Category: Uncategorized

CAMBRIDGE, Mass., April 22, 2025 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that new data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago.

The study explored the technology behind Ernexa’s lead cell therapy product, ERNA-101, which uses specially engineered cells to deliver treatment directly to ovarian tumors. By secreting immune-stimulating cytokines, this cell therapy treatment aims to reshape the tumor microenvironment and enhance anti-tumor immune responses, fighting off the cancer. The study was led by Michael Andreeff, M.D., Ph.D., from The University of Texas MD Anderson Cancer Center.

“We believe ERNA-101 represents a powerful new way to engage the immune system against difficult-to-treat cancers like ovarian cancer,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “This study reinforces the promise of our treatments and their potential to reshape the future of cell therapy. We aim to offer hope for patients with advanced ovarian cancer, who often face limited treatment options and poor long-term outcomes.”

Details of the poster presentation session include:
Session Category: Immunology
Session Title: Local Treatments, Novel Tools, and Delivery Systems to Manipulate Tumor Immunity
Date and Time: Monday, April 28, 2025 at 2:00–5:00 pm CDT
Location: Poster Section 37
Poster Board Number: 12
Published Abstract Number: 3473

Conference attendees can learn the results of the study at the presentation. They can also meet with Ernexa’s Chief Scientific Officer, Robert Pierce, M.D., and the study’s authors.

About ErnexaTherapeutics

Ernexa Therapeutics (Nasdaq: ERNA) is developing innovative cell therapies for the treatment of advanced solid tumors and autoimmune disease. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, without needing patient-specific cell harvesting.

Ernexa is developing two highly innovative cell therapy products, both currently in preclinical stages. ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system’s response to recognize and attack cancer cells. ERNA-102 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer.

For more information, visit www.ernexatx.com.

Forward-Looking Statements

This press release contains 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, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. Forward-looking statements are based upon Ernexa’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.

Media & Investor Relations Contact

[email protected]

Hangzhou, CHINA, April 22, 2025 (GLOBE NEWSWIRE) — Webus International Limited (“Webus” or the “Company”) (NASDAQ: WETO), a leading provider of AI-driven mobility solutions specializing in premium, customizable chauffeur services worldwide, today announced plans to establish a new subsidiary in Osaka, Japan, marking a significant milestone in the Company’s global expansion strategy.

Webus has signed strategic cooperation agreements with leading local accommodation operators in Osaka, including a comprehensive property management company with approximately $500 million in assets under management. The Company’s expansion includes establishing an Osaka headquarters, acquiring land for coastal resorts and boutique accommodations, developing homestay hotels and luxury resorts, creating cultural tourism packages, and building a dedicated vehicle fleet with local drivers—ensuring quality control in this high-demand market.

The property management company’s business encompasses land acquisition, house construction and trading, as well as rental and homestay hotel operation, providing Webus with extensive resources across the entire real estate value chain. The Japanese tourism market is booming, with Osaka’s GDP growing approximately 4% last year and 28 daily direct flights operating between Shanghai and Osaka alone, attracting visitors from China, Europe, and North America.

“After evaluating the market in Japan, I’ve witnessed the extraordinary opportunity in Osaka,” said Nan Zheng, CEO of Webus. “By establishing our own accommodations and transportation resources in this booming market, we ensure reliable, high-quality services year-round, especially during peak seasons.”

The Company will leverage its “Wetour” brand for the Japanese market, focusing on mid-to-high-end tourism with boutique groups and private tours offering in-depth cultural experiences for international tourists.

Osaka is poised for additional growth. In 2023, Osaka welcomed 15.6 million international tourists, surpassing its 2019 peak, with spending of $22.67 billion. Nationally, Japan hosted 36.9 million visitors in 2024, spending JPY 8 trillion ($51.2 billion), contributing 7.5% to GDP, with 2025 projections targeting 40 million visitors and JPY 9–10 trillion, and a 2030 goal of 60 million and JPY 15 trillion (JNTO, Statista).

About Webus International Limited

Webus International Limited is a leading provider of AI-driven mobility solutions specializing in premium, customizable chauffeur services worldwide. Through our innovative “Mobility-as-a-Service” (MaaS) model, we deliver exceptional personalized transportation experiences with our extensive fleet of luxury vehicles and professional chauffeurs worldwide.

Our flagship brand “Wetour” specializes in customized travel services, offering airport transfers, intercity transportation, private guided tours, and luxury chartered services for both leisure and business travelers. Leveraging proprietary technology, our platform integrates real-time AI support with 24/7 multilingual itinerary management, ensuring seamless mobility solutions across all international destinations we serve. For more information, please visit our website at www.webus.vip or www.wetourglobal.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. These forward-looking statements include, without limitation, the Company’s statements regarding the trading of its ordinary shares on the Nasdaq Capital Market. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions, and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

Investor Relations Contact:

Matthew Abenante, IRC
President
Strategic Investor Relations, LLC
Tel: 347-947-2093
Email: [email protected]

HOUSTON, April 22, 2025 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a leader in advanced energy management platforms, announced today that it has been awarded $6,703,500 by the Texas Space Commission as part of a $26 million grant award focused on strengthening Texas’ leadership in space exploration and technology. The announcement was made public by the Commission and covered by SpaceNews.

KULR’s selection supports its role in an ambitious program to develop cold-temperature lithium-ion battery solutions for the next generation of Lunar and Martian missions. The initiative is being carried out in close collaboration with NASA Johnson Space Center (JSC) and in partnership with South 8 Technologies, aligning public, private, and academic stakeholders to deliver scalable, space-rated battery technology.

“This award underscores KULR’s commitment to powering the next era of space exploration with safe, high-performance, and environmentally adaptive KULR ONE Space platform,” said Michael Mo, CEO of KULR Technology Group. “Working alongside visionary partners at NASA JSC and South 8, we’re proud to anchor this Texas-led effort to develop scalable, space-rated battery technology that advances national objectives and commercial innovation.”

Throughout the program, KULR will manage the design, testing, and production of lithium-ion cells using liquefied gas (LiGas) electrolyte from South 8 Technologies. These cells will operate down to -60°C and be integrated into the KULR ONE Space platform, optimized for extreme environments encountered during lunar and Martian missions.

Located just minutes from NASA Johnson Space Center, KULR’s Webster, TX facility will serve as the engineering and test hub for this effort, performing advanced battery safety testing and performance validation. The project aligns with NASA’s Artemis objectives by reducing heater energy requirements, improving safety margins, and enabling longer-duration operations in deep space environments.

For more information about KULR Technology Group and its advanced energy solutions, please visit www.kulr.ai.

About KULR Technology Group Inc.

KULR Technology Group Inc. (NYSE American: KULR) delivers cutting-edge energy storage solutions for space, aerospace, and defense by leveraging a foundation of in-house battery design expertise, comprehensive cell and battery testing suite, and battery fabrication and production capabilities. The Company’s holistic offering allows the delivery of commercial off-the-shelf and custom next-generation energy storage systems in rapid timelines for a fraction of the cost compared to traditional programs. On December 4, 2024, KULR announced that its Board of Directors has agreed to include bitcoin as a primary asset in its treasury program and committed to allocating up to 90% of its surplus cash to the acquisition of bitcoin. For more information, please visit www.kulr.ai.

