Imuron

STEVEN LYDEAMORE

CEO

IMMURON

(ASX:IMC)

◾ Company Name: Immuron ◾ Company ASX code: IMC, NASDAQ: IMRN ◾ Key areas: Orally delivered polyclonal antibodies produced from hyperimmune antibody-rich bovine colostrum, for prevention and treatment of gut-mediated diseases ◾ Key Personnel: Steven Lydeamore, CEO | Jerry Kanellos, COO ◾ Locations: Australia, United States, Canada ◾ Market Cap as of 15/09/22: $18.90M ◾ 52 Week share price as of 15 September: $0.076 - $0.170 ◾ Company Website: immuron.com.au

COMPANY PROFILE

It is rare to find a biopharmaceutical company generating revenue from both product sales and developing new drugs in the clinic, but dual-listed, AustralianNorth American company Immuron is one such example.

Immuron has developed two commercial oral immunotherapeutic products for the treatment of gutmediated diseases, and it has four clinical programs entering Phase II trials.

The company’s advanced stage reflects a substantial market opportunity, according to CEO Steven Lydeamore, who joined the company in June this year.

“Our products are a subset of the multi-billion dollar global digestive health market,” he says.

“There are opportunities to grow sales of our two commercialised products, Travelan® and Protectyn® , and opportunities to further develop our intellectual property portfolio.

“We have a patented and validated technology platform from which three products, IMM-124E, CampETEC and IMM-529, are entering trials in traveller’s diarrhoea, campylobacter and enterotoxigenic Escherichia coli (E.coli) and Clostridioides difficile infections, respectively, and there are opportunities for expanded use of Travelan® .

“Travelan® is presently in clinical trials for traveller’s diarrhoea and Immuron is conducting additional research into infectious diseases with various divisions of the U.S. Department of Defense.”

Resurgence of Travelan® drove Immuron global sales increase of 425% in FY22 approaching $1 million. Prior to the pandemic, sales peaked at $2.9 million for three quarters of FY20.

Travelan® is an orally administered passive immunotherapy in tablet form that prophylactically reduces the risk of traveller’s diarrhoea, a digestive tract disorder commonly caused by pathogenic bacteria. Travelan® is experiencing renewed growth in North America, with sales up 494% in FY22, as travel begins to rapidly increase following two years of heavy restrictions.

The active ingredient in Travelan® is hyperimmune bovine colostrum powder, a rich source of antibodies that bind to E. coli in the gastrointestinal tract, preventing them from attaching to the intestinal wall and thereby neutralising their ability to cause traveller’s diarrhoea.

The global market for traveller’s diarrhoea is growing by 7% each year, and, assuming a penetration rate of just 15%, Travelan® stands to be worth $83 million in North America and around $50 million in Europe.

Meanwhile, Protectyn® is an immune supplement scientifically formulated to be rich in anti-LPS antibodies to target pathogenic bacteria and the harmful LPS toxins they produce in the gut, reducing their ability to disrupt the healthy function of the gut, liver and immune system.

The two drugs are produced through Immuron’s proprietary technology platform, which combines the natural health benefits of bovine colostrum with a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal tract.

Travelan®’s potential has recently been rubber-stamped by the US Department of Defense, which provided a $6.4 million grant to Immuron and the US Naval Medical Research Center (NMRC) to examine a dosing regimen more suited for use by the US military; clinical trials are underway.

The Uniformed Services University is anticipated to commence a randomised clinical trial with Travelan® this financial year to evaluate the effectiveness for prophylaxis during deployment or travel to a high-risk region for traveller’s diarrhoea.

In addition, market evaluation is being undertaken before initiating further trials of IMM-529 for treatment of Clostridioides difficile infections, and Immuron partner NMRC is on clinical hold for two proposed trials of a new therapeutic, CampETEC in campylobacter and enterotoxigenic E.coli.

KEY INVESTMENT HIGHLIGHTS

JANUARY 12, 2022: US Department of Defense awards $6.2M to IMC to clinically evaluate a military strength dosing regimen of traveller’s diarrhoea drug Travelan® . JULY 7, 2022: Immuron receives European Patent Notification on drug composition to treat Clostridioides difficile associated disease. JULY 11, 2022: Immuron reports North American Travelan® sales have skyrocketed by 494%, and global sales up 431%.