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EFSH Profile
1847 Reports 15.0% Increase in Revenue to $14.9 Million for the First Quarter of 2024

1847 Executes Letter of Intent to Sell 1847 Cabinets Inc. for $27.6 Million

Check Out the Investor Presentation HERE

https://www.youtube.com/watch?v=kCeoKSa6b7E

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Hello Everyone,

We have another profile that we need to get on your radar heading into this week.

Pull up EFSH Immediately and start your research.

Capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises or lower-middle market businesses with limited exit options despite the intrinsic value of their business.

Given this dynamic, 1847 Holdings (NYSE: EFSH) can consistently acquire businesses it views as “solid” for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems of those businesses in order to improve operations.

The end result? These improvements may lead to a sale or IPO of an operating subsidiary at higher valuations than the purchase price and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH’s ability to pay regular and special dividends to shareholders.

1847 seeks to invest in companies whose business models enable them to drive their own growth. We anticipate this will permit us to invest successfully, and develop deep expertise, in nine primary industries. Our experience and sector focus compounds our ability to evaluate and execute investment opportunities quickly, and add significant value post-closing.

1847 Holdings LLC (NYSE American:EFSH), was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue, and former Principal of Lazard Freres Strategic Realty Investors. 1847 Holdings’ investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises or lower-middle market businesses with limited exit options despite the intrinsic value of their business. Given this dynamic, 1847 Holdings can consistently acquire businesses it views as “solid” for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems of those businesses in order to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at higher valuations than the purchase price and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to 1847 Holdings’ ability to pay regular and special dividends to shareholder

EFSH Competitive Advantages

▪ Robust Network
▪ National network of personal relationships with intermediaries, seasoned operating executives, entrepreneurs and managers

▪ Disciplined Deal Sourcing
▪ Leverages relationships with more than 3,000 qualified deal sources through regular calling, mail and email campaigns, industry events, etc.

▪ Differentiated Acquisition Capabilities in the Small Business Market
▪ Concentrated efforts on mature companies with sustainable value propositions, which can be supported by its resources and institutional expertise

▪ Value Proposition for Business Owners
▪ Employ a creative, flexible approach by tailoring each acquisition structure tommeet liquidity needs and qualitative objectives of the target

▪ Operating Partner
▪ Consistently work with a strong network of seasoned operating partners, former executives with extensive experience building, managing, and optimizing successful small business across a range of industries

▪ Small Business Market Experience
▪ Since 2000, the management team has collectively been presented with several thousand investment opportunities and actively worked with 30 small businesses on all facets of strategy, development and operations

1847 Reports 15.0% Increase in Revenue to $14.9 Million for the First Quarter of 2024

Gross profit increases 13.3% in Q1 2024 vs Q1 2023

NEW YORK, NY / ACCESSWIRE / May 16, 2024 / 1847 Holdings LLC(“1847” or the “Company”) (NYSE American:EFSH), a holding company specializing in identifying over-looked, deep value investment opportunities in middle market businesses, today provided a business update and reported financial results for the first quarter ended March 31, 2024.

Q1 2024 Key Highlights

Total Revenue was $14.9M in Q1 2024 compared to $13.0M in Q1 2023, a 15.0% year-over-year increase

Gross profit was $5.6M in Q1 2024 compared to $4.9M in Q1 2023, a 13.3% year-over-year increase

Executed Letter of Intent to Sell 1847 Cabinets Inc. for $27.6 Million

Executed non-binding LOI to acquire a large, established millwork, cabinetry and door manufacturer based in Las Vegas, NV with revenues of $28.6 million, with a purchase price of $16.75 million which represents approximately 3.2x 2023 EBITDA

Announced ICU Eyewear subsidiary diversified manufacturing to reduce production costs and fortify supply chain

Announced ICU Eyewear subsidiary’s strategic expansion of partnerships, adding 300 new locations with leading US retailer

Completed refinancing and upsizing of $15 million revolving credit facility for ICU Eyewear subsidiary

Expanded Wolo Manufacturing Corp subsidiary into India through supply chain diversification program

Restructured promissory notes to non-dilutive debt instruments

Divested Asien’s Appliance business, significantly enhancing balance sheet

Mr. Ellery W. Roberts, CEO of 1847 Holdings, commented, “I am pleased to report we achieved a 15.0% year-over-year increase in revenue and a 13.3% year-over-year increase in gross profit. Additionally, revenues from the automotive supply segment increased by 41.1% to $1.8 million. This growth can be attributed to strategic initiatives begun in Q4 2023, coupled with a new credit facility established in late January 2024, further empowering the acceleration of this business segment’s expansion. This achievement reaffirms the substantial value that 1847 delivers to our subsidiaries, both financially and operationally. During the quarter, we successfully divested of our Asien’s Appliance, significantly enhancing our balance sheet. This resulted in a $1.1 million gain for Q1 2024. By strategically divesting of Asien’s, we anticipate a reduction in 1847 Holdings’ expenses by approximately $10.9 millionannually, which should positively impact margins across our primary business lines. The divestiture of Asien’s enables us to streamline operations, optimize resource allocation, and position 1847 Holdings for sustained growth and profitability. This underscores our commitment to delivering shareholder value, as we continue to pursue opportunities for growth and enhanced profitability, in alignment with our long-term strategic goals.”

Mr. Ellery continued, “We’re maintaining a strong acquisition pipeline, focusing on companies offering value and positive cash flow, while minimizing dilution for shareholders. Recently, we announced a non-binding LOI to acquire a prominent millwork, cabinetry, and door manufacturer headquartered in Las Vegas, NV. This target boasts revenues of $28.6 million, with a purchase price of $16.75 million which represents approximately 3.2x 2023 EBITDA. This acquisition presents an attractive opportunity for 1847, with favorable negotiated terms and the potential to complete the transaction without equity-based funding at this time.”

“Additionally, we executed a non-binding LOI to sell all of the assets of 1847 Cabinets Inc.Under the terms of the LOI, the buyer has proposed an enterprise value of $27.6 million for the acquisition of all of the assets of 1847 Cabinets, including $11.5 million in earn-out payments over a three-year period, representing a 5.91x multiple of 2023 EBITDA of approximately $4.7 million. We are advancing this transaction and anticipate closing within 90 days. Proceeds from the sale will be utilized to repay senior secured debt and other liabilities, allocate funds for working capital and future acquisitions, and potentially initiate a share repurchase program. This strategic move validates our ability to purchase, operate, and enhance asset value, thereby strengthening our financial position and enabling strategic resource reallocation to capitalize on emerging opportunities within our portfolio and beyond,” concluded Mr. Roberts.

Q1 2024 Financial HighlightsTotal revenues were $14,913,497 for the three months ended March 31, 2024, as compared to $12,965,603 for the three months ended March 31, 2023.

Revenues from the retail and eyewear segment were $3,896,167 for the three months ended March 31, 2024 and $2,792,712 for the period from February 9, 2023 (date of acquisition) to March 31, 2023.

Revenues from the construction segment increased by $326,244, or 3.7%, to $9,238,969 for the three months ended March 31, 2024 from $8,912,725 for the three months ended March 31, 2023. The increase in revenues was primarily attributed to an increase in new multi-family projects and an increase in the average customer contract value.

Revenues from the automotive supplies segment increased by $518,195, or 41.1%, to $1,778,361 for the three months ended March 31, 2024 from $1,260,166 for the three months ended March 31, 2023. The increase in revenues was primarily attributed to an improved supply chain with manufacturers and heightened customer demand.

Total cost of revenues was $9,325,561 for the three months ended March 31, 2024, as compared to $8,032,294 for the three months ended March 31, 2023.

Cost of revenues for the retail and eyewear segment was $2,998,933, or 77.0% of retail and eyewear revenues, for the three months ended March 31, 2024, and $1,947,011, or 69.7% of retail and eyewear revenues, for the period from February 9, 2023 (date of acquisition) to March 31, 2023.

Cost of revenues for the construction segment decreased by $216,761, or 4.0%, to $5,158,266 for the three months ended March 31, 2024 from $5,375,027 for the three months ended March 31, 2023.

Cost of revenues for the automotive supplies segment increased by $458,106, or 64.5%, to $1,168,362 for the three months ended March 31, 2024 from $710,256 for the three months ended March 31, 2023.

Total general and administrative expenses were $2,132,600 for the three months ended March 31, 2024, as compared to $1,501,639 for the three months ended March 31, 2023.

Total professional fees were $3,025,149 for the three months ended March 31, 2024, as compared to $387,821 for the three months ended March 31, 2023.

Total operating expenses were $18,023,128 for the three months ended March 31, 2024, as compared to $12,922,180 for the three months ended March 31, 2023, resulting in a loss from operations of $3,109,631 for the three months ended March 31, 2024, as compared to income from operations of $43,423 for the three months ended March 31, 2023.

Net loss from continuing operations was $11,156,579 for the three months ended March 31, 2024, as compared to a net income of $1,152,096 for the three months ended March 31, 2023. Such change was primarily due to an increase of amortization of debt discounts by $3,262,939 and losses on change in fair value of warrant liabilities of $1,902,200, on change in fair value of derivative liabilities of $612,462 and on extinguishment of debt of $421,875 in the 2024 period. Additionally, the net income for the 2023 period included a preliminary gain on bargain purchase of $2,639,861.

ACQUISITIONS

1847 Holdings (NYSE: EFSH) has acquired ICU, a leading designer of Over-the-Counter (OTC), non-prescription reading glasses, sunglasses, blue light-blocking eyewear, sun readers, and outdoor specialty sunglasses in February 2023. ICU was founded in 1956 and is headquartered in Hollister, California.

ICU is a recognized leader in reading eyewear and sunglasses, as well as select health and personal care items. ICU has 10 brands and a comprehensive and innovative product offering of over 3,000 SKUs across the reading glass, sunglass, and health & personal care segments.

ICU’s customer base consists of a broad range of national, regional, and specialty retailers comprising over 7,500 retail locations. ICU is the only OTC eyewear supplier in the U.S. to have meaningful penetration in all significant retail channels including grocery, specialty, office supply, pharmacy, and outdoor sports stores.

Acquisition Highlights:
- Revenue in excess of $19M and $1.7M of adjusted EBTIDA in 2021.
- ICU has developed a highly profitable and sustainable business model, with solid financials, positive EBITDA, and a gross margin of approximately 40%.
- ICU has 10 brands and a comprehensive and innovative product offering of over 3,000 SKUs across the reading glass, sunglass, and health & personal care segments.
- ICU’s customer base consists of a broad range of national, regional, and specialty retailers comprising over 7,500 retail locations.
- The company’s eyewear line has earned the title of #1 provider of OTC eyewear at Target.
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Kyle’s Custom Wood Shop, Inc.: Headquartered in Boise, ID, the company believes strong housing demand in the region is driven by out-of-state immigration into Idaho. Current operations are focused primarily in the Boise area, providing opportunities to capitalize on high-growth adjacent regions. In addition to regional expansion, EFSH plans to expand capacity by increasing the network of builders, participating in new bids, and investing in facilities and labor resources. Product line expansion and broadening sales channels to include multifamily housing remodels, and DIY segments could further accelerate growth.

Financial Highlights:
- Revenues from the construction segment (incl. Kyle’s) increased by $21,830,922, or 523.6%, to $26,000,227 for the nine months ended September 30, 2022 from $4,169,305 for the nine months ended September 30, 2021.
- Cost of sales for the construction segment increased by $13,555,821, or 594.6%, to $15,835,830 for the nine months ended September 30, 2022 from $2,280,009 for the nine months ended September 30, 2021.
- Gross profit was $10,164,397 and $1,889,296 for the nine months ended September 30, 2022 and 2021, respectively.
WOLO Manufacturing Corp.: A leader in horn technology (electric, air, truck marine, electronic specialty, air & backup alarms) and vehicle emergency warning lights offering the highest quality and the largest selection for cars, trucks, and industrial equipment. Wolo has supplied innovative automotive products: horns, emergency warning lights, security, and lighting, to the automotive aftermarket for more than 45 years.

The company sells its products to big-box national retail chains, through specialty and industrial distributors, as well as online/mail order retailers and OEMs. With a stellar reputation for innovative design, its current product line consists of over 455 products, including 54 patented products, as well as over 90 exclusive trademarks.

Financial Highlights:
- Revenues from the automotive supplies segment increased by $833,742, or 20.9% to $5,114,755 for the nine months ended September 30th, 2022 from $4,231.013 for the nine months ended September 30th, 2021.
- Cost of sales for the automotive supplies segment increased by $369,368, or 13.9%, to $3,028,040 for the nine months ended September 30th, 2022 from $2,658.672 for the nine months ended September 30, 2021.
- Gross profit was $2,086,715 and $1,572,341 for the nine months ended September 30, 2022 and 2021, respectively.
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In October 2021, 1847 acquired High Mountain Door & Trim, Inc. & Innovative Cabinets & Design for an aggregate purchase price of approximately $15.4 million

Brief Overview
- ▪ High Mountain specializes in all aspects of finished carpentry products and services, including doors, door frames, base boards, crown molding, cabinetry, bathroom sinks and cabinets, bookcases, built-in closets, fireplace mantles, etc., working primarily with large homebuilders of single-family homes and commercial and multi- family developers
- ▪ Sierra Homes d/b/a Innovative Cabinets & Design specializes in custom cabinetry and countertops for a client base consisting of single-family homeowners, builders of multi-family homes, as well as commercial clients
‍Financial Highlights
- ▪ Revenues from the construction segment increased by $1,182,633, or 11.8%, to $11,230,579 for the three months ended September 30, 2023, from $10,047,946 for the three months ended September 30, 2022. The increase in revenues was primarily attributed to an increase in new multi-family projects and an increase in the average customer contract value.
- ▪ Cost of revenues for the construction segment decreased by $1,072,127, or 16.4%, to $5,472,716 for the three months ended September 30, 2023, from $6,544,843 for the three months ended September 30, 2022.
1847 Provides Update on Pending Strategic Transactions Expected to Increase Cashflow, Strengthen Balance Sheet, and Enhance Capital Structure

NEW YORK, NY / ACCESSWIRE / May 28, 2024 / 1847 Holdings LLC (“1847” or the “Company”) (NYSE American:EFSH), a holding company specializing in identifying over-looked, deep value investment opportunities in middle market businesses, today provided a business update on its pending strategic transactions.

Ellery W. Roberts, CEO of 1847 Holdings, commented, “Following a strong first quarter, in which we achieved solid revenue growth and successfully divested Asien’s Appliance, I am pleased to report we are making continued progress on a series of additional strategic initiatives expected to significantly enhance shareholder value. As an example, we are rapidly advancing towards finalizing our definitive agreement to acquire a prominent millwork, cabinetry, and door manufacturer, which generated very significant EBITDA in 2023. Through the combination of this and other planned activities, we expect to significantly lower our leverage ratio via an increase in net EBITDA relative to outstanding debt. In turn, we plan to accelerate our repayment of debt, extend the duration of remaining indebtedness, as well as eliminate any equity-linked aspects of repayment. As a result, we expect 1847 will be in a significantly stronger financial position, generating meaningful cash flow with an enhanced balance sheet and capital structure. We expect to complete the outstanding transactions in the near term and look forward to providing updates as developments unfold.”

1847 Provides Update on the Sale of 1847 Cabinets Inc.

PUBLISHED

APR 29, 2024 8:00AM EDT

NEW YORK, NY / ACCESSWIRE / April 29, 2024 / 1847 Holdings LLC (“1847” or the “Company”) (NYSE American:EFSH), a holding company specializing in identifying over-looked, deep value investment opportunities in middle market businesses, today provided an update on the sale of 1847 Cabinets Inc.

As previously announced on April 23, 2024, the Company executed a non-binding Letter of Intent (“LOI”) with a prospective strategic buyer to sell all of the assets of 1847 Cabinets Inc.(“1847 Cabinets”). Under the terms of the LOI, the buyer has proposed an enterprise value of $27.6 million for the acquisition of all of the assets of 1847 Cabinets, including $11.5 million in earn-out payments over a three-year period, representing a 5.91x multiple of 2023 EBITDA of approximately $4.7 million. The transaction continues to progress through routine due diligence and the Company currently expects the transaction to close within the next 90 days.

Mr. Ellery W. Roberts, CEO of 1847 Holdings, commented, “We are pleased with the progress we have made advancing this transaction. Currently, the proposed acquisition is undergoing confirmatory due diligence and negotiation of a definitive purchase agreement, both of which are progressing according to plan. As a result, we currently anticipate the closing to take place within 90 days. Given the purchase price, our intention is to utilize the cash proceeds to repay senior secured debt and other liabilities, allocate funds for working capital and future acquisitions, as well as potentially initiate a share repurchase program. This sale represents an important strategic move for 1847, one that validates our ability to purchase, operate and enhance the value of assets and then reach a sale, of which will significantly enhance our financial position, enabling us to reallocate resources strategically and capitalize on emerging opportunities within our portfolio and beyond, with a long-term focus on maximizing value for shareholders.”

“While this sale marks a significant milestone, it’s just one aspect of our broader strategy aimed at optimizing asset allocation and enhancing overall shareholder returns. The proposed transaction highlights what we believe is the considerable undervaluation of the Company relative to the intrinsic value of our portfolio companies. The acquisition price underscores the inherent value and potential of 1847 Cabinets, as it is priced at a substantial premium compared to the current market valuation for the entire company,” concluded Mr. Roberts.

First Quarter In The Bag: A Look At All The Milestones 1847 Holdings Hit So Far This Year

NEW YORK, NY / ACCESSWIRE / April 18, 2024 / When it comes to deal-making, capital raises and share buying, 1847 Holdings LLC(AMEX:EFSH) had a busy first quarter of 2024. The New York City publicly traded diversified acquisition holding company is making a name for itself, acquiring small businesses and then deploying resources to strengthen the enterprise and improve operations, with an eye toward spinning them out or growing them internally. All of 1847’s hard work is paying off, with the PE firm making a lot of moves that position it for growth this year and beyond.

Take its moves to shore up capital during the first three months of the year, for starters. 1847 kicked off the quarter by securing a $750,000 credit facility for its Wolo Manufacturing Corp. unit, which makes vehicle horns and safety products for cars, trucks, industrial equipment and emergency vehicles. The money went to fulfill orders amid stronger-than-expected demand, strengthen Wolo’s liquidity and give it increased financial flexibility, said 1847 CEO Ellery Roberts. “With this enhanced credit capacity, combined with growing customer demand and easing of supply-chain pressure, Wolo has the potential to increase its sales by 50% to 70% year-over-year in 2024,” Roberts said. It’s already on the road to that. In the first two months of 2024, Wolo’s reporting revenue increased 40% year-over-year in both January and February. 1847 also secured a $1 million credit facility for its High Mountain Door & Trim Inc. (“High Mountain”) subsidiary, underscoring its focus on growing its portfolio companies.

Then there’s the closing of its previously announced public offering of securities in late February, raising $5 million in gross proceeds. The public offering, handled by Spartan Capital Securities, gives 1847 more firepower to make buys and invest in its businesses.

