Wow out old left field- I am just digesting how this news could impact Botanix’s value.

https://www.durbin.senate.gov/newsroom/press-releases/durbin-leads-senators-in-demanding-answers-from-pfizer-eli-lilly-on-new-telehealth-platforms-amid-concerns-of-inappropriate-prescribing

There will be a senate inquiry into Pfizer and Eli Lilly’s online telehealth platform. Is there room for abuse and over prescribing or a breach of possible kickback laws for drug companies.

I need to do more reading but I wanted to highlight this and kickstart some conversations around this topic.

Botanix uses a telehealth set up and access to a doctor who can prescribe a medication for AHH. It then uses independent rx provider Upscript to dispense this medication. Does this provide Botanix with an arms length protection? Does this protect the overprescribing of said drug and Medicare / Medicaid rebates that the government is worried about in the US. Or does this threaten all online telehealth platforms. A must watch piece of the puzzle for Botanix holders.

This could potentially add a lot of value or place uptake pace in danger if this distribution plan is vetoed by senate.

My gut feeling is that Big pharma running telehealth and distribution networks themselves may be vetoed.

Let me know your thoughts.

informative article in end points https://endpts.com/next-gen-biotech-acquirers-find-ma-momentum-in-q2/

Take overs/ buyouts for 2024- looks to me like there is some room for Dermatology and Neurodevelopmental drugs - nothing on the list so far !

Another Analyst firm E and P has started covering BOT with a price target of 0.55c. I won’t share full report but Botanix has shared this with investors. Check their website.

Ecclock numbers are up. 44% increase and Kaken’s largest % increasing product. This adds further weight to the recent details and likelihood of uptake in the US as there has been very solid growth in Japan. Kaken predicting further increase in sales for FY 2024.

6A1177772_BOT.pdf

A very good day for BOT holders:

increasing receipts from Kaken sales >$300k for the qrt a big increase from last qrt.

meeting A requested with FDA and hopefully a faster final approval in the wings.

Setting itself up nicely for M&A

https://endpts.com/fresh-tracks-pauses-phi-atopic-dermatitis-trial-to-save-money-forge-exit-strategy/

Todays article sighting financial stress as a few of us have concluded. Even with Botanix recent capital Freshtacks may not exist in 12 months with the following stated:

”It appears nothing is off the table regarding the biotech’s exit plans. It is considering financing, mergers, company or asset sales, and licensing, among other options. It’s been mulling its next strategic steps since March.”

It seems to have tried to hold its dermatitis drug following successful phase I trials. However to get this drug through to any further clinical trials it will need a lot more money. Pharmaceutical companies obviously won’t pay as much for a phase I drug. Despite rebranding it doesn’t appear that things are too rosy for Freshtracks.

The completion of capital raise to buy out all remaining payments to Fresh tracks from Botanix.

This means Botanix will now keep all profits and have no more milestone payments due.

6A1160149_BOT.pdf

6A1159413_BOT.pdf

Presentation at upcoming biotech conference this week.

For completeness:

The ultimate research question is why Brickell Biotech sold Sofporonium Bromide to Botanix if the drugs is a) so great b) so potentially profitable? Why wouldn’t they take this drug through FDA approval themselves. 

I think both Botanix and Brickell needed something from each other at the right time. 

Botanix needed a commercial product to add to its pipeline – I think COVID added a legitimate time delay to Botanix’s original pipeline plans. 

A faster pathway to revenue generation would help the market to regain faith in Botanix and hopefully increase the share price and investor returns. A commercial drug plus a phase III and multiple phase II drugs is a much more attractive buyout target for big pharma than just a clinical company. 

Brickell Biotech was a small US clinical stage company. Brickell listed on the NASDAQ in 2019. Prior to this it was valued between $50 to $100 million privately in 2015. 

Brickell underwent 5 funding rounds totalling $33.5 million. The biggest investor were Amorepacific Ventures, Charlie Steifel and Pallisades.

2010 Funding Round 1 - $6.2 million

2013 Funding Round 2 - $7.0 million 

2014 Funding Round 3 - $2.2 million

2015 Funding Round 4 - $10 million

2021 Funding Round 5 - $8.1 million

Bodor Labs licenced SB to Brickell and in 2015 Brickell licenced SB to Kaken for Japan and parts of Asia. Brickell got upfront payments and milestones and tiered royalties which were undisclosed. 

2015 also saw Brickell expand its drug offerings into Posoriasis and Auto-immune disease. In 2019 Brickell acquired Vical for its DNA delivery tech for an undisclosed amount. Needless to say Brickell was a clinical stage company relying on funding rounds and small licensing revenue for SB from Kaken. 

Nasdaq listing was successful and saw Brickell Biotech’s (BBI) SP soar. Positive Phase IIB results for 15% SB impressed the market and the stock hit $3.39. COVID affected biotech badly. In October 2020 the stock price was down to 0.56c and in Nov 2020 the Brickell CFO resigned. 

Final funding round in 2021 for $8.1 million kept Brickell afloat. In Sept 2021 Brickell bought another drug DYRKA program in clinical stages.

The stock price dropped again and by May 2022 it was as low as $0.29c. The problem was that SB would take too long to get FDA approval so there was no immediate revenue possibility. I speculate that with Brickell collecting immunology assets and inflammatory assets that it needed to offload the most advanced sellable asset to inject some enthusiasm back into the share price and to fund the rest of the pipeline. 

However the sale of SB to Botanix  for $9 million upfront and $168 million in future sales and milestones did little for the Brickell share price. FDA approval would be 12 months plus away and so there would be a lag before any future revenue or milestone payments were achieved. 

On June 30^th 2022 it looks like the Brickell Board made a decision to do a reverse stock split 1-45 in an attempt to lift the minimum share price bid back above $1.00, as per NASDAQ compliance requirements.

After the stock split BBI returned to NASDAQ compliance in July of 2022 but that was short lived and Brickell again faced delisting in August, 2022. It was in September this same year that Brickell rebranded and announced a strategic shift into immunology and inflammation fields and away from dermatology. 

I feel like as a clinical stage company Brickell was struggling financially during COVID like most of the market and BOTANIX came along at the right time with a chunk of cash and a possible injection of life back into the stock price which was ailing around and below the $1.00 minimum bid price.  

I suspect Botanix ultimately ended up with the better end of the deal. 

Botanix is now 2-3 months away from potential FDA approval and transition to a commercial pharmaceutical company. All just speculation on my part but I think we will look back at this time as a very strange era in biotech history. I think Vinnie was there with a nice price at the right time and Brickell looks like they needed this. 

Competition to SB

Specifically I have dug into THVD-102. 

I think with any investment research it is important to understand a drug’s potential future revenue and any drugs that might eat potential future market share.

To understand THVD-102 lets follow its journey. There are some very illuminating outcomes and familiar characters. 

