Market Newsdesk

ATLANTA, March 11, 2025 (GLOBE NEWSWIRE) — Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with PTSD in the fourth quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.

In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend aims to explore the unique properties of AL001 and its effects on lithium delivery in the brain compared to marketed lithium salts. The study could illuminate the path forward in patients with PTSD by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.

By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current lithium salts (carbonate and citrate) approved by the U.S. Food and Drug Administration (“FDA”) are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Although lithium does not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients. The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of a mild transient amnesia.

“With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM, promising a leap forward from the current, burdensome options,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “This advancement stands to potentially enhance the lives of over 9 million Americans suffering from PTSD by providing a more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.”

About AL001

AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.

About Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

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. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

Contacts:


Email: [email protected] or call: 1-844-722-6333

Photos accompanying this announcement are available at

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BOSTON, March 11, 2025 (GLOBE NEWSWIRE) — X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it will report financial results for the fourth quarter and full year ended December 31, 2024 and provide corporate updates on Tuesday, March 25, 2025.

The company will host a conference call and webcast on the same day at 8:30 a.m. ET. The conference call can be accessed by dialing 1-800-267-6316 from the United States or 1-203-518-9783 internationally, followed by the conference ID: X4PHARMA. The live webcast will be accessible through the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the conclusion of the call, a webcast replay will be available on the website.

About X4 Pharmaceuticals

X4 is delivering progress for patients by developing and commercializing innovative therapies for those with rare diseases of the immune system and significant unmet needs. Leveraging expertise in CXCR4 and immune system biology, X4 has successfully developed mavorixafor, an orally available CXCR4 antagonist that is currently being marketed in the U.S. as XOLREMDI^® in its first indication. The company is also evaluating additional uses of mavorixafor and is conducting a global, pivotal Phase 3 clinical trial (4WARD) in people with certain chronic neutropenic disorders. X4 is headquartered in Boston, Massachusetts. For more information, please visit www.x4pharma.com.

Investor Contact:

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

X4 Media Contact:

Rhiannon Jeselonis
Ten Bridge Communications
[email protected]

COLUMBUS, Ohio, March 11, 2025 (GLOBE NEWSWIRE) — Core Molding Technologies, Inc. (NYSE American: CMT) (“Core Molding”, “Core” or the “Company”), a leading engineered materials company specializing in molded structural products, principally in building products, industrial and utilities, medium and heavy-duty truck and powersports industries across the United States, Canada and Mexico today reported financial and operating results for the fiscal periods ended December 31, 2024.

Fiscal Year
2024
Highlights

• Net sales of $302.4 million, down 15.5% from $357.7 million in the prior year; and product sales of $291.1 million, down 16.2% from the prior year. The decrease in sales is primarily the result of lower demand from customers in all of the Company’s significant markets.
• Gross margin of $53.3 million, or 17.6% of net sales, compared to $64.5 million or 18.0% of net sales, in the prior year.
• Selling, general and administrative expenses of $36.6 million, or 12.1% of net sales, compared to $38.0 million or 10.6% of net sales, in the prior year same period.
• Operating income of $16.7 million, or 5.5% of net sales, versus operating income of $26.5 million, or 7.4% of net sales, in the prior year.
• Total liquidity at year-end was $91.8 million, net cash provided by operating activities was $35.2 million, free Cash Flow¹ was $23.6 million for the year, and the Debt to Trailing Twelve Months Adjusted EBITDA¹ was less than 1 times or 0.64 times.
• Return on Capital Employed (ROCE) was 9.9% and ROCE excluding cash was 13.1% for the year.
• Net income of $13.3 million, or $1.51 per diluted share, compared to net income of $20.3 million, or $2.31 per diluted share, a year ago. Adjusted net income of $14.3 million, or $1.63 per diluted share, compared to adjusted net income of $20.8 million, or $2.36 per diluted share, in the prior year.
• Adjusted EBITDA¹ of $33.8 million, or 11.2% of net sales, compared to $42.9 million, or 12.0% of net sales, in the prior year.

Fourth
Quarter
2024
Highlights

• Net sales of $62.5 million, down 15.3% from $73.8 million in the prior year; and product sales of $60.0 million, down 17.1% from the prior year. Sales declined primarily due to lower demand from customers in medium and heavy-duty truck and powersports.
• Gross margin of $9.9 million, or 15.8% of net sales, compared to $10.9 million or 14.8% of net sales, in the prior year.
• Selling, general and administrative expenses of $9.0 million, or 14.4% of net sales, compared to $8.4 million or 11.4% of net sales, in the prior year same period.
• Operating income of $0.9 million, or 1.4% of net sales, versus $2.5 million, or 3.4% of net sales, in the prior year.
• Net loss of $39 thousand, or $0.00 per diluted share, compared to net income of $2.2 million, or $0.25 per diluted share, a year ago. Adjusted net income of $0.8 million, or $0.10 per diluted share, compared to net income of $2.6 million, or $0.30 per diluted share, in the prior year.
• Adjusted EBITDA¹ of $5.7 million, or 9.2% of net sales, compared to $7.1 million, or 9.6% of net sales in the prior year.

¹ Adjusted EBITDA, Free Cash Flow, Adjusted Net Income, Return on Capital Employed Excluding Cash, and Debt to Trailing Twelve Months Adjusted EBITDA are non-GAAP financial measures as defined and reconciled below.

David Duvall, the Company’s President and Chief Executive Officer, said, “Fiscal 2024 was another successful year for the Company in improving our business model and a testament to our work over the last three years to improve and stabilize margins, even with lower sales.   As with all of Core’s successful transformations or Must Win Battles in the last several years, we first optimize the execution process to meet our future vision.   I am pleased with our team’s successful initiatives to improve operational efficiencies, reduce costs, and increase product line profitability in our plants.   This resulted in better stability in our margins and record operational cash flow for Core Molding in 2024 of $35 million.  

