Median overall survival (OS) from THIO treatment extends to 16.9 months
Newest data strengthens regulatory strategy
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.
As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population1. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.2
“Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin,” said Vlad Vitoc, M.D., CEO of MAIA. “THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in third-line treatment where the cancer is typically even more resistant to therapy. Our findings suggest great benefits to patients with unmet medical needs who see little hope for the future.
“With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,” Dr. Vitoc concluded.
Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.
About THIO
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 (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO 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. THIO 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 THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
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 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.
__________________________
1 Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
February 4, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV:LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to provide an update on its wholly owned Angel Island project near Silver Peak, Nevada, USA and associated Lithium Extraction Facility (“Pilot Plant”) in Amargosa Valley Nevada. The Company has completed the successful implementation of process improvements at its Pilot Plant. These changes were developed in collaboration with Amalgamated Research, LLC (“ARi”) of Twin Falls, Idaho, a research and development company specializing in industrial implementation of process technologies. Century Lithium is now shifting the focus at its Pilot Plant from research and development to demonstration.
“The initial results from ARi are very encouraging, indicating greater efficiency can be achieved that could result in positive reductions in the estimated capital and operating costs at Angel Island,” said Century Lithium President and CEO, Bill Willoughby. “Century Lithium remains committed to delivering value to our shareholders through Angel Island, one of the few advanced lithium projects in the United States. We are optimistic about the long-term fundamentals of the lithium market and the strategic importance of Angel Island to the future mineral supply in the United States.”
Project Update
The processing testing program (“Program”) implemented ARi’s proprietary adsorption-based technology for Direct Lithium Extraction (“DLE”) and was accomplished in conjunction with ARi’s Twin Falls testing facilities and Century Lithium’s Pilot Plant. The results of the Program are positive and further validate the efficiency of Century Lithium’s extraction technology. The Program augmented Century Lithium’s DLE system with the addition of ARi equipment and expertise. Early results indicate Century Lithium can eliminate the recycle loops within its DLE and lithium carbonate areas, while increasing eluate grades. The Company believes this will result in a substantial reduction in estimated capital and operating costs at Angel Island.
The decision to shift the focus at the Pilot Plant to demonstration mode is two-fold; it will allow the Company to focus on providing dedicated testing to prospective strategic partners or potential end-users and reduce the ongoing operating costs of the Pilot Plant. Current Pilot Plant operations will continue to convert a backlog of lithium solutions, which were made prior to the commissioning of the on-site lithium carbonate process at the Pilot Plant, into battery-grade lithium carbonate.
Moving Forward
The Company recently announced a non-binding Memorandum of Understanding (“MOU”) with Orica Specialty Mining Chemicals (see news release). The non-binding MOU outlines the intent of Century Lithium and Orica to formalize a multiyear offtake agreement for Orica to purchase sodium hydroxide from Angel Island. The favorable outlook for the sodium hydroxide by-product contributes significantly to Century Lithium’s low-cost lithium carbonate production model.
Ongoing engineering is focused on mining, and the leaching, filtration, DLE, and lithium carbonate processing areas. The Company continues to compile all data generated at the Pilot Plant. The data will be used in engineering models and to run analytical tests on full-scale construction designs focused on further reducing the estimated capital and operating costs for producing lithium carbonate at Angel Island.
Century Lithium remains focused on seeking strategic partnerships with potential end-users and market participants interested in securing a domestic supply of battery-grade lithium carbonate. The Company continues to move forward with permitting work to ensure that our future operations at Angel Island will align with both regulatory requirements and Century Lithium’s environmental and social stewardship goals.
Qualified Person
Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.
ABOUT Ari
Amalgamated Research LLC (ARi) is a supplier of chromatography, adsorption, and ion exchange technology and equipment specialized in commercializing innovative technology at large industrial scale. ARi has developed a cost-effective and streamlined solution for adsorption-based direct lithium extraction that maximizes plant profitability while minimizing upfront capital cost. ARi’s patented fluid distribution and mixing technology de-risks scale-up allowing separation processes to be reliably scaled from pilot plant data up to industrial vessels exceeding 20-ft in diameter, with no degradation in equipment performance. ARi provides a full spectrum of customer support services, from proof of concept through to industrial-scale installation. Comprehensive analytical services and a wide range of pilot equipment are available on-site to support process development and scale-up. Please visit arifractal.net for more information.
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced stage lithium company, focused on developing its wholly owned Angel Island project in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make high purity lithium carbonate product samples from Angel Island lithium-bearing claystone on-site at its Pilot Plant in Amargosa Valley, Nevada.
Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery quality lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan expected to yield an average of 34,000 tonnes per year of lithium carbonate over a 40-year mine-life.
Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”; and on the Frankfurt Stock Exchange under the symbol “C1Z”.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development
Tonix is Preparing for Potential Launch of TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025
CHATHAM, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the promotion of Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately. Ms. Fogarty joined Tonix in 2016 and previously served as Executive Vice President of Product Development. Ms. Fogarty has over 25 years of experience in pharmaceutical and biotech product development, manufacturing and quality, for both small and large molecules, at notable pharmaceutical and biotech companies.
