Market Newsdesk

Quantum Announces Preliminary Fiscal Fourth Quarter 2025 Financial Results

SAN JOSE, Calif.–(BUSINESS WIRE)–
Quantum Corporation (Nasdaq: QMCO) (“Quantum” or the “Company”), a leader in solutions for AI and unstructured data, today announced select preliminary financial results for its fiscal fourth quarter of 2025 ended March 31, 2025.

Based on preliminary unaudited financials, the Company expects its reported results for fiscal fourth quarter of 2025 to reflect the following:

• Revenue of $65 – $67 million, in line with guidance of $66 million, plus or minus $2.0 million
• Gross margin of approximately 44%, plus or minus 1%
• GAAP net loss of approximately $3.5 million, plus or minus $1.0 million

Quantum will release its full results for the fiscal fourth quarter and full fiscal year ended March 31, 2025 in mid-June 2025.

About Quantum

Quantum delivers end-to-end data management solutions designed for the AI era. With over four decades of experience, our data platform has allowed customers to extract the maximum value from their unique, unstructured data. From high-performance ingest that powers AI applications and demanding data-intensive workloads, to massive, durable data lakes to fuel AI models, Quantum delivers the most comprehensive and cost-efficient solutions. Leading organizations in life sciences, government, media and entertainment, research, and industrial technology trust Quantum with their most valuable asset – their data. Quantum is listed on Nasdaq (QMCO). For more information visit www.quantum.com.

Quantum and the Quantum logo are registered trademarks of Quantum Corporation and its affiliates in the United States and/or other countries. All other trademarks are the property of their respective owners.

Forward-Looking Information

The results reported in this press release are preliminary and unaudited, and are subject to change. The Company has not yet completed its annual financial close process for the fiscal 2025 fourth quarter and full fiscal year, and its independent auditors have not completed their audit of the Company’s financial statements for the full fiscal year ended March 31, 2025. The financial results in this earnings report does not present all necessary information for an understanding of the Company’s results of operations for the fiscal 2025 fourth quarter and full fiscal year. As the Company completes its financial close process and finalizes its financial statements, and as its independent auditors complete their review of the Company’s financial statements for the fiscal year ended March 31, 2025, it is possible the Company may identify items that require adjustments to the preliminary financial information set forth in this press release, and those changes could be material. The Company does not intend to update such financial information prior to the filing of its Annual Report on Form 10-K with the Securities and Exchange Commission (the “SEC”) for the fiscal year ended March 31, 2025, except as otherwise required by law.

The information provided in this press release may include 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. These forward-looking statements are largely based on our current expectations and projections about future events and financial trends affecting our business. Such forward-looking statements include, in particular, statements related to our financial results for the fourth quarter ended March 31, 2025.

These forward-looking statements may be identified by the use of terms and phrases such as “anticipates”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “plans”, “projects”, “targets”, “will”, and similar expressions or variations of these terms and similar phrases. Additionally, statements concerning future matters and other statements regarding matters that are not historical are forward-looking statements. Investors are cautioned that these forward-looking statements relate to future events or our future performance and are subject to business, economic, and other risks and uncertainties, both known and unknown, that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by any forward-looking statements.

These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, including without limitation, the following: risks related to the completion of the Company’s annual financial close process and the independent auditors’ audit of the Company’s financial statements for the full fiscal year; any changes to the assumptions underlying the Company’s closing process and auditors’ audit; risks that the Company may identify additional items that require adjustments to the preliminary financial information; risks related to the need to address the many challenges facing our business; the impact macroeconomic and inflationary conditions on our business, including potential disruptions to our supply chain, employees, operations, sales and overall market conditions; the competitive pressures we face; risks associated with executing our strategy; the distribution of our products and the delivery of our services effectively; the development and transition of new products and services and the enhancement of existing products and services to meet customer needs and respond to emerging technological trends; estimates and assumptions related to the cost (including any possible disruption of our business) and the anticipated benefits of the transformation and restructuring plans, including equity and debt financing options; the outcome of any claims and disputes; the ability to meet stock exchange continued listing standards; risks related to our ability to implement and maintain effective internal control over financial reporting in the future; and other risks that are described herein, including but not limited to the items discussed in “Risk Factors” in our filings with the SEC, including our Annual Report on Form 10-K filed with the SEC on June 28, 2024, and any subsequent reports filed with the SEC. We do not intend to update or alter our forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250506988584/en/

Investor Relations Contacts:

Shelton Group

Leanne K. Sievers | Brett L. Perry

E: [email protected]

P: 214-272-0070

Media Contact:

Matter Communications

Sara Beth Fahey

E: [email protected]

P: 401-351-9507

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Software Technology Data Management Apps/Applications

MEDIA:

Logo

Sangamo Therapeutics Announces Important Derisking Milestones in Pathway to Anticipated BLA Submission for ST-920 in Fabry Disease

• All dosed patients have passed one-year milestone required by U.S. Food and Drug Administration (FDA) for Accelerated Approval regulatory pathway for ST-920.
• According to preliminary analysis, mean estimated glomerular filtration rate (eGFR) slope at 52-weeks continued to remain positive.
• Productive Type B Chemistry, Manufacturing and Controls (CMC) meeting with FDA provided clear CMC pathway to planned Biologics License Application (BLA) submission.
• Pivotal data readout expected by end of second quarter of 2025.

RICHMOND, Calif.–(BUSINESS WIRE)–
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced important derisking events in the pathway to a planned BLA submission for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.

All dosed patients in the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec have now completed at least 52-weeks of follow-up, a key milestone required by the FDA for an Accelerated Approval regulatory pathway for ST-920. Preliminary analysis of clinical data collected as of this 52-week milestone date across all 32 dosed patients indicates that the mean eGFR slope continued to remain positive, following the last clinical update at the WORLDSymposium in February 2025, with a data cutoff date of September 12, 2024. The product candidate continues to be well tolerated. A pivotal data readout is expected by the end of the second quarter of 2025.

