contact:
Bret Shapiro
COO – Head of Capital Markets
COREIR
(561)-479-8566-Cell
[email protected]|www.coreir.com

Early evidence of disease control was observed in the ongoing Phase 1 ACESOT-1051 trial, with three patients achieving stable disease in the 70 mg and 100 mg cohorts treated with the WEE1 inhibitor, APR-1051

$16.5 million in cash and cash equivalents as of June 30, 2025

DOYLESTOWN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the second quarter ended June 30, 2025, and provided a business update.

“We are pleased with our progress in 2025, as emerging data from both of our lead programs demonstrate evidence of clinical activity,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “In the ACESOT-1051 trial of our oral WEE1 inhibitor APR-1051, we have observed three patients with stable disease to date, one in the 70mg cohort and two in the 100mg cohort, including an early clinical signal in an HPV-positive head and neck squamous cell carcinoma, and in rectal and uterine cancer patients. For our macrocyclic ATR inhibitor, ATRN-119, the ongoing dose escalation study has shown early activity, with seven patients achieving stable disease to date, including three with meaningful tumor shrinkage at the 550 mg twice daily dose. Overall, these early signs of clinical validation continue to strengthen our confidence in the potential of our DDR assets and to deliver meaningful therapeutic advances for patients with cancer.”

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

• APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with well-defined biomarkers that may predict sensitivity to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
• Patients are currently being enrolled at the 100 mg once-daily dose level in the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051). Based on data to date, APR-1051 has demonstrated an encouraging tolerability profile. Following successful clearance of the 100 mg cohort, dose escalation is expected to continue with enrollment at 150 mg level. Earlier in 2025, the dosing schedule was revised based on pharmacokinetic data to potentially further support a higher therapeutic window.
• Enrollment criteria in the ACESOT-1051 trial have been expanded to include patients with HPV+ tumors. Evidence of early disease control has been observed in a patient diagnosed with HPV+ head and neck squamous cell carcinoma (HNSCC) treated with a subtherapeutic 70 mg once daily oral dose of APR-1051. At the first radiographic assessment, this patient was noted to have stable disease with a 5% tumor reduction.
• Additional safety and efficacy data from the ACESOT-1051 study are anticipated in the second half of 2025, with completion of the dose-escalation phase expected in the first half of 2026.   Aprea intends to submit an abstract to a major oncology conference.
• Pending additional data, future arms of ACESOT-1051 may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
• For more information, refer to ClinicalTrials.gov NCT06260514.

Collaboration with MD Anderson Cancer Center

• Aprea entered into a translational research collaboration with MD Anderson Cancer Center earlier in 2025. New preclinical results on APR-1051 showed: 1) potent single-agent activity for APR-1051 across a broad panel of human and murine head and neck cancer cell lines, including HPV+ subtypes, and 2) significant anti-tumor synergy with APR-1051 plus anti–PD-1 therapies in HPV+ HNSCC models, positioning APR-1051 as a candidate for combination-based clinical trials.

ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

• ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
• ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. Seven patients have demonstrated stable disease to date, with three patients in the 550 mg twice daily cohort showing tumor shrinkage of 7%, 14% and 21%. Dose limiting toxicity was observed in two patients at 550 mg twice daily. Patients are now being dosed at a 400 mg twice daily schedule to further refine and optimize therapeutic efficacy and tolerability.   
• Additional safety and efficacy data from ABOYA-119 are expected in the second half of 2025 and the recommended Phase 2 dose is expected to be identified in the first half of 2026.
• Pending additional data, future arms of ABOYA-119 may evaluate ATRN-119 in combination with other therapies to address unmet medical needs for a distinct patient population.
• For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914. 

Select Financial Results for the Second quarter Ended June 30, 2025

• As of June 30, 2025, the Company reported cash and cash equivalents of $16.5 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of June 30, 2025, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into Q2 2026.
• For the second quarter ended June 30, 2025, the Company reported an operating loss of $3.4 million, compared to an operating loss of $3.8 million in the second quarter of 2024.
• Research and Development (R&D) expenses were $1.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the second quarter of 2024. The decrease in R&D expense was primarily related to higher expenses in 2024 related to study start up activities in preparation for enrollment of the first patient into ACESOT-105, our Phase 1 dose-escalation study of APR-1051, and a decrease in personnel costs.
• General and Administrative (G&A) expenses were $1.6 million for the quarter ended June 30, 2025, compared to $1.9 million for the second quarter of 2024. The decrease in G&A expense was primarily related to a decrease in professional fees primarily related to legal expenses and a decrease in personnel costs.
• The Company reported a net loss of $3.2 million ($0.53 per basic share) on approximately 6.1 million weighted average common shares outstanding for the quarter ended June 30, 2025, compared to a net loss of $3.5 million ($0.58 per basic share) on approximately 5.9 million weighted average common shares outstanding for the comparable period in 2024.

