August 6, 2024 – Vancouver, Canada – Century Lithium Corp. (TSXV:LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report the successful addition of a lithium carbonate stage at the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada, USA, part of the Company’s 100%-owned Angel Island Mine (the Project). Prior to this addition, concentrated lithium solutions from the Pilot Plant were treated by Saltworks Inc. at their facility in Richmond B.C. where samples of battery quality lithium carbonate were produced. During the first days of startup of the lithium carbonate stage, Century’s team at the Pilot Plant successfully treated 200 liters of concentrated lithium solution and produced 20 kg of high-grade lithium carbonate onsite.
“At this point in time, the ability to make lithium carbonate at our Pilot Plant is an important step forward, in line with recommendations from our recently completed Feasibility Study” commented President and CEO Bill Willoughby. “The drop in lithium prices over the last year has taken a toll on the share price of all lithium companies. Despite the downturn, domestic production is still key to the security of supply in the U.S. While it is becoming well known that a vast amount of lithium is contained within the claystone deposits of Nevada, the benefit in unlocking these resources is the ability to produce a battery quality lithium product onsite and thereby reducing or eliminating the need for downstream processing.”
The Company continues work at the Pilot Plant, utilizing the Company’s patent-pending process for chloride leaching combined with Direct Lithium Extraction (DLE) to generate data as the Company works to identify further technological breakthroughs to make the extraction of lithium from clay more economic. Adding the lithium carbonate stage at the Pilot Plant is one of the recommendations made in the Feasibility Study, not only to further demonstrate that battery quality lithium carbonate can be made, but to better understand and minimize the recycle streams from the DLE stage through to final product in the process. With the assistance of engineers from Hargrove Engineers and Constructors, Century’s team configured equipment to run 40-liter batches of concentrated lithium solution though precipitation, washing and drying steps. Final assays on the lithium carbonate are pending.
Qualified Person
Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced stage lithium company, focused on developing its 100%-owned Angel Island Mine in west-central Nevada, USA. Century Lithium recently completed a Feasibility Study on its Clayton Valley Lithium Project and is currently in the permitting stage, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.
ON BEHALF OF CENTURY LITHIUM CORP. WILLIAM WILLOUGHBY, PhD., PE President & Chief Executive Officer
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
High-throughput, high-content imaging-based assay developed to screen convalescent sera for neutralizing antibodies to SARS-CoV-2 variants
Study highlights Tonix’s internal R&D capabilities in infectious disease that include a COVID-19 vaccine selected by NIH for Project NextGen and a host-directed anti-viral program awarded a DoD/DTRA contract for up to $34 million
CHATHAM, N.J., Aug. 06, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the publication of a research paper in Microorganisms, a scientific, peer-reviewed, open access journal of microbiology. The article titled, “High-Throughput Screening Assay for Convalescent Sera in COVID-19: Efficacy, Donor Selection, and Variant Neutralization,” by Kota, et al.1, highlights proprietary high-throughput, high-content imaging technology to screen convalescent sera for generating neutralizing, fully-human monoclonal antibodies (mAbs) against SARS-CoV-2 variants and potentially other pathogens.
“This article highlights Tonix’s capabilities in developing fully human mAbs against SARS-CoV-2 and other pathogens,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Our phenotypic imaging system can be used to identify antibodies to counter SARS-CoV-2 and its variants and potentially other infectious agents.”
“COVID-19 rates are on the rise again, and there is growing concern that the short-term protection provided by mRNA vaccines may not be sufficient to control COVID-19 as a public health threat,” continued Dr. Lederman. “Our new publication highlights the capabilities of Tonix’s screening and therapeutic discovery and development technologies.”
In addition to this technology, Tonix has several other research and development programs to prevent and treat viral illnesses. Tonix is developing TNX-801, a live-virus vaccine based on horsepox to protect against mpox and smallpox. TNX-801 is also the vector underlying our Recombinant Pox Virus (RPV) platform technology and to engineer vaccines to protect against other viruses. TNX-1800, which uses the RPV technology, is a potential vaccine against COVID-19 that was selected by National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), for inclusion in clinical trials as part of its Project NextGen for prevention of COVID-19. Tonix also is developing TNX-4200, an orally available CD45 antagonist with broad-spectrum efficacy against a range of viral families. Tonix recently was awarded a $34 million contract from the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA), to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug submission and to fund a first-in-human Phase 1 clinical study using TNX-4200.
In support of our infectious disease programs, Tonix’s experienced team utilizes state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at our research and development center (RDC) located in Frederick, Md. The RDC is located in Maryland’s “I-270 biotech corridor” and is close to the center of the U.S. biodefense research community.