Furthermore, in April 2025, Sangamo held a productive Type B meeting with the FDA, providing Sangamo with a clear CMC pathway to a planned BLA submission in the first quarter of 2026, including clarity on plans for process validation, path to commercial specifications and the commercial launch manufacturing site. This BLA submission timeline would facilitate a potential approval and commercial launch as early as the second half of 2026.

“Following last year’s alignment with the FDA on an Accelerated Approval regulatory pathway for ST-920, we are excited to have now gathered the one-year mean eGFR slope data that will serve as the primary efficacy endpoint for our planned BLA submission,” said Nathalie Dubois-Stringfellow, Ph. D., Chief Development Officer at Sangamo. “Coupled with our recent productive FDA Type B meeting, we have a clear regulatory pathway to a potential approval decision for ST-920 and we continue to advance BLA preparation activities.”

Discussions with the European Medicines Agency (EMA) on the proposed pathway to potential approval for isaralgagene civaparvovec in Europe are ongoing. In addition, Sangamo continues to engage in business development negotiations for a potential Fabry commercialization agreement.

About the STAAR Study

The Phase 1/2 STAAR study is a global open-label, single-dose, dose-ranging, multicenter clinical study designed to evaluate the safety and tolerability of isaralgagene civaparvovec, or ST-920, a gene therapy product candidate in patients with Fabry disease. Isaralgagene civaparvovec requires a one-time infusion without preconditioning. The STAAR study enrolled male and female patients who are on ERT, are ERT pseudo-naïve (defined as having been off ERT for six or more months), or who are ERT-naïve. The FDA has granted Orphan Drug, Fast Track and RMAT designations to isaralgagene civaparvovec, which has also received Orphan Medicinal Product designation and PRIME eligibility from the EMA and Innovative Licensing and Access Pathway from U.K. Medicines and Healthcare products Regulatory Agency.

About Fabry Disease

Fabry disease is a lysosomal storage disorder caused by mutations in the galactosidase alpha gene (GLA), which leads to deficient alpha-galactosidase A (α-Gal A) enzyme activity, which is necessary for metabolizing globotriaosylceramide (Gb3). The buildup of Gb3 in the cells can cause serious damage to vital organs, including the kidney, heart, nerves, eyes, gut and skin. Symptoms of Fabry disease can include decreased or absent sweat production, heat intolerance, angiokeratoma (skin blemishes), vision problems, kidney disease, heart failure, gastrointestinal disturbance, mood disorders, neuropathic pain and tingling in the extremities.

About Sangamo Therapeutics

Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including in the central nervous system. Sangamo’s pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit www.sangamo.com and connect with us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements regarding Sangamo’s current expectations. These forward-looking statements include, without limitation, statements relating to: the safety and efficacy and therapeutic potential of isaralgagene civaparvovec; the potential for isaralgagene civaparvovec to qualify for the FDA’s Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to serve as the primary efficacy endpoint for, and otherwise support, any such approval; expectations concerning the timing of the pivotal data readout and the availability of additional data to support a potential BLA submission for isaralgagene civaparvovec, and the timing of such submission; expectations concerning Sangamo’s regulatory pathway for isaralgagene civaparvovec, including potential regulatory approval and commercial launch of isaralgagene civaparvovec and the timing thereof; Sangamo’s plans to seek a potential collaboration partner for isaralgagene civaparvovec; expectations concerning potential approval of isaralgagene civaparvovec in other jurisdictions; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to Sangamo’s lack of capital resources to obtain regulatory approval for and commercialize its product candidates in a timely manner or at all, including Sangamo’s ability to secure a partnership for isaralgagene civaparvovec and its other product candidates; the uncertain timing and unpredictable nature of clinical trial results, including the risk that the therapeutic effects observed in the latest preliminary clinical data from the Phase 1/2 STAAR study will not be durable in patients and that final clinical trial data from the study will not validate the safety and efficacy of isaralgagene civaparvovec, including that the 52-week data from the Phase 1/2 STAAR study will not support a BLA submission and/or that the 104-week data from such study will not verify the clinical benefit of isaralgagene civaparvovec or support FDA approval, and that the patients withdrawn from ERT will remain off ERT; the uncertain regulatory approval process, including the risk that Sangamo will not be able to achieve regulatory approval of isaralgagene civaparvovec on the expected timeframe or at all; risks related to the complex process of manufacturing product candidates; Sangamo’s need for substantial additional funding to execute its operating plan and to continue to operate as a going concern; the effects of macroeconomic factors or financial challenges on the global business environment, healthcare systems and Sangamo’s business and operations; the research and development process; the unpredictable regulatory approval process for product candidates across multiple regulatory authorities; the potential for technological developments that obviate technologies used by Sangamo; Sangamo’s reliance on collaborators and the potential inability to secure additional collaborations; and Sangamo’s ability to achieve expected future financial performance.

There can be no assurance that Sangamo and its current or potential future collaborators will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and its collaborators. These risks and uncertainties are described more fully in Sangamo’s Securities and Exchange Commission, or SEC, filings and reports, including in Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC, and future filings and reports that Sangamo makes from time to time with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250506348008/en/

Investor Relations

Louise Wilkie

[email protected]

Media Inquiries

Melinda Hutcheon

[email protected]

KEYWORDS: North America United States Ireland United Kingdom Europe California

INDUSTRY KEYWORDS: Health FDA Genetics Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo

UWM Holdings Corporation Announces First Quarter 2025 Results

First Quarter Loan Origination Volume of $32.4 Billion, up 17% Year Over Year, Highest Q1 Originations Since 2022

PONTIAC, Mich.–(BUSINESS WIRE)–UWM Holdings Corporation (NYSE: UWMC) (the “Company”), the publicly traded indirect parent of United Wholesale Mortgage (“UWM”), today announced its results for the first quarter ended March 31, 2025. Total loan origination volume was $32.4 billion for the first quarter 2025. The Company also reported 1Q25 total revenue of $613.4 million and a net loss of $247.0 million, inclusive of a decline in fair value of mortgage servicing rights of $388.6 million.

