The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is dipping after the company released its latest quarterly report.

The cannabinoid-focused pharmaceutical dermatology company's quarter seemed to be a good one, but the market has reacted poorly.

Right now, the Botanix share price is 7.8 cents – 3.7% lower than its previous close.

Let's take a closer look at today's news from Botanix.

The news driving the Botanix share price

The Botanix share price is sliding despite the company's productive quarter that ended on 30 June. Let's take a look at what it was up to over the period.

Financial update

Botanix provided a brief financial update on its performance this quarter.  

The company stated it had $21.6 million in cash at the end of the quarter. That's enough to fund an estimated 12.8 future quarters.

During the quarter, it had net cash outflows of around $1.7 million and it invested roughly $1.2 million in research and development activities.

New drugs

The Botanix share price is dipping despite plenty of productivity over the 3 months ended 30 June.

Botanix launched the Phase 1B rosacea clinical study trial for its BTX 1702 product in June.

The trial is investigating the safety and tolerability of different concentrations of BTX 1702 over an 8-week period.

It's currently being hampered by COVID-19 restrictions. The company's looking at adding more trial sites to minimise the impact of potential future lockdowns.

Additionally, Botanix announced positive results from its BTX 1204A pilot study in canines with atopic dermatitis during the quarter.

The company said atopic dermatitis in canines is similar to that in humans and that the study's results are a good indication the treatment could be transferable.

Also, during the quarter Botanix launched the next phase of its BTX 1801 development program.

The program is aiming to help the nasal decolonisation of Staphylococcus aureus in haemodialysis patients.

It hopes BTX 1801 will help to prevent bloodstream infections in those undergoing haemodialysis, of which the company says there's an "urgent need and significant market opportunity".

Botanix Pharmaceuticals share price snapshot

The Botanix share price hasn't been having a great year so far on the ASX.

It is currently 39% lower than it was at the start of 2021. However, it has gained 58% since this time last year.

The company has a market capitalisation of around $78 million, with approximately 973 million shares outstanding.

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The 2021 financial year was overall a very good one for ASX shares. The S&P/ASX 200 Index (ASX: XJO) managed to put on a performance of 24% for the 12 months to 30 June 2021. That makes FY2021 one of the best financial years ever for the Australian share market.

But some sectors inevitably performed better than others. That's capitalism for you. And the sector we're looking at today – ASX cannabis shares – certainly had its fair share of both winners and losers.

So let's check out how this popular sector fared in the financial year that has just passed us by.

How did the top ASX cannabis shares fare in FY21?

Below is a table of how the ASX's top cannabis shares performed in FY2021:

As you can see, it was something of a mixed bag. If you were lucky enough to hold Creso Pharma shares over the financial year, you would have enjoyed a very pleasing gain of more than 350%. However, if you were unfortunate enough to have money invested in Ecofibre, you instead would have had to cop a nasty near-70% loss for your time, effort and capital.

Highs or red eyes for ASX cannabis?

While each company had its own individual trials, triumphs and tribulations, it's worth noting this is a sector that often moves in tandem. This is due to the unique but uniform challenges ASX cannabis shares all face. The most prominent of these is, of course, the legal status of cannabis itself.

Whilst recreational use of cannabis/marijuana is still illegal in many countries, including Australia, recent changes have been happening.

Perhaps at the forefront of these changes is the ever-evolving regulatory landscape in the United States. As it currently stands, 18 US states currently allow recreational use of cannabis.

Most recently, we saw the state of New York 'legalise it' back in April. This saw an immediate boost to the values of ASX cannabis shares despite the Australian market implications being limited.There is also debate in Mexico over the potential legalisation of cannabis. If this went ahead, it could open up a market of nearly 130 million people.

Another headache…

On the other hand, ASX cannabis shares have seen some setbacks in this arena as well. Last October, New Zealand held a 'reefer-rendum' on legalising recreational use of cannabis across the ditch. It failed, meaning that, at least for now, recreational use of cannabis remains illegal in the Land of the Long White Cloud. This was a big setback for the ASX cannabis sector here in Australia.

But, as you may have noted, there were some clear winners in this space regardless. As we noted earlier, Creso Pharma was the top performer in its sector.

Creso managed to capture investor attention through its acquisition of Halucenex Life Sciences. Halucenex specialises in psychedelic compounds and stands to benefit if the US state of California legalises psilocybin (the active drug in 'magic mushrooms'). This is still currently being debated in the Californian Congress but investors certainly seem optimistic.

It's also worth noting that some of the worst-performing ASX cannabis shares of FY21 were once known as some of the best performers.

Companies like Althea and Xalra were top-performing companies as recently as last year. But the tide has definitely turned for some of these companies' share prices. Mostly, complications surrounding the pandemic, as well as regulatory issues, are mostly to blame here for the woes of Ecofibre and Cann Group in particular.

The post Blazing it? How the top ASX cannabis shares performed in FY21 appeared first on The Motley Fool Australia.

The clinical stage synthetic cannabinoid company's shares ended the day a massive 20% higher at 7.8 cents.

However, despite this strong gain, the Botanix share price is still down 40% since the start of the year.

Why did the Botanix share price rocket higher?

With no news out of the company, today's gain in the Botanix share price is a bit of a mystery.

However, as I mentioned above, with its shares down by materially since the start of the year, some investors may believe they had fallen to an attractive level. Especially given some of its promising studies that are currently underway.

One of those is the BTX 1204 Pilot Study. BTX 1204A is a new higher dose formulation of synthetic cannabidiol (CBD) for atopic dermatitis. It leverages the company's Permetrex formulation used in the recent successful BTX 1801 Phase 2a study.

Management notes that results from a pilot study of canines with atopic dermatitis provides encouraging data to support further investigation. It also provides a clinically efficient approach to inform progression to further human studies.

What else has been happening?

Optimism over the aforementioned BTX 1801 Phase 2a study could also be giving the Botanix share price a lift. A recent update revealed that BTX 1801 was safe, well tolerated, clinically effective, and successful at achieving decolonisation of Staph aureus in the nose.

The success of this study has seen the company launch the next phase of BTX 1801 development, targeting the nasal decolonisation of Staph aureus in haemodialysis patients to prevent bloodstream infections.

Management highlights that there is an urgent need and significant market opportunity for novel approaches to prevent bloodstream infections in haemodialysis patients. Positively, plans for a Phase 2b clinical study are well advanced and can be fully funded with existing capital reserves.

Some investors may be hoping positive updates relating to these studies will keep the Botanix share price heading in the right direction during the second half of the year.

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Botanix Pharmaceuticals Ltd (ASX: BOT) shares are flat today following the company's release of its FY21 half-year results on Friday night. At the time of writing, the Botanix share price is trading at 11 cents, the same price at which it closed Friday's session. 

It seems the weekend has given shareholders plenty of time to digest the pharmaceutical cannabinoid company's numbers, leaving them indifferent.

Botanix share price fails to ignite

Due to the pre-revenue nature of pharmaceutical development, Botanix is heavily reliant on non-operational income. And today, the Botanix share price is languishing after the company recorded a 14% decrease in its operational revenue to $88,871.

As a result, the company significantly reduced its expenditure during the half, particularly on employee benefits and research and development (R&D) expenses. The addition of a considerable $6.88 million R&D incentive scheme refund also enabled the company to deliver a profit of $664,129 for the half.