About Aprea

Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statement


Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs, our ability to continue as a going concern, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.

Investor Contact:

Mike Moyer
LifeSci Advisors
[email protected]

Aprea Therapeutics, Inc.
Consolidated Balance Sheets
		June 30,				December 31,
		2025				2024
Assets		(unaudited)
Current assets:
Cash and cash equivalents		$	16,532,199			$	22,849,885
Prepaid expenses and other current assets			395,011				726,254
Total current assets			16,927,210				23,576,139
Property and equipment, net			70,665				81,522
Restricted cash			40,673				40,170
Other noncurrent assets			271,162				281,662
Total assets		$	17,309,710			$	23,979,493
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	1,195,838			$	1,352,240
Accrued expenses			1,971,830				2,008,735
Total current liabilities			3,167,668				3,360,975
Commitments and contingencies
Series A convertible preferred stock, $0.001 par value, 40,000,000 shares authorized; 31,194 and 56,227 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively			727,361				1,311,063
Stockholders’ equity:
Common stock, $0.001 par value, 400,000,000 shares authorized, 5,752,175 and 5,481,055 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively			5,752				5,481
Additional paid-in capital			352,250,747				350,971,225
Accumulated other comprehensive loss			(10,628,417	)			(10,627,379	)
Accumulated deficit			(328,213,401	)			(321,041,872	)
Total stockholders’ equity			13,414,681				19,307,455
Total liabilities and stockholders’ equity		$	17,309,710			$	23,979,493

Aprea Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
		Three Months Ended June 30,								Six Months Ended June 30,
		2025				2024				2025				2024
Grant revenue		$	118,111			$	561,574				280,574			$	942,143
Operating expenses:
Research and development			1,912,213				2,557,679			$	4,395,279			$	4,158,052
General and administrative			1,593,671				1,850,819				3,358,650			$	3,780,685
Total operating expenses			3,505,884				4,408,498				7,753,929				7,938,737
Loss from operations			(3,387,773	)			(3,846,924	)			(7,473,355	)			(6,996,594	)
Other income (expense):
Interest income, net			178,027				382,374				382,753			$	665,777
Foreign currency (loss) gain			(29,124	)			(5,502	)			(80,927	)		$	50,674
Total other income			148,903				376,872				301,826				716,451
Net loss		$	(3,238,870	)		$	(3,470,052	)		$	(7,171,529	)		$	(6,280,143	)
Other comprehensive loss:
Foreign currency translation			(1,681	)			(1,948	)			(1,038	)		$	(17,031	)
Total comprehensive loss		$	(3,240,551	)		$	(3,472,000	)		$	(7,172,567	)		$	(6,297,174	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.53	)		$	(0.58	)		$	(1.19	)		$	(1.24	)
Weighted-average common shares outstanding, basic and diluted			6,083,329				5,937,291				6,038,845			$	5,067,809

Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for GTx-104 Seeking Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)

NDA Supported by Data from Phase 3 STRIVE-ON Safety Trial, which Met Primary Endpoint and Provided Evidence of Clinical Benefit Compared to Orally Administered Nimodipine

PRINCETON, N.J., Aug. 12, 2025 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights for the quarter ended June 30, 2025.

“During our first quarter of 2026 we continued to execute on our clinical and corporate goals, led by the submission of our NDA to the FDA for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeutics. “Our NDA for GTx-104 was a significant milestone for the Company and built on more than a decade of painstaking research and innovation. Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx-104 as well as potential medical and pharmacoeconomic benefits of GTx-104 in the treatment of aSAH. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe the STRIVE-ON trial results point to a very promising role for GTx-104 as a potential breakthrough for the care of aSAH patients. We are hopeful the FDA will accept our NDA for formal review, and look forward to continued engagement with the FDA during the review process.”

First Quarter 2026 Corporate Highlights

• Submission to the FDA of the Company’s NDA for GTx-104. The application included a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine.

