MEDIVIR AB - INTERIM REPORT JANUARY - JUNE 2024

"Our study shows a superior profile with the combination of fostrox and Lenvima in advanced liver cancer"

STOCKHOLM, Aug. 22, 2024 /PRNewswire/ -- 

April – June    
Financial summary for the quarter

• Net turnover amounted to SEK 1.1 (2.0) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.7 (-26.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.47).
• Cash flow from operating activities amounted to SEK -26.3 (-17.9) million.
• Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.

Significant events during the quarter

• In April it was announced that Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701.
• In April it was announced that Medivir completed a so-called Type C meeting with the FDA and that the company's preparations for the planned phase 2b study in the fostrox program are progressing according to plan, with a few adjustments in study design that have limited impact on timeline and study size.
• In April, MIV-711 was granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes Disease (LCPD), an unusual hip disease that affects children between the ages 2 and 12.
• The AGM in May re-elected board members Uli Hacksell, Lennart Hansson, Bengt Westermark and Yilmaz Mahshid, and elected Angelica Loskog and Anna Törner as new board members. Uli Hacksell was re-elected as Chairman of the Board.
• In June it was announced that Medivir has selected a global CRO partner for the planned phase 2b study evaluating fostrox+ Lenvima® compared to Lenvima alone in second-line liver cancer/hepatocellular cancer (HCC).
• On June 26 new positive data showing further improved effect with longer time to progression in Medivir's ongoing phase 1b/2a trial of fostrox + Lenvima in advanced HCC, were presented at the ESMO GI Cancer Congress in Munich.

January – June
Financial summary for the period

• Net turnover amounted to SEK 1.6 (2.4) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -63.3 (-45.2) million. Basic and diluted earnings per share amounted to SEK -0.55 (-0.81).
• Cash flow from operating activities amounted to SEK -61.3 (-34.1) million.
• Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.

Events after the end of the period

• In July it was announced that Medivir will present updated clinical data from the phase 1b/2a study with fostrox in advanced HCC, at the ESMO Cancer Congress in Barcelona in September

Conference call for investors, analysts and the media

The Interim Report January - June 2024 will be presented by Medivir's CEO, Jens Lindberg.

Time: Thursday, August 22, 2024, 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

Medivir is working decisively to ensure that the combination of fostrox and Lenvima® becomes the first approved treatment alternative after first line standard-of-care in advanced liver cancer. At the ESMO-GI congress in Munich in June, we presented new data from the ongoing phase 1b/2a study. These data indicate that fostrox + Lenvima provides a substantially better effect than previously shown in second-line liver cancer treatment, which generated significant positive attention, both from analysts and clinical experts. 

Our ongoing phase 1b/2a study with fostrox + Lenvima continues to show increasingly promising data and we see the opportunity to become the first approved medical treatment in a market worth ~$2.5 billion annually.

The data presented at the ESMO-GI congress in Munich at the end of June showed good tolerability during longer treatment and that the clinical effect has continued to improve. The Objective Response Rate (ORR) was 24%, higher than the 5–10% ORR seen in other published studies in second-line HCC. The estimated median time to progression at the time of ESMO-GI was 10.8 months, which is substantially better than what's been shown in other studies in second-line HCC. It is tremendously encouraging that the patient in the study who has benefited the longest is still responding to treatment after 2 years.

We now look forward to presenting detailed and mature data highlighting the combination's clinical value in second-line liver cancer at the ESMO Congress in Barcelona in mid-September.

The strong and continuously improving data strengthen our belief in the combination's potential as the first approved treatment option in second-line liver cancer.  Preparations for our planned phase 2b study continue based on the feedback we received at our Type C meeting with the FDA.

For the phase 2b study, we have recently chosen a CRO partner with a global presence and a strong track record in oncology studies and in particular HCC studies. We are now initiating the next study phase to identify investigators and hospitals for the study and to complete the study protocol. This will lead us to opening an IND in the US, which is expected to take place in H2 2024.

Regarding the projects out-licensed to collaborators, our partner Vetbiolix, a veterinary biotechnology company based in France, was in April able to report positive results from a clinical Proof-of-Concept study in periodontitis (tooth loss) in dogs with its candidate drug VBX-1000 (MIV-701), which was out-licensed to Vetbiolix in 2019. Vetbiolix is now preparing to evaluate VBX-1000 in a phase 2/3 study in dogs. Tooth loss is an immense problem for dogs and today there is no approved treatment. Vetbiolix estimates that the global market for oral care in pets amounts to approximately SEK 3 billion. 

Our project for partnership MIV-711 received Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. It creates new opportunities for collaborations and future income.

At the annual general meeting, our board of directors was strengthened with two new members, Angelica Loskog and Anna Törner. Their competence and experience will contribute strongly to Medivir's success, where the clinical development of fostrox is our focus.

We are convinced of the potential of fostrox to become a valuable treatment option that makes a real difference to patients with liver cancer. There is a clear need and an obvious place for fostrox in the treatment landscape. Our goal is to become the first approved treatment alternative in second-line for patients with primary liver cancer. 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 not been subject to auditors' review.

The information was submitted for publication at 08.30 CET on August 22, 2024.

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SOURCE Medivir