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MAIA Biotech Completes Enrollment For Phase 2 Trial Of Its Candidate THIO To Fight Non-Small Cell Lung Cancer

Benzinga

By Meg Flippin, Benzinga MAIA Biotechnology Inc. (AMEX: MAIA), the clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, completed enrollment for its phase 2 trial for THIO, its lead therapy to fight advanced non-small cell lung cancer or NSCLC. NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%. THIO targets and compromises the function of telomeres, which play a key role in helping cancer cells live and spread. Telomeres are made from DNA sequences and proteins and sit at the end of chromosomes, capping and protecting them in the cell division progress. Telomeres can be regenerated with the support of telomerase, an enzyme present in the early stages of growth and development in humans and in very few cells of adults. Telomerase is present in nearly all cancers and is expressed in 80% of NSCLC tumors. Evaluating The Effectiveness THIO is recognized by telomerase, leading to the uncapping of telomeres and thus resulting in rapid tumor cell death. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death. The phase 2 THIO-101 go-to-market clinical trial is designed to evaluate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with NSCLC. In preclinical models in vivo, MAIA demonstrated that low doses of THIO followed by anti-PD-L1 or anti-PD1 therapy completely eliminated advanced tumors and produced cancer cell-specific memory to activate the immune system against the cancer cells after extended periods with no need for additional treatment. Enrollment Reached Ahead Of Schedule Earlier in February, the trial reached its enrollment target of 41 patients for the 180 mg dose. Initially, the trial was designed to test three dose levels but following the selection of 180 mg/cycle as the optimal dose in December all patients were enrolled at that dose level and trial enrollment was completed ahead of schedule, the company said in a press release. “Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer when announcing the enrollment results. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months.” THIO Well Tolerated The main objectives of the trial are to evaluate the safety, tolerability and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. THIO is currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. MAIA Biotechnology said treatment with THIO followed by cemiplimab (Libtayo®) followed by THIO has been generally well tolerated to date in a heavily pre-treated population. “As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC,” said Vitoc. While THIO is currently being tested for NSCLC, telomerase is present in 85% to 95% of human cancers and contributes to the proliferation and reproductive immortality of cancer cells. As a result, the company is studying THIO in models of several tumor types with active telomerase, including rate indications in liver, colorectal and brain cancers. That could result in further use cases for MAIA’s lead treatment. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 29, 2024 08:15 AM Eastern Standard Time

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TeamBuilder's Innovative Staff Scheduling Solution Recognized in KLAS Insights Report

TeamBuilder

TeamBuilder, an innovative workforce management solution, has been featured in the latest insights report by KLAS, a renowned healthcare research firm. The report, titled "Emerging Insights Case Study on Workforce Management and Predictive Staff Scheduling through a Digital Platform," highlights TeamBuilder's pioneering approach to staff scheduling and its positive impact on healthcare organizations. Staff scheduling in healthcare has a unique set of challenges that can be exacerbated by provider volume and manual processes for clinical workflow management. These challenges can lead to problematic patient care and poor provider and staff experiences. The TeamBuilder solution, built specifically for ambulatory care, is intended to alleviate organizational pain points around staff scheduling by assessing the needs of day-to-day operations and offering predictive staff scheduling. Key findings from the case study include: Improved Operational Efficiency: TeamBuilder's predictive staff scheduling reduces administrative burdens and streamlines day-to-day operations, allowing healthcare organizations to focus on delivering quality patient care. Enhanced Staff Experience: Users of TeamBuilder's platform reported positive experiences, citing the ease of use, real-time notifications, and centralized communication features as key strengths. Positive Organizational Outcomes: TeamBuilder's digital schedule and recommendation engine drive positive outcomes, including workforce management optimization, reduced staffing costs, and improved visibility into staffing utilization across multiple sites. "What's been done traditionally around using staffing ratios often leads to chronic overstaffing and understaffing because they don't account for nuances like shifting patient volume, provider workflow and sites that answer phones," said David Howard, CEO and Founder of TeamBuilder. "What we've been able to do with TeamBuilder is to use data science to consume all of the nuances of a clinic's operating model and provide managers with the optimal schedule each week. No more paper. No more guessing." To read the full report, visit TeamBuilder — News. About TeamBuilder: TeamBuilder is a predictive staff scheduling platform built specifically for ambulatory care. Contact Details TeamBuilder Media info@teambuilder.io Company Website https://teambuilder.io/

