I'm a Theratechnologies shareholder but I wanted to share some info about another Cdn biotech company that I’ve taken a starter, spec position in - Bioasis Technologies (TSX-V: BTI, OTCQB: BIOAF). Others may want to take a look at this in the very near term as it’s a small biotech with a very interesting, “pre-clinical yet quasi-proven already” technology. I bought shares partially because I have some excess funds that I can allocate to my “possible 10-bagger” part of my portfolio ;) but also because I have a friend who has been following the blood-brain barrier (BBB) space for many years and thinks this company has a very high probability shot at solving the problem of getting therapeutics across the BBB. As he always tells me “their xB3™ technology can transport almost any antibody into the brain, it has never failed to do that in animal models & tests and the drugs still work after they have been transported by xB3™.” The nudge that finally gave me confidence to buy shares was an analyst report that came out last week https://www.edisongroup.com/company/bioasis-technologies/2935/ and is summarized with:
We initiated coverage on Bioasis this week, with them showing significant upside potential to current share price. We value Bioasis, a Canadian biopharma company focused on non-invasive delivery of therapeutics across the blood-brain barrier, at C$47.8m or C$0.71/basic share, a 173% upside potential to the current share price of C$0.26. 

That report by Edison goes a long way to telling the story although I believe it has been written in a very conservative manner in order to 1) get the target price down to something which is credible at this stage, and 2) leave substantial room to increase it over the coming 12 months.
 
Quick Company Overview:

Ticker: TSX-V: BTI, OTCQB (USA): BIOAF
Website: www.bioasis.us

Quick Summary:
  • Bioasis Technologies has a proprietary platform, called xB3™, for the delivery of therapeutics across the Blood-Brain Barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases. This platform is being used i/ in-house for their own drug development efforts for brain-related diseases and disorders and ii/ is also licensable by pharmas for their own pipeline development, thus providing Bioasis with two revenue streams.
  • The overall market for drugs to treat brain disorders is estimated to reach a value of nearly US$137. 7 billion by 2025. The growth in the market is being driven by steps taken by the FDA and EMA to help faster market entry of central nervous system (CNS) acting drugs.
  • Research based on the xB3™ platform has achieved success in the transport of dozens of compounds across the blood-brain barrier in both in-vitro and in-vivo studies. They have conducted research studies at more than 20 leading research institutions and biopharmaceutical companies.
  • Bioasis’ lead product xB3™-001, based on the approved drug Herceptin, is in development for the treatment of HER2+ breast cancer and brain metastases. Independent market research has projected peak revenues for xB3™-001 of $440 million worldwide for the treatment of breast cancer brain metastases and $3.8 billion for the treatment of HER2+ breast cancer.
  • xB3™-001, which is anticipated to enter clinical development in early 2021, may be eligible for accelerated approval by the FDA with a de-risked, much shorter and extremely capital efficient development path.
  • The company’s current market cap (at .26 Cdn share price) is a depressed ~$12MM USD.  I expect that will change quickly when they announce a meaningful licensing deal which provides the necessary non-dilutive capital.
  • The company has been in the “penalty box” due to prior management missteps (primarily in their ability to raise international funding) but with a new CEO and near-term opportunities for non-dilutive (no share issuance) funding they are eager to “hit the ice and score some goals”. Fortunately, personnel and funding issues are both problems that can be solved. The most difficult part is ensuring the science side of the business is rock solid and that has always been the case without question – whew! J
  • Technically (stock chart), the stock is looking good - now trading above both its 200dma and 50dma.
 
In my own research so far (more to come on that as I get time to digest and summarize my notes), Bioasis has also been subject to its share of mismanagement and financing challenges, but they seem to have recently changed (or is about to change) most of the factors that led to those issues. There are several signs the company appears to be about to close their first meaningful licensing deal. The new CEO (in that role for over a year now), has recently stated at the last Annual General Meeting and in public company documents:
  • "We are undertaking ongoing negotiations in relation to broad strategic licensing arrangements for our platform and we anticipate that these deals will be catalysts for the company moving forward".
  • "Partnering anticipated to deliver multiple catalysts in coming months"
  • "Seek to have our technology adopted as broadly as possible. Quite often companies are interested in the xB3™ platform to enhance the brain exposure of new, soon to be proven drug targets and molecules."
  • "Now have new potential partnerships on the horizon".
  • "Funding for the continued development of xB3™-001 is anticipated to come from licensing transactions currently under negotiation".
  • "I look forward to reporting near term on positive results flowing from our business development initiatives".
Once a minor amount of funding is obtained (let’s ballpark at least $3MM) the company can move forward towards filing an IND for their -001 program for brain metastases. They have already held their Type-B meeting with the FDA. It concluded with a positive assessment and the FDA suggesting the company apply for accelerated approval before moving forward with the design of their Phase II. Of note, tumor shrinkage in Phase II is directly cited on the FDA website in providing examples of candidates for accelerated approval.

Further, a licensing deal could be for one of the company’s non-core programs, and therefore while providing funding for the research budget for the core program(s), it will not diminish the upside potential of the company. This licensing deal should also provide validation that a major pharma will be utilizing Bioasis’ technology to better the pharma’s own drug development efforts. Also, there are many other programs to license in the near and intermediate future to provide further non-dilutive capital and validation of the technology. I refer you to their website or corporate deck for details on their other drug development programs.

Now let’s get back to Bioasis’ lead program xB3™-001. Brain metastases are among the most common form of brain cancer in adults. For example, HER2-positive breast cancer has a high incidence of the cancer spreading from its primary site in the breast to the brain. The prognosis for these brain metastases is often fatal as the resulting brain tumors are largely untreatable because anti-cancer drugs cannot cross the blood-brain barrier at effective levels. xB3™-001 is their own in-house drug development program combining the already FDA approved Herceptin ($7.1B in sales in 2017) breast cancer drug with xB3™ (xB3™ peptide fused to Herceptin antibody). Trastuzumab, sold under the brand name Herceptin among others, was approved for medical use in the United States in 1998.[3] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. This “combined” drug trial is for treating Her2+ breast cancer that has metastasized to the brain. The goal is to get the current standard of care drug (Herceptin) for breast cancer into the brain to attack this brain cancer. Using Herceptin alone does not have efficacy to do this. Of course to do this, the Herceptin has to get across the BBB and that is what the xB3™ component does.

Bioasis plans to start a phase 1b/2a trial with xB3™-001. The trial's patients will be very sick people. It is unethical to do only the usual phase 1 dosing and safety testing with them. They must actually be treated for efficacy. A lot of people will be watching this trial. They most certainly will start watching if phase 1b/2a is successful. No company that can effectively treat brain tumours in this phase is likely to remain a microcap for long. And if meetings with the FDA, post this phase, indicate that a larger phase 2 will be designed to facilitate an FDA decision to grant breakthrough status to xB3™-001, then the investing public might begin to realize that xB3™-001 could be approved for commercial release without going through a long and costly phase 3 and that post phase 2 it could be a player for billions in annual revenue.

I do believe, provided they get some additional funding, that the science foundation built over the past decade of its existence, will allow this small company to finally showcase that their xB3 Platform can be used to create an unlimited number of patented therapeutics for the treatment of many currently untreatable brain and other CNS diseases.