About

ABOUT LIDDS

An innovative drug delivery platform for the benefit of patients and pharma companies

LIDDS AB (publ) develops efficient drugs for cancer and other diseases based on our unique proprietary NanoZolid® technology. NanoZolid helps solve some of the main problems with the way drugs work in the body and affect the patients’ quality of life. NanoZolid enables controlled, long-term and personalized release of the drug for up to six months. NanoZolid can be combined with traditional small molecules as well as with large biological molecules such as antibodies.

LIDDS’ most advanced project is Liproca® Depot, a product for local treatment of prostate cancer. This project is investigated in clinical studies, a Phase IIb-study is ongoing. Industrial scale manufacturing is conducted in collaboration with Recipharm. LIDDS has other development projects where NanoZolid is combined with pharmaceutical substances, for example cytostatics and immunological drugs.

LIDDS also offers pharma industry access to NanoZolid for their drug development projects through licensing agreements. Recently such agreements have been signed with Belina Pharma and Ferring Pharmaceuticals.
LIDDS was founded by scientists and entrepreneurs at Uppsala University, University of Gothenburg and the life science incubator PULS AB. LIDDS’ share is traded on Nasdaq, First North, since 2014

Improving quality of life for patients

A key challenge in all drug development is to balance effect and safety. An effective treatment will always bring a certain risk of side-effects. Not only does this cause the patient discomfort, in order to keep the side-effects at a manageable level it may be necessary to limit the dose of the drug to a level where it may not be as effective as desired. LIDDS offers a solution to this dilemma by treating the disease area locally to avoid side effects and frequent injections.

LIDDS has developed NanoZolid®, a unique technology that helps solve some of the main problems with the way drugs work in the body and affect the patients’ quality of life. NanoZolid retains the effect of the original drug compound but reduces the side effects.

Systemic treatment of severe diseases such as cancer means that very potent substances will affect several organs, not just the site of the tumor. Large parts of the body are exposed to the effects and side effects of the drug. This limits the dose and adversely affects the patients’ quality of life.

LIDDS aims to provide the market with the NanoZolid technology for local treatment of cancer and other diseases without the serious side effects that occur with systemic treatment.

CEO STATEMENT

 

LIDDS has delivered positive results and news for some considerable time, which confirms the strategic change implemented in 2015

LIDDS has delivered positive results and news for some considerable time, which confirms the strategic change implemented in 2015. The LIDDS NanoZolid® technology constitutes the bedrock for building a broad portfolio of pharmaceutical projects, which diversifies risk and provides good prospects for future revenue.

There are high expectations on the NanoZolid® technology platform, which offers efficient, controlled and long-term release of medication with minor side effects and the possibility of fewer treatments. The technology has been proven to work with several different types of pharmaceutical substances, which provides LIDDS with considerable potential for developing new drugs, but also for research partnerships and licensing agreements with pharmaceutical companies.

The research agreement concluded with Ferring in July pertains to a product development project where LIDDS, using the NanoZolid® technology, will formulate an innovative, controlled release drug that is sustained over a prolonged period. The first step in the collaboration is that LIDDS, using the NanoZolid® technology, will develop a new injectable drug formulation, after which there is an option for Ferring to sign an exclusive licensing agreement with the right to use the NanoZolid® technology for the original drug. The agreement also entails LIDDS being reimbursed for the project’s development costs. The concluded agreement complements LIDDS’s own research projects and does not compete with our own research portfolio.

The agreement that was signed with Belina Pharma is going according to plan. LIDDS is developing a new depot formulation to improve breast cancer treatment. It is positive that LIDDS is able to show revenue for the first time in our interim report. Both external agreements are a clear acknowledgement of the pharmaceutical industry’s interest in the patented NanoZolid® technology’s ability to improve the effects of existing drugs.   

In addition to the agreements entered into with Ferring and Belina, LIDDS also has its own development projects in which the NanoZolid® technology is combined with antiandrogens, cytostatics and immune-active molecules for the treatment of various types of cancer tumours, such as prostate and lung cancer.

The potential for local treatment with NanoZolid® in combination with biological drugs provide the company with an entirely new commercial arena, as local immunotherapy is expected to be demanded due to the severe and frequent side effects of systemic immunotherapy. LIDDS is currently strengthening its organisation with an experienced specialist in immuno-oncology to increase the pace of preclinical research and to integrate more types of immunomodulating substances into NanoZolid®.

The commercial strategy for LIDDS, with ongoing development projects such as Liproca® Depot and NanoZolid® with docetaxel, has a clear objective of entering into strategic partnerships after Phase I/II. The most attractive potential licensees in prostate cancer and lung cancer have been identified.  LIDDS has also conducted a commercial analysis in immuno-oncology and examined what is, for us, a completely new cancer indication of strategic interest.

The most attractive pharmaceutical companies have been identified based on their market channels, business interests, patent situation and assessed needs for life cycle management. During 2017, contacts will be initiated or developed with the pharmaceutical companies where the greatest business synergies have been identified.