Mat Ishbia, Chairman, Chief Executive Officer and President of UWMC, said, “The first quarter marked another win for UWM. We executed with precision and broker market share grew. When rates briefly dipped, we swiftly capitalized on the refinance opportunity—all while maintaining our best-in-class performance in the purchase market. In both Q4 of 2024 and Q1 of 2025, we once again proved our ability to quickly adapt and scale in response to rate changes, a direct result of the investments and groundwork we’ve laid over the past three years. Our focus remains on building long-term, sustainable value—not chasing short-term gains—and we’re confident in our ability to perform across all market conditions, even amid economic uncertainty and volatility.”

First Quarter 2025 Highlights

• Originations of $32.4 billion in 1Q25, compared to $38.7 billion in 4Q24 and $27.6 billion in 1Q24
• Purchase originations of $21.7 billion in 1Q25, compared to $21.9 billion in 4Q24 and $22.1 billion in 1Q24
• Total gain margin of 94 bps in 1Q25 compared to 105 bps in 4Q24 and 108 bps in 1Q24
• Total revenue of $613.4 million in 1Q25 compared to $720.6 million in 4Q24 and $585.5 million in 1Q24
• Net loss of $247.0 million in 1Q25 compared to net income of $40.6 million in 4Q24 and net income of $180.5 million in 1Q24
• Adjusted EBITDA of $57.8 million in 1Q25 compared to $118.2 million in 4Q24 and $101.5 million in 1Q24
• Total equity of $1.6 billion at March 31, 2025, compared to $2.1 billion at December 31, 2024, and $2.5 billion at March 31, 2024
• Unpaid principal balance of MSRs of $214.6 billion with a WAC of 5.44% at March 31, 2025, compared to $242.4 billion with a WAC of 4.76% at December 31, 2024, and $229.7 billion with a WAC of 4.58% at March 31, 2024
• Ended 1Q25 with approximately $2.4 billion of available liquidity, including $485.0 million of cash and available borrowing capacity under our secured and unsecured lines of credit

Production and Income Statement Highlights (dollars in thousands, except per share amounts)
	Q1 2025				Q4 2024				Q1 2024
Loan origination volume(1)	$	32,351,776			$	38,664,357			$	27,630,535
Total gain margin(1)(2)		0.94	%			1.05	%			1.08	%
Total revenue	$	613,370			$	720,596			$	585,519
Net income (loss)		(247,028	)			40,613				180,531
Diluted earnings (loss) per share		(0.12	)			0.02				0.09
Adjusted net income (loss)(3)		(195,300	)			33,040				141,121
Adjusted EBITDA(3)		57,803				118,158				101,490
(1) Key operational metric (see discussion below)
(2) Represents total loan production income divided by loan origination volume.
(3) Non-GAAP metric (see discussion and reconciliations below).

Balance Sheet Highlights as of Period-end (dollars in thousands)
		Q1 2025				Q4 2024				Q1 2024
Cash and cash equivalents		$	485,024			$	507,339			$	605,639
Mortgage loans at fair value			8,402,211				9,516,537				7,338,135
Mortgage servicing rights			3,321,457				3,969,881				3,191,803
Total assets			14,048,433				15,671,116				12,797,334
Non-funding debt (1)			3,149,687				3,401,066				2,311,850
Total equity			1,635,349				2,053,848				2,457,058
Non-funding debt to equity (1)			1.93				1.66				0.94
(1) Non-GAAP metric (see discussion and reconciliations below).

Mortgage Servicing Rights (dollars in thousands)
		Q1 2025				Q4 2024				Q1 2024
Unpaid principal balance		$	214,615,072			$	242,405,767			$	229,706,006
Weighted average interest rate			5.44	%			4.76	%			4.58	%
Weighted average age (months)			19				24				22

First Quarter Business and Product Highlights

Sphere LOS Partnership

• We partnered with Sphere LOS, providing our brokers with an all-in-one workflow platform. The platform will be offered for free for UWM clients for two years to help with adoption of the software.

TRAC Lite Expansion

• TRAC Lite, a cost-effective title option for borrowers, was expanded to additional states. Now available in 14 states, this product is offered for a flat fee ranging from $375 to $475.

Paid Search Accelerator

• A UWM tool, designed to help loan officers increase their online visibility and lead generation. For a fixed cost, this tool helps enhance the online presence and brand building for loan officers, increase leads driven to LO’s Mortgage Matchup profiles and raises Google ads to the top of search results.

Product and Investor Mix – Unpaid Principal Balance of Originations (dollars in thousands)
Purchase:		Q1 2025			Q4 2024			Q1 2024
Conventional		$	13,179,468		$	13,841,424		$	12,160,107
Government			6,673,499			6,069,761			7,567,925
Jumbo and other (1)			1,894,070			1,941,420			2,393,397
Total Purchase		$	21,747,037		$	21,852,605		$	22,121,429
Refinance:		Q1 2025			Q4 2024			Q1 2024
Conventional		$	4,339,327		$	8,898,500		$	1,716,281
Government			4,699,294			6,415,421			2,657,541
Jumbo and other (1)			1,566,118			1,497,831			1,135,284
Total Refinance		$	10,604,739		$	16,811,752		$	5,509,106
Total Originations		$	32,351,776		$	38,664,357		$	27,630,535
(1) Comprised of non-agency jumbo products, construction loans, and non-qualified mortgage products, including home equity lines of credit (“HELOCs”) (which in many instances are second liens).