Investor Relations:

KULR Technology Group, Inc.
Phone: 858-866-8478 x 847
Email: [email protected]

BAYONNE, N.J., April 22, 2025 (GLOBE NEWSWIRE) — BCB Bancorp, Inc. (the “Company”), (NASDAQ: BCBP), the holding company for BCB Community Bank (the “Bank”), today reported a net loss of $8.3 million for the first quarter of 2025, compared to net income of $3.3 million in the fourth quarter of 2024, and net income of $5.9 million for the first quarter of 2024. Its loss per diluted share for the first quarter of 2025 was ($0.51), compared to earnings per diluted share of $0.16 in the preceding quarter and $0.32 in the first quarter of 2024.

The Company also announced that its Board of Directors declared a regular quarterly cash dividend of $0.16 per share. The dividend will be payable on May 21, 2025 to common shareholders of record on May 7, 2025.

“Our first-quarter loss was primarily driven by a $13.7 million specific reserve tied to a $34.2 million loan in the cannabis sector,” Michael Shriner, President and Chief Executive Officer of BCB Bank, explained. “Although the borrower remains current, the significant deterioration in their financial condition warranted a downgrade to non-accrual status and the establishment of the reserve. We also increased reserves for our discontinued Business Express Loan portfolio by $3.1 million, in response to the portfolio’s continued elevated deterioration and broader macroeconomic headwinds.”

“While these credit actions have impacted short-term results, they reflect our disciplined and proactive approach to risk management,” added Mr. Shriner. “Thanks to the positive capital actions taken throughout 2024, we remain well-capitalized, giving us the flexibility to address credit challenges head-on.”

“BCB Bank has bolstered its credit risk team with new hires who we believe bring deep expertise and a rigorous approach to underwriting,” said Mr. Shriner. “These efforts are part of a broader initiative to strengthen our credit quality oversight. Following a comprehensive portfolio review using a conservative risk framework, we’ve adjusted the risk ratings on a number of loans to better reflect current market realities. Importantly, the majority of our customers remain current on their payments, and our team is actively engaging with borrowers to secure updated financials and support improved risk profiles.”

Executive Summary

• Total deposits were $2.687 billion at March 31, 2025 compared to $2.751 billion at December 31, 2024.
• Net interest margin was 2.59 percent for the first quarter of 2025, compared to 2.53 percent for the fourth quarter of 2024, and 2.50 percent for the first quarter of 2024.
  • Total yield on interest-earning assets was 5.20 percent for the first quarter of 2025, compared to 5.33 percent for both the fourth quarter of 2024, and the first quarter of 2024.
  • Total cost of interest-bearing liabilities decreased 24 basis points to 3.33 percent for the first quarter of 2025, compared to 3.57 percent for the fourth quarter of 2024, and decreased 21 basis points to 3.54 percent for the first quarter of 2024.
• The efficiency ratio for the first quarter was 61.6 percent compared to 62.1 percent in the prior quarter, and 58.8 percent in the first quarter of 2024.
• The annualized return on average assets ratio for the first quarter was (0.95) percent, compared to 0.36 percent in the prior quarter, and 0.61 percent in the first quarter of 2024.
• The annualized return on average equity ratio for the first quarter was (10.4) percent, compared to 4.0 percent in the prior quarter, and 7.5 percent in the first quarter of 2024.
• The provision for credit losses was $20.8 million in the first quarter of 2025 compared to $4.2 million for the fourth quarter of 2024. In the first quarter of 2024, the Bank recorded a provision of $2.1 million.
• The allowance for credit losses (“ACL”) as a percentage of non-accrual loans was 51.6 percent at March 31, 2025 compared to 77.8 percent for the prior quarter-end and 155.4 percent at March 31, 2024. Total non-accrual loans were $99.8 million at March 31, 2025, $44.7 million at December 31, 2024 and $22.2 million at March 31, 2024.
• Total loans receivable, net of the allowance for credit losses, of $2.918 billion at March 31, 2025, decreased 2.6 percent from $2.996 billion at December 31, 2024, and decreased 9.6 percent, from $3.227 billion at March 31, 2024.

Balance Sheet Review

Total assets decreased by $125.3 million, or 3.5 percent, to $3.474 billion at March 31, 2025, from $3.599 billion at December 31, 2024. The decrease in total assets was mainly related to a decrease in net loans and in cash and cash equivalents.

Total cash and cash equivalents decreased by $64.5 million, or 20.3 percent, to $252.8 million at March 31, 2025, from $317.3 million at December 31, 2024. The decrease in cash was primarily due to the reduction of the Bank’s exposure to wholesale funding by paying down high cost brokered deposits.

Loans receivable, net, decreased by $78.6 million, or 2.6 percent, to $2.918 billion at March 31, 2025, from $2.996 billion at December 31, 2024. Total loan decreases during the period included decreases totaling $62.3 million in commercial real estate and multi-family loans, construction loans, 1-4 family residential loans and home equity loans. The allowance for credit losses increased $16.7 million to $51.5 million, or 51.6 percent of non-accruing loans and 1.73 percent of gross loans, at March 31, 2025, as compared to an allowance for credit losses of $34.8 million, or 77.8 percent of non-accruing loans and 1.15 percent of gross loans, at December 31, 2024.

Total investment securities increased by $14.7 million, or 13.2 percent, to $125.9 million at March 31, 2025, from $111.2 million at December 31, 2024, representing current year purchases.

Deposits decreased by $64.4 million, or 2.3 percent, to $2.687 billion at March 31, 2025, from $2.751 billion at December 31, 2024. Brokered deposits decreased $112.5 million, and were offset by increases in certificates of deposit, money market accounts, transaction accounts and savings accounts which totaled $48.4 million.

Debt obligations decreased by $49.8 million to $448.5 million at March 31, 2025 from $498.3 million at December 31, 2024, due to maturities and paydowns of our FHLB advances. The weighted average interest rate of FHLB advances was 4.33 percent at March 31, 2025 and 4.35 percent at December 31, 2024. The weighted average maturity of FHLB advances as of March 31, 2025 was 0.83 years. The interest rate of our subordinated debt balances was 9.25 percent at March 31, 2025 and at December 31, 2024.

Stockholders’ equity decreased by $9.2 million, or 2.8 percent, to $314.7 million at March 31, 2025, from $323.9 million at December 31, 2024. The decrease was attributable to the decrease in retained earnings of $11.6 million, or 8.2 percent, to $130.3 million at March 31, 2025 from $141.9 million at December 31, 2024. Offsetting this were increases in accumulated other comprehensive income, and additional paid in capital on stock, which totaled $2.4 million.

First Quarter 2025 Income Statement Review

The Company reported a net loss of $8.3 million for the first quarter ended March 31, 2025 as compared to net income of $5.9 million for the first quarter ended March 31, 2024. The decline was primarily driven by an increase to the Provision for loan losses of $18.8 million. offset by $5.8 million decrease in income tax provisioning. Also, net interest income decreased by $1.1 million, or 4.9 percent, to $22.0 million for the first quarter of 2025, from $23.1 million for the first quarter of 2024. The decrease in net interest income resulted from lower interest income which was partially offset by lower interest expense.

