On August 19, 2021 Scandion Oncology reported its half year report for 2021 (Press release, Scandion Oncology, AUG 19, 2021, View Source,c3399288 [SID1234586740]). The following is taken from the report.

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Bo Rode Hansen, President and CEO comments

"Positive interim CORIST results highlight an intensive quarter – The second quarter of 2021 was as busy and rewarding as the first three months. We reached several milestones both clinically and organizationally. Most importantly, we reported positive interim results from our Phase II
clinical study CORIST."

Highlights during Q2 2021

On 21 April, Scandion Oncology announced that Dr. Richard L. Schilsky, a seasoned and highly profiled international leader, was appointed as member of Scandion Oncology’s clinical advisory board
On 2 June, Scandion Oncology appointed Johnny Stilou as new CFO. He has long experience from both Danish and international listed companies.
On 24 June, Scandion Oncology reported positive results from the dose-finding part 1 of the CORIST Phase II study. A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI had been determined and the SCO-101 treatment in the optimized combination resulted in notable potentiation of the biological activity of FOLFIRI. Furthermore, from the CORIST study the RAS oncogene has been identified as a predictive biomarker of optimal SCO-101 effect. This discovery will be used to optimize the inclusion of patients in part 2. These positive data have significantly de-risked the further development of SCO-101 and the company is now ready to advance to the proof-of-concept study (part 2) of CORIST.
On 30 June, Scandion Oncology announced promising preclinical data from the ongoing collaboration with Alligator Bioscience AB, exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology’s drug candidate SCO-101 and Alligator Bioscience’s candidate drug mitazalimab together with chemotherapy.
Highlights after the end of the period

On 19 July, Scandion Oncology announced the date for the Scandion Oncology Capital Markets Day, which will take place on September 8, 2021.
The half year report 2021 is available on the Company’s website: www.scandiononcology.com.

Audiocast today, 19 August at 10:00 am CET

Today at 10:00 Scandion Oncology’s executive management will host a webcast and conference call presenting the results and a company update.

At the end of the presentation there will be a Q&A session.
This information is information that Scandion Oncology A/S is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 19 August 2021, at 8:30 CET

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 19 August 2021, at 8:30 CET

On August 19, 2021 Medivir AB reported that Interim Report January – June 2021 (Press release, Medivir, AUG 19, 2021, View Source;interim-report-january–june-2021-301358672.html [SID1234586772])

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April – June
Financial summary for the quarter

Net turnover amounted to SEK 0.9 (4.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.1 (-12.4) million. Basic and diluted earnings per share amounted to SEK -0.35 (-0.52) and SEK -0.35 (-0.52) respectively.
Cash flow from operating activities amounted to SEK -21.9 (-23.3) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events during the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He took up his new role in connection with Medivir’s AGM on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.
In May, positive results from an investigator-initiated phase II clinical study of remetinostat in patients with squamous cell carcinoma (SCC) were released on clinicaltrials.gov.
In May, the design for the upcoming phase 1b/2a combination study with the company’s leading candidate drug, MIV-818 against liver cancer, was presented. In the study, MIV-818 will be administered in two combinations, with either lenvatinib, a tyrosine kinase inhibitor, or pembrolizumab, an anti-PD-1 checkpoint inhibitor.
January – June
Financial summary for the period

Net turnover amounted to SEK 10.8 (11.4) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -24.3 (-33.1) million. Basic and diluted earnings per share amounted to SEK -0.57 (-1.49) and SEK -0.57 (-1.49) respectively.
Cash flow from operating activities amounted to SEK -23.3 (-40.0) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events after the end of the period

In July, Malene Jensen was appointed Vice President Clinical Development. She will assume her role on September 6, 2021.
In August, it was announced that data from the MIV-818 phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) Congress in September.
In August, the positive results from the phase II study with remetinostat against basal cell carcinoma were published in the scientific journal Clinical Cancer Research.
In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
Conference call for investors, analysts and the media
The Interim Report January – June 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.

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.

CEO’s message
The clinical development of MIV-818 remains in focus. Positive topline results in the phase 1b monotherapy study. The design determined for the phase 1b/2a combination study in the clinical MIV-818 program.

Medivir’s central task is to advance the clinical program for our leading candidate drug MIV-818, which has the potential to be a liver-directed, orally administered drug that can help patients with various cancers of the liver. This work has also characterized our operations also in the past quarter.

In April we were able to announce that the results from the first part of the phase 1b study with MIV-818 were positive with a good safety and tolerability profile. Thereby, we were also able to determine the starting dose for the second part of the study, where we combine MIV-818 with standard treatment. Data from the first part of the phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) scientific conference in September.