“With $45 million of new revenue wins in 2024, we plan to continue ramping our “Invest For Growth” strategy in 2025 as we continue to add resources to our sales & marketing function, now led by our CCO Alex Bantz. We focused on the execution processes with our sales function in 2024 and now we are investing in initiatives to leverage the execution processes into generating sales. Bottom line is that we need to spend more time working directly with our large customers at their locations, helping to solve their problems, and much more time presenting and displaying our capabilities at trade shows. Our three fundamental pillars that support Core’s Must Win Battle this year include 1) Grow Wallet Share by leveraging our relationships with many trusted blue chip customers, 2) Business Diversification and expansion into promising end markets supported by large addressable markets, including Constructions, Industrial, Energy, and Medical where we have seen early successes in 2024, and 3) M&A expansion through one or more strategic acquisitions to drive new sales channels where we have the processes to cross sell, a new geographic footprint advantage, or a process that is complementary to our current processes that grows our wallet share potential.   Our growing sales opportunity pipeline is currently $275 million.”      

John Zimmer, the Company’s EVP and Chief Financial Officer, commented, “The fiscal 2024 demand environment stayed under pressure most of the year and we quickly adjusted costs to match our revenue projections. As we signaled early in 2024, sales were down 15.5%, and we ended the year with net sales of $302.4 million, primarily based on macroeconomic challenges. Our ongoing operational improvements and cost reductions resulted in full year gross margins of 17.6%, even with the loss of fixed cost leverage on lower sales. By maintaining gross margins within our long-term range of 17% to 19% and controlling our sales, general and administrative costs, we were able to generate strong free cash flows of $23.6 million.   

“We are excited about our sales opportunities in 2025. Most of our 2024 new wins will positively impact revenues in 2025, with full production cycles expected in 2026. We also project the truck cycle upturn starting in the second half of 2025, which continues throughout 2026 due to the new regulation changes in 2027. Despite areas of sales growth in 2025, we expect the full year sales to be flat based on the phase-out of approximately $30 million of Volvo programs, offset by higher tooling revenues and new program revenues resulting from new business wins in 2024. Without this Volvo transition, we would have anticipated Core’s sales up about 10% for the year. This demonstrates the early success of our Invest For Growth strategy, which we kicked off in 2024.”

2024
Capital Expenditures

The Company’s capital expenditures for 2024 were $11.5 million, including $2.5 million of capacity and new program investments. The Company plans for 2025 capital expenditures of approximately $10 to $12 million to meet current demand and allow for expansion.

Financial Position at
December 31, 2024

The Company’s total liquidity at the end of 2024 was $91.8 million, with $41.8 million in cash, $25.0 million of undrawn capacity under the Company’s revolving credit facility and $25.0 million of undrawn capacity under the Company’s capex credit facility. The Company’s term debt was $21.5 million at December 31, 2024. The Debt to Trailing Twelve Months Adjusted EBITDA¹ was less than one times Adjusted EBITDA¹ at the end of the fiscal year.

¹Debt to Trailing Twelve Months Adjusted EBITDA, Adjusted EBITDA, Adjusted Net Income, and return on capital employed are metrics and non-GAAP financial measures as defined and reconciled below.
Conference Call

The Company will conduct a conference call today at 10:00 a.m. Eastern Time to discuss financial and operating results for the fiscal year ended December 31, 2024. To access the call live by phone, dial (844) 881-0134 and ask for the Core Molding Technologies call at least 10 minutes prior to the start time. A telephonic replay will be available through March 18, 2025, by calling (877) 344-7529 and using passcode ID: 2691885#. The live webcast of the call will also be available for replay later on the Company’s Investor Relations website at www.coremt.com/investor-relations/events-presentations/.

About Core Molding Technologies, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets. Factors that could cause actual results to differ from those reflected in forward-looking statements relating to our operations and business include: dependence on certain major customers, and potential loss of any major customer due to completion of existing production programs or otherwise; general macroeconomic, social, regulatory and political conditions, including uncertainties surrounding volatility in financial markets; changes in the plastics, transportation, marine and commercial product industries (including changes in demand for production), efforts of the Company to expand its customer base and develop new products to diversify markets, materials and processes and increase operational enhancements; the imposition of new or increased tariffs and the resulting consequences; Company’s initiatives to quote and execute manufacturing processes for new business, acquire raw materials, address inflationary pressures, regulatory matters and labor relations; the Company’s financial position or other financial information; and other risks and uncertainties described in the Company’s filings with the SEC. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.

Company Contact:

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

Investor Relations Contact:

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

– Financial Statements Follow –

Core Molding Technologies, Inc. Consolidated Statements of Operations (in thousands, except share and per share data)
	Three Months Ended December 31,								Year Ended December 31,
		2024				2023				2024				2023
Net sales:
Products	$	60,047			$	72,439			$	291,092			$	347,375
Tooling		2,451				1,339				11,286				10,363
Total net sales		62,498				73,778				302,378				357,738
Total cost of sales		52,613				62,841				249,118				293,218
Gross margin		9,885				10,937				53,260				64,520
Selling, general and administrative expense		9,016				8,420				36,565				37,983
Operating income		869				2,517				16,695				26,537
Other (income) and expense
Interest (income) expense		(94	)			175				(193	)			1,011
Net periodic post-retirement benefit		(180	)			(63	)			(593	)			(220	)
Total other (income) and expense		(274	)			112				(786	)			791
Income before income taxes		1,143				2,405				17,481				25,746
Income tax (benefit) expense		1,182				223				4,182				5,422
Net (loss) income	$	(39	)		$	2,182			$	13,299			$	20,324
Net income per common share:
Basic	$	—			$	0.25			$	1.53			$	2.37
Diluted	$	—			$	0.25			$	1.51			$	2.31

Core Molding Technologies, Inc. Product Sales by Market (unaudited, in thousands)
	Three Months Ended December 31,						Year Ended December 31,
		2024			2023			2024			2023
Medium and heavy-duty truck	$	34,241		$	40,626		$	163,915		$	181,376
Power sports		12,220			20,115			68,445			84,688
Building products		2,689			1,879			17,011			28,743
Industrial and Utilities		6,347			4,231			18,829			23,658
All Other		4,550			5,588			22,892			28,910
Net Product Revenue	$	60,047		$	72,439		$	291,092		$	347,375

