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Strength in both segments contributed to 
consolidated year-over-year revenue growth for Q4 2024

Consolidated revenue increased sequentially every quarter throughout 2024, reflecting the success of the Company’s transformation strategy to higher-growth markets

Management expects double-digit consolidated revenue growth in 2025, driven by anticipated OSS segment revenue of over 20% and consolidated EBITDA break even for the year

ESCONDIDO, Calif., March 19, 2025 (GLOBE NEWSWIRE) — One Stop Systems, Inc. (“OSS” or the “Company”) (Nasdaq: OSS), a leader in rugged Enterprise Class compute for artificial intelligence (AI), machine learning (ML) autonomy and sensor processing at the edge, reported results for the three- and twelve-month periods ended December 31, 2024. Comparisons for the three- and twelve-month periods are to the same year-ago periods unless otherwise noted.

“I am pleased to report a return to consolidated year-over-year revenue growth for the fourth quarter, as sales from both our OSS and Bressner segments grew at double digit rates. Throughout 2024 we executed on our multi-year transformation, making significant progress in shifting our business toward higher-margin, higher-growth markets. We invested in our platform, strengthened our pipeline, and deepened collaboration with customers developing high-performance, Enterprise Class, edge computing solutions for both commercial and defense applications,” stated OSS President and CEO, Mike Knowles.

“As efforts to reposition the Company for revenue growth gained momentum during 2024 and our business model evolved, we adjusted our legacy inventory and program costs to better align with our focus on improving efficiencies and increasing profitability. We believe the progress we made in 2024 strengthened our business, positioning the Company for higher sales and profitability in 2025 and beyond,” concluded Mr. Knowles.

2024 Fourth-Quarter Financial Summary

Consolidated revenue was $15.1 million, compared to $13.2 million in the fourth quarter of 2023. The 15.1% year-over-year increase was a result of a $1.3 million increase in Bressner segment revenue and a $642,000 year-over-year increase in OSS segment revenue. The 10% year-over-year increase in OSS segment revenue was primarily due to higher revenue from defense and commercial customers, as well as new customer-funded development orders, aligned directly with the Company’s strategic focus and plan.

The following table sets forth net revenue by segment for the three months ended December 31, 2024, and December 31, 2023 (Dollars may not calculate due to rounding):

	Three Months Ended
Entity:	December 31,  2024			% of Net Revenue			December 31,  2023			% of Net Revenue			% Change
OSS	$	7,042,613		46.5	%		$	6,401,047		48.7	%		10.0	%
Bressner		8,097,533		53.5	%			6,754,161		51.3	%		19.9	%
Total net revenue	$	15,140,146		100.0	%		$	13,155,209		100.0	%		15.1	%

During the fourth quarter ended December 31, 2024, the Company took a charge related to contract losses of $1.2 million for incurred and anticipated costs to satisfy performance obligations on a customer-funded development contract that was entered into in 2022.   This charge reduced reported gross margin, net income, and adjusted EBITDA for the three- and twelve-month periods ended December 31, 2024. Management does not currently foresee any further charges related to this customer-funded development contract.  

Consolidated gross margin percentage was 15.7%, compared to 33.7% in the prior year quarter. Gross margin, excluding the one-time charges, was 23.8%, compared to 33.7% in the same period last year. The decrease in gross margin was primarily due to product mix.

On a segment basis, the OSS segment had a gross margin of 9.4%, compared to 45.9% for the same period a year ago. OSS segment gross margin, excluding the one-time charges, was 26.8%, compared to 45.9%. The decrease from the same period last year was primarily driven by product mix. The Company’s Bressner segment had a gross margin percentage of 21.2%, compared to 22.2% in the same period last year.  

Total operating expenses increased 15.1% to $5.5 million. This increase was predominantly attributable to higher general and administrative costs related to planned sales and program management investments made during the quarter.

The Company reported a net loss of $3.1 million, or $(0.15) per share, as compared to a net loss of $278,000, or $(0.01) per share, in the prior year period.

Adjusted EBITDA, a non-GAAP metric, was a loss of $2.3 million, inclusive of $1.2 million in one-time charges, compared to adjusted EBITDA of $322,000 in the prior year period.

As of December 31, 2024, the Company reported cash and short-term investments of $10.0 million and total working capital of $24.0 million, compared to cash and short-term investments of $11.8 million and total working capital of $35.6 million at December 31, 2023. The reduction in cash and short-term investments was primarily driven by the paydown of $1 million of notes payable.  

2024 Twelve Months Financial Summary

Consolidated revenue was $54.7 million, compared to $60.9 million for the same period last year. The 10.2% year-over-year reduction in consolidated revenue was primarily a result of approximately $4.8 million related to a former media customer, for whom shipments ceased in the second quarter of 2023. This decrease was partially offset by higher sales to customers in the military and defense end markets. In addition, Bressner segment revenue declined by $2.0 million on a year-over-year basis, associated with slower economic activity in the German economy.  

The following table sets forth net revenue by segment for the twelve months ended December 31, 2024, and December 31, 2023 (Dollars may not calculate due to rounding):

	Twelve Months Ended
Entity:	December 31,  2024			% of Net Revenue			December 31,  2023			% of Net Revenue			% Change
OSS	$	24,558,809		44.9	%		$	28,809,888		47.3	%		(14.8	)%
Bressner		30,135,550		55.1	%			32,086,910		52.7	%		(6.1	)%
Total net revenue	$	54,694,358		100.0	%		$	60,896,798		100.0	%		(10.2	)%

For the year ended December 31, 2024, the Company incurred a total of $8.3 million of one-time charges that reduced reported gross margin, net income, and adjusted EBITDA. During the fourth quarter of 2024, the Company took a charge related to contract losses of $1.2 million for incurred and anticipated costs to satisfy performance obligations on a customer-funded development contract that was entered into in 2022.   Additionally, during the year, OSS incurred $7.1 million of inventory charges related to obsolete and slow-moving inventory associated with the transition of the Company’s business model and operating strategies, as well as slower adoption and movement in certain commercial and defense edge compute markets. Management does not currently foresee any further significant adjustments to costs related to this customer-funded development contract or inventory charges, outside of historical trends.  

Consolidated gross margin percentage was 14.1%, compared to 29.5% in the prior year. On a full year basis, consolidated gross margin, excluding one-time charges, was 29.3%, compared to 29.5% in 2023.

On a segment basis, the Company’s OSS segment had a gross margin of 2.5%, compared to 35.6% for the same period a year ago. OSS segment gross margin, excluding one-time charges, was 36.4%, up from 35.6% for 2023. The Company’s Bressner segment had a gross margin of 23.5%, compared to 24.0% in the same period last year.  

Total operating expenses decreased 18.6% to $21.1 million. This decrease was predominantly attributable to a charge of $5.6 million for an impairment of goodwill that occurred during the 2023 twelve-month period, the elimination of costs associated with organizational restructuring, timing of certain new product introduction activities and the deployment of engineering resources onto customer funded development efforts, partially offset by increased costs for personnel and for tradeshow participation.

The Company reported a net loss of $13.6 million, or $(0.65) per share, as compared to a net loss of $6.7 million, or $(0.32) per share, in the prior year. Non-GAAP net loss and loss per share was $11.6 million, or $(0.56) per share, as compared to non-GAAP net loss and loss per share of $415,000, or $(0.02) per share, in the prior year period. Net loss and non-GAAP net loss for the period ended December 31, 2024, are inclusive of $8.3 million of one-time charges.

Adjusted EBITDA, a non-GAAP metric, was a loss of $10.3 million, inclusive of $7.1 million of inventory-related charges and a $1.2 million contract loss related to a customer-funded development contract that was entered into in 2022, compared to adjusted EBITDA of $1.1 million in the prior year.

2025 Full Year Outlook

The Company anticipates consolidated revenue of $59 to $61 million for the full year of 2025. This includes expected OSS segment revenue of approximately $30 million, representing over 20% year-over-year growth in the OSS segment. In addition, the Company expects to be EBITDA break-even for the full year of 2025. Management expects revenue and profitability to improve at a higher rate in the second half of 2025 based on current trends and the Company’s expanding sales pipeline.   

Conference Call

OSS will hold a conference call to discuss its results for the fourth quarter of 2024, followed by a question-and-answer period.

Date: Wednesday, March 19, 2025
Time: 10:00 a.m. ET (7:00 a.m. PT)
Toll-free dial-in: 1-800-717-1738
International dial-in: 1-646-307-1865
Conference ID: 35863 (required for entry)
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1706031&tp_key=7e52a82afd

A replay of the call will be available after 1:00 p.m. ET on March 19, 2025, through April 2, 2025.

Toll-free replay: 1-844-512-2921
International replay: 1-412-317-6671
Passcode: 1135863

About One Stop Systems

One Stop Systems, Inc. (Nasdaq: OSS) is a leader in AI enabled solutions for the demanding ‘edge’. OSS designs and manufactures Enterprise Class compute and storage products that enable rugged AI, sensor fusion and autonomous capabilities without compromise. These hardware and software platforms bring the latest data center performance to harsh and challenging applications, whether they are on land, sea or in the air.

OSS products include ruggedized servers, compute accelerators, flash storage arrays, and storage acceleration software. These specialized compact products are used across multiple industries and applications, including autonomous trucking and farming, as well as aircraft, drones, ships and vehicles within the defense industry.

OSS solutions address the entire AI workflow, from high-speed data acquisition to deep learning, training and large-scale inference, and have delivered many industry firsts for industrial OEM and government customers.

As the fastest growing segment of the multi-billion-dollar edge computing market, AI enabled solutions require—and OSS delivers—the highest level of performance in the most challenging environments without compromise.

OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com. You can also follow OSS on X, YouTube, and LinkedIn.

Non-GAAP Financial Measures

We believe that the use of adjusted earnings before interest, taxes, depreciation and amortization, or adjusted EBITDA, is helpful for an investor to assess the performance of the Company. The Company defines adjusted EBITDA as income (loss) before interest, taxes, depreciation, amortization, acquisition expense, impairment of long-lived assets, financing costs, government funded programs, fair value adjustments from purchase accounting, stock-based compensation expense, and expenses related to discontinued operations.

Adjusted EBITDA is not a measurement of financial performance under generally accepted accounting principles in the United States, or GAAP. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash operating expenses, we believe that providing a non-GAAP financial measure that excludes non-cash and non-recurring expenses allows for meaningful comparisons between our core business operating results and those of other companies, as well as providing us with an important tool for financial and operational decision making and for evaluating our own core business operating results over different periods of time.

Our adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in our industry, as other companies in our industry may calculate non-GAAP financial results differently, particularly related to non-recurring and unusual items. Our adjusted EBITDA is not a measurement of financial performance under GAAP, and should not be considered as an alternative to operating income or as an indication of operating performance or any other measure of performance derived in accordance with GAAP. We do not consider adjusted EBITDA to be a substitute for, or superior to, the information provided by GAAP financial results.

