MEDIVIR AB – YEAR-END REPORT JANUARY – DECEMBER 2022

Continued strong recruitment in the dose escalation part of the fostrox study.

October – December

Financial summary for the quarter

• Net turnover amounted to SEK 2.3 (13.9) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.9 (-23.5) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.44) and SEK -0.32 (-0.44) respectively.
• Cash flow from operating activities amounted to SEK -24.7 (-5.4) million.
• Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million.

Significant events during the quarter

• In October the nomination committee was appointed ahead of the 2023 AGM. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.
• Pia Baumann was recruited in November as new Chief Medical Officer, taking office in February 2023.
• Medivir presented new data, showing additive efficacy of fostrox in combination with anti-PD1 in experimental tumor models, at the SITC Immunotherapy Conference in November.
• Medivir completed a pre-IND meeting with the US Food and Drug Administration and received positive feedback on the development plan in preparation for an IND for its candidate drug fostrox.

January – December

Financial summary for the period

• Net turnover amounted to SEK 4.4 (25.5) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -84.8 (-59.5) million. Basic and diluted earnings per share amounted to SEK -1.59 (-1.20) and SEK -1.59 (-1.20) respectively.
• Cash flow from operating activities amounted to SEK -101.8 (-48.7) million.
• Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million.

Significant events after the end of the period

• On January 11 it was announced that Medivir’s partner Infex Therapeutics has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for MET-X, the company’s broad spectrum Metallo-beta-lactamase inhibitor (MBLI) based on Medivir’s MBLI program.

Conference call for investors, analysts and the media

The Year-End Report January - December 2022 will be presented by Medivir’s CEO, Jens Lindberg.
 
Time: Wednesday, February 15, 2023, at 14.00 (CET).

Phone numbers for participants from:

Sweden + 46 8 505 163 86

Europe +44 20 3198 4884

US +1 412-317 6300

Pin code 1872625#

The conference call will also be streamed via a link on the website: www.medivir.com

The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message

Taking over as CEO of Medivir in January 2022, I was given the privilege of leading a great team to develop cancer medicines that can really make a difference.

Our main focus in 2022 has been the continued clinical development of Medivir's proprietary candidate drug fostroxacitabine bralpamide (fostrox). Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer makes fostrox attractive to combine with several other drugs for the treatment of hepatocellular carcinoma HCC.

The combination study is progressing as expected in ongoing dose escalation cohorts. The measures taken to accelerate patient recruitment at the end of the summer had the desired effect. Since then, interest in the study has been very high, with patients standing in line waiting for new cohorts to be opened. We look forward to shortly establishing the recommended dose for the first combination arm and subsequently initiating the phase 2a portion of the study.

We have also presented new data for fostrox during the year. At the EASL Liver Cancer Summit in February, Medivir was able to present biomarker data from the phase 1 study with fostrox which, among other things, shows that fostrox provides a tumor-selective effect in the liver by causing the desired DNA damage and cell death in tumor cells in the liver but not in normal or healthy liver cells. At the SITC Immunotherapy Conference in November, Medivir presented new data showing that the combination of fostrox with anti-PD1 provides an improved effect in experimental tumor models and creates changes in the tumor microenvironment consistent with increased immune-mediated antitumor activity.

It is also gratifying that we, at our pre-IND meeting with the US Food and Drug Administration FDA in December, received positive feedback on the IND preparation program for fostrox. We plan to submit an IND application to the US authority in 2023.

In Medivir's business development, we focus on our two clinical projects for partnership, remetinostat and MIV-711. The data packages for both projects have been strengthened during the year and we continue our dialogues with external parties in order to find the best possible solution for each substance.

Medivir's clinical project birinapant was out-licensed to IGM Biosciences in 2021. IGM is conducting ongoing clinical development work with the phase I clinical study in solid tumors with birinapant in combination with IGM's own DR5 agonist antibody IGM-8444. As of Q4 2022, IGM reported that the fourth dose-escalation cohort was ongoing and no dose-limiting toxicities were observed to date.

Medivir's preclinical research program USP-1 was out-licensed in 2020 to US-based Tango Therapeutics, which announced that it has selected TNG348, a USP-1 inhibitor from this research program, as a development/drug candidate in the treatment of BRCA1/2 mutated cancers. Tango intends to open an IND in the US in 2023 for TNG348.

Also our preclinical program MBLI aimed at addressing the threat of resistant bacteria appears to be moving towards clinical development. It is licensed to INFEX Therapeutics in England, which recently received QIDP-designation from the FDA and communicated its intention to initiate a phase 1 program in 2023.

I would like to take this opportunity to wish our new CMO Pia Baumann a warm welcome to the team. Pia is a cancer specialist with solid experience in global drug development, which will be very valuable in the continued clinical development of fostrox.

We are glad to note the strong interest in fostrox and that the measures taken have yielded results in patient recruitment for the soon-to-be-completed phase 1b part of the study. Our work to ensure that fostrox can become an effective drug against liver cancer continues unabated. We hope and believe that it will lead to a treatment that makes a real difference for the patients and for the care and thus also for our shareholders. I look forward to keeping you informed of Medivir’s continued development.

Jens Lindberg

Chief Executive Officer

For further information, please contact

Magnus Christensen, CFO

Phone: +46 (0)8 5468 3100

E-mail: magnus.christensen@medivir.com

This report has not been subject to auditors' review.

The information was submitted for publication at 08.30 CET on February 15, 2023.

Tags: