Market Newsdesk

• Topline results from the OV329 Phase 1 safety, tolerability and biomarker study remain on track for a readout in Q3 2025
• $7.0 million royalty monetization agreement signed with Immedica Pharma AB for future ganaxolone royalties, delivering capital to the Company from a non-pipeline asset
• OV4071, the first ever oral KCC2 direct activator, is completing an IND-enabling package; Ovid anticipates first-in-human studies in Q2 2026
• Cash, cash equivalents and marketable securities of $38.3 million as of June 30, 2025 are expected to support currently planned operations and development programs into early 2H 2026

NEW YORK, Aug. 13, 2025 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today reported business updates and financial results for the second quarter ended June 30, 2025.

“Our pipeline continues to advance across multiple fronts, with several key readouts anticipated in the near and mid-term. We are on track to share Phase 1 safety, tolerability, and biomarker data for OV329, a potential best-in-class medicine for conditions driven by excess neuronal excitation, including treatment-resistant seizures and pain,” said Dr. Jeremy Levin, D.Phil., MB BChir., Chairman and CEO of Ovid Therapeutics. “Simultaneously, our KCC2 program is advancing well. We expect to read out safety and tolerability data for OV350, our first-in-human KCC2 direct activator, before the end of the year, setting the stage for our broader pipeline of oral KCC2 direct activators. We are also completing IND-enabling work for OV4071 and plan to initiate a Phase 1/1b healthy volunteer and patient study in early 2026. Collectively, these milestones may provide compelling de-risking evidence for drugging and directly activating a new target in the brain with substantial therapeutic opportunity.”

KEY PIPELINE AND BUSINESS UPDATES

OV329: Phase 1 Topline Readout Planned for Q3 2025

OV329, a next-generation GABA-aminotransferase (GABA-AT) inhibitor, is progressing through a Phase 1 clinical trial in healthy volunteers. Topline results, including pharmacodynamic (PD), safety, and exploratory target engagement data, are anticipated in late Q3 2025.

OV329 is rationally designed to be a safer, well tolerated inhibitor of GABA-AT, a validated mechanism of action for reducing neuronal excitation and thereby, seizures. It has been shown to endogenously increase levels of GABA, the major inhibitory neurotransmitter, in the brain. OV329 is intended to replace vigabatrin, a first-generation GABA-AT inhibitor that is associated with serious safety concerns, including irreversible ocular changes and blindness in some patients, which limits its clinical use.

OV329 is significantly more potent than vigabatrin and, in preclinical studies, demonstrated synaptic and extrasynaptic inhibition, along with anti-convulsant activity in nine different animal seizure models. At projected therapeutic doses, OV329 has demonstrated a potentially favorable therapeutic index and did not induce sedation. OV329 is being developed for the possible treatment of drug-resistant epilepsies (DREs), with broader potential across a range of indications in which neuronal hyperexcitation is implicated.

OV329:
Clinical Development

Across previously completed cohorts, OV329 has been well tolerated, with no serious adverse events observed to date. The Company believes this emerging profile supports OV329’s potential as a novel treatment that leverages a validated mechanism of action (MOA), while addressing the safety limitations that have historically constrained broader clinical use of the first-generation GABA-AT inhibitor.

The Phase 1 study in healthy volunteers is designed with a highly rational biomarker-driven clinical development strategy that incorporates cutting-edge tools to evaluate central GABAergic activity. Several exploratory biomarkers are being used to assess OV329’s intended pharmacodynamic effects. These biomarkers include transcranial magnetic stimulation (TMS) to assess cortical inhibition, magnetic resonance spectroscopy (MRS) to measure GABA levels in the medial parietal lobe, and quantitative electroencephalography (EEG) to evaluate brainwave patterns. TMS has previously been studied in healthy volunteers treated with the first-generation GABA-AT inhibitor vigabatrin, providing a partially validated and clinically relevant comparator to help interpret OV329’s intended CNS effects. Together, these translational biomarkers offer early insights into pharmacodynamic effects and strengthen the foundation for a rational and differentiated anti-seizure development program.

Pending the results of the Phase 1 study, Ovid plans to initiate a Phase 2a trial in adults with treatment-resistant focal onset seizures. The development approach is intended to preserve flexibility to explore additional forms of DRE and select developmental and epileptic encephalopathies (DEEs) in both adult and pediatric populations.

Progressing a First-in-Class Portfolio of Oral KCC2 Direct Activators Toward the Clinic

The Company is making significant progress on its portfolio of first-in-class direct activators for the potassium-chloride cotransporter 2 (KCC2). KCC2 is a neuron-specific chloride transporter that plays a central role in regulating neuronal excitability and enabling GABA to exert its inhibitory effect. Ovid’s portfolio includes multiple unique molecules that have been shown to bind to and directly activate KCC2, reflecting a potentially differentiated, mechanism-based approach to addressing serious neurological and neuropsychiatric brain conditions. Direct activation is also believed to contribute to a preferable safety profile.

OV350 (Intravenous KCC2 Direct Activator): The Company is actively studying the first-ever KCC2 direct activator in healthy volunteers. The safety, tolerability and pharmacokinetic data for OV350 are anticipated to be available in Q4 2025. This milestone is designed to establish safety of this new class of potential medicines – direct activators of KCC2. Findings from this program are helping to guide Ovid’s development of its oral KCC2 candidates.

OV4071 (Oral KCC2 Direct Activator): IND-enabling activities are underway for OV4071, the Company’s first oral KCC2 development candidate. The Company remains on track to initiate a proof-of-concept clinical study early in 2026. OV4071 is initially being developed for the treatment of psychosis, including in Parkinson’s disease and Lewy body dementia—areas with substantial unmet need and a defined regulatory pathway.

Broader Oral KCC2 Portfolio: In addition to OV4071, the Company is advancing multiple oral and injectable KCC2 activator programs selected from its proprietary library.