• Submission of the NDA has the potential to trigger the exercise of up to $7.6 million in warrants issued as part of a private placement the Company completed in September 2023. Under the terms of the September 2023 private placement, each warrant is exercisable for one share of common stock at an exercise price of $3.003 per share. These warrants are immediately exercisable and will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of an NDA for the Company’s product candidate GTx-104 or (ii) September 25, 2028.

• The FDA typically has a 60-day period to determine if the Company’s NDA is complete and acceptable for filing. Grace has obtained Orphan Drug Designation from the FDA for GTx-104, which generally provides seven years of marketing exclusivity in United States upon FDA approval of the NDA. Additionally, the Company believes that its U.S. and international patent estate will provide additional marketing exclusivity for GTx-104.

First Quarter 2026 Financial Results

The Company reported a net loss of $3.4 million, or $0.21 per share, for the three months ended June 30, 2025, an increase of $0.8 million from the net loss of $2.6 million, or $0.24 per share, for the three months ended June 30, 2024. The increase in net loss was primarily due to a $1.9 million difference in the change in fair value of derivative warrant liabilities and a $0.7 million decrease in income tax benefit, partially offset by a $1.8 million decrease in research and development expenses and a $0.1 million decrease in general and administrative expenses.

Total research and development expenses were approximately $0.9 million for the three months ended June 30, 2025, compared to $2.7 million for the three months ended June 30, 2024. The decrease of approximately $1.8 million was primarily due to a $1.9 million decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, offset in part by a $0.1 million increase in professional fees in connection with the preparation and submission of our NDA to the FDA.

General and administrative expenses were approximately $2.1 million for the three months ended June 30, 2025, a decrease of $0.1 million from $2.2 million for the three months ended June 30, 2024. The decrease was primarily a result of decreased legal, accounting, tax, audit and other professional fees related to the continuance and domestication completed in October 2024, offset in part by an increase in salaries and benefits due to merit increases, increases in other general and administrative expenses primarily due to costs for GTx-104 commercial assessment, and an increase in stock-based compensation due to the issuance of new stock option awards.

Cash Runway

As of June 30, 2025, cash and cash equivalents were $20.0 million, a net decrease of approximately $2.1 million compared to cash and cash equivalents of $22.1 million at March 31, 2025.

The private placement the Company completed in February 2025 included common warrants exercisable for shares of common stock (or pre-funded warrants in lieu thereof) at an exercise price of $3.395 per share. Each common warrant is immediately exercisable and will expire on the earlier of (i) the 60th day after the date the FDA approves the NDA for GTx-104 and (ii) September 25, 2028. Potential gross proceeds from the exercise of the February 2025 common warrants are $15.0 million.

The private placement the Company completed in September 2023 included common warrants exercisable for shares of common stock at an exercise price of $3.003 per share. Each common warrant is immediately exercisable and will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of the NDA for GTX-104 or (ii) five years from the date of issuance. Potential gross proceeds from the exercise of the September 2023 common warrants are $7.6 million.

While the Company believes that current cash and cash equivalents provide cash runway through at least the next twelve months, the runway could extend into the second quarter of calendar 2027 if all of the common warrants issued in connection with the Company’s February 2025 and September 2023 private placements are exercised at the election of the investors.

About the STRIVE-ON Trial

The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored or were comparable to GTx-104, including: 54% patients had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients had favorable functional outcomes at 90 days. In addition, there were fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine. Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient’s underlying disease. There were eight deaths on the GTx-104 arm compared to four deaths on the oral nimodipine arm. The survival status of one patient on the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine.

About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is aSAH, a relatively uncommon type of stroke that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About the Grace Therapeutics Asset Portfolio

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion.

GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTx-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The Company received written responses to its End of Phase 1 meeting in GTx-102 where the FDA made recommendations on the path toward an NDA. The FDA provided guidance on the design of a single pivotal efficacy and safety trial, including the neurological assessment scale for the primary endpoint, that could, with appropriate confirmatory evidence, support an NDA. The further development of GTx-102 has been deprioritized in favor of focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-102.

GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, which are used for the treatment of PHN, the Company believes that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-101.

About Grace Therapeutics

Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.

For more information, please visit:


www.gracetx.com
.