Botanix continued working on the development of its range of treatments including BTX 1801, BTX 1702, and BTX 1503. In February, the company announced positive data from its BTX 1801 Phase 2a nasal decolonisation proof of concept study.

Other news

Today, Botanix also announced the expansion of its management team with the addition of three new hires in the United States. The company advised the purpose of the new roles is to drive its antimicrobial and dermatology programs.

The new hires will assume the positions of chief medical officer, vice president, and head of commercial. These additions also come with the termination of executive director Michael Thurn.

Botanix mentioned in the announcement that recent positive data from its BTX 1801 antimicrobial study underpins the acceleration of the company's commercial capabilities.

Botanix share price under the microscope

Botanix is in the clinical development of synthetic cannabinoid pharmaceuticals. The company's primary focus is on dermatology and antimicrobial applications.

Despite the volatility, the S&P/ASX 200 Index (ASX: XJO) has now returned around 5.7% to investors in the past year. In comparison, the Botanix share price has netted shareholders more than 57% returns over the same period, a return nearly ten times that of the index.

However, in less positive news, Botanix shares have slipped by around 35% over the past month. 

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Botanix Pharmaceuticals Ltd (ASX: BOT) shares are edging lower today despite the company reporting it has received a research and development (R&D) tax refund. At the time of writing, the Botanix share price has fallen 3.45% lower to 14 cents.

What did Botanix Pharmaceuticals report?

In this morning's ASX release, Botanix reported it has received an R&D Tax Incentive refund of $6.87 million. The company had $19.2 million in cash as at 31 December.

Botanix stated that the tax refund alongside positive data from its BTX 1801 antimicrobial Phase 2a study places it in a strong position for clinical programs and corporate development in the 2021 calendar year.

The federal government provides the R&D Tax Incentive to support companies in their research and development programs. Companies can receive refunds of up to 43.5% of eligible R&D expenditure.

Commenting on the tax refund, Vince Ippolito, president and executive chair, said:

The receipt of the R&D refund provides the company with a strong financial position and funding flexibility across our product development pipeline. Following the announcement of our successful BTX 1801 study data last week, Botanix is well positioned to execute on our dermatology and antimicrobial programs and extend our leading position in synthetic cannabinoid research and development.

Botanix Pharmaceuticals share price and company snapshot

Botanix Pharmaceuticals is a clinical-stage cannabinoid therapeutics company. It focuses on developing safe and effective topical treatments for serious skin conditions. The company has an exclusive license to use a proprietary drug delivery system, Permetrex, for direct skin delivery of active pharmaceuticals in all skin diseases.

Botanix shares listed on the ASX in January 1985. The company has a current market capitalisation of $141 million.

Year to date, the Botanix share price is up 7.7% and has surged around 600% from its 30 March lows.

Over the past 12 months, Botanix shares have gained 55%. By comparison, the All Ordinaries Index (ASX: XAO) is down 1% over the past calendar year.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price has returned from its trading halt with a bang on Wednesday.

In morning trade, the clinical stage synthetic cannabinoid company's shares are up 31% to a record high of 19 cents.

Why is the Botanix share price rocketing higher?

Investors have been fighting to buy Botanix shares this morning following the release of an announcement in relation to its BTX 1801 Phase 2a nasal decolonisation proof of concept study.

According to the release, top-line data from the study shows that two different BTX 1801 formulations (ointment and gel containing synthetic cannabidiol) were safe, well tolerated, and successful at eradicating Staphylococcus aureus (Staph) bacteria from the nose of healthy participants that were nasally colonised with Staph.

The release explains that the primary objectives focused on evaluating safety and tolerability, as well as evaluating the effectiveness of two different candidate formulations of BTX 1801.

Each formulation was applied twice daily for five consecutive days to the inner surface of the nose and compared to respective vehicle or placebo formulations without synthetic cannabidiol.

At day seven, Staph eradication was demonstrated in 76.2% and 68.8% of the participants in the BTX 1801 ointment and gel groups respectively, compared with just 27.8% of participants in the combined vehicle groups.

On day 12, which was seven days after the end of the treatment period, BTX 1801 demonstrated Staph eradication in 38.1% of participants in the ointment group and 25% in the gel group. This compares to 16.7% for the combined vehicle groups.

Why is this important?

The company notes that antibiotic resistance is a significant global challenge in the context of public health. In fact, the UN is forecasting that drug resistant diseases could cause 10 million deaths each year by 2050 and result in an annual economic loss of US$100 trillion if new solutions are not found.

Furthermore, Staph and methicillin-resistant Staph (MRSA) are the leading cause of Surgical Site Infections (SSIs) and approximately 80% of SSIs are caused by the patient infecting themselves from their own nose.

Antibiotics used for nasal decolonisation, such as Bactroban, have seen a significant increase in the development of resistance, with some hospitals restricting its use after recording resistance rates as high as 95%.

This opens the door for new treatments to be developed to tackle these issues. Botanix appears hopeful synthetic cannabidiol could be the answer.

Botanix President and Executive Chairman, Vince Ippolito, commented: "We are very pleased to announce this top-line data that demonstrates synthetic cannabidiol (CBD) is a safe and effective nasal decolonisation agent. Moreover, this is the first time that synthetic CBD has been shown to have clinical utility as an antimicrobial agent in humans."

"These results support continued development of BTX 1801 for the treatment of a variety of infections, in addition to the prevention of post-surgical infections," he added.

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Botanix Pharmaceuticals Ltd (ASX: BOT) shares are lifting off today after the company released its quarterly report. At the time of writing, the Botanix share price is trading 6.06% higher at 17.5 cents.

What is driving the Botanix share price?

The Botanix share price is climbing higher today as the cannabinoid company released its quarterly report to the ASX.

In its clinical development sector, Botanix completed a successful meeting with the United States Food and Drug Administration (FDA) regarding clinical studies for its BTX 1801 synthetic cannabidiol product in the US. According to Botanix, the FDA provided feedback on how the company might obtain fast-track designation for the product's new drug application (NDA).

Additionally, the FDA advised that the proposed drug development plan and data package presented were sufficient to initiate clinical development in the US and ultimately support an NDA submission. The FDA encouraged Botanix to request a fast-track designation for BTX 1801 following the submission of an IND application.

Furthermore, Botanix reported that its dermatology program, BTX 1702, is poised to commence. The company's phase 1 clinical study will begin recruitment once travel and clinical trial restrictions across Australia and New Zealand cease.

Corporate update

During the quarter, Botanix had net cash flows of $2.8 million, with $2.2 million being invested in research and development.

Botanix retained $19.2 million in cash at the end of the quarter and claims to be in a strong financial position.

About the Botanix share price

Botanix is a clinical stage synthetic cannabinoid company focused on developing safe and effective treatments for serious skin diseases. It aims to leverage the anti-inflammatory, immune modulating and antimicrobial properties of synthetic cannabidiol to this point.

Investors will be anticipating the outcome of the company's application for an R&D tax incentive refund of approximately $6.8 million. If received, funds will be invested into product development. In addition, Botanix continues to assess opportunities and partnerships in the development of new products that can be rapidly brought to market for antimicrobial or dermatological applications.