In December, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
“Siobhan is an invaluable member of our team and an outstanding leader who has contributed in many ways to our success since she joined in 2016, and we are excited that she is executing at a higher level in her new role as our first CTO,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Her energy, insights and organizational abilities will be welcome as we enter into a landmark time for the Company with the upcoming PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia. In addition to her stewardship of TNX-102 SL, Siobhan has played key roles advancing our pipeline of small molecule, biologics and live-virus vaccines.”
Ms. Fogarty started her career with Elan Corporation as a formulation scientist where she gained experience in several different areas of drug delivery, including solid, liquids, IV, and transdermal formulations. At Elan, she took products from concept to commercial manufacture in both Ireland and the U.S. Ms. Fogarty moved to Glaxo SmithKline, London, as a manufacturing strategist after the merger of Glaxo and SmithKline Beecham. Returning to product development, Ms. Fogarty established European product development sites for Fuisz Technologies and Biovail Corporation, leading multi-disciplinary teams for the development of products from early conceptual/preclinical development, through the various clinical phases and transferring to U.S./Canadian manufacturing sites during registration for commercialization. Subsequently, Ms. Fogarty started a consultancy firm, eMSc, that advised pharmaceutical and biotech companies in product development and implementation of a phased approach to quality. Ms. Fogarty obtained her masters in Pharmaceutical Sciences at Trinity College, Dublin, and is a European Union Qualified Person. Her primary degree is in Industrial Chemistry from the University of Limerick where she interned at Pfizer.
“I am grateful for the incredible eight years I have already enjoyed working at Tonix and look forward to the challenges and opportunities of my new role,” said Ms. Fogarty. “Tonix is entering a momentous time, and it is an honor to assume these new responsibilities as part of this extraordinary team.”
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the area of infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its second quarter 2025 financial results after market close on Monday, February 10, 2025. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (February 10, 2025) at 5:00 pm ET to discuss the results.
After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.
With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 140 years. Euroseas trades on the NASDAQ Capital Market under the ticker ESEA. Euroseas operates in the container shipping market. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company, which is responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New time charter contracts. Euroseas executed two new time charter contracts for M/V Synergy Antwerp and M/V Synergy Keelung. The charter contracts are at gross daily rates of $35,500 for a minimum period of 36 months and a maximum period of 39 months at the charterer’s option. Both contracts will take effect at the completion of the vessels’ respective current charters; M/V Synergy Antwerp’s new charter is expected to commence in May 2025, and M/V Synergy Keelung’s new charter is expected to commence in June 2025.
Favorable rates and improved coverage. The new time charters are expected to contribute roughly $57.0 million in EBITDA during the minimum contracted period. The new charters improve the company’s 2025 and 2026 charter coverage to 82% and 45%, respectively. Additionally, Euroseas announced that M/V Synergy Keelung will be retrofitted with energy-saving devices (ESDs) and the upgrade costs will be shared with the charterer.
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 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.
Key Points: – Palantir stock surged 25% to a record high following better-than-expected fourth-quarter results and strong guidance. – The company’s U.S. commercial revenue grew 64% year over year, while U.S. government revenues rose 45%. – CEO Alex Karp emphasized Palantir’s pivotal role in AI and national security, predicting sustained momentum over the next three to five years.
Palantir Technologies saw its stock price soar by 25% on Tuesday, hitting a record high after delivering robust fourth-quarter earnings and an optimistic outlook fueled by artificial intelligence (AI) advancements. The Denver-based software company reported adjusted earnings of 14 cents per share on revenue of $828 million, surpassing analysts’ expectations of 11 cents per share and $776 million in revenue.
The company also provided strong guidance for the first quarter of 2025, forecasting revenue between $858 million and $862 million—well above the $799 million analysts had anticipated. For the full year, Palantir expects revenue between $3.74 billion and $3.76 billion, again exceeding estimates of $3.52 billion. This impressive performance has driven Palantir’s stock up 36% year-to-date, continuing its explosive 340% growth throughout 2024 as AI adoption accelerates.
CEO and co-founder Alex Karp attributed the company’s momentum to the increasing adoption of its AI-powered platforms across both commercial and government sectors. Palantir’s U.S. commercial revenue surged 64% year over year, while its U.S. government revenue climbed 45%. Karp described the company’s trajectory as “unlike anything that has come before,” reinforcing its dominance in AI and data analytics.
Palantir, long recognized for its work with U.S. defense and intelligence agencies, has also seen rising demand for its AI-driven commercial software solutions. The company expects U.S. commercial sales to grow by 54% in 2025, reflecting broader enthusiasm for AI-driven business intelligence and operational efficiency.