Core Molding Technologies, Inc. Consolidated Balance Sheets (in thousands)
	Year Ended December 31,
		2024				2023
Assets:
Current assets:
Cash and cash equivalents	$	41,803			$	24,104
Accounts receivable, net		30,118				41,711
Inventories, net		18,346				22,063
Prepaid expenses and other current assets		12,621				15,001
Total current assets		102,888				102,879
Right of use asset		2,112				3,802
Property, plant and equipment, net		80,807				81,185
Goodwill		17,376				17,376
Intangibles, net		4,430				6,017
Other non-current assets		1,937				2,118
Total Assets	$	209,550			$	213,377
Liabilities and Stockholders’ Equity:
Liabilities:
Current liabilities:
Current portion of long-term debt	$	1,814			$	1,468
Accounts payable		17,115				23,958
Contract liabilities		2,286				5,204
Compensation and related benefits		7,585				10,498
Accrued other liabilities		7,911				5,058
Total current liabilities		36,711				46,186
Other non-current liabilities		2,620				3,759
Long-term debt		19,706				21,519
Post retirement benefits liability		3,152				2,960
Total Liabilities		62,189				74,424
Stockholders’ Equity:
Common stock		86				86
Paid in capital		45,760				43,265
Accumulated other comprehensive income, net of income taxes		2,292				5,301
Treasury stock		(36,145	)			(31,768	)
Retained earnings		135,368				122,069
Total Stockholders’ Equity		147,361				138,953
Total Liabilities and Stockholders’ Equity	$	209,550			$	213,377

Core Molding Technologies, Inc. Consolidated Statements of Cash Flows (in thousands)
	Year Ended December 31,
		2024				2023
Cash flows from operating activities:
Net income	$	13,299			$	20,324
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		13,399				12,912
Deferred income tax		473				2,473
Share-based compensation		2,495				2,923
Loss on the disposal of assets		241				80
Losses (Gain) on foreign currency		1,180				(58	)
Change in operating assets and liabilities:
Accounts receivable		11,593				2,550
Inventories		3,718				1,808
Prepaid and other assets		1,673				(5,825	)
Accounts payable		(8,105	)			(4,916	)
Accrued and other liabilities		(3,729	)			3,551
Post retirement benefits liability		(1,086	)			(980	)
Net cash provided by operating activities		35,151				34,842
Cash flows from investing activities:
Purchase of property, plant and equipment		(11,525	)			(9,100	)
Net cash used in investing activities		(11,525	)			(9,100	)
Cash flows from financing activities:
Gross borrowings on revolving loans		—				37,098
Gross repayment on revolving loans		—				(38,962	)
Payment on principal of term loans		(1,548	)			(1,288	)
Payments for taxes related to net share settlement of equity awards		(1,440	)			(2,669	)
Purchase of common shares		(2,939	)			—
Net cash used in financing activities		(5,927	)			(5,821	)
Net change in cash and cash equivalents		17,699				19,921
Cash and cash equivalents at beginning of year		24,104				4,183
Cash and cash equivalents at end of year	$	41,803			$	24,104
Cash paid for:
Interest	$	1,074			$	1,234
Income taxes	$	2,158			$	5,250
Non cash investing activities:
Fixed asset purchases in accounts payable	$	367			$	298

Non-GAAP Financial Measures

This press release contains financial information determined by methods other than in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Core Molding management uses non-GAAP measures in its analysis of the Company’s performance. Investors are encouraged to review the reconciliation of non-GAAP financial measures to the comparable GAAP results available in the accompanying tables.

Reconciliation of Non-GAAP Financial Measures

Adjusted EBITDA represents net income before, as applicable from time to time, (i) interest expense, net, (ii) provision (benefit) for income taxes, (iii) depreciation and amortization of long-lived assets, (iv) share based compensation expense, (v) plant closure costs, and (vi) nonrecurring legal settlement costs and associated legal expenses unrelated to the Company’s core operations. Free Cash Flow represents net cash (used in) provided by operating activities less purchase of property, plant and equipment and net working capital. Return on capital employed (ROCE) represents earnings before (i) interest expense, net and (ii) provision (benefit) for income taxes divided by (i) stockholders’ equity and (ii) current and long-term debt. ROCE excluding cash represents ROCE less ending cash balance. These measures have limitations as analytical tools and should not be considered in isolation or as an alternative to performance measure derived in accordance with GAAP as an indicator of our operating performance. We present Adjusted EBITDA, Free Cash Flow, Debt to Trailing Twelve Months Adjusted EBITDA and ROCE because management uses these measures as key performance indicators, and we believe that securities analysts, investors and others use these measures to evaluate companies in our industry. Our calculation of these measures may not be comparable to similarly named measures reported by other companies. The following tables present reconciliations of net income to Adjusted EBITDA, Cash Flow from Operating Activities to Free Cash Flow and Net Income per Share to Adjusted Net Income per Share, the most directly comparable GAAP measures, and ROCE, for the periods presented:

Core Molding Technologies, Inc. Net (Loss) Income to Adjusted EBITDA Reconciliation (unaudited, in thousands)
	Three months ended December 31,								Twelve Months Ended December 31,
		2024				2023				2024				2023
Net (loss) income	$	(39	)		$	2,182			$	13,299			$	20,324
Provision for income tax expense		1,182				223				4,182				5,422
Total other (income) and expenses(1)		(273	)			112				(786	)			791
Depreciation and amortization		3,362				3,315				13,318				12,831
Share-based compensation		428				700				2,495				2,923
Severance Costs		1,066				570				1,294				570
Adjusted EBITDA	$	5,726			$	7,102			$	33,802			$	42,861
Adjusted EBITDA as a percent of net sales		9.2	%			9.6	%			11.2	%			12.0	%
(1)Includes net interest (income) expense, and non-cash periodic post-retirement benefit cost