The Botanix share price has increased 75% over the past twelve months and is currently trading just shy of its 52-week high. Based on the current Botanix share price, the company has a market capitalisation of around $141 million.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price has been on fire on Wednesday.

At one stage today, the clinical stage synthetic cannabinoid company's shares were up over 22% to a record high of 16.5 cents.

In afternoon trade the Botanix share price has faded a touch but is still up a sizeable 11% to 15 cents at the time of writing.

Why is the Botanix share price rocketing higher?

Investors have been buying Botanix shares following the release of an announcement this morning.

According to the release, research data from its antimicrobial platform has been published in Nature Research's peer-reviewed journal, Communications Biology.

The lead author is Dr Mark Blaskovich, Director of the University of Queensland's Centre for Superbug Solutions in the Institute for Molecular Science. He is joined by Botanix Directors Matt Callahan and Dr Michael Thurn as co-authors.

The company explained that the research represents the culmination of research collaborations involving leading antimicrobial researchers across the world. Furthermore, all research data generated is fully owned by Botanix and is the subject of several patent applications.

What was said about the research?

The release reveals that Communications Biology editors summarised the article as follows:

"Blaskovich et al. demonstrate the antimicrobial applications of cannabidiol in a range of pathogenic bacteria, including MRSA and the capacity to kill the Gram-negative bacteria Neisseria gonorrhoeae. This article highlights the potential for cannabidiol in the age of antimicrobial resistance."

Botanix President and Executive Chairman, Vince Ippolito, was delighted with the development. He said:

"The published data clearly establishes Botanix as the world leader in characterising and exploiting the pharmaceutical potential of synthetic cannabinoids as antimicrobials – and vast potential for the development of novel and effective treatments. Congratulations to all the collaborators involved in this significant body of research."

BTX 1801 Phase 2a antimicrobial study update

In addition to this, the company provided an update on its BTX 1801 Phase 2a antimicrobial study.

According to the release, the BTX 1801 antimicrobial clinical study is complete and it is on track to announce data within the first quarter of 2021.

This study aims to test the ability of the nasally applied BTX 1801 ointment to eradicate Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nose of individuals known to carry these bacteria in their nasal cavity.

Botanix notes that nasal "carriage" of Staph and/or MRSA greatly increases the risks of serious and sometimes life-threatening infections following surgery, as patients essentially infect themselves.

At present, nasal decolonisation is a commonly used method for preventing surgical site infections. However, overuse of the widely available antibiotic Bactroban (also known as mupirocin) has led to a significant increase in the development of bacterial resistance to antibiotics.

The double-blind, vehicle controlled BTX 1801 Phase 2a clinical study has been designed to evaluate the safety and local tolerability of two formulations of BTX 1801 to decolonise Staph and MRSA in the nose of healthy adults.

All eyes will be on the Botanix share price when that data is released.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is trading higher today on news the company has completed its phase 2a clinical study for BTX 1801.

In mid-morning trade, the Botanix share price was up 8% to 13.5 cents. It has since retreated to 13 cents, up 4% at the time of writing. In comparison, the All Ordinaries Index (ASX: XAO) is currently up 0.4% to 6,915 points.

Botanix is a synthetic cannabinoid pharmaceutical company that focuses on dermatology and antimicrobial products. The BTX 1801 gel prevents surgical site infections by killing bacteria during surgery incisions. Botanix aims to combat the growing global antibiotic resistance that affects millions each year.

What's driving the Botanix share price higher?

The Botanix share price is on the move after the company advised that all 60 of its participants have completed the BTX 1801 phase 2a clinical study. The purpose of the trial was to evaluate the safety, tolerability and efficiency of BTX 1801 for the prevention of surgical site infections.

As the data is being collated, the company plans to update the market with its report in early 2021.

Furthermore, the results will be used to support a fast-track designation and new drug application with the United States Food and Drug Administration (FDA).

Timeline of BTX 1801

In April this year, Botanix received a major boost from the FDA's Office of Antimicrobial Products. BTX 1801 was awarded with a qualified infectious disease product status. This allows a five-year regulatory exclusivity, meaning generic products cannot enter the market. Furthermore, the company was given priority FDA review and faster two-way communication.

Last month, Botanix completed a pre-investigational new drug (IND) meeting with the FDA. The productive appointment gave the company an opportunity to seek advice and clarification on what's required to initiate clinical studies.

In addition, the company received feedback on the drug development plan for BTX 1801 to fast-track its FDA process.

Management commentary

Commenting on the BTX 1801 progress, Botanix president and executive chair Vince Ippolito said:

There has not been a new class of antibiotic for the treatment of gram-positive bacteria in more than 30 years and serious staph and MRSA infections have become very difficult to treat.

The company has worked diligently to complete the BTX 1801 Phase 2a study despite the significant disruption caused by the COVID-19 pandemic by conducting the study in Western Australia.

About the Botanix share price 

The Botanix share price has been surging higher since COVID-19 stormed the world earlier this year. From a low of 2.3 cents in March, the Botanix share price reached a 52-week high of 15 cents 2 weeks ago.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is surging higher today after a positive announcement.

In the minutes after market open, shares in the synthetic cannabinoid company jumped as high as 11.5 cents. The Botanix share price has retreated slightly during the day to 11 cents, up 15.79% at the time of writing.

What does Botanix do?

Botanix is a synthetic cannabinoid pharmaceutical company that focuses on dermatology and antimicrobial products.

Based in Perth, Australia and in Philadelphia, United States, the company has a pipeline of product candidates undergoing clinical trials. Botanix aims to address patients who have serious skin diseases, as well as prevent surgical site infections.

Pre-IND meeting completed

Botanix advised that it successfully completed a pre-Investigational New Drug (IND) meeting. The appointment took place with the United States Food and Drug Administration's (FDA) office of Infectious Diseases for its lead antimicrobial program, BTX 1801.

The pre-IND meeting provided Botanix an opportunity to seek advice and clarification from the FDA on what's required to initiate clinical studies. In addition, the company received feedback on the drug development plan for BTX 1801 to fast-track its FDA process. In April, Botanix was granted Qualified Infectious Disease Product status, giving the company priority FDA review and faster two-way communication.

Before the meeting had occurred, Botanix submitted data outlining the successful results from its pre-clinical studies. In addition, the company also provided the FDA with future manufacturing and clinical development plans.

The FDA stated that the data and development package was sufficient to begin clinical trials in the US. Should the study become a success, an IND application will follow.

Currently, Botanix is in a Phase 2a trial for BTX1801 in Western Australia. The study is fully enrolled and expected to be finished at the end of the calendar year. Data from the antimicrobial trial will be available shortly after completion, and provided to investors in due course.

What did management say?

Botanix president and executive chair Vince Ippolito commented on the achievement, saying:

We are very pleased with the excellent outcomes from the Pre-IND meeting. Botanix is now well placed to initiate clinical development of BTX 1801 in the US under an accelerated development path with the FDA.

About the Botanix share price

The Botanix share price has been on a wild run of late, jumping from 4.9 cents at the start of September to 10.5 cents today. This represents a gain of more than 114% in the space of less than 3 months.

Reaching a 52-week high in October of 12.5 cents, Botanix is just shy of regaining that feat again.

