ANEW MEDICAL, INC. Acquires License to Needle-Free Dry Powder Autoinjector from Transfertech Sherbrooke (“TTS”)

Rhea-AI Summary

ANEW MEDICAL, INC. (Nasdaq: WENA) has signed an exclusive worldwide license agreement with Transfertech Sherbrooke (TTS) for Nanoject, a needle-free, freeze-dried nanopowder autoinjector for medicines and vaccines. This patented technology uses a miniature shock tube to deliver nano-sized or micron-sized particles of medicine at high speed into the skin. The company aims to offer both single-use disposable and reusable multi-dose devices.

ANEW's CEO, Dr. Joseph Sinkule, sees this as an opportunity to generate near-term revenue while advancing their early-stage human Klotho gene therapy program. The technology offers advantages such as improved storage at room temperatures, better long-term stability, and novel programmed time-released formulations. ANEW plans to focus on key therapeutic areas including pain, fertility medicines, growth hormones, erectile dysfunction, and vaccines.

Positive

• Exclusive worldwide license agreement for innovative needle-free drug delivery technology
• Potential for near-term revenue generation
• Patented technology with advantages over traditional liquid drug solutions
• Targeting multiple high-value therapeutic areas
• Opportunity for partnerships with pharmaceutical companies

Negative

• Early-stage technology, may require significant development and regulatory approval
• Potential competition from existing alternative drug delivery methods
• Success dependent on market adoption and acceptance of new technology

Financial Analyst

The acquisition of the Nanoject license is a strategic move for ANEW MEDICAL, potentially diversifying their revenue streams. While financial terms weren't disclosed, this deal could significantly impact ANEW's future earnings. The addressable market is substantial, with over 16 billion injections annually in the US and Canada alone. However, investors should note that commercialization timelines and regulatory hurdles aren't specified, which introduces uncertainty. The company's focus on near-term revenue generation is promising, but without concrete financial projections or timelines, it's difficult to quantify the immediate impact on ANEW's bottom line. This technology could be a game-changer if successfully brought to market, potentially disrupting the $17 billion global injectable drug delivery market.

Medical Research Analyst

The Nanoject technology represents a significant advancement in drug delivery systems. Its ability to deliver dry powder nanoparticles offers several advantages:

• Improved storage at room temperature
• Better long-term stability
• Potential for novel time-released formulations

These features could revolutionize vaccine distribution and reduce cold chain dependencies. The pain-free, needle-free approach could improve patient compliance, especially for chronic conditions requiring frequent injections. However, the efficacy and bioavailability of drugs delivered via this method need to be thoroughly validated. Clinical trials will be important to demonstrate equivalence or superiority to traditional injection methods across various drug classes.

Market Research Analyst

ANEW's acquisition of the Nanoject license positions them in a high-growth market. The global needle-free injection system market is projected to reach $20.17 billion by 2027, growing at a CAGR of 15.7%. Key drivers include:

• Rising prevalence of chronic diseases
• Increasing demand for self-administration devices
• Growing focus on patient comfort and safety

ANEW's strategy to target pain medications, fertility drugs and vaccines aligns well with market trends. However, they'll face competition from established players and other emerging technologies. The success will largely depend on clinical validation, cost-effectiveness and their ability to secure partnerships with pharmaceutical companies for drug reformulations.

NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- ANEW MEDICAL, INC. (“ANEW” or the “Company”) (Nasdaq: WENA) announced the signing of an exclusive worldwide license agreement with Transfertech Sherbrooke (“TTS”) regarding Nanoject, a needle-free, freeze-dried nanopowder autoinjector for medicines and vaccines.

Needle phobia and injection or blood-drawing anxiety are prevalent among adults and children, creating barriers to adhering to doctor visits and medication protocols. Alternatives to needle/syringes have been introduced including creams, patches, inhalers, liquid autoinjectors, but they have significant cost and formulation limitations for topical applications.

The patented Nanoject core delivery device exploits the pressure-driven flow generated by the triggering of a miniature shock tube to “shoot” nano-sized or micron-sized particles of medicine (drugs, proteins, DNA, RNA) at high speed (600 meters/second) into the skin for intradermal and subcutaneous tissue delivery.