Forward-Looking Statements

Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “estimates,” “potential,” “should,” “may,” “will,” “plans,” “continue,” “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding, the Company’s cash runway, the future prospects of the Company’s GTx-104 drug candidate, the timing and outcome of the Company’s NDA submission for GTx-104, the Company’s belief that the data and regulatory packages as currently structured will be sufficient for submission of such NDA, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, GTx-104’s potential to achieve medical and pharmacoeconomic benefit, GTx-104’s commercial prospects, the future prospects of the Company’s GTx-102 drug candidate, GTx-102’s potential to provide clinical benefits to decrease symptoms associated with A-T, the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-102, the timing of an NDA filing for GTx-102, the future prospects of the Company’s GTX-101 drug candidate, GTX-101’s potential to be administered to PHN patients to treat the severe nerve pain associated with the disease and any future patent and other intellectual property filings made by the Company for new developments are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome of the Company’s NDA application for GTx-104; (iii) changes to regulatory pathways; and (iv) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 to be filed with the Securities and Exchange Commission (“SEC”) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.

For more information, please contact:

Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: [email protected]
www.gracetx.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: [email protected]

—tables to follow—

GRACE THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets
(Unaudited)

		June 30, 2025				March 31, 2025
(Expressed in thousands except share data)		$				$
Assets
Current assets:
Cash and cash equivalents			20,005				22,133
Receivables			20				126
Prepaid expenses			500				453
Total current assets			20,525				22,712
Equipment, net			14				15
Intangible assets			41,128				41,128
Goodwill			8,138				8,138
Total assets			69,805				71,993
Liabilities and Stockholders’ equity
Current liabilities:
Trade and other payables			2,315				1,930
Total current liabilities			2,315				1,930
Derivative warrant liabilities			1,628				1,141
Deferred tax liability			2,312				2,312
Total liabilities			6,255				5,383
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value per share; 10,000,000 authorized; none issued and outstanding as of June 30, 2025 and March 31, 2025			—			—
Common stock, $0.0001 par value per share; 100,000,000 authorized; 13,828,562 and 13,718,106 shares issued and outstanding as of June 30, 2025 and March 31, 2025, respectively			1				1
Additional paid-in capital			293,636				293,334
Accumulated other comprehensive loss			(6,038	)			(6,038	)
Accumulated deficit			(224,049	)			(220,687	)
Total stockholders’ equity			63,550				66,610
Total liabilities and stockholders’ equity			69,805				71,993

GRACE THERAPEUTICS, INC.

Condensed Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)

		Three months ended
		June 30, 2025				June 30, 2024
(Expressed in thousands, except share and per share data)		$				$
Operating expenses
Research and development expenses			(955	)			(2,708	)
General and administrative expenses			(2,135	)			(2,255	)
Loss from operating activities			(3,090	)			(4,963	)
Foreign exchange gain (loss)			10				(8	)
Change in fair value of derivative warrant liabilities			(487	)			1,395
Interest and other income, net			205				235
Other (expense) income, net			(272	)			1,622
Loss before income tax benefit			(3,362	)			(3,341	)
Income tax benefit			—				724
Net loss and total comprehensive loss			(3,362	)			(2,617	)
Basic and diluted loss per share			(0.21	)			(0.24	)
Weighted-average number of shares outstanding			15,924,522				10,928,543

Additional members to join the Advisory Committee in the coming weeks to optimize performance, increase visibility and unlock capital raising opportunities

Arthur brings deep expertise, exposure and connectivity to both digital assets and traditional finance

TAMPA, Fla., Aug. 12, 2025 (GLOBE NEWSWIRE) — Upexi, Inc. (NASDAQ: UPXI) (the “Company” or “Upexi”), a brand owner specializing in the development, manufacturing and distribution of consumer products with diversification into the cryptocurrency space, today announced the establishment of the Upexi Advisory Committee, composed of highly prominent individuals from the digital assets and traditional finance industries. Upexi will seek to leverage the expertise, visibility and network of the Advisory Committee by:

• Accessing members’ world-leading cryptocurrency, financial and legal/regulatory expertise for optimized decision-making and performance
• Harnessing members’ commanding visibility, industry stature and influence to elevate Upexi’s brand and presence
• Utilizing members’ unparalleled connectivity and network to unlock high-impact initiatives, including capital raising efforts

In conjunction with the establishment of the Advisory Committee, Upexi today has welcomed Arthur Hayes (Twitter: @CryptoHayes) as its first member. A former equity derivatives trader at Deutsche Bank and Citigroup, Arthur’s deep financial acumen and bold vision quickly propelled him to the forefront of the digital assets space, where he co-founded BitMEX, one of the world’s largest cryptocurrency exchanges, and revolutionized digital asset trading with the invention of the perpetual swap – the most widely-traded crypto financial product of all time. Arthur is widely regarded as a thought leader whose market insights and macroeconomic commentary are followed closely by investors around the world. His fearless approach to innovation and profound impact on the industry has cemented his legacy as one of the space’s most iconic and respected voices.