The company is still considered as a small-cap share with a market capitalisation of $102.1 million.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is soaring higher today following the release of its September quarter update.

At the time of writing, the synthetic cannabinoid company's shares are up 15% to a year-high of 11.5 cents.

What did Botanix announce?

Botanix recorded strong results for the period ending 30 September, the first quarter of FY21. During the quarter, net cash flows equated to $2.56 million, with $2.3 million invested in research and development activities.

Botanix reported a strong financial position, holding a cash balance of $22.1 million. Most notably, this represents more than 2 years of financing the company's ongoing operations.

In addition, Botanix president Vince Ippolito participated in a company presentation at the 2020 ASX Small & Mid-Cap virtual conference last month. The presentation provided an overview of its development programs as well as new data supporting Botanix's antimicrobial platform. The company said it was continuing to explore funding opportunities and partnerships that would help in the development of antimicrobial treatments.

Clinical development programs

BTX 1801

Botanix advised it was well-advanced for the recruitment of its BTX 1801 phase 2a clinical study. The trial will seek to evaluate the safety, tolerability and efficiency of BTX 1801 for the prevention of surgical site infections.

The enrolment will consist of 60 volunteers who will undergo twice-daily treatments across a five-day period. Botanix said the study would be done in a cost-effective manner, with target completion later this year.

BTX 1503

The company noted its BTX 1503 acne program achieved an important drug development milestone in July. The successful end of its phase 2 meeting with the United States Food and Drug Agency (FDA) highlighted the safety profile of BTX 1503. This allowed several waivers for studies that are normally required for dermatology drug registration.

Botanix said it was currently reviewing the timetable for its phase 3 study, pending the completion of its BTX 1702 phase 2 trial, and lifting of COVID-19 restrictions.

BTX 1702

Travel restrictions have temporarily halted the BTX 1702 rosacea program. Botanix said once borders were eased between Australia and New Zealand, recruitment would begin. The six-week randomised study will aim to evaluate patients with moderate to severe papulopustular rosacea.

Given the overlapping characteristics between rosacea and acne, the study will also provide supporting information for the BTX 1503 program.

Botanix share price summary

The Botanix share price has performed strongly since the market meltdown in March. The synthetic cannabinoid company's shares are up 500% for the period, from 2.3 cents to today's price of 11.5 cents.

The company has a market capitalisation of $107 million, and still has a long way to go to reach its 52-week high of 26 cents.

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The ASX is littered with lots of companies that show potential to become the next market darling. While I mostly invest in the mid-to-large cap space, I do look for small cap ASX shares that could deliver strong returns.

Every company has a story to sell. The trick is to identify value and opportunities. Researching your chosen business is a great start, but it also pays off to look at its rivals and the macro-environment.

Here are my top 2 small cap ASX shares that I think will perform in 2021.

Botanix Pharmaceuticals Ltd (ASX: BOT)

Botanix is a synthetic cannabinoid pharmaceutical company that focuses on dermatology and antimicrobial products.

Pipeline products include the BTX 1801 gel which prevents surgical site infections by killing bacteria during surgery incisions. Currently in a phase 2a study, Botanix aims to combat the growing global antibiotic resistance that affects millions each year.

In April, Botanix received a major boost from the United States Food and Drug Administration (FDA). The company's flagship BTX 1801 received a Qualified Infectious Disease Product status. The incentivised status grants an additional five-year regulatory exclusivity, meaning generic products cannot enter the market. Furthermore, Botanix is eligible for a priority FDA review, cutting the standard review period to 6 months from the original 12 months. Furthermore, fast-track designation enables Botanix to have more frequent communication with the FDA during the drug development and review process.

At the time of writing, the Botanix share price is trading at 10 cents, up 7.5% for the day. With a market capitalisation of $97 million, if the company can perform to market expectations, its share price will soar.

Botanix could be a game-changer for infection preventative diseases. I would keep an eye on the medical company as a speculative buy.

Osteopore Ltd (ASX: OSX)

A medical technology company based in Australian and Singapore, Osteopore specialises in the production of 3D printed bioresorbable implants. The in-house manufactured product is used in conjunction with surgical procedures to assist with the natural stages of bone healing.

Osteopore recently secured an initial US distribution agreement with Bioplate Inc. that looks to penetrate the world's largest healthcare market in the second half of 2020. The company also gained approval from the Therapeutics Goods Administration (TGA) for market entry in Australia. Osteopore's new geographical presence should see incoming revenue streams as it expands manufacturing capabilities.

Allied Market Research estimates the market opportunities for bone graft substitutes will be US$3.9 billion by 2025. Osteopore's current sales come from the cranial/maxillofacial (CMF) area which represents 20% of the entire market. Other market segments like dental and cosmetic (nasal) are comparable to size with CMF, which Osteopore is now starting to penetrate.

Most significantly, 40% of the bone graft substitute market derives from orthopaedic and spine. This untapped opportunity could be huge from Osteopore should it succeed in its clinical trials.

The Osteopore share price has moved 0.9% higher today to 53 cents at the time of writing. The med tech company is valued at $62 million and has no debt. In light of this, I think the Osteopore share price might surge much higher if it can develop new distribution networks.

I believe this relatively new ASX-listed company (floated in September 2019) could be destined for big things. I would consider snapping up Osteopore as a small cap ASX share in the buy zone today.

The post Why I think these small cap ASX shares will perform in 2021 appeared first on The Motley Fool Australia.

The Botanix Pharmaceuticals Ltd (ASX: BOT) share price surged more than 20% higher in early trade after the company released an announcement regarding a milestone achievement.

What did Botanix announce?

Prior to the market's open this morning, Botanix reported that the company has completed a major milestone in the development of its BTX 15030 treatment. According to the company's media release, Botanix has successfully completed an End of Phase 2 meeting for BTX 1503 with the Food and Drug Administration (FDA).

Completion of the Phase 2 meeting allows Botanix to construct a drug development plan and registration for BTX 1503. The company is now preparing to start designing Phase 3 clinical studies. According to the announcement, the FDA noted the excellent safety profile of BTX 1503 and allowed for several waivers that are normally required for dermatology drug registration.

Progression of the BTX 1503 Phase 3 study will remain pending until the completion of the company's BTX 1702 clinical study and the lifting of COVID-19 restrictions. Due to the limitations imposed by the pandemic, Botanix does not expect large Phase 3 dermatology studies to commence until the end of 2020.

What does Botanix do?

Botanix is an ASX listed, synthetic cannabinoid company that develops pharmaceutical products through well-controlled randomised clinical trials. The company's cannabinoid development platforms encompass 2 separate segments; dermatology and antimicrobial products.

According to Botanix, the company's products utilise the unique, anti-inflammatory and antimicrobial properties of cannabinoids. Botanix currently has a pipeline of product candidates undergoing clinical trials.

The company's BTX 1801 is an antimicrobial product that is currently enrolled in a Phase 2A study and is designed to prevent surgical site infections. Following today's announcement, Botanix now has a drug development plan for its dermatology product BTX 1503 for acne treatment.

In its quarterly report released in late April, Botanix noted that restrictions associated with the COVID-19 pandemic have resulted in the delay and uncertainty of clinical programs.

