Medivir AB – Interim Report January – June 2020

On August 20, 2020 Medivir AB reported that Interim Result January – June 2020 (Press release, Medivir, AUG 20, 2020, View Source;interim-report-january—june-2020-301115445.html [SID1234563883])

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April – June
Significant events during the quarter

Following the positive opinion given by the European Medicines Agency (EMA), the European Commission granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
The Board of Directors appointed Yilmaz Mahshid as the new CEO of Medivir. Yilmaz Mahshid has long and broad experience from qualified roles in the life science sector. He will assume his position on September 14, 2020.
The U.S. Food and Drug Administration (FDA) granted orphan drug designation to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC).
Financial summary for the quarter

Net turnover amounted to SEK 4.0 (3.7) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -12.4 (-12.5) million. Basic and diluted earnings per share amounted to SEK -0.52 (-0.51) and SEK -0.52 (-0.51) respectively.
Cash flow from operating activities amounted to SEK -23.3 (-35.5) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 94.9 (191.9) million
January – June
Financial summary

Net turnover amounted to SEK 11.4 (5.7) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -33.1 (-66.6) million. Basic and diluted earnings per share amounted to SEK -1.49 (-2.81) and SEK -1.49 (-2.81) respectively.
Cash flow from operating activities amounted to SEK -40.0 (-91.8) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 94.9 (191.9) million.
Significant events after the end of the quarter

In July, a research collaboration was initiated with the Drug Discovery and Development Platform (DDD) at SciLifeLab on potential inhibitors of SARS CoV-2. Through the collaboration, DDD will get access to Medivir’s unique proprietary protease-targeted compound library.

Conference call for investors, analysts and the media
The Interim Report January – June 2020 will be presented by Medivir’s President & CEO, Uli Hacksell.

Time: Thursday, August 20, 2020, at 14.00 (CET).

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

Northwest Biotherapeutics Announces $5 Million Financing: Non-Dilutive Debt; No Amortization For 7 Months; Maturity of 21 Months

On August 19, 2020 Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the remaining outstanding clinical trial data for the Company’s Phase 3 trial of DCVax-L for Glioblastoma brain cancer as described in the Company’s last report on July 24, 2020 has now been completed by the specialty analytics firms (Press release, Northwest Biotherapeutics, AUG 19, 2020, View Source [SID1234569921]). With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.

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This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset.

When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.

As previously reported, the statisticians’ work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company’s Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.

The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.

NW Bio Announces Completion of Further Data Gathering For Phase III Trial

On August 19, 2020 Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the remaining outstanding clinical trial data for the Company’s Phase 3 trial of DCVax-L for Glioblastoma brain cancer as described in the Company’s last report on July 24, 2020 has now been completed by the specialty analytics firms (Press release, Northwest Biotherapeutics, AUG 19, 2020, View Source [SID1234569920]). With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset.

When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.

As previously reported, the statisticians’ work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company’s Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.

The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.

Biofrontera announces conference call to be held on August 27, 2020 to discuss half-year 2020 financial results

On August 19, 2020 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it will be releasing its financial results for the first six months ended June 30, 2020 on Wednesday, August 26, 2020 (Press release, Biofrontera, AUG 19, 2020, View Source [SID1234568550]).

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Conference calls for shareholders and interested investors will be held on Thursday, August 27, 2020, at the following times:

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Prescient Therapeutics is developing novel personalised therapies against a range of cancers – Small Caps

On August 19, 2020 Prescient Therapeutics (ASX: PTX) reported Chief Executive Officer Steven Yatomi-Clarke joins Small Caps to discuss the company’s novel approach to treating cancer using targeted and cellular therapy (Press release, Prescient Therapeutics, AUG 19, 2020, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-is-developing-novel-personalised-therapies-against-a-range-of-cancers-small-caps [SID1234565490]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Prescient Therapeutics is the only ASX-listed company developing CAR-T technology, which is a type of cellular therapy that reprograms a cancer patient’s immune cells to recognise and destroy cancer.

The clinical stage oncology company recently announced it will be teaming up with the Peter MacCallum Cancer Centre to advance its cell therapy research, including next generation CAR-T.