	For the Three Months Ended December 31,								For the Year Ended  December 31,
	2024				2023				2024				2023
Net loss	$	(3,134,782	)		$	(277,560	)		$	(13,634,333	)		$	(6,716,176	)
Depreciation and amortization of intangibles		226,417				263,743				1,041,837				1,077,516
Amortization of right-of-use assets, net of changes in lease liability		(2,488	)			(30,208	)			29,885				22,592
Stock-based compensation expense		564,176				454,461				1,988,125				2,345,358
Interest expense		3,206				29,662				74,116				117,774
Interest income		(100,805	)			(159,487	)			(477,745	)			(544,958	)
Impairment of goodwill		–				–				–				5,630,788
Employee retention credit (ERC)		–				–				–				(1,716,727	)
Provision for income taxes		157,120				41,796				726,502				927,128
Adjusted EBITDA	$	(2,287,156	)		$	322,407			$	(10,251,613	)		$	1,143,296

FOOTNOTE: Adjusted EBITDA for the fourth quarter and full year ended December 31, 2024, included a charge related to contract losses of $1.2 million for incurred and anticipated costs to satisfy performance obligations on a customer-funded development contract that was entered into in 2023. Adjusted EBITDA for the full year ended December 31, 2024, also included inventory-related charges of $7.1 million.  

(Dollars may not calculate due to rounding)

Adjusted EPS excludes the impact of certain items and, therefore, has not been calculated in accordance with GAAP. We believe that exclusion of certain selected items assists in providing a more complete understanding of our underlying results and trends and allows for comparability with our peer company index and industry. We use this measure along with the corresponding GAAP financial measures to manage our business and to evaluate our performance compared to prior periods and the marketplace. The Company defines non-GAAP income (loss) as income or (loss) before amortization, government funded programs, impairment of long lived assets, stock-based compensation, expenses related to discontinued operations, and acquisition costs. Adjusted EPS expresses adjusted income (loss) on a per share basis using weighted average diluted shares outstanding.

Adjusted EPS is a non-GAAP financial measure and should not be considered in isolation or as a substitute for financial information provided in accordance with GAAP. These non-GAAP financial measures may not be computed in the same manner as similarly titled measures used by other companies. We expect to continue to incur expenses similar to the adjusted income from continuing operations and adjusted EPS financial adjustments described above, and investors should not infer from our presentation of these non-GAAP financial measures that these costs are unusual, infrequent or non-recurring.

The following table reconciles non-GAAP net income and basic and diluted earnings per share:

	For the Three Months Ended  December 31,								For the Full Year Ended December 31,
	2024				2023				2024				2023
Net loss	$	(3,134,782	)		$	(277,560	)		$	(13,634,333	)		$	(6,716,176	)
Amortization of intangibles		–				–				–				42,154
Impairment of goodwill		–				–				–				5,630,788
Employee retention credit (ERC)		–				–				–				(1,716,727	)
Stock-based compensation expense		564,176				454,461				1,988,125				2,345,358
Non-GAAP net loss	$	(2,570,606	)		$	176,901			$	(11,646,208	)		$	(414,603	)
Non-GAAP net loss per share:
Basic	$	(0.12	)		$	0.01			$	(0.56	)		$	(0.02	)
Diluted	$	(0.12	)		$	0.01			$	(0.56	)		$	(0.02	)
Weighted average common shares outstanding:
Basic		21,120,396				20,632,300				20,953,397				20,854,777
Diluted		21,120,396				20,632,300				20,953,397				20,854,777

FOOTNOTE: Non-GAAP net loss for the fourth quarter and full year ended December 31, 2024, included a charge related to contract losses of $1.2 million for incurred and anticipated costs to satisfy performance obligations on a customer-funded development contract that was entered into in 2023. Non-GAAP net loss for the full year ended December 31, 2024, also included an inventory charge of $6.1 million.  

(Dollars may not calculate due to rounding)

Forward-Looking Statements

One Stop Systems cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by One Stop Systems or its partners that any of our plans or expectations will be achieved, including but not limited to, our ability to expand our product offerings and further penetrate our target markets, future demand for AI/ML integrations, expected or anticipated increase in revenues, and our business strategies. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in our business, including risks described in our prior press releases and in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our latest Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Media Contacts:

Robert Kalebaugh
One Stop Systems, Inc.
Tel (858) 518-6154
Email contact

Investor Relations:

Andrew Berger
Managing Director
SM Berger & Company, Inc.
Tel (216) 464-6400
Email contact

