Author: aweinsoff@channelchek.com

Release – Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

August 18, 2025 7:05am EDT Download as PDF

Ensures Intellectual Property Protection Until 2040

LOS ALTOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.

“While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts. We have completed a Phase I clinical study in healthy volunteers and have received Orphan Drug Designation for the prevention of delayed graft function (DGF) in patients undergoing kidney transplantation.”

About UNI-494
UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

About Acute Kidney Injury
Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

Release – The Oncology Institute and Doctors Healthcare Plans Partner to Elevate Oncology Care Management in South Florida

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TOI

Aug 18, 2025

PDF Version

CERRITOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — The Oncology Institute of Hope and Innovation (NASDAQ: TOI), a national leader in value-based oncology care, is pleased to announce a strategic partnership with Doctors HealthCare Plans, a Medicare Advantage plan serving members across South Florida. The Oncology Institute will provide delegated utilization management services and clinical advisory support, helping Doctors HealthCare Plans ensure high-quality, cost-effective cancer care for their members.

Under this partnership, The Oncology Institute will deliver comprehensive utilization management functions for oncology services, leveraging its robust clinical protocols, medical director oversight, and technology-enabled workflows. The collaboration also includes advisory services to support optimal oncology benefit design and evidence-based care pathways, empowering the plan’s providers to deliver personalized and clinically appropriate treatment for every patient.

This partnership builds on TOI’s national track record of managing medical cost risk across diverse, value-based arrangements. TOI currently supports delegated risk contracts across multiple states and payer types, consistently achieving cost savings while improving quality and patient satisfaction.

“We are proud to support Doctors HealthCare Plans with our delegated UM and oncology advisory services,” said Dr. Dan Virnich, CEO of The Oncology Institute. “By combining our clinical expertise with a collaborative, data-driven approach to utilization management, we can help ensure that patients receive the right care at the right time, improving outcomes and supporting affordability across the system.”

“This partnership is a reflection of our ongoing commitment to provide high-quality, high-value care to our members,” said Brandon Haushalter, CEO of Doctors HealthCare Plans. “With TOI’s leadership in oncology management and value-based care, we’re confident this collaboration will bring greater transparency, clinical rigor, and support to our providers while enhancing the member experience.”

The partnership underscores a shared commitment to advancing oncology care through smarter utilization management, setting a new standard for how health plans and specialty providers can work together to improve the cancer care journey.

About The Oncology Institute (www.theoncologyinstitute.com):
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.

About Doctor’s Healthcare Plans (https://www.doctorshcp.com/):
Doctors HealthCare Plans (DHCP) is a Florida-based, locally owned and operated Medicare Advantage Health Plan offering coverage for eligible Medicare beneficiaries across Miami-Dade and Broward County. The health plan was founded on a deep commitment to the community and provides an extensive network of providers, pharmacies, and hospitals. DHCP’s mission is to develop and establish a healthcare organization that is responsive and attentive to the needs of all beneficiaries by offering high-quality and cost-effective health care services.

Media
The Oncology Institute, Inc.
marketing@theoncologyinstitute.com

Investors
ICR Healthcare
TOI@icrhealthcare.com

Release – Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 15, 2025 3:44pm EDT Download as PDF

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women

Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated

Commercial availability of Tonmya is expected in the fourth quarter

Company to host webcast and conference call on Monday August 18, 2025 at 8:30 AM ET

CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years. We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome.”

“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.

Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in Tonmya-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).

“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” said Philip Mease, M.D., Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

The latest Phase 3 trial, RESILIENT, was recently published in Pain Medicine with data on primary and secondary endpoints measuring pain, patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.

“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives.” Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System. “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Tonix thanks the participants and investigators involved in its fibromyalgia clinical trials, and FDA for its commitment to approving new treatments for this condition.

Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.

For more information, visit TonmyaHCP.com or download the TONMYA Fact Sheet here.

Webcast Information
Tonix will host a webcast and conference call on Monday, August 18 at 8:30 AM ET to discuss the approval of Tonmya. The live webcast of the call will be available on the Investors section of Tonix’s website: https://ir.tonixpharma.com/news-events/ir-events. To participate by phone, please register in advance using this link to obtain a local or toll-free phone number and your personal pin. A replay of the webcast will be available for approximately 90 days following the live event. The slides presented during the webcast will be made available on the “Presentations” page of the “Investors” section of the Company’s website.

About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.

About Tonmya™ (cyclobenzaprine HCl sublingual tablets)
Tonmya, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, Tonmya is now approved as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.

About the Phase 3 Clinical Trials: RELIEF and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of Tonmya™ (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.

RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with Tonmya compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).

Tonix Pharmaceuticals Holding Corp.
Tonix is a fully-integrated biotechnology company. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc., our wholly-owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
investor.relations@tonixpharma.com

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Meagen Hagans
Weber Shandwick
(757)358-2033
MHagans@webershandwick.com

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:

  • In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
  • With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
  • During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
  • In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS

  • Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
  • Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
  • Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
  • Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
  • CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
  • Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

  • MAO inhibitors: Life-threatening interactions may occur.
  • Other serotonergic drugs: Serotonin syndrome has been reported.
  • CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
  • Tramadol: Seizure risk may be enhanced.
  • Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
  • Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
  • Pediatric use: The safety and effectiveness of TONMYA have not been established.
  • Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
  • Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 15, 2025

Release – QuoteMedia Announces Q2 2025 Financial Results and Strong Growth Outlook

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QMCI

August 14, 2025 17:50 ET | Source: QuoteMedia, Inc.

PHOENIX, Aug. 14, 2025 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, today announced financial results for the quarter ended June 30, 2025, reporting 5% year-over-year revenue growth to $4.93 million. The Company also secured several major new contracts expected to contribute meaningfully to revenue beginning in the third quarter.

QuoteMedia provides banks, brokerage firms, private equity firms, financial planners and sophisticated investors with a more economical, higher quality alternative source of stock market data and related research information. We compete with several larger legacy organizations and a modest community of other smaller companies. QuoteMedia provides comprehensive market data services, including streaming data feeds, on-demand request-based data (XML/JSON), web content solutions (financial content for website integration) and applications such as Quotestream Professional desktop and mobile.

Q2 2025 Financial Highlights (vs. Q2 2024)

  • Revenue: $4.93 million, up $253,265 (5%); FX-neutral growth of 6%(1)
  • Adjusted EBITDA(1): $99,121, compared to $493,393, reflecting lower capitalized development costs
  • Net Loss: $853,582, compared to $251,173, due to the accounting impact of development cost capitalization changes

Management Commentary

“We delivered solid revenue growth this quarter and closed major new contracts that will begin generating revenue in Q3,” said Robert J. Thompson, QuoteMedia’s Chairman of the Board. “We are also in advanced negotiations for additional large-scale deployments, which we expect to further enhance our performance.”

The Company’s Q2 profitability was impacted by how development costs were capitalized:

  • A smaller proportion of development costs were capitalized compared to previous quarters, resulting in more costs being expensed immediately.
  • Because development costs are amortized over three years, amortization expense remains elevated from prior periods, temporarily reducing Adjusted EBITDA.

While the accounting for development costs significantly impacted our bottom line, it had no impact on cash flow. Gross margin, EBITDA, and profitability are expected to improve in future quarters as amortization expense decreases.

Outlook

“We are confident in a strong second half of 2025,” Thompson added. “Our pipeline is robust, and we are proud of the team’s ability to secure and implement high-value contracts.”

Conference Call Details

QuoteMedia will host a conference call Friday, August 15, 2025, at 2:00 PM Eastern Time to discuss the Q2 2025 financial results and provide a business update.

