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): March 18, 2019
resTORbio, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-38359 |
81-3305277 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
500 Boylston Street, 12th Floor
Boston, MA 02116
(Address of principal executive offices, including zip code)
(857) 315-5521
(Registrant’s telephone number, including area code)
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 (see General Instructions A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 March 18, 2019, resTORbio, Inc. announced its financial results for the quarter and year ended December 31, 2018. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current 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, as amended (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
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Exhibit Number |
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Description |
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99.1 |
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Press release issued by resTORbio, Inc. on March 18, 2019, furnished herewith. |
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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Date: March 18, 2019 |
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resTORbio, Inc. |
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By: |
/s/ Chen Schor |
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Chen Schor |
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President and Chief Executive Officer |
Exhibit 99.1
resTORbio Reports Fourth Quarter and Full Year 2018 Financial Results
Positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA); Phase 3 program of RTB101 expected to initiate in 2Q19
Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson’s disease (PD) expected to initiate in 1Q19
BOSTON, Massachusetts, March 18, 2019 – resTORbio, Inc. (Nasdaq:TORC), a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat age-related diseases, today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2018.
“In 2018, we made substantial progress advancing RTB101, our selective TORC1 inhibitor product candidate. We reported positive Phase 2b data showing that RTB101 10 mg once daily reduced the incidence of respiratory tract infections, or RTIs, and infections of any kind, in elderly subjects. Recently we announced a positive End-of-Phase 2 meeting with the FDA and expect to initiate the Phase 3 program in the second quarter of 2019,” said Chen Schor, Co-Founder, President and CEO of resTORbio. “Additionally, we look forward to initiating our Phase 1b/2a clinical trial in Parkinson’s disease this quarter and continuing to expand our team and pipeline to broadly address aging-related diseases.”
Recent Highlights and Outlook
Expanding Drug Discovery Capabilities to Target the Biology of Aging: The Company is expanding its drug discovery capabilities to develop additional TORC1 inhibitor candidates, as well as exploring other pathways that underly the aging process. resTORbio’s lead program is targeting TORC1, which is a well-validated signaling pathway associated with the biology of aging.
Plans to Initiate Phase 3 Program Following End-of-Phase 2 Meeting with the FDA: resTORbio recently announced the design of its Phase 3 program for RTB101 10 mg once daily, following its End-of-Phase 2 meeting with the FDA. The Company is planning to conduct two randomized, double-blinded, placebo-controlled Phase 3 clinical trials assessing 10 mg of RTB101 once daily versus placebo for 16 weeks. The trials are expected to enroll subjects 65 years of age or older, excluding current smokers and subjects with chronic obstructive pulmonary disease (COPD). Results from two Phase 2 clinical trials enrolling more than 900 elderly subjects support the selection of the dose and patient population that will be used in the Phase 3 program. The primary endpoint of both Phase 3 trials will be a reduction in the percentage of subjects with clinical symptoms consistent with an RTI based on prespecified diagnostic criteria (defined as clinically symptomatic respiratory illness) with or without laboratory-confirmation of a pathogen. The Company plans to enroll approximately 1,000 subjects in the first Phase 3 clinical trial starting in the southern hemisphere in the second quarter of 2019 and approximately 1,600 subjects in the second Phase 3 clinical trial starting in the northern hemisphere in the fourth quarter of 2019.
Initiation of a Phase 1b/2a Trial in PD Expected in the First Quarter of 2019: Selective and broad inhibition of TORC1 has been shown to extend lifespan and ameliorate a number of aging-related diseases in several preclinical studies across multiple species, including models of neurodegenerative diseases such as PD. TORC1 inhibition with RTB101, in combination with sirolimus, a rapalog, may ameliorate PD by potentially inducing autophagy to clear protein aggregates in neurons, increasing lysosomal biogenesis and decreasing glucosylceramide (GL1) synthesis. As neurodegenerative diseases such as PD are associated with the accumulation of aggregated toxic proteins, the Company believes the induction of autophagy with RTB101 in combination with a rapalog may have potential therapeutic benefit for patients with PD. The Company plans to initiate a Phase 1b/2a trial in patients with PD by the end of the first quarter of 2019.