About TNX-4200* The TNX-4200 program aims to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study. Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield. The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.
About Project NextGen Project NextGen is a $5 billion initiative to develop the next generation of vaccines and therapeutics to combat COVID-19. Based at the HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority and the NIH’s NIAID, Project NextGen was stood up to coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people. The program will focus on several areas, including mucosal vaccines, vaccines that provide broader protection against variants of concern and a longer duration of protection, pan-coronavirus vaccines, and new and more durable monoclonal antibodies.
About TNX-801* and Tonix’s RPV Platform TNX-801 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is being developed to target smallpox, and mpox (monkeypox). TNX-801 is also the basis of the RPV platform based on a horsepox vector, which is being adapted as a COVID-19 vaccine, term TNX-1800*. Horsepox is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern vaccinia (VACV) strains in immunocompromised mice.2 Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials.
About TNX-1800* TNX-1800 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is designed to express the spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems. NIAID will cover the full cost of Phase 1 clinical trials, while Tonix will supply the vaccine candidate. The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated3 and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.4
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL*, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was awarded Fast Track designation from the FDA. Tonix expects a decision on marketing approval from the FDA in 2025. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 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.
Kota, K.P. et al. (2024) Microorganisms July 23, 2024.https://doi.org/10.3390/microorganisms1208150
Trefry, SV et al., BioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
Awasthi M, et al. Viruses. 2023. 15(10):2131. doi: 10.3390/v15102131.
Awasthi M et al Vaccines (Basel). 2023. 11(11):1682. doi: 10.3390/vaccines11111682.PMID: 38006014
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
CHATHAM, NJ / ACCESSWIRE / August 1, 2024 / When it comes to chronic pain conditions, fibromyalgia is among the most common, afflicting more than ten million people in the United States. Globally, 3-6% of the world’s population suffers from this chronic disease that has no cure. While it is more prevalent in women, men and children across every race can also be afflicted with fibromyalgia.
With so many people suffering from a disease that brings widespread pain, fatigue and cognitive issues, it’s no wonder the market for symptom treatment has seen steady growth over the years and is poised for more. By 2031, the fibromyalgia treatment market is projected to reach $3.86 billion growing at a CAGR of 3.3% between now and then.
Fibromyalgia is a Serious Disease
This form of chronic pain has become such a problem in the United States that the Food & Drug Administration (FDA) considers the disease to be a serious condition, which means it is a disease associated with morbidity that has a substantial impact on day-to-day functioning. After all, 70% of sufferers have difficulty with daily activities, 90% report poor sleep quality and 20% file disability claims.
Most treatments on the market today are a combination of medication and self-care focused on reducing symptoms and improving the quality of life. Unfortunately, due to dissatisfaction with the available treatment options, many patients (at the direction of their medical providers) turn to opioids to relieve their pain. As it stands, more people diagnosed with fibromyalgia are prescribed opioids than the bestselling FDA-approved drug duloxetine (generic Cymbalta). That’s concerning, given opioids can be addictive and with time, life-threatening.
Of patients prescribed opioids for chronic pain, 21% to 29% misuse them while an average of 8% to 12% develop opioid use disorder. A U.S. policy to address opioid use, which killed more than 100,000 Americans in 2022, is aimed at curtailing imports of fentanyl and synthetics. Many experts believe a concurrent and perhaps more effective strategy is to provide pain sufferers relief with non-addictive products.
Fast Track Granted to TNX-102 SL*
The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia. Tonix says the designation validates that fibromyalgia is a serious condition and that TNX-102 SL, which has no known addictive properties, has the potential to address this unmet medical need.
The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially get new treatments to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development.
“The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options,” said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. “If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years.”
TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity, setting it apart from existing treatments, which fail to manage sleep disturbances that exacerbate fibromyalgia symptoms, the company says.
In recent Phase 3 trials, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.
New Drug Application Coming Soon
In addition to receiving Fast Track status, Tonix announced it is making progress on its new drug application (NDA), which it plans to submit to the FDA in the second half of this year. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding the application for TNX-102 SL.
Tonix plans to request Priority Review designation for TNX-102 SL, and if granted, the FDA may accelerate the review of the new drug application.
“The NDA being prepared supports TNX-102 SL’s potential position as a first-line non-addictive therapy for fibromyalgia, indicated for long-term daily use at bedtime,” said Lederman.
*TNX-102 SL is an investigational new drug and has not been approved for any indication.
Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024
Conference Call Today at 8:00 a.m. Eastern Time
PRINCETON, N.J., Aug. 01, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune® HPV (formerly PDS0101) in this indication.
PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune® HPV + pembrolizumab, and the triple combination of Versamune® HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune® HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune® HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.
The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune® HPV + pembrolizumab combination has received Fast Track designation.
“We appreciate the FDA’s support in the development of both the double and triple Versamune® HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune® HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy.”
Kirk Shepard, MD, Chief Medical Officer, continued, “We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial.”
Conference Call Details Date: August 1, 2024 Time: 8:00 a.m. ET Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here Call MeTM Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
MALVERN, Pa., July 31, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the pricing of its underwritten public offering of 30,434,783 shares of its common stock at an offering price of $1.15 per share of common stock for gross proceeds of $35 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Ocugen. In addition, Ocugen has granted to the underwriter a 30-day option to purchase up to 4,565,217 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about August 2, 2024, subject to the satisfaction of customary closing conditions.
Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.
Titan Partners Group, a division of American Capital Partners, is acting as the sole book-running manager for the offering.
The offering is being made by Ocugen pursuant to a shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the Securities and Exchange Commission (the “SEC”) on April 18, 2024, which became effective on May 1, 2024. The securities may be offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement was filed with the SEC on July 31, 2024. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the preliminary prospectus supplement and the accompanying base prospectus, and when available, copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Titan Partners Group, LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
AboutOcugen,Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding Ocugen’s expectations regarding the timing of the completion of the offering and the anticipated use of proceeds. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the SEC, including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by applicable law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, changed circumstances or otherwise, after the date of this press release.
PRINCETON, N.J., July 31, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the Company will host a conference call to provide a clinical program update on Thursday, August 1, 2024, at 8:00 a.m. ET.
Conference Call Details Date: August 1, 2024 Time: 8:00 a.m. ET Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here Call Me™ Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
MALVERN, Pa., July 31, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has commenced an underwritten public offering (the “offering”) of its common stock. In addition, Ocugen expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the aggregate number of shares of its common stock to be sold in the public offering at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock in the offering are to be sold by Ocugen. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Ocugen intends to use the net proceeds of the proposed offering for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.
Titan Partners Group, a division of American Capital Partners, is acting as the sole book-running manager for the proposed offering.
The offering is being made by Ocugen pursuant to a shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the Securities and Exchange Commission (the “SEC”) on April 18, 2024, which became effective on May 1, 2024. The securities may be offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying base prospectus relating to and describing the proposed terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained, when available, from Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
AboutOcugen,Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding market conditions, completion, timing, size and use of proceeds of the proposed offering and our intention to grant the underwriter a 30-day option to purchase additional shares. There can be no assurance that we will be able to complete the proposed public offering on the anticipated terms, or at all. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the SEC, including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by applicable law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, changed circumstances or otherwise, after the date of this press release.
Company plans Phase 2 trial in first-recurrence head & neck cancer,
in combination with immune checkpoint inhibitor
Atlanta, GA, July 31, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review.
GeoVax and a specially convened clinical advisory committee have completed a comprehensive review of the recently completed PNP-002 Phase 1b/2a trial, together with the previously completed PNP-001 Phase 1 trial. The Phase 1b/2a trial evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with advanced head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol assessed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. This review concluded that Gedeptin demonstrated acceptable safety and efficacy to support continued development. No new safety signals were identified in the PNP-002 trial in heavily pretreated head & neck cancer patients. The therapy demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin in an expanded Phase 2 clinical trial.
The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrence squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. The Company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection with the trial activation anticipated during the first half of 2025.
“Based on the review of the two clinical trials completed with Gedeptin, we believe that this therapy, combined with an immune checkpoint inhibitor, has the potential to represent an active therapy against solid tumors. As such, in alignment with the Gedeptin clinical advisory committee, we have initiated efforts in support of an expanded Phase 2 trial, combining Gedeptin with an immune checkpoint inhibitor as therapy in squamous cell head and neck cancer,” stated J. Marc Pipas, M.D., GeoVax Executive Medical Director, Oncology.
“We are pleased to announce the plans for this novel, expanded Phase 2 clinical trial of Gedeptin, seeking to demonstrate efficacy and safety of Gedeptin and an immune checkpoint inhibitor combination therapy in support of such neoadjuvant therapy. We look forward to activation of this trial and are pursuing development plans in additional solid tumor indications in partnership with leading academic oncology centers. Further updates will be provided during the remainder of 2024,” added David Dodd, GeoVax’s Chairman and CEO.
About Gedeptin®
Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a non-human gene, which expresses an enzyme that converts a nontoxic prodrug into a highly active antitumor compound in situ.