THVD-102 was initially developed by TheraVida Inc in 2016. TheraVida developed a proprietary patent protected product for the treatment of hyperhidrosis. The company ran a small phase 2 trial combining Oxybutynin (muscarinic receptor antagonist) and Pilocarpine (muscarinic receptor agonist). Importantly this combination of drugs was a possible step forward in hyperhidrosis treatments. 

Phase 2 trials found that Oxybutynin + placebo treatment performed similarly to the combination therapy of Oxybutynin and Pilocarpine, however there was a statistically significant improvement in associated dry mouth symptoms for patients on the drug combined with Pilocarpine. 

The severity of dry mouth side-effects stopped people wanting to take the Oxybutynin alone. 

This was a desirable outcome, the combined THVD-102 drug was thought to be a potential oral treatment for hyperhidrosis and a competitor to Allergan’s Botox injections.

Enter Roivant Sciences Ltd a self-described next generation “big pharma” company proclaiming that its competitive advantage is that is adaptable and nimble.  With a NASDAQ (ROIV) listing and current shareprice $9.70, Market Cap $7.4 Billion and 758.43 million shares on issue.

Roivant’s Mission statement:

“To improve the delivery of healthcare of patients by treating every inefficiency as an opportunity.”

Roivant’s Goal:

“To identify novel or clinically validated targets and biological pathways in areas of high unmet medical need. Then seek to acquire, in-license or discover promising drug candidates against those pathways or targets.”

Roivant Sciences Ltd has developed an agile “VANT” model. Vants are subsidiaries of Roivant’s Sciences Ltd. These Vants specialise in therapeutic areas including immunology, dermatology and oncology. 

Dermavant  founded in 2014 is Roivant Sciences -dermatology subsidiary. Dermavant’s mission is to advance clinical phase dermatology candidates and is willing to carry out preclinical work. 

Dermavant’s flagship drug is VTAMA (Tapinarof 1.0% cream) which gained FDA approval for treatment of plaque psoriasis in adults, in May 2022. Dermavant purchased all global rights to Tapinarof (except in China) from GSK in 2018. They also assumed the responsibility for all developmental milestones owed to third parties.  Roivant paid GSK US$330 million and agreed to run all phase III clinical trials for both psoriasis and atopic dermatitis. 

Dermavant paid GSK $198 million for the preclinical drug with a further $132 million in developmental milestone payments. 

VTAMA is also a potential treatment for atopic dermatitis in children and adults. The drug yielded positive phase III outcomes as a safe and effective treatment for adult and paediatric (non-steroidal option) for the treatment of dermatitis, in March 2023. 

Dermavant has a history of buying pre-clinical drugs and running phase III themselves (presumably to get the drug for cheap). This has proved to be a winning formula for VTAMA through to Feb 2023 the company had sold 100,000 prescriptions, written by 8,600 unique prescribers for plaque psoriasis. Net product revenue for the December 2022 qrt was US$9.2 million. 

Back to THVD-102 – In 2018 Dermavant bought the rights to TheraVida ‘s hyperhidrosis drug THVD-102 and renamed the drug RVT-504. This deal consisted of an upfront fee and milestone commitments of a undisclosed size. The plan was to run this oral drug through phase III trials and hopefully launch it as a competitor to Allergan’s BOTOX. 

Fast forward to June 2022 and Pfizer partnered with Roivant Sciences in a deal to launch TYK2 inhibitor Brepocitnib for the treatment of dermatomyositis and lupus. 

This was an expensive deal and meant that mothballing several Vant subsidiaries would be necessary. Dermavant lost half its dermatology program funding. RVT-504 for hyperhidrosis was cut. So this drug has not been developed any further. 

Now to the interesting part. Howie McKibbon Botanix Pharmaceuticals current Chief Operations Officer most recently served as Senior Vice President for world-wide commercial operations at Dermavant from 2017-2019. Therefore he would have been very familiar with hyperhidrosis market as he was present at the time of the Dermavant purchase of THVD-102. He had not doubt realised this competitor had mothballed their program and would be years away from being a viable competitor to the more advanced SB program. 

He would certainly be privy to Dermavant’s dermatological program and the fact that this company had a gap in both the acne and hyperhidrosis space. 

Roivant Sciences has certainly been known to partner/ licence and buy rights to pharmaceuticals including pre-clinical drugs. I found it interesting that during recent meetings with share-holders there was a huge stress placed on Botanix being very happy to go to market themselves. Perhaps this was a signal that they would not be willing to take a low offer for a preclinical drug from the likes of companies like Dermavant. They are likely holding out for the big offers once the SB has FDA approval and sales.  All speculation of course. DYOR. 

Pls note the one and only time I have shared this on another forum first. I wrote this in response to a poster's question elsewhere. I have included this on Strawman for completeness of any and all analysis on Botanix Pharmaceuticals.

Botanix pharmaceuticals is no longer a pre-revenue biotech.

Botanix is entitled to royalties for sales of SB from Kaken Pharmaceuticals in Japan. Details are still vague on sales numbers and royalty amounts but will become clearer with the next few 4Cs.

Further news announced yesterday is that Kaken has struck a deal to sell SB into South Korea through Dong Wha Pharmaceuticals. Botanix will be entitled to royalties on sales in South Korea also.

While the company states the sales royalties will not be significant a new territory of SB distribution further derisks this drug. It increases likelihood of FDA approval in the US come September. This will be a direct sales and revenue path of Botanix.

6A1152943_BOT 1.pdf

Bot has just dropped below last credit raise price of 9c last month. This has stifled upward momentum it was finally achieving hitting 12c in the last month.

September is D-day for the FDA decision for its lead drug Sofporonium Bromide. This drug is a shoe in (famous last words)! The team leading this company are likely to have first sales rolling out of factories within a month of approval.

Similar to Neuren’s manufacturers Acadia, the team is very experienced who will be manufacturing the product. They have used the suppliers previously with other pharma companies that the team has been involved in.

Read previous straw re market opportunity. We are watching a replica unfold with Kaken’s product Ecclock in Japan.

This one leaves me scratching my head. I could end up with egg on my face but I am pretty confident about this one’s share price significantly rallying on approval.

Botanix has passed mid-cycle review with FDA de-risking Sofporonium Bromides chance of approval in September.

This is a new best in class alternative to surgery. Hence likely to take market share from incumbents on approval. Alternative treatments have a lot of side-effects. https://themarketherald.com.au/__trashed-2023-04-03/amp/

https://www.theaustralian.com.au/business/stockhead/after-neurens-success-which-other-asx-health-stocks-are-knocking-on-the-us-fda-door/news-story/725965da0628dfabb9f7f04833661d08

Interesting post FDA approval of Neuren there is a resurgence in interest of asx biotechs. One glaring omission is Botanix Pharmaceuticals which is awaiting the mid-cycle review for Sofporonium Bromide with the FDA in the next 6 days. There is strong confidence that this treatment for axillary hyper hydrosis will be approved q3 this year. It will be best in class treatment (see previous straws) and has already met stringent Japanese standards and has been approved.

