Nutriband granted patent protecting its AVERSA abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China
April 11, 2025 07:00 ET
ORLANDO, Fla., April 11, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received notification that its patent has been granted in Macao for its patent entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology.
The Macao Intellectual Property Office granted patent J/9010 on February 11, 2025 as recorded in Macao Official Bulletin No. 10 on March 5, 2025. Macao is a Special Administrative Region (SAR) of the People’s Republic of China that has its own patent system and patent laws which are separate and distinct from those of mainland China.
The AVERSA™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao.
Nutriband’s AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them.
Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1
____________________________________________________ 1 Health Advances AVERSA Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
NEW YORK, April 11, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”) announced today that it has secured the rights to a new data center site in Saint-Jérôme, Québec (“MTL-3”), which is under development and will support the previously announced 5MW colocation agreement with Cerebras Systems (“Cerebras”), a leader in generative AI infrastructure.
The facility spans approximately 202,000 square feet on 7.7 acres and is being developed to support current contracted capacity, with future expansion potential subject to utility approvals. The transaction was executed under a lease-to-own structure, which includes a fixed-price purchase option exercisable within 12 months. The lease term is 20 years, with two 5-year extension options.
The project is being delivered through WhiteFiber, Bit Digital’s high-performance computing platform. The facility is being retrofitted to Tier 3 standards, with development costs expected to total approximately CAD $55 million (approximately $40MM USD), and a targeted go-live date of July 2025.
“This milestone represents continued momentum in our strategy to deliver purpose-built AI infrastructure at scale,” said Sam Tabar, CEO of Bit Digital. “Speed to market is a key differentiator in the AI infrastructure space, and this site reflects our ability to mobilize and deliver capacity on accelerated timelines. We’re proud to advance our partnership with Cerebras while expanding our data center footprint in the greater Montréal region, a growing hub for AI innovation.”
Cerebras has contracted for 5MW (IT load) of built-to-suit infrastructure under a five-year colocation agreement announced in February 2025. Under the terms of the agreement, Cerebras holds a right of first refusal (ROFR) for any additional megawatt capacity that becomes available at the site.
About Bit Digital
Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. The Company’s HPC business operates under the WhiteFiber Inc. (“WhiteFiber”) brand. Our operations are located in the US, Canada, and Iceland. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com, or follow us on LinkedIn or X.
Investor Notice
Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.
Safe Harbor Statement
This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy –
– Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use –
– Results to be presented in poster sessions at the NKF Spring Clinical Meetings –
LOS ALTOS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced new patient-reported outcomes data from its pivotal Phase 2 study of OLC as well as from a new survey conducted by the National Kidney Foundation (NKF) with sponsorship from Unicycive. OLC is an investigational treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The findings will be presented today in poster sessions at the NKF Spring Clinical Meetings taking place in Boston.
OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis and set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
“As many as two out of three of patients with end-stage kidney disease undergoing dialysis don’t consistently adhere to their phosphate binder treatment; common barriers are side effects, pill burden, and unpalatable formulations,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial. “These new patient-reported outcomes underscore the potential of OLC to enhance adherence, reduce treatment burden and improve patient satisfaction. OLC could be a welcome new phosphate binder choice for patients with hyperphosphatemia due to its favorable tolerability, small, easy-to-swallow size and low pill burden.”
Patient-Reported Outcomes Data Patient-reported outcomes from the open-label Phase 2 UNI-OLC-201 clinical trial compared patients’ satisfaction with their pre-trial phosphate binders versus OLC at the end of the study based on responses to a questionnaire completed by 80 patients. This research will be presented by Guru Reddy, PhD., in the poster titled “Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence” (Poster # G-018) on Thursday, April 10, from 5:15–7:30 p.m. ET.
Results:
OLC reduced pill burden by 50% – patients took a median of three tablets of OLC per day versus six tablets of phosphate binders prior to the trial.
OLC improved adherence – 70% of patients reported consistent adherence with OLC compared to 58% who reported adherence to their pre-trial phosphate binders.
OLC was preferred – 79% of patients indicated a preference for OLC versus 4% who preferred their pre-trial phosphate binder medications.
