Market Newsdesk

ROSEMONT, Ill., March 31, 2025 (GLOBE NEWSWIRE) — Wintrust Financial Corporation (“Wintrust”) (Nasdaq: WTFC) today announced it will release first quarter 2025 earnings results after the market closes on Monday, April 21, 2025 and host a conference call on Tuesday, April 22, 2025 at 9:00 a.m. (CDT).

For individuals wanting to listen to a simultaneous audio-only web cast, this may be accessed at Webcast Link.

Individuals interested in participating in the call by addressing questions to management should register for the call at Conference Call Link to receive a dial-in number and unique PIN to access the call seamlessly. It is recommended that you join 10 minutes prior to the event start (although you may register and dial in at any time during the call).

An accompanying slide presentation will be available on the Company’s web site at http://www.wintrust.com, Investor Relations link.

A replay of the audio-only webcast and an accompanying slide presentation will subsequently be available at http://www.wintrust.com, Investor Relations, Investor News and Events, Presentations & Conference Calls link.   The text of the first quarter 2025 earnings release will be available at http://www.wintrust.com, Investor Relations, Investor News and Events, Press Releases link.

About Wintrust

Wintrust is a financial holding company with approximately $65 billion in assets whose common stock is traded on the NASDAQ Global Select Market. Guided by its “Different Approach, Better Results” philosophy, Wintrust offers the sophisticated resources of a large bank while providing a community banking experience to each customer. Wintrust operates more than 200 retail banking locations through 16 community bank subsidiaries in the greater Chicago, southern Wisconsin, west Michigan, northwest Indiana, and southwest Florida market areas. In addition, Wintrust operates various non-bank business units, providing residential mortgage origination, wealth management, commercial and life insurance premium financing, short-term accounts receivable financing/outsourced administrative services to the temporary staffing services industry, and qualified intermediary services for tax-deferred exchanges. For more information, please visit www.wintrust.com.

Forward-Looking Information

This press release contains forward-looking statements within the meaning of the federal securities laws. Investors are cautioned that such statements are predictions and that actual events or results may differ materially. Wintrust’s expected financial results or other plans are subject to a number of risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” and the forward-looking statement disclosure contained in Wintrust’s Annual Report on Form 10-K for the most recently ended fiscal year. Forward-looking statements speak only as of the date made and Wintrust undertakes no duty to update the information.

FOR MORE INFORMATION CONTACT:

Timothy S. Crane, President & Chief Executive Officer
David A. Dykstra, Vice Chairman & Chief Operating Officer
(847) 939-9000
Website address: www.wintrust.com

SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, with a focus on severe eye diseases, today provided fourth quarter and full year 2024 financial results and business updates.

Research and Development Pipeline Highlights

The company prioritized its ophthalmology pipeline programs that have the potential to provide new or improved treatment options in multiple severe and disabling eye diseases. Surrozen will focus its Wnt biology expertise and Wnt signal modulation antibody technologies on its ophthalmology programs including development of new treatment options for retinopathies. 

Other Business Highlights

The company also completed the first closing of a two-tranche financing of $175 in aggregate gross proceeds which funds multiple ophthalmology programs through Phase 1 safety, tolerability and efficacy studies. 

“In 2024, we continued to leverage our research capabilities and significant expertise in antibody engineering technologies focused on Wnt signal modulation. We received notification that Boehringer planned to further develop SZN-413 to advance the compound and prepare it for clinical testing, nominated a portfolio of novel preclinical ophthalmology candidates for severe eye diseases and completed a research collaboration with TCGFB to utilize Surrozen’s antibody developments capabilities and expertise to discover antibodies targeting TGF-β” said Craig Parker, President and Chief Executive Officer of Surrozen. “More recently, we were pleased to announce a private financing to advance our novel ophthalmology-focused pipeline toward the clinic”

Financial Results for the Fourth Quarter and Full Year 2024

Cash Position: Cash and cash equivalents were $34.6 million as of December 31, 2024, compared to $31.0 million as of September 30, 2024, and $36.0 million as of December 31, 2023. In addition, Surrozen received gross proceeds of approximately $76.4 million upon closing of the financing in March 2025.

