The company’s Felix™ System has successfully completed its Phase III clinical trial, proving it works faster than traditional methods, without adverse effects, and with scientists preferring it over the most widely used traditional IVF technologies.

Memphasys reached its primary endpoint comparing its Embryo Utilisation Rate against existing Density Gradient Centrifugation (DGC) and Swim-Up IVF techniques.

The trial has proven Felix is as good as the Swim-Up technique and “superior” to the world’s most used DGC method. And, Felix has other benefits in relation to both existing methods, which I’ll run through shortly.

To say Memphasys is working to address an unmet need is an understatement – the demand for solutions to fertility issues is enormous.

Most of us know of someone who’s been through the IVF process. It’s stressful, expensive, and utterly devastating if it doesn’t work. Memphasys’ technology could be the answer for would-be parents who’ve seen other IVF options and multiple rounds of IVF fail.

“Yes” and “Absolutely,” Memphasys MD and CEO Dr David Ali told HotCopper.

“The trial was extremely rigorous, and we chose an endpoint of embryo utilisation because that’s the benchmark of Assisted Reproductive Technology (ART) cycle success. We now have data that meets this benchmark.  

“We’ve really met the acid test in proving that our device works effectively.”

Memphasys partnered with Monash IVF Group (ASX: MVF), another Australian reproductive and fertility services company, for the trials.

IVF has long focussed on female fertility, but andrology – the science of male reproduction – suggests 50% of the onus of creating a baby actually lies with men. That’s right, male infertility is just as likely to be the problem in failed conception!

Memphasys’ work was based on the male side of fertility being the ‘forgotten half’.

Male infertility can be caused by issues including low sperm count, poor sperm quality, hormonal imbalances, genetic disorders, and more.

Global authority on reproductive biology, Emiritus Professor Dr John Aitken, leads a team studying fertility at The University of Newcastle’s Centre for Reproductive Science. He wrote the book The Infertility Trap and is the Scientific Director of Memphasys.

“Our understanding of the male reproductive system is approximately 20 years behind our understanding of the female system,” he said.

“One in 20 men is infertile, yet we do not have a medical specialty in male reproduction.”

(You can read more about Professor Aitken’s work in the area here.)

It’s in this male reproduction side where Memphasys is positioned – and is set to make a real difference for patients and its shareholders.

Memphasys’ Felix™ system “works with sperm in a way other devices can’t,” Dr David Ali said.

Dr Ali is also an expert in the field; he holds a PhD in Pharmacokinetics and is a published researcher. He’s presented at international conferences and worked in drug discovery, clinical project management, clinical pathology, business development, and operations at senior levels – so there are no novices here.

“Our trial results reinforce the ability of Felix to effectively separate high-quality sperm and improve embryo utilisation rates.

“While other methods are focussed on sorting sperm according to the motility, size and quality, the process takes 45 minutes to an hour.

“The whole Memphasys Felix process can take six minutes!”

It’s not hard to see this will eventually reduce staffing costs – labs will need fewer people and fewer qualified people as you can have a technician run the Felix device rather than an andrologist or embryologist.

Perhaps even more importantly, the risk of damage and contamination is reduced due to the single cartridge design. The risk of sperm getting mixed up and confused is much lower, need we say more!

“The clinical trial reported no adverse events related to the FelixTM System,” Dr Ali said.

“And 100% of scientists preferred the FelixTM System over DGC; while more than half of the scientists preferred the FelixTM Systemover Swim-Up.”

“As of now, we have a product that’s clinically validated,” he said.

“Memphasys is preparing data to enter the CE Mark regulatory process”.

“Once registration is achieved this will provide the company with the opportunity to market the Felix™ System in Europe, Australia and India, as well as in markets where mutual recognition of conformity assessment is already recognised.

“This includes countries like Japan, Canada, U.S., and Switzerland, where Felix is already being sold.”

But that’s only the start.

“We already have distribution agreements in Japan, Canada, and New Zealand through Vitrolife, a Letter of Intent (LOI) with Heranova in China, and R&D sales through Panacea Medizintech LLC in the United Arab Emirates (UAE),” Dr Ali said.

