On March 1, 2022 Sterling Pharma Solutions, a global contract development and manufacturing organisation, reported that it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of the sale, which is expected to close in Q4, 2022, have not been disclosed (Press release, Novartis, MAR 1, 2022, View Source [SID1234609418]).

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Under the terms of the agreement, Sterling will acquire the 111-acre site, which includes three active pharmaceutical ingredient (API) manufacturing buildings, as well as facilities to support development and scale up in line with Sterling’s core business focus. The site currently manufactures a number of APIs across a range of therapeutic areas, and the deal includes an ongoing supply agreement between Sterling and Novartis from the Ringaskiddy facility. Upon closing, the workforce will transition to Sterling.

Sterling’s Chief Executive Officer, Kevin Cook, said: "The addition of this new, world-class facility and its highly skilled workforce, with its history of quality and regulatory excellence, to Sterling’s portfolio, will enable us to provide expanded capacity to our customers. The site at Ringaskiddy has a number of synergies with our current global facilities enabling us to continue our growth strategy in the small molecule market, as well as extending our capabilities in several key technological areas such as peptide manufacturing and large-scale chromatography."

This announcement follows several investments in Sterling’s manufacturing capabilities in 2021, as well as the acquisition of its Germantown site in Wisconsin from Alcami in 2020, and a dedicated antibody-drug conjugate facility in Deeside, UK in 2021.

The addition of the Ringaskiddy campus will see Sterling’s global network grow to five facilities across the UK, Europe and the US, with a workforce of over 1,000 employees.

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.