Direct activation of KCC2 may be a promising new therapeutic approach to restore inhibitory tone in the brain and has potential utility across a broad range of disorders characterized by neuronal hyperexcitability.

Monetization of Ganaxolone Royalties Provides Strategic Capital

In June 2025, Ovid entered into an agreement with Immedica Pharma AB to sell its worldwide ganaxolone royalty rights and licensing for $7.0 million. This monetization covers 100% of royalty rights and includes the transfer or licensing of Ovid’s global ganaxolone intellectual property, with Immedica assuming associated patent maintenance and prosecution costs.

This capital transaction strengthens Ovid’s balance sheet, extends its operational runway, and enables the Company to focus capital and strategic efforts on its wholly owned small molecule pipeline. Ovid has not been pursuing active development of ganaxolone, and the transaction has no impact on its current pipeline programs.

BUSINESS STRATEGY AND UPDATES

Ovid expects its cash runway to support operations and clinical development programs into early second half 2026, during which time multiple pipeline and regulatory milestones are anticipated. These anticipated milestones include topline results for OV329 safety, tolerability and biomarker data (Q3 2025); potential initiation of a Phase 2a patient study for OV329 in drug-resistant epilepsies (Q1 2026); results from the Phase 1 study of OV350 (Q4 2025); and the potential initiation of a proof-of-concept trial for the first oral KCC2 direct activator, OV4071 (Q2 2026).

Given the breadth and depth of its pipeline, and the broad therapeutic opportunity it may yield, the Company will continue to explore a range of strategic options to accelerate development and offset costs, such as partnerships, co-development and regional opportunities for select programs, as well as monetizing equity positions, intellectual property and non-CNS applications of its candidates. The Company will continue to manage its clinical development programs, operations and cash expenditures with fiscal discipline to support the potential achievement of key value-creating clinical milestones.

Second
Quarter
2025
Financial Results

• Cash, cash equivalents and marketable securities as of June 30, 2025 totaled $38.3 million.
• Revenues from royalty agreements were $6.3 million for the second quarter ended June 30, 2025, as compared to $169,000 for the same period in 2024.
• Research and development expenses were $6.5 million for the second quarter ended June 30, 2025, compared to $12.6 million for the same period in 2024. The decrease is related to the organizational restructuring in Q2 2024 to re-prioritize Ovid’s clinical and preclinical pipeline programs.
• General and administrative expenses were $4.9 million for the second quarter ended June 30, 2025, as compared to $8.1 million for the same period in 2024. The decrease was driven by the organizational restructuring and related cost-reduction efforts.
• Total operating expenses were $11.3 million for the second quarter ended June 30, 2025, as compared to $20.7 million for the same period in 2024.
• Ovid reported a net loss of $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.06, for the second quarter of 2025, as compared to a net income of $8.5 million, or basic and diluted net income per share attributable to common stockholders of $0.12, for the same period in 2024.

About Ovid Therapeutics

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications and; OV350, OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com.

Forward-Looking Statements

This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation: statements regarding the expected timing of initiation, completion, and results and data of Ovid’s clinical studies; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; the potential use and development of OV329, OV350, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; the potential therapeutic opportunity of OV329, OV350, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; the expected timing of initiation of a proof-of-concept trial for OV4071 and the submission to initiate clinical development; Ovid’s clinical pipeline strategy and plans for future clinical studies; the expected timing of IND-enabling and formulation efforts for molecules from its KCC2 direct activator library and related regulatory submissions; Ovid’s potential future business development opportunities; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its business strategy, or risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions or unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Condensed Consolidated Statements of Operations
Unaudited
(in thousands, except share and per share data)	For The Three Months Ended June 30, 2025				For The Three Months Ended June 30, 2024
Revenue:
License and other revenue	$	6,272			$	169
Total revenue		6,272				169
Operating expenses:
Research and development		6,465				12,582
General and administrative		4,880				8,104
Total operating expenses		11,345				20,686
Loss from operations		(5,073	)			(20,517	)
Other income (expense), net		389				29,038
(Loss) income before provision for income taxes		(4,684	)			8,521
Provision for income taxes		—				—
Net (loss) income	$	(4,684	)		$	8,521
Net (loss) income per share of Series A preferred stock, basic	$	(64.73	)		$	118.07
Net (loss) income per share of Series A preferred stock, diluted	$	(64.73	)		$	117.61
Weighted-average Series A preferred stock shares outstanding, basic and diluted		1,250				1,250
Net (loss) income per share of common stock, basic	$	(0.06	)		$	0.12
Net (loss) income per share of common stock, diluted	$	(0.06	)		$	0.12
Weighted-average common stock shares outstanding, basic		71,109,514				70,916,471
Weighted-average common stock shares outstanding, diluted		71,109,514				71,200,798

Select Condensed Consolidated Balance Sheet Data
Unaudited
(in thousands)	June 30, 2025			December 31, 2024
Cash, cash equivalents and marketable securities	$	38,347		$	53,075
Working capital(1)		33,165			45,418
Total assets		77,428			92,167
Total stockholders’ equity		55,789			68,226
(1)Working capital defined as current assets less current liabilities

Contact

Investor Relations & Media

Victoria Fort
[email protected]

GREENWICH, Conn., Aug. 13, 2025 (GLOBE NEWSWIRE) — Gabelli Funds, LLC, is hosting our annual Aerospace & Defense Symposium at The Harvard Club in New York City on September 4^th. The conference will draw top executives from more than ten companies, with a focus on the themes of strong demand outlook, high barriers to entry, large aftermarket opportunity, growth in excess of GDP, defense spending, and M&A potential for the Aerospace and Defense industry. Attendees will also have the opportunity to meet with management in a one-on-one setting. Prospective attendees can learn more about the symposium on our website.