Reigning In Expenses, Debt

Shoring up capital isn’t the only way 1847 improved operations during the first quarter. It’s also paying off debt and cutting expenses including by divesting 1847 Asien Inc. The unit provides a wide variety of appliance services. By letting go of that asset, 1847 Holdings said it reduces expenses by around $10.9 million a year and should positively impact margins. The divestment also reduces total liabilities by about $4.5 million. The PE firm was also able to pay off $1.95 million in debt, which Roberts said removes a potential equity overhang.

1847 has also been active on the profit-booking front. It recently engaged Spartan Capital Securities, LLC., to pursue a potential spinoff of 1847 Cabinets Inc., a designer, manufacturer and installer of cabinets, doors and millwork for residential construction. 1847 aims to capitalize on the growth and outlook for the company by either a spin-off of 1847 Cabinets into a separate publicly traded company or a sale to a well-paying suitor. 1847 is hoping to replicate the success it had with 1847 Goedeker’s. In April 2019, 1847 paid $6.5 million for the online purveyor of appliances, furniture and home goods. By June of 2021 when it went public, the company was valued at roughly $60 million.

Its ICU Eyewear Holdings Inc. subsidiary also grew during the quarter, recently adding two additional manufacturing partners in the Philippines and the U.S. ICU reports it was able to secure favorable rates and eliminate certain tariffs, which it said should “significantly” reduce its cost of goods. The move also reduces its reliance on production in China and enhances operations, which not only makes it more efficient but potentially a more attractive acquisition target, the company said.

CEO Acquires Common Shares At $3.30

CEO Roberts demonstrated his faith in 1847 by purchasing shares of the company’s stock in the first quarter. Roberts paid $3.30 per share to acquire 154,364 shares in early March, after acquiring 6,251 shares in late January for $1.353 a share. All told, Roberts owns 169,648 shares in the company he created. When insiders, namely CEOs, buy shares of their company it signals executives have confidence in the business and/or think the stock is undervalued. It’s something investors pay close attention to. If insiders were selling shares rather than purchasing them, it could be a red flag that something is amiss.

It’s been a busy three months for 1847, and more moves are expected in the months to come. After all, the PE firm is paying down debt, shoring up capital and positioning its portfolio companies for potentially successful exits or to grow internally. What more can investors ask for?

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NEWS
MANAGEMENT TEAM

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An Experienced CEO:

The company was founded by CEO Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue, and Principal of Lazard Freres Strategic Realty Investors.

Ellery W. Roberts leading the reins has helped elevate EFSH to an NYSE listing and his expertise could soon lead the company to much greater heights!
- Mr. Roberts has 20+ years of private equity investing experience; directly involved in $3+ billion transactions.
- He formed RW Capital Partners LLC, an investment manager approved by the Investment Committee of the U.S. Small Business Administration in 2010 to raise and manage a Small Business Investment Company.
- He previously was a Managing Director of Parallel Investment Partners LP, responsible for ~$400 million in invested capital across two funds.
- He served as a Principal at Lazard Freres & Co. working in their Real Estate Principal Investment Area, where he was a senior team member involved in the investment of over $2.4 billion of capital.
- Mr. Roberts worked at Colony Capital, Inc., a $625 million private equity fund.
- He has experience as an Investment Banker in the Corporate Finance division of Smith Barne.
“I’m pleased to report revenues increased by 27.6% to $15.4 million and we achieved net income of $1.0 million for the first quarter of 2023. At the same time, our gross profit increased 35.0% over the same period last year. These results are further validation of the strength of our platform and our ability to acquire undervalued, cash flow positive, lower-middle market businesses at attractive valuations with minimum dilution to shareholders. Importantly, we are reaffirming our prior guidance of revenue in excess of $90 million in 2023.”

CEO Ellery W. Roberts

Vernice L. Howard – Chief Financial Officer

Ms. Howard has served as Chief Financial Officer since September 2021. She has over 30 years of experience in the fields of finance and accounting. Prior to joining us, she worked for Independent Electrical Contractors, Inc. and its affiliates for over eleven years as Chief Financial Officer, where she was responsible for providing leadership to the organization in the areas of finance, human resources and general facilities administration, in addition to setting policies, procedures, strategies, practices and overseeing the organization’s assets. The foundation of Ms. Howard’s accounting and finance experience began with public accounting for several years gaining experience in tax and auditing in the entertainment and nonprofit sectors as Chief Financial Officer for The Cronkite Ward Company, a television production company, and Director of Finance for Community Action Group (CAG), a nonprofit organization. Before her work with Independent Electrical Contractors, Inc., Ms. Howard’s professional background established an emphasis in forensic accounting. Ms. Howard is a Founding Member of Chief, which is a DC based vetted network of C-level or rising VP’s supporting and connecting exceptional women. Ms. Howard holds a Master of Business Administration in Finance from Trinity Washington University Graduate School of Business Management and Bachelor of Science in Accounting from Duquesne University.

Glyn C. Milburn – Vice President of Operations

Mr. Milburn joined 1847 in February 2023 after serving as a member of the company’s board of directors since August 2022. Mr. Milburn brings diverse operational and strategic expertise across multiple sectors, including commercial finance, labor negotiations, and operations management.

Before joining 1847, Mr. Milburn served as a Director at Ygrene Energy Fund, a consumer finance company based in California. Mr. Milburn also served as Partner at Jimmy Blackman & Associates, a full-service government and public affairs firm, where he was responsible for business strategy, client management, communications, and campaign management for a client portfolio comprised of large public safety labor unions, banking/finance companies, and hotel operators across the state of California. Mr. Milburn has also served as a special assistant in the City of Los Angeles, where he held two positions, one in the office of Los Angeles Mayor Eric Garcetti’s Office of Economic Development and another in the office of Los Angeles City Council. Previously, Mr. Milburn served as Executive Vice President of Texas AF2 Holdings, managing a portfolio of sports franchises handling their operations, compliance, and strategic planning.

Mr. Milburn co-founded Provident Investment Advisors LLC, a special investment vehicle for energy, technology, and healthcare ventures, where he served as a managing member. Mr. Milburn also serves on the board of directors ofPolished.comInc. Mr. Milburn holds a B.A. degree in Public Policy from Stanford University and an M.B.A. from the Kelley School of Business at Indiana University.

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June 9, 2024
UMAC
Read the Investor Presentation HERE

Just 2 weeks ago, CEO Allan Evans, COO Drew Camden, and 2 board members collectively acquired more than 40,000 shares through open market purchases

For the 45 days post-acquisition in the first quarter, UMAC generated approximately $619,000 in combined sales

UMAC is focused on becoming a leading supplier to the American drone industry

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Hello Everyone,

We have another undiscovered company that we wanted to put on your plate before Thursday’s session.

This is one that just iPO’d and we have never taken a look at before.

Pull up (NYSE: UMAC) right away and start your research on it.

Unusual Machines is gathering great teams, revenue generating customers, valuable IP, and high-quality brands, growing both organically and through strategic acquisitions within the highly fragmented drone industry. The Company is focused on investing in the development or acquisition of FPV products and services that serve a broad set of industries including consumer, public safety, and drone delivery. The Company’s Fat Shark and Rotor Riot subsidiaries are setting the standard for FPV immersive experiences and are expected to continue to corner the consumer FPV market as Unusual Machines expands into new enterprise verticals over the next 24 months.

As Unusual Machines capitalizes on the wealth of opportunities in the rapidly evolving drone market it is well positioned for long-term success.UMAC manufactures and sells drone components and drones. Products are sold across a diversified brand portfolio with established track records including Fat Shark and Hypetrain Motors. The Company also retails small, acrobatic FPV (first-person-view) drones and equipment directly to consumers through the curated Rotor Riot e-commerce store. With a changing regulatory environment, Unusual Machines seeks to be the dominant tier 1 parts supplier to the fast growing multi-billion dollar US drone industry. The global drone accessories market is currently valued at $17.5B and is set to top $115B by 2032.

INVESTMENT HIGHLIGHTS
- Expanding portfolio of drone technology solutions through consolidation of highly fragmented drone industry
  - Acquisitions of Fat Shark and Rotor Riot create strong initial position
  - Targeting additional acquisitions that are cash flow positive and complement retail sales or component initiatives
- US-based development and assembly provides strong competitive advantage
  - Made-in-USA extremely attractive amid national security concerns
  - Regulatory and DoD procurement provide for major immediate growth drivers
- IP protections
  - 12 patents issues and 8 patents pending; includes US, EU, Korea, Canada, China, Japan, and UK
- Addressing a global opportunity
  - Consumer drones forecasted to grow to $20 billion by 2030, a 20.8% CAGR
  - Drone components market was valued at $15 billion in 2022, growing at a 11.4% CAGR to $28 billion in 2028
- Highly experienced leadership team
Unusual Machines Announces Insider Share Purchases

ORLANDO, FL / ACCESSWIRE / May 31, 2024 / Unusual Machines, Inc. (NYSE American:UMAC) (“Unusual Machines” or the “Company”), a drone and drone components manufacturer, today announced that key executives and directors have purchased additional shares of the company’s stock. Between May 20 and May 30, 2024, CEO Allan Evans, COO Drew Camden, board member Sanford Rich, and board member Cristina Colon collectively acquired more than 40,000 shares through open market purchases.

This recent insider buying brings insider ownership (including its largest shareholder Red Cat Holdings, Inc.) to approximately 64% of the Company, underscoring the leadership team’s commitment to aligning their interests with those of the shareholders and reflecting their confidence in Unusual Machines’ strategic direction and growth potential.

“Our recent insider purchases highlight our unwavering confidence in Unusual Machines’ trajectory,” stated Evans. “We are on a path to meaningful growth, driven by our recent IPO, strategic acquisitions, and expansion into the defense sector. This personal investment in the company is a clear signal of our belief in the value and future of Unusual Machines. We remain committed to driving shareholder value and are excited about the opportunities ahead.”

Unusual Machines has been making strides since its IPO, including the successful acquisitions of Rotor Riot and Fat Shark from Red Cat Holdings. These acquisitions form the cornerstone of the Company’s operations, driving revenue through both e-commerce and B2B sales channels.

In a recent letter to shareholders, Evans emphasized the Company’s strategic priorities, which include expanding Rotor Riot’s operations, progressing towards domestic production of NDAA-compliant products, and developing defense sector components. These initiatives are designed to capitalize on the growing demand for drone technology and establish Unusual Machines as a leading player in the industry.

Unusual Machines Issues Letter to Shareholders

CEO Allan Evans shares post-IPO achievements and provides insight into the Company’s strategic expansion into defense sector

ORLANDO, Fla., May 15, 2024 (GLOBE NEWSWIRE) — Unusual Machines, Inc. (NYSE American: UMAC) (“Unusual Machines” or the “Company”), a drone and drone components manufacturer, today announced it filed its 10-Q with the U.S. Securities and Exchange Commission for the first quarter of 2024 and provided the following letter to its shareholders from CEO Allan Evans.

Dear Shareholders,

We are excited to present our first shareholder letter following our recent IPO. This marks a milestone in our journey and we are incredibly grateful for your support and confidence in Unusual Machines. The IPO, financial results, and recent press releases have led to a significant number of questions from shareholders. We would like to take this opportunity to provide more context and hopefully a deeper of our operations and what these represent for Unusual Machines’ future.

Recent IPO and Acquisitions

In our first quarter, we successfully completed our initial public offering (IPO) on the NYSE American, raising gross proceeds of $5 million. Simultaneously, we closed the acquisitions of Rotor Riot and Fat Shark from Red Cat Holdings. The costs associated with our public listing and these strategic acquisitions are detailed in our 10-Q filing. These one-time expenses impact our short-term financials and can make it challenging to discern the basic operations of the company from the financial statements alone.

Cash Position

We view managing our cash position and cash flow as the most important aspect of our business. During the first quarter, we incurred one-time expenses as we finalized our IPO and had costs related to the integration of Fat Shark and Rotor Riot. We will continue to streamline and closely manage our cash spend. We ended the quarter with approximately $3.2 million in cash, which we believe provides sufficient operating capacity to achieve our growth objectives as discussed below.

Operational Overview

Rotor Riot and Fat Shark form the underpinning of Unusual Machines operations. Historically, Rotor Riot has generated revenue through the sale of first-person view (FPV) drones and drone parts via its e-commerce platform. Fat Shark is the basis of our B2B sales, supplying products through the Rotor Riot store and to other retailers. For the 45 days post-acquisition in the first quarter, we generated approximately $619,000 in combined sales. While it is a limited operating period, we achieved over 30% gross margins combined, which we aim to sustain and improve as we scale.

Importantly, the Rotor Riot e-commerce site has consistently grown 20-30% over the past few years. We intend to continue leveraging this platform as our primary consumer sales channel. Meanwhile, Fat Shark will be integrated with our other premium branded products like Hype Train Motors as we expand our customized B2B sales offerings.

Expanding into the Defense Sector

Historically, our operations have focused on producing and selling drone parts to enthusiasts through our e-commerce channel. Recognizing the growing importance of drones in combat, we have initiated a strategic initiative to begin developing NDAA-compliant drone components for the defense sector. The critical role drones have played in recent conflicts, such as in Ukraine and Israel, has heightened the U.S. Department of Defense’s demand for cost-effective drones and a reliable non-Chinese supply chain. We are confident that our expertise and partnerships Initiative will position us to start to win business and secure necessary Blue UAS certifications that will enable us to rapidly enter this emerging market.

Corporate Changes

Since our IPO, we have implemented several strategic corporate changes. We relocated our headquarters to Orlando to better align with our operations and reincorporated in Nevada to reduce costs. Additionally, we appointed a new auditor and worked with them to finalize our first quarter 10-Q filing with the SEC. These steps underscore our commitment to financial transparency and integrity as we grow.

Looking Ahead

Our priorities moving forward are clear:
- Rotor Riot: As our primary revenue source, we will continue to invest in and expand Rotor Riot’s operations, driving both top-line growth and improved margins while finalizing the transition from Red Cat.
- NDAA-Compliant Production: We are progressing towards domestic production of drone components, with our first product, a flight controller, expected by the end of June. We expect this to be the first product that will get Blue UAS certification. This is a crucial step in accessing the U.S. B2B market.
- Defense Components: Developing products for the defense sector is a focal point for growth. The current demand for drone technology also provides opportunities for non-dilutive financing. This segment is cyclical due to the government fiscal year ending in September so it is our current primary business development focus through the second and third quarters.
We are enthusiastic about the future of Unusual Machines. The acquisitions and our strategic shift towards the defense market present significant opportunities along with some uncertainty. Your support is invaluable, and we thank you for your trust and confidence in our vision. We are a small company and appreciate your feedback. Please reach out with any questions or comments.

Sincerely,
Allan Evans
CEO of Unusual Machines

First Quarter Financial Results
- Sales totaled approximately $0.6 million for the period since acquisitions of Fat Shark and Rotor Riot of February 16, 2024 through March 31, 2024. We did not have any sales prior in the prior year or prior to the completion of the acquisitions.
- Gross margin for the three months ended March 31, 2024 was approximately 33%. We did not have any sales or gross profit in the prior year.
- Our loss from operations was approximately $1.1 million for the three months ended March 31, 2024 as compared to a loss of $0.6 million for the three months ended March 31, 2023.
- Net loss attributable to common shareholders for the first quarter 2024 was approximately $1.1 million or $0.18 per share as compared to a net loss of approximately $0.6 million for the first quarter 2023 or $0.17 per share. The decrease primarily relates to additional expenses as it relates to the completion of our IPO and acquisitions and additional costs incurred related to the transition and integration of Fat Shark and Rotor Riot.
- We had approximately $3.2 million of cash as of March 31, 2024 as compared to $0.9 million as of December 31, 2023. The increase in cash primarily relates to the closing of our IPO for gross proceeds of $5.0 million in February 2024 offset by our increase in net loss and cash used as consideration related to the acquisitions of Fat Shark and Rotor Riot.
Unusual Machines Completes Acquisitions of Fat Shark and Rotor Riot

SAN JUAN, Puerto Rico, Feb. 22, 2024 (GLOBE NEWSWIRE) — Unusual Machines, Inc. (NYSE American: UMAC) (“Unusual Machines” or the “Company”) announced today the closing of its acquisitions of Fat Shark Holdings, Ltd. (“Fat Shark”), a pioneer in the design and manufacture of ultra-low latency first-person-view (FPV) goggles, and Rotor Riot LLC (“Rotor Riot”), a curated e-commerce marketplace focused on serving drone enthusiasts.

“With the acquisitions of Fat Shark and Rotor Riot, Unusual Machines is well positioned to serve the FPV drone market,” said Allan Evans, CEO of Unusual Machines. “These strategic moves provide the basis from which we are able to focus on delivering great products to enthusiasts, drone builders, and FPV pilots.”

The integration of Fat Shark and Rotor Riot into Unusual Machines is expected to bolster the Company’s market position, leveraging Fat Shark’s technical prowess in FPV goggles and Rotor Riot’s robust e-commerce platform and community engagement. Historical revenues for the two companies for the 12-months ended April 30, 2023, were $5.8 million, up 26.1% from $4.6 million in the 12-months ended April 30, 2022.

Unusual Machines’ business is focused on expanding its customer base through superior products and rapid adoption. The Company is committed to investing in new products and intellectual property and aims to explore and pursue additional acquisitions that complement and enhance its current offerings, with an emphasis on expanding customer relationships and integrating third-party solutions.

By targeting promising FPV drone companies, Unusual Machines aims to provide a domestic alternative to international players. “Our acquisitions of Fat Shark and Rotor Riot mark the beginning of an exciting journey toward leadership in the nascent domestic drone industry,” added Evans. “We are committed to unlocking the full potential of FPV technology and delivering superior experiences to our customers worldwide.”

Unusual Machines Formalizes CEO’s Contract for Two Years Along with Other Corporate Updates

ORLANDO, Fla., May 07, 2024 (GLOBE NEWSWIRE) — Unusual Machines, Inc. (NYSE American: UMAC) (“Unusual Machines” or the “Company”), a drone and drone components manufacturer, today announced it had formalized its contract for Allan Evans to continue to serve as CEO following Unusual Machine’s Board of Directors unanimous approval for two years.

The contract follows a rapid series of business developments since Dr. Evans became the CEO less than six months ago. Since his initial appointment, Unusual Machines successfully listed on the NYSE American, acquired Rotor Riot and Fat Shark from Red Cat Holdings, reincorporated in Nevada, and joined the Red Cat Futures Initiative as part of the Company’s expansion into the U.S. government segment of the market.

“It’s been a whirlwind of energy and excitement as we work to grow as fast as we possibly can,” said Dr. Evans, CEO of Unusual Machines. “Our team is fully bought-in to the mission, and we are well-positioned to drive growth with a focus on getting to cash flow positive. I believe in what we are doing, where we are going, and who we are doing it with.”

The Company continues to show strong growth with its existing operations from the acquisitions of Rotor Riot and Fat Shark. Unusual Machines is developing drone components to be manufactured in compliance with the National Defense Authorization Act (NDAA) with a focus on U.S.-based production. The Company expects to release a U.S.-made flight controller for FPV drones during the second quarter of 2024 that will be eligible, through the Company’s partners, for Blue UAS certification, a U.S. Department of Defense program certifying drones approved for government use.