This company has run foul of investors due to mixed acne results in 2019 and is still suffering from poor investor sentiment not unlike PXS.

Although not sub 1 cent.

https://stockhead.com.au/experts/tim-borehams-20-asx-stocks-that-are-primed-to-run-in-2023-part-2/?amp

#1 ASX Small Cap Biotech and potentially 3 phase 3 Products in 2023 #A US Pharmaceutical take over target in the making

This week Botanix Pharmaceuticals announced a successful phase 1b/2 trial of its Rosacea drug BTX 1702. The share price bumped 10% which given current market conditions was not a surprise. The only thing rewarded in the current market is profit and a well-controlled balance sheets. Speculative pre-revenue biotech stocks have taken a beating during the recent market cycle and this is likely to continue. However with mid to long-term time frames this may be a once in a lifetime opportunity to accumulate at share price lows. 

The latest Rosacea ASX announcement, clinical outcomes and study photos can found here (https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02581684-6A1115189?access_token=83ff96335c2d45a094df02a206a39ff4)

Rosacea is a socially embarrassing skin condition, where patients experience very red and blotchy skin. This has traditionally been incredibly hard to treat.

Botanix Medical Adviser Dr. Ira Lawrence comments on the success of the trial using Botanix synthetic CBD formulation BTX 1702 and the novel Permatrex delivery system:

“To achieve this level of inflammatory lesion reduction and improvement in both IGA and CEA within 8 weeks is very exciting, particularly with such an excellent safety profile. There is potential for even greater efficacy if the treatment period is extended to 12 weeks duration, especially if the efficacy continues to improve, as it did at each time point assess in this study, and could represent the possibility of best-in-class performance with BTX 1702.”

I believe Botanix Pharmaceuticals is a hidden gem. With approval of its flagship drug for Axillary Hyperhidrosis Pending in 2H FY 23 and manufacturing preparations already underway, this is one biotech which has a strong possibility of transitioning to a revenue generating business by the end of next year. 

Botanix has no debt. On Sept 12 it completed a successful capital raise with AUS $7.5 Million worth of shares to sophisticated and institutional investors. The balance sheet is healthy with enough funds for Sofpironium Bromide FDA filing and manufacturing. As well as funds assigned for the BTX1801 anti-microbial drug Phase 2b trial and potentially the Acne BTX 1503 Phase III trial. 

See the table below to follow this companies pipeline. 

Current Product Pipeline 

There are 2 more Phase III studies pending  for FY 23 and there should be enough money for completion  of the BTX 1503 study. However with the latest Rosacea trial success it is more than likely that share-holders may see a further capital raise next year to push this drug through Phase III trials more quickly. I think this will be money well spent. 

The last 2 rounds of capital raisings that have taken place in the past 4 years have been filled quickly by sophisticated and institutional investors. Retail shareholders have not been given an opportunity to participate and have had to buy on market. It would be nice to allow current shareholders to access capital raisings at a discount to SP in the future as a reward for their patience. 

An alternative possibility to another capital raise to fund the Rosacea phase III trial will be to partner with a larger US pharmaceutical company. Vince Ippolito, Executive Chairman, has suggested a Botanix buyout is the ultimate goal however the timing of this is pure speculation. His last successful early stage pharmaceutical company sale to Pfizer had at least  1 successful FDA drug approved. So the earliest likelihood of a future sale would be following Sofpironium Bromide  FDA approval in the later half of next year.

The results look very promising for a stand-alone rosacea drug and a phase III trial next year. This recent clinical trial also helped to further prepare for the BTX 1503 moderate to severe acne trial which is due to start its phase III trial next year also. The safety efficacy of a stronger dosage of 10% synthetic CBD is now established. There were no adverse effects recorded with the new stronger concentration. 

Market Opportunity

*Projections from Euroz Hartley Report based on Kaken pharmaceuticals revenues where Eclock (Sofpironium Bromide 5% gel)  is already approved In Japan and being sold.

** Projections use Eclock prescription sales estimates and US nearest competitor QBrexa pricing (approximately US $540/ month) to estimate FY 23 potential revenue. 

In its latest Botanix report Euroz Hartley made a valuation comparison to another ASX listed company, Clinuvel (CUV). With its current maket cap of just under $1 billion and its estimated sales of US $45 million in FY 22. It currently has a share price of $18.41 per share.

With approval of Sofpironium Bromide 15% gel first year revenue projections of US $130 million+ makes a compelling case as to why investors may want to look at a little closer at Botanix Pharmaceuticals.

Cheers

Nnyck

Botanix Pharmaceuticals has just announced acceptance of its filing for Sofpironium Bromide as A NDA with the FDA. Botanix has a very experienced team that between them have successfully launched approx 40 dermatological products in the the US.

SB has already passed the stringent hurdles of the Japanese regulatory system and is generating revenue.

This will mean If FDA approved SB -Botanix will become an income generating pharmaceutical company by Q4 FY 23.

6A1111220_BOT.pdf

Interesting article highlighting some fan favourites PME included but also mentions Neuren Pharmaceuticals and Botanix Pharmaceuticals potential to be market giants if dominoes fall the right way. The elusive next CSL many of us are hunting for.

https://www.livewiremarkets.com/wires/is-another-csl-hiding-on-the-asx

#Botanix #FDA filing accelerated #2clinicaltrialsontrackforcompletionQ3

22/23 are shaping up to be pivotal years for this small Australian biotech. Currently sitting with a $68 million market cap and $17 miilion cash on hand. 

I am a strong believer in this company due to the proximity to revenue and the range of potential products. This I believe diversifies the risk of my investment. The conditions targeted are common problems that have lacked innovation for decades. Often competitors such as acne drugs can have severe side effects (e.g. roacutane and suicidal ideation and intolerance to sun exposure). So far synthetic CBD is proving to be incredibly safe in all clinical trials. 

There is a current Product Pipeline of 5 drugs for a range of conditions. 1 pending FDA approval and commercialisation. 

Table 1: Current Product Pipeline

(Source: https://botanixpharma.com/pipeline/)

This week’s announcement was very positive for Botanix Pharmaceuticals next step toward revenue generation. It’s new drug to treat PrimaryAxillary Hyperhydrosis (excess sweating) Sofpironium Bromide (SB) filling for NDA status with the FDA has been bought forward to this quarter. There is a very high chance of FDA approval given that 85% of patients who used SB experienced clinically meaningful improvement in their condition during the Phase 3 trial. Plus SB is already approved and currently being sold in Japan. 

If successful SB will be Botanix' first product to market. 