Core Molding Technologies, Inc. Computation of Debt to Trailing Twelve Months Adjusted EBITDA (unaudited, in thousands)
	Trailing Twelve Month Adjusted EBITDA
Net income	$	13,299
Provision for income taxes		4,182
Total other expenses(1)		(786	)
Depreciation and amortization		13,318
Share-based compensation		2,495
Severance Costs		1,294
Adjusted EBITDA	$	33,802
Total Outstanding Term Debt as of December 31, 2024	$	21,520
Term debt to Trailing Twelve Months Adjusted EBITDA		0.64
(1)Includes net interest (income) expense and non-cash periodic post-retirement benefit cost

Core Molding Technologies, Inc. Computation of Return on Capital Employed Fiscal Year Ended December 31, 2024 and 2023 (unaudited, in thousands)
		2024				2023
Equity	$	147,361			$	138,953
Structure debt		21,520				22,987
Total structured investment	$	168,881			$	161,940
Operating income	$	16,695			$	26,537
Return on capital employed		9.9	%			16.4	%

Core Molding Technologies, Inc. Computation of Return on Capital Employed Excluding Cash Fiscal Year Ended December 31, 2024 and 2023 (unaudited, in thousands)
		2024				2023
Equity	$	147,361			$	138,953
Structure debt		21,520				22,987
Less Cash	$	(41,803	)		$	(24,104	)
Total structured investment, Excluding Cash		127,078				137,836
Operating income	$	16,695			$	26,537
Return on capital employed, Excluding Cash		13.1	%			19.3	%

Core Molding Technologies, Inc. Free Cash Flow Fiscal Year Ended December 31, 2024 and 2023 (unaudited, in thousands)
		2024				2023
Cash flow provided by operations	$	35,151			$	34,842
Purchase of property, plant and equipment		(11,525	)			(9,100	)
Free cash flow surplus	$	23,626			$	25,742

Core Molding Technologies, Inc. Adjusted Net (Loss) Income per Share (unaudited, in thousands)
	Three Months Ended December 31,							Twelve Months Ended December 31,
		2024				2023			2024			2023
Net (Loss) Income	$	(39	)		$	2,182		$	13,299		$	20,324
Severance Costs (net of tax)	$	842			$	450		$	1,022		$	450
Adjusted net income	$	803			$	2,632		$	14,321		$	20,774
Weighted average common shares outstanding – basic		8,644,000				8,653,000			8,693,000			8,550,000
Weighted average common and potentially issuable common shares outstanding- diluted		8,720,000				8,878,000			8,787,000			8,772,000
Net (loss) income per share – basic	$	—			$	0.25		$	1.53		$	2.37
Severance Costs (net of tax)		0.10				0.05			0.12			0.05
Adjusted net income per share – basic	$	0.10			$	0.30		$	1.65		$	2.42
Net (loss) income per share – diluted	$	—			$	0.25		$	1.51		$	2.31
Severance Costs (net of tax)		0.10				0.05			0.12			0.05
Adjusted net income per share – diluted	$	0.10			$	0.30		$	1.63		$	2.36

LIVERMORE, Calif. and ATHENS, Greece, March 11, 2025 (GLOBE NEWSWIRE) — Advent Technologies Holdings, Inc. (NASDAQ: ADN) (“Advent “or the “Company”), an innovation-driven leader in the fuel cell and hydrogen technology space, is pleased to announce that the European Climate, Infrastructure and Environment Executive Agency (CINEA) and Advent’s wholly owned Greek subsidiary, Advanced Energy Technologies S.A. have each signed the grant agreement for the Company’s monumental RHyno Project. This EU Innovation Fund grant will provide Advent with €34,534,318 in non-dilutive funding over the lifetime of the project, with funding to be received incrementally contingent upon completion of certain performance milestones.

Dr. Nora Gourdoupi, Senior Vice President, Corporate Business Development and leader of the RHyno project commented “I am very proud of our team, and especially Dr. Olga Bereketidou, who demonstrated strong commitment in getting this project over the finish line. We met all the technical challenges head on and laid out a realistic and manageable road map for the completion of this project. The RHyno project is a big win for everyone at Advent, and it will certainly be a big win for Kozani, the Region of Western Macedonia, and the country of Greece.”

Jim Coffey, Advent’s Chief Operating Officer added “The RHyno project will be transformative. It is the result of many years of hard work and dedication put in by our teams in Patras, Kozani, and Athens, Greece. The project positions the Company extremely well for the development of strong industrial partnerships, collaborations with top academic institutions, and validates our recent outreach efforts to municipal and government leaders in Kozani and Athens.”

Gary Herman, Chief Executive Officer stated, “Everyone on the team worked very hard for this achievement. Advent had the highest ranking amongst all the 337 proposals submitted in the Innovation Fund 2023 Call from across Europe. We thank our Advent colleagues, and especially our advisor on this project, PwC Greece (PwC) and its responsible engagement leader, Mr. Iannis Voutsinos We would also like to thank the collaborative efforts of Mr. Ioannis Kaltsas, Head of Division at the European Investment Bank, and Mr. Georgios Amanatides, the Regional Governor of Western Macedonia who were instrumental and contributed to our success.

About RHyno Project

The Advent Renewable Hydrogen Innovative Technologies (RHyno) project involves the establishment of infrastructure for developing innovative fuel cells, electrolysers, and their key components including Advent ground-breaking Membrane Electrode Assembly technology at a megawatt (MW) scale. RHyno aims to pioneer the use of innovative materials to enhance power density and lifespan while significantly reducing the weight and volume of power systems through a streamlined balance of plant.

The state-of-the-art facility is designed to optimize production processes, boost efficiency, and industrialize fuel cell and electrolyser technologies. These advancements are essential for decarbonizing carbon intense industries, such as the aviation, maritime and heavy-duty automotive sectors, with further potential for spillover to other sectors, positioning Advent at the forefront of the clean energy transition.

