Live Koligo Therapeutics Ltd ASX: KOL

FNN Interview| Koligo Therapeutics Ltd | ASX: KOL (5:59 mins)

Fixed Priced IPOType of Offer
25 Feb 19Offer Open
22 Mar 19Pay By
$0.20Price
Up to A$7 millionSize of Offer
$2,000 Minimum Investment
APP Securities/Novus CapitalLead Manager

Introduction

Koligo Therapeutics Ltd (ASX: KOL) (the Company) was incorporated on 27 June 2018 for the primary purpose of acquiring Koligo Therapeutics, Inc (Koligo) a US 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™, for the treatment of chronic pancreatitis patients, 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. Since 14 months ago, when sales commenced to a limited number of initial hospital customers, Koligo has generated revenues of approximately $1,600,000 from sales of this product.  

Koligo is currently developing Kyslecel™ v2.0, an improved formulation that is intended to extend the product’s shelf life and thus expand Koligo’s geographic reach. Koligo also seeks to develop and commercialize a range of other transformative cell therapies for a range of indications, including 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, pre-vascularised cell/tissue structures are 3D bio-printed for transplantation into humans with blood vessels already embedded in the tissue.

 

Koligo’s short to medium-term Product Pipeline

Koligo’s longer-term Project Pipeline

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 owned by Koligo.

Investment Highlights

  • Commenced sales of cell therapy product Kyslecel™ for the treatment of chronic or acute recurrent pancreatitis, already generating over $1,600,000 in revenue
  • Significant unmet medical need for Kyslecel™, as the current treatments for chronic or acute recurrent pancreatitis seldom provide meaningful long-term relief to patients
  • No other business or enterprise is known by Koligo to be widely selling a product similar to Kyslecel™ as a commercial for-profit endeavour
  • India and China are among the countries with large numbers of pancreatitis sufferers, and Koligo is planning to enter international markets, potentially through out-licensing and partnerships with established market participants, subject to the receipt of all relevant regulatory approvals
  • The pre-clinical pipeline 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
  • Potential to become a successful regenerative medicine platform for the development and commercialisation of scalable bioengineered tissue transplant products
  • Backed by US based institutional investor who also previously backed the ASX-listed Keytone Dairy and DroneShield
  • Board and management with significant experience in regenerative medicine, biotech and successful ASX-listed small-cap companies (including Immutep (formerly Prima BioMed), nearmap and iiNet
  • Australian public markets are home to several regenerative medicine companies, including Cynata Therapeutics (ASX:CYP), Polynovo (ASX:PNV), and most recently, Exopharm (ASX:EX1) listed in December 2018. On listing, the only 3D bioprinting company on the ASX

Offer overview

The Company is raising $6 million with the ability to accept oversubscriptions of an additional $1 million, for a total of $7 million.  

The proceeds of the offer will be used for the following:

  • Research and development;
  • Expansion of sales and operational staff
  • Expansion of manufacturing facilities;
  • Working capital; and
  • Costs associated with the listing and the IPO.

Koligo’s Products in More Detail

Kyslecel™

Chronic or acute recurrent pancreatitis is a painful, long-standing inflammation of the pancreas that alters the organ’s normal structure, gets worse over time and leads to permanent damage. The disease eventually impairs a patient’s ability to digest food and make pancreatic hormones which are critical to controlling energy levels in the blood. Chronic or acute recurrent pancreatitis has increased worldwide due to better diagnosis, increasing obesity, and increasing alcohol consumption in the developed world.  In the U.S., chronic or acute recurrent pancreatitis affects approximately 128,000 people, with an estimated 16,000 to 39,000 new diagnoses each year.

 

There are several medical treatments available for the treatment of chronic or acute recurrent pancreatitis. One such treatment undertaken by patients is a Total Pancreatectomy (“TP”), which involves the surgical removal of a patient’s entire pancreas. TP is effective at reducing pain in 85-94% of patients; however, it immediately results in type 3c diabetes due to removal of the regions of the pancreas (islets) that produce insulin.

Kyslecel™ is used after a patient has undergone a TP to relieve the pain and inflammation caused by chronic or acute recurrent pancreatitis. Kyslecel™ is an islet-autotransplantation (IAT) product, i.e., a product made from a patient’s own pancreatic islets (the cells that produce insulin) that are reintroduced into a patient’s body to produce insulin needed to regulate blood sugar. TP results in immediate diabetes for the patient, and Kyslecel™ can reduce the risk of diabetes from TP by preserving the patient’s insulin-producing cells (pancreatic islets) that regulate blood sugar. Below is a summary of the process involved in TP-IAT involving Kyslecel™.