Interest income decreased by $5.1 million, or 10.3 percent, to $44.2 million for the first quarter of 2025 from $49.3 million for the first quarter of 2024. The average balance of interest-earning assets decreased $255.9 million, or 6.9 percent, to $3.444 billion for the first quarter of 2025 from $3.699 billion for the first quarter of 2024, while the average yield decreased 13 basis points to 5.20 percent for the first quarter of 2025 from 5.33 percent for the first quarter of 2024.

Interest expense decreased by $4.0 million to $22.2 million for the first quarter of 2025 from $26.1 million for the first quarter of 2024. The decrease resulted from a decrease in the average rate paid on interest-bearing liabilities of 21 basis points to 3.33 percent for the first quarter of 2025 from 3.54 percent for the first quarter of 2024, while the average balance of interest-bearing liabilities decreased by $256.2 million to $2.701 billion for the first quarter of 2025 from $2.957 billion for the first quarter of 2024.

The net interest margin was 2.59 percent for the first quarter of 2025 compared to 2.50 percent for the first quarter of 2024. The increase in the net interest margin compared to the first quarter of 2024 was the result of a decrease in the cost of interest-bearing liabilities partially offset by the decrease in the yield on interest-earning assets.

During the first quarter of 2025, the Company recognized $4.2 million in net charge-offs compared to $1.1 million in net charge-offs in the first quarter of 2024. The Bank had non-accrual loans totaling $99.8 million, or 3.36 percent of gross loans, at March 31, 2025 as compared to $44.7 million, or 1.48 percent of gross loans, at December 31, 2024. The allowance for credit losses on loans was $51.5 million, or 1.73 percent of gross loans, at March 31, 2025, and $34.8 million, or 1.15 percent of gross loans, at December 31, 2024. The provision for credit losses was $20.8 million for the first quarter of 2025 compared to $4.2 million for the fourth quarter of 2024. Management believes that the allowance for credit losses on loans was adequate at March 31, 2025 and December 31, 2024.

Non-interest income decreased by $318 thousand to $1.8 million for the first quarter of 2025 from $2.1 million in the first quarter of 2024. The decrease in total non-interest income was mainly related to decreases in gains on equity securities and BOLI income of $245 thousand and $67 thousand, respectively.

Non-interest expense decreased by $178 thousand, or 1.2 percent, to $14.7 million for the first quarter of 2025 when compared to non-interest expense of $14.8 million for the first quarter of 2024. The decrease in these expenses for the first quarter of 2025 was primarily driven by lower regulatory assessment charges, offset by higher salaries and employee benefits.

The income tax provision decreased by $5.8 million, to an income tax credit of $3.4 million for the first quarter of 2025 when compared to a $2.5 million provision for the first quarter of 2024.

Asset Quality

During the first quarter of 2025, the Company recognized $4.2 million in net charge offs, compared to $1.1 million in net charge-offs for the first quarter of 2024.

The Bank had non-accrual loans totaling $99.8 million, or 3.36 percent of gross loans, at March 31, 2025, as compared to $22.2 million, or 0.68 percent of gross loans, at March 31, 2024. More than 60% of the non-accrual loans are current with all payments of principal, interest, taxes and insurance, including the previously mentioned loan that has been allocated a specific reserve.  However, given that the normal standard for non-accrual is a 90 day delinquency, logic and transparency dictates that this population of loans possess certain weaknesses that are beyond payment status and therefore, even though they are current, they should be placed on non-accrual.  Although our borrowers have made payment of their loan obligations to BCB a priority, our evaluation of their financial condition causes some concern about their continued ability to do so. The allowance for credit losses was $51.5 million, or 1.73 percent of gross loans, at March 31, 2025, and $34.6 million, or 1.06 percent of gross loans, at March 31, 2024. The allowance for credit losses was 51.6 percent of non-accrual loans at March 31, 2025, and 155.4 percent of non-accrual loans at March 31, 2024.

About BCB Bancorp, Inc.

Established in 2000 and headquartered in Bayonne, N.J., BCB Community Bank is the wholly-owned subsidiary of BCB Bancorp, Inc. (NASDAQ: BCBP). The Bank has twenty-three branch offices in Bayonne, Edison, Hoboken, Fairfield, Holmdel, Jersey City, Lyndhurst, Maplewood, Monroe Township, Newark, Parsippany, Plainsboro, River Edge, Rutherford, South Orange, Union, and Woodbridge, New Jersey, and four branches in Hicksville and Staten Island, New York. The Bank provides businesses and individuals a wide range of loans, deposit products, and retail and commercial banking services. For more information, please go to www.bcb.bank.

Forward-Looking Statements

This release, like many written and oral communications presented by BCB Bancorp, Inc., and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies 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. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results.

The most significant factor that could cause future results to differ materially from those anticipated by our forward-looking statements include the ongoing impact of global tariffs imposed by the Trump administration, higher inflation levels, and general economic and recessionary concerns, all of which could impact economic growth and could cause increased loan delinquencies, a reduction in financial transactions and business activities, including decreased deposits and reduced loan originations, our ability to manage liquidity and capital in a rapidly changing and unpredictable market, supply chain disruptions, and labor shortages. Other factors that could cause future results to vary materially from current management expectations as reflected in our forward-looking statements include, but are not limited to: the global impact of the military conflicts in the Ukraine and the Middle East; unfavorable economic conditions in the United States generally and particularly in our primary market area; the Company’s ability to effectively attract and deploy deposits; changes in the Company’s corporate strategies, the composition of its assets, or the way in which it funds those assets; shifts in investor sentiment or behavior in the securities, capital, or other financial markets, including changes in market liquidity or volatility; the effects of declines in real estate values that may adversely impact the collateral underlying our loans; increase in unemployment levels and slowdowns in economic growth; our level of non-performing assets and the costs associated with resolving any problem loans including litigation and other costs; the impact of changes in interest rates and the credit quality and strength of underlying collateral and the effect of such changes on the market value of our loan and investment securities portfolios; the credit risk associated with our loan portfolio; changes in the quality and composition of the Bank’s loan and investment portfolios; changes in our ability to access cost-effective funding; deposit flows; legislative and regulatory changes, including increases in Federal Deposit Insurance Corporation, or FDIC, insurance rates; monetary and fiscal policies of the federal and state governments; changes in tax policies, rates and regulations of federal, state and local tax authorities; demands for our loan products; demand for financial services; competition; changes in the securities or secondary mortgage markets; changes in management’s business strategies; changes in consumer spending; our ability to hire and retain key employees; the effects of any reputational, credit, interest rate, market, operational, legal, liquidity, or regulatory risk; expanding regulatory requirements which could adversely affect operating results; civil unrest in the communities that we serve; and other factors discussed elsewhere in this report, and in other reports we filed with the SEC, including under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K, and our other periodic reports that we file with the SEC.

Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.

Explanation of Non-GAAP Financial Measures

Reported amounts are presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”). This press release also contains certain supplemental Non-GAAP information that the Company’s management uses in its analysis of the Company’s financial results. The Company’s management believes that providing this information to analysts and investors allows them to better understand and evaluate the Company’s financial results for the periods in question.