ONE STOP SYSTEMS, INC. (OSS)
CONSOLIDATED BALANCE SHEETS
	Audited				Audited
	December 31,				December 31,
	2024				2023
ASSETS
Current assets
Cash and cash equivalents	$	6,794,093			$	4,048,948
Short-term investments		3,217,065				7,771,820
Accounts receivable, net		8,177,371				8,318,247
Inventories, net		13,176,156				21,694,748
Prepaid expenses and other current assets		836,364				611,066
Total current assets		32,201,048				42,444,829
Property and equipment, net		1,669,026				2,370,224
Operating lease right-of use assets		1,536,094				1,922,784
Deposits and other		38,093				38,093
Goodwill		1,489,722				1,489,722
Total Assets	$	36,933,982			$	48,265,652
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	2,068,017			$	1,201,781
Accrued expenses and other liabilities		4,806,675				3,202,519
Current portion of operating lease obligation		285,937				390,926
Current portion of notes payable		1,035,050				2,077,895
Total current liabilities		8,195,679				6,873,121
Deferred tax liability, net		52,574				44,673
Operating lease obligation, net of current portion		1,513,684				1,765,536
Total liabilities		9,761,937				8,683,330
Commitments and contingencies
Stockholders’ equity
Common stock, $0.0001 par value; 50,000,000 shares authorized; 21,148,810 and 20,661,341 shares issued and outstanding at December 31, 2024 and 2023, respectively		2,115				2,066
Additional paid-in capital		49,082,737				47,323,673
Accumulated other comprehensive income		140,254				675,310
Accumulated deficit		(22,053,061	)			(8,418,727	)
Total stockholders’ equity		27,172,045				39,582,322
Total Liabilities and Stockholders’ Equity	$	36,933,982			$	48,265,652

ONE STOP SYSTEMS, INC. (OSS)
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars may not calculate due to rounding)
	For the Three Months Ended December 31,								For the Year Ended December 31,
	2024				2023				2024				2023
Revenue:
Product	$	14,280,939			$	12,335,554			$	51,003,350			$	59,200,580
Customer funded development		859,207				819,655				3,691,009				1,696,217
		15,140,146				13,155,209				54,694,358				60,896,797
Cost of revenue:
Product		10,829,859				8,229,397				42,953,344				41,907,604
Customer funded development		1,930,800				491,242				4,022,707				1,034,571
		12,760,659				8,720,639				46,976,051				42,942,175
Gross (loss) profit		2,379,487				4,434,570				7,718,307				17,954,622
Operating expenses:
General and administrative		2,413,102				1,970,746				8,971,909				9,264,447
Impairment of goodwill		–				–				–				5,630,788
Marketing and selling		1,821,918				1,667,765				8,005,982				6,651,516
Research and development		1,250,377				1,127,194				4,097,229				4,331,024
Total operating expenses		5,485,397				4,765,704				21,075,120				25,877,775
Loss from operations		(3,105,910	)			(331,134	)			(13,356,813	)			(7,923,153	)
Other income (expense), net:
Interest income		100,805				159,487				477,745				544,958
Interest expense		(3,206	)			(29,662	)			(74,116	)			(117,774	)
Employee retention credit (ERC)		–				418,431				–				1,716,727
Other income (expense), net		30,647				(452,886	)			45,353				(9,806	)
Total other income, net		128,246				95,370				448,982				2,134,105
Loss before income taxes		(2,977,664	)			(235,764	)			(12,907,831	)			(5,789,048	)
Provision for income taxes		157,119				41,796				726,502				927,128
Net loss	$	(3,134,783	)		$	(277,560	)		$	(13,634,333	)		$	(6,716,176	)
Net loss per share:
Basic	$	(0.15	)		$	(0.01	)		$	(0.65	)		$	(0.32	)
Diluted	$	(0.15	)		$	(0.01	)		$	(0.65	)		$	(0.32	)
Weighted average common shares outstanding:
Basic		21,120,396				20,632,300				20,953,397				20,854,777
Diluted		21,120,396				20,632,300				20,953,397				20,854,777

ONE STOP SYSTEMS, INC. (OSS)
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
	For the Twelve Months Ended December 31,
	2024				2023
Cash flows from operating activities:
Net loss	$	(13,634,333	)		$	(6,716,176	)
Adjustments to reconcile net loss to net cash provided by operating activities:
Deferred income taxes		28,082				(95,496	)
Loss (gain) on disposal of property and equipment		354				–
Provision for bad debt		85,447				4,160
Impairment of goodwill		–				5,630,788
Warranty reserves		(79,962	)			11,846
Amortization of intangibles		–				42,154
Depreciation		1,041,837				1,035,362
Amortization of right-of-use assets		377,206				1,241,445
Inventory reserves		7,348,390				962,458
Stock-based compensation expense		1,988,125				2,345,358
Employee retention credit		–				(1,716,727	)
Changes in operating assets and liabilities:
Accounts receivable		(190,339	)			3,095,701
Inventories		658,303				(1,636,153	)
Prepaid expenses and other current assets		(238,554	)			(100,848	)
Accounts payable		926,231				(3,408,487	)
Accrued expenses and other liabilities		1,928,436				83,789
Operating lease liabilities		(347,321	)			(1,218,853	)
Net cash provided by operating activities		(108,098	)			(439,679	)
Cash flows from investing activities:
Redemption of short-term investment grade securities		4,553,535				2,342,552
Purchases of property and equipment, including capitalization of labor		(362,748	)			(821,753	)
Net cash provided by investing activities		4,190,787				1,520,799
Cash flows from financing activities:
Proceeds from exercise of stock options and warrants		237,749				62,422
Payment of payroll taxes on net issuance of employee stock options		(466,762	)			(597,856	)
Repayments on notes payable		(954,939	)			(1,352,637	)
Employee retention credit benefit		–				1,716,727
Net cash (used in) provided by financing activities		(1,183,952	)			(171,344	)
Net change in cash and cash equivalents		2,898,737				909,776
Effect of exchange rates on cash		(153,592	)			26,977
Cash and cash equivalents, beginning of period		4,048,948				3,112,196
Cash and cash equivalents, end of period	$	6,794,093			$	4,048,948

PHILADELPHIA, March 19, 2025 (GLOBE NEWSWIRE) — Kaskela Law LLC announces that a shareholder class action lawsuit has been filed against CareDx, Inc. (NASDAQ: CDNA) on behalf of certain investors who purchased shares of the company’s stock between April 30, 2020 and November 3, 2022 (the “Class Period”).

