Category: Report

  • (Nasdaq: MGRX) Profile

    Mangoceuticals, Inc. logo

    OUR NEW PROFILE IS:   (NASDAQ: MGRX)

    52% OF MEN EXPERIENCE SOME FORM OF ERECTILE DYSFUNCTION THROUGHOUT THEIR LIFE AND THAT TOTAL INCREASES ANYWHERE FROM 5-15% BETWEEN AGES 40 AND 70

    MANGOCEUTICALS LAUNCHES MANGORX MEXICO SUBSIDIARY, PAVING THE WAY FOR OVER-THE-COUNTER RETAIL OF ERECTILE DYSFUNCTION LINE OF PRODUCTS IN LATIN AMERICA

    MGRX EXPERIENCED SEQUENTIAL REVENUE GROWTH OF 28.8% FROM Q1 TO Q2, 42.5% FROM Q2 TO Q3, AND 59% FROM Q1 TO Q3

    SUBSCRIPTION SALES INCREASED 65% FROM Q1 TO Q3, WITH Q2 TO Q3 SEQUENTIAL GROWTH OF 47%

    MANGOCEUTICALS, INC.’S DEBUT COMMERCIAL SURPASSES 9.3 MILLION VIEWS ON YOUTUBE

    *****BREAKING NEWS RELEASED THIS MORNING*****

    MANGOCEUTICALS TO INTRODUCE “PRIME”, POWERED BY KYZATREX®️ (CIII TESTOSTERONE UNDECANOATE CAPSULES), FOR AN FDA APPROVED ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT) PRODUCT

    THE DALLAS BASED, DIRECT-TO-CONSUMER TELEMEDICINE COMPANY SECURES MARKETING AGREEMENT WITH MARIUS PHARMACEUTICALS BRINGING KYZATREX TO THE TELEHEALTH MARKET AS ‘PRIME’ BY MANGORX

    Dallas, Texas & Raleigh, NC, Dec. 13, 2023 (GLOBE NEWSWIRE) — Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product (‘GROW’) and erectile dysfunction (ED) drug (‘Mango’), is excited to announce that it has entered into a Marketing Agreement with Marius Pharmaceuticals(“Marius”) to market and sell KYZATREX®️, an innovative FDA-approved oral Testosterone Replacement Therapy (TRT) product, under the program, ‘PRIME’ by MangoRx.

    PRIME will be available on MangoRx’s telemedicine platform with an anticipated launch date of January 31, 2024.

    KYZATREX, a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions, is one of only three FDA approved TRT treatments that is delivered orally–as opposed to the traditional, invasive, and inconvenient injection-based drug delivery protocol. KYZATREX delivers testosterone in a softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity.

    Testosterone deficiency is often first recognized through symptoms of fatigue or low energy, decreased sex drive, lower muscle mass and many other negative downstream impacts. PRIME, powered by KYZATREX, can help men restore Testosterone to normal levels and improve how they feel. In a 6-month open-label clinical study of 139 hypogonadal patients, 88% of patients taking KYZATREX had normal testosterone levels at Day 90 (worst case scenario (WCS) efficacy calculation, excluding Site 104).1 Among study completers (n=127), 96% of KYZATREX patients achieved normal testosterone levels at Day 90.2 With PRIME, MangoRx will expand broad-based consumer access to this innovative therapy.

    TRT treatments have traditionally been delivered through intramuscular needle injection, a subcutaneous implant, or a topical gel. These applications have suffered from different drawbacks depending on the delivery method, such as painful administration, uneven absorption, risk of transfer to others, and disruptions to the body’s natural diurnal rhythm allowing for peak performance early in the day.

    Twice daily oral TRTs offer painless administration, promote steady absorption, lower SHGB levels, increase free T levels to give the body more usable testosterone, and work with the body’s natural diurnal rhythm. Oral softgels are also convenient, mess-free, and discreet.

    Shalin Shah, CEO of Marius, shared, “This expansion into telehealth marks an important step in the care of Testosterone Deficient patients. Testosterone Deficiency is a serious chronic disease and has been inadequately addressed by previous generations of products. KYZATREX marks a shift in the treatment paradigm and a meaningful opportunity for patients seeking to restore optimal testosterone levels. Marius is excited to partner with MangoRx as an innovative partner in the DTC marketplace. We look forward to the Mango team bringing more awareness around the significance of Testosterone as a metabolic hormone and its role in optimal health for men with Low T.”

    PRIME by MangoRx will bring KYZATREX to patients spanning 48 states through the Company’s telemedicine platform, which is optimized to deliver a smooth medical prescription process, including blood work and synchronous telehealth visits with a fully licensed prescribing physician. Orders will be reviewed and, pending approval, fulfilled, then discreetly shipped via MangoRx’s URAC accredited mail order partner pharmacy directly to the patient’s doorstep.

    Jacob Cohen, MangoRx’s Co-Founder and CEO, noted, “PRIME represents a critical expansion into a new vertical with massive market potential and very little competition on the consumer side, while remaining completely consistent with our established identity as a company committed to providing new and innovative pharmaceutical based solutions helping men achieve optimal performance in all areas of life. We are extremely fortunate to be working with Marius and to be one of only a few companies with access to this innovative product. With our established marketing and telemedicine infrastructure in place, we are ready to hit the ground running and take PRIME to patients in need across the country next month.”

    Testosterone deficiency affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.3,4 Between 10% and 40% of men worldwide suffer from low testosterone levels.5

    _____________________

    Hello Everyone,

    We saw a slew of double digit winners in November that we profiled here on the newsletter.  It was a tremendous month for us here on our newsletter.  If you have been following then you already know.

    We have a new profile for tomorrow that we want you to research right away.

    Pull up MGRX immediately.

    Mangoceuticals, Inc. is a company focused on developing, marketing, and selling a variety of men’s health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men’s wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED). The Company has developed a new brand of ED product under the brand name “Mango” (think “Man Go”).

    Created using a special formulation featuring the same active ingredient as in Cialis (Tadalafil), each part of the Mango formulation plays a critical role in helping men achieve optimum performance. We believe the key to our success lies in our unique blend of ingredients, which are used in U.S. Food and Drug Administration (“FDA”) approved drugs. Mango contains a combination of Tadalafil, Oxytocin, and L-Arginine that have been traditionally used to treat sexual dysfunction.

    Mango is a prescription medication that must be approved by a physician. After an individual has completed an online telehealth visit, our network of medical providers will review and approve a prescription if medically appropriate. Mango is a rapidly dissolved tablet (RDT) that is absorbed orally. For best results, we advise taking Mango at least 15 minutes before engaging in sexual activity. Tadalafil, one of the main ingredients in Mango, typically has effects that last up to 36 hours.

    Mangoceuticals is making waves in the men’s health market with its innovative approach and commitment to redefining the standards for ED treatment. Unlike many competitors offering generic medications, Mangoceuticals takes pride in creating its own expertly formulated ED compounds, ensuring a superior experience for customers.

    The men’s health sector is ripe with potential, offering attractive opportunities as companies meet the growing demand for male-centric wellness solutions. Recent market research projects a staggering compound annual growth rate (CAGR) of 15.00% by 2029, signaling substantial potential for investors. A confluence of factors, including a rise in men’s health awareness, a paradigm shift in societal norms that emphasize self-care, and ground-breaking developments in medical technology and research, are just a few of the factors driving the growth in this sector.

    The men’s health market encompasses a diverse range of products and services, including pharmaceuticals, dietary supplements, fitness equipment, personal care products, telehealth services, and tailored wellness programs. These offerings cater to various aspects of men’s health, including physical fitness, mental wellness, and nutritional support.

    Beyond product offerings, Mangoceuticals understands the importance of education and information in men’s health. MangoRx is dedicated to providing comprehensive knowledge and resources, empowering men to make informed decisions about their well-being. By sharing information confidently and breaking down barriers, Mangoceuticals is destigmatizing the conversation around men’s health.

    MangoRx offers a convenient telemedicine platform, allowing men to access their products without leaving their homes. By eliminating the need for in-person doctor visits, MangoRx provides a discreet and accessible solution for men’s health needs. With a streamlined process, users can create an account, complete a telemedicine session, and have their prescribed products delivered to their doorstep.

    The MangoRx approach differs from other ED treatments in its commitment to education and refreshing approach to the topic. While the subject matter is serious, MangoRx embraces a fun and confident attitude. By injecting humor into their brand, they aim to empower men on their journey to better health, ensuring that the pursuit of ‘intimate well-being’ is an enjoyable experience.

    Mango (Man-Go)

    Mango, Mangoceuticals’ flagship product, is a groundbreaking solution designed to address men’s unique concerns. Unlike many competitors offering generic medications, Mangoceuticals takes pride in creating its own expertly formulated ED compounds, ensuring a superior experience for customers. Crafted with FDA-approved ingredients, Mango combines a selection of compounds to target the challenges men face in intimate situations.

    Mango stands out with its rapid-dissolving mango-flavored tablets, which deliver quicker results by efficiently entering the bloodstream. These sublingual Rapid Dissolving Tablets (RDTs) contain the same active ingredient as Cialis (tadalafil), as well as the MGRX unique blend. By incorporating this combination, Mango offers a tasty, efficient, and powerful solution for men seeking faster relief from the symptoms of ED.

    Earlier this month, MGRX announced via Twitter that Mango is now available in Nevada. This expansion marks a significant milestone for Mangoceuticals as they continue to broaden their market reach and offer their cutting-edge men’s health and wellness products to new potential customers.

    Mango is now available in 44 states, including Nevada and the District of Columbia.

    MANGOCEUTICALS, INC. PROVIDES UPDATE TO SHAREHOLDERS ON Q3 ACHIEVEMENTS AND GUIDANCE ON YEAR END AND NEAR-TERM INITIATIVE

    Dallas, Texas, Oct. 19, 2023 (GLOBE NEWSWIRE) — Mangoceuticals, Inc. (NASDAQ:MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated erectile dysfunction (ED) drug branded “Mango,” is pleased to provide the following updates to current and prospective shareholders on the Company’s recent 3rd quarter achievements, along with guidance on year end and near-term initiatives. MangoRx is pleased to report on the following topics:

    Year to Date Company Achievements (through September 30, 2023)

    • Revenue Growth: The Company experienced sequential revenue growth of 28.8% from Q1 to Q2, 42.5% from Q2 to Q3, and 59% from Q1 to Q3. We attribute this growth to three primary factors: 1) the growing prominence of the Mango brand, 2) the Company’s aggressive marketing efforts through digital initiatives as well as sponsorships and promotions with Barstool Sports and the various podcast platforms launched with Audacy (as referenced in our press release dated September 6, 2023), and 3) funds raised in our initial public offering.
    • Customer Acquisition: To date, we have successfully onboarded a rapidly growing customer base with an Average Order Value (AOV) of $105. Our goal is to continuously increase our customer base through additional prospecting and retargeting efforts. We have also launched an aggressive email marketing campaign to reach out to customer leads that have expressed interest in our products. To date, we have received positive results and plan to continue these efforts on an ongoing basis.
    • Customer Subscriptions and Refills: Historically, subscribing customers have accounted for approximately 10% of all new orders with an Average Order Value (AOV) of approximately $130. Subscription sales increased 65% from Q1 to Q3, with Q2 to Q3 sequential growth of 47%, demonstrating an accelerating growth curve.

    Additionally, many of our subscribing customers manually refill additional orders prior to receiving their scheduled auto-refill prescriptions, which we believe reflects the strong value-add role our Mango ED products have for our customers. Our goal is to grow the share of new orders that come from subscribing customers from 10% to 20-25%, which if successful, we expect will drive greater predictability and growth in revenues and cash flow, allowing the Company to invest even more aggressively in new customer acquisition.

    • New Orders and Refills: For the nine-months ending September 30, 2023, new orders accounted for 76% of total revenues while refills/auto-refills accounted for 24% of total revenues. Sales from refills/auto-refills have grown sequentially by more than 50% over the past two consecutive quarters.

    4th Quarter Goals and Initiatives

    • New Men’s Health Product Categories: The Company has developed, and is in the process of developing, new men’s health and wellness pharmaceutical grade products expected to be launched and marketed and made available on www.MangoRx.com through our telemedicine portal. These product categories include, but are not limited to: hair loss, weight loss, performance, and various hormone therapies.

    The Company has been working with internal product developers, third-party software developers, packaging vendors, marketing agencies, doctors’ networks, and the Company’s related-party compounding pharmacy, to ensure the timely and successful launch of these new and innovative products. The Company anticipates launching at least one additional product category by the end of the 4th quarter or the first quarter of 2024, funding permitted.

    • New Web Design and User Experience: The Company has undertaken a complete redesign of its website, www.MangoRx.com. Currently, the Company’s website is singularly geared toward its erectile dysfunction Mango products. As the Company expands into new product categories, a newer design and user interface experience is necessary for the promotion and marketing of those new products. The Company anticipates launching its new web presence by the end of the 4th quarter.
    • Launch of Affiliate Marketing Program: The Company is extremely pleased with the launch of its Affiliate Marketing Program, which allows various companies, influencers, and publishers to market and sell MangoRx products as an affiliate. Interested parties can sign up to become an affiliate at www.MangoRevenue.com, where they will have access to Company approved media, tools, and content to use on their own marketing platforms. If a purchase is made using their unique link or code, these affiliates are paid a commission on each product sold. Since launching the program in early October 2023, the Company has already signed up 100 affiliates in short order and has a goal of achieving 500 affiliates by the end of 2023.

    The Company estimates that a well-executed and managed affiliate marketing program may be able to drive up to 20% of the Company’s overall gross revenues.

    • Ongoing Marketing Initiatives: The Company has recently retained digital marketing agency Accelerated Digital Media (ADM), a digital media and marketing agency that specifically focuses on direct-to-consumer telemedicine and pharmaceutical brands. With clients including NURX, TalkSpace, and Keeps, management believes that the ADM team has the skills necessary to launch and execute an effective digital marketing strategy to assist with our social media advertising on top-of-funnel ad platforms such as Meta (Instagram/Facebook), Google, and YouTube.

    All of this is in addition to the Company’s current sponsorships of various nationally recognized podcasts such as NoJumper and PlugTalk with Adam22, Pillow Talk with Ryan Pownall, OnlyStansby BarStool Sports and Glenny Balls, Monday Morning Podcast with Bill Burr, Fly on the Wall with Dana Carvey and David Spade, The Dale Jr Podcast with Dale Earnhard Jr., and We’re Here To Helpwith Jake Johnson and Gareth Reynolds.

    The Company is consistently reviewing additional marketing and sponsorship opportunities to further enhance brand recognition throughout the 4th quarter and beyond.

    • Global Expansion Opportunities: The Company has begun the process of identifying potential additional markets outside of the United States which it may seek to market and sell its Mango ED products in the future, with some of these markets requiring a doctor’s prescription (e.g., the United Kingdom) and others where ED products can be sold over the counter at local pharmacies (e.g., Mexico and other parts of South America). The Company’s decision to become the headline sponsor for the upcoming Raindance Film Festival in London is due to its interest in the United Kingdom as a potential viable option for global expansion.

    Jacob Cohen, the Company’s Co-Founder and Chief Executive Officer stated, “We are extremely grateful to our loyal shareholders for your patience and commitment. We are fully dedicated to making Mango one of the top names in men’s health and wellness and we believe we have a strong plan to deliver on that commitment. As we approach the close of 2023, we believe we are finally beginning to see accelerating growth in brand recognition and revenues. We plan to continue to invest and reinvest in driving new customer acquisition in our flagship Mango ED products, funding permitting, while expanding into new verticals where our prior investments in the Mango brand are expected to have an established footprint with prospective customers. Stay tuned. The excitement is just beginning!”

    MANGOCEUTICALS EXPANDS ITS MEN’S HEALTH PRODUCT LINE WITH COMPOUNDED HAIR GROWTH TREATMENT ‘GROW’ BY MANGORX

    DALLAS, TX / ACCESSWIRE / November 16, 2023 / Mangoceuticals, Inc. (NASDAQ:MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated erectile dysfunction (ED) drug branded “Mango,” today announced the expansion of its men’s health product line with the addition of its hair growth treatment, ‘Grow.’

    The custom compounded hair growth treatment combines four clinically proven hair growth products – Minoxidil, Finasteride, Vitamin D3, and Biotin – encapsulated in convenient chewable, mint-flavored tablets. The product is now available for delivery by prescription through MangoRx’s website.

    “The launch of ‘Grow’ signifies a giant step in the Company’s overall progress and mission to provide our customers with custom and innovative products and solutions under the MangoRx brand,” said Jacob Cohen, MangoRx’s co-founder and CEO. “When it comes to hair, we’re all about the upward and onward journey. Grow aligns with MangoRx’s mantra of performance, evolution, and achieving the best version of oneself. Unlike most of our competitors, we have reinforced our commitment and ongoing investment in providing oral dissolvable tablets with distinctive flavors. This ensures our customers avoid the hassle of messy topical treatments, preventing their hair from appearing wet and greasy. With Grow, it is confidence that’ll go to your head!”

    Grow’s unique compounded formula combines Minoxidil, which encourages blood flow and follicle development, with Finasteride, blocking the formation of DHT (a known cause of male pattern baldness), along with supplements Vitamin D3, slowing hair-follicle calcification, and Biotin, which plays a crucial role in healthy hair growth. When combined, the four clinically proven hair growth products work to promote new growth in three to six months.

    “As a healthcare provider, I offer my professional endorsement of this compounded oral dissolvable tablet as a valuable option for addressing hair loss concerns,” said Dr. Douglas Christianson, ND, advisory board member of MangoRx. “The meticulously formulated combination of Minoxidil, Finasteride, Biotin, and Vitamin D3 aligns with evidence-based approaches to hair restoration. This cutting-edge solution has demonstrated clinical efficacy in fostering hair regrowth and enhancing the overall health of the hair. It stands as a medically sound choice for individuals seeking to address hair loss.”

    According to the American Hair Loss Association, by the age of 35 two-thirds of American men will experience some degree of increased hair loss, and by the age of 50, approximately 85 percent of men have significantly thinning hair. The process of male pattern baldness can begin before the age of 21 for approximately 25% percent of men.

    Interested consumers can use MangoRx’s telemedicine platform for a smooth medical prescription that is exclusively compounded for each individual. Orders will then be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep.

    DAILY HAIR TREATMINT

    GROW BY MANGORX

    (4 Active Ingredients in 1)

    BENEFITS:

    Powerful Ingredients: Packed with Minoxidil, Finasteride, Vitamin D3, and Biotin for proven hair growth.

    Regrow & Renew: Ingredients have been clinically shown to regrow hair in 3-6 months, stopping hair loss in its tracks.

    Minty Freshness: Enjoy the burst of mint flavor as you chew your way to stronger hair!

    Follicle Fuel: Boosts circulation to your hair roots, helping your mane thrive.

    Monthly Magic: 30-day or 90-day supply to keep the good hair vibes flowing.

    OUR UNIQUE FORMULA

    Grow by MangoRx is a uniquely compounded pharmaceutical hair growth formula housed in a sleek tin with a 30 or 90-day supply of chewable mint-flavored tablets. Infused with power-packed ingredients, Grow is designed to target the root causes of thinning hair and promote growth.

    MINOXIDIL

    Boosts circulation to follicles, helping them thrive and regrow hair in just 3-6 months.

    FINASTERIDE

    Targets male pattern hair loss by blocking the hormone responsible for hair growth interruption.

    BIOTIN

    Feeds your hair by aiding in keratin production, ensuring strands are healthy, strong, and shiny.

    VITAMIN D3

    An essential vitamin to nurture and strengthen hair, enhancing its natural resilience.

    Grow by MangoRx, a proven blend of 4 hair growth ingredients, ensures that taking the steps toward a fuller head of hair has never been easier. Mint-flavored and easy to take, Grow by MangoRx is more than a product—it’s a promise to help you reclaim the hair you love. Join the revolution and let Grow bring your hair back to life!

    MANGOCEUTICALS, INC.’S DEBUT COMMERCIAL SURPASSES 9.3 MILLION VIEWS ON YOUTUBE

    MANGOCEUTICALS LAUNCHES MANGORX MEXICO SUBSIDIARY, PAVING THE WAY FOR OVER-THE-COUNTER RETAIL OF ERECTILE DYSFUNCTION LINE OF PRODUCTS IN LATIN AMERICA

    Tapping into a market of more than 40,000 pharmacies, retail outlets, and convenience stores across Mexico in 2024 and fueling International Sales Access Across Latin America

    Dallas, Texas, Dec. 06, 2023 (GLOBE NEWSWIRE) — Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product (‘GROW’) and erectile dysfunction (ED) drug (‘Mango’), is excited to announce the establishment of its subsidiary, MangoRx Mexico, which will act as the lynchpin of the Company’s Mexican and expanded Latin American sales strategies for its Mango ED products.

    The Company has engaged one of the largest international law firms, Diaz Reus International Law Firm, to establish its subsidiary presence in Mexico. With offices across five continents, Diaz Reus represents major Fortune 500 brands including Oracle, Nissan, Sony, and Allianz, to name a few.

    “This has enormous implications for our growth trajectory going forward for several important reasons,” noted Jacob Cohen, MangoRx’s Co-Founder and CEO. “First, ED medications – such as branded and generic Viagra (Sildenafil) and Cialis (Tadalafil) – are available to consumers over-the-counter in Mexico. That presents increased margin and sales volume potential for what we already produce and market here in the United States. Second, Mexico is a completely untapped market as our research indicates that we will be the only company offering an ED product in a flavored rapid-dissolve tablet (RDT).”

    Next steps include establishing a manufacturing partner, applying for, and achieving certification with, the Comisión Federal para la Protección contra Riesgos Sanitarios (“COFEPRIS”), and establishing and formalizing distribution partnerships. The Company is already engaged in substantive negotiations with potential manufacturing partners, and it intends to formalize those relationships before the end of 2023.

    Cohen added, “This is not a sudden shift. We have been working on this strategy since May 2023, and we are now in the final stages of cementing our lab partner for production, packaging, and fulfillment of products. We are also already in discussions with multiple potential distribution partners in Mexicowho have existing relationships with more than 40,000 pharmacies, retail outlets, and convenience stores across the country.”

    In addition, achieving the COFEPRIS certification offers additional advantages for further expanding sales of MangoRx products internationally into other large and growing Latin American markets that offer ED medications as OTC products. Specifically, the COFEPRIS is recognized in the following additional countries: Columbia, Ecuador, El Salvador, Chile, Costa Rica and Panama.

    MangoRx has hired market commercialization professional, Efraim (Efi) Karchmer, as President of MangoRx Mexico. Efi will be tasked with spearheading all initiatives involved in establishing the business operations of the new subsidiary. Mr. Karchmer has more than 25 years’ experience in sales, marketing, and distribution of diverse products in a multinational and multicultural environment.

    According to a recent market study and analysis report conducted by Groupo Knobloch, the estimated annual market size in Mexico for ED pharmaceutical products is USD $216 million with approximately 24 million units sold annually and growing at a rate of 4% per year at an average sales price of USD $8.50 per unit.

    “Adding a new and significant market segment with fundamental advantages over our core marketplace could be one of the most important and transformative strategic steps with have taken as a company,” concluded Cohen. “The path from here to full launch of Latin American sales for MangoRx products is a top priority, and we look forward to providing updates very soon.”

    About MangoRx

    MangoRx is focused on developing a variety of men’s health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men’s wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED) and hair growth. Interested consumers can use MangoRx’s telemedicine platform for a smooth medical prescription that is exclusively compounded for each individual. Orders will then be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep.

