DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Making Progress. In the third quarter, DLH effectively navigated changes in the competitive landscape and transition in the industry overall, preserving margin delivery and strong operating cash flow. Headwinds such as the transition of CMOP locations, unbundling of DOD contracts, and scope reductions as a result of government efficiency efforts all impacted the quarter.
3Q25 Results. Revenue was $83.3 million, compared to $100.7 million in the year ago quarter. We had forecasted $83 million. DLH reported adjusted EBITDA of $8.1 million, down from $10 million in 3Q24 and our $8.5 million estimate. Net income was $0.3 million, or $0.02/sh, versus $1.1 million, or $0.08/sh last year. We had projected $0.35 million, or $0.02/sh.
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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.
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.
Phase 1b Kidney Transplant Data Presented. Eledon presented data from its Phase 1b trial using tegoprubart as part of an immunosuppressive regimen at The World Transplant Congress. The data from the first 32 patients at two dosage cohorts continues to show meaningful improvement over the standard of care. We believe this supports our expectations for strong data for the Phase 2 BESTOW trial in November.
Study Design. The presentation included data from 32 patients receiving kidney transplants followed by an immunosuppressive regimen tegoprubart instead of tacrolimus, the standard of care. The primary endpoints are safety and pharmacokinetics. Secondary endpoints include patient survival, graft survival, biopsy proven acute rejection, with kidney function measured by eGFR and iBOX score.
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.
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.
Cadrenal Announces New Trial Design. Cadrenal announced that it plans to begin a trial testing tecarfarin in patients who are starting renal dialysis, both with and without atrial fibrillation (ESKD-Afib). This design reflects recent studies showing that the first several months after starting dialysis are an ultra-high risk period for mortality and cardiac events. The trial will test tecarfarin efficacy in reducing these events and could begin in late 2025 to early 2026.
Modified Study Design Focuses On Highest Risk Period. The initiation of renal dialysis impacts several important cardiovascular and renal functions. New studies show that the first six months after starting dialysis have a 20-fold increase in cardiovascular events and mortality. This has not previously been recognized due to pathologies of the underlying conditions that lead to CKD and dialysis.
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.
NORWOOD, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading multi-state cannabis operator focused on improving lives every day, today announced its financial results for the second quarter ended June 30, 2025.
Management Commentary
“We delivered growth and expanded operations across our business during the second quarter, continuing our progress of building a leading cannabis consumer packaged goods company,” said Jon Levine, MariMed Chief Executive Officer. “Our ‘Expand the Brand’ strategy is working. Our innovative, high-quality portfolio of brands grew or maintained their market share across our core markets. We remain confident in delivering the shareholder value our investors deserve by leveraging our brands as the primary growth engine of our company. Looking ahead, we anticipate increasing product distribution through the addition of adult-use sales in Delaware, a new licensing agreement in Maine, and our recently announced entry into Pennsylvania. In addition, the strength of our balance sheet affords us optionality with respect to M&A and licensing opportunities.”
“We delivered sequential growth in both wholesale and retail revenues for the second quarter, a substantial increase in adjusted EBITDA, and we were cash flow positive,” said Mario Pinho, MariMed Chief Financial Officer. “Our performance reflects strong execution in Massachusetts, full-quarter contributions from Delaware, and a solid retail strategy. With the METRC system migration in Illinois behind us and Missouri under active review, we remain confident in the revenue catalysts we have built for the second half of the year, including adult use in Delaware, entry into Pennsylvania, and expanded wholesale.”
Financial Highlights1
The following table summarizes the Company’s consolidated financial highlights (in millions, except percentage amounts):
1 See the reconciliations of non-GAAP financial measures to the most directly comparable GAAP measures and additional information about non-GAAP measures in the section entitled “Discussion of Non-GAAP Financial Measures” below and in the financials information included herewith.
CONFERENCE CALL
MariMed management will host a conference call on Thursday, August 7, 2025 at 8:00 a.m. Eastern time, to discuss these results. The conference call may be accessed through MariMed’s Investor Relations website, or by clicking the following link: Q2 2025 MRMD Earnings Call.
SECOND QUARTER 2025 OPERATIONAL HIGHLIGHTS
During the second quarter, the Company announced the following development in the implementation of its strategic growth plan:
April 1: Launched its Nature’s Heritage™-branded cannabis flower, pre-rolls, and vapes in Illinois, marking the first time the brand’s premium products are available in the state.
