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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.)

Research News and Market Data on VVX

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.

Release – Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

August 14, 2025 7:00am EDT Download as PDF

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– Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC)

– OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden

– Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026

LOS ALTOS, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2025, and provided a business update.

“Our team has made great progress in the second quarter, and we have requested a Type A meeting with the FDA to resolve the CRL and obtain regulatory approval. We believe we have built multiple approaches to correct the deficiency noted for our third-party manufacturing vendor, which was unrelated to OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Meanwhile, the recently published pivotal trial data in CJASN continue to highlight OLC’s best-in-class potential. Given the high rates of patient non-compliance with existing phosphate lowering therapies, we remain fully committed to meeting this clear need for improved treatment options for managing hyperphosphatemia in dialysis patients.”

Key Highlights & Upcoming Milestones

  • Unicycive has requested a Type A meeting with the FDA to discuss resolution of the CRL received in June in regard to its New Drug Application for OLC. Typically, Type A meetings are granted by the FDA within 30 days of the request. The Company plans to provide an investor update in the third quarter once it has received the FDA’s written feedback.
  • In July, the Company announced the publication of pivotal clinical study data describing the safety and tolerability of OLC in CKD patients on dialysis in CJASN. Data demonstrated that OLC was well tolerated, with over 90% of patients achieving effective phosphate control with most individuals needing no more than one tablet per meal.

Financial Results for the Quarter Ended June 30, 2025

Research and Development (R&D) expenses were $1.8 million for the three months ended June 30, 2025, compared to $4.9 million for the three months ended June 30, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs.

General and Administrative (G&A) expenses were $5.2 million for the three months ended June 30, 2025, compared to $2.5 million for the three months ended June 30, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation.

Other income was $0.5 million for the three months ended June 30, 2025, compared to other income of $17.3 million for the three months ended June 30, 2024, primarily due to the change in fair value of our warrant liability.

Net loss attributable to common stockholders for the three months ended June 30, 2025, was $6.4 million, compared to net income attributable to common stockholders of $3.0 million for the three months ended June 30, 2024. The increased net loss for the three-month period ended June 30, 2025 was primarily due to the change in fair value of our warrant liability.

As of June 30, 2025, cash and cash equivalents totaled $22.3 million. The Company believes that it has sufficient resources to fund operations into the second half of 2026.

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 agent 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 about Unicycive, 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; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. 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.

View full release here.

Producer Prices Jump Most in 3 Years: Complicates Fed’s Rate Cut Timeline

Posted on by slightbourne@noblecapitalmarkets.com

The Federal Reserve’s carefully orchestrated path toward interest rate cuts hit an unexpected roadblock Thursday as producer price data revealed the most significant inflationary surge in over three years, casting doubt on the central bank’s timeline for monetary easing.

The Producer Price Index (PPI) jumped 0.9% in July, dramatically exceeding economists’ expectations of just 0.2% and marking the sharpest monthly increase since early 2022. This surge pushed annual producer inflation to 3.3%, the highest level since February and a stark reminder that the battle against rising prices remains far from over.

More concerning for policymakers was the performance of core producer prices, which strip out volatile food and energy costs to provide a clearer picture of underlying inflation trends. These prices rose 0.6% monthly, representing the largest increase since March 2022 and a significant acceleration from June’s flat reading. The annual core rate also hit 3.3%, matching February’s peak.

The timing of this inflation shock couldn’t be more problematic for the Federal Reserve. Just days after consumer price data showed inflation pressures remaining stubbornly above the Fed’s 2% target, producer prices have delivered another unwelcome surprise. Markets, which had priced in a virtual certainty of rate cuts beginning in September, are now recalibrating their expectations.

This producer price acceleration tells a troubling story about cost pressures flowing through the economy. Unlike consumer prices, which measure what households pay, producer prices capture the costs businesses face when purchasing goods and services. When these prices rise rapidly, companies face a critical decision: absorb the higher costs and accept reduced profit margins, or pass them along to consumers through higher retail prices.