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AIRO Group Holdings, Inc. (NASDAQ: AIRO)		Elbit Systems Ltd. (NASDAQ: ESLT)
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Astronics Corporation (NASDAQ: ATRO)		New Horizon Aircraft Ltd. (NASDAQ: HOVR)
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The Harvard Club
, New
York City
Thursday, September 4, 2025 starting at 7:45 am

Registratio
n
link
:

CLICK HERE

Contact

General Inquiries

Isabella DeLuca

Client Relations
P: 914-921-5101
E:[email protected]

Sadie Keating

Marketing Associate
P: 914-921-5107
E:[email protected]

Research Team

Tony Bancroft

Portfolio Manager
P: 914-921-5083
E:[email protected]

Michael Burgio

Research Analyst
P: 914-921-7797
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Daniel Gleim

Research Analyst
P: 914-921-7797
E:[email protected]

Gabelli Funds, LLC is a registered investment adviser with the Securities and Exchange Commission and is a wholly owned subsidiary of GAMCO Investors, Inc.

Contact:
Tony Bancroft, Portfolio Manager
(914) 921-5083

• First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI)
  

BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102. The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company’s drug product candidate targeting Wilms’ Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. The goal of the study is to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence.

“Glioblastoma remains one of the most aggressive and hard-to-treat cancers, and as a result, there is a pressing need for more effective therapies. Investigational treatments targeting WT1 in GBM have shown a potential correlation between expansion of antigen-specific T cells and survival,” said Dr. Reardon. “CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM.”

Matteo Levisetti, MD, chief medical officer at Cue Biopharma, added, “Glioblastoma is an immunologically ‘cold’ tumor representing a disadvantage for treatment with standard immunotherapies such as checkpoint inhibitors, but is known to express high levels of the Wilms’ Tumor 1 oncofetal protein. We believe the mechanism of action of CUE-102, to preferentially activate and expand WT1 tumor-specific T cells, has the potential to activate and generate an enhanced anti-tumor immune response against glioblastoma. We are highly encouraged by the clinical data generated to date from the CUE-100 series, CUE-101 and CUE-102, and look forward to reporting results from this investigator sponsored trial.”

About CUE-102

CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1-specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 has demonstrated anti-tumor activity and a favorable tolerability profile with no dose limited toxicities observed in a Phase 1 open label, dose escalation and expansion trial (NCT05360680), for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1.

About Glioblastoma
Glioblastomas are the most common primary cancer of the brain and the most aggressive type of brain tumor. There are ~13,000 new cases diagnosed each year in the United States. The most common length of survival following diagnosis is ~12 to 15 months, with fewer than ~3 to 5 percent of people surviving longer than five years.

About the CUE-100 Series

The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including CUE-102’s ability to potentially improve clinical outcomes in recurrent GBM and the potential of the Immuno-STAT platform to treat a variety of cancers; and the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to shift its focus to its autoimmune assets and achieve the cost savings that it is projecting; the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact

Marie Campinell 
Senior Director, Corporate Communications
Cue Biopharma, Inc.
[email protected]

Media Contact

Jonathan Pappas
LifeSci Communications
[email protected]

GRAPEVINE, Texas, Aug. 13, 2025 (GLOBE NEWSWIRE) — Solo Brands, Inc. (NYSE: SBDS) (“Solo Brands” or “the Company”) a leading portfolio of lifestyle brands (Solo Stove, Chubbies, Isle and Oru) that are redefining the outdoor and apparel industries, today announced that management will participate in the 16^th Annual Midwest IDEAS Investor Conference at The InterContinental Chicago Magnificent Mile on August 27, 2025.

The Company will host one-on-one investor meetings throughout the day, with their presentation scheduled for 10:45-11:20 AM CT on August 27^th. John Larson, Chief Executive Officer, Laura Coffey, Chief Financial Officer, and Mark Anderson, Senior Director, Treasury & IR, will be attending the conference on behalf of Solo Brands. The presentation will be webcast live and can be accessed through the investor relations section of Solo Brands at https://investors.solobrands.com/events-and-presentations/events/default.aspx. A replay will be available shortly after the presentation has concluded. To schedule a one-on-one meeting, please contact the Three Part Advisors conference team at (817) 769-2373 or [email protected]

About Solo Brands, Inc.

Solo Brands, headquartered in Grapevine, TX, is a leading omnichannel lifestyle brand company. Leveraging e-commerce, strategic retail relationships and physical retail stores, Solo Brands offers innovative products to consumers through five lifestyle brands – Solo Stove and TerraFlame, known for firepits, stoves, and accessories; Chubbies, a premium casual apparel and activewear brand; ISLE, maker of inflatable and hard paddle boards and accessories; and Oru Kayak, innovator of origami folding kayaks.

Contacts:

Mark Anderson, Senior Director of Treasury & Investor Relations for Solo Brands
[email protected]

Three Part Advisors, LLC:
Sandy Martin: [email protected], 214-616-2207
Steven Hooser: [email protected], 214-872-2710

Continuing to enroll nAMD patients in a Phase 1 trial of TH103, a novel, differentiated anti-VEGF agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina; initial clinical data is expected in Q4 2025

Cash and cash equivalents of $88.4M as of June 30, 2025, expected to fund operations into Q4 2026

PALO ALTO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) — Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update.

“We continued to enroll treatment-naïve nAMD patients in our open-label Phase 1 clinical trial of TH103 in the second quarter of 2025” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “TH103 has exhibited differentiated anti-VEGF properties in multiple preclinical studies, and we believe it has the potential to improve efficacy and extend treatment duration compared to currently approved agents. We look forward to reporting initial clinical data later this year which will provide an initial read of safety and efficacy data of TH103 at multiple dose levels and help inform the next stage of our clinical development program.”

