ASX: BOTSummary:BOT is a pharmaceutical company which is...

ASX: BOT

Summary:

BOT is a pharmaceutical company which is developing drugs using synthetic CBD (Cannabis) oil to treat topical skin diseases and antimicrobial applications.

Botanix Pharmaceuticals was started in Australia, but now has offices both in Australia and the U.S. It is listed on the ASX and U.S stock exchange (unsure of the code..).

Management:

Vince Ippolito – “played a leading role in two of the largest dermatology acquisitions completed in the past decade with combined valuations of $7.8 billion.”

(This guy is here to sell the company to bigger pharmaceutical)

Matt Callahan – Founder, previous director of many pharmaceutical companies, 4 FDA approvals previously.

Dr Michael Thurn, Dr Stewart Washer, Dr Bill BoschI – loads of experience

Pipeline:

PRODUCT	INDICATION	PHASE 1	PHASE 1B	PHASE 2	PHASE 3	STATUS
BTX 1503 Gel	Moderate to severe acne	-----------------------------------------------------------------------------------------------------------à				Successful End of Phase 2 Meeting with FDA
BTX 1702 Solution	Rosacea	------------------------------------------------------------------------à				Phase 1b study
BTX 1801 Ointment	Antimicrobial	----------------------------------------------------------------------------------------à				Phase 2a study

Milestones:

BTX 1503

23/10/2019	BTX 1503 Acne Phase 2 Study Results Presentation
22/10/2019	Botanix Announces BTX 1503 Data and Progression to Phase 3
12/09/2018	Botanix BTX 1503 Clinical Trial Update
23/07/2018	Investigators Meeting Completed for BTX 1503 Phase 2 Trial
27/06/2018	First Patients Recruited into BTX 1503 Phase 2 Acne Trial
13/06/2018	Australian Ethics approval for Acne Study

Basically, Phase 2 results were good in Australia, then they repeated the trials in the U.S and it was a mix bag with the vehicle performing just as good..

Which was clarified in the 23/10/2019 report.

They This why the company is unvalued.

BTX 1702

17/07/2020	BTX 1503 End of Phase 2 Milestone with FDA
24/06/2020	Botanix Provides Update on Development Activities
09/12/2019	Botanix Initiates BTX 1702 Rosacea Study
16/09/2019	Botanix announces new clinical program to target rosacea

Basically, from early 2020 it has been on hold due to COVID.

BTX 1801

03/02/2021	Phase 2a Study Shows BTX 1801 Eradicates S. Aureus
20/01/2021	Antimicrobial Data Published in Peer-Reviewed Journal
11/11/2020	FDA Clears Development Path for BTX 1801
08/09/2020	New Antimicrobial Data and Conference Presentation
12/08/2020	BTX 1801 Phase 2a Antimicrobial Study Underway
24/04/2020	FDA Grants BTX 1801 QIDP Designation Status
13/03/2020	Antimicrobial Platform Update and Launch of BTX 1801 Study
06/09/2019	BOT antimicrobial data presented at ASM-ESCMID Conference
15/07/2019	Botanix Antimicrobial Platform Addresses Global Threat
24/06/2019	New BTX 1801 Data Presented at ASM Microbe 2019
20/06/2019	BTX 1801 Kills Superbugs Without Resistance World-First
19/07/2018	Botanix Joins with UQ to Accelerate Development of BTX 1801

This is the bread winner. FDA has given fast tracking status to expediate this, if I remember correctly this is not an easy feat. QIDP status is an additional five years of regulatory exclusivity, on top of the standard exclusivity that is afforded to new drugs as part of the FDA’s approval procedure. QIDP recipients are also eligible for priority review status that expedites the FDA’s review period, from the standard 12 months to around six months.

The UN estimates that the ongoing development of resistanceto antibiotics could lead to 10 million deaths every year by 2050 and economiclosses of US$100 trillion if new antibiotics are not found.
According to the UN, Staph and MRSA are the most troublesome resistance formingbacteria worldwide and are the leading cause of post-surgical infections andsurgical site infections. BTX1801 does not allow resistance forming bacteria.

An independent peer review journal was done on this formulation stating BTX1801 could be used for other applications such as gonorrhoea, meningitis and legionnaires disease.

Other

20/05/2019

Dermatology Industry Leader Joins Botanix

Vince joined here.

Broker Data:

See attached.

As at 31 December than company had notional cash of $35m.

About 2-3 years of cashflow, so no new capital raises on the horizon.

*Edit - this summary excludes the lastest announcements with management.