Botanix announcement confirms commercialisation preparations are already underway. Vince Ippolito President and Executive Chairman released this statement:

“over the coming months Botanix will commence the process of preparing for inspection of its contract manufacturing site and other FDA pre-approval activities.”

Furthermore Rosacea (BTX 1702) Phase 2 Clinical Trial is fully recruited and underway. This clinical trial is crucial in advising synthetic CBD dosage that will be used in upcoming Phase 3 Acne trial. 

The canine dermatitis pilot study (BTX 1204A) is also fully enrolled and due for completion in Q3. This will advise whether future human dermatitis trials will be pursued and provide another quick to market commercialisation opportunity if successful in the veterinary market. 

Recent Broker report released by Euroz Hartley. Taking in to consideration the latest SB drug for HH. Lifts price target back to 0.25c. Still rosacea, atopic dermatitis and anti-microbial platforms to factor in.

https://botanixpharma.com/wp-content/uploads/BOT_13May22.pdf

#newacquisition #derisked #commercialisationpathwayto #REVENUE

I did a quick post this morning before I got to dig in tonight to all the nitty gritty released by Botanix Pharmaceuticals recently. 

This month news has been coming thick and fast. Significant price inflection points for the company are multiple over the next 6-12 month timeframe.

I have been invested in this stock IRL since 2018 and have slowly been building a position. I fundamentally believe in the science of this company and BOT has a world class team and track record of players in the dermatology start up space. Please see previous straws. 

A few of us have been playing the guess the new commercial product that Botanix is acquiring game – well the suspense is finally over and our answer arrived today. (My guess was wrong)

 Who are Botanix Pharmaceuticals?

They are an ASX listed dermatology and anti-microbial company that is developing new classes of unique drugs to solve inflammatory and bacterial issues on the skin. 

Major Pipelines:

 Skin

·      Atopic dermatitis- 1204 A (developing in canines first for faster commercialisation – testing very similar beast to the dermatitis seen in human skin)

·      Rosacea – BTX 1702 (PHASE 2B)

·      Acne-BTX 1503 (Pending PHASE 3)

 Penetration formula

 ·      Permetrex delivery system (patented) dermatological invention to allow larger amounts of drug molecules to cross the dermis 

 Anti-microbial

·      BTX 1801 – (PHASE 2B) nasal gel to prevent blood stream infections in haemodialysis patients

·      This drug has recently achieved FDA QIDP (Qualified Infectious Disease Product) status – meaning fast track registration on successful trials and extended protections against competitors and sole revenue for commercialisation for multiple years.

 New acquisition (Just announced)

Sofpironium Bromide (SB) to treat Axial Hyperhidrosis

·      FDA approval planned for 2^nd half of 2022

·      US Commercialisation ready end of 2023 (upon successful approval) leading to earlier than expected revenue for this company

·      Removal of the need to raise further capital as will self-fund

·      Sitting on $17 million in the bank – sufficient funds for new acquisition and completion of dermatological clinical trials, prior to revenue from commercialisation of SB

Summing up the new announcement: 

BOT today released news that is has just acquired a new drug called Sofpironium Bromide (concentration 15% gel) let’s use the acronym ‘SB’ for short moving forward. 

There have been strategic plans eluded to by CEO Vince Ippolito over the past few announcements. He is building a team to drive this dermatology company to speedy commercialisation. 

What is SB?

·      Treats: Axillary Hyperhidrosis  (HH) (excess sweating) not the normal sweat from heat and exercise but tonnes of people profusely sweat even while sitting still (affecting quality of life – many people out there have to change their shirts multiple times a day). 

·      Major Zones of HH: Face and Head (called craniofacial), Underarms (called Axillary), Hands and Palms (called Palmer – I like to call it the sweaty Clive), Feet ( called Plantar)

·      Drug class: An anticholinergic/ muscarinic antagonist that gets through the skin (it is a drug molecule that binds to sweat glands and stops the sweat before it is produced and released through the pores in the skin)

·      Safety: The drug is safe and readily broken down and quickly eliminated with minimal side-effects

What do people with HH currently have as a treatment?

Clinical strength anti-perspirants:

·      Old Spice (need I say more!) 

·      Degree

·      Certain Dry 

·      Sweat Block

Limited effectiveness 

Older Prescription Products (contain aluminium chloride a known irritant)

·      Drysol

·      Cuvposa (oral) 

·      Qbrexza (wipe)

Skin irritants and oral side-effects

Invasive

·      Botox armpit injections

·      Heat energy – burn nerve endings

Painful and recurring

Surgical

·      Cut nerve endings

Severely invasive and more sweating elsewhere

So what is the deal with SB?

·      Purchased from:  Brickell BIO (NASDAQ listed company) who developed it through successful phase III trials. Successful randomised double blind control trial (the ‘gold standard’ in research) run on 350 people found that SB met all primary and secondary endpoints in their study

·      Real terms: There was a significant reduction in sweat compared to people who used the vehicle alone (like a placebo in the dermatology world).

·      Side effects: No serious side-effects even after 24 month continued trial 

Why does SB matter for BOT?

Because there has been no new drug molecules in the space for 20 years. The other options out there have significant side effects such as urinary retention, fatigue, blurred vision, constipation, dry mouth.

So I am going to say it…….What is the total addressable market (TAM)?

Estimated $2.8B globally by 2030

How many people suffer from HH?

15 million sufferers in US alone

How long is the HH patent for SB?

Covered till 2034

Novel applicator system patent expires 2039

The kicker is – this drug is de-risked for investors but how?

Brickell BIO had a commercial deal in place with a leading Japanese Drug Company already, called Kaken Pharmaceuticals. 

 Why does this matter?

 Because although SB has passed a successful Phase III trial it hasn’t yet got FDA approval in the US. However Kaken Pharmaceuticals has achieved the equivalent approval already with PMDA (Pharmaceuticals and Medical Devices Agency) which is the Japanese equivalent of the FDA. 

Meaning this drug is largely de-risked Kaken and Botanix and Brickell BIO are all now working together to get SB approved in the US. FDA submission is due later in the year and usually most drugs take 12 months to achieve approval for a successful submission. 

While this is in process Kaken will continue to sell the ECCLOCK^R drug and bring in revenue that it will share with both Botanix  (25% of royalties and sales milestones go to BOT) and Brickell BIO. 

Interesting side note Japan is one of the biggest markets for HH in the world. Apparently lots of Japanese people suffer from excess sweating. 1 in 20 people or a prevalence of 5.75 % of the population have HH (https://onlinelibrary.wiley.com/doi/full/10.1111/1346-8138.16050). What we can learn on Strawman… if curious this link will lead you to a Journal article from 2021 in the Journal of Dermatology. 

What is the DEAL?

Botanix now owns the product that Kaken sells so they have become an inherited Japanese partner for ECCLOCK sales.  Lease terms  mean Kaken will pay some royalties ongoing to Botanix and some to Brickell as original developer. 