Business Updates

• Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in neovascular Age-related Macular Degeneration (nAMD) patients. Initial clinical data is expected in the fourth quarter of 2025.  
• Kalaris recently expanded its leadership team with the hire of Kristine Curtiss, Senior Vice President of Clinical. Ms. Curtiss has over 25 years of clinical research and operations experience in ophthalmology-focused biotech companies, overseeing programs and building departments.

Financial Results for the Second Quarter Ended June 30, 2025

Cash and Cash Equivalents: As of June 30, 2025, Kalaris had cash and cash equivalents of $88.4 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash and cash equivalents was primarily a result of the completion of its merger with AlloVir.

Research and Development Expenses: Research and development expenses were $8.4 million for the quarter ended June 30, 2025, compared with $3.2 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in costs related to the outsourcing of manufacturing and clinical-related costs as Kalaris initiated its Phase 1 clinical trial in June 2024.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the quarter ended June 30, 2025, compared with $1.0 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in insurance, legal, accounting, and professional fees associated with operating as a public company.

Net Loss: For the quarter ended June 30, 2025, net loss was $11.4 million or $0.61 per share, compared with a net loss of $5.7 million or $4.26 per share for the quarter ended June 30, 2024. The total number of shares of common stock outstanding as of June 30, 2025 was 18,702,418.

About Kalaris

Kalaris is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. The company is focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor and has been specifically engineered for potentially improved VEGF inhibition and longer retention in the retina. TH103 is currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD), with plans to develop TH103 for additional neovascular and exudative diseases of the retina such as Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, prospects, plans and objectives of management of Kalaris, including the therapeutic potential of TH103, the anticipated timeline for reporting initial clinical data from the Phase 1 clinical trial of TH103, and the sufficiency of Kalaris’ cash resources for the period anticipated, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of Kalaris as well as assumptions made by, and information currently available to, the management of Kalaris and are subject to risks and uncertainties. There can be no assurance that future developments affecting Kalaris will be those that it has anticipated. Forward-looking statements include, but are not limited to, statements concerning the following: the future operations of Kalaris, including research and development activities; the nature, strategy and focus of Kalaris; the development and commercial potential and potential benefits of any product candidate of Kalaris, including expectations around intellectual property protection; anticipated clinical drug development activities and related timelines, including the expected timing for announcement of data and other clinical results; the uncertainties associated with Kalaris’ product candidate, as well as risks associated with the clinical development and regulatory approval of its product candidate, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; risks related to the inability of Kalaris to obtain sufficient additional capital to continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; Kalaris’ competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; potential adverse reactions or changes to business relationships resulting from the completion of the merger with AlloVir, Inc.; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the merger, including with respect to future financial and operating results; the risk of involvement in current and future litigation, including securities class action litigation, that could divert the attention of the management of Kalaris, harm Kalaris’ business and for which Kalaris may not have sufficient insurance coverage to cover all costs and damages; and such other factors as are set forth in Kalaris’ public filings with the SEC, including, but not limited to, those described under the heading “Risk Factors”. Kalaris may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Kalaris makes. The forward-looking statements contained in this press release are made as of the date of this press release, and Kalaris does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Kalaris Therapeutics Investor Contact:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

+1 212 915 2577

[email protected]

[email protected]

Kalaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data)
	Three Months Ended June 30,								Six Months Ended June 30,
		2025				2024				2025				2024
Operating expenses
Research and development	$	8,440			$	3,211			$	14,470			$	5,172
General and administrative		3,816				976				8,140				1,578
Total operating expenses		12,256				4,187				22,610				6,750
Loss from operations		(12,256	)			(4,187	)			(22,610	)			(6,750	)
Total other income (expense), net		906				(1,463	)			1,064				(2,307	)
Net loss	$	(11,350	)		$	(5,650	)		$	(21,546	)		$	(9,057	)
Net loss per share, basic and diluted	$	(0.61	)		$	(4.26	)		$	(1.89	)		$	(6.87	)
Weighted-average shares outstanding, basic and diluted		18,701,286				1,325,706				11,417,677				1,319,129

Kalaris Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands)
	June 30,				December 31,
		2025				2024
Assets
Current assets
Cash and cash equivalents	$	88,426			$	1,639
Other current assets		3,225				967
Total current assets		91,651				2,606
Other assets		1,191				3,556
Total assets	$	92,842			$	6,162
Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)
Current liabilities	$	7,651			$	24,703
Long-term liabilities		32,076				32,076
Total liabilities		39,727				56,779
Redeemable convertible preferred stock		—				45,999
Total stockholders’ equity (deficit)		53,115				(96,616	)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$	92,842			$	6,162

SALT LAKE CITY, Aug. 13, 2025 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference.

Virtual Presentation Details


Date: August 20, 2025
Time of Presentation: 2:20 p.m. ET
Format: Corporate update with Q&A

A webcast of the presentation will be available on the “Events” section of the Clene website. Alternatively, one can register for and view the webcast, along with accompanying slides, here: https://goto.webcasts.com/starthere.jsp?ei=1717088&tp_key=22f1f30884&sti=clnn. A replay of the presentation will also be available through the conference portal and the Emerging Growth YouTube Channel, http://www.YouTube.com/EmergingGrowthConference, following the event.

About the Emerging Growth Conference


The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of Individual and Institutional investors, as well as Investment advisors and analysts.

All sessions will be conducted through video webcasts and will take place in the Eastern time zone.

About Clene

Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8^® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8^® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.

