Press release

Medivir invites to a conference call on new clinical data and further studies with MIV-818

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) invites to a conference call on the supporting clinical data from the completed dose escalation section of the phase 1b study with MIV-818, presented today at the European Society for Medical Oncology (ESMO) congress. The conference call will be held today, September 16, at 15:00 CET, to update on the study and the plan for the MIV-818 program.

Medivir's lead candidate drug MIV-818 has the potential to become a liver-targeted, orally administered drug that can help patients with liver cancer. In April, it was announced that the overall results from the first part of the phase 1b study with MIV-818 were positive with a good safety and tolerability profile. The results from the completed dose escalation part of the phase 1b study will be presented today as an e-poster (number 527P) at ESMO. The poster is presented by Dr Debashi's Sarker, King's College, London.

The overall safety profile was in line with expectations for this type of drug and patient population. A total of nine evaluable patients with various types of advanced cancer in the liver were enrolled. These were patients that had exhausted approved therapies prior to being enrolled. An important sign of efficacy was that four patients with hepatocellular carcinoma (HCC) showed stable disease in the liver over an extended period of time. Furthermore, liver biopsies from patients demonstrated delivery of MIV-818 to the liver, and a selective effect of MIV-818 on cancer cells across different types of cancer. 

-    “These positive study results provide further support for Medivir's development of MIV-818 in HCC. We are now looking forward to explore MIV-818 further in combination with two other mechanism of actions,” says Fredrik Öberg, Medivir’s Chief Scientific Officer.

Conference call for investors, analysts and the media
Presenters from Medivir: Magnus Christensen, interim CEO, Tom Morris, CMO and Fredrik Öberg, CSO.
Time: Today, Thursday September 16, 2021, at 15.00 CET
Phone numbers for participants from: 
Sweden + 46 8 519 993 83
Europe + 44 33 3300 9273
US +1 646 722 4904

The conference call will also be streamed via a link on the website:
The presentation will be available on Medivir’s website after the conference call.

For further information, please contact:
Magnus Christensen, Interim CEO, Medivir AB 
Phone: +46 (0)8 5468 3100

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.45 CET on September 16, 2021.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 
11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. 

About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of MIV-818, a pro-drug designed to selectively treat liver cancer cells and to minimize side effects.  
Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list.