Allan Marshall, Upexi’s Chief Executive Officer, stated, “The Advisory Committee will be a catalyst for Upexi’s next stage of growth – driving performance, amplifying our brand and unlocking transformative opportunities. It will expand our footprint in the Solana ecosystem through strategic partnerships and targeted investments and help us champion Solana among institutions and corporates. With our culture of innovation and unique position at the intersection of cryptocurrencies and traditional finance, there is no more fitting inaugural member than Arthur Hayes.”

“Maelstrom, an investment fund focused on digital assets, backed Upexi months ago due to its clear treasury model expertise, deep connectivity to traditional finance, and a risk-conscious strategy designed to maximize value while resonating with a broad spectrum of investors,” said Arthur Hayes. “Since then, Upexi has executed on its vision with precision, and I’m eager to help cement its position as the definitive Solana treasury company.”

Additional Advisory Committee members will be announced over the coming weeks, with Committee-related content and initiatives forthcoming over the coming year and beyond. See www.upexi.com/advisorycommittee for more information and to stay up to date.

Arthur Hayes is the CIO of Maelstrom, a family office that invests across the crypto ecosystem. He is also the co-founder of BitMEX – the first crypto unicorn. Prior to entering the crypto industry, he worked as a trader in the capital markets divisions of Deutsche Bank and Citibank. Arthur holds a Bachelors of Economics from the Wharton School of Business. He has appeared on major business news networks including Bloomberg and CNBC. He is active on X (@cryptohayes) and releases a monthly newsletter (Crypto Trader Digest) read by thousands of investors globally.

Follow on: Instagram | LinkedIn | Medium | Substack | X

About Upexi, Inc.

Upexi is a brand owner specializing in the development, manufacturing, and distribution of consumer products. The Company has entered the cryptocurrency industry and cash management of assets through a cryptocurrency portfolio. For more information on Upexi’s treasury strategy and future developments, visit www.upexi.com.

Follow Upexi on X – https://x.com/upexitreasury
Follow CEO, Allan Marshall, on X – https://x.com/upexiallan
Follow CSO, Brian Rudick, on X – https://x.com/thetinyant

About Maelstrom

Maelstrom is an investment fund focused on digital assets. It is managed by the family office of Arthur Hayes (co-founder, BitMEX). The fund’s mandate is to build a portfolio of infrastructure companies that will serve as the foundation of the next wave of trustless decentralization. Website: Maelstrom.Fund

Follow on: LinkedIn | Naver | X | YouTube

Forward Looking Statements

This news release contains “forward-looking statements” as that term is defined in Section 27A of the United States Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations, or intentions regarding the future. For example, the Company is using forward looking statements when it discusses the anticipated use of proceeds. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with business strategy, potential acquisitions, revenue guidance, product development, integration, and synergies of acquiring companies and personnel. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward- looking statements. Although we believe that the beliefs, plans, expectations, and intentions contained in this press release are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Maelstrom

Media Contact
[email protected]

Upexi Company Contact

Brian Rudick, Chief Strategy Officer
Email: [email protected]  
Phone: (216) 347-0473

Upexi Media Contact

Gasthalter & Co.
[email protected] 

Upexi Investor Relations Contact

KCSA Strategic Communications
Valter Pinto, Managing Director
(212) 896-1254
[email protected]

• In a gold-standard model of obesity, treatment with ARD-201 resulted in approximately 19% body weight reduction after 30 days of treatment.
• ARD-201 was also associated with attenuated weight regain after discontinuation of tirzepatide.
• In combination with low-dose tirzepatide, ARD-201 improved weight loss compared to high dose tirzepatide alone.
• Aardvark plans two separate Phase 2 clinical trials for ARD-201: Phase 2 POWER trial to focus on weight rebound in patients discontinuing GLP-1RA therapy, and Phase 2 STRENGTH trial to focus on weight loss as a monotherapy and in combination with GLP-1RA.