“Allan’s leadership has propelled us forward at an unprecedented pace,” added Andrew Camden, Chief Operating Officer of Unusual Machines. “His strategic foresight is transforming our operations, enabling us to tackle new markets and achieve ambitious goals with precision and confidence. It is exciting working with Allan. His dedication to innovation and excellence is driving our team to new heights of succes s in this burgeoning industry.”

Brian Hoff, Chief Financial Officer of Unusual Machines, added, “The Company has gone through a tremendous amount of change in the last couple of months. Starting with Allan joining the Company, he made an immediate and positive impact through his leadership and fostering of a strong culture. He has a clear vision and path forward for the Company that positions us to fill a big need within the industry, and I look forward to partnering with him for years to come.”

The Company changed its independent registered accounting firm to Salberg & Company, P.A. (“Salberg”), as previously announced in an 8-K filed with the SEC on April 16, 2024. Mr. Hoff added, “We are excited to have retained an experienced audit firm like Salberg as the Company moves forward. We have been working diligently to complete our quarterly review procedures and anticipate filing our required quarterly report with the SEC on time.”

‍

NEWS

Unusual Machines to Participate on the Drone Panel at the “Charting the Course: Navigating the Intersection of TMT and Business in the AI Era” Conference Presented by Maxim Group LLC on Tuesday, June 4, 2024 at 10:00 A.M. E.T.

May 31, 2024 8:03am EDT

Unusual Machines Announces Insider Share Purchases

May 16, 2024 11:37am EDT

Unusual Machines CEO Discusses Growth and Strategic Plans Post-IPO

May 15, 2024 4:10pm EDT

Unusual Machines Issues Letter to Shareholders

May 15, 2024 7:00am EDT

Unusual Machines to Host Q1 Earnings Call on May 15

May 07, 2024 4:15pm EDT

Unusual Machines Formalizes CEO’s Contract for Two Years Along with Other Corporate Updates

Mar 07, 2024 4:01pm EST

Unusual Machines Appoints FPV Drone Expert Andrew Camden as Chief Operating Officer

Feb 22, 2024 4:01pm EST

Unusual Machines Completes Acquisitions of Fat Shark and Rotor Riot

Feb 16, 2024 4:01pm EST

Unusual Machines Announces Closing of $5,000,000 Initial Public Offering

Feb 14, 2024 9:00am EST

Unusual Machines Announces Pricing of Initial Public Offering

‍

MANAGEMENT

Allan Evans

Chief Executive Officer and Director

Allan Evans is the Chief Executive Officer of the Company. Further, Mr. Evans was appointed as a director of the Company in November 2023. Previously, he was the Chief Operating Officer of Red Cat from January 2021 to November 2023 and was the Chief Executive Officer of Fat Shark. He is a serial entrepreneur with a history of founding and leading technological innovation. He has extensive experience in overseeing different emerging technologies. From August 2017 to October 2020, he served as a board member for Ballast Technologies, a company that specialized in technology for location-based entertainment. In November 2012, he co-founded Avegant, a technology company focused on developing next generation display technology to enable previously impossible augmented reality experiences. He led design, development, and initial production of the Glyph head mounted display and oversaw technology research and patent strategy while serving as Chief Technology Officer of Avegant until 2016. He has 47 pending or issued patents that cover a range of technologies from implantable medical devices to mixed reality headsets. Academically, his work has an h-index of 15, an i-index of 28, and has been cited in more than 1,000 publications. He has extensive experience with new technologies, engineering, business development, and corporate strategy, and his expertise in these areas strengthens the Company’s collective knowledge and capabilities.

Brian Hoff

Chief Financial Officer

Brian Hoff has served as Chief Financial Officer of Unusual Machines since November 2022. Mr. Hoff brings extensive experience in leading high growth accounting & finance teams. Mr. Hoff previously serviced as Chief Financial Officer of Auddia, Inc. (Nasdaq: “AUUD”) from April 2021 to October 2022. From October 2019 to April 2021 Mr. Hoff served as Vice President, Accounting & Finance at STACK Infrastructure, a leading provider of digital infrastructure to high growth companies owned by IPI Partners. From November 2011 to October 2019 Mr. Hoff was Corporate Controller and Director of Finance at Coalfire, a leading cyber-security firm owned by The Carlyle Group and The Chertoff Group. Prior to that Mr. Hoff spent four years in public accounting. Mr. Hoff is a certified public accountant and holds a B.S. in Accounting from the University of Colorado.

Drew Camden

Chief Operating Officer

Drew Camden serves as Chief Operating Officer of Unusual Machines. Camden’s ascent in the drone industry began with his captivating FPV Freestyle videos on YouTube. Appointed President of Rotor Riot in 2018, he diversified Rotor Riot’s business by expanding media production and creating an e-commerce revenue stream. Camden established Rotor Riot’s first formal headquarters in Orlando, transformed retail operations, and launched a line of ready-to-fly FPV freestyle drones, positioning Rotor Riot for acquisition by Red Cat Holdings in 2020. He continued to lead Rotor Riot, generating a remarkable 50% year-over-year average revenue growth. In 2024 he saw Rotor Riot through its acquisition by Unusual Machines and joined the executive team. Prior to his work in the drone industry, Camden earned a bachelor’s degree in Engineering Physics from Tulane University and worked four years as an Engineer for General Motors.

SINCERELY,

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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. 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June 5, 2024
NNVC
As of December 31, 2023 NNVC had cash and cash equivalent current assets balance of approximately $5.31 Million

This Innovative Biotech Company Is Taking A Novel, Game-Changing Approach To Eradicating Many Respiratory Viruses Once And For All Including Tripledemic Threat Of COVID, RSV, FLU…

ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate

READ THE INVESTOR PRESENTATION HERE

___________________________

Hello Everyone,

We have a new profile that we want you to put back on your radar for Wednesday’s session.

This is a company that we profiled a few weeks back when it was sitting at lower levels.

As biotech stages a big comeback, NanoViricides, Inc. (NYSE American: NNVC) looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.

NanoViricides, Inc. (NYSE American: NNVC) is a global leader in the application of nanomedicine technologies to the safe and effective treatment of viruses and their variants INCLUDING drugs against Covid-19, RSV and other respiratory viruses!

Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031.

NANOVIRICIDES are better because they destroy viruses and their variants without relying on the patient’s immune system, thereby making them effective for populations that include geriatric and pediatric patients.

Antibodies only bind by two points to the virus, and destruction of the complex requires effective immune function, which is not the case in sick patients..

Vaccines only train the body into producing antibodies against the virus in the vaccine. Antibodies and vaccines are easily overcome by viruses by mutating in the field, hence the need for annual influenza vaccine updates.

NNVC 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 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 (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 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 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 certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses 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.

RECENT COMPANY HIGHLIGHTS:
- - NanoViricides, Inc’s lead drug, NV-387, is in Phase 1 clinical trials.
  - Broad spectrum antiviral NV-387 showing promise against many virus families including and beyond Tripledemic (i.e. COVID-19, RSV, FLU) .
  - No adverse events in Phase I SAD and MAD studies even at the highest dose 40mg/Kg
  - Found to be non-immunogenic, non-mutagenic, non-allergenic, and non-phototoxic.
  - Strong safety allows use in pediatrics, adults with co-morbidities, and immune-compromised patients unlike limitations of products currently in the market.
  - Developed Oral Syrup and Oral Gummies (soft solids) – good for geriatric and pediatric patients
  - Drugs expected to continue to be effective even as the virus generates variants – unique receptor site doesn’t change
  - Technology mimics unique receptor site used by virus; delivers to specific targets using receptor-recognition (no bulky antibodies)
A 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.

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.

A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design

A single nanoviricide micelle may be capable of completely engulfing a Virus Particle. Nanoviricide micelles self-assemble from multiple chains. A single chain micelle shown for convenience. Illustration not to scale.

Each nanoviricide drug is designed as an antiviral agent specifically targeted for a particular type of virus or group of viruses. Most existing anti-viral agents are known to have non-specific effects against both host cells and viral machinery at the same time often leading to side effects. Most current anti-viral agents act inside human cells. It is believed that this intracellular mechanism leads to significant opportunities for unwanted side effects against host cells. Nanoviricides, on the other hand, are designed to work directly against virus particles in bodily fluids. The Company believes that this approach may make nanoviricides inherently safer than existing approaches.

A nanoviricide is designed to seek and attach to a specific virus particle, engulfing the virus particle in the process, thereby rendering it incapable of infecting new cells, and disabling it completely. This suggested mechanism of action encompasses much more than what the current entry and fusion inhibitors are expected to do. The fusion and entry inhibitors do not completely cover the virus particle, likely blocking only a few sites on the virus particle. This means the virus particle may still be capable of infecting cells using its unblocked attachment sites. In contrast, a nanoviricide, because of its larger size and flexible nature, is expected to engulf the virus particle completely, thus disabling the virus particle. The action of a nanoviricide, if it works as designed, may be expected to be superior to antibody agents that attack viruses. Antibodies, being large, are expected to block relatively greater portions of the virus particle surface compared to small molecule entry inhibitors. However, antibodies depend upon the human immune system responses for clearing the virus particle. In contrast, nanoviricides are thought to be capable of acting as completely programmed chemical robots that finish their task of destroying the virus particle on their own.

NV 387 IN CLINICAL TRIALS

The drug, developed in response to the COVID-19 pandemic, demonstrated exceptional safety in clinical trials, even at the highest dose levels, with NO adverse events reported. The unique mechanism of action involves mimicking a cell membrane, encapsulating and blocking the virus.

Beyond COVID-19, the drug also displayed promising results against respiratory syncytial virus (RSV), offering a potential solution for infants and seniors where existing treatments like ribavirin may be contraindicated due to side effects.

The clinical trials involved both oral tablets and oral gummies, catering to various age groups, including pediatrics. NV 387 exhibited broad-spectrum activity against multiple strains of coronaviruses, showcasing effectiveness 10 times greater than remdesivir in preclinical studies.

The ongoing clinical trial progress and positive results position NanoViricides at the forefront of antiviral drug development, marking a significant milestone in their journey from preclinical research since 2005 to clinical trials.

The company believes 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!

NV-387 ADDRESSES AN UNMET MEDICAL NEED FOR BROAD-SPECTRUM, SAFE AND EFFECTIVE ANTIVIRAL DRUG THAT WORKS AGAINST MULTIPLE VIRAL THREATS:

There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.

NNVC believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.

NV-387 ADDRESSES LARGE MARKET SIZES:

Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*.

*Source: Transparency Market Research

The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**.

**Source: Growth+ Market Reports.

NANOVIRICIDES TECHNOLOGY WILL TRANSFORM THE WAY VIRUSES & THEIR VARIANTS ARE TREATED WORLDWIDE!

NNVC’s novel approach has already enabled variant-proof drugs, blocking the complete viral life cycle without requiring help from the host’s defense systems! If both the viral re-infection cycle, and viral replication cycle arms of the viral lifecycle are blocked, a cure for many viral diseases is possible!!

The Company’s 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 also developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg.

A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricides

SHELTON, CONNECTICUT – Wednesday, May 8, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes activity against orthopoxvirus family (Smallpox/Mpox), with both inhalation and skin abrasion (sexual) modes of infection acquisition. Ectromelia virus infection of mice is a model for Smallpox infection in humans, and also serves as a surrogate for MPox infection in humans. All three viruses belong to the orthopoxvirus family.

NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.

This lung infection study substantiates the results of the previously reported intradigital footpad infection study that: (i) NV-387 has comparable antiviral activity as tecovirimat, and
(ii) NV-387 plus tecovirimat has much stronger antiviral activity than either drug alone.

We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly. In this study, we found that NV-387 alone treated animals survived 15 days, tecovirimat alone treated animals survived 16 days, and NV-387 plus tecovirimat treated animals survived 19 days, whereas vehicle-treated animals died in 8 days.

This lung-infection study emulates infection from aerosolized dispersion of the virus, as may be expected in a bioterrorism scenario.

Survival Lifespan of Lethally Infected Mice – Lung Infection with Ectromelia Virus

Previously, on November 14, 2023, we have reported that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment, with both treatments resulting in 14 days survival, whereas vehicle treated animals died in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat resulted in a significantly improved survival of 17 days in this study.

Survival Lifespan of Lethally Infected Mice – Intradigital Footpad Infection with Ectromelia Virus

This intradigital footpad infection study emulates the skin-to-skin transfer of the virus as in sexual transmission, such as that in the case of current Clade 1 MPox virus epidemic in the DR Congo; Clade 1 MPox is more deadly than the Clade 2 MPox; the latter had caused a small pandemic recently with sexual mode of transmission (https://www.sciencefocus.com/news/monkey-pox-new-strain , May 5, 2024).

Tecovirimat is the drug approved for smallpox under “animal rule” and is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA). It was mobilized from the stockpile during the recent MPox Clade 2 pandemic. BARDA is interested in development of additional poxvirus therapeutics as per a recent Broad-Agency Announcement (BAA). There is significant interest in the development of a smallpox therapeutic that works well by itself, as well as in combination with the known drug, tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.

Therefore we believe that NV-387 is a viable clinical candidate to be developed by itself for the treatment of poxvirus infections under the US FDA “Animal Rule”. In addition, we believe that the combination of NV-387 and tecovirimat could reduce the potential for escape resistant generation against tecovirimat, as is known with other drug combination studies against viruses.

A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.

A Novel Broad-Spectrum Antiviral with Activity Against RSV -Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral Treatment

SHELTON, CONNECTICUT – Tuesday, May 14, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that antiviral activity of NV-387 against RSV/A2 is strong enough to have resulted in full survival of lethally infected animals was achieved.

In this study, extended dosing of NV-387 given orally was compared with a high dose of ribavirin given orally. Two doses were given on first day of dosing followed by one daily dose for next 9 days (total 11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21 days study period, with no signs of pathology apparent on the last day of observation. In contrast, ribavirin led to death of all animals by 14 days.

Survival Lifespan of Lethally Infected Mice – Lung Infection with RSV A2

TreatmentSurvival, DaysIncrease in
Survival, DaysIncrease in
Survival, %NV-387, Oral22+ (Complete)> 14> 175%Ribavirin, Oral14675%Vehicle800%

Thus we believe NV-387 oral treatment is capable of curing RSV infection. There is currently no approved treatment for RSV other than ribavirin. A safe and effective treatment remains an unmet medical need.

“This is an extremely significant result. To date, in our lethal infection animal models, we have not observed uniform survival with any of the treatments (including approved drugs) against most viruses including Influenza A, Smallpox/Mpox, and Coronaviruses,” said Anil R. Diwan, PhD, adding, “Our studies are designed to be so lethal that the survival lifetime itself can be used as the ranking parameter to evaluate the effectiveness of a treatment. Complete survival is not expected in such studies, unless the drug is extremely effective.”

Previously, in July 2023, we reported that NV-387 treatment led to survival in lethally RSV infected animals equal to that observed with ribavirin treatment. In this study, we extended the dosing regimens of both ribavirin and NV-387, to determine if that improves survival.

Ribavirin is the only currently approved drug for RSV infection, that can be used only as a last resort because of its extensive toxicity that limits its effectiveness.

RSV is an important disease in infants and children less than 5 years old, as well as in older persons over 65 years old. According to the CDC, each year in the United States, RSV leads to approximately:
58,000-80,000 hospitalizations among children younger than 5 years old;
60,000-160,000 hospitalizations among adults 65 years and older;
6,000-10,000 deaths among adults 65 years and older; and
100–300 deaths in children younger than 5 years old.

Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer). Abrysvo was recently approved for use in pregnant women for protection of infants. Synagis (palivizumab), an antibody, as well as a new antibody, nirsevimab (Beyfortus®) have been approved by the US FDA for protection of newborn children at risk of RSV disease, but not for treatment of RSV infection and disease.
About NanoViricides

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. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.

Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 “cold sores” and HSV-2 “genital ulcers”. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants.

The Company is also developing drugs against a number of viral diseases including 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 certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses 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.
This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. API means active pharmaceutical ingredient.

The Sustained, Slow Declining, Blood Concentration Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect -A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More

