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Restorbio, Inc. (TORC) SEC Filing 10-Q Quarterly report for the period ending Sunday, September 30, 2018

Restorbio, Inc.

CIK: 1720580 Ticker: TORC

Exhibit 99.1

resTORbio Reports Third Quarter 2018 Financial Results

 

Additional positive data from Phase 2b trial further support RTB101’s potential in reducing the incidence of respiratory tract infections (RTIs) in high-risk elderly patients

 

Initiation of pivotal Phase 3 program of RTB101 in RTIs expected in 1H19

 

Initiation of a Phase 2a trial of RTB101 in combination with a rapalog in Parkinson’s disease by the end of 1Q19

 

BOSTON, Massachusetts, November 13, 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 provided a corporate update and reported financial results for the third quarter ended September 30, 2018.

 

“Our recent accomplishments highlight the therapeutic potential of TORC1 inhibition to decrease the incidence of respiratory tract infections by enhancing immune function in the elderly,” said Chen Schor, Co-Founder, President and CEO of resTORbio. “The additional results from our Phase 2b trial, showing that RTB101 10 mg once daily (QD) reduced both the incidence of RTIs and severity of RTI symptoms, support our strategy to further evaluate RTB101 in high-risk elderly in a planned pivotal Phase 3 program. We also observed signals in our Phase 2b trial that RTB101 may reduce the incidence of urinary tract infections (UTIs), and we are developing our strategy for this indication. We continue to explore the potential benefits of TORC1