NovAccess Global Inc. Annual Report Snapshot

Hey there!

Think of this as our chat about NovAccess Global Inc.'s past year. We're going to break down their annual report into plain English, so you can easily understand what they do, how they're doing, and if they might be a good fit for your investments. No fancy finance jargon, just the facts explained simply.

Great news! We've got our first chunk of information from their annual filing for the fiscal year ended September 30, 2024. Let's dive in!

Here's what we'll cover once the information comes in:

• What does this company do and how did they perform this year? NovAccess Global Inc. is a biopharmaceutical company. In plain English, that means they're in the business of developing new medicines. Specifically, they're focused on creating novel immunotherapies to treat brain tumor patients, starting in the United States and hoping to expand globally. Their special sauce is using a patient's own immune system to fight cancer.

  A big part of their story is the acquisition of StemVax, LLC in September 2020. StemVax holds an exclusive patent license for a product called StemVax Glioblast (SVX-GB/TLR-AD1) from Cedars-Sinai Medical Center. This product is designed to target glioblastoma, which is the most common and deadliest type of adult brain tumor.

  Right now, they're in the very early stages of getting their drug approved. They're preparing an Investigational New Drug Application (IND) to submit to the FDA (Food and Drug Administration) to get permission to start human clinical trials. They expect it will take about 12 to 18 months just to get the data ready for this IND application. After that, if trials are successful and the FDA gives the green light, they plan to commercialize the product. This means they're a company with a lot of potential, but also a long road ahead before they can sell anything.

• How much money did they make and how fast are they growing? Since they're still in the drug development phase, they aren't generating significant revenue from product sales yet.

• What went well and what was tough for them this year?

  • What went well: They're actively working towards getting their brain tumor immunotherapy into human trials, which is a huge step for any biopharma company. They also highlight their team's expertise in various scientific fields and their advisory board's experience in clinical trials and market growth. The acquisition of StemVax in 2020 was a key move, giving them a specific product candidate (SVX-GB/TLR-AD1) to focus on.
  • What was tough: The biggest challenge is the long and expensive process of drug development and FDA approval. The 12-18 month timeline just to submit the IND application means they're still quite a ways off from generating revenue from their main product. This phase requires significant investment without immediate returns.

• Are they sitting on a pile of cash or drowning in debt? The total market value of their common stock held by regular investors (non-affiliates) was quite small, around $337,901 as of March 31, 2024. This is based on a stock price of just $0.010 per share. This indicates it's a very small company, often referred to as a "penny stock," which can carry higher risks. They are also classified as a "Smaller Reporting Company," which means they have fewer reporting requirements than larger companies.

• What could potentially hurt the stock price? The company indicated they have not filed all required reports with the SEC for the past 90 days, even though they have filed them for the preceding 12 months. This could be a red flag for investors, as consistent and timely reporting is important for transparency. Beyond that, the inherent risks of a biopharmaceutical company are significant: there's no guarantee their drug will be approved by the FDA, clinical trials can fail, and the process is very costly and time-consuming.

• Any big changes in leadership or company direction? The acquisition of StemVax in 2020 was a significant strategic move.

• What's their plan for the future? Their immediate plan is to gather the necessary data and submit their IND application to the FDA within the next 12-18 months. After that, they aim to conduct human clinical trials to prove their drug is safe and effective, with the ultimate goal of commercializing the product and expanding globally.

This initial look shows NovAccess Global Inc. is a very early-stage biopharma company with a clear focus on a high-risk, high-reward drug development path. Investors should weigh the significant potential of their immunotherapy against the long timeline, high costs, and inherent uncertainties of clinical trials and regulatory approval, especially given their current financial scale and reporting status.