SHELTON, CONNECTICUT – Tuesday, June 4, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a nonhuman primate (NHP) animal model.
The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidateNV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau ofblood concentration of the drug with very slow decline over a 24 hour period in a cynomolgusmonkey model.
The maximum concentration as well as the plateau concentration increased in a dose-dependentmanner, as expected.
This sustained drug level in the blood stream for a relatively long period of time enablesinfrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a”chemical nanomachine”. It is made up of polymer with its size chosen to minimize loss by renalfiltration.
The observed pharmacokinetic profile of NV-387 supports a once-daily or less frequent dosingregimen.
The Company has already developed an injectable formulation of NV-387, namely NV-387Solution for Injection, Infusion, and Inhalation.
An injection of NV-387 would be useful for moderate to severe illness, especially because of thesustained blood profile that requires infrequent dosing.
An infusion would be suitable for severely ill hospitalized patients.
Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patientusing a simple handheld nebulizer over a period of a few minutes. Such delivery can enable directattack on the virus where such attack is most needed in the cases of severe lung infection.
The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics.
We have found that NV-387 could cure lethal lung infection in RSV infected animals even withan oral dose. There is no approved drug for RSV treatment other than the toxic, last resort drugribavirin, which was not very effective in this lethal study compared to NV-387.
We have also found that NV-387 IV administration as well as PO (oral) administration wassubstantially superior to each of the approved drugs Tamiflu, Rapivab and Xofluza in anInfluenza A/H3N2 lethal lung infection model.
We believe that NV-387 is expected to possess similar strong antiviral activity against InfluenzaA/H5N1 “Bird Flu” viruses as well. Our belief is based on the putative mechanism of NV-387.
NV-387 is a host-mimetic, direct acting antiviral designed as decoy, to look like a cell decoratedwith sulfated proteoglycans, to which over 90% of human pathogenic viruses, including H5N1,are known to bind.
We have found that NV-387 has strong antiviral activity against all tested coronaviruses,including SARS-CoV-2 pseudovirions. NV-387 was substantially more effective than remdesivirin a lethal coronavirus infection animal study. We believe that NV-387 has a strong potential forthe treatment of COVID as well as “Long COVID”.
COVID continues to cause substantially more fatalities annually than Influenza viruses. LongCOVID has substantial personal as well as societal costs. Available drug, Paxlovid (Pfizer) hassignificant limitations for patient suitability. Thus a new drug against COVID and Long COVIDis sorely needed.
About NanoViricidesNanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a development stage companythat is creating special purpose nanomaterials for antiviral therapy. The Company’s novelnanoviricide® class of drug candidates are designed to specifically attack enveloped virusparticles and to dismantle them. Additionally, nanoviricides mimick the host-side features that theviruses continue to require in spite of mutations, and therefore the viruses would be highlyunlikely to escape the nanvoricide drugs.
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV,COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections.
NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with noreported adverse events even at the highest and repeated dosages. This trial was conducted by thedrug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.
The Company is currently focused on advancing NV-387 into Phase II human clinical trials fortreatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 “coldsores” and HSV-2 “genital ulcers”. The Company cannot project an exact date for filing an INDfor any of its drugs because of dependence on a number of external collaborators and consultants.
The Company is also developing drugs against a number of viral diseases including oral andgenital 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. NanoViricidesholds a worldwide exclusive perpetual license to this technology for several drugs with specifictargeting 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 certain Coronaviruses. The Company intends to obtain a license forpoxviruses and/or enteroviruses if the initial research is successful. The Company’s technology isbased on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas fromTheraCour Pharma, Inc. The Company’s business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specific viruses, as established at itsfoundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug developmentof any pharmaceutical product is extremely lengthy and requires substantial capital. As with anydrug development efforts by any company, there can be no assurance at this time that any of theCompany’s pharmaceutical candidates would show sufficient effectiveness and safety for humanclinical development. Further, there can be no assurance at this time that successful results againstcoronavirus in our lab will lead to successful clinical trials or a successful pharmaceuticalproduct.
This press release contains forward-looking statements that reflect the Company’s currentexpectation regarding future events. Actual events could differ materially and substantially fromthose projected herein and depend on a number of factors. Certain statements in this release, andother written or oral statements made by NanoViricides, Inc. are “forward-looking statements”within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. You should not place undue reliance on forward-looking statements sincethey involve known and unknown risks, uncertainties and other factors which are, in some cases,beyond the Company’s control and which could, and likely will, materially affect actual results,levels of activity, performance or achievements. The Company assumes no obligation to publiclyupdate or revise these forward-looking statements for any reason, or to update the reasons actualresults could differ materially from those anticipated in these forward-looking statements, even ifnew information becomes available in the future. Important factors that could cause actual resultsto differ materially from the company’s expectations include, but are not limited to, those factorsthat are disclosed under the heading “Risk Factors” and elsewhere in documents filed by thecompany from time to time with the United States Securities and Exchange Commission andother regulatory authorities. Although it is not possible to predict or identify all such factors, theymay include the following: demonstration and proof of principle in preclinical trials that ananoviricide is safe and effective; successful development of our product candidates; our abilityto seek and obtain regulatory approvals, including with respect to the indications we are seeking;the successful commercialization of our product candidates; and market acceptance of ourproducts.
The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer toresearch findings including clinical trials as the customary research usage and do not indicateevaluation of safety or effectiveness by the US FDA.
“NOAEL” means “No-Observed-Adevrese-Event-Level”, which is the maximum dosageemployed at which there were no adverse events found in animal studies.
“MTD” means “Maximum Tolerated Dose”, which is the maximum dosage employed that doesnot compromise survival of the animals.
FDA refers to US Food and Drug Administration. IND application refers to “Investigational NewDrug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to”Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Productsfor Human Use, which is the European Medicines Agency’s (EMA) committee responsible forhuman medicines. API stands for “Active Pharmaceutical Ingredient”. API means activepharmaceutical ingredient.

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NEWS

June 4, 2024 – This is NHP PK profile of NV-387 which showed desirable unusually slow declineMay 29, 2024 – A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More – Novel Host-Mimetic, Virus Killing Technology PlatformMay 23, 2024 – NanoViricides Bolsters Partnership Efforts – Engages Aagami IncMay 20, 2024 – The RSV animal study lung histopathology results are astounding. They indicate complete cure ofRSV by NV-387 treatment. Only partial protection for some time by ribavirin treatment.May 15, 2024 – NanoViricides Has Filed its Quarterly Report – NV-387 Advancing to Phase II Clinical Trial for the Treatment of RSV InfectionMay 14, 2024 – A Novel Broad-Spectrum Antiviral with Activity Against RSV – Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral TreatmentMay 10, 2024 – NanoViricides to Participate in the 2024 EF Hutton Annual Global Conference On May 15 in New York CityMay 8, 2024 – A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricidesMay 6, 2024 – NA Novel Broad-Spectrum Antiviral with Activity Against Influenza A – NV-387 Possesses Strong Anti-Influenza-A Virus Activity, and May Have Activity Against H5N1 Bird Flu Virus, Says NanoViricidesApril 30, 2024 – NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected SoonFebruary 15, 2024 – NanoViricides Has Filed its Quarterly Report – NV-387 Clinical Trial Healthy Subjects Part Successfully Completed, COVID Patient Treatment on the HorizonFebruary 1, 2024 – Clinical Trial Demonstration of Safety and Tolerability of NV-CoV-2 Has Implications Beyond COVID Treatment, Explains NanoViricides – NV-387 Could be As Revolutionary as AntibioticsJanuary 29, 2024 – Safety in Multiple-Ascending-Dose Healthy Subjects Clinical Trial Part Successfully Established for the NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2 with No Adverse Events FoundJanuary 4, 2024 – NanoViricides to Present at the Biotech Showcase in San Fransisco

MANAGEMENT

‍

Anil R. Diwan, PhDExecutive 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.

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 INTERACTIVE OFFERS LLC FOR A ONE DAY NNVC 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. 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.
June 4, 2024
GVH
Globavend Holdings Announces MOU to Acquire Top Logistics, a Key One-stop Logistics Solutions Provider in Australia

Specializing in Direct Injection from Hong Kong & Southern China to Australia and New Zealand

The company’s revenues nearly doubled from FY2021 to 2022 — from USD $13.3M to $24M — before dropping a bit to $18.6M in 2023

GVH’s gross profits went from $984k in 2021 to $1.4M in 2022 to $1.9M in 2023 — nearly doubling in two years

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Hello Everyone,

We have another new profile for Mondays session that we want you to research.

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

Pull up GVH Immediately.

Globavend Holdings Limited is an emerging e-commerce logistics provider, that formulates and implements integrated, end-to-end, cross-border logistics solutions for their customers with the provision of air freight forwarding services and related logistics services as their principal business. Their business model principally involves the provision of (i) integrated cross-border logistics services, which include air freight forwarding services offered as an integral part thereof; and (ii) air freight forwarding services, offered as a modularized logistics service segmented from our integrated cross-border logistics services. Their logistics network covers Hong Kong and four cities in Australia, namely Sydney, Melbourne, Brisbane, and Perth, as well as New Zealand.

Their integrated cross-border logistics services is our dominant business segment, which involve order processing, parcel consolidation, cross-border transportation (primarily by way of air freight), and air freight forwarding, followed by ground transportation and delivery at destination cities, together with other value-added services. While traditional logistics services providers typically provide fragmented logistics services and require customers to coordinate with various service providers, they, as an integrated cross-border logistics services provider, carry out the coordination with different players in the logistics value chain, including warehousing, customs clearance, and air freight or ground transportation services. This has effectively reduced the lead time and hassle and greatly improved the efficiency in fulfilling service orders. As an integral part of our integrated cross-border logistic services, we have also developed our own proprietary all-in-one shipping solution, which was modified by us internally on a shipping software purchased by us in 2019.

Their proprietary all-in-one shipping solution has been or can be connected to the internal sales or booking systems of customers, as well as the carrier management systems of the ground transportation carriers, to facilitate effective logistics management, the details of which are explained. Their services are provided primarily on a contract logistics basis, under which we provide our enterprise customers with customized integrated logistics services covering the entire delivery process.

Their services start by enterprise customers making errinstructions in their own internal sales or booking systems, which integrate into their own proprietary all-in-one shipping solution. Upon receipt of booking instructions, their services start and cover from order origination to the final point of sale or delivery without further efforts or coordination from customers. This service is a customized one so as to fit a customer’s own business model, representing a seamless combination of order processing, parcel consolidation, transportation, and delivery. For customers engaging our services with agreed price quotations, we can provide one-off or on-demand integrated cross-border logistics services. Alternatively, customers can also request for our logistics services on a modularized or one-off basis, i.e., they can request for any segment of our logistics services within the integrated cross-border logistics solution on a stand-alone basis. As part of our integrated cross-border logistics services, they also provide related logistics services, which include the provision of supporting transportation for freight forwarding purpose, storage of consignment, labelling of consignments, other related logistic services for freight forwarding purpose, freight management services via our proprietary all-in-one shipping solution, and delivery at destination.

They engage (i) air freight carriers for the provision of cargo spaces, (ii) supporting ground transportation companies for the ground transportation services in Australia and New Zealand, (iii) customs clearance companies in Australia and New Zealand for the preparation of freight documentation and arrangement for customs clearance, and (iv) local delivery service providers for dispatching and distributing our customers’ goods to their designated destination in Australia and New Zealand. Their integrated cross-border logistics services, together with their proprietary all-in-one shipping solution, enable them to provide efficient and customer-oriented services. This has resulted in their customers continuously engaging us for one-stop air freight forwarding services and comprehensive logistic services, allowing us to gradually build our customer base.

Globavend Holdings Announces MOU to Acquire Top Logistics, a Key One-stop Logistics Solutions Provider in Australia

Strategic acquisition intended to enhance the company’s business presence in Australia

PERTH, AUSTRALIA, May 29, 2024 (GLOBE NEWSWIRE) — Globavend Holdings Limited (Nasdaq: GVH) (the “Company” or “Globavend”), an emerging e-commerce logistics provider, today announced it has entered into a non-binding Memorandum of Understanding (“MOU”) to make an equity investment in Top Logistics Australia Pty Ltd (“Top Logistics”), a key one stop logistics solutions provider in Australia. Under the MOU, the Company would make an equity investment in Top Logistics on fulfillment and/or waiver of certain conditions precedent to be set out in the definitive agreement, which is subject to a further and ongoing discussions and due diligence.

Top Logistics is a full-service logistics provider headquartered in Sydney with a very strong presence in Australia, having warehouses in Sydney, Melbourne and Brisbane with space over 15,000 square metres. It specializes in sea & air freight, import, customs clearance, cargo-deconsolidation, packing and fulfillment, transport and logistics, as well as warehousing services.

Wai Yiu Yau, CEO of Globavend stated “The proposed transaction aligns with Globavend’s strategy to solidify its business presence and expansion into Australia. According to the 2024 Australian Post eCommerce Industry Report, 8 in 10 Australian households shopped online in 2023 and 9.5 million households in Australia have received a parcel in 2023. Australian has spent AUD63.6 billion (approximately US$42.4 billion) in 2023 in shopping online. Given the market presence of Top Logistics has, we believe the proposed acquisition will further boost our business performance and help our business to thrive in future.”

NEWS

Globavend Holdings Announces MOU to Acquire Top Logistics, a Key One-stop Logistics Solutions Provider in Australia3 days agoGlobavend Holdings Limited Enters Into a US$20,000,000 Equity Line of Credit Facility to be Registered on Form F-1Mar 18, 2024Globavend Holdings Limited Announces Closing of its Initial Public OfferingNov 10, 2023Globavend Holdings Limited Announces Pricing of Initial Public OfferingNov 7, 2023

MANAGEMENT

Mr. Wai Yiu Yau

Founder, Chairman of the Board and Chief Executive Officer
- Over 15 years of experience in logistics industry
- Prior positions include Regional Operations Manager (Asia Pacific) at DHL eCommerce Limited
- Holds Bachelor of Science Degree in International Shipping Transport and Logistics and MBA from Hong Kong Polytechnic University and Chinese University of Hong Kong
Mr. Tsz Ngo Yu

Chief Financial Officer Appointee
- Over 15 years of experience in finance, auditing, accounting, and corporate governance
- Former audit manager at Deloitte Touche Tohmatsu
- A member of the Certified Public Accountants Australia
- A fellow member of the Hong Kong Institute of Certified Public Accountants
- Holds Bachelor of Commerce Degree in Accounting and Finance and Master of Applied Finance from Monash University
Ms. San Man Leng

Independent Director Appointee and Chair of Audit Committee
- Licensed CPA in California, member of American Institute of CPA.
- Over 20 years of experience in accounting, auditing, business consulting, and corporate services.
- Holds Bachelor of Arts degree in Business Economics from University of Southern California.
Mr. Ho Chuen Shin

Independent Director Appointee, Chair of Compensation Committee and Nomination Committee
- Solicitor of High Court in Hong Kong with over 8 years of corporate practice experience
- Advises companies and sponsors in IPOs and post listing compliance
- A member of the Certified Public Accountants Australia
- Holds Bachelor of Laws Degree and Postgraduate Certificate in Laws from Chinese University of Hong Kong
Mr. Fan Cheung

Independent Director Appointee
- Over 13 years of experience in logistics, including international business expansion and corporate governance
- Served at S F Express (Hong Kong) Limited, Deputy Director of Financial Planning
- Chartered Secretary and Chartered Governance Professional
- Holds Bachelor of Social Science degree, Bachelor of Laws degree, and Master of Corporate Governance degree
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 LEGENDS MEDIA LLC FOR A ONE DAY GVH 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. 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.
June 1, 2024
(NYSE: MAIA) Profile
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MAIA BOASTS A ROBUST CLINICAL PIPELINE IN MULTIPLE HARD-TO-TREAT CANCER INDICATIONS

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

MAIA Just Made Another 52 Week High Earlier in This Session

READ THE INVESTOR PRESENTATION HERE

_______________________________________________________________________________________________________________

Hello Everyone,

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

This is a company that we have profiled in the past at much lower levels.

Pull up MAIA and start your research on it immediately.

MAIA Just made another 52 week high today.

This one could be on the verge of a breakout here as it enters mid-$4 territory.

MAIA has been on a Bull Run since before the New Year and with a strong partnership with Regeneron on the books there is no telling what the limit on MAIA could be.

• 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

‍

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.

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)

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 more efficacious
• Follow THIO to commercial stage within 4-5 years

MAIA BIOTECHNOLOGY PROVIDES POSITIVE PHASE 2 CLINICAL UPDATES FOR LEAD ANTICANCER AGENT AND OUTLINES TARGETED MILESTONES FOR 2024

January 17, 2024 9:00am EST
- Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial
- Multiple clinical milestones ahead for THIO-101 Phase 2 trial
- Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024.

In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.

“We are entering 2024 with strong momentum and great excitement about our programs and pipeline,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care.”

“In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” Dr. Vitoc continued.

“Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point.”

Key 2023 Achievements

Positive Preliminary Efficacy Data: Key findings from THIO-101 included:
- 100% preliminary disease control rate (DCR) in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
- DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.
Third orphan drug designation (ODD) granted to THIO: MAIA’s portfolio of immuno-oncology therapies with ODDs now includes a third hard-to-treat cancer, glioblastoma, the most aggressive and most common type of brain cancer with only limited treatment options.

U.S. FDA Investigational New Drug (IND) Clearance: The FDA cleared U.S.-based evaluation for THIO as part of THIO-101. The trial drew a strong pace of enrollment in 2023 compared with previous NSCLC trials by other drug developers.

Dose Selection: A 180mg/cycle dose of THIO was selected for THIO-101 based on stronger efficacy compared to other doses. The selected dose showed unprecedented disease control and overall response rates for a NSCLC clinical trial.

Next Generation Telomere Targeting Agents: MAIA’s second-generation telomere-targeting program is engaged in research and development for new prodrugs derived from lipid-modified THIO molecules. Capable of acting through similar mechanisms of activity as THIO, the higher potency of these compounds at lower dose levels will be investigated further in 2024.

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

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 cemiplimab (Libtayo®) 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. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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.

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)

COMPARABLE COMPANIES

MAIA BIOTECHNOLOGY ANNOUNCES STRONG EFFICACY OF THIO AS THIRD-LINE TREATMENT FOR NON-SMALL CELL LUNG CANCER PATIENTS

March 06, 2024 8:48am EST Download as PDF
- Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC)
- ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

As of January 8, 2024, overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

“As an impressive measure of efficacy, the strong response rate of 38% in third-line treatment supports our premise that THIO administration prior to cemiplimab can improve tumor responses to immunotherapy in advanced NSCLC patients resistant to CPIs and other standard treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Around 60-70% of NSCLC patients do not have a targetable mutation and cannot benefit from a biomarker-targeted therapy, making it the greatest unmet medical need population in lung cancer. In currently available treatments for these patients in third-line, response rates range around 6%.¹ We are encouraged by the excellent efficacy findings in THIO-101 to date, adding impressive ORR to unprecented disease control rates (DCR), and further demonstrating the potential of our first-in-class treatment to redefine the standard of care for NSCLC patients.”

The efficacy evaluable population defined in the THIO-101 protocol considers all subjects who received at least one dose of THIO treatment and have at least one postbaseline tumor assessment (scans). Two third-line patients in the 180mg dose cohort did not have recorded scans at the data cutoff. Safety remained consistent with previous reports.

The Company recently announced early completion of enrollment in the THIO-101 trial. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

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.

NEWS

May 17, 2024 8:37am EDT

MAIA Biotechnology to Present at the BIO International Convention 2024

May 16, 2024 8:37am EDT

MAIA Biotechnology Abstract Accepted for Poster Presentation at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting

Apr 30, 2024 8:08am EDT

MAIA Biotechnology Announces Share Purchase by Director Adelina Louie in Private Placement

Apr 29, 2024 8:08am EDT

MAIA Biotechnology Announces Share Purchase by Director Stan Smith, Ph.D. in Private Placement

Apr 23, 2024 8:51am EDT

MAIA Biotechnology Announces $1.00 Million Private Placement

Apr 05, 2024 8:01am EDT

MAIA Biotechnology to Present at Two Investor Conferences in April 2024

Mar 28, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchases by Directors Cristian Luput and Ramiro Guerrero

Mar 26, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchase by Director Adelina Louie in Private Placement

Mar 26, 2024 8:01am EDT

MAIA Biotechnology Announces $1.33 Million Private Placement

Mar 22, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchase by Director Stan Smith, PhD in a $2.9 Million Private Placement

Mar 21, 2024 3:00pm EDT

MAIA Biotechnology Welcomes Prominent Medical Oncology Scientist Dr. Saadettin Kilickap to its Scientific Advisory Board

Mar 07, 2024 9:45am EST

MAIA Biotechnology to Participate in the 36th Annual ROTH Conference

Mar 06, 2024 11:04am EST

MAIA Biotechnology and Nationwide Children’s Hospital Announce Presentation of THIO’s Potency in Pediatric Brain Tumors at American Association of Cancer Research Annual Meeting

Mar 06, 2024 8:48am EST

MAIA Biotechnology Announces Strong Efficacy of THIO as Third-Line Treatment for Non-Small Cell Lung Cancer Patients

Mar 05, 2024 8:45am EST

MAIA Biotechnology CEO Details Immuno-Oncology Cancer Treatment Candidates and Development Pipeline in Letter to Shareholders

Feb 27, 2024 10:30am EST

MAIA Biotechnology Appoints Leading Immuno-Oncology Scientist Dr. Remus Vezan as Scientific Advisor

Feb 22, 2024 10:30am EST

MAIA Biotechnology Completes Enrollment in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer

Feb 07, 2024 8:01am EST

MAIA Biotechnology Announces Publication in Nature Communications on Positive Effects of THIO for Potential Treatment of Small Cell Lung Cancer

Jan 24, 2024 7:15am EST

MAIA Biotechnology Announces Publication of International PCT Patent Application Covering Anticancer Telomere-Targeting Compounds

Jan 17, 2024 9:00am EST

MAIA Biotechnology Provides Positive Phase 2 Clinical Updates for Lead Anticancer Agent and Outlines Targeted Milestones for 2024

Jan 05, 2024 8:00am EST

MAIA Biotechnology to Present at Biotech Showcase 2024 on January 9, 2024

Dec 19, 2023 7:00am EST

MAIA Biotechnology Announces Dose Selection in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer

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MANAGEMENT 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.

