On November 23, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the publication of its Interim Report for the period January – September 2021 (Press release, Allarity Therapeutics, NOV 23, 2021, View Source [SID1234595982]). The report is available as an attached document and on the company’s website.

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Steve Carchedi, CEO of Allarity Therapeutics, commented on the company’s accomplishments during the period, stating, "It continues to be an exciting time for Allarity and the third quarter of 2021 was no exception. We are now close to a pivotal event in the company’s history: Becoming a US-based company listed on Nasdaq in the US. In parallel to preparing for this pivotal event, we achieved several significant milestones during Q3, including the agreement on irofulven with Lantern Pharma and receiving an acceptance & review notification from the FDA for our pre-market approval (PMA) application for the Dovitinib-DRP companion diagnostic. In line with this progress, in September, we announced our agreement with Lonza Group for the manufacturing of dovitinib. Regarding IXEMPRA and stenoparib, our focus has been on expanding our active clinical trial sites for both programs. Based on this level of overall progress, I remain very optimistic about what Allarity can accomplish once our transformation to becoming a US NASDAQ-listed company is complete."

Summary of the Interim Report for Q3 2021

Consolidated group revenue amounted to 0 MDKK (0 MDKK).
Consolidated group loss before depreciation amounted to -20.3 MDKK (-11.8 MDKK).
Consolidated group loss before net financials amounted to -20.4 MDKK (-12.0 MDKK).
Consolidated net result amounted to -20.6 MDKK (-8.5 MDKK).
Consolidated earnings per share (EPS) amounted to -0.05 DKK (-0.05 DKK).

2020 numbers in brackets.

Highlights during Q3 2021

July

On July 5, Allarity Therapeutics received acceptance & review notification from the U.S. FDA for the Company’s pre-market approval application for the DRP for dovitinib.
On July 7, Allarity Therapeutics issued share units as payment-in-kind for services rendered during the Rights Issue in Q2 2021
On July 25, the company announced that it had entered into an agreement with Lantern Pharma for future clinical development of irofulven.

August

On August 5, the company announced that its oral PARP inhibitor, stenoparib, had demonstrated additional pre-clinical antiviral activity against new variants of Coronavirus.
On August 16, the company published a notice to convene an Extraordinary General Meeting to be held on August 31.
On August 18, the company published an elaboration on the contents of the meeting agenda for the Extraordinary General Meeting announced on August 16.
On August 19, the company announced a new publication date for the publication of the Q2 2021 interim report.
On August 19, the company published the interim report for the period January – June 2021.
On August 23, the company announced that it had filed a Form S-4 Registration Statement with the U.S. Securities & Exchange Commission for Listing of Allarity Therapeutics, Inc. on U.S. Nasdaq.
On August 26, the company announced an extraordinary exercise period for warrants of series ALLR TO 3 set to August 30 – September 13.
On August 31, the company published the minutes of the extraordinary general meeting held announced on August 16.

September

On September 14, the company announced that it had received approximately SEK 16.5 million from subscription to warrants of series ALLR TO 3.
On September 15, the company announced an update to the announcement of the outcome of exercise of the ALLR TO 3 warrants, Allarity had received approximately SEK 23.3 million.
On September 16, the company announced that it would present dovitinib survival data from DRP-screened RCC patients at the ESMO (Free ESMO Whitepaper) 2021 Virtual Congress.
On September 23, the company announced it would collaborate with Lonza Group to Manufacture dovitinib, Allarity’s most advanced clinical therapeutic candidate.
Highlights after the period

November

On November 5, the company announced that the U.S. SEC had issued an order declaring Allarity Therapeutics Inc.’s Form S-4 Registration Statement effective.
On November 5, the company published a notice of an extraordinary general meeting to be held on November 22, 2021.
On November 11 the company’s oral PARP inhibitor, stenoparib, had demonstrated pre-clinical antiviral activity against the delta variant of Coronavirus.
On November 22, the Extraordinary General Meeting approved the Reorganization Agreement, initially announced on May 20, 2021.
The report is available on: View Source

On November 23, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that members of the Company’s management team will be presenting virtually at the following conferences (Press release, Altimmune, NOV 23, 2021, View Source [SID1234595981]):

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Piper Sandler 33rd Annual Virtual Healthcare Conference
November 29-December 2, 2021
Webcast available now
5th Annual NASH Summit 2021
November 30, 2021
9:00 am Eastern Time
4th Annual Evercore ISI HealthCONx Conference
December 2, 2021
10:55 am Eastern Time
Presentation materials, including webcast links to the Piper Sandler and Evercore ISI presentations, will be accessible on the Events section of the Altimmune website.

On November 23, 2021 EORTC reported that Squamous cell carcinomas of the head and neck (SCCHN) are a complex group of cancers that present in a very heterogeneous fashion (Press release, EORTC, NOV 23, 2021, View Source [SID1234595980]). To complicate things further, patients often do not seek treatment until their cancer is at an advanced stage and has spread (metastasis). The EORTC UPSTREAM trial set out to investigate the effect of targeting treatment to the specific gene alteration (biomarker) found in an individual patient’s tumour. Patients for whom no pre-specified biomarkers are identified in their tumour are treated by immunotherapy. Results from one group in the trial treated with immunotherapy were published recently in the European Journal of Cancer*.

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Between November 2017 and August 2018, the Phase 2 trial enrolled 72 patients with SCCHN recurrent metastases whose disease had progressed after being given platinum-based chemotherapy. Of these, 26 who had no specific biomarkers to target, or where the tumour biopsy was not of sufficient quality to determine them, received treatment with monalizumab, a monoclonal antibody that prevents cancer cells blocking immune response to the tumour.

Patients in this group showed little response to the experimental treatment. As a result, there was no further recruitment to the monalizumab alone group, and this part of the trial was closed. Disease control was seen in six patients with stable disease, and minor responses to treatment in 20 with progressive disease. The median duration of stable disease was 3.8 months. Median progression-free survival (the length of time that a patient lives with the disease, but it does not get worse) was 1.7 months, and overall survival 6.7 months.

The researchers will continue the trial in the other groups. Despite the disappointing results among the single therapy patients, they believe that their results demonstrate the feasibility of the UPSTREAM trial.

"Umbrella trials such as UPSTREAM look at how well drugs and treatments work in patients with the same type of cancer but different biomarkers. Even though we have seen that monotherapy with monalizumab has a negligible effect on recurrent SCCHN, we are hopeful that, in those patients where we have been able to identity biomarkers, a combination of treatments will have a better effect. UPSTREAM is currently investigating monalizumab in combination with durvalumab, and a randomised Phase 3 study will compare cetuximab, another antibody that targets damage to the epidermal growth factor receptor, with or without monalizumab" says Principal Investigator Dr Rachel Galot, from the Cliniques Universitaires Saint-Luc, Brussels, Belgium. "We expect to have further results from the trial in the next six months".

On November 23, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming virtual investor conferences (Press release, Kura Oncology, NOV 23, 2021, View Source [SID1234595979]):

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A fireside chat at the Evercore ISI 4th Annual HealthCONx Conference at 11:20 a.m. ET / 8:20 a.m. PT on November 30, 2021; and

A fireside chat at the JMP Securities Hematology and Oncology Summit at 2:20 p.m. ET / 11:20 a.m. PT on December 7, 2021.
Audio webcasts of the Evercore and JMP events will be available in the Investors section of Kura’s website at www.kuraoncology.com, with archived replays available following both events.

On November 23, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in two upcoming virtual investor conferences (Press release, Oncorus, NOV 23, 2021, View Source [SID1234595978]):

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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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33rd Annual Piper Sandler Virtual Healthcare Conference: A corporate presentation will be available on-demand starting Monday, November 22nd at 10:00 a.m. ET.
Evercore ISI 4th Annual HealthCONx Conference: Fireside chat on Wednesday, December 1st, 2021 at 4:45 p.m. ET.
A webcast of each conference presentation will be available under the Investors & Media section of Oncorus’ website at View Source A replay of the presentations will be archived on Oncorus’ site for 30 days following the event.