About

ABOUT LIDDS

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

LIDDS AB (publ) develops injectable 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 which affect patient quality of life. NanoZolid® enables the controlled, long-term and personalized release of drugs for up to six months. NanoZolid® can be combined with traditional small molecules as well as with larger molecules.

LIDDS has a broad range of projects where NanoZolid® is combined with cytotoxic drugs used in the treatment of cancer as well as projects in the fast-growing area of immuno-oncology. LIDDS most advanced project is Liproca® Depot, a product for local treatment of prostate cancer.

LIDDS also offers the pharmaceutical industry access to NanoZolid for their drug development projects through licensing agreements. LIDDS recently concluded a licensing agreement in China and has a number of other agreements in place. The development of these projects is subject to the research and business priorities of the licensees.

Industrial scale manufacturing is undertaken in collaboration with Recipharm. LIDDS has other development projects where NanoZolid® is combined with pharmaceutical substances, for example cytostatics and immunological drugs.

LIDDS was founded by scientists and entrepreneurs at Uppsala University, University of Gothenburg and the life science incubator PULS AB. LIDDS shares are traded on Nasdaq Stockholm First North.

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, but 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. NanoZolid® offers a solution to this dilemma with the controlled and personalized release of active drugs, resulting in fewer side effects and less frequent injections.

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 patient’s quality of life. LIDDS NanoZolid® technology allows the local treatment of cancer and other diseases without the serious side effects that occur with systemic treatments.

NanoZolid® controlled drug release can also be used for the treatment of systemic diseases where it is administered subcutaneously resulting in fewer treatments, increased patient compliance and reduced healthcare costs.

MESSAGE FROM THE CEO

 

The NanoZolid® platform is unique and constantly creates new business opportunities.

Our two new focus areas, NanoZolid® in combination with a STING agonist, as well as a preparation for subcutaneous depot treatment, both have great potential that may result in new partnerships and agreements in the relatively short term.

For several years, LIDDS has been developing new drug variants with controlled intratumoral release with the aim of increasing the effect of drugs without causing severe systemic side effects. Now that the NanoZolid® technology can be used for both an injectable intratumoral and a subcutaneous depot, we have an even greater foundation for a broad portfolio of drug projects.  This means risk diversification as well as good opportunities for future earnings.

The new preclinical results with NanoZolid® in combination with a STING agonist are definitely an important milestone for the LIDDS technology platform. A single injection of NanoZolid® in combination with a STING agonist produces an effect that is as good or better than three injections with a standard STING agonist. Several major pharmaceutical companies, including Merck, Bristol Myers-Squibb, Novartis and GSK, have STING agonists in the preclinical phase or in phase I studies.,. The results with NanoZolid® / STING create opportunities for interesting discussions with major stakeholders in the pharmaceutical industry. Our positive results could solve the challenge presented by their substances in that they must be administered intratumorally and are short-acting, which may require weekly injections. We offer the major pharmaceutical companies a more commercial product that involves fewer treatments, requires significantly fewer healthcare resources and limits suffering for cancer patients.

Intratumoral immunotherapy with systemic effects is generally in demand due to severe and frequent side effects when the drugs are given systemically, i.e. intravenously. In parallel with the STING project, LIDDS is evaluating a prioritized selection of immuno-active drug substances. The NanoZolid® platform can be used to improve the properties of the drug, reduce side effects and also limit the number of injections into cancer tumors.

A new interesting business area was confirmed during the summer when NanoZolid® proved to be well tolerated when a depot was injected subcutaneously. The release of the drug then occurs in a controlled manner over a longer period of time, i.e. provides a sought-after systemic effect. There are many drugs that have to be injected daily and a single injection of NanoZolid® with an active substance could instead provide the same effect over several months. A long-acting injection may also mean avoiding the problem of patients forgetting to take their medication.

