UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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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 (see General Instruction A.2. below):
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Indicate by check mark whether the registrant is an emerging growth company 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 August 9, 2022, Oncternal Therapeutics, Inc., issued a press release announcing its financial results for the second quarter ended June 30, 2022. A copy of this press release is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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.
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Oncternal Therapeutics, Inc. |
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Date: August 9, 2022 |
By: |
/s/ Richard G. Vincent |
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Name: Richard G. Vincent |
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Title: Chief Financial Officer |
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2
Exhibit 99.1
Oncternal Therapeutics Provides Business Update and
Announces Second Quarter 2022 Financial Results
SAN DIEGO, August 9, 2022 -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today provided a business update and reported financial results for the second quarter of 2022.
“The second quarter of 2022 was highlighted by an encouraging data update at ASCO from our Phase 1/2 study of zilovertamab plus ibrutinib in patients with MCL and CLL. We were especially excited by the results in MCL and CLL patients with loss of p53 function, which is a challenging population to treat with current standard of care BTK inhibitor monotherapy” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We are now looking forward to critical near-term catalysts for the company, including the planned initiation of our Phase 3 Study ZILO-301, the submission of our IND for the first-in-human study of ONCT-808, our ROR1-targeting CAR expressing T cell therapy candidate, and the further advancement towards the clinic of ONCT-534, our Dual-Acting Androgen Receptor Inhibitor (DAARI) product candidate that may address key resistance mechanisms in metastatic prostate cancer. All this is underpinned by focused execution and prudent cash and resource management. We currently expect our cash runway will last into the first half of 2024.”
Recent Highlights
Expected Upcoming Milestones
Second Quarter 2022 Financial Results
Our grant revenue was $0.2 million for the second quarter ended June 30, 2022. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH).
Our total operating expenses for the second quarter ended June 30, 2022 were $12.0 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $8.8 million, and general and administrative expenses for the quarter totaled $3.2 million. Net loss for the second quarter was $11.7 million, or a loss of $0.23 per share, basic and diluted.
As of June 30, 2022, we had approximately 52.2 million shares of common stock outstanding, $78.9 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations into the first half of 2024. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. The lead clinical program is zilovertamab, an investigational monoclonal antibody designed to inhibit ROR1, a type I tyrosine kinase-like orphan receptor. Zilovertamab is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), in investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). Oncternal is also developing ONCT-808, a chimeric antigen receptor T (CAR-T) cell therapy that targets ROR1, which is currently in advanced preclinical development as a potential treatment for hematologic cancers and solid tumors. The early-stage pipeline also includes ONCT-534, a dual-action androgen receptor inhibitor (DAARI) that is in advanced preclinical development as a potential treatment for castration resistant prostate cancer, including those with clinically important resistance to approved androgen receptor inhibitors. More information is available at https://oncternal.com/.
Forward-Looking Information
Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding Oncternal’s development programs, including the anticipated timing for announcing additional preclinical and clinical data; timing of reaching any milestones, including IND submissions; timing for regulatory communications; Oncternal’s expected cash runway; and the potential that Study ZILO-301 can serve as a registrational clinical trial; and the expected initiation of clinical trials, including Study ZILO-301. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; we have not conducted head-to-head studies of zilovertamab in combination with ibrutinib compared to ibrutinib monotherapy and data from separate studies may not be directly comparable due to the differences in study protocols, conditions and patient populations; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical
outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; later developments with the FDA may be inconsistent with the minutes from the completed end of Phase 2 meeting, including that the proposed Study ZILO-301 that may not support registration of zilovertamab in combination with ibrutinib which is a review issue with the FDA upon submission of a BLA; and other risks described in Oncternal’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact Information:
Investors
Richard Vincent
858-434-1113
rvincent@oncternal.com
Media
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com
Oncternal Therapeutics, Inc.
Condensed Consolidated Balance Sheets Data
(in thousands)
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June 30, 2022 (Unaudited) |
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December 31, 2021 |
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Cash and cash equivalents |
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$ 78,900 |
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$ 90,765 |
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Total assets |
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81,526 |
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93,585 |
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Total liabilities |
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7,525 |
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5,465 |
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Accumulated deficit |
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(135,775 |
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(114,130 |
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Total stockholders’ equity |
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74,001 |
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88,120 |
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Oncternal Therapeutics, Inc.
Condensed Consolidated Statements of Operations Data
(Unaudited; in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Grant revenue |
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$ |
191 |
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$ |
883 |
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$ |
937 |
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$ |
1,631 |
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Operating expenses: |
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Research and development |
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8,761 |
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5,192 |
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15,740 |
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9,105 |
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General and administrative |
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3,225 |
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3,381 |
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6,904 |
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6,174 |
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Total operating expenses |
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11,986 |
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8,573 |
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22,644 |
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15,279 |
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Loss from operations |
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(11,795 |
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(7,690 |
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(21,707 |
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(13,648 |
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Interest income |
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54 |
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8 |
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62 |
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18 |
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Net loss |
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$ |
(11,741 |
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$ |
(7,682 |
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$ |
(21,645 |
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$ |
(13,630 |
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Net loss per share, basic and diluted |
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$ |
(0.23 |
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$ |
(0.16 |
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$ |
(0.44 |
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$ |
(0.28 |
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Weighted-average shares outstanding, basic and diluted |
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50,064 |
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49,364 |
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49,748 |
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49,230 |
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