The Phase 1b/2a trial (ClinicalTrials.gov Identifier: NCT03754933) evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entailed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A previously completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.
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®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. 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.
Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1
Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2
Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025
CHATHAM, N.J., July 31, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets), based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 20241.
“The consensus report from the NASEM concludes that fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It has long been recognized that fibromyalgia can arise after a viral illness and is considered an infection-associated chronic condition.2,3 The NASEM definition confirms that fibromyalgia occurs after infection with the SARS-CoV-2 virus in some patients with Long COVID. Tonix is planning to file a New Drug Application (NDA) for Tonmya in the second half of this year for the indication of fibromyalgia with the U.S. Food and Drug Administration (FDA). We believe that diagnosing fibromyalgia in Long COVID patients will increase the potential market for Tonmya following approval as compared to market estimates from before the COVID-19 pandemic.”
Dr. Lederman continued, “Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately 5.3% of U.S. adults suffer from Long COVID, or 14 million people.5 Fibromyalgia is commonly diagnosed in Long COVID patients6-8. Although it is unknown how many Long COVID patients meet the diagnostic criteria for fibromyalgia, the National Institutes of Health (NIH)-sponsored RECOVER study found many Long COVID patients suffer from pain at multiple sites9. The Company has previously presented its analysis of real-world evidence from the TriNetX claims database suggesting that over 40% of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia.10,11 The Company completed a proof-of-concept study in Long COVID patients who presented with multisite pain and found a nominal benefit in fatigue with TNX-102 SL treatment with no new safety signals. We hope this new definition of Long COVID will allow patients suffering from chronic pain and other debilitating symptoms to access the care they need.”
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 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 anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About Tonmya* (also known as TNX-102 SL)
Tonmya™ (cyclobenzaprine HCl sublingual tablets) is a centrally acting, non-opioid, non-addictive, investigational drug being developed as a daily bedtime medication for the management of fibromyalgia, alcohol use disorder and agitation in Alzheimer’s disease. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride TNX-102 SL provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Tonix has recently announced receipt of the formal minutes from both recent pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for Tonmya for the management of fibromyalgia. At these meetings, the Company and the FDA agreed on the proposed content and timing of an NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in 2025. Tonmya for the management of fibromyalgia has been granted FDA Fast Track designation.
About the Phase 2 PREVAIL Study
The Phase 2 PREVAIL study was a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with Long COVID. The trial was conducted at approximately 30 sites in the U.S. The study was not significant on the primary efficacy endpoint of the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Nominal activity of TNX-102 SL was shown in fatigue.
For more information, see ClinicalTrials.gov Identifier: NCT05472090.
About Long COVID
Long COVID is an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. Long COVID is the term widely recognized for the post-COVID syndrome formerly known as Post-acute sequelae of COVID-19, or PASC. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems.
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.
*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Total revenue was €51.7 mm in Q2 2024, while net gaming revenue1 was €54.4 mm in the period, 39% above Q1 2023.
Mexico revenue was €25.3 mm in Q2 2024, while net gaming revenue was €28.2 mm in the period, 57% above Q2 2023.
Spain revenue (and net gaming revenue) reached €21.8 mm in Q2 2024, 25% above Q2 2023.
Net income excluding the non-cash variation in fair value of public warrants2 was €5.5 mm in H1 2024 versus a net loss of €0.7 mm in H1 2023.
Total cash position of €40.5 mm as of June 30, 2024.
Increasing full year 2024 net gaming revenue outlook to €205 – 215 mm and Adj. EBITDA3 outlook to positive €2.5 – 7.5 mm.
Madrid, Spain and Tel Aviv, Israel, July 31, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited4 financial results for the quarter ended June 30, 2024.
Aviv Sher, CEO of Codere Online, commented on the results, “We are very pleased with our performance in the second quarter of 2024, with net gaming revenue of €54.4 million, a 39% increase over the prior year period. In the quarter we saw improved customer engagement and customer acquisitions in part due to targeted additional marketing investments made around certain major sports betting events (i.e. Eurocup and Copa America). As a result, performance in our core Mexican and Spanish businesses was strong (notwithstanding all the Spanish victories in the Eurocup), with net gaming revenue growing by 57% in the second quarter in Mexico to over €28 million and 25% in Spain to nearly €22 million.”
Oscar Iglesias, CFO of Codere Online, stated, “We are pleased to have delivered positive Adjusted EBITDA for the second consecutive quarter despite the increased marketing spend around the Eurocup and Copa America. The €1.3 million in Adjusted EBITDA in the second quarter is nearly €6 million better than the prior year period and for the year-to-date period we have generated €3.0 million.”