Dr. Joseph Sinkule, the CEO, Chairman and Founder of ANEW, stated: “ANEW continues to evaluate opportunities that can generate near-term revenue for the Company, and we utilize our expertise to develop new and novel patented technologies for medical product development – medical products that are urgently needed in the treatment of human diseases. Our early-stage human Klotho gene therapy program is advancing quite well, however we have been looking for assets that may bring in revenue much earlier than the Klotho neurosciences programs. The nanoparticle injector is quite unique, is patent-protected, and will become a major advance in drug delivery. The dry powder nanoparticles of drugs, proteins and DNA/RNA offer numerous advantages over liquid drug solutions such as improved storage at room temperatures, better long-term stability, and novel programmed time-released formulations. We are planning to offer two formats: a single-use disposable device that you can toss in a normal trash bin after administration, and a re-usable, multi-dose device for repeated use.” Dr. Sinkule continues, “Accurate and reproducible dose delivery at targeted skin depths can be controlled by nanoparticle size and shape, particle density, formulation excipients and velocity (gas-powered delivery). Our collaborators at TTS and the Université de Sherbrooke bring to the table a family of issued US and international patents and decades of knowhow which provide protection from competition.”

ANEW’s CFO, Jeffrey LeBlanc, stated: “We are developing a patented, low-cost method to deliver medicines to patients that are needle free and pain free, which will improve the quality of life for patients receiving hypodermic needle and syringe-administered medicines and vaccines. We will focus on several key therapeutic areas, including drugs for pain, fertility medicines, growth hormones, erectile dysfunction, and vaccines. We will develop and market our own products, but also work with pharma partners to launch novel patent-protected versions of their drugs via supplemental NDAs.”

Eric Boyd, the Managing Director for the Nanoject business unit, will manage general operations and key partnerships, including the licensing alliance with TTS and Dr. Martin Brouillette’s lab at the Université de Sherbrooke. Mr. Boyd, having over 35 years of experience advising public and private companies, stated: “No one likes needles, and more than 16 billion injections a year are given in the US and Canada. Hypodermic needle injections are painful, generate dangerous and costly medical waste, and can cause infection and contamination risks to patients. There are patients with chronic conditions that require frequent, often self-administered injections like insulin or fertility meds. This technology is ideal for self-administration.”

Michel Lambert, the CEO and President of TTS, stated: “We are pleased to place this important technology in the hands of experts in this field and we look forward to the close interaction of the Company with the inventor, Professor Dr. Martin Brouillette, and the Université de Sherbrooke.”

About TTS and Université de Sherbrooke. TTS is a limited partnership having its head office at 35 Radisson Street, Office 200, Sherbrooke, Quebec, Canada, J1L 1E2, acting and represented by its General Partner,  GESTION SOCPRA SCIENCES ET GÉNIE INC. The Université de Sherbrooke is a world-renowned French-language public research University in Sherbrooke, Quebec, Canada. TTS is the University’s external technology transfer office.

About ANEW MEDICAL, INC. ANEW MEDICAL, INC. (Nasdaq: WENA) is a technology and medical product development company focused on the development of therapeutics and diagnostics for a broad range of chronic and life-threating disease indications. ANEW’s current portfolio consists of its proprietary gene therapy program using DNA and RNA as therapeutics and diagnostics. Other assets include clinical-stage programs involving antibody biologics targeting cancer and autoimmune diseases, and drug delivery via a needle-free dry powder jet autoinjector called Nanoject.

For more information, contact:

Investor Relations
Email: IR@anewmeds.com
Website: https://www.anewmeds.com/press-releases/

Forward-Looking Statements:

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

FAQ

What is the Nanoject technology licensed by ANEW MEDICAL (WENA)?

Nanoject is a needle-free, freeze-dried nanopowder autoinjector for medicines and vaccines. It uses a miniature shock tube to deliver nano-sized or micron-sized particles of medicine at high speed into the skin for intradermal and subcutaneous tissue delivery.

How does ANEW MEDICAL (WENA) plan to commercialize the Nanoject technology?

ANEW plans to offer two formats: a single-use disposable device and a reusable, multi-dose device. They will focus on key therapeutic areas including pain, fertility medicines, growth hormones, erectile dysfunction, and vaccines, while also working with pharmaceutical partners to launch novel versions of existing drugs.

What are the advantages of the Nanoject technology licensed by ANEW MEDICAL (WENA)?

The Nanoject technology offers advantages such as improved storage at room temperatures, better long-term stability, and novel programmed time-released formulations. It also addresses issues of needle phobia and injection anxiety, potentially improving patient adherence to medication protocols.

How does ANEW MEDICAL (WENA) expect this license agreement to impact its business?

ANEW sees this as an opportunity to generate near-term revenue while continuing to advance their early-stage human Klotho gene therapy program. The company aims to develop and market their own products as well as partner with pharmaceutical companies to launch novel patent-protected versions of existing drugs.