“We are at the very beginning of our trajectory and the AI revolution,” Karp said in his letter to shareholders. “We plan to be a cornerstone—if not the cornerstone—company driving this transformation in the U.S. over the next three to five years.”
Karp also emphasized Palantir’s commitment to national security, stating that the company is “very long America” and aims to enhance U.S. military capabilities to deter potential adversaries. His comments come amid rising competition in AI, particularly following China’s DeepSeek AI breakthroughs, which have raised concerns over technological supremacy and national security implications.
The strong earnings report prompted several Wall Street firms to raise their price targets for Palantir’s stock. Bank of America analyst Mariana Perez Mora called Palantir an AI “value adder” and increased her price target, while Morgan Stanley upgraded the stock from underweight to equal weight. Analyst Sanjit Singh admitted that concerns over slowing growth had been overstated, saying, “Given the strength of the outlook, we acknowledge that we were wrong about our core fundamental catalyst of slowing growth below the 30% level.”
With AI adoption showing no signs of slowing, Palantir’s strong financial results and forward-looking guidance have solidified its status as a key player in the evolving AI landscape. Investors remain highly optimistic about the company’s future, as it continues to expand its AI-powered solutions across both public and private sectors.
Key Points: – Triumph Group to be acquired for $3 billion by Warburg Pincus and Berkshire Partners – Deal offers 123% premium to shareholders – Transaction expected to close in second half of 2025 – Company will become privately held, focusing on aerospace component innovation
Triumph Group, a leading aerospace components manufacturer, has agreed to be acquired by affiliates of Warburg Pincus and Berkshire Partners in an all-cash transaction valued at approximately $3 billion. The deal, which will take the company private, represents a substantial premium of 123% over Triumph’s unaffected stock price and signals significant confidence in the aerospace industry’s future.
Under the terms of the agreement, Triumph shareholders will receive $26.00 per share in cash, a premium that demonstrates the strong strategic value perceived by the private equity firms. The transaction is expected to close in the second half of 2025, subject to shareholder approval and regulatory clearances.
Dan Crowley, Triumph’s chairman, president, and CEO, highlighted the strategic importance of the deal, noting that it will provide the company with enhanced capabilities to meet evolving customer needs. The transaction comes after years of portfolio optimization and building a world-class team of aerospace engineering professionals.
Warburg Pincus and Berkshire Partners bring extensive experience in the aerospace and defense sectors. Dan Zamlong from Warburg Pincus emphasized the firms’ deep investment history in aerospace platforms, expressing excitement about partnering with Triumph’s global team to capture growing demand for high-quality aerospace components.
The acquisition reflects the ongoing consolidation and strategic repositioning within the aerospace industry. Triumph, founded in 1993 and headquartered in Radnor, Pennsylvania, designs, develops, manufactures, and repairs aerospace and defense systems and components for both original equipment manufacturers and military and commercial aircraft operators.
Blake Gottesman of Berkshire Partners highlighted Triumph’s critical role in the aerospace and defense industry, noting the firm’s history of partnering with market-leading aerospace companies. The transaction is not contingent on financing, underscoring the financial strength of the acquiring partners.
Warburg Pincus brings significant financial muscle to the deal, with over $86 billion in assets under management and a diverse portfolio of over 230 companies. Berkshire Partners, a 100% employee-owned investor, is currently investing from its Fund XI, which closed in 2024 with approximately $7.8 billion in commitments.
The transaction will result in Triumph becoming a privately held company, delisting from the New York Stock Exchange. The company plans to continue its scheduled financial reporting, with third-quarter fiscal 2025 earnings expected to be released by February 10, 2025.
ATLANTA, Feb. 03, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM) (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced it has purchased an additional $5 million in Bitcoin as part of its treasury strategy, first announced in June of last year.
With yesterday’s purchase of 51 BTC, the Company now holds 71.5 Bitcoin in its treasury, substantially increasing its position in the leading cryptocurrency.
“Adopting Bitcoin as part of our treasury strategy underscores our long-standing belief in Bitcoin as a significant financial asset and a store of value,” said Brandon Mintz, CEO of Bitcoin Depot. “We have always believed in providing easy access to Bitcoin for everyone, and this move reaffirms our confidence in Bitcoin’s potential for growth. Given the recent accounting standards update, it also allows our shareholders to benefit from future BTC appreciation.”
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 8,400 kiosk locations as of December 31, 2024. Learn more at www.bitcoindepot.com.
Cautionary Statement Regarding Forward-Looking Statements This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor 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 our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
Key Points: – Trump implements 25% tariffs on Canada and Mexico, 10% on China – Retaliatory measures from trading partners already in motion – Multiple industries expected to face significant price increases
Wall Street experienced a seismic shock as President Trump’s aggressive tariff strategy sent financial markets into a tailspin, with major indexes suffering significant losses and investors bracing for potential economic repercussions. The Nasdaq Composite plummeted over 2%, while the S&P 500 spiraled 1.6% and the Dow Jones Industrial Average tumbled more than 550 points.