Short-term payments: Remember BOT has $17 million in the bank

·      Botanix to pay Brickell US $3 M upfront payment for SB (Leaves $14 million in the bank)

·      Botanix will pay Brickell a further US $2 M if it helps SB get NDA (New Drug Application) filling with FDA within certain time frame (Leaves $12 M)

·      Botanix will pay US $4 M if FDA approval received before 30/09/2023 (Leaves US$8 M) but nothing extra if not achieved by  17/02/2024 date (back to US $12 M)

·      Botanix will pay US $4 M if marketing approval is achieved by international regulatory authority in Europe or UK approves SB (Leaves $4 M or $8M)

·      Botanix will pay US $4 M if marketing approval is achieved by international regulatory authority in Europe or UK approves SB if approved for a new indication (Leaves US $2 M or $8 M or $4 M depending on above)

·      Botanix will pay for some reimbursement expenses for SB occurred in recent months (no details yet)

·      Payments are back ended in this deal – There will be a one-time sales milestone payment once sales of SB exceed US $75 M for the first time in a year.

·      Capped payments at $160 M ( to pay this net sales for SB would need to reach US $1.8 B. 

·      Botanix will pay royalties to Brickell and Bodor (original patent holder) aggregate start at 12% and rise to 20% if annual net sale are above US $500 M.

So far SB targets Axillary Hyperhidrosis (armpits) however Permetrex Delivery may be able to aid further indications (cross dermis more readily) for:

·       Palms, feet and breasts

·       This will add additional revenue if successful 

Follow up research will be provided when I get a chance. 

Interesting potential de-risked impending revenue for Botanix. Learn more through the following links:

https://www.youtube.com/watch?v=iyFBq4-Go7U&t=6s

https://www.youtube.com/watch?time_continue=2&v=64FX5QIUSF8&feature=emb_logo

Huge news for Botanix more details to follow. Management taking strides to purchase commercial ready products to fund business.

https://www.globenewswire.com/news-release/2022/05/03/2435013/0/en/Brickell-Biotech-Announces-Sale-of-Sofpironium-Bromide-to-Botanix-Pharmaceuticals.html

Botanix Pharmaceuticals released a very positive announcement today and didn't go red! Trust me you would get it if you held. The company is certainly demonstrating its salt with its ability to navigate the FDA maze.

BTX1801 - Anti-bacterial product had received previous FDA fast track status for post surgical infections. Matt Callahan and the team revealed a slight change in tactic late last year - with a pivot toward bloodstream infections in haemodialysis patients instead. It was clear that this approach would be more clear cut for designing trials, there was a significant need and essentially no registered competition.

The FDA clearly agrees. Results for the study are expected by the end of the year.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02514465-6A1088574?access_token=83ff96335c2d45a094df02a206a39ff4

No doubt many of us are finding it harder to find decent returns in the current markets. I know as someone heavily invested in health care and the tech space my IRL portfolio has seen prettier days.

With the health care index tipping as low as -12.68% compared to the benchmark S&P ASX 200 you can be forgiven for looking away and going to the pub.

However there are some bright spots in amongst the carnage. Kalkine media has just released an article highlighting the best year to date returning healthcare stocks https://kalkinemedia.com/au/amp/news/stock-market/from-imc-to-ala-healthcare-stocks-with-best-ytd-returns

It will be no surprise to current Strawman holders some of the better performing stocks these include:

IMC

Neu

LCT

BOT

ALA

I currently hold Neu and BOT IRL and on Strawman.

Neu has had multiple major milestones over the past 6/12. Its major lift was toward the end of last year however positive momentum has continued in 2022 with YTD returns of 7.96%. Share holders are patiently waiting for the second company inflection point in June this year. Shareholders are optimistic of FDA approval of its drug Trofinetide for the treatment of Rhett Syndrome after a successful Phase 3 study. I am keen to stay invested for this as well as a possible rest of the world deal for this same drug- this could be announced anytime.

BOT has seen even better YTD returns of 41%. Management has been actively recruiting and made recent high caliber hires to join its Board to help with upcoming commercialization. A new Non-Executive Director position has just been filled by Danny Sharp - who has 30 years experience in commercial banking with specialties in healthcare and technology. He also currently sits on the Board of Alcidion (ALC).

The CEO and President of BOT have been hitting the pavement at recent roadshows eluding to a likely upcoming commercial deal with an expanded product line involving their patented skin delivery system Permatrex. They are actively seeking assets to acquire that can quickly and easily utilize the delivery system and be ready for immediate commercialisation. This may provide a revenue stream much quicker than shareholders had been expecting.

It is nice to hold stocks with plenty of cash in the bank and further upcoming inflection points.

Biopharm magazines have frequently mentioned the number of cashed up pharma companies that are looking to buy startups with progressed assets. In an inflationary world that is becoming increasingly difficult to get access to capital, I see the biopharm sector as being a promising anomaly.

Botanix Pharmaceuticals has just received a $2.75 million R & D tax incentive. Adding to its already strong cash position of $16.8 million. Renewed interest in this stock and impending readouts across multiple phase studies and products has seen a nice SP rise for holders in the last few months.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02503247-6A1083605?access_token=83ff96335c2d45a094df02a206a39ff4

#Botanixbigyear2022  #Upcominginflectionpoints #Interviewsharecafe

Biotech investing can be a long, drawn out, high risk, exhilarating and frustrating endeavor. It certainly isn’t for everyone. Botanix Pharmaceuticals has been one of my most memorable stocks. I have been invested in and out since 2018.

As small cap investors we can get caught up in a story. Early biotechs especially – often have no revenue and will come cap in hand to investors, time and time again. As early entrants you will witness first-hand how often cash can magically be transformed to smoke – it is amazing to watch.

However, investors can keep coming back attracted to a story – the allure of the unicorn, the cancer cure, the miracle breakthrough, it can keep you hooked. Other times biotechs attract people who have been personally affected by whatever ailment a company is attempting to fix, hoping that the drug will give relief to loved ones or lengthen or improve quality of life.

Unlike other biotechs that I have been invested in Botanix has not asked for anything from me as an investor, other than time, patience, a strong will and cast iron stomach. Since I have been invested there have been no on market capital raises and there are not currently any plans for one in sight.

Botanix is in the unique position of having $17 million cash on hand. Given the current macroeconomic headwinds in the biotech space the past year – this is nothing to sneeze at.

The cash burn has been very well managed (refer to reports and previous straws). Botanix raised $40 million at $0.20c a share from US investors in 2019. This has kept the company ticking along nicely.

Executive Director – Matt Callahan was interviewed on Share Café this week to discuss 2022 and impending inflection points for this company.

 Summary of Botanix Pharmaceuticals Position:

 Market Cap: $52 M market cap

Cash on hand: $17 million

Current SP: 0.054c

Shares on issues: 973,142,074

Matt Callahan has overseen: 5 drugs approved through FDA process

Vince Ippolito President and Executive Chairman of Botanix: 2 previous companies sold to big pharma for $2.6 billion and $5.2 billion.

