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The Technology was developed by DeepCube, Nano’s In-house Deep Learning-Based AI Group

This Patent Brings Functionality of Language Comprehension

Comparable to ChatGPT to a New Frontier in Log Files & Data

The IP is Another Milestone in the Progress of the Company’s Software for Proprietary Use and Commercial Offering for Other Customers

Waltham, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) — Nano Dimension Ltd. (Nasdaq: NNDM) (“Nano Dimension” or the “Company”), a leading supplier of Additively Manufactured Electronics (“AME”) and multi-dimensional polymer, metal & ceramic Additive Manufacturing (“AM”) 3D printing solutions, today announced the filing of a patent titled “Large Language Models for the Log File Analysis of Industrial Machines” (“The LLM Log Patent” or “The Patent”), which is critical for real-time data analysis and scalable deployment across the Company’s own systems as well as industrial solutions provided to outside customers.

The focus of the Patent is “log data alpha-numeric streams”, which relate to the operation and parameters of a given industrial process and can generate hundreds of parallel subsystems. Currently, real-time analysis of these logs is not possible given the quantity of data; thus, queries and investigations are usually reserved for failure cases long after the occurrence and are limited in scale.

Nano Dimension’s Patent brings capabilities similar to ChatGPT to analyzing extensive log streams. The data can be evaluated in real-time applying highly efficient and economical scalability. By processing those tens or hundreds of concurrent log streams in parallel, the model finds not only patterns and correlations within each stream (i.e., within each module), but more importantly, patterns and correlations between various modules in real-time. As advanced manufacturing increasingly occurs by many industrial systems in a given location, often referred to as “a cell”, or across a network, such analysis of distributed systems becomes paramount. This benefits Nano Dimension’s systems, which are being designed with DeepCube Group’s deep-learning based AI wherever possible, as well as third party customers and partners, who are increasingly looking to the Company to leverage the same software in their own respective industrial systems.

The LLM Log Patent filing is part of a library of the Company’s patents, which includes over 250 patents, of which over 105 are granted.

Dr. Eli David, Chief Technology Officer of AI for the Company, commented: “The filing of the patent Large Language Models for the Log File Analysis of Industrial Machines, is a significant milestone in Nano Dimension and DeepCube Group’s development. This is exactly the type of learning, advancement, and outcome we foresaw in combining our deep learning-based AI with the industrial case of 3D printing or additive manufacturing. We see this as a leading technology that will not only be to the benefit of Nano Dimension’s 3D printing systems, but also other industrial customers, who have been engaged with us at an increasing rate. This Patent brings us into a new era by addressing two distinct issues with existing log stream analysis – real-time and scalability.”

About Nano Dimension

Nano Dimension’s (Nasdaq: NNDM) vision is to transform existing electronics and mechanical manufacturing into Industry 4.0 environmentally friendly & economically efficient precision additive electronics and manufacturing – by delivering solutions that convert digital designs to electronic or mechanical devices – on demand, anytime, anywhere.

Nano Dimension’s strategy is driven by the application of deep learning-based AI to drive improvements in manufacturing capabilities by using self-learning & self-improving systems, along with the management of a distributed manufacturing network via the cloud.

Nano Dimension has served over 2,000 customers across vertical target markets such as aerospace & defense, advanced automotive, high-tech industrial, specialty medical technology, R&D and academia. The company designs and makes Additive Electronics and Additive Manufacturing 3D printing machines and consumable materials. Additive Electronics are manufacturing machines that enable the design and development of High-Performance-Electronic-Devices (Hi-PED®s). Additive Manufacturing includes manufacturing solutions for production of metal, ceramic, and specialty polymers-based applications – from millimeters to several centimeters in size with micron precision.

Through the integration of its portfolio of products, Nano Dimension is offering the advantages of rapid prototyping, high-mix-low-volume production, IP security, minimal environmental footprint, and design-for-manufacturing capabilities, which is all unleashed with the limitless possibilities of additive manufacturing.

For more information, please visit  

www.nano-di.com

.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Nano Dimension is using forward-looking statements in this press release when it discusses the advantages and benefits of LogGPT, benefits to Nano Dimension’s systems as well as third party customers and partners, and that LogGPT brings the Company into a new era. Because such statements deal with future events and are based on Nano Dimension’s current expectations, they are subject to various risks and uncertainties. Actual results, performance, or achievements of Nano Dimension could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Nano Dimension’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 30, 2023, and in any subsequent filings with the SEC. Except as otherwise required by law, Nano Dimension undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Nano Dimension is not responsible for the contents of third-party websites.