“We are having conversations with external parties who wish to engage us in distribution arrangements or licensing deals. If a particular entity is interested in buying the device, I’m interested in looking at a deal around that.

“The message to our shareholders will be commercialisation, commercialisation, commercialisation in 2025, getting this product registered, trying to expedite that time, and to get it sold in market, and do commercial deals – that will be the focus.”

The commercial opportunity is substantial. On that, Dr Ali has told HotCopper: “China is 33% of the global market, one of their clinics could do up to the same number of cycles as Australia would do in one year.”

“It’s a huge market; there’s huge opportunity there.”

Next on the hit list would be Japan as well as India, the latter of which has seen 11 couples deemed sterile birth healthy children in the wake of a 2023 trial of Felix.

“When you think that both China and India have mandates given by the Government to increase the population, there’s no reason why Felix won’t fit into the reproductive paradigm in those countries,” he said.

“Really importantly, our revenue model is extremely exciting as well,” Dr Ali explained.

“It’s based off the printer and ink revenue model. Nowadays you purchase a printer unit which is relatively cheap – as is our console.

“The revenue and return sales are generated by the consumable… which is the cartridge. Each cartridge is a single-use cartridge, so if you’re doing 20,000 cycles a year, you will be using 20,000 cartridges, for example, and you must use new cartridges each time. It’s a really good way to generate revenue.”

MEM’s Felix™ System is an automated sperm separation device, utilising electrophoresis and a proprietary membrane technology to gently separate sperm for Assisted Reproductive Technology (ART) procedures.

The Felix™ device consists of two main components: a console, which supplies electrical power, and a sterile disposable cartridge for sperm isolation and selection.

Memphasys has identified a need in the equine industry.

“We’ve found the device can actually be used off the shelf to separate sperm for horses or horse breeding,” he said.

“No more R&D has to go into changing Felix or altering Felix from its current state, which is a huge advantage.

“We are currently talking to people in the equine market that are interested in the device and applying it to horses.

“There are applications across many other animals – we’ll be happy to explore those.”

There’s a new RoXsta (rapid in-vitro antioxidant assessment) in the wings too.

Memphasys’s RoXsta device will quickly measure oxidative stress which can affect fertility in both humans and animals because oxidation can affect sperm quality.

“It’s a very high-value area to look at,” Dr Ali said.

“We expect to be the first in market as a point of care rapid clinical diagnostic and we see clinicians in the IVF space could use this device within their clinic rooms.

“They’ll be able to get readings on oxidative stress levels for their patients and then be able to prescribe the right medication or antioxidants to them almost immediately.

“This will transform oxidative stress diagnostics.

“It will help to resolve and manage many key factors in: Male fertility; cardiovascular disease; livestock health; food technology; and the cosmetics industry – it can be used in multiple industries globally and for multiple applications within those industries.

“We are hopeful for another huge success.”

Given all of this, you’d have to think that big pharma and device companies could be watching, or even circling.

Time will tell.

Memphasys last traded at 0.7c.

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Associate Professor Chen, who works as a consultant ophthalmologist at the Institute as well as Royal Perth Hospital and Perth Children’s Hospital, will be speaking at the Asia Pacific Vitreo-Retina Society (APVRS) on November 23.

The focus of his presentation will be PYC’s ongoing phase 1/2 studies of drug candidate VP-001 in patients with RP11, with a particular focus on improved vision observed in the eye treated with VP-001 when compared to the untreated eye and baseline assessments.

This comes at an important stage for PYC’s development of the candidate, as it prepares to negotiate with the US Food and Drug Administration (FDA) in relation to a registrationaltrial for VP-001, anticipated to begin in mid-2025.

Leading up to this, the company will dedicate much of 1H of 2025 to engagement with the FDA around the design of this trial.

PYC shares moved up on this news, and at 13:08 AEDT, they were trading at $1.83 – a rise of 0.55% since the market opened.

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Recce is developing its flagship patented next-gen anti-infective, R327, with clinical results so far across Diabetic Foot Infection (DFI) and Acute Bacterial Skin and Skin Structure Infection (ABSSI); and, Urosepsis/Urinary Tract Infection (UTI) trials, pointing towards a potential commercial value proposition.