Collaboration and License Revenue: Collaboration and license revenue for the fourth quarter and full year ended December 31, 2024 was zero and $10.0 million, respectively, as compared to zero for the same periods in 2023. The increase was due to the recognition of a milestone achieved under the collaboration and license agreement with BI in September 2024.

Research Service Revenue – Related Party: Research service revenue – related party for the fourth quarter and full year ended December 31, 2024 was both $0.7 million, compared to zero for the same periods in 2023. The increase was related to the research service provided to TCGFB, Inc. in 2024 under the research collaboration agreement.

Research and Development Expenses: Research and development expenses for the fourth quarter and full year ended December 31, 2024 were $5.4 million and $21.1 million, respectively, as compared to $6.1 million and $27.2 million for the same periods in 2023. The decrease was primarily due to the restructuring executed in 2023 to prioritize and focus our resources on clinical stage programs, as well as the discontinuation of the clinical development of SZN-1326. Research and development expenses include non-cash stock-based compensation expenses of $0.2 million and $1.2 million for the fourth quarter and full year ended December 31, 2024, as compared to $0.4 million and $1.3 million for the same periods in 2023.

General and Administrative Expenses: General and administrative expenses for the fourth quarter and full year ended December 31, 2024 were $3.9 million and $15.1 million, respectively, as compared to $3.6 million and $15.8 million for the same periods in 2023. The variance was primarily due to the restructuring executed in 2023. General and administrative expenses include non-cash stock-based compensation expenses of $0.7 million and $2.9 million for the fourth quarter and full year ended December 31, 2024, as compared to $0.8 million and $3.1 million for the same periods in 2023.

Restructuring: Restructuring charges for the fourth quarter and full year ended December 31, 2024 were both zero, as compared to $40,000 and $2.8 million for the same periods in 2023. The decrease was attributable to a restructuring plan implemented and completed in 2023.

Interest Income: Interest income for the fourth quarter and full year ended December 31, 2024 was $0.4 million and $1.7 million, respectively, as compared to $0.5 million and $2.3 million for the same periods in 2023. The decrease was primarily related to the decrease in our cash and cash equivalents.

Loss on Issuance of Common Stock, Pre-Funded Warrants and Warrants: Loss on issuance of common stock, pre-funded warrants and warrants for the fourth quarter and full year ended December 31, 2024 was zero and $20.4 million, respectively, as compared to zero for the same periods in 2023. The increase was due to the fair value of pre-funded warrants and warrants issued greater than the proceeds received in a private placement closed in April 2024.

Other (Expense) Income, Net: Other (expense) income, net for the fourth quarter and full year ended December 31, 2024 was a net other expense of $19.8 million and $19.3 million, respectively, as compared to a net other income of $0.3 million and $0.4 million for the same periods in 2023. The variance was primarily related to the non-cash change in fair value of warrant liabilities.

Net Loss: Net loss for the fourth quarter and full year ended December 31, 2024 was $28.0 million and $63.6 million, respectively, as compared to $8.9 million and $43.0 million for the same periods in 2023.

About Ophthalmology Portfolio 

About SZN-8141 for retinal diseases 

SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism which has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema (DME) and neovascular Age Related Macular Degeneration (wet AMD). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

About SZN-8143 for retinal diseases 

SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema (UME). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in clinical trials. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

About SZN-413 for Retinal Diseases

SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient’s disease.

About Surrozen

Surrozen is a biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway. Surrozen is developing tissue-specific antibodies designed to engage the body’s existing biological repair mechanisms with a current focus in ophthalmology.

Forward-Looking Statements
 
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease, as well as the potential benefits of such product candidates), the Company’s partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales and the potential of TGF-β to be a novel, first-in-class therapeutic to treat the pathology of Idiopathic Pulmonary Fibrosis. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for Sits product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Investor/Media Contact:


Email:


 



[email protected]

– Favorable long-term safety and robust broad-spectrum efficacy sustained over 1-year for once daily brilaroxazine in open-label extension (OLE) trial –

– Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025 –

– Full data set from RECOVER OLE expected in Q2 2025 –

CUPERTINO, Calif., March 31, 2025 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the full year ended December 31, 2024 and summarized recent business highlights.