The sweeping tariffs, set to take effect on Tuesday, include 25% duties on Canada and Mexico, and 10% on China, with energy imports from Canada receiving a slightly lower 10% rate. Trump’s announcement has sent shockwaves through global markets, with the president already hinting at potential future tariffs on the European Union.
Goldman Sachs strategists warn that these tariffs could potentially reduce S&P 500 earnings forecasts by 2-3%, with a potential market value decline of approximately 5%. The move has caught many investors off guard, who had previously expected tariffs would only be imposed after failed trade negotiations.
The tariffs’ impact extended dramatically into the energy sector, with oil prices experiencing significant volatility. West Texas Intermediate crude futures jumped as much as 3.7%, outpacing global benchmarks and highlighting potential supply chain disruptions. The 10% levy on Canadian energy imports and 25% tariff on Mexican crude supplies threaten to reshape North American energy dynamics.
Refineries in the Midwest, which heavily rely on Canadian heavy crude, are particularly vulnerable. The tariffs are expected to cause immediate price increases, with refiners like Irving Oil already signaling potential fuel price hikes. The strategic oil storage hub in Cushing, Oklahoma, and Gulf Coast refineries will feel the most immediate effects of these trade barriers.
Commodities experts warn that while the tariffs might provide a short-term boost to oil prices, they raise substantial concerns about global economic growth. The complex energy supply chain could face significant restructuring, potentially increasing fuel costs for American consumers and challenging the intricate economic relationships between the United States, Canada, and Mexico.
Retaliatory measures were swift, with Canadian Prime Minister Justin Trudeau announcing 25% counter-tariffs on approximately $107 billion of American-made products. The tit-for-tat escalation threatens to create a complex web of economic challenges for multiple nations.
Consumer discretionary stocks bore the brunt of the market reaction, with automakers and tech companies experiencing significant downturns. Tech giants like Nvidia and Apple saw substantial share price declines, reflecting broader market anxieties about the potential long-term economic implications of these tariffs.
The Federal Reserve remains cautious, with interest rates held steady due to concerns about potential inflationary pressures. The tariffs are expected to directly impact consumers across multiple industries, with potential price increases anticipated for automobiles, auto parts, clothing, computers, and various other goods.
Noble Capital Markets’ Research Analyst Joe Gomes suggests that while the full implications of these tariffs remain uncertain, companies have been proactively preparing for potential trade barriers. Over the past few months, many businesses have been developing contingency strategies to mitigate the immediate economic impact, implementing supply chain adjustments and financial buffers to minimize potential disruptions from the new tariff regime.
The global economic landscape now appears increasingly uncertain, with trade tensions threatening to disrupt carefully established international economic relationships. Technology and manufacturing sectors seem particularly vulnerable to these protectionist measures.
Harnessing AI to Revolutionize Vaccine and Therapy Development
ATLANTA, GA, February 3, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, announced today its endorsement of President Donald J. Trump’s Stargate Initiative, which aims to harness advanced technologies including Artificial Intelligence (AI) to strengthen U.S. healthcare, biosecurity, and global innovation leadership. This announcement aligns with GeoVax’s commitment to leveraging AI across its vaccine and cancer immunotherapy programs to accelerate research, optimize operations, and deliver life-saving solutions.
Revolutionizing Healthcare with AI
GeoVax has embedded AI into its platforms for vaccine development and cancer immunotherapy, enabling groundbreaking advances:
Vaccine Development: AI drives target discovery and design for vaccines using the Modified Vaccinia Ankara (MVA) platform, including GEO-CM04S1, GeoVax’s next-generation vaccine for COVID-19, and vaccines for Mpox and Smallpox. AI predicts pathogen mutations, ensuring long-lasting and variant-proof vaccines.
Cancer Immunotherapy: AI optimizes GeoVax’s Gene-Directed Enzyme Prodrug Therapy (GDEPT) for solid tumors, including predictive modeling of tumor microenvironments, real-time adjustment of protocols to maximize therapeutic efficacy, and identifying synergistic combinations with immune checkpoint inhibitors.
Clinical Targeting: AI-powered analytics will refine patient stratification, ensuring that GeoVax’s therapies reach underserved populations most in need, aligning with the initiative’s national focus to maximize therapeutic efficacy.
Manufacturing and Operations: AI improves GeoVax’s vaccine production scalability and supply chain management, ensuring timely delivery to strategic stockpiles.
Aligned with the Stargate Vision
President Trump’s Stargate Initiative, supported by up to $500 billion in private-sector investment, represents a bold step forward in embracing transformative technologies. GeoVax proudly aligns with this vision, advancing U.S. healthcare innovation and pandemic preparedness.
David Dodd, GeoVax Chairman and CEO, stated: “President Trump’s Stargate Initiative exemplifies leadership in harnessing AI to address critical healthcare challenges. GeoVax is honored to support this initiative, highlighting its application of AI to develop vaccines and therapies that save lives and enhance biosecurity. We are proud to contribute to a future where the United States leads the world in healthcare innovation.”