    NEWS

     PUBLISHED

    6 DAYS AGO

    MANGOCEUTICALS LAUNCHES MANGORX MEXICO SUBSIDIARY, PAVING THE WAY FOR OVER-THE-COUNTER RETAIL OF ERECTILE DYSFUNCTION LINE OF PRODUCTS IN LATIN AMERICA

    PUBLISHED

    NOV 29, 2023

    MANGOCEUTICALS SELECTS TRYBE LABS AS ITS NATIONWIDE BLOOD COLLECTION AND TESTING SERVICES PROVIDER

    PUBLISHED

    NOV 16, 2023

    MANGOCEUTICALS EXPANDS ITS MEN’S HEALTH PRODUCT LINE WITH COMPOUNDED HAIR GROWTH TREATMENT ‘GROW’ BY MANGORX

    PUBLISHED

    NOV 2, 2023

    MANGOCEUTICALS, INC. LAUNCHES CHARITABLE INITIATIVE IN SUPPORT OF MEN’S HEALTH AWARENESS MONTH

    PUBLISHED

    OCT 26, 2023

    MANGOCEUTICALS LAUNCHES TIKTOK INFLUENCER INITIATIVE AND BECOMES THE PRESENTING SPONSOR OF THE ONLY STANS PODCAST WITH GLENNY BALLS

    PUBLISHED

    OCT 19, 2023

    MANGOCEUTICALS, INC. PROVIDES UPDATE TO SHAREHOLDERS ON Q3 ACHIEVEMENTS AND GUIDANCE ON YEAR END AND NEAR-TERM INITIATIVES

    PUBLISHED

    OCT 13, 2023

    MANGOCEUTICALS ANNOUNCES TV AIR DATES FOR INTERVIEW FEATURING CEO JACOB COHEN ON BLOOMBERG TV AND FOX BUSINESS

    PUBLISHED

    OCT 12, 2023

    MANGOCEUTICALS ANNOUNCES THE OFFICIAL LAUNCH OF MANGORX AFFILIATE MARKETING PROGRAM TO ENHANCE AND ACCELERATE TOPLINE GROWTH

    PUBLISHED

    SEP 14, 2023

    MANGOCEUTICALS BRAND MANGORX ANNOUNCED AS RAINDANCE FILM FESTIVAL’S HEADLINE SPONSOR

    PUBLISHED

    SEP 7, 2023

    MANGOCEUTICALS EXPANDS ITS NATIONWIDE MARKETING EFFORTS WITH A MULTIPLATFORM AUDIO POWERHOUSE ACROSS AMERICA

    PUBLISHED

    AUG 30, 2023

    MANGOCEUTICALS LAUNCHES NEW HIGH-PRODUCTION QUALITY AD PROVIDING FRESH INSIGHT INTO ITS PROPRIETARY MANGO ERECTILE DYSFUNCTION PILL FORMULA

    PUBLISHED

    AUG 16, 2023

    MANGOCEUTICALS LAUNCHES NEW SILDENAFIL BASED ERECTILE DYSFUNCTION PRODUCT WITH SIGNATURE MANGO FLAVOR & RAPID DISSOLVE

    MANAGEMENT

    Photo of Jacob Cohen

    JACOB COHEN

    Co-Founder and Chief Executive Officer

    Jacob Cohen is a serial entrepreneur, corporate finance and executive management professional with over 20 years of investment banking and capital markets experience having started and growing multiple companies in various industry sectors including marketing, advertising, healthcare, IT and financial services. Prior to founding the Company, Mr. Cohen was the co-founder and managing partner of several boutique investment bank and strategic advisory firms where he advised both early and later stage companies in raising capital in the form of debt and/or equity and in both private and public markets.

    Prior to his experiences in investment banking, Mr. Cohen served as the Chief Financial Officer of The Renewed Group, Inc., a manufacturer, wholesaler and retailer of eco-friendly and sustainable apparel primarily made from recycled textiles and under the brand name REUSE JEANS from 2010 through the end of 2013. Further, Mr. Cohen served from 2008 through 2010 as Executive Vice President and Controller of Metiscan, Inc., a publicly traded company, and as the President and Chief Executive Officer of one of its subsidiaries, Shoreline Employment Services, Inc. During his tenure at Metiscan, Mr. Cohen was instrumental in restructuring, reorganizing and operating the company and its five subsidiaries, and successfully raised over $8 million in equity financing for growth capital. Mr. Cohen also spearheaded the company’s financial audit process and managed its various filings with the SEC.

    From 2007 through 2008, Mr. Cohen served as the Chief Operating Officer of Artfest International, which he assisted in taking public at the end of 2007. Throughout his career, Mr. Cohen was involved in starting many new ventures, including The AdvertEyes Network, a digital signage advertising company where he served as founder and CEO. Other positions include investment advisor and institutional equity research analyst for Solomon Advisors and Huberman Financial, securities broker-dealers, from 2003 through 2005, and investment banker for Allegiance Capital, a middle market investment bank specializing on mergers and acquisitions, from 2005-2007. Mr. Cohen holds a Bachelor of Arts in International Economics and Finance from Brandeis University in Waltham, Massachusetts.

    Mr. Cohen has served as Chief Executive Officer of the Company since October 2021, as a director from October 2021 to present, and as Chairman from September 2022 to present. Mr. Cohen also currently serves as Chief Executive Officer and as a director of American International Holdings Corp (“American International”), a publicly traded company which is the majority owner and parent to Epiq Scripts, LLC, and which is the former sole owner of the Company, having fully divested its ownership in June 2022, and as Chief Executive Officer of Ronin Equity Partners, Inc., a private investment company, which role he has held since August 2016. Mr. Cohen also serves the Chief Executive Officer of Cohen Enterprises, Inc., a private investment company, which position he has held since November 2013.

    Jonathan Arango is a Business Development Executive with more than 10 years of hands-on experience in pharmacy operations and management, business development, team management, and strategic relationship development. He has a history of driving significant revenue growth for companies in multiple sectors. Mr. Arango participates in numerous ambitious ventures, spanning multiple industries such as e-commerce, medical & health, restaurants, and cryptocurrency.

    Photo of Jonathan Arango

    JONATHAN ARANGO

    Co-Founder and President

    Mr. Arango has served as the Co-Founder, President and Director of the Company since October 2021. Prior to his appointment to the Company, Mr. Arango served as Chief Operating Officer of Murphy Rx LLC, a retail and specialty pharmacy based out of Murphy, Texas, which he previously owned, from June 2020 to March 2022. Prior to owning a pharmacy, Mr. Arango founded and served as CEO of Golden Heights Medical Consulting, a healthcare marketing agency that specialized in customer acquisition and medical ancillary services from February 2017 to January 2019. He also served as an independent contractor providing marketing and sales services from April 2015 to February 2017.

    Before entering the healthcare industry, Mr. Arango ran an independent marketing and sales agency from 2013 to 2018 (A&J Marketing). A&J Marketing was contracted by multiple companies spanning different industries to generate and substantially scale revenue in multiple sectors. Industries included were Home Improvement, Oil & Gas, Health & Wellness, Professional Development, and E-commerce.

    Photo of Amanda Hammer

    AMANDA HAMMER

    Chief Operating Officer

    Amanda Hammer has been a member of the MangoRx team since late 2022 and has been instrumental in launching and optimizing MangoRx’s eCommerce platform. She is a proven leader with a track record of success having recently completed a 4-year tenure at D Magazine Partners, a Dallas based multimedia company, where she held roles leading Audience Development, Brand, and Digital Operations, quickly rising to become the company’s first named Chief Operations Officer. Prior to that, Amanda worked in private equity consulting and assisting newly acquired business verticals with optimizing sales and marketing processes, improving subscription retention, and training new talent to enhance productivity and maximize revenue streams.

    Amanda obtained dual Bachelor of Arts degrees—in Graphic Design and Communication Studies—from the University of Iowa. She has also obtained a Negotiation and Leadership Certificate from Harvard Law School and is a recent graduate of the Texas Women’s Foundation Leadership Institute.

    Photo of Eugene M. Johnston

    EUGENE M. JOHNSTON

    Chief Financial Officer

    Mr. Johnston has served as Chief Financial Officer of the Company since October 2022. Since February 2015, Mr. Johnston has served as Audit Manager for Greentree Financial Group, Inc., an accounting and auditing firm. From August 1999 to September 2014, Mr. Johnston served as Chief Executive Officer of Peoplesway.com, Inc., a skincare and nutritional products company, and from August 1999 to present, Mr. Johnston has served as a member of the Board of Directors of Peoplesway.com, Inc. From January 1999 to July 1999, Mr. Johnston served as Chief Executive Officer of RMC Group, Inc., a skincare and nutritional products company. Prior to that, from April 1987 to January 1989, Mr. Johnston served as Vice President of Sales Administration at WeCare Distributors, Inc., a skincare and nutritional products company.

    Mr. Johnston received a Bachelor’s in Science in Business Administration from the University of North Carolina Charlotte.

    SINCERELY,

    DISCLAIMER

    THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

    OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TWELVE THOUSAND FIVE HUNDRED USD BY BULLZEYE MEDIA LLC FOR A ONE DAY MGRX AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. 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READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

  • (Nasdaq: SLNH) Profile

    OUR NEW PROFILE IS:   (NASDAQ: SLNH)

    THIS DATA CENTER JUGGERNAUT IS SOLVING RENEWABLE ENERGY’SBIGGEST PROBLEM ALL WHILE BENEFITING FROM THE RISE OF BITCOIN

    REVENUE IN THE THIRD QUARTER INCREASED BY 176% TO $5.8 MILLION COMPARED TO $2.1 MILLION IN THE SECOND QUARTER OF 2023

    SOLUNA HARNESSES THE POWER OF COMPUTING TO ACCELERATE THE RENEWABLE ENERGY FUTURE

    SLNH COMPLETED A 1-25 REVERSE SPLIT BACK IN OCTOBER, KNOCKING THE FLOAT DOWN TO JUST 1.22 MILL

    MILL

    ____________________

    Hello Everyone,

    Bitcoin has been on a wild ride since the start of 2023, surging by over 80% since January. The leading digital coin exploded to an 18-month peak in November.

    Despite this, many experts believe that the current rally could be just the beginning and that bitcoin has the potential to go further than its previous highs.

    Many digital coins have been rebounding from their lows, with investors expressing more positive sentiments. According to Standard Chartered Bank, bitcoin will reach $100,000 by the end of 2024. The next catalyst, wrote the bank’s Geoff Kendrick and team, will be the approvals of several U.S.-based spot bitcoin ETFs, which they expect “are likely to come sooner than expected.”

    “We think a number of spot ETFs will now be approved in Q1-2024 for both BTC and ETH, paving the way for institutional investment,” they said.

    Pull up SLNH Imm

    SLNH is a leading developer of green data centers for Bitcoin mining and other intensive computing applications.

    The company builds modular, scalable data centers that convert wasted renewable energy into computing power for intensive, batchable applications such as cryptocurrency mining, AI, and machine learning. This solution provides a cost-effective alternative to battery storage or transmission lines.

    IT WORKS LIKE THIS:

    • →Power plants generate renewable energy.
    • SLNH buys its excess energy.
    • →They then use that energy to power their data centers.

    MAJOR CATALYSTS

    • An industry first. The company’s data center solution provides a cost-effective alternative to battery storage or transmission lines, helping power plant owners sell EVERY megawatt they have. Leveraging SLNH’s team’s unique combination of energy and technology expertise, the company is the first to offer such a revenue-generating solution,giving asset owners a competitive advantage. The company’s solution is poised to be the industry standard within 3 years!
    • A $120B+ market opportunity. The company’s long-term strategy is to dominate a few relatively small niche markets (digital coin mining, GPU cloud, etc.) by offering a truly zero-carbon cloud to a variety of end markets that are currently not served by data centers. Then, it will swiftly expand into broader, related markets. $9B+ Digital currencies, $5B Scientific research $50B+ Artificial intelligence and machine learning, and $60B+ Additional compute-intensive tasks.
    • Bitcoin has been exploding this year. The first market SLNH is applying its strategy to is the digital currency market. And many digital coins including Bitcoin have been rebounding tremendously!
    • Revenue potential. As described in the company’s earnings power illustration, the combined revenue potential for its sites: Project Dorothy 1A, Project Dorothy 1B, and Project Sophie is $37.5 million on an annualized basis!
    • Strong Q3 Results. The company financial results for the third quarter ended September 30, 2023, including a 176% increase in revenue and operating profit milestone.
    • A competitive edge SLNH has one of the industry’s lowest mining costs when referring to cost of revenue (mining) and all-in business costs!
    • Meeting a growing need. Stronger policies and raised climate goals are driving renewables to new records. By 2026, global renewable electricity capacity is forecast to rise more than 60% from 2020 levels to over 4 800 GW – equivalent to the current total global power capacity of fossil fuels and nuclear combined
    • Experienced management. SLNH has formed a new Advisory Board and the appointment of Daniel Golding, a former head of advanced engineering and data center innovation at Google. The Advisory Board has been formed to further accelerate the Company’s plan to offer its AI customers purpose-built facilities powered by renewable energy at groundbreaking costs.

    THE COMPANY IS IN THE BUSINESS OF BUYING CURTAILED RENEWABLE ENERGY TO PROVIDE ENERGY-INTENSIVE COMPUTING SERVICES FOR PROFITS SUCH AS USING CURTAILED ENERGY TO MINE BITCOIN.

    It’s a very straightforward business: to create an economy in the curtailed (wasted) renewable energy subsector. The company locates sites with curtailed energy (that meets its criteria) and then builds facilities around them to produce marketable products and services. (Batchable computing).

    Up to 30% of the power of renewable energy projects can go to waste but Soluna’s data centers enable clean electricity asset owners to ‘Sell. Every. Megawatt!’

    Soluna Holdings, Inc. (NASDAQ: SLNH) works with some of the largest plant owners in the world and brings its advanced facilities to different projects.

    SLNH is building projects that absorb renewable energy and can take the projects out of their ailing positions where they don’t monetize all the energy.

    The company brings in a data center solution; a computing solution, that is built on-site with the facility to absorb the wasted energy and convert it to a global resource. A low-cost, clean, green, and sustainable energy.

    WHY IS THIS IMPORTANT?

    SLNH is helping power plants reach their revenue goals and get more megawatts to the grid. This in turn will make renewable, affordable energy the world’s primary power source.

    HOW IS THIS BEING DONE?

    • →By bringing demand to power plants. 
    • →Building mobile data centers at the location where power is generated. 
    • →And applying that energy to the growing, worldwide demand for high-intensive computing.

    SLNH is a team of experts, professionals & entrepreneurs suited to bring green to power plants, grids, and the world economy.

    LEADING CURTAILMENT SOLUTIONS PROVIDER TO THE RENEWABLE ENERGY BUSINESS

    We buy excess energy from directly renewable power plants and convert it to clean, low-cost global computing

    FOCUS ON RETURN OF INVESTED CAPITAL (ROIC) & CAPITAL DISCIPLINE

    Focus on low power cost (~2.7 ¢ per kWh) and efficient CAPEX for capital deployment optimization. Design projects to return capital invested in 2 years

    LONG-TERM STRATEGY BEYOND BITCOIN TO AI

    The company takes excess energy from renewable energy sources and funnels it to batch-oriented, to power batch-oriented computing. Digital currency is one of them.
    The company has the right plan for a volatile environment that they have specifically engineered to thrive even in a digital coin downturn.

    A GROWING PIPELINE OF PROJECTS…

    The company’s data centers can buy every excess megawatt to use for batch-oriented, computing-intensive processes such as digital currency mining or machine learning, and this solution is as low-risk and low-friction to use as a smartphone.

    PROJECTS INCLUDE:

    PROJECT DOROTHY 1A AND 1B – TEXAS (FLAGSHIP SITE)

    SLNH has now monetized a groundbreaking 1,286 MWh of curtailed (wasted) energy for its Power Partner at Project Dorothy. This is equivalent to driving an electric car for more than 4.8 million miles (assuming 3 miles per kWh).

    Soluna Bolsters Revenue Potential with Purchase of More than 8,250 Machines to Power Project Dorothy 1B!

    The 25 MW Project Dorothy 1B is a proprietary mining joint venture between Soluna and Navitas Global. The first 5 buildings, which is approximately 6 MW, were set to be energized by the end of June. The remainder is expected to be completed and energized in the third quarter. The site’s run-rate revenue from mining is approximately $18 million annually.

    Once Project Dorothy 1B is operational, the 50 MW Project Dorothy Phase 1 will be fully online with a mix of hosting and proprietary mining.

    PROJECT SOPHIE

    • →On April 6, 2023 Soluna announced a 25 MW hosting contract with a sustainability focused hosting customer.
    • →Since then, Soluna has deployed miners to the entire site and has been running at full capacity.
    • →In June, the site achieved one of the highest utilization in its operating history
    • →The site holds great revenue potential, estimated at $3.21 million on an annualized basis. (As of Earnings Power Illustration June 21, 2023.)
    • →Hosting diversification – New hosting customers have been signed and deployed at Project Sophie. Three new hosting contracts have been signed and deployed since September.

    PROJECT KATIE

    • →Project Kati continues the development process, completing the first of the three required ERCOT interconnection studies in the planning phase. It has also advanced legal agreements with its power partner.

    DIVERSIFYING REVENUE STREAMS

    SLNH HAS COMPLETED ITS REGISTRATION FOR ANCILLARY SERVICES TO DIVERSIFY ITS REVENUE STREAMS.

    Ancillary Services Adds More Revenue and Lowers Power Cost – Soluna registered for ERCOT’s Demand Response Program establishing the company as a key contributor to intelligent and flexible energy solutions, promoting environmental and economic advantages for Texas.

    Soluna will be able to make over $10/MWh in additional revenue to Project Dorothy providing this grid resilience support and potentially reduce its power costs below $20/MWh, making it among the lowest cost players in the industry!

    THE AI EDGE…

    SLNH has launched Helix, an initiative to design an upgrade to its existing data center to address the needs of AI training workloads.

    The company believes the overwhelming unmet demand for power and computing space in the AI field will allow Soluna to transform its super low cost computing infrastructure to meet AI’s exponentially growing needs.

    Soluna’s data centers and proprietary MaestroOS software have been designed for this opportunity since inception. As Soluna converts its asset base to be AI-centric, it expects to offer its AI customers purpose-built facilities powered by renewable energy at groundbreaking costs.

    SLNH HAS ALREADY ACHIEVED RECORD LOW POWER COSTS PAVING THE WAY FOR AI COMPUTING AT PROJECT DOROTHY!

    And bringing on Daniel Golding’s expertise with more than 30 years of experience at companies like Google and Iron Mountain will accelerate Helix!

    The continual challenge in AI will be access to power, sustainability, physical space and compute availability. Soluna with its Helix program is on the path to solve this, and Daniel’s expertise will accelerate this mission. He will provide valuable advice to the Management Team and Board of Directors as the company steers the ship to phase two of its strategic business plan.

    SLNH expects to add more of the brightest minds in AI, data center development, and renewable energy to its Advisory Board in the coming months.

    The transformation of the global economy needed to achieve net-zero emissions by 2050 would be universal and significant.

    There’s a good reason why green stocks, or clean energy stocks, are some of the smartest choices for any portfolio going forward. The space is not only helping to preserve the environment and create new industries but also may make electric cars more affordable.

    Renewable energy sources such as wind, solar, and hydroelectric power are expected to play a big part in our future. While renewable energy is a big topic, curtailment is a very big problem that is little talked about and one that could create many problems down the road….

    By building infrastructure to help renewable energy become a ‘superpower,’ Soluna Holdings, Inc. (NASDAQ: SLNH) has a game-changing solution to curtailment.

    THE COMPANY’S SCALABLE DATA CENTERS TURN WASTED ENERGY INTO REVENUE WITHIN 6 MONTHS!

    SLNH is also a green data center crypto mining company and despite the headlines buzzing around companies like Marathon Digital and Riot Platforms, SLNH is an undetected player with substantial room for growth.

    But to give an idea of just how well the arena is doing, Marathon Digital has gained nearly 400% in 2023 and Riot Platforms is up nearly 200% in the past 12 months!

    NEWS

    PUBLISHED

    NOV 29, 2023

    SOLUNA JUMPSTARTS ANCILLARY SERVICES REVENUE

    PUBLISHED

    NOV 28, 2023

    SOLUNA TO PRESENT AT WATER TOWER RESEARCH’S HYBRID US CLIMATE INVESTOR CONFERENCE ON DECEMBER 7

    PUBLISHED

    NOV 22, 2023

    SOLUNA SIGNS AGREEMENT WITH NOTEHOLDERS TO FACILITATE EARLY PAYOFF OF CONVERTIBLE NOTES

    PUBLISHED

    NOV 15, 2023

    SOLUNA HOLDINGS REPORTS Q3 RESULTS

    PUBLISHED

    NOV 6, 2023

    SOLUNA ESTABLISHES ADVISORY BOARD, TAPS AI AND DATA CENTER LEADERSHIP

    PUBLISHED

    OCT 31, 2023

    SOLUNA REGAINS COMPLIANCE WITH NASDAQ MINIMUM BID PRICE REQUIREMENT

    PUBLISHED

    OCT 25, 2023

    SOLUNA AND BIT DIGITAL ANNOUNCE YEAR-LONG HOSTING PARTNERSHIP

    PUBLISHED

    OCT 24, 2023

    SOLUNA ACHIEVES RECORD LOW POWER COSTS PAVING THE WAY FOR AI COMPUTING AT PROJECT DOROTHY

    PUBLISHED

    OCT 13, 2023

    SOLUNA ANNOUNCES IMPLEMENTATION OF 1-FOR-25 REVERSE STOCK SPLIT

    PUBLISHED

    OCT 12, 2023

    SOLUNA ANNOUNCES 1-FOR-25 REVERSE STOCK SPLIT

    PUBLISHED

    OCT 5, 2023

    SOLUNA TO PARTICIPATE IN WATER TOWER RESEARCH FIRESIDE CHAT SERIES

    PUBLISHED

    SEP 26, 2023

    SOLUNA PROJECT DOROTHY 1 REACHES FULL CAPACITY OF 50 MW, COMPANY HITS 2.6 EH/S HASHRATE MILESTONE

    PUBLISHED

    AUG 14, 2023

    SOLUNA HOLDINGS REPORTS Q2 RESULTS

    PUBLISHED

    JUL 25, 2023

    SOLUNA HITS NEW HEIGHTS: APPROACHES 2 EH/S MILESTONE IN BITCOIN MINING OPERATIONS

    PUBLISHED

    JUL 18, 2023

    SOLUNA TO PARTICIPATE IN WATER TOWER RESEARCH FIRESIDE CHAT SERIES

    PUBLISHED

    JUN 26, 2023

    SOLUNA SECURES NASDAQ’S APPROVAL FOR 180-DAY EXTENSION TO MEET BID PRICE REQUIREMENT

    MANAGEMENT TEAM

    John Belizaire

    John Belizaire

    Chief Executive Officer

    David Michaels

    Chief Financial Officer
    Soluna Holdings, Inc.

    Jessica Thomas

    Chief Accounting Officer
    Soluna Holdings, Inc.

    Dipul Patel

    Dipul Patel

    Chief Technology Officer
    Soluna Computing, Inc.

    Mary O’Reilly

    Mary O’Reilly

    Chief People Officer
    Soluna Computing, Inc.

    Larbi Loudiyi

    VP, Power
    Soluna Computing, Inc.

    Phillip Ng

    Phillip Ng

    VP, Corporate Development
    Soluna Computing, Inc.

    Nick Lancaster

    VP, Engineering
    Soluna Computing, Inc.

    Chase Stowell

    Sr. Business Unit Controller
    Soluna Computing, Inc.

    Jim Reynolds

    Sr. Director, Operations
    Soluna Computing, Inc.

    SINCERELY,

    DISCLAIMER
    THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.
    OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TEN THOUSAND USD BY SICA MEDIA LLC FOR A ONE DAY SLNH AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.
  • (Nasdaq: ANIX) Profile

    Anixa Biosciences, Inc.