“Our late stage brilaroxazine program has consistently shown what we believe to be robust broad-spectrum efficacy across all major symptom domains of schizophrenia and a well-tolerated safety profile. Importantly, initial long-term data from our OLE study showed that these favorable efficacy and safety findings were sustained over time. We expect to report the full data set from the RECOVER OLE study, which will also include vocal and blood biomarker data as additional independent measures of efficacy, in the second quarter of 2025,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Brilaroxazine has a robust data package that includes a successful placebo-controlled Phase 3 trial with a long-term open label extension for up to 1-year, a successful Phase 2 study and a compelling drug-drug interaction study. We believe the differentiated potential of once daily brilaroxazine to address all major unmet needs for patients with schizophrenia continues to be strong, and we are targeting a potential New Drug Application (NDA) submission for brilaroxazine in the fourth quarter of 2026.”

Fourth Quarter 2024 and Recent Business Highlights

Clinical Program Highlights

• Positive preliminary topline data for the OLE portion of the Company’s ongoing Phase 3 RECOVER study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia announced (December 2024)
  • Robust broad-spectrum efficacy that was sustained over 1 year
  • Dose dependent efficacy, with decreases in PANSS total scores of -15.2, -18.6 and -20.8 points at the 15, 30, and 50 mg doses respectively, from baseline to end-of-treatment at 52 weeks (1 year)
  • Pooled data of brilaroxazine at the 15, 30, and 50 mg doses (N = 113) demonstrated clinically meaningful and sustained long-term (1-year) efficacy for schizophrenia:
    • PANSS Total scores: 18.6-point decrease (71.6 → 53), p ≤ 0.0001
    • PANSS Positive Symptoms: 5.2-point decrease (17.7 →12.5), p ≤ 0.0001
    • PANSS Negative Symptoms: 4.5-point decrease (19.5 →15.0), p ≤ 0.0001
  • Generally well tolerated with no single side effect >5%
  • Favorable compliance, with a discontinuation rate of 35%, primarily due to withdrawal of consent (22%), participant lost to follow up (7%), and treatment-related adverse events (TRAE) (1.6%)
  • 15.2% reported at least one TRAE, which were mostly mild (12.2%) or moderate (3%) in severity and transient in nature
  • Most common TRAEs ≥1% were weight increase (3.2%), insomnia (1.8%) and somnolence (1.6%)

• No drug-related serious adverse events (SAEs) observed or major safety concerns reported for brilaroxazine after up to 1 year of treatment

Corporate Highlights

• Positive topline data from the long-term OLE portion of the Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia presented as an oral presentation on March 30th at the 2025 Congress of the Schizophrenia International Research Society (SIRS) in Chicago, Illinois
• Completed a public follow-on offering with aggregate gross proceeds of approximately $18.0 million (December 2024)
• Positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial presented as a poster presentation at the Central Nervous System (CNS) Summit 2024 on November 12th in Boston, Massachusetts

Anticipated Milestones and Events

• Full data analysis of the OLE trial including long-term safety, tolerability and efficacy, as well as vocal and blood biomarker data expected in Q2 2025
• Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in mid-2025, subject to receipt of additional financing
• Potential NDA submission for brilaroxazine in schizophrenia targeted for the fourth quarter of 2026
• Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected later in 2025
• Pursue partnership opportunities for the development of our pipeline

Financial Results for 2024

The Company reported a net loss of approximately $29.9 million, or $0.90 per share, for the fiscal year ended December 31, 2024, compared to a net loss of approximately $39.3 million, or $1.65 per share, for the fiscal year ended December 31, 2023.

As of December 31, 2024, the Company’s cash and cash equivalents totaled approximately $13.5 million compared to approximately $23.4 million as of December 31, 2023.

About Reviva 

Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which 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. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Corporate Contact:

Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com

Investor Relations Contact:

LifeSci Advisors, LLC
Bruce Mackle
[email protected]

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

• Record Gross Revenue: Achieved record annual gross revenue of $46.0 million, representing a 32% increase from $34.9 million in 2023.
• Fourth Quarter Results: Gross revenue reached an all-time quarterly high of $13.3 million in Q4 2024, marking a 20% increase compared to Q4 2023.
• Improved Adjusted EBITDA: Substantially narrowed Adjusted EBITDA loss from $6.7 million in Q4 2023 to $4.7 million in Q4 2024, underscoring enhanced operational efficiency.