Recent evidence suggests businesses are increasingly choosing the latter option. Economists point to growing margin pressures from tariffs on imported goods as a key driver behind this trend. Analysis from Nationwide indicates that while companies initially absorbed most tariff-related cost increases, margins are becoming increasingly strained by higher costs for imported goods, leading to expectations of stronger price pass-through to consumers in coming months.

The mechanics behind July’s surge reveal interesting dynamics within the economy. Analysis from Capital Economics highlighted an unusual increase in margins for wholesalers and retailers, suggesting that some of the price increases reflect strategic business decisions rather than pure cost pressures. This margin expansion indicates companies may be regaining pricing power after years of competitive pressure.

Financial markets reacted swiftly to the news, with stock indices declining as investors grappled with the implications for Federal Reserve policy. The probability of a September rate cut, which stood at 100% just Wednesday, dropped to approximately 95% following the release, while expectations for a larger 0.5% cut nearly evaporated entirely.

The producer price shock arrives at a particularly sensitive moment for Federal Reserve Chair Jerome Powell, who is scheduled to address the Jackson Hole Economic Symposium on August 22. This highly anticipated speech was expected to lay the groundwork for the Fed’s transition from restrictive monetary policy to a more accommodative stance. However, the recent inflation data complicates that narrative considerably.

For consumers already feeling the squeeze from elevated prices, the producer price surge offers little comfort. With businesses facing higher input costs and showing increased willingness to pass these expenses along, household budgets may face additional pressure in the months ahead. The disconnect between the Fed’s 2% inflation target and current price trends suggests that relief for American families remains elusive.

The path forward for monetary policy now appears more uncertain than at any point in recent months. While labor market softening and economic growth concerns continue to build the case for rate cuts, persistent inflation pressures argue for maintaining restrictive policies longer. Powell and his colleagues face the challenging task of balancing these competing forces while maintaining credibility in their inflation-fighting mission.

As markets await Powell’s Jackson Hole remarks, one thing has become clear: the Federal Reserve’s policy decisions will require careful calibration as conflicting economic signals continue to complicate the monetary policy landscape.

The Oncology Institute, Inc. (TOI) – Patient Additions And Pharmacy Division Drive 2Q25 Revenues Above Expectations

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, August 14, 2025

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Revenues Were Driven By New Patients Under Contract. The Oncology Institute reported a loss for 2Q25 of $17.0 million or $(0.15) per share. Revenues of $119.8 million exceeded our estimate of $110.4 million. The company discussed newly active or pending contracts that will add covered lives during 2H25. It reiterated its guidance for Revenues, Gross Profit, Adjusted EBITDA, and Free Cash Flow. Cash on June 30, 2025 was $30.3 million.

Patient Services Were Close To Our Expectations. The Patient Services division reached $55.9 million. New payor contracts added patients during 1H25 that began generating revenues, although they have a period of higher cost during the transition to TOI management. We expect the patient mix to include more continuing patients during 2H25, improving margins while new contracts continue to drive growth.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

SKYX Platforms (SKYX) – Revised Forecasts Reflect Phased Rollout, Long-Term Outlook Intact

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, August 14, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q2 results. SKYX reported Q2 revenue of $23.1 million, up 7.5% year over year and 14.7% sequentially. Gross margin expanded 190bps to 30.3%, supported by a favorable mix shift toward proprietary tech-embedded products. The adj. EBITDA loss of $2.6 million was slightly wider than our forecast of a $2.3 million loss but reflects underlying operating leverage as revenue scales.

Smart City partnership reinforces revenue growth trajectory. The company’s partnership with the $3 billion Smart City development in Miami’s Little River District positions it for sustained long-term growth. We expect the rollout to drive meaningful topline and branding impact over time, with strategic visibility among large-scale developers likely to reinforce future adoption of SKYX’s technology in both residential and commercial verticals.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Bitcoin Tumbles on Hot Inflation Data

Posted on by slightbourne@noblecapitalmarkets.com

Bitcoin’s remarkable ascent to record highs came to an abrupt halt Thursday as inflation concerns and policy clarity sent the cryptocurrency tumbling more than 3% from its peak above $123,500.