    OUR NEW PROFILE IS:   (NASDAQ: ANIX)

    ANIX HAS TWO VACCINES AIMED TO PREVENT BREAST CANCER AND OVARIAN CANCER

    ANIX HAD $23 MILLION IN CASH AS OF JULY 2023

    CHECK OUT THE INVESTOR PRESENTATION HERE

    https://www.youtube.com/watch?v=gIHCXB_LDwI

    ____________________

    Hello Everyone,

    Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors around.

    As devastating as cancer is, it’s also a big business. And when cancer and Wall Street collide, it can lead to substantial opportunities to capitalize. It’s no wonder investors are turning their eyes toward healthcare companies specializing in oncology

    Precedence Research projects that the global oncology market will increase at a compound annual growth rate of 8.2 percent to reach US$581.25 billion in 2030.

    Players in the oncology sector are thriving. Biotech stocks experienced a lift in early December after it was learned that AbbVie will be buying cancer developer ImmunoGen for $10 billion!

    Scientific advances are creating new and previously only imaginable ways to treat and prevent diseases.

    Anixa Biosciences, Inc. is developing therapies and vaccines that are focused on critical unmet needs in oncology.

    Pull up ANIX immediately and start your research on the company.

    The company’s programs are using the body’s immune system to take multiple approaches in fighting cancer—CAR-T cell therapy to treat cancer and vaccines to prevent cancer.

    Anixa’s therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology.

    The Company’s vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple-negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer.

    These vaccine technologies focus on immunizing against “retired” proteins that are expressed in certain forms of cancer.

    THE CAR-T METHOD:

    The exciting field known as immunotherapy has enabled the development of drugs that modulate the immune system to battle cancer.We know that our bodies, through the function of our immune systems, are able to “cure” cancer. It is now known that some number of cells in our bodies are becoming cancerous all the time. These transformations are driven by many factors including genetics and environment.

    Most of the time without us being consciously aware, these cells are destroyed and cleared by our immune system. As our immune function declines with age, some cells are able to survive and eventually become tumors, either liquid or solid. We also know that the tumors themselves have developed mechanisms to suppress immune cell function. Such is the case with pediatric tumors as well adult cancers.

    Considering this understanding, the field of immunotherapy tries to boost the ability of our immune cells to battle the cancer. There are a number of methods that scientists have devised to induce our immune systems to battle cancer. One of those approaches is known a Chimeric Antigen Receptor T-cell technology, better known by the acronym, CAR-T.

    CAR-T therapy is a treatment where a patient’s T-cells, a type of immune cell, are removed from the body. These cells are then modified in a laboratory through the advanced techniques of genetic engineering, and increased in number, and then infused back into the patient. In many ways, this is the ultimate personalized medicine. The specific genetic engineering is what makes the patient’s own T-cells even more powerful as a tumor fighter. This genetic engineering causes a special receptor to be present on the surface of the T-cell. This receptor is known as the CAR—the Chimeric Antigen Receptor.

    The pharmaceutical industry continues to be a hotbed of innovation and CAR-T cell-based compositions are a key innovation area in immuno-oncology!

    CAR-T THERAPY FOR OVARIAN CANCER:

    The markets for solid tumors are much larger than the markets for leukemias and lymphomas, especially B-cell cancers. Therefore, ANIXfeels that the scope of opportunities for its CAR- T therapy is very large should the company demonstrate efficacy in solid tumors.

    ANIX’S FIRST INDICATION WILL BE OVARIAN CANCER, FOLLOWED BY OTHER TUMOR TYPES.

    • ↪Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches.
    • ↪Late-stage diagnosis results in relatively high risks of recurrence and often poor prognosis. While the five-year survival rate for stage 1 ovarian cancer is over 80%, the corresponding survival rate for Stage 4 cancer is 20%. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.

    THE FIRST POTENTIAL ANTI-ANGIOGENIC CAR-T THERAPY:

    ANIX has an exclusive worldwide license from The Wistar Institute.

    The company believes its CER-T approach will work in solid tumors, especially ovarian cancer, where others have failed.

    • ↪FSHR is a unique target
    • ↪FSH is a natural ligand (not synthetic)
    • ↪The company’s approach may provide anti-angiogenic synergy
    • ↪The company’s CAR-T may execute a dual mechanism of action in destroying the tumor

    PREVIOUS CHALLENGES:

    • ↪The CAR-T cells may not br susceptible to the highly suppressive tumor microenvironment
    • ↪As the CAR-T cells are destroying vasculature, they make it leakier, enabling simultaneous, localized delivery of oher agents including chemotherapy
    • ↪CAR-T mediated cell death may be more powerful than ther anti-angiogensis drugs

    COLLABORATORS INCLUDE:

    MOFFITT CANCER CENTER:

    Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999.

    THE WISTAR INSTITUTE CANCER CENTER:

    Founded in 1892 as the nation’s first independent biomedical research institute and located on the campus of the University of Pennsylvania, Wistar is an international leader in the biomedical research fields of cancer, immunology and infectious diseases, a National Cancer Institute (NCI)-designated Cancer Center, and part of the NCI’s select network of national cancer research centers, holding an ‘Exceptional’ rating — the highest possible ranking awarded.

    CANCER VACCINES:

    Vaccines harness the immune system to keep people safe from infectious diseases. Thanks to broad-based vaccination programs, some of the most terrifying diseases in history, small pox and polio among them, have been eliminated from existence.

    Unfortunately, there’s been little success in developing a preventative (prophylactic) vaccine against cancer.

    Most vaccines attack pathogens, such as viruses and bacteria. The immune system is better able to assail these agents because they come from outside the body. Cancer, however, is a different matter. The disease is caused by aberrant cells that arise out of our resident cells. That can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system. Once these aberrant cells gain critical mass, they become cancer.

    Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs. These drugs do not attack cancer directly, but rather modulate the immune system in ways that enable it to destroy or dramatically impair cancer cells.

    Imagine if we could train the immune system to kill cancer cells as they arise before they form into tumors. Perhaps, we could eliminate the onset of cancer. The difficulty has been to identify an agent that allows the immune system to target malignant cells without harming healthy tissue.

    • ↪Cleveland Clinic researchers have identified a protein called alpha-lactalbumin that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child. Alpha-lactalbumin is never present on any other cell in the body. However, it does show up in many types of breast cancer, including an aggressive and deadly form of the disease known as Triple Negative Breast Cancer (TNBC).
    • ↪In addition, Cleveland Clinic researchers have identified that the extracellular domain of anti-Mullerian hormone receptor II (AMHR2-ED) is expressed in normal ovaries, and nowhere else in the body, with this expression ceasing after menopause. However, this protein is also expressed in cancerous ovary cells.
    • ↪Cleveland Clinic, has received an “Intention to Grant” notice from the European Patent Office (“EPO”) for the patent application titled “Ovarian Cancer Vaccines.”

    BY DEVELOPING VACCINES THAT TARGET ALPHA-LACTALBUMIN AND AMHR2-ED, ANIX FEELS THE IMMUNE SYSTEM CAN DESTROY BREAST CANCER CELLS AND OVARIAN CANCER CELLS, RESPECTIVELY, AS THEY ARISE AND ULTIMATELY PREVENT TUMORS FROM FORMING!

    Anixa’s ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. However, AMHR2-ED is expressed again in the majority of ovarian cancers.

    THE MARKET FOR PROPHYLACTIC CANCER VACCINES IS SIZABLE, BIGGER IN FACT THAN THE MARKET FOR ANY TYPE OF CANCER THERAPEUTIC. AFTER ALL, DOCTORS ADMINISTER CANCER DRUGS ONLY AFTER A PATIENT HAS BEEN DIAGNOSED, WHILE A VACCINE CAN BE ADMINISTERED TO A FAR WIDER POPULATION.

    BREAST CANCER:

    In the U.S., nearly 300,000 women are expected to be diagnosed with breast cancer this year.

    OVARIAN CANCER:

    Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.

    PHASE 1 TRIAL FOR BREAST CANCER VACCINE: CONDUCTED BY CLEVELAND CLINIC, FUNDED BY U.S. DEPARTMENT OF DEFENSE (DOD)

    AN OPEN-LABEL PHASE 1 DOSE-ESCALATION TRIAL

    DESIGN

    Participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response

    PHASE 1A
    (IN PROGRESS)

    • ↪18-24 Patients who have been treated for TNBC
    • ↪Safety will be monitored
    • ↪Immune Response will be monitored
    • ↪Maximum Tolerated Dose (“MTD”) determined

    PHASE 1B
    (ENROLLMENT OPEN)

    • ↪Healthy women w/mutations
    • ↪Chosen to undergo prophylactic mastectomy
    • ↪Vaccinate before surgery and evaluate immune response and resected tissue
    • Unique opportunity to garner supplemental data after studying breast tissue to determine if T cells are surveilling the tissue without any visible cancer tumors

    PHASE 1C
    (ENROLLMENT OPEN)

    • Additional cohort combining vaccine with Keytruda
    • ↪Patients treated for TNBC
    • ↪Combine Keytruda w/ vaccine to evaluate if there is synergy

    POSITIVE CLINICAL RESULTS AS OF APRIL 2023:

    • ↪Enrollment of women who have had TNBC and have undergone standard of care, but are at risk of recurrence
    • ↪42% of TNBC survivors will relapse within 5 years
    • ↪MTD reached in Q4 2022 § Data from all vaccinated women tested to date presented at AACR in April 2023
    • ↪16 patients dosed through July 2023
    • ↪No safety concerns
    • ↪Immune responses observed at all dose levels
    • ↪All patients had some immune response
    • ↪Intensity of responses varied with patients

    IN SUMMARY…

    One of the most aggressive and difficult-to-treat ailments, cancer is a disease that involves the uncontrolled division and growth of malignant cells.The goal to prevent the disease or eradicate it has been monumental in big pharma for decades.

    With multiple catalysts over the next 12 months across its clinical pipeline, now is a pivotal time to have Anixa Biosciences, Inc. (NASDAQ: ANIX) on your radar. The company has 2 clinical trials in progress, showing positive results!

    ANIX highlights:

    • ↪$25M+ in cash as of July 2023
    • ↪A low-cost business model
    • ↪Developing programs with partners
    • ↪Leveraging existing infrastructure of partners
    • ↪Maintaining low overhead and cash burn
    • ↪Potential to out-license programs to pharma for late stage clinical development and commercialization

    NEWS

    ANIXA BIOSCIENCES ANNOUNCES EUROPEAN PATENT ON OVARIAN CANCER VACCINE TECHNOLOGY

    NOVEMBER 27, 2023

    ANIXA BIOSCIENCES TO PRESENT AT THE OVARIAN CANCER RESEARCH ALLIANCE (OCRA) OVARIAN CANCER NATIONAL CONFERENCE

    OCTOBER 31, 2023

    ANIXA BIOSCIENCES APPOINTS ACCOMPLISHED MEDICAL ONCOLOGIST AND BIOTECHNOLOGY EXECUTIVE, DR. MARK A. GOLDBERG, TO CANCER BUSINESS ADVISORY BOARD

    OCTOBER 23, 2023

    ANIXA BIOSCIENCES COMPLETES TREATMENT OF FIRST PATIENT COHORT IN OVARIAN CANCER CAR-T CLINICAL TRIAL

    OCTOBER 13, 2023

    ANIXA BIOSCIENCES ANNOUNCES ISSUANCE OF ADDITIONAL U.S. PATENT FOR OVARIAN CANCER VACCINE TECHNOLOGY

    OCTOBER 3, 2023

    ANIXA BIOSCIENCES ESTABLISHES CANCER BUSINESS ADVISORY BOARD

    SEPTEMBER 19, 2023

    ANIXA BIOSCIENCES TO PARTICIPATE IN SEPTEMBER INVESTOR CONFERENCES

    AUGUST 31, 2023

    ANIXA BIOSCIENCES ANNOUNCES TREATMENT OF THIRD PATIENT IN OVARIAN CANCER CAR-T CLINICAL TRIAL

    AUGUST 28, 2023

    ANIXA BIOSCIENCES ANNOUNCES INVITED PRESENTATION ON OVARIAN CANCER CAR-T THERAPY AT THE 8TH ANNUAL CAR-TCR SUMMIT

    AUGUST 14, 2023

    COULD ANIXA BIOSCIENCES (NASDAQ:ANIX) BE DEVELOPING THE VACCINE TO END ONE OF THE DEADLIEST TYPES OF BREAST CANCER?

    AUGUST 10, 2023

    ANIXA BIOSCIENCES ANNOUNCES OPENING OF ENROLLMENT FOR KEYTRUDA® ARM IN ONGOING BREAST CANCER VACCINE CLINICAL TRIAL

    AUGUST 7, 2023

    ANIXA BIOSCIENCES ANNOUNCES NOTICE OF ALLOWANCE OF ADDITIONAL PATENT ON OVARIAN CANCER VACCINE TECHNOLOGY

    JULY 27, 2023

    ANIXA BIOSCIENCES ANNOUNCES ISSUANCE OF CANADIAN PATENT FOR ITS CAR-T CANCER THERAPY TECHNOLOGY

    JULY 11, 2023

    ANIXA BIOSCIENCES ANNOUNCES TREATMENT OF SECOND PATIENT IN ITS OVARIAN CANCER CAR-T CLINICAL TRIAL

    MAY 22, 2023

    ANIXA BIOSCIENCES CLARIFIES POSTER PRESENTATION ON COMPANY WEBSITE

    APRIL 17, 2023

    ANIXA BIOSCIENCES AND CLEVELAND CLINIC PRESENT POSITIVE DATA FOR PHASE 1 STUDY OF BREAST CANCER VACCINE

    APRIL 17, 2023

    ANIXA BIOSCIENCES ANNOUNCES PRESENTATION ON BREAST CANCER VACCINE TRIAL AT THE 2023 AACR ANNUAL MEETING

    MARCH 27, 2023

    ANIXA BIOSCIENCES REASSURES SHAREHOLDERS IT HAS NO ACCOUNTS AT SILICON VALLEY BANK

    MARCH 13, 2023

    ANIXA BIOSCIENCES TO PROVIDE CORPORATE UPDATE AT ITS 2023 ANNUAL MEETING OF STOCKHOLDERS

    MARCH 2, 2023

    ANIXA BIOSCIENCES ANNOUNCES NOTICE OF ALLOWANCE OF ADDITIONAL KEY PATENT ON BREAST CANCER VACCINE TECHNOLOGY

    FEBRUARY 27, 2023

    MANAGEMENT TEAM

    Amit Kumar, Ph.D.

    AMIT KUMAR, PH.D.

    Chairman & Chief Executive OfficerDr. Kumar has been an investor, founder, director and CEO of several technology enterprises, both public and private. As CEO, he took CombiMatrix Corporation public and ran it for a decade while listed on the NASDAQ Global Market. He has worked in venture capital with OAK Investment Partners, and has been an advisor to investment funds, venture capital firms, and Fortune 500 companies. He was on the Board of Directors of Acacia Research Corporation from 2002-2008. Dr. Kumar is currently Chairman and CEO of Anixa Biosciences and he sits on the Board of other public and private companies. He has served on the Board of the American Cancer Society since 2016. He received his AB in Chemistry from Occidental College. After graduate studies at Stanford University and Caltech, he received his Ph.D. from Caltech and followed that with a post-doctoral fellowship at Harvard.

    Michael Catelani

    MICHAEL CATELANI

    President, COO & CFOMr. Catelani is a seasoned executive with over 30 years of finance and operations management experience. He currently serves as President, Chief Operation Officer & Chief Financial Officer of Anixa Biosciences. Previously, Mike cofounded Tacere Therapeutics, Inc., a privately held biotech company, and served as its Chairman, President & Chief Financial Officer until its sale. Prior to Tacere, Mike served on the Board of Directors and was the Chief Financial Officer of Benitec Biopharma Limited, an Australian Stock Exchange-listed biotech company. Mike was Vice President and Chief Financial Officer at Axon Instruments, a leading designer and manufacturer of instrumentation and software systems for biotechnology and diagnostics research. Axon was a U.S. corporation publicly traded on the Australian Stock Exchange. Previously, he was the Vice President of Finance for Media Arts Group, Inc., an NYSE-listed company. Mike has also worked with several early-stage start-ups in a variety of industries, including biotechnology, cleantech  and retail, in both advisory and management roles and has served as a contract CFO for a number of established businesses in the biotech field. Mike began his professional career at Ernst & Young and is a CPA (Inactive). He received his BS degree in business administration, with a concentration in accountancy from Sacramento State University and earned his MBA from the University of California, Davis.

    Pamela D. Garzone, Ph.D.

    PAMELA D. GARZONE, PH.D.

    Chief Development OfficerDr. Garzone is a senior pharmaceutical executive with over 25 years of diverse experience in the industry and is recognized for her strategic, scientific, clinical and regulatory leadership in drug development. Prior to joining Anixa, Dr. Garzone held executive roles in clinical development with several companies, including Calibr, a division of the Scripps Research Institute, and Pfizer. She previously held positions of increasing responsibility at companies such as Elan Pharmaceuticals and Genetics Institute, starting her industry career at Genentech. Prior to her industry experience, she was an Assistant Professor, Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy. She earned a B.S. degree in Pharmacy from Purdue University and an M.S. in Pharmacy Practice from the University of Pittsburgh. She received her Ph.D. in Clinical Science from the University of Pittsburgh.

    SINCERELY,

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    OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TEN THOUSAND USD BY SICA MEDIA LLC FOR A ONE DAY ANIX AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. 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  • (Nasdaq: GDC) Profile

    OUR NEW PROFILE IS:   (NASDAQ: GDC)

    ____________________

    GD CULTURE GROUP EXPANDS INTO LIVESTREAMING INTERACTIVE GAMES ON TIKTOK

    GDC HAS BEEN SEEING A LOT OF ACTIVITY OVER THE PAST 7 DAYS

    GD CULTURE GROUP UNVEILS ITS TRANSFORMATIVE AND PHOTOREALISTIC AI-DRIVEN DIGITAL HUMAN TECHNOLOGY ON TIKTOK

    GD CULTURE GROUP ENTERS INTO MEMORANDUM OF UNDERSTANDING WITH PIER E MEDIA FOR EXPANSION INTO TIKTOK AGENCY BUSINESS

    __________________________________________

    Hello Everyone,

    We have another profile for you to look at and research IMMEDIATELY.

    Pull up GDC.

    This is another company that we just looked at over a week ago and it went viral, touching $5.16 on record interest after a massive gap up in the morning when the company dropped breaking news.

    Since then there has been a pullback after some profit taking.

    We think now is a good time to research this one again.

    GD Culture Group Limited (the “Company”) (Nasdaq: GDC), is a Nevada holding company currently conducting business through its subsidiaries, AI Catalysis Corp. (“AI Catalysis”). The company plans to enter into the livestreaming market with focus on e-commerce and livestreaming interactive games through its wholly owned U.S. subsidiary, AI Catalysis, a Nevada corporation incorporated in May 2023.

    *****BREAKING NEWS RELEASED TODAY*****

    GD CULTURE GROUP UNVEILS ITS TRANSFORMATIVE AND PHOTOREALISTIC AI-DRIVEN DIGITAL HUMAN TECHNOLOGY ON TIKTOK

    NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) — GD Culture Group Limited (“GDC” or the “Company”) (Nasdaq: GDC), a Nevada holding company currently conducting business through its subsidiaries, AI Catalysis Corp. (“AI Catalysis”), today announced that it has applied cutting-edge AI-driven digital human technology (the “Technology”) to optimize its users’ experience on TikTok.

    The Technology is designed to create digital humans with lifelike appearances, facial expressions, and movements seamlessly bridging the gap between reality and the digital world. The remarkably realistic appearances of the digital humans are achieved through high-quality modeling, rendering, and animation. In addition, powered by state-of-the-art natural language processing (“NLP”) and machine learning, the Technology features with strong personal traits, accurate facial animation, perfect lip synchronization, emotional expression, and speech synthesis of digital humans.

    In response to the burgeoning demand within the digital landscape, AI Catalysis generates lifelike digital humans tailored for digital human live-streaming e-commerce and virtual anchors, creating innovative digital characters. In the first phase of the deployment, AI Catalysis applies the Technology to create a digital human IP matrix. A total of 30 virtual anchors have been created and are now live on TikTok. The visually appealing anchors have unique appearances, personalities, and voices, which are expected to provide value to their viewers and followers with informative, entertaining, and inspiring content. All video content creation will adhere to AI technology’s ethical standards, ensuring that the content is constructive, positive, and conveys effective information. The current enriched content covers a variety of categories, including financial and tech information, travel tips, and brand discovery. A consistent flow of short videos featuring the virtual anchors is being uploaded across 30 TikTok accounts. Virtual anchors can also represent brands and products with customized content and distinct personality. They can be seamlessly integrated with a brand’s social marketing and e-commerce strategy. This initiative aims to build and maintain a strong online presence for digital humans and accelerate AI Catalysis’s deployment for digital humans. Upon widespread deployment, digital humans will transform the business and media landscape.

    AI Catalysis is also dedicated to developing, creating, and sharing generative virtual human content. Here is the 36-second video sample of a digital human developed by AI Catalysis. https://youtube.com/shorts/IWTIfsh-YfY?feature=share

    These are the Company’s main business:

    AI-DRIVEN DIGITAL HUMAN TECHNOLOGY

    The Technology is designed to create digital humans with lifelike appearances, facial expressions, and movements seamlessly bridging the gap between reality and the digital world. Powered by state-of-the-art natural language processing (“NLP”) and machine learning, these digital humans have remarkably realistic appearances through high-quality modeling, rendering, and animation.

    The company aims to provide technology application services of digital human creation and customization for social media influencers or SMBs (Small and Medium-sized Businesses) in the consumer industry, to help the clients optimize their online marketing and advertising.

    LIVE-STREAMING E-COMMERCE BUSINESS

    The company has introduced online e-commerce businesses on TikTok. The business focus is on capturing TikTok’s popular trend by offering carefully selected product choices with smooth delivery, aiming to redefine the online shopping experience. The company formulates a dual strategy employing both short video and live streaming to offer online shoppers a more convenient and interactive shopping experience. By growing the horizontal coverage of social media platforms and vertical user base on selected product categories, the company can create value for its customers and business partners.

    LIVE STREAMING INTERACTIVE GAME

    The company has launched a live-streamed game on Tiktok that offers real-time and immersive gaming experience, where viewers can actively participate as players during the livestream. The company plans to diversify its game offerings and the anchor personalities for TikTok users. It aims to serve the TikTok audience 24/7 and plans to introduce digital hosts to ensure non-stop entertainment using the digital human technology.

    GD CULTURE GROUP’S PORTFOLIO COMPANY DIGITRAX RELEASES ITS PATENTED AI MUSIC PRODUCTION TOOL KR38R PRO

    NEW YORK, Nov. 22, 2023 (GLOBE NEWSWIRE) — GD Culture Group Limited (“GDC” or the “Company”) (Nasdaq: GDC), a Nevada holding company conducting business through its subsidiaries AI Catalysis Corp. (“AI Catalysis”), today announced that its portfolio company, DigiTrax Entertainment, Inc., (“DigiTrax”), a music company at the forefront of transforming the music industry by pioneering the use of artificial intelligence (AI) solutions, has released its first AI music production software plugin tool, KR38R PRO (“Creator”). The launch heralds the release of a serious of DigiTrax’s patented AI-powered products, with a vision to leverage the technology to reshape the future of music, revolutionize music creation, and redefine music experiences.

