Company Announcements

October – December

• Net sales amounted to 2.4 (0.3) MSEK
• The operating result for the period was -8.9 (-12.5) MSEK
• The net result was -8.9 (-12.5) MSEK corresponding to earnings per share of SEK -0.26 (-0.42)
• Cash flow from operating activities amounted to -9.9 (-10.1) MSEK
• Cash and cash equivalents amounted to 34.0 (36.1) MSEK

January – December

• Net sales amounted to 3.6 (0.3) MSEK
• The operating result for the period was -37.3 (-32.3) MSEK
• The net result was -37.3 (-32.3) MSEK corresponding to earnings per share of SEK -1.16 (-1.20)
• Cash flow from operating activities amounted to -42.6 (-27.4) MSEK

 Significant events during 2021

• An R&D agreement was signed with Johnson & Johnson Enterprise Innovation Inc (J&J) with an exclusive option for J&J to sign a global license agreement.
• LIDDS’ Chinese partner Puheng Pharma announced that an international multi-center study is requested in phase III for a market approval of Liproca® Depot in China.
• A directed share issue was carried out, bringing proceeds of 45 MSEK before issue costs to the company.
• The dose escalating Phase I study for treatment with NanoZolid® formulated docetaxel of solid tumors was closed. Data showed that the combination is safe and well tolerated.

Significant events after the reporting period

• The R&D project with J&J has moved into the next phase.
• A financing agreement of up to 40.8 MSEK signed with Nice&Green

CEO comment

Lately, we have been making great progress in our projects. LIDDS has been able to report topline results from the NanoZolid formulated docetaxel (nanodotax) project. The results show that the systemic exposure of docetaxel after treating solid tumors with nanodotax is low and that activity in both injected lesions and in systemic inflammatory markers was observed. We are pleased to see that the treatment is safe and well tolerated and that the reported adverse events are generally mild and local. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. We intend to submit data from the study for publication in a scientific journal. Based on the unexpected immunological findings in the phase I study it is important to further investigate the treatment mechanism of NanoZolid formulated docetaxel. We plan to do so in the study approved by the Swedish Medical Product Agency (MPA) in May last year investigating docetaxel in prostate cancer patients preoperatively.

We have also reached a key milestone in January 2022 when the R&D project with Johnson & Johnson Enterprise Innovation Inc. progressed into next phase. The aim is to develop an oncology product based on the NanoZolid technology for an undisclosed indication. We are very proud of this collaboration which is also increasing our know-how and experience on both sides. The project has now entered stage 2 of the feasibility program.

An important regulatory milestone achieved is the scientific advice given by the European Medicines Agency (EMA) on our Liproca Depot phase III study protocol. Overall, EMA agreed with our proposed study design including most importantly the primary endpoint being time to progression and to the suggested number of patients. The scientific advice given by EMA is a key regulatory validation of our clinical plans.

In parallel to moving our clinical projects forward, we have continued to set a new direction for the company strategically. Our projects must meet certain requirements to be included in our project pipeline. Projects must have a clear benefit regarding efficacy and safety while simultaneously being able to meet certain commercial requirements. It may seem obvious, but those criteria have been the guiding stars in the strategic revisit of our portfolio meaning that we have decided to focus on the most promising projects. We have also renamed our projects in development. We are eager to give a detailed presentation of our new strategy, vision, and update on our project portfolio on our upcoming Capital Market Day on the 9th of March 2022. Don’t miss it.

The efforts on making the move to Nasdaq’s main market are continuing. A part of that process, but also as a part of visualizing that LIDDS is taking the next phase in its development, has been to develop a new graphic look and content impacting on both the Year-end report and our website. Our new website will be launched shortly. Please visit www.liddspharma.com for further information.

We are also happy to welcome Matthew Lindon as Chief Scientific Officer from March 1. Matthew has over 20 years’ experience of drug discovery and development from the pharmaceutical sector and will be an important asset when developing LIDDS project portfolio. It is also with great pleasure we can announce that LIDDS has recruited a new Project Manager in Charlotta Grånäs Folkesson. Charlotta has a background as a Project Manager at biotechnology companies such as BioImage A/S and Vipergen ApS and as a scientist at the pharmaceutical company Novo Nordisk A/S in Denmark.

The team that will realize LIDDS vision of becoming a global drug delivery company are starting to come together. LIDDS will, through a small, efficient, and highly specialized organization, continue to focus on developing better and safer treatments with a high value. We started this year with a lot of progress and my colleagues, and I are looking forward to an eventful 2022.

Thank you for your continued support of LIDDS!

Uppsala, February 2022

Nina Herne, CEO

The interim report is available on the company’s website https://liddspharma.com/investors/#financial-reports

For further information, please contact

Nina Herne, CEO
Phone: +46 (0)70 714 74 57,
E-mail: nina.herne@liddspharma.com

Jenni Björnulfson, CFO
Phone: +46 (0)708 55 38 05
E-mail: jenni.bjornulfson@liddspharma.com

LIDDS Certified Adviser is Redeye AB.
Tel: [+46] 8 121 576 90
E-mail: certifiedadviser@redeye.se

This information is information that the company is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the aforementioned contact persons, on February 23, 2022 at 17.30 CET.

LIDDS in brief:
LIDDS is a Swedish drug delivery company based on the proprietary technology NanoZolid®. With NanoZolid®, LIDDS can formulate drugs for local administration, with a maintained and controlled release for up to six months. The technology is versatile, can be used across different drug classes and solve problems within many indication areas. LIDDS offers the NanoZolid® technology to partners and has developed its own pipeline focused on oncology, where the technology enables delivery of a local and high drug dose, administered over time with very limited side effects. LIDDS has a broad pipeline with several projects in clinical development, both in early and late-stage clinical phase, and projects about to enter clinical development. The company is listed on Nasdaq First North Growth market.

 

Attachment

• LIDDS Year-end report 2021 220223 ENG