NANO DIMENSION INVESTOR RELATIONS CONTACT

Investor Relations | [email protected]

FREDERICK, Md., Sept. 27, 2023 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced that it has partnered with Colcom, Inc. to offer SteraMist iHP products as part of Colcom’s life sciences and healthcare portfolio of products.

With a combined 50 years of technical sales expertise, Colcom, Inc. has joined forces with TOMI under the leadership of Bridget Collins. Established in 1970, Colcom, Inc. is a trusted supplier of high-quality clinical and laboratory equipment. Given its established customer base and extensive expertise in the decontamination industry, this partnership will be mutually advantageous.

Bridget Collins, President of Colcom, Inc., states, “Colcom, Inc. takes great pride in offering SteraMist products alongside our top-tier solutions for the clinical and laboratory sectors. Experienced in the decontamination field, we found SteraMist technology to be superior and believe this collaboration seamlessly aligns with the needs of many of our current customers. We look forward to partnering with TOMI and delivering SteraMist products to our community.”

“We are proud to announce Colcom, Inc. as a sales partner and greatly look forward to working together. Bridget’s extensive expertise in decontamination will serve as a catalyst for our continued expansion within the life science and healthcare sectors,” states E.J. Shane, COO of TOMI.

Learn more about Colcom, Inc. here.

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®  

TOMI™ Environmental Solutions, Inc. (NASDAQ: TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology ® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI products are designed to service a broad spectrum of use sites, including, but not limited to, hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments. 
  
For additional information, please visit https://steramist.com/ or contact us at [email protected]  

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to partnership with Colcom, Inc.. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements involve a number of risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control. As such, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors. Important factors that could affect our performance and cause results to differ materially from management’s expectations are described in the section entitled “Risk Factors,” in our Annual Report on Form 10-K and other SEC filings. These factors include: our history of losses that may prevent us from achieving profitability in the future; our lack of long-term customer contracts and our inability to rely on our sales history or backlog as an indicator of our future sales; that we are subject to a variety or risks associated with doing business internationally; our success in business depends on our ability to adequately protect our intellectual property; and that our stock price is volatile and there is a limited market for our shares. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:  

John Nesbett/Rosalyn Christian  

IMS Investor Relations  

[email protected]  

$3 million awarded by DoD to University of North Carolina Institute of Trauma Recovery to support a proposed 180-patient, randomized, placebo-controlled trial in acute trauma patients

Investigator sponsored trial to evaluate the potential for TNX-102 SL
¹
to reduce the frequency and severity of acute stress reaction, acute stress disorder, and post-traumatic stress disorder (PTSD)

Acute stress disorder is identified in 13-21% of motor vehicle accidents;
^2,3
Individuals with acute stress disorder have an increased risk of developing PTSD; U.S. lifetime PTSD prevalence is approximately 6%
^4-
7

CHATHAM, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that the University of North Carolina (UNC) Institute for Trauma Recovery has been awarded a $3 million grant from the Department of Defense (DoD) to investigate the potential of Tonix’s TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to reduce the frequency and severity of adverse effects of acute trauma. Such adverse effects include acute stress reaction (ASR), acute stress disorder (ASD), and posttraumatic stress disorder (PTSD). ASR refers to the body’s immediate response to trauma, whereas ASD represents the short-term effects of trauma, and PTSD represents the long-term effects of trauma.

“In addition to emergency care to treat and help patients recover from physical wounds, whether in the emergency room or on the battlefield, we must also address the unmet need for treatment options to address ‘invisible wounds’ that survivors may experience following a traumatic event,” said Samuel McLean, M.D., Professor of Psychiatry and Emergency Medicine at the UNC School of Medicine at UNC, School of Medicine, and lead principal investigator of the proposed study. “To address these needs, we are investigating TNX-102 SL as a potential treatment for patients who experience trauma and traumatic stress.”

The proposed Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department after a motor vehicle collision. The trial will enroll approximately 180 trauma survivors at study sites around the U.S. Participants will be randomized in the emergency department to receive a two-week course of either TNX-102 SL or placebo.

Initiation of patient enrollment in the proposed investigator sponsored OASIS trial is anticipated in the beginning of 2024, subject to Investigational New Drug (IND) application submission and U.S. Food and Drug Administration (FDA) clearance.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. The AURORA study is a major national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the health care arm of Google’s parent company Alphabet.

