Announcement • Jul 06
Immuron Advances Imm-529 Partnering Strategy and Provides Updates on Clinical Development Immuron Limited engaged Pullan Consulting to provide business development services to assist in securing a strategic partnership for IMM-529. Pullan Consulting specializes in guiding biotechnology and pharmaceutical companies through the partnering process, from strategy development and partner identification to negotiation and transaction execution. Immuron has U.S. Food and Drug administration approval for IMM-529 Investigational New Drug application (IND 32095) for clinical development of IMM-529 as a product to specifically prevent or treat Clostridioides difficile infection in a Phase 2 clinical trial. IMM-529 has a validated biological target. FDA-approved monoclonal antibody Bezlotoxumab was developed as a first-in-class therapy designed to prevent recurrence of Clostridioides difficile infection by neutralizing toxin B, the major driver of recurrent disease. IMM-529’s polyclonal antibodies offer multivalent defense compared with monoclonal single-epitope antibodies. IMM-529 also has an advantage over current standard of care antibiotic treatments that disrupt microbiota. IMM-529 decolonizes the gut facilitating clearance of the pathogen, recovery of the microbiome and prevention of recurrent infection. Immuron has completed an Investigational Brochure and clinical protocol and has secured a principal investigator and three Australian sites. This trial is eligible for Australia’s Clinical Trial Notification scheme, a fast-track method for initiating trials. Immuron has manufactured and released drug product for supply of a clinical trial. The trial protocol is for a randomized, double blind, placebo-controlled clinical study of IMM-529 with Standard of Care for the treatment of Clostridioides difficile infection in subjects with first episode Clostridioides difficile infection or recurrent Clostridioides difficile infection. Up to 60 subjects will be enrolled in the study. Subjects would be randomly assigned to IMM-529 plus Standard of Care or placebo plus Standard of Care in a 2:1 ratio at multiple sites. The primary objective would be to evaluate the safety and tolerability of IMM-529 together with Standard of Care in patients with Clostridioides difficile infection or recurrent Clostridioides difficile infection. Determination of efficacy would be assessed by the measurement and comparison of mortality rate, disease symptoms and recurrence rate for each treatment group. Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It is anticipated that first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to 98,000 patients would be eligible if IMM-529 is positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue for IMM-529 is projected at USD 400 million. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts. The Company is seeking partners to advance clinical development of IMM-529. Under a licensing model, the licensee typically funds development, registration, and commercialization costs. Common licensing agreements include upfront fees upon execution of the document, as well as developmental milestone payments and royalties on product sales. Terms from select historical Clostridioides difficile infection-focused deals that show a range of possible transaction structures are shown below. With upfront payments ranging from USD 1 million to USD 50 million, milestone payments ranging from USD 25 million to USD 570 million, and typical royalties on sales in the mid-to-high single digit percentage range, a successful development partnership for its IMM-529 asset could prove transformational for Immuron. Destiny Pharma licensed NTCD-M3 (nontoxigenic Clostridioides difficile strain, live biotherapeutic) to Sebela Pharmaceuticals with upfront USD 1 million; up to USD 570 million milestones (including USD 19 million development and up to USD 550 million sales) plus royalties. Summit Therapeutics licensed Ridinilazole (small molecule antibiotic) to Eurofarma with USD 2.5 million upfront; up to USD 25 million milestones plus royalties. Assembly Biosciences licensed Microbiome GI programs to Allergan (later AbbVie) with USD 50 million upfront plus milestones and royalties. The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile. Treatment of Clostridioides difficile infection also involves antibiotic use, and the heavy reliance on antibiotics to control Clostridioides difficile does not allow for the gut flora to regenerate and predisposes the patient to relapsing Clostridioides difficile infection. Clostridioides difficile is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States. Clostridioides difficile infection affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. Immuron collaborated with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum that contains antibodies targeting three essential Clostridioides difficile virulence components. IMM-529 targets Toxin B, the spores, and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P). Immuron’s proprietary technology is based on polyclonal immunoglobulins derived from engineered hyper-immune bovine colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and the products are orally active. Bovine immunoglobulins can withstand the acidic environment of the stomach and are resistant to proteolysis by the digestive enzymes found in the Gastrointestinal tract. Bovine immunoglobulins also possess this unique ability to remain active in the human Gastrointestinal tract delivering its full benefits directly to the bacteria found there. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce. New Risk • Apr 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.5m market cap, or US$7.46m). Minor Risk Currently unprofitable and not forecast to become profitable next year (AU$4.4m net loss next year). New Risk • Apr 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.8m market cap, or US$7.72m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$3.7m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). 
