MEDIVIR AB – January Interim Report



Stockholm, April 30, 2024 /PRNewswire/—— Following completion of the Type C meeting with the FDA, preparations for the planned Phase 2b study continue as planned, reinforced by the fact that the median time to progression increased to 7 months for fostrox + Lenvima.

January “March”

Financial Highlights for the Quarter

  • Net turnover reaches Swedish Krona 0.5 (0.4) million.
  • Loss before interest, taxes, depreciation and amortization (EBITDA) is Swedish krona -26.7 (-18.9) million.Basic earnings per share and diluted earnings per share are respectively SEK-0.23 (-0.34) and SEK-0.23 (-0.34) respectively.
  • The cash flow generated from operating activities is Swedish Krona-35.0 (-16.1) million.
  • The ending cash and cash equivalents balance is 153.4 Swedish Krona (100.8) million

Major events of the season

  • In January this year, Tango Therapeutics announced that it had injected the first patient with TNG348, a new USP1 inhibitor from the preclinical USP1 program licensed by Medivir in 2020.
  • Positive results from an ongoing Phase 1b/2a study in advanced liver cancer (HCC) showed further improvement in response and time to progression were also presented at the 2017 ASCO GI Symposium. san francisco.
  • In January, targeted issuance to Hallberg Management Proceeded for approx. SEK 20 million Before deducting issuance expenses.
  • In February, Medivir’s Nominating Committee announced changes Anders Hallbergappointed by health investment partnerleft the Nominating Committee and was replaced by Stefan Bengtsenappointed by CA FastTate Corporation.

Events after the end of the period

  • Medivir partner Vetbiolix (US-based veterinary biotech company) announced in April Francereported positive results from a proof-of-concept clinical trial of its drug candidate VBX-1000 (formerly known as MIV-701) for canine periodontitis.
  • It was announced in April that Medivir had completed a so-called Type C meeting with the FDA, and preparations for the company's planned Phase 2b study are continuing as planned, with some adjustments to the study design that have limited impact on timing and impact.
  • In April, MIV-711 was granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), a rare hip disease affecting children aged 2-12 years. Internal diseases.

Investor, Analyst and Media Conference Call

January Interim Report – March 2024 Will be introduced by Medivir CEO, Jens Lindbergh.

time: Tuesday, April 30, 202410 a.m. (CET).

To access the webcast and find information about the conference call, click here!

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

Following the meeting, the briefing will be posted on the Medivir website.

CEO's message

“Our goal is the combination of fotrox and Lenvima ® It will be the first alternative drug approved for second-line treatment of primary liver cancer. Following a Category C meeting with the FDA, preparations for our planned Phase 2b study continue, and patients in the ongoing Phase 1b/2a study continue to benefit from treatment with fostrox + Lenvima for longer than expected, with sustained results. This preparation is reinforced by the fact that improvements have been made.

Medivir's proprietary drug candidate fostrox is a targeted smart chemotherapy drug that selectively kills cancer cells in the liver. Fostrox + Lenvima constitute a unique, potentially complementary drug combination that has shown promising results in Medivir's ongoing Phase 1b/2a study.

At the International ASCO-GI Conference san francisco In January, results from fotrox + Lenvima showed that the proportion of patients achieving clinically relevant reductions in liver tumors was higher than expected for second-line treatment. Data evaluated by researchers and local radiologists showed an objective response rate (ORR) of 25% (RECIST v1.1), significantly higher than the 5% to 10% shown in previous studies for second-line treatment of HCC. The update also showed continued good tolerability without any new unexpected side effects.

Clinical outcomes continue to improve as patients remain on treatment longer than expected. As of this writing, about 30% of patients are still receiving treatment in the study. The median time to progression has now been further extended to 7 months compared with the ASCO GI of 5 months, significantly longer than shown in previous second-line HCC studies. The patient who benefited the longest is still on treatment 20 months later and remains in partial response. Results from the entire study are expected by the end of 2024, depending on when the last patients continue to benefit from the treatment.

Our data have generated significant interest and discussions with leading global experts, especially at ASCO GI, have confirmed the relevance of the fostrox + Lenvima combination in the second-line treatment of HCC, for patients who currently do not have any approved treatment alternatives.As research data becomes increasingly exciting, the opportunity to become the first approved drug treatment on the market arises Approximately US$2.5 billion Per year.

Therefore, we have stepped up our efforts to ensure that fostrox's development program proceeds at maximum speed, thereby creating the possibility of so-called accelerated approval. Simplified slightly, it can be described as conditional regulatory approval to prescribe to patients, while the data must be confirmed in subsequent confirmatory Phase 3 studies. That means fostrox has a chance of reaching patients three years sooner than it would otherwise. During the quarter, we also held a Category C meeting with the FDA to discuss study design. FDA provides clarifying guidance, meaning we are now closer to planned final study design Phase 2b Research is proceeding as previously planned. While these measures are being taken, we are continuing discussions with potential partners for fostrox.

Additionally, when it comes to projects where Medivir has previously been licensed to partners, the progress is exciting. In January of this year, Tango Therapeutics initiated a Phase 1/2 study and dosed the first patient with TNG348, a USP-1 inhibitor under Medivir’s preclinical USP1 program licensed in 2020 developing. Francecan report positive results from a clinical proof-of-concept study of its drug candidate VBX-1000 (formerly MIV-701, licensed to Vetbiolix in 2019) for canine periodontitis disease.

In addition, our collaborative program MIV-711 has been granted rare pediatric disease designation and orphan drug designation by the FDA for the treatment of Legg-Calvé-Perthes disease. In addition to the opportunities this creates for partnerships and future revenue, it also demonstrates the quality of Medivir's research.

The continued clinical development of fostrox is our focus, and promising data showing further improvements in clinical efficacy in second-line HCC reinforce our belief that fostrox can be an effective anti-cancer drug that makes a real difference to patients. fostrox has a clear need and a clear place in the therapeutic space.

The goal is to become the first alternative drug approved for second-line treatment of patients with primary liver cancer. I look forward to updating you on the continued development of Medivir.

Jens Lindbergh
CEO

For more information please contactMagnus ChristensenChief Financial Officer
Tel: +46 (0)8 5468 3100
Email: magnus.christensen@medivir.com

This report has not been reviewed by the auditors.

This information was submitted for publication at 08.30 CET April 30, 2024

This information is brought to you by Cision http://news.cision.com

https://news.cision.com/medivir/r/medivir-ab—interim-report-january—march-2024,c3970347

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https://mb.cision.com/Main/652/3970347/2769125.pdf

Full report (PDF)





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