LIDDS has now commenced the Phase IIb trial for the treatment of prostate cancer in which the first patients have been treated. The drug dose in LPC-004 is up to 200 percent higher compared to the previous trial, LPC-003, and patients will be monitored for six months. The trial, involving 50-60 patients, will evaluate the maximum tolerable dose and show the effect of Liproca® Depot on specific cancer biomarkers.

We are proud that a scientific article that presents results from the earlier Phase II trials with Liproca®Depot has now been accepted for publication in the respected American journal, The Journal of Urology.

The positive preclinical results of NanoZolid® in combination with docetaxel represent an increased focus on this type of cytostatic for the treatment of solid tumours. Planning for the Phase I trial is ongoing and is expected to commence in 2018. Docetaxel is indicated for a number of different types of cancer tumours, which is why there are many application areas and licensing options for NanoZolid® with docetaxel.

The company’s latest patent application for the NanoZolid® technology, which, upon approval, will provide patent protection until 2037, would provide enhanced and significantly longer protection for the company’s NanoZolid® technology as well as for any drug that will be developed with the platform. From a commercial perspective, longer patent protection means a significantly higher value for future out-licensing of LIDDS projects. The company has strong substantive legal protection in all major markets. LIDDS has recently applied for a patent for NanoZolid® in combination with all known biomolecules for local immunotherapy, in order to protect future drug candidates in immunotherapy. 

Autumn will continue to be interesting for LIDDS. In addition to the Phase IIb prostate cancer trial, there are several interesting preclinical cancer projects in our pipeline and our aim is to enter into additional licensing or partnership agreements with pharmaceutical companies.

LIDDS will continue to develop innovative and effective anti-cancer drugs. Drugs based on already approved substances in our patented technology, NanoZolid®, shall be as effective as the original drug but with limited side effects – this is my goal and vision as well as that of LIDDS.

Monica Walter
CEO

BUSINESS MODEL

LIDDS enables new treatments and revitalizes existing products

LIDDS business strategy is to use the NanoZolid® technology for three purposes: In our own in-house drug development, for outlicensing to other pharma companies for use in their development of new drugs, and as a tool for life cycle management of established medicines.

In-house drug development

LIDDS’ objective is to develop pharmaceutical products in combination with NanoZolid® that are as effective as the original compounds, but have fewer and less side effects. We plan to out-license our projects to pharma companies after phase I or II, depending on indications. Our current focus is on oncology, where our most advanced project Liproca® Depot for prostate cancer is currently being investigated in a Phase IIb clinical trial and thereby validating the NanoZolid technology. LIDDS has ongoing preclinical projects for cytotoxic drugs and local immunotherapy. There are also a number of other areas where the unique NanoZolid technology can bring great benefits, e.g. inflammatory diseases and other areas where compliance or side effects can be a problem.

Collaborative drug development

LIDDS also offers pharma companies access to NanoZolid for their drug development projects through licensing agreements. An exclusive development and option agreement has been signed with Belina Pharma, in which NanoZolid will be used to develop a new innovative product that can improve breast cancer treatment. Another research agreement with Ferring Pharmaceuticals concerns a product development project where NanoZolid will be used to formulate an innovative, controlled release drug sustained over a prolonged period.

Rejuvenating established products

With NanoZolid LIDDS also offers a patented solution addressing life cycle management to the pharma industry. NanoZolid can be used to reformulate drugs that have a need for improvement or a need for prolonged patent protection.

LIDDS enables new treatments and revitalizes existing products

LIDDS develops new and unique solutions to address the problems related to drugs, i.e. devastating side effects and frequent treatments with pills or injections, that can be avoided by treating the disease locally.

The NanoZolid® technology, validated with clinical results in Phase II studies, can be used in combination with many different types of pharmaceutical molecules, thus our research pipeline in oncology is broad, targeting several cancer and tumor types. Manufacturing is validated in industrial scale for our prostate cancer product, Liproca® Depot.

LIDDS plans to out-license the projects to pharma companies after Phase I or II depending on indications. The prostate cancer project is planned to be out-licensed after Phase II whereas other projects such as solid tumor treatment with cytotoxic drugs is typically a Phase I opportunity.

LIDDS preclinical projects in immuno-oncology can potentially be for sale earlier, depending on upcoming results. LIDDS expects a license agreement to include upfront payment, milestone payments and royalty.

 

Board directors and auditors

Jan Törnell
Chairman of the Board since 2015

Born 1960.15 years of experience in executive roles in the pharmaceutical industry in various countries. Professor with medical background. CEO of Oncorena AB and AB Innoext. Former Vice President of Global Strategy for AstraZeneca Oncology & Infection. Professor of Physiology at the Sahlgrenska Academy, University of Gothenburg. Chairman of Glactone Pharma AB and board member of Diaprost AB. Partners in P.U.L.S. and member of the investment committee.