Building on Operation Warp Speed’s Legacy
GeoVax’s efforts reflect the spirit of President Trump’s Operation Warp Speed, which accelerated COVID-19 vaccine development and deployment. By integrating AI into its research and operational strategies, GeoVax aims to continue pushing the boundaries of what is possible in medical science.
A Commitment to Life-Saving Innovation
GeoVax remains steadfast in its mission to develop innovative vaccines and immunotherapies, leveraging the power of AI to meet the healthcare needs of today and prepare for the challenges of tomorrow. With AI now embedded in its processes, GeoVax anticipates shorter development timelines, increased efficiency in clinical trials, and enhanced capacity to deliver life-saving therapies globally. Collaborations with academic institutions, industry partners and federal agencies will further amplify the reach and impact of GeoVax’s innovative programs under the Stargate framework. AI-enabled supply chain optimization will further ensure efficient vaccine distribution to high-priority populations and regions.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “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 and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. 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.
CHATHAM, N.J., Feb. 03, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading on February 5, 2025.
The reverse stock split is intended to increase the per share trading price of Tonix’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market (Rule 5550(a)(1)). Tonix’s common stock will continue to trade on the NASDAQ Capital Market under the symbol “TNXP” and under a new CUSIP number, 890260839. As a result of the reverse stock split, every one hundred pre-split shares of common stock outstanding will become one share of common stock. The reverse split will also apply to common stock issuable upon the exercise of Tonix’s outstanding warrants and stock options. The reverse stock split will not proportionately reduce the number of shares of authorized common stock, as permitted under Nevada law, as shareholder approval for the reverse stock split was obtained on October 30, 2024.
Tonix’s transfer agent, VStock Transfer LLC, which is also acting as the exchange agent for the reverse split, will provide instructions to shareholders regarding the process for exchanging share certificates. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole post-split share and no shareholders will receive cash in lieu of fractional shares.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. In July 2024, Tonix announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Full year 2024 total revenue of $2.4 billion, net income of $360.9 million, and Adjusted EBITDA of $714.2 million
Record full year 2024 oil & gas royalty volumes of 3.4 million BOE, up 9.6% year-over-year
Fourth quarter 2024 total revenue of $590.1 million, net income of $16.3 million, and Adjusted EBITDA of $124.0 million
Completed $9.6 million in oil & gas mineral interest acquisitions during fourth quarter
In January 2025, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized
TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) today reported financial and operating results for the quarter and full year ended December 31, 2024 (the “2024 Quarter” and “2024 Full Year”). This release includes comparisons of results to the quarter and year ended December 31, 2023 (the “2023 Quarter” and “2023 Full Year”, respectively), as well as the quarter ended September 30, 2024 (the “Sequential Quarter”). All references in the text of this release to “net income” refer to “net income attributable to ARLP.” For a definition of Adjusted EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.
Total revenues in the 2024 Quarter decreased 5.6% to $590.1 million compared to $625.4 million for the 2023 Quarter primarily as a result of reduced coal sales volumes, which declined 2.3%, and lower transportation revenues. Net income for the 2024 Quarter was $16.3 million, or $0.12 per basic and diluted limited partner unit, compared to $115.4 million, or $0.88 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues, higher per ton operating expenses, which include $13.1 million of non-cash accruals for certain long-term liabilities, and $31.1 million of non-cash impairment charges in the 2024 Quarter due to market uncertainty at our MC Mining operation, partially offset by a $14.0 million increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Quarter was $124.0 million compared to $185.4 million in the 2023 Quarter.
Total revenues in the 2024 Quarter decreased 3.8% compared to $613.6 million in the Sequential Quarter primarily as a result of reduced coal sales prices, which declined 5.7% due in part to lower export price realizations. Net income for the 2024 Quarter decreased by 81.1% compared to the Sequential Quarter as a result of lower revenues and higher non-cash accruals relating to certain long-term liabilities and impairment charges in the 2024 Quarter, partially offset by an increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Quarter decreased 27.2% compared to the Sequential Quarter, as a result of higher non-cash accruals for certain long-term liabilities in the Illinois Basin, higher expenses related to the continuation of challenging geological conditions at our Tunnel Ridge and MC Mining operations in Appalachia, and lower revenue per ton for spot coal sold and per BOE in the Royalties segment.
Total revenues decreased 4.6% to $2.45 billion for the 2024 Full Year compared to $2.57 billion for the 2023 Full Year primarily due to lower coal sales volume, partially offset by higher other revenues. Net income for the 2024 Full Year was $360.9 million, or $2.77 per basic and diluted limited partner unit, compared to $630.1 million, or $4.81 per basic and diluted limited partner unit, for the 2023 Full Year as a result of lower revenues, increased operating expenses and non-cash impairment charges, partially offset by a $22.4 million increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Full Year was $714.2 million compared to $933.1 million in the 2023 Full Year.