    After seven years of dedicated efforts in human-AI collaboration, KR38R PRO is built upon a total of seven DigiTrax’s patents on AI-powered music composition to provide instantaneous creative possibilities to songwriters and musicians. The Creator has been trained on music theory to fully understand the music language of songwriters and musicians. It is equipped with essential parameters such as key, chord sequences, beats per bar, and more to prompt the composition engine. KR38R PRO seamlessly integrates into existing creation workflows and is compatible with many leading digital audio workstations, including Pro Tools, Ableton, Cubase, and FL Studio.

    KR38R PRO empowers musicians by streamlining the composition process while ensuring complete control over their productions. Based on its tiered subscription service, Creator makes the whole production process easier with the offering of its add-on downloadable STUDIO and SOUND PACKS featuring full session files, instruments, sounds, MIDI, and presets for Hip-Hop, EDM, Pop, and Country genres.

    Mr. Xiaojian Wang, Chairman and Chief Executive Officer of the Company, commented, “We’re proud to announce the launch of DigiTrax’s latest product KR38R PRO, which showcasing our commitment to exploring new frontiers in AI-driven technologies. KR38R PRO aims to empower users in today’s highly competitive music industry by expediting their creative process. The application of this state-of-the-art technology is expected to have revolutionary impact to the industry, unleashing enormous possibilities and values for artists and labels. The launch of KR38R PRO signifies the start of a series of DigiTrax’s patented AI-empowered music technology releases. We anticipate unveiling more products in 2023 and 2024. We believe that this series of products will cater to the needs of established artists, music stakeholders and entertainment technophiles, strengthen the competitiveness of our users in the ever-evolving entertainment industry, and create substantial value for our shareholders.”

    About GD Culture Group Limited

    GD Culture Group Limited (the “Company”) (Nasdaq: GDC), is a Nevada holding company currently conducting business through its subsidiaries, AI Catalysis Corp. (“AI Catalysis”). The company plans to enter into the livestreaming market with focus on e-commerce and livestreaming interactive games through its wholly owned U.S. subsidiary, AI Catalysis, a Nevada corporation incorporated in May 2023. The Company’s main businesses include AI-driven digital human technology, live-streaming e-commerce business and live streaming interactive game. For more information, please visit the Company’s website at https://www.gdculturegroup.com/.

    About DigiTrax Entertainment, Inc.

    DigiTrax Entertainment, Inc. is a music technology company that uses artificial intelligence to develop new ways of creating and experiencing music. The company has developed a patented AI process that leverages evolutionary algorithms trained on music theory as the key innovation of the KR38R platform. The platform leverages AI for new music creation and to help artists and music labels unlock additional value from existing content. DigiTrax Entertainment, Inc. is currently participating in the NVIDIA Inception and Intel AI Partner Programs. https://digitrax.ai/

    GD CULTURE GROUP ENTERS INTO MEMORANDUM OF UNDERSTANDING WITH PIER E MEDIA FOR EXPANSION INTO TIKTOK AGENCY BUSINESS

    NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) — GD Culture Group Limited (“GDC” or the “Company”) (Nasdaq: GDC), a Nevada holding company conducting business through its subsidiaries AI Catalysis Corp. (“AI Catalysis”), today announced the signing of a Memorandum of Understanding (the “MOU”) between AI Catalysis and Pier E Media, a leading influencer agency that connects brands with influential content creators, to expand its agency business on TikTok. The collaboration marks GDC’s strategic expansion into TikTok agency business, which is critical in boosting the Company’s performance in eCommerce and game live streaming sectors and strengthening its connections with TikTok content creators.

    Pursuant to the MOU, AI Catalysis and Pier E Media shall act as the Movement directors. Additionally, Pier E Media grants the rights to AI Catalysis to utilize its agency license and TikTok accounts.

    The signing of the MOU is essential to the AI Catalysis’s talent acquisition and business expansion. The partnership incorporates a system for talents recruitment and nurturing, which paves the way for building a diverse pool of talented TikTok content creators to invigorate AI Catalysis’s content creator community. Consequently, AI Catalysis is in a better position to provide a wide array of engaging content, injecting impetus to the growth of its eCommerce and game live-streaming operations.

    The cooperation also aims to deepen the relationship between AI Catalysis and its creators through the offering of its specialized services. AI Catalysis is committed to catering to the needs and requirements of the creators across the board, with a comprehensive provision of services including technical support, eCommerce operation, supply chain integration, platform expertise, and monetization opportunities. In particular, AI Catalysis focuses on fostering closer connections between its creators and their audience, by empowering the content creators with AI Catalysis’s AI Digital Human avatars technology. This technology aims to enhance content personalization and quality.

    Mr. Xiaojian Wang, Chairman and Chief Executive Officer of the Company, expressed his enthusiasm for the collaboration: “We are excited to announce our partnership with Pier E Media, which not only positions us as a premier TikTok agency but also underscores our commitment to nurturing stronger relationships with creators. This collaboration showcases our dedication to reshaping influencer marketing and empowering TikTok content creators. We are dedicated to providing creators with the tools they need to excel in the digital landscape.”

    About Pier E Media

    Pier E Media was established in 2017, and our core team consists of professionals from top domestic and international e-commerce and talent agency companies, including Douyin/TikTok. We have rich experience in talent management and channels. Pier E Media is dedicated to helping brands with integrated overseas digital platform marketing. Our team can provide end-to-end services such as account incubation, influencer collaborations, and ecommerce operations, aiming to maximize client benefits. Website: https://www.pieremedia.com/

    About AI Catalysis

    AI Catalysis is a leading digital marketing and AI technology company dedicated to empowering creators and influencers to excel in the digital space. With a focus on innovation and cutting-edge solutions, the company is committed to driving excellence in influencer marketing, ecommerce, and game livestreaming while nurturing stronger relationships with creators. For more information, please visit AI Catalysis’s website at: https://aicatalysis.com/.

    NEWS

    PUBLISHED

    4 HOURS AGO

    FROM DIGITAL AVATARS TO AI AGENTS: GD CULTURE GROUP TO EXPAND ITS AI FRONTIER WITH GPT-4-POWERED AI AGENT

    PUBLISHED

    NOV 22, 2023

    GD CULTURE GROUP’S PORTFOLIO COMPANY DIGITRAX RELEASES ITS PATENTED AI MUSIC PRODUCTION TOOL KR38R PRO

    PUBLISHED

    NOV 21, 2023

    GD CULTURE GROUP ENTERS INTO MEMORANDUM OF UNDERSTANDING WITH PIER E MEDIA FOR EXPANSION INTO TIKTOK AGENCY BUSINESS

    PUBLISHED

    NOV 20, 2023

    GD CULTURE GROUP UNVEILS ITS TRANSFORMATIVE AND PHOTOREALISTIC AI-DRIVEN DIGITAL HUMAN TECHNOLOGY ON TIKTOK

    PUBLISHED

    NOV 3, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES CLOSING OF $10 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES

    PUBLISHED

    NOV 1, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES $10 MILLION REGISTERED DIRECT PRICED AT-THE-MARKET UNDER NASDAQ RULES

    PUBLISHED

    SEP 5, 2023

    GD CULTURE GROUP EXPANDS INTO LIVESTREAMING INTERACTIVE GAMES ON TIKTOK

    PUBLISHED

    AUG 28, 2023

    GD CULTURE GROUP LIMITED EXPANDS GRIDS OF THE FUTURE PORTFOLIO WITH TIKTOK TO DRIVE GROWTH OF LIVE-STREAMING E-COMMERCE BUSINESS SEGMENT

    PUBLISHED

    AUG 21, 2023

    GD CULTURE GROUP LIMITED UNVEILS REBRANDING INITIATIVES REFLECTING ITS TRANSFORMATION AND FOCUS ON GROWTH AND INNOVATION

    PUBLISHED

    JUN 7, 2023

    GD CULTURE GROUP LIMITED PARTICIPATES AND PRESENTS AT BITBLOCK SUMMIT HELD IN NEW YORK CITY ON JUNE 1, 2023

    PUBLISHED

    JUN 6, 2023

    GD CULTURE GROUP LIMITED ESTABLISHES SUBSIDIARY IN NEW YORK TO ADVANCE OPERATIONS AND BUSINESS GROWTH

    PUBLISHED

    MAY 2, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES DOWNSIZE OF ITS REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES AND PRIVATE PLACEMENT TO $9.55 MILLION

    PUBLISHED

    MAY 2, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES $11.55 MILLION REGISTERED DIRECT PRICED AT-THE-MARKET UNDER NASDAQ RULES AND PRIVATE PLACEMENT

    MANAGEMENT TEAM

    Xiaojian Wang

    Chief Executive Officer, President, Chairman of the Board and Director

    Mr. Wang was the Vice President of Business Development at Foregrowth Inc. in Vancouver, Canada, where he formulated and executed comprehensive business plans, achieving defined sales targets and driving market expansion, conducted training sessions for financial advisors, equipping them with in-depth knowledge of compliance requirements, market insights, and product features, and conducted extensive research and due diligence on potential alternative investment opportunities, resulting in successful acquisitions and partnerships. Prior to that, Mr. Wang was a Private Banking Consultant and an Interbank Commercial Paper Trader at China Minsheng Bank in Chongqing, China. Mr. Wang received his Bachelor of Science in Mathematics degree from University of British Columbia in 2012.

    Zihao Zhao

    Chief Financial Officer

    Mr. Zhao was a senior audit assistant at PricewaterhouseCoopers, PWC, Shanghai from 2016 to 2019. Mr. Zhao received his Bachelor of Science in Taxation degree from Shanghai Lixin University of Accounting and Finance in 2016.

    Lu Cai

    Chief Operating Officer

    Ms. Cai has over 10 years of extensive experience in financial management and consulting. Since July 2020, Ms. Cai has been the Chief Executive Officer of Beijing Boda Shengshi Financial Consulting Co., Ltd, a firm that offers initial public offering and pre-marketing consulting services in China. From July 2017 to May 2020, Ms. Cai was a Vice President of SINO-TONE Beijing Consulting Co., Ltd, a consulting firm based in Beijing, China. Ms. Cai graduated from Beijing Foreign Studies University.

    Shuang Zhang

    Vice President and Director

    Ms. Zhang was appointed as the Vice President and a director of the Company, effective October 4, 2022. Ms. Zhang, co-founded Highlight Media in 2016 and has been its Chief Executive Officer since 2017. During her tenure as the Chief Executive Officer, Ms. Zhang managed the planning, creation and publication of books about the company history of industry leaders in China, published in top financial publications in China. From 2015 to 2016, Ms. Zhang was the director of public relations at Ctrip, an online travel company in China. From 2004 to 2015, Ms. Zhang was the editor-in-chief of China Business News, responsible for editing, performance, and quality control. Ms. Zhang received her bachelor’s degree in journalism from Heilongjiang University in China in 1991 and her Master of Business Administration degree from the Antai College of Management and Economics of Shanghai Jiaotong University.

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  • (NYSE American: MAIA) Profile

    OUR NEW PROFILE IS:  (NYSE AMERICAN: MAIA)

    MAIA BIOTECHNOLOGY RECENTLY ANNOUNCES SHARE REPURCHASE PROGRAM 

    MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA.

         -THIS IS THE THIRD ORPHAN DRUG DESIGNATION GRANTED TO THIO, FOLLOWING THE RECEIPT OF ORPHAN DRUG DESIGNATIONS FOR HEPATOCELLULAR CARCINOMA (HCC) AND SMALL-CELL LUNG CANCER (SCLC) IN 2022. RECEIVING THREE DESIGNATIONS HIGHLIGHTS THE FDA’S RECOGNITION OF THIO’S POTENTIAL TO TREAT MULTIPLE TYPES OF CANCERS, INCLUDING RARE ONES LIKE GLIOBLASTOMA

    READ THE INVESTOR PRESENTATION HERE

    _______________________________________________________________________________________________________________

    Hello Everyone,

    We have a new NYSE profile for Tuesday’s session.

    This is a company that we have profiled in the past at higher levels and it has come down over the past week after announcing an offering at significantly higher levels from it’s current price.

    There could be significant room to run based on the chart if it were to see some interest and momentum.

    Pull up MAIA and start your research on it tonight.

    MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a first-in-class cancer telomere targeting agent in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with telomerase-positive cancer cells.

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

    • Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
    • Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
    • Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.

    “We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”

    “In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”

    “Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”

    Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.

    About Orphan Drug Designation

    The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    About THIO-101, a Phase 2 Clinical Trial

    THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

    MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

    • Substantial THIO program progress including unprecedented disease control rate (DCR) of 100% in second-line non-small cell lung cancer (NSCLC)
    • Key THIO findings in gliomas, pediatric brain cancer, and second generation THIO-derived cancer therapies
    • Strong pace of enrollment in THIO-101 Phase 2 trial exceeds average enrollment pace in similar NSCLC trials

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

    “Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024.”

    Third Quarter Business Highlights and Recent Developments

    THIO Program

    Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

    Highly Potent Anticancer Activity in Gliomas: MAIA’slead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

    THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

    Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

    THIO-101 Phase 2 Clinical Trial

    U.S. FDA Clearance of THIO IND Application: TheU.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

    Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

    Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

    Third Quarter 2023 Financial Results

    Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

    Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

    General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

    Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

    Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

    For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    About THIO-101, Phase 2 Clinical Trial

    THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

    MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

    OCT 12, 2023 9:20AM EDT

    Treatment demonstrates decreased cancer cell proliferation and increased tumor sensitivity to ionizing radiation

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, announced that study data shows THIO’s potent anticancer activity in Diffuse Intrinsic Pontine Glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children.

    The data was recently presented at the Society for Neuro-Oncology’s 2023 Pediatric Neuro-Oncology Research Conference and published in the Neuro-Oncology journal (Volume 25, Issue Supplement_1, June 2023, Page i13). The study evaluated THIO as a potential treatment for DIPG based on inducing direct telomeric DNA damage mediated cancer cell death and activating antitumor immunity in DIPG through the intracellular cGAS/STING pathway, which resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

    Radiotherapy is the only standard of care treatment option for DIPG, yet it is rarely curative. In recent years, several immunotherapy strategies have emerged as potential treatments for DIPG. However, the low mutational burden and rare infiltration of T lymphocytes renders these tumors immunologically “cold” and, therefore, poses challenges for general immunotherapy.

    “We have shown that THIO treatment sensitized DIPG cells to ionizing radiation (IR), leading to a significant decrease in DIPG cell proliferation in vitro and in vivo models,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “These encouraging preclinical studies may support further potential preclinical and clinical development of THIO to be used in combination with IR to treat children with high-risk pediatric brain tumors.”

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer(NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

    September 28, 2023 8:01am EDT

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

    “This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation,” said Vlad Vitoc, MAIA’s Chief Executive Officer. “By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders.”

    With a share repurchase program, MAIA may repurchase shares from time to time through various methods, including in open market transactions, in privately negotiated transactions or otherwise, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, in compliance with applicable state and federal securities laws. The timing, as well as the number and value of shares repurchased under the program, will be determined by the Company at its discretion and will depend on a variety of factors, including our assessment of the intrinsic value of the Company’s common stock, the market price of the Company’s common stock, general market and economic conditions, available liquidity, compliance with the Company’s debt and other agreements, applicable legal requirements, the nature of other investment opportunities available to the Company, and other considerations. The Company is not obligated to purchase any shares under the repurchase program, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund the repurchases by using cash on hand and expected free cash flow to be generated in the future.

    Significant Market Opportunity

    • Cancer is the most dominant of the age-related disease categories and has life altering impacts in the lives of patients and their close ones
    • The number oF people aged 80 years or older is expectedtotriplebetween 2020 and 2050 to reach 426 million
    • Approximately40%ofpeoplealivetodayareprojectedtobediagnosed with a cancer type in their lifetime, and 20% will die of it
    • NSCLC is the leading tumor type: Mortality 1.7M / Sales $32B (2022)
    • CRCissecond:Mortality1M/Sales$20B(2022)

    Clinical Programs

    THIO-101: Ph 2 trial THIO + LIBTAYO® (cemiplimab) – enrolling (35 patients dosed to date)

    • Go-to-market trial in second line NSCLC
    • Objectives: select most efficacious dose and expand into pivotal trial
    • Started in 2022 in Australia & Europe; to include US in 2023
    • Regeneron clinical supply agreement for Libtayo®
    • File for accelerated approval in 2025
    • Part A (Safety Lead-in) Complete: No dose-limiting toxicities (DLTs), No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reactions (SUSAR); Safety profile substantially better than current Standard of Care (SoC)
    • Preliminary Survival: first 2 patients dosed in Part A continue to be alive, 12.2 and 11.5 months from treatment initiation; progression free after last dose, 10.2 and 8.5 months respectively, with no new treatment; in real-world clinical practice, observed survival in similar heavily pretreated patients is 3-4 months; weeks without therapy
    • Disease Control Rate: 82%; subjects with 1+ post-baseline response assessment (n=11, 06/23/23); DCR for SoC in third line: 25-35%
    • Part B (efficacy/dose selection) initiated THIO-102: Ph 2 trial THIO + CPIs
    • Go-to-market trial in late line of therapy in multiple tumor. types: Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC, 90% of primary type of liver cancers), and Solid Tumors of any type (ST)
    • 3 umbrellas in each: THIO + Libtayo (REGN); Keytruda (MRK); Tecentriq (Genentech/Roche)
    • Objectives: select most efficacious combination by tumor type and expand into pivotal trials (9+ possible market entry indications)
    • Start in 2023, to include US, Europe, Asia, etc.
    • File for accelerated approvals in 2026 and beyond THIO-103: Ph 2/3 trial of THIO + CPIs
    • First line NSCLC and SCLC
    • Expand to Breast, Prostate, Pancreatic, Ovarian, Gastric Cancer, etc.

    THIO is a Unique Direct Telomere Targeting Agent
    • Potential to be used in combination with other anticancer and immune therapies
    • Dual, novel mechanism of action: telomere

    targeting + immunogenic
    • FDA awarded THIO 2 Orphan Drug

    Designations: HCC and SCLC!
    • Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

    MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

    October 10, 2023 8:01 am EDT   CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its lead asset THIO showed highly potent anticancer activity in gliomas, an aggressive type of brain tumor that originates from glial cells. THIO’s novel dual mechanism of action – direct telomere targeting and immune system activation, has previously demonstrated similar efficacy in multiple types of telomerase-active tumors.

    THIO was evaluated in various in vitro and in vivo models of gliomas. The results demonstrate the promising therapeutic role of THIO for the treatment of primary and temozolomide-resistant recurrent gliomas through specific telomerase-mediated induction of telomeric DNA damage in glioma cells

    “High grade adult gliomas are among the most difficult-to-treat cancers, with less-than-desirable clinical outcomes. These encouraging results further highlight THIO’s excellent anti-cancer activity across several cancer indications,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We look forward to evaluate THIO as a treatment for brain cancer in clinical setting.”

    “THIO was effective in the majority of human and mouse glioma cell lines with no apparent toxicity against normal astrocytes. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the art care temozolomide (TMZ). THIO induced apoptosis in several human glioma cell lines that grow as three-dimensional tumor mass-mimicking neurospheres,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “Additionally, THIO produced telomeric DNA damage responses not only in glioma cell lines, but also in diverse human-derived tumor specimens (PDXs). In vivo, THIO significantly decreased tumor proliferation in glioblastoma xenografts and a PDX model of glioblastoma.”

    The reviewed results were published in: Clin Cancer Res (2021) 27 (24): 6800–6814.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    Partnership with Regeneron

    • Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

    • Equivalent to $32M non-dilutive participation (largest financing move to date)

    • Potentially expand existing relationship and target new companies

    Strong and Growing IP Portfolio

    • Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending

    Next Generation Potential Telomere Targeting Therapeutics
    • 84 new molecules engineered in last 12

    months; Same mechanism of action as THIO • MAIA-2021-020, MAIA-2022-012 and

    MAIA-2021-029 significantly moreCefficacious
    • Follow THIO to commercial stage within 4-5 years

    NEWS

    PUBLISHED

    NOV 17, 2023

    MAIA BIOTECHNOLOGY (NYSE: MAIA) HAS RECEIVED FDA ORPHAN DRUG DESIGNATION FOR THIO AS A TREATMENT FOR MOST AGGRESSIVE BRAIN CANCER

    PUBLISHED

    NOV 15, 2023

    MAIA BIOTECHNOLOGY ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING

    Nov 10, 2023 7:01am EST

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

    Nov 07, 2023 8:15am EST

    MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

    Oct 30, 2023 8:41am EDT

    MAIA BIOTECHNOLOGY REVEALS HIGHER ANTICANCER POTENCY OF TELOMERE-TARGETING COMPOUNDS DERIVED FROM THIO

    Oct 24, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES 100% DISEASE CONTROL IN SECOND-LINE NON-SMALL CELL LUNG CANCER DEMONSTRATING IMPRESSIVE POSITIVE PRELIMINARY EFFICACY DATA FOR ONGOING THIO-101 PHASE 2 TRIAL

    Oct 19, 2023 8:35am EDT

    MAIA BIOTECHNOLOGY TO PRESENT PRELIMINARY SAFETY AND EFFICACY DATA FROM THIO-101 PHASE 2 CLINICAL TRIAL AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY CONGRESS 2023

    Oct 17, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY TO PRESENT LATEST FINDINGS FOR SECOND GENERATION THIO PROGRAM AT TURKISH BIOCHEMICAL SOCIETY’S INTERNATIONAL BIOCHEMISTRY CONGRESS 2023

    Oct 12, 2023 9:20am EDT

    MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

    Oct 10, 2023 11:15am EDT

    MAIA BIOTECHNOLOGY ACCELERATES ENROLLMENT IN THIO-101 PHASE II CLINICAL TRIAL AS EFFICACY IS OBSERVED IN DOSED PATIENTS

    Oct 10, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

    Oct 03, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

    Sep 28, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

    Aug 08, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

    Jul 11, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS UPDATES ON DISEASE CONTROL RATES FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

    Jul 10, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS UPDATES ON PRELIMINARY SURVIVAL DATA FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

    Jun 20, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES UPDATES IN ENROLLMENT IN PHASE II CLINICAL TRIAL: THIO-101 HAS ENROLLED 29 PATIENTS

    Jun 07, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY FILES SECOND PATENT FOR NEW TELOMERE-TARGETING MOLECULES PROGRAM

    May 08, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

    Apr 27, 2023 4:10pm EDT

    MAIA BIOTECHNOLOGY, INC. ANNOUNCES CLOSING OF PUBLIC OFFERING

    Apr 24, 2023 9:06pm EDT

    MAIA BIOTECHNOLOGY, INC. ANNOUNCES PRICING OF PUBLIC OFFERING

    Apr 20, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS PRELIMINARY SURVIVAL DATA IN PART A OF THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

    MANAGEMENT TEAM

    team

    VLAD VITOC, MD, MBA

    CHIEF EXECUTIVE OFFICER AND CHAIRMAN

    Dr. Vitoc is our Chairman of Board, Chief Executive Officer, and President. Dr. Vitoc has a broad array of experience across commercial strategic analysis and planning and medical affairs, in which he has 20 years of experience. During that time, Dr. Vitoc has managed and supported over 20 early, launch, and mature stage compounds, which have included targeted therapies and immune therapies across more than 25 tumor types, including colorectal cancer, hepatocellular carcinoma, lung cancer, breast cancer, prostate cancer, and renal cell carcinoma. Vlad received an M.D. from the University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania, and his M.B.A. from the University of South Carolina.

    team

    JOSEPH F. MCGUIRE

    CHIEF FINANCIAL OFFICER

    Mr. McGuire is our Chief Financial Officer, and he brings over 30 years of experience to MAIA, having served as Chief Financial Officer for several privately held and publicly traded companies in the healt

    team

    SERGEI M. GRYAZNOV, PHD

    CHIEF SCIENTIFIC OFFICER

    Dr. Gryaznov is our Chief Scientific Officer. Dr. Gryaznov is an internationally recognized scientist and expert in the areas of modern drug discovery and development, oncology, telomerase, immune-regulatory therapeutics, nucleosides, nucleotides, DNA and RNA analogues, lipid and other conjugates, small molecules, and nucleic acid based therapeutic agents. Dr. Gryaznov is the co-inventor of a novel telomere-by-telomerase-targeting therapeutic approach to potential cancer treatment and responsible for leading the research team that characterized THIO’s telomere targeting activity, our lead compound in development. Dr. Gryaznov obtained an M.S., with Honors, in Organic Chemistry and a Ph.D. in Chemistry of Natural Products from M.V. Lomonosov Moscow State University. Dr. Gryaznov also completed a post-doctoral fellowship program in Chemistry at Northwestern University in Evanston, IL.

    team

    MIHAIL OBROCEA, MD

    CHIEF MEDICAL OFFICER

    Mihail is a board-certified internist and hematologist/oncologist with over 25 years’ experience in drug development in both academia and pharmaceutical/biotechnology industry. His broad clinical drug development expertise in both hematology and oncology covers equally early and late-stage development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Mihail completed a residency program in internal medicine at Yale University followed by a fellowship program in hematology/oncology at Dartmouth with academic appointment as Instructor of Medicine in the division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth.