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

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.

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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May 29, 2024
INDP Profile
As of March 31, 2024, the Company had cash and cash equivalents of $9.7 million

Upcoming poster, titled, “Preliminary results of a phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors,” at the American Society of Clinical Oncology annual meeting on upcoming presentation in Chicago.

Reported preliminary positive results from second cohort of Phase 1 trial and initiated multi-dose cohort in March 2024.

Announced granting of key patent that helped to further expand intellectual property portfolio in January 2024.

Check Out the Investor Presentation HERE

Hello Everyone,

We have another company on our radar for Wednesdays session that has several catalysts that you are going to want to research.

Pull up INDP right away.

This one has under 6 million shares in the float.

Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.

What’s our timeline? Dr. Roger Waltzman, Chief Medical Officer, shares our journey… $INDP #IndaptusTherapeutics #Biotech #CancerResearch #Immunotherapy pic.twitter.com/MPTUWhgIGO
— Indaptus Therapeutics, Inc. (@indaptus) March 21, 2024

Over the past 12 months we haven’t seen any insider selling. We did see one substantial Insider purchase over over 100K shares at 2.34, which are at moderately higher levels than it is currently sitting.

Indaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting

Results Indicate Decoy Platform Broadly Boosts Immune System’s Ability to Fight Tumors Directly and Indirectly

NEW YORK, April 11, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10 ^th. The poster details mechanism of action data that demonstrates the Company’s Decoy platform successfully induces, matures or activates multiple immune cell types involved in anti-tumor responses.

The latest findings significantly enhance the Company’s understanding of its “Decoy” platform technology, which uses killed, non-pathogenic bacteria engineered to activate the immune system to attack tumors. The study highlights the platform’s effectiveness in engaging key innate and adaptive immune cells, including, natural killer cells, natural killer T cells, dendritic cells, CD4 ⁺, and CD8 ⁺T cells. In some settings, the platform also produced additive or synergistic activity in combination with IL-2, an approved cancer drug. Additionally, the data reveal that the Decoy platform may not only boost the immune system’s ability to recognize and kill tumor cells, but potentially also overcome a mechanism that suppresses the immune response. The results suggest that the Company’s Decoy bacteria can both directly and indirectly prime the immune system to more effectively fight cancer.

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors. This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20’s potential as a multifaceted immunotherapy.”

The Company recently initiated the multi-dose cohort of its Phase 1 clinical trial in solid tumors.

Jeffrey Meckler, Indaptus’ Chief Executive Officer, added, “We are encouraged by the promising results observed in our preclinical studies and our ongoing Phase 1 clinical trial. The recognition and validation from prestigious organizations such as the AACR, coupled with the support and insights we are receiving from medical experts, partners and investors at the conference, inspire us to continue advancing our technology and demonstrating its significant therapeutic potential for the treatment of solid tumors.”

The full poster can be accessed on the Indaptus Therapeutics website by clicking here .

https://x.com/indaptus/status/1767924964231921834?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1767924964231921834%7Ctwgr%5E4c14ecd2075f6769cc275fba1838280486225e16%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.insiderfinancial.com%2Fprofile%2Findp-profile33

SCIENCE & PIPELINE

Novel Insights. Novel Therapies.

Historically, we know that tumor regression has been observed in the presence of bacterial infection. We also know that bacteria contain immune system danger signals, called pathogen-associated molecular patterns (PAMPs), that collectively can activate all of the cellular components of our innate and adaptive immune pathways. PAMPs are recognized by receptors, such as Toll-like (TLR), NOD, STING and RIG-I, that are found on and involved in activation of many different innate and adaptive immune cells.

Our platform is based on the hypothesis that highly efficient anti-tumor immunotherapy will require safe activation of both innate and adaptive cellular immunity in both tumors and immune organs, and that this might be achieved with a multi-targeted package of bacterial PAMPs, in the form of attenuated and killed, intact but non-pathogenic bacteria delivered intravenously. While current therapies are increasingly becoming more and more personalized and costly, we are advancing an approach designed to be widely accessible, with broad anti-tumor and anti-viral activity not dependent on the targeting of specific tumor or viral antigens.

Current Approaches

Current immunotherapies only cure a very small percentage of advanced cancer patients because they activate only one or a few innate or adaptive immune cell types.

The Indaptus Approach

Goal: to safely and effectively activate both innate and adaptive cellular anti-tumor pathways by passively targeting both the tumor and immune organs.

A Unique Approach

Previous research has shown that lipopolysaccharide (LPS), an endotoxin that binds to Toll-like receptor 4 (TLR4), is a key bacterial PAMP that activates the immune system. Activated TLR4 has been shown to play a role in dendritic cell activation and T-cell-mediated anti-tumor immune responses. Our novel insights have enabled us to create attenuated and killed, non-pathogenic gram-negative bacteria with unique levels of LPS – levels that have now been shown in pre-clinical studies to be sufficient to synergize with other PAMPs in the bacteria to safely prime and/or activate innate and adaptive immune pathways. We currently have a broad patent portfolio with 34 issued or granted patents that are based on the technology originally developed by our Founder and Chief Scientific Officer, Dr. Michael Newman, at Indaptus’ predecessor company, Decoy Biosystems.

Based on our successes to date, we are now building a pipeline of therapeutic candidates designed to be delivered intravenously, targeting cancers and infectious diseases with high unmet medical needs.

Results to Date

We are currently advancing our lead candidate, Decoy20, through Phase 1 clinical trial. To date, Decoy20 and/or related candidates have demonstrated broad anti-tumor and anti-viral activity in pre-clinical models, including high percentage complete and durable anti-tumor responses in combination with different classes of existing therapeutics.
- In oncology, Decoy candidates have demonstrated the ability to eradicate established tumors in a murine model of hepatocellular carcinoma in combination with either a non-steroidal anti-inflammatory drug (NSAID) or an anti-PD-1 agent, and more efficiently with both. Tumor eradication has occurred with a wide therapeutic index and has led to induction of 100% immunological memory. In combination with low-dose chemotherapy, Decoy candidates have also produced highly efficient eradication of established tumors in a mouse model of non-Hodgkin’s Lymphoma (NHL), also with induction of immunological memory. Combination-mediated tumor eradication has also been observed with a human tumor xenograft NHL model with inclusion of a targeted antibody. Decoy candidates have also produced significant single agent activity in murine models of both metastatic pancreatic carcinoma and orthotopic, colorectal carcinoma.
- In infectious disease, single agent Decoy therapeutics have produced significantly broader activity than standard of care treatment in a pre-clinical model of chronic Hepatitis B infection, as well as single agent activity against chronic HIV infection in a pre-clinical humanized mouse model.
Generation and/or activation of the cells required for innate and adaptive anti-tumor and anti-viral immune responses takes place, to a significant extent, outside of the tumor or sites of infection, including in the spleen. Our intravenous therapeutic candidates are expected to passively target the liver, spleen, and leaky vasculature of tumors, producing immune activation in an immune organ, as well as a common site for primary and metastatic cancer and HBV infection, the liver. As our therapeutic candidates are expected to be cleared very quickly by the liver and spleen, we anticipate a low risk of non-specific autoimmune side effects relative to other types of immunotherapies designed for continuous exposure.

We have initiated our Phase 1 clinical trial of Decoy20 in December 2022 and dosed our first patient in March 2023.

Indaptus Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Company to present poster at American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024 highlighting initial results from its Phase 1 clinical trial of Decoy20

NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We continue to make steady progress in our clinical development plans and are receiving regular validation for results reported to date, both through a presentation in April at the American Association for Cancer Research (AACR) annual meeting, and the acceptance of further data to be presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting, which is considered among the top annual oncology conferences. We are encouraged by the results we have reported, along with the early results we are seeing as we advance our trial, and believe they are indicative of the potential for Decoy20, and indeed our platform as a whole. We look forward to reporting more about our progress as it develops.”

Key recent highlights:
- Presenting poster, titled, “Preliminary results of a phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors,” at the American Society of Clinical Oncology annual meeting on upcoming presentation in Chicago.
- Presented poster outlining mechanism of action of Decoy platform at the American Association for Cancer Research Annual Meeting in April 2024.
- Reported preliminary positive results from second cohort of Phase 1 trial and initiated multi-dose cohort in March 2024.
- Announced granting of key patent that helped to further expand intellectual property portfolio in January 2024.
Financial Highlights for First Quarter ended March 31, 2024

Research and development expenses for the three-month period ended March 31, 2024, were $1.6 million, a decrease of $0.3 million, or 15%, compared with $1.9 million in the three-month period ended March 31, 2023. The decrease was primarily due to the manufacturing processes of Decoy20 that were conducted in the three months period ended March 31, 2023.

General and administrative expenses for the three-month period ended March 31, 2024, were $2.4 million, a decrease of $0.2 million, or 9%, compared with $2.6 million in the three-month period ended March 31, 2023. The decrease was primarily due to decreased legal fees, recruitment costs and directors’ and officers’ insurance expenses, and was offset by an increase in payroll and related expenses and investor relations expenses.

Loss per share for the three-month period ended March 31, 2024 was $0.45, compared with $0.51 for the three-month period ended March 31, 2023.

As of March 31, 2024, the Company had cash and cash equivalents of $9.7 million. As of December 31, 2023, the Company had cash and cash equivalents of $13.4 million. The Company expects that its current cash and cash equivalents will support its ongoing operating activities through the third quarter of 2024. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate strategy.

Net cash used in operating activities was $3.9 million for the three-month period ended March 31, 2024, compared with net cash used in operating activities of $4.9 million for the three-month period ended March 31, 2023. The $1.0 million decrease in net cash used was primarily attributable to a decrease in our research and development and general and administrative expenses and was also attributable to a settlement fee that was paid in February 2023.

There was no net cash provided by or used in investing activities in the three months ended March 31, 2024. Net cash provided by investing activities was approximately $2.1 million for the three months ended March 31, 2023, which was related to the maturity of $9.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.

Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $0.3 million, which was provided by issuance and sale of our common stock under the At The Market Offering Agreement. There was no net cash provided by or used in financing activities in the three months ended March 31, 2023.

European Patent Office Approves Key Patent for Indaptus Therapeutics’ Platform Technology

PUBLISHED

JAN 4, 2024 8:00AM EST

Patent will provide additional protection covering a composition targeting any viral infection, including hepatitis B, HIV, and influenza

NEW YORK, Jan. 04, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc.(Nasdaq: INDP), a clinical stage biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate stabilized packages of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces that the European Patent Office (EPO) has informed the company that it will grant a European patent related to the company’s platform technology, covering a composition that can be used in the prevention or treatment of viral infections.

The patent, titled “Methods of Treatment of Infections Using Bacteria,” (Application 19 866 580.4) provides protections for the application of the Company’s Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application.

Jeffrey Meckler, Indaptus Therapeutics CEO, commented, “The continued protection of our intellectual property both in the U.S. and abroad will provide a competitive advantage for the Company, which should ultimately drive significant shareholder value over time. We continue to explore the applications of our technology platform beyond solid tumors, for which we are currently engaged in a Phase 1 clinical trial, and look forward to updating our shareholders on scientific progress.”

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Indaptus Therapeutics’ Decoy20 Demonstrated a Broad Immune Response of More than Fifty Cytokines and Chemokines in Patients Following a Single Dose in First Cohort of Ongoing Phase 1 Study

PUBLISHED

NOV 6, 2023 8:00AM EST

Poster presented at 38th Annual Meeting of the Society for Immunotherapy of Cancer Showed Favorable Safety Profile and Achievement of Stable Disease in All Four Patients in First Cohort.

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc.(Nasdaq: INDP), a clinical biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate a stabilized package of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. A broad expression of cytokines and chemokines associated with innate and adaptive anti-tumor immune responses was observed, while adverse events were generally tolerable and resolved within 30 minutes to three days. Decoy20 is designed to “re-set” the immune system’s response to cancer. The poster was presented on November 4, 2023, at the Society for Immunotherapy of Cancer in San Diego.

“We are impressed that we saw short-term induction of more than 50 cytokines, chemokines and biomarkers and believe this is unprecedented with a single agent. These early data support our long-standing hypothesis that the Decoy platform may induce robust immune responses across multiple types of immune cells that we believe are important for the eradication of solid tumors,” commented Indaptus CEO Jeffrey Meckler.

“The relatively brief duration of exposure to Decoy20 supports our hypothesis of utilizing a “pulse-prime” approach, providing a short period of activation to avoid unwanted toxicities that may occur from prolonged immune activation,” commented Michael Newman, Ph.D., Indaptus Founder and Chief Scientific Officer.

As reported in the poster, trial subjects experienced transient induction of over 50 different biomarkers associated with immune responses, and generally anticipated transient adverse events.After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure. In contrast, therapeutics that are designed to be continuously present over weeks, months, or even years, such as CAR-T, can induce this type of toxicity. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most returned to baseline by 24-48 hours. Lymphocyte cell populations were transiently reduced in the blood and then rebounded, suggesting that these critical immune cells were redistributing from the circulation to lymph nodes, immune organs or sites of tumor. This supports the hypothesis of an “immune resetting” proposed mechanism of action.

In addition, each of the subjects was observed to have stable disease four weeks after a single dose, with three of them having started the trial with progressive disease.

“We look forward to continuing the trial with the current cohort having a lower dose, given the broad potential immune activation we have observed,” added Roger Waltzman, M.D., Indaptus’ Chief Medical Officer. “We anticipate that in the next stage of the trial we will assess the effect of weekly dosing (as opposed to the single dose in these first two cohorts), while analyzing a host of biomarkers, immune and tumor cells in peripheral blood, and immune cell populations in the tumor microenvironment, coupled with standard radiographic measurements.”

The poster was titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.” First cohort patients received a single dose of 7×107 killed Decoy20 bacteria via a one-hour IV infusion.

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NEWS
- Indaptus Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update
- GlobeNewswireIndaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting
- GlobeNewswireIndaptus Therapeutics to Present at the MedInvest Biotech and Pharma Investor Conference
- GlobeNewswireIndaptus Therapeutics Previews Positive Mechanism of Action Data to be Presented at the American Association for Cancer Research Annual Meeting
- GlobeNewswireIndaptus Therapeutics to Participate in Tribe Public Webinar On Wednesday, March 20, 2024
- Indaptus Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update
- GlobeNewswireIndaptus Therapeutics Announces Positive Results from Second Cohort of Phase 1 Trial; Company Initiates Multi-Dose Cohort
- GlobeNewswireIndaptus Therapeutics to Present at the 2024 BIO CEO & Investor Conference
- GlobeNewswireIndaptus Therapeutics Expands Digital Presence with Launch of Social Media Channels
- GlobeNewswireEuropean Patent Office Approves Key Patent for Indaptus Therapeutics’ Platform Technology
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MANAGEMENT TEAM

JEFFREY A. MECKLER

Chief Executive Officer

Jeffrey Meckler currently serves as our Chief Executive Officer, bringing more than 30 years of financial and healthcare leadership experience to the company. Most recently, Jeff was the CEO of Intec Pharma, and prior to that, CEO of Cocrystal Pharma, transforming it from a research company into a clinical and development company. Earlier in his career, Jeff was managing director of the Andra Group, a life sciences consulting firm, and acted as a director and interim CEO of Cypress Bioscience after its acquisition by Royalty Pharma. Jeff started his career at Pfizer, where he held a series of positions in manufacturing systems, market research, business development, strategic planning and corporate finance, which included playing a significant role in acquisitions and divestitures. He has also served as a director of QLT, Inc., Cocrystal Pharma, ClearFarma USA, Kyalin Bioscience, and Alveolus, and currently serves as director of Travere Therapeutics, where he also previously served as Chairman. Jeff is the past President and continues to serve on the Board of Children of Bellevue, a non-profit organization focused on advocating and developing pediatric programs at Bellevue Hospital Center. He holds a B.S. in industrial management, an M.S. in industrial administration from the Tepper School of Business at Carnegie Mellon University, and a J.D. from Fordham University’s School of Law.

MICHAEL J. NEWMAN, PH.D.

Founder and Chief Scientific Officer

A founder of the company, Dr. Michael Newman currently serves as our Chief Scientific Officer. Most recently, he was Founder and CEO of Decoy Biosystems, where he developed the technology that serves as the foundation of Indaptus. With more than 35 years of experience carrying out and managing oncology drug discovery through early development in academia and at pharmaceutical and biotechnology companies, Michael has also served as a consultant to ~35 companies, assisting with target identification and prioritization, management of R&D, fundraising, and in/out-licensing. His previous positions include faculty appointments in biochemistry at Brandeis University and the Roche Institute of Molecular Biology, Senior Associate Director of Oncology at Sandoz Pharmaceuticals (world-wide head of Cancer Biology), Executive Director of Oncology at Novartis Pharmaceuticals (Head of Cancer Biology in the U.S.), and senior management positions at several Biotechnology companies, where he also managed drug discovery programs in inflammation, diabetes, and infectious disease. Michael received a Bachelor’s degree in biology from the University of California at San Diego, a Ph.D. in cell and developmental biology from Harvard Medical School (National Science Foundation Pre-doctoral Fellow) and carried out post-doctoral research at Cornell University.

WALT A. LINSCOTT

Chief Operating Officer

Walt Linscott brings more than three decades of global leadership, entrepreneurial and professional experience with broad business development, operational, regulatory, and transactional experience in the Life Sciences sector to his current role as Chief Operating Officer at Indaptus. Most recently, he held the position of Chief Business Officer at the company. Prior to Indaptus he was the Chief Business Officer at Intec Pharma. He is also a Founding executive member of Oxford Strategic Alliance, a multinational business development and referral enterprise for strategic advice, management and investment development/management for individuals and companies that are globalizing. Previously, Walt served as President, COO and General Counsel at Treiber Therapeutics, an anti-viral-focused venture he co-founded. He has also served in a variety of General Counsel and Corporate Secretary roles at Cocrystal Pharma, Carestream Health, and Solvay Pharmaceuticals, where he also led compliance, IP, security, privacy, public affairs and government affairs functions. In addition, he was previously an Associate and Partner at Thompson Hine where he founded the firm’s Atlanta office, served as Partner in Charge, and as Chair of the firm’s Life Science Practice Group. Walt holds a Master of Science in Experimental and Translational Therapeutics with honors from the University of Oxford, a Master’s degree in Global Business from the University of Oxford and Master’s degree in Entrepreneurship from Cambridge University. He earned his J.D. from the University of Dayton School of Law where he served as Managing Editor of the Law Review. After graduating with a Bachelor’s degree from Syracuse University and prior to entering law school, he earned a commission and served on active duty as an Officer in the United States Marine Corps. Walt is also a Certified Flight Instructor and was previously a professional stunt pilot.