SAN DIEGO, Aug. 12, 2025 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions. Data in the validated diet-induced obesity (DIO) mouse model (a conventional model recognized for its strong translational relevance in the field of glucagon-like peptide-1 receptor agonists (GLP-1RAs)) demonstrated potential applications for ARD-201, including for the attenuation of weight gain after withdrawal from GLP-1RA therapies, as a monotherapy for weight loss without GLP-1RA therapy, as well as for weight loss in combination with GLP-1RA therapy. Details of the study will be submitted for peer review publication.

“Weight maintenance remains a major challenge for many patients seeking an off-ramp from treatment with GLP-1RA therapies. These new findings highlight the potential of ARD-201 as an oral therapy that can help patients to not only achieve meaningful weight loss but also to sustain it,” said Timothy Kieffer, Ph.D., Chief Scientific Officer at Aardvark. “The low dose of tirzepatide corresponds to a human equivalent dose substantially lower than what is used clinically, supporting the potential for improved tolerability with a highly complementary oral option.”

In a study designed to show the potential of ARD-201 as a weight loss therapy, DIO mice treated with oral ARD-201 showed substantial weight loss of approximately 19% after 30 days of treatment (see Figure A). Additional studies assessed the impact of ARD-201 alone and in combination with low dose (1 nmol/kg/day) tirzepatide after 15 days of treatment with high-dose tirzepatide (10 nmol/kg/day) (see Figure B). In that study, ARD-201 as a monotherapy showed improved weight maintenance compared to the negative (vehicle) control and demonstrated similar weight maintenance compared to continued treatment with high-dose tirzepatide, a benchmark therapy within the GLP-1RA class. Moreover, the combination of ARD-201 and the low dose of tirzepatide showed continued weight loss compared to high-dose tirzepatide.

(A) Body weight changes in DIO mice treated with ARD-201, sitagliptin diet, or vehicle.
(B) Body weight in mice given a high-dose of tirzepatide (10 nmol/kg/day, Part 1) followed by either low-dose tirzepatide (1 nmol/kg/day), high-dose tirzepatide (10 nmol/kg/day), ARD-201, or ARD-201-tirzepatide combo (Part 2).

Randy J. Seeley, Henry King Ransom Professor of Surgery at the University of Michigan, who was not associated with the study, commented: “Innovation in obesity therapy will come in different ways.  Aardvark is harnessing a unique mechanism that has the potential to produce significant weight loss on its own in pill form and be used in combination with a GLP-1 agonist for additional benefits. Using compounds uniquely in the weight maintenance phase opens up the real possibility of using different approaches to induce weight loss, and then help patients keep that weight off for the long run.”

Driven by these new preclinical insights, Aardvark is advancing ARD-201 into two Phase 2 trials:
Phase 2 POWER Trial (Prevention Of WEight Regain):

• Expected to initiate in 2H 2025, this trial will evaluate ARD-201’s potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~15%), reducing the burden of chronic injectable use.
• The trial will assess outcomes over 24 weeks with an interim analysis at 12 weeks.

Phase 2 STRENGTH Trial (Sitagliptin and TAS2R for weight Reduction with Exercise, Nutrition, and GLP-1RATrial and Hunger assessment):

• Planned for initiation in 1H 2026, this trial will explore placebo-adjusted weight loss of ARD-201 alone and the additive effects of ARD-201 combined with GLP-1RA therapy.
• Key secondary endpoints include assessing absolute weight loss and the quality of weight loss, specifically evaluating lean muscle versus fat reduction.

These two focused trials will replace the previously planned EMPOWER trial and are designed to enhance the precision and clarity of data collection compared to the EMPOWER trial.

“These results from a validated, predictive preclinical model strengthen our conviction in the ARD-201 program,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “ARD-201’s oral, combination approach could alter the obesity treatment landscape by providing a new solution for weight maintenance after successful GLP-1 therapy.”