OLC improved patient satisfaction – 98% of patients agreed that OLC was easy to take versus 38% who said that about their pre-trial phosphate binder medication, and 89% reported they were satisfied with OLC treatment versus 49% who were satisfied with pre-trial phosphate binders.
Patient Survey Results In partnership with Unicycive, NKF conducted an online survey of patients undergoing dialysis to assess the top barriers to phosphate binder adherence and to better understand what treatment characteristics could improve adherence. A total of 200 patients aged 40 and older completed the online survey from February 15 to May 16, 2024. This research will be presented by Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities, in a poster titled “Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients” (Poster # G-297) on Thursday, April 10, from 5:15-7:30 p.m. ET.
Results showed:
Forgetfulness (63%) was the primary barrier to consistent medication use followed by excessive pill number (47%) and large pill size (47%).
Additional barriers to adherence included difficulties carrying pills (45%), gastrointestinal side effects (29%), unpleasant taste (20%), social embarrassment when taking medication (13%), and cost (10%).
Patients were more likely to prefer medication regimens with fewer and smaller pills, underscoring the impact of pill burden on adherence.
About Oxylanthanum Carbonate (OLC) Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
By The Comtech Editorial Team – Apr 9, 2025 | 2 min read
CHANDLER, Ariz. – April 9, 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global communications technology leader, announced today that Comtech Satellite Networks Technologies Corp., located in Montreal, Canada, recently completed initial deliveries of the Company’s next generation Very Small Aperture Terminal (“VSAT”) systems to a strategically significant allied Navy partner in the Asia Pacific (“APAC”) region.
The initial deliveries of Comtech’s VSAT systems mark an important milestone for a comprehensive Navy fleet modernization program. To support the program, Comtech’s next generation VSAT systems are being installed on a wide range of Naval platforms including ships, submarines, and ground-based stations to provide access to advanced multi-orbit satellite communications (“SATCOM”) capabilities across air, land, and sea domains.
“With nearly 60 years of experience designing and developing some of the most trusted VSAT systems in the industry, we remain committed to supporting our partner’s urgent operational requirements,” said Daniel Gizinski, President of Comtech’s Satellite & Space Communications Segment. “This important milestone builds on the trust we have established with a key military ally in the APAC region and further illustrates Comtech’s global leadership in next generation VSAT systems.”
Following months of rigorous testing and performance validation by the end customer, Comtech’s next generation VSAT systems were selected for full-rate production with deliveries continuing over a two-year period.
The next generation VSAT systems delivered to the APAC Navy partner are based on Comtech’s ELEVATE software-defined, multi-orbit VSAT technology. These systems include powerful IP traffic optimization technologies to mitigate delays inherent to SATCOM, mesh capabilities to allow shorter transmission latency with less bandwidth consumption, and spread spectrum techniques to reduce interference generated when transmitting from small antennas.
Comtech designs, develops, and delivers scalable, software-defined, multi-orbit satellite solutions and ground systems for leading satellite service providers, enterprise customers, and government partners around the world. Built on nearly 60 years of experience deploying field-proven VSAT SATCOM systems, Comtech remains committed to accelerating innovation to connect people across the globe with the best available networks on all SATCOM orbits.
About Comtech
Comtech Telecommunications Corp. is a leading provider of satellite and space communications technologies; terrestrial and wireless network solutions; Next Generation 911 (NG911) and emergency services; and cloud native capabilities to commercial and government customers around the world. Through its culture of innovation and employee empowerment, Comtech leverages its global presence and decades of technology leadership and experience to create some of the world’s most innovative solutions for mission-critical communications. For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Continues to Strengthen its Pandemic Preparedness and Biodefense Vaccine Portfolio
ATLANTA, GA, April 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Patent Application No. 18/394,555 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover prevention of Marburg virus infection utilizing GeoVax’s proprietary MVA-based Marburg vaccine.
Previous presentations of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.