“No medications are currently available at or near the point of care to treat patients suffering from traumatic events and support long-term health, whether U.S. military exposed to life-threatening events or civilians experiencing traumatic events such as motor vehicle collisions,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Acute stress reaction and posttraumatic stress symptoms are common among civilian motor vehicle collision survivors. The AURORA study, which has collected thousands of data points from motor vehicle collisions, will allow us to better investigate the correlation between motor vehicle collisions and the emergence of acute stress disorder or PTSD symptoms. And leveraging support from the AURORA study and utilizing the DoD’s non-dilutive capital to primarily fund OASIS allows Tonix and UNC to streamline trial efficiency, reduce costs and increase trial power through enriching the target patient population.”

Added Brandon Staglin, President of One Mind, “For individuals who experience trauma and traumatic stress, the need for effective treatments is an urgent one. The OASIS trial’s focus on evaluating a promising potential treatment option exemplifies the kind of evidence-based outcomes One Mind and our partners hoped to achieve as part of the AURORA initiative’s broader efforts to improve the lives of trauma survivors.”

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives.⁵ In the U.S. alone, one-third of emergency department visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.⁸ Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.⁹

About TNX-102 SL in Post-Traumatic Stress Disorder

Sleep disturbances in PTSD are a potential target for pharmacotherapy. TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for once-daily bedtime dosing and rapid transmucosal absorption such that cyclobenzaprine plasma levels rapidly rise during the onset of sleep and first four hours of sleep, then rapidly fall through the second half of sleep through awakening. Cyclobenzaprine has potent binding and antagonist activity at 5-HT_2A, α₁-adrenergic, H₁-histaminergic, and M₁ muscarinic receptors, each of which play roles in the pharmacological management of insomnia. The sublingual transmucosal formulation of cyclobenzaprine is designed to bypass first-pass hepatic metabolism, increasing the ratio in plasma of the parent cyclobenzaprine to the long-lived active metabolite, norcyclobenzaprine, which has a longer half-life and consequently less circadian variation with once-daily dosing. The use of TNX-102 SL 5.6 mg administered daily at bedtime to reduce PTSD symptoms and improve sleep quality in patients with PTSD is supported by the results of a Phase 2 trial (AtEase NCT02277704 in military-related PTSD) and two Phase 3 trials (HONOR or NCT03062540 in military-related PTSD and RECOVERY or NCT03841773 in PTSD). ^10-12 In each of these studies, early improvements in sleep were associated with TNX-102 SL treatment as measured by the PROMIS sleep disturbance (SD) scale. Moreover, in AtEase and HONOR, early and sustained improvement in sleep were associated with TNX-102 SL treatment by the Clinician Administered PTSD Scale (CAPS-5)¹³ “sleep disturbance” item. Primary analyses comparing change from baseline CAPS-5 total severity between TNX-102 SL 5.6 mg and placebo at week 12 were not significant in AtEase, HONOR or RECOVERY. However, in HONOR and RECOVERY at week 4, TNX-102 SL treatment was associated with an improvement in CAPS-5 total severity as compared to placebo. Moreover, secondary analyses in all three studies showed TNX-102 SL treatment was associated with benefits on the patient global impression of change (PGIC), indicating that across studies TNX-102 SL treated patients self-reported greater symptom improvement than those treated with placebo. The most common side-effects were administration site reactions described as tongue numbness or abnormal taste and reported by approximately 30% of participants. There were no unexpected safety findings. Together these studies, with approximately 650 trauma-exposed patients (included 254 patients treated with TNX-102 SL 5.6 mg), provide preliminary evidence that TNX-102 SL is well-tolerated and may promote recovery from PTSD via a pharmacodynamic mechanism of sleep-dependent emotional memory processing.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which 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, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. 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.

Tonix Pharmaceuticals Holding Corp.
*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1. TNX-102 SL has not been approved for any indication
2. Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Association. Pg 284
3. Dai W, et al. BMC Psychiatry. 2018. 18, 188
4. U.S. Department of Veterans Affairs. Epidemiology and Impact of PTSD. www.ptsd.va.gov/professional/treat/essentials/epidemiology.asp#one
5. Goldstein RB, et al. Soc Psychiatry Psychiatr Epidemiol. 2016. 51(8):1137-48
6. Kessler RC, et al. Arch Gen Psychiatry. 2005. 62(6):593-602
7. U.S. Department of Veteran Affairs. How Common is PTSD in Adults? www.ptsd.va.gov/understand/common/common_adults.asp
8. Wisco BE, et al. J Clin Psychiatry. 2014. 75(12):1338-46
9. Thompson M. Time. 2015;185(12):40-3
10. Sullivan GM, et al. Psychiatry Res. 2021. 301:113974
11. Rauch SAM, et al. J Clin Psychiatry. 2021. 82(4)
12. Ivanova A, et al. J Biopharm Stat. 2022. 32(3):441-449
13. U.S. Department of Veterans Affairs. PTSD Checklist for DSM-5 (PCL-5). https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp#obtain

