STOCKHOLM, Feb. 15, 2024 /PRNewswire/ — “The clinical efficacy of fostrox in combination with Lenvima continues to improve with median time to progression having increased to over 6 months”

October – December

Financial summary for the quarter

• Net turnover amounted to SEK 4.4 (2.3) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -20.1
  
  (-17.9) million. Basic and diluted earnings per share amounted to SEK -0.28 (-0.32) and SEK -0.28 (-0.32) respectively.
• Cash flow from operating activities amounted to SEK -4.6 (-24.7) million.
• Cash and cash equivalents at the end of the period amounted to SEK 169.5 (117.4) million.

Significant events during the quarter

• In October, data from an investigator evaluation showed continued promising tumor control with fostrox + Lenvima in HCC. All patients in the phase 2a study had dosed at least two treatment cycles.
• 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.
• The Q3 report and the subsequent webcast included in-depth interim data from the 18 patients in the phase 1b/2a study who had a minimum follow-up of 12 weeks. These data continued to demonstrate clear patient benefit for the fostrox + Lenvima combination.
• In November it was announced that the company’s interactions with the FDA regarding fostrox’s clinical development plan had intensified with a first Type D meeting with a positive response regarding critical elements of the design for the planned phase 2b study.
• Late November it was announced that the development of an updated formulation of fostrox, suitable for commercial manufacture, had been finalized.
• In December, Medivir’s partner IGM Biosciences, communicated a strategic pipeline cost-saving prioritization that among other things affects IGM’s DR-5-agonist, aplitabart, in combination with birinapant, which was licensed in from Medivir in 2021.
• In December it was announced that Medivir has signed an agreement with Lonza for the manufacture of fostrox drug substance for the planned phase 2b study.
• In December it was announced that the durable clinical benefit in the ongoing phase 1b/2a study continues to improve, as data become more mature.
• In December, a rights issue was carried out, through which the company received proceeds of approximately SEK 129 before deduction of costs attributable to the rights issue.

January – December

Financial summary for the period

• Net turnover amounted to SEK 7.6 (4.4) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -88.7 (-84.8) million. Basic and diluted earnings per share amounted to SEK -1.48 (-1.59) and SEK -1.48 (-1.59) respectively.
• Cash flow from operating activities amounted to SEK -59.7 (-101.8) million.
• Cash and cash equivalents at the end of the period amounted to SEK 169.5 (117.4) million.

Events after the end of the period

• In January, a directed issue to Hallberg Management AB was carried out amounting to approximately SEK 20 million before deduction of issuance costs.
• In January, positive data from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression was presented at the ASCO GI Symposium in San Francisco.
• In January Tango Therapeutics announced that it has dosed the first patient with TNG348, a new USP1-inhibitor from the preclinical USP1 program inlicensed from Medivir in 2020

Conference call for investors, analysts and the media

The Year-End Report January – December 2023 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Thursday, February 15, 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

Fostrox in combination with Lenvima continues to show improved efficacy for patients with advanced primary liver cancer (HCC). The data presented in January 2024 at the ASCO-GI congress in San Francisco showed a further increase in the proportion of patients who achieve a clinically relevant reduction of their liver tumor and that patients stay on treatment longer with interrupted tumor growth. These data attracted very strong interest, which makes us even more convinced of fostrox’s future role in the treatment of HCC and creates the opportunity for a faster route to market.

The unmet medical need in the treatment of advanced HCC is significant. Primary liver cancer is the third leading cause of cancer-related deaths. In today’s treatment guidelines, an immunotherapy combination (Tecentriq®/Avastin®) is recommended as first-line treatment. However, when this combination has stopped working, there are no approved alternatives for second-line treatment. There is thus a large need for additional treatment options in second-line that attacks the tumor in different ways compared to what Tecentriq and Avastin does. Fostrox is an organ specific, so-called smart chemotherapy, that selectively kills cancer cells in the liver. Together with Lenvima, these two form a unique combination of complementary drugs that have shown promising interim results in an ongoing phase 1b/2a study, including a complete tumor response in one patient.

All patients in the study have now had at least 18 weeks of follow-up. The more mature and in-depth data we see from the study, the more convincing the clinical benefit for patients has become. Data from this study was presented at the ASCO GI Congress on January 19, 2024. These results, evaluated by investigators and local radiologists, showed further improvement as the Overall Response Rate (ORR) had increased to 25% (RECIST 1.1), a notably higher percentage than the 5-10% shown in second-line HCC in previous studies. The update also showed continued good tolerability without any new unexpected side effects.

At the time of this quarterly report over 40% of patients remain on treatment in the study, and the clinical efficacy keeps improving. The median time to progression has increased further to 6.3 months, compared to 5.1 months at ASCO GI, significantly better than previous studies in second-line HCC. The patient who has benefited the longest remains on treatment after 18 months with partial response and continued shrinking tumor. Our data was met with great interest at ASCO GI, where we had the opportunity to discuss with leading global experts what the fostrox + Lenvima combination could mean for these patients. The discussions confirmed the great need that exists in the second-line treatment of HCC, where patients are today without any approved treatment alternative.

With these promising data, fostrox has the opportunity to become the first approved medicinal treatment in a market worth ~2.5 billion USD annually, through a so-called accelerated approval by the regulatory authorities.

We have therefore put in a higher gear in 2023 to ensure maximum momentum in fostrox’s development program based on this possibility of accelerated approval. In Q4 2023 the development of an updated, commercially adapted formulation of fostrox was completed. In parallel, we have initiated the process with the FDA for a so-called Type C meeting to discuss the final study design of the planned registrational phase 2b study.

In conjunction with these measures, we can now also deepen our 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 is entering clinical stage. In January 2024, Tango Therapeutics initiated a phase 1/2 study and dosed the first patient with TNG348, a USP-1 inhibitor developed from the preclinical USP1 program that was in-licensed from Medivir in 2020. INFEX Therapeutics also intends to initiate phase 1 study in 2024 – with the preclinical program MBLI, previously in-licensed from Medivir. IGM Biosciences has completed the fifth dose escalation cohort in the company’s phase 1 study in solid tumors with Medivir’s clinical project birinapant in combination with its own DR5 agonist antibody IGM-8444, now called aplitabart.

For Medivir, the clinical development of fostrox is clearly in focus. With the promising data showing further improved clinical efficacy compared to expected treatment results in second-line HCC, we are even more confident that fostrox can become an effective liver cancer drug that makes a real difference to patients.

I would like to thank old and new shareholders for the trust in our rights issue and for the capital injection that benefited us in the directed share issue. 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 February 15, 2024

The following files are available for download:

 

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