FOURTH QUARTER (October–December 2022)
- Operating loss totaled SEK -8,972,042 (-4,190,243).
- Loss for the period totaled SEK -8,912,366 (-4,190,243).
- Cash flow from operating activities totaled SEK -9,565,926 (-4,979,465).
- Earnings per share before dilution totaled SEK -0.41 (-0.21).
- Earnings per share after dilution amounted to SEK -0.41 (-0.21).
- Proposed dividend of SEK 0.00 per share (0.00).
THE PERIOD (January–December 2022)
- Operating loss totaled SEK -32,280,497 (-11,926,914).
- Loss for the period totaled SEK -32,220,821 (-11,969,591).
- Cash flow from operating activities totaled SEK -25,135,980 (-11,059,072)
- Earnings per share before dilution totaled SEK -1.50 (-0.64).
- Earnings per share after dilution amounted to SEK -1.50 (-0.64).
SIGNIFICANT EVENTS DURING THE FOURTH QUARTER
- New publication with OXC-201 (TH5487) that demonstrates a positive effect in the treatment of allergic asthma in disease models (Tanner et al., Frontiers in Pharmacology, October 17, 2022; DOI 10.3389/fphar.2022.999180).
- Scientific advisory meeting at the Swedish Medical Products Agency for the planned clinical Phase 2 solid cancer study.
- New publication with OXC-101 (TH1579) demonstrating that cancer cells with amplified levels of c-Myc are particularly sensitive to treatment with OXC-101. (Henriksson et al., Overexpressed c-Myc Sensitizes Cells to TH1579, a Mitotic Arrest and Oxidative DNA Damage Inducer., Biomolecules 2022 Nov 29;12(12):1777. doi: 10.3390/biom12121777).
- Scaled up OXC-101 synthesis and produced 40 kilograms of drug compound, despite difficulties in obtaining the raw material due to the impact of the COVID-19 pandemic.
SIGNIFICANT EVENTS DURING THE PERIOD
- Subscription of new shares through the use of warrants was carried out in late January, which thus generated SEK 20,616,102 before issue costs for Oxcia.
- On April 1, 2022, an Extraordinary General Shareholder Meeting resolved on the election of Eva Nordström as a new ordinary Board member of Oxcia and, as a preparation ahead of the IPO, a 10:1 split in shares. Furthermore, decisions were made on two warrants programs: one for management with 120,000 warrants (after the split) and one for the Board of Directors with 120,000 warrants (after the split).
- The Annual General Meeting on June 14 re-elected the Board of Directors and auditor, discharged the Board and CEO from liability, and approved the various proposals of the Board on mandates for share issues.
- New publication with OXC-101 (karonudib, TH1579) demon- strating that OXC-101 can also improve the effect of conventional chemotherapy in preclinical acute myeloid leukemia (AML) disease models. (Centio et al., "Inhibition of oxidized nucleotide sanitation by TH1579 and conventional chemo- therapy cooperatively enhance oxidative DNA-damage and survival in AML", Mol Cancer Ther, doi: 10.1158/1535-7163.).
- The Swedish Ethical Review Authority approves supplementary application for the clinical Phase 1 blood cancer study concerning the addition of further clinical study centers (Örebro University Hospital) and amendments to exclusion criteria.
- Agreements with Pantheon UK Ltd (Thermofisher) for labeling, packaging, and distribution of OXC-101 ahead of the clinical Phase 2 study.
- Agreements with FGK Clinical Research GmbH in Munich, Germany to write study protocols, and to contact clinical sites in Europe and the US to obtain documentation on which countries and clinical sites are to be contracted ahead of the clinical Phase 2 study.
- Recommended clinical Phase 2 dose and dosage regime for solid cancers established.
- The OXC-201 project was presented at the 6th Annual IPF Summit in Boston, August 29–September 1.
- Delivery from Mercachem Syncom Weert B.V. (Symeres) of scaled-up amounts of OXC-201 and an analogue for impending safety studies.
- Austin Smith was appointed Chief Medical Officer (CMO), succeeding Cecilia Ahlin.
- William Stafford, Translational Director and Sandra Ekstedt, Senior Scientist, began their employment in September.
- The Board of Directors decided to postpone the company’s listing of Class B shares, with the intent to wait until the financial market has recovered. At the same time, efforts are under way to locate alternate financing.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD
- Thomas Helleday Foundation and Oxcia obtained approved patent BR112015011497-0 in Brazil with requirements that encompass OXC-101.
- No other significant events that affect earnings and financial position occurred after the end of the period.