At the time of writing – 1.30PM in afternoon trades on Tuesday 1 October 2024 – Recce’s one-year returns are up over +16%.

We’ve seen a number of other biotech companies hit the bourse in recent history with investor interest in the sector.

Some stocks in particular – demonstrate solid performance YTD.

LTR Pharma (ASX:LTP), developing a nasal spray Viagra competitor, has posted gains of +444% YTD; while Cleo Diagnostics (ASX:COV), developing a blood test for early detection of ovarian cancer, is up +128% YTD.

Recce Pharma, for its part, has been on the bourse for closer to a decade now, after a 20c IPO raise and opening at about 40cps back in January 2016.

It’s been trading at 51cps and hit an all-time high of $1.45 back in late August of 2020 ­– the first year of COVID.

Outside of that anomalous period, however ­– let’s just define that as January 1 this year onwards ­– Recce shares hit a record high of 69cps back in April. That was around the same time the company received safety committee approval for fast-transfusion dosages in UTI patients of 4,000mg of R327 via intravenous (IV) administration.

Such volatility isn’t unusual for biotech companies and its history of price action reflects a textbook case for the sector. There’s exposure to unexpected market trends and consequent sentiment, and, a market forever somewhat risk-off if clinical results don’t meet expectations.

Biotech companies are also notoriously long-term value propositions, especially if they’re in the early days of getting through regulatory approvals – and perhaps by being publicly listed they’re forever star-crossed.

Shareholder and investment communities are typically defined by some level of impatience when progress is perceived to be tracking slowly for any company, but this is especially true for biotech ­– where a well-liked stock can easily become a pariah overnight.

But Recce Pharmaceuticals has pivoted, now, towards one market where it may see a good deal of momentum pick up – and it’s been gearing up for a busy end to 2024.

A large part of that hinges on a relatively freshly minted relationship which Recce has, which is underlined by a Memorandum of Understanding (MOU) with regional healthcare entity Etana Biotechnologies Indonesia.

Etana and Recce’s relationship doesn’t exist in a vacuum: It has the attention of Indonesia’s government.

In February of 2024, the Chairman of Indonesia’s National Research and Innovation – in an acronym, BRIN – Mr Laksana Tri Handoko, highlighted the Indonesian Government’s growing interest in innovation when it comes to biomedicine, which aligns with its larger overhead goal to tackle the health challenge of antimicrobial resistance (AMR).

“We need to build a national capability, especially after the lesson of the recent pandemic,” he said.

“This collaboration is a continuation of the close relationship we have with Australia, which I see will grow moving forward. We want to build our expertise together and I look forward to the work to start with us.”

It wasn’t just BRIN – Indonesia’s Health Minister, Mr Budi Sadikin, also pointed to greater cohesion between Indonesia’s and Australia’s biomed private sectors and public agencies.

“The global health challenge of antimicrobial resistance is a pressing issue on the world stage,” he said, also in February.

“Indonesia welcomes collaborative initiatives and supports efforts to combat antimicrobial resistance, including the development of innovative therapeutics for infectious diseases.”

Alongside Etana, Recce ultimately wants to launch a Phase III diabetic foot infection clinical trial of R327 in Indonesia.

If successful, this would be Recce’s first Phase III clinical trial marking a significant company milestone.

 Indonesia is a country boasting a massive population centre in South East Asia and part of  the Valeriepieris circle. Otherwise known as the Yuxi Circle, it’s a relatively small area of Earth’s surface that contains half the human population.

Indonesia, for its part, has a population of some 275.5 million – making it the fourth most populous country in the world.

When it comes to sepsis and diabetes:

“This bilateral collaboration between Recce and Etana, signifies the Australian and Indonesian Governments’ shared commitment to advancing public health, fostering innovation and addressing the global challenge of AMR in the Asia Pacific region,” Recce Pharma CEO James Graham said in February.

“By combining our expertise and resources, we can make significant strides towards a healthier and more resilient future for both our nations and the global community.”

RCE last traded at 51cps.

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Disclaimer: The Market Online & HotCopper had a commercial relationship with Recce at the time this was written.