Second Quarter 2025 Outlook

We anticipate second quarter production to be in the $38 to $45 billion range, with gain margin from 90 to 115 basis points.

Dividend

Subsequent to March 31, 2025, for the eighteenth consecutive quarter, the Company’s Board of Directors declared a cash dividend of $0.10 per share on the outstanding shares of Class A common stock. The dividend is payable on July 10, 2025, to stockholders of record at the close of business on June 18, 2025. Additionally, the Board approved a proportional distribution to SFS Corp., which is payable on or around July 10, 2025.

Earnings Conference Call Details

As previously announced, the Company will hold a conference call for financial analysts and investors on Tuesday, May 6, 2025, at 10:00 AM ET to review the results and answer questions. Interested parties may register for a toll-free dial-in number by visiting:

https://registrations.events/direct/Q4I746365

Please dial in at least 15 minutes in advance to ensure a timely connection to the call. Audio webcast, taped replay and a transcript and supporting materials will be available on the Company’s investor relations website at https://investors.uwm.com/.

Key Operational Metrics

“Loan origination volume” and “Total gain margin” are key operational metrics that the Company’s management uses to evaluate the performance of the business. “Loan origination volume” is the aggregate principal of the residential mortgage loans originated by the Company during a period. “Total gain margin” represents total loan production income divided by loan origination volume for the applicable periods.

Non-GAAP Metrics

The Company’s net income does not reflect the income tax provision that would otherwise be reflected if 100% of the economic interest in UWM was owned by the Company. Therefore, for comparison purposes, the Company provides “Adjusted net income (loss),” which is our pre-tax income (loss) together with an adjusted income tax provision (benefit), which is calculated as the provision for income taxes plus the tax effects of net income attributable to non-controlling interest determined using a blended statutory effective tax rate. “Adjusted net income (loss)” is a non-GAAP metric. “Adjusted diluted EPS” is defined as “Adjusted net income (loss)” divided by the weighted average number of shares of Class A common stock outstanding for the applicable period, assuming the exchange and conversion of all outstanding Class D common stock for Class A common stock, and is calculated and presented for periods in which the assumed exchange and conversion of Class D common stock to Class A common stock is anti-dilutive to EPS.

We also disclose Adjusted EBITDA, which we define as earnings before interest expense on non-funding debt, provision for income taxes, depreciation and amortization, adjusted to exclude stock-based compensation expense, the change in fair value of MSRs due to valuation inputs or assumptions, gains or losses on other interest rate derivatives, the impact of non-cash deferred compensation expense, the change in fair value of the Public and Private Warrants, the non-cash income/expense impact of the change in the Tax Receivable Agreement liability, and the change in fair value of retained investment securities as we believe these adjustments are not indicative of our performance or results of operations. Adjusted EBITDA includes interest expense on funding facilities, which are recorded as a component of interest expense, as these expenses are a direct operating expense driven by loan origination volume. By contrast, interest expense on non-funding debt is a function of our capital structure and is therefore excluded from Adjusted EBITDA.

In addition, we disclose “Non-funding debt” and the “Non-funding debt to equity ratio” as a non-GAAP metric. We define “Non-funding debt” as the total of the Company’s senior notes, lines of credit, borrowings against investment securities, and finance leases and the “Non-funding debt-to-equity ratio” as total non-funding debt divided by the Company’s total equity.

Management believes that these non-GAAP metrics provide useful information to investors. These measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for any other operating performance measure calculated in accordance with GAAP and may not be comparable to a similarly titled measure reported by other companies.

The following tables set forth the reconciliations of these non-GAAP financial measures to their most directly comparable financial measure calculated in accordance with GAAP (dollars in thousands, except per share amounts):

Adjusted net income		Q1 2025				Q4 2024				Q1 2024
Earnings (loss) before income taxes		$	(260,816	)		$	42,332			$	184,264
Adjusted income tax (provision) benefit			65,516				(9,292	)			(43,143	)
Adjusted net income (loss)		$	(195,300	)		$	33,040			$	141,121
Adjusted EBITDA		Q1 2025				Q4 2024				Q1 2024
Net income (loss)		$	(247,028	)		$	40,613			$	180,531
Interest expense on non-funding debt			50,081				44,882				40,243
Provision (benefit) for income taxes			(13,788	)			1,719				3,733
Depreciation and amortization			11,340				11,094				11,340
Stock-based compensation expense			8,310				8,999				5,876
Change in fair value of MSRs due to valuation inputs or assumptions			250,821				(456,253	)			(141,059	)
Loss on other interest rate derivatives			—				469,538				—
Deferred compensation, net			914				2,191				1,063
Change in fair value of Public and Private Warrants			(685	)			(8,495	)			(686	)
Change in Tax Receivable Agreement liability			(442	)			(110	)			180
Change in fair value of investment securities			(1,721	)			3,980				269
Adjusted EBITDA		$	57,803			$	118,158			$	101,490

Non-funding debt and non-funding debt to equity	Q1 2025				Q4 2024				Q1 2024
Senior notes	$	2,786,467			$	2,785,326			$	1,989,250
Secured lines of credit		250,000				500,000				200,000
Borrowings against investment securities		88,775				90,646				94,064
Finance lease liability		24,445				25,094				28,536
Total non-funding debt	$	3,149,687			$	3,401,066			$	2,311,850
Total equity	$	1,635,349			$	2,053,848			$	2,457,058
Non-funding debt to equity		1.93				1.66				0.94

