Medlab Clinical

DR SEAN HALL

CEO

(ASX:MDC)

◾ Company Name: Medlab Clinical ◾ Company ASX code: MDC ◾ Key areas: Biotechnology, drug enhancement and delivery technologies, new drug development with primary focus on pain, depression and stress. ◾ Key Personnel: Dr Sean Hall, CEO | Kerem Kaya, CFO ◾ Locations: Sydney, Australia ◾ Market Cap as of 15/09/22: $28.08M ◾ 52 Week share price as of 15 September: $6.450 - $30.000 ◾ Company Website: medlab.co

COMPANY PROFILE

Ensuring the active pharmaceutical ingredient (API) of medicines is delivered effectively and absorbed by the human body has been a major challenge throughout medical history.

In a traditional pill, around 80-90% of the API (Active Pharmaceutical Ingredient) is often lost through digestion, however one Aussie biotech has a market-ready solution; the NanoCelleTM technology of Medlab Clinical which is changing the way medicine is delivered for better patient outcomes.

It has potential to replace injections, rejuvenate existing medicines, improve the delivery and effectiveness of new drugs and vaccines utilising the NanoCelle chemical shrinking process to reduce the molecular size of the API to nanoscale.

A NanoCelle enhanced particle is 200 times smaller than a red blood cell, which is ~7.5 to 8.7um in diameter and ~1.7 to 2.2um in thickness. At such small scale, the API can be administered in a range of different ways, including application as a spray inside the cheek, under the tongue, as a nasal spray, lotion, or skin patch.

In bypassing the gut and liver, less active ingredient is required to reach the desired target, which can also lead to other benefits such as fewer side effects, lower toxicity and more rapid absorption particularly useful for acute pain.

Medicines that would traditionally take up to an hour to take effect do so within a few minutes the company says, adding that the NanoCelle-enhanced medicines have been clinically proven to have up to 5 times superior bioavailability over other drug delivery methods at equivalent doses, and are also ideal for those with difficulty swallowing, injecting or with gastrointestinal complications.

But where the patented NanoCelle process stands out commercially is its ease of adaptability, making it highly scalable and cost effective. NanoCelle adds just three additional chemistry steps to existing drug manufacturing processes.

Furthermore, no additional equipment beyond that found in a modern liquid pharmaceutical manufacturing facility is required to make thousands of litres of liquid NanoCelle-enhanced medicines every few hours – stable-at-roomtemperature solutions which optimise delivery of medicines and vaccines, with greatly reduced transport and storage temperature requirements.

Proof of concept has been shown for a needle-free NanoCelle nasal spray for insulin, and for enhancement of generic drugs such as statins (cholesterol) and loratadine (antihistamines).

Successful P1/P2 clinical trials of a NanoCelle cannabis product (NanaBis) for pain relief have already proven safety, efficacy and potential for opioid sparing or replacement.

The NanoCelle tech underpins Medlab’s current products and research, such as programs for pain and stress (NanaBis and NanoCBD), depression (MDC2000) and the Australian government sponsored mRNA Covid nasal vaccine research.

Medlab currently has three TGA listed products that use NanoCelle, with NanoCelle D3, NanoCelle Activated B12, and NanoCelle D3+K2 available for consumer purchase.

NanaBis and NanoCBD are also available under the Special Access Scheme, pending P3 clinical trials and FDA/TGA approval. Over 350,000 doses of NanoCelle products have been safely delivered to patients. 2022 has been a milestone year for Medlab, which has established research collaborations with leading Australian universities, clinically validating and patent protecting NanoCelle in all Western territories.

KEY INVESTMENT HIGHLIGHTS

◾ NanoCelle® drug enhancement and delivery technology now patent protected in all Western territories, independently validated for superior bioavailability, and approaching diverse partnering deals on multiple drugs. ◾ Lead pain management drug candidate NanaBis™ entering final clinical stages to support FDA New Drug Applications and subsequent commercial sales. ◾ Medlab Clinical shareholders have approved the company’s proposal to dual list on the NASDAQ later this year, providing access to the deep pool of biotech-savvy investors and capital in the world’s largest market.