Oxcia AB (publ) publishes interim report fort the second quarter 2023

25th August 2023

Oxcia AB (publ) Interim report

1 January- 30 June 2023

Second quarter (April-June 2023)

  • Operating loss totaled SEK -6 937 299 (-7 068 278)
  • Loss for the period totaled SEK -6 600 725 (-7 068 278)
  • Cash flow from operating activities totaled SEK 395 205 (-5 963 346)
  • Earnings per share before dilution totaled SEK -0,31 (-0,33)
  • Earnings per share after dilution amounted to SEK -0,31 (-0,33)

Period (January-June 2023)

  • Operating loss totaled SEK -23 503 674 (-12 381 412)
  • Loss for the period totaled SEK -23 051 192 (-12 381 412)
  • Cash flow from operating activities totaled SEK -6 365 730 (-10 957 130)
  • Earnings per share before dilution totaled SEK -1,07 (-0,58)
  • Earnings per share after dilution amounted to SEK -1,07 (-0,58)

Significant events in the second quarter

  • 3 posters describing OXC-101’s unique mechanism of action and promising safety profile in patients with advanced solid malignancies were presented at American Association for Cancer Research (AACR) annual meeting, Orlando, Florida 14-19 April. The studies will be published in the proceedings supplement of the AACR journal Cancer Research.
  • Oxcia were represented at the BIO US 2023 investor and partner meeting in Boston.
  • Presentation of OXC-101 from idea to clinical candidate at International Drug Discovery Science & Technology (IDDST) 2023, Tokyo, Japan 8-10 May.
  • Tablets were manufactured for continued clinical studies with OXC-101.
  • Recruiting of prostate, ovarian and endometrial cancer patients in the approved expansion groups in clinicval phase 1 study initiated.
  • New data was obtained demonstrating significant effects of OXC-201 in fibrosis and inflammation markers inhuman IPF lung samples.
  • A contract was signed with Lonza for formulation development of OXC-201.
  • Accepted poster presentation showing OXC-201 effects in IPF will be presented at European Respiratory Society (ERS), Milan, 9-23 September 2023.
  • The ordinary annual general meeting on June 13 re-elected the board and auditor, giving the board and CEO discharge from liability and approves the board’s proposal for a mandate for issue.

Significant events in the period

  • Thomas Helleday´s Foundation for Medical Research receives approval of patent BR112015011497, which includes OXC-101, in Brazil. Oxcia has a lifetime, exclusive license to the patent rights from the foundation.
  • A new report ”Small molecule-mediated OGG1 inhibition attenuates pulmonary inflammation and lung fibrosis in a murine lung fibrosis model” was published the 26th January in the scientific journal Nature Communication (doi 10.1028; Tanner L et al.). The report shows pre-clinical data that OXC-201 (TH5487) is a promising new therapy for idiopathic pulmonary fibrosis.
  • EIC (European Innovation Council) selects Oxcia’s OXC_201 as one of the projects receiving grants within the EIC Transition program. Oxcia receives an amount of 2.5 million Euro. EIC is Europe´s leading innovation program for identifying, developing and scaling-up groundbreaking technologies and innovations. Oxcia is the only Swedish company receiving a grant in this call.
  • In fierce competition, Oxcia receives a grant of SEK 3 million in a call for collaborative projects for better health from Swelife and MedTech4Health. In this project, Oxcia collaborates with Karolinska Institute, Karolinska University Hospital and Örebro University Hospital to demonstrate efficacy as well as additional evidence of safety of OXC-101 in monotherapy and in combination with chemotherapy in refractory (relapsed) AML.
  • Oxcia participates in, for instance, Bio-Europe meetings and has meetings with potential investors and collaborators.

Significant events after the end of the period

  • OXC-101´s preclinical effects in AML, a blood cancer disease, are presented at IDDST 12th July 2023, Amsterdam, Netherlands.
  • No other significant events that affect earnings and financial position occurred after the end of the period.