Investor Contact Kevin Gardner LifeSci Advisors [email protected] 617-283-2856

PALM BEACH GARDENS, Fla., Aug. 13, 2025 (GLOBE NEWSWIRE) — Great Elm Capital Corp. (“we,” “our,” the “Company” or “GECC”) (NASDAQ: GECC), a business development company, today announced it has entered into an amendment to its revolving credit facility (the “Revolving Credit Facility”) with City National Bank (“CNB”) to, among other things, increase the borrowing capacity under the Revolving Credit Facility from $25.0 million to $50.0 million. The amendment allows the Company, under certain circumstances, to increase the overall borrowing capacity to a maximum of $90.0 million. In addition, the amendment reduces the interest rate on the Revolving Credit Facility to the applicable Secured Overnight Financing Rate (“SOFR”) plus 2.50% from SOFR plus 3.00%.     

“We are very pleased to announce this amendment to our revolving credit facility with CNB,” said Matt Kaplan, GECC’s Chief Executive Officer. “The increased borrowing capacity is a testament to our growing capital base and strong operational performance since partnering with CNB on the initial $25.0 million commitment in 2021. The amended facility not only reduces our borrowing costs, but it also enhances our flexibility to fund attractive opportunities with compelling, risk-adjusted returns. Additionally, we believe shifting our liability mix to more floating rate debt is a prudent step in the current interest rate environment.”

About Great Elm Capital Corp.

GECC is an externally managed business development company that seeks to generate current income and capital appreciation by investing in debt and income generating equity securities, including investments in specialty finance businesses and CLOs. For additional information, please visit http://www.greatelmcc.com.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this communication that are not historical facts are “forward-looking” statements within the meaning of the federal securities laws. These statements include statements regarding our future business plans and expectations. These statements are often, but not always, made through the use of words or phrases such as “expect,” “anticipate,” “should,” “will,” “estimate,” “designed,” “seek,” “continue,” “upside,” “potential” and similar expressions. All such forward-looking statements involve estimates and assumptions that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed in the statements. The key factors that could cause actual results to differ materially from those projected in the forward-looking statements include, without limitation: conditions in the credit markets, our expected financings and investments, including interest rate volatility, inflationary pressure, the price of GECC common stock and the performance of GECC’s portfolio and investment manager. Information concerning these and other factors can be found in GECC’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission. GECC assumes no obligation to, and expressly disclaims any duty to, update any forward-looking statements contained in this communication or to conform prior statements to actual results or revised expectations except as required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

This press release does not constitute an offer of any securities for sale.

Media & Investor Contact:

Investor Relations        
[email protected]

ProPhase Delivers Significant Operational and Financial Improvements, Advances Multiple Non-Dilutive Liquidity Initiatives, and Targets Transformational Growth Catalysts

Company granted key U.S. patent on BE-Smart

^™

Esophageal Adenocarcinoma Risk Assessment test (August 2025)

Company to hold a virtual conference call Wednesday, August 13, 2025, at 2:00 PM ET

UNIONDALE, NY, Aug. 13, 2025 (GLOBE NEWSWIRE) — ProPhase Labs, Inc. (NASDAQ: PRPH), (the “Company” or “ProPhase”) a diversified diagnostics, genomics, and consumer healthcare company, today reported financial and operational results for the three and six months ended June 30, 2025.

Ted Karkus, CEO of ProPhase Labs, will present to shareholders today, Wednesday, August 13, 2025, at 2:00 p.m. ET during the live Virtual Non-Deal Roadshow Series. The details are available below.

Second Quarter 2025 and Year-to-Date Highlights and Subsequent Events

• Achieved a clear earnings turnaround, including significant positive impacts from subsequent events.
• Strengthened equity position – Stockholders’ equity increased to $11.5 million at June 30, 2025, from $7.4 million at year-end 2024.
• Secured final patent covering BE-Smart^™, strengthening IP portfolio. Accelerated commercialization pathway – BE-Smart^™ positioned for faster market entry following favorable regulatory shifts; development continues under CLIA framework.
• Streamlined operations – Reduced operating expenses by over 35% YTD through disciplined portfolio optimization and cost controls.
• Eliminated high-cost debt – Majority of merchant cash advance debt repaid, lowering overhead and increasing financial flexibility.
• Removed largest monthly cash drain from subsidiaries in Q2 2025.
• Completed strategic portfolio realignment – Sale of PMI and Pharmaloz Real Estate generated $8.7M gain and eliminated $20M+ in debt/liabilities.
• Improved margins and narrowed losses in Q2 2025 vs. Q2 2024.

BE-Smart

^™

Esophageal Pre-Cancer Diagnostic Test Continues Towards Commercialization

In August 2025, the United States Patent and Trademark Office granted a key U.S. patent on the Company’s BE-Smart^™ Esophageal Adenocarcinoma Risk Assessment test. ProPhase Labs owns the full intellectual property portfolio behind BE-Smart^™.

Nebula Genomics Operations Streamlined

Jason Karkus, President of Nebula Genomics stated: “Over the past year, we have successfully transformed Nebula Genomics into a leaner, stronger, and more scalable business. By streamlining operations, exiting our in-house lab, right-sizing our team, optimizing technology expenses, and focusing on high-ROI marketing, we have moved from consistent historical losses, including prior to our acquisition, to a break-even position today, with a clear path to sustained profitability as subscription renewals and cost efficiencies continue. With a stronger cost structure, enhanced sequencing partnerships, and improved customer economics, Nebula is well positioned for the next phase of growth, whether through a strategic sale that delivers immediate value or continued expansion over the next 9 to 12 months to significantly increase enterprise value.”

$50 Million Opportunity with Crown Medical Collections progresses

Crown Medical Collections estimates the recovery of approximately $50 million in insurance payments, net of contingency fees, on behalf of ProPhase. After significant due diligence and preparation, this initiative has moved to important next steps. Due to the nature of litigation, the Company has been advised to be cautious in providing additional details at the current time. In conjunction, management is actively pursuing non-dilutive funding strategies, including Debtor-In-Possession (DIP), or similar financings.