Mr. Iglesias further added, “Thanks to this solid performance in the first half of the year, we are well on track to meet the profitability and cash generation expectations we set out to achieve in the beginning of the year, while still delivering significant top line growth. As such, we are raising our outlook for the full year 2024 and now expect to generate between €205 – 215 million of net gaming revenue, which represents a growth of 22% year-on-year at the midpoint, and between €2.5 – 7.5 million of positive Adjusted EBITDA.”
Recent Events
Board Changes
In the AGM held on June 24, 2024, Mr. Gabriel Saenz de Buruaga, Mr. Taavi Davies and Mr. Claude Noesen were appointed as directors, succeeding Mr. Patrick Ramsey, Ms. Michal Elimelech, and Mr. Laurent Teitgen.
Mr. Gonzaga Higuero, CEO of Codere Group, was re-appointed as director and named Chairman of the Board.
Research Coverage
On July 11, 2024, Craig-Hallum Capital Group initiated coverage of Codere Online6.
For more information about research firms currently covering Codere Online please access the Analyst Coverage section of our website.
Conference Call Information
Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, July 31, 2024. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.
About Codere Online Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.
Forward-Looking Statements Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans.
These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, and (xii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.
Financial Information and Non-GAAP Financial Measures Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).
This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue and Adjusted EBITDA. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.
Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.
This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
Use of Projections This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.
For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.
Preliminary Information This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.
No Offer or Solicitation This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Industry and Market Data In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications Guillermo.Lancha@codere.com (+34) 628 928 152
1 Net Gaming Revenue is a non-IFRS measure. Please see reconciliation of Net Gaming Revenue to Revenue at the end of the report. 2 Net income excluding the non-cash variation in fair value of public warrants is a non-IFRS measure. Reconciliation: H1 2024 figure reflects a net loss of €0.2 mm (€0.3 mm in H1 2023) excluding a €5.8 mm loss (€0.3 gain in H1 2023) from the variation in fair value of public warrants. Figures presented for illustrative purposes and do not include any potential impacts on the provision for corporate income taxes. 3 Adjusted EBITDA outlook is a forward-looking non-IFRS measure. Please see important disclaimers at the end of the report. 4 See “Preliminary Information” below. 5 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives. 6 Codere Online does not endorse, recommend, or have any affiliation with Craig-Hallum Capital Group LLC or their research. The views, opinions, and recommendations expressed by Craig-Hallum Capital Group LLC are their own and do not reflect the views or opinions of Codere Online. Investors should conduct their own independent research and consult with a financial advisor before making any investment decisions. Codere Online is not responsible for any losses or damages arising from the use of this information. 7 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia, VAT impact from entry fees in Mexico and the impact from the application of inflation accounting (IAS 29) in Argentina.
Atlanta, GA, July 30, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report second quarter 2024 financial results on Tuesday, August 6, 2024, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
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®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. 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.
Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia, including improvement in pain and sleep quality
Tonix granted FDA Fast Track Designation for Tonmya™; NDA submission on track for the second half of 2024
CHATHAM, N.J., July 30, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, being held August 5-9, 2024 in Amsterdam, Netherlands. Details on the presentation can be found below.
A copy of the Company’s poster presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the IASP website here.
Poster Presentation Details
Presenter:
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
Title:
Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromic Improvement
Abstract:
#WE685
Date/Time:
Wednesday, August 7, 2024, 3:15 p.m. CEST
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya*, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to Tonmya for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.
*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
SKYX will Offer a Variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and More
MIAMI, July 30, 2024 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive smart platform technology company with over 94 issued and pending patents in the U.S. and globally, and which owns over 60 lighting and home décor websites with a mission to make homes and buildings become smart, safe, and advanced as the new standard, announced today a collaboration with world leading home improvement retailer, Home Depot, for its advanced and smart plug & play products.
SKYX will offer a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, and Recessed Lights among others. A large assortment of these advanced and smart products is expected to be offered on Home Depot’s website in the next coming months, while some advanced and smart plug & play retrofit kit products are expected to arrive in select stores and online to be offered as a fixture upgrade.
Steve Schmidt President of SKYX Platform said: “We are truly excited that we are collaborating with the world leading home improvement company Home Depot. Our technology offers a variety of products for both retail and professional segments; therefore, I view this collaboration as a tremendous growth opportunity for us that can have a significant impact on our business”.
Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said: “We are excited to work together with Home Depot, a global leader in retail and professional industries. We strongly believe that this opportunity will have a significant effect on our business and market penetration for both our retail and professional sales channels”.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 94 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