Cautionary Note Regarding Forward-Looking Statements

This press release and our earnings call include forward-looking statements. These forward-looking statements are generally identified using words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict” and similar words indicating that these reflect our views with respect to future events. Forward-looking statements in this press release and our earnings call include statements regarding: (1) our ability to quickly capitalize on the refinance markets and its impact on our market performance; (2) our ability to adapt and scale our business when interest rates move; (3) the launch of our internal servicing; (4) our ability to handle our origination volume while limiting the impact on our fixed costs; (5) our position amongst our competitors and ability to capture market share; (6) our beliefs regarding opportunities in 2025 for our business and the broker channel; (7) our beliefs regarding operational profitability; (8) growth of the wholesale and broker channels, the impact of our strategies on such growth and the benefits to our business of such growth; (9) our growth and strategies to remain the leading mortgage lender, and the timing and drivers of that growth; (10) the benefits and liquidity of our MSR portfolio; (11) our beliefs related to the amount and timing of our dividend; (12) our expectations for future market environments, including interest rates, levels of refinance activity and the timing of such market changes; (13) our expectations related to production, gain margin and our overall success in the second quarter of 2025; (14) our performance in shifting market conditions and the comparison of such performance against our competitors; (15) our ability to produce results in future years at or above prior levels or expectations, and our strategies for producing such results; (16) our position and ability to capitalize on market opportunities and the impacts to our results and (17) our investments in technology and the impact to our operations, ability to scale and financial results. These statements are based on management’s current expectations, but are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to materially differ from those stated or implied in the forward-looking statements, including: (i) UWM’s dependence on macroeconomic and U.S. residential real estate market conditions, including changes in U.S. monetary policies, more specifically caused by changes in Presidential Administration that affect interest rates and inflation; (ii) UWM’s reliance on its warehouse and MSR facilities and the risk of a decrease in the value of the collateral underlying certain of its facilities causing an unanticipated margin call; (iii) UWM’s ability to sell loans in the secondary market; (iv) UWM’s dependence on the government-sponsored entities such as Fannie Mae and Freddie Mac; (v) changes in the GSEs, FHA, USDA and VA guidelines or GSE and Ginnie Mae guarantees; (vi) our ability to comply with all rules and regulations in connection with the launch of our internal servicing; (vii) UWM’s dependence on Independent Mortgage Advisors to originate mortgage loans; (viii) the risk that an increase in the value of the MBS UWM sells in forward markets to hedge its pipeline may result in an unanticipated margin call; (ix) UWM’s inability to continue to grow, or to effectively manage the growth of its loan origination volume; (x) UWM’s ability to continue to attract and retain its broker relationships; (xi) UWM’s ability to implement technological innovation, such as AI in our operations; (xii) the occurrence of a data breach or other failure of UWM’s cybersecurity or information security systems; (xiii) the occurrence of data breaches or other cybersecurity failures at our third-party sub- servicers or other third-party vendors; (xiv) UWM’s ability to continue to comply with the complex state and federal laws, regulations or practices applicable to mortgage loan origination and servicing in general; and (xv) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission including those under “Risk Factors” therein. We wish to caution readers that certain important factors may have affected and could in the future affect our results and could cause actual results for subsequent periods to differ materially from those expressed in any forward-looking statement made by or on behalf of us. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date hereof.

About UWM Holdings Corporation and United Wholesale Mortgage

Headquartered in Pontiac, Michigan, UWM Holdings Corporation (UWMC) is the publicly traded indirect parent of United Wholesale Mortgage, LLC (“UWM”). UWM is the nation’s largest home mortgage lender, despite exclusively originating mortgage loans through the wholesale channel. UWM has been the largest wholesale mortgage lender for ten consecutive years and is the largest purchase lender in the nation. With a culture of continuous innovation of technology and enhanced client experience, UWM leads the market by building upon its proprietary and exclusively licensed technology platforms, superior service and focused partnership with the independent mortgage broker community. UWM originates primarily conforming and government loans across all 50 states and the District of Columbia. For more information, visit uwm.com or call 800-981-8898. NMLS #3038.

UWM HOLDINGS CORPORATION CONSOLIDATED BALANCE SHEETS (in thousands, except shares and per share amounts)
			March 31, 2025			December 31, 2024
Assets			(Unaudited)
Cash and cash equivalents
(includes restricted cash of $16.1 million and $16.0 million, respectively)		$	485,024		$	507,339
Mortgage loans at fair value			8,402,211			9,516,537
Derivative assets			43,958			99,964
Investment securities at fair value, pledged			102,982			103,013
Accounts receivable, net			472,299			417,955
Mortgage servicing rights			3,321,457			3,969,881
Premises and equipment, net			153,855			146,199
Operating lease right-of-use asset
(includes $91,208 and $92,553 with related parties)			92,450			93,730
Finance lease right-of-use asset, net
(includes $22,221 and $22,737 with related parties)			22,464			23,193
Loans eligible for repurchase from Ginnie Mae			750,769			641,554
Other assets			200,964			151,751
Total assets		$	14,048,433		$	15,671,116
Liabilities and Equity
Warehouse lines of credit		$	7,573,139		$	8,697,744
Derivative liabilities			27,922			35,965
Secured line of credit			250,000			500,000
Borrowings against investment securities			88,775			90,646
Accounts payable, accrued expenses and other			652,701			580,736
Accrued distributions and dividends payable			159,856			159,827
Senior notes			2,786,467			2,785,326
Operating lease liability
(includes $97,768 and $99,199 with related parties)			99,010			100,376
Finance lease liability
(includes $24,182 and $24,608 with related parties)			24,445			25,094
Loans eligible for repurchase from Ginnie Mae			750,769			641,554
Total liabilities			12,413,084			13,617,268
Equity:
Preferred stock, $0.0001 par value – 100,000,000 shares authorized, none issued and outstanding as of March 31, 2025 or December 31, 2024			—			—
Class A common stock, $0.0001 par value – 4,000,000,000 shares authorized, 200,781,659 and 157,940,987 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively			20			16
Class B common stock, $0.0001 par value – 1,700,000,000 shares authorized, none issued and outstanding as of March 31, 2025 or December 31, 2024			—			—
Class C common stock, $0.0001 par value – 1,700,000,000 shares authorized, none issued and outstanding as of March 31, 2025 or December 31, 2024			—			—
Class D common stock, $0.0001 par value – 1,700,000,000 shares authorized, 1,397,782,620 and 1,440,332,098 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively			140			144
Additional paid-in capital			4,298			3,523
Retained earnings			160,407			157,837
Non-controlling interest			1,470,484			1,892,328
Total equity			1,635,349			2,053,848
Total liabilities and equity		$	14,048,433		$	15,671,116