April 3: Expanded the line-up of its top-selling Betty’s Eddies™-branded cannabis chews with the introduction of a new caramel chew, Betty’s Caramelt Away.
April 8: Promoted Ryan Crandall to Chief Commercial Officer to lead the Company’s commercial strategy and activities, including Sales, Marketing, Product Development, and Retail Operations. He had served as the Company’s Chief Revenue Officer since July 2022, and previously was its Chief Products Officer and SVP, Sales for four years.
May 29: Expended its branded product line-up with the introduction of MycroDose by Nature’s Heritage, a vegan pill that combines full-spectrum cannabis with the added benefits of functional mushrooms.
OTHER DEVELOPMENTS
Subsequent to the end of the second quarter, the Company announced the following further developments:
July 14: Expanded the distribution of Betty’s Eddies to Maine for both adult-use cannabis consumers and medical patients through a new licensing partnership.
July 31: Announced a Managed Services Agreement (“MSA”) to assume day-to-day management of a cultivation and processing facility in Pennsylvania owned by a division of multi-state cannabis operator TILT Holdings. In addition, a licensing agreement will enable the Company to distribute its award-winning, branded products in Pennsylvania, which is anticipated to become the next state to expand its legal cannabis program to include adult-use sales.
DISCUSSION OF NON-GAAP FINANCIAL MEASURES
MariMed’s management uses several different financial measures, both GAAP and non-GAAP, in analyzing and assessing the overall performance of its business, making operating decisions, and planning and forecasting future periods. The Company has provided in this release several non-GAAP financial measures: Non-GAAP Adjusted EBITDA and non-GAAP Adjusted EBITDA margin, Non-GAAP Gross margin, Non-GAAP Operating expenses and Non-GAAP Net income (loss), as supplements to Revenue, Gross margin, Operating expenses, Income (loss) from operations, Net income (loss) and other financial measures prepared in accordance with GAAP.
Management believes these non-GAAP financial measures are useful in reviewing and assessing the performance of the Company, and when planning and forecasting future periods, as they provide meaningful operating results by excluding the effects of expenses that are not reflective of its operating business performance. In addition, the Company’s management uses these non-GAAP financial measures to understand and compare operating results across accounting periods and for financial and operational decision-making. The presentation of these non-GAAP measures is not intended to be considered in isolation or as a substitute for the financial information prepared in accordance with GAAP.
Management believes that investors and analysts benefit from considering non-GAAP financial measures in assessing the Company’s financial results and its ongoing business, as it allows for meaningful comparisons and analysis of trends in the business. In particular, non-GAAP adjusted EBITDA is used by many investors and analysts themselves, along with other metrics, to compare financial results across accounting periods and to those of peer companies.
As there are no standardized methods of calculating non-GAAP financial measures, the Company’s calculations may differ from those used by analysts, investors and other companies, even those within the cannabis industry, and therefore may not be directly comparable to similarly titled measures used by others.
Management defines non-GAAP Adjusted EBITDA as income (loss) from operations, determined in accordance with GAAP, excluding the following items:
depreciation and amortization of property and equipment;
amortization of acquired intangible assets;
impairment or write-downs of acquired intangible assets;
inventory revaluation;
stock-based compensation;
severance;
legal settlements; and
acquisition-related and other expenses.
For further information, please refer to the publicly available financial filings available on MariMed’s Investor Relations website, as filed with the U.S. Securities and Exchange Commission, or as filed with the Canadian securities regulatory authorities on the SEDAR website.
ABOUT MARIMED MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
IMPORTANT CAUTION REGARDING FORWARD-LOOKING STATEMENTS: The information in this release contains “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which are subject to several risks and uncertainties. All statements other than statements of historical facts contained in this release, including without limitation statements regarding projected financial results for 2025, including anticipated openings of dispensaries and facilities, timing of regulatory approvals, plans and objectives of management for future operations, are forward-looking statements. Without limiting the foregoing, the words “anticipates”, “believes”, “estimates”, “expects”, “expectations”, “intends”, “may”, “plans”, and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Forward-looking statements are based on our current beliefs and assumptions regarding our business, timing of regulatory approvals, the ability to obtain new licenses, business prospects and strategic growth plan, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated in these forward-looking statements due to various risks, uncertainties, and other important factors, including, among others, reductions in customer spending, our ability to recruit and retain key personnel, and disruptions from the integration efforts of acquired companies.
