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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.

The year has begun in the best possible way!

LIDDS patent for NanoZolid® has now been approved in both the EU and the US. This means we can offer licensees patent protection until 2017, which is an enormous advantage. This also benefits commercial revenues by increasing royalties for licensing agreements.

LIDDS currently has two clinical trials underway and both projects, NZ-2HOF (Liproca® Depot) and NZ-DTX, will be licensed out after the study results have been reported. Extensive work is now taking place to prepare for and complete these negotiations. For our existing Liproca® Depot licensing agreement in China, our partner Jiangxi Puheng plans to submit an application for a clinical trial to the China National Medical Products Administration following the release of the LPC-004 results. Jiangxi Puheng will meet the costs of the study.

In line with the plan, preliminary results from the Phase IIb prostate cancer study, LPC-004, will be presented during Q3. In the first part of the study, 20 patients were injected with significantly higher drug volumes compared with the previous LPC-002 and LPC-003 studies. The Data Safety Monitoring Board concluded that the doses are both tolerable and safe. The aim for the first part of the LPC-004 study is to assess the relationship between dosage and safety, while the other part of the study with 41 patients focuses on measuring the effect on the PSA cancer marker, prostate volume, MRI and quality of life. The study includes a total of 61 patients and some of these men will be offered the opportunity to participate in an open label study where an additional Liproca® Depot injection is given when the PSA value has returned to its original value prior to the initial treatment. Preliminary results from some of the patients in the open label study look promising as the antiandrogen effect appears to be significantly longer than six months, which would mean longer treatment intervals with fewer treatment sessions.

LIDDS other clinical project which is in Phase I relates to treatment of solid tumors with NanoZolid® in combination with docetaxel, a cytostatic agent used to treat many different types of cancer. The first patient has been treated without complications at the Karolinska University Hospital and we hope that more patients can be recruited soon.

LIDDS has several projects with different types of immuno-active drugs under development. Immunotherapy is a very attractive and costly complementary treatment in cancer care which has meant that all the major pharmaceutical companies have made large investments in pre-clinical and clinical research. Immunotherapy has been shown to cure cancer in certain patient groups and significant resources are now being put into developing the most effective treatments so that more patient groups can be helped. At the same time there is large demand for intratumoral immunotherapy because of the serious side effects which occur when certain immunoactive substances are administered systemically, i.e. into the blood stream.

Positive pre-clinical studies have been undertaken by LIDDS with a TLR9 agonist and a pre-clinical program is currently underway. We have recently had confirmation of a positive freedom-to-operate analysis, which means LIDDS can develop its own product with this specific TLR9 agonist. We plan to carry out a Phase I study expected to start in 2020. With positive results, LIDDS can offer out licensing of its own product for intratumoral treatment with patent protection until 2037.

NanoZolid® in combination with a STING agonist is another immunotherapy project under development where there are opportunities for out licensing once the pre-clinical program is completed.

In parallel with the STING and TLR9 projects, LIDDS is evaluating a selection of immuno-active drugs for intratumoral treatment. We are focusing on those drugs which must be given intratumorally, those that have severe systemic side effects, and those drugs that have short-lasting effects and which require frequent treatments.

Based on the NanoZolid® technology platform, LIDDS will develop innovative and effective drugs for intratumoral treatment and drugs with systemic effects which are released from a subcutaneous depot. Our vision and goal is that NanoZolid®-based drugs will be at least as effective as the original drug but with fewer side effects and require fewer treatment sessions for patients. In this way our drugs will create value for patients, healthcare providers and the pharmaceutical industry.

Monica Wallter
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: 36 142 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: 1 939 268 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 Wallter
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

Holdings: 500 shares, 25 000 warrants

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.

Holdings: 70 000 shares, 25 000 warrants

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.

Holdings: 500 shares, 25 000 warrants

Charlotta Gauffin
Head of Clinical Trial Management

Master of Science M.Sc. and Ph.D. in organic chemistry from Uppsala University. About 20 years of experience in the pharmaceutical industry, within research and clinical development. Has held senior clinical project management positions at Quintiles and Q-Med/Galderma, with experience from a range of indications within drug and medical devicedevelopment. Born 1971.

Markus Thor
Head of Business Development

MBA from Stockholm School of Economics and M.Sc. in Chemistry from Umeå University.

25 Years of experience in the pharmaceutical industry with positions within business development and R&D including Vice President & Head of Business Development at Biovitrum AB, Chief Business Officer at Kancera AB and Senior Scientist at Pharmacia. He has been responsible for negotiating and closing a range of international licensing deals and other transactions in various therapeutic areas and development stages. Before joining LIDDS Markus Thor was Senior Investment Advisor, Life Sciences at Business Sweden. Born 1971.