Foolish takeaway

The Botanix share price was up more than 20% in early trade after hitting an intraday high of 6.5 cents. At the time of writing, however, the company's shares have been sold down and are currently trading flat for the day at 5.3 cents.

The post This ASX cannabis share just hit a milestone appeared first on The Motley Fool Australia.

Last year was a bear market for cannabis stocks globally. During 2019, the excitement that had followed the legalisation of marijuana in many jurisdictions was replaced by cautio as investors realised early forecasts weren't necessarily matching reality.

We take a look at what 2020 holds for 4 ASX cannabis shares.

State of play

There are now more than 30 shares on the ASX that are wholly or partly involved in the cannabis business. Research firm New Frontier Data suggests the Australian cannabis market, both legal and illegal, is worth between $4.6 billion and $6.3 billion, with an estimated 2 million users consuming nearly 400,000 kilos of cannabis per year. Europe-based firm Prohibition Partners has estimated Australia's recreational marijuana market could be worth up to $8.8 billion per annum in a decade if it is legalised soon. In September, the ACT legalised the possession and cultivation of small amounts of cannabis for personal use. The legislation, however, conflicts with Commonwealth laws that prohibit the possession of cannabis.

What's in store in 2020?

Interest in the cannabis sector dwindled over 2019 as investor sentiment waned. ASX-listed cannabis companies are generally relatively young businesses making their way in a new industry. Those with ties to relatively more mature United States and Canadian companies stand to benefit from their deeper market knowledge.

In Australia, access to medical cannabis remains constrained; doctors must make an application to the Therapeutic Goods Administration's Special Access Scheme including clinical justification for a prescription for cannabis. Medical cannabis is not subsidised under the Pharmaceutical Benefits Scheme (PBS) so can be expensive, costing users around $200 to $600 per month.

Increasing clinical evidence of the efficacy of medical cannabis should facilitate medical and social acceptance of its use. This may also increase pressure for some medicinal cannabis products to be listed on the PBS, especially where these products can replace more expensive or riskier drugs. Increased medical and societal acceptance of the use of medical cannabis over time should assist in increasing the uptake of medical cannabis users. More favourable legislation including legalisation of recreational cannabis use would also give these ASX shares a boost.

Althea Group Holdings Ltd (ASX: AGH)

Althea established a UK subsidiary, Althea MMJ UK Ltd, in early 2019. The UK has a population of 66 million, implying potential to treat up to 2.9 million people with medicinal cannabis (according to Althea's estimates). In July the first UK clinic (in London) was established, followed by the Bristol clinic. The first patient to be prescribed Althea's medicinal cannabis in the UK received their product on 31 July.

In late 2019, Althea entered a memorandum of understanding with nimbus health GmbH to supply Althea products for sale and distribution in Germany. Nimbus is a wholesale pharmaceutical license holder, which estimates it has access to 25% of German cannabis patients through its pharmacy network. According to Althea, the German market consists of approximately 60,000 patients currently and is expected to grow to 1 million by 2024.

In December, Althea announced 3,688 patients had now been treated with its medicinal cannabis products in Australia. An average of 35 patients were added each business day in the first half of December, up 46% from November. Althea's immediate focus is on rapidly building its prescriber base. The goal is to reach 10,000 patients in Australia in 2020, while adding new products to the range and continuing expansion in the UK and Germany.

Auscann Group Holdings (ASX: AC8)

Auscann released its cannabinoid-based hard shell capsules for clinical evaluation in December. Auscann's capsules are designed to address stability, consistency, and dosing problems that exist with current oil-based cannabinoid medicines. Dose-controlled capsules are easy to administer and allow for consistent monitoring of health outcomes. Following positive test results, Auscann will be in a position to progress on an accelerated path to commercialisation. The company aims to have the capsules available for doctors to prescribe in the first half of calendar the year 2020.

Auscann is also in the final stages of constructing a product development facility in Perth. This will enable Auscann to build a product pipeline to accompany and improve their capsules. Construction is anticipated to be completed this quarter. 

Botanix Pharmaceuticals Ltd (ASX: BOT)

Botanix received ethics approval to conduct a Phase 1b study into the treatment of papulopustular rosacea in the fourth quarter of 2019. In the same quarter, Botanix began a study into the use of cannabidiol as an antibiotic effective against staph and golden staph. Top line results from Botanix's Phase 2 atopic dermatitis study are due to be reported in the first quarter of 2020, with the atopic dermatitis market estimated to be worth US$25 billion by 2027.

Botanix is moving forward with preparation for Phase 3 clinical trials into its cannabidiol acne solution in 2020. Phase 2 clinical studies in 2019 did not show statistically significant results using the solution in US sites, but did show statistically significant results in Australian sites. Efficacy results in Australian sites were in line with leading topical acne prescription products.

Cann Group Ltd (ASX: CAN)

Cann Group plans to split the construction of its third grow facility (located in Mildura) into 3 stages. Staged construction is expected to ensure production capacity more closely matches anticipated growth in demand for medicinal cannabis. The first stage is expected to provide for a production capacity of 25,000 kilograms of dried flower with target commissioning in late 2020. The timetable for stages 2 and 3 will be determined based on ongoing product demand.

Cann Group's first medicinal cannabis product produced from its Australian cultivation operations was packed by IDT in December and is undergoing stability testing. Dried flower was packed into 10 gram bottles with testing data due to be available at the end of January. This will allow for commercial launch to Australian patients in early 2020. Patients can access the product under the Special Access Scheme, with product distributed to pharmacies and hospitals by Symbion Health under their distribution agreement.

Foolish takeaway

This year will be an interesting one for cannabis stocks. The euphoria associated with the early days of legalisation has worn off as investors look hard at the realities of operating in the emerging industry. As the Australian industry takes tentative steps towards maturity we will look for companies growing customer numbers and revenues, and producing positive clinical study results.

The post What's in store for these 4 ASX cannabis shares in 2020? appeared first on The Motley Fool Australia.

This year was a difficult one for ASX cannabis shares as well as cannabis stocks globally with share prices worldwide retreating from previous highs. In Australia the medical marijuana industry remains in its infancy. Nonetheless, the initial market euphoria associated with legalisation has well and truly worn off.

We take a look at how two ASX medical marijuana shares, Botanix Pharmaceuticals Ltd (ASX: BOT) and Cann Group Ltd (ASX: CAN), performed in 2019.

What can cannabis be used for?

Cannabis contains THC and CBD compounds which interact with the body's endocannabinoid system. This interaction impacts the release of neurotransmitters from the brain which relay messages about pain, sleep, stress, and other functions. THC is known for its relaxing and pain-relieving effects and can assist in the treatment of nausea, anxiety, low appetite, insomnia, and act as a muscle relaxant. CBD can be used in pain and nausea management, as well as in the treatment of seizures, migraines, mental disorders, and inflammation. Cannabis also has antioxidant and anti-inflammatory properties that have shown promise in skincare and cosmetic products used to treat acne, dry-skin, eczema, and anti-aging concerns.