These factors are not intended to be an all-encompassing list of risks and uncertainties that may affect our business and results of operations. These statements are not a guarantee of future performance and involve risk and uncertainties that are difficult to predict, including, among other factors, changes in demand for the Company’s services and products, changes in the law and its enforcement, and changes in the economic environment. Additional information regarding these and other factors can be found in our reports filed with the U.S. Securities and Exchange Commission. In providing these forward-looking statements, the Company expressly disclaims any obligation to update these statements publicly or otherwise, whether as a result of new information, future events or otherwise, except as required by law.
All trademarks and service marks are the property of their respective owners.
Neither the CSE nor its Regulation Services accepts responsibility for the adequacy or accuracy of this release.
For More Information Contact:
Howard Schacter, Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
Data from patients who remained on tegoprubart for a year showed overall mean 12-month eGFR of approximately 68 mL/min/1.73 m² post-transplant
Preliminary iBox data, a key biomarker of kidney function and immunologic response, supports that tegoprubart may improve 5-year graft survival vs. current standard of care
Tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes
Conference call to be held today at 4:30 p.m. ET
IRVINE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated data from the Company’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the oral presentation, titled “Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study,” were presented today at the World Transplant Congress (WTC) taking place in San Francisco, CA.
“The data presented today at WTC further reinforce our belief that tegoprubart has the potential to not only provide better protection and long-term preservation of kidney function following transplantation, but also to offer a safer alternative to traditional immunosuppressive therapies by minimizing harmful side effects,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The continued strength of the Phase 1b data through 12 months of treatment is highly encouraging as we look ahead to topline results from our Phase 2 BESTOW trial, expected in November, which compares tegoprubart to tacrolimus, the current standard of care.”
As of the July 2025 cutoff date, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients (n=12) who remained on tegoprubart. Kidney function in the intention-to-treat population (n=15) was approximately 63 mL/min/1.73 m2 at 12 months. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant.
In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score. Based on data collected to date, abbreviated iBox scores were -3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors. A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4-5% difference in 5-year graft survival suggesting that tegoprubart may have a predicted 5-year allograft survival rate of over 96%.
Mean tegoprubart treatment exposure to date was 233 days. Tegoprubart continues to be well-tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes, a side effect associated with standard of care immunosuppression therapy.
There were six (18.8%) rejection episodes, and 75% of patients who experienced a rejection had received low-dose rabbit antithymocyte globulin (rATG) induction. All rejection episodes were successfully treated. Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1.73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR of approximately 34 mL/min/1.73 m² at 12 months.
All 32 patients received rATG induction therapy and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids.
Cohort 1 has completed enrollment and evaluated tegoprubart at a dose of 20 mg/kg with rATG induction up to 6 mg/kg.
Cohort 2 is currently enrolling and is evaluating a lower tegoprubart dose of 10 mg/kg, with a required rATG dose of 4.5 mg/kg.
The primary endpoint of the study is safety and pharmacokinetics. Secondary and exploratory endpoints include patient and graft survival, biopsy-proven acute rejection, kidney function as measured by estimated by eGFR, and abbreviated iBox score.
Eledon is also conducting a Phase 2 trial (BESTOW; NCT05983770) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Topline results from the Phase 2 BESTOW trial are anticipated in November 2025.
Full details of the WTC oral presentation are below:
Title: Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study Session: Oral Presentation, Kidney Novel Immunosuppressant Strategies Presenter: John Gill, MD, MS, University of British Columbia, Vancouver, Canada Session Date and Time: Wednesday, August 6, 2025: 10:00 a.m. – 11:15 a.m. PT
Conference Call
Eledon will hold a conference call today, August 6, 2025 at 4:30 p.m. Eastern Time to discuss the updated Phase 1b trial results. To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
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, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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About iBox
iBox is a composite biomarker panel developed by the Paris Transplant Group to predict long-term kidney graft survival. It combines kidney function (eGFR, proteinuria), immunologic response (donor-specific antibodies), and histopathology (Banff scores) into a single prognostic score. Validated across four independent cohorts, including two Phase 3 trials (BMS BENEFIT and BENEFIT-EXT), iBox has demonstrated strong predictive accuracy (C-statistic >0.8) for 5-year graft loss and outperforms traditional markers like biopsy-proven acute rejection. Both full and abbreviated iBox models have been qualified by the European Medicines Agency (EMA) and accepted by the U.S. FDA into the Biomarker Qualification Program. The iBox Composite Biomarker Panel is under review by the FDA as a Reasonably Likely Surrogate Endpoint (RLSE) for use as a co-primary endpoint in Phase 2/3 trials, supporting potential accelerated approval of novel immunosuppressive therapies. This makes iBox the first transplant-specific endpoint formally recognized under FDA’s biomarker qualification framework.