Despite turbulence in the business environment and in the finance market, in Q4 we continued to maintain focus on developing our drug candidates,OXC-101 and OXC-201, and took several steps toward reaching our milestones for 2023 and 2024. We ended 2 0 2 2 by publishing two peer-reviewed scientific articles in partnership with key opinion leaders in academia. One article indicated an exciting new possibility for OXC-201 in allergic asthma, and another provided further proof that OXC-101 has promising effects on cancer cells.
Clinical development for OXC-101 is moving forward
In November, we had a fruitful scientific advisory meeting with the Swedish Medical Products Agency that has helped us develop the details for the clinical Phase 2 trial protocol in solid cancers. I am extremely gratified with the very positive response we received from clinics in Belgium and Germany that are interested in participating in the trial.
The clinical Phase 1 trial in advanced solid cancers has planned for an expanded cohort of patience with ovarian, uterine or prostate cancer beginning in Q1 2023. This is intended to include more patients at the recommended Phase 2 dose and to obtain a greater understanding of how OXC-101 can best be used.
In the last quarter of 2022, we also analyzed data from the ongoing clinical Phase 1 trial in advanced blood cancers, where we are seeing promising results in illnesses such as AML, and are now planning for continued trials in 2023.
New supporting preclinical data for OXC-101
In late November, Oxcia partnered with Karolinska Institutet to publish further proof that OXC-101 has interesting and promising effects in cancer cells. The publication shows that OXC-101 is particularly effective in killing cancers with c-Myc1 and also reduces c-Myc levels in the cancer. c-Myc is a transcription factor2 and proto-oncogene3, and is behind many types of cancer such as aggressive prostate cancer and ovarian cancer. There have been many attempts to affect c-Myc, but as yet no one has succeeded in developing a treatment. The fact that OXC-101 affects c-Myc levels and cancers that express c-Myc is therefore a very exciting discovery. c-Myc could be used as a biomarker for treatment with OXC-101 in clinical development, which is something we will continue to study.
In partnership with Thermofisher Scientific, we established a method for large-scale production of the OXC-101 drug com- pound in accordance with Good Manufacturing Practice (GMP). At the end of the year, we had 40 kilograms of the new OXC-101 compound. This is crucial, and allows us to produce new tablets for continued clinical development.
Significant interest around OXC-201
There is significant interest in OXC-201 as a new type of treatment for pulmonary fibrosis, and we have received confirmation that the project is developing in line with the wishes of drug companies. It was particularly encouraging to note that Mikael Dolsten, Chief Scientific Officer of Pfizer, called attention to Oxcia’s ongoing scientific partnership with his company around OXC-201 in his keynote presentation at the Nordic Life Science Days on November 7.
OXC-201 also has potential in indications other than pulmonary fibrosis. The partnership with Professor Arne Egesten of Lund University continues to yield results. In October, the article “Pharmacological OGG1 inhibition decreases murine allergic airway inflammation” was published in the peer-reviewed journal Frontiers in Pharmacology in partnership with Professor Egesten’s and Professor Helleday’s research groups. The article shows that OXC-201 could have a broader application with positive effects in disease models for allergic asthma, which is a chronic inflammatory pulmonary disease with a large market potential. The main focus remains on the treatment of pulmonary fibrosis, but this new data will be followed up on and the potential investigated further.
As announced last autumn, the Board of Directors decided to postpone the planned listing until the business environment and finance market have stabilized. Oxcia’s finances look good for 2023, but we need more capital to conduct the planned clinical Phase 2 trial. We will intensify our efforts to evaluate vari- ous possibilities for financing in order to choose the best path forward. Oxcia is very well prepared for a listing, and the process will begin when there is a suitable opportunity.
In summary, we are making a strong entry into 2023, a year with several key activities and milestones for our two main projects. Studies will be finalized and new ones initiated. We will present Oxcia’s exciting science and projects at conferences. The Oxcia team, which was further reinforced in 2022, is more than ready
Ulrika Warpman Berglund
This year-end release has been approved by the board and the CEO for publication. The information was submitted, through the care of the above contact person, for publication on February 15m 2023, at 11.00 am CET.
For further information:
Ulrika Warpman Berglund, VD, Oxcia AB (publ)
Phone: +46 (0) 73 270 9605
Briefly about Oxcia
Oxcia AB is a pioneer in oxidative DNA damage and DNA Damage Response (DDR – the processes the body uses to repair the damage that occurs to DNA) with a focus on developing new safe treatments for patients suffering from diseases caused by cancer or inflammation. Oxcia currently has two DDR drug candidates, both with the potential to become first-in-class drugs. OXC-101 is in early clinical development as novel cancer therapy. OXC-201 is developed against inflammatory and fibrosis-related diseases, such as pulmonary fibrosis and allergic asthma, and is in the preclinical phase.
More information about Oxcia is available at www.oxcia.com