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LIDDS Interim report January – September 2021

LIDDS Interim report January – September 2021
22 November, 2021 Robin Danielsson

JANUARY – SEPTEMBER 2021

  • Net sales amounted to MSEK 1.2 (0.0)
  • Operating expenses amounted to MSEK -29,5 (-19,8)
  • Profit/loss before and after tax amounted to MSEK -28.4 (-19.8)
  • Earnings per share amounted to SEK -0.90 (-0.76)
  • Cash flow from operating activities amounted to MSEK -32.7 (-17.3)
  • Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (88%)

JULYSEPTEMBER 2021

  • Net sales amounted to MSEK 0.4 (0.0)
  • Operating expenses amounted to MSEK -8.2 (-6.6)
  • Profit/loss before and after tax amounted to MSEK -7.8 (-6.6)
  • Earnings per share amounted to SEK -0.26 (-0.23)
  • Cash flow from operating activities amounted to MSEK -9.2 (-5.2)
  • Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (87%)

SIGNIFICANT EVENTS DURING THE THIRD QUARTER 2021

  • As part of the warrants-based incentive programme 2021/2024, a total of 146,000 warrants were subscribed to, by the CEO and key personnel at LIDDS. The remaining warrants are kept by LIDDS and will be offered to future key personnel in relation to employment.

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

  • In October, the company announced that no further patients will be enrolled in its dose escalating Phase I study (NZ-DTX-001). The primary objective of the trial was to study safety of NanoZolid®-docetaxel in solid tumors.
  • The data collected in the trial demonstrates safety and tolerability, an active and local drug release of docetaxel over an extended period of time and signs of clinical effect in injected tumors. LIDDS plan to communicate topline results during Q4 2021.

CEO Statement

The autumn has made its entrance in Sweden and when reflecting on the progress we have made during the third quarter of this year I feel pride.

We are making good progress in our projects and in October we communicated the closing of our NZ-DTX-001 study. The scope of the study was to investigate safety and tolerability of the NanoZolid®-formulated cytotoxic drug docetaxel in patients with superficial tumours which also was accomplished. We are currently closing the study and preparing for next clinical step which will be communicated in 2021 together with the top-line results from the study. This program is clearly on strategy and a good example of the value LIDDS is generating given a safety profile of docetaxel that is severely limiting its application as a systemic drug. Local intratumorally administration will improve the safety and efficacy profile of docetaxel thus allowing targeting of new types of patients.

LIDDS has previously communicated the intent to initiate a clinical investigation of our first immunoncology drug which is a TLR9 agonist. I am personally very excited about this drug given the improved behaviour of it when formulated in our technology for local administration. Since I joined LIDDS we have performed preclinical studies where we have combined the TLR9 agonist with another substance and the data looks very promising. We even see signs of immune activity in non-treated tumours in our animal studies. Given the signs of abscopal effects when combining TLR9 we have decided to go into clinical development with a combination therapy rather than a monotherapy. This change means a delay in our clinical study but given the observed data we believe the combination will generate best value for all stakeholders. I can promise you that we will do our outmost to progress this program as promptly as possible. We are all excited and looking forward to the clinical data on this specific project!

The collaboration with Johnson & Johnson is progressing according to plan and we hope to be able to expand the cooperation in the future. In parallel, we are working on validating our phase III plans for Liproca Depot. As an important step, we submitted our phase III study protocol to the European Medicines Agency (EMA) for Scientific Advise (SA) on Sep 27.

We have set a direction for the company by defining what strategic areas to focus on to reach our key targets and our Vision 2026 which is to make “LIDDS the preferred solution and partner for elegant and optimal drug delivery – enabling better health!”. We are a drug delivery company and will remain so by investing in our technology and our projects, and in our people and our partnerships. The unique value of LIDDS is to deliver drugs that are both safer and more efficacious by administration of NanoZolid®-formulated depots delivering a controlled and sustained local release of drugs. We will present more details regarding our strategic focus early next year.

An important strategic focus area is to secure long-term financing of LIDDS to provide resources for a sustainable growth. We are currently continuing our preparations to make the move to Nasdaq Stockholm’s main list. This is part of the long-term perspective and something we work intensively on. As senior executives need to be in place in the company for at least a quarter before being listed on the main market this has taken longer time with the entrance of myself and of the new CFO. The ambition is to make the move in first half of 2022. The requirements that are added when listing on the main market represent an opportunity to increase the quality of our work, sharpen our value propositions and becoming a more mature company.

Given our vision, strategies and plans it is important to continue to grow the organization in an efficient and sustainable way. To be successful we need the best competences onboard. I am therefore very pleased that we have now the support of Johan Harmenberg. Johan has an excellent and relevant background as Chief Medical Officer in several oncology companies. With this background I am convinced that he will contribute very positively to our growth journey.

My colleagues and I are looking forward to the rest of 2021 and to 2022 where we expect to be able to present more details about our new strategic direction and about the progresses that we make in our projects. Progresses that ultimately will make a real difference to patients.

Thank you for your continued support of LIDDS!

Nina Herne, CEO

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

For more information, please contact: 
Nina Herne, CEO, LIDDS +46 (0)70 714 74 57,  nina.herne@liddspharma.com

Jenni Björnulfson, CFO +46 (0)70 855 38 05, jenni.bjornulfson@liddspharma.com

LIDDS AB (PLC) is required to disclose this information in accordance with the EU Market Abuse Regulation. The information was submitted through the agency of the aforementioned contact, for publication on November 22, 2021 at 16.45 CET.

LIDDS AB (PLC) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and is superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens, and also has in-house development projects in the clinical as well as the preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit www.liddspharma.com.

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