According to the complaint, during the Class Period, CareDx and certain of the company’s executive officers made a series of materially false and misleading statements to investors about CareDx’s business and operational practices. Specifically, the defendants are alleged to have
attributed CareDx’s financial success to demand for its testing services and the popularity of its RemoTraC home testing program, while in reality, CareDx’s testing services growth relied almost entirely on unethical and improper schemes to bill Medicare fraudulently for unnecessary tests and pay kickbacks to doctors. Among its many unlawful and improper practices, defendants took advantage of its RemoTraC home testing program to systematically push its expensive AlloSure tests – each of which cost Medicare $2,841 – on patients who did not need the test and did not meet Medicare’s criteria for receiving them.

The complaint details how, through a series of partial disclosures, investors learned the truth about CareDx’s business and operational practices between October 2021 and November 2022.
For example, on October 28, 2021, shares of the company’s stock fell $19.34 per share, or over 27% in value, after CareDx disclosed that it was under investigation by the DOJ, the SEC, and a state regulatory agency in connection with a False Claims Act investigation. Shares of the company’s stock continued to decline in value – to as low as $16.00 per share, as CareDx slowly disclosed additional negative information to investors, including the resignations of several key executives and the filing of a whistleblower complaint.

The investigation seeks to determine – on behalf of CareDx’s current shareholders – whether the members of CareDx’s board of directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct and misstatements.

Current CareDx stockholders


who purchased or acquired shares of the company’s stock



prior to October 28, 2021



are encouraged to contact


Kaskela Law LLC


(D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) to receive additional information about their legal rights and options at (484) 229 – 0750,


or by clicking on the following link (or by copying and pasting the link into your browser):

https://kaskelalaw.com/case/caredx-2/

Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about Kaskela Law LLC please visit www.kaskelalaw.com. This notice may constitute attorney advertising in certain jurisdictions.

CONTACT:

KASKELA LAW LLC

D. Seamus Kaskela, Esq.
Adrienne Bell, Esq.
18 Campus Blvd., Suite 100
Newtown Square, PA 19073
(484) 229 – 0750
www.kaskelalaw.com

SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced participation in the “Other pharmaceuticals as preventive tools” panel at a World Health Organization (WHO) global meeting on H5N1 influenza preparedness and response. The meeting, titled “What research is important to prepare and respond to H5N1 influenza outbreaks,” will be held virtually on March 19, 2025, from 1:00-7:15pm Central European Time (CET)/5:00-11:15am Pacific Time (PT), and the panel discussion will take place from 6:30-7:00 pm CET/10:30-11:00am PT.

“Global discussion forums are critical for the development of effective treatments to combat outbreaks of influenza, including the growing threat of H5N1,” said Les Tari, Ph.D., chief scientific officer of Cidara. “As the virus spreads, the need for robust strategies to prevent and respond to flu outbreaks is becoming increasingly critical. Our long-acting antiviral influenza preventative, CD388, currently in a 5,000 subject Phase 2b study, shows promise as a new modality that has demonstrated potent activity against all influenza A and B strains, including H5N1, in preclinical studies. I look forward to discussing the potential of CD388 with global leaders as a universal preventative of influenza outbreaks.”

H5N1 is one of several influenza viruses that causes a highly infectious respiratory disease in birds called avian influenza (or “bird flu”). Infections in mammals, including humans, have also been documented.

Meeting details:

Influenza H5 pathogens have been included in the list of priority pathogens by the WHO R&D Blueprint for Epidemics. To coordinate efforts for research preparedness of H5N1 outbreaks, this global consultation will review current and novel vaccines and preventive pharmaceuticals. The key objectives of this meeting are to identify knowledge gaps and priority research questions, outline regulatory pathways for mRNA vaccines and other novel approaches, and review other therapeutics, including monoclonal antibodies and long-acting antivirals.

About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.

About Cidara Therapeutics

Cidara Therapeutics is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

This 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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, whether CD388 will have activity against H5N1 and other potential pandemic influenza strains, and promising CD388 clinical data generated to date. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:

Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

MEDIA CONTACT:

Michael Fitzhugh
LifeSci Communications
(628) 234-3889
[email protected]

Event to be held via webcast on March 25, 2025 at 4:00 p.m. ET

To highlight differentiated drug discovery capabilities with its Generative Phosphoproteomics AP3 platform and program updates from the Phase 2b study of ACR-368 and Phase 1 study of ACR-2316

WATERTOWN, Mass., March 19, 2025 (GLOBE NEWSWIRE) — Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, announced it will be holding a virtual R&D event on March 25, 2025 from 4:00 p.m. to 5:15 p.m. ET. The agenda will feature presentations by Acrivon’s leadership and founding team and endometrial cancer key opinion leaders, followed by a Q&A session.

Key Opinion Leader Participants:

• Mansoor Raza Mirza, M.D., chief oncologist at Copenhagen University Hospital, Denmark; medical director of the Nordic Society of Gynecologic Oncology-Clinical Trial Unit (NSGO-CTU); vice president of the European Society of Gynecological Oncology (ESGO); board of directors, Gynecologic Cancer Inter-Group (GCIG)
• Robert L. Coleman, M.D., co-director of the Gynecologic Oncology Group (GOG) Partners Foundation, Inc.; chief medical officer at Vaniam Group
• Jesper Olsen, Ph.D., professor at the University of Copenhagen; deputy director at the Novo Nordisk Foundation Center for Protein Research; academic co-founder of Acrivon

A live webcast of the event will be available through a link on the Events & Presentations page within the investor section of the company’s website at https://ir.acrivon.com/news-events/events-presentations. The webcast will be available for at least 30 days following the event.

