On behalf of the directors of Koligo Therapeutics Limited (Company), I am delighted to invite you to become
a shareholder of the Company.
The Company is seeking to raise a minimum $6,000,000 through an issue of 30,000,000 Shares at a price
of $0.20 per Share (Public Offer). Oversubscriptions of up to a further 5,000,000 Shares at an issue price of
$0.20 per Share to raise up to a further $1,000,000 may be accepted under the Public Offer. The maximum
amount which can be raised under the Public Offer is therefore $7,000,000.
The Company was formed on 27 June 2018 for the primary purpose of acquiring Koligo Therapeutics, Inc.
(Koligo), a U.S.-based biotechnology company focused on the development and commercialisation of a
range of cell therapy, three-dimensional (3D) bioprinted tissue and other regenerative medicine products for
serious unmet medical needs.
Koligo has successfully commercialised and has recently commenced selling its first cell therapy transplant
product, Kyslecel™, in the United States. Kyslecel™ is used in the treatment of patients suffering from chronic or acute recurrent pancreatitis, a debilitating and painful condition with few effective treatment options.
Kyslecel™ is regulated by the United States Food and Drug Administration (FDA). Koligo has determined that
Kyslecel™ meets the criteria to be regulated in the U.S. under Section 361 of the U.S. Public Health Service
Act and applicable FDA regulations and therefore is qualified for sale in the United States without FDA premarket clearance or approval. Refer to the Legal Report in Section 10 for further details.
Kyslecel™ was developed based on research conducted by Koligo’s scientific founders, Stuart Williams,
PhD and Balamugaran Appakalai, PhD, into cell transplant technologies at the University of Louisville, a
global leader in regenerative medicine, beginning in 2011. Koligo has exclusively (for a limited period of time)
licensed the intellectual property related to the development and manufacturing of Kyslecel™ from University
of Louisville’s research foundation. Dr. Williams and Dr. Appakalai now lead Koligo’s product development
Kyslecel™ has to date been sold at two hospitals and medical centres with programs that specialise in conditions affecting the pancreas. These medical providers benefit from using Kyslecel™ because their patients
have access to cellular transplantation procedures without the providers having to incur the risk, expense and
uncertainty of establishing in-house capabilities to produce pancreatic islets used to treat those conditions.
Between November 2017 (when Koligo began selling Kyslecel™ to a select number of pancreatic centres)
and the date of this Prospectus, Koligo generated approximately $1,600,000 in revenues from the sale of
Koligo believes the market for Kyslecel™ in the U.S. is significant. An estimated 16,000 to 39,000 people
in the U.S. are diagnosed with chronic or acute recurrent pancreatitis each year2
. Koligo knows of no other business or enterprise in the U.S. that is widely selling a product similar to Kyslecel™ as a commercial
for-profit endeavour. Since there is currently limited competition, Koligo believes it can capture a significant
part of this market.
Koligo is currently developing Kyslecel™ v2.0, an improved formulation of Kyslecel™ that is intended to extend its shelf life, which is expected to be launched in the second half of 2019, subject to completion of its development. Koligo believes the worldwide market for Kyslecel™ v2.0 is larger than the market for Kyslecel™,
given that Kyslecel™ v2.0 is expected to be available to more patient groups and is expected to be shipped
over longer distances, including to international markets (subject to meeting foreign regulatory requirements).
However, it is not possible to reliably quantify the size of the markets of Kyslecel™ and Kyslecel™ v2.0 in
terms of potential revenue.
Koligo also intends to develop a pipeline of regenerative medicine products that will utilise 3D bioprinting,
adipose-derived cells (regenerative cells derived from fat tissue) and other tissue processing techniques (referred to as Koligo’s 3D-V technology platform) for novel cell therapy and engineered tissue products. The
products that Koligo intends to develop using its 3D-V technology platform are KT-CP-203 and KT-DM-103
(Stylecel-L), engineered tissue products containing pancreatic islets for the treatment of pancreatitis, type 1
diabetes, and other pancreatic diseases.
Longer term, the Company aims to be a leader in the development of novel cell therapy and engineered tissue
products for liver failure, neurological diseases, metabolic disorders, and genetic disorders, using Koligo’s
3D-V technology platform.
Koligo’s proprietary cell therapy, 3D bioprinting, and tissue engineering technologies are protected by patents
exclusively licensed by Koligo, a patent application filed by Koligo and non-patented proprietary databases,
processes, and know-how.
The Company seeks to support its commercialisation strategy and research and development work through
applying the funds raised in the Public Offer to expand its sales and marketing capabilities, undertake
pre-clinical and clinical studies, and invest in technology to support its product pipeline.
Before making your decision to invest, I ask that you carefully read this Prospectus, consider the extensive
risks of investing in the Company (which include the risk factors set out in Sections 3.7 and 7) and seek professional advice if required.
On behalf of the Board, I commend the Public Offer to you and look forward to welcoming you as a Shareholder.