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 ongoing clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, 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 sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. 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.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Alcon (NYSE: ALC), a global leader in eye care, has signed a definitive agreement to acquire STAAR Surgical Company (NASDAQ: STAA) in a cash transaction valued at approximately $1.5 billion. The acquisition is aimed at bolstering Alcon’s position in the surgical vision correction market, particularly in addressing the growing global demand for alternatives to LASIK.
The deal will see Alcon purchasing all outstanding shares of STAAR common stock at $28 per share, representing a 59% premium to STAAR’s 90-day volume-weighted average price and a 51% premium over its August 4 closing price.
STAAR Surgical is best known for its EVO family of Implantable Collamer Lenses (ICLs), which offer minimally invasive, reversible vision correction for patients with moderate to high myopia, including those with astigmatism. These lenses are implanted behind the iris and in front of the eye’s natural lens, offering a surgical option that avoids corneal tissue removal.
For Alcon, the acquisition is a strategic complement to its existing laser vision correction business. By incorporating STAAR’s EVO ICL technology, the company aims to provide a broader spectrum of refractive solutions for patients, especially those who are not ideal candidates for LASIK or other laser procedures.
The need for such alternatives is expanding rapidly. Global studies suggest that by 2050, half of the world’s population will be myopic, with approximately 500 million people falling into the high myopia category—a group that often requires advanced vision correction techniques.
Alcon expects the acquisition to be accretive to earnings by the second year post-closing. The company plans to finance the purchase through short- and long-term credit facilities and noted that the transaction is not subject to a financing condition.
STAAR has faced recent market challenges, including fluctuating demand in key international markets such as China. By joining Alcon, STAAR is expected to benefit from increased operational scale and broader global distribution, which could accelerate the adoption of its EVO ICLs.
The transaction has received unanimous approval from both companies’ boards of directors. It is expected to close within six to twelve months, pending customary closing conditions, including regulatory clearances and approval by STAAR shareholders.
Financial advisors on the deal include Morgan Stanley for Alcon and Citi for STAAR, while legal counsel was provided by Gibson, Dunn & Crutcher LLP and Wachtell, Lipton, Rosen & Katz, respectively.
As part of ongoing developments, STAAR is scheduled to release its Q2 2025 earnings on August 6, though it will not hold an investor conference call due to the pending acquisition.
All CDI-988 doses, ranging from 100 mg to 1200 mg, in the Phase 1 study were well tolerated
Company expects to initiate Phase 1b study with CDI-988 in norovirus-infected healthy subjects later this year
Lack of approved norovirus treatments or vaccines creates critical unmet medical need
BOTHELL, Wash., Aug. 05, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the presentation of favorable safety and tolerability data from a randomized, double-blinded, placebo-controlled Phase 1 study with its oral, direct-acting pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium (MHSRS), being held August 4-7 in Kissimmee, Florida. The results support Cocrystal’s continued clinical development of CDI-988 as a potential norovirus prophylaxis and treatment.
In An Oral Pan-viral Protease Inhibitor for the Prevention and Treatment of Norovirus and Coronavirus Infections: Mechanism of Action and Phase 1 Study Results, Sam Lee, Ph.D., Cocrystal President and co-CEO, discussed findings from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. Data indicate that all doses, ranging from 100 mg to 1200 mg, were well tolerated. Overall treatment-emergent adverse events among CDI-988 subjects were 28% (10/36) compared with 40% (4/10) among placebo subjects for the SAD cohorts, and 53% (19/36) and 92% (11/12), respectively, for the MAD cohorts. Headache was the most common adverse event. All subjects in the SAD cohorts and all but one in the MAD cohorts completed the study. No severe treatment-emergent adverse events, no clinically relevant ECG changes and no clinically significant pathology results were reported from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts.
“Consistent with interim results from the Phase 1 study, CDI-988 was well-tolerated with a favorable safety profile across all dose levels tested in this study,” said Dr. Lee. “Our plan to continue CDI-988’s clinical development for norovirus is particularly relevant for the military, where this highly transmissible pathogen poses significant operational and economic risks. In confined settings such as naval vessels and military installations, norovirus can rapidly spread, causing debilitating gastrointestinal symptoms that could compromise mission readiness.
