On March 1, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL) (the "Company" or "Candel"), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that it has entered into a loan and security agreement with Silicon Valley Bank for $25 million, $20 million of which will be available immediately (Press release, Candel Therapeutics, MAR 1, 2022, View Source [SID1234609226]). An additional $5 million may be made available in the future if certain conditions and milestones are met. The loan agreement requires monthly payments of interest only for 24 months, after which the principal is repayable in 24 monthly payments. This financing extends the Company’s cash runway into the fourth quarter of 2023.

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"This access to additional capital positions us well ahead of important anticipated catalysts for the Company, including initial clinical data from the phase 2 clinical trial of CAN-2409 in non-small cell lung cancer, data from our phase 1 clinical trial of CAN-2409 in combination with Opdivo for the first-line treatment of high-grade glioma, data from our phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma, and initiation of our phase 3 clinical trial of CAN-2409 in high-grade glioma," said Paul Peter Tak, MD, PhD, FMedSci, Chief Executive Officer of Candel. "We are especially pleased with the attractive terms and non-dilutive nature of this financing, which bolsters our cash position and provides additional operational flexibility."

On March 1, 2022 Tiziana Life Sciences Ltd.’s (Nasdaq: TLSA) former subsidiary, AccuStem Sciences, Inc. (OTC PINK: ACMSY) (formerly AccuStem Sciences Ltd.), reported publication of new data in the European Journal of Cancer (Press release, Tiziana Life Sciences, MAR 1, 2022, View Source [SID1234609260]). Results demonstrate that StemPrintER is highly prognostic for risk of distant recurrence in women with breast cancer.

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Investigators from the European Institute of Oncology (IEO) in Milan and The Royal Marsden Hospital in London evaluated 776 tumor samples from the TransATAC cohort, a subgroup of estrogen receptor positive (ER+), post-menopausal patients from the prospective, randomized ATAC trial. The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including OncotypeDX, Prosigna, EndoPredict and Breast Cancer Index.

In this analysis, investigators demonstrated that patients with a StemPrintER Risk Score (SPRS) Low result had significantly better outcomes than patients with a SPRS High result. Patients with a SPRS Low result had a 5.8% risk of distant recurrence at 10 years versus 23.2% risk of distant recurrence in patients with a SPRS High result.1

"Many genomic classifiers have been evaluated in the TransATAC cohort," said Salvatore Pece, Full Professor at the Milan University Medical School and Director of the Hormone-Related Cancers and Stem Cell Pathobiology Lab at IEO. "It is exciting that StemPrintER appears to perform as well as other commercially-available tests and indicates the potential for this novel test to inform clinical decision making."

On March 1, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Allakos, MAR 1, 2022, View Source [SID1234609279]).

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Recent Events

Initiated a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis in the fourth quarter of 2021.

Reported topline data from ENIGMA 2, a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic gastritis/eosinophilic duodenitis ("EG"/"EoD") in the fourth quarter of 2021.

Reported topline data from KRYPTOS, a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic esophagitis ("EoE") in the fourth quarter of 2021.
Upcoming Milestones

Hold an End-of-Phase 2 meeting with the FDA during second quarter of 2022 to discuss the Phase 2/3 KRYPTOS data and the development path with subcutaneous lirentelimab in patients with EoE.

Report topline data from the Phase 3 study of lirentelimab in patients with EoD (EoDyssey) in the third quarter of 2022.

Initiate a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the middle of 2022.

Complete IND-Enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.
Fourth Quarter and Full Year 2021 Financial Results

Research and development expenses were $72.9 million in the fourth quarter of 2021 as compared to $28.5 million in the same period in 2020, an increase of $44.4 million. Research and development expenses were $196.3 million for the full year 2021 as compared to $105.5 million in the same period in 2020, an increase of $90.8 million.

General and administrative expenses were $23.2 million in the fourth quarter of 2021 as compared to $15.8 million in the same period in 2020, an increase of $7.4 million. General and administrative expenses were $75.1 million for the full year 2021 as compared to $51.5 million in the same period in 2020, an increase of $23.6 million.

Allakos reported a net loss of $94.4 million in the fourth quarter of 2021 as compared to $44.3 million in the same period in 2020, an increase of $50.1 million. Net loss per basic and diluted share was $1.73 for the fourth quarter of 2021 compared to $0.86 in the same period in 2020. Net loss was $269.9 million for the full year 2021 as compared to $153.5 million in the same period in 2020, an increase of $116.4 million. Net

loss per basic and diluted share was $5.01 for the full year 2021 compared to $3.10 in the same period in 2020.

Allakos ended the fourth quarter of 2021 with $424.2 million in cash, cash equivalents and marketable securities.

On March 1, 2022 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, MAR 1, 2022, View Source [SID1234609320]). The dividend is payable on May 2, 2022 to stockholders of record at the close of business on April 1, 2022.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable June 1, 2022, to stockholders of record at the close of business on May 10, 2022.

On March 1, 2022 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; "ONO") reported that it has filed a lawsuit for an injunction and damages (value of the subject matter of the suit is about 32 billion yen) against patent infringement, based on the patent on the anti-PD-L1 antibody owned by ONO (JP5885764; JP6258428), to the Tokyo District Court on February 28 against AstraZeneca K.K., which has been marketing Imfinzi (durvalumab) (Press release, Ono, MAR 1, 2022, View Source [SID1234609346]).

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　ONO is a research and development company that creates world-class, innovative new drugs under the corporate philosophy, "Dedicated to the Fight against Disease and Pain." We recognize intellectual property as an extremely important management asset. Therefore, we have decided to take appropriate measures against acts that infringe our intellectual property rights, leading to the filing of such a lawsuit this time.

　Considering that the treatment is related to the life-saving of patients, we will not ask for a sales injunction of Imfinzi in this lawsuit, if we would make an agreement with AstraZeneca K.K. which will pay to ONO an appropriate consideration including royalties even outside the proceedings.