Conference Call Details:

Date: August 15, 2025

Time: 2:00 PM Eastern Time

Dial-in numbers: 888-999-3182; 848-280-6330
Conference ID: 3818457 PIN: 2420

Or use the Conference Link below to bypass the operator: https://link.meetingpanel.com/?id=quotemedia-second-quarter-results

An audio rebroadcast of the call will be available later at: www.quotemedia.com

About QuoteMedia

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, The Goldman Sachs Group, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Credential Qtrade Securities, CNW Group, iA Private Wealth, Ally Invest, Inc., Suncor, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Stock-Trak, Mergent, Cision and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

Statements about QuoteMedia’s future expectations, including future revenue, earnings, and transactions, as well as all other statements in this press release other than historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. QuoteMedia intends that such forward-looking statements be subject to the safe harbors created thereby. These statements involve risks and uncertainties that are identified from time to time in the Company’s SEC reports and filings and are subject to change at any time. QuoteMedia’s actual results and other corporate developments could differ materially from that which has been anticipated in such statements.

Below are the specific forward-looking statements included in this press release:

  • We experienced solid revenue growth, and we expect to see even greater improvement throughout the year
  • In future quarters, amortization expense will decrease reflecting the lower levels of capitalized development costs, and our profitability will increase accordingly. Additionally, this will lead to improvement in our gross margin as well as EBITDA moving forward.
  • We are looking forward to a strong second half of 2025

QuoteMedia Investor Relations

Dave Shworan
Email: dave@quotemedia.com
Call: (250) 954-3216 ext. 2101

Note 1 on Non-GAAP Financial Measures

We believe that Adjusted EBITDA, as a non-GAAP pro forma financial measure, provides meaningful information to investors in terms of enhancing their understanding of our operating performance and results, as it allows investors to more easily compare our financial performance on a consistent basis compared to the prior year periods. This non-GAAP financial measure also corresponds with the way we expect investment analysts to evaluate and compare our results. Any non-GAAP pro forma financial measures should be considered only as supplements to, and not as substitutes for or in isolation from, or superior to, our other measures of financial information prepared in accordance with GAAP, such as net income attributable to QuoteMedia, Inc.

We define and calculate Adjusted EBITDA as net income attributable to QuoteMedia, Inc., plus: 1) depreciation and amortization, 2) stock compensation expense, 3) interest expense, 4) foreign exchange loss (or minus a foreign exchange gain), and 5) income tax expense. We disclose Adjusted EBITDA because we believe it is a useful metric by which to compare the performance of our business from period to period. We understand that measures similar to Adjusted EBITDA are broadly used by analysts, rating agencies, investors and financial institutions in assessing our performance. Accordingly, we believe that the presentation of Adjusted EBITDA provides useful information to investors. The table below provides a reconciliation of Adjusted EBITDA to net income attributable to QuoteMedia, Inc., the most directly comparable GAAP financial measure.


In addition to the non-GAAP measures discussed above, we also analyze certain measures, including net revenues and operating expenses, on an FX-neutral basis to better measure the comparability of operating results between periods. Management believes that changes in foreign currency exchange rates are not indicative of the company’s operations and evaluating growth in net revenues and operating expenses on an FX-neutral basis provides an additional meaningful and comparable assessment of these measures to both management and investors. FX-neutral results are calculated by translating the current period’s local currency results with the prior period’s exchange rate. FX-neutral growth rates are calculated by comparing the current period’s FX-neutral results by the prior period’s results.

Release – Comstock Announces Second Quarter 2025 Results And Corporate Updates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

August 14, 2025

Raises $30 Million From Oversubscribed Offering and Eliminates Debt & Obligations

VIRGINIA CITY, NEVADA, August 14, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock,” “our,” and the “Company”), today announced its second quarter 2025 results, business updates and an updated 2025 business outlook.

Recent Corporate Liquidity and Capital Resources Events

  • Closed the initial $20 Million of Series A Investment and completed the separation of Fuels into Bioleum Corporation;
  • Raised $30 million in gross proceeds to fully fund and accelerate the commercialization of its R2v3/RIOS Responsible Recycling certified zero-landfill industry-scale solar panel recycling facilities, each capable of recycling over 3.3 million panels per year, and to eliminate debts and advance additional site selections and other key development initiatives;
  • Paid down outstanding promissory notes by issuing 2,900,000 common shares to an existing, leading shareholder that positions the elimination of $8,390,000 of debt obligations;
  • Entered a final payoff agreement with Kips Bay in full satisfaction of the Company’s convertible note obligation;  
  • Eliminated all liabilities associated with the previous acquisitions of AST (Fuels); Northern Comstock (Mining); Haywood mineral properties and quarry (Mining) and LINICO (Metals);
  • Proforma combined cash balance exceeded $45 million between Comstock and Bioleum’s recent capital raises; and
  • Common shares outstanding on August 13, 2025, and August 14, 2025, was 35,930,913 and 49,264,247, respectively.

“The past five months have clarified the technological capabilities and leadership teams of two extraordinary companies, a Nevada-based renewable metals company and an Oklahoma-based renewable oil and gas company, that, remarkably, are now rapidly moving to deploy urban silver mines and sustainable oil fields and biorefineries that do not ever deplete or stop producing. In both instances now, multiple, sophisticated, strategic and financial investors have all made material investments in us,” stated Corrado De Gasperis, Executive Chairman and CEO of Comstock Inc. “Everything is accelerating to industry-scale production.”

Selected Segment Highlights for Comstock Metals

“Solar panel recycling is a win-win-win – good for consumers, the economy, and our planet,” said Evelyn Butler, Vice President of Technical Services at the Solar Energy Industries Association (SEIA). “We congratulate Comstock Metals on this achievement – one of our Preferred Recycling Partners – and we look forward to continuing this partnership for the benefit of the entire solar energy industry.” Comstock Metals is the only certified R2v3/RIOS Responsible Recycling Standard by State Electronic Records Institute (SERI).

Comstock Metals

  • Recorded billings of $2.31 million ($1.1 million was deferred) in first half of 2025, versus nil in the first half of 2024;
  • Certified to the R2v3/RIOS Responsible Recycling Standard by SERI, authenticating the first zero-waste recycling process that safely repurposes all the recycled solar panel materials into new commercial applications.
  • Entered into a Master Services Agreement (MSA) with RWE Clean Energy (“RWE”), serving as a preferred, strategic partner for the end-of-life recycling, disposal, and decommissioning services for RWE’s solar installations;
  • Received well over 4 million pounds of end-of-life solar materials from RWE in the first half of 2025;
  • Commenced operating three shifts and expanded the dedicated team to 20 full time employees;
  • Received an additional county permit for expanded storage in the immediate proximity of the processing facilities;
  • Secured additional intake (tipping) revenue arrangements across the U.S., including industry leading customers; and
  • Finalized industry-scale equipment design and ordered the purchase of all equipment for delivery in Q4 2025.

“Comstock Metals has continued growing stronger than ever. Comstock Metals became the first company in North America to earn the stringent R2v3 and RIOS certifications for zero-waste solar panel recycling,” said Comstock Metals President, Dr. Fortunato Villamagna. “This groundbreaking certification validates that our recycling facility and processes meet the highest global standards for safety, environmental stewardship, and total waste elimination. In fact, under the R2v3/RIOS standard (including the specialized Appendix G), we demonstrated a 100% landfill-free recycling process. Every component of an end-of-life solar panel (glass, aluminum, semiconductor fines, and other metals) is fully reclaimed and repurposed into new raw materials. The capital we just raised allowed us to order and place deposits down on the equipment today. We wasted no time.”

Selected Segment Highlights for Comstock Mining

  • Closed on the sale and monetization of the northern district claims for approximately $3 million in proceeds;
  • Increased both Comstock economic mineralized material estimates based on significantly higher gold and silver prices;
  • Developed actionable plans for expanding and upgrading the Dayton resource into proven and probable reserves; and
  • Assessed productive post-mining land uses and identified prerequisites for post-mining development.

“The rapidly rising industrial silver demand and ongoing geopolitical concerns, compounded by decades of questionable monetary policy, created an unprecedented runup in gold and a possibly greater set up for silver prices over the next several years. Our historic, world-class Nevada mining assets are well positioned for expansion and monetization with sophisticated strategic and financial partners,” said Comstock’s Chief Financial Officer and Comstock Mining President, Mr. Judd Merrill.