The selloff began after July’s producer price data showed a shocking 0.9% monthly increase versus expectations of just 0.2%, immediately cooling market expectations for aggressive Federal Reserve rate cuts. The inflation surprise highlighted bitcoin’s sensitivity to monetary policy shifts and broader economic conditions.

Adding pressure were comments from Treasury Secretary Scott Bessent clarifying the government’s approach to bitcoin reserves. While acknowledging the US holds $15-20 billion worth of bitcoin, Bessent stated the government won’t actively purchase cryptocurrency for strategic reserves, instead relying on asset seizures and confiscations for any growth.

This dual blow highlighted bitcoin’s vulnerability to both policy uncertainty and macroeconomic headwinds, demonstrating how quickly bullish narratives can shift.

The broader cryptocurrency market suffered alongside bitcoin, with Ethereum falling 3.6% and MicroStrategy dropping over 4%. The selloff underscored how crypto assets remain closely tied to traditional financial market dynamics despite their decentralized nature.

Bitcoin’s recent surge had been fueled by corporate treasury adoption, following MicroStrategy’s strategy of adding bitcoin to balance sheets. Spot bitcoin ETF inflows and the Trump administration’s pro-crypto stance, including executive orders exploring cryptocurrency in 401(k) plans, had provided additional momentum.

However, Thursday’s action reminded investors that bitcoin’s correlation with traditional risk assets strengthens during uncertainty periods. As investors reassessed Fed policy prospects amid persistent inflation, they simultaneously reduced appetite for speculative investments.

The inflation data’s impact highlights bitcoin’s evolution from purely speculative asset to one increasingly influenced by mainstream financial conditions. Higher producer prices suggest inflationary pressures may persist, potentially keeping monetary policy restrictive longer than anticipated.

For bitcoin investors, the environment presents competing forces. While long-term structural support remains through corporate adoption and regulatory clarity, near-term price action appears tied to economic conditions and policy developments. Bitcoin’s ability to maintain recent gains may depend on inflation trends and Fed policy decisions.

Despite Thursday’s pullback, fundamental drivers supporting bitcoin’s longer-term outlook remain intact. Corporate demand continues, regulatory frameworks are clarifying, and institutional infrastructure keeps expanding. However, the day’s events showed that even bullish crypto narratives remain subject to monetary policy and economic realities.

Trading around $118,400 after the decline, bitcoin’s next move likely depends on whether inflation pressures build or moderate, directly influencing both monetary policy expectations and risk asset appetite. The intersection of traditional monetary policy and cryptocurrency markets has never been clearer, suggesting bitcoin’s path forward will remain closely tied to broader economic conditions.

Gildan and HanesBrands Join Forces to Create a Global Powerhouse in Basic Apparel

Posted on by slightbourne@noblecapitalmarkets.com

In a landmark deal set to reshape the global apparel industry, Gildan Activewear Inc. and HanesBrands Inc. have agreed to merge, forming one of the largest basic apparel companies in the world. The agreement, announced August 13, 2025, combines two industry leaders with complementary strengths, aiming to expand market reach, enhance manufacturing efficiency, and unlock significant cost savings.

The transaction values HanesBrands at approximately $2.2 billion in equity and $4.4 billion in enterprise value. Upon completion, HanesBrands shareholders will own about 19.9% of the combined company. The deal is expected to close in late 2025 or early 2026, pending shareholder and regulatory approvals.

The merger will give Gildan access to HanesBrands’ iconic innerwear labels such as Hanes, Playtex, and Maidenform, while strengthening its retail penetration for its own activewear brands. The companies plan to leverage their combined strengths to expand sales across multiple channels and geographies.

Gildan’s vertically integrated, low-cost manufacturing network is a core advantage in the deal. By combining operations, the new entity expects to realize at least $200 million in annual cost synergies within three years—$50 million in 2026, $100 million in 2027, and another $50 million in 2028. These savings will come from streamlining supply chains, consolidating production, and reducing overlapping expenses.

From day one, the transaction is expected to boost Gildan’s adjusted diluted earnings per share, with projected growth of over 20% once full synergies are achieved. The combined entity’s adjusted EBITDA would have been approximately $1.6 billion for the 12 months ending June 29, 2025.

