UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 12, 2020
Onconova Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-36020 | 22-3627252 |
| (State or Other Jurisdiction | (Commission | (I.R.S. Employer |
| of Incorporation or Organization) | File Number) | Identification No.) |
375 Pheasant Run
Newtown, PA 18940
(267) 759-3680
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Not Applicable
(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 (17CFR 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, par value $.01 per share | ONTX | The Nasdaq Stock Market LLC | ||
| Common Stock Warrants | ONTXW | The Nasdaq Stock Market LLC |
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 ¨
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2020, Onconova Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2020, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information contained in this Form 8-K (including the exhibit hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Exhibit | |
| 99.1 | Press release issued by the Company dated November 12, 2020 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: November 12, 2020 | Onconova Therapeutics, Inc. | |
| By: | /s/ MARK GUERIN | |
| Name: Mark Guerin | ||
| Title: Chief Financial Officer | ||
Exhibit 99.1
Onconova Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
| · | ON 123300, our proprietary multi-kinase inhibitor, enters into the clinic for advanced solid tumors |
| · | Investigator-initiated study advances with combination of oral rigosertib and nivolumab in K-RAS mutated non-small cell lung cancer |
| · | Actively evaluating strategic opportunities to further enhance our portfolio |
Conference call begins at 4:30 p.m. ET today
NEWTOWN, Pa., November 12, 2020 (GLOBE NEWSWIRE) – Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today reported financial results for the quarter ended September 30, 2020 and provided a business update.
Management commentary
“During the third quarter, our product pipeline advanced while we pursued various licensing opportunities. We are particularly pleased that ON 123300, our proprietary, differentiated, first-in-class multi-kinase inhibitor, entered the clinic with HanX Biopharmaceuticals, our partner in China,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “The HanX Phase 1 dose-escalation study has enrolled three patients to date, and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified.
“In parallel, we are preparing to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration by the end of this year, with patient enrollment expected to begin in the first quarter of 2021. We expect that our Phase 1 dose-escalation and dose-expansion study in the U.S. will differ from the HanX study in dose regimens and treatment cycles, and believe that data from these two studies will generate important information to inform anticipated later-stage studies. Our plan is to enroll patients with a variety of advanced solid tumors including an initial focus on HR+ HER2- postmenopausal metastatic breast cancer patients with resistance to approved second-generation CDK 4/6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin’s lymphoma based on efficacy data from our preclinical models. We believe that, with its novel mechanism of action targeting both CDK4/6 and ARK5, ON 123300 presents an innovative approach for potentially treating HR+ HER2- metastatic breast cancer that is or has become resistant to the commercial CDK4/6 inhibitors, and potentially other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma.”
“Important investigator-initiated studies are also underway or planned with oral rigosertib,” added Richard Woodman, M.D, Chief Medical Officer. “We are currently supporting a Phase 1 dose-escalation study at a leading medical center in New York City exploring the use of rigosertib in combination with the PD-1 inhibitor nivolumabin progressive K-RAS mutated non-small cell lung cancer (NSCLC). That study has enrolled five patients to date, and is designed to identify the recommended Phase 2 dose of the combination for future studies. Results are expected in 2021. In addition, an investigator-initiated phase 1b/2 study with rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa has opened, with first-patient-in expected 2021. Additional investigator-initiated preclinical studies with rigosertib are under consideration.”
“Our focus is on advancing our pipeline, and while we believe ON 123300 and oral rigosertib have excellent prospects, we are also engaged in licensing discussions, both for geographic rights to certain of our assets, and evaluating the potential to in-license additional compounds to expand our product portfolio,” Dr. Fruchtman concluded.
Third quarter financial results
Cash and cash equivalents as of September 30, 2020 were $24.2 million, compared with $22.7 million as of December 31, 2019. The Company expects that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2022. During the third quarter of 2020, the Company received $2.7 million from the exercise of warrants.
Research and development expenses were $4.2 million for the third quarter of 2020, compared with $3.5 million for the third quarter of 2019. The increase was primarily related to higher consulting fees and manufacturing costs related to clinical supply for ON 123300, partially offset by lower expenses for the oral rigosertib combination program and the Phase 3 INSPIRE study.
General and administrative expenses were $2.1 million for the third quarter of 2020, compared with $1.6 million for the third quarter of 2019. The increase was due to higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses.
Net loss for the third quarter of 2020 was $6.2 million, compared with $4.6 million for the comparable prior-year quarter.
Conference call and webcast
Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for the 2020 third quarter, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 8687160.
A live webcast of the conference call will be available in the Investors & Media section of the Company's website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is currently in a dose-escalation and expansion Phase 1 trial in China, and the IND filing in the U.S. is anticipated in the fourth quarter of 2020. Onconova’s product candidate, oral rigosertib, is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. Preclinical work with rigosertib in COVID-19 is ongoing as well. We do not anticipate conducting clinical trials with rigosertib in COVID-19 without securing additional funding. For more information, please visit https://www.onconova.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova expectations regarding its clinical development plans and patents. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova's clinical trials and regulatory approval of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, our collaborations, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Contact information
Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/
Investor Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
[Tables to follow]
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,198 | $ | 22,726 | ||||
| Receivables | 46 | 98 | ||||||
| Prepaid expenses and other current assets | 757 | 650 | ||||||
| Total current assets | 25,001 | 23,474 | ||||||
| Property and equipment, net | 56 | 50 | ||||||
| Other non-current assets | 150 | 150 | ||||||
| Total assets | $ | 25,207 | $ | 23,674 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,725 | $ | 4,271 | ||||
| Accrued expenses and other current liabilities | 3,339 | 3,795 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 9,290 | 8,292 | ||||||
| Warrant liability | 176 | 113 | ||||||
| Deferred revenue, non-current | 3,526 | 3,695 | ||||||
| Total liabilities | 12,992 | 12,100 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 1,845 | 1,112 | ||||||
| Additional paid in capital | 432,499 | 413,879 | ||||||
| Accumulated other comprehensive loss | (2 | ) | (18 | ) | ||||
| Accumulated deficit | (422,127 | ) | (403,399 | ) | ||||
| Total stockholders' equity | 12,215 | 11,574 | ||||||
| Total liabilities and stockholders' equity | $ | 25,207 | $ | 23,674 | ||||
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine months months ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue | $ | 66 | $ | 63 | $ | 174 | $ | 2,153 | ||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 2,147 | 1,640 | 6,548 | 6,634 | ||||||||||||
| Research and development | 4,193 | 3,521 | 12,364 | 11,490 | ||||||||||||
| Total operating expenses | 6,340 | 5,161 | 18,912 | 18,124 | ||||||||||||
| Loss from operations | (6,274 | ) | (5,098 | ) | (18,738 | ) | (15,971 | ) | ||||||||
| Change in fair value of warrant liability | 56 | 476 | (63 | ) | 80 | |||||||||||
| Other (loss) income, net | (23 | ) | 27 | 73 | 135 | |||||||||||
| Net loss | (6,241 | ) | (4,595 | ) | (18,728 | ) | (15,756 | ) | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.03 | ) | $ | (0.75 | ) | $ | (0.11 | ) | $ | (2.63 | ) | ||||
| Basic and diluted weighted average shares outstanding | 180,877,623 | 6,141,933 | 170,297,531 | 5,994,423 | ||||||||||||