Selected Highlights for Bioleum Corporation (“Bioleum”)

  • Closed on a strategic Series A investment from subsidiaries of Marathon Petroleum Corp. (“MPC”) and completed an initial $20 Series A preferred equity financing;
  • Secured the first site and advanced site-specific engineering for the first planned Oklahoma-based Bioleum refinery;
  • Qualified for the second $1 million of the $3 million in incentive awards from Oklahoma’s Quick Action Closing Fund;
  • Secured a $152 million allocation of Qualified Private Activity Bonds from Oklahoma’s State Treasurer’s Office;
  • Acquired and restarted Madison, Wisconsin pilot facility, and commenced integration of the Madison team;
  • Hired exceptional, biofuel industry veterans to expand and accelerate development;
  • Advanced a Series A preferred equity financing offering with an expanding group of strategic investors; and
  • Advanced research and development with NREL combined applications of Bioleum’s and NREL’s breakthrough process for producing sustainable aviation fuel (“SAF”) from lignin that is functionally identical to petroleum jet fuel.

“We have developed an unprecedented, versatile, and exceptionally high-yield, ultra-low-carbon biofuel platform that integrates waste streams and purpose-grown crops to produce up to 200 million barrels — about 8 billion gallons — of sustainable fuel annually by 2035,” said Kevin Kreisler, newly appointed CEO of Bioleum Corporation. “Our proven commercial process converts wasted and unused woody biomass byproducts into renewable fuels and, when combined with dedicated energy crops, creates an efficient, scalable network of ‘endless oil wells’ hidden in plain sight.”

Bioleum Separation Completed: A Bold New Chapter

“We have officially separated and contributed the assets that formerly comprised Comstock’s fuels segment into Bioleum, a newly formed company dedicated to accelerating and maximizing the production and use of lignocellulosic biomass derived fuels – or BioleumTM –and attracting the necessary capitalization to do so, stated Mr. De Gasperis. “We expect that before the end of this year, Bioleum will also be fully deconsolidated from Comstock’s consolidated financial statements and will have stand-alone, audited Bioleum Corporation financial statements. Bioleum’s formation marks the next chapter in this rapid evolution – one where our renewable fuels platform can accelerate under its own banner with singular focus and clarity with the ultimate objective of also becoming a publicly traded company.”

Comstock now owns $65 million face value convertible preferred stock in Bioleum, convertible into 32.5 million common shares, positioning an exceptional value potential for Comstock’s shareholders and preserving Comstock’s ability to accelerate the growth and delivery of that value directly to Comstock’s shareholders, ultimately through a public offering.

Outlook: Commercialization and Monetization 

Corporate 

The growth opportunities for both Comstock Metals and Bioleum have developed well beyond our original plans, and we have attracted some of the most sophisticated partners for investment, feedstock, technology, operations, and offtake, with many now evaluating or having already direct investments and that are exploring deeper integrations and strategic transactions.

The Company’s Corporate objectives for the rest of 2025 include:

  • Monetize our legacy real estate and non-strategic investments for over $50 million;
  • Support the next phases of Metals growth; and
  • Finalize, communicate and implement plans to unlock maximum value from the separation of Bioleum.

This ultimately results in two high-growth companies: a renewable metals and mining company headquartered in Nevada, and a renewable fuels company headquartered in Oklahoma and with major operations already functioning in Wisconsin.

Comstock Metals

Comstock Metals has now been operating its first commercial demonstration facility for over 18 months and in November of 2024, submitted permits for the first industry-scale photovoltaic recycling facility. The industry-scale facilities are anticipated to ultimately operate at least 100,000 tons of annual capacity. Site selection activities are ongoing for the next two industry-scale facilities and associated storage sites. The Company plans to ultimately build up to 7 industry-scale U.S. based recycling facilities.

The Company’s Metals objectives for the rest of 2025 include:

  • Expand local county storage capacity adjacent to our first industry-scale facility;
  • Complete permitting for our first industry-scale facility in Silver Springs, NV;
  • Procure, deploy, and assemble plant and equipment for our first industry-scale facility in Silver Springs, NV;
  • Secure additional Master Service Agreements (MSA) with national and regional customers;
  • Complete site selection and preliminary development for two additional solar panel recycling locations;
  • Expand the system globally with international strategic and capital partners; and
  • Advance and expand R&D efforts to recover more and higher-purity materials from recycled streams for offtake.

The capital expenditures for the first 100,000 tons of annual capacity for the first industry scale facility are expected to be approximately $12.0 million which includes expanded storage. In 2025, approximately $10.0 million of capital expenditures is required with additional up to $2.0 million, spent in early 2026. Billable revenues are expected to be eight times greater in 2025, as compared to 2024, or over $3.5 million, with proportionate future increases in 2026, as we scale up our first industry-scale facility. The Company has already ordered the equipment associated with the capital expenditures.

For the remainder of 2025, we plan on accelerating and increasing our lead in metals as our solar panel recycling systems rapidly expands market share nationally and we have now already placed our orders for the first industry-scale facility in Silver Springs, NV,” concluded Mr. De Gasperis. “We are moving fast to deploy in the fourth quarter of 2025 and commission the facility in the first quarter of 2026, so that we can be operating and processing panels profitably in the second quarter of 2026.”

Comstock Mining

Comstock Mining has amassed the single largest known repository of historical and current geological data within the Comstock mineral district, including extensive geophysical surveys, geological mapping, and drilling data, including the Dayton resource.

The Company’s Mining objectives for 2025 include:

  • Receive cash proceeds of over $2.0 million from prior mineral leases and asset sales from the northern claims;
  • Commercialize agreements that either monetize or enable resource expansion of the central claims with others; and
  • Complete the preliminary mine plans that enable the economic development of the southern district claims.

The Company’s 2025 efforts will apply economic analysis to Comstock’s existing gold and silver resources progressing toward preliminary economic feasibility for the southern part of the district and the ultimate development of full mine and reclamation plans and the development of post productive land and community development plans. 

Bioleum

Bioleum’s biorefining technologies are commercially ready for deployment and offer growth-enabling performance. Bioleum is actively engaged in the planning and deployment of its first commercial demonstration facility and pursuing joint development and licensing agreements representing future revenue sources from technical and engineering services, royalties, and equity participation. These efforts include securing associated supply chain participants (including feedstock, site selection, engineering, construction and procurement, and offtake), performing preliminary and final engineering, and facilitating commissioning, construction, and operations, including with globally and locally recognized current and developing renewable fuels producers that, in certain cases, also represent a source of strategic capital for funding the projects.

Bioleum’s objectives for the rest of 2025 include:

  • Complete separation of Bioleum as a separate, stand-alone, well-capitalized, renewable fuels focused on advancing delivery of hundreds of millions of barrels by 2035 and a public offering;
  • Complete Bioleum’s ongoing Series A preferred equity financing;
  • Execute definitive lease, EPC, feedstock, and offtake agreements, complete all engineering, and continue to advance Bioleum’s first commercial biorefinery site in Oklahoma;
  • Acquire and develop initial commercial scale purpose grown energy crop farm to provide additional feedstock for our first commercial biorefinery;
  • Secure sufficient project-level financing for first Oklahoma-based commercial biorefinery project;
  • Execute additional revenue generating licenses and other commercial agreements;
  • Expand Wisconsin pilot production capabilities to up to two barrels per week of intermediates and fuels; and
  • Advance our innovation and development efforts toward even higher yields, lower costs and lower capital.

