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Oxcia AB Publishes Year-End Report for 2023

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Fourth quarter (October-December 2023)

  • Operating loss totaled SEK -5,741,054 (-8,972,042).
  • Loss for the period totaled SEK -5,393,601 (-8,912,366).
  • Cash flow from operating activities totaled SEK -5,064,247 (-9,565,926).
  • Earnings per share before dilution totaled SEK -0.23 (-0.41).
  • Earnings per share after dilution amounted to SEK -0.23 (-0.41).
  • Proposed dividend of SEK 0.00 per share (0.00).

Period (January-December 2023)

  • Operating loss totaled SEK -33,658,614 (-32,280,497).
  • Loss for the period totaled SEK -32,608,036 (-32,220,821).
  • Cash flow from operating activities totaled SEK –17,801,871 (-23,135,980).
  • Earnings per share before dilution totaled SEK -1,49 (-1.50).
  • Earnings per share after dilution amounted to SEK -1,49 (-1.50).

Significant events in the third quarter (Oct-Dec)

Technology and Science

  • Initiation/start up meeting with Uppsala Akademiska University Hospital to participate in clinical phase 1 / 2 study MASTIFF (OXC-101) in advanced solid cancers, focusing on gynecological and prostate cancers.

Governance

  • Extraordinary General Meeting on 10 October 2023 in Life City, Solna. The extraordinary general meeting approves the board’s decision on the rights issue and approves the establishment of two incentive programs, P 2023/2026 with stay put bonus and S 2023/2026 qualified employee options.

Finance

  • The right issue is subscribed by 62 % and thus gives an outcome of 26.9 MSEK before overhead costs of approximately 0.2 MSEK. Several existing owners increased their involvement in Oxcia and a number of new owners are added.

Significant events in the period (Jan-Dec)

Technology and Science

  • Tablets manufactured according to GMP (Good Manufacturing Practice) at Thermo Fisher Scientific for continued clinical studies with OXC-101.
  • Recruiting of prostate, ovarian and endometrial cancer patients in the approved expansion groups in clinical phase 1 study with OXC-101 initiated.
  • Contracting the clinical research organization ACRO for the expansion of clinical Phase 1 / 2 trial MASTIFF in South Africa.
  • Submitted application to SAHPRA, South African Health Products Regulatory Authority, for approval of Clinical Phase 1 / 2 trial MASTIFF (OXC-101) in South Africa.
  • A new report, ”Small molecule-mediated OGG1 inhibition attenuates pulmonary inflammation and lung fibrosis in a murine lung fibrosis model” was published the 26th of January in the scientific journal Nature Communication (doi 10.1028; Tanner L, et al). The report shows pre-clinical data demonstrating that OXC-201 (TH5487) is a promising new therapy for idiopathic pulmonary fibrosis.
  • New data demonstrating significant effects of OXC-201 in fibrosis and inflammation markers in human IPF lung slices.
  • A contract signed with Lonza for formulation development of OXC-201.

Conferences

  • Oxcia participates in, for instance, BIO US Boston and BIO- Europe meetings and has meetings with potential investors and collaborators.
  • 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- 19th of April. The studies were published in the on-line proceedings supplement of the AACR journal Cancer Research.
  • Presentation of OXC-101 from idea to clinical candidate at International Drug Discovery Science & Technology (IDDST) 2023, Tokyo, Japan 8-10th of May.
  • Presentation of the preclinical effects of OXC-101 in AML, a blood cancer disease, at IDDST 12th July 2023, Amsterdam, Netherlands.
  • Presentation of the new promising results showing significant effects of OXC-201 on fibrosis- and inflammation markers in human IPF lung cuts at two conferences- IPF Summit, Boston, 19-21st September and ERS (European Respiratory Society), Milan, 9-23rd September.

 Finance and grants

  • EIC (European Innovation Council) selects Oxcia’s OXC-201 as one of the projects receiving grants within the EIC Transition program. Oxcia received an amount of 2.5 million Euro. EIC is Europe’s leading innovation program for identifying, devel oping 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.

Governance

  • The ordinary annual general meeting on June 13th, 2023, re-elects 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 after the end of the period Technology and Science • Application to Medical Product Agency to expand on-going clinical Phase 1 trial in advanced blood cancer patients (OXC 101) to a clinical Phase 1 / 2 trial in refractory/relapsed AML and MDS in combination with chemotherapy (anthracycline)
  • No other significant events that affect earnings and financial position occurred after the end of the period.

CEO Comment

Dear shareholders,

 2023 ends with a successful rights issue that enables expansion outside of Sweden of the clinical phase 1 / 2 study with OXC 101 in advanced solid cancers. Furthermore, additional clinical trial sites in Sweden have been initiated, and new preclinical data strengthening OXC-201’s potential as a promising new treatment for pulmonary fibrosis has been obtained.

 A successful rights issue was carried out in the last quarter of 2023 to ensure that the prioritized activities in 2024 can be carried out. Thanks to the continued strong support of existing and new shareholders, we will be able to complete the expansion of the ongoing clinical phase 1 / 2 study in advanced solid cancers (focus on gynecological and prostate cancers) outside Sweden and in a cost-effective way drive the development forward and strengthen the clinical experience with OXC-101. In addition, Akademiska University Hospital, Uppsala, has started to recruit patients for the clinical phase 1 / 2 study in advanced solid cancers with OXC-101.

The last patient in the dose-escalation part for advanced blood cancers with OXC-101 was recruited during Q4 and an addendum to the study protocol has been designed where safety and efficacy will be studied with OXC-101 in combination with a certain type of chemotherapy, anthracyclines. Together with a Danish research group and the Karolinska Institute, we have shown this combination to have synergistic effects in preclinical disease models for AML. It will therefore be exciting to follow the combination treatment in patients.

OXC-201, Oxcia’s drug candidate against idiopathic pulmonary fibrosis, continues to show very positive effects in various disease models. These data further reinforce that OXC-201 has great potential as a new treatment for pulmonary fibrosis. The project team is focused on developing a good formulation for OXC-201 that can be used in toxicology studies and in patients.

During 2023 we have prepared a great foundation for an exciting year in 2024 with important studies and milestones for both projects. The rights issue and the grants we received give us the opportunity to carry out the activities. We also see signs that the capital market may improve in the coming years and open up for opportunities to accelerate OXC-101 into phase 2. The journey forward is very inspiring, developing projects with the possibility of improving treatment for seriously ill patients is an incredible driving force. Stockholm in February 2024. Ulrika Warpman Berglund CEO

Stockholm in February 2024.

Ulrika Warpman Berglund
CEO

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 22 2024, at 08.30 am CET.

Oxcia AB (publ):s year end report 2023 can be found:
www.oxcia.com/investerare/pressmeddelanden or www.oxcia.com/investerare/finansiellarapporter

For more information contact:

Ulrika Warpman Berglund, CEO, Oxcia AB (publ)

Telephone: +46 (0) 73 270 9605
ulrika.warpmanberglund@oxcia.com

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

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