About the EU Innovation Fund

The EU Innovation Fund is one of the world’s largest funding programmes for the commercial demonstration of innovative low-carbon technologies, aiming to bring to market industrial solutions to decarbonize Europe and support its transition to climate neutrality. Among the wide range of financial instruments available on the EU level, it plays a unique role due to its size and focus on the last steps in the rollout of innovative clean tech.

About Advent Technologies Holdings, Inc.

Advent Technologies Holdings, Inc. is a U.S. corporation operating in the fuel cell, methanol, and hydrogen technology sector. Advent focuses on developing and manufacturing the Membrane Electrode Assembly (MEA) and the fuel cell stack, the most critical component of the fuel cell system. Advent is headquartered in Livermore, CA, with offices in Athens and Patras, Greece. The Company holds approximately 150 patents related to HT-PEM fuel cell technology. Advent’s fuel cells enable the use of green eFuels (eMethanol), renewable natural gas, or hydrogen on board. The HT-PEM fuel cells are highly efficient in terms of thermal management and highly resilient under extreme environmental conditions, offering an “Any Fuel. Anywhere.” platform. Applications include stationary, portable, data center, off-grid power generation markets, and heavy-duty mobility (automotive, aviation, marine).  

For more information, visit www.advent.energy.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company’s ability to maintain the listing of the Company’s common stock on Nasdaq; future financial performance; public securities’ potential liquidity and trading; impact from the outcome of any known and unknown litigation; ability to forecast and maintain an adequate rate of revenue growth and appropriately plan its expenses; expectations regarding future expenditures; future mix of revenue and effect on gross margins; attraction and retention of qualified directors, officers, employees and key personnel; ability to compete effectively in a competitive industry; ability to protect and enhance Advent’s corporate reputation and brand; expectations concerning its relationships and actions with technology partners and other third parties; impact from future regulatory, judicial and legislative changes to the industry; ability to locate and acquire complementary technologies or services and integrate those into the Company’s business; future arrangements with, or investments in, other entities or associations; and intense competition and competitive pressure from other companies worldwide in the industries in which the Company will operate; and the risks identified under the heading “Risk Factors” in Advent’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on August 13, 2024, as well as the other information filed with the SEC. Investors are cautioned not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read Advent’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements. Advent’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should consider these risks and uncertainties.

Contacts

Advent Technologies Holdings, Inc.
[email protected]

PRINCETON, N.J., March 11, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, will present at the Zacks SCR Life Sciences Virtual Investor Forum on Thursday, March 13, 2025, and the 2025 Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer Conference in New Orleans on Friday, March 28 – Saturday, March 29, 2025.

Details of the presentations are as follows:

Zacks SCR Life Sciences Virtual Investor Forum

Date: Thursday, March 13, 2025
Event: Investor Presentation
Time: 2:30 p.m. PM ET
Registration: https://www.virtualinvestorconferences.com/wcc/eh/4814904/lp/4894272/pds-biotechnology-corporation-nasdaq-pdsb

2025 CAGLA NeauxCancer Conference

Date: Friday, March 28, 2025
Event: Scientific Presentation
Session: Innovation Track
Time: 4:00 p.m. PM ET
Location: The Roosevelt, New Orleans
Registration: To live stream the event, click here. For virtual registration, click the link below then select “Investor” in the “Registration Type” dropdown menu: https://web.cvent.com/event/d39429d9-aa77-42d9-9527-e1933ab84f19/regProcessStep1

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune^® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune^® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:

Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: [email protected]

Media Contact:

Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: [email protected]

Singapore, March 11, 2025 (GLOBE NEWSWIRE) — YY Group Holding Limited (NASDAQ: YYGH) (“YY Group”, “YYGH”, or the “Company”) is pleased to announce that YY Circle Malaysia, a subsidiary of YY Group, has successfully signed six new strategic deals in Malaysia since January 2025. This achievement highlights YY Circle’s commitment to delivering innovative solutions and building strong partnerships in the hospitality and staffing sectors.

The newly secured partnerships include prominent hotel brands such as Four Points by Sheraton and Hyatt, with operations already commenced at the start of this month. Additionally, Holiday Inn and Marriott Resort & Spa are set to launch their collaborations with YY Circle in April 2025, further solidifying the company’s footprint in the hospitality sector.

These partnerships bring YY Circle Malaysia’s annual revenue pipeline to an impressive US$13 million, marking significant growth in its third year in Malaysia. This upward trajectory underscores promising prospects for YY Circle’s planned overseas expansion and reinforces its position as a leader in the on-demand staffing industry.

Building Strong Partnerships

The new deals underscore YY Circle’s growing influence among international hotel chains. By partnering with globally recognized brands, the company strengthens its foothold in the Malaysian market while laying the foundation for expansion into new markets.

A Promising Future

“These partnerships mark a significant milestone in our journey of growth and innovation,” said Mike Fu, Chief Executive Officer and Executive Director of YY Group Holding Limited. “We are excited to collaborate with these esteemed clients and are committed to delivering exceptional value that supports their operational excellence and success.”

YY Circle Malaysia’s Country Manager, Ken Teng is equally thrilled for the potential that he sees in the Malaysian market, stating, “Having established a strong presence in hospitality, we’re now excited to expand into other sectors like cleaning and retail, unlocking new opportunities for growth.”

With its innovative solutions, YY Circle Malaysia continues to demonstrate its ability to meet the evolving needs of the clients, and drive value for its partners.

About YY Circle:

YY Circle Malaysia, a subsidiary of YY Group Holding Limited, is a leading provider of on-demand staffing solutions and hotel management systems. With a focus on innovation and partnership, YY Circle is committed to empowering businesses in the hospitality industry to achieve their operational goals seamlessly.

About YY Holdings Limited:

YY Group Holding Limited is a Singapore-based data and technology-driven company that specializes in creating enterprise intelligent labor matching services and smart cleaning solutions. Rooted in innovation and a commitment to user-centric experiences, YY Circle leverages app-based technology to optimize the labor sourcing market and the Internet of Things to revolutionize the cleaning industry.