The Company believes that Crown Medical’s efforts should start to generate significant cash flow within the next few months and in some cases, possibly sooner. If Crown’s efforts succeed, this could serve as a significant, non-dilutive financial influx in the second half of 2025 to support strategic development of ProPhase’s core businesses. Notably, the Company currently carries only $20 million dollars total accounts receivable, net, in its financials for this initiative (less than half of what Crown estimates the Company will net.)

New Crypto Treasury Strategy Designed to Capture Upside Without Sacrificing Shareholder Value

The Board has approved a strategic treasury initiative involving the acquisition and long-term holding of select digital assets, including Bitcoin. This initiative is designed as an additional growth lever, complementing, not replacing, our core diagnostics and consumer health businesses. The Company is not pursuing a reverse merger but is seeking to partner with leading players in the crypto space while continuing to advance its core businesses, each with significant underlying value.

In Conjunction with the Company’s Potential Crypto Treasury Strategy, Board Exploring Implementing Guardrails for Share Issuance

The Board is committed to protecting shareholder interests and is evaluating guardrails to avoid unnecessary dilution. The proposed increase in authorized shares to one billion is solely to ensure the flexibility to act quickly if the stock price rises significantly, enabling potential raises of hundreds of millions of dollars at premium valuations with minimal dilution. This disciplined approach mirrors our January 2021 raise of $37.5M at $12.50 per share, well above the $2 per share price months earlier.

Our objective is to generate substantial capital with minimal impact on existing shareholders, while leveraging other potential liquidity events, including the Crown Medical Collections initiative and a possible sale of Nebula Genomics, to fund the crypto treasury strategy without issuing new shares.

The Company will provide additional details regarding this important initiative next week.

CEO Commentary:

Ted Karkus, Chairman and CEO of ProPhase Labs, stated:

“The first half of 2025 was transformational for ProPhase. We divested non-core operations, reduced liabilities by more than ten million dollars, and recorded a significant gain, all while continuing to streamline our cost structure. These steps dramatically improved our balance sheet and sharpened our focus on our highest-potential opportunities in diagnostics and consumer health.

Operationally, we turned gross margins positive and cut our operating loss nearly in half year-over-year. The FDA’s recent non-enforcement stance on LDTs positions our BE-Smart™ test for a faster path to market, and we are executing our plan to bring this important innovation to patients sooner. Our team is committed to disciplined execution and advancing the commercial potential of our core pipeline while aggressively exploring the new crypto treasury initiative.”

CEO to present to Shareholders

ProPhase will also present to shareholders today, August 13, 2025, at 2:00 p.m. ET during the live Virtual Non-Deal Roadshow Series hosted by Renmark Financial Communications Inc. During this presentation, Ted Karkus will offer further insights into the Company’s trajectory and respond to investor questions.

Investors interested in participating in this live event will need to register using the link below. After the event, a replay will be available on The Company’s investor website. 

REGISTER HERE:
https://www.renmarkfinancial.com/events/second-quarter-2025-results-virtual-conference-call-nasdaq-prph-wUOjCShxnL

• To ensure smooth connectivity, please access this link using the latest version of Google Chrome.
  

Financial Results

For the three months ended June 30, 2025, net revenue was $1.2 million as compared to $1.5 million for the three months ended June 30, 2024. The Company did not generate any revenues from diagnostic services for the three months ended June 30, 2025 and 2024, respectively.

Cost of revenues for the three months ended June 30, 2025 were $0.5 million, comprised of $0.1 million for diagnostic services and $0.4 million for consumer products. Cost of revenues for the three months ended June 30, 2024 were $1.7 million, comprised of $0.7 million for diagnostic services and $1.0 million for consumer products.

We realized a gross margin profit of $0.7 million for the three months ended June 30, 2025 as compared to a gross margin loss of $0.2 million for the three months ended June 30, 2024. The increase of $0.9 million was a result of increased consumer products with better margin product mix. For the three months ended June 30, 2025 and 2024, we realized an overall gross margin of 58.9% and (10.3)%, respectively. Gross margin for diagnostic services was zero or not applicable due to no revenue in the 2025 and 2024 comparable periods, respectively. Gross margin for consumer products was 67.8% and 36.8% in the 2025 and 2024 comparable periods, respectively. Gross margin for consumer products have historically been influenced by fluctuations in quarter-to-quarter production volume, fixed production costs and related overhead absorption, raw ingredient costs, inventory mark to market write-downs and timing of shipments to customers.

General and administration expenses for the three months ended June 30, 2025 were $4.6 million as compared to $6.9 million for the three months ended June 30, 2024. The decrease in general and administration expenses of $2.3 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 was principally related to a decrease in personnel expenses, overhead costs and professional fees and removal of costs related to the divestiture of PMI.

Research and development costs for the three months ended June 30, 2025 were $4,000 as compared to $140,000 for the three months ended June 30, 2024. The decrease in research and development costs of $136,000 for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 was principally due to decreased activities related to product research and field testing as a result of refined focus and efforts.

As a result of the effects described above, net loss from the continuing operations for the three months ended June 30, 2025 was $4.5 million, or $(0.11) per share, as compared $5.5 million, or $(0.29) per share, for the three months ended June 30, 2024. Diluted loss per share related to the continuing operations for the three months ended June 30, 2025 and 2024 were $(0.11) per share and $(0.29) per share, respectively.

Our aggregate cash and cash equivalents as of June 30, 2025 were $169,000 as compared to $678,000 at December 31, 2024. Our working capital deficit was $1.1 million and $1.5 million as of June 30, 2025 and December 31, 2024, respectively. The decrease of approximately $0.5 million in our cash and cash equivalents for the six months ended June 30, 2025 was principally due to $4.2 million cash used in operating activities and repayment of notes payable for $2.5 million, offset by proceeds from issuance of common stock and notes payable of $4.7 million. We also received $800,000 from sale of PMI. Total stockholders’ equity increased to $11.4 million as of March 31, 2025 as compared to $7.4 million at December 31, 2024.