CEO comments

Dear shareholders,

Oxcia continues to develop unique revolutionary treatments through the innovative use of oxidative DNA damage and DNA damage response processes to treat cancer as well as inflammation and fibrosis related diseases. New results from state-of-the-art research in human IPF lung further strengthen OXC-201 as a promising new treatment against IPF. An expansion cohort in advanced patients with prostate, ovarian and endometrial cancer has been initiated with OXC-101. The capital market remains challenging, which leads to a delayed clinical phase 2 study with OXC-101.

Idiopathic lung fibrosis (IPF) is a life-threatening disease with scarring of the lung that worsens over time and makes it increasingly difficult to breath. There are two approved drugs on the market that slow down the course of the disease. Unfortunately, their use is limited by side effects and interactions with other drugs. There is a great medical need to find new types of treatments. Oxcia’s OXC-201 offers a unique mechanism of action that affects multiple signaling pathways and disease processes involved in IPF with the potential to prevent further lung damage.  

During the first quarter of this year, Oxcia received a prestigious grant from the EIC (European Innovation Council) for continued preclinical development of OXC-201.During the second quarter, additional state-of-the-art studies with OXC-201 were performed in samples from human IPF lung. The results further strengthen the potential of OXC-201 as a new effective treatment against IPF. Dr. Christina Kalderén, Preclinical Director and responsible for the OXC-201 program, will have an oral presentation with these new results at the IPF summit conference in Boston on September 19-21, Dr. Sandra Ekstedt, senior scientist, will present OXC-201 as a new possible IPF treatment at the European Respiratory Society (ERS) conference in Milan, Italy on September 9-13. Many companies have shown interest in new treatment options for IPF. That OXC-201 has been selected to be presented at conferences that reach both pharmaceutical companies, doctors and Key opinion leaders is therefore of great importance.

With the development of OXC-101, Oxcia is fighting cancer by exploiting one of cancer’s Achilles’ heels – its inherent high levels of oxidative stress and DNA damage. OXC-101 kills the cancer by stopping cancer cell division, generating more oxidative stress and DNA damage, so much so that the cancer cell can no longer survive. This tdual mechanism is unique to OXC-101, increasing efficacy, tolerability and the number of patients that can be treated. On Oxcia’s website there is now an animated film that explains the mechanism of action (https://oxcia.com/pipeline/oxc101-karonudib-th1579/).

During the second quarter, the recruitment of advanced and progressive patients with prostate, ovarian and endometrial cancer was initiated in an expansion group in an ongoing clinical phase 1 study in advanced solid cancers. As the capital market continues to be challenging (see below), we can in this way continue to generate knowledge and value in the OXC-101 program before the start of the clinical phase 2 study.

During spring, discussions with existing and potentially new shareholders continued. The capital market remains challenging with great caution in investing. Our assessment is that an IPO can take place at the earliest in 12-18 months. Oxcia thus needs to ensure adequate finances until the end of 2024. We still have good hopes of bringing in new capital and avoiding curtailing operations. The operations are continuously reviewed and prioritized in order to cost-effectively increase the value of the programs. As previously mentioned, we are very pleased that Oxcia received prestigious grants which allow us to proceed without delay with the preclinical development of OXC-201, which is mainly financed via the EIC grant. Completion of phase 1 study in blood cancers and expansion cohort in AML is also partly financed by grants. The planned phase 2 study in solid cancers unfortunately has to be postponed and we are now evaluating other study options that, at a limited cost, can provide us with additional data on the effect of OXC-101.

During autumn, the work continuous to identify new investors in and outside of Sweden. This entails discussions with potential partners concerning co-operation and in-licensing opportunities and applications for grant funding. We have started update meetings and discussions with shareholders and further update meetings will be held after the summer. We look forward to continuing the good dialogue and a joint journey forward.

Best summer greetings,

Ulrika Warpman Berglund