Bioleum’s commercialization plans are squarely focused on operationalizing its newly integrated pilot facilities in Wisconsin and commercializing its first fully integrated demonstration scale facility in Oklahoma. Bioleum also offers integrations of its solutions into existing agriculture, forestry, pulp and paper, ethanol, and petroleum infrastructure to generate additional technical services, engineering and royalty revenues. The plans also include integrating Bioleum’s high yield Bioleum refining platform with Hexas’ high yield energy crops to provide enough feedstock to produce upwards of 100 barrels of fuel per acre per year, effectively transforming agricultural lands into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost domestic and global energy independence.

CONFERENCE CALL DETAILS

Comstock’s Executive Chairman and Chief Executive Officer, Corrado De Gasperis, and its Chief Financial Officer, Judd Merrill, will present an overview of the second quarter 2025 financial results, upcoming milestones, and how the Company’s systemic platform is optimizing results on Thursday, August 14, 2025, via a webinar.

Investors and all other interested parties are invited to register below.

Date:     August 14, 2025
Time:     4:30 p.m. ET
Register: Webinar Registration

HAVE QUESTIONS? There will be an allotted time following the results presentation for a Q&A session. Unaddressed questions will be reviewed by management and responded to accordingly. You may submit your question(s) beforehand in the registration form (linked above) or by email at: ir@comstockinc.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that enable, support and sustain clean energy systems across entire industries by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable electrification metals, like silver, aluminum, copper, and other critical minerals from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
Judd B. Merrill, Chief Financial Officer
Tel (775) 413-6222
ir@comstockinc.com

For media inquiries:
Zach Spencer, Director of External Relations
Tel (775) 847-7573
media@comstockinc.com

Forward-Looking Statements 

This press release and any related calls or discussions may include 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. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Release – Eledon Pharmaceuticals Reports Second Quarter 2025 Operating and Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

August 14, 2025

PDF Version

Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart

Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025

Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025

IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.

“We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.”

Year-to-Date 2025 Business Highlights

  • Presented updated data at the World Transplant Congress (WTC) in August 2025 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 32 participants demonstrated that tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, sepsis, or new-onset diabetes. Kidney function, as assessed by estimated glomerular filtration rate (eGFR), generally stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for participants (n=12) who remained on tegoprubart. For comparison, data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFRs of approximately 53 mL/min/1.73 m2 at 12 months after kidney transplant.
  • In June 2025, a third patient was treated with tegoprubart as a cornerstone component of the immunosuppression treatment regimen following kidney xenotransplantation conducted at Massachusetts General Hospital (MGH) in collaboration with eGenesis.
  • Announced the first three islet cell transplant recipients treated at the University of Chicago Medicine’s Transplant Institute in an investigator-initiated trial evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection achieved insulin independence. An additional three islet transplant recipients have now been enrolled as well, bringing the total enrollment in the trial to six patients.
  • Preclinical data in liver allotransplantation utilizing tegoprubart was presented at WTC 2025 demonstrating markedly prolonged graft survival in non-human primates (NHPs) by targeting the CD40 Ligand pathway and the potential for transplant tolerance induction.
  • Announced a second investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in patients with impaired kidney function.
  • Hosted an R&D Day in New York City that highlighted recent progress for the Company’s lead investigational candidate, tegoprubart, with a focus on its clinical development progress in organ and cell transplantation, including the ongoing Phase 2 BESTOW trial. The event featured members of Eledon’s executive team and leading experts in the field of transplantation. A replay of the R&D Day event can be found on Eledon’s website at https://ir.eledon.com/news-and-events/events
  • In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among investors as Eledon approaches key regulatory milestones.

Anticipated Upcoming Milestones for 2H 2025

  • November 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • Launch an investigator-initiated trial at MGH evaluating tegoprubart as part of an immunosuppression regimen to induce donor-specific immune tolerance through mixed chimerism.
  • Enroll three additional patients in the investigator-led clinical trial at UChicago Medicine in subjects with type 1 diabetes treated with tegoprubart as part of an immunosuppression regimen for the prevention of pancreatic islet transplant rejection.

Second Quarter 2025 Financial Results

Cash, cash equivalents and short-term investments totaled $107.6 million as of June 30, 2025 compared to $140.2 million as of December 31, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.

Research and development (R&D) expenses for the second quarter of 2025 were $20.3 million, including $1.1 million of non-cash stock-based compensation expense, compared to $10.1 million, including $0.8 million of non-cash stock-based compensation expense, for the comparable period in 2024.

General and administrative expenses for the second quarter of 2025 were $4.5 million, including $1.6 million of non-cash stock-based compensation expense, compared to $4.4 million, including $2.2 million of non-cash stock-based compensation expense, for the comparable period in 2024.

Net loss for the second quarter of 2025 was $11.2 million, or $0.13 per basic common share, compared to a net loss of $44.9 million, or $0.92 per basic common share, for the comparable period in 2024.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, liver allograft transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

Release – Bit Digital, Inc. Announces Second Quarter of Fiscal Year 2025 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTBT

    NEW YORK, August 14, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies headquartered in New York City, today announced its financial results for the Second Quarter of 2025. The Company will host a conference call on August 15, 2025, at 10:00 AM ET to discuss results (click here for registration information).

    WhiteFiber IPO and Retained Stake
    In August 2025, Bit Digital completed the initial public offering of its high-performance computing subsidiary, WhiteFiber, Inc. The results reported in this release include WhiteFiber’s contributions for the full second quarter on a consolidated basis.

    As of August 13, 2025, Bit Digital held 27,043,749 shares of WhiteFiber, representing approximately 74.3% of the company. Based on WhiteFiber’s closing price of $17.32 per share on that date, the Company’s retained stake was valued at approximately $468.4 million. Following the IPO, Bit Digital will continue to consolidate WhiteFiber’s results in its financial statements, with public ownership reflected as non-controlling interest, unless and until the Company’s ownership or control falls below the threshold required for consolidation under U.S. GAAP.

    Financial Highlights for the Second Quarter of 2025

    • Total revenue for the second quarter of 2025 was $25.7 million; an 11.7% decrease compared to $29.0 million in the second quarter of 2024. The decline was primarily driven by a decrease in digital asset mining revenue as the Company focused on Ethereum-native treasury and staking strategies, which was partially offset by growth across other segments.
    • Revenue from digital asset mining was $6.6 million, a 58.8% decrease compared to $16.1 million in the prior year’s quarter. The decline was driven by increased network difficulty, the halving event in April 2024, and a reduction in active hash rate.
    • Revenue from cloud services was $16.6 million, a 32.8% increase compared to $12.5 million in the prior year’s quarter.
    • Revenue from colocation services was $1.7 million, compared to none in the prior-year quarter as the business was launched in late 2024.
    • Revenue from ETH staking was $0.4 million, a 2.3% decrease compared to $0.4 million in the second quarter of 2024. An increase in staking rewards was offset by a lower realized ETH price during the quarter.
    • Net income for the second quarter of 2025 was $14.9 million, or $0.07 per diluted share, compared to a net loss of $12.0 million, or $(0.09) per diluted share, in the prior-year quarter.
    • Adjusted EBITDA for the second quarter of 2025 was $27.8 million, compared to $(3.8) million in the second quarter of 2024. Second quarter 2025 adjusted EBITDA includes a $27.2 million gain on digital assets.
    • Cash and cash equivalents totaled $181.2 million as of June 30, 2025, compared to $95.2 million as of December 31, 2024.
    • Total digital assets were $91.2 million as of June 30, 2025, compared to $161.4 million as of December 31, 2024. Subsequent to quarter-end, the Company liquidated substantially all BTC and used the proceeds to acquire ETH.

    Ethereum Treasury Strategy
    During the second quarter, Bit Digital initiated a strategic transition to become a pure-play Ethereum treasury and staking company. The Company intends to allocate the majority of its capital to ETH accumulation and staking yield generation, positioning itself as a leading public ETH vehicle.

    The Company’s ETH position[1] has grown materially as a result of this initiative:

    • June 30, 2025: 30,663 ETH held.
    • July 7, 2025: 100,603 ETH held.
    • August 11, 2025: 121,076 ETH held, valued at approximately $511.5 million as of that date, following additional purchases funded by the Company’s June and July 2025 equity offerings to support the ETH treasury strategy.

