On November 30, 2020 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the Interim Report for the period January – September 2020 (Press release, Allarity Therapeutics, NOV 30, 2020, View Source [SID1234571985]). The report is available as an attached document and on the company’s website.

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Steve Carchedi, CEO of Oncology Venture, Steve stated, "During Q3 we have continued the transformation of the Company, as we adopted a new company name and corporate brand-identity as Allarity Therapeutics. As part of our company transformation, we welcomed two new board members, Mr. Soren Gade, Member of the European Parliament, and Ms. Gail Maderis, President & CEO of Antiva Biosciences. In addition, Mr. Jens Knudsen joined the Allarity Executive Management team as our new CFO. All three of these new team members bring extensive experience in and deep knowledge of Oncology therapeutics development coupled with diagnostics that will greatly benefit Allarity. We also announced several positive developments on our stenoparib (PARPi) program. We are now in full control of the development program, we are progressing with our Phase 2 trial of this drug in ovarian cancer, and stenoparib has also shown promising in vitro anti-viral activity against Coronavirus in pre-clinical studies. In addition, we provided an updated timeline for our dovitinib program. Overall, I continue to be very optimistic on the future of our company and our priority therapeutic programs, and I look forward to continuing to share our progress. After all, the patients are waiting."

Summary of the Interim Report

Consolidated group revenue amounted to 0 MDKK (0.5 MDKK).
Consolidated group loss before depreciation amounted to -34.3 MDKK (-46.0 MDKK).
Consolidated group loss before net financials amounted to -35.1 MDKK (-46.8 MDKK).
Consolidated net result amounted to -27.5 MDKK (-59.1 MDKK).
Consolidated earnings per share (EPS) amounted to -0.18 DKK (-0.65 DKK).
2019 numbers in brackets.

Highlights during Q2 2020

On 13 July, the company announced that it had acquired full ownership of its PARP inhibitor program (at the time known as 2X-121, now stenoparib) by acquiring all outstanding shares in Oncology Venture US Inc., formerly 2X Oncology, Inc., from its external shareholders and warrant holders.

On 14 July, the company announced a directed issue of 2,255,639 shares under its existing convertible loan note agreement with Negma Group LTD and Park Partners GP.

On 14 August, the company announced a directed issue of 1,893,939 shares under its existing convertible loan note agreement with Negma Group LTD and Park Partners GP.

On 21 August, the company published that it would offer 1,619,912 new shares, each with a subscription price of DKK 0.05, to a small number of recipients as part of the clean-up of outstanding incentive commitments and obligations made by prior management.

On 21 August, the company announced that it had called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF. A total of 5,980,020 shares at a price per share of SEK 1.3420441 was issued to Global Corporate Finance.

On 26 August, the company announced that its PARP inhibitor stenoparib (formerly known as 2X-121) had shown in vitro anti-viral activity against Coronavirus in pre-clinical studies. Based on these findings, the company planned to advance the compound into human clinical trials as a potential therapy for COVID-19.

On 28 August, the company published the Interim Report for the period January – June 2020.

On 21 September, the company published a notice to convene an Extraordinary General Meeting on 7 October 2020.

On 21 September, the company announced its plans to change its company name to Allarity Therapeutics and restructure its Board of Directors subject to approval of shareholders at the upcoming EGM.
Highlights after the period

On 6 October, the company announced that it has called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF. A total of 5,370,617 shares was issued to Global Corporate Finance.

On 6 October, the company announced that a small group of recipients had received a total of 1,619,912 shares in exchange for previously annulled warrants.

On 7 October, the company announced that the Extraordinary General Meeting had approved the adoption of the Company’s new name, Allarity Therapeutics, as well as the restructuring of its Board of Directors, and a revision of the Company’s Articles of Association.

On 9 October, Allarity Therapeutics published that following the Company’s name change from Oncology Venture A/S to Allarity Therapeutics A/S, the Company will be trading under its new short name ALLR from Monday, 12 October 2020.

On 23 October, Allarity Therapeutics announced several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dovitinib, one of Allarity’s priority programs.

On 26 October, Allarity Therapeutics announced that the United States Patent and Trademark Office (USPTO) had issued Notices of Allowance to the Company for three new DRP biomarker patents in conjunction with use of several of its clinical pipeline drugs.

On 4 November, the company announced that Jens Erik Knudsen, CPA, MBA, had been appointed as its new Chief Financial Officer (CFO), effective immediately, replacing outgoing CFO Henrik Moltke.

On 5 November, the company announced that it had drawn down a second tranche under its convertible note agreement with Negma Group LTD and Park Partners GP.
The report is available on:

View Source
Online webcast/conference call

Allarity Therapeutics A/S will host a live webcast on 30 November 2020, at 5:00 p.m. CET to discuss the company’s third quarter 2020 results and provide a business and financial update.

Attendees are encouraged to pre-register in order to be able to watch the presentation slides using this link:

View Source

On November 30, 2020 Saniona reported its interim report for the third quarter 2020 (Press release, Saniona, NOV 30, 2020, View Source,institutional%20investors%20and%20sector%20specialists. [SID1234571984])

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Financial highlights

Jan – Sep 2020 (Jan – Sep 2019)

Net revenues were SEK 4.6 M (2.7 M)
EBIT was SEK -97.0 M (-75.8 M)
Net profit/loss was SEK -117.3 M (-72.3 M)
Earnings per share were SEK -3.47 (-2.89)
Diluted earnings per share were SEK -3.47 (-2.89)
Q3 2020 (Q3 2019)

Net revenues were SEK 2.2 M (0.3 M)
EBIT was SEK -40.9 M (-26.0 M)
Net profit/loss was SEK -52.7 M (-27.7 M)
Earnings per share were SEK -1.24 (-1.00)
Diluted earnings per share were SEK -1.24 (-1.00)
Business highlights in Q3 2020

On August 10, 2020, Saniona announced the direct issue of shares raising USD $65 million (approximately SEK 567 million) with a syndicate of U.S. and international institutional investors and sector specialists. The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital, New Leaf Venture Partners, and other U.S. and international investors including the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
On August 26, 2020, Saniona announced the expansion of its executive team with the appointments of Jason A. Amello as Chief Financial Officer, Trista Morrison as Chief Communications Officer, and Linea Aspesi as Chief Human Resources Officer.
On September 23, 2020, Saniona completed the exercise of warrants of series TO2, which were issued in connection with Saniona’s rights issue and directed issue in the first quarter of 2020. In total, 1,329,141 warrants of series TO2 were exercised, corresponding to a subscription rate of approx. 90 percent. Saniona will thereby receive proceeds of SEK 33.2 million (USD 3.6 million), before issue costs, which amount to approx. SEK 0.4 million.
Significant events after the reporting period

On October 9, 2020, Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). In both indications, the FDA recommended that the clinical development program include a supportive Phase 2b study followed by a Phase 3 study. In PWS, Saniona expects to begin the Phase 2b study in the first half of 2021. In HO, Saniona is working on a plan, which it intends to present to the FDA to ensure that should Tesomet receive regulatory approval for HO, its use would be restricted only to the appropriate patients. Once this is addressed, Saniona anticipates beginning the HO Phase 2b study in the first half of 2021.
On November 9, 2020, Saniona announced that it had refined its pipeline to align its early-stage discovery research with its strategic focus on rare diseases. Saniona regained exclusive, global rights to its GABAa5 negative allosteric modulator program ("GABAa5 program") from Boehringer Ingelheim, which terminated this collaboration for strategic reasons. The termination of the collaboration provided Saniona with rights to a portfolio of more than 800 molecules, and it does not impact the 2020 collaboration between Saniona and Boehringer Ingelheim, which remains ongoing. Separately, Saniona and the Treatment Research Center (TRC) at the University of Pennsylvania jointly discontinued their collaboration to develop NS2359 for cocaine addiction. Saniona will evaluate the applicability of the GABAa5 program assets and NS2359 in rare diseases.
On November 23, 2020, Saniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. Tesomet was well tolerated, and no clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.

"In the third quarter, we continued to transform Saniona into a fully-integrated biopharmaceutical company with the ability to discover, develop and ultimately commercialize our own innovative treatments for rare diseases. We were particularly encouraged by the positive data from the Phase 2 open-label extension study of Tesomet in HO, which we intend to discuss with FDA as we clarify the path forward in this rare indication," said Rami Levin, President & Chief Executive Officer of Saniona. "During the quarter, one of our most important achievements was raising USD $65 million, which coupled with our existing cash resources, will fund our current operating plan into the second half of 2022, as originally planned. We believe access to U.S. patients, physicians and the U.S. financial market are critical for Saniona to unlock its long-term potential, and as such we are continuing to build our U.S. team and considering listing our shares on the U.S. Nasdaq exchange in addition to our existing listing on Nasdaq Stockholm."

There are multiple potential advantages to a dual listing, including increased visibility and access to a greater number of potential investors, as well as potential increased liquidity (trading volume) from different markets with different macroeconomic conditions, allowing investors to purchase and sell shares on either exchange.

This information is such information as Saniona AB (publ) is obliged to make 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 8:00 CET on November 30, 2020.