Botanix Pharmaceuticals 

Botanix focuses on the development of topical treatments for serious skin diseases utilising the anti-inflammatory, immune modulating and antimicrobial properties of synthetic cannabidiol. The company is in the process of conducting clinical trials for formulations to treat acne, atopic dermatitis, rosacea, bacterial infections, and psoriasis. The Botanix share price is currently trading at 8.3 cents

Phase 2 acne study

The Botanix share price halved in October when it released the results of its Phase 2 acne studies, falling from 24 cents to 11 cents in days. The results found the primary endpoint reduction in inflammatory lesions was not statistically significant. Results were skewed by patients in US sites which showed an unusually high vehicle response. Nonetheless, Australian clinic sites showed statistically significant improvements, with efficacy in line with leading topical acne prescription products. Results from the Phase 2 study have given Botanix confidence to proceed with preparation for Phase 3 clinical studies.

Dermatitis study

The company is on track to report top line results from its Phase 2 atopic dermatitis study in the first quarter of 2020 following a 12-week double-blind vehicle-controlled study into the safety and efficacy of its BTX 1204 solution. The atopic dermatitis market is estimated to be worth US$25 billion by 2027. Botanix's Phase 1b study showed promising results supporting safety and efficacy – BTX 1204 was twice as effective as a placebo with treatment success similar to many competitive topical products.

Future results

Ethics approval to conduct a Phase 1b study using Botanix product BTX 1702 in the treatment of papulopustular rosacea was received in the fourth quarter of 2019. In the same quarter, Botanix began a study into the use of cannabidiol as an antibiotic effective against staph and golden staph. In 2020 we can expect to see results reported which could provide a boost to the Botanix share price. The company had cash of $36.3 million at the end of September which should allow it to fund its activities for the time being.

Cann Group

Cann Group's vision is to become a leading developer and supplier of cannabis, cannabis resin, and medicinal cannabis products. The company holds all required licenses for cultivation, production, manufacture, import, and export. Cann Group shares have fallen from $2 at the start of 2019 to 52 cents currently.

Cultivation

Cann Group currently has two cultivation facilities in action, from which 51 successful harvests have been completed. Production from Cann Group's Southern facility is servicing domestic supply initiatives and the testing of export pathways. Production from the Northern facility is supporting several research programs. The company is in the process of developing marketing and supply opportunities in overseas markets and expanding the range of locally produced and imported products available for Australian patients.

Distribution

Cann Group announced its entry into a national distribution agreement with Symbion Pty Ltd in November. Under the agreement, Symbion will distribute medical cannabis products imported and produced by Cann Group for supply to approved Special Access Scheme patients. Symbion supplies healthcare services and products to more than 4,000 pharmacies and 1300 hospitals across Australia.

Grow Facility

Cann Group shares fell 40% in late November following news the pot producer planned to split construction of its Mildura facility into 3 stages. The facility, Cann Group's third, was expected to be commissioned in the third quarter of 2020 and have a production capacity of 70,000 kilograms of dried flower per annum. The increased capacity was expected to contribute to revenues of $220 million to $280 million based on dried cannabis flower. An offtake agreement with Aurora Cannabis Inc was supposed to offset the risk of the expanded production footprint.

Cann Group announced it planned to stage construction of the facility in order to ensure production capacity more closely matched anticipated growth in demand for medicinal cannabis. The first stage is expected to provide for a production capacity of 25,000 kilograms of dried flower with target commissioning in late 2020. The timetable for stages 2 and 3 will be determined based on ongoing product demand. Revenue forecasts have not been updated, however, could be expected to shift downwards with the drop in production capacity.

Manufacture

Cann Group has partnered with IDT Australia Limited (ASX: IDT) for manufacturing support for cannabis-based product formulations. This provides Cann Group with an integrated pathway through the full supply chain. In December Cann Group announced the first product to be produced from its Australian operations had been packed and would undergo stability testing. Dried flower had been packed into 10 gram bottles with testing data due to be available at the end of January. This will allow for commercial launch to Australian patients in early 2020. Patients can access the product under the Special Access Scheme. The product will be distributed to pharmacies and hospitals by Symbion under the distribution agreement.

Foolish takeaway

It was a rough 2019 for both Botanix and Cann Group. Botanix experienced a set-back in clinical study results, while Cann Group saw delays to the construction of its third grow facility. Next year Botanix will see the results of additional clinical studies, while Cann Group will see its product distributed to customers for the first time. Could this spur a turnaround for these two ASX cannabis shares? We will be watching in 2020 to find out.

The post How did these ASX cannabis shares perform in 2019? appeared first on The Motley Fool Australia.

The cannabis industry has been out of form this year and almost all pot stocks are nursing disappointing declines.

But things are looking up for a couple of them on Monday. Here's why these two cannabis shares are starting the week on a high:

AusCann Group Holdings Ltd (ASX: AC8)

The AusCann share price has jumped 4.5% to 23 cents. This morning the medical cannabis company announced that it has appointed TGA-licensed Aspen Pharmacare Australia to provide packaging for its medicinal cannabis pharmaceutical products.

The agreement with Aspen is for an initial three-year period that can be extended. It will include GMP packaging services for AusCann's proprietary solid hard shell capsules. These will be manufactured by its manufacturing partner, PCI Pharma, and then packaged by Aspen in consumer ready packs at its Australian facility. This means that a commercial launch may not be too far away for AusCann.

Botanix Pharmaceuticals Ltd (ASX: BOT)

The Botanix share price pushed 4.5% higher to 11 cents this morning. This follows an announcement relating to the synthetic cannabidiol product it uses. According to the release, the US Drug Enforcement Administration (DEA) has advised Botanix's partner Purisys, that its synthetic cannabidiol product is no longer scheduled as a controlled substance.

Executive Chairman and President, Vince Ippolito, explained why this is a positive. He said: "This change in the regulation of synthetic CBD in the US will make a major difference to the speed of developing Botanix products and greatly reduces the risks and costs of clinical development."

"The ability to manufacture at one site and distribute nationally and internationally means our supply chain is significantly simplified and our ability to recruit the best clinical sites (regardless of DEA license status) is greatly enhanced. The change in regulation has come at a favourable time, where the Company is actively preparing for large late-stage studies across our dermatology programs," Mr Ippolito added.

The post Why these ASX cannabis shares are starting the week on a high appeared first on The Motley Fool Australia.

It's been a year of highs and lows for cannabis shares. Marijuana shares were favourites of investors earlier this year but have since suffered setbacks: the vaping crisis in the United States (US) as well as issues on the home front have burned ASX marijuana shares, with prices pulling well back from their recent highs.

As the reality dawns that marijuana is a commodity like any other, investors have started to reassess cannabis stocks. With the market maturing in the US and Canada, fears of increased competition and price compression have reset investor expectations.

Auscann Group Holdings Ltd (ASX: AC8) has lost 65% of its value to sit around 27 cents from 77 cents in January. Cann Group Ltd (ASX: CAN) is down to $1.01 from highs of $2.57 in April. Likewise Creso Pharma Ltd (ASX: CPH) is languishing around 20 cents after reaching 55 cents in June. Althea Group Holdings Ltd (ASX: AGH) has pulled back to 38 cents from highs of over $1.20 in July and Botanix Pharmaceuticals Ltd (ASX: BOT) is down to 11 cents from 27 in September.

With prices having pulled back to less exuberant levels, is it time to consider taking a punt on the cannabis stock party? After all, the global legal marijuana market is expected to reach US$66.3 billion in size by 2025, spurred by increased legalisation and the use of marijuana in medical and recreational applications.