UWM HOLDINGS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except shares and per share amounts)
	For the three months ended
	March 31, 2025				December 31, 2024				March 31, 2024
Revenue	(Unaudited)				(Unaudited)				(Unaudited)
Loan production income	$	304,751			$	407,229			$	298,954
Loan servicing income		190,517				173,300				184,702
Interest income		118,102				140,067				101,863
Total revenue		613,370				720,596				585,519
MSR valuation adjustments
Change in fair value of mortgage servicing rights		(388,585	)			309,149				(15,563	)
Gain (loss) on other interest rate derivatives		—				(469,538	)			—
MSR valuation adjustments, net		(388,585	)			(160,389	)			(15,563	)
Expenses
Salaries, commissions and benefits		192,800				193,155				154,241
Direct loan production costs		43,127				54,958				31,436
Marketing, travel, and entertainment		22,190				30,771				19,111
Depreciation and amortization		11,340				11,094				11,340
General and administrative		68,148				60,314				40,809
Servicing costs		30,434				29,866				30,324
Interest expense		120,410				142,342				98,668
Other expense (income)		(2,848	)			(4,625	)			(237	)
Total expenses		485,601				517,875				385,692
Earnings (loss) before income taxes		(260,816	)			42,332				184,264
Provision (benefit) for income taxes		(13,788	)			1,719				3,733
Net income (loss)		(247,028	)			40,613				180,531
Net income (loss) attributable to non-controlling interest		(233,349	)			31,694				171,801
Net income (loss) attributable to UWMC	$	(13,679	)		$	8,919			$	8,730
Earnings (loss) per share of Class A common stock:
Basic	$	(0.08	)		$	0.06			$	0.09
Diluted	$	(0.12	)		$	0.02			$	0.09
Weighted average shares outstanding:
Basic		164,100,022				155,584,329				94,365,991
Diluted		1,598,383,240				1,598,241,235				1,598,647,205

Addendum to Exhibit 99.1

This addendum includes the Company’s Consolidated Balance Sheets as of March 31, 2025, and the preceding four quarters and Statements of Operations for the quarter ended March 31, 2025, and the preceding four quarters for purposes of providing historical quarterly trending information to investors.

CONSOLIDATED BALANCE SHEETS (in thousands, except shares and per share amounts)
	March 31, 2025			December 31, 2024			September 30, 2024			June 30, 2024			March 31, 2024
Assets	(Unaudited)						(Unaudited)			(Unaudited)			(Unaudited)
Cash and cash equivalents, including restricted cash	$	485,024		$	507,339		$	636,327		$	680,153		$	605,639
Mortgage loans at fair value		8,402,211			9,516,537			10,141,683			8,236,183			7,338,135
Derivative assets		43,958			99,964			66,977			54,962			34,050
Investment securities at fair value, pledged		102,982			103,013			108,964			105,593			108,323
Accounts receivable, net		472,299			417,955			561,901			516,838			554,443
Mortgage servicing rights		3,321,457			3,969,881			2,800,054			2,650,090			3,191,803
Premises and equipment, net		153,855			146,199			147,981			146,750			145,265
Operating lease right-of-use asset		92,450			93,730			95,123			96,474			97,801
Finance lease right-of-use asset, net		22,464			23,193			24,020			25,061			26,890
Loans eligible for repurchase from Ginnie Mae		750,769			641,554			391,696			279,290			577,487
Other assets		200,964			151,751			145,072			130,247			117,498
Total assets	$	14,048,433		$	15,671,116		$	15,119,798		$	12,921,641		$	12,797,334
Liabilities and Equity
Warehouse lines of credit	$	7,573,139		$	8,697,744		$	9,207,746		$	7,429,591		$	6,681,917
Derivative liabilities		27,922			35,965			93,599			26,171			26,918
Secured line of credit		250,000			500,000			300,000			—			200,000
Borrowings against investment securities		88,775			90,646			93,662			91,406			94,064
Accounts payable, accrued expenses and other		652,701			580,736			573,865			486,138			477,765
Accrued distributions and dividends payable		159,856			159,827			159,818			159,766			159,702
Senior notes		2,786,467			2,785,326			1,991,216			1,990,233			1,989,250
Operating lease liability		99,010			100,376			101,833			103,247			104,637
Finance lease liability		24,445			25,094			25,836			26,787			28,536
Loans eligible for repurchase from Ginnie Mae		750,769			641,554			391,696			279,290			577,487
Total liabilities		12,413,084			13,617,268			12,939,271			10,592,629			10,340,276
Equity:
Preferred stock, $0.0001 par value – 100,000,000 shares authorized, none issued and outstanding as of each of the periods presented		—			—			—			—			—
Class A common stock, $0.0001 par value – 4,000,000,000 shares authorized; shares issued and outstanding – 200,781,659 as of March 31, 2025, 157,940,987 as of December 31, 2024, 113,150,968 as of September 30, 2024, 95,587,806 as of June 30, 2024 and 94,945,635 as of March 31, 2024		20			16			11			10			9
Class B common stock, $0.0001 par value – 1,700,000,000 shares authorized, none issued and outstanding as of each of the periods presented		—
Class C common stock, $0.0001 par value – 1,700,000,000 shares authorized, none issued and outstanding as of each of the periods presented		—
Class D common stock, $0.0001 par value – 1,700,000,000 shares authorized; shares issued and outstanding – 1,397,782,620 as of March 31, 2025, 1,440,332,098 as of December 31, 2024 and 1,502,069,787 as each of the rest of periods presented		140			144			149			150			150
Additional paid-in capital		4,298			3,523			2,644			2,305			2,085
Retained earnings		160,407			157,837			116,561			111,021			111,980
Non-controlling interest		1,470,484			1,892,328			2,061,162			2,215,526			2,342,834
Total equity		1,635,349			2,053,848			2,180,527			2,329,012			2,457,058
Total liabilities and equity	$	14,048,433		$	15,671,116		$	15,119,798		$	12,921,641		$	12,797,334

CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except shares and per share amounts) (Unaudited)
	For the three months ended
	March 31, 2025				December 31, 2024				September 30, 2024				June 30, 2024				March 31, 2024
Revenue
Loan production income	$	304,751			$	407,229			$	465,548			$	357,109			$	298,954
Loan servicing income		190,517				173,300				134,753				143,910				184,702
Interest income		118,102				140,067				145,297				121,394				101,863
Total revenue		613,370				720,596				745,598				622,413				585,519
MSR valuation adjustments
Change in fair value of mortgage servicing rights		(388,585	)			309,149				(446,100	)			(142,485	)			(15,563	)
Gain (loss) on other interest rate derivatives		—				(469,538	)			226,936				27,166				—
MSR valuation adjustments, net		(388,585	)			(160,389	)			(219,164	)			(115,319	)			(15,563	)
Expenses
Salaries, commissions and benefits		192,800				193,155				181,453				160,311				154,241
Direct loan production costs		43,127				54,958				58,398				45,485				31,436
Marketing, travel, and entertainment		22,190				30,771				22,462				24,438				19,111
Depreciation and amortization		11,340				11,094				11,636				11,404				11,340
General and administrative		68,148				60,314				53,664				55,051				40,809
Servicing costs		30,434				29,866				25,009				25,787				30,324
Interest expense		120,410				142,342				141,102				108,651				98,668
Other expense (income)		(2,848	)			(4,625	)			421				(1,105	)			(237	)
Total expenses		485,601				517,875				494,145				430,022				385,692
Earnings (loss) before income taxes		(260,816	)			42,332				32,289				77,072				184,264
Provision (benefit) for income taxes		(13,788	)			1,719				344				786				3,733
Net income (loss)		(247,028	)			40,613				31,945				76,286				180,531
Net income (loss) attributable to non-controlling interest		(233,349	)			31,694				38,240				73,236				171,801
Net income (loss) attributable to UWMC	$	(13,679	)		$	8,919			$	(6,295	)		$	3,050			$	8,730
Earnings (loss) per share of Class A common stock:
Basic	$	(0.08	)		$	0.06			$	(0.06	)		$	0.03			$	0.09
Diluted	$	(0.12	)		$	0.02			$	(0.06	)		$	0.03			$	0.09
Weighted average shares outstanding:
Basic		164,100,022				155,584,329				99,801,301				95,387,609				94,365,991
Diluted		1,598,383,240				1,598,241,235				99,801,301				95,387,609				1,598,647,205

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250506538862/en/

For inquiries regarding UWM, please contact:

INVESTOR CONTACT

BLAKE KOLO

[email protected]

MEDIA CONTACT

NICOLE ROBERTS

[email protected] 

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

Logo

BlackSky Successfully Completes Commissioning for First Gen-3 Satellite and Prepares to Ship Second Unit for Expected Launch in Q2

Gen-3 exceeding expectations for tasking-to-delivery performance amid positive customer demand on early very high-resolution 35-centimeter imagery and AI-driven analytics samples

HERNDON, Va.–(BUSINESS WIRE)–
BlackSky Technology Inc. (NYSE: BKSY) has successfully completed commissioning its first Gen-3 satellite. The first satellite continues to exceed expectations for tasking-to-delivery performance amid positive customer feedback on early very high-resolution 35-centimeter imagery and AI-driven analytics samples.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250506677697/en/

“BlackSky has demonstrated incredible, industry-leading speed for launch to on-orbit operations, completing commissioning for our first Gen-3 satellite a full month ahead of schedule,” said Brian O’Toole, BlackSky CEO. “This pace of performance is a testament to our team’s experience, quality and rigor of our design, production and test practices, giving BlackSky a distinct advantage for scaling this service quickly and reliably for our customers.”

“The regular cadence of Gen-3 launches will produce a robust combination of capacity and low-latency, high-revisit capabilities to support near-term, early access customers and long-term demand for real-time space-based dynamic monitoring services,” said O’Toole.

Satellite commissioning processes begin immediately after deployment from a launch vehicle and typically includes initial tracking, making first contact and the sequential activation of critical subsystems. Follow-on activities include calibrating payloads, sensors, communications and control systems, and optimizing automated operations across the entire constellation-to-ground architecture. During the Gen-3 commissioning process, BlackSky’s first Gen-3 satellite quickly produced imagery within five days and AI-enabled analytics within three weeks of launch.

“BlackSky has received resounding positive customer response to early very high-resolution 35-centimeter imagery samples. The crispness and detail have enhanced the utility of these data products by giving users the ability to make observations often accomplished with higher resolution systems. In many instances analysts were able to discern details like sunroofs on top of automobiles or individual people and their shadows. This incredible amount of detail, combined with AI-enabled analytics makes available an expansive new set of mission solutions and reduces the speed of analyses over large volumes of imagery from days to minutes,” said O’Toole.

