Third quarter (July-September 2023)
Operating loss totaled SEK -4,413,886 (-10,927,043).
Loss for the period totaled SEK – 4,163,243 (-10,927,043).
Cash flow from operating activities totaled SEK -6,371,895 (-4,612,924).
Earnings per share before dilution totaled SEK -0.19 (-0.51).
Earnings per share after dilution amounted to SEK -0.19 (-0.51).
Significant events in the third quarter
• 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 in South Africa.
• Presenting the preclinical effects of OXC-101 in AML, a blood cancer disease, at IDDST 12th July 2023, Amsterdam, Netherlands.
• Presenting 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.
• Notice of the Extraordinary General Meeting to be held on 10 October 2023 at 5:00 p.m. at Life City, Solnavägen 3, Solna, Sweden, with the following matters: resolution on approval of the Board of Directors’ resolution on a rights issue and resolution on the implementation of an incentive program through the issue of warrants of series P2023/2026 and stay- on bonus and of warrants of series
S2023/2026 (qualified employee stock options).
Significant events in the period
• 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.
• A contract signed with Lonza for formulation development of OXC-201.
• New data demonstrating significant effects of OXC-201 in fibrosis and inflammation markers in human IPF lung slices.
• Tablets manufactured according to GMP (Good Manufacturing Procedure) 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.
• 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 will be published in the 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.
• 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, 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.
• The ordinary annual general meeting on June 13th 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
• Initiation/start up meeting with Uppsala Akademiska University Hospital to participate in clinical phase 1 / 2 MASTIFF in advanced solid cancers, focusing on gynecological and prostate cancers.
• 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.
• The right issue is subscribed by 62 % and thus gives an out- come of 26.9 MSEK before overhead costs of approximately0.2 MSEK. Several existing owners increased their involvement in Oxcia and a number of new owners are added.
• No other significant events that affect earnings and financial position occurred after the end of the period.
The Oxcia team shows its determination, creativity, and initiative. Oxcia’s shareholders show their continued support and commitment to the business. With joint efforts we have found a good way forward in the still cold capital market in order to further increase the value of the projects and Oxcia in a cost-effective manner.
OXC-101 is a mitotic MTH1 inhibitor and belongs to a new drug class. To date, OXC-101 has been given at various dose levels to 50 advanced and heavily pretreated patients with various solid tumours (the MASTIFF study) and 11 advanced and fragile patients suffering from blood cancers. What we have learned and what the doctors running the phase 1 trials are experiencing, is that OXC-101 is a well-tolerated drug candidate and where the main side effect observed (neutropenia) is easily controlled. OXC-101 has also been shown to provide clinical benefits by slowing disease progression to stable disease for as long as 1.5 years, as well as shown efficacy in AML (a certain type of severe blood cancer). The initial clinical data thereby support continued clinical development of OXC-101.
Despite this progress, the difficult situation on the financial market means that the Company is currently deemed unable to raise capital to carry out a larger Phase 2 study. At the same time, it is essential that the Company can drive development forward in a cost-effective manner in order to strengthen the clinical experience with the product and create opportunities to demonstrate efficacy in less pretreated patients than those treated so far.
For a more limited cost, the Company intends to expand the current Phase 1 clinical trial to a Phase 1 / 2 trial and to also include patients in South Africa (Sweden remains). Initially, we will focus the clinical development in advanced/relapsed gynecological and prostate cancer patients. These patients have a high unmet medical need and there is a good rational for OXC-101 to be effective in these diseases (preclinical and initial clinical data). In addition, Oxcia already works closely with prominent doctors and researchers who are also key opinion leaders, which is a great advantage.
The patients in South Africa are less pre-treated than those in Sweden, there are more patients and the costs of running a study are lower in South Africa. The study means that patients get an opportunity for continued treatment that they otherwise cannot obtain and thus patients are treated with OXC-101 earlier in the treatment ladder. This increases the possibilities of showing a good response to OXC-101, something that has been requested both in discussion with major pharmaceutical companies and ahead of an upcoming stock market listing.
In South Africa, clinical studies are carried out according to the same standard as Europe (IHC-GCP). They have their own counterpart to the Swedish Medical Product Agency (SAHPRA, South Africa Health Products Regulatory Authority) and the ethics committee that approves clinical trials. Many oncological clinical trials are already on-going there and Oxcia’s CMO Austin Smith and clinical trial leader Maria Klockare, have both previous experience from clinical trials in South Africa. With tremendous determinations, the Oxcia team together with contracted South Africa Clinical Research Organization, ACRO, and South Africa’s Clinical Lead Dr. Bassa at the Steve Biko Hospital, Pretoria, managed to compile and submit the application to SAHPRA in two weeks, an activity that normally takes 3 months. Once again, we showed that with joint decisive forces we can achieve extraordinary results.
Oxcia’s preclinical project OXC-201, which is being developed into a promising new treatment for idiopathic pulmonary fibrosis, has continued to receive a lot of attention. This spring, Oxcia, as the only Swedish company this year, received a grant from EIC Transition, which finances most of the preclinical development. The project also received a lot of attention during September when Dr. Christina Kalderén, OXC-201 project manager and Dr. Sandra Ekstedt, senior researcher, presented OXC-201 at two international conferences (IPS summit, Boston and ERS, Milano).
Finally, I would like to express my warm thanks to all shareholders, for the interest and commitment shown at the summer and autumn information meeting, where we discussed the Company’s plans and activities and received very positive responses. The rights issue gave strong support to our plans and was subscribed to 62 %. Several of the existing owners subscribed more than their share and we also brought in a number of new owners. The result of the rights issue ensures that we can carry out the prioritized activities.
Oxcia’s project portfolio has a good potential to deliver value for patients and shareholders.
Ulrika Warpman Berglund CEO
This press 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 November 23, 2023, at 11.00 am CET.
For more information contact:
Ulrika Warpman Berglund, CEO, Oxcia AB (publ)
Telephone: +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