“The absence of approved norovirus treatments or vaccines creates a critical unmet medical need,” he added. “Norovirus presents significant vaccine development challenges due to its high genetic variability and mutation rate. CDI-988’s mechanism of action targeting viral replication and its broad-spectrum coverage offers a promising solution as a potential prophylactic and therapeutic intervention across all norovirus genogroups including GII.4 and GII.17. This could be a new approach to outbreak prevention and management. We expect to initiate a Phase 1b challenge study with CDI-988 in norovirus-infected healthy subjects later this year.”
MHSRS is an annual educational symposium with approximately 4,000 attendees that provides a collaborative environment for military medical care providers with deployment experience, research and academic scientists, international partners and industry on research and related healthcare initiatives falling under the topic areas of combat casualty care, military operational medicine, clinical and rehabilitative medicine, information sciences, military infectious diseases and radiation health effects. More information is available here.
Pan-viral Protease Inhibitor CDI-988 CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a compelling first potential oral treatment for noroviruses, and for coronaviruses.
Norovirus Infection 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. Norovirus outbreaks occur most commonly in semi-closed communities such as hospitals, nursing homes, childcare facilities, cruise ships, schools and disaster relief sites. Norovirus infections are estimated to cost society approximately $60 billion annually worldwide.
Structure-Based Drug Discovery Platform Technology Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute and chronic viral diseases.
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 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 the potential efficacy of CDI-988 as a potential breakthrough for norovirus prophylaxis and treatment, and the potential characteristics of and market for such product candidate and the Company’s plan to initiate a Phase 1b study in 2025. 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed without development programs. Further information on our risk factors is contained in our filings with the SEC, including 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.
Advances knowledge about the use of tecarfarin in patients with severe kidney impairment, including dialysis
Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial
Addresses a critical current treatment gap in patients with ESKD
PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is planned to begin later this year and will include patients with and without atrial fibrillation (AFib).
Patients with severe kidney disease are already at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality.
“There is a critical need for safe, effective anticoagulants for use in ESKD patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “Tecarfarin’s orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. This study will be an important step forward for the continued development of tecarfarin in ESKD and in other areas with real opportunities to improve patient outcomes with a potentially better vitamin K antagonist.”
Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation.
“Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need,” said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy specifically. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven.
Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). The company has submitted an Orphan Drug Designation Request to the US FDA for patients with chronic kidney disease who have an implanted mechanical heart valve (and consequently require lifelong anticoagulation with a VKA) who also have genetic predisposition to impaired CYP2C9 metabolism, and resulting associated challenges with achieving reliable degrees of anticoagulation with the long-term use of warfarin.
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/and connect with us on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; initiation of registration trial in patients with ESKD and AFib, developing transformative therapeutics to specifically address limitations of current anticoagulation therapy; addressing a critical current treatment gap in patients with ESKD; enrollment in the planned clinical trial beginning later this year; the planned study being an important step forward for the continued development of tecarfarin in ESKD; improving patient outcomes with a potentially better vitamin K antagonist; tecarfarin offering potential promise in patients initiating dialysis; addressing the unmet needs in anticoagulation therapy; and Cadrenal’s ability to pursue business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to specifically address limitations of current anticoagulation therapy; the ability to address a critical current treatment gap in patients with ESKD; the ability to advance an innovative solution to address the unmet needs in anticoagulation therapy; the ability to initiate and successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Product Updates All Three Trials Are On Schedule. Ocugen reported a 2Q25 loss of $14.7 million or $(0.05) per share. During the quarter, the clinical trials made progress to keep the products on schedule for 3 BLA filings beginning in 2026. The quarter also included a licensing agreement covering OCU400 in South Korea and the reverse merger to form OthroCellix, a new company focused on regenerative medicine.
OrthoCellix Has Been Formed To Develop NeoCart. Ocugen and Carisma Therapeutics, Inc. announced a reverse merger that will create a new company developing regenerative cellular therapies. As discussed in our Research Note on June 24, NeoCart cellular therapy is outside its main focus. The transaction is expected to close in September-October with the new company valued at $150 million. The Phase 3 pivotal trial is expected to begin in FY2025.