    In the second quarter, Bit Digital earned approximately 166.8 ETH in staking rewards. As of June 30, approximately 21,568 ETH were actively staked, generating an annualized effective yield of approximately 3.1% for the quarter. As of August 11, 2025, Bit Digital had 105,015 ETH actively staked.

    Bitcoin Mining Update
    In June 2025, the Company announced plans to sunset its bitcoin mining operations as part of its transition to an Ethereum-focused strategy. The process is expected to result in the sale of mining assets or the orderly closure of operations as hosting contracts expire or equipment becomes unprofitable.

    During the second quarter, the Company earned 68.2 BTC, compared to 83.3 BTC in the prior quarter, reflecting both network difficulty, curtailments, and the ongoing fleet redeployed following the exit from a hosting partners facility. As of June 30, 2025, the Company’s active hash rate was approximately 1.2 EH/s], with a fleet efficiency of approximately 25 J/Th. The Company expects active hash rate to increase with the deployment of 3,575 previously purchased S21 mining units, of which 2,130 have been deployed since June 30, 2025. Bitcoin mined on an ongoing basis is used for settlement of related expenses and conversions into ETH.

    Management Commentary
    “This quarter marked the beginning of Bit Digital’s transformation into a dedicated Ethereum treasury and staking platform,” said Sam Tabar, CEO of Bit Digital. “In June, we formally launched our ETH strategy and have already scaled our holdings significantly, reaching 121,076 ETH as of August 11, 2025. Our objective is to build one of the largest on-chain ETH balance sheets in the public markets and to generate attractive staking yields for shareholders. This isn’t a trend we’re chasing — we’ve held ETH since 2021 and have deep conviction in its long-term value.”

    “We intend to opportunistically and cost-effectively scale our ETH position using a disciplined capital allocation framework. This includes deploying proceeds from operations and leveraging various capital markets tools where appropriate to maximize returns while maintaining prudent risk management. We are valuation-sensitive and focused on growing long-term value per share, not simply scaling for the sake of it.”

    “At the same time, we are methodically winding down our bitcoin mining operations and redeploying capital into ETH. The recently completed WhiteFiber IPO unlocked substantial value for shareholders, and our retained stake gives us additional financial strength as we pursue this new direction. “It also provides strategic flexibility that could be monetized over time to further support our ETH strategy in a non-dilutive way. With a growing ETH treasury and a strong balance sheet, we believe we are well-positioned to deliver sustainable, ETH-based returns over the long term.”

    Footnotes
    [1] Includes approximately 6,062 ETH and ETH-equivalents held in an externally managed fund as of June 30, 2025, and 6,085 ETH and ETH-equivalents as of July 31, 2025.

    About Bit Digital
    Bit Digital is a publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies. The Company began accumulating and staking ETH in 2022 and now operates one of the largest institutional Ethereum staking infrastructures globally. Bit Digital’s platform includes advanced validator operations, institutional-grade custody, active protocol governance, and yield optimization. Through strategic partnerships across the Ethereum ecosystem, Bit Digital aims to deliver exposure to secure, scalable, and compliant access to onchain yield. For additional information, please contact ir@bit-digital.com or follow us on LinkedIn or X.

    Investor Notice
    Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report) and any subsequently filed quarterly reports on Form 10-Q and any Current Reports on Form 8-K.  If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. See “Safe Harbor Statement” below.

    Safe Harbor Statement
    This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

    InPlay Oil Corp. Announces Second Quarter 2025 Financial and Operating Results and Provides Operations Update

    Posted on by aweinsoff@channelchek.com
    InPlay Oil Logo (CNW Group/InPlay Oil Corp.)

    Research News and Market Data on IPOOF

    Aug 14, 2025, 07:30 ET

    CALGARY, AB, Aug. 13, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company“) announces its financial and operating results for the three and six months ended June 30, 2025 which is our first quarter following the April 7, 2025 closing date of the strategic acquisition of Cardium focused light oil assets in the Pembina area of Alberta (the “Acquisition“). InPlay’s condensed unaudited interim financial statements and notes, as well as its Management’s Discussion and Analysis (“MD&A”) for the three and six months ended June 30, 2025 will be available at “www.sedarplus.ca” and on our website at “www.inplayoil.com“. An updated corporate presentation is available on our website.

    We are excited about InPlay’s future following the highly accretive acquisition completed in the second quarter. This transformative transaction has significantly enhanced the Company’s scale, market capitalization, and long-term sustainability. With a longer reserve life and an expanded inventory of high quality drilling locations, the combined Company is well positioned to generate strong free adjusted funds flow (“FAFF”)(3) for many years to come.

    InPlay is off to a very strong start with second quarter production exceeding expectations by approximately 1,000 boe/d. This outperformance was driven by base production performing above expectations and seven (7.0 net) wells brought onstream in March significantly outperforming our type curves by ~135% on average based on the first 120 days of initial production (“IP”). Notably, three wells brought onstream in March ranked among the top ten Cardium producers in April with two of them holding the number one and two spots in April and May, and ranking second and third in June. These wells achieved payout in under 90 days in a US$60 WTI pricing environment. As a result of this outperformance, current production based on field estimates remains at 19,400 boe/d even though no new wells have been brought on since March. We now expect 2025 average production to be at the upper end of our guidance range. In addition, strong capital efficiencies are expected to result in capital spending landing in the lower half of our previously announced capital budget of $53 – $60 million. The Company continues to prioritize free cash flow generation to be used for debt reduction and the continued return of capital to shareholders through our monthly dividend.

    Another exciting development is the recent announcement that Delek Group Ltd. (“Delek”) has become a 32.7% strategically aligned shareholder of InPlay. Delek brings a proven track record of value creation in the energy sector. They hold a 45% working interest in the largest natural gas field in the Mediterranean, with an estimated 23 TCF of recoverable natural gas. Additionally, Delek has been instrumental in the growth of Ithaca Energy plc, where they hold a 52% equity stake and have overseen production growth from 30,000 boe/d to over 120,000 boe/d since 2019.

    For the remainder of 2025, InPlay plans to drill 5.0 – 5.5 net Cardium wells in Pembina. InPlay’s second half drilling campaign recently commenced in August, with the spudding of a three well pad which are in close proximity to the Company’s top producing Cardium wells and are expected to be on production near the beginning of October. The application of InPlay’s drilling and completion techniques to the acquired assets is expected to drive continued strong performance from new wells with additional capital directed to facility upgrades, optimization and required infrastructure projects.

    InPlay will continue to be disciplined and timely in capital spending in the current commodity price environment, maintaining a focus on strong FAFF, debt reduction, per share growth and continuation of our return to shareholder strategy. To further enhance stability and mitigate risk, the Company has secured commodity hedges extending through 2025 and into 2026. InPlay has hedged over 70% of natural gas production and approximately 60% of light crude oil production for the second half of 2025.

    Second Quarter 2025 Highlights

    • Successfully closed the strategic acquisition of Cardium focused light oil assets at highly accretive metrics, enhancing FAFF by 65% on a per share basis, expanding our drilling inventory to over 400 locations, lowering our corporate base decline rate to 24% and strengthening dividend sustainability (2025 forecasted FAFF equal to 2.5 times base dividend).
    • Achieved average quarterly production of 20,401 boe/d(1) (62% light crude oil and NGLs), a 125% increase from Q1 2025, including a 13% increase to light crude oil and liquids weighting to 62% from 55% and a 35% increase in light oil weighting to 51% from 38% in the first quarter of 2025 with oil being the main driver behind our netbacks.
    • Generated strong quarterly Adjusted Funds Flow (“AFF”)(2) of $40.1 million ($1.49 per basic share(3)).
    • Achieved significant FAFF of $35.5 million ($1.32 per basic share(3)) allowing the Company to reduce net debt by approximately $26 million, more than originally forecasted, resulting in a quarterly annualized net debt to earnings before interest, taxes and depreciation (“EBITDA”)(3) ratio of 1.2 times.
    • Realized operating income of $50.5 million(3), an increase of 140% compared to Q1 2025 leading to a strong operating income profit margin(3) of 55%, up from 54% in Q1 2025.
    • Improved field operating netbacks(3) to $27.20/boe, a 6% increase compared to Q1 2025 despite an 11% decrease to WTI pricing (13% decrease to realized crude oil pricing) and a 22% decrease in AECO natural gas pricing compared to Q1 2025.
    • Returned $7.9 million to shareholders via monthly dividends, representing a 10% yield relative to the current share price. Since November 2022, InPlay has distributed $52 million in dividends (including dividends declared to date in the third quarter).