For more information on the Company, please log on to https://yygroupholding.com/.

Investor Contact

Phua Zhi Yong, Chief Financial Officer
YY Group
[email protected]

Mark Wendou Niu, Chief Strategy Officer
YY Group
[email protected]

Delivered record full-year total revenue and AVISE CTD average selling price

Improved full-year adjusted EBITDA loss and cash use by over 40%

Commercialized new biomarkers to enhance clinical utility of AVISE CTD

CARLSBAD, Calif., March 11, 2025 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today reported financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights.

		Three Months Ended December 31,				Year Ended December 31,
			2024				2024
(in thousands, except ASP data)
Revenue		$	13,655			$	55,641
Gross margin			62.1	%			59.5	%
Operating expenses		$	11,860			$	46,748
Loss from operations		$	(3,383	)		$	(13,636	)
Net loss		$	(3,761	)		$	(15,115	)
Adjusted EBITDA		$	(2,535	)		$	(10,149	)
Cash, cash equivalents and restricted cash		$	22,236			$	22,236
Trailing-twelve-month average selling price (ASP)		$	411			$	411

2024 Financial Highlights:

• Delivered record total revenue of $55.6 million on the strength of continued ASP expansion
• Expanded AVISE^® CTD trailing twelve-month average selling price (ASP) of $411, an increase of $75 per test
• Grew gross margin by 300 basis points to 62.1% in the fourth quarter and 59.5% for the full year over the same periods in 2023
• Improved net loss by $1.8 million in the fourth quarter and by over $8 million for the full year compared to the same periods in 2023
• Improved adjusted EBITDA loss by $1.3 million in the fourth quarter and by nearly $7 million for full-year from the same periods in 2023
• Ended 2024 with a cash and restricted cash balance of $22.2 million

2024 and Recent Business Highlights:

• Achieved key commercial milestone with completion of 1,000,000^th patient tested by AVISE CTD
• Featured five abstracts at the 2024 American College of Rheumatology (ACR) annual meeting highlighting Exagen’s innovative research on novel T Cell biomarkers for Lupus and sero-negative autoantibodies for rheumatoid arthritis, in addition to a plenary presentation in collaboration with Johns Hopkins University, highlighting a urinary biomarker panel that holds the potential to guide precision management of Lupus Nephritis patients
• Secured New York State Department of Health approval for and executed commercial launch of new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays in January 2025

“The execution of our operational turnaround continued in earnest during 2024, which is reflected in our transformative financial results and is a testament to the strength of our team and strategy,” said John Aballi, President and CEO. “We have continued to grow profitable revenue and expand gross margins while significantly reducing operating expenses and cash burn.”

“Additionally, the successful launch of our new AVISE CTD biomarkers this past January is a significant milestone in our commitment to improving patient care. With these accomplishments, Exagen is better positioned for success, and I am excited about the momentum we carry into 2025 as we drive towards profitability.”

Financial Outlook  

The company expects total revenue of at least $14.5 million for the first quarter of 2025, and anticipates to be on-track to deliver positive adjusted EBITDA in the fourth quarter of 2025. The company expects to provide its full-year 2025 financial outlook in connection with the release of its first quarter 2025 financial results.

Conference Call

A conference call to provide a business update and review fourth quarter and full-year 2024 financial results is scheduled for today March 11, 2025 at 8:30 AM Eastern Time (5:30 AM Pacific Time). Interested parties may access the conference call by dialing (201) 389-0918 (U.S.) or (877) 407-0890 (international). Additionally, a link to a live webcast of the call will be available in the Investor Relations section of Exagen’s website at investors.exagen.com.

Participants are asked to join a few minutes prior to the call to register for the event. A replay of the conference call will be available until Monday, April 14, 2025 at 11:59 PM Eastern Time (8:59 PM Pacific Time). Interested parties may access the replay by dialing (201) 612-7415 (U.S.) or (877) 660-6853 (international) using passcode 13751928. A link to the replay will also be available in the investor relations section of Exagen’s website.

Use of Non-GAAP Financial Measures (Unaudited)

In addition to the financial results prepared in accordance with generally accepted accounting principles in the United States (GAAP), this press release contains the metric adjusted EBITDA, which is not calculated in accordance with GAAP and is a non-GAAP financial measure. Adjusted EBITDA excludes from net loss interest income (expense), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense and other expenses or income that management believes are not representative of the company’s operations. Such items could have a significant impact on the calculation of GAAP net loss.

Exagen uses adjusted EBITDA internally because the company believes these metrics provide useful supplemental information in assessing its operating performance reported in accordance with GAAP. Exagen believes adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses the company believes are not indicative of our ongoing performance. However, this non-GAAP financial measure may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes.

This non-GAAP financial measure is not meant to be considered in isolation or used as a substitute for net loss reported in accordance with GAAP, should be considered in conjunction with our financial information presented in accordance with GAAP, has no standardized meaning prescribed by GAAP, is unaudited, and is not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that Exagen may exclude for purposes of these non-GAAP financial measures, and the company may in the future cease to exclude items that it has historically excluded for purposes of these non-GAAP financial measures. Likewise, Exagen may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by the company in this press release and the accompanying reconciliation table have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures.

A reconciliation of net loss to non-GAAP adjusted EBITDA is provided in the financial schedules that are part of this press release.

About Exagen

Exagen is a leading provider of autoimmune testing and its purpose as an organization is to provide clarity in autoimmune disease decision making with the goal of improving patients’ clinical outcomes. Exagen is located in San Diego County, California.

For more information, please visit Exagen.com or follow @ExagenInc on X.