Upcoming Milestones Summarised Nicely (share café interview slide)

Botanix planning to commercialize and market its own products in the short term. Add revenue to fund clinical pipeline a priority. Next 6-9 months expect announcements on immediate commercialization deal in the dermatology space.

Pipeline

Target Markets

No evidence of anti-microbial resistance with synthetic CBD in studies conducted so far!!!!!! - ground breaking (2021 paper released in https://www.nature.com/articles/s42003-020-01530-y.pdf Communications Biology

Further studies in antibacterial properties of synthetic CBD underway this year. Game changer.

No new products in the dermatology space with a new mechanism of action for 25 years. Synthetic CBD is safe in large dose testing so far. FDA very likely to approve drug due to safety.

Alternatives - oral antibiotics Roacutane suicide risk for teens (Matt believes FDA would not approve such a drug for acne in modern times). Alternatives have significant side effects - synthetic CBD no recorded negative side-effects.

During the interview Matt acknowledges the disconnect between the clinical development pipeline and the share price. Also mentions how incredulous the team were to announce positive antimicrobial trial data and to watch the share price drop. He believes the next few months will see SP growth back to 20-25c range. 

Hints: to watch this space with upcoming announcements next qrt on doggy dermatitis trial and commercialisation opportunities.

Matt states and I paraphrase ‘Vince Ippolito is a commercial animal and is raring to go.’

Dermatology products are a much easier to sell in the US then most other drugs. With 5000 Dermatologists keen to trial new potentially beneficial products for the patients. Matt sees a salesforce of 30-40 people on the ground as a future strategy to get potential products selling.

Disc: Held Strawman and IRL

Botanix Pharmaceuticals Management

24.09.21

 Botanix has announced the expansion of their Senior management team with the appointment of a new Senior Vice President of Pharmaceutical Development Dr. Jack Hoblitzell PhD. 

The nay sayers could potentially argue this is a sign of bloated management expenses for a company that currently has no revenue outside Australian Government R&D grants. However, it all depends on the calibre of the new recruit. Botanix has been reasonable with cash flow management and managers keep salaries low and opt for future options in their packages. 

Botanix has made no secret of future strategies to add quick revenue streams. The following angles are being pursued:

1) BTX1204A for canines and 

2) Leveraging its exclusive lease of the ‘Permetrex’ delivery system (alcohol free system to improve penetration of drug molecules through the skin). 

A quick LinkedIn stalk and review of Dr. Hoblitzell (why is some random chic from Australia looking at my profile?) suggests that he is a very appropriate hire at this point for the company. 

Dr. Hoblitzell BIO

The press release promoted him claiming he has experience leading world class technical operations to deliver new product launches (tick).

Years of experience with regulatory submissions – wrangling FDA (tick).

Excellence in manufacturing and supply chain management. If anyone else was around for the great acne debacle of 2019 you would get this! CBD was a restricted drug in some states in the US and could not be transported across state lines…..nightmare. (so tick tick).

Experience supporting pipeline development and ACCELERATING the development and SCALE UP for commercial capabilities (tick tick tick). 

Dr. Holblitzell is a registered pharmacist.

Where has he come?

 I note a lot of Pfizer ties revealing themselves for Botanix Pharmaceuticals. 

Formerly: 

Snr Vice President Of Technical Operations at Assertio Therapeutics Inc. May 2020-June 2021 (not there long). Assertio Therapeutics has a $0.04 Billion dollar market cap. This company specialized in pain relief drugs: diclofenac potassium, indomethacin, oxycodone Hcl. 

Dr. Hoblitzell has a fairly long history of overseeing mergers of pharmaceutical companies. This is also a point that Vince Ippolito CEO has frequently addressed that Botanix is a likely buy out target with the number of product pipelines they are developing. Frequently, referencing Jazz pharmaceuticals buyout of GW pharmaceuticals for $7.2Billion for their CBD based epileptic medication. 

Of course everyone invested or researching Botanix Pharmaceuticals is well aware of our illustrious CEOs background. One of the main reasons I have stayed invested. He oversaw the Pfizer buyout of Anacor Pharmaceuticals dermatology platform for $4.5Billion. 

Dr. Holblitzell has also been Senior Director of Pharmaceutical Technology and Global Manufacturing Services at Pfizer. Here he is endorsed by several Pfizer colleagues. At Pfizer he was responsible for the integration of King Pharmaceutical products and processes into the Pfizer co-development and manufacturing supply networks. 

He was also Vice President of Technical Operations at Zyla Life Sciences for 5 years. 

He was endorsed by former colleagues from King Pharmaceuticals where he worked before a buyout by Pfizer. 

Lynn F Palmer Senior Vice President: Technical Operations of Pharmaceuticals at Osmotica Pharmaceuticals (Worked together with Dr. Holblitzell at King Pharmaceuticals) wrote:

“Jack is a practical and effective Pharmaceutical Development Executive. He has effectively  led the development of multiple formulations, and scaled them up to commercial scale. He has extensive industry and technical knowledge of formulation development, product stability, pharmaceutical packaging and equipment capability and setup. I strongly endorse him. “

Pfizer’s brief

 A pharmaceutical company that applies science and global resources to improve health and well-being at every stage of life. Pfizer has a $246 Billion market cap. 

Interesting to note Pfizer looks to “set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals.” (synergy with animals here as well) 

Summary

He seems like a great get. 

A lot of tie ins with Pfizer for both he and Vince – is this the hope? A Pfizer buyout?

I am really curious as to why a po-dunk back water Perth company with a $64 Million dollar market cap, currently trading at $0.074 per share is attracting these recruits. I certainly have my thesis – the CBD molecule patents and FDA fast track approval status achieved for their anti-microbial platforms are certainly compelling. 

Announcement: Canine Atopic Dermatitis Program Launched 

29.09.21

Today Botanix Pharmaceuticals announced the BTX1204A proof of concept (POC) canine study for atopic dermatitis is underway. 

Pilot study results have been encouraging and this POC also has a two-fold goal of testing effectiveness of the treatment and testing a much stronger formulation which will likely be used in human trials of atopic dermatitis going forward. 

The canine study will be carried out in Aus and NZ. 

45 canines will be tested across 3 sites. The results of three study groups will be compared BTX1204A high dose, BTX 1204A low dose and Vehicle arm. Canines are tested twice daily for 28 days. 

Results will be rated on the Enhanced Pruritis Score (EPS) and Canine Atopic Dermatitis Extent and Severity Index (CADESI-04).

There is great hope that successful results will lead to a quick to market product in the canine space. There is an added benefit, as successful trials in dogs will be encouraging to pursue further human trials with these stronger dosage formulations (as dog and human dermatitis is biologically very similar).