    He started his career in pharmaceutical industry at Pfizer Oncology leading the CD40 agonist and IGF-1R antibodies projects, which entered in early clinical trials. Subsequently he led the Medical Affairs Oncology group at MedImmune, Gaithersburg MD and later as VP, Clinical Development Oncology at MannKind Corp., Valencia, CA successfully brought into clinic two cancer vaccine programs. As a Global Project Lead for AbbVie Biotherapeutics in Redwood City, CA, he was responsible for the early clinical oncology monoclonal antibody programs and as Head, Medical Sciences at Pharmacyclics, Sunnyvale CA he took part in the commercial launch of ibrutinib (IMBRUVICA™) program in mantle cell lymphoma and chronic lymphocytic leukemia. As VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, a venture pharma company supported the medical and business operations of the Pfizer Oncology partnership on the Phase 3, pivotal trial which led to the FDA approval of Besponsa® (inotuzumab ozogamicin) in the R/R adult B-cell ALL.

    Later as US Clinical Lead at Nanobiotix Corp, a biotechnology company based in Paris, France which develops nanotechnologies for use in radiation oncology, established the US clinical programs and was involved in the strategic business development, investor, and partner interaction. As a Program Lead at Juno Therapeutics Inc and later Celgene he had the US clinical oversight of 2 clinical trials including the registration Ph 3 trial in second line aggressive large B-cell lymphomas of BREYANZI® (lisocabtagene maralucel) an autologous CD19 targeted CAR T program approved in both US and EU in R/R large B-cell lymphoma. More recently, as Project and Clinical Lead at Atara Bio, a T-cell therapy company based in Thousand Oaks, CA he supported the pre-clinical and clinical development of the Atara’s allogeneic CAR T platform for both lymphoma and solid tumor indications.

    Mihail published in oncology peer-reviewed literature and is co-author of a couple of books related to cancer vaccines and immunology as well as he holds several patents in the field of biotechnology.

    SINCERELY,

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  • (NASDAQ: SOPA) Profile

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    OUR NEW PROFILE IS:   (NASDAQ: SOPA)

    WITH CASH ON HAND OF $8.2 MILLION (APPROXIMATELY $0.26 PER SHARE) AND BOOK VALUE OF $9.9 MILLION(APPROXIMATELY $0.32 PER SHARE) AS OF 30 SEPTEMBER 2023, SOPA IS WELL CAPITALISED FOR CONTINUING ACQUISITIONS OF SEA COMPANIES IN ITS DIGITAL ADVERTISING, TRAVEL, LIFESTYLE, TELECOMMUNICATIONS, AND LOYALTY/FINTECH VERTICALS FOR THE REST OF 2023 AND 2024

    SOPA JUST ANNOUNCEED THAT REVENUES INCREASED 117% YOY; GROSS PROFIT MARGIN IMPROVED TO 28.1%; CASH OPERATING EXPENSES DECLINED 32.6% YOY

    SOPA’S PORTFOLIO OF COMPANIES BOASTS MORE THAN 3.3 MILLION REGISTERED USERS AND OVER 205,000 REGISTERED MERCHANTS

    SOCIETY PASS INC. (NASDAQ: SOPA) ANNOUNCES PLANS TO SPINOUT TWO PROFITABLE BUSINESS UNITS INTO NEW PUBLICLY-TRADED COMPANIES VIA NASDAQ IPOS IN 2024

          _________________

    Hello Everyone,

    We have another Nasdaq that is sitting under .50 right now that we want to bring to your attention.

    Pull up SOPA immediately.

    SOPA is a data-driven ecosystem that was founded in 2018. It focuses on loyalty, fintech, and e-commerce in the rapidly growing markets of Vietnam, Indonesia, Philippines, Singapore, and Thailand. These countries account for more than 80% of the population in Southeast Asia. SoPa operates six interconnected verticals, including loyalty, digital media, travel, telecoms, lifestyle, and F&B, and has offices in Los Angeles, Bangkok, Ho Chi Minh City, Jakarta, Manila, and Singapore. It seamlessly connects millions of registered consumers and hundreds of thousands of registered merchants and brands across multiple product and service categories throughout Southeast Asia, with a critical focus on acquisitions.

    SOPA is an acquisition-focused holding company operating 5 interconnected verticals (loyalty, digital media, travel, telecoms, and lifestyle), which seamlessly connects millions of registered consumers and hundreds of thousands of registered merchants/brands across multiple product and service categories throughout SEA.

    Society Pass completed an initial public offering and began trading on the Nasdaq under the ticker SOPA in November 2021.SoPa acquires fast growing e-commerce companies and expands its user base across a robust product and service ecosystem. SoPa integrates these complementary businesses through its signature Society Pass fintech platform and circulation of its universal loyalty points or Society Points, which has entered beta testing and is expected to launch broadly at the beginning of 2023. Society Pass loyalty program members earn and redeem Society Points and receive personalised promotions based on SoPa’s data capabilities and understanding of consumer shopping behaviour. SoPa has amassed more than 3.7 million registered consumers and over 650,000 registered merchants and brands. It has invested 2+ years building proprietary IT architecture to effectively scale and support its consumers, merchants, and acquisitions.

    Society Pass leverages technology to tailor a more personalised experience for customers in the purchase journey and to transform the entire retail value chain in SEA. SoPa operates Thoughtful Media Group, a Thailand-based, a social commerce-focused, premium digital video multi-platform network; NusaTrip, a leading Indonesia-based Online Travel Agency; VLeisure, Vietnam’s leading provider of hotel management and payment solutions; Gorilla Global, a Singapore-based, mobile network operator; Leflair.com, Vietnam’s leading lifestyle e-commerce platform.

    Society Pass Inc’s (Nasdaq: SOPA) 9 Mths 2023 Financials : Revenues Increased 117% yoy; Gross Profit Margin Improved to 28.1%; Cash Operating Expenses Declined 32.6% yoy

    NEW YORK, Nov. 15, 2023 (GLOBE NEWSWIRE) — Society Pass Incorporated (Nasdaq: SOPA) (“SoPa”), Southeast Asia (SEA)’s next generation, data-driven, loyalty, fintech and e-commerce ecosystem, today announces unaudited financial results for third quarter ended 30 September 2023and a filing of its 3Q 2023 Form 10-Q with the Securities and Exchange Commission (SEC).

    Click Here (on SEC website) to view 3Q 2023 Form 10-Q filing.

    Summary Points:

    • With cash on hand of $8.2 million (approximately $0.26 per share) and book value of $9.9 million(approximately $0.32 per share) as of 30 September 2023, SoPa is well capitalised for continuing acquisitions of SEA companies in its digital advertising, travel, lifestyle, telecommunications, and loyalty/fintech verticals for the rest of 2023 and 2024.

    • 9 months 2023 revenues grew 117.0% year on year (from $2,994,416 in 9 months 2022 to $6,498,878in 9 months 2023).

    • 3Q 2023 revenues grew 10.7% year on year (from $2,050,264 in 3Q 2022 to $2,269,066 in 3Q 2023).

    • 3Q 2023 revenues grew 3.7% quarter on quarter (from $2,187,232 in 2Q 2023 to $2,269,066 in 3Q 2023).

    • 9 months 2023 gross profit grew 523.2% year on year (from $293,004 in 9 months 2022 to $1,825,960 in 9 months 2023).

    • 3Q 2023 gross profit grew 82.7% year on year (from $307,935 in 3Q 2022 to $562,564 in 3Q 2023).

    • 3Q 2023 gross profit declined 2.5% quarter on quarter (from $577,159 in 2Q 2023 to $562,564 in 3Q 2023).

    • 9 months 2023 gross profit margin grew to 28.1% in 9 months 2023 from 9.8% in 9 months 2022.

    • 3Q 2023 gross profit margin grew to 24.8% in 3Q 2023 from 15.0% in 3Q 2022.

    • 3Q 2023 gross profit margin declined to 24.8% in 3Q 2023 from 26.4% in 2Q 2023.

    • While 9 months 2023 revenues grew 117.0% year on year, 9-month 2023 cash operating expenses declined 32.6% year on year (from $15,275,821 in 9 months 2022 to $10,295,103 in 9 months 2023).

    • While 3Q 2023 revenues grew 10.7% year on year, 3Q 2023 cash operating expenses declined 54.6% year on year (from $7,426,684 in 3Q 2022 to $3,368,443 in 3Q 2023).

    • While 3Q 2023 revenues grew 3.7% quarter on quarter, 3Q 2023 cash operating expenses increased 15.1% quarter on quarter (from $2,927,505 in 2Q 2023 to $3,368,443 in 3Q 2023).

    • 9 months 2023 digital advertising revenues represent 70.5% of total revenues and grew 278.0% year on year from ($1,211,428 in 9 months 2022 to $4,579,429 in 9 months 2023).

    • 3Q 2023 digital advertising revenues represent 78.7% of total revenues and grew 47.3% year on year from ($1,211,428 in 3Q 2022 to $1,784,695 in 3Q 2023).

    • 3Q 2023 digital advertising revenues represent 78.7% of total revenues and grew 18.1% quarter on quarter from ($1,510,960 in 2Q 2023 to $1,784,695 in 3Q 2023).

    • 9 months 2023 travel revenues represent 22.1% of total revenues and grew 704.2% year on year from ($178,206 in 9 months 2022 to $1,433,133 in 9 months 2023).

    • 3Q 2023 travel revenues represent 17.2% of total revenues and grew 119.1% year on year from ($178,206 in 3Q 2022 to $390,384 in 3Q 2023).

    • 3Q 2023 travel revenues represent 17.2% of total revenues and declined 29.8% quarter on quarter from ($556,042 in 2Q 2023 to $390,384 in 3Q 2023).

    • Since inception, SoPa has onboarded approximately 3.7 million registered consumers, approximately 650,000 registered merchants/brands and approximately 10,000 influencers onto its ever-expanding next generation digital ecosystem and loyalty platform in SEA.

    • SoPa operates five verticals in SEA: digital advertising, travel, lifestyle, fintech/loyalty, and telecoms.

    • SoPa operates in five SEA countries: Singapore, Vietnam, Indonesia, Philippines and Thailand.

    • SoPa employs approximately +200 people throughout SEA.

    Raynauld Liang, Society Pass Inc Chief Executive Officer, explains, “Our compelling revenue growth and dramatic profit margin expansion, as evidenced in the Company’s 9 months 2023 financial performance, substantiate our acquisitions-focused business plan to build the next generation digital ecosystem and fintech loyalty platform here in SEA. Despite 9 months 2023 revenues growing 117% year-on-year in the five largest economies of SEA, our 9 months 2023 cash operating expenses DECLINED by 32.6%. Just as importantly, our profit margins are materially improving on a year-to-year basis. We realized 28.1% gross profit margin in 9 months 2023, markedly improving from 9.8% in 9 months 2022.”

    Mr. Liang further elaborates, “I confidently forecast profitability for our two main subsidiaries, Thoughtful Media and NusaTrip, in financial year 2023. Both subsidiaries now contribute more than 90% of SoPa’s revenues. With the Singapore launch of our SoPa Loyalty App Launch in June 2023, we are now allowing our customers to earn loyalty points through fintech/loyalty platform and our subsidiaries will translate into significant revenue generation going forward. In addition, our business plan of spinning out our main subsidiaries will generate outsized returns for our shareholders.”

    SOCIETY PASS INC. (NASDAQ: SOPA) ANNOUNCES PLANS TO SPINOUT TWO PROFITABLE BUSINESS UNITS INTO NEW PUBLICLY-TRADED COMPANIES VIA NASDAQ IPOS IN 2024

    NEW YORK, NY, Oct. 10, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Society Pass Inc. (Nasdaq: SOPA) (“SoPa” or the “Company”), Southeast Asia’s (“SEA”) next generation, data-driven, loyalty, fintech and e-commerce ecosystem, announces that its Board of Directors, together with its financial and legal advisors, have evaluated a comprehensive range of strategic restructuring options to unlock shareholder value. As a result of these discussions, SoPa will pursue a spinout and initial public offering on Nasdaq in 2024 for its digital advertising ecosystem, Thoughtful Media Group Inc(“TMG”), and for its online travel platform, NusaTrip Inc (“NusaTrip”).

    Thailand-based TMG, the premier digital advertising network in SEA, operates in Thailand, Vietnam, Indonesia, and Philippines and connects advertisers/brands/merchants with over 10,000 influencers to targeted audiences in SEA via its social media-focused advertising ecosystem. TMG delivers significant returns on investment on advertising spend for its clients by more efficiently and effectively generating additional revenues across thousands of creator channels in industries such as fashion & beauty, lifestyle, video games, cooking, automotive, travel, luxury, and sports.

    Nusatrip, a leading Indonesia-based online travel agency, offers a comprehensive range of airlines and hotels on its travel platform for corporate and retail customers across SEA. With its first mover advantage, NusaTrip has onboarded over 1.2 million registered users, over 500 airlines and over 650,000 hotels around the world as well as connected with over 80 million unique visitors. Initially only focused on the Indonesian market, NusaTrip has expanded to other SEA countries to become a first-choice travel provider throughout SEA.

    SoPa believes that its separately-traded TMG and NusaTrip subsidiaries will increase SoPa shareholder value as investors can more clearly evaluate the performance and future potential of these profitable businesses on a standalone basis, whilst allowing each business to pursue its own distinct strategy and capital allocation policy. Both TMG and NusaTrip are managed by separate executive teams.

    “We believe that separating and listing our principal businesses in 2024 will improve our ability to unlock hidden value for all our stakeholders,” says Raynauld Liang, the Chief Executive Officer of SoPa. “Both TMG and NusaTrip are profitable and have large and growing market opportunities. This new proposed group structure will further increase both their operational agility and ability to focus on delivering exceptional solutions to their customers.”

    Mr. Liang further notes, “SoPa’s actions follow the leads of both Johnson & Johnson (JNJ) and Kellogg’s (K) spinning out operating subsidiaries and we plan on having the same success.”

    CORE BUSINESS

    SOPA AIMS TO MEET THE GROWING DEMAND FOR BETTER SERVICES IN ASIA BY ACQUIRING MARKET-LEADING COMPANIES AND PARTNERING WITH VISIONARY ENTREPRENEURS. THE COMPANY FOCUSES ON SIX KEY VERTICALS.

    • Loyalty

    SoPa Loyalty offers a universal, open-loop loyalty platform that generates permanent customer loyalty, replaces cash discounting, and creates additional revenues for merchants. The platform helps merchants retain existing customers, attract new ones, reduce customer turnover, and sync customer data in real time. Personalized marketing campaigns are also part of the SoPa Loyalty package.

    • Digital Media

    Thoughtful Media Group (TMG) is a Los Angeles-based company that operates a global multi-platform network. TMG has generated tens of millions of dollars in advertiser-branded content and deployed thousands of videos that have garnered billions of views across social media platforms such as YouTube, Daily Motion, and Facebook. It has also sourced hundreds of Asian content producers and digital media/product developers and launched brands into the markets of Thailand, Vietnam, the Philippines, China, and the US. Over the years, Thoughtful Media Group has gathered social influencer data, which it now uses to track 1 billion authenticated global video views a month across key social platforms.

    • Travel

    NusaTrip is a leading online travel agency (OTA) in Southeast Asia that provides services to individuals and businesses. They have connected more than 80 million unique visitors with over 500 airlines and 200,000 hotels worldwide through various local payment options. NusaTrip has partnerships with low-cost carriers in Asia and full-service airlines globally, enabling them to offer real-time global fare shopping to help travelers find the best deals. They also work with hotel wholesalers in multiple countries to provide real-time price optimization for their customers.

    • Lifestyle

    Leflair is an online shopping platform that provides access to over 3,500 Vietnamese and international brands in fashion, accessories, beauty, personal care, and home furnishings. It helps to expand markets by enabling local brands to sell their products internationally and foreign brands to enter new markets. Additionally, Leflair has filter and search programs designed to optimize the user’s shopping experience.

    • Telecom

    Gorilla is a mobile virtual network operator based in Singapore that leverages blockchain and web3 technology. It has plans to expand into Malaysia, Vietnam, and Thailand and aims to increase its registered user base to over 50,000 while driving app downloads to over 20,000. Gorilla offers an innovative suite of services that include e-SIM cards, local calling, international roaming, data, and SMS texting. These services are entirely owned by the users, allowing for easy transfer or sharing via blockchain wallets.

    • Food & Beverage

    In this vertical, there are three primary businesses.

    • Pushkart is a prominent online grocery delivery application in Metro Manila, with an average transaction amount of $40. This unit aims to expand its merchant coverage to 25 grocery stores, extend its reach to 10 new Philippine cities, increase its registered users to over 300,000, and boost app downloads to over 150,000.
    • Handycart is an online grocery delivery app based in Vietnam. It specializes in serving the Korean restaurant market in Hanoi. Handycart plans to expand its merchant coverage to 500 restaurants in Hanoi and aims to enter the HCMC market. Handycart is also looking to increase its registered user base to over 500,000 and drive app downloads to more than 200,000.
    • Mangan is a popular food delivery app operating on Luzon Island. It charges merchants a commission of at least 20 percent and delivery fees. On average, each transaction through the app amounts to around US$13. Mangan aims to increase its registered user base to over 500,000 and achieve over 150,000 app downloads.

    NEWS

    PUBLISHED

    5 DAYS AGO

    SOCIETY PASS INC’S (NASDAQ: SOPA) 9 MTHS 2023 FINANCIALS : REVENUES INCREASED 117% YOY; GROSS PROFIT MARGIN IMPROVED TO 28.1%; CASH OPERATING EXPENSES DECLINED 32.6% YOY

    PUBLISHED

    6 DAYS AGO

    SOCIETY PASS INC (NASDAQ: SOPA) APPLIES TO EXTEND AN ADDITIONAL 180 DAYS TO MEET THE $1.00 MINIMUM BID PRICE REQUIREMENT

    PUBLISHED

    NOV 8, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) / NUSATRIP INC EXPANDS GEOGRAPHIC COVERAGE THROUGH STRATEGIC PARTNERSHIP WITH CHINA-BASED GUANGZHOU JUNWEI INTERNATIONAL TRAVEL SERVICE CO. LTD TO ENHANCE TRAVEL EXPERIENCE FOR CUSTOMERS IN SOUTHEAST ASIA AND CHINA

    PUBLISHED

    NOV 2, 2023

    GREENRIDGE GLOBAL INITIATES EQUITY RESEARCH ON SOCIETY PASS INC (NASDAQ: SOPA): LOYALTY WALLET-BASED ECOMMERCE ECOSYSTEM & INFLUENCER ADVERTISING AGENCY POISED FOR OUTSIZED GROWTH IN FAST GROWING SOUTHEAST ASIA

    PUBLISHED

    NOV 1, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) AWARDED THE 2023 APEA FAST ENTERPRISE AWARD FOR E-COMMERCE CATEGORY

    PUBLISHED

    OCT 24, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) / THOUGHTFUL MEDIA GROUP INC VENTURES INTO CONCERT SPONSORING IN INDONESIA; DEVELOPING AN INNOVATIVE REVENUE STREAM AND CREATING UNIQUE MARKETING OPPORTUNITIES FOR ADVERTISERS

    PUBLISHED

    OCT 17, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) / THOUGHTFUL MEDIA GROUP INC LAUNCHES 1ST EVER MEDIAGRAM TO BUILD INDONESIA ONLINE FITNESS COMMUNITY; MEDIAGRAM PLATFORM PROJECTED TO GENERATE +20% OF TMG GROUP REVENUES IN 2024

    PUBLISHED

    OCT 12, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) ANNOUNCES EQUITY LINE OF UP TO $40 MILLION TO INVEST INTO OPERATING SUBSIDIARIES PROJECTED TO GO PUBLIC IN 2024

    PUBLISHED

    OCT 10, 2023

    SOCIETY PASS INC. (NASDAQ: SOPA) ANNOUNCES PLANS TO SPINOUT TWO PROFITABLE BUSINESS UNITS INTO NEW PUBLICLY-TRADED COMPANIES VIA NASDAQ IPOS IN 2024

    PUBLISHED

    SEP 5, 2023

    KEYNOTE SPEAKERS AND 34 COMPANIES TO PRESENT AT THE PLANET MICROCAP SHOWCASE: VANCOUVER ON SEPTEMBER 6-7, 2023 AT THE FAIRMONT WATERFRONT VANCOUVER

    PUBLISHED

    AUG 29, 2023

    SOCIETY PASS INC (NASDAQ:SOPA) PRESENT AT THE PLANET MICROCAP SHOWCASE: VANCOUVER 2023 ON WEDNESDAY, SEPTEMBER 6, 2023 & 1×1 MEETINGS ON THURSDAY, SEPTEMBER 7, 2023

    PUBLISHED

    AUG 21, 2023

    ASCENDIANT CAPITAL MARKETS: SOCIETY PASS INC. (NASDAQ: SOPA) 2Q 2023 SAW STRONG REVENUE GROWTH OF 338% YEAR ON YEAR; MAJOR ACQUISITION AND EXPECTED CASH PROBABILITY IN 2H 2023 TO DRIVE SHARE PRICE HIGHER

    PUBLISHED

    AUG 16, 2023

    SOCIETY PASS INC (NASDAQ: SOPA)/THOUGHTFUL MEDIA GROUP INC. ENTERS PHILIPPINES MARKET AND LAUNCHES CREATOR ECONOMY FOCUSED ADVERTISING PLATFORM

    PUBLISHED

    AUG 14, 2023

    MAXIM: SOCIETY PASS (NASDAQ: SOPA) – COMPELLING VALUATION; POSITIVE ON ORGANIC GROWTH & M&A; RAISES REVENUE TARGETS FOR 2023 AND 2024

    PUBLISHED

    AUG 10, 2023

    SOCIETY PASS INC’S (NASDAQ: SOPA) 2Q/1H 2023 FINANCIAL RESULTS ILLUSTRATE CONTINUING BREAKNECK REVENUE GROWTH AND EXCEPTIONAL PROFIT MARGIN EXPANSION; CONFIDENTLY FORECASTS ACHIEVING CASH PROFITABILITY IN 2H 2023

    PUBLISHED

    AUG 4, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) ANNOUNCES PAYMENTS PARTNERSHIP WITH 2C2P TO ENHANCE THE ONLINE SHOPPING EXPERIENCE IN SOUTHEAST ASIA

    PUBLISHED

    JUL 20, 2023

    SOCIETY PASS INC’S (NASDAQ: SOPA) TRAVEL SUBSIDIARY, NUSATRIP INC, ACQUIRES IATA-LICENSED VIETNAM INTERNATIONAL TRAVEL AND SERVICE JSC; ACQUISITION ADDS APPROXIMATELY US$2 MILLION IN GMV TO NUSATRIP REVENUE BASE

    PUBLISHED

    JUL 12, 2023

    SOCIETY PASS INC (NASDAQ: SOPA): ASCENDIANT CAPITAL MARKETS INITIATES RESEARCH COVERAGE FOR SOCIETY PASS INC – US$ BILLION MARKET POTENTIAL DUE TO FAST GROWING ONLINE PLATFORM IN ATTRACTIVE SOUTHEAST ASIA MARKETS

    PUBLISHED

    JUL 7, 2023

    SOCIETY PASS INC (NASDAQ: SOPA) SUBSIDIARY, NEXTGEN RETAIL INC, TO ACQUIRE INDONESIA’S PT INETINDO INFOCOM TO CREATE AN ONLINE AND OFFLINE ELECTRONICS AND GAMING RETAILER IN THE WORLD’S 4TH MOST POPULOUS ECONOMY

    PUBLISHED

    JUN 22, 2023

    SOCIETY PASS (NASDAQ: SOPA) TO FORMALLY INTRODUCE SOCIETY PASS LOYALTY APP AT LAUNCH PARTY IN SINGAPORE ON WEDNESDAY, 28 JUNE 2023

    MANAGEMENT  

    RAYNAULD LIANG

    Co-Founder / Chief Executive Officer

    As Chief Executive Officer, Mr. Raynauld Liang has full P&L responsibility for the group with specific focus on general management, group strategy, acquisitions, corporate finance, control, audit, compliance and legal functions. Mr. Liang brings over 20+ years of corporate finance and investment experience.