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039

NEW YORK, NY, Sept. 27, 2023 (GLOBE NEWSWIRE) — Integrated Wellness Acquisition Corp (NYSE: WEL) (the “Company”) announced that it notified Refreshing USA, LLC, that the Company had elected to terminate the Agreement and Plan of Merger among the parties, dated as of February 10, 2023 (the “Merger Agreement”), effective immediately, pursuant to Section 8.1(b) thereof, since the conditions to the closing of the initial business combination were not satisfied or waived by the outside date of July 31, 2023 (the “Termination”). As a result, the Merger Agreement is of no further force and effect, with the exception of certain specified provisions in the Merger Agreement, which shall survive the Termination and remain in full force and effect in accordance with their respective terms. The Company and its sponsor intend to seek alternative ways to consummate an initial business combination.

About Integrated Wellness Acquisition Corp

Integrated Wellness Acquisition Corp (NYSE: WEL) is a special purpose acquisition company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization, or similar business combination with one or more businesses. While Integrated Wellness may pursue an acquisition opportunity in any industry or sector, it intends to focus on businesses in the health, nutrition, fitness, wellness, and beauty sectors and the products, devices, applications, and technology driving growth within these verticals. Integrated Wellness is led by Chief Executive Officer Steven Schapera, Chairman of the Board Antonio Varano Della Vergiliana, Chief Financial Officer James MacPherson, and Chief Operating Officer Robert Quandt. Integrated Wellness’ independent directors include Gael Forterre, Scott Powell, and Hadrien Forterre.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus for the offering filed with the SEC. Copies are available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contact Information:
Steven Schapera
Chief Executive Officer
Integrated Wellness Acquisition Corp
Email: [email protected]
Website: www.integratedwellnessholdings.com

• Clinical trial evaluating the Company’s novel mRNA biomarkers demonstrated sensitivity for colorectal cancer of 94% with specificity of 97% and advanced adenoma sensitivity of 81%

• Pulsus Group’s 4th International Conference on Gastroenterology, to be held in Paris, France, brings together world-renowned speakers to share discoveries and receive updates in the field of Gastroenterology

BERKELEY, Calif. and MAINZ, Germany, Sept. 27, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it will present the positive detailed results from its ColoFuture study at the 4^th International Conference on Gastroenterology which occurs on October 16th – 18th in Paris, France. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert^®, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories.

“The data generated from this study represents a potentially ground-breaking milestone for CRC detection and we are excited to share the details of our findings with the attending audience of international medical experts,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Multiple novel mRNA biomarkers were identified for possible integration into our pivotal FDA PMA clinical trial, and we look forward to comparing ColoFuture’s data outcome with results from our eAArly DETECT clinical study which remains on track to report in Q4 of this year.”

Presentation Details:

Abstract	QC-ICGR23-128
Session	Poster session, 4th International Conference of Gastroenterology, Paris, France
Title	A novel and non-invasive mRNA and AI based early Colorectal Cancer and Advanced Adenoma detection approach – First interim data review of the international COLOFUTURE case control study
Speaker	Dr. Moritz Eidens

The ColoFuture study was an international clinical trial assessing the performance of ColoAlert with the Company’s novel mRNA markers to determine sensitivity and specificity for colorectal adenocarcinoma and advanced precancerous lesions in the colon. It included 220 subjects aged 40-85 (45% female, 55% male, average age 62.3 years) from participating centers in Germany, Norway and Denmark. The Company reported topline results from ColoFuture in September 2023, and key highlights included a sensitivity of 94% and specificity of 97% for colorectal cancer, along with a sensitivity of 81% for advanced adenomas. The eAArly DETECT study is the U.S. component of ColoFuture which is enrolling 250 subjects across 25 sites.

The 4^th International Conference on Gastroenterology brings together world-renowned speakers including scientists, doctors, professors, examiners, instructors, and researchers to share discoveries and ground-breaking ideas in the field of gastrointestinal research.