Legalisation 2.0 just occurred in Canada, allowing for the use of cannabis in edibles, drinks, and topical forms. New Zealand is set to hold a referendum on the legalisation of marijuana in 2020. In Australia, the Australian Capital Territory recently passed legislation legalising the possession of small quantities of marijuana for personal use.

So, which ASX marijuana stocks could be worth taking a second look at in November? Let's take a closer look at 3 of the main players in the cannabis sector.

Auscann Group Holdings

Auscann seeks to harness the properties of cannabinoids to utilise in medicines targeting neuropathic and chronic pain. Focusing on product development and clinic studies, as opposed to cultivation, manufacture or dispensing, Auscann specialises in what it sees as the high value parts of the supply chain.

Auscann intends to release its pharmaceutical cannabinoid-based product to clinical trial by the end of 2019. The hard-shell capsule provides doctors with a stable cannabinoid-based medicine for the treatment of chronic pain. Key objectives for upcoming quarters include educating healthcare professionals about the characteristics of Auscann's product and providing selected physicians with capsules for prescription to a controlled body of patients.

Auscann is constructing a product development facility in Perth, which is at an advanced stage. The facility will enable Auscann to create a product pipeline to accompany and improve the cannabinoid-based pharmaceutical capsules. Partnerships have been established across the supply chain to ensure the supply of raw material and aid the distribution of end products.

FY19 was a year of transition for Auscann as the company progressed from medical cannabis startup to pharmaceutical company. Income in FY19 was $1,532,376. Total expenses were $9,181,597, resulting in a loss of $7,649,221 before tax. A placement was conducted in July 2018 that raised $33.4 million from institutional investors and $1.9 million from retail investors. Auscann is funded until FY20 with $25 million in cash as of 30 June 2019.

Althea Group Holdings

Shares in Althea dropped 23% to 40 cents on Friday after Althea confirmed that strategic shareholder and supplier Aphria had sold 36,697,000 shares in the company, equivalent to 15.7% of the company's issued capital. Aphria sold its shares to institutional investors at a price of 40 cents per share, a steep discount to the 52 cents the shares were trading at before the trading halt was called on Wednesday.

Althea holds a number of licenses and permits allowing it to import, cultivate, produce, and supply medicinal cannabis in Australia. It raised nearly $20 million in its IPO and nearly tripled in price from 20 cents on its debut on the ASX a little over a year ago. Aphria, a cornerstone shareholder, was supplying expertise and the products Althea distributes in Australia.

The Aphria supply agreement has now been extended to 2027. Althea is set to take over the production of products once its facility in Victoria is completed – $3 million in funds from the IPO were earmarked for its construction.

In October Althea completed its acquisition of Peak Processing Solutions, a Canadian extraction and manufacturing company. The acquisition is designed to leverage Canada's legalisation 2.0, which allows the sale of cannabis-infused edibles, drinks, nutraceuticals, and cosmetic products.

Cann Group Ltd

Cann Group Ltd has licences allowing it to cultivate cannabis and produce cannabis for medicinal purposes. Works are underway on the company's third cultivation and production facility which is on track to be commissioned in the third quarter of calendar 2020. The facility is expected to have a production capacity of 70,000 kilograms of dry flower per annum and is being funded with a mix of debt and existing cash reserves. An offtake agreement with Canadian-based Aurora Cannabis Inc was entered into in FY19, which offsets the risk of the expanded production footprint.

The increased capacity is expected to generate revenues of $220 million to $280 million based on cannabis dried flower. A term sheet for debt financing has been signed with an Australian bank, which will be announced once the revised project budget is confirmed. Revenues currently remain highly variable as local manufacturing capacity comes online.

Revenue in FY19 was $2,347,668 and other income was $1,904,975. Administration and corporate costs were $13,466,524 while research and development costs were $1,047,608 in FY19. Total losses were $10,926,317. Cash at hand end of FY19 was $46,388,192.

During FY19, a minority investment was made in Pure Cann NZ in order to expand the regional position ahead of regulatory changes expected to legalise medical marijuana in New Zealand shortly. A small investment was also made in Emerald Clinics, which intend to build a network of medical cannabis clinics in Australia.

Foolish takeaway

The highs that cannabis shares reached earlier in the year have definitely come back down to earth with a thump. Over time, marijuana will become a product like any other, subject to the same competitive forces that drive outcomes in other sectors.

None of the 3 ASX marijuana shares discussed above have yet turned a profit, but each shows potential. Althea dipping below 40 cents may be an indication that it has been oversold, while for Auscann, much rests on the outcome of its clinical trial. Cann Group's future looks promising once the new greenhouse facility commences production; however, current variability in revenues may be deterring investors.

The post Which ASX cannabis shares should you buy in November? appeared first on The Motley Fool Australia.

Listed cannabis stocks worldwide have pulled back from their highs lately, tainted by the vaping crisis in the US. Canopy Growth has seen its share price drift down to just above US$20 from highs of over US$50 in April. Rival Aurora Cannabis has likewise seen its share price fall from over US$13 in March to around US$4.80.

Australian stocks have not been immune either. Auscann Group Holdings Ltd (ASX: AC8) has lost 65% of its value to sit around 27 cents from 77 cents in January. Cann Group Ltd (ASX: CAN) is down to $1.22 from highs of $2.57 in April. Likewise Creso Pharma Ltd (ASX: CPH) is languishing around 28 cents after reaching 55 cents in June.

Have pot stocks gone to pot?

The gloss has well and truly come off cannabis stocks, as it seems the next big thing has become passé. But the fundamentals of the worldwide cannabis market haven't changed over 2019. The global legal marijuana market is expected to reach US$66.3 billion in size by 2025, spurred by increased legalisation and the use of marijuana in medical and recreational applications.

New Zealand is set to hold a referendum on the legalisation of marijuana in 2020. Meanwhile, in Canada, where marijuana was legalised in 2018, legalisation 2.0 has just occurred – next generation cannabis products such as edibles, drinks, and topical forms are now available. In Australia, the Australian Capital Territory recently passed legislation legalising the possession of small quantities of marijuana for personal use.

Blazing highs

So have the pot stocks been oversold? Sure, the sector is not as hot as it once was, but that doesn't mean it doesn't still have potential. Althea Group Holdings Ltd (ASX: AGH), for example, debuted on the ASX a little over a year ago at 20 cents and is now sitting at around 54 cents.

Althea holds a number of licenses and permits allowing it to import, cultivate, produce, and supply medicinal cannabis in Australia. The IPO, which was oversubscribed, raised almost $20 million with a portion earmarked to construct a 3-tonne per year grow facility in Victoria. Already distributing five products, Althea's plan is to grow current revenue and sales and commence domestic production.

Expertise is being supplied by listed Canadian grower and strategic shareholder, Aphria. Althea distributes products supplied by Aphria in Australia. Once the production facility in Victoria is built Althea intends to produce Australian versions of these products, named 'Capilano', 'Champlain Indica', 'Jasper', and 'Rideau'. Althea will import clone starting materials to do so.

To connect patients and prescribing doctors, Althea has created an app called Althea Concierge. Althea Concierge contains a directory for patients of all registered medical practitioners able to prescribe Althea products. For medical practitioners, the app assists in obtaining relevant approvals and permits to supply medical cannabis.