ROGER J. WALTZMAN

Chief Medical Officer

Roger Waltzman, M.D., M.B.A. currently serves as our Chief Medical Officer. Dr. Waltzman is a board-certified medical oncologist whose career highlights include the roll of Chief Medical Officer of publicly traded company, Molecular Templates (2019-2023) and multiple senior drug development roles at Novartis Oncology (2007–2013), where he played a leading role in the development of imatinib, nilotinib, and ruxolitinib. From 2013 to 2016, Dr. Waltzman was the Full Development Head of Malaria Drug Development at Novartis. More recently, Dr. Waltzman was CMO at Rgenix (now Inspirna), where he supervised the development of immuno-oncology and metabolic inhibitor assets through Phase 1 a/b. Previously, he served as CSO at Jaguar Health and Napo Pharmaceuticals, where he led scientific aspects of development and commercialization of Mytesi® (crofelemer).

Before joining the industry, Dr. Waltzman held assistant professorships in medical oncology and palliative care at Saint Vincent’s Hospital and Mount Sinai School of Medicine in New York. He completed his fellowship in hematology/oncology at Memorial Sloan Kettering Cancer Center. Dr. Waltzman earned a Master of Business Administration at Columbia Business School and a Doctor of Medicine and Bachelor of Arts from Brown University.

NIR SASSI

Chief Financial Officer

Nir Sassi currently serves as our Chief Financial Officer, bringing a broad skillset across management, corporate finance, due diligence, accounting, and financial analysis. Prior to joining Indaptus, Nir spent 11 years at Intec Pharma, starting as Vice President of Finance and ending his tenure there as Chief Financial Officer. Previous to that, Nir served as a Senior Manager at PricewaterhouseCoopers Israel for eight years, including two years relocation to the PWC New York office. He is a certified public accountant in Israel and holds a Bachelor’s degree in economics and accounting from Ben Gurion University in Beer Sheva, Israel.

SINCERELY,

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May 21, 2024
GRYP Profile
Total mining revenue for 2023 of $21.1 million while Total mining revenue in Q1 2024 of $7.5 million, compared to $4.8 million in Q1 2023

Gryphon has authorized a stock repurchase program, allowing for the buyback of up to $5 million of its common stock

In 2023, the company produced 788 bitcoin-equivalent coins. At the present valuation, that’s $48.5 million USD in crypto

Certified 100% renewable energy operation heading into 2024

READ THE INVESTOR PRESENTATION HERE

In a recent interview with @TheStreet, Gryphon Digital Mining CEO Rob Chang highlighted the growing institutional demand for #Bitcoin, attributing it to the coin’s intrinsic value and scarcity. Tune into the full interview here: https://t.co/GYjGo3B6sC $GRYP #BitcoinMining
— Gryphon Digital Mining (@GryphonMining) March 15, 2024

Hello Everyone,

We have had some explosive profiles over the past few weeks.

You should remember this next one.

We profiled it before a few months back where it saw an average of trade of 1.50 on the session.

Exactly 2 weeks later it hit 1.89 for a 26% move. I hope that you were watching it.

Put GRYP back on your radar Immediately.

Gryphon Digital Mining is a public Bitcoin miner that recently has been listed on the NASDAQ exchange and has established itself as a leader in sustainability and efficiency. Led by Rob Chang, the management team leverages its many years in the public Bitcoin miner space and utilizes an asset-light Business model to compete in this highly competitive industry.

Gryphon Digital Mining has grown significantly in the past three years by adding sustainable hashing power to its operations through strategic partnerships and ASIC fleet upgrades. The company has recently been listed on the NASDAQ exchange through a reverse merger with the public company Akerna.

Gryphon Digital attempted to execute a reverse merger in 2021 with Sphere 3D, a public net carbon-neutral cryptocurrency miner, but they both mutually agreed to not proceed with the merger. Gryphon Digital decided to enter a master services agreement to manage all of Sphere 3D’s blockchain operations for a five year period at a 22.5% gross profit royalty. Although the agreement is through August 2026, Sphere 3D has moved to terminate this arrangement. Gryphon believes that the agreement will continue on despite the litigation and forecasts over $6 million in 2024E revenue from the partnership.

Bitcoin mining involves specialized computers (ASICs) verifying transactions and solving complex mathematical problems to add blocks to the blockchain. Miners compete through computing power to solve these problems, with the first successful miner adding the block and receiving new bitcoins and transaction fees as a reward. The process ensures network security and decentralization, with difficulty adjusting based on how many miners are in the network to maintain a consistent block time. Bitcoin miners are all preparing for the upcoming Bitcoin supply halving which occurs every ~4 years and cuts the rewards given to miners in each block by half. This halving is expected to occur in April 2024, and miners that are operating with inefficient and obsolete fleets will not be able to survive. Historically, inefficient miners have been forced to stop operating because the cost to mine a Bitcoin doubles immediately once the halving occurs since the rewards are halved; so, miners must have a strategic plan to mitigate this. The Bitcoin mining space has already seen some consolidation in the market and many public players like Cleanspark and Marathon are shopping around for smaller companies to acquire for additional cost synergies and computing power. Gryphon Digital Mining is well-positioned to outperform less efficient public miners going into the Bitcoin halving this year and can now utilize the public capital markets for its M&A strategy and rely on its seasoned leadership team that has managed through multiple Bitcoin cycles in the past to execute sustainable growth. Additionally, the asset-light model that Gryphon Digital utilizes will enhance its flexibility and enable the company to respond to new developments in the digital asset ecosystem unlike other larger miners in the space.

Bitcoin’s code enforces a cap of 21 million coins, with 93.5% already in circulation and the remaining 1 million to be gradually distributed over the upcoming century. The mining reward halves every four years, resulting in a diminishing rate of new Bitcoin creation, making it a deflationary asset. Like in previous cycles, the price of Bitcoin has begun to see material gains in the winter period approaching the next halving; miners demand higher prices for the asset since the rewards get halved. After Bitcoin reaches the previous cycle’s all-time-high, price discovery will be unleashed again and the lucrative summer period will start.

April operational updates including record average self-mining hashing power of 914 PH/s. $GRYP CEO @omnipotent32 joins @McnallieM and @cazenove_uk to discuss insight into corporate achievements and developments. Watch the interview here: https://t.co/2hanQXR5Mx $GRYP $BTC
— Gryphon Digital Mining (@GryphonMining) May 7, 2024

Gryphon Digital Mining, Inc. Reports Fiscal Year 2023 Financial Results

LAS VEGAS, NV / ACCESSWIRE / April 1, 2024 / Gryphon Digital Mining, Inc.(Nasdaq:GRYP) (“Gryphon” or the “Company”), a bitcoin mining company that is independently certified to be 100% renewable and pursuing a negative carbon strategy, today reported financial results for its fiscal year ended December 31, 2023.

Rob Chang, CEO of Gryphon, commented, “2023 and the year to date has been a transformational period for Gryphon, culminating in our Nasdaq listing in February. Our positive net cash flow in 2023 and Breakeven Cost (as defined below) per Bitcoin of approximately $18,200 demonstrate our industry leading operational efficiency. Our current self-mining hashrate stands at 0.9 exahash, and we have ambitious plans to expand. Our aim is to quickly reach 10 exahash, propelling us from a smaller player to a significant industry presence – all the while leading the way in financial sustainability and efficiency.”

Mr. Chang added, “Gryphon’s management team, featuring former c-suite executives from industry giants Marathon and Riot, brings industry leading experience and a proven track record of success. With such pedigreed experience, we think we are well-equipped to achieve our goals and establish ourselves as a premier player in the market. In sum, with our strong foundation, operational efficiency, and strategic expansion plans, Gryphon believes it is well-positioned to navigate the challenges of the post-halving landscape, achieve a position as an industry leader, and deliver long-term value to our shareholders.”

Financial Highlights of Fiscal Year 2023
- Total mining revenue for 2023 of $21.1 million, compared to the prior year $21.4 millionin 2022.
- Breakeven Cost[1] per Bitcoin in 2023 was $18,217, compared to $14,964 in 2022. The company is focused on Breakeven Costs, which we believe is the best measure of what it costs to mine bitcoin on an operating basis. Some of our peers only focus on electricity costs and leave out the other costs to mine. We believe that a focus on the Breakeven Costs to produce a bitcoin at the mine level has the potential to offer the transparency needed to compare operations on an apples-to-apples basis.
- The Company recognized a net loss for the year of ($28.6) million, which includes non-cash expenses of $36.5 million. Non-cash expenses mainly consisted of depreciation, non-cash machine impairment and the non-cash notional valuation of the company’s BTC loan. This compares to net income in 2022 of $3.5 million, which was also subject to non-cash expenses, and benefited from $24.5 million in non-cash gains due to a non-cash gain on the extinguishment of debt and the non-cash notional valuation of the company’s BTC loan.
- Adjusted EBITDA[2] was $4.8 million, compared to $7.4 million in the prior year.
[1] The Company defines Breakeven Cost per Bitcoin as (a) Cost of Revenues (excluding depreciation) divided by (b) total bitcoin generated and received from the hashrate contributed to the mining pool operator. The Company mined approximately 739 and 815 Bitcoin, respectively for the year ended December 31, 2023 and 2022, respectively.[2] The Company defines Adjusted EBITDA as (a) GAAP net income (loss) plus (b) adjustments to add back the impacts of (1) depreciation and amortization, (2) interest expense, (3) income tax expense (benefit) and (4) adjustments for non-cash and non-recurring items which currently include (i) stock compensation expense, (ii) impairments of miners pursuant to ASC 360, (iii) impairments of digital currency pursuant to ASC 350 (iv) realized gain from use of digital assets as it relates to the bitcoin denominated note payable and (v) gain/loss on debt extinguishment.

Balance Sheet Highlights as of December 31, 2023

Assets
- Cash and cash equivalents: $915,000
- Bitcoin: 67.2
- Total current assets: $5.4 million
- Total mining assets (including deposits & intangible assets): $13.4 million
- Total assets: $18.8 million
Liabilities and Stockholders’ Equity
- Current liabilities: $19.4 million
- Total liabilities: $19.4 million
As of February 29, 2024, the Company had cash holdings of $1.4 million, Bitcoin holdings of approximately 60.4 Bitcoin with a fair market value of $3.7 million and 330.3 Bitcoin of Bitcoin denominated debt.

2024 Outlook

Based on an average price of Bitcoin of $70,000 and an average network hashrate of 550 exahash for 2024, we are currently projecting gross profit of approximately $16.6 millionfrom mining operations. We have posted a gross profit sensitivity analysis in our investor presentation, which can be found on slide 14 of our investor deck on our company website.

Sphere 3D Litigation

On March 25, 2024, Gryphon filed a motion with the United States District Court for the Southern District of New York seeking permission to file a motion for prejudgment attachment, seeking to secure $10 million in equity proceeds that Sphere recently received from a settlement related to Core Scientific’s bankruptcy exit. We want to ensure that the funds are available to satisfy any judgment we may receive due to Sphere’s breach of contract, where it entered into at least four hosting agreements with other providers, violating the exclusivity clause of its agreement with Gryphon. We are seeking damages amounting to at least $30 million. Over the last four months, Sphere has revealed its growing financial troubles. On November 28, 2023, in a filing in the Core Bankruptcy Action, Sphere’s counsel acknowledged that the company was operating with a $200 million net loss and that recent losses had overtaken revenue by a two-to-one margin. Sphere’s stated rationale for terminating the contract – that a malicious actor had diverted bitcoin transfers from Sphere to a third party – was not only unfounded, but was, in fact, evidence of gross negligence on the part of Sphere that allowed activities from malicious actors where Gryphon became the victim. Gryphon engaged an independent third-party security firm who confirmed that Gryphon’s systems were not compromised.

Gryphon Digital Mining Announces April Operational Update

Machine Upgrades Lead to New Company All-Time Bests in Hashing Power and Efficiency

LAS VEGAS, NV / ACCESSWIRE / May 6, 2024 / Gryphon Digital Mining, Inc. (NASDAQ:GRYP) (“Gryphon” or the “Company”), a bitcoin mining company that is independently certified to be 100% renewable and pursuing a negative carbon strategy, has released its unaudited operational update for April 2024.

Key highlights for the month:
- Produced approximately 40 bitcoin
  - Approximately $2.6 million in value based on an average April bitcoin price of $66,183
  - Production of 1.33 BTC/day on average, or about $88,244/day
- Achieved bitcoin efficiency of 43 BTC/EH
- New Company record average self-mining hashing power of 914 PH/s in April
- Machine upgrade program completed with the installation of Bitmain S21 200 TH/s machines
- 21 bitcoin in treasury as of April 30, 2024
- Average machine efficiency improved to 28.7 J/T in April
- Scope 1 and Scope 21 operations continue to be 100% electrified by zero-carbon emitting Hydro power
“April signified the beginning of our post go-public improvement program as we ordered and installed a batch of state-of-the-art Bitmain S21 200 TH/s machines to upgrade our mining fleet. The result of this effort was a new Company all-time high in average hashing power at 914 PH/s as well as a new Company all-time best in average mining efficiency at 28.7 J/T as our new machines are currently tracking to be 43% more efficient than the machines they replaced,” noted Rob Chang, CEO of Gryphon. “For the month, we earned bitcoin valued at approximately $2.6 million based on an average bitcoin price of $66,183, which includes record setting days when bitcoin mining transaction fees were particularly valuable.”

April’s bitcoin efficiency performance of 43 BTC/EH continues to showcase Gryphon’s commitment to running its operations at peak performance. In monthly rankings over the last twelve-months, Gryphon ranked #1 in bitcoin efficiency on six occasions. Since Gryphon commenced operations in September 2021, it has consistently placed among the top of these publicly available bitcoin efficiency scores – ranking at or tied for first in 17 of the 31 months, or about 55% of the time.

The Company held 21 bitcoin in its treasury as of the end of April as coins were sold to finance the mining fleet upgrade in a non-dilutive manner.

Conference Schedule:
- Consensus 2024 by CoinDesk held in Austin, TX on May 29 th – 31 st
- Mining Disrupt in Miami, FL on June 24 th – 26 th
- Bitcoin 2024 held in Nashville, TN on July 25 th – 27 th
- Blockchain Futurist Conference in Toronto, ON on August 13 th – 14 th
Gryphon Digital Mining Announces Stock Repurchase Program; Machine Upgrade Program Completed Ahead of Schedule

LAS VEGAS, NV / ACCESSWIRE / April 22, 2024 / Gryphon Digital Mining, Inc. (Nasdaq:GRYP) (“Gryphon” or the “Company”), a leading bitcoin mining company that is independently certified to be 100% renewable and pursuing a negative carbon strategy, is pleased to announce a new share buyback program, authorized by its Board of Directors (the “Board”), and the completion of its machine upgrade program ahead of schedule.

Stock Repurchase Program

This strategic move allows for the repurchase of up to $5 million of Gryphon’s common stock, underscoring its ongoing commitment to enhancing shareholder value.

“This share buyback program authorization demonstrates the Board and management team’s confidence in Gryphon’s strategy and commitment to shareholder value creation while maintaining a balanced approach to capital allocation moving forward. From our track record of ranking at the top of peer bitcoin efficiency charts throughout our operational existence and being among the lowest cost producers of bitcoin at ~$18,200per bitcoin in 2023, our dedication towards shareholder friendly decisions is relentless.” said Rob Chang, CEO, President, and Director. “The authorization of a share buyback program is a key initiative that we expect to create long-term value for shareholders. In an industry where share sales are common, Gryphon is showing that share capital management goes both ways.”

The buyback program does not obligate the Company to purchase any particular number of shares and there is no guarantee as to the exact number of shares that will be repurchased by the Company. The program may be suspended, modified or terminated by the Company at any time and for any reason, without prior notice.

Miner Upgrades Completed Ahead of Schedule

Mr. Chang added, “We have completed our miner upgrade program ahead of schedule, which is set to significantly boost our operational efficiency. Our previously announced batch of Bitmain S21 200 TH/s miners that were ordered to replace a portion of our older fleet of machines are now deployed. This improvement is expected to add approximately 23 PH/s to our hashing power and improve our average fleet efficiency to 28.5 J/T. Gryphon’s self-mining hashrate now stands at approximately 0.94 EH/s.”

NEWS

Gryphon Digital Mining, Inc. Reports First Quarter 2024 Financial Results1 day agoGryphon Digital Mining to Host First Quarter 2024 Earnings Conference Call2 days agoGryphon Digital Mining Announces April Operational UpdateMay 6, 2024Gryphon Digital Mining Announces Stock Repurchase Program; Machine Upgrade Program Completed Ahead of ScheduleApr 22, 2024Gryphon Digital Mining Announces March Operational UpdateApr 4, 2024Gryphon Digital Mining to Participate in Upcoming Investor ConferencesApr 3, 2024Gryphon Digital Mining, Inc. Reports Fiscal Year 2023 Financial ResultsApr 1, 2024Gryphon Digital Mining Reschedules Q4 and FY 2023 Earnings Call to Tuesday, April 2 at 9:00am ETMar 27, 2024Gryphon Digital Mining Publishes Carbon Emissions Assessment Proving its 100% Renewable StatusMar 25, 2024Sphere 3D Corp. Provides February 2024 Production and Operation UpdatesMar 22, 2024Gryphon Digital Mining to Host Fourth Quarter and Year End 2023 Earnings Conference CallMar 21, 2024Gryphon Digital Mining Announces Participation in 36th Annual Roth ConferenceMar 12, 2024Gryphon Digital Mining Announces February Operational UpdateMar 11, 2024Gryphon Digital Mining Announces January Operational UpdateFeb 13, 2024

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MANAGEMENT

ROB CHANG

CEO, President, & Director

Rob is an experienced executive who most recently was the CFO of Riot Blockchain and has consulted for other publicly traded blockchain mining companies. He has over 25 years of experience in the financial services industry including serving as the Managing Director and Head of Metals & Mining at Cantor Fitzgerald where he was recognized by Bloomberg as the Best Precious Metals Analyst in Q1 2016. His career achievements include rescuing a NASDAQ-listed company from bankruptcy despite regulatory and industry headwinds. Mr. Chang is frequently quoted and a regular guest of several media outlets including Bloomberg, Reuters, CNBC, and The Wall Street Journal. Mr. Chang also previously served as Director of Research and Portfolio Manager at an investment firm that managed $3 billion in assets. He currently sits on the boards of Ur-Energy and Fission Uranium. Mr. Chang completed his MBA at the University of Toronto’s Rotman School of Management.

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SIM SALZMAN

CFO

Sim Salzman is a results-oriented Chief Accounting/Financial Officer with over 20 years of experience in public and private accounting serving clients in the cryptocurrency, hospitality, retail, food and beverage, gaming, non-profit, residential and commercial construction, real estate and low-income housing industries.