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Actively dosing patients in OCU400 Phase 3 liMeliGhT clinical trial and on track for 2026 BLA filing
OrthoCellix reverse merger intended to unlock the value of NeoCart/regenerative cell therapies and enable the Company to focus capital on modifier gene therapy platform
Signed binding term sheet for exclusive Korean rights to OCU400 with upfront fees and near-term development milestone payments totaling up to $11 million
MALVERN, Pa., Aug. 01, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported second quarter 2025 financial results along with a business update.
“While our modifier gene therapy clinical trials advance—now with two in late-stage—we are securing strategic partnerships and evolving the business to support three successful Biologics License Application (BLA) filings over the next three years,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We have also made important appointments to our Board of Directors, Retina Scientific Advisory Board, and Leadership Team to provide the Company with scientific and strategic know-how to bring us closer to delivering paradigm-changing gene therapies to millions of people with blindness diseases.”
In June, the Company announced a proposed reverse merger with OrthoCellix, a wholly-owned subsidiary, and Carisma Therapeutics, Inc. to create a Nasdaq-listed, late clinical-stage regenerative cell therapy company with a first-in-class technology platform, focused on orthopedic diseases. The combined company will focus on the development of OrthoCellix’s NeoCart® technology for the treatment of articular knee cartilage defects. Previously, NeoCart® received Regenerative Medicine Advanced Therapy (RMAT) designation and concurrence from the U.S. Food and Drug Administration (FDA) on a single, confirmatory Phase 3 clinical trial to enable submission of a BLA.
Aligned with Ocugen’s business development strategy to pursue regional partnerships for OCU400, the Company signed a binding term sheet to negotiate and enter into a licensing agreement with a well-established leader in the pharmaceutical and healthcare sector in Korea for exclusive Korean rights to OCU400. Pursuant to the term sheet, under the license agreement, in addition to the upfront and milestone fees, the Company will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea in addition to a royalty of 25% on net sales of OCU400 generated by Ocugen’s partner. Ocugen will manufacture commercial supply of OCU400 under terms of a supply agreement. A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating return for shareholders.
Following the FDA’s agreement to proceed with a Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST for Stargardt disease, the agency granted Rare Pediatric Disease Designation (RPDD) to OCU410ST in May. This designation underscores the urgent need to address Stargardt disease, which remains a significant unmet medical need. Stargardt disease is an inherited retinal disorder that typically presents in childhood and affects approximately 100,000 people in the U.S. and Europe combined, and approximately 1 million globally. Currently, there is no FDA-approved treatment available for Stargardt disease.
The OCU410ST Phase 2/3 GARDian3 clinical trial is progressing well with the first patient dosed in July after FDA clearance in June. The GARDian3 clinical trial builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow-up in evaluable treated eyes compared to untreated eyes. Additionally, evaluable treated eyes showed a 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 when compared to untreated eyes.
Positive preliminary efficacy and safety data from the OCU410 Phase 1 ArMaDa clinical trial at 12 months demonstrated no drug-related serious adverse events (SAEs), 23% slower geographic atrophy (GA) lesion growth in treated eyes versus fellow eyes after a single injection, and 2-line/10-letter gain in visual acuity in treated eyes when compared to untreated fellow eyes. Preliminary results from ongoing Phase 2 clinical trial (N=31), 6-month interim analysis, demonstrated a 27% slower lesion growth and preservation of retinal tissue. These data support the potential for OCU410 to provide a one-time treatment for life for the 2-3 million people in the U.S. & EU combined who suffer from GA.
Patients are actively being recruited in the United States and Canada for the OCU400 Phase 3 liMeliGhT clinical trial, which remains on track for BLA and MAA submissions in 2026. This is the only broad retinitis pigmentosa (RP) gene-agnostic trial to address multiple genetic mutations with a single therapeutic approach. In addition, the European Medicines Agency has granted eligibility to submit the OCU400 Marketing Authorization Application (MAA) through the centralized procedure, based on the current study design and statistical analysis plan.
Regarding the Company’s inhaled vaccines portfolio, the National Institute of Allergy and Infectious Diseases (NIAID) intends to initiate the Phase 1 clinical trial for OCU500 in the third quarter of 2025.