Synthetic CBD studies so far have indicated huge potential anti-inflammatory and anti-bacterial properties of their products. 

There is a huge need and TAM for safe and effective products for dermatitis. 1 in 10 people will develop dermatitis at some point in their lifetime (31 million US figures). 

BTX1702: Update

1b Rosacea study – randomised double blind vehicle-controlled study has successfully started recruiting across sites in Aus and NZ. This study has an 8 week treatment period. 

BOT is looking for 120 recruits. 

Botanix is establishing itself as a multi-pronged product developer. There are now 2 development platforms 1) Dermatology and 2) Anti-microbial. Botanix Pharmaceuticals is pursuing effective, clinical based, FDA approved solutions for acne, rosacea and dermatitis. Plus hoping to be the first company to market with a new drug class of anti-biotic. This will be the first new type of anti-biotic class developed in 30 years. 

As a long suffering share holder I am excited about the smart pivot of management to pursue the canine option. This product if successful will be much quicker to get to manufacturing stage to provide this company its first revenue stream. I could see this happening within 12 months. There is plenty of money in the bank with +$21.56 Million not bad for a company with a $65 Million dollar market cap. Management is proving very wise to date keeping their cash burn low and taking massive pay haircuts during covid in exchange for future options. 

Founder led and large management holdings that have not been sold down on intermittent share price rices help me to keep the faith. 

On Tuesday 2nd of Feb 2021 BOT went into a much anticipated trading holt for the release of results of its BTX1801 Clinical Phase 2a study. Preceding weeks had seen BOT share price peak at 18c around the 25th of January in anticipation of results. This was a far cry from the 29c the company reached on 2nd of August 2019 on anticipation of a less mature stage of the company without the anti-microbial drug potential in the mix. 

The share price leading into the anti-microbial BTX1801 announcement was also a much bigger discount to the Cowan investment of 20c per share made by the US company in 2019 in the lead up to BTX1503 acne results.

As investors are aware following mixed results of BTX1503 acne in 2019 the share price more than halved to 12c on October 25th. It continued its gradual decline to as low as 2c around March 2020 before a slow climb back to its recent 18c peak prior to the anti-microbial results. 

Results released on the 3rd  of February 2021 were excellent. Primary end points of the phase 2a study were met. The CBD BTX1801 gel and ointment formulations both successfully and safely reduced Staph infections in the nasal cavity of patients verse a vehicle control. A collective shareholder sigh of relief and anticipation was warranted.

Mr Market had a very odd response to this result.

Each clinical trial stage passage potentially de-risks the drug and improves chances of success and future commercialisation. This process is analogous to climbing each progressive rung of a ladder.  Share-holders would then rightly anticipate share price rises accordingly as each rung is passed in Biotech companies. However despite this result trading saw a closing price of 17c on the 3rd following the announcement and a gradual decline to 13c at close on the 8th of Feb, 2021. This price was near parody to the SP after the disappointing mixed results of the acne BTX1503 drug in 2019. 

The share price does not currently appear to reflect a successful 2a BTX 1801 trial outcome. 

Seemingly the market failed to acknowledge the passage up another rung of the ladder toward a potentially efficacious and safe new anti-biotic class with synthetic CBD BTX1801. This will be the first new class of antibiotics in 60 years. It was also the first human trial in the world to show that CBD can kill Staph aureus in 76% of patients after 5 days of treatment and that it has residual effects for up to 28 days. 

This was a phase 2a study so optimal treatment dosages and comparisons to other drugs on market was not the study design. Safety and early efficacy and formulation methodology are being established. Nothing more nothing less. Was it safe, tick, was it effective, tick.

The meeting of the primary end points of this BTX1801 study can likely be extrapolated to  provide further supporting evidence for the other drugs in the pipeline using synthetic CBD. Acne successfully kills staph aureus. Staph is part of the natural flora of the skin and overgrowth of this bacterial gets into pores causing acne. Ergo reduce bacterial load reduce acne. 

Hence the results are another rung or two up the ladder toward successful commercialisation of potentially 2 pipeline drugs.

Biotech investing is a complex game and one where opportunities can be found and advantages can be had for those with a scientific background. Scientific language seems to be the area of confusion where market price can be won or lost or confusion and games can ensue to the advantage of those who know how to play. What do the primary end points mean? What are p values? What sample sizes carry statistical significance. Market misreads are certainly not unique and hesitation of market responses can be used to traders and investors advantages. However it can also lead share-holders to sell when they should hold or buy more. 

Add to the complexity that traditional value investing rules do not apply when assessing a Biotech. Firstly there is rarely a commercial product producing income in early start up companies. R and D tax refunds are often the only revenue these early stage businesses rely on. Otherwise outside investment from bigger pharmaceutical companies or entities with a vested interest may produce some capital. 

So why would an investor take on the risk of investing in the Biotech? How does one even start to value or understand the market capitalisation of these kinds of companies when traditional metrics are out the window?

Each investor has their own reasons and motivations: some believe in the science or the potential life altering outcomes of the new therapeutic or diagnostic test being developed while others know that the biotech space is traditionally a high risk and high reward play. 

Biotech companies rely on their shareholders to provide working capital to progress from pre-clinical through to often costly phase 3 trials.

I believe value comes from novelty, the problem being solved, the need and the potential addressable market and the number of products in the pipeline of the Biotech. 

So rather than looking at balance sheet and revenue growth the incremental value increases occur with the rungs climbed up the ladder from the pre-clinical proof of concept through to the Phase 1 safety through to the Phase 3 results. All are significant milestones for these companies. 

90% of drugs fail to reach commercial products due to safety issues. Botanix Pharmaceuticals has a SAFE synthetic CBD product across all its drug channels: acne, anti-microbial and rosacea.

In a study of 640 phase 3 novel therapeutics 54% failed in clinical development. So even if a drug makes it to phase 3 less than half will be approved to commercialisation. 57% of those drugs will fail due to inadequate efficacy (Hwang T.J., Carpenter D., Lauffenburger J.C., Wang B., Franklin J.M., Kesselheim A.S. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern. Med. 2016;176:1826–1833). BTX1801 reduced Staph infections and destroys the bacteria through destruction of the cell wall. This drug potentially can be used without Staph aureus building resistance to it (lab tests only so far).

BTX 1801 anti-microbial once again has shown to be safe, tick, effective in 2a trials, tick. Given its tolerability and safety profile there are low drop out rates in previous trials and likely to be compliance of participants in trials moving forward. The management team also has experience with following FDA study guidelines given their vast experience at previous companies. Failing to comply with FDA study regulations are another reason trials frequently fail. 

I perceive the biggest likely hurdle for this company is not failure in trials due to efficacy, safety or not following FDA regulations. The biggest risk given COVID is recruitment and trial interruptions moving forward. Hopefully this can be mitigated or future trials can be continued in Australia and New Zealand as opposed to the US to ensure continued timely progression of the companies pipeline. 