The Company provides measurements and ratios based on tangible stockholders’ equity and efficiency ratios. These measures are utilized by regulators and market analysts to evaluate a company’s financial condition and, therefore, the Company’s management believes that such information is useful to investors. For a reconciliation of GAAP to Non-GAAP financial measures included in this press release, see “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

	Statements of Operations – Three Months Ended,
	March 31,2025			December 31, 2024			March 31, 2024			Mar 31, 2025 vs. Dec 31, 2024				Mar 31, 2025 vs. Mar 31, 2024
Interest and dividend income:	(In thousands, except per share amounts, Unaudited)
Loans, including fees	$	38,927		$	41,431		$	43,722			-6.0	%			-11.0	%
Mortgage-backed securities		561			473			305			18.6	%			83.9	%
Other investment securities		968			978			975			-1.0	%			-0.7	%
FHLB stock and other interest-earning assets		3,736			3,771			4,283			-0.9	%			-12.8	%
Total interest and dividend income		44,192			46,653			49,285			-5.3	%			-10.3	%
Interest expense:
Deposits:
Demand		5,418			5,866			5,257			-7.6	%			3.1	%
Savings and club		151			156			166			-3.2	%			-9.0	%
Certificates of deposit		10,762			12,218			14,983			-11.9	%			-28.2	%
		16,331			18,240			20,406			-10.5	%			-20.0	%
Borrowings		5,856			6,219			5,736			-5.8	%			2.1	%
Total interest expense		22,187			24,459			26,142			-9.3	%			-15.1	%
Net interest income		22,005			22,194			23,143			-0.9	%			-4.9	%
Provision for credit losses		20,845			4,154			2,088			401.8	%			898.3	%
Net interest income after provision for credit losses		1,160			18,040			21,055			-93.6	%			-94.5	%
Non-interest income income :
Fees and service charges		1,173			1,187			1,215			-1.2	%			-3.5	%
(Loss) gain on sales of loans		–			(554	)		45			-100.0	%			-100.0	%
Realized and unrealized (loss) gain on equity investments		(115	)		(661	)		130			-82.6	%			-188.5	%
Bank-owned life insurance (“BOLI”) income		608			636			675			-4.4	%			-9.9	%
Other		125			330			44			-62.1	%			184.1	%
Total non-interest income		1,791			938			2,109			90.9	%			-15.1	%
Non-interest expense:
Salaries and employee benefits		7,403			7,117			6,981			4.0	%			6.0	%
Occupancy and equipment		2,723			2,483			2,644			9.7	%			3.0	%
Data processing and communications		1,844			1,754			1,853			5.1	%			-0.5	%
Professional fees		692			599			595			15.5	%			16.3	%
Director fees		418			269			277			55.4	%			50.9	%
Regulatory assessment fees		709			769			1,142			-7.8	%			-37.9	%
Advertising and promotions		179			212			216			-15.6	%			-17.1	%
Other		692			1,164			1,130			-40.5	%			-38.8	%
Total non-interest expense		14,660			14,367			14,838			2.0	%			-1.2	%
(Loss) Income before income tax provision		(11,709	)		4,611			8,326			-353.9	%			-240.6	%
Income tax (benefit) provision		(3,385	)		1,339			2,460			-352.8	%			-237.6	%
Net (Loss) Income		(8,324	)		3,272			5,866			-354.4	%			-241.9	%
Preferred stock dividends		482			475			434			1.6	%			11.0	%
Net (Loss) Income available to common stockholders	$	(8,806	)	$	2,797		$	5,432			-414.8	%			-262.1	%
Net (Loss) Income per common share-basic and diluted
Basic	$	(0.51	)	$	0.16		$	0.32			-413.8	%			-260.4	%
Diluted	$	(0.51	)	$	0.16		$	0.32			-414.7	%			-260.5	%
Weighted average number of common shares outstanding
Basic		17,113			17,056			16,930			0.3	%			1.1	%
Diluted		17,113			17,108			16,939			0.0	%			1.0	%

Statements of Financial Condition	March 31,2025			December 31,2024			March 31, 2024			March 31, 2025 vs. December 31, 2024			March 31, 2025 vs. March 31, 2024
ASSETS	(In Thousands, Unaudited)
Cash and amounts due from depository institutions	$	11,977		$	14,075		$	11,795			-14.9	%		1.5	%
Interest-earning deposits		240,773			303,207			340,653			-20.6	%		-29.3	%
Total cash and cash equivalents		252,750			317,282			352,448			-20.3	%		-28.3	%
Interest-earning time deposits		735			735			735			–			–
Debt securities available for sale		116,496			101,717			86,966			14.5	%		34.0	%
Equity investments		9,357			9,472			9,223			-1.2	%		1.5	%
Loans held for sale		–			–			–			–			–
Loans receivable, net of allowance for credit losses on loans
of $51,484, $34,789 and $34,563 , respectively		2,917,610			2,996,259			3,226,877			-2.6	%		-9.6	%
Federal Home Loan Bank of New York (“FHLB”) stock, at cost		22,066			24,272			24,917			-9.1	%		-11.4	%
Premises and equipment, net		12,474			12,569			12,744			-0.8	%		-2.1	%
Accrued interest receivable		16,354			15,176			17,442			7.8	%		-6.2	%
Deferred income taxes		22,814			17,181			17,555			32.8	%		30.0	%
Goodwill and other intangibles		5,253			5,253			5,253			0.0	%		0.0	%
Operating lease right-of-use asset		12,622			12,686			12,186			-0.5	%		3.6	%
Bank-owned life insurance (“BOLI”)		76,648			76,040			74,081			0.8	%		3.5	%
Other assets		8,643			10,476			8,768			-17.5	%		-1.4	%
Total Assets	$	3,473,822		$	3,599,118		$	3,849,195			-3.5	%		-9.8	%
LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Non-interest bearing deposits	$	542,621		$	520,387		$	531,112			4.3	%		2.2	%
Interest bearing deposits		2,143,887			2,230,471			2,460,547			-3.9	%		-12.9	%
Total deposits		2,686,508			2,750,858			2,991,659			-2.3	%		-10.2	%
FHLB advances		405,499			455,361			472,949			-10.9	%		-14.3	%
Subordinated debentures		43,024			42,961			37,624			0.1	%		14.4	%
Operating lease liability		13,087			13,139			12,579			-0.4	%		4.0	%
Other liabilities		10,982			12,874			14,253			-14.7	%		-22.9	%
Total Liabilities		3,159,100			3,275,193			3,529,064			-3.5	%		-10.5	%
STOCKHOLDERS’ EQUITY
Preferred stock: $0.01 par value, 10,000 shares authorized		–			–			–			–			–
Additional paid-in capital preferred stock		25,243			24,723			27,733			2.1	%		-9.0	%
Common stock: no par value, 40,000 shares authorized		–			–			–			0.0	%		0.0	%
Additional paid-in capital common stock		201,804			200,935			199,726			0.4	%		1.0	%
Retained earnings		130,291			141,853			138,643			-8.2	%		-6.0	%
Accumulated other comprehensive loss		(4,269	)		(5,239	)		(7,624	)		–			–
Treasury stock, at cost		(38,347	)		(38,347	)		(38,347	)		0.0	%		0.0	%
Total Stockholders’ Equity		314,722			323,925			320,131			-2.8	%		-1.7	%
Total Liabilities and Stockholders’ Equity	$	3,473,822		$	3,599,118		$	3,849,195			-3.5	%		-9.8	%
Outstanding common shares		17,163			17,063			16,957