    TAN YEE SIONG

    Chief Financial Officer

    As Chief Financial Officer, Mr. Tan engaged in financial operation management, mergers and acquisitions, financial planning and analysis, audit and regulatory compliance and legal functions for the company. Responsible for all SEC filing matters, Mr. Tan possesses more than 15 years of audit, internal control, tax , merger & acquisition and risk mitigation experience.

    PATRICK SOETANTO

    Chief Operating Officer

    Mr. Patrick Soetanto manages supply chain, network planning, operations planning, vendor contracts, and process improvement. He also coordinates technology, marketing, sales and finance teams to define and implement operations strategy, structure, and processes. Mr. Patrick Soetanto focuses on performance monitoring to ensure consistency with established policies, goals and objectives; and He conducts due diligence on any new business integration.

    ROKAS SIDLAUSKAS

    Chief Marketing Officer

    As Manila and Philippines based Chief Marketing Officer, responsible for marketing, business development, PR, CRM, SEO, social media and product development coordination across business units.

    HOWIE NG

    Chief Technology Officer

    As Group VP of Technology, manages technology team and is responsible for design/implementation of architecture, including security, database, frontend, backend and middleware, API, microservices, loyalty and payment gateways.

    CHAM NGO

    Vietnam GM

    As Head of Leflair Business Unit, Ms. Cham Ngo oversaw the successful re-launch of Leflair onto Vietnam market in September 2021. Coordinates with Marketing/Sales, Operations and Technology teams as well as identifies partner opportunities. As Country General Manger based in Vietnam, manages country operations with P&L responsibility.

    PETER DICHIARA

    Chairman, General Counsel and Corporate Secretary

    In his roles with Society Pass and its subsidiaries, Mr. DiChiara is responsible for leading and organizing the legal matters and the management of Society Pass and its subsidiaries.

    KRIANGKRAI CHAIMONGKOL

    Thoughtful Media Group Inc CEO

    Joining our Company in April 2023, Mr. Chaimongkol is the CEO of Thoughtful Media Group. He is responsible for leading business operations of the company including business strategy, marketing and sales, digital planning function for the company with the main in charge of brand awareness, reputation and raising top-line growth of TMG Group in the market.

    HENG YAN RONG

    Thailand GM

    As the general manager for Thailand. My responsibility include building and maintaining new/ existing business networks and business opportunities, handling human resource matters and managing corporate partnerships relationships, responsible for all financial related matters.

    ARBIE PAGDANGANAN

    VP of Product Development

    As VP of Product Development, Ms. Arbie Pagdanganan is responsible for regional product development & design work of websites and apps in Society Pass ecosystem. Aligns with Marketing, Sales and Operations teams to provide consistent brand message and elevate design system. As Country General Manger based in Philippines, manages country operations with P&L responsibility.

    SINCERELY,

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  • (Nasdaq: GDC) Profile

    OUR NEW PROFILE IS: (NASDAQ: GDC)

    ____________________

    GD CULTURE GROUP EXPANDS INTO LIVESTREAMING INTERACTIVE GAMES ON TIKTOK

    GDC HAS BEEN ON A SLOW AND STEADY MOVE NORTH THROUGHOUT 2023

    __________________________________________

    Hello Everyone,

    We have another profile for you to look at and research before the open on Monday morning.

    Pull up GDC.

    This is another company that we have never looked at before but are excited to be able to profile it right now.

    GD Culture Group Limited (the “Company”) (Nasdaq: GDC), is a Nevada holding company currently conducting business through its subsidiaries, AI Catalysis Corp. (“AI Catalysis”). The company plans to enter into the livestreaming market with focus on e-commerce and livestreaming interactive games through its wholly owned U.S. subsidiary, AI Catalysis, a Nevada corporation incorporated in May 2023.

    LOOK AT THE CHART ON THIS ONE.  THE MOVE NORTH HAS BEEN SLOW AND STEADY UP FROM  THE $2 LEVEL

    These are the Company’s main business:

    AI-DRIVEN DIGITAL HUMAN TECHNOLOGY

    The Technology is designed to create digital humans with lifelike appearances, facial expressions, and movements seamlessly bridging the gap between reality and the digital world. Powered by state-of-the-art natural language processing (“NLP”) and machine learning, these digital humans have remarkably realistic appearances through high-quality modeling, rendering, and animation.

    The company aims to provide technology application services of digital human creation and customization for social media influencers or SMBs (Small and Medium-sized Businesses) in the consumer industry, to help the clients optimize their online marketing and advertising.

    LIVE-STREAMING E-COMMERCE BUSINESS

    The company has introduced online e-commerce businesses on TikTok. The business focus is on capturing TikTok’s popular trend by offering carefully selected product choices with smooth delivery, aiming to redefine the online shopping experience. The company formulates a dual strategy employing both short video and live streaming to offer online shoppers a more convenient and interactive shopping experience. By growing the horizontal coverage of social media platforms and vertical user base on selected product categories, the company can create value for its customers and business partners.

    LIVE STREAMING INTERACTIVE GAME

    The company has launched a live-streamed game on Tiktok that offers real-time and immersive gaming experience, where viewers can actively participate as players during the livestream. The company plans to diversify its game offerings and the anchor personalities for TikTok users. It aims to serve the TikTok audience 24/7 and plans to introduce digital hosts to ensure non-stop entertainment using the digital human technology.

    GD CULTURE GROUP EXPANDS INTO LIVESTREAMING INTERACTIVE GAMES ON TIKTOK

    NEW YORK, Sept. 05, 2023 (GLOBE NEWSWIRE) — GD Culture Group Limited (“GDC” or the “Company”), a holding company currently conducting business through Shanghai Highlight Media Co., Ltd. (“Highlight Media”) and AI Catalysis Corp. (“AI Catalysis”), today announced that AI Catalysis has launched an interactive livestreaming game (the “Game”) on TikTok.

    The Game offers real-time and immersive gaming experience. Upon joining the livestream, the Game prompts viewers to participate as players and pick one of two teams. The two player teams will compete with each other by giving commands to player avatars, challenging bosses, and purchasing in-game items to enhance gameplay. The livestream hosts offer commentary, tips and insights to excite the players. The Game has a feature allowing viewers to gift virtual tokens to their favorite hosts. The Hosts also interact with viewers’ chats and comments, which creates a sense of community. This fresh gaming style, already a hit in Asia, brings instant thrill-packed experiences to TikTok enthusiasts. The Game is easy to play, fun, and ready to entice whenever players choose to join in.

    The Game has gained strong momentum and has drawn attention of many TikTok users. AI Catalysis plans to diversify its game offerings and the anchor personalities for TikTok users. Currently, the Company has collaborated with two hosts – one with humor in spades and another with a keen gaming insight. AI Catalysis aims to serve the TikTok audience 24/7 and plans to introduce digital hosts to ensure non-stop entertainment.

    “We are excited to introduce this dynamic gaming experience to the TikTok community,” commented Mr. Xiaojian Wang, Chairman and Chief Executive Officer of the Company. “The synergy of real-time interaction and gaming engagement hits the sweet spot of today’s digital appetite. Moving forward, our goal is to enhance our impact on TikTok, diversify people’s way of entertainment, and deliver lasting value to our shareholders.”

    NEWS

    PUBLISHED

    NOV 3, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES CLOSING OF $10 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES

    PUBLISHED

    NOV 1, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES $10 MILLION REGISTERED DIRECT PRICED AT-THE-MARKET UNDER NASDAQ RULES

    PUBLISHED

    SEP 5, 2023

    GD CULTURE GROUP EXPANDS INTO LIVESTREAMING INTERACTIVE GAMES ON TIKTOK

    PUBLISHED

    AUG 28, 2023

    GD CULTURE GROUP LIMITED EXPANDS GRIDS OF THE FUTURE PORTFOLIO WITH TIKTOK TO DRIVE GROWTH OF LIVE-STREAMING E-COMMERCE BUSINESS SEGMENT

    PUBLISHED

    AUG 21, 2023

    GD CULTURE GROUP LIMITED UNVEILS REBRANDING INITIATIVES REFLECTING ITS TRANSFORMATION AND FOCUS ON GROWTH AND INNOVATION

    PUBLISHED

    JUN 7, 2023

    GD CULTURE GROUP LIMITED PARTICIPATES AND PRESENTS AT BITBLOCK SUMMIT HELD IN NEW YORK CITY ON JUNE 1, 2023

    PUBLISHED

    JUN 6, 2023

    GD CULTURE GROUP LIMITED ESTABLISHES SUBSIDIARY IN NEW YORK TO ADVANCE OPERATIONS AND BUSINESS GROWTH

    PUBLISHED

    MAY 2, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES DOWNSIZE OF ITS REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES AND PRIVATE PLACEMENT TO $9.55 MILLION

    PUBLISHED

    MAY 2, 2023

    GD CULTURE GROUP LIMITED ANNOUNCES $11.55 MILLION REGISTERED DIRECT PRICED AT-THE-MARKET UNDER NASDAQ RULES AND PRIVATE PLACEMENT

    MANAGEMENT TEAM

    Xiaojian Wang

    Chief Executive Officer, President, Chairman of the Board and Director

    Mr. Wang was the Vice President of Business Development at Foregrowth Inc. in Vancouver, Canada, where he formulated and executed comprehensive business plans, achieving defined sales targets and driving market expansion, conducted training sessions for financial advisors, equipping them with in-depth knowledge of compliance requirements, market insights, and product features, and conducted extensive research and due diligence on potential alternative investment opportunities, resulting in successful acquisitions and partnerships. Prior to that, Mr. Wang was a Private Banking Consultant and an Interbank Commercial Paper Trader at China Minsheng Bank in Chongqing, China. Mr. Wang received his Bachelor of Science in Mathematics degree from University of British Columbia in 2012.

    Zihao Zhao

    Chief Financial Officer

    Mr. Zhao was a senior audit assistant at PricewaterhouseCoopers, PWC, Shanghai from 2016 to 2019. Mr. Zhao received his Bachelor of Science in Taxation degree from Shanghai Lixin University of Accounting and Finance in 2016.

    Lu Cai

    Chief Operating Officer

    Ms. Cai has over 10 years of extensive experience in financial management and consulting. Since July 2020, Ms. Cai has been the Chief Executive Officer of Beijing Boda Shengshi Financial Consulting Co., Ltd, a firm that offers initial public offering and pre-marketing consulting services in China. From July 2017 to May 2020, Ms. Cai was a Vice President of SINO-TONE Beijing Consulting Co., Ltd, a consulting firm based in Beijing, China. Ms. Cai graduated from Beijing Foreign Studies University.

    Shuang Zhang

    Vice President and Director

    Ms. Zhang was appointed as the Vice President and a director of the Company, effective October 4, 2022. Ms. Zhang, co-founded Highlight Media in 2016 and has been its Chief Executive Officer since 2017. During her tenure as the Chief Executive Officer, Ms. Zhang managed the planning, creation and publication of books about the company history of industry leaders in China, published in top financial publications in China. From 2015 to 2016, Ms. Zhang was the director of public relations at Ctrip, an online travel company in China. From 2004 to 2015, Ms. Zhang was the editor-in-chief of China Business News, responsible for editing, performance, and quality control. Ms. Zhang received her bachelor’s degree in journalism from Heilongjiang University in China in 1991 and her Master of Business Administration degree from the Antai College of Management and Economics of Shanghai Jiaotong University.

    SINCERELY,

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  • (Nasdaq: SXTP) Profile

    Sixty Degrees Pharmaceuticals

    OUR NEW PROFILE IS: (NASDAQ: SXTP)

    ____________________

    SXTP HAS JUST 5 MILLION SHARES IN THE FLOAT ACCORDING TO FINVIZ

    SXTP PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES

    READ THE INVESTOR PRESENTATION HERE

    __________________________________________

    Hello Everyone,

    I hope that you are paying attention.

    We sent out our last profile at 2 pm Monday when the company was sitting right under 1.10.  During Tuesdays session it ran all the way up to 1.43 on above average interest after releasing news.  This was another overnight double digit run.

    Moving on………………

    We have a brand new company that we want you to take a look at.  This is a company that just IPO’d right before the summer and is sitting at a significant discount from it’s initial levels.

    This one has a tiny float and a market cap just over $3Mill right now.

    We have recently seen what happens when these low float plays pick up momentum.

    Pull up SXTP.

    60 Degrees Pharmaceuticals, a growth-oriented biotech company, specializes in the development and commercialization of new therapies used to treat and prevent serious infectious diseases.

    Cutting-edge biological science and applied research form the foundation of our highly-focused, advanced clinical strategy.

    In 2019, 60P’s malaria prevention product, ARAKODA® (tafenoquine), was made commercially available after receipt of U.S. regulatory approval in 2018.

    Our current product development targets include tick- borne, viral, fungal and other serious infectious diseases with unmet needs we perceive in the marketplace.

    PORTFOLIO

    Investment Highlights

    ▪ ARAKODA – a long-acting, potentially broad-spectrum, anti-infective already FDA-approved for malaria prevention and commercially available in the U.S.

    ▪ Safe, long acting, mechanistically differentiated antimalarial approved by FDA
    ▪ Discovered by US Army and successfully brought to market by 60P
    ▪ 1,100+ patient exposures in 8+ published clinical trials, weekly dosing for up to one year
    ▪ Commercially available in U.S. via network of major national distributors
    ▪ Existing commercial/regulatory infrastructure expected to facilitate cost-effective pathway to new/expanded indications following targeted clinical trial and label changes

    ▪ Arakoda Regimen of Tafenoquine – Research agenda involving babesiosis and other diseases
    ▪ Malaria, COVID-19, fungal, tick-borne illness of interest to the Company affect millions and are associated with a potentially high revenue unmet medical need ▪ Company has strong IP for malaria, COVID-19, and other indications
    ▪ Accelerated clinical recovery from babesiosis is suggested by case studies of immunosuppressed patients administered tafenoquine
    ▪ 2024: Execute Phase IIA treatment study in hospitalized babesiosis patients
    ▪ 2025: sNDA and/or confirmatory babesiosis patient study

    ▪ Experienced management team and Board
    ▪ Team has together led/managed four clinical trials
    ▪ Collectively led multiple pharmaceutical product approvals/product launches ▪ Collectively led/provided guidance on 20+ public & private entities
    ▪ Participated in/led multiple public listings

    Intellectual Property & Licensing

    60 Degrees Pharmaceuticals has freedom to operate

    • U.S. Arakoda Patents (2 issued/6 in progress)
      • T afenoquine for malaria prevention patent family: Earliest expiration December 2034
      • Tafenoquine for lung Infections/COVID Treatment: Earliest expiration March 2041
    • U.S. Celgosivir Patents
      • Dengue/RSV (4 issued/2 in progress)
    • International Patents

    ■ 6/2 for Celgosivir issued/in progress, 1/8 for tafenoquine issued/in progress

    ■ Clinical, non-clinical and manufacturing information

    60 DEGREES PHARMACEUTICALS SUSPENDS PHASE IIB STUDY OF TAFENOQUINE FOR COVID-19, PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES

    October 12, 2023 at 4:16 PM EDT

    • FDA advice to Company suggested execution of ACLR8-LR, a placebo-controlled Phase IIB study of tafenoquine in COVID-19 patients, may not be feasible in the U.S.
    • Company will therefore focus efforts on further commercialization related to ARAKODA® (tafenoquine) for prophylaxis of malaria, and prepare for a Phase IIA study of tafenoquine in hospitalized babesiosis patients
    • Company is preparing for submission of a pre-IND meeting request with FDA for babesiosis in the current fourth quarter of 2023, and plans to appoint a chief commercial officer to lead ARAKODA commercialization

    WASHINGTON, Oct. 12, 2023 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that its subsidiary, 60P Australia Pty Ltd, will not re-submit its investigational new drug application (“IND”) for ACLR8-LR, a Phase IIB study of tafenoquine compared to placebo in patients with mild to moderate COVID-19 disease and low risk of disease progression. Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention. The Company’s Board of Directors decided on October 6, 2023, that recent advice from the FDA made moving forward with the ACLR8-LR clinical development plan unfeasible.

    The FDA has approved or authorized two marketed oral products, Lagrevio™ and Paxlovid™, for use in cases of mild-to-moderate COVID-19 disease to reduce the rate of hospitalizations and deaths in patients with high risk of disease progression. However, the FDA has explicitly not authorized the use of those products in patients with low risk of COVID-19 disease progression. Accordingly, Lagrevio and Paxlovid are not recommended by public health agencies for that purpose.

    Current literature on COVID-19 shows that low risk patients have a very low risk of hospitalization. However, patients may wish to make a risk-based decision together with their physician to use a therapeutic that accelerates clinical recovery from COVID-19 symptoms if such a therapeutic were available. FDA guidance for industry implies that a regulatory pathway does exist for approval of new therapeutics that produce “sustained clinical recovery” in COVID-19 patients. FDA-approved or authorized oral therapies have either failed or have not been studied against that endpoint.

    60P’s early, published Phase IIA clinical data suggested the possibility of a 2 – 2.5 day improvement in clinical recovery from cough, fever, and shortness of breath.1 Simulations of data from the same study suggested this might also be the case for the FDA’s preferred endpoint of “sustained clinical recovery” from all acute symptoms excluding impaired taste and smell (see accompanying figure).

    However, in a recent IND withdrawal acknowledgement letter from the FDA, the agency implied that a placebo-controlled study in the U.S. is permissible only if study enrollment is “restricted to a patient population in which nirmatrelvir/ritonavir or other approved or authorized therapeutics are not clinically appropriate.”

    As a practical matter, the population of patients in the U.S. with medical contraindications to Paxlovid™ and Lagevrio™ is vanishingly small, which would make patient recruitment very challenging. The Company also considered the FDA’s recommended approach of a standard of care add-on design. However, such a combination approach may not make clinical sense in a low-risk population or be Phase III enabling. In either case, the Company’s Board of Directors determined that raising capital to support a protracted development campaign, or one requiring three additional studies, was not feasible in the current market environment.

    Accordingly, as outlined in its registration statement and subsequent communications to the investment community, 60P will instead continue to prepare to conduct a Phase IIA study of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the end of 2023.

    An estimated 47,000 cases of babesiosis (infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the United States each year, and the incidence rate is increasing. Estimates are that 10 percent of Lyme disease patients are co-infected with babesiosis. Post-exposure prophylaxis following a tick bite is a recognized indication to prevent Lyme disease, and it is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis.

    60P also intends to hire a commercial operations executive to expand its commercialization efforts related to ARAKODA (tafenoquine), an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by the FDA in 2018. In the second quarter of 2023, sales of ARAKODA increased by 150 percent relative to the same period in 2022, at an accelerating growth rate.

    NEWS

    PUBLISHED

    OCT 19, 2023

    60 DEGREES PHARMA TO PRESENT REVIEW OF SAFETY, EFFICACY DATA OF 8-AMINOQUINOLINES FOR MALARIA AND BABESIOSIS TREATMENT AT ILADS ANNUAL SCIENTIFIC MEETING IN BOSTON

    PUBLISHED

    OCT 12, 2023

    60 DEGREES PHARMACEUTICALS SUSPENDS PHASE IIB STUDY OF TAFENOQUINE FOR COVID-19, PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES

    PUBLISHED

    SEP 18, 2023

    60 DEGREES PHARMA WITHDRAWS COVID PHASE IIB IND, WILL RESUBMIT PENDING ASSESSMENT OF ABILITY TO MEET FDA REQUIREMENTS

    PUBLISHED

    SEP 6, 2023

    60 DEGREES PHARMACEUTICALS TO PARTICIPATE IN H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE

    PUBLISHED

    SEP 1, 2023

    GENETIC TECHNOLOGIES LIMITED AND 60 DEGREES PHARMACEUTICALS INTERVIEWS TO AIR ON THE REDCHIP MONEY REPORT(R) ON BLOOMBERG TV

    PUBLISHED

    AUG 30, 2023

    60 DEGREES PHARMACEUTICALS STUDY RESULTS PUBLISHED BY NEW MICROBES AND NEW INFECTIONS DEMONSTRATE TAFENOQUINE EXHIBITS BROAD SPECTRUM ANTIFUNGAL ACTIVITY

    PUBLISHED

    AUG 22, 2023

    60 DEGREES PHARMACEUTICALS RECEIVES ADDITIONAL U.S. PATENT COVERING TAFENOQUINE FOR PREVENTION OF PLASMODIUM FALCIPARUM MALARIA

    PUBLISHED

    AUG 15, 2023

    60 DEGREES PHARMACEUTICALS REGISTERS ACLR8-LR, A PHASE IIB STUDY OF TAFENOQUINE FOR TREATMENT OF COVID-19, ON CLINICALTRIALS.GOV

    PUBLISHED

    JUL 31, 2023

    60 DEGREES PHARMACEUTICALS AWARDED CANADIAN PATENT COVERING TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAIVE SUBJECTS

    PUBLISHED

    JUL 21, 2023

    60 DEGREES PHARMACEUTICALS AND UNICYCIVE THERAPEUTICS INTERVIEWS TO AIR ON BLOOMBERG TV ON THE REDCHIP MONEY REPORT(R)

    PUBLISHED

    JUL 14, 2023

    WALLACHBETH CAPITAL ANNOUNCE CLOSING OF 60 DEGREES PHARMACEUTICALS IPO AT $5.30 PER UNIT

    PUBLISHED

    JUL 14, 2023

    60 DEGREES PHARMACEUTICALS ANNOUNCES CLOSING OF INITIAL PUBLIC OFFERING

    MANAGEMENT TEAM

    Geoffrey Dow

    Chief Executive Officer & President

    Geoffrey Dow is the CEO, President, and a Director of 60 Degrees Pharmaceuticals, Inc. (60P). He has over 20 years of experience in product development for tropical diseases and a strong publication and patent history. He has 13 years of leadership and advisory experience in the antimalarial drug development program at the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity. Dr. Dow co-founded 60P in 2010 and has been instrumental in various projects including securing FDA-regulatory approval for tafenoquine (Arakoda) for malaria prophylaxis, managing post-marketing regulatory commitments, and ensuring the company adheres to GMP, quality, and pharmacovigilance requirements. He has also published several important safety reviews, clinical trials, and non-clinical studies. Dr. Dow’s ultimate goal is to develop and secure regulatory approval and commercial success of products for new indications in infectious disease. He holds a B.Sc. (Hons) in Veterinary and Biomedical Science from Murdoch University, Perth, Western Australia (1994), a Ph.D. in Veterinary and Biomedical Science from Murdoch University (2000), and an MBA from the University of Maryland at College Park (2012).

