Medivir (MVIR) Investor Update summary

Rights issue

• Board proposed a SEK 148m preferential rights issue, subject to EGM approval on 1 Dec 2023; full subscription would raise gross proceeds before costs.

• Subscription undertakings and intentions cover 21.7% (SEK 32m); external guarantees cover 45.9% (SEK 68m), for total coverage of 67.6% (SEK 100m).

• Shareholders receive 1 subscription right per share, exercisable for 1 new share; subscription price SEK 2.65, a 46.6% discount to TERP.

• Full subscription would increase shares from 56.7m to 112.5m; non-participating shareholders face up to 49.6% dilution.

• Subscription period scheduled for 7–21 Dec 2023; outcome expected 22 Dec 2023.

Use of proceeds

• Net proceeds priorities: 20% for continued phase 1b/2 fostrox follow-up and 15% for pivotal Lenvima + fostrox study design and regulatory preparations.

• 30% allocated to study initiation across geographies, including the US and Japan, and CMC readiness; 10% to Asia partnering discussions.

• 25% allocated to general corporate purposes and extending cash runway to H1 2025.

Clinical development

• In the fully enrolled phase 1b/2 HCC study, interim data for 18 of 21 patients with at least 12 weeks’ follow-up showed improved ORR of 22% versus prior interim data and extended median time to progression.

• More than 50% of patients remained on treatment; safety and tolerability profile continued to be good. Further phase 1b/2 data update planned for Q1 2024.

• A pivotal phase 2b study of fostrox + Lenvima in 2L HCC is planned for 2024, aiming for potential accelerated FDA approval by 2027.

• Fostrox has FDA and EMA orphan drug designations; the 2L HCC market was estimated at USD 2.5bn by 2028.