About Acrivon Therapeutics

Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology medicines for patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary Generative Phosphoproteomics platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner yielding terabytes of high resolution proprietary quantitative data for pathway-based drug design, indication finding, and response prediction. These distinctive capabilities enable AP3’s direct application for streamlined rational drug discovery for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designations for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer or for patients with ovarian cancer, who may benefit from ACR-368 treatment.

In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target.

Acrivon has developed its AP3 Interactome, a proprietary, computational analytics platform driven by Generative Phosphoproteomics machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.

Investor and Media Contacts:

Adam D. Levy, Ph.D., M.B.A.
[email protected]

Alexandra Santos
[email protected]

PHILADELPHIA, March 19, 2025 (GLOBE NEWSWIRE) — Kaskela Law LLC announces that a shareholder class action lawsuit has been filed against Mercury Systems, Inc. (NASDAQ: MRCY) (“Mercury”) on behalf of certain investors who purchased shares of the company’s stock between February 3, 2021 and February 6, 2024.

According to the complaint, during that time period Mercury and certain of the company’s executive officers made a series of materially false and misleading statements to investors regarding, among other things, Mercury’s integration of companies acquired pursuant to its M&A Strategy, and the negative impact to Mercury’s financial performance caused by defendants’ failure to fully integrate the company’s acquisitions.

As detailed in the complaint, beginning in August 2022, investors began learning about the extent of defendants’ collective fraud through a series of corrective disclosures, which caused the company’s stock price to fall from a trading level of above $50.00 per share to below $30.00 – a decline in value of approximately 40%.

The investigation seeks to determine whether the members of Mercury’s board of directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct and misstatements.

Current Mercury stockholders


who purchased or acquired shares of the company’s stock



prior to August 2022



are encouraged to contact


Kaskela Law LLC


(D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) to receive additional information about their legal rights and options at (484) 229 – 0750,


or by clicking on the following link (or by copying and pasting the link into your browser):

https://kaskelalaw.com/case/mercury-systems/

Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about Kaskela Law LLC please visit www.kaskelalaw.com. This notice may constitute attorney advertising in certain jurisdictions.

CONTACT:

KASKELA LAW LLC

D. Seamus Kaskela, Esq.
Adrienne Bell, Esq.
18 Campus Blvd., Suite 100
Newtown Square, PA 19073
(888) 715 – 1740
(484) 229 – 0750
www.kaskelalaw.com

VANCOUVER, British Columbia, March 19, 2025 (GLOBE NEWSWIRE) — NOVAGOLD RESOURCES INC. (“NOVAGOLD” or “the Company” (NYSE American, TSX: NG) will release its 2025 first quarter report before market open on April 1, 2025, followed by a conference call and video webcast to discuss the results at 8:00 am PT (9:00 am MT/11:00 am ET).

During the webcast, NOVAGOLD’s President and Chief Executive Officer, Greg Lang; and Vice President and Chief Financial Officer, Peter Adamek, will provide a summary of the Company’s first quarter financial results and an update on the Donlin Gold project.

Questions may be submitted prior to the call at [email protected]. There will also be an opportunity to ask questions during the webcast following the presentation.

The video webcast and conference call-in details are provided below.

Video Webcast:		www.novagold.com/investors/events
North American callers:		1-833-752-3655
International callers:		1-647-846-8520

The webcast will be archived on NOVAGOLD’s website for one year. For a transcript of the call, please see https://www.novagold.com/investors/presentations/ to download or email [email protected].

NOVAGOLD Contacts:

Mélanie Hennessey
Vice President, Corporate Communications

Frank Gagnon
Manager, Investor Relations

604-669-6227 or 1-866-669-6227
www.novagold.com

• Weekly subcutaneous administration of sabirnetug was well-tolerated in the Phase 1 study
• Systemic exposure following subcutaneous administration supports further clinical development
• Development of sabirnetug delivered subcutaneously has the potential for decreased treatment burden and increased patient convenience
  

NEWTON, Mass., March 19, 2025 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development.

“We are pleased that the results of our initial clinical study support further clinical development of sabirnetug administered subcutaneously, underscoring the potential for increasing patient convenience of this formulation relative to intravenous treatment,” said Daniel O’Connell, Chief Executive Officer of Acumen. “The timely completion of this study highlights the strength of our clinical team and partners, and our commitment to advancing our clinical pipeline efficiently and effectively. Based on these data, we believe that further development of subcutaneous sabirnetug as a more convenient administration option for patients is warranted.”

The Phase 1 study in healthy volunteers enrolled 12 subjects who received single IV doses of 2,800 mg and 16 subjects who received four weekly SC doses of 1,200 mg. The most frequently reported adverse events included injection site reactions (62.5%), all of which were mild (Grade 1) in severity and resolved. No other safety signals were identified. Importantly, SC administration of sabirnetug produced sufficient systemic exposure to enable further clinical studies of SC dosing.

Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in patients with AD. The SC formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volume SC injection with increased dispersion and absorption of co-administered therapies. ENHANZE® has been commercially validated as a component of nine approved therapies.

The Phase 2 ALTITUDE-AD study of IV sabirnetug is currently ongoing.