Forward Looking Statements

Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Exagen’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Exagen’s goals, strategies, positioning, and ambitions; evaluations and judgments regarding financial results and the potential implications of those results, potential future financial and business performance, including any improvements to adjusted EBITDA, net loss and potential profitability; the potential utility and effectiveness of Exagen’s services and testing solutions; potential shareholder value and growth and full-year 2025 guidance. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, and delays in ongoing and planned clinical trials involving its tests; and changes in laws and regulations related to Exagen’s regulatory requirements. Exagen’s commercial success depends upon attaining and maintaining significant market acceptance of its testing products among rheumatologists, patients, third-party payors and others in the medical community; Exagen’s ability to successfully execute on its business strategies; third-party payors not providing coverage and adequate reimbursement for Exagen’s testing products, including Exagen’s ability to collect on funds due; Exagen’s ability to obtain and maintain intellectual property protection for its testing products; regulatory developments affecting Exagen’s business; and other risks described in Exagen’s prior press releases and Exagen’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Exagen’s Annual Report or Form 10-K for the year ended December 31, 2024, to be filed with the SEC on or before March 14, 2025 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 Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist 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.

Contact:

Ryan Douglas
Exagen Inc.
[email protected]
760.560.1525

Exagen Inc.
Statements of Operations
(in thousands, except share and per share data)
		Three Months Ended December 31,								Year Ended December 31,
			2024				2023				2024				2023
		(Unaudited)
Revenue		$	13,655			$	13,765			$	55,641			$	52,548
Costs of revenue			5,178				5,620				22,529				23,092
Gross margin			8,477				8,145				33,112				29,456
Operating expenses:
Selling, general and administrative expenses			10,204				12,216				41,373				47,428
Research and development expenses			1,656				1,076				5,375				4,865
Total operating expenses			11,860				13,292				46,748				52,293
Loss from operations			(3,383	)			(5,147	)			(13,636	)			(22,837	)
Interest expense			(563	)			(566	)			(2,234	)			(2,335	)
Interest income			185				146				767				1,516
Loss before income taxes			(3,761	)			(5,567	)			(15,103	)			(23,656	)
Income tax expense			—				(6	)			(12	)			(33	)
Net loss		$	(3,761	)		$	(5,573	)		$	(15,115	)		$	(23,689	)
Net loss per share, basic and diluted		$	(0.20	)		$	(0.31	)		$	(0.83	)		$	(1.34	)
Weighted-average number of shares used to compute net loss per share, basic and diluted			18,427,887				17,836,090				18,203,044				17,679,467

Exagen Inc.
Balance Sheets
(in thousands, except share and per share data)
		December 31,
			2024				2023
Assets
Current assets:
Cash and cash equivalents		$	22,036			$	36,493
Accounts receivable, net			7,835				6,551
Prepaid expenses and other current assets			6,584				4,797
Total current assets			36,455				47,841
Property and equipment, net			5,283				5,201
Operating lease right-of-use assets			2,401				3,286
Other assets			550				616
Total assets		$	44,689			$	56,944
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,137			$	3,131
Operating lease liabilities			1,096				976
Borrowings-current portion			423				264
Accrued and other current liabilities			7,850				7,531
Total current liabilities			13,506				11,902
Borrowings-non-current portion, net of discounts and debt issuance costs			19,822				19,231
Non-current operating lease liabilities			1,664				2,760
Other non-current liabilities			157				357
Total liabilities			35,149				34,250
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2024 and December 31, 2023; 17,640,328 and 17,045,954 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively			18				17
Additional paid-in capital			303,853				301,893
Accumulated deficit			(294,331	)			(279,216	)
Total stockholders’ equity			9,540				22,694
Total liabilities and stockholders’ equity		$	44,689			$	56,944

Exagen Inc.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
The table below presents the reconciliation of adjusted EBITDA, which is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures (UNAUDITED)” above for further information regarding the Company’s use of non-GAAP financial measures.
		Three Months Ended December 31,								Twelve Months Ended December 31,
			2024				2023				2024				2023
(in thousands)
Adjusted EBITDA
Net loss		$	(3,761	)		$	(5,573	)		$	(15,115	)		$	(23,689	)
Other (Income) Expense			(185	)			(146	)			(767	)			(1,516	)
Interest Expense			563				566				2,234				2,335
Income tax expense			—				6				12				33
Depreciation and amortization expense			415				508				1,724				2,168
Stock-based compensation expense			433				763				1,763				3,617
Adjusted EBITDA (Non-GAAP)		$	(2,535	)		$	(3,876	)		$	(10,149	)		$	(17,052	)

Funded by a grant from the Roblox Community Fund, AVID’s Creator Planet integrates with key educational standards and includes free classroom resources for teachers and students

SAN DIEGO, March 11, 2025 (GLOBE NEWSWIRE) — Today, AVID (Advancement Via Individual Determination), a leader in closing the opportunity gap for students, and Super League (Nasdaq: SLE), a leader in redefining the gaming industry as a media channel, announce the launch of AVID Creator Planet, an educational adventure on Roblox designed for students ages 13+ to learn valuable executive function and durable skills in and out of the classroom.

Funded by a grant from the Roblox Community Fund, AVID Creator Planet focuses on practicing durable skills such as problem-solving, critical thinking, collaboration, and communication. Each phase – from planning and construction to adaptation and evaluation – challenges learners to apply these principles in dynamic and interactive scenarios. To bring the AVID Creator Planet learning experience into the classroom, AVID has created a full suite of free resources around the game in AVID Open Access, including step-by-step lessons and all the resources necessary for teachers and students.

Set in Equinova, an extraterrestrial planet, Roblox users learn durable skills and practice engineering design through building challenges that use a variety of materials to construct towers, bridges, and ramps, and have problem-solving skills tested through sudden “remixes” like meteor strikes and dust storms. Users can partner with friends to compete against other teams, learning teamwork skills along the way. AVID Creator Planet incorporates design thinking principles, and the narrative emphasizes leading with empathy – encouraging students to “Build for a Better Tomorrow.”

Super League’s award-winning Roblox development studio has been creating in the education space on the platform since 2020, launching custom worlds for education and non-profit partners and integrating educational components into multiple Roblox experiences for IP owners.

“Super League is committed to making immersive experiences that are not only entertaining but also educational – making the time young people spend in virtual worlds more beneficial to their development,” said Super League Chair and CEO Ann Hand. “We are honored to support AVID’s mission to ensure students in the academic middle are college and career ready and bring incredible learning content to Roblox’s community of 85M+ daily users.”

