UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 18, 2020
Kronos Bio, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39592 | 82-1895605 | ||||||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
1300 So. El Camino Real, Suite 300 San Mateo, California 94402 | ||||||||
| (Address of principal executive offices including zip code) | ||||||||
Registrant’s telephone number, including area code: (650) 781-5200
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Common Stock, $0.001 par value per share | KRON | The Nasdaq Stock Market LLC | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On November 18, 2020, Kronos Bio, Inc. announced its financial results for the quarter ended September 30, 2020. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| KRONOS BIO, INC. | ||||||||||||||
| Dated: November 18, 2020 | By: | /s/ Norbert Bischofberger | ||||||||||||
Norbert Bischofberger, Ph.D. | ||||||||||||||
President and Chief Executive Officer | ||||||||||||||
Exhibit 99.1
Kronos Bio Reports Recent Business Progress and Third Quarter 2020 Financial Results
Acquired from Gilead Sciences a portfolio of SYK inhibitors, including lead investigational therapy entospletinib being developed for frontline treatment of NPM1-mutated acute myeloid leukemia
Expanded executive team and board of directors with hiring of COO and CFO and appointment of audit committee chair, respectively
Completed upsized initial public offering of common stock on October 14, 2020, raising $287.5 million in gross proceeds
San Mateo, Calif., and Cambridge, Mass., November 18, 2020 – Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third quarter 2020 financial results.
“Kronos Bio experienced transformational growth in 2020. With the acquisition of the portfolio of SYK inhibitors from Gilead Sciences, we are positioned to initiate late-stage clinical testing next year of our lead investigational therapy entospletinib in patients with newly diagnosed NPM1-mutated acute myeloid leukemia. Furthermore, in the first half of 2021, we plan to begin clinical testing of KB-0742, our CDK9 inhibitor, in patients with advanced solid tumors,” said Norbert Bischofberger, Ph.D., president and CEO. “We have expanded our leadership team and filled key roles across the organization. Additionally, with the completion of two financing rounds, including our upsized IPO, we are well-capitalized to execute on our mission to develop and deliver therapies that have the potential to change patients’ lives.”
Recent Highlights
•In July 2020, acquired Gilead Sciences’ portfolio of spleen tyrosine kinase (SYK) inhibitors, including entospletinib, which Kronos Bio is developing as a frontline treatment for patients with NPM1-mutated acute myeloid leukemia (AML).
•Expanded the company’s leadership team with the hiring of Barbara Kosacz, chief operating officer and general counsel, and Dr. Yasir Al-Wakeel, chief financial officer and head of corporate development, and appointed Elena Ridloff to the company’s Board of Directors as chair of the audit committee.
•In September 2020, closed a private financing round of approximately $155.2 million of convertible notes.
•In October 2020, completed an upsized initial public offering (IPO) of 15,131,579 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.
•In October 2020, published in Cell Chemical Biology the results of a preclinical study of KB-0742, the company’s potent oral, highly selective cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors. These results were previously presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020.
Exhibit 99.1
Third Quarter Financial Highlights
•Cash, Cash Equivalents and Short-Term Investments: As of September 30, 2020, cash, cash equivalents and short-term investments totaled $211.3 million, which excludes approximately $263.9 million in net proceeds from the company’s October 2020 upsized IPO.
•R&D Expenses: Research and development expenses were $16.8 million for the third quarter of 2020, which includes $0.2 million in stock-based compensation expense.
•G&A Expenses: General and administrative expenses were $4.1 million for the third quarter of 2020, which includes $1.0 million in stock-based compensation expense.
•Net Loss: Net loss was $39.7 million, or $6.48 per basic and diluted share, for the quarter ended September 30, 2020. This includes a non-recurring $15.2 million non-cash change in fair value of convertible notes.
About Kronos Bio, Inc.
Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing therapies that seek to transform the lives of those affected by cancer. The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth. Kronos Bio’s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML). The company is also developing KB-0742, an oral inhibitor of cyclin dependent kinase 9 (CDK9), for the treatment of MYC-amplified solid tumors.
Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit www.kronosbio.com or follow the company on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, implied and express statements regarding intentions, beliefs, projections, outlook analyses or current expectations concerning, among other things: our expectations about timing and execution of anticipated milestones, including planned IND submissions, initiation of clinical trials and the availability of clinical data from such trials; our cash forecasts; our expectations about our partners’ and collaborators’ ability to execute key initiatives; and the ability of our lead product candidates to treat the underlying causes of their respective targets. These forward looking statements may be accompanied by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and other words of a similar meaning. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our clinical trials, strategy and future operations; the delay of any current or planned clinical trials or the development of the Company’s drug candidates, including, but not limited to entospletinib and KB-0742; the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the final prospectus dated October 9, 2020 and filed pursuant to Rule 424(b) under the Securities of 1933, as amended, with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Kronos Bio’s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kronos Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Kronos Bio explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
###
Contact:
Stephanie Yao
Executive Director, Investor Relations and Corporate Communications
650-525-6605
media@kronosbio.com
Kronos Bio, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 16,755 | $ | 3,526 | $ | 30,125 | $ | 8,698 | |||||||||||||||
| General and administrative | 4,054 | 797 | 6,831 | 2,262 | |||||||||||||||||||
| Total operating expenses | 20,809 | 4,323 | 36,956 | 10,960 | |||||||||||||||||||
| Loss from operations | (20,809) | (4,323) | (36,956) | (10,960) | |||||||||||||||||||
| Other income (expense), net: | |||||||||||||||||||||||
| Change in fair value of convertible notes payable | (15,215) | — | (15,215) | — | |||||||||||||||||||
| Interest expense | (3,889) | (1) | (3,890) | (3) | |||||||||||||||||||
| Interest and other income, net | 200 | 311 | 774 | 311 | |||||||||||||||||||
| Total other income (expense), net | (18,904) | 310 | (18,331) | 308 | |||||||||||||||||||
| Net loss | (39,713) | (4,013) | (55,287) | (10,652) | |||||||||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||||||||
| Net unrealized gain (loss) on available-for-sale securities | (117) | — | 65 | — | |||||||||||||||||||
| Net comprehensive loss | $ | (39,830) | $ | (4,013) | $ | (55,222) | $ | (10,652) | |||||||||||||||
| Net loss per share, basic and diluted | $ | (6.48) | $ | (0.74) | $ | (9.39) | $ | (2.05) | |||||||||||||||
| Weighted-average shares of common stock, basic and diluted | 6,127,146 | 5,409,433 | 5,886,191 | 5,196,681 | |||||||||||||||||||
Kronos Bio, Inc.
Selected Balance Sheet Data
(in thousands, except share and per share amounts)
(Unaudited)
| September 30, 2020 | December 31, 2019 | ||||||||||
| Cash, cash equivalents and short-term investments | $ | 211,265 | $ | 92,184 | |||||||
| Total assets | 262,556 | 102,686 | |||||||||
| Total liabilities | 215,929 | 2,982 | |||||||||
| Convertible preferred stock | 122,907 | 122,907 | |||||||||
| Total stockholders’ deficit | (76,280) | (23,203) | |||||||||