As at the date of Althea's prospectus, 57 patients had been prescribed Althea products in Australia. By October this year, 2,329 patients had been prescribed Althea medicinal cannabis products in Australia, and 463 new patients were on boarded in September 2019 alone. That's equivalent to 22 new patients per business day. There are now 334 health care professionals prescribing Althea products in Australia. Revenue for the September 2019 quarter was up 184% compared to the previous quarter.

In July, Althea agreed to acquire Canadian extracting and manufacturing company Peak Processing Solutions, with the acquisition approved by Althea shareholders and completed in October. Funded via an institutional placement, the acquisition is designed to take advantage of new Canadian regulations allowing for the sale of cannabis infused edibles, drinks, nutraceuticals, and cosmetic products. Canada's cannabis industry is expected to double in size to AU$5.4 billion by 2020.

Botanical healing

Another bright spark in Australia's cannabis landscape is Botanix Pharmaceuticals Ltd (ASX: BOT). Shares in the synthetic cannabinol company have been on the tear in the later half of this year, up 140% since June to 24 cents from a low of 10 cents, before crashing down to 11 cents today.

Botanix focuses on the development of topical treatments for serious skin diseases and has successfully completed its first acne patient studies. Last night, however, the company released the results of its Phase 2 acne studies, which found the primary endpoint reduction in inflammatory lesions was not statistically significant, sending the shares into a nose dive today.

The company leverages a proprietary drug delivery system under exclusive license to enhance topical delivery of synthetic cannabinoid by delivering high doses of the drug to the skin without the use of preservatives or irritating levels of alcohol or petrol derivatives.

CBD is well suited to treating skin disease with anti-inflammatory properties and antimicrobial effects. Clinical programs are underway to assess the efficacy of Botanix products in the treatment of acne, psoriasis, atopic dermatitis, and rosacea. Acne is the most common skin condition in the US, with more than 50 million sufferers. The atopic dermatitis market is estimated to be worth US$25 billion by 2027, while rosacea is estimated to impact 16 million Americans.

The release of interim results from a psoriasis study on 19 June showed significant anti-inflammatory and immune modulating activity. On 20 June Botanix released data showing its antimicrobial product was able to kill superbugs and had a potency similar to powerful antibiotics. As a result, the Botanix share price leapt from 14 cents on 19 June to 21 cents the next day.

Botanix conducted a $40 million institutional placement in August at 21 cents per share to fund clinical development programs and accelerate the commercialisation strategy. The company had AU$40 million cash on hand at the end of August and is well funded to execute its clinical studies.

Yet another medicinal marijuana company, Cronos Australia, is eying a November listing on the ASX, after backing out of an earlier listing attempt in 2018. Cronos focuses on the distribution and supply of medical marijuana.

Leveraging an 'asset light' model by outsourcing cultivation and manufacture gives Cronos the flexibility to focus on products, brands, distribution and IP, according to the company's prospectus. A memorandum of understanding has been signed with Sigma regarding the potential for Sigma to distribute Chronos products, which may be documented in a binding distribution agreement.

Foolish takeaway

Reports indicate that worldwide sales of legal cannabis have experienced growth rates of over 40% in recent years. Global demand for cannabis is predicted to grow by 17% to 23% per annum over the next decade. Australia's marijuana industry is still in its infancy, but it is attracting a flurry of listed competitors eager to make the most of green fields opportunities.

The post The cannabis collapse: ASX marijuana shares going cheap appeared first on The Motley Fool Australia.

In afternoon trade the S&P/ASX 200 index is on course to give back yesterday's gains. At the time of writing the benchmark index is down 0.25% to 6,655.5 points.

Four shares that have fallen more than most today are listed below. Here's why they have tumbled lower:

The Botanix Pharmaceuticals Ltd (ASX: BOT) share price has crashed 46% lower to 13 cents. Investors have been heading to the exits in their droves after the cannabis-focused medical dermatology company released topline data from its Phase 2 BTX 1503 study. That study was evaluating its safety and efficacy in patients with moderate to severe acne. Unfortunately, the topline data revealed that the primary endpoint of reducing inflammatory lesions did not achieve statistical significance.

The Elixinol Global Ltd (ASX: EXL) share price is down 10% to $1.90. The cannabis company's shares have come under pressure today following the release of an update on its Japanese operations. According to the release, Elixinol Global has established that non-compliant hemp-derived cannabidiol (CBD) products were being sold by Elixinol Japan. This non-compliance relates to the strict requirements in Japan on sourcing CBD from only hemp stalk and seed.

The Pro Medicus Limited (ASX: PME) share price has fallen 6% to $28.25. The healthcare technology company's shares have come under pressure today despite there being no news out of it. However, with its shares up significantly this year and trading on sky-high earnings multiples, I suspect that some investors have been taking a little profit off the table today.

The Tinybeans Group Ltd (ASX: TNY) share price has sunk 14.5% lower to $2.06. This morning the family-focused social media platform released its first quarter update. Although Tinybeans delivered strong revenue growth compared to the prior corresponding period, it fell quarter on quarter. At the end of the quarter, the company had Monthly Active Users of 1.28 million. This was up 50,000 on the previous quarter.

The post Why Botanix, Elixinol Global, Pro Medicus, & Tinybeans shares tumbled lower appeared first on The Motley Fool Australia.

It looks set to be a disappointing day of trade for the Botanix Pharmaceuticals Ltd (ASX: BOT) share price on Wednesday.

The cannabis-focused medical dermatology company's shares look set to be sold off after a disappointing study result.

What did Botanix announce?

Late on Tuesday night the company released topline data from its Phase 2 BTX 1503 study. This study was evaluating its safety and efficacy in patients with moderate to severe acne and preparations for a Phase 3 clinical program.

Expectations were high that BTX 1503 could become the new standard of care for acne sufferers, replacing existing treatment options that come with horrific side effects.

According to Botanix's release, its 12-week randomised, double blind, vehicle-controlled study enrolled 368 patients with moderate to severe acne across 35 dermatology sites in Australia and the USA.

Unfortunately, the topline data revealed that the primary endpoint (aim) of reducing inflammatory lesions did not achieve statistical significance.

And while the secondary endpoint of reducing non-inflammatory endpoints was statistically significant, the primary endpoint is the one that matters. Especially given that other promising drugs under development are also aiming to leverage the antimicrobial properties of synthetic cannabidiol in a similar way.

However, there is a glimmer of hope for Botanix and its shareholders. While its result was not statistically significance, management blamed this on an abnormally positive result from a placebo group. Discounting this, the result is potentially a positive.

Vince Ippolito, President and Executive Chairman of Botanix said: "We are pleased with the overall efficacy outcomes, clean safety profile and highly significant Australian data. We are very thankful to all of the investigators and patients who helped Botanix rapidly complete this Phase 2 study."

What now?

Management appears intent on trying to commercialise the product despite this disappointing result.

It advised that "Botanix is moving forward with its preparations for Phase 3 clinical program and planning an end-of-Phase 2 meeting with the US Food and Drug Administration."

The post Why the Botanix share price could crash lower on Wednesday appeared first on The Motley Fool Australia.