MEDIVIR AB - INTERIM REPORT JANUARY - SEPTEMBER 2023

STOCKHOLM, Oct. 27, 2023 /PRNewswire/ -- Updated data show that the combination fostrox + Lenvima® provides improved clinical efficacy compared to Lenvima study data alone in second-line HCC

July – September

Financial summary for the quarter

• Net turnover amounted to SEK 0.8 (1.1) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.4 (-13.9) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.27) and SEK -0.42 (-0.27) respectively.
• Cash flow from operating activities amounted to SEK -21.0 (-19.7) million.
• Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.

Significant events during the quarter

• 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. Interim data from an investigator evaluation showed promising tumor control and good tolerability.
• In September, Medivir reported promising interim data from an independent evaluation of the phase 1b dose-escalation arm of fostrox in combination with Lenvima, where, among others, one patient achieved a complete tumor response and two patients a partial tumor response, out of a total of six patients.
• In September, Medivir, together with leading cancer experts, arranged a webinar on the treatment landscape and the unique treatment challenges in primary liver cancer (HCC).
• In September, data on the additive efficacy of fostrox in combination with Lenvima or Nexavar® in non-clinical tumor models were presented at the ILCA Annual Meeting.
• In September, Medivir's partner Tango Therapeutics received IND approval from the FDA to start a phase 1/2 clinical trial with TNG348. TNG348 is a USP-1 inhibitor developed by Tango Therapeutics from the preclinical USP1 program that was in-licensed from Medivir in 2020.

January – September

Financial summary for the period 

• Net turnover amounted to SEK 3.2 (2.1) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -68.5 (-66.9) million. Basic and diluted earnings per share amounted to SEK -1.23 (-1.27) and SEK -1.23 (-1.27) respectively.
• Cash flow from operating activities amounted to SEK -55.1 (-77.1) million.
• Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.

Events after the end of the period

• In October, data from the fostrox + Lenvima combination was presented, showing continued promising tumor control in HCC from an investigator evaluation. All patients in the phase 2a study had dosed at least two treatment cycles at this timepoint.
• In October, the Board of Directors announced that Anette Lindqvist is leaving her position as Board Member of Medivir AB due to personal reasons.
• In October the nomination committee was appointed ahead of the AGM in May 2024. The Nomination Committee consists of Karl Tobieson, 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.
• This Q3 report and subsequent webcast presents in-depth interim data from the 18 patients in the phase 1b/2a study who have had minimum 12 weeks follow-up. These data continue to demonstrate clear patient benefit for the fostrox + Lenvima combination.

Conference call for investors, analysts and the media

The Interim Report January - September 2023 will be presented by Medivir's CEO, Jens Lindberg.

Time: Friday, October 27, 2023, at 14.00 (CET).

To access the webcast and find information about the teleconference, please klick HERE!

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

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

CEO's message

During and after the quarter, we have seen continued promising signs of clinical benefit in the study with fostrox in combination with Lenvima®, and at our Q3 webcast today we can present in-depth and more mature data that clearly shows the increased clinical benefit for patients when fostrox is added to Lenvima. This makes us even more convinced of the future role of fostrox in the treatment of primary liver cancer (HCC).

The unmet medical need in the treatment of advanced HCC is very large. In current treatment guidelines, Tecentriq®/Avastin® is recommended as preferred first-line treatment, but for those who do not respond to that treatment, there are no approved therapeutic options in second-line. The most recent treatment guidelines from NCCN (National Comprehensive Cancer Network) and BCLC (Barcelona Clinic Liver Cancer), respectively, emphasize the medical need and recommend clinical studies as a primary second-line treatment option. This shows that there is a clear potential for the combination of fostrox and Lenvima to transform second-line treatment and contribute to patients gaining access to an approved treatment with increased clinical benefit. This is also supported by interim data from our ongoing phase 1b/2a study, an open-label, multicenter, dose-escalation and dose-expansion study.

All patients in the study have now undergone at least two treatment cycles and during the past quarter we have presented interim data that showed both early and durable improved clinical benefit combined with a good safety and tolerability profile when fostrox is combined with Lenvima. It includes a first patient who achieved a complete tumor response, which is extremely rare in this difficult-to-treat patient group.

Today we present even more mature interim data from 18 of a total of 21 patients in the study who underwent at least 12 weeks of follow-up. These data demonstrate further improved clinical efficacy compared to previously presented interim data with, among other things, a 22% Overall Response Rate (ORR) and an extended median time to progression of ~5 months. The benefit of Lenvima in HCC is recognized and today we can present updated data showing that fostrox in combination with Lenvima improves the clinical efficacy with a maintained tolerability profile compared to Lenvima study data alone in second-line HCC. This is encouraging news for a patient group in need of better treatment options and we look forward to providing a more complete review of these data at our regular conference call later today. The compelling data from the phase 1b/2a study and the large, unmet medical need in HCC create an opportunity for a faster path to market. These factors, together with the fact that fostrox has received so-called orphan drug status for the treatment of HCC in the USA and Europe, are the most significant parameters for the possibility of obtaining so-called accelerated/conditional approval by the regulatory drug authorities. Given that the promising results in phase 1b/2a hold the study through, the next step in the clinical development of fostrox will therefore be designed based on the possibility of accelerated/conditional approval. Medivir's newly established Scientific Council of world-leading liver cancer experts unveiled in August, with its collective expertise and clinical experience, is strongly committed to help guiding the design of the continued clinical development plan for fostrox.

The promising interim results enables deepened discussions with potential partners, in accordance with previously communicated plans.

We can also note that several of the projects that Medivir has licensed out to collaboration partners will enter the clinical phase next year. Tango Therapeutics has received FDA approval for its Investigational New Drug (IND) application and will initiate a phase 1/2 trial in 2023 with TNG348, a USP-1 inhibitor developed from the preclinical USP1 program in-licensed from Medivir 2020. INFEX Therapeutics also intends to initiate a phase 1 study in 2024 with the preclinical program MBLI, which was previously in-licensed from Medivir. IGM Biosciences has previously been studying a fifth cohort in the company's phase 1 clinical study in solid tumors with Medivir's clinical project birinapant in combination with its own DR5 agonist antibody IGM-8444, now called aplitabart.

The clinical development of fostrox is still our main focus, and the clear signs of improved patient benefit have further strengthened our belief that fostrox can become an effective treatment against liver cancer that makes a real difference to patients, and thus also to 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: [email protected]

This report has been subject to auditors' review.

The information was submitted for publication at 08.30 CET on October 27, 2023.

The following files are available for download:

SOURCE Medivir