About ProPhase Labs Inc.

ProPhase Labs Inc. (Nasdaq: PRPH) (“ProPhase”) is a next-generation biotech, genomics and consumer products company. Our mission is to build a healthier world through bold innovation and actionable insight. We’re revolutionizing healthcare with industry-leading Whole Genome Sequencing solutions, groundbreaking diagnostic development – such as our potentially life-saving test for the early detection of esophageal cancer – and a world class direct-to-consumer marketing platform for cutting edge OTC dietary supplements. We develop, manufacture, and commercialize health and wellness solutions to enable people to live their best lives. We are committed to executional excellence, smart diversification, and a synergistic, omni-channel approach. ProPhase Labs’ valuable subsidiaries, their synergies, and significant growth underscore our potential for long-term value. www.ProPhaseLabs.com In August 2025, the United States Patent and Trademark Office granted a key U.S. patent covering the Company’s BE-Smart^™ Esophageal Adenocarcinoma Risk Assessment test.

Forward-Looking Statements

Except for the historical information contained herein, this document contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our strategy, plans, objectives and initiatives, including our expectations regarding the future revenue growth potential of each of our subsidiaries, our expected timeline for commercializing our BE-Smart Esophageal Cancer Test, our expectations regarding future liquidity events, the success of our efforts to collect accounts receivables and anticipated timeline for any payments relating thereto, and our ability to successfully transition into a consumer products company. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include but are not limited to our ability to obtain and maintain necessary regulatory approvals, general economic conditions, consumer demand for our products and services, challenges relating to entering into and growing new business lines, the competitive environment, and the risk factors listed from time to time in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any other SEC filings. The Company undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Readers are cautioned that forward-looking statements are not guarantees of future performance and are cautioned not to place undue reliance on any forward-looking statements.

Media Relations and Institutional Investor Contact:

ProPhase Labs, Inc.
[email protected]

Retail Investor Relations Contact:

Renmark Financial Communications
John Boidman: [email protected]
Tel.: (416) 644-2020 or (212) 812-7680
www.renmarkfinancial.com

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

		June 30, 2025				December 31, 2024
			(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	169			$	678
Accounts receivable, net			20,086				20,058
Inventory, net			830				1,143
Prepaid expenses and other current assets			3,484				2,615
Current assets in discontinued operations			—				6,143
Total current assets			24,571				30,637
Property, plant and equipment, net			3,581				7,501
Prepaid expenses, net of current portion			151				217
Operating lease right-of-use asset, net			45				4,115
Intangible assets, net			8,459				9,750
Goodwill			5,231				5,231
Other assets			3				310
Non-current assets in discontinued operations			—				5,439
TOTAL ASSETS		$	42,041			$	63,200
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	15,032			$	13,717
Accrued diagnostic services			75				31
Accrued advertising and other allowances			151				151
Finance lease liabilities			2,625				2,147
Operating lease liabilities			102				1,214
Short-term loan payable, net of discount of $304 and $237			2,425				3,207
Deferred revenue			1,418				1,698
Income tax payable			1,374				1,987
Other current liabilities			1,765				2,115
Current liabilities in discontinued operations			—				5,867
Total current liabilities			25,626				32,134
Non-current liabilities:
Unsecured promissory notes, net of discount of $127			—				9,873
Unsecured long-term debt, net of discount of $216 and $423			436				1,779
Due to sellers (see Note 3)			2,000				2,000
Deferred revenue, net of current portion			654				784
Operating lease liabilities, net of current portion			—				3,762
Finance lease liabilities, net of current portion			1,889				2,591
Non-current liabilities in discontinued operations			—				2,924
Total non-current liabilities			4,979				23,713
Total liabilities			30,605				55,847
COMMITMENTS AND CONTINGENCIES
Stockholders’ equity
Preferred stock authorized 1,000,000, $0.0005 par value, no shares issued and outstanding			—				—
Common stock authorized 50,000,000, $0.0005 par value, 41,541,205 and 29,874,029 shares outstanding, respectively			29				23
Additional paid-in capital			120,145				129,921
Subscription receivable			—				—
Accumulated deficit			(58,899	)			(58,393	)
Treasury stock, at cost, 8,692,005 and 12,940,967 shares (1), respectively			(49,643	)			(64,000	)
Accumulated other comprehensive loss			(196	)			(198	)
Total stockholders’ equity			11,436				7,353
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	42,041			$	63,200

(1) This is net of 6,000,000 collateral shares.

See accompanying notes to these condensed consolidated financial statements

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share amounts)

(unaudited)

		For the three months ended
		June 30, 2025				June 30, 2024
Revenues, net		$	1,247			$	1,504
Cost of revenues			513				1,659
Gross profit (loss)			734				(155	)
Operating expenses:
General and administration			4,624				6,933
Research and development			4				140
Total operating expenses			4,628				7,073
Loss from operations			(3,894	)			(7,228	)
Debt extinguishment loss			(287	)			—
Interest expense			(587	)			(522	)
Loss from disposal of fixed assets			(823	)			—
Loss from operations before income taxes			(3,693	)			(7,750	)
Income tax (expense) benefit			(779	)			2,287
Loss from continuing operations after income taxes			(4,472	)			(5,463	)
Discontinued operations:
Loss from discontinued operations, net of tax			—				(690	)
Gain from disposal of discontinued operations			—				—
Income (loss) from discontinued operations			—				(690	)
Net income (loss)		$	(4,472	)		$	(6,153	)
Other comprehensive income:
Unrealized gain on marketable securities			2				(58	)
Total comprehensive loss		$	(4,470	)		$	(6,211	)
Net earnings (loss) per share:
Loss from continuing operations, basic and diluted		$	(0.11	)		$	(0.29	)
Income (loss) from discontinued operations, basic and diluted		$	—			$	(0.04	)
Net loss per share, basic and diluted		$	(0.11	)		$	(0.33	)
Weighted average common shares outstanding:
Basic			41,541				18,888
Diluted			41,541				18,888

