List of Regenerative Medicine Companies in Australia - 8

Antibody-based therapeutics for tissue repair applications

AdvanCell is a clinical stage radiopharmaceutical company developing an innovative pipeline of 212Pb-based Targeted Alpha Therapies for cancer patients. AdvanCell’s platform technology addresses the most significant challenge in Targeted Alpha Therapy – the reliable and scalable supply of isotope. AdvanCell’s novel drug discovery, preclinical processes, and state-of-the-art facilities leverage daily access to 212Pb, the ideal isotope for Targeted Alpha Therapy.

Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Clinical trials of Cymerus MSC products in osteoarthritis (Phase 3) and in severe complications arising from COVID-19 (Phase 2) are currently ongoing. Planning is also underway for further clinical trials of Cymerus MSC products in GvHD (through licensee Fujifilm), critical limb ischemia, idiopathic pulmonary fibrosis, renal transplantation, and diabetic foot ulcers. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of numerous diseases, including the clinical targets mentioned above, as well as asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.

Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular medicines to treat serious and life-threatening inflammatory diseases with significant, unmet medical needs. The Company's Phase 3 off-the-shelf mesenchymal lineage cell product candidates are: • RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) • Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection • REVASCOR® for advanced chronic heart failure, and • MPC-06-ID for chronic low back pain due to degenerative disc disease. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection.

Cambium Bio Limited (ASX:CMB) is a Sydney-based clinical-stage regenerative medicine company focusing on the development of innovative biologics for ophthalmology and tissue regeneration applications. The Company's proprietary technology, based on human platelet lysate, is being leveraged to create a pipeline of novel therapeutics with a primary focus on ophthalmology. Cambium Bio's lead product candidate, Elate Ocular®, is being developed to address significant unmet medical needs in the treatment of dry eye disease. In addition, the Company's stem cell platform, Progenza™, is being applied to the development of therapies for knee osteoarthritis and other tissue repair indications. Cambium Bio is committed to advancing its pipeline through clinical development and commercialization, with the goal of providing transformative treatments to improve patient outcomes. For more information about the Company and its programs, please visit www.cambium.bio

SDIP has unique patented platform that will revolutionize the world of fixation implants. SDIP`s compounds totally adsorb to the body when the host cells repair the damaged tissue avoiding unnecessary removal surgical interventions. In last two decades, there have been numerous attempts to develop bioresorbable fixation implants, but these devices have fallen short in providing the optimal degradation and also they degrade to acidic by-products causing local inflammation and delayed tissue regeneration. SDIP leaves no acidic/basic by-products behind. The properties of SDIP can be tuned to address different clinical needs in fixing a range of damaged soft and interface tissues. At SDIP Innovations, we are committed to stick to the customer-driven strategies tightly in the mission of revolutionizing the resorbable implants and provide a universally safer option for the patients.

S2N’s vision is a world where neuronal loss no longer means loss. Our regenerative medicine technology starts with the human hair follicle and ends with production of millions of pure neurons, all gene modification free. We aim to transform health, science and society.

Tessara Therapeutics Pty Ltd is a regenerative medicine company developing RealBrain® technology to break therapeutic barriers in the biopharmaceutical industry. RealBrain® technology is based on human mimetic 3D neural micro-tissues designed to have high physiological relevance, manufactured at industrial scale for unprecedented reproducibility. Priority applications include a high-throughput drug screening platform that includes a range of models of healthy and diseased brain tissue, and a regenerative medicine platform to develop next generation safe and efficacious tissue therapies for significant unmet neurological medical needs.