CEO Commentary
“Due to the continued strength of our coal contracts, our average coal sales price per ton for the 2024 Full Year of $63.38 came close to the record level achieved in the 2023 Full Year of $64.17. However, lower sales volumes, higher operating costs and several non-cash accruals caused 2024 Full Year financial results to fall short of last year’s record revenues and net income,” said Joseph W. Craft III, Chairman, President and CEO. “The cold winter weather at the start of this year has driven higher natural gas prices and increased coal consumption in the eastern United States, helping reduce inventories. We are seeing customer solicitations for both near-term and long-term supply contracts, and if the colder weather continues to be above normal, we are hopeful we can reach our goal to ship 30 million tons to the domestic market in 2025.”
Mr. Craft continued, “Having substantially completed major infrastructure projects at Tunnel Ridge, Hamilton, Warrior, and River View in 2024, we expect to see improved costs and productivity along with reduced capital spending this year. Additionally, the combination of cold winter weather and new LNG export terminal capacity should support strong domestic natural gas prices in 2025, benefiting both our Coal and Royalties segments.”
Mr. Craft concluded, “The increase in forecasted electricity demand, particularly from data centers and growth in AI, is highlighting the inadequacy of current resource plans without extended use of fossil fuel plants. These market realities, coupled with what we expect to be a more favorable regulatory environment, are laying the foundation for Alliance to continue serving as a cornerstone of the country’s reliable electricity infrastructure for years to come. We look forward to what we can achieve in 2025.”
Coal Operations
Total coal sales volumes for the 2024 Quarter decreased 2.3% compared to the 2023 Quarter while remaining relatively consistent compared to the Sequential Quarter. In Appalachia, tons sold decreased by 17.1% and 24.6% in the 2024 Quarter compared to the 2023 Quarter and Sequential Quarter, respectively, primarily as a result of lower production levels which reduced domestic sales volumes from our Tunnel Ridge operation. Partially offsetting these decreases, tons sold increased by 2.8% and 10.5% in the Illinois Basin compared to the 2023 Quarter and Sequential Quarter, respectively, due to improved sales performance from our River View, Hamilton, and Gibson South mines. Coal sales price per ton increased by 4.4% in Appalachia compared to the 2023 Quarter as a result of higher domestic price realizations at our Tunnel Ridge mine. In the Illinois Basin, coal sales prices decreased by 3.9% in the 2024 Quarter compared to the Sequential Quarter primarily due to reduced domestic price realizations from our Hamilton operation. ARLP ended the 2024 Quarter with total coal inventory of 0.6 million tons, representing decreases of 0.7 million tons and 1.4 million tons compared to the end of the 2023 Quarter and Sequential Quarter, respectively.
Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 12.8% and 5.2% in the Illinois Basin compared to the 2023 Quarter and Sequential Quarter, respectively, due primarily to reduced production, higher labor costs and lower recoveries at several mines in the region as well as an $11.0 million non-cash deferred purchase price adjustment recorded in the 2024 Quarter related to the 2015 acquisition of our Hamilton mine. In Appalachia, Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 20.9% and 17.4% compared to the 2023 Quarter and Sequential Quarter, respectively, due to lower recoveries across the region as well as challenging mining conditions which reduced production and led to higher materials and supplies and maintenance costs at our Tunnel Ridge operation.
Royalties
Segment Adjusted EBITDA for the Oil & Gas Royalties segment decreased to $25.6 million in the 2024 Quarter compared to $31.0 million and $28.7 million in the 2023 Quarter and Sequential Quarter, respectively, due primarily to lower average sales price per BOE, which decreased 17.2% and 7.3%, respectively, partially offset by decreased expenses. A reduction in oil & gas volumes compared to the Sequential Quarter also contributed to the sequential decrease.
Segment Adjusted EBITDA for the Coal Royalties segment increased 3.6% to $10.5 million for the 2024 Quarter compared to $10.2 million for the 2023 Quarter as a result of higher royalty tons sold, which increased 9.4%, partially offset by increased selling expenses and lower average royalty rates per ton received from the Partnership’s mining subsidiaries. Compared to the Sequential Quarter, Segment Adjusted EBITDA decreased 4.8% due to higher selling expenses, partially offset by increased sales volumes.
Balance Sheet and Liquidity
As of December 31, 2024, total debt and finance leases outstanding were $490.8 million, including $400 million in recently issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.69 times and 0.50 times debt to trailing twelve months Adjusted EBITDA, respectively, as of December 31, 2024. ARLP ended the 2024 Quarter with total liquidity of $593.9 million, which included $137.0 million of cash and cash equivalents and $456.9 million of borrowings available under its revolving credit and accounts receivable securitization facilities. ARLP also held 482 bitcoins valued at $45.0 million as of December 31, 2024.
Distributions
On January 28, 2025, the Board of Directors of ARLP’s general partner (the “Board”) approved a cash distribution to unitholders for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on February 14, 2025, to all unitholders of record as of the close of trading on February 7, 2025. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.