Corporate Updates
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In February 2019, resTORbio appointed Erkan Baloglu, Ph.D., M.B.A., as Vice President of Drug Discovery and Medicinal Chemistry. |
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In December 2018, resTORbio appointed William Marshall, M.D., as Vice President of Medical Sciences. |
Fourth Quarter and Full Year 2018 Financial Results
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R&D Expenses: Research and development (R&D) expenses were $4.3 million for the three months ended December 31, 2018 and $31.1 million for the year ended December 31, 2018, as compared to $6.8 million for the three months ended December 31, 2017 and $16.8 million for the year ended December 31, 2017. The increase in R&D expenses year-over-year was primarily due to the Company’s completed Phase 2b trial in RTIs and preparations for its Phase 3 clinical trials. |
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December 31, 2017 and $2.0 million for the year ended December 31, 2017. The increase in G&A expenses year-over-year was primarily due to an increase in headcount as well as increased operating costs as a result of the Company’s transition from a private company to a public company, including legal, accounting, insurance and investor relations expenses. |
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Net Loss: Net loss was $5.8 million, or $0.21 per share, for the three months ended December 31, 2018, and $37.6 million, or $1.42 per share, for the year ended December 31, 2018. Net loss was $23.1 million, or $5.11 per share, for the three months ended December 31, 2017, and $33.8 million, or $8.42 per share, for the year ended December 31, 2017. |
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Cash and Cash Equivalents: Cash, cash equivalents and marketable securities were $108.0 million as of December 31, 2018, as compared to $53.3 million as of December 31, 2017. The Company expects that current cash, cash equivalents and marketable securities as of December 31, 2018 will be sufficient to fund its operating expenses at least into the second quarter of 2020. |
About resTORbio
resTORbio, Inc. is a clinical stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat age-related diseases. resTORbio’s lead program selectively inhibits TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiovascular and central nervous systems. Learn more about resTORbio, Inc. at https://www.restorbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding our ability to expand our drug discovery capabilities to develop additional TORC1 inhibitors, our plans to initiate a Phase 1b/2a clinical trial of RTB101 in combination with sirolimus in Parkinson’s disease during the first quarter of 2019, our plans to develop RTB101 alone or in combination with rapalogs, including the therapeutic potential and clinical benefits thereof and the potential patient populations that may be addressed by our product candidates, our ongoing and future clinical trials for RTB101 , including the timing of the initiation and anticipated results of these trials, the continued expansion of our pipeline into Parkinson’s disease and UTIs, the intended regulatory path for our product candidates and interactions with regulatory authorities, our ability to replicate results achieved in our clinical trials in any future trials, our cash position and expected cash runway, our expectations regarding our uses of capital, expenses, future accumulated deficit and other 2018 financial results, and our ability to fund operations at least into the second quarter of 2020, constitute forward-looking statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions.
Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our planned Phase 3 clinical trials in RTIs and/or development of RTB101, either alone or in combination with a rapalog, such as everolimus or sirolimus; our ability to successfully demonstrate the efficacy and safety of our lead product candidate; the clinical results for our lead product candidate which may not support further development of additional indications; uncertainties related to the results of our clinical trials predictive of future results in connection with future trials, including our planned Phase 3 clinical trials; the timing and outcome of our planned interactions with regulatory authorities; and obtaining, maintaining and protecting our intellectual property; as well as those risks more fully discussed in the section entitled “Risk Factors” in the Annual Report on Form 10-K filed by resTORbio, Inc. with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing its views as of any subsequent date. resTORbio explicitly disclaims any obligation to update any forward-looking statements.
Investor Contact
Jennifer Robinson
resTORbio, Inc.
857-772-7029
jrobinson@restorbio.com
Media Contact
Amir Khan
Biosector 2
212-462-8767
Amir.Khan@Syneoshealth.com
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2018 |
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2017 |
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2018 |
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2017 |
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Operating expenses: |
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Research and development |
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$ |
4,349 |
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$ |
6,792 |
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$ |
31,065 |
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$ |
16,839 |
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General and administrative |
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2,011 |
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731 |
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8,640 |
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2,043 |
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Total operating expenses |
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6,360 |
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7,523 |
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39,705 |
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18,882 |
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Loss from operations |
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(6,360 |
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(7,523 |
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(39,705 |
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(18,882 |
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Other income (expense), net |
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629 |
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(15,531 |
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2,117 |
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(14,896 |
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Loss before income taxes |
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(5,731 |
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(23,054 |
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(37,588 |
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(33,778 |
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Income tax expense |
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26 |
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— |
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26 |
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— |
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Net loss |
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$ |
(5,757 |
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$ |
(23,054 |
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$ |
(37,614 |
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$ |
(33,778 |
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Net loss per share —basic and diluted |
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$ |
(0.21 |
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$ |
(5.11 |
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$ |
(1.42 |
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$ |
(8.42 |
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Weighted-average number of common shares used in net loss per share — basic and diluted |
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28,051 |
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4,515 |
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26,439 |
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4,010 |
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CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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December 31, |
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December 31, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash, cash equivalents and marketable securities |
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$ |
108,028 |
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$ |
53,349 |
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Prepaid expenses and other current assets |
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1,506 |
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876 |
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Deferred offering costs |
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— |
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929 |
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Total current assets |
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109,534 |
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55,154 |
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Restricted cash |
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84 |
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— |
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Property and equipment, net |
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321 |
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39 |
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Total assets |
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$ |
109,939 |
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$ |
55,193 |
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Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
2,989 |
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$ |
1,515 |
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Accrued liabilities |
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2,727 |
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3,987 |
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Total current liabilities |
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5,716 |
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5,502 |
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Other liabilities |
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19 |
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— |
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Total liabilities |
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5,735 |
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5,502 |
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Redeemable convertible preferred stock |
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— |
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81,620 |
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Stockholders' equity (deficit): |
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Common stock |
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3 |
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1 |
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Additional paid-in capital |
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175,635 |
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1,849 |
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Accumulated deficit |
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(71,393 |
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(33,779 |
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Accumulated other comprehensive loss |
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(41 |
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— |
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Total stockholders' equity (deficit) |
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104,204 |
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(31,929 |
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Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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$ |
109,939 |
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$ |
55,193 |
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