February 29, 2024 08:00 AM Eastern Standard Time

Charges Dismissed Against Dr. Mohammad Faghihi, Farzaneh Modarresi, and Faezeh Faghihi

dr mohammad faghihi

In a significant legal victory, Dr. Mohammad Faghihi, alongside Farzaneh Modarresi and Faezeh Faghihi, have been exonerated of all previously held charges. This announcement marks the resolution of a prolonged legal examination, affirming their commitment to ethical and lawful conduct. The allegations, which pertained to purported violations of international sanctions, were rigorously investigated, leading to this unequivocal dismissal. This outcome substantiates the integrity of the individuals involved and dissolves any misgivings regarding their professional and personal endeavors. Dr. Faghihi, expressing relief and optimism for the future, stated, "We are immensely thankful that justice has prevailed, and we can now focus on our passion for medical science without the weight of these accusations. We extend our heartfelt appreciation to our legal team, family, and friends who have supported us through this challenging time." The dismissal allows these dedicated professionals to continue their valuable contributions to the medical field without the distraction of legal obstacles. About Dr. Mohammad Faghihi: Dr. Mohammad Faghihi is a revered figure in the field of medical genetics, renowned for his pioneering work on non-coding RNAs and their significant role in gene regulation and epigenetics. An alumnus of Shiraz University of Medical Sciences and the esteemed Karolinska Institute, where he earned his Ph.D., Dr. Faghihi has dedicated his career to unraveling the complexities of the human genome and its implications in neurological disorders. His extensive body of research, which has been published in numerous high-impact scientific journals, has not only advanced our understanding of genetic mechanisms but also opened up promising avenues for novel therapeutic strategies. As a committed educator and an innovative researcher, Dr. Faghihi continues to inspire and lead in the biomedical sciences, contributing to breakthroughs that could reshape the future of medical treatments and patient care. For further insight into his professional background, accolades, and contributions to medical science, you may explore his detailed research history and achievements. www.DrMohammadFaghihi.com Scholar Achievements on Google Citations: https://scholar.google.com/citations?user=VT2HrSkAAAAJ&hl=en&oi=ao For Press Inquiries please contact: ALPHABULL LLC Phone: +1 (800) 530-0142 Email: cs@alphabull.io Contact Details AlphaBull.IO PR AlphaBull Public Relations +1 800-530-0412 cs@alphabull.io Company Website https://www.drmohammadfaghihi.com/