About ColoAlert

^®


ColoAlert^®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert^® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert^® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert^® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed N.V.

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert^®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert^® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter/X and Facebook.

For media inquiries:

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Josh Stanbury
+1 416 628 7441
[email protected]

For investor inquiries, please contact [email protected]

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

FARMINGTON HILLS, Mich., and PITTSBURGH, Sept. 27, 2023 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders and Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI^™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.

“The FDA’s approval of RYZUMVI marks a significant milestone for our Eye Care Division and underscores Viatris’ commitment to advancing eye care and enhancing access for both eye care professionals and patients,” said Viatris Eye Care Division President Jeffrey Nau, Ph.D. “Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases. Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes. We look forward to launching RYZUMVI in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders.”

In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils¹, which can last up 24 hours². Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)² and blurred vision², which may make it difficult to read, work and drive.^3,4

“We are pleased to receive FDA approval of RYZUMVI eye drops and look forward to Viatris’ successful commercial execution,” said Rick Rodgers, MBA, Interim Chief Executive Officer of Ocuphire. “We are grateful to the many patients and investigators who participated in our clinical trials, as well as the Ocuphire and Viatris teams for their commitment to patients.”

RYZUMVI was evaluated in the comprehensive MIRA clinical trial program involving more than 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial. In the MIRA-2 and MIRA-3 trials, a total of 553 subjects aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd) were randomized. Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent. The percentage of subjects with study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater (p<0.01) at all time points measured from 60 minutes through 24 hours in the RYZUMVI group compared with the placebo (vehicle) group across both of the MIRA-2 and MIRA-3 trials (see Figure 1 in the US PI). The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years. Pediatric subjects aged 12 to 17 years (n=27) were treated in MIRA-2 and MIRA-3 and pediatric subjects, aged 3 to 11 years (n=11) were treated in MIRA-4.

The most common ocular adverse reactions reported in >5% of subjects were instillation site discomfort including pain, stinging and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction reported in >5% of subjects was dysgeusia (6%).

About Pharmacologically-Induced Mydriasis

An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (back-of-the-eye) either for routine check-ups, disease monitoring or surgical procedures¹. Pharmacologically-induced mydriasis can last up to 24 hours in adults and children². Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)² and blurred vision², which may make it difficult to read or work and drive^3,4.

About RYZUMVI

^™

(Phentolamine Ophthalmic Solution) 0.75%

RYZUMVI is an anti-microbial preservative-free, topical eye drop formulation of phentolamine ophthalmic solution 0.75% that is FDA-approved to treat pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. RYZUMVI is a relatively non-selective alpha-1 and alpha-2 adrenergic agonist. Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors. Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter. Phentolamine directly antagonizes the mydriatic effect of an α-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.

RYZUMVI

^TM

Important Safety Information

Warnings and Precautions

• Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis).

• Potential for Eye Injury or Contamination: To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. 

• Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses. 

Adverse Reactions 
The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). 

Click here for full Prescribing Information.

About Ocuphire Pharma

Ocuphire Pharma, Inc. is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders. Phentolamine is currently being developed in clinical trials for a number of refractive eye disorder indications in partnership with Viatris. Ocuphire’s lead retinal product candidate, APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) in clinical development for diabetic retinopathy. APX3330 is not approved for use by any regulatory health authority in any country.

About Viatris

Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, and a variety of over-the-counter consumer products. With more than 38,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter, LinkedIn, Instagram and YouTube.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the FDA’s approval of RYZUMVI; the timing of RYZUMVI’s commercial launch in the U.S., and Ocuphire’s business strategy. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) risks that the Viatris partnership may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates; (x) the success and timing of commercialization of any of Ocuphire’s product candidates; and (xi) the maintenance of Ocuphire’s intellectual property rights. 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 risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Ocuphire Contacts:

Corporate: 

Rick Rodgers
Interim President & CEO
[email protected] 

Investor Relations 

Corey Davis, Ph.D. 
LifeSci Advisors
[email protected]

Viatris Contacts:

Media:
+1.724.514.1968
[email protected]

Jennifer Mauer
[email protected]

Matt Klein
[email protected]

Investors:
+1.724.514.1813
[email protected]

Bill Szablewski
[email protected]