    Bryan Smith

    Chief Medical Officer

    Bryan Smith is the Chief Medical Officer of 60 Degrees Pharmaceuticals, Inc. (60P). He is a medical doctor with expertise in clinical pharmacology, pharmacovigilance, regulatory strategy development, and translational medicine. He has over 30 years of experience in governmental research and leadership and is a retired military colonel. He joined the company in 2016 and works with the senior management team to establish all functional areas, including compliance with laws and regulations and overseeing research and development projects. Dr. Smith is also a Senior Medical Director, Clinical and Regulatory Affairs at Fast-Track Drugs & Biologics, LLC since 2019, where he is responsible for developing clinical development plans, managing clinical and regulatory projects, and designing and writing clinical trial protocols. He has also served as the Chief Medical Officer and member of Amivas LLC, where he established all functional areas required to secure FDA approvals. Additionally, from 2016 to 2019, he was the Principal Medical Consultant at Clinical Network Services, Inc. where he provided medical, clinical pharmacology, regulatory, and translational medicine review, oversight and consultation as requested for over 25 unique clients in a range of activities and tasks for devices, small molecules, and large molecules in a range of therapeutic areas. He holds a Bachelor of Science in General Science, with highest honors, from Oregon State University and a Doctor of Medicine from Uniformed Services University of the Health Sciences.

    Tyrone Miller

    Treasurer

    Tyrone Miller is the Treasurer of 60 Degrees Pharmaceuticals, Inc. (60P). He joined the company in 2014 and has held various roles including Chief Financial Officer. He has experience raising over $6 million in external financing and established a multinational financial reporting system. He provides strategic advice in areas of financing and business planning to the company. He is also the founder and Principal of Tax & Accounting Practice at Miller Tax & Advisory since 2011, where he advises business owners on accounting, financial, and tax matters and has designed accounting systems for private businesses. Prior to that, he was a Senior Accountant at Sachs Figurelli, LLC from 2002 to 2011 where he prepared and processed corporate and individual tax returns, consulted on accounting processes for various businesses, and managed staff in preparation and processing of payroll and personal property returns. He is a Certified Public Accountant and received a Bachelor’s of Business Administration with a concentration in International Business from Emory University in 1996.

    SINCERELY,

    DISCLAIMER

    THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

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  • (Nasdaq: NNVC) Profile

    OUR NEW PROFILE IS:   (NYSE AMERICAN: NNVC)

    NV-387 IS HIGHLY ACTIVE AGAINST TESTED CORONAVIRUSES INCLUDING SARS-COV-2 IN PRE-CLINICAL STUDIES

    THE ENTIRE FLOAT ON NNVC IS JUST 11.2 MILL ACCORDING TO FINVIZ!!!!

    READ THE INVESTOR PRESENTATION HERE

    ______________________________________________________________

    Hello Everyone,

    We have another new profile that we want you to research right away.  This is one you should research immediately.

    This is a company that we have never profiled on this newsletter before.

    NNVC has several promising catalysts that we want you to take a look at right away.  

    This one has a small float and a history of volatility like several of our latest profiles.

    NEW ERA IN TARGETED ANTI-VIRAL THERAPEUTICS  

    NanoViricides, Inc. is a globally leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.

    Our anti-viral therapeutics, that we call “nanoviricides®” are designed to appear to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. Viruses would not be able to escape the nanoviricide by viral mutations since they continue to bind to the same cellular receptor and thus would be captured by the nanoviricide. Virus escape by mutations is a major problem in the treatment of viral diseases using conventional drugs.

    FINVIZ HAS THE ENTIRE FLOAT AT JUST 11.2 MILLION.  THAT WOULD EXPLAIN THE VOLATILITY ON THE CHART.  YOU WILL NOTICE THAT THIS ONE HAS BOUNCED OFF OF THE LOWS SEVERAL TIMES IN THE PAST YEAR.

    NOTEWORTHY CATALYSTS

    • Broad-Spectrum, Pan-Coronavirus Drug NV-CoV-2 (API NV-387) for COVID, certain cases of long COVID, Seasonal Coronaviruses, MERS is in Clinical Trials. Two formulaJons are in clinical trials at present: Oral Syrup which can be titrated for body weight and is therefore preferable in pediatric seeng, and Oral Gummies, a fixed strength dosage form generally preferable for adults. We believe they would be highly effecJve for mild-to-moderate (non-hospitalized) cases of COVID. AddiJonally, NV-CoV-2 Solu=on for Injec=on, Infusion, and Inhala=on is developed for hospitalized COVID patients with severe disease; direct lung inhalaJon should provide significantly superior benefits by providing high pulmonary local concentraJon of the drug. NV-CoV-2 (NV-387) was found to have strong effecJveness in mulJple coronaviruses in vitro, and also strong effecJveness even when compared to remdesivir in animal studies of lethal lung infecJon. We believe the human clinical trial results should be consistent with these pre-clinical studies, and if so, would establish NV-CoV-2 as perhaps the most effecJve COVID treatment. There is no safe and effecJve COVID drug that covers all the paJent populaJons and disease severiJes at present, indicaJng significant unmet medical needs.
    • NV-387 Expanded Indications Program. We are elucidating the breadth of the anJviral spectrum of NV-387 at present. NV-387 is based on mimicking sulfated proteoglycans to a_ack the virus parJcle. A large number of viruses bind to such structures before gaining cell entry, including RSV, human MetaPneumoVirus (hMPV), certain Adenoviruses, other respiratory pathogens, as well as a number of systemic viruses such as Dengue viruses, Chickengunya, among others. Successful addiJonal indicaJons against any such viruses, if any, would significantly improve the return on investment, while fulfilling unmet medical needs.
    • Such additional indications would be eligible for Phase II/III studies with NV-387 having completed Phase I studies already.
    • Additonally, NV-387-R Could Result in Potential Cure Against a Number of Non-Latency Viruses.
    • HerpeCideTM Program. Variants of NV-HHV-101 are expected to become clinical drug candidates for topical treatment of HSV-2 “genital ulcers”, and HSV-1 “cold sores” soon aqer NV-HHV-101 goes into clinical studies. NV-HHV-101 is anJcipated to further expand into additional indications against chickenpox – a possibly orphan drug in the USA – and PHN (a morbidity of shingles persistent pain that may last for six months or longer, aqer the rash resolves).
    • We are also developing drugs against HIV.
      NanoViricides, Inc. is possibly the first in the world to have developed an orally effecJve nanomedicine.

    VERSATILE PLATFORM TECHNOLOGY

    A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates

    Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone “nanomicelle”, separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry.

    Virus-specific nanoviricides have been created against important viruses such as HIV, Influenza and Bird Flu by choosing highly virus-specific ligands

    Broad-spectrum nanoviricides have been created that can bind to possibly as many as 90-95% of known viruses. The Company is developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg. This is similar to antibiotics such as penicillin against bacteria that exploit a feature common to all bacteria.

    NANOVIRICIDES BROAD SPECTRUM ANTIVIRAL COULD CHANGE HOW WE TREAT VIRAL INFECTIONS

    So far, NanoViricides has built a robust foundation of promising preclinical research that demonstrates the unique antiviral platform’s potential to treat not just COVID-19 but a wide range of other common and hard-to-treat viral diseases like other coronaviruses, RSV, shingles, herpes, rabies and the flu.

    The reason it could have such broad applicability is because the NanoViricides platform was specifically designed to target a particular binding site that’s common across many viruses and doesn’t change even as a virus mutates. Essentially, the nanoviricide platform mimics the binding site on a human cell that a virus would normally target in order to infect that cell. Then it seeks out the virus and when the virus binds to the nanoviricide instead, the drug candidate immediately engulfs the virus, where it’s unable to infect the patient’s cells or reproduce.

    THE FIRST OF THESE DRUGS IS NOW IN HUMAN PHASE 1A AND 1B CLINICAL TRIALS

    The Phase 1a/1b clinical trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) safety and tolerability studies in healthy subjects. NanoViricides reported that 26 of the 36 volunteers in the SAD study and 17 of the 36 volunteers in the MAD study have already completed the program. And so far, the early data looks promising. Neither adverse events nor serious adverse events have been found to date in either study.

    “The excellent safety and tolerability of NV-CoV-2 in both formulations in the clinical trials is consistent with the results of pre-clinical animal studies, giving us confidence that our preclinical animal studies can be expected to be predictive of human clinical trials,” said NanoViricides Executive Chairman and President, Anil R. Diwan, Ph.D.

    ONGOING PHASE 1A AND 1B CLINICAL TRIALS WILL GIVE FIRST INDICATION OF NANOVIRICIDES EFFICACY IN HUMANS

    With that baseline of safety and tolerability, the next part of the trial is to enroll COVID patients in the trial and start evaluating whether the positive preclinical effectiveness results for the drug will translate to human trials. Once this trial is finished, NanoViricides plans to seek permission to move into phase 2 clinical trials from multiple regulatory agencies worldwide.

    Of note, the same drug was found to be effective in pre-clinical studies against another important respiratory virus, RSV. Such a broad spectrum antiviral effectiveness is reminiscent of the development of antibiotics against bacteria. This could be a game-changing development in antiviral therapeutics.

    This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.

    NANOVIRICIDES TREATMENT FOR RSV

    NanoViricides (NYSE American: NNVC), a leading developer of antiviral treatments through its nanomedicines platform, is developing a safe and effective alternative therapeutic for RSV. Its drug candidate, NV-387, has already been shown to not have the toxicity or side effects associated with Ribavirin, according to the company. It reports that in the recent pre-clinical animal study, NV-387 almost matched the efficacy of Ribavirin with no toxicity. This animal study was designed to mimic the lethal lung pneumonia in infants caused by RSV infection.

    Importantly, NV-387 is already in phase 1 human clinical trials as the active ingredient in the company’s COVID drug candidate NV-CoV-2. The company has just reported that it was found to be completely safe, with no side effects found to date, in this continuing phase 1 Study. For this reason, the company anticipates soon being able to advance NV-387 to a phase 2 human clinical trial against RSV.

    If the results of animal studies are replicated in humans, this nanoviricides drug could become truly a game-changer in the treatment of RSV infections.

    CGMP PRODUC=ON IN MUL=-KILOGRAM SCALE IN OUR OWN FACILITY

    We have completed producJon of the drug in mulJ-Kg quanJJes for the GLP porJon of the IND enabling Safety/Toxicology studies. This producJon was performed under cGMP-compliant condiJons in our State of the Art cGMP-capaead on, by building our own capability. We believe we have thus minimized the manufacturing risk for our en=re pla4orm technology.

    ble Manufacturing Facility for Clinical Drug Produc=on in Shelton, CT. We have engaged in the producJon of the cGMP manufactured drug product for the upcoming human clinical trials at this plant. cGMP Manufacturing capability is a major risk for new pharma companies, especially in nanomedicines. We are happy to report that we are tackling this risk hThe NanoViricides facility in Shelton, CT, contains customizable mulJ-product cGMP manufacturing

    capability, as well as advanced nanomedicines characterizaJon and R&D laboratory, to support clinical drug
    manufacture of any of our drug candidates, enabling cost-effecJve, speedy entry to clinic. Moreover, its
    Manufacturing Scale is more than sufficient to support ini=al marke=ng needs, enabling early revenues upon drug approval.

    GLOBAL, STRONG, PIONEERING, INTELLECTUAL PROPERTY WITH RUNWAY BEYOND 2040

    Strong Global Intellectual Property Posi=on with Drug Patents to Expire Beyond 2040

    All of our drug candidates are based on broad & exclusive world-wide licenses in perpetuity from TheraCour Pharma, Inc. The licensed fields include human diseases of COVID, VZV, HSV-1, HSV-2, all Influenza viruses including H5N1 and pandemic H1N1, HIV, Dengue, Ebola, Marburg, Rabies, etc. These licenses are extremely broad and cover development of drugs a_acking the stated virus in pathological indicaJon benefieng from viral load reducJon. NanoViricides intends to own the regulatory drug licensure (use of enJty for indicaJon), and may commercialize the same on its own or further sublicense to other Pharma companies.

    NanoViricides has exclusive worldwide licenses from TheraCour Pharma, Inc., to field-defining, pioneering, proprietary intellectual property and global patent applicaJons, that have already issued into 61 patents in countries including the U.S., Australia, Japan, China, Canada, and all of Africa. Issued patents are “first-in-class” with no prior art, showcasing the Company’s leadership posiJon in this field. The patents cover broad composiJons of ma_er, methods of making, and uses. The first of the fundamental patents has expiraJon date in 2026. We have begun to patent IP estate around each of our drug candidates separately. Two internaJonal PCT patent applicaJons have been made for the COVID space; resulJng patents would expire in 2040. AddiJonal applicaJons are expected soon. This provides substanJal runway for commercial realizaJon.

    UNIQUE, NOVEL, POST-IMMUNOTHERAPEU=C “BIND-ENCAPSULATE-DESTROY” MECHANISM ENABLES FIRST-IN-CLASS PRODUCTS

    Beyond An=bodies and Vaccines: AnJbodies have been developed as drugs against viruses. However, each anJbody only binds by two points to the virus, and destrucJon of the complex requires effecJve immune funcJon, which is not the case in sickness. Vaccines only train the body into producing anJbodies against the virus in the vaccine. AnJbodies and vaccines are easily overcome by viruses by mutaJng in the field as is now well known from COVID.

    A Nanoviricide is A Nanomachine that Completes the Task of Destroying Virus without Help from the Pa=ent’s Immune System Key Issue of Drug Resistance from Viral Muta=ons is Unlikely with Nanoviricides Drugs due to Unique Biomime=c Technology

    In contrast, a nanoviricide should work against all strains of the virus because they sJll bind the same way to the same host cell receptor. The nanoviricide® technology plalorm mimics the host cell. We design and develop a virus-binding ligand that mimics the site on the host cell receptor to which the virus binds. This ligand is then chemically a_ached to a special polymer to make a nanoviricide®. The virus is expected to be fooled into binding to the nanoviricide, like a venus-fly-trap. The nanoviricide is then expected to engulf the virus and possibly destroy it. A nanoviricide a_acks the virus with hundreds of virus-binding sites on its surface. The nanoviricide is capable of dismantling the virus, and the resulJng complexes are fully biodegradable in the body.

    Not shown here, is a nanoviricide’s ability to encapsulate drugs inside it, protect them from bodily environments, and deliver them as per design. This ability can be harnessed to develop cures for many viruses.

    NANOVIRICIDES, INC. HAS FILED ITS ANNUAL REPORT: BROAD-SPECTRUM ANTIVIRAL NV-387 (NV-COV-2) IN PHASE 1A/1B CLINICAL TRIAL IS HIGHLY ACTIVE AGAINST CORONAVIRUSES AS WELL AS RSV

    SHELTON, CONNECTICUT — Monday, October 16, 2023 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2023 with the Securities and Exchange Commission (SEC) on Friday, October 13, 2023. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057823002146/nnvc-20230630x10k.htm ).

    We reported that, as of June 30, 2023, we had cash and cash equivalent current assets balance of approximately $8.15 Million. In addition, we reported approximately $8.1 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.53 Million. In comparison, as of June 30, 2022, we had cash and cash equivalent balance of approximately $14.4 Million, P&E assets of approximately $8.7 Million (after depreciation), and total current liabilities of approximately $0.41 Million.

    We estimate that we have sufficient funds to complete the on-going human clinical trials for our lead drug candidate NV-CoV-2 which is the drug product based on our “nanoviricide” active pharmaceutical ingredient (“API”), NV-387.

    We believe that the successes of NV-387 as a broad-spectrum antiviral (see below) bode well for validating the multiple modalities in which our Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.

    We believe that NV-387 works by a novel mechanism of action, that of blocking the re-infection cycle of the viral disease. We believe that NV-387 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (for example, the S protein, and its products S1 and S2 proteins from coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of covering the virus, generally incompletely, and require immune system assistance for clearing the resulting complex.

    We believe that NV-387 mimics the “Sulfated Proteoglycans” (“S-PG”) family of virus attachment receptors. This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (KSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV – Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. Therefore, NV-387 may be anticipated to exhibit strong antiviral activity against at least some, if not many, of these viruses.

    We have found that NV-387 is highly active against tested coronaviruses including SARS-CoV-2 in pre-clinical studies. We are expanding our pre-clinical studies to evaluate the antiviral activity of NV-387 against other viruses. We believe that this work would expand the range of indications for NV-387. Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).

    We have already found that NV-387 is highly effective against a lethal lung infection by RSV in an animal study, a result which is expected to add significantly to the commercial potential of NV-387 if the drug proves out further in clinical studies. We believe that we will be able to take RSV into Phase 2 clinical studies once the current Phase 1 studies are completed.

    We believe that NV-387 has a broad spectrum of antiviral activity that is reminiscent of the antibacterial activity of antibiotics. We believe that the Nanoviricides Platform Technology is poised to revolutionize the fight against viruses just as antibiotics revolutionized the fight against bacterial infections. Antibiotics attack a bacteriological common feature, the peptidoglycan wall, of bacteria. Analogously, NV-387 is designed to attack a virological common feature, the binding of viruses to S-PG family attachment receptors.

    RSV is an important pathogenic virus that can cause lethal infection in infants as well as seniors and immunocompromised persons. Two different vaccines against RSV have been recently approved by the US FDA, but none are for pediatric use at present. Two different antibodies have been approved as prophylactic (i.e. to prevent RSV infection) for babies, but are not approved as therapeutics (i.e. after disease occurs). There is no safe and effective therapeutic available for RSV. Ribavirin, a highly toxic drug that attacks red blood cells and can cause multi-organ failures is reserved for use as a last resort only in extremely severe hospitalized cases of RSV. NV-387 was almost as active as ribavirin. Additionally, NV-387 has been found to be extremely safe in pre-clinical studies. Thus, we believe NV-387 could be a clinical quality drug candidate for the treatment of RSV infections.

    GrowthPlus Reports, in June 2023, said the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.

    NV-387 is in Phase 1 human clinical trial as two oral formulations: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies in India. The drug sponsor, Karveer Meditech Pvt. Ltd., is our licensee and collaborator and has the rights to develop and commercialize the drugs in India. As of now, 26 out of a target of 36 healthy human subjects have completed the clinical trial. There were no reports of adverse events or serious adverse events, indicating both of these formulations and the API NV-387 are extremely safe in humans. These results are consistent with our pre-clinical safety/toxicology animal studies.

    In addition to the S-PG family, another important attachment receptor family is “Sialylated Glycoproteins”. Influenza viruses, some pathogenic Adenoviruses that cause epidemic kerato-conjunctivitis (EKC), as well as a large number of other viruses bind to sialic acid which is the terminal part of these receptors. We are making headways in developing nanoviricides that mimic this class of receptors.

    We call the broad-spectrum nanoviricides based on such general features as the S-PG and the Sialic based receptors that are widely used by viruses for attachment as “Modality #1” of the application of nanoviricide platform technology. This modality is expected to result in very broad spectrum antiviral agents, as evidenced by NV-387.

    In another methodology, that we call “Modality #2”, we have developed nanoviricides that specifically bind to a specific type of virus, mimicking the cell-surface receptor to which the virus binds in order to gain entry into cells (called the “cognate” receptor). We have developed NV-HHV-1 as an antiviral that is active against certain herpesviruses. NV-HHV-1 has completed IND-enabling studies. Its first indication, formulated as a skin cream, is for the treatment of Shingles rash. It has been found to be active against HSV-1 (“cold sores”), HSV-2 (“genital herpes”) and VZV (Chickenpox and Shingles) in pre-clinical studies. We have also developed an anti-HIV drug candidate that mimics CD4 which is used by HIV.

    No matter how much a virus mutates, changes, or generates new variants, it continues to utilize the same attachment receptor(s) and the same cognate receptor(s) and, further, binds to the receptor(s) at the same locations. Thus, the virus is expected to be unlikely to escape a nanoviricide drug if our nanoviricide properly mimics the location on the cellular receptor that the virus uses.

    This very much sought-after feature sets apart our Nanoviricides Platform Technology from other antiviral approaches. The virus learns to escape readily the battery of conventional approaches, which is comprised of antibodies, vaccines, and small chemical drugs, as has been amply evidenced in the COVID-19 pandemic, the recurring Influenza pandemics and epidemics, the on-going HIV pandemic, and other instances.

    We are particularly excited about our “Modality #3” of applying the Nanoviricide Platform Technology that we believe will enable true cures for a large number of viral infections. In this modality, we have been able to create a nanoviricide that (i) blocks the virus particle from infecting a new cell in the first place, and (ii) holds in its belly another API that blocks the virus that has infected a cell from making and releasing its copies. We believe such a nanoviricide would be a true cure for infections of viruses that do not generate latent infections in the body. This modality goes beyond the conventional approach of treating a patient with multiple drugs simultaneously, in at least two ways: (i) as an infrequent single drug treatment that improves patient compliance, and (ii) by virtue of the improvement in the pharmacokinetics of the guest API due to the nanoviricide encapsulant. We have already demonstrated that NV-387-g-R, which is remdesivir as guest encapsulated within the polymeric micelle of NV-387, protects remdesivir from bodily metabolism.

    In a fourth modality, we are conducting preliminary research to harness the power of the Nanoviricide Platform Technology to cure latent virus infections as well.

    We have not only established a broad and expanding antiviral drug pipeline, led by NV-387 for coronavirus infections (clinical), NV-387 for RSV infections (advanced pre-clinical), and NV-HHV-1 for treatment of Shingles rash (IND-enabling), and many other pre-clinical drug candidates, but have also developed the Nanoviricide Platform Technology to the level that cures against many virus infections can now be envisaged.

    We have made significant progress despite limited resources in our endeavor of curing viral infections using the power of the Nanoviricide Platform Technology, and this year, we have been able to take the first nanoviricide drug into human clinical trials. We believe this opens a new era in the development of NanoViricides, Inc. We plan on seeking non-dilutive as well as equity-based funding as we go forward in this quest.

    What is a “nanoviricide”?
    A “nanoviricide” is a uniform polymer that self-assembles into nanoscale droplets called “micelles”, that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus “looks like” a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called “lipid-lipid mixing.” We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.

    About NanoViricides, Inc.
    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of factors including external collaborators and consultants. NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.

    NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

    The Company is also developing drugs against a number of viral diseases including RSV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, if the initial research is successful. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

    As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

    NEWS

    PUBLISHED

    OCT 16, 2023

    NANOVIRICIDES, INC. HAS FILED ITS ANNUAL REPORT: BROAD-SPECTRUM ANTIVIRAL NV-387 (NV-COV-2) IN PHASE 1A/1B CLINICAL TRIAL IS HIGHLY ACTIVE AGAINST CORONAVIRUSES AS WELL AS RSV

    PUBLISHED

    OCT 12, 2023

    NANOVIRICIDES, INC. TO PRESENT AT THE PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY CONFERENCE IN BOSTON ON OCTOBER 16, 2023 AT 6:07PM ET

    PUBLISHED

    OCT 3, 2023

    MULTI-BILLION DOLLAR TREATMENT MARKET FOR LUNG INFECTION THAT CAUSES OVER 200,000 HOSPITALIZATIONS ANNUALLY WITH ELDERLY, YOUNG AT MOST RISK HAS GAME-CHANGING NEW ENTRANT

    PUBLISHED

    SEP 27, 2023

    MULTI-BILLION DOLLAR TREATMENT MARKET FOR LUNG INFECTION THAT CAUSES OVER 200,000 HOSPITALIZATIONS ANNUALLY WITH ELDERLY, YOUNG AT MOST RISK HAS GAME-CHANGING NEW ENTRANT

    PUBLISHED

    SEP 19, 2023

    FIRST HUMAN CLINICAL TRIALS OF A POTENTIALLY “GAME-CHANGING BROAD SPECTRUM ANTIVIRAL” ARE PROGRESSING SUCCESSFULLY – DRUG COULD TREAT COVID, RSV AND MANY OTHER RESPIRATORY VIRUSES

    PUBLISHED

    AUG 31, 2023

    NANOVIRICIDES PROGRESSING WELL WITH NEW COVID STUDY

    PUBLISHED

    AUG 21, 2023

    THE PHASE 1A/1B HUMAN CLINICAL TRIAL OF NV-COV-2, THE COMPANY’S BROAD-SPECTRUM ANTIVIRAL DRUG, IS PROGRESSING SUCCESSFULLY, REPORTS NANOVIRICIDES

    PUBLISHED

    JUL 19, 2023

    SARS-COV-2 IS NOT DONE YET — COULD THIS NEW DRUG IN CLINICAL TRIALS BE THE SAFEST OPTION FOR TREATING COVID-19?