February 28, 2024 04:27 PM Eastern Standard Time

Mothers’ Milk Bank Announces Critical Need for Donor Milk

Mothers' Milk Bank

Mothers’ Milk Bank (MMB), the California-based nonprofit, is inviting lactating mothers to join its network of milk donors, aiming to expand its pool of contributors. This announcement comes on the heels of a new University of Iowa study on the health benefits of donated breast milk for extremely premature infants. The importance of donated breast milk has garnered international media attention in recent months after tennis champion Serena Williams shared her milk donation in a viral social media post. In response to the significant demand for human donor milk and the urgent need to support our communities' most vulnerable members, Mother’s Milk Bank is leading a comprehensive initiative to recruit new milk donors. This initiative includes "Milk Meet-Ups," providing opportunities for individuals to begin the month-long process of qualifying as milk donors. These Meet-Ups will kick off with an in-person Milk Drive on February 29 in Madera County at the Madera Department of Public Health, marking the start of an ambitious Milk Donor Drive aiming to enlist 5,000 new donors throughout 2024. Mothers’ Milk Bank Milk Meet-Up Schedule: Madera County (north of Fresno): Madera Department of Public Health Date: February 29, 2024 | Time: 10:30am - 12:30pm Location: 1604 Sunrise Ave, Madera, CA 93638 | Oz Conference Room Los Angeles County: Henry Mayo’s Lactation Department Date: March 28, 2024 | Time: TBD Location: 23861 McBean Pkwy Suite B-14 Valencia CA, 91355 VIRTUAL Milk Drive with Lucile Packard Children's Hospital Click to start the donor registration process beginning April 1, 2024 Santa Cruz County: Watsonville Community Hospital Date: May 2, 2024 | Time: 10:00am - 12:00pm Location: 75 Nielson St., Watsonville, CA 95076 | Conference Room 1 & 2 Sacramento County: McKinley Park Date: May 3, 2024 | Time: 10:00am - 1:00pm Location: 601 Alhambra Blvd, Sacramento, CA 95816 Placer County: Women’s & Children’s Center Date: May 4, 2024 | Time:10:00am - 1:00pm Location: 1600 Eureka Rd., Roseville, CA 95661 | Building B Premature infants, medically fragile babies, and those with special medical needs depend on donated breast milk for their survival. In 2023, over 2,000 generous donors contributed to Mothers’ Milk Bank, providing 1.64 million ounces of this life-saving mothers’ milk to babies in need across the United States. Recognizing the growing demand, Mothers’ Milk Bank anticipates an increased need in 2024. To meet this demand, the organization aims to recruit 5,000 lactating mothers from diverse backgrounds to become donors of this precious "liquid gold”. The process to become a donor typically takes a month, resulting in an ongoing need to recruit new donors to ensure a steady supply of donor milk. On average, most donors only send milk for less than one year or until their baby turns one, it is critical to consistently raise awareness of the importance of donating surplus mothers’ milk. “We are experiencing a pressing need for more milk donors, and it's vital for the welfare of the infants depending on our services that we expand our donor network without delay," states Jennifer Benito-Kowalski, chief executive officer of Mothers' Milk Bank. Mothers who are currently breastfeeding and have excess milk are encouraged to consider donating to help fill this crucial need. To start the process, visit the Mothers’ Milk Bank website to fill out an application. Those who are unable to donate breast milk can still help by sponsoring a cooler for $98 or by making a financial contribution. Why donate breast milk? The need for donated breast milk remains constant, especially for infants facing health complications. According to the National Institute of Health, more than 300,000 babies require advanced medical care in neonatal intensive care units across the United States every year. This need may arise when infants are born prematurely before their mother's milk has developed, when they face specific health challenges during infancy, or when they are adopted or born through surrogacy. Eligible milk donors include lactating mothers whose bodies produce more milk than their own baby needs, when they have lost their own child postpartum and need to help their body transition from lactation, or simply because they are altruistically driven to support infant health through equal access to breast milk. How does milk donation work? Mothers’ Milk Bank screens all potential breast milk donors through a comprehensive but easy, facilitated process per internationally recognized guidelines. All donated milk is pooled, pasteurized and tested before distribution to hospitals and families in need. There is no cost to becoming a milk donor – nor are donors compensated. Mothers’ Milk Bank provides donors with professional support and resources during the donation process and covers all screening and shipping costs. Lactating mothers interested in becoming a donor can learn more about the Milk Meetups and Spring Donor Drive at MothersMilk.org. To get started send an email to donate@MothersMilk.org, call 1-877-375-6645, Ext. 3 or apply online. *** To schedule an interview, contact Liza Batallones at 415-766-0846 or liza@landispr.com. Hi-res images are available for download here. About Mothers’ Milk Bank Founded nearly 50 years ago, the Mothers’ Milk Bank is a leading nonprofit organization based in San Jose, California, that is dedicated to providing screened, donated human milk to all babies. The organization collects, pasteurizes, and distributes safe human milk to hospitals and families in need, ensuring that infants receive the essential nutrition required for optimal health and development. With a commitment to improving the lives of babies, Mothers’ Milk Bank plays a vital role in supporting families and advancing neonatal care across California and beyond. More information at MothersMilk.org. Contact Details Landis Communications, Inc. Liza Batallones +1 415-766-0846 liza@landispr.com Company Website https://mothersmilk.org/