He has over two years of experience as the Chief Financial Officer and Chief Accounting Officer of one of the largest bitcoin mining Companies that grew its market cap from $500 million to approximately $8 billion within my first twelve months. There I was responsible for implementing a new accounting system, streamlining financial processes, improving efficiency and accuracy of financial reporting, forecasting, and budgeting, building a lean but high-performing financial team, and collaborating closely with senior management to align financial goals with overall business objectives while maximizing shareholder returns. Utilized the capital and debt markets to raise over $2 billion in liquidity for operational purposes.

Sim has experience as the Chief Financial Officer of a growing media and hospitality organization responsible for implementing core competencies and timely analytical reviews. Embraced multiple roles while leading a corporate restructuring that positively impacted the top and bottom line.

Five years’ experience with one of the country’s leading hospitality development and management companies as the Corporate Controller responsible for over $215M in annual revenues across 20 venues located on the Las Vegas Strip.

Sim set up policies and procedures for State and Federal compliance in regards to filing deadlines such as Unclaimed Property, Form 1042, Sales & Use Tax, Commerce and Modified Business Tax. Dealt directly with the external Tax Firm to file various annual 1065’s and liaison to the IRS for research and guidance on any pertinent issues.

Sim’s prior experience includes working for eight years in public accounting with four leading firms with clients in various industries. Passed the Uniform CPA Exam.

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CHRIS ENSEY

Chief Technical Advisor

Chris is a leading expert in crypto data centers and has consulted North America’s largest public mining firms on building successful operations. He is a technology executive with a career spanning blockchain, cybersecurity, and enterprise software. His mix of technical and business acumen has led to successful leadership roles including acting CEO and COO of Riot Blockchain, CTO of BlueVoyant and COO and founder of Dunbar Cybersecurity. Mr. Ensey has 25 years of experience developing mission-critical software with an emphasis on large data, analytic processing, and cloud technologies. He has driven numerous products to market, including solutions for managed security services, cyber risk management, and digital healthcare. He began his career as a system engineer and integrator working on national intelligence and defense programs with SAIC. Chris has a bachelor’s degree in Computer Engineering from Virginia Tech.

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BRITTANY KAISER

Chair of the Board

Brittany Kaiser is an entrepreneur, activist, and globally recognized expert in data protection and privacy. As Co-Founder of the Own Your Data Foundation, she teaches digital literacy education and training to governments, corporates, and families. She is also a Co-Founder of the Digital Asset Trade Association (DATA) for legal advocacy where she does legislative drafting and lobbying on privacy and blockchain laws. Ms. Kaiser sits on the board of many companies across industries, working on data ethics, compliance, and privacy protocols. Ms. Kaiser is also the author of Targeted published globally by Harper Collins, and she is the main subject of Netflix’s original documentary “The Great Hack”, nominated for an Emmy, BAFTA, and shortlisted for an Oscar. As a renowned thought leader and public speaker, Ms. Kaiser is represented by CAA and has spoken at prestigious events at the United Nations, the European and British Parliaments, the G20, and WebSummit, as well as guest lecturing at universities such as Harvard, Oxford, and Columbia.

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STEVE GUTTERMAN

Director

Steve has built, led, acquired and invested in market-changing companies for 25 years. He is currently the CEO of Falcon International, one of the largest private cannabis companies in California.

Previously, he served as President of Harvest, since acquired by Trulieve to form the largest cannabis company in the US as measured by revenue. Prior to Harvest, he held a variety of senior roles including at E*TRADE Financial, where he was EVP and COO of E*TRADE Bank, where he was instrumental in the Bank’s growth from $1 billion in assets to $35 billion. He was the CEO of GeoPoll, a leading market research company in developing world countries, and was Managing Director of MBH Enterprises, a private equity company focused on technology and infrastructure investments. He holds a JD/MBA from Columbia University and a BA from Tufts University.

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HEATHER COX

Director

Heather Cox was most recently the Chief Digital Health and Analytics Officer for Humana. In this role, Heather was accountable for building Humana’s digital care delivery operations and leading enterprise advanced analytics, including the application of Artificial Intelligence at scale in healthcare.

Prior to joining Humana, Heather served as Chief Technology and Digital Officer at USAA, where she led the teams responsible for designing and building personalized and digitally enabled end-to-end experiences for USAA members. Heather has also designed, built, and served as CEO of Citi FinTech at Citigroup, building a fintech start-up that allowed the company to harness the innovation in the global fintech ecosystem and to adapt to a future dominated by mobile technology. Before that she, headed Card Operations for Capital One.

Heather was named by American Banker magazine as the #3 Woman to Watch nationally in banking by American Banker Magazine in October 2017. She was also named to American Banker’s Women to Watch list in 2011, 2013 and 2016. In 2015, she was named one of the 10 Most Innovative CEOs in Banking by Bank Innovation, as well as Digital Banker of the Year by American Banker. In 2018, Heather was appointed to the NRG Energy Board of Directors and was elected to the Atlantic Union Bankshares Board of Directors in August 2022.

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JESSICA BILLINGSLEY

Director

Jessica is a seasoned executive and innovator with decades of experience in frontier technology. She is named on multiple patents including advancements in supply chain technology and anti-counterfeit solutions using blockchain and NFTs. Her experience includes leading successful public and private companies as CEO and serving on multiple boards of directors. Jessica possesses in-depth expertise in private and public capital markets and has successfully navigated complex transactions to drive growth and business transformation. She is also FINRA securities licensed.

Previously, as Founder, Chairman of the Board, and CEO of Akerna (Nasdaq: KERN), a Software as a Service ag-tech company, she successfully publicly listed, completed multiple accretive acquisitions, maintained market leadership for over a decade, and exited via strategic acquisition. Jessica currently serves on the boards of Gryphon Digital Mining (NASDAQ:GRYP), Nu Energy (NASDAQ:NXU), OARO, and the Young President’s Organization (YPO) Entrepreneurship Network Board.

She has been recognized with numerous awards, including Inc. Top 100 Female Founder and Fortune’s Most Promising Woman Entrepreneur. Her insights and thought leadership have been featured in numerous prominent media outlets, in addition to her active contribution to Entrepreneur and Rolling Stone publications.

SINCERELY,

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May 20, 2024
SYTA
2023 Revenue was $8.2 Million, a year of strong growth and expansion for Siyata Mobile. Revenue increased 27% and gross margin increased 92% over 2022

SIYATA MOBILE ANNOUNCES NEW ORDERS TOTALING OVER $2.2 MILLION; SD7 ACHIEVES ‘STOCKED’ STATUS WITH THIRD MAJOR U.S. WIRELESS CARRIER

READ THE COMPANY PRESENTATION HERE

https://twitter.com/SiyataMobile/status/1790400108720161106?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1790400108720161106%7Ctwgr%5Ed40b778a6f613422310530ef3ca723cba4ce6919%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.insiderfinancial.com%2Fprofile%2Fsyta222

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Hello Everyone,

Todays profile closed up near the high of the day after making a strong double digit move.

We have another company that we want you to look at for tomorrow’s session.

This one has been on the move over the past week or so since the company started to release several different news announcements.

Pull up SYTA immediately.

Siyata Mobile Inc. (NASDAQ: SYTA) is a leading global developer and provider of Push-to-Talk Over Cellular (“PTT/PoC”) systems for enterprise customers. The company specializes in connected vehicle products for professional fleets and markets its products under the Uniden® Cellular brand.

Since its inception in 2012, Siyata has amassed a customer base that includes cellular operators, commercial vehicle technology distributors, and fleets of all sizes in Canada, the U.S., Europe, Australia and the Middle East.

Recognized by the Toronto Venture Stock Exchange in 2018 as a Venture Top 50 Company, Siyata aims to deliver the highest quality and most technologically advanced mobile communication devices for global corporate workforces, fleets, homes and buildings.

The company has long been an industry pioneer, delivering the world’s first 3G connected vehicle device as well as the world’s first 4G/LTE vehicle-mounted smartphone for First Responders and commercial fleets and vehicles, thereby creating a new category in the cellular device market with a dedicated smartphone tailor-made for the commercial vehicle market.

Siyata’s suite of technology includes numerous PTT and legacy devices, as well as cellular boosters designed to improve cellular signals in corporate warehouses, government embassies, retirement home campuses, banks and manufacturing plants.

The company’s flagship product, the Uniden UV350, is the world’s first vehicle-mounted 4G/LTE smartphone with crystal clear quality, carrier grade PTT, voice, text, video and data applications built into a single device. Specifically designed for First Responder and commercial fleet vehicles, the UV350 runs on cellular LTE networks that provide nationwide and global coverage, replacing traditional single purpose two-way radios that require a monthly fee and limited network coverage.

The Uniden UV350 is currently available through Bell Mobility, Canada’s largest LTE network and PTT community, as well as AT&T in the U.S. Further expanding its availability, Siyata is completing network approval with another U.S. Tier 1 operator to launch the UV350 in Q3 2019.

Despite Siyata’s small size, no other competitor offers as comprehensive of a portfolio of products. Siyata Mobile Inc. (Nasdaq: SYTA) provides disruptive solutions aimed at the Push-to-talk-over-Cellular (PoC) industry, with three complementary product categories targeted to the same core channels and customers. Large global telecommunications customers provide potential rapid entry into a $50 billion North American market.

You will notice the move that this one has made off of its recent lows, under $2.

Siyata Mobile SD7 Mission Critical Push to Talk Over Cellular Device Featured

UScellular Keeps Business and Government Customers Connected with Intuitive Mission Critical Push to Talk Solution

“Siyata’s SD7 rugged Mission Critical Push to Talk over cellular radio handset is an industry leading device that offers UScellular business customers an alternative to land-mobile radios,” By Kim Kerr, senior vice president, enterprise sales and operations for UScellular.

While State And Local Budgets Experience A Squeeze, Siyata Mobile Provides Police With Affordable And Modern Communication Technology

Siyata’s unique approach of offering an affordable mission-critical PTT over Cellular handset that looks and operates like a two-way radio may allow first responder agencies to equip more of their staff than ever before with a reliable and easy-to-use handset to keep more staff connected. With a track record as a pioneer in the industry and with solutions catering to various uses in areas with and without strong cellular coverage, Siyata has earned a solid reputation for reliability and versatility. With rising budget cuts, this maybe solution that state and local governments are looking for.

As a leading developer and distributor of cutting-edge Mission Critical Push to Talk Over Cellular (PoC) devices, including its flagship products, the SD7 Handset and VK7 Vehicle Kit, Siyata is aiming to revolutionize the way industries worldwide connect and collaborate.

In a rapidly evolving landscape, the SD7 Handset stands out to us as the pinnacle of next-generation communication solutions. Designed to seamlessly integrate with existing systems while offering unparalleled functionality, the SD7 stands to bridge the gap between traditional two-way radios and modern cellular networks. Its reportedly rugged design, military-standard durability, and nationwide coverage is designed to ensure reliability and effectiveness across various verticals, from first responders to construction teams.

Complementing the SD7 is Siyata’s innovative VK7 Vehicle Kit, working to transform any vehicle into a mobile communication hub. With its reportedly seamless integration, robust features, and reliable connectivity, the VK7 is designed to enhance safety and efficiency for commercial fleets, emergency responders, and more.

According to Siyata Mobile, it’s not just disrupting the market; it’s setting new standards for communication excellence. With a track record of exponential growth, a strong presence in key global markets, and a visionary leadership team, we see this as an attractive investment for investors interested in the future of communication technology

Top Reason to have SYTA on your radar
- Market Disruption: Siyata Mobile (NASDAQ: SYTA) is poised to disrupt the multi-billion-dollar Land Mobile Radio (LMR) industry with its cutting-edge Mission Critical Push to Talk Over Cellular (PoC) technology
- Next-Gen Communication: With the SD7 and VK7, Siyata offers next-generation communication solutions that bridge the gap between traditional two-way radios and modern cellular networks.
- Innovative In-Vehicle Solutions: The VK7 Vehicle Kit is designed to transform any vehicle into a mobile communication hub, enhancing safety and efficiency for commercial fleets and emergency responders
- Global Reach: Siyata operates in key geographies including the United States, Canada, Europe, Australia, and the Middle East, offering solutions tailored to diverse market needs.
- Rapid Industry Growth: The Mission Critical Push to Talk Over Cellular (PoC) industry is experiencing rapid growth, with a forecasted global PoC growth of approximately 9.4% CAGR, reaching approximately $6.95 billion by 2027
- Strong Market Position: With a full-year 2023 revenue of $8.2 million, up 27% year-over-year, Siyata demonstrates its ability to capture market share and deliver consistent growth.
- Comprehensive Product Portfolio: From rugged handsets to in-vehicle devices, Siyata offers a comprehensive product portfolio to cater to the communication needs of various industries, including first responders, hospitals, schools, security, construction, and hospitality
- Visionary Leadership: Led by CEO Marc Seelenfreund and a seasoned management team, Siyata is guided by a vision of innovation, excellence, and market leadership in communication technology
- High Growth Earnings: SYTA is expected to become profitable in the coming quarters.
- High Growth Revenue: SYTA’s revenue is forecast to grow dramtically in 2024 and beyond
https://twitter.com/SiyataMobile/status/1777432316081586616?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1777432316081586616%7Ctwgr%5Ed40b778a6f613422310530ef3ca723cba4ce6919%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.insiderfinancial.com%2Fprofile%2Fsyta222

SD7: A Game-Changer in Mission Critical Push to Talk Over Cellular Technology!

SIYATA SD7

Siyata Specializes in Rugged PTT Handsets: SD7 is its Next Generation PoC Handset Complementing its Portfolio of Disruptive Handsets

THE SD7 IS A GAME CHANGER

A Perfect Upgrade from land mobile radio (LMR):
- forwardA simple, purpose built, highly functional and rugged Android-based PTT only handset
- forwardRugged IP68 rated design protects against dust and debris
- forwardExcellent sound quality allowing for clear communication in the presence of background noise
- forwardAll the benefits of PoC without the headaches of managing the current generation of rugged smartphones and feature phones
- forwardRobust Next Gen 5G product portfolio coming
The Evolution of ptt
- double_arrowStay connected wherever you use a mobile phone or Wi-Fi
- double_arrowMilitary Standard 810H and IP68 ratings
- double_arrowCost effective PTT cellular rate plan
- double_arrowMission Critical PTT – QCI’s 65, 66, 69 70
Rock solid Performance
- double_arrowA simple, functional and rugged Android-based PTT-only device
- double_arrowRugged IP68 rated design protects against dust, debris and liquids
- double_arrowSuperior sound quality for clear communication despite background noises
- double_arrowAll the benefits of cellular with none of the headaches of today’s smartphones
https://www.youtube.com/watch?v=AftgMN3akY4

https://www.youtube.com/watch?v=jFiCIKsxp2s

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NEWS

Tue May 14th, 2024
- SIYATA MOBILE ANNOUNCES NEW ORDERS TOTALING OVER $2.2 MILLION; SD7 ACHIEVES ‘STOCKED’ STATUS WITH THIRD MAJOR U.S. WIRELESS CARRIER
Mon May 13th, 2024
- SIYATA MOBILE’S SD7 HANDSET ADDED TO AT&T FIRSTNET’S ‘FREE FEATURE PHONE FOR LIFE’ PROMOTION
Fri May 10th, 2024
- SIYATA MOBILE ANNOUNCES CLOSING OF APPROXIMATELY $4.0 MILLION PUBLIC OFFERING OF COMMON SHARES AND PRE-FUNDED WARRANTS
Thu May 9th, 2024
- SIYATA MOBILE TO SHOWCASE PTT SOLUTIONS AT CRITICAL COMMUNICATIONS WORLD 2024 MAY 14-16 AT DUBAI WORLD TRADE CENTRE
Wed May 8th, 2024
- SIYATA MOBILE ANNOUNCES PRICING OF ITS $4.0 MILLION PUBLIC OFFERING OF COMMON SHARES AND PRE-FUNDED WARRANTS
Mon Apr 8th, 2024
- SIYATA MOBILE ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 FINANCIAL RESULTS
Fri Apr 5th, 2024
- SIYATA MOBILE TO HOST FOURTH QUARTER AND YEAR END 2023 FINANCIAL RESULTS CALL AT 8:30 A.M. ET ON APRIL 9, 2024
Thu Apr 4th, 2024
- SIYATA ADDS NEW CHANNEL PARTNER WITH 3AM INNOVATIONS, A SOFTWARE PROVIDER FOR FIRST RESPONDERS
Thu Mar 21st, 2024
- SIYATA FURTHER EXPANDS GLOBAL DISTRIBUTION IN AGREEMENT WITH LEADING MOBILITY, LOGISTICS AND INFRASTRUCTURE CONGLOMERATE IN THE MIDDLE EAST
Mon Mar 11th, 2024
- SIYATA MOBILE INC. TO SHOWCASE PORTFOLIO AT IWCE 2024
Tue Mar 5th, 2024
- SIYATA MOBILE SD7 PUSH-TO-TALK OVER CELLULAR DEVICE FEATURED
Thu Feb 22nd, 2024
- SIYATA MOBILE RECEIVES 1000 UNIT ORDER FOR UV350 DEVICES
Tue Feb 6th, 2024
- SIYATA EXPANDS ALLIANCE WITH LEADING T-MOBILE DEALER, HYPERION PARTNERS, TO INCLUDE DISTRIBUTION OF SD7 HANDSETS
Thu Feb 1st, 2024
- ALLCAN DISTRIBUTORS LAUNCHES CHATTERPTT CANADA, PARTNERS WITH SIYATA MOBILE
Mon Jan 29th, 2024
- SIYATA AND ESCHAT TO SUPPORT 2024 SPECIAL OLYMPICS WITH PUSH-TO-TALK (PTT) HANDSETS AND SERVICE
Mon Jan 22nd, 2024
- SIYATA EXPANDS DEALER NETWORK WITH ADDITION OF LARGE VERIZON ELITE PARTNER
Wed Dec 20th, 2023
- SIYATA RECEIVES FIRST ORDER FOR SD7 HANDSETS IN HIGHER EDUCATION
Tue Dec 12th, 2023
- A YEAR END MESSAGE FROM MARC SEELENFREUND, SIYATA MOBILE’S CEO
Thu Dec 7th, 2023
- SIYATA MOBILE ANNOUNCES $900,000 FOLLOW-ON ORDERS
Thu Nov 30th, 2023
- SIYATA ANNOUNCES REVERSE STOCK SPLIT
Mon Nov 27th, 2023
- SIYATA RECEIVES PURCHASE ORDER FOR SD7 HANDSETS AND VK7 VEHICLE KITS FOR USE IN NEW VERTICAL MARKET
‍

MANAGEMENT TEAM

Marc Seelenfreund – CEO

Founder and CEO of Siyata . Prior to establishing Siyata Mr. Seelenfreund was a VP at Sunrise Corporation in New York focusing on financing publicly traded technology companies. Mr. Seelenfreund has a law degree and is a board member at a leading private university.

Gerald Bernstein – CFO

Mr. Bernstein spend 20 years focusing on private equity financing and tax efficient corporate structuring in multi-jurisdictional arenas. Mr. Bernstein holds a Bachelor of Commerce as well as a Graduate Diploma in Public Accountancy- both from McGill University. Member of the Canadian Institute of Chartered Accountants since 1987 and a professional chartered accountant.