BlackSky has made final preparations to send its second Gen-3 unit to Rocket Lab Launch Complex 1 in Mahia, New Zealand, in anticipation of launch in Q2. The Gen-3 launch schedule is proceeding as planned as the company prepares to integrate high-cadence, very high-resolution 35-centimeter imagery into customers’ daily workflows later this year.

About BlackSky

BlackSky is a real-time, space-based intelligence company that delivers on-demand, high frequency imagery, analytics, and high-frequency monitoring of the most critical and strategic locations, economic assets, and events in the world. BlackSky owns and operates one of the industry’s most advanced, purpose-built commercial, real-time intelligence systems that combines the power of the BlackSky Spectra® tasking and analytics software platform and our proprietary low earth orbit satellite constellation.

With BlackSky, customers can see, understand and anticipate changes for a decisive strategic advantage at the tactical edge, and act not just fast, but first. BlackSky is trusted by some of the most demanding U.S. and international government agencies, commercial businesses, and organizations around the world. BlackSky is headquartered in Herndon, VA, and is publicly traded on the New York Stock Exchange as BKSY. To learn more, visit www.blacksky.com and follow us on X.

Forward-Looking Statements

Certain statements in this press release may contain forward-looking statements within the meaning of the federal securities laws with respect to BlackSky. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. 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 document. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. In addition, forward-looking statements reflect our expectations, plans, or forecasts of future events and views as of the date of this communication. We anticipate that subsequent events and developments will cause their assessments to change. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Additional risks and uncertainties are identified and discussed in BlackSky’s disclosure materials filed from time to time with the SEC which are available at the SEC’s website at http://www.sec.gov or on BlackSky’s Investor Relations website at https://ir.blacksky.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250506677697/en/

Investor Contact

Aly Bonilla

VP, Investor Relations

[email protected]

Media Contact

Pauly Cabellon

Sr. Director, External Communications

[email protected]

KEYWORDS: United States North America Idaho

INDUSTRY KEYWORDS: Data Management Aerospace Technology Manufacturing Professional Services Satellite Data Analytics Software Artificial Intelligence Government Technology Defense

MEDIA:

Photo

A BlackSky Gen-3 satellite image with AI-enabled analytics highlighting various-sized military planes and helicopters in Yelizovo, Russia, collected April 21, 2025. BlackSky’s advanced, proprietary automated detection and identification algorithms transform very high-resolution Gen-3 imagery into actionable insights at machine speed and scale over strategic and tactical objects of interest.

Photo

A BlackSky Gen-3 satellite image with AI-enabled analytics highlighting various military ships and submarines at Bandar-Abbas Port, Iran, collected March 30, 2025. BlackSky’s advanced, proprietary automated detection and identification algorithms transform very high-resolution Gen-3 imagery into actionable insights at machine speed and scale over strategic and tactical objects of interest.

Logo

U.S. Patent Office Issues New Patent to RenovoRx for Novel Trans-Arterial Micro-Profusion (TAMP™) Therapy Platform

Patent Expands Protection of TAMP therapy platform, Including Methods to Deliver an Agent, such as a Chemotherapeutic Drug, Near a Tumor

RenovoRx Currently Holds a Strong and Growing IP Portfolio with 19 Issued Patents and 12 Pending Patents Supporting the Commercialization of RenovoCath Device

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath^®, a novel, FDA-cleared drug-delivery device, today announced that it has received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent NO. 12,290,564, becomes effective today, May 6, 2025.

This patent, titled “Methods for Treating Tumors,” expands protection of methods for drug delivery with RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, enabled by the Company’s proprietary RenovoCath device. The patent covers new methods for treating a tumor by delivering drugs locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature. The new patent provides protection through November of 2037.

With its issuance, RenovoRx now holds a robust portfolio of 19 issued patents and 12 pending patents. RenovoRx’s strong and growing intellectual property portfolio provides key support to the Company’s continuing commercialization of RenovoCath.

“The issuance of this new patent highlights the innovation behind our TAMP therapy platform and strengthens our competitive position,” said Shaun Bagai, CEO of RenovoRx. “This marks our ninth U.S. patent and 19^th global patent which further expands our growing IP portfolio. Our robust IP portfolio is an essential asset as we advance and scale our commercialization of RenovoCath as a stand-alone device, which we began generating revenues in December of 2024.”

Mr. Bagai added, “The expansion of our IP portfolio also supports our ongoing Phase III clinical trial. TIGeR-PaC is evaluating our investigational drug-device combination product candidate using the TAMP therapy platform enabled by RenovoCathfor the intra-arterial administration of chemotherapy (intra-arterial gemcitabine (IAG)), versus systemic chemotherapy delivery, for the treatment of locally advanced pancreatic cancer.”

About RenovoCath

Based on its FDA clearance, RenovoCath^® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath^® device for the intra-arterial administration of chemotherapy (intra-arterial gemcitabine, known as IAG)).

About RenovoRx, Inc.

RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath^®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational IAG utilizes RenovoCath, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The combination of intra-arterial infusion of chemotherapy, gemcitabine, and the RenovoCath device is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).

The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon new drug application approval by the FDA.

RenovoRx is also implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Cautionary Note Regarding Forward-Looking Statements

This press release the conference presentation referred to herein, and statements of the Company’s management made herein and therein contain 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, including but not limited to statements regarding (i) the strength of our intellectual property portfolio and the anticipated benefits of the issued patent described herein, (ii) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts and full patient enrollment for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (iii) the potential of RenovoCath^® or TAMP™ as standalone commercial products, our anticipated timing for and levels of revenue generation from RenovoCath sales, and our commercialization plans in general, (iv) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (v) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives, future value and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250506838726/en/

KCSA Strategic Communications

Valter Pinto or Jack Perkins

T: 212-896-1254

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: FDA Health General Health Pharmaceutical Oncology Health Technology Other Science Medical Devices Research Science Clinical Trials

MEDIA:

Logo