See accompanying notes to these condensed consolidated financial statements

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

		For the six months ended
		June 30, 2025				June 30, 2024
Cash flows from operating activities
Net loss		$	(506	)		$	(12,418	)
Less: Gain (loss) from discontinued operations, net of tax			8,644				(1,431	)
Net loss from continuing operations			(9,150	)			(10,987	)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Realized loss on marketable debt securities			—				18
Depreciation and amortization			2,831				3,141
Amortization of debt discount			849				369
Amortization on operating lease right-of-use assets			210				222
Stock-based compensation expense			1,029				2,385
Inventory reserve			—				(63	)
Loss (gain) from disposal of fixed assets			868				(19	)
Debt extinguishment loss			718				—
Changes in operating assets and liabilities:
Accounts receivable			(28	)			3,322
Inventory			313				394
Prepaid expenses and other current assets			(803	)			(777	)
Deferred tax asset			—				(4,900	)
Other assets			—				847
Accounts payable and accrued expenses			448				3,896
Accrued diagnostic services			44				(87	)
Accrued advertising and other allowances			—				(13	)
Deferred revenue			(410	)			(768	)
Deferred tax liability			—				—
Lease liabilities			(29	)			(927	)
Income tax payable			(613	)			(618	)
Other liabilities			(350	)			(1,181	)
Net cash used in operating activities – continuing operations			(4,225	)			(5,746	)
Net cash provided by (used in) operating activities – discontinued operations			597				(4,236	)
Net cash used in operating activities			(3,628	)			(9,982	)
Cash flows from investing activities
Proceeds from sales of marketable securities			—				3,374
Proceeds from sales of fixed assets			120				150
Capital expenditures			—				(867	)
Net cash provided by investing activities – continuing operations			120				2,657
Net cash provided by (used in) investing activities – discontinued operations			800				(98	)
Net cash provided by investing activities			920				2,559
Cash flows from financing activities
Proceeds from issuance of note payable, net			687				3,868
Proceeds from issuance of common shares, net			3,558				4,624
Repayment of note payable			(2,511	)			(888	)
Net cash provided by financing activities – continuing operations			2,234				7,604
Net cash used in financing activities – discontinued operations			(35	)			(10	)
Net cash provided by financing activities			2,199				7,594
Decrease in cash and cash equivalents			(509	)			171
Cash and cash equivalents at the beginning of the period			678				1,609
Cash and cash equivalents at the end of the period		$	169			$	1,780
Supplemental disclosures:
Cash paid for income taxes		$	347			$	454
Interest payments		$	672			$	1,237
Supplemental disclosure of non-cash investing and financing activities:
Issuance of common stock as commitment fee for future financing		$	158			$	—

See accompanying notes to these condensed consolidated financial statements

Non-GAAP Financial Measures and Reconciliation

In an effort to provide investors with additional information regarding our results of operations as determined by accounting principles generally accepted in the United States of America (“GAAP”), we disclose certain non-GAAP financial measures. The primary non-GAAP financial measures we disclose are EBITDA and Adjusted EBITDA.

We define “EBITDA” as net income (loss) before net interest expense, income taxes, depreciation and amortization. Adjusted EBITDA further adjusts EBITDA by excluding acquisition costs, other non-cash items, and other unusual or non-recurring charges (as described in the table below).

Non-GAAP financial measures should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. These non-GAAP financial measures do not reflect a comprehensive system of accounting, differ from GAAP measures with the same names and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. We compute non-GAAP financial measures using the same consistent method from quarter to quarter and year to year. We may consider whether other significant items that arise in the future should be excluded from the non-GAAP financial measures.

We use EBITDA and Adjusted EBITDA internally to evaluate and manage the Company’s operations because we believe they provide useful supplemental information regarding the Company’s ongoing economic performance. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our operating results primarily because they exclude amounts that are not considered part of ongoing operating results when planning and forecasting and when assessing the performance of the organization. In addition, we believe that non-GAAP financial information is used by analysts and others in the investment community to analyze our historical results and in providing estimates of future performance and that failure to report these non-GAAP measures could result in confusion among analysts and others and create a misplaced perception that our results have underperformed or exceeded expectations.

The following table sets forth the reconciliations of EBITDA and Adjusted EBITDA excluding other costs to the most comparable GAAP financial measures (in thousands):

	For the three months ended
	June 30, 2025				June 30, 2024
GAAP loss from continuing operations (1)	$	(4,472	)		$	(5,463	)
Interest, net		587				522
Income tax benefit		779				(2,287	)
Depreciation and amortization		1,349				1,536
EBITDA		(1,757	)			(5,692	)
Share-based compensation expense		508				796
Non-cash rent expense (2)		442				67
Adjusted EBITDA from continuing operations	$	(807	)		$	(4,829	)

⁽¹⁾ We believe that net loss from continuing operations is the financial measure calculated and presented in accordance with GAAP that is most directly comparable to EBITDA and Adjusted EBITDA. EBITDA and Adjusted EBITDA measure the Company’s operating performance without regard to certain expenses. EBITDA and Adjusted EBITDA are not presentations made in accordance with GAAP and the Company’s computation of EBITDA and Adjusted EBITDA may vary from others in the industry. EBITDA and Adjusted EBITDA have important limitations as analytical tools and should not be considered in isolation or as substitutes for analysis of the Company’s results as reported under GAAP.

⁽²⁾ The non-cash portion of rent, which reflects the extent to which our GAAP rent expense recognized exceeds (or is less than) our cash rent payments. For newer leases, our rent expense recognized typically exceeds our cash rent payments, while for more mature leases, rent expense recognized is typically less than our cash rent payments.