With greater scale, a broader product range, and enhanced brand strength, the merged company is positioned to better withstand seasonal and economic fluctuations. By blending HanesBrands’ strong retail presence with Gildan’s manufacturing efficiency, the partnership aims to offer greater value to both customers and shareholders.

The combined company will remain headquartered in Montréal, Québec, while maintaining a strong presence in Winston-Salem, North Carolina, preserving HanesBrands’ historical roots. Additionally, Gildan plans to review strategic alternatives for HanesBrands Australia, which could include a sale or other restructuring.

Looking ahead, Gildan projects net sales growth of 3–5% annually from 2026 to 2028, with capital expenditures of 3–4% of sales to support growth and integration. The company intends to resume share buybacks once its leverage ratio returns to target levels.

If successful, the merger will create a dominant player in the basic apparel space, offering a more diversified product portfolio, expanded global reach, and a more resilient supply chain. For both brands, this union marks a significant step toward shaping the future of affordable, high-quality apparel worldwide.

Release – Alliance Resource Partners, L.P. Announces the Promotion of Jesse M. Parrish to Sr. Vice President and Chief Commercial Officer of Alliance Coal, LLC

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

August 13, 2025

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) is pleased to announce the promotion of Jesse M. Parrish to Sr. Vice President and Chief Commercial Officer of ARLP’s subsidiary, Alliance Coal, LLC (“Alliance Coal”), effective immediately. In Mr. Parrish’s expanded role, he will oversee Alliance Coal’s commercial strategy including oversight of the sales, marketing, and logistics functions as well as its government relation functions. Mr. Parrish will continue to report to Joseph W. Craft III, President and Chief Executive Officer of Alliance Coal and ARLP.

Mr. Craft explained, “Jesse’s expanded role is a natural evolution of our vision for him as he assumes more of my day-to-day responsibilities allowing me more time to focus on strategic growth opportunities for ARLP. President Trump has declared his administration will do whatever it takes to ensure that the United States can build and maintain the largest, most powerful and most advanced AI infrastructure anywhere on the planet. To achieve global AI dominance, America has to maintain, extend and expand the current electric generating assets and invest significantly in new generation infrastructure. ARLP’s aim is to pursue opportunities in the growing power infrastructure sector and preserve our nation’s coal fleet.”

Mr. Parrish joined Alliance Coal in April 2025 as Senior Vice President of Operations and previously spent over a decade in different senior capacities in the eastern U.S. coal industry. Timothy J. Whelan’s role as Sr. Vice President of Sales and Marketing, will remain unchanged, and he and his team remain the primary contact for Alliance Coal’s customers and other commercial partners.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the second largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is positioning itself as a reliable energy partner for the future by pursuing opportunities that support the growth and development of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

The Oncology Institute Reports Second Quarter 2025 Financial Results and Reaffirms Full Year 2025 Guidance

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TOI

Aug 13, 2025

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CERRITOS, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based community oncology groups in the United States, today reported financial results for its three months ended June 30, 2025.

Daniel Virnich, CEO of TOI, commented, “We delivered another strong quarter with over 20% year-over-year revenue growth. This was driven by exceptional performance in our pharmacy business, which grew over 40% year-over-year, as well as the addition of over 50,000 new capitated lives to our value-based business. We are also in the process of expanding our partnership into new geographic regions of Florida with a major health plan which, once finalized, will double the amount of lives we cover for this payor. The momentum we’re seeing in new contract signings, combined with continued strength in pharmacy, gives us increasing confidence that we’ll achieve revenue at the high end of our guidance range for the year and achieve Adjusted EBITDA positivity as we exit 2025.”

Recent Operational Highlights

  • Fee-for-service revenue growth of 10% over Q2 2024, driven by momentum in new markets.
  • Retail Pharmacy and Dispensary set fill records, contributing $62.6 million revenue and over $11 million in gross profit in Q2.
  • Planned expansion of existing fully delegated capitated partnership with Elevance into two new counties in Central Florida, which, if finalized, will more double the number of lives under our current relationship. Expanded capitation relationship as of July 1 with Silver Summit Health Plan in Nevada to serve all of their Medicaid patients in Clark County.
  • Welcomed Dr. Jeff Langsam as our new Chief Clinical Officer, leading our efforts around therapeutics, Utilization Management and MSO practice engagement and Kristin England as our new Chief Administrative Officer overseeing our Enterprise Central Business Operations and Technology Strategy and AI Enablement.