	Three Months Ended March 31,
	2025										2024
	Average Balance			Interest Earned/Paid			Average Yield/Rate (3)				Average Balance			Interest Earned/Paid			Average Yield/Rate (3)
	(Dollars in thousands)
Interest-earning assets:
Loans Receivable (4)(5)	$	2,994,529		$	38,927			5.27	%		$	3,299,938		$	43,722			5.30	%
Investment Securities		117,205			1,529			5.22	%			96,226			1,280			5.32	%
Other Interest-earning assets (6)		331,808			3,736			4.57	%			303,291			4,283			5.65	%
Total Interest-earning assets		3,443,542			44,192			5.20	%			3,699,455			49,285			5.33	%
Non-interest-earning assets		125,974										125,480
Total assets	$	3,569,516									$	3,824,935
Interest-bearing liabilities:
Interest-bearing demand accounts	$	560,565		$	2,369			1.71	%		$	560,190		$	2,230			1.59	%
Money market accounts		394,282			3,049			3.14	%			369,096			3,027			3.28	%
Savings accounts		252,227			151			0.24	%			277,731			166			0.24	%
Certificates of Deposit		1,005,669			10,762			4.34	%			1,239,807			14,983			4.83	%
Total interest-bearing deposits		2,212,743			16,331			2.99	%			2,446,824			20,406			3.34	%
Borrowed funds		488,418			5,856			4.86	%			510,503			5,736			4.49	%
Total interest-bearing liabilities		2,701,161			22,187			3.33	%			2,957,327			26,142			3.54	%
Non-interest-bearing liabilities		543,660										552,959
Total liabilities		3,244,821										3,510,286
Stockholders’ equity		324,695										314,649
Total liabilities and stockholders’ equity	$	3,569,516									$	3,824,935
Net interest income				$	22,005									$	23,143
Net interest rate spread(1)								1.87	%									1.79	%
Net interest margin(2)								2.59	%									2.50	%
(1) Net interest rate spread represents the difference between the average yield on average interest-earning assets and the average cost of average interest-bearing liabilities.
(2) Net interest margin represents net interest income divided by average total interest-earning assets.
(3) Annualized.
(4) Excludes allowance for credit losses.
(5) Includes non-accrual loans.
(6) Includes Federal Home Loan Bank of New York Stock.

	Financial Condition data by quarter
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands, except book values)
Total assets	$	3,473,822		$	3,599,118		$	3,613,770		$	3,793,941		$	3,849,195
Cash and cash equivalents		252,750			317,282			243,123			326,870			352,448
Securities		125,853			111,189			108,302			94,965			96,189
Loans receivable, net		2,917,610			2,996,259			3,087,914			3,161,925			3,226,877
Deposits		2,686,508			2,750,858			2,724,580			2,935,239			2,991,659
Borrowings		448,523			498,322			533,466			510,710			510,573
Stockholders’ equity		314,722			323,925			328,113			320,732			320,131
Book value per common share1	$	16.87		$	17.54		$	17.50		$	17.17		$	17.24
Tangible book value per common share2	$	16.56		$	17.23		$	17.19		$	16.86		$	16.93
	Operating data by quarter
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands, except for per share amounts)
Net interest income	$	22,005		$	22,194		$	23,045		$	23,639		$	23,143
Provision for credit losses		20,845			4,154			2,890			2,438			2,088
Non-interest income (loss)		1,791			938			3,127			(3,234	)		2,109
Non-interest expense		14,660			14,367			13,929			13,987			14,838
Income tax (benefit) expense		(3,385	)		1,339			2,685			1,163			2,460
Net (loss) income	$	(8,324	)	$	3,272		$	6,668		$	2,817		$	5,866
Net (loss) income per diluted share	$	(0.51	)	$	0.16		$	0.36		$	0.14		$	0.32
Common Dividends declared per share	$	0.16		$	0.16		$	0.16		$	0.16		$	0.16
	Financial Ratios(3)
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
Return on average assets		(0.95	%)		0.36	%		0.72	%		0.30	%		0.61	%
Return on average stockholders’ equity		(10.40	%)		4.04	%		8.29	%		3.52	%		7.46	%
Net interest margin		2.59	%		2.53	%		2.58	%		2.60	%		2.50	%
Stockholders’ equity to total assets		9.06	%		9.00	%		9.08	%		8.45	%		8.32	%
Efficiency Ratio4		61.61	%		62.11	%		53.22	%		68.55	%		58.76	%
	Asset Quality Ratios
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands, except for ratio %)
Non-Accrual Loans	$	99,833		$	44,708		$	35,330		$	32,448		$	22,241
Non-Accrual Loans as a % of Total Loans		3.36	%		1.48	%		1.13	%		1.01	%		0.68	%
ACL as % of Non-Accrual Loans		51.6	%		77.8	%		98.2	%		108.6	%		155.4	%
Individually Analyzed Loans		122,517			83,399			66,048			60,798			65,731
Classified Loans		251,989			152,714			98,316			87,033			97,739
(1) Calculated by dividing stockholders’ equity, less preferred equity, to shares outstanding.
(2) Calculated by dividing tangible stockholders’ common equity, a non-GAAP measure, by shares outstanding. Tangible stockholders’ common equity is stockholders’ equity less goodwill and preferred stock. See “Reconciliation of GAAP to Non-GAAP Financial Measures by quarter.”
(3) Ratios are presented on an annualized basis, where appropriate.
(4) The Efficiency Ratio, a non-GAAP measure, was calculated by dividing non-interest expense by the total of net interest income and non-interest income. See “Reconciliation of GAAP to Non-GAAP Financial Measures by quarter.”

	Recorded Investment in Loans Receivable by quarter
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands)
Residential one-to-four family	$	232,456		$	239,870		$	241,050		$	242,706		$	244,762
Commercial and multi-family		2,221,218			2,246,677			2,296,886			2,340,385			2,392,970
Construction		118,779			135,434			146,471			173,207			180,975
Commercial business		330,358			342,799			371,365			375,355			378,073
Home equity		66,479			66,769			67,566			66,843			65,518
Consumer		2,271			2,235			2,309			2,053			2,847
	$	2,971,561		$	3,033,784		$	3,125,647		$	3,200,549		$	3,265,145
Less:
Deferred loan fees, net		(2,467	)		(2,736	)		(3,040	)		(3,381	)		(3,705	)
Allowance for credit losses		(51,484	)		(34,789	)		(34,693	)		(35,243	)		(34,563	)
Total loans, net	$	2,917,610		$	2,996,259		$	3,087,914		$	3,161,925		$	3,226,877
	Non-Accruing Loans in Portfolio by quarter
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands)
Residential one-to-four family	$	1,138		$	1,387		$	410		$	350		$	429
Commercial and multi-family		89,296			32,974			27,693			27,796			12,627
Construction		586			586			586			586			3,225
Commercial business		8,374			9,530			6,498			3,673			5,916
Home equity		439			231			123			43			44
Consumer		–			–			20			–			–
Total:	$	99,833		$	44,708		$	35,330		$	32,448		$	22,241
	Distribution of Deposits by quarter
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands)
Demand:
Non-Interest Bearing	$	542,620		$	520,387		$	528,089		$	523,816		$	531,112
Interest Bearing		537,468			553,731			527,862			549,239			552,295
Money Market		405,793			395,004			366,655			371,689			361,791
Sub-total:	$	1,485,881		$	1,469,122		$	1,422,606		$	1,444,744		$	1,445,198
Savings and Club		254,732			252,491			255,115			258,680			272,051
Certificates of Deposit		945,895			1,029,245			1,046,859			1,231,815			1,274,410
Total Deposits:	$	2,686,508		$	2,750,858		$	2,724,580		$	2,935,239		$	2,991,659