    Second Quarter 2025 Financial & Operations Overview:

    InPlay’s second quarter results exceeded expectations and marked the first reporting period incorporating the recently acquired assets, with pro forma operations effective April 8, 2025. Due to the outstanding efforts of our team and InPlay’s strong knowledge and focus in the area, the acquired assets were seamlessly integrated with no disruption to the Company’s ongoing operations.

    Quarterly production averaged 20,401 boe/d(1) (62% light crude oil and NGLs) which was approximately 1,000 boe/d above internal forecasts. Base production exceeded expectations, and the seven (7.0 net) wells drilled on the combined assets in the first quarter significantly outperformed internal forecasts by approximately 135% (based on IP 120) as highlighted in the table below.

    02-25 Pad (per well average)14-33 Pad (per well average)08-01 Pad (per well average)
    boe/dOil and NGLs %boe/dOil and NGLs %boe/dOil and NGLs %
    IP 3088788 %68075 %26589 %
    IP 6093787 %49366 %29087 %
    IP 9092285 %56963 %28886 %
    IP 12089285 %43060 %28583 %
    IP 150 N/AN/A48758 %27582 %
    Current79182 %29944 %21777 %
    >300% above type curve>75% above type curve>25% above type curve

    InPlay generated AFF of $40.1 million ($1.49 per basic share) a 138% increase from the first quarter of 2025. Limited capital spending in the second quarter of $4.6 million, resulted in $35.5 million of FAFF ($1.32 per basic share), highlighting the strong FAFF generation of the combined Company. These strong results were achieved despite an 11% decrease to WTI pricing (13% decrease to realized crude oil pricing) and a 22% decrease in AECO natural gas pricing compared to Q1 2025. The Company paid $7.9 million ($12.0 million in the first half of 2025) in dividends during the quarter.

    During the quarter InPlay generated a net loss of $3.2 million. After excluding one-time transaction costs and the impact of unrealized mark-to-market hedging gains/losses, InPlay generated adjusted net income(3) of $2.0 million ($0.08 per basic share) in the quarter.

    Strong results had net debt levels at the end of the quarter at $223 million, $5 million lower than originally anticipated. The quarterly annualized net debt to EBITDA ratio for the second quarter of 1.2x is evidence that our post-Acquisition accelerated debt reduction goals are well on track.

    Operating synergies and stronger production allowed InPlay to maintain operating costs per boe in the second quarter in line with pre-acquisition levels and synergies have started to show a reduction in G&A cost per boe.

    Financial and Operating Results:

    (CDN) ($000’s)Three months ended
    June 30    		Six months ended
    June 30
    2025202420252024
    Financial
    Oil and natural gas sales91.641.5130.679.5
    Adjusted funds flow(2)40.120.156.936.7
        Per share – basic(3)(5)1.491.342.712.44
        Per share – diluted(3) (5)1.491.302.712.36
        Per boe(3)21.5925.5721.2723.34
    Comprehensive income (loss)(3.2)5.4(6.1)7.1
    Per share – basic(5)(0.12)0.36(0.29)0.47
    Per share – diluted(5)(0.12)0.35(0.29)0.46
    Dividends7.94.112.08.2
    Per share0.090.090.090.09
    Capital expenditures – PP&E and E&E4.66.218.531.7
    Property acquisitions (dispositions)293.3–293.6(0.0)
    Net debt(2)(223.2)(50.8)(223.2)(50.8)
    Shares outstanding(5)27.815.027.815.0
    Basic weighted-average shares(5)26.915.021.015.0
    Diluted weighted-average shares(5)26.915.521.015.5
    Operational
    Daily production volumes
    Light and medium crude oil (bbls/d)10,3283,6716,8983,561
    Natural gas liquids (boe/d)2,4011,4381,9891,462
    Conventional natural gas (Mcf/d)46,02921,29135,30021,645
    Total (boe/d)20,4018,65714,7708,631
    Realized prices(3)
    Light and medium crude oil & NGLs ($/bbls)75.1383.2472.5078.07
    Conventional natural gas ($/Mcf)1.831.432.002.05
    Total ($/boe)49.3652.6348.8450.58
    Operating netbacks ($/boe)(4)
    Oil and natural gas sales49.3652.6348.8450.58
    Royalties(6.35)(6.43)(6.20)(6.10)
    Transportation expense(0.71)(0.98)(0.84)(1.04)
    Operating costs(15.10)(14.81)(15.06)(15.09)
        Operating netback(4)27.2030.4126.7428.35
    Realized gain (loss) on derivative contracts(0.20)0.25(0.12)0.27
        Operating netback (including realized derivative contracts) (4)27.0030.6626.6228.62

    On behalf of the entire InPlay team and our Board of Directors, we thank our shareholders for their ongoing support as we execute our strategy of disciplined growth, reliable returns, and long-term value creation. We would like to send a special thanks to our employees for their significant effort in enabling a smooth integration of the new assets. We are very optimistic about building on the momentum from our strategic Acquisition that has transformed the future of the Company.

    Notes:
    1.See “Production Breakdown by Product Type” at the end of this press release.
    2.Capital management measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
    3.Non-GAAP financial measure or ratio that does not have a standardized meaning under International Financial Reporting Standards (IFRS) and GAAP and therefore may not be comparable with the calculations of similar measures for other companies. Please refer to “Non-GAAP and Other Financial Measures” contained within this press release and in our most recently filed MD&A.
    4.Supplementary measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
    5.Common share and per common share amounts have been updated to reflect the six for one (6:1) common share consolidation effective April 14, 2025.

    For further information please contact:

    Doug Bartole
    President and Chief Executive Officer
    InPlay Oil Corp.
    Telephone: (587) 955-0632    		Darren Dittmer
    Chief Financial Officer
    InPlay Oil Corp.
    Telephone: (587) 955-0634

    View full release here.

    Release – NIH Contract Expands DLH’s Position as a Digital Transformation and Cybersecurity Leader

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on DLHC

    August 14, 2025

    PDF Version

    Company to Continue Providing Information Technology Services for National Institutes of Health

    ATLANTA, Aug. 14, 2025 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of digital transformation and cyber security, science research and development, and systems engineering and integration, today announced that it has been awarded a task order valued at up to $46.9 million to continue providing information technology services including enterprise IT systems management, cyber security, software development, cloud computing, and more to the National Institutes of Health’s Office of Information Technology (“OIT”). OIT plays a central role in providing and supporting the information technology resources necessary to execute NIH’s critical health missions.

    “With our unique position at the intersection of scientific research and advanced technology, DLH remains a natural partner for innovation alongside the National Institutes of Health,” said Zach Parker, DLH President and CEO. “DLH engineers, application developers, and IT will continue to bring their industry-leading information technology, systems integration, and customer support expertise to provide crucial support for this customer while also asked to conduct technology assessments and impact strategic modernization plans.”

    This $46.9 million task order includes a base period and multiple options aggregating to a three-year period of performance. Through this award, DLH will leverage a comprehensive suite of digital transformation and cyber security solutions to support approximately 7,000 end-customers. As part of this new effort, DLH will design and implement a cloud migration strategy built on partnerships with leading commercial CSP vendors including Azure, AWS, and Google.