Second Quarter 2025 Financial Highlights

All comparisons are to the quarter ended June 30, 2024 unless otherwise noted

  • Consolidated revenue of $119.8 million increased of 21.5% from $98.6 million
  • Gross profit of $17.5 million, increased 34.4%
  • Net loss of $17.0 million compared to net loss of $15.5 million
  • Basic and diluted (loss) earnings per share of $(0.15) compared to $(0.17)
  • Adjusted EBITDA of $(4.1) million compared to $(8.7) million
  • Cash and cash equivalents of $30.3 million as of June 30, 2025

Outlook for Fiscal Year 2025

TOI uses Adjusted EBITDA and Free Cash flow, each a non-GAAP metric, as an additional tool to assess its operational and financial performance. See “Financial Information: Non-GAAP Financial Measures” below. In reliance on the unreasonable efforts exception provided under Regulation S-K, TOI is not reasonably able to provide a quantitative reconciliation for forward-looking information of Adjusted EBITDA and Free Cash Flow to net (loss) income and net cash provided by operations, respectively, the most directly comparable GAAP financial measures, without unreasonable efforts due to uncertainties regarding taxes, capital expenditures, operating activities, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized (gains) losses on investments, practice acquisition-related costs, consulting and legal fees, transaction costs and other non-cash items. The variability of these items could have an unpredictable, and potentially significant, impact on TOI’s future GAAP financial results. Nevertheless TOI reaffirms its full year 2025 guidance:

2025 Guidance
Revenue$460 to $480 million
Gross Profit$73 to $82 million
Adjusted EBITDA$(8) to $(17) million
Free Cash Flow$(12) to $(21) million


The Company, given the revenue growth in the first half of the year, currently believes it can reach the higher-end of the revenue guidance range for 2025. Additionally, the Company expects Adjusted EBITDA of approximately $(2.5) to $(3.5) million in the third quarter of 2025. TOI’s achievement of the anticipated results is subject to risks and uncertainties, including those disclosed in its filings with the U.S. Securities and Exchange Commission. The outlook does not take into account the impact of any unanticipated developments in the business or changes in the operating environment, nor does it take into account the impact of TOI’s acquisitions, dispositions or financings. TOI’s outlook assumes a largely open global market, which would likely be negatively impacted if recent tariff rate increases and exchange rate changes persist and adversely affect world trade.

Webcast and Conference Call

TOI will host a conference call on Wednesday, August 13, 2025 at 5:00 p.m. (Eastern Time) to discuss second quarter results and management’s outlook for future financial and operational performance.

The conference call can be accessed live over the phone by dialing 1-877-407-0789, or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13754165. The replay will be available until Wednesday, August 20, 2025.

Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of TOI’s website at https://investors.theoncologyinstitute.com.

About The Oncology Institute, Inc.

Founded in 2007, The Oncology Institute, Inc. (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. For more information visit www.theoncologyinstitute.com.

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “preliminary,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “predict,” “potential,” “guidance,” “approximately,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding projections, anticipated financial results, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations. These statements are based on various assumptions and on the current expectations of TOI and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by anyone as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of TOI. These forward-looking statements are subject to a number of risks and uncertainties, including the accuracy of the assumptions underlying the 2025 full fiscal year outlook and the Q3 2025 outlook with respect to Adjusted EBITDA discussed herein, the outcome of judicial and administrative proceedings to which TOI may become a party or investigations to which TOI may become or is subject that could interrupt or limit TOI’s operations, result in adverse judgments, settlements or fines and create negative publicity; changes in TOI’s patient or payors’ preferences, prospects and the competitive conditions prevailing in the healthcare sector; failure to continue to meet stock exchange listing standards; the impact of COVID-19 on TOI’s business; those factors discussed in the documents of TOI filed, or to be filed, with the SEC, including the Item 1A. “Risk Factors” section of TOI’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 26, 2025 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that TOI currently is evaluating or does not presently know or that TOI currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect TOI’s plans or forecasts of future events and views as of the date of this press release. TOI anticipates that subsequent events and developments will cause TOI’s assessments to change. TOI does not undertake any obligation to update any of these forward-looking statements. These forward-looking statements should not be relied upon as representing TOI’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Financial Information; Non-GAAP Financial Measures