Patient recruitment for the phase IIb trial for the treatment of prostate cancer has taken longer than planned. The Data Safety Management Board concluded at the July meeting that doses of Liproca® Depot of up to 5,500 mg are a tolerable and safe dosage and that additional patients may be recruited to the second part of the trial. LIDDS has therefore applied for and received approval from the authorities in Canada and Finland that patients with larger prostates, up to 80 ml, may also be included in the trial. This will increase the inclusion rate in the LPC-004 trial.  LIDDS has also notified the authorities that patient numbers will be increased to 60 and that they will be followed for six months. This means that the trial is likely to end in the first half of 2019. Another three university hospitals have been contracted for the second part of LPC-004.

Prior to the phase I trial of NanoZolid® combined with docetaxel scheduled to commence this autumn, GMP manufacturing is in progress and an application for clinical trials has been submitted to the Swedish Medical Products Agency. The trial will be conducted at clinics in Scandinavia. Docetaxel is indicated for various types of cancer tumors, so there are a number of commercial possibilities. This will be our second clinical project where solid tumors will be treated intratumorally with cytostatics.

Our goal is to sign strategic partnerships and to license out our own development projects after phase I/II or after preclinical results within, for example, the area of immunology which is a very high priority area among researching pharmaceutical companies. We have also identified the most attractive pharmaceutical companies based on their market channels, business interests, patent situations and their estimated life cycle management needs, and have ongoing dialogue with several of them.

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 technology, as well as for any drug that will be developed within the scope of the platform.

LIDDS, with the NanoZolid® platform, will develop innovative and effective drugs for intratumoral treatment, as well as drugs with systemic effects that are released from a subcutaneous depot. NanoZolid®-based drugs should be at least as effective as the original drug but provide limited and/or fewer side effects as well as fewer treatments for the patient. 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 out- licensing to other pharmaceutical companies for use in their drug development projects, and as a tool for life cycle management of established medicines. LIDDS business model means that development lead times for NanoZolid® are significantly shorter than for traditional pharmaceutical companies.

In-house drug development

LIDDS objective is to develop pharmaceutical products in combination with NanoZolid® that are as effective as the original compounds but with fewer side effects. We aim to out-license our projects to pharmaceutical companies after the pre-clinical phases or phase I or II, subject to indications. Our most advanced project, Liproca® Depot for the treatment of prostate cancer, is currently in a Phase IIb clinical trial. LIDDS has concluded a licensing and development agreement in China for Liproca® Depot.

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, including inflammatory diseases and other areas where patient compliance and convenience are drivers.

Collaborative drug development

LIDDS offers pharmaceutical companies access to NanoZolid® for their drug development projects through licensing agreements. Under these licensing agreements, LIDDS provides the NanoZolid®-based formulation for further development by our partner. The continued development of these projects is subject to the research and business priorities of the licensees.

Rejuvenating established products

With NanoZolid®, LIDDS also offers a patented solution that addresses life cycle management in the pharmaceutical industry. NanoZolid® can be used to reformulate drugs that require improvement or prolonged patent protection.

LIDDS enables new treatments and revitalizes existing products

LIDDS develops new and unique solutions to address common problems related to drugs, in particular the devastating side effects and frequent treatments that are required with pills or injections.

The NanoZolid® technology has been validated with clinical results in Phase II studies and can be used in combination with many different types of pharmaceutical molecules. As a result, our research pipeline in is broad, targeting several cancer and tumor types using both new and well-established drugs, as well as the treatment of systemic diseases where convenience and patient compliance are drivers.

LIDDS plans to out-license projects to pharmaceutical companies after the pre-clinical phases or phase I or II, subject to indications. The Liproca® Depot 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.

Following the successful pre-clinical study in immuno-oncology using a STING-agonist, LIDDS is looking to out-license NanoZolid® for this purpose as early as possible, subject to research results.

LIDDS expects a license agreement to include upfront payment, milestone payments and royalty.

Partnering with Recipharm, the GMP manufacturing process is validated in industrial scale for our prostate cancer product, Liproca® Depot.

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: 33 142 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: 1 759 492 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 Axén
Director of Biomaterials & Devices

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