Outlook
“For 2025, we expect improved coal production costs to counterbalance lower market prices, keeping Coal segment margins near 2024 Full Year levels,” commented Mr. Craft. “In the Oil & Gas Royalty business, we achieved record production volumes for the 2024 Full Year despite only making modest additions to our overall acreage position. We continue to favor the cash flow generation profile and ability to self-fund growth in the Oil & Gas Royalties segment, and therefore, will actively pursue growth in this segment in 2025.”
Mr. Craft concluded, “Looking forward, we anticipate a more supportive regulatory environment from the new administration that will help address the growing need for affordable, reliable baseload power without prematurely retiring critical generation sources. As the realities of physics meet the needs of the grid, we believe previously announced retirements will be delayed and our products will remain a cornerstone of energy security in some of the strongest industrial growth areas of the country for years to come.”
ARLP is providing the following guidance for the full year ending December 31, 2025 (the “2025 Full Year”):
Conference Call
A conference call regarding ARLP’s 2024 Quarter and Full Year financial results is scheduled for today at 10:00 a.m. Eastern. To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13750955.
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 evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement 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.
The statements and projections used throughout this release are based on current expectations. These statements and projections are forward-looking, and actual results may differ materially. These projections do not include the potential impact of any mergers, acquisitions or other business combinations that may occur after the date of this release. We have included more information below regarding business risks that could affect our results.
FORWARD-LOOKING STATEMENTS: With the exception of historical matters, any matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Those forward-looking statements include expectations with respect to our future financial performance, coal and oil & gas consumption and expected future prices, our ability to increase or maintain unitholder distributions in future quarters, business plans and potential growth with respect to our energy and infrastructure transition investments, optimizing cash flows, reducing operating and capital expenditures, infrastructure projects at our existing properties, growth in domestic electricity demand, preserving liquidity and maintaining financial flexibility, and our future repurchases of units and senior notes, among others. These risks to our ability to achieve these outcomes include, but are not limited to, the following: decline in the coal industry’s share of electricity generation, including as a result of environmental concerns related to coal mining and combustion, the cost and perceived benefits of other sources of electricity and fuels, such as oil & gas, nuclear energy, and renewable fuels and the planned retirement of coal-fired power plants in the U.S.; our ability to provide fuel for growth in domestic energy demand, should it materialize; changes in macroeconomic and market conditions and market volatility, and the impact of such changes and volatility on our financial position; changes in global economic and geo-political conditions or changes in industries in which our customers operate; changes in commodity prices, demand and availability which could affect our operating results and cash flows; the outcome or escalation of current hostilities in Ukraine and the Israel-Gaza conflict; the severity, magnitude and duration of any future pandemics and impacts of such pandemics and of businesses’ and governments’ responses to such pandemics on our operations and personnel, and on demand for coal, oil, and natural gas, the financial condition of our customers and suppliers and operators, available liquidity and capital sources and broader economic disruptions; actions of the major oil-producing countries with respect to oil production volumes and prices could have direct and indirect impacts over the near and long term on oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in competition in domestic and international coal markets and our ability to respond to such changes; potential shut-ins of production by the operators of the properties in which we hold oil & gas mineral interests due to low commodity prices or the lack of downstream demand or storage capacity; risks associated with the expansion of and investments into the infrastructure of our operations and properties, including the timing of such investments coming online; our ability to identify and complete acquisitions and to successfully integrate such acquisitions into our business and achieve the anticipated benefits therefrom; our ability to identify and invest in new energy and infrastructure transition ventures; the success of our development plans for our wholly owned subsidiary, Matrix Design Group, LLC, and our investments in emerging infrastructure and technology companies; dependence on significant customer contracts, including renewing existing contracts upon expiration; adjustments made in price, volume, or terms to existing coal supply agreements; the effects of and changes in trade, monetary and fiscal policies and laws, and the results of central bank policy actions, including interest rates, bank failures, and associated liquidity risks; the effects of and changes in taxes or tariffs and other trade measures adopted by the United States and foreign governments; legislation, regulations, and court decisions and interpretations thereof, both domestic and foreign, including those relating to the environment and the release of greenhouse gases, such as the Environmental Protection Agency’s recently promulgated emissions regulations for coal-fired power plants, and state legislation seeking to impose liability on a wide range of energy companies under greenhouse gas “superfund” laws, mining, miner health and safety, hydraulic fracturing, and health care; deregulation of the electric utility industry or the effects of any adverse change in the coal industry, electric utility industry, or general economic conditions; investors’ and other stakeholders’ increasing attention to environmental, social, and governance matters; liquidity constraints, including those resulting from any future unavailability of financing; customer bankruptcies, cancellations or breaches to existing contracts, or other failures to perform; customer delays, failure to take coal under contracts or defaults in making payments; our productivity levels and margins earned on our coal sales; disruptions to oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in