“Projects like AVID Creator Planet check all the boxes for educational experiences and content we look to make available to eager learners on Roblox. Creator Planet leans into signature Roblox learning advantages – immersive 3D environments, realistic behaviors of objects and materials, and most importantly, the kind of teamwork multiplayer, real-time collaboration makes possible,” said Roblox VP of Education Rebecca Kantar. “AVID’s deep roots in schools will benefit learners ready to engage in deeper learning, problem-solving, and creating with peers, just as engineers do.”

About AVID:


AVID
(Advancement Via Individual Determination) is a national nonprofit that supports hundreds of thousands of schools and educators and serves millions of students, preparing them for success in college, career, and life. For more information about AVID, please visit www.AVID.org.

About Super League:

Super League (Nasdaq: SLE) is redefining the gaming industry as a media channel for global brands. As a leading end-to-end immersive content partner, Super League enables marketers, advertisers, and IP owners to reach massive audiences through creativity, innovation, and gameplay within the world’s largest immersive platforms. Boasting an award-winning development studio, a vast community of native creators, and a proprietary suite of tools that maximize user engagement, Super League is a one-of-a-kind holistic solutions provider. Whether a partner is focused on building a world-class creative experience, achieving a lift in brand awareness, inspiring deeper customer loyalty, or finding new sources of revenue, Super League is at the forefront – always pioneering within immersive worlds. For more information, visit superleague.com.

Contact:

[email protected]

[email protected]

– Topline data expected as early as mid-2025 –

SOUTH SAN FRANCISCO, Calif., March 11, 2025 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.

“We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine, delivered in a pill formulation, which will seek to demonstrate improved immune responses of our second-generation constructs,” said Steven Lo, Chief Executive Officer of Vaxart. “As norovirus continues to spread across the United States and globally, it has never been more important to address this urgent public health need. With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025.”

The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study.

If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, receipt of funding from BARDA, future cash runway and funding milestones, the results of the FDA’s review of any trials, studies, or data, results from preclinical and clinical trials and the timing of such results and such trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to complete the Phase 1 trial of its oral bivalent norovirus vaccine; Vaxart’s ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data, including their design, and the timing of such trials and of receiving and reporting such clinical results and trial data; Vaxart’s expectations regarding timing of enrollment in studies; and Vaxart’s expectations with respect to the effectiveness of its product candidates and the potential of its vaccine pill platform. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contact

Vaxart Media and Investor Relations        
Matt Steinberg
FINN Partners
[email protected]
(646) 871-8481

Enhanced assay granted approval by New York State’s Clinical Lab Evaluation Program (CLEP) for patients with DLBCL

clonoSEQ is the only DLBCL MRD assay available for clinical use and covered by Medicare

SEATTLE, March 11, 2025 (GLOBE NEWSWIRE) —  Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that it has launched an upgraded version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL) using circulating tumor DNA (ctDNA).

The enhanced clonoSEQ assay, which incorporates an optimized DNA extraction methodology and maximizes sample input, delivers a 7-fold increase in sensitivity. The assay leverages the same powerful technology as prior versions, detecting MRD by reading the full immune receptor sequence of the malignant B cells rather than relying on individual point mutations. Maintaining this proprietary approach enables improvements in sensitivity while preserving the exquisite specificity that minimizes risk of overtreatment due to false positives.

The enhanced assay was previously made available for research use in November 2023 and is already being incorporated into both biopharma-sponsored and investigator-initiated prospective trials. Data generated using this assay and presented at ASH 2024 by Bond and colleagues demonstrated that in patients for which MRD was assessed by clonoSEQ, MRD negativity post-cycle six was highly prognostic of progression-free survival.

“The enhancements to our clonoSEQ ctDNA-based DLBCL test offering strengthen the assay’s already-deep clinical sensitivity without compromising our unparalleled specificity,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “The assay’s strong performance on both fronts makes it possible to deliver accurate, actionable insights in the clinic and empowers drug developers to precisely target treatment intensification strategies for patients who remain MRD-positive at end of frontline therapy while minimizing the risk of overtreatment.”

clonoSEQ is the first and only DLBCL MRD test available for clinical use. Having secured Medicare coverage for clonoSEQ in DLBCL in July of 2022, Adaptive has since provided MRD testing for more than 2,800 DLBCL patients and was used to manage and inform patient care by over 640 providers in 2024 alone. The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) recently approved the enhanced version of the clonoSEQ ctDNA assay for the detection and monitoring of MRD in patients with DLBCL. This comes on the heels of the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas, which included language recommending ctDNA testing for MRD assessment for patients with PET-positive DLBCL at end of first-line treatment.

DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about 1 out of every 3 NHL patients in the United States. More than 18,000 people are diagnosed with DLBCL each year. About 30–40% of patients will experience relapse, most of them within the first two years. MRD testing can help doctors assess treatment response, detect early signs of cancer recurrence, and adjust treatment plans.

Because DLBCL outcomes can vary widely following frontline treatment, the ability of MRD results to accurately risk stratify patients in this setting is critical, as an MRD test can help clinicians differentiate a likely cure from an impending relapse. As the number of clinical trials in DLBCL exploring novel MRD-directed treatment consolidation strategies to reduce relapse rates grows, the role for clonoSEQ as a highly sensitive and specific ctDNA-based test will continue to expand.

About clonoSEQ

clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for patients with diffuse large B-cell lymphoma (DLBCL) is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive’s CLIA-certified lab in Seattle. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU). For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request.

clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematologic malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.

About Adaptive Biotechnologies

Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business segments: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer and autoimmune disorders. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

Forward Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

ADAPTIVE INVESTORS:

Karina Calzadilla, Vice President, Investor Relations and FP&A
201-396-1687
[email protected]

ADAPTIVE MEDIA:

Erica Jones, Associate Director, Corporate Communications
845-344-7542
[email protected]