COLUMBIA, Md., March 31, 2025 (GLOBE NEWSWIRE) — Rekor Systems, Inc. (NASDAQ: REKR), a global leader in roadway intelligence, today announced its financial results for the fiscal year that ended December 31, 2024. Throughout 2024, Rekor demonstrated substantial progress in efficiently scaling operations while consistently delivering increased value to customers and shareholders.

In addition to achieving significant financial milestones, the Company reported several noteworthy operational and strategic achievements:

• Rekor Scout^® Certified for Deployment in New Jersey: Rekor’s leading-edge platform, Rekor Scout^®, earned official certification for use in New Jersey, marking a key step forward in the expansion of its innovative roadway monitoring technology and creating significant opportunities for further market penetration.
• Electric Vehicle Movement Study in Phoenix Metropolitan Region: Successfully deployed Rekor’s Vehicle Insite application across 90 sites in the Phoenix metropolitan area to study electric vehicle (EV) usage patterns. This project underscores the Company’s capacity for managing complex, large-scale deployments and positions Rekor as a leader in intelligent infrastructure supporting sustainable transportation solutions.
• Strategic Partnership with Soundhound AI: Rekor partnered with Soundhound AI to pioneer groundbreaking emergency vehicle technologies, integrating advanced audio-visual artificial intelligence capabilities. This first-of-its-kind collaboration will revolutionize emergency response by significantly enhancing situational awareness and responsiveness.

Additionally, the Company expanded its AI-powered Rekor Command^® platform in the fourth quarter to further support traffic and emergency operations centers. Data overload and a lack of real-time insights often hinder effective decision-making in the fast-paced traffic management environment. The new Rekor Command^®Priority Ranking feature took the first step in providing traffic and emergency operations center operators with AI-powered decision support, enabling them to prioritize and respond to high-impact incidents more quickly, accurately, and efficiently in real-time.

Recently, the Company unveiled the next evolution in AI-powered decision support with the launch of the Rekor Command^®Related Events feature, enabling operators to treat all events in a geographic area as a single event rather than a series of isolated, individual events, supporting faster and improved communications with both responders and the public, and ensuring accurate, comprehensive, and timely information sharing. Rekor’s continued investment in AI-driven traffic management center decision support highlights its ongoing commitment to improving roadway safety and efficiency.

“We are pleased with our financial and operational achievements in 2024,” said Rekor CFO Eyal Hen. “Our record revenue growth, alongside consistent improvement in operational efficiency, highlights our dedication to strategic execution and innovation. With our expanding market presence and strong partnerships, Rekor is well-positioned for continued momentum throughout 2025 and beyond.”

In early January, the Rekor Board of Directors established an Executive Committee to review Company operations, focusing on strategically realigning resources and evaluating the Company’s go-to-market approach. This initiative aims to accelerate revenue growth and reduce dependence on external financing. As part of this strategic realignment, the Company made selective workforce reductions and appointed new executive leaders with significant experience scaling companies globally in the critical infrastructure sector.

These executives will guide sales and operational resources, focusing specifically on Rekor Scout^® products and services for public safety and commercial markets and Rekor Discover^® products designed for advanced roadway data collection. Rekor Scout^® solutions serve diverse users, from local police departments and government agencies to commercial and residential property owners worldwide. Rekor Discover^® has gained substantial domestic traction in multiple states, including Georgia, South Carolina, Virginia, New Mexico, Arkansas, and Florida.

Robert A. Berman, Interim President and CEO and Board Chairman, concluded: “Our strategic realignment underscores Rekor’s commitment to disciplined growth, operational efficiency, and enhancing shareholder value. By focusing our resources on proven, high-impact products such as Rekor Scout^® and Rekor Discover^® and strengthening our leadership with seasoned executives who have successfully scaled global infrastructure businesses, we are well-positioned to accelerate revenue growth while reducing our reliance on external capital.”

Year and Three Months Ended December 31, 2024 Financial Results

This section highlights the changes for the year and three months ended December 31, 2024, compared to the year and three months ended December 31, 2023.