Due to its unique mechanism of action, MIV-818 is attractive to combine with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). We have been working on refining the design for the next step in the clinical program, the upcoming phase 1b/2a combination study with MIV-818, and at the end of May we presented how the study is structured. MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor, or with pembrolizumab, an anti-PD-1 checkpoint inhibitor.

The study is an open-label, multi-center phase 1b/2a study that begins with a dose escalation part to determine the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combinations of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with HCC who have progressed on, or are intolerant of, first line standard therapy.

We plan to recruit the first patient for the combination study in the second half of 2021. However, we cannot guarantee that the Covid-19 pandemic will not affect our schedule.

MIV-818 is proprietary and wholly owned by Medivir, i.e. we do not have to pay any future milestones or royalties to any third party.

We have two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.

During the quarter, positive results were published from an investigator-initiated clinical phase II study of remetinostat in patients with squamous cell carcinoma (SCC). The study was conducted at the Stanford University School of Medicine in California, USA. The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. In August, the positive results from the phase II study with remetinostat in patients with BCC were also published in the scientific journal Clinical Cancer Research.

The results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin-associated cancers in addition to cutaneous T-cell lymphoma (CTCL). Medivir renegotiated in August a multi-party agreement with the originators of remetinostat and TetraLogic Pharmaceuticals Corporation and The Leukemia & Lymphoma Society regarding the financial obligations for remetinostat in order to create better conditions for business development.

Medivir’s birinapant project, for the treatment of solid tumors, was outlicensed to the American company IGM Biosciences at the beginning of the year. IGM has the global and exclusive rights to develop birinapant. According to IGM’s Q2 report, they plan to initiate clinical trials with birinapant in combination with their proprietary antibody IGM-8444 during 2021.

At Medivir’s AGM on May 5, former CEO Yilmaz Mahshid was elected new board member and Uli Hacksell was elected chairman of the board. This guarantee continued scientific vitality and business acumen in the Board’s work.

In July, Malene Jensen was recruited as Vice President Clinical Development and a member of the company’s management team. With extensive experience in clinical development, Malene will focus on the clinical studies with MIV-818.

I am really impressed by the determination and dedication shared by all Medivir employees. The goal is to develop an effective drug against liver cancer through MIV-818. Given that this work continues to show good results, it could make a big difference for patients and for healthcare and thus also for the company’s shareholders.

On August 19, 2021 Calliditas Therapeutics reported that During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1 (Press release, Calliditas Therapeutics, AUG 19, 2021, View Source [SID1234586741]). We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.

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During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval. In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon. The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2."

Renée Aguiar-Lucander, CEO

Summary of Q2 2021
April 1 – June 30, 2021

No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively.
Operating loss amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 165.2 million and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.
Significant events during Q2 2021, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for Nefecon, reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
In May 2021, Calliditas announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon.
Significant events after the end of reporting period, in summary
In July 2021, Calliditas signed a loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million before transaction costs.
Investor presentation August 19, 14:30 CET
Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

On August 19, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported the second quarter 2021 (Press release, Oncopeptides, AUG 19, 2021, View Source [SID1234586773]).

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Financial overview April-June

Net sales amounted to SEK 66.4 M (0.0)
Operating loss amounted to SEK 344.8 M (loss: 399.3)
Loss for the period was SEK 24.1 M (loss: 401.0)
Loss per share, before and after dilution, was SEK 0.32 (loss: 6.79)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Financial overview January-June

Net sales amounted to SEK 85.7 M (0.0)
Operating loss amounted to SEK 692.2 M (loss: 696.2)
Loss for the period was SEK 258.8 M (loss: 698.4)
Loss per share, before and after dilution, was SEK 3.63 (loss: 12.20)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Significant events April-June

An application for conditional marketing authorization of melflufen in the EU was submitted in April
Topline results from the phase 3 OCEAN study were announced in May
Patient enrollment in the phase 2 PORT study was completed in May
A German affiliate was established in May
Clinical abstracts on melflufen was presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June
New clinical and preclincal melflufen data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June
Significant events after the reporting period

Updated results from the phase 3 OCEAN study were announced on July 8: melflufen met the primary endpoint of superior PFS
Overall survival data, also released on July 8, led to the FDA requesting a partial clinical hold of all clinical studies with melflufen, pending further investigation
FDA issued a safety alert to patients and health care professionals on July 28, regarding an increased risk of death associated with Pepaxto in the OCEAN study.

Conference call for investors, analysts and the media

Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall, CMO, Klaas Bakker and CFO, Anders Martin-Löf.

The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on August 19, 2021.

On August 18, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2021 first half results on Wednesday, August 25, 2021 (Press release, Bavarian Nordic, AUG 18, 2021, View Source [SID1234586727]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at https://bit.ly/3xzOiQo.

To join the Q&A session dial one of the following numbers and state the participant code 8569159: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.