On November 30, 2020 NuCana plc (NASDAQ: NCNA) reported that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist (Press release, Nucana BioPharmaceuticals, NOV 30, 2020, View Source [SID1234571982]). Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

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In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study, which led to gemcitabine plus cisplatin becoming the current standard of care for the first-line treatment of patients with advanced biliary tract cancer, an Objective Response Rate of 26% was achieved in the efficacy-evaluable population.

Dr. Mairéad McNamara, Co-Chief Investigator of the ABC-08 study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust remarked: "Acelarin combined with cisplatin demonstrated a favorable safety profile and achieved good tumor control. Responses were seen across all five biliary tract cancer sub-types, including a Complete Response in one patient, a very rare occurrence in this patient population. In ABC-02, only one out of 161 efficacy-evaluable patients who received gemcitabine plus cisplatin achieved a Complete Response. Additionally, one patient with Stable Disease, whose tumor had initially been considered unsuitable for surgical resection, was able to have complete surgical removal of the tumor following treatment with Acelarin plus cisplatin. Four patients were still alive at the end of follow-up, having survived between 16 and 36 months."

"We are very encouraged by the final efficacy and safety data from ABC-08", said Hugh S. Griffith, NuCana’s founder and CEO. "We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer. We continue to drive recruitment in the ongoing Phase III NuTide:121 Study where we believe we have the potential opportunity to apply for accelerated approval based on Objective Response Rate. We remain on track to enroll the required number of patients in NuTide:121 by the end of 2021 in order to conduct the first interim analysis in 2022."

Professor Juan Valle, Co-Chief Investigator of the ABC-02, ABC-08 and NuTide:121 studies and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust said: "Biliary tract cancer is a devastating disease for which more effective treatments are desperately needed. While targeted therapies and immunotherapies may play a role in the treatment of biliary tract cancer in the future, chemotherapy will remain the backbone of treatment. Medicines like Acelarin, with the potential for improved efficacy and safety, would be welcome additions to the treatment options for patients with biliary tract cancer."

About NuTide:121

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 130 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2). The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in the first-line setting for patients with advanced biliary tract cancer is the combination of gemcitabine and cisplatin.

On November 30, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC) (Press release, Zymeworks, NOV 30, 2020, View Source [SID1234571981]).

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The FDA grants Breakthrough Therapy designation to new medicines that are intended to treat a serious condition and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Zanidatamab will now be eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program.

"This Breakthrough Therapy designation from the FDA, based on data generated in BTC patients treated in the initial Phase 1 trial, is recognition of the potential of zanidatamab to provide a new approach to cancer treatment," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "This milestone supports our strategy for accelerated approval and will help make zanidatamab available for patients as quickly as possible."

"BTC is a rare and aggressive cancer," said James Priour, Senior Vice President, Commercial, at Zymeworks. "Receiving this designation from the FDA is testament to the potential of zanidatamab to be the first HER2-targeting therapy approved for metastatic BTC patients."

Earlier this year, Zymeworks initiated a global Phase 2b registration-enabling study of single agent zanidatamab in patients with previously treated HER2 gene-amplified BTC. This study, which is currently enrolling patients, is designed to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety and may enable submission of a Biologics License Application (BLA) as early as 2022.

This Breakthrough Therapy designation was based on an ongoing clinical trial of zanidatamab in patients with locally advanced (unresectable) and/or metastatic HER2-expressing tumors including BTC. Updated clinical data for single agent zanidatamab patients with BTC has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Virtual Gastrointestinal Cancers Symposium (ASCO GI) January 15-17, 2021.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. In addition to Breakthrough Therapy designation for zanidatamab in BTC, the US FDA has granted two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the US FDA, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

About Biliary Tract Cancer

Biliary tract cancer (BTC), including gallbladder cancer and cholangiocarcinoma (bile duct cancer), accounts for approximately 3% of all adult cancers and is associated with a poor prognosis. Globally, more than 210,000 people are diagnosed with BTC every year. Most patients (> 65%) with BTC are diagnosed with tumors that cannot be removed surgically, and even those patients who undergo potentially curative surgery have a high recurrence rate. Treatment options are limited for patients with advanced BTC who experience disease progression after front-line chemotherapy.

The human epidermal growth factor receptor 2 (HER2) is a well-described target for anti-cancer therapy. Tumor cells that produce a higher than normal level of HER2 tend to grow more quickly and spread to other parts of the body. About 5% to 19% of patients with BTC have tumors that express HER2, suggesting that these patients may potentially benefit from HER2-targeted therapy. Currently no HER2-targeted therapy has been approved for the treatment of BTC.

On November 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, Intellia Therapeutics, NOV 30, 2020, View Source [SID1234571979]). Intellia also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies and SVB Leerink are acting as joint book-running managers for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered by Intellia pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.