David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our next-generation COVID-19 vaccine, our Mpox/smallpox vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses represents our commitment to addressing highly fatal endemic threats throughout the world. Such viruses have mortality rates between 50%-90% depending on the specific virus strain. Our team is committed to supporting the successful advancement of such a vaccine, as we recognize the critically important medical and biodefense need, reflected by the inclusion of Marburg virus in the FDA Priority Review Voucher program. Within the critically needed area of hemorrhagic fever viruses, GeoVax has successfully developed vaccine candidates addressing Ebola Zaire, Ebola Sudan and Marburg, all having demonstrated impressive results when evaluated in non-human primates. The USPTO’s recognition of our Marburg vaccine technology further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread over 23 patent families.”
Dodd continued, “Our focus extends beyond individual product candidates—we are building a broad, durable defense platform against hemorrhagic fever viruses. We believe this strategy, supported by compelling preclinical data and prioritized by global health authorities, positions GeoVax to play a central role in pandemic preparedness and biodefense.”
About Marburg Virus
Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization (WHO) as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa and the virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.
About the GeoVax MVA Platform
GeoVax’s vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
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. 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.
Agreement includes the use of Tonix’s TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana’s genetically engineered pig organs in xenotransplantation
Establishes framework for Makana’s kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients
CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), (“Tonix”) a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Makana Therapeutics, Inc. (“Makana”), a global leader in the field of xenotransplantation, today announced a collaborative research agreement under which Tonix and Makana will study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible organs and cells for the treatment of organ failure. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell transplant. The goal of the preclinical studies is to support the submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to support compassionate use for patients undergoing xenotransplantation.
“We are excited to partner with Makana in support of our mutual goal to offer novel solutions for patients requiring organ or cellular transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We believe this strategic agreement is a promising step towards utilizing xenotransplantation in the clinic. Makana’s novel genetically engineered (GE) pigs, which have deleted swine leukocyte antigen (SLA)2, has shown improved human compatibility and several other advantages over other technologies including high rates of fertility and birthing, which potentially increases their ability to produce viable organs to satisfy a commercial market globally.”
“Despite significant progress and momentum in the field of xenotransplantation, improving organ compatibility to prevent rejection remains an ongoing challenge,” said Joseph Tector, M.D., Ph.D., Founder of Makana and a practicing transplant surgeon. “This collaboration provides Makana the opportunity to combine its novel GE pig organs with TNX-1500 in our ongoing and future preclinical studies. We view anti-CD40L as a critical part of an effective immunomodulatory regimen for successful xenotransplantation. This collaboration enables us to pursue co-development of our GE organs with the TNX-1500, which has shown best-in-class pharmacokinetics and pharmacodynamics in a human study after showing best-in-class results in preventing rejection in 6-month studies of allo- and xenotransplantation in animals. Our mutual goal is to obtain the best human results as soon as possible.”
“We are thrilled with this collaboration utilizing TNX-1500 as an important element of our xenotransplant therapy. The collaboration with Tonix gives Makana the right product and the right partner to bring Makana toward clinical development,” said Mark Platt, President and Chief Executive Officer of Makana. “Most organ-failure patients today will never receive a lifesaving/life-changing transplant. Our achievement in developing the SLA DR knockout pig has yielded encouraging results with preclinical kidney xenografts and positions us to deliver strong outcomes in clinical development.”
TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for the CD40 ligand. CD40L is an attractive drug development target for transplant immunomodulation since the engagement of the CD40L plays a pivotal role in immune system activation by modulating both antibody and cellular immune responses.
About Makana’s Genetically Engineered (GE) Pigs
Makana began developing pigs for xenotransplantation in 2010. Makana’s 2013 creation of the Triple Knockout (TKO) Pig, lacking three key glycans responsible for hyperacute and acute organ rejection in humans, resulted in the first 1-year preclinical xeno-kidney survivor in animals1. This discovery revitalized the xeno-field and today Makana’s TKO genetics are employed across the xenotransplantation field.
Realizing that the first clinical xenografts failed because of antibody mediated rejection, Makana deferred rushing to the clinic and employed the same stepwise scientific approach to show that these early clinical failures occur because of the development of antibodies against SLA. The final result is that Makana has developed the new TKO plus SLA DR KO pig that eliminates the next barrier to clinical success. Now Makana is poised to achieve longer term clinical success.