Some of the financial information and data contained in this press release, such as Adjusted EBITDA and Free Cash Flow, have not been prepared in accordance with United States generally accepted accounting principles (“GAAP”). TOI’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies. The presentation of non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial measures determined in accordance with GAAP. Because of the limitations of non-GAAP financial measures, you should consider the non-GAAP financial measures presented in this press release in conjunction with TOI’s financial statements and the related notes thereto.

TOI believes that the use of Free Cash Flow provides an additional tool to assess the Company’s financial performance, evaluate its ability to generate cash from operations, and plan for future investments and obligations. Free Cash Flow is useful in understanding the cash available for strategic initiatives. It also helps in comparing TOI’s financial performance with other similar companies, many of which use similar non-GAAP financial measures to provide insights into their cash generation capabilities. However, the principal limitation of Free Cash Flow is that it does not account for certain cash outflows or inflows that are required by GAAP to be recorded in TOI’s financial statements. TOI defines Free Cash Flow as net cash flow provided by (used in) operations plus cash paid for interest, less capital expenditures.

TOI believes that the use of Adjusted EBITDA provides an additional tool to assess our operations and results of our performance, to plan and forecast future periods, and factors and trends in, and in comparing our financial measures with, other similar companies, many of which present similar non-GAAP financial measures to investors. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recorded in TOI’s financial statements.

TOI defines Adjusted EBITDA as net (loss) income plus depreciation, amortization, interest, taxes, non-cash items, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized gains or losses on investments and other adjustments to add-back the following: consulting and legal fees related to acquisitions, one-time consulting and legal fees related to certain advisory projects, software implementations and debt or equity financings, severance expense and temporary labor and recruiting charges to build out our corporate infrastructure.

View full release here.

Release – MAIA Biotechnology Granted European Patent for Next Generation Telomere-Targeting Agents for Cancer Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

August 13, 2025 9:01am EDT Download as PDF

Cancer-fighting immunosuppressive agents shown to disrupt telomeres and suspend growth of cancer cells 

CHICAGO , Aug. 13, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the European Patent Office has decided to grant a patent broadly covering a portfolio of ateganosine-based analogues for telomere-targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint inhibitors (CPIs). The patent, titled “Mercaptopurine Ribonucleoside Analogues for Altering Telomerase Mediated Telomere,” was invented by MAIA’s Chief Scientific Officer Sergei M. Gryaznov, PhD and Scientific Advisory Board member Jerry W. Shay, PhD.

“Mercaptopurine nucleoside analogues are cancer-fighting immunosuppressive agents that disrupt the structure and function of telomeres and reduce immune system activity, interfering with the growth of cancer cells and causing programmed cancer cell death. As an important extension of MAIA’s innovative cancer treatment platform, these new compounds are key next-generation telomere-targeting agents with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” said Dr. Gryaznov.

“The new IP is expected to further secure and expand the value of our first-in-class telomere-targeting compounds across the European scientific community,” added MAIA Chairman and CEO Vlad Vitoc, M.D.

MAIA’s global patent and patent-pending estate covers several areas including telomerase mediated telomere altering compounds and treatment of therapy-resistant cancers. Further, ateganosine’s immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors, has been filed worldwide. MAIA’s IP portfolio for ateganosine currently comprises 10 issued patents worldwide including Europe (validated in 19 countries) along with 24 pending patent applications.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released August 13, 2025

Release – U.S. District Court Dismisses Class Action Lawsuit Against Direct Digital Holdings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

August 13, 2025 8:30 am EDT Download as PDF

HOUSTON, Aug. 13, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), has been granted a motion to dismiss a shareholder class action lawsuit by the U.S. District Court, Southern District of Texas, Houston Division, subject to potential appeal. 