equipment, raw material, service or labor costs or availability, including due to inflationary pressures; changes in our ability to recruit, hire and maintain labor; our ability to maintain satisfactory relations with our employees; increases in labor costs, adverse changes in work rules, or cash payments or projections associated with workers’ compensation claims; increases in transportation costs and risk of transportation delays or interruptions; operational interruptions due to geologic, permitting, labor, weather, supply chain shortage of equipment or mine supplies, or other factors; risks associated with major mine-related accidents, mine fires, mine floods or other interruptions; results of litigation, including claims not yet asserted; foreign currency fluctuations that could adversely affect the competitiveness of our coal abroad; difficulty maintaining our surety bonds for mine reclamation as well as workers’ compensation and black lung benefits; difficulty in making accurate assumptions and projections regarding post-mine reclamation as well as pension, black lung benefits, and other post-retirement benefit liabilities; uncertainties in estimating and replacing our coal mineral reserves and resources; uncertainties in estimating and replacing our oil & gas reserves; uncertainties in the amount of oil & gas production due to the level of drilling and completion activity by the operators of our oil & gas properties; uncertainties in the future of the electric vehicle industry and the market for EV charging stations; the impact of current and potential changes to federal or state tax rules and regulations, including a loss or reduction of benefits from certain tax deductions and credits; difficulty obtaining commercial property insurance, and risks associated with our participation in the commercial insurance property program; evolving cybersecurity risks, such as those involving unauthorized access, denial-of-service attacks, malicious software, data privacy breaches by employees, insiders or others with authorized access, cyber or phishing attacks, ransomware, malware, social engineering, physical breaches, or other actions; and difficulty in making accurate assumptions and projections regarding future revenues and costs associated with equity investments in companies we do not control.
Additional information concerning these, and other factors can be found in ARLP’s public periodic filings with the SEC, including ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 23, 2024, and ARLP’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, filed on May 9, 2024, August 7, 2024 and November 7, 2024, respectively. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.
Reconciliation of Non-GAAP Financial Measures (Unaudited)
Reconciliation of GAAP “net income attributable to ARLP” to non-GAAP “EBITDA,” “Adjusted EBITDA,” “Distribution Coverage Ratio” and “Distributable Cash Flow” (in thousands).
EBITDA is defined as net income attributable to ARLP before net interest expense, income taxes and depreciation, depletion and amortization and Adjusted EBITDA is EBITDA adjusted for certain items that we characterize as unrepresentative of our ongoing operations. Distributable cash flow (“DCF”) is defined as Adjusted EBITDA excluding equity method investment earnings, interest expense (before capitalized interest), interest income, income taxes and estimated maintenance capital expenditures and adding distributions from equity method investments and litigation expense accrual. Distribution coverage ratio (“DCR”) is defined as DCF divided by distributions paid to partners.
Management believes that the presentation of such additional financial measures provides useful information to investors regarding our performance and results of operations because these measures, when used in conjunction with related GAAP financial measures, (i) provide additional information about our core operating performance and ability to generate and distribute cash flow, (ii) provide investors with the financial analytical framework upon which management bases financial, operational, compensation and planning decisions and (iii) present measurements that investors, rating agencies and debt holders have indicated are useful in assessing us and our results of operations.
EBITDA, Adjusted EBITDA, DCF and DCR should not be considered as alternatives to net income attributable to ARLP, net income, income from operations, cash flows from operating activities or any other measure of financial performance presented in accordance with GAAP. EBITDA and DCF are not intended to represent cash flow and do not represent the measure of cash available for distribution. Our method of computing EBITDA, Adjusted EBITDA, DCF and DCR may not be the same method used to compute similar measures reported by other companies, or EBITDA, Adjusted EBITDA, DCF and DCR may be computed differently by us in different contexts (i.e., public reporting versus computation under financing agreements).
Investor Relations Contact Cary P. Marshall Senior Vice President and Chief Financial Officer 918-295-7673 investorrelations@arlp.com
MALVERN, Pa., Feb. 03, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU400 Advanced Therapy Medicinal Product (ATMP) classification. OCU400 is the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.
“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States (U.S.) and Europe by 2027.”
ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance as the Company pursues Marketing Authorization Application (MAA) filing in 2026.
Underscoring the vital need for gene-agnostic treatments for diseases with multiple mutations such as RP, both the U.S. Food and Drug Administration (FDA) and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA)/MAA submissions. Ocugen intends to file simultaneously in the U.S. and Europe upon completion of the Phase 3 trial.
The Phase 3 OCU400 liMeliGhT clinical trial is currently enrolling. The study has a sample size of 150 participants—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic. In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older, with early through late-stage advancement of RP, are being recruited to participate in the liMeliGhT study.
“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”
RP affects nearly 310,000 patients in the U.S., EU, and Canada. Currently, RP is associated with mutations in more than 100 genes and there are no approved treatment options that slow or stop the progression of multiple forms of RP.
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health 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 treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements
Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “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,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