	Reconciliation of GAAP to Non-GAAP Financial Measures by quarter
	Tangible Book Value per Share
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands, except per share amounts)
Total Stockholders’ Equity	$	314,722		$	323,925		$	328,113		$	320,732		$	320,131
Less: goodwill		5,253			5,253			5,253			5,253			5,253
Less: preferred stock		25,243			24,723			29,763			28,403			27,733
Total tangible common stockholders’ equity		284,226			293,949			293,097			287,076			287,145
Shares common shares outstanding		17,163			17,063			17,048			17,029			16,957
Book value per common share	$	16.87		$	17.54		$	17.50		$	17.17		$	17.24
Tangible book value per common share	$	16.56		$	17.23		$	17.19		$	16.86		$	16.93
	Efficiency Ratios
	Q1 2025			Q4 2024			Q3 2024			Q2 2024			Q1 2024
	(In thousands, except for ratio %)
Net interest income	$	22,005		$	22,194		$	23,045		$	23,639		$	23,143
Non-interest income (loss)		1,791			938			3,127			(3,234	)		2,109
Total income		23,796			23,132			26,172			20,405			25,252
Non-interest expense		14,660			14,367			13,929			13,987			14,838
Efficiency Ratio		61.61	%		62.11	%		53.22	%		68.55	%		58.76	%

Contact:	Michael Shriner, President & CEO Jawad Chaudhry, EVP & CFO (201) 823-0700

A Scientific Breakthrough in Skin Renewal: A Clinically Proven Dual-Action, Slow-Release, Overnight Skin Renewal Cream for a Resurfaced, Smoother, and More Even-Looking Complexion

NEW YORK, April 22, 2025 (GLOBE NEWSWIRE) — Obagi Medical (“Obagi”), the fastest-growing professional skincare brand in the U.S. in 2024* and a subsidiary of Waldencast plc, (NASDAQ: WALD) (“Waldencast”), proudly introduces its latest breakthrough: Retinol + PHA Refining Night Cream. This advanced formulation is engineered to optimize skin renewal by leveraging the efficacy of Entrapped Retinol with the scientifically proven gentle exfoliating properties of Polyhydroxy Acid (PHA) Gluconolactone. This synergistic combination enhances cell turnover while reinforcing the skin barrier, resulting in a visibly refined, smoother, and more even complexion.

Expanding on Obagi’s trusted retinol portfolio, this innovative formula incorporates PHA—a next-generation exfoliant with a larger molecular structure than Alpha Hydroxy Acids (AHAs) and Beta Hydroxy Acids (BHAs). This distinction allows for effective resurfacing with minimal irritation, making it ideal for individuals seeking to improve skin texture and tone while maintaining hydration and skin barrier integrity. Additionally, the formula features Entrapped Retinol, a slow-release delivery technology that gradually delivers retinol into multiple layers of the skin over time. This controlled release helps maximize efficacy while minimizing the irritation commonly associated with vitamin A products. The result is an effective yet gentle introduction to retinol, suitable for beginners and those with sensitive skin who may struggle with stronger retinoids.

“Patient compliance is the key to achieving visible results. By using a slow-release, encapsulated retinol combined with a gentle exfoliating and hydrating PHA, this formula makes it easier for patients to tolerate nightly use,” said Dr. Suzan Obagi, Chief Medical Director at Obagi. “As a result, they may experience improved skin texture and a noticeable reduction in blemishes.”

Retinol + PHA Refining Night Cream is fortified with eight additional dermatologically recognized ingredients to support hydration, minimize irritation, and enhance skin resilience. These ingredients include:

• Sodium Hyaluronate – A potent humectant that deeply hydrates and retains moisture.
• Vitamin E (Tocopherol) – A powerful antioxidant that shields against oxidative stress while nourishing the skin.
• Squalane – A bio-compatible lipid that enhances hydration, reinforces the skin barrier, and improves texture.
• Glycerin – A clinically proven hydrating agent that maintains moisture balance and supports skin resilience.

A four-week clinical study demonstrated the efficacy of Retinol + PHA Refining Night Cream, with participants experiencing significant improvements in skin texture and tone, including:

• 29% increase in skin smoothness*
• 10% improvement in skin tone evenness*
• 90% of users reporting visibly smoother skin texture*
• 90% observing a reduction in the appearance of blemishes*

“At Obagi, our mission is to transform skin. We wanted to create a retinol solution that delivers real results while being accessible to those with sensitive skin, blemish concerns, or who aren’t ready for higher-strength retinoids,” said Justin Giouzepis, Chief Marketing Officer of Obagi. “This formula was designed with both professionals and their patients in mind—addressing unmet needs with a gentle yet effective approach. We’re thrilled to report that our clinical data found that in just eight weeks, there was a 2.3x increase in the number of participants who felt comfortable in their own skin.”

The Retinol + PHA Refining Night Cream, priced at $135 is now available through partnering professional channels. They will be available for customers to purchase on Obagi.com on 5.5.2025.

*Results based on a 2024-2025 8-week clinical test. Data on file at Obagi Cosmeceuticals LLC.

About Obagi Medical

Obagi Medical is an industry-leading, advanced skincare line rooted in research and skin biology, with a legacy of 35+ years of experience. Initially known for its leadership in the treatment of hyperpigmentation with the Obagi Nu-Derm^® System, Obagi products are designed to address a variety of skin concerns, including premature aging, photodamage, skin discoloration, acne, and sun damage. As the fastest-growing professional skincare brand in the U.S. in 2024,* Obagi empowers individuals to achieve healthy, beautiful skin. The brand continues to lead in physician-recommended skincare solutions and is recognized as the #1 Physician-Recommended Brand for At-Home Skincare Products for Hyperpigmentation, Fine Lines & Wrinkles, and Sagging Skin & Loss of Elasticity.** More information about Obagi is available on the brand’s website, https://www.obagi.com.

*Among the Top 10 Professional Skin Care Brands in the U.S., According to Kline’s 2024 Global Professional Skin Care Series (China, Europe and the U.S.)