February 28, 2024 06:00 AM Pacific Standard Time

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Kadimastem Takes Another Step Towards Signing the Merger Agreement with Nasdaq Listed IMCC

Kadimastem

In accordance with the MOU, Kadimastem will provide IMCC a loan of up to $650,000, which will be used by IMCC to restructure its current operations for sale allow Kadimastem to enter the public platform on the NASDAQ Kadimastem Ltd. (TASE: KDST), a leading cell therapy company in the clinical development stages of breakthrough products for the treatment of ALS and diabetes, has completed another step on the way to signing a merger with the U.S. NASDAQ listed company IMCC; IM Cannabis Corp (“IMCC”), (which is also listed in Canada on the CNSX) as reported several weeks ago, thus becoming a Nasdaq-listed company. The Company signed a loan agreement with IMCC, in accordance with their MOU. The loan amounts up to about $650,000 with the goal of organizing the current IMCC operations and preparing it for sale under a contingent value right (CVR) to be distributed to IMCC record shareholders prior to the consummation of the merger with Kadimastem', hence allowing Kadimastem to enter into IMCC’s public platform on the NASDAQ without taking ownership of IMCC’s current operations. Once and subject to the completion of the merger transaction and signing of the definitive documentation, pursuant to the MOU Kadimastem shareholders are expected to hold 88% of the shares of the combined company post -merger upon which Kadimastem will no longer be trading on the Tel Aviv Stock Exchange. The MOU is in line with the Company's strategic plan, to approach the target markets of its field of activity and the US capital markets. As part of the terms of the MOU, Kadimastem undertook to have approximately $5 million in funds, including capital raised simultaneously with the completion of the transaction and the commencement of trading from existing shareholders and additional investors. Ronen Twito, Executive Chairman of the Board said, "We are moving one step further towards a merger deal with IMCC that is planned to enable us to trade on the NASDAQ. This will assist Kadimastem’s development in the US capital markets especially in view of FDA approval to start a phase IIa multi-site clinical trial in the US for the ALS product candidate, as well as our development plans for additional product candidates, and especially the diabetes product candidate. I believe that together with IMCC’s professional management we will be able to promote the transaction quickly and professionally and generate significant value to our shareholders upon completion of the transaction." Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science. Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Sarah Bazak +972 73-797-1613 s.bazak@kadimastem.com Company Website https://www.kadimastem.com/

February 28, 2024 09:00 AM Eastern Standard Time

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Moving Fast: Candel’s (NASDAQ: CADL) CAN-3110 Granted FDA Fast Track Designation For Recurrent High-Grade Glioma Following Fast Track Designation For CAN-2409 In Pancreatic Cancer

Candel Therapeutics

By Jeremy Golden, Benzinga A clinical-stage biopharmaceutical company has been granted Fast Track Designation by the FDA for a first-in-class drug candidate. Focused on developing multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) was granted the designation for CAN-3110, a replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate for patients with recurrent high-grade glioma (HGG). The Needham, Mass.-based company hopes CAN-3110 will improve overall survival in this patient population. A phase 1b clinical trial of CAN-3110 in recurrent HGG, led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School, is ongoing. Candel Therapeutics plans to report additional data, including the potential benefits from multiple injections of CAN-3110, from the clinical trial in the second half of 2024. Designed to facilitate the development and expedite the review of medicines that can treat serious conditions, Fast Track Designation offers an investigational medicine eligibility for more frequent interactions with the FDA to discuss the candidate’s development plan. The medicine may be eligible for priority review if relevant criteria are met. “Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “A strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110 in the Phase 1b trial.” Additionally, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in the high-impact journal Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a near-doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of about 12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. Positive HSV-1 serology was a predictor of response and was associated with improved survival; the mOS in this population reached 14 months. 50 to 80% of American adults have oral herpes (HSV-1), which causes cold sores or fever blisters near or in the mouth. Caused by HSV-1 or HSV-2, genital herpes affects one out of every six people in the U.S. aged 14 to 49. Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response. “Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” Chiocca, the study director, said. “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.” In December 2023, Candel Therapeutics also received Fast Track Designation for both non-small cell lung cancer (NSCLC) and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, its most advanced product candidate. An investigational viral immunotherapy, CAN-2409 is designed to stimulate an individualized, systemic immune response to the patient’s specific tumor. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC. Featured photo by Hush Naidoo Jade Photography on Unsplash. Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