The lawsuit alleged false and misleading disclosures made by the Company in its public filings. After reviewing the statements offered by the plaintiff, the Court ruled “…none of the statements constitute either materially false statements or omissions that would lead a rational investor to rely on them.”  

Keith Smith, President of Direct Digital Holdings, commented, “We appreciate the Court’s thoughtful consideration and ultimate conclusion in the dismissal of this case.”

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).

The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.

Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: ability to service debt or dividend payment obligations; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; costs, risks and uncertainties related to restatement of certain prior period financial statements; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; the appeals process in any litigation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.

Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.

At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”

Contacts:

Investors:
IMS Investor Relations
Walter Frank/Jennifer Belodeau
(203) 972-9200
investors@directdigitalholdings.com

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

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SOURCE Direct Digital Holdings

Released August 13, 2025

Release – Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 13, 2025

PDF Version

MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).

EMA provided this opinion based on safety and tolerability that OCU410ST demonstrated in the Phase 1 GARDian trial, including 48% slower lesion growth and statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up in evaluable treated eyes compared to untreated eyes. The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The unique adaptive design of this trial includes a masked interim analysis of 24 subjects in the study (16 in treatment group and 8 in control group) at 8 months. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the Company’s planned Biologics License Application (BLA) and MAA in the EU.

“This positive opinion endorses a single trial as the basis for both BLA and MAA submissions and brings us closer to providing a one-time, modifier gene therapy to approximately 100,000 Stargardt patients in the U.S. and Europe combined,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We are very encouraged about the prospect of addressing the unmet medical need that exists for these patients who currently have no approved treatment options available to them.”

The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. Alignment with the EMA follows recent important milestones for the OCU410ST program, including Rare Pediatric Disease Designation (RPDD) in May, IND clearance in June, and first patient dosing in July. With enrollment scheduled to be complete in the first quarter of 2026 the Company remains on track for a BLA filing in the first half of 2027, aligned with its goal of three BLAs in the next three years.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – Comstock Prices $30 Million Upsized and Oversubscribed Public Offering of Common Stock

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

  • With the elimination of all outstanding debt and approximately $45 million in expected cash on hand, Comstock is positioned to fully fund the commercialization of its first industry-scale Comstock Metals facility and advance key development initiatives
  • Offering includes participation from fundamental institutional investors, including a long-only mutual fund, a leading alternative asset manager, several preeminent global investment managers, and existing investors

Virginia City, Nevada, August 12, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”), today announced that it has priced its previously announced underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $2.25 per share (the “Offering”). All of the shares of common stock in the offering are to be sold by Comstock. The gross proceeds to the Company from this offering are expected to be approximately $30 million before deducting underwriting discounts and commissions and other offering expenses. This Offering positions the Company to fully fund its commercialization for its industry-scale solar panel recycling facilities, each capable of recycling over 3 million panels per year, and to advance site selection and other key development initiatives.

“We are pleased to secure this level of fundamental support from leading institutional investors,” said Corrado De Gasperis, Executive Chairman and CEO of Comstock. “By eliminating all outstanding debt and fortifying our cash position, we have established an incredibly strong foundation for immediate and future growth. We believe our solar panel recycling business is uniquely positioned to accelerate commercialization of our industry-leading technologies and industry-scale recycling facilities.”

The Company intends to use the net proceeds from this offering for capital expenditures associated with commercializing its first industry scale facility for Comstock Metals, development expenses, and general corporate purposes, including the payment of existing indebtedness. The offering is expected to close on August 14, 2025, subject to customary closing conditions.

The Company has granted the underwriter a 30-day option to purchase up to an additional 2,000,000 shares of common stock to cover over-allotments, if any, at the per share public offering price, less underwriting discounts and commissions.

Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-285744) (including a base prospectus) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and declared effective on March 24, 2025. The offering is being made only by means of a preliminary prospectus supplement and a final prospectus supplement and the accompanying base prospectus that form a part of the registration statement. These documents, including the preliminary prospectus supplement relating to the offering, are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying base prospectus relating to the offering may be accessed for free on the SEC’s website at www.sec.gov or obtained by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

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.