Revenues

The increase in revenue for the year and three months ended December 31, 2024, compared to the for the year and three months ended December 31, 2023, was primarily attributable to our Urban Mobility revenue stream, which consists of revenue derived from roadway data aggregation activities. For the year and three months ending December 31, 2024, revenue attributable to ATD was $10,125,000 and $2,697,000, respectively, and is included as part of the Urban Mobility revenue stream.

Cost of Revenue, excluding Depreciation and Amortization

For the year and three months ended December 31, 2024, the cost of revenue, excluding depreciation and amortization, increased compared to the corresponding prior periods primarily due to an increase in personnel and other direct costs, such as hardware, that were incurred to support our increase in revenue. Additionally, during the year and three months ended December 31, 2024, $3,672,000 and $1,085,000 of the increase was related to our acquisition of ATD. The additional increase in the cost of revenue, excluding depreciation and amortization, as well as the reduction in the Adjusted Gross Margin, was related to the mix of sales in 2024. Typically, our software sales carry a higher Adjusted Gross Margin. 

Loss from Operations, excluding impairment of intangible assets

Loss from operations, excluding impairment of intangible assets for the year and three months ended December 31, 2024, compared to the year and three months ended December 31, 2023, increased primarily due to some of the additional operating costs of ATD, including the additional depreciation and amortization of intangible assets associated with the acquisition.

EBITDA and Adjusted EBITDA

The Company calculates EBITDA as net loss before interest, taxes, depreciation, and amortization. The Company calculates Adjusted EBITDA as net loss before interest, taxes, depreciation, and amortization, adjusted for (i) impairment of intangible assets, (ii) loss on extinguishment of debt, (iii) stock-based compensation, (iv) losses or gains on sales of subsidiaries, and (v) other unusual or non-recurring items. EBITDA and Adjusted EBITDA are not measurements of financial performance or liquidity under accounting principles generally accepted in the U.S. (“U.S. GAAP”) and should not be considered as an alternative to net earnings or cash flow from operating activities as indicators of our operating performance or as a measure of liquidity or any other measures of performance derived in accordance with U.S. GAAP. EBITDA and Adjusted EBITDA are presented because we believe they are frequently used by securities analysts, investors, and other interested parties to evaluate a Company’s ability to service and/or incur debt. However, other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do.

The following table sets forth the components of the EBITDA and Adjusted EBITDA for the periods included (dollars in thousands):

Rekor has scheduled a conference call to discuss the year end 2024 results on Monday, March 31, 2025, at 4:30 P.M. (Eastern).

Any person interested in participating in the call should please dial in approximately 10 minutes prior to the start of the call using the following information:

North America: 877-407-8037 / 201-689-8037

International: 


Click here for participant International Toll-Free access numbers

Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=UaMhmm4p

REPLAY INFORMATION

A replay will be made available online approximately two hours following the live call for a period of two weeks. To access the replay, use the following numbers:
Replay Dial-In: 877-660-6853 / 201-612-7415
Access ID: 13751639

An archived webcast will also be available to replay this conference call directly from the Company’s website under Investors, Events & Presentations.

About Rekor Systems, Inc.
Rekor Systems, Inc. (NASDAQ: REKR) is a leader in developing and implementing state-of-the-art roadway intelligence systems using AI-enabled computer vision and machine learning. As a pioneer in the implementation of digital infrastructure, Rekor is collecting, connecting, and organizing the world’s mobility data – laying the foundation for a digitally-enabled operating system for the roadway. With our Rekor One^® Roadway Intelligence Engine at the core of our technology, we aggregate and transform trillions of data points into intelligence through proprietary computer vision, machine learning, and big data analytics that power our platforms and applications. Our solutions provide actionable insights that give governments and businesses a comprehensive picture of roadways while providing a collaborative environment that drives the world to be safer, greener, and more efficient. To learn more, please visit our website: https://rekor.ai, and follow Rekor on social media on LinkedIn, X (formerly Twitter), Threads, and Facebook.

Forward-Looking Statements

This press release and its links and attachments contain statements concerning Rekor Systems, Inc. and its future expectations, plans, and prospects that constitute “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, including statements regarding the impact of Rekor’s core suite of AI-powered technology and the size and shape of the global market for ALPR systems. Such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” by the negative of these terms or by other similar expressions. You are cautioned that such statements are subject to many risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual circumstances, events or results may differ materially from those projected in the forward-looking statements, particularly as a result of various risks and other factors identified in our filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events, or otherwise.