Botanix pharmaceuticals is now a company with diverse and maturing product pipeline with a 2b Rosacea trial about to begin Q1 2021. This addresses a unique market in its own right and simultaneously provides an FDA building block toward Phase 3 BTX1503 acne the final phase prior to commercialisation. Further anti-microbial BTX1801 advancement should be fast tracked and phase 2b trials should also begin this year. 

Given this companies progression up the ladder I do believe it is currently significantly undervalued. Share-holders will stay and more will be added to the register to help fund future studies but reward is needed to incentivize new money into Biotech companies. That is the nature of the high risk high reward play. Opportunity costs can indeed be great if money remains parked in these companies without bouts of significant reward. 

It is obviously up to the each individual shareholder to assess whether the progression of the drug pipeline of this company has merit. 

In the next 2-3 weeks Botanix Pharmaceuticals is about to reach a significant clinical milestone in its drug development program. 

Results of  the Clinical 2a Antimicrobial BTX 1801 program is just about due and this will be a huge potential inflection point for this company. 

Share price took a beating on mixed results for its acne phase 2b trial in 2020 seeing the Share price drop from a peak for 29c to lows of 2c. 

Investor faith in this company has waivered. However the Australian arm of these results were incredibly promising. The poor result from the US arm was due to complications in formulation consistency in this country, who was not experienced in the development of the carrier solution Permatrix or in the manufacturing of synthetic CBD used. This issue has since been rectified by sourcing a consistent manufacturing solution for future trials in the US.  

Botanix is developing simultaneous programs:

1)    Entering phase 3 Clinical trials for acne BTX 1503 in 2021

a.     Addressable market currently US$2.9 billion annually in the US

b.     Botanix addressable market estimated to be US $4.2 billion annually and US $7billion by 2024

2)    Completing Anti-microbial 2a testing and data readout Jan 2021

3)    Commencing Rosacea BTX 1702 1b trial in 2021 

a.     Addressable market US$2.6 billion by 2025

Multiple drug development programs I believe somewhat de-risks investment in this company.

Optimism in the antimicrobial  BTX1801 programs success is based on the efficacy of results in previous clinical phase 1 trials and new data recently supplied to the market. The mechanism of action of synthetic CBD has been identified. The drug effects the cell wall of gram positive bacteria allowing penetration and eventual cell death of the bacteria without any apparent development of resistance to the new anti-biotic. This has been shown to eradicate MRSA (Methicillin resistant Staph Aureus bacteria) in both Porcine and Human Invitro studies (human stomach skin harvested from recent abdominoplasties). MRSA has been found to be eradicated completely in a 24 hour period after application of the new formulation. 

Large groups of the population are known to carry MRSA nasally and anally. Self- infection is the route cause of most Surgical Site infections post-surgery. One of BTX1801s major target markets will be post-surgical site infections (SSI). The current anti-biotic most commonly used in SSI control is Bacitracin / mupirocin but it is increasingly ineffective and useless against MRSA. 

WHO (World Health Organisation) has forecast deaths due to anti-microbial resistance to hit 10 million p.a. by 2050. This will overtake expected deaths by Cancer at this point. Estimates suggest that SSI cost the health care systems globally around US$10 billion dollars annually. The addressable market for SSI is estimated to reach $US 5.9 billion annually by 2023. This is a huge market for any new successful anti-biotic to target. 

If successful BTX1801 will be a leading new drug in SSI. No new class of anti-biotics have been successfully developed in the past 30 years. This drug will have first mover advantage plus FDA fast tract QIDP status. Which means fast track of development programs to market plus 5 year exclusivity and a further 5 year protection of markets to competitors. 

Human studies have now been completed, where BTX 1801 was applied nasally over 5 day treatment period in healthy subjects vs a control. Patients were followed for 28 days to see if there was reduction or complete eradication of MRSA. Successful outcomes should see a significant re-rate and restoration of faith in Botanix Pharmaceuticals simultaneous programs. 

Investment in the Acne program alone saw US international investment at 20c per share in 2020. The additional anti-microbial programs success should see this price plus a significant increase based on the huge potential addressable market of SSI. Furthermore Anti-microbials will have other addressable markets – animal anti-biotics etc….. 

The incredible safety profile of this drug will also solidify its game changing status on a global stage. 

The current CEO Vince Ippolito has been responsible for negotiating significant buy outs of dermatological companies by Big Pharma. He was at the helm of Anacor pharmaceuticals when it was bought by Pfizer for $US 5.2 billion. There is a likely buyout potential for Botanix Pharmaceuticals on successful BTX1801 trials. Or at a future stage with further progression of its simultaneous Rosacea and Acne drugs. 

Phase 2a clinical trials imminent. BTX1801 anti microbial results are fast approaching. All participants recruited for 1 week double blind randomized control trial. Follow up data taken up to 28 days following trial. 
 

This is a potentially game changing anti-biotic which has been supported by in vitro studies on porcine and human skin samples. BTX 1801 was shown to effectively kill MRSA. This is one of the most prolific anti-biotic resistant gram positive bacteria. Successful treatment of this bacteria will save lives and safety of hospitals and surgeries world wide.

FDA has approved QDIP fast track development status. Paving the way for US trials and fast track development of BTX1801 following positive phase 2a outcome in OZ. 
 

If Botanix is successful this drug may become the standard of care, replacing Bactroban for post-op surgical site wound infection management. 
 

price at 10.5 c close of trade 13.11.20 seems incredibly cheap. Company is also commencing clinical phase 3 studies in 2021 for its acne drug. 2019 SP reached highs of 29c before the successful trials and data of BTX 1801. 

More waiting games for BOT holders. Significant market over-reaction and SP halving chance to average down. SP likely to return to previous highs with successful phase 3 FDA progression announcement for BTX 1503 by management in feb / March 2020. $40 million in the bank after capital raise, $7M tax break for R and D due. Multiple products in pipeline. Large retail ownership very unhappy with handling of phase 2 results announcement and panic sell-off due to strange and still unexplained large vehicle response in US arm of study (however not dissimilar to vehicle responses in competitive drugs which are sucessfully on market, with much worse safety profiles). However results show BTX 1503 significantly reduced inflammatory and non-inflammatory skin lesions in Australian arm of study with excellent safety profile. Given this medication aimed largely at teens the safety profile will be a significant competitive advantage if phase 3 is successful. Phase 2 clinical trials are focused on safety profiles of drugs which BTX 1503 has certainly met. 

Waiting game for BOT holders. Clinical phase 2 acne results due any day. Funding secured and pushing on with new rosacea trials. If phase 2 successful should see reasonable SP lift. 

Retrace to 23c today likely due to overall market suppression given latest US manufacturing data and recession fears. 

AGM due 30th of October.