About Sabirnetug (ACU193)

Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.

About ALTITUDE-AD (Phase 2)

Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer’s disease. The study will enroll approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD). The global study is currently ongoing at multiple investigative sites located in the United States, Canada, UK, and the European Union. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173.

About Halozyme’s ENHANZE

^®

Technology

Halozyme’s commercially validated proprietary ENHANZE^® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume and delivery rates of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered rapidly in minutes subcutaneously. ENHANZE^® may also benefit subcutaneous biologics by reducing the need for multiple injections.

About Acumen Pharmaceuticals, Inc.

Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193) and its subcutaneous formulation. l. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.

Investors:

Alex Braun
[email protected]

Media:

Jon Yu
ICR Healthcare
[email protected]

CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) — Onconetix, Inc., (Nasdaq: ONCO) (“Onconetix” or the “Company”), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.

The presentation, titled, “Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,” will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital – University Hospital of Southern Denmark.

“The abstract accepted for presentation at EAU congress will showcase the importance of early detection of prostate cancer, particularly using Proclarix, a biomarker-based blood test,” stated Ralph Schiess, PhD, CEO of Proteomedix, a wholly-owned subsidiary of Onconetix, and added: “Proclarix has already demonstrated in multiple studies that it can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer while minimizing the risk of missing clinically significant cancer when compared to standard of care.”

Details on the presentation are as follows:

Presentation Title:	Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort
Presenter:	Zedan Raid A.H, Lillebaelt Hospital – University Hospital of Southern Denmark, Department of Oncology, Vejle, Denmark
Session Title:	Diagnostic and prognostic biomarkers in prostate cancer
Date and Time:	March 23, 2025, from 5:15 PM to 6:45 PM CET

About Proclarix^®

Proclarix^® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix^® is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix^® risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix^® is included in both the European (EAU) and American (AUA) guidelines.

About Onconetix, Inc.

Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR, which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor and Media Contact Information:

Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101

Investor Contact Information:

Onconetix Investor Relations
Email: [email protected]

Fan Favorite Totals 8.7 Million Downloads, 100 Episodes Since 2023 Debut

LOS ANGELES, March 19, 2025 (GLOBE NEWSWIRE) — PodcastOne (NASDAQ: PODC), a leading publisher and podcast sales network, announced today that Brittany Cartwright is now the solo host of the When Reality Hits podcast. The popular weekly podcast originally debuted in 2023 and features the Bravolebrity dishing on some of the biggest headlines in reality tv.

What happens when the cameras stop rolling for Brittany Cartwright on The Valley? TRUE reality hits! Brittany takes you inside her crazy life as she explores motherhood, friendship, relationships, dating, and reality TV. Nothing is off-limits in this candid look at her real life with tons of fun, lots of laughs, honest opinions, and plenty of special guests!

“Since launching When Reality Hits two years ago, Brittany has proven herself to be a dynamic voice in podcasting,” said Kit Gray, President and Co-Founder of PodcastOne. “We are excited to continue our partnership with her in this familiar yet new venture and look forward to growing her platform each week.”

“I couldn’t be more pleased to continue to host When Reality Hits. Working alongside the team at PodcastOne to create compelling weekly content and sharing my innermost thoughts and perspective has been a dream come true. I can’t wait to see what the future holds,” said Cartwright.

America’s sweetheart Brittany launched to popularity via the iconic Bravo series Vanderpump Rules and has gone on to co-star in the network’s latest hit series, The Valley. When Reality Hits with Brittany Cartwright joins a lineup of PodcastOne’s top charting programming, including Kharma and Chaos, Bitch Bible, Melissa Gorga On Display, Let’s Talk with Heather Dubrow, Off the Vine with Kaitlyn Bristowe and LadyGang.

PodcastOne continues to develop and produce compelling and entertainment-based content to generate excitement and intrigue in the audio and streaming space. With podcasts being the fastest growing medium by far, PodcastOne is a leader in expanding audiences and forging synergistic relationships for its podcasters. PodcastOne’s full roster of programming is available on PodcastOne, YouTube, Apple Podcasts, Spotify, Amazon and wherever podcasts are heard.

About PodcastOne

PodcastOne
(NASDAQ: PODC) is a leading podcast platform that provides creators and advertisers with a comprehensive 360-degree solution in sales, marketing, public relations, production, and distribution. PodcastOne has surpassed 3.9 billion total downloads with a community of 200 top podcasters, including Adam Carolla, Kaitlyn Bristowe, Jordan Harbinger, LadyGang, A&E’s Cold Case Files, and Varnamtown. PodcastOne has built a distribution network reaching over 1 billion monthly impressions across all channels, including YouTube, Spotify, Apple Podcasts, and iHeartRadio. PodcastOne is also the parent company of PodcastOne Pro which offers fully customizable production packages for brands, professionals, or hobbyists. For more information, visit www.podcastone.com and follow us on Facebook, Instagram, YouTube, and X at @podcastone.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including: LiveOne’s reliance on its largest OEM customer for a substantial percentage of its revenue; LiveOne’s and PodcastOne’s ability to consummate any proposed financing, acquisition, merger, distribution or other transaction, the timing of the consummation of any such proposed event, including the risks that a condition to the consummation of any such event would not be satisfied within the expected timeframe or at all, or that the consummation of any proposed financing, acquisition, merger, special dividend, distribution or transaction will not occur or whether any such event will enhance shareholder value; PodcastOne’s ability to continue as a going concern; PodcastOne’s ability to attract, maintain and increase the number of its listeners; PodcastOne identifying, acquiring, securing and developing content; LiveOne’s intent to repurchase shares of its and/or PodcastOne’s common stock from time to time under LiveOne’s announced stock repurchase program and the timing, price, and quantity of repurchases, if any, under the program; LiveOne’s ability to maintain compliance with certain financial and other covenants; PodcastOne successfully implementing its growth strategy, including relating to its technology platforms and applications; management’s relationships with industry stakeholders; LiveOne’s ability to extend and/or refinance its indebtedness and/or repay its indebtedness when due; uncertain and unfavorable outcomes in legal proceedings and/or PodcastOne’s and/or LiveOne’s ability to pay any amounts due in connection with any such legal proceedings; changes in economic conditions; competition; risks and uncertainties applicable to the businesses of PodcastOne, LiveOne and/or LiveOne’s other subsidiaries; and other risks, uncertainties and factors including, but not limited to, those described in PodcastOne’s Annual Report on Form 10-K for the fiscal year ended March 31, 2024, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 1, 2024, PodcastOne’s Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2024, filed with the SEC on February 14, 2025, and in PodcastOne’s other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof, and PodcastOne disclaims any obligation to update these statements, except as may be required by law. PodcastOne intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Press Contacts