Glenn Kennedy – VP Sales

Mr. Kennedy has over 25 years of sales experience in the telecommunications industry. Prior to joining Siyata in 2016, Mr. Kennedy has managed sales nationally for Motorola Canada, HTC Communications Canada and Sonim Technologies. Mr. Kennedy holds an Bachelor of Arts in Honors Business Administration from the Richard Ivey School of Business at the University of Western Ontario.

DIRECTORS

Peter Goldstein, Chairman of the Board

With over 30 years of diverse and global entrepreneurial, client advisory and capital market experience, Mr. Goldstein has a successful track record in leading and building companies in the capital markets. Mr. Goldstein has achieved capital market objectives by drawing on his strengths in M&A, strategic planning and transaction structuring, as well as his own entrepreneurial success. He has steered and completed initial public offerings (IPO), uplisting and reverse merger transactions, secured private placements and designed successful crowdfunding campaigns. Mr. Goldstein advised the Company on its recently upsized $12.6 Million U.S. Initial Public Offering and listing on the NASDAQ.

Stephen Ospalak, Board Member

Over 20 years in telecom, currently SVP Marketing & Operations at BMG Inc. Served as interim CEO for AiTelecom; Global Integration Officer for Virgin Management Inc.; Canadian VP & Board Advisor for Brightstar, and as SVP Operations at Iusacell. Served as VP of Products & Services at Telus Communications Inc. responsible for an annual spend > $US 1billion in wireless & wireline equipment. Led the planning and execution of Clearnet’s market debut and nationwide launch of the iDEN and PCS Cellular services, setting the North American PCS launch record. Held management positions at AT&T.

Michael Kron, Board Member

Mr. Kron has over 20 years of experience in investment and corporate finance, currently chairman and CFO at AnywhereCommerce Inc. He also co-founded Zellers Optical Centers and played a key role in the sale to Vision Associates of Atlanta. He was the co-founder and CFO of Miazzi Ventures where he founded Mamma.com Inc and later sold to Intasys Corporation at a $44M valuation. Mr. Kron holds a Bcomm from Concordia University as well as a Graduate Diploma in Public Accountancy from McGill University. He has been a member of the Canadian Institute of Chartered Accountants since 1987.

Lourdes Felix, Board Member

Lourdes Felix is a corporate finance executive offering over fifteen years of combined experience in public accounting and in the private sector in building, leading, and advising corporations through complex restructurings. Ms. Felix was previously the controller for a mid-size public accounting firm for over seven years and was responsible for the operations and financial management of regional offices. Ms. Felix has been a Director of BioCorRx Inc. since March 7, 2013. Ms. Felix was appointed Chief Executive Officer of BioCorRx on November 9, 2020 and became Chief Financial Officer of BioCorRx on October 1, 2012. Ms. Felix was President of BioCorRx from February 26, 2020 until she resigned upon her appointment as CEO on November 9, 2020. Ms. Felix holds a Bachelor of Science degree in Business Management and Accounting from University of Phoenix.

SINCERELY,

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May 14, 2024
NNVC
As of December 31, 2023 NNVC had cash and cash equivalent current assets balance of approximately $5.31 Million

This Innovative Biotech Company Is Taking A Novel, Game-Changing Approach To Eradicating Many Respiratory Viruses Once And For All Including Tripledemic Threat Of COVID, RSV, FLU…

ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate

READ THE INVESTOR PRESENTATION HERE

___________________________

Hello Everyone,

As biotech stages a big comeback, NanoViricides, Inc. (NYSE American: NNVC) looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.

NanoViricides, Inc. (NYSE American: NNVC) is a global leader in the application of nanomedicine technologies to the safe and effective treatment of viruses and their variants INCLUDING drugs against Covid-19, RSV and other respiratory viruses!

Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031.

NANOVIRICIDES are better because they destroy viruses and their variants without relying on the patient’s immune system, thereby making them effective for populations that include geriatric and pediatric patients.

Antibodies only bind by two points to the virus, and destruction of the complex requires effective immune function, which is not the case in sick patients..

Vaccines only train the body into producing antibodies against the virus in the vaccine. Antibodies and vaccines are easily overcome by viruses by mutating in the field, hence the need for annual influenza vaccine updates.

NNVC 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 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 (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 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 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 certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses 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.

RECENT COMPANY HIGHLIGHTS:
1. - NanoViricides, Inc’s lead drug, NV-387, is in Phase 1 clinical trials.
  - Broad spectrum antiviral NV-387 showing promise against many virus families including and beyond Tripledemic (i.e. COVID-19, RSV, FLU) .
  - No adverse events in Phase I SAD and MAD studies even at the highest dose 40mg/Kg
  - Found to be non-immunogenic, non-mutagenic, non-allergenic, and non-phototoxic.
  - Strong safety allows use in pediatrics, adults with co-morbidities, and immune-compromised patients unlike limitations of products currently in the market.
  - Developed Oral Syrup and Oral Gummies (soft solids) – good for geriatric and pediatric patients
  - Drugs expected to continue to be effective even as the virus generates variants – unique receptor site doesn’t change
  - Technology mimics unique receptor site used by virus; delivers to specific targets using receptor-recognition (no bulky antibodies)
A 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.

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.

A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design

A single nanoviricide micelle may be capable of completely engulfing a Virus Particle. Nanoviricide micelles self-assemble from multiple chains. A single chain micelle shown for convenience. Illustration not to scale.

Each nanoviricide drug is designed as an antiviral agent specifically targeted for a particular type of virus or group of viruses. Most existing anti-viral agents are known to have non-specific effects against both host cells and viral machinery at the same time often leading to side effects. Most current anti-viral agents act inside human cells. It is believed that this intracellular mechanism leads to significant opportunities for unwanted side effects against host cells. Nanoviricides, on the other hand, are designed to work directly against virus particles in bodily fluids. The Company believes that this approach may make nanoviricides inherently safer than existing approaches.

A nanoviricide is designed to seek and attach to a specific virus particle, engulfing the virus particle in the process, thereby rendering it incapable of infecting new cells, and disabling it completely. This suggested mechanism of action encompasses much more than what the current entry and fusion inhibitors are expected to do. The fusion and entry inhibitors do not completely cover the virus particle, likely blocking only a few sites on the virus particle. This means the virus particle may still be capable of infecting cells using its unblocked attachment sites. In contrast, a nanoviricide, because of its larger size and flexible nature, is expected to engulf the virus particle completely, thus disabling the virus particle. The action of a nanoviricide, if it works as designed, may be expected to be superior to antibody agents that attack viruses. Antibodies, being large, are expected to block relatively greater portions of the virus particle surface compared to small molecule entry inhibitors. However, antibodies depend upon the human immune system responses for clearing the virus particle. In contrast, nanoviricides are thought to be capable of acting as completely programmed chemical robots that finish their task of destroying the virus particle on their own.

NV 387 IN CLINICAL TRIALS

The drug, developed in response to the COVID-19 pandemic, demonstrated exceptional safety in clinical trials, even at the highest dose levels, with NO adverse events reported. The unique mechanism of action involves mimicking a cell membrane, encapsulating and blocking the virus.

Beyond COVID-19, the drug also displayed promising results against respiratory syncytial virus (RSV), offering a potential solution for infants and seniors where existing treatments like ribavirin may be contraindicated due to side effects.

The clinical trials involved both oral tablets and oral gummies, catering to various age groups, including pediatrics. NV 387 exhibited broad-spectrum activity against multiple strains of coronaviruses, showcasing effectiveness 10 times greater than remdesivir in preclinical studies.

The ongoing clinical trial progress and positive results position NanoViricides at the forefront of antiviral drug development, marking a significant milestone in their journey from preclinical research since 2005 to clinical trials.

The company believes 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!

NV-387 ADDRESSES AN UNMET MEDICAL NEED FOR BROAD-SPECTRUM, SAFE AND EFFECTIVE ANTIVIRAL DRUG THAT WORKS AGAINST MULTIPLE VIRAL THREATS:

There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.

NNVC believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.

NV-387 ADDRESSES LARGE MARKET SIZES:

Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*.

*Source: Transparency Market Research

The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**.

**Source: Growth+ Market Reports.

NANOVIRICIDES TECHNOLOGY WILL TRANSFORM THE WAY VIRUSES & THEIR VARIANTS ARE TREATED WORLDWIDE!

NNVC’s novel approach has already enabled variant-proof drugs, blocking the complete viral life cycle without requiring help from the host’s defense systems! If both the viral re-infection cycle, and viral replication cycle arms of the viral lifecycle are blocked, a cure for many viral diseases is possible!!

The Company’s 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 also developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg.

A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricides

SHELTON, CONNECTICUT – Wednesday, May 8, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes activity against orthopoxvirus family (Smallpox/Mpox), with both inhalation and skin abrasion (sexual) modes of infection acquisition. Ectromelia virus infection of mice is a model for Smallpox infection in humans, and also serves as a surrogate for MPox infection in humans. All three viruses belong to the orthopoxvirus family.

NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.

This lung infection study substantiates the results of the previously reported intradigital footpad infection study that: (i) NV-387 has comparable antiviral activity as tecovirimat, and
(ii) NV-387 plus tecovirimat has much stronger antiviral activity than either drug alone.

We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly. In this study, we found that NV-387 alone treated animals survived 15 days, tecovirimat alone treated animals survived 16 days, and NV-387 plus tecovirimat treated animals survived 19 days, whereas vehicle-treated animals died in 8 days.

This lung-infection study emulates infection from aerosolized dispersion of the virus, as may be expected in a bioterrorism scenario.

Survival Lifespan of Lethally Infected Mice – Lung Infection with Ectromelia Virus

Previously, on November 14, 2023, we have reported that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment, with both treatments resulting in 14 days survival, whereas vehicle treated animals died in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat resulted in a significantly improved survival of 17 days in this study.

Survival Lifespan of Lethally Infected Mice – Intradigital Footpad Infection with Ectromelia Virus

This intradigital footpad infection study emulates the skin-to-skin transfer of the virus as in sexual transmission, such as that in the case of current Clade 1 MPox virus epidemic in the DR Congo; Clade 1 MPox is more deadly than the Clade 2 MPox; the latter had caused a small pandemic recently with sexual mode of transmission (https://www.sciencefocus.com/news/monkey-pox-new-strain , May 5, 2024).

Tecovirimat is the drug approved for smallpox under “animal rule” and is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA). It was mobilized from the stockpile during the recent MPox Clade 2 pandemic. BARDA is interested in development of additional poxvirus therapeutics as per a recent Broad-Agency Announcement (BAA). There is significant interest in the development of a smallpox therapeutic that works well by itself, as well as in combination with the known drug, tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.

Therefore we believe that NV-387 is a viable clinical candidate to be developed by itself for the treatment of poxvirus infections under the US FDA “Animal Rule”. In addition, we believe that the combination of NV-387 and tecovirimat could reduce the potential for escape resistant generation against tecovirimat, as is known with other drug combination studies against viruses.

A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.

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NEWS
MANAGEMENT

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Anil R. Diwan, PhDExecutive 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.

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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.

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 INTERACTIVE OFFERS LLC FOR A ONE DAY NNVC 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. 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.

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May 13, 2024
TGL
Treasure Global to Report Third Quarter Fiscal Year 2024 Results on May 14, 2024

8% of Malaysia has already bought into the concept with 2,680,000 registered ZCITY users in the country with a population of 34 million

TGL Recently Took Measures to DRASTICALLY Reduce the Size of the Float!!

READ THE COMPANY PRESENTATION HERE

___________________________

Hello Everyone,

We have a new profile that we want you to get on your radar for next week.

This is a company that just completed a 1:70 reverse split back in February.

This drastically reduces the float when a company does that.

We have covered a few companies recently that completed reverse splits and went on to show immense volatility due to the limited number of shares available.

There is no way to tell if this is exact but Finviz has the entire float at just over a Half Million Shares.

If true then that could explain why TGL has been on the move.

This one just touched 6 bucks on Friday and has closed green 3 of the last 4.

Two of those sessions it closed up double digits (12.5% & 17%).

Recently the company announced that it will report its financial results for the third quarter of fiscal year 2024, which ended on March 31, 2024, after market close on Tuesday, May 14, 2024. This could be a major catalyst this week for the company depending on what they report.

TGL has demonstrated consistent year over year profit growth from the company.

Recently revenues have been down and profits have been up because the company has been focusing on increasing growth in higher-margin revenue channels.

Gross profit for the second quarter of the 2024 fiscal year was approximately $0.35 million, a 48% improvement year-on-year, from approximately $0.23 million for the second quarter of the 2023 fiscal year. The increase in gross profit was primarily due to initiatives mentioned above that the Company is implementing to grow gross margins.

Treasure Global Inc (TGL) is a Malaysian e-commerce company whose mission is to “bring together the worlds of online e-commerce and offline physical retailers.”

Its proprietary app, ZCITY, is kind of like Google Pay meets Groupon, but operates in Malaysia.

ZCITY gives users a simplified e-payment solution while allowing them to earn rewards from cash rebates to exclusive discounts and vouchers.

From the merchant side, companies can send ZCITY users personalized deals based on purchase history, location, and preferences — all powered by artificial intelligence.

ZCITY even allows users to pay things such as utility bills, rent, or TV subscriptions, all while earning “Zcoins,” which can be redeemed for a variety of rewards.

Launched in Malaysia in July 2020, ZCITY has already achieved significant market penetration, with 2,680,000 registered users and 2,000 registered merchants/brands as of December 2023.

To put that in perspective, Malaysia’s population is 34 million, meaning 8 percent of them are registered users on ZCITY.

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TGL’s other main app is TAZTE, which is kind of like the Malaysian Yelp but with payment integration via ZCITY.

Merchants can set discounts, provide rewards, and offer loyalty programs all through the app. It also features inventory management and consumer behavior analysis.

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Recent Business Highlights
- Over 2.68 million registered users as of December 31, 2023.
- 53% of paid users transacted three or more times in the quarter ended December 31, 2023.
- Quarterly active users for the quarter ended December 31, 2023 were 156,979.
- Paid users down by 64% year-over-year.
- A total of 0.58 million transactions were transacted by our registered users in the quarter ended December 31, 2023.
- Signed a memorandum of understanding between ZCITY and Malaysia’s leading healthcare group, UCSI Hospital, to pioneer stem cell healthcare tourism for Indonesia, Hong Kong and China.
- Signed an agreement for Treasure Global’s Abe Yus to supply its high-selling curry puffs to the world’s largest convenience store chain.
- Announced major shareholder lock-up agreement.
- Unveiled premium store, paving the way for an elevated ZCITY experience and substantial growth.
- Announced closing of $4.0 million public offering.
- Signed agreement to retire convertible debt notes.
- Hosted historic artificial intelligence (“AI”) robot for TikTok Live Commerce in Malaysia.
- Entered booming global gaming market, launching 10 mini games integrated with AI Game Creator in ZCITY’s 3D World.
- Launched ZCITY Live Commerce solution on Meta Platforms.
- Collaborated with AIO Synergy Solutions on development of data center for AI applications.
Revenue Streams:
- E-vouchers — “Users can purchase ewallet reload vouchers, petrol vouchers, shopping vouchers with instant rebates”
- Zmembership — “Offering bundles of discounted promo codes and attractive Zcoins to enhance consumption”
- Zstore — “An ecommerce platform to earn more rewards while purchasing goods; referral program; lower prices with the Group Buy function”
- Bill Payment — “Offering more than 15 billers enabling users to pay utility bills, loans, etc in 1 app”
- TAZTE — “An end-to-end smart order system focused on SME Food & Beverage (F&B) Merchants”
- Foodlink Global — “F&B franchisor revenue streams including start up fee and monthly licensing fees”
- Others — “Miscellaneous income e.g. affiliate income, commissions and advertisement, etc”
Treasure Global’s ZCITY Secures US$2Million Marketing Contract through its AI Marketing Engine

Promoting Prestige Korean Beauty Products to Malaysia and Southeast Asia market

NEW YORK and KUALA LUMPUR, Malaysia, May 09, 2024 (GLOBE NEWSWIRE) — Treasure Global Inc (NASDAQ: TGL) (“Treasure Global” or the “Company”), an innovative technology solutions provider, is thrilled to announce that its subsidiary, ZCITY, has secured a groundbreaking US$2 million marketing contract. This contract, honored by Satria Dunia Sdn Bhd, aims to promote prestige Korean beauty products through ZCITY’s advanced artificial intelligence marketing engine (“AI Marketing Engine”).

This strategic move signifies a significant milestone for Treasure Global as ZCITY expands its presence and capabilities in the beauty industry. Leveraging ZCITY’s cutting-edge artificial intelligence technology, Treasure Global is poised to maximize brand visibility and drive sales growth for its clients’ Korean beauty products.

The Malaysian beauty market presents immense potential for revenue generation, with Korean beauty products gaining significant traction in recent years. According to market statistics, the revenue of the Korean beauty products market in Malaysia is projected to surge, with a compound annual growth rate (“CAGR”) of 9.54% from 2023 to 2032. In 2022 alone, the market revenue was valued at approximately US$313 million, underscoring the lucrative opportunities present in the region.¹

“This alliance underscores our commitment to revolutionizing the beauty industry through innovative marketing solutions. With ZCITY’s AI Marketing Engine, we are well-positioned to capitalize on the burgeoning demand for prestige Korean beauty products in Malaysia and beyond. This collaboration represents a strategic move to drive revenue growth and solidify our presence in the dynamic beauty market,” said Sam Teo, Chief Executive Officer of Treasure Global.

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NEWS

MAY 10, 2024 7:00PM EDT

Treasure Global Announces 2024 Annual General Meeting of Shareholders

MAY 09, 2024 8:00AM EDT

Treasure Global’s ZCITY Secures US$2Million Marketing Contract through its AI Marketing Engine

MAY 01, 2024 8:00AM EDT

Treasure Global to Report Third Quarter Fiscal Year 2024 Results on May 14, 2024

APR 11, 2024 8:30AM EDT

Treasure Global’s ZCITY is Anticipated to be Appointed Operator of Malaysia Pavilion, Tapping into Lucrative China Market

MAR 26, 2024 8:00AM EDT

Treasure Global Successfully Regains Compliance with Nasdaq Minimum Bid Price Requirement

MAR 08, 2024 8:00AM EST

Treasure Global’s AI-Powered ZCITY Premium Store Surpasses Expectations, Selling over 6,000 Bill Saver Bonanza Packs Within Four Months of Launch

FEB 23, 2024 11:00AM EST

Treasure Global Announces 1:70 Reverse Stock Split

FEB 22, 2024 8:00AM EST

Treasure Global and Silica-AI Forge Strategic Partnership to Revolutionize AI and IoT Landscape Across Southeast Asia

FEB 14, 2024 5:00PM EST

Treasure Global Reports Second Quarter Fiscal Year 2024 Results

FEB 05, 2024 8:30AM EST

Treasure Global CEO Demonstrates Confidence in Company’s Future Through Share Purchase

‍

MANAGEMENT TEAM

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 INTERACTIVE OFFERS LLC FOR A ONE DAY TGL 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. 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.
May 12, 2024