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): May 9, 2018
RESTORBIO, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38359 | 81-3305277 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. 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:
| ☐ | 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)) |
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 8.01 Other Events.
On May 9, 2018, resTORbio, Inc. issued a press release titled “resTORbio Completes Dosing of Patients in Phase 2b Study to Reduce the Incidence of Respiratory Tract Infections in the Elderly.” A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by resTORbio, Inc. on May 9, 2018. | |
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.
| RESTORBIO, INC. | ||||||||
| Date: May 9, 2018 | By: | /s/ Chen Schor | ||||||
| Chen Schor President and Chief Executive Officer | ||||||||
Exhibit 99.1
resTORbio Completes Dosing of Patients in Phase 2b
Study to Reduce the Incidence of Respiratory Tract
Infections in the Elderly
Topline 16-week data now expected in the third quarter of 2018
BOSTON, Massachusetts, May. 9, 2018 – resTORbio, Inc. (NASDAQ:TORC), a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases, today announced that dosing has been completed in its Phase 2b trial evaluating the safety, tolerability and efficacy of RTB101, an orally-administered, selective TORC1 inhibitor, alone or in combination with everolimus, in reducing the incidence of respiratory tract infections (RTIs) in 652 elderly subjects.
“RTIs are a leading cause of hospitalizations and death among the elderly and are mainly caused by viruses that lack effective treatments,” said Chen Schor, President and CEO of resTORbio. “Selective TORC1 inhibition has the potential to improve the function of the aging immune system and thereby reduce the incidence of RTIs, regardless of the causative pathogen, representing a new paradigm for meeting the needs of at-risk elderly patients. Increasing scientific data suggest that TORC1 inhibition also has the potential to improve the function of other aging organ systems. We are pleased to have dosed all patients in our Phase 2b study, and we look forward to reporting topline data in the third quarter of 2018.”
The randomized, double-blind placebo-controlled Phase 2b trial was initiated to evaluate the safety, tolerability and efficacy of RTB101 alone or in combination with everolimus in reducing the incidence of RTIs. The study enrolled 652 subjects at increased risk of RTI-associated morbidity and mortality, defined as aged 85 and over or 65-84 with comorbidities. The study consists of two parts during which elderly subjects were enrolled during the winter cold and flu seasons in the southern (Part 1) and northern (Part 2) hemispheres. Part 2 of the study commenced in the U.S. in the fourth quarter of 2017 following an interim analysis of Part 1 results. Part 2 is a 4-arm study comparing placebo to 10 mg of RTB101 dosed once daily (QD), 10 mg of RTB101 dosed twice daily (BID), or 10 mg of RTB101 and 0.1 mg of everolimus dosed QD. All subjects were treated with study drug for 16 weeks, followed by eight weeks of follow-up.
About resTORbio
resTORbio, Inc. is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 – an evolutionary conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems. RTB101, resTORbio’s lead drug candidate, is a selective, orally administered, TORC1 inhibitor
currently being investigated in a Phase 2b clinical trial as a first in-class immunotherapy for reducing the incidence of respiratory tract infections in the elderly by enhancing the function of the immune system. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases.
Forward Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. 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 plans to develop and commercialize RTB101 alone or in combination with everolimus, including the therapeutic potential and clinical benefits thereof, our ongoing and future clinical trials for RTB101 alone or in combination with everolimus, including the timing of initiation of these trials and of the anticipated results, 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: the delay of any planned clinical trials and/or development of RTB101, either alone or in combination with everolimus; 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; 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 with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in resTORbio’s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent resTORbio’s 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:
Beth DelGiacco
Stern Investor Relations, Inc.
212-362-1200
beth@sternir.com
Media Contact:
Michael Lampe
Scient PR
484-575-5040
michael@scientpr.com