Without access to TP with Kyslecel™, patients generally have limited treatment options (such as therapeutic endoscopy, partial pancreatic resections, and pain management with powerful opioids) that provide limited relief.

 

The diagram above shows how Kyslecel is used.

Kyslecel™v2.0

Koligo is currently developing Kyslecel™ v2.0, an improved formulation of Kyslecel™ that is intended to extend its shelf life. Kyslecel™ v2.0 is expected to launch in the second half of 2019, subject to completion of its development, and will allow Koligo to ship Kyslecel™ over longer distances, including international markets.

Other Products

Koligo also intends to develop and commercialise 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 initial additional 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.

Images (clockwise from top L to R): Spheriods being bio-printed, islets that have re-vascularised, magnified images of bio-printed spheroid containing islets.

Revenue Model

Koligo’s revenue is derived principally from the sale of products and performance of services to hospitals. Revenue is earned and recognised when product and services are received by the customer.

Growth Strategy

In order to increase its sales of Kyslecel™ (and subsequently Kyslecel™ v2.0), Koligo intends to focus on the following growth strategies:

  • expanding Koligo’s sales force and investing in the marketing of Kyslecel™;
  • increasing the number of insurers that reimburse for Kyslecel™;
  • expanding the network of hospitals and doctors who offer Kyslecel™; and
  • evaluating international opportunities for Kyslecel™ v2.0 through potential licensing and collaboration agreements for specific countries and regions.

Beyond increasing the sales of these products, Koligo is seeking to develop and commercialise a range of other products for a range of indications, as described above.

Board and Management

Members of the Company’s Board and management are experienced in the regenerative medicine industry and in successful ASX small-caps. The calibre, ability and relevant experience of the Board are highlighted by the following:

  • Matthew Lehman Executive Director and Chief Executive Officer has over 18 years’ executive experience at numerous biotechnology and pharmaceutical companies, including Immutep (ASX:IMM; NASDAQ:IMPP) (formerly Prima BioMed (ASX:PRR; NASDAQ:PBMD);
  • Peter James, Non-Executive Chairman has over 30 years’ public company experience as Chair, Non-Executive Director and Chief Executive Officer across a range of publicly listed and private companies. He is currently Chair of several ASX-listed companies, including Macquarie Telecom, nearmap Ltd, DroneShield and Keytone Dairy Corporation;
  • Stuart Williams PhD, Executive Director and Chief Technology Officer is an internationally recognised expert in regenerative medicine and is 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; and
  • Mike Hughes, MD (Chief Medical Officer) started the clinical islet transplant program at the Jewish Hospital in Louisville, Kentucky.

Risks

You are encouraged to read the Replacement Prospectus carefully as it contains detailed information about the Company and the Offer. Like all investments, an investment in the Company carries risk. As set out in Section 7 of the replacement prospectus, the Company is subject to a range of risks, including but not limited including regulatory risks, market adoption and ongoing acceptance of Kyslecel™, intellectual property protection, product development for the pipeline and manufacturing and facilities risks.

 

Section 734(6) disclosure: The issuer of the securities is Koligo Therapeutics Limited ACN 627 117 677. The securities to be issued are ordinary shares. The disclosure document for the offer can be obtained by clicking on the link above. The offers of the securities are made in, or accompanied by, a copy of the disclosure document. Investors should consider the disclosure document in deciding whether to acquire the securities. 

OnMarket has a limited allocation. The offer may close early and the 'Pay By' dates may change. Duplicate bids under the same investment profile, investor name or residential address may be cancelled.

The information contained herein is intended solely for persons within Australia. This communication is not for publication or distribution, directly or indirectly, in or into the United States of America, including its territories and possessions, any state of the United States of America and the District of Colombia (collectively, the “US”). This communication is not an offer of securities for sale into the US. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the US, except pursuant to an applicable exemption from registration. No public offering of securities is being made in the US.

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Koligo Therapeutics Ltd (ASX: KOL) is a US 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 commenced selling its first cell therapy transplant product, Kyslecel™, for the treatment of chronic pancreatitis patients, generating $1.6 million in revenue from sales of this product. Koligo is also working on other transformative cell therapies for a range of indications, including type 1 diabetes, and other pancreatic diseases.

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