    “DLH will continue to test, validate, refine, and incubate bold new ideas and innovation on behalf of the vital work our customers carry out,” said Diane Yarnell, President, Health IT. “Our experts deliver full project management life-cycle solutions to modernize IT, improve the customer experience and business processes, optimize systems, train personnel, and integrate emerging technologies such as artificial intelligence.”

    About DLH

    DLH (NASDAQ: DLHC) enhances technology, public health, and cyber security readiness missions through science, technology, cyber, and engineering solutions and services. Our experts solve some of the most complex and critical missions faced by customers today, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,400 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of technology, innovation, and world-class expertise, to improve lives across the globe. For more information, visit www.DLHcorp.com.

    Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

    This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH`s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2024 as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

    Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

    CONTACTS:
    INVESTOR RELATIONS
    Contact: Chris Witty
    Phone: 646-438-9385
    Email: cwitty@darrowir.com

    Release – Hemisphere Energy Announces 2025 Second Quarter Results, Declares Quarterly Dividend, and Provides Operations Update

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on HMENF

    August 14, 2025 8:00 AM EDT | Source: Hemisphere Energy Corporation

    Vancouver, British Columbia–(Newsfile Corp. – August 14, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) provides its financial and operating results for the second quarter ended June 30, 2025, declares a quarterly dividend payment to shareholders, and provides operations update.

    Q2 2025 Highlights

    • Attained quarterly production of 3,826 boe/d (99% heavy oil).
    • Generated $24.4 million, or $70.06/boe, in revenue.
    • Achieved total operating and transportation costs of $14.18/boe.
    • Delivered an operating field netback1 of $14.9 million, or $42.77/boe.
    • Realized quarterly adjusted funds flow from operations (“AFF”)1 of $10.3 million, or $29.47/boe.
    • Executed a $2.2 million capital expenditure1 program, including preparatory spending for Hemisphere’s upcoming drilling program.
    • Generated free funds flow1 of $8.1 million, or $0.07/share.
    • Distributed $2.4 million, or $0.025/share, in base dividends to shareholders during the quarter.
    • Distributed $2.9 million, or $0.03/share, in special dividends to shareholders during the quarter.
    • Purchased and cancelled 1.3 million shares for $2.3 million under the Company’s Normal Course Issuer Bid (“NCIB”).
    • Renewed the Company’s $35 million two-year extendible credit facility.
    • Exited the first quarter with positive working capital1 of $13.9 million.
    (1) Operating field netback, adjusted funds flow from operations (AFF), free funds flow, capital expenditure, and working capital are non-IFRS measures, or when expressed on a per share or boe basis, non-IFRS ratio, that do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other entities. Non-IFRS financial measures and ratios are not standardized financial measures under IFRS and may not be comparable to similar financial measures disclosed by other issuers. Refer to the section “Non-IFRS and Other Specified Financial Measures”.

    Selected financial and operational highlights should be read in conjunction with Hemisphere’s unaudited condensed interim consolidated financial statements and related notes, and the Management’s Discussion and Analysis for the three months ended June 30, 2025 which are available on SEDAR+ at www.sedarplus.ca and on Hemisphere’s website at www.hemisphereenergy.ca. All amounts are expressed in Canadian dollars unless otherwise noted.

    Quarterly Dividend

    Hemisphere is pleased to announce that its Board of Directors has approved a quarterly base cash dividend of $0.025 per common share in accordance with the Company’s dividend policy. The dividend will be paid on September 12, 2025 to shareholders of record as of the close of business on August 29, 2025. The dividend is designated as an eligible dividend for income tax purposes.

    Operations Update

    With significant volatility in the economy and oil markets earlier this year, Hemisphere elected to defer the majority of its capital spending into the latter third of the year. With relatively flat base production, the Company has focused on balance sheet strength and shareholder returns through its share buyback program, base quarterly dividends, and the announcements of two special dividends year-to-date.

    The Company’s drilling program is now scheduled to commence late in the third quarter. It will include several development wells in Atlee Buffalo in addition to at least one new well in Marsden, which will test a second oil-bearing zone on Hemisphere’s lands adjacent to its oil treating facilities and active polymer pilot project.

    Management will continue to closely monitor oil market volatility and adjust capital spending accordingly. With almost $14 million in working capital, an undrawn credit line, and stable cash flow from its production base, Hemisphere is in a unique position to act on potential acquisition opportunities and continued shareholder returns in addition to executing its drilling program.

    EnerCom Denver Conference

    Ms. Ashley Ramsden-Wood, Chief Development Officer of Hemisphere, will be presenting at the EnerCom Denver Conference on Tuesday, August 19 at 2:45 pm Mountain Daylight Time (1:45 pm Pacific Daylight Time). The presentation will be livestreamed on EnerCom’s website at www.enercomdenver.com/webcast (Confluence C) and archived on Hemisphere’s website at www.hemisphereenergy.ca.

    About Hemisphere Energy Corporation

    Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood enhanced oil recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.

    For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:

    Don Simmons, President & Chief Executive Officer
    Telephone: (604) 685-9255
    Email: info@hemisphereenergy.ca

    Website: www.hemisphereenergy.ca

    Forward-looking Statements

    Certain statements included in this news release constitute forward-looking statements or forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “anticipate”, “continue”, “estimate”, “expect”, “forecast”, “may”, “will”, “project”, “could”, “plan”, “intend”, “should”, “believe”, “outlook”, “potential”, “target” and similar words suggesting future events or future performance. In particular, but without limiting the generality of the foregoing, this news release includes forward-looking statements including that Hemisphere’s drilling program is now scheduled to commence late in the third quarter and will include several development wells in Atlee Buffalo in addition to at least one new well in Marsden, which will test a second oil-bearing zone on Hemisphere’s lands; that Hemisphere may adjust capital spending depending on oil market volatility; that Hemisphere is in a unique position to act on potential acquisition opportunities and continued shareholder returns; and that a dividend will be paid September 12, 2025 to shareholders of record as of the close of business on August 29, 2025.

    Forward‐looking statements are based on a number of material factors, expectations or assumptions of Hemisphere which have been used to develop such statements and information but which may prove to be incorrect. Although Hemisphere believes that the expectations reflected in such forward‐looking statements or information are reasonable, undue reliance should not be placed on forward‐looking statements because Hemisphere can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the current and go-forward oil price environment; that Hemisphere will continue to conduct its operations in a manner consistent with past operations; that results from drilling and development activities are consistent with past operations; the quality of the reservoirs in which Hemisphere operates and continued performance from existing wells; the continued and timely development of infrastructure in areas of new production; the accuracy of the estimates of Hemisphere’s reserve volumes; certain commodity price and other cost assumptions; continued availability of debt and equity financing and cash flow to fund Hemisphere’s current and future plans and expenditures; the impact of increasing competition; the general stability of the economic and political environment in which Hemisphere operates; the general continuance of current industry conditions; the timely receipt of any required regulatory approvals; the ability of Hemisphere to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which Hemisphere has an interest in to operate the field in a safe, efficient and effective manner; the ability of Hemisphere to obtain financing on acceptable terms; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and expansion and the ability of Hemisphere to secure adequate product transportation; future commodity prices; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which Hemisphere operates; and the ability of Hemisphere to successfully market its oil and natural gas products.

    The forward‐looking statements included in this news release are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward‐looking statements including, without limitation: changes in commodity prices; changes in the demand for or supply of Hemisphere’s products, the early stage of development of some of the evaluated areas and zones; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans of Hemisphere or by third party operators of Hemisphere’s properties, increased debt levels or debt service requirements; inaccurate estimation of Hemisphere’s oil and gas reserve volumes; limited, unfavourable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time‐to‐time in Hemisphere’s public disclosure documents, (including, without limitation, those risks identified in this news release and in Hemisphere’s Annual Information Form).