Company Contact:

Rekor Systems, Inc.
Eyal Hen
Chief Financial Officer
Phone: +1 (443) 545-7260
[email protected]

Media & Investor Relations Contact:

Rekor Systems, Inc.
Charles Degliomini
[email protected]

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FDA accepted New Drug Application filing for priority review for CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025

MIAMI, March 31, 2025 (GLOBE NEWSWIRE) — Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2024.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “The fourth quarter of 2024 was transformational for Fortress, marked by two FDA approvals — Emrosi™ and UNLOXCYT™ — as well as the FDAs’ recent acceptance of the New Drug Application for CUTX-101. Additionally, we congratulate Fortress-founded partner company, Checkpoint Therapeutics, Inc. (“Checkpoint”), as earlier this month they signed an exciting agreement that delivers FDA approved UNLOXCYT into the capable and established global commercial organization at Sun Pharma, which is expected to expedite patient access. This transaction is also a successful milestone for Fortress as we expect to receive approximately $28 million at closing in addition to a 2.5% royalty on net sales of UNLOXCYT, and up to an additional $4.8 million if the contingent value right (CVR) is achieved. These milestones continue to validate the Fortress business model. We aim to acquire and advance assets to their full potential, in this specific case, with an exit strategy that benefits patients and maximizes value for our shareholders.”

Dr. Rosenwald continued, “Looking ahead, we are focused on our next key milestone: the September 30, 2025, Prescription Drug User Fee Act (“PDUFA”) goal date for CUTX-101. Upon approval of the New Drug Application, our majority-owned subsidiary, Cyprium Therapeutics, may be eligible for a Priority Review Voucher. The commercial launch of Emrosi for inflammatory lesions of rosacea is underway with first prescriptions filled, and we expect continued revenue growth, portfolio milestone achievements and additional future monetization opportunities given our significant pipeline of late clinical-stage candidates and recently approved products. This is an exciting time for Fortress, and we remain committed to building shareholder value while delivering innovative treatment options to patients with unmet medical needs.”

Recent Corporate Highlights



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Monetization Updates

• In March 2025, our subsidiary Checkpoint entered into an agreement to be acquired by Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”). Fortress owns approximately 6.9 million shares (including Class A Common on an as-converted basis) of Checkpoint’s common stock and is eligible for a 2.5% royalty on future sales of UNLOXCYT (cosibelimab-ipdl), pursuant to a royalty agreement between Checkpoint, Sun Pharma and Fortress. Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right (CVR) entitling the stockholder to receive up to an additional $0.70 in cash if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the contingent value rights agreement. The transaction is expected to be completed in the second quarter of 2025. The transaction is subject to customary closing conditions, including required regulatory approvals and approval by the holders of a majority of the voting power of outstanding shares of Checkpoint common stock, and by the holders of a majority of the shares of Checkpoint common stock that are not held by Fortress or by certain other affiliates of Checkpoint. In connection with the transaction, Fortress, which holds a majority of Checkpoint’s outstanding voting power, has agreed to vote in favor of the transaction.
• In July 2024, our majority-owned and controlled subsidiary company Urica Therapeutics (“Urica”), entered into an asset purchase agreement, royalty agreement and related agreements with Crystalys Therapeutics (“Crystalys”). Urica transferred rights to dotinurad, its URAT1 inhibitor product candidate in development for the treatment of gout, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity and granted Urica a secured 3% royalty on future net sales of dotinurad.

Regulatory Updates

• In November 2024, the U.S. Food and Drug Administration (“FDA”) approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg), also known as DFD-29. Emrosi has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions of rosacea. In February 2025, we hosted a webcast to discuss the U.S. commercial launch plan for Emrosi, and in March 2025, we announced the launch of Emrosi by our partner company, Journey Medical Corporation (“Journey Medical”) (Nasdaq: DERM).
• In December 2024, the FDA approved UNLOXCYT, also known as cosibelimab, our anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation. UNLOXCYT was developed at our partner company, Checkpoint (Nasdaq: CKPT).
• The FDA recently accepted the New Drug Application (“NDA”) submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a PDUFA goal date of September 30, 2025. In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics (“Sentynl”), a wholly owned subsidiary of Zydus Lifesciences Ltd. Sentynl completed the rolling submission of the NDA for CUTX-101 in the fourth quarter of 2024. Cyprium Therapeutics, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA Priority Review Voucher that may be issued at NDA approval.