The trial will begin in early 2025 and focus particularly on proving the concept of the skin disease that is caused by cutaneous lupus erythematosus (CLE), with this being reflected in the study’s name: HERACLES (or ‘Harnessing Endogenous Regulators Against CLE Study’).

The drug SOF-SKN is a first-in-class oligonucleotide TLR7/8 antagonist which is designed around not only controlling CLE symptoms but treating them at the source.

With expectations of early results from the trial, Noxopharm anticipates that it will provide a pipeline for the company’s Sofra platform of drugs (those that treat inflammation, autoimmunity, and mRNA vaccine enhancement) to become marketable for the treatment of other autoimmune diseases such as rheumatoid arthritis.

CEO Dr Gisela Mautner said the trial’s announcement represented an important stage in Noxopharm’s development.

“This trial marks the return of Noxopharm to the small group of ASX-listed Australian companies that have made it to the clinical trial stage,” she said.

“It is a major milestone that we have achieved in record time, and we are really pleased to be going back to the clinic with our first asset from the very promising Sofra platform.

“We have been methodical and thorough in our approach, and we will continue to complywith established and approved procedures of conducting clinical trials as we begin thisimportant phase of the drug development journey.

“While there is still a lot of work ahead, we are pressing forward as rapidly as possible and in line with the strategy we have set out over the past 18 months.

“At the big picture level, we very much see this as just the first chapter in developing theSofra platform across larger markets.”

The amrekt seemed enthused by the news, and at 11:25 AEST, Noxopharm shares were trading at 8.8 cents, a rise of 7.32% since the market opened.

The platform – established 17 years ago – has a product range including paternity testing, animal health, general consumer health and wellness, and is available in more than 42 countries.

Genetic Technologies is hoping that as well as leveraging the geneType’s accessibility to more customers, its presence on the EasyDNA platform will also deliver a gross margin of more than 70%.

Profitability targeting is a key focal point here, with the company aiming to reach this by reducing its cash spending from A$800k to A$200k a month.

The addition of geneType to the EasyDNA platform allows the company to build on work already done to grow consumer interest in the latter platform, especially through the Influencer campaigns and Stayhealthy initiatives in the United States.

EasyDNA’s platform revolves around providing clinicians and customers with a streamlined online process to facilitate information about clinical tests, and has been realised in conjunction with partners Nest Genomics, DNA Nexus, DNA Visit, Gene By Gene and Fabric Genomics.

Genetic Technologies shares have been trading at 4.1 cents.

First announced in mid-late May, Telix will offer American Depositary Shares (ADS) on the tech-heavy bourse that sports NVIDIA, Apple and Microsoft as its crown jewels.

Each ADS will represent one ordinary share in Telix.

The underwriters of the deal have an option to acquire up to 15% of the total ADS offering, which includes Morgan Stanley, Jefferies, and two other firms.

Morgan Stanley, if it is isn’t obvious, are a pretty good mob to have around for such a thing – it’s not like they haven’t got clients who’ll be interested.

The move comes at a fortuitous time for Telix Pharmaceuticals. The company’s stock price has been the beneficiary of recent test results the market liked.

At the same time, by looking at US IPO activity, it’s clear the biotech sector broadly is having a rebound in 2024 (which I also mean to include healthcare.)

Jefferies – another investment bank underwriting Telix’s IPO – are reasonably bullish on biotech.

According to their analysts, 2024 is the best environment biotech companies have been in since early COVID, with investment coming back to the notoriously risk-on sector.

The $5.97B market cap Telix is up +14% over the last week; up +17% over the last month, and, up +63% YoY.

TLX last traded at $17.89/sh.

The company – developing a blood test to detect ovarian cancer as opposed to relying on ultrasound – has declared its blood tests detected 90% of early-stage cancers in participating patients.

“[The test] significantly outperforms current clinical workflows that use CA125 and ultrasound to predict malignancy,” the company wrote on Wednesday.

CA125 refers to an existing type of blood test that looks for a protein of the same name with “CA” standing for “cancer antigen.”

In mid-March, the company posted partial evidence showing that its product correctly caught cancers in the participating donors of blood whose diagnoses were missed in a CA125 test.