About  ARD-201

ARD-201 is an oral fixed dose combination of a dipeptidyl peptidase4 (DPP4) inhibitor and ARD-101, a gut restricted small molecule agonist of select taste receptors (TAS2Rs) expressed in the intestinal lumen. These receptors normally respond to nutrients and are part of the gut brain axis that helps regulate food intake. Activation of TAS2Rs stimulates the release of endogenous signaling molecules, including cholecystokinin (CCK) and GLP-1, which play key roles in promoting satiety and reducing hunger.  DPP4 inhibitors, which are widely used for the treatment of diabetes, extend the biological activity of gut hormones, including GLP-1, by preventing their enzymatic inactivation. Together, these mechanisms allow ARD-201 to enhance and prolong the body’s natural signals for fullness.

Separately, ARD-101 is being evaluated in the Phase 3 HERO (Hunger Elimination or Reduction Objective) trial for hyperphagia associated with Prader-Willi Syndrome (PWS).

About Aardvark Therapeutics, Inc.

Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. As we recognize that hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food), our programs are designed to explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. ARD-101 is also being studied in hypothalamic obesity. Additionally, Aardvark is developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials, with a goal of addressing some of the limitations of currently marketed GLP-1RA therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.  

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. Words including, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-201’s potential, including its potential as an oral therapy that can help patients achieve meaningful weight loss and also help to sustain it; the potential for ARD-201 to provide improved tolerability or to be a highly complementary oral option; the potential for ARD-201 to alter the obesity treatment landscape or provide a new solution for weight maintenance after successful GLP-1 therapy; the trial design for the POWER and STRENGTH trials and the expected timing for commencing such trials; and the development path for ARD-201. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Aardvark has filed or may subsequently file with the U.S. Securities and Exchange Commission. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
[email protected]

CAMARILLO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) — via IBN – Newton Golf Company (NASDAQ: NWTG) (“Newton Golf” or the “Company”), a technology-forward golf company focused on performance-driven innovation, today announced it will host a webcast and investor Q&A session following the release of its second quarter 2025 financial results.

Webcast Details

Date: Thursday, August 14, 2025
Time: 4:30 PM ET
Format: Webcast with Q&A
Registration:https://zoom.us/webinar/register/WN_85RM9Et2RXm-e0bnl49Qjw

During the webcast, Greg Campbell, Chairman and Chief Executive Officer, and Jeff Clayborne, Chief Financial Officer, will discuss the Company’s second quarter results, recent business highlights, and outlook for the remainder of 2025. The presentation will be followed by a Q&A session.

The webcast is open to all shareholders, prospective investors, analysts, and members of the media. Participants are encouraged to submit questions in advance by emailing: [email protected].

A replay of the webcast will be made available on the Company’s investor relations website at www.NewtonGolfIR.com shortly after the event concludes.

Investor Alerts

Stay updated with the latest from Newton Golf! Sign up for investor alerts at newtongolfir.com/email-alerts to receive company news and strategic developments directly to your inbox.

About NEWTON GOLF

At Newton Golf, we harness the power of physics to revolutionize golf equipment design. Formerly known as Sacks Parente, our rebranding reflects our commitment to innovation inspired by Sir Isaac Newton, the father of physics. By applying Newtonian principles to every aspect of our design process, we create precision-engineered golf equipment—including Newton Motion shafts and Gravity putters—that deliver unmatched stability, control, and performance. Our mission is to empower golfers with scientifically advanced tools that maximize consistency and accuracy, ensuring every swing is backed by the laws of physics.

For more information, visit the Company’s investor relations website at www.NewtonGolfIR.com or contact Investor Relations at [email protected].

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the future financial performance of Newton Golf Company (the “Company”) and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “projects,” “potential,” “continues,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding the expected benefits of the reverse stock split, the Company’s ability to maintain compliance with Nasdaq listing requirements, the potential for increased institutional investor interest, the Company’s future growth strategy, expansion of its product portfolio, anticipated financial performance, and future business prospects.

These forward-looking statements reflect the Company’s current expectations and projections based on information available as of the date of this release and are subject to a number of risks and uncertainties, including, but not limited to, general economic, financial, and business conditions; changes in consumer demand and industry trends; the Company’s ability to successfully implement its strategic initiatives; competition in the golf equipment market; supply chain disruptions; regulatory compliance and legal proceedings; and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

The Company cautions investors that forward-looking statements are not guarantees of future performance and actual results may differ materially from those projected. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Media Contact:

Beth Gast

BG Public Relations

[email protected]

Investor Contact:

Scott McGowan

Investor Brand Network (IBN)

Phone: 310.299.1717

[email protected]