    PUBLISHED

    JUL 13, 2023

    NANOVIRICIDES TESTING ORAL GUMMY AND SYRUP COVID-19 TREATMENT – PROACTIVE RESEARCH ANALYST

    PUBLISHED

    JUL 11, 2023

    NOVEL NANOMEDICINE PLATFORM WITH PIPELINE OF ANTIVIRALS GOES TO HUMAN TRIALS – WHAT OTHER VIRUSES COULD THIS COVID TREATMENT TARGET?

    PUBLISHED

    JUL 11, 2023

    COMPANY’S BROAD-SPECTRUM ANTIVIRAL NV-387 HAS DEMONSTRATED EXCELLENT EFFECTIVENESS IN RSV IN A LETHAL LUNG DISEASE ANIMAL MODEL, REPORTS NANOVIRICIDES

    PUBLISHED

    JUL 6, 2023

    NANOVIRICIDES INC. (NYSE AMERICAN: NNVC) BEGINS LONG-AWAITED CLINICAL TRIALS FOR ITS ANTI-VIRAL NANOMEDICINE NV-COV-2, ORAL, AMID CONTINUING NEED FOR COVID TREATMENT

    PUBLISHED

    JUL 6, 2023

    CLINICAL TRIAL OF BROAD-SPECTRUM ANTIVIRAL DRUG NV-COV-2 IS PROGRESSING WELL, SAYS NANOVIRICIDES – NV-COV-2 IS POSITIONED TO FULFILL MANY UNMET MEDICAL NEEDS

    PUBLISHED

    JUN 29, 2023

    NANOVIRICIDES TAKE BIG STEP FORWARD BEGINNING TRIALS ON ITS ANTIVIRAL DRUG NV-COV-2

    PUBLISHED

    JUN 29, 2023

    NANOVIRICIDES ANNOUNCES THAT CLINICAL TRIALS OF ITS BROAD-SPECTRUM ANTIVIRAL DRUG NV-COV-2 HAVE BEGUN

    PUBLISHED

    MAY 31, 2023

    NANOVIRICIDES, INC. TO PRESENT AT THE BIO INTERNATIONAL CONVENTION IN BOSTON ON JUNE 5TH, 2023 AT 3:15PM ET

    MANAGEMENT TEAM

    Anil R. Diwan, PhD

    Executive Chairman, President

    Dr. Diwan has been President and Chairman of the Board of the Company since its founding in 2005 Dr. Diwan spearheaded the efforts for the Company’s 2013 uplisting from the OTC Markets to NYSE-American. Dr. Diwan has led several of the Company’s financing efforts since 2010.

    Dr. Diwan invented novel polymeric micelle-based nanomedicine technologies as early as 1991. Dr. Diwan is a prolific inventor and a serial entrepreneur. Prior to co-founding NanoViricides, Inc., he has founded TheraCour Pharma, Inc., a privately held company focused in nanomedicines and cell-targeted drug delivery, and AllExcel, Inc., a company with diverse portfolios including nanomedicines, small chemicals, device technologies, as well as informatics. He has won several NIH SBIR (small business innovation research) grant awards. Anil holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India, and has consistently held high scholastic ranks and honors. Dr. Diwan has over 25 years of Bio-Pharmaceutical R&D experience with over 20 years as an entrepreneur.

    He has several patents issued internationally resulting from three fundamental international patent applications. Under Dr. Diwan’s leadership, NanoViricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while robustly expanding the drug pipeline every year. Dr. Anil R. Diwan was recognized as “Researcher of the Year” by BusinessNewHaven, a Connecticut Area Business Journal, in 2014.

    Ms. Meeta R. Vyas, MBA (Fin.), BS (Chem. Eng.)

    interim Chief Financial Officer

    Ms. Vyas is known as a strong leader with board level experience and successful achievements as a Senior Executive in a broad range of entities including publicly listed corporations, non-revenue generating entities, and medium to large size companies. Meeta has over twenty-five years of experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, in areas ranging from Finance and Operations to Strategy and Management. Meeta holds the distinction of being the first Indian woman to be named CEO of a publicly listed US corporation, Signature Brands, Inc., best known for “Mr. Coffee” and “Health-O-Meter” brand products. As CEO, acting COO and Vice Chairman of the Board of Signature Brands, Inc., she was responsible for the development and implementation of a turnaround plan, resulting in a return to profitability and growth within a short period of time. Later, as the CEO of the World-Wide Fund for Nature – India (WWF-India) and then as a Vice President of the National Audubon Society (USA), both non-revenue generating entities, Meeta successfully raised unrestricted funding that significantly exceeded annual requirements and also instituted financial processes to measure a variety of performance metrics. Earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the highly successful information technology outsourcing program at General Electric (GE). Also at GE, Ms. Vyas ran GE Appliances’ Range Products business unit having revenues exceeding $1 Billion where her team doubled operating income in less than two years. Prior to that, as a management consultant with McKinsey and Company, she served publicly listed companies in chemicals, industrial, and technology markets, primarily focusing on growth strategies, valuations, post-merger integrations, and logistics operations. Meeta is married to NanoViricides, Inc. President and Chairman Anil R. Diwan.

    Ms. Vyas holds a MBA in Finance from Columbia University’s Graduate School of Business, and a BS in Chemical Engineering from the Massachusetts Institute of Technology.

    NanoViricides won the IAIR AWARD as Best North American Company for Leadership in the Nanomedicine Sector.

    Randall W. Barton, PhD.

    Chief Scientific Officer – Consulting

    Dr. Barton has experience in drug discovery and development of both small molecule and biological drug candidates in virology, immunology, inflammation, and cardiovascular diseases in the pharmaceutical and biotech industry as well as academic research and teaching experience. Most recently, he was Vice-President of Drug Discovery at A&G Pharmaceuticals, a biologics and diagnostics company. He retired at the Director level after 20 years at Boehringer Ingelheim Pharmaceuticals. During his time at Boehringer Ingelheim he performed drug development pre-clinical studies on nevirapine (Viramune), a non-nucleoside inhibitor of HIV reverse transcriptase and an important HIV drug.

    Prior to joining Boehringer Ingelheim, he was on the faculty at the University of Connecticut Medical School where he was the recipient of an NIH Career Development Award conducting research and teaching in immunology. Dr. Barton has authored over 80 scientific publications, and has been the principal investigator leading to 5 patents. He has a Ph.D. in biochemistry from the University of Tennessee at Oak Ridge National Laboratory and a B.A. from Indiana University.

    Jayant Tatake, PhD.

    Vice President, R&D

    Jay Tatake is an organic chemist with over 25 years of experience in Research and Process Development of fine chemicals. His experience encompasses production scale-up, and large scale manufacture of raw materials for pharmaceuticals. Before joining NanoViricides, Inc., he was Assistant Director of Analytical R&D at Interpharm, Inc. Prior to that, he was Director of Analytical Services at Pharmax Group, Inc. Dr. Tatake has several years experience in Analytical methods development and Quality Control in cGMP environment. His experience includes bio-analytical methods development. Prior to Pharmax Group, he was in the Pharmacology Department, University of Connecticut Health Center, where he synthesized and developed novel bio-conjugates for bio-diagnostics applications.

    Jay has a Ph.D. from Department of Chemical Technology, University of Bombay. He is a member of American Chemical Society (ACS). He has published several papers in leading journals and is a co-inventor of several patents.


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  • (NYSE American: MAIA) Profile

    OUR NEW PROFILE IS:   (NYSE AMERICAN: MAIA)

    MAIA BIOTECHNOLOGY RECENTLY ANNOUNCES SHARE REPURCHASE PROGRAM 

    MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

    READ THE INVESTOR PRESENTATION HERE

    ______________________________________

    Hello Everyone,

    We have a new NYSE profile for today’s session.

    This could be a hidden gem with a major catalyst driving an intense reversal off of the 52 week low that it just recently hit.

    The company released major news this morning that you should look into and research.

    MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a first-in-class cancer telomere targeting agent in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with telomerase-positive cancer cells.

    *****BREAKING NEWS JUST RELEASED THIS MORNING*****

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

    • Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
    • Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
    • Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.

    “We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”

    “In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”

    “Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”

    Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.

    About Orphan Drug Designation

    The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    About THIO-101, a Phase 2 Clinical Trial

    THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

    MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

    • Substantial THIO program progress including unprecedented disease control rate (DCR) of 100% in second-line non-small cell lung cancer (NSCLC)
    • Key THIO findings in gliomas, pediatric brain cancer, and second generation THIO-derived cancer therapies
    • Strong pace of enrollment in THIO-101 Phase 2 trial exceeds average enrollment pace in similar NSCLC trials

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

    “Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024.”

    Third Quarter Business Highlights and Recent Developments

    THIO Program:

    Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

    Highly Potent Anticancer Activity in Gliomas: MAIA’slead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

    THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

    Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

    THIO-101 Phase 2 Clinical Trial

    U.S. FDA Clearance of THIO IND Application: TheU.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

    Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

    Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

    Third Quarter 2023 Financial Results

    Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

    Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

    General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

    Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

    Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

    For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    About THIO-101, Phase 2 Clinical Trial

    THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

    MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

    OCT 12, 2023 9:20AM EDT

    Treatment demonstrates decreased cancer cell proliferation and increased tumor sensitivity to ionizing radiation

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, announced that study data shows THIO’s potent anticancer activity in Diffuse Intrinsic Pontine Glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children.

    The data was recently presented at the Society for Neuro-Oncology’s 2023 Pediatric Neuro-Oncology Research Conference and published in the Neuro-Oncology journal (Volume 25, Issue Supplement_1, June 2023, Page i13). The study evaluated THIO as a potential treatment for DIPG based on inducing direct telomeric DNA damage mediated cancer cell death and activating antitumor immunity in DIPG through the intracellular cGAS/STING pathway, which resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

    Radiotherapy is the only standard of care treatment option for DIPG, yet it is rarely curative. In recent years, several immunotherapy strategies have emerged as potential treatments for DIPG. However, the low mutational burden and rare infiltration of T lymphocytes renders these tumors immunologically “cold” and, therefore, poses challenges for general immunotherapy.

    “We have shown that THIO treatment sensitized DIPG cells to ionizing radiation (IR), leading to a significant decrease in DIPG cell proliferation in vitro and in vivo models,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “These encouraging preclinical studies may support further potential preclinical and clinical development of THIO to be used in combination with IR to treat children with high-risk pediatric brain tumors.”

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer(NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

    September 28, 2023 8:01am EDT

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

    “This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation,” said Vlad Vitoc, MAIA’s Chief Executive Officer. “By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders.”

    With a share repurchase program, MAIA may repurchase shares from time to time through various methods, including in open market transactions, in privately negotiated transactions or otherwise, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, in compliance with applicable state and federal securities laws. The timing, as well as the number and value of shares repurchased under the program, will be determined by the Company at its discretion and will depend on a variety of factors, including our assessment of the intrinsic value of the Company’s common stock, the market price of the Company’s common stock, general market and economic conditions, available liquidity, compliance with the Company’s debt and other agreements, applicable legal requirements, the nature of other investment opportunities available to the Company, and other considerations. The Company is not obligated to purchase any shares under the repurchase program, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund the repurchases by using cash on hand and expected free cash flow to be generated in the future.

    Significant Market Opportunity

    • Cancer is the most dominant of the age-related disease categories and has life altering impacts in the lives of patients and their close ones
    • The number oF people aged 80 years or older is expectedtotriplebetween 2020 and 2050 to reach 426 million
    • Approximately40%ofpeoplealivetodayareprojectedtobediagnosed with a cancer type in their lifetime, and 20% will die of it
    • NSCLC is the leading tumor type: Mortality 1.7M / Sales $32B (2022)
    • CRCissecond:Mortality1M/Sales$20B(2022)

    Clinical Programs

    THIO-101: Ph 2 trial THIO + LIBTAYO® (cemiplimab) – enrolling (35 patients dosed to date)

    • Go-to-market trial in second line NSCLC
    • Objectives: select most efficacious dose and expand into pivotal trial
    • Started in 2022 in Australia & Europe; to include US in 2023
    • Regeneron clinical supply agreement for Libtayo®
    • File for accelerated approval in 2025
    • Part A (Safety Lead-in) Complete: No dose-limiting toxicities (DLTs), No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reactions (SUSAR); Safety profile substantially better than current Standard of Care (SoC)
    • Preliminary Survival: first 2 patients dosed in Part A continue to be alive, 12.2 and 11.5 months from treatment initiation; progression free after last dose, 10.2 and 8.5 months respectively, with no new treatment; in real-world clinical practice, observed survival in similar heavily pretreated patients is 3-4 months; weeks without therapy
    • Disease Control Rate: 82%; subjects with 1+ post-baseline response assessment (n=11, 06/23/23); DCR for SoC in third line: 25-35%
    • Part B (efficacy/dose selection) initiated THIO-102: Ph 2 trial THIO + CPIs
    • Go-to-market trial in late line of therapy in multiple tumor. types: Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC, 90% of primary type of liver cancers), and Solid Tumors of any type (ST)
    • 3 umbrellas in each: THIO + Libtayo (REGN); Keytruda (MRK); Tecentriq (Genentech/Roche)
    • Objectives: select most efficacious combination by tumor type and expand into pivotal trials (9+ possible market entry indications)
    • Start in 2023, to include US, Europe, Asia, etc.
    • File for accelerated approvals in 2026 and beyond THIO-103: Ph 2/3 trial of THIO + CPIs
    • First line NSCLC and SCLC
    • Expand to Breast, Prostate, Pancreatic, Ovarian, Gastric Cancer, etc.

    THIO is a Unique Direct Telomere Targeting Agent
    • Potential to be used in combination with other anticancer and immune therapies
    • Dual, novel mechanism of action: telomere

    targeting + immunogenic
    • FDA awarded THIO 2 Orphan Drug

    Designations: HCC and SCLC!
    • Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

    MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

    October 10, 2023 8:01 am EDT   CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its lead asset THIO showed highly potent anticancer activity in gliomas, an aggressive type of brain tumor that originates from glial cells. THIO’s novel dual mechanism of action – direct telomere targeting and immune system activation, has previously demonstrated similar efficacy in multiple types of telomerase-active tumors.

    THIO was evaluated in various in vitro and in vivo models of gliomas. The results demonstrate the promising therapeutic role of THIO for the treatment of primary and temozolomide-resistant recurrent gliomas through specific telomerase-mediated induction of telomeric DNA damage in glioma cells

    “High grade adult gliomas are among the most difficult-to-treat cancers, with less-than-desirable clinical outcomes. These encouraging results further highlight THIO’s excellent anti-cancer activity across several cancer indications,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We look forward to evaluate THIO as a treatment for brain cancer in clinical setting.”

    “THIO was effective in the majority of human and mouse glioma cell lines with no apparent toxicity against normal astrocytes. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the art care temozolomide (TMZ). THIO induced apoptosis in several human glioma cell lines that grow as three-dimensional tumor mass-mimicking neurospheres,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “Additionally, THIO produced telomeric DNA damage responses not only in glioma cell lines, but also in diverse human-derived tumor specimens (PDXs). In vivo, THIO significantly decreased tumor proliferation in glioblastoma xenografts and a PDX model of glioblastoma.”

    The reviewed results were published in: Clin Cancer Res (2021) 27 (24): 6800–6814.

    About THIO

    THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

    Partnership with Regeneron

    • Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

    • Equivalent to $32M non-dilutive participation (largest financing move to date)

    • Potentially expand existing relationship and target new companies

    Strong and Growing IP Portfolio

    • Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending

    Next Generation Potential Telomere Targeting Therapeutics
    • 84 new molecules engineered in last 12

    months; Same mechanism of action as THIO • MAIA-2021-020, MAIA-2022-012 and

    MAIA-2021-029 significantly moreCefficacious
    • Follow THIO to commercial stage within 4-5 years

    NEWS

    Nov 10, 2023 7:01am EST

    FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

    Nov 07, 2023 8:15am EST

    MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

    Oct 30, 2023 8:41am EDT

    MAIA BIOTECHNOLOGY REVEALS HIGHER ANTICANCER POTENCY OF TELOMERE-TARGETING COMPOUNDS DERIVED FROM THIO

    Oct 24, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES 100% DISEASE CONTROL IN SECOND-LINE NON-SMALL CELL LUNG CANCER DEMONSTRATING IMPRESSIVE POSITIVE PRELIMINARY EFFICACY DATA FOR ONGOING THIO-101 PHASE 2 TRIAL

    Oct 19, 2023 8:35am EDT

    MAIA BIOTECHNOLOGY TO PRESENT PRELIMINARY SAFETY AND EFFICACY DATA FROM THIO-101 PHASE 2 CLINICAL TRIAL AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY CONGRESS 2023

    Oct 17, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY TO PRESENT LATEST FINDINGS FOR SECOND GENERATION THIO PROGRAM AT TURKISH BIOCHEMICAL SOCIETY’S INTERNATIONAL BIOCHEMISTRY CONGRESS 2023

    Oct 12, 2023 9:20am EDT

    MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

    Oct 10, 2023 11:15am EDT

    MAIA BIOTECHNOLOGY ACCELERATES ENROLLMENT IN THIO-101 PHASE II CLINICAL TRIAL AS EFFICACY IS OBSERVED IN DOSED PATIENTS

    Oct 10, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

    Oct 03, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

    Sep 28, 2023 8:01am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

    Aug 08, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

    Jul 11, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS UPDATES ON DISEASE CONTROL RATES FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

    Jul 10, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS UPDATES ON PRELIMINARY SURVIVAL DATA FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

    Jun 20, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY ANNOUNCES UPDATES IN ENROLLMENT IN PHASE II CLINICAL TRIAL: THIO-101 HAS ENROLLED 29 PATIENTS

    Jun 07, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY FILES SECOND PATENT FOR NEW TELOMERE-TARGETING MOLECULES PROGRAM

    May 08, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

    Apr 27, 2023 4:10pm EDT

    MAIA BIOTECHNOLOGY, INC. ANNOUNCES CLOSING OF PUBLIC OFFERING

    Apr 24, 2023 9:06pm EDT

    MAIA BIOTECHNOLOGY, INC. ANNOUNCES PRICING OF PUBLIC OFFERING

    Apr 20, 2023 8:00am EDT

    MAIA BIOTECHNOLOGY REPORTS PRELIMINARY SURVIVAL DATA IN PART A OF THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

    MANAGEMENT TEAM

    team

    VLAD VITOC, MD, MBA

    CHIEF EXECUTIVE OFFICER AND CHAIRMAN

    Dr. Vitoc is our Chairman of Board, Chief Executive Officer, and President. Dr. Vitoc has a broad array of experience across commercial strategic analysis and planning and medical affairs, in which he has 20 years of experience. During that time, Dr. Vitoc has managed and supported over 20 early, launch, and mature stage compounds, which have included targeted therapies and immune therapies across more than 25 tumor types, including colorectal cancer, hepatocellular carcinoma, lung cancer, breast cancer, prostate cancer, and renal cell carcinoma. Vlad received an M.D. from the University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania, and his M.B.A. from the University of South Carolina.

    team

    JOSEPH F. MCGUIRE

    CHIEF FINANCIAL OFFICER

    Mr. McGuire is our Chief Financial Officer, and he brings over 30 years of experience to MAIA, having served as Chief Financial Officer for several privately held and publicly traded companies in the healt

    team

    SERGEI M. GRYAZNOV, PHD

    CHIEF SCIENTIFIC OFFICER

    Dr. Gryaznov is our Chief Scientific Officer. Dr. Gryaznov is an internationally recognized scientist and expert in the areas of modern drug discovery and development, oncology, telomerase, immune-regulatory therapeutics, nucleosides, nucleotides, DNA and RNA analogues, lipid and other conjugates, small molecules, and nucleic acid based therapeutic agents. Dr. Gryaznov is the co-inventor of a novel telomere-by-telomerase-targeting therapeutic approach to potential cancer treatment and responsible for leading the research team that characterized THIO’s telomere targeting activity, our lead compound in development. Dr. Gryaznov obtained an M.S., with Honors, in Organic Chemistry and a Ph.D. in Chemistry of Natural Products from M.V. Lomonosov Moscow State University. Dr. Gryaznov also completed a post-doctoral fellowship program in Chemistry at Northwestern University in Evanston, IL.

    team

    MIHAIL OBROCEA, MD

    CHIEF MEDICAL OFFICER

    Mihail is a board-certified internist and hematologist/oncologist with over 25 years’ experience in drug development in both academia and pharmaceutical/biotechnology industry. His broad clinical drug development expertise in both hematology and oncology covers equally early and late-stage development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Mihail completed a residency program in internal medicine at Yale University followed by a fellowship program in hematology/oncology at Dartmouth with academic appointment as Instructor of Medicine in the division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth.

    He started his career in pharmaceutical industry at Pfizer Oncology leading the CD40 agonist and IGF-1R antibodies projects, which entered in early clinical trials. Subsequently he led the Medical Affairs Oncology group at MedImmune, Gaithersburg MD and later as VP, Clinical Development Oncology at MannKind Corp., Valencia, CA successfully brought into clinic two cancer vaccine programs. As a Global Project Lead for AbbVie Biotherapeutics in Redwood City, CA, he was responsible for the early clinical oncology monoclonal antibody programs and as Head, Medical Sciences at Pharmacyclics, Sunnyvale CA he took part in the commercial launch of ibrutinib (IMBRUVICA™) program in mantle cell lymphoma and chronic lymphocytic leukemia. As VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, a venture pharma company supported the medical and business operations of the Pfizer Oncology partnership on the Phase 3, pivotal trial which led to the FDA approval of Besponsa® (inotuzumab ozogamicin) in the R/R adult B-cell ALL.

    Later as US Clinical Lead at Nanobiotix Corp, a biotechnology company based in Paris, France which develops nanotechnologies for use in radiation oncology, established the US clinical programs and was involved in the strategic business development, investor, and partner interaction. As a Program Lead at Juno Therapeutics Inc and later Celgene he had the US clinical oversight of 2 clinical trials including the registration Ph 3 trial in second line aggressive large B-cell lymphomas of BREYANZI® (lisocabtagene maralucel) an autologous CD19 targeted CAR T program approved in both US and EU in R/R large B-cell lymphoma. More recently, as Project and Clinical Lead at Atara Bio, a T-cell therapy company based in Thousand Oaks, CA he supported the pre-clinical and clinical development of the Atara’s allogeneic CAR T platform for both lymphoma and solid tumor indications.

    Mihail published in oncology peer-reviewed literature and is co-author of a couple of books related to cancer vaccines and immunology as well as he holds several patents in the field of biotechnology.

    SINCERELY,

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