Revenue-generating regenerative medicine and 3D bio-printing company Koligo Therapeutics to undertake IPO and list on the ASX
Koligo Therapeutics, Inc. (“Koligo”) is a US regenerative medicine company developing and commercializing a range of three-dimensional (3D) bio-printed cell and tissue therapies for unmet medical needs.
Koligo is unique in that, unlike most biotechnology companies, it has a product that is qualified for sale in the United States. Its first product Kyslecel™ is an autologous (meaning the patient’s own cells are used) pancreatic islet cell therapy used to treat chronic or recurrent acute pancreatitis, a debilitating and painful condition with few effective treatment options. Koligo commenced sales of Kyslecel™ in November 2017, generating approximately A$1.6 million in revenue in the recent 14 months, from a limited number of its initial hospital customers. Short-term, Koligo is working on expanding its sales to a larger number of hospitals throughout the United States.
To make Kyslecel™, the surgeon at a qualified hospital removes the patient’s diseased pancreas (the source of pain and inflammation) and sends it to Koligo’s U.S. Food and Drug Administration (FDA)-registered facility in Louisville, Kentucky. Koligo isolates the pancreatic islets and uses them to produce Kyslecel™. Koligo then ships Kyslecel™ back to the surgeon for re-infusion into the patient’s liver, where the islets are intended to engraft and produce insulin needed to regulate blood sugar. The procedure, combined with the product, reduces the risk of diabetes, has favorable safety and efficacy rates, reduces pain, increases quality of life, and reduces dependency on insulin drugs.
Koligo is also working on launching Kyslecel V2.0 by mid-2019. This next generation of the product is expected to have an extended shelf life and will therefore allow for wider geographic distribution and potential international marketing opportunities. India and China are also among the countries with large numbers of pancreatitis sufferers, and Koligo is also planning to enter other international markets, potentially through out-licensing and partnerships with established market participants, subject to the receipt of all relevant regulatory approvals.
Kyslecel™ and Kyslecel V2.0 are only the first steps in Koligo’s development. Koligo is also developing a pipeline of other regenerative medicine products utilising its 3D bio-printing
platform which is subject to the completion of its development, clinical testing and regulatory approval. This pipeline (in pre-clinical stages of development) includes novel engineered tissue products containing pancreatic islets for the treatment of pancreatitis, type 1 diabetes
, and other pancreatic diseases; as well as 3D printed pre-vascularised
cell/tissue structures for multiple indications, including liver failure, neurological diseases, metabolic disorders, and genetic disorders
Oversimplifying somewhat, the pre-vascularised cell/tissue structures are 3D bio-printed for transplantation into humans with blood vessels already embedded in the tissue.
Koligo Therapeutics Limited (pending ASX code: KOL) (the “Company”), an Australian company which has agreed to acquire Koligo, is conducting the IPO of the business going forward. The Company has lodged a Replacement Prospectus with the Australian Securities and Investments Commission to raise up to A$7 million.
In the Australian public markets, there have been several successful IPOs of regenerative medicine businesses including Cynata Therapeutics (ASX:CYP) and Polynovo (ASX:PNV), which listed at market capitalisations of less than A$30 million, and now have market capitalisations in excess of A$200 million and A$350 million respectively. Most recently, another regenerative medicine company, Exopharm (ASX:EX1) listed in December 2018, with its share price more than doubling following the listing and remaining at that level, with a market capitalisation of A$20 million. Given Koligo’s focus on 3D bio-printing, of relevance is the fact that the ASX is also home to the successful 3D-printing company Titomic (ASX:TTT) with a current market capitalisation of over A$500 million (up from the initial market capitalisation of less than A$50 million). Uniquely, Koligo is expected to be the only ASX-listed 3D bio-printing company, however 3D bio-printing companies in public markets outside of Australia have enjoyed considerable success.
The Company’s team is comprised of proven individuals with extensive experience in emerging technologies, commercialising and marketing products, regenerative medicine and in the bio-technology industry; it includes Peter James (Chairman)
whose experience includes that of the current Chair of ASX-listed companies Keytone Dairy Corporation Ltd (ASX:KTD)
and Nearmap Ltd (ASX:NEA)
. Koligo’s Executive Director, CEO and co-founder Matthew Lehman
was CEO of Prima Biomed
Ltd (now Immutep), a dual-listed public company (ASX:PRR (now IMM) and NASDAQ:PBMD (now IMMP)) developing cancer immunotherapies, where he obtained “Fast Track” from the FDA and “Orphan Drug” designation for Prima Biomed’s lead product at the time. Stuart Williams
, (Executive Director and Chief Technology Officer) is a cell biologist and bioengineer with decades of industry and entrepreneurial experience, more than 23 issued patents, and 400+ peer-reviewed publications and the Endowed Chair of Cardiovascular Innovation and Director of the Bioficial Organs Program
at the University of Louisville. Balamurugan Appakalai, PhD (Chief of Manufacturing)
is a well-recognized pioneer in islet isolation technology and has processed 800+ human pancreases. Mike Hughes, MD (Chief Medical Officer)
started the clinical islet transplant program at the Jewish Hospital in Louisville, Kentuck.