Holdings: 30 142 shares, 250 000 warrants

Daniel Lifveredson
Board member since 2017

Born 1976. Master of Science in Engineering, Industrial Economy, Chalmers tekniska högskola in Gothenburg. CEO and owner of Excore AB, specialized in counseling in connection with corporate transactions in the segment of medium-sized companies. Long experience in international business. Daniel Lifveredson is engaged as a partner in several companies.

Holdings: 1 688 653 shares, 200 000 warrants

IngaLill Forslund Larsson
Board member since 2015

Born 1954. Economist with specialization in Marketing from the University of Uppsala. Leg. Midwife. Many years of sales and marketing responsibility in the pharmaceutical industry, including business responsibility for Urology, Global Marketing at Ferring Pharmaceuticals. Has held several commercial roles at AstraZeneca, among other things, responsible for a number of product launches. Senior Consultant at Lisberg Executive Search and Boyden International. CEO of a private real estate and consulting company. Board experience from several life science companies.

Holdings: 10 000 shares, 125 000 warrants

Maria Forss
Board member since 2015

Born 1972. Master’s degree in Economics from the School of Business, Economics and Law and Concordia University, Montreal. Active as Vice President Business Development & Global Marketing at the Swedish listed company Vitrolife since 2012. Maria Forss has for 20 years worked with product development, business development and marketing of pharmaceutical products in global roles at AstraZeneca, as well as in the virtual company DuoCort, where she as CEO and project managers had been instructed to take a new drug from clinical trials to regulatory approval and sales of the company. She has experience in product development of medicines from early phase to commercialization, and from several board positions in the pharmaceutical and medical technology companies.

Holdings: 18 100 shares, 150 000 warrants

Anders Bjartell
Board member since 2015

Born 1959. Professor and chief of urology at Skåne University Hospital since 2006. PhD in Medical cell research. European specialist degree in Urology. Visiting investigator at Memorial Sloan-Kettering Cancer Center in New York, 2005-2007. Associate Editor of European Urology, 2005-2012. Responsible for clinical trials in prostate cancer at the urology clinic SUS Malmö since 2007. National Principal Investigator for several new drugs for prostate cancer in recent years. Research group leader for urological cancer research at the Institute for Translational Medicine at Lund University. Published over 200 original scientific articles. H-index 39. Have experience in board work in European Urology, foundations and life science.e.

Holdings: 12 200 shares, 25 000 warrants

Auditor
Mazar SET Audit agency AB

Visiting address: Järnvägsgatan 7
SE-252 24 Helsingborg

Telefon: +46 42 37 19 00

Hemsida: www.mazars.se

Senior executives and management

Monica Walter
CEO

International Diploma in Marketing & Economics from University of Lund, Sweden.
Former CEO of Ellen AB (publ) from 2008 to 2014 and CEO of Probi AB (publ) 2000-2003. Senior international management positions in Pharmacia between 1986-1995. Global Category Director at Pharmacia & Upjohn during 1996-2000.

Holdings: 20 019 shares, 125 000 warrants

Bengt Norvik
CFO

Accountant from the University of Uppsala. Former CFO of Know IT AB (publ), Pargon AB and AB Upnod. Bengt runs his own business Markett Affärsutveckling AB, which provides consulting services in management, economics and finance. Bengt has experience from both listed as start-ups in Life Science, IT industry and commerce. Born 1955.

Holdings: 33 274 shares, 25 000 warrants

Stefan Grudén
Director of pharmaceutical R & D

Pharmacists, M.Sc. Pharm., From Uppsala University. 17 years experience in pharmaceutical research and development, including 15 years in senior services and Pharmacy Manager both Galenica AB, Malmö and Orexo AB, Uppsala, Sweden. Participated in the development of over 50 projects, of which more than a third have been upscaled to production scale and currently on the market as commercial products. Have a vast experience in solid and semi-solid drug delivery technologies. He comes from a position as Innovation Coordinator of Orexo AB. Born 1972

Niklas Axen
Director of Materials & Device

M.Sc. Engineering Physics at Uppsala University, PhD and Associate Professor of Materials Science at Uppsala University. Niklas Axen has previously worked in product development at De Beers and Hemapure, and has been in charge of R & D including Cerbio AB, Doxa AB and AB OrtoWay. Born 1963.

Martin Johansson
Head of preclinical R&D in immunotherapy

M.Sc. chemical engineering Lund University, Ph.D. and associate professor in organic chemistry at Lund University. 17 years of experience in medicinal chemistry and preclinical research and development. Formed Chief Scientific Officer with Respiratorius AB and senior research scientist at AstraZeneca Discovery R&D Södertälje Discovery R&D, Södertälje. Project manager for Glactone Pharma AB. Born 1971.

Carl-Gustaf Golander
Head of Clinical R & D

Master of Science, M.Sc. and PhD from the Royal Institute of Technology and MBA in Project Management from Linköping Institute of Technology. About 10 years of experience as an expert in biomaterials and then 25 years experience in drug development. Has held various senior R & D positions at Pharmacia, Q-Med, Orexo, Quintiles, and BAAU Pivotal Therapeutics and helped in the development of dozens of pharmaceutical and medical device products in various indications. Born 1953