MEDIVIR AB - INTERIM REPORT JANUARY - JUNE 2023

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Aug 18, 2023, 02:48 ET

STOCKHOLM, Aug. 18, 2023 /PRNewswire/ -- Continued strong momentum and promising signs of patient benefit in the combination study with fostrox and Lenvima^®

April – June
Financial summary for the quarter

Net turnover amounted to SEK 2.0 (0.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.3
(-21.5) million. Basic and diluted earnings per share amounted to SEK -0.47 (-0.42) and SEK -0.47 (-0.42) respectively.
Cash flow from operating activities amounted to SEK -17.9 (-17.6) million.
Cash and cash equivalents at the end of the period amounted to SEK 82.8 (162.8) million.

Significant events during the quarter

In April, new data were presented showing synergistic anti-tumor effect of fostrox in triple combination with anti-PD1 and Lenvima^® in non-clinical tumor models.
Medivir's patent application for fostrox was approved by the patent authority in China.

January – June
Financial summary for the period

Net turnover amounted to SEK 2.4 (1.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -45.2
(-52.9) million. Basic and diluted earnings per share amounted to SEK -0.81 (-1.00) and SEK -0.81 (-1.00) respectively.
Cash flow from operating activities amounted to SEK -34.1 (-57.5) million.
Cash and cash equivalents at the end of the period amounted to SEK 82.8 (162.8) million.

Events after the end of the period

In August, Medivir's Scientific Advisory Council was formed, consisting of five world-leading experts in liver cancer.
In August, the 15th patient was included in the phase 2a study with fostrox in combination with Lenvima^®, which shows promising tumor control and good tolerability.

Conference call for investors, analysts and the media
The Interim Report January - June 2023 will be presented by Medivir's CEO, Jens Lindberg.

Time: Friday, August 18, 2023, at 14.00 (CET).

For dial-in numbers to the conference call, please see information on the website; www.medivir.com/investors/calendar

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
The inclusion of patients with primary liver cancer (HCC) in the phase 2a part of the combination study, where fostrox is given in combination with Lenvima^®, has continued rapidly. The strong interest, both from investigators and patients, has contributed to us already being able to include 15 patients in the study at the beginning of August. We also see promising signs of patient benefit in the study.

Our clinical development of fostroxacitabine bralpamide (fostrox) has so far shown good results and been met by great interest. The medical need for a new, effective treatment in HCC is very large and the strong interest in participating in the combination study is a confirmation that the combination fostrox and Lenvima^® is seen as a potentially attractive treatment option. The fact that Lenvima^® today is established as a standard treatment for second-line HCC means that the combination of fostrox and Lenvima^® has clear potential to provide patients with an increased clinical benefit from their treatment.

The very promising signs of patient benefit in the study strengthen our belief that fostrox can become a valuable drug in the treatment of HCC. 7 of the first 10 patients have sustained tumor control in the liver after three months of treatment and the patient who has benefited the longest remains on treatment after 12 months with maintained tumor shrinkage. We also see that the majority of patients have stabilized their disease and remain on fostrox + Lenvima, despite the fact that all patients have discontinued previous treatment due to tumor growth.

The safety and tolerability profile of treatment with fostrox and Lenvima^® remains promising. The proportion of patients who had to reduce their dose of Lenvima^® is lower than expected and only 1 out of a total of 21 patients had to stop treatment due to side effects with fostrox. We look forward to presenting clinical data in more detail from the ongoing study at an upcoming scientific congress.

At AACR in April, we presented new data on synergistic anti-tumor effect of fostrox in triple combination with anti-PD1 and Lenvima^® in non-clinical tumor models. These data show that fostrox's unique liver-directed mechanism of action opens up completely new combinations with three different approaches to effectively treat HCC.

In June, the dose escalation part was completed also for the second combination arm of the phase 1b study, with fostrox in combination with the anti-PD-1 checkpoint inhibitor Keytruda^®. With our choice of fostrox in combination with Lenvima^® for the second-line treatment, we will, based on an established and safe dose in the combination fostrox + Keytruda^®, explore the possibility of fostrox as a triple combination partner with immunotherapy in first-line HCC.

I am very pleased that we have introduced our newly established Scientific Advisory Council where we have succeeded in attracting some of the world's leading experts on liver cancer. The scientific advisory council, with its expertise and clinical experience, will be very important for the continued development of fostrox.

Regarding our out-licensed projects, IGM Biosciences is studying a fifth cohort in the company's clinical phase 1 study in solid tumors with our clinical project birinapant in combination with its own DR5 agonist antibody IGM-8444, now called aplitabart. Furthermore, both Tango Therapeutics and INFEX Therapeutics intend to initiate phase 1 programs in 2023/2024 with preclinical programs (USP1 and MBLI respectively) previously in-licensed from Medivir.

The clinical development of fostrox remains in focus and the great interest in the ongoing study as well as the promising signs of patient benefit have strengthened our belief that fostrox can become an effective treatment against liver cancer that makes a real difference for patients and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development.

Jens Lindberg
Chief Executive Officer