February 28, 2024 08:15 AM Eastern Standard Time

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Cyber Startup Secures 7 Million Networks, 500 Million Connected Devices – SAM Seamless Network Protects Customers Of Verizon, Virgin Media, Orange And Bezeq

OurCrowd

By Jeremy Ruden, Benzinga A small startup headed by a former officer in Israel’s elite 8200 Military Intelligence cyber unit is silently protecting 500 million connected devices in more than seven million homes and businesses around the world. This is the age of the Internet of Things (IoT) with millions of smart devices connected by Wi-Fi. From garage doors to smartwatches, all have access to private Wi-Fi, and many were designed without any attention to security. Once hacked, they provide a gateway into home and business networks where cyber criminals can wreak havoc, stealing personal information and holding entire companies to ransom. “In the US, an average household has 22 connected devices,” says Sivan Rauscher, a former 8200 officer and Co-Founder and CEO of SAM Seamless Network, an Israeli startup at the forefront of securing millions of IoT devices on a global level. “We record an average of 16 attacks a day on every network.” https://youtu.be/x94vQ0CBQyY?si=XHO89NQBkNcWzbpF Fueled by the spread of 5G wireless technology, the growth of smart devices snowballed during the pandemic – and the numbers keep growing. By the end of 2024, experts expect there will be more than 17 billion IoT devices connected worldwide. These are not just tablets or smartphones but include everything from household heating systems to online factory machinery. Many of the smart devices will also be enhanced with artificial intelligence, capable of making autonomous decisions. With this increased connectivity come major security concerns. “When you have more connected devices in your perimeter, you’re opening more back doors into your data,” says Rauscher, a rare female CEO in the male-dominated world of cyber security. “It’s just like when you move into a larger house, there are more entry points for thieves. It’s the same with information – the more connectivity, the larger the threat of a breach.” SAM is currently raising a funding round via OurCrowd, the Jerusalem-based investment platform that allows accredited investors to access privately held startups. Prime Target While major corporations can look to giants like Cisco (NASDAQ: CSCO) and Check Point (NASDAQ: CHKP) for their cybersecurity needs, SAM targets small and medium-sized enterprises, which make up the vast majority of companies – including 99% of all businesses in Europe. Unlike large, security-conscious multinationals, most Wi-Fi networks in small businesses and home offices are unmanaged, unsecured and without an information officer, leaving them prey to hackers. “The fast adoption of 5G, combined with the proliferation of smart devices operating on unsupervised networks, can be catastrophic for millions of home and business users. Even with the implementation of basic security requirements on IoT devices, the threat of a silent invasion through them is very real,” says Rauscher. “SAM is the best and most cost-efficient defense to this threat and we’re proud that our solution, which is constantly adopting to the changing threat landscape, is being adopted by some of the world’s top providers.” SAM’s platform is securing networks provided by some of the largest telecommunication companies in the world. including Verizon (NYSE: VZ) in the U.S., Virgin Media in the U.K., Orange in Belgium, Bezeq in Israel and other major European providers. The company’s cloud-based software can work with any system and is deployed remotely, which means the customer doesn’t have to fiddle with complicated settings or pieces of hardware. SAM’s system works automatically through the user’s router or other onsite gateway – usually provided by an internet service provider or as an off-the-shelf product. Unrecognized Devices SAM has a special relationship with Verizon, which is both a client and an investor through its investment arm Verizon Ventures. Verizon and SAM also launched the Device ID platform, allowing users to monitor their home network for new or previously unrecognized devices. This allows customers to manage certain details of their devices, like customized naming conventions, allowing for better control of their home network and connected devices. This visibility also results in improved customer service and troubleshooting from the viewpoint of Verizon, which is truly able to “see” the connected home network. SAM has several key investors including BlackBerry, which co-led the Series B round with Verizon Ventures, Intel Capital, Night Dragon, Target Global, Ericsson, ADT Security Corporation and Blumberg Capital. OurCrowd is leading SAM’s Series C investment round, which is now funding. The company is constantly updating its security in response to new threats identified on the networks. “We employ a data-driven approach to identify emerging threats and attacks on these IoT devices, relying on data from millions of IoT devices across our networks,” says Rauscher. “We’re actively looking and researching vulnerabilities in IoT devices we believe pose a significant threat to our customers.” IoT regulation Western governments are aware of the security risks posed by IoT devices. “Malicious cyber actors may leverage your home network to gain access to personal, private, and confidential information,” the U.S. NSA warned in Best Practices for Securing Your Home Network, published in 2023. Last July, the U.S. government announced a national IoT security label that manufacturers and retailers can use to assure consumers that their smart connected IoT devices meet a certain level of cyber-safety. The EU is not making IoT security optional. This year, the European Commission imposed minimum requirements for the security of smart devices. Products not meeting the standards will be banned from the EU market. The UK has similar legislation due to take effect in April 2024. While such government programs don’t apply to IoT devices that are already in use today, they will create a more informed consumer and raise awareness among other parties in the ecosystem, such as retailers or ISPs, motivating them to take action. For more information about the SAM Seamless Network investment round on the OurCrowd platform, click HERE. Featured photo courtesy of SAM Seamless Network. OurCrowd was started in 2013, driven by the idea that the business of building startups grows bigger and better when the global ‘crowd’ gains access to VC-level investment opportunities.Today, OurCrowd is a global venture and alternative investing platform that empowers institutions and individuals to invest and engage in emerging companies. OurCrowd vets and selects companies, invests its capital, and provides its global network with unparalleled access to co-invest and contribute connections, talent and deal flow. OurCrowd builds value for its portfolio companies throughout their lifecycles, providing mentorship, recruiting industry advisors, navigating follow-on rounds and creating growth opportunities through its network of multinational partnerships. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Lisa Graston lisa.graston@ourcrowd.com Company Website http://www.ourcrowd.com

February 28, 2024 08:00 AM Eastern Standard Time

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Tonix Pharmaceuticals drug TNX-102 SL gets FDA ok for US Department of Defense funded trial

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial. This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and post traumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense. The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision. The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course. Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health. This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

February 28, 2024 06:56 AM Eastern Standard Time

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Tonix Pharmaceuticals' Fibromyalgia Trial Shows Promising Results in Webinar Presentation

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share positive Phase 3 data on Tonmya, also known as TNX-102 SL, for the management of fibromyalgia, and discussed the company's plans to file for FDA approval in the second half of 2024. Dr. Lederman highlighted that Tonmya, a centrally acting, non-opioid, non-addictive bedtime medication, showed promising results in the RESILIENT Phase 3 study. The study met its pre-specified primary endpoint by significantly reducing daily pain compared to placebo in participants with fibromyalgia. Additionally, significant improvements were observed in key secondary endpoints related to sleep quality, fatigue reduction, and overall fibromyalgia symptoms and function. Based on these positive results, Tonix Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia. The company hosted a webinar featuring key opinion leaders in fibromyalgia, highlighting the significance of the trial results. Interested individuals can access the webinar through Tonix Pharmaceuticals' website or the accompanying press release. Led by renowned experts like Professor Leslie Arnold and Professor Dan Clau, the webinar offers valuable insights into the treatment landscape for fibromyalgia. Tonix Pharmaceuticals remains committed to advancing innovative solutions for fibromyalgia and improving patient outcomes. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

February 28, 2024 06:54 AM Eastern Standard Time

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