    The forward‐looking statements contained in this news release speak only as of the date of this news release, and Hemisphere does not assume any obligation to publicly update or revise any of the included forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.

    View full release here.

    Release – CoreCivic Announces New Contract Award To Resume Operations At West Tennessee Detention Facility

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CXW

    August 14, 2025

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    BRENTWOOD, Tenn., Aug. 14, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has been awarded a new contract under an intergovernmental services agreement (IGSA) between the City of Mason, Tennessee, and U.S. Immigration and Customs Enforcement (ICE) to resume operations at the Company’s 600-bed West Tennessee Detention Facility, a facility that has been idle since September 2021.

    The IGSA expires in August 2030 and may be further extended through bilateral modification. The agreement provides for a fixed monthly payment plus an incremental per diem payment based on detainee populations. Total annual revenue once the facility is fully activated is expected to be approximately $30 million to $35 million, with margins consistent with the CoreCivic Safety segment. We expect this award to have a minimal impact on earnings in the third quarter of 2025, and accretive to earnings beginning in the fourth quarter of 2025, with full ramp currently expected to be complete by the end of the first quarter of 2026.

    Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “We are grateful for the trust our government partner has placed in us in reactivating the West Tennessee Detention Facility. Including the West Tennessee Detention Facility, we have reactivated four previously idle facilities aggregating approximately 6,600 beds, and made available to ICE over 1,000 additional detention beds through four contract modifications announced earlier this year, providing the agency with over 7,600 beds to help the agency meet its growing needs.”

    Patrick D. Swindle, CoreCivic’s President and Chief Operating Offer added, “We are also grateful for the cooperation the City of Mason has provided in quickly working to expedite the reactivation of the facility. When fully activated, we expect to add well over 200 jobs to the local community, and we look forward to working with the City under this new relationship.”

    About CoreCivic

    CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest operators of such facilities in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release includes statements as to our beliefs and expectations of the outcome of future events that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.

    Contact:  Investors: Jeb Bachmann – Managing Director, Investor Relations – (615) 263-3024
    Media: Steve Owen – Vice President, Communications – (615) 263-3107

    Release – Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

    Posted on by aweinsoff@channelchek.com

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    August 14, 2025

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    • Favorable CDI-988 Phase 1 safety and tolerability reported
    • Challenge study with CDI-988 as a norovirus preventive and treatment planned later this year

    BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

    “Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, oral antiviral candidate CDI-988 as a prophylaxis and treatment,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are encouraged by the favorable safety and tolerability results from our Phase 1 study with CDI-988. This novel protease inhibitor has the potential to transform how we manage this highly contagious virus, which spreads rapidly in military facilities, cruise ships, nursing homes, hospitals and other confined environments. As a prophylactic treatment, CDI-988 could potentially prevent rapid spread of norovirus outbreaks in close quarters.

    “We developed CDI-988 for the treatment of norovirus and coronavirus infections using our proprietary structure-based drug discovery platform technology. We are encouraged by our recent in vitro data demonstrating CDI-988 inhibits newly re-emerging norovirus GII.17 strains that are responsible for the 2024-2025 norovirus outbreaks,” added Dr. Lee.

    “The absence of any approved norovirus treatments or vaccines creates a substantial market opportunity for Cocrystal,” said James Martin, Cocrystal’s CFO and co-CEO. “With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most pressing unmet needs.”

    Antiviral Product Pipeline Overview

    We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

    Influenza Programs
    Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance.

    Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. About 8 percent of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year.

    • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
      • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
      • In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 study.
      • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
      • In May 2024 we completed enrollment in the Phase 2a human challenge study.
      • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
      • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
      • In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain.
    • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
      • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
      • Dry powder inhalation formulation development and toxicology studies have been completed.
    • Influenza A/B program
      • Our efforts to develop a preclinical lead of novel influenza replication inhibitors for pandemic and season influenza are ongoing.

    Norovirus Program
    Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

    In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

    • Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
      • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential treatment for noroviruses and coronaviruses.
      • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
      • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of CDI-988 in healthy subjects.
      • In August 2023 we announced our selection of CDI-988 as our lead compound for the treatment for noroviruses, in addition to coronaviruses.
      • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
      • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
      • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe in 2024-2025.
      • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS).
      • We plan to initiate a human challenge Phase 1b study in the U.S. in 2025 to evaluate CDI-988 as a norovirus prophylaxis and treatment.

    SARS-CoV-2 and Other Coronavirus Program
    By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.

    • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
      • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
      • In September 2023 we dosed the first healthy subject in our norovirus/coronavirus CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
      • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
      • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
      • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the MHSRS.

    Second Quarter Financial Results

    Research and development (R&D) expenses for the second quarter of 2025 were $1.1 million, compared with $4.3 million for the second quarter of 2024, with the decrease primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for the second quarter of 2025 were $1.0 million, compared with $1.1 million for the second quarter of 2024, with the decrease primarily due to a reduction in salaries and wages.

    Net loss for the second quarter of 2025 was $2.1 million, or $0.20 per share, compared with net loss for the second quarter of 2024 of $5.3 million, or $0.53 per share.  

    Six Months Financial Results

    R&D expenses for the first six months of 2025 were $2.5 million, compared with $7.3 million for the first six months of 2024. G&A expenses for the first half of 2025 were $2.0 million, compared with $2.3 million for the first half of 2024.

    Net loss for the first six months of 2025 was $4.4 million, or $0.43 per share, compared with a net loss for the first six months of 2024 of $9.3 million, or $0.91 per share.

    Cocrystal reported unrestricted cash as of June 30, 2025 of $4.8 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first six months of 2025 was $5.1 million, compared with $8.2 million for the first six months of 2024. The Company had working capital of $4.9 million and 10.2 million common shares outstanding as of June 30, 2025.  

    About Cocrystal Pharma, Inc.

    Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human Phase 1b challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

    Investor Contact:
    Alliance Advisors IR
    Jody Cain
    310-691-7100
    jcain@allianceadvisors.com

    View full release here.

    Release – V2X Appoints Retired Brigadier General Stan Budraitis as Vice President, Business Development – Army Aviation Programs

    Posted on by aweinsoff@channelchek.com
    V2X (PRNewsfoto/V2X, Inc.)

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    August 14, 2025

    MCLEAN, Va., Aug. 14, 2025 /PRNewswire/ — V2X (NYSE: VVX), today announced the appointment of Stan Budraitis as Vice President, Business Development – Army Aviation Programs. Budraitis joins V2X following a distinguished 35-year career as a U.S. Army Aviator, retiring in April 2023 as a Brigadier General.

    Most recently, Budraitis served as the Deputy Commanding General at the U.S. Army Aviation Center of Excellence and Commandant of the Aviation School at Fort Rucker, Alabama. Throughout his career, he held key leadership and operational roles across Army aviation, including multiple command assignments and two overseas deployments to Afghanistan and Kuwait. He is a Master Army Aviator with over 2,000 flight hours in rotary-wing aircraft, including the UH-1, OH-58, and UH-60.

    “Stan’s deep operational experience and strategic insight into Army aviation make him an outstanding addition to the V2X team,” said L. Roger Mason, Chief Growth Officer of V2X. “His leadership will be instrumental in advancing our support for Army aviation customers and expanding our mission-critical capabilities as we pursue new opportunities.”

    Budraitis holds a bachelor’s degree in Business Administration from William Carey University and a master’s degree in Strategic Studies from the U.S. Army War College. His military decorations include the Bronze Star Medal (with Oak Leaf Cluster), the Meritorious Service Medal (with four Oak Leaf Clusters), and the Master Army Aviator Badge.

    About V2X
    V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

    Investor Contact
    Mike Smith, CFA
    Vice President, Treasury, Corporate Development and Investor Relations
    IR@goV2X.com
    719-637-5773

    Media Contact
    Angelica Spanos Deoudes
    Director, Corporate Communications
    Angelica.Deoudes@oV2X.com
    571-338-5195

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    SOURCE V2X, Inc.