In addition to the notable leadership appointments, Ocugen welcomed the National Security Commission on Emerging Biotechnology (NSCEB) and U.S. Rep. Chrissy Houlahan to its manufacturing facility as part of the NSCEB’s Biotech Across America events, highlighting biotech innovation in Pennsylvania. Rep. Houlahan subsequently announced the bipartisan BIOTech Caucus to build greater awareness and understanding of biotechnology among lawmakers and support transformative advances in healthcare. Dr. Musunuri supports the formation of this very important bipartisan BIOTech Caucus that includes senior congressional leaders such as Rep. Pete Sessions in addition to local leaders, which will prioritize biotechnology at the national level to ensure U.S. leadership globally.
“The meaningful progress Ocugen is making across its novel modifier gene therapy platform, along with strategic leadership changes and significant external alliances are evidence of a strong first half of 2025,” said Dr. Musunuri. “We look forward to providing critical program updates and data in the coming months.”
OCU400 for RP – On track to complete enrollment in support of BLA/MAA filings in 2026. Data and Safety Monitoring Board (DSMB) convened and found no SAEs related to OCU400 and recommended to continue study dosing as planned.
OCU410ST for Stargardt Disease– FDA granted RPDD for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. FDA cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST and dosing has been initiated.
OCU410 for GA – Phase 1 data at 12 months demonstrates reduced lesion growth, preservation of retinal tissue, and—most importantly—a positive effect on the functional visual measure of low luminance visual acuity (LLVA). Interim Phase 2 data at 6 months demonstrated very encouraging results consistent with Phase 1 data.
Ophthalmic Biologic Product
OCU200 – DSMB approved continuation of dosing in the third cohort and the Company intends to complete the Phase 1 clinical trial in the second half of 2025.
Second Quarter 2025 Financial Results
The Company’s cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, compared to $58.8 million as of December 31, 2024, providing cash runway into the first quarter of 2026. The Company had 292.2 million shares of common stock outstanding as of June 30, 2025.
Total operating expenses for the three months ended June 30, 2025 were $15.2 million and included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million. This compares to total operating expenses for the three months ended June 30, 2024 of $16.6 million that included research and development expenses of $8.9 million and general and administrative expenses of $7.7 million.
Ocugen reported a $0.05 net loss per common share for the three months ended June 30, 2025, compared to a $0.06 net loss per common share for the three months ended June 30, 2024.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s executive leadership team will host the call, which will be open to all listeners. There also will be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast: Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 9627149 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. 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, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s financial condition and expected cash runway into the first quarter of 2026, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,and Ocugen’s negotiations regarding the license agreement with a Korean partner and Ocugen’s potential merger transaction regarding the OrthoCellix business, 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; 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; that a definitive agreement for the license with a Korean partner will be delayed or not executed at all, or that, if executed, it may not be on terms anticipated; that the OrthoCellix merger transaction may not close or, if closed, may not result in the benefits anticipated. These and other risks and uncertainties are more fully described in our annual and 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.
NORWOOD, Mass., July 31, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed,” “the Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, today announced a strategic agreement with TILT Holdings (“TILT”) (CBOE: TILT) (OTCPK: TLLTF) that will expand the distribution of the Company’s award-winning portfolio of medical marijuana products to Pennsylvania.
On July 30, 2025, Standard Farms, LLC (“Standard Farms”), a wholly owned subsidiary of TILT, entered into a Management Services Agreement (the “MSA”) with MariMed Advisors, Inc., a Delaware corporation and wholly owned subsidiary of MariMed (the “Manager”). Under the terms of the MSA, effective September 1, 2025, MariMed will assume the day-to-day management of TILT’s Standard Farms cultivation and processing facility in White Haven, Pennsylvania. Standard Farms will remain the sole permit holder. As Manager, MariMed will provide comprehensive management services to Standard Farms, including oversight of budgeting, financial planning, and compliance with applicable laws, and will maintain quality management programs. The Manager will also be responsible for advising on accounting, managing business bank accounts, and ensuring compliance with tax and licensing requirements. In addition, Standard Farms intends to produce and distribute MariMed’s award-winning brands in Pennsylvania, the fifth most populous state in the country, pursuant to a licensing arrangement with MariMed.
Pursuant to the MSA, which has an initial term of four years, MariMed will receive a management fee of 12.5% of Standard Farm’s gross revenue.
“We are thrilled to bring our brands to consumers in the great state of Pennsylvania, a strong medical marijuana market that is likely to become the next cannabis adult-use market,” said Jon Levine, MariMed’s Chief Executive Officer. “These agreements align with our ‘Expand the Brand’ strategy, a top priority initiative that is driving us toward becoming the leading consumer packaged goods company in medical marijuana. We will continue to identify opportunities to expand the distribution of our brands into new, high-growth markets and deeper in our existing markets.”