Clinical Updates

• In March 2025, we announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg (“DFD-29” or “Emrosi”) for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association – Dermatology. The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. The full publication is available at https://jamanetwork.com/journals/jamadermatology/article-abstract/2830693. Information on such website is not a part of this release.
• In January 2025, we announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus (“CMV”) vaccine, when administered to human leukocyte antigen matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation.
• In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral doxycycline 40 mg capsules (Oracea®) in healthy subjects. With its extended-release formulation, Emrosi provides higher dermal concentration than doxycycline from day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea, and as demonstrated in Emrosi’s Phase 3 clinical trials.
• In September 2024, we presented longer-term data from Checkpoint’s pivotal trial of UNLOXCYT in locally advanced and metastatic cSCC during the European Society for Medical Oncology Congress 2024. The longer-term results for UNLOXCYT demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses.
• In May 2024, we announced that the first patient was dosed in a multicenter, placebo-controlled, randomized Phase 2 study of Triplex in patients undergoing liver transplantation. The trial will enroll up to 416 CMV seronegative prospective liver transplant recipients and will be conducted across up to 20 nationally recognized transplant centers in the U.S. The trial is funded by a grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health that could provide over $20 million in non-dilutive funding. We believe this data set could ultimately be used to support the approval of Triplex in this setting.

Commercial Product Updates

• Journey Medical’s net product revenues for the full year ended December 31, 2024, were $55.1 million, compared to net product revenues of $59.7 million for the full year ended December 31, 2023.

General Corporate:

• In March 2025, Fortress entered into a strategic collaboration with Partex NV to identify and evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing by Fortress.
• Throughout 2024, Fortress raised total net proceeds of approximately $21.1 million through equity offerings.
• Throughout 2024, Checkpoint raised total net proceeds of approximately $32.8 million through equity offerings and the exercise of existing warrants.
• Throughout 2024, our partner Mustang Bio, Inc. (“Mustang”) raised total net proceeds of approximately $11.2 million through equity offerings and the exercise of existing warrants. Subsequently, Mustang raised net proceeds of $6.9 million in a public offering in February 2025.
• Throughout 2024, our partner Avenue Therapeutics, Inc. (“Avenue”) raised total net proceeds of approximately $9.8 million through equity offerings and the exercise of existing warrants.
• Throughout 2024, Journey Medical raised total net proceeds of approximately $7.9 million through equity offerings.
• In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the pause should be lifted.
• Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. (“Oaktree”), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in an outstanding debt reduction of approximately $15 million of debt excluding accrued interest and prepayment fees.

Financial Results:

• As of December 31, 2024, Fortress’ consolidated cash and cash equivalents totaled $57.3 million, compared to $58.9 million as of September 30, 2024, and $80.9 million as of December 31, 2023, a decrease of $1.6 million for the fourth quarter and a decrease of $23.6 million for the full year.
• Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and includes $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang and $20.3 million attributable to Journey Medical.
• Fortress’ consolidated net revenue totaled $57.7 million for the full year ended December 31, 2024, which included $55.1 million in net revenue generated from our marketed dermatology products. This compares to consolidated net revenue totaling $84.5 million for the full year ended 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.
• Consolidated research and development expenses including license acquisitions totaled $56.9 million for the full year ended December 31, 2024, compared to $106.1 million for the full year ended December 31, 2023.
• Consolidated selling, general and administrative costs were $87.7 million for the full year ended December 31, 2024, compared to $91.0 million for the full year ended December 31, 2023.
• Consolidated net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the full year ended December 31, 2024, compared to net loss attributable to common stockholders of $(68.7) million, or $(8.47) per share for the full year ended December 31, 2023.

About Fortress Biotech

Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has eight marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements

Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and completion of the closing of the acquisition of Checkpoint by Sun Pharma and the failure to realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contact:

Jaclyn Jaffe
Fortress Biotech, Inc.
(781) 652-4500
[email protected]

Media Relations Contact:

Tony Plohoros
6 Degrees
(908) 591-2839
[email protected]