On March 23, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and fourth quarter and full year 2020 financial results (Press release, Kronos Bio, MAR 23, 2021, View Source [SID1234577025]).

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"2020 was a transformational year for Kronos Bio, during which we made our debut as a public company through an upsized IPO and acquired a portfolio of SYK inhibitors, including the lead compound entospletinib, currently in late-stage clinical development. We also hired key talent to execute on our company’s vision and advanced the clinical development of our two lead therapeutic programs," said Norbert Bischofberger, Ph.D., president and CEO. "Thus far in 2021, we have continued to successfully carry out our plans, including proceeding to assess MRD negative CR as the primary endpoint in our Phase 3 trial to support potential accelerated approval of entospletinib. We also dosed the first patient in our Phase 1/2 trial of KB-0742, our oral CDK9 inhibitor targeting MYC-amplified cancers, and expect to report initial safety, PK and PD data from this trial in the fourth quarter of this year. We have put together the pieces necessary for the foundation of a successful company, and I expect 2021 to be a year of important clinical execution for our company."

2020 and Recent Clinical and Business Highlights

Clinical Highlights

In March 2021, announced that data from a pre-clinical study of KB-0742 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, being held virtually April 10-15.
In March 2021, following receipt of minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), announced that the company will proceed with its plan to assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint in a registrational Phase 3 trial to support potential accelerated approval of entospletinib, an investigational spleen tyrosine kinase (SYK) inhibitor being developed for the frontline treatment of patients with NPM1-mutated acute myeloid leukemia. The company plans to initiate the Phase 3 trial in mid-2021, with MRD negative CR data expected in the second half of 2023.
In February 2021, announced that the first patient was dosed in the company’s Phase 1/2 clinical trial of KB-0742, the company’s potent oral, highly selective cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors. The company announced FDA clearance of the Investigational New Drug (IND) application for KB-0742 in December 2020. Initial safety, PK and PD data from the dose-escalation stage of the Phase 1/2 study is expected in the fourth quarter of this year, with data from the study’s expansion cohorts expected in 2022.
In October 2020, published in Cell Chemical Biology the results of a preclinical study of KB-0742. These results were previously presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020.
In July 2020, acquired a portfolio of SYK inhibitors from Gilead Sciences. The portfolio includes the clinical stage compounds entospletinib, which has been evaluated in Phase 1 and Phase 2 clinical trials in oncology patients, and lanraplenib, which has been evaluated in Phase 2 clinical trials in patients with autoimmune diseases.
Business Highlights

In October 2020, completed an upsized initial public offering (IPO) of 15,131,579 shares of common stock, including full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of $287.5 million, before deducting underwriting discounts and commissions and offering expenses. This followed a $155.2 million private financing in August 2020.
Announced the appointments of Marianne De Backer, Ph.D., MBA, and Elena Ridloff, CFA, to the company’s board of directors.
Expanded the company’s executive leadership team with the hiring of Christopher Dinsmore, Ph.D., chief scientific officer; Barbara Kosacz, chief operating officer and general counsel; Yasir Al-Wakeel, BM BCh, chief financial officer and head of corporate development; and Pasit Phiasivongsa, Ph.D., senior vice president, pharmaceutical development and manufacturing.
Fourth Quarter and Year End 2020 Financial Highlights

Cash, Cash Equivalents and Investments: As of December 31, 2020, cash, cash equivalents and investments totaled $462.1 million, which includes $263.7 million in net proceeds from the company’s October 2020 upsized IPO.
R&D Expenses: Research and development expenses were $13.1 million for the fourth quarter of 2020, which includes $0.8 million in non-cash stock-based compensation expense. For the full year of 2020, R&D expenses were $43.3 million, which includes $6.6 million in acquisition costs for the SYK inhibitor portfolio, $2.6 million for its new research facility in Cambridge, Massachusetts, and $1.4 million in non-cash stock-based compensation.
G&A Expenses: General and administrative expenses were $8.0 million for the fourth quarter of 2020, which includes $1.2 million in non-cash stock-based compensation expense. For the full year of 2020, G&A expenses were $14.8 million, which includes $2.4 million in non-cash stock-based compensation.
Net Loss: Net loss for the fourth quarter was $33.2 million, or $0.70 per share, including non-cash stock-based compensation of $2.0 million. For the full year of 2020, the Company’s net loss was $88.4 million, or $5.43 per share, including non-cash stock-based compensation expense of $3.8 million.