The company also reported on Wednesday that CLEO’s own blood test methodology (and product) has now shown superior performance to “all current routine clinical tools,” which in its view, is evidence of “significant global potential.”

Despite these positive results, the company’s share price was unmoved in the first twenty minutes of trade and remained at 17cps.

“Having demonstrated now that the CLEO ovarian cancer blood test is far superior to CA125 and ultrasound in our initial pre-surgical triage market, we open up new dialogue with physicians to consider the potential material benefits that CLEO brings for their patients,” CLEO CEO Richard Allman said.

“More broadly, these encouraging results on early-stage cancer detection provide impetus for us to progress the development of CLEO’s screening test for ovarian cancer.”

So far, all clinical evidence has been posted in peer-reviewed journals, which the company describes as a strategy to acquire “gold standard” clinical data.

COV last traded at 17cps.

Our webinar explores what it takes for ASX-listed companies to get new health care developments – whether that be drugs, apps or other technologies – through the complexities of Australia’s Therapeutic Goods Association approvals process.

The TGA sits under the Federal Department of Health, and regulates the safety, efficacy and quality of everything from sunscreens to vitamin supplements, prescription medicines and medical devices. America’s big brother to the TGA is the US Food and Drug Administration. Some companies target the FDA first – looking to tap into a bigger market from the start.

Our webinar guests are:

We also feature insights from Bioshares editor, Mark Pachacz.

Bioshares is an online investor resource delivering research notes specific to Health Care sector companies. Bioshares also has a Biotech Summit which will be held in Fremantle, July 12-13.

While the TGA did not respond to our invitations to join the webinar panel, you can also look at our special report on the topic – which can be downloaded free from The Market Online here. The report is titled: What it takes to get a new drug to market in Australia – Demystifying the clinical trials and approvals process.

The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.

That was the message today as four biotech companies and Life Sciences WA presented to 200 brokers and investors at the Broker Meets Biotech event in Perth.

It was hosted by Brian Leedman, a Healthcare sector leader who drove the development of ResApp Health- the company behind smartphone tech that analyses a cough to diagnose respiratory illnesses including pneumonia, asthma and bronchiolitis. That business, which began as a University of Queensland start-up, was acquired by Pfizer in a $179 million deal in 2022.

Mr Leedman is now chair of Blinklab, which has an app to assist in evaluation and diagnosis of conditions including autism and ADHD through measuring blinking rates and neurobehavior – again using a smart-phone.

Blinklab is listing on the ASX early next month after raising $7 million with 20 cent shares. There have been eight studies since 2020, and a feasibility study including 280 child subjects, found the Software as a Medical Device had sensitivity for identifying autism spectrum disorder at 85 per cent. The company is working towards US Food and Drug Administration approval by early 2026.

Other presenters today included Orthocell (ASX:OCC) chief operating officer Alex McHenry.

Orthocell has collagen-based devices for tissue and tendon healing, but now also for repairing peripheral nerve damage caused by injuries.

Company investors include Chris Ellison of Mineral Resources (ASX:MIN) and the McCusker Family, and the company has Professor Fiona Wood and Kim Beazley on the Board.

Meanwhile, HITIQ (ASX:HIQ) has a smart mouthguard with 15,000 data points to measure the forces experienced in the brain during hard impact and concussion. It’s been developed to support the identification, monitoring and management of sport-related brain injuries.

HITIQ chief commercial officer Damien Hawes discussed the company, which has secured a cornerstone agreement with the AFL. While it’s being adopted across professional contact sports and the military, the company is working to bring the mouthguards and accompanying subscription-based app, to grassroots players.

Also presenting today was Canadian-based clinical-stage psilocin company Tryp Therapeutics which has a Prospectus to raise $6.5 million with 2 cent shares, after being acquired by Exopharm (ASX:EX1).

Tryp MD and CEO Jason Carroll said Tryp was developing an IV infusion of psilocin – a compound from psychedelic mushrooms – to treat pain and anxiety disorders. He said the IV infusion addressed limitations of orally-administered psilocybin used by competitors. It has trialled its treatment for binge eating disorder and is also targeting conditions including anxiety, depression, fibromyalgia and irritable bowel syndrome.

Disclaimer: The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.