OP-MYD-002609

¹ Wilson FA, Stimpson JP, Wang Y. Inconsistencies Exist in National Estimates of Eye Care Services Utilization in the United States. J Ophthalmol. 2015;2015:435606. doi: 10.1155/2015/435606. Epub 2015 Aug 9. PMID: 26346484; PMCID: PMC4546761
² PARAMYD® (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% US Prescribing Information. Somerset, NJ.: Akorn, Inc.; 2001.
³ Goel S, Maharajan P, Chua C, Dong B, Butcher M, Bagga P. Driving ability after pupillary dilatation. Eye (Lond). 2003 Aug;17(6):735-8. doi: 10.1038/sj.eye.6700490. PMID: 12928686
⁴ Siderov J, Bartlett JR, Madigan CJ. Pupillary dilation: the patient’s perspective. Clinical and Experimental Optometry. 1996;79(2):62-66. doi: 10.1111/j.1444-0938.1996.tb04976.

• The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys’ earlier FemBloc studies –
  
• FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway –
  

ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc^®. The FDA approved multi-center pivotal trial is designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option.

Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc^® in late-stage clinical development for permanent birth control and its now-United States Food and Drug Administration (FDA)-cleared product, FemaSeed^® for infertility treatment. The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.

“After just announcing the start of the FINALE trial in August, we are delighted to announce the first academic site is activated to enroll in FemBloc’s FINALE pivotal trial, led by a thought leader in the field of gynecology,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We appreciate the long-standing support for the FemBloc technology evidenced by the prominent investigators who are electing to participate in the FINALE trial, as we work to bring this much needed option to women.”

About the FINALE Pivotal Clinical Trial

Femasys ‘FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] trial (NCT05977751) is designed as a prospective, multi-center, open-label, single-arm study to evaluate the safety and efficacy of FemBloc, a novel, non-surgical female permanent birth control approach. The primary endpoint is pregnancy rate, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. The trial is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for one year. Follow-up will continue annually for five years post-market. For more information, visit www.FemBloc.com.

About FemBloc

^®

FemBloc^® is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in the U.S. alone. For more information, visit www.FemBloc.com.

About Femasys

Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys’ FemBloc^® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys’ FemaSeed^® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is now FDA-cleared (and also approved in Canada). The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada and other non-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s diagnostic products include FemVue^® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath^®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv^®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

Forward-Looking Statements 

This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. 

Contacts: 

Investors 

Chuck Padala 
LifeSci Advisors, LLC 
917-741-7792 
[email protected]

Femasys Inc. 

Investor Contact: 
[email protected]

Media Contact: 
[email protected]

SANTA MONICA, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) — Super League (Nasdaq: SLE) (“Super League” or the “Company”), a global leader in providing immersive experiences across the world’s largest metaverse gaming platforms, today announced that on September 25, 2023, the Company received a written notice from The Nasdaq Stock Market (”Nasdaq”) informing Super League that it has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) (the “Rule”) for continued listing on the Nasdaq Capital Market.

On October 4, 2022, Super League was notified by Nasdaq that it was not in compliance with the minimum bid price rule because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. To regain compliance with the Rule, the Company’s common shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days. This requirement was met on September 22, 2023.

ABOUT SUPER LEAGUE

Super League (Nasdaq: SLE) is a leading strategically-integrated publisher and creator of games and experiences across the world’s largest immersive digital platforms. From metaverse gaming powerhouses such as Roblox, Minecraft and Fortnite, to the most popular Web3 environments such as Sandbox and Decentraland, to bespoke worlds built using the most advanced 3D creation tools, Super League’s innovative solutions provide incomparable access to massive audiences who gather in immersive digital spaces to socialize, play, explore, collaborate, shop, learn and create. As a true end-to-end activation partner for dozens of global brands, Super League offers a complete range of development, distribution, monetization and optimization capabilities designed to engage users through dynamic, energized programs. As an originator of new experiences fueled by a network of top developers, a comprehensive set of proprietary creator tools and a future-forward team of creative professionals, Super League accelerates IP and audience success within the fastest growing sector of the media industry. For more, go to superleague.com.

FORWARD LOOKING STATEMENTS

Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including our expectations regarding our ability to maintain compliance with the Nasdaq continued listing requirements, and our financial condition, growth and strategies. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to our ability to regain compliance with Nasdaq’s listing requirements, the potential de-listing of our shares on Nasdaq, our strategy, business plans and focus, and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Investor Relations Contact:

Shannon Devine/ Mark Schwalenberg
MZ North America
[email protected]

CONTACT

For Super League
Gillian Sheldon
[email protected]