“We are excited to partner with the MariMed team and to support their expansion,” said TILT Chief Executive Officer, Tim Conder. “We are eager to work closely with MariMed through this MSA agreement, providing their trusted and high-quality branded products to medical marijuana patients throughout Pennsylvania. These brands lead in other markets, and we expect similar success here. Our team has done a tremendous job building a foundation of quality and trust with patients under the Standard Farms banner, and we expect this foundation to be the right launching pad for MariMed. We view this partnership as another positive step forward in the strategic review process we have been conducting over the past few quarters.”
ABOUT MARIMED MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
ABOUT TILT TILT is dedicated to helping cannabis businesses build their brands. Through a diverse portfolio of companies providing technology, hardware, cultivation and production, TILT services brands and cannabis retailers across North America, South America, Israel and the European Union. TILT’s core business is Jupiter Research LLC, a wholly-owned subsidiary and leader in the vaporization segment focused on hardware design, research, development and manufacturing. Jupiter recently received EU medical device certification for Europe’s first handheld liquid inhalation device. Additionally, TILT operates Commonwealth Alternative Care, Inc., Inc. in Massachusetts, and Standard Farms Ohio, LLC in Ohio and is the permit holder of record for Standard Farms LLC in Pennsylvania. TILT is headquartered in Scottsdale, Arizona. For more information, visit www.tiltholdings.com.
IMPORTANT CAUTION REGARDING FORWARD-LOOKING STATEMENTS:
The information in this release contains “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which are subject to several risks and uncertainties. All statements other than statements of historical facts contained in this release, including without limitation statements regarding projected financial results for 2025, including anticipated openings of dispensaries and facilities, timing of regulatory approvals, plans and objectives of management for future operations, are forward-looking statements. Without limiting the foregoing, the words “anticipates”, “believes”, “estimates”, “expects”, “expectations”, “intends”, “may”, “plans”, and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Forward-looking statements are based on our current beliefs and assumptions regarding our business, timing of regulatory approvals, the ability to obtain new licenses, permits, business prospects and strategic growth plan, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated in these forward-looking statements due to various risks, uncertainties, and other important factors, including, among others, reductions in customer spending, our ability to recruit and retain key personnel, and disruptions from the integration efforts of acquired companies.
These factors are not intended to be an all-encompassing list of risks and uncertainties that may affect our business and results of operations. These statements are not a guarantee of future performance and involve risk and uncertainties that are difficult to predict, including, among other factors, changes in demand for the Company’s services and products, changes in the law and its enforcement, and changes in the economic environment. Additional information regarding these and other factors can be found in our reports filed with the U.S. Securities and Exchange Commission. In providing these forward-looking statements, the Company expressly disclaims any obligation to update these statements publicly or otherwise, whether as a result of new information, future events or otherwise, except as required by law.
All trademarks and service marks are the property of their respective owners.
TILT Company Contact: Lynn Ricci, VP of Investor Relations & Corporate Communications TILT Holdings Inc. lricci@tiltholdings.com
MariMed Company Contact: Howard Schacter, Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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We Look Forward To Data At The World Transplant Congress. Eledon is scheduled to present interim data from its Phase 1b study at the World Transplant Congress (WTC), to be held August 2 to 6. We have also seen an abstract discussing a single patient in the Phase 2 BESTOW trial that had an unrelated fungal infection. While we do not consider the abstract to be significant, it may have raised safety concerns for investors.
WTC Abstract From One Patient May Have Been Misinterpreted. The abstract discusses “a unique case of pulmonary mucomycosis” in a patient enrolled in the Phase 2 BESTOW trial. Four weeks after receiving a kidney transplant and the tegoprubart regimen, he developed fever due to a rare fungal infection that was treated and resolved. “The patient remained on tegoprubart infusions and showed evidence of clinical improvement, without evidence of rejection or infection at follow-up visits”, stated the abstract.
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IRVINE, Calif., July 30, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that the company will host a conference call and webcast on Wednesday, August 6, 2025 at 4:30 p.m. ET to discuss updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation. These data, from approximately 30 kidney transplant recipients, are being presented at the World Transplant Congress (WTC) in San Francisco, CA on August 6, 2025.
To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
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, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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