**According to Kline’s Physician- Dispensed Skin Care: U.S. Perception and Satisfaction Survey 2023.

About Waldencast

Founded by Michel Brousset and Hind Sebti, Waldencast’s ambition is to build a global best-in-class beauty and wellness operating platform by developing, acquiring, accelerating, and scaling conscious, high-growth purpose-driven brands. Waldencast’s vision is fundamentally underpinned by its brand-led business model that ensures proximity to its customers, business agility, and market responsiveness, while maintaining each brand’s distinct DNA. The first step in realizing its vision was the business combination with Obagi Cosmeceuticals and Milk Makeup. As part of the Waldencast platform, its brands will benefit from the operational scale of a multi-brand platform; the expertise in managing global beauty brands at scale; a balanced portfolio to mitigate category fluctuations; asset-light efficiency; and the market responsiveness and speed of entrepreneurial indie brands. For more information please visit: https://ir.waldencast.com/.

Media Contact:

[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/19348f80-4f45-44c4-990a-dc3de7df67b7

WESTLAKE VILLAGE, Calif., April 02, 2025 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, is pleased to announce that Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC (Padagis) have requested a stay to the ongoing patent litigation between Padagis and the Company, and the Company has agreed to enter a joint stipulation to stay the case, which was filed in the U.S. District Court for the District of Delaware on April 2, 2025. After the Court enters the joint stipulation, all calendared dates and trial for the patent litigation will be vacated.

As part of the joint stipulation agreement, Padagis is required to report to Arcutis any U.S. Food and Drug Administration (FDA) correspondence regarding their Abbreviated New Drug Application (ANDA) for their potential generic alternative to Arcutis’ patented product, ZORYVE® (roflumilast) cream 0.3% for plaque psoriasis. In addition, the parties agreed to extend the 30-month Hatch-Waxman stay of regulatory approval by one day for every day the litigation is stayed as of March 24, 2025, such that in the event the litigation resumes in the future, Arcutis will still benefit from the entirety of the stay afforded to it under the Hatch-Waxman Act.

“This joint stipulation is a positive development for Arcutis that fully preserves our ability to assert our intellectual property while also preserving the Hatch-Waxman stay. As we have previously communicated, we maintain confidence in the strength of our broad patent portfolio that protects the innovative aspects of ZORYVE and in our legal position against Padagis. If and when the stay is lifted, we will continue to vigorously defend our intellectual property rights as appropriate, and to fight against any attempts by Padagis to infringe our patents,” said Frank Watanabe, president and CEO, Arcutis. “Our focus is to continue to build upon the strong adoption of ZORYVE as a safe and effective therapy and alternative to steroids for three major inflammatory dermatoses and continue to deliver meaningful innovation to millions of individuals impacted by plaque psoriasis, seborrheic dermatitis and atopic dermatitis.”

Patent protection for ZORYVE cream 0.3% extends until at least 2037.  ZORYVE cream 0.3% is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.

INDICATIONS

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.

Forward-Looking Statements

This press release contains 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. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding Arcutis’ patent portfolio, regulatory processes and litigation and related proceedings, as well as adoption of ZORYVE. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:



Media



Amanda Sheldon, Head of Corporate Communications
[email protected]

Investors



Latha Vairavan, Vice President, Finance and Corporate Controller
[email protected]

NEW YORK, April 01, 2025 (GLOBE NEWSWIRE) — Levi & Korsinsky, LLP notifies investors in Zynex, Inc. (“Zynex, Inc.” or the “Company”) (NASDAQ: ZYXI) of a class action securities lawsuit.

CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Zynex, Inc. investors who were adversely affected by alleged securities fraud between March 13, 2023 and March 11, 2025. Follow the link below to get more information and be contacted by a member of our team:

https://zlk.com/pslra-1/zynex-inc-lawsuit-submission-form?prid=139943&wire=3

ZYXI investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500.

CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (1) Zynex shipped products, including electrodes, in excess of need; (2) as a result of this practice, the Company inflated its revenue; (3) the Company’s practice of filing false claims drew scrutiny from insurers, including the U.S. military health insurance program, Tricare; (4) as a result, it was reasonably likely that Zynex would face adverse consequences, including removal from insurer networks and penalties from the federal government; and (5) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

WHAT’S NEXT? If you suffered a loss in Zynex, Inc. during the relevant time frame, you have until May 19, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate.

WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

CONTACT:

Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 17th Floor
New York, NY 10004
[email protected] 
Tel: (212) 363-7500
Fax: (212) 363-7171
www.zlk.com 

BURLINGTON, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) — Cerence Inc. (NASDAQ: CRNC), AI for a world in motion, today announced it has named Christian Mentz, a highly regarded business leader in automotive technology, as the company’s Chief Revenue Officer. In this role, Mr. Mentz will lead Cerence’s global sales and business development, sales engineering, and marketing organizations, driving the company’s go-to-market strategy, accelerating growth, and expanding the company’s relationships with its automaker and mobility customers worldwide.

Mr. Mentz joins Cerence after more than four years in progressing roles at Amazon. In his most recent role at Amazon Smart Vehicles, Christian successfully led the global Business and Marketing organization, driving commercial operations and go-to-market strategies across a wide range of automotive digital cabin products and services. Prior to joining Amazon, Mr. Mentz held several automotive sales and leadership roles during a more than ten-year tenure at Nuance Communications, including Vice President – Automotive Sales & Sales Engineering. Mr. Mentz has continuously demonstrated passion for innovation and advancing technologies throughout his career, having held several consulting and advisory roles for technology companies, including as an advisor to AI and machine learning firm Dessa.

“Christian is a tenured and accomplished executive who brings transformational leadership and a proven ability to build deep customer relationships,” said Stefan Ortmanns, CEO, Cerence. “Christian’s long and successful career and progressive leadership give him unique, direct experience in automotive AI and voice technology that will be critical as Cerence accelerates toward the next generation of AI-powered, immersive customer experiences.”

“Having spent a substantial part of my career working on the intersection of AI and automotive to drive advancements and collaboration in infotainment and the digital cabin, I am honored and excited to join Cerence as its Chief Revenue Officer,” said Christian Mentz. “As our industry continues to undergo significant transformation, I look forward to working with the entire Cerence team to leverage our deep expertise as a pioneer in automotive and generative AI to propel innovation in partnership with our customers worldwide.”

Mr. Mentz holds a Master’s Degree in Communications from The Philipp University of Marburg, Germany, and continued his education in Change and Innovation Management at the University of St. Gallen, Switzerland.

To learn more about Cerence, visit www.cerence.com, and follow the company on LinkedIn and Twitter.

About Cerence Inc.

Cerence (NASDAQ: CRNC) is the global industry leader in creating unique, moving experiences for the mobility world. As an innovation partner to the world’s leading automakers and mobility OEMs, it is helping advance the future of connected mobility through intuitive, AI-powered interaction between humans and their vehicles, connecting consumers’ digital lives to their daily journeys no matter where they are. Cerence’s track record is built on more than 20 years of knowledge and 475 million cars shipped with Cerence technology. Whether it’s connected cars, autonomous driving, e-vehicles, or two-wheelers, Cerence is mapping the road ahead. For more information, visit www.cerence.com.