Makana has achieved the field’s longest and most consistent preclinical survival without the need to insert human transgenes into its pig genetics. Rejection continues as a barrier to survival in the limited number of emergency IND human transplants performed with transgenic pigs, further supporting Makana’s focus on antigen discovery and deletion in lieu of relying on inserted transgenes to evade the human immune response.
Without the need for transgenes, the future commercialization of Makana’s xeno-organs through breeding will be straightforward. When compared to transgenic animals, Makana’s knockout-only pigs will breed with greater efficiency and eliminate the challenge of retaining transgenic expression. This is an important consideration, reducing both the cost of therapy and the complexity of GE pig production.
Makana’s preclinical successes with SLA-deleted pig kidneys in animal xenotransplantation has depended on the co-administration of primatized 5c8 anti-CD40L monoclonal antibody. Tonix’s TNX-1500 is an Fc-modified version of humanized 5c8, which maintains the activity of 5c8, while improving tolerability.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154 or 5c8 Ag.4 The combining sites of TNX-1500 are derived from humanized 5c8 or ruplizumab, which showed promise in treating systemic lupus erythematosus.5 Chimeric primatized 5c8 showed promise in preventing rejection of organ rejection in animals.6 TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts and renal xenografts.7-9
*TNX-1500 is an investigational new biologic and is not approved for any indication
Citations
Estrada JL, et al. Xenotransplantation. 2015;22(3):194-202.
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 U.S. 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. 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.
About Makana Therapeutics
Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana’s focus on scientifically validated genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products. For more information on Makana, please visit www.makanatherapeutics.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
NORWOOD, Mass., April 08, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report first quarter 2025 financial results on May 7, 2025 after the markets close. Management will host a conference call on May 8, 2025 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q125 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
RESTON, Va., April 8, 2025 /PRNewswire/ — V2X Inc. (NYSE: VVX), has been awarded a $62 million contract to continue its critical work ensuring operational readiness of the COBRA DANE radar system in Alaska. This award solidifies V2X’s position as a leading provider of operational readiness, capability enhancements, and engineering support for COBRA DANE, an extremely powerful and sophisticated radar in the U.S. Space Force arsenal.
“V2X has been the trusted partner in ensuring the continuous operational readiness of COBRA DANE,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “Additionally, V2X has incorporated various engineering enhancement to this essential system, extending its capabilities and readiness. This full-spectrum support emphasizes our differentiated capabilities in radar operations, readiness, and commitment to supporting national security by providing persistent space domain awareness and missile defense.”
Standing 120 feet tall with a 95-foot diameter phased-array face, COBRA DANE is a critical component of the nation’s defense architecture. It can detect and track objects up to 2,000 miles away, supporting U.S. Ballistic Missile Defense. Additionally, the radar plays a key role in space domain awareness, identifying and characterizing satellites and debris in Earth’s orbit.
With this contract extension, V2X continues its legacy in providing full-spectrum mission solutions to ensure the continuous readiness of this essential radar system. The extension work is expected to be completed by March 2027.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Senior Director, Marketing and Communications Angelica.Deoudes@goV2X.com 571-338-5195
CALGARY AB, April 7, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company“) is pleased to announce that it has closed the previously announced strategic acquisition of Cardium light oil focused assets in the Pembina area of Alberta (the “Acquired Assets“) from Obsidian Energy Ltd. (the “Vendor“) for net consideration of approximately $301 million (the “Acquisition“).
The highly accretive Acquisition was funded by a combination of net proceeds released to InPlay pursuant to its previously announced $32.8 million bought deal subscription receipt financing (the “Financing“), an amended $330 million credit facility with a $190 million revolving credit facility, a letter of credit facility of up to $30 million, a fully drawn $110 million two-year amortizing term loan and the issuance of 54,838,709 InPlay common shares to the Vendor at a deemed price of $85 million or $1.55 per share (the “Share Consideration“). The Share Consideration is subject to a six-month lock up period, which may be shortened in certain circumstances.
In accordance with their terms, each one (1) subscription receipt issued pursuant to the Financing was automatically exchanged for one (1) InPlay Share concurrently with the completion of the Acquisition, and the net proceeds were released to InPlay from escrow and used to fund a portion of the cash consideration payable to the Vendor under the Acquisition. Previous holders of subscription receipts of InPlay are not required to take any action to receive the underlying InPlay Shares. Trading in the subscription receipts on the Toronto Stock Exchange is expected to be halted today and the subscription receipts delisted in due course.