:

(310) 246-4600
[email protected]

IR Contact

:

Chris Donovan
(914) 352-5853
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/87325d39-40dd-4a41-b728-27fe6d1a0f19

SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — Resmed (NYSE: RMD, ASX: RMD), the global leader in health technology focused on sleep, breathing, and care delivered in the home, today announced the publication of a landmark meta-analysis in The Lancet Respiratory Medicine, demonstrating that CPAP therapy significantly reduces the risk of death for people with obstructive sleep apnea (OSA). Analyzing data from over 1 million sleep apnea patients worldwide, the study provides the strongest evidence to date that CPAP therapy not only alleviates OSA symptoms but can also prolong life.

OSA affects over one billion people worldwide,¹ with over 80% of cases undiagnosed and untreated.² This chronic sleep-related breathing disorder can impair daily functioning and has been associated with serious health conditions, including hypertension, diabetes, cardiovascular disease, and stroke.³ The study reinforces that untreated OSA is a major but modifiable risk factor for both all-cause and cardiovascular-related death, highlighting the importance of consistent CPAP use. As the gold standard for OSA treatment, CPAP therapy is widely recognized for its effectiveness. When used correctly, it works overnight and only requires air; no drugs, surgery, or invasive procedures.

The study, led by global experts in sleep and respiratory medicine and supported by Resmed, found that people with OSA who use CPAP therapy have:

• A 37% lower risk of dying from any cause compared to those with OSA who do not use CPAP.
• A 55% lower risk of dying from cardiovascular disease, reinforcing CPAP’s supportive benefits for heart health in people living with OSA.
• A dose-response relationship, meaning that the more consistently CPAP is used, the greater the survival benefits for people living with OSA.

“For people with OSA, using CPAP versus not using CPAP can literally be a matter of life or death,” said Carlos Nunez, M.D., Resmed’s Chief Medical Officer. “Decades of research have shown CPAP can improve quality of life, and this study now provides the most comprehensive evidence yet that CPAP also prolongs lives for people living with OSA.”

This meta-analysis is the largest of its kind to date, pooling data from over 1 million OSA patients across 30 studies, including 10 randomized controlled trials (RCTs) and 20 real-world evidence studies (RWEs). Researchers analyzed long-term outcomes over the average follow-up period of nearly five years, testing the hypothesis that CPAP therapy reduces both all-cause and cardiovascular mortality in OSA patients.

“The results of the study strongly suggest that CPAP therapy is a life-saving intervention for people with OSA,” said Atul Malhotra, M.D, senior author of the study, Research Chief of Pulmonary, Critical Care and Sleep Medicine at the University of California San Diego School of Medicine and Pulmonologist at UC San Diego Health. “It’s not only about sleep apnea treatment but also about supporting heart health and extending life.”

“These findings should serve as a wake-up call,” added Jean-Louis Pépin, study co-author, Professor of Clinical Physiology at Grenoble University Hospital and Director of the HP2 Laboratory INSERM U1300. “Every additional hour of CPAP treatment translates to improved chance of survival for people living with OSA. Patients who stay on CPAP therapy aren’t just breathing easier at night; they’re potentially adding years to their lives.”

To read the full study, see the publication in The Lancet Respiratory Medicine.
To learn more about how life-changing CPAP therapy can be, visit www.resmed.com/video-story-gallery.

Study authors: Adam V. Benjafield PhD; Prof Jean-Louis Pepin; Prof Peter A. Cistulli; Alison Wimms PhD; Florent Lavergne MSc; Fatima H. Sert Kuniyoshi PhD, Sibyl H. Munson PhD, Brendan Schuler BS; Shrikar Reddy Badikol MSc; Kelly C. Wolfe BS; Leslee Willes MPH; Colleen Kelly PhD; Tetyana Kendzerska MD; Dayna A. Johnson PhD; Prof Raphael Heinzer MD, Prof Chi-Hang Lee MD, Prof Atul Malhotra MD.

About Resmed

Resmed (NYSE: RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.

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¹ Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. PMID: 31300334; PMCID: PMC7007763.
² Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 ;20(9):705-6
³ Yeghiazarians Y, Jneid H, Tietjens JR, et al. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation 2021; 144(3): e56-e67.