Contact Information

Kate Hickman | Tel: 339-215-4583 | Email: [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ee36fe30-9e57-4d87-a2e9-a134a9e68f81

BOSTON, Sept. 05, 2023 (GLOBE NEWSWIRE) — X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the approval of once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency.

“The submission of our first NDA is a significant milestone in X4’s journey to transform the care of those living with rare immunodeficiencies,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “We’re excited that this submission moves us one step closer to introducing what could be the first approved product in the U.S. for those with WHIM syndrome. We also continue to advance our clinical program evaluating mavorixafor in people with chronic neutropenic disorders.”

The FDA takes 60 days to determine whether an NDA is sufficiently complete prior to accepting it for filing. X4 has requested priority review for the application which, if granted, would provide a target FDA review period of six months from the application acceptance for filing date.

The NDA submission is supported by the results of the global, pivotal, 4WHIM Phase 3 clinical trial of once-daily, oral mavorixafor in individuals with WHIM syndrome. The 4WHIM trial met its primary endpoint and key secondary endpoint and was generally well tolerated in the trial, with no treatment-related serious adverse events reported and no discontinuations for safety events. The 4WHIM data also revealed that mavorixafor treatment resulted in reductions in the rate, severity, and duration of infections in trial participants versus placebo. These and additional 4WHIM Phase 3 data were published in oral presentations at the annual meetings of both the Clinical Immunology Society (CIS) and European Hematology Association (EHA).

About Mavorixafor and WHIM Syndrome

WHIM syndrome is a rare, inherited, combined immunodeficiency disease caused by reduced mobilization and trafficking of white blood cells from the bone marrow due to over-signaling of the CXCR4/CXCL12 pathway. WHIM syndrome is named for its four common clinical findings: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis, although not all patients experience all symptoms, and not all symptoms are required for a diagnosis. People with WHIM syndrome characteristically have very low blood levels of neutrophils (neutropenia) and lymphocytes (lymphopenia), and as a result, experience frequent, recurrent infections with a high risk of lung disease, refractory warts from underlying human papillomavirus (HPV) infection, limited antibody production due to low levels of immunoglobulin, and an increased risk of developing certain types of cancer.

Mavorixafor is an investigational small-molecule antagonist of CXCR4 being developed as a once-daily oral therapy for WHIM syndrome. For the WHIM syndrome indication, mavorixafor has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Designation in the U.S., and Orphan Drug Status in both the U.S. and European Union.

About the 4WHIM Phase 3 Clinical Trial

The 4WHIM Phase 3 clinical trial was a global, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of oral, once-daily mavorixafor in people with genetically confirmed WHIM syndrome. The trial enrolled 31 participants aged 12 and older who received either mavorixafor (n=14) or placebo (n=17) orally once daily for 52 weeks. An open-label extension phase of the clinical trial is ongoing (NCT03995108).

About X4 Pharmaceuticals

X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company driven to improve the lives of people with rare diseases of the immune system. Our lead clinical candidate is mavorixafor, a small molecule antagonist of chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy across a variety of immunodeficiencies, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome and certain chronic neutropenic disorders. Following successful completion of a global, pivotal, Phase 3 clinical trial, we are seeking U.S. approval of oral, once-daily mavorixafor for the treatment of people aged 12 years and older with WHIM syndrome. We are also currently planning a Phase 3 clinical program evaluating mavorixafor in certain chronic neutropenic disorders. We continue to leverage our insights into CXCR4 and immune system biology at our corporate headquarters in Boston, Massachusetts and at our research center of excellence in Vienna, Austria. For more information, please visit our website at www.x4pharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding the FDA’s review of the NDA for mavorixafor in WHIM syndrome, if accepted, and commercial launch of mavorixafor, if approved. Any forward-looking statements in this press release are based on management’s current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, the risk that the FDA does not accept the NDA submission for mavorixafor for the treatment of WHIM syndrome; the risk that such NDA is not approved by the FDA or such approval is delayed; the risk that commercial launch of mavorixafor in WHIM syndrome, if approved, is delayed; the risk that the potential market performance for mavorixafor, if approved, may differ materially from projections; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 4, 2023, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

Contacts:

Daniel Ferry (investors)
Managing Director, LifeSci Advisors
[email protected]
(617) 430-7576

Brett Whelan (media)
LifeSci Communications
[email protected]

SAN DIEGO, Sept. 05, 2023 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the completion of its registered direct offering of common stock and warrants to purchase common stock priced at-the-market under Nasdaq rules with an institutional investor and an investor affiliated with the licensor of one of the company’s early stage product candidates. The aggregate gross proceeds to Daré, before deducting offering expenses payable by Daré, were $7.0 million. The closing occurred on September 1, 2023.

“This financing strengthened our balance sheet, providing cash to help us deliver on important portfolio milestones this year,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “In addition to the commercial launch of XACIATO in the U.S. by Organon, we are looking forward to the commencement of patient enrollment in our pivotal Phase 3 clinical study of Ovaprene, our investigational, hormone-free, monthly intravaginal contraceptive, and topline data from our Phase 1 clinical study of DARE-PDM1, an investigational proprietary hydrogel formulation of diclofenac we are developing as a vaginally administered treatment for primary dysmenorrhea, more commonly referred to as menstrual cramps and pain,” continued Ms. Johnson. “We also look forward to an end-of-Phase-2 meeting, targeted for 2023, with the FDA for our Sildenafil Cream, 3.6% program, to support Phase 3 commencement in early 2024; our investigational formulation of sildenafil is designed to treat female sexual arousal disorder and/or female sexual interest/arousal disorder utilizing the active ingredient in Viagra®. In addition, we are pleased to announce that we previously entered into a license agreement with Douglas Pharmaceuticals, a New Zealand based pharmaceutical company, under which we acquired exclusive rights to develop and commercialize in the United States an investigational, novel proprietary lopinavir and ritonavir combination soft gel vaginal insert for the treatment of cervical intraepithelial neoplasia, also known as cervical dysplasia. There is no FDA-approved pharmaceutical treatment for cervical dysplasia, a precancerous condition in women strongly linked to HPV infection, the most common sexually transmitted infection in the U.S. Current surgical procedures to treat cervical dysplasia are invasive and can adversely impact future pregnancies. A pharmaceutical approach could provide women with an important alternative to surgery to treat this condition.”

Daré’s completed equity financing included minority participation by an investor affiliated with Douglas.

About Daré Bioscience

Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.

Daré’s first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Forward-Looking Statements

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to commercial launch of XACIATO in the U.S., plans and expectations with respect to Daré’s product candidates, including anticipated timing for commencement and conduct of clinical trials, announcement of topline results and meetings with the FDA, and the anticipated FDA approval pathway for a product candidate, the expectation that a product candidate could be a first-in-category product, and the potential market size and opportunity for a product candidate, if approved. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, and public health emergencies on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including their potential impact on Daré’s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cyber attacks, security breaches or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Investors on behalf of Daré Bioscience, Inc.:
Lee Roth / Julia Weilman
Burns McClellan
[email protected] / [email protected]
646.930.4406 / 646.732.4443

OR

Media on behalf of Daré Bioscience, Inc.:
Jake Robison
Evoke Canale
[email protected]
619.849.5383

Source: Daré Bioscience, Inc.