Immediately following completion of the Acquisition, InPlay has 167,636,627 InPlay Shares issued and outstanding, inclusive of the underlying 21,145,625 InPlay Shares issued upon conversion of subscription receipts previously issued pursuant to the Financing and the Share Consideration issued to the Vendor.
Concurrent with completion of the Acquisition, InPlay entered into an amended and restated credit agreement with a syndicate of lenders (the “Lenders“) pursuant to which the aggregate available borrowing capacity under InPlay’s Senior Credit Facility has been increased from $110 million to $330 million by way of an increased $190 million revolving credit facility with a term out date extended to June 30, 2026, a fully drawn $110 million two-year amortizing term loan (the “Term Loan“) and a letter of credit facility of up to $30 million. The Term Loan includes quarterly amortization payments of $4.1 million. The covenant and security package under the new Term Loan is substantially the same as the revolving credit facility, with the exception of an additional affirmative covenant to satisfy certain prescribed hedging requirements during the period the Term Loan remains outstanding.
In accordance with a shareholder rights agreement between InPlay and the Vendor, the Vendor nominated Stephen E. Loukas, President and Chief Executive Officer and Peter D. Scott, Senior Vice President and Chief Financial Officer, both of Obsidian Energy Ltd., for election to the InPlay Board of Directors at the Special Meeting. Both nominees were elected as directors of InPlay to serve until the next annual meeting of shareholders or until their successors are elected or appointed. The Vendor nominees have agreed to support the resolutions brought before InPlay shareholders at the 2025 annual general meeting of shareholders.
Reader Advisories
Forward-Looking Information and Statements
This document contains certain forward–looking information and statements within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends”, “forecast” and similar expressions are intended to identify forward-looking information or statements. In particular, but without limiting the foregoing, this document contains forward-looking information and statements pertaining to the following: the Company’s business strategy, milestones and objectives; light crude oil and NGLs weighting estimates; expectations regarding future commodity prices; future oil and natural gas prices; future liquidity and financial capacity; future results from operations and operating metrics; future costs, expenses and royalty rates; future interest costs; the exchange rate between the $US and $Cdn; future development, exploration, acquisition, development and infrastructure activities and related capital expenditures; the amount and timing of capital projects; and methods of funding our capital program.
The internal projections, expectations, or beliefs underlying our Board approved 2025 capital budget and associated guidance are subject to change in light of, among other factors, changes to U.S. economic, regulatory and/or trade policies (including tariffs), the impact of world events including the Russia/Ukraine conflict and war in the Middle East, ongoing results, prevailing economic circumstances, volatile commodity prices, and changes in industry conditions and regulations. InPlay’s 2025 financial outlook and revised guidance provides shareholders with relevant information on management’s expectations for results of operations, excluding any potential acquisitions or dispositions, for such time periods based upon the key assumptions outlined herein. Readers are cautioned that events or circumstances could cause capital plans and associated results to differ materially from those predicted and InPlay’s revised guidance for 2025 may not be appropriate for other purposes. Accordingly, undue reliance should not be placed on same.
Forward-looking statements or information are based on a number of material factors, expectations or assumptions of InPlay which have been used to develop such statements and information, but which may prove to be incorrect. Although InPlay believes that the expectations reflected in such forward-looking statements or information are reasonable, undue reliance should not be placed on forward-looking statements because InPlay can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the current U.S. economic, regulatory and/or trade policies; the impact of increasing competition; the general stability of the economic and political environment in which InPlay operates; the timely receipt of any required regulatory approvals; the ability of InPlay to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which InPlay has an interest in to operate the field in a safe, efficient and effective manner; the ability of InPlay to obtain debt financing on acceptable terms; the anticipated tax treatment of the monthly base dividend; that other than the tariffs that came into effect on March 4, 2025 (some of which were subsequently paused on March 6, 2025), neither the U.S. nor Canada (i) increases the rate or scope of such tariffs (if they come into effect in the future), or imposes new tariffs, on the import of goods from one country to the other, including on oil and natural gas, and/or (ii) imposes any other form of tax, restriction or prohibition on the import or export of products from one country to the other, including on oil and natural gas; the potential scope and duration of tariffs, export taxes, export restrictions or other trade actions; magnitude and duration of potential new or increased tariffs may be imposed on goods imported from Canada into the United States, which could adversely impact InPlay’s revenues; the potential for new and increased U.S. tariffs and protectionist trade measures on Canadian oil and gas imports; changes in political and economic conditions, including risks associated with tariffs, export taxes, export restrictions or other trade actions; impacts of any tariffs imposed on Canadian exports into the United States by the Trump administration and any retaliatory steps taken by the Canadian federal government; that InPlay’s results and operations could be adversely affected by economic or geopolitical developments, including protectionist trade policies such as tariffs, or other events; conditions in international markets, including social and political conditions, civil unrest, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, tariffs and other protectionist measures; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and the ability of InPlay to secure adequate product transportation; future commodity prices; that various conditions to a shareholder return strategy can be satisfied; the ongoing impact of the Russia/Ukraine conflict and war in the Middle East; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which InPlay operates; and the ability of InPlay to successfully market its oil and natural gas products.
Without limitation of the foregoing, readers are cautioned that the Company’s future dividend payments to shareholders of the Company, if any, and the level thereof will be subject to the discretion of the Board of Directors of InPlay. The Company’s dividend policy and funds available for the payment of dividends, if any, from time to time, is dependent upon, among other things, levels of FAFF, leverage ratios, financial requirements for the Company’s operations and execution of its growth strategy, fluctuations in commodity prices and working capital, the timing and amount of capital expenditures, credit facility availability and limitations on distributions existing thereunder, and other factors beyond the Company’s control. Further, the ability of the Company to pay dividends will be subject to applicable laws, including satisfaction of solvency tests under the Business Corporations Act (Alberta), and satisfaction of certain applicable contractual restrictions contained in the agreements governing the Company’s outstanding indebtedness. Further, the actual amount, the declaration date, the record date and the payment date of any dividend are subject to the discretion of the InPlay Board of Directors. There can be no assurance that InPlay will pay dividends in the future.
The forward-looking information and statements included herein are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward-looking information or statements including, without limitation: changes in industry regulations and legislation (including, but not limited to, tax laws, royalties, and environmental regulations); the risk that the Pembina Cardium asset acquisition may not be completed on the anticipated terms or timing; risks related to an international trade war, including the risk that the U.S. government imposes additional tariffs on Canadian goods, including crude oil and natural gas, and that such tariffs (and/or the Canadian government’s response to such tariffs) adversely affect the demand and/or market price for InPlay’s products and/or otherwise adversely affects InPlay, or lead to the termination of InPlay’s financing arrangements for the Pembina Cardium asset acquisition, including specifically that the imposition of tariffs or similar measures in excess of 10% would be an adverse tariff event for the purposes of InPlay’s new credit facilities to be entered into in connection with the transaction and that the lenders thereunder may choose not to fund the transaction; the continuing impact of the Russia/Ukraine conflict and war in the Middle East; potential changes to U.S. economic, regulatory and/or trade policies as a result of a change in government; inflation and the risk of a global recession; changes in our planned 2025 capital program; changes in our approach to shareholder returns; changes in commodity prices and other assumptions outlined herein; the risk that dividend payments may be reduced, suspended or cancelled; the potential for variation in the quality of the reservoirs in which InPlay operates; changes in the demand for or supply of InPlay’s products; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans or strategies of InPlay or by third party operators of InPlay’s properties; changes in InPlay’s credit structure, increased debt levels or debt service requirements; inaccurate estimation of InPlay’s light crude oil and natural gas reserve and resource volumes; limited, unfavorable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time-to-time in InPlay’s continuous disclosure documents filed on SEDAR+ including InPlay’s Annual Information Form dated March 27, 2024 and the annual management’s discussion & analysis for the year ended December 31, 2024.
This document contains future-oriented financial information and financial outlook information (collectively, “FOFI”) about InPlay’s financial and leverage targets and objectives, potential dividends, and beliefs underlying our Board approved 2025 capital budget and associated guidance, all of which are subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraphs. The actual results of operations of InPlay and the resulting financial results will likely vary from the amounts set forth in this document and such variation may be material. InPlay and its management believe that the FOFI has been prepared on a reasonable basis, reflecting management’s reasonable estimates and judgments. However, because this information is subjective and subject to numerous risks, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, InPlay undertakes no obligation to update such FOFI. FOFI contained in this document was made as of the date of this document and was provided for the purpose of providing further information about InPlay’s anticipated future business operations and strategy. Readers are cautioned that the FOFI contained in this document should not be used for purposes other than for which it is disclosed herein.
The forward-looking information and statements contained in this document speak only as of the date hereof and InPlay does not assume any obligation to publicly update or revise any of the included forward-looking statements or information, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.
Risk Factors to FLI
Risk factors that could materially impact successful execution and actual results of the Company’s 2025 capital program and associated guidance and estimates include:
risks related to an international trade war, including the risk that the U.S. government imposes additional tariffs on Canadian goods, including crude oil and natural gas, and that such tariffs (and/or the Canadian government’s response to such tariffs) adversely affect the demand and/or market price for the Company’s products and/or otherwise adversely affects the Company;
volatility of petroleum and natural gas prices and inherent difficulty in the accuracy of predictions related thereto;
the extent of any unfavourable impacts of wildfires in the province of Alberta.
changes in Federal and Provincial regulations;
the Company’s ability to secure financing for the Board approved 2025 capital program and longer-term capital plans sourced from AFF, bank or other debt instruments, asset sales, equity issuance, infrastructure financing or some combination thereof; and
those additional risk factors set forth in the Company’s MD&A and most recent Annual Information Form filed on SEDAR+.
SOURCE InPlay Oil Corp.
For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Kevin Leonard, Vice President, Business Development, InPlay Oil Corp., Telephone: (587) 893-6804
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm, said today it will release its first-quarter financial results on Thursday, May 8, 2025, at approximately 4:15 p.m., U.S. Eastern Time.
The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Friday, May 9. Dial-in details are as follows:
The dial-in number for U.S. participants is+1 (800) 715-9871.
International participants should call+1 (646) 307-1963.
The security code to access the call is9414856.
Participants are requested to dial in at least five minutes before the scheduled start time.
A recording of the conference call will be accessible on ISG’s investor relations page for approximately four weeks following the call.
About ISG
ISG (Nasdaq: III) is a global AI-centered technology research and advisory firm. A trusted partner to more than 900 clients, including 75 of the world’s top 100 enterprises, ISG is a long-time leader in technology and business services that is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth. The firm, founded in 2006, is known for its proprietary market data, in-depth knowledge of provider ecosystems, and the expertise of its 1,600 professionals worldwide working together to help clients maximize the value of their technology investments.
RESTON, Va., April 7, 2025 /PRNewswire/ — V2X (NYSE: VVX) will highlight its latest readiness innovations at the 2025 Sea-Air-Space Exposition, hosted by the Navy League of the United States, from April 7–9 at the Prince George’s Exhibit Hall. Attendees can visit V2X at Booth 200 to explore solutions designed to enhance the operational effectiveness of the U.S. Navy, U.S. Marine Corps, and other defense customers. Throughout the event, V2X will feature a range of solutions that advance readiness and meet the evolving demands of modern missions, including:
Weapon System Integration
V2X develops, integrates, and sustains mission-critical weapon system capabilities to enhance combat readiness across airborne platforms. V2X delivers secure, platform-agnostic Weapon System Integration (WSI) solutions, ensuring warfighters can rapidly adapt to emerging threats.
Enables enhanced weapons carriage and deployment across fourth- and fifth-generation aircraft.
Supports real-time sense, control, and engagement for greater operational effectiveness.
Enhanced Situational Awareness for Air-to-Ground Operations
V2X will also highlight its advanced communications and situational awareness solutions that enable seamless, multi-domain integration on the battlefield.
The Gateway Mission Router (GMR) provides secure, real-time connectivity across airborne and ground platforms, delivering a Common Operating Picture for enhanced warfighter situational awareness.
GMR integrates with existing platform communications, optimizing data flow while maintaining a low size, weight, power, and cost (SWaP-C) footprint.
New capabilities include Wireless Intercom and Maintenance Data Offload, reinforcing V2X’s support for the DoD’s Combined Joint All-Domain Command and Control initiative.
Full-Spectrum Aviation Readiness
With decades of performance, V2X delivers full-spectrum aviation readiness that keeps more than 1,600 aircraft mission-ready—earning top performance scores across the defense aviation industry. By leveraging advanced technologies and data analytics, V2X provides real-time visibility into flight operations, maintenance, readiness, and supply chains. Our vertically integrated capabilities—ranging from organic engineering and rapid prototyping to four FAA-certified Part 145 repair stations—support critical maintenance, upgrades, and modifications that drive industry-leading aircraft availability rates. V2X’s long-standing support of the Navy’s T-45 and C-12 programs underscores its track record of exceeding expectations and delivering measurable readiness gains.
Visit Booth 200 to meet V2X leaders and explore how the company is advancing aviation readiness and reinforcing its commitment to the Navy, Marine Corps, and mission success across the force.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Senior Director, Marketing and Communications Angelica.Deoudes@goV2X.com 571-338-5195
NORWOOD, Mass., April 07, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer has promoted Ryan Crandall to Chief Commercial Officer, effective immediately. In his new role, Mr. Crandall will lead the Company’s commercial strategy and activities, including Sales, Marketing, Product Development, and Retail Operations. He has served as MariMed’s Chief Revenue Officer since July 2022, and prior was the Company’s Chief Products Officer and SVP, Sales for four years. Mr. Crandall will continue to report to MariMed CEO Jon Levine.
“Ryan has been a driving force behind creating our innovative and trusted portfolio of brands and establishing them as top sellers in our core markets,” said Mr. Levine. “He has also guided our efforts to deliver an exceptional customer experience at our retail locations. His promotion to Chief Commercial Officer is well-deserved and I look forward to his continued contributions to value generation for our customers and shareholders.”
Mr. Crandall entered the cannabis industry in 2014 when he co-created Betty’s Eddies™, a brand of all-natural, cannabis-infused chews that MariMed acquired prior to his joining the company in 2018. Prior, he held a series of executive positions with increasing sales responsibilities in major cybersecurity and software corporations, including RSA Security and EMC2.
“I am honored and excited to step into the role of Chief Commercial Officer at MariMed,” said Mr. Crandall. “Being a part of this great company, with its award-winning brands, dedication to strategic growth initiatives, and commitment to its mission of improving lives, has been a fantastic journey. I’m eager to deepen my collaboration with our talented team, building on our collective success to strengthen MariMed’s position as a leading cannabis products company.”
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies
FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia
If approved by FDA, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., April 07, 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 presented data in a poster presentation at the AAPM 2025 Annual Meeting, held April 3-6, 2025, in Austin, Texas. A copy of the Company’s poster, titled “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Designed as a bedtime treatment to target non-restorative sleep and provide durable benefits, TNX-102 SL has shown statistically significant, robust activity in reducing fibromyalgia pain in two pivotal Phase 3 studies,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Fibromyalgia has historically been overlooked and unrecognized as a chronic pain condition. Patients’ needs have been inadequately addressed by the previously approved products, which results in many patients being prescribed chronic opioids, which are believed to be ineffective, and are instead a deleterious treatment strategy. Designed to address this nociplastic pain, TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
In two pivotal randomized, placebo-controlled clinical trials, the efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) was assessed with a primary endpoint of reducing the weekly average of daily pain from baseline after 14 weeks of treatment using the numeric rating scale scores. In both studies, TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile via a novel mechanism of targeting the sleep disturbance associated with fibromyalgia. TNX-102 SL is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep. TNX-102 SL is designed for rapid, transmucosal absorption and, as demonstrated in pharmacokinetic studies, bypassing first-pass hepatic metabolism resulting in greater bioavailability of cyclobenzaprine that aligns with the sleep cycle to target non-restorative sleep for the purpose of facilitating recovery from the fibromyalgia syndrome.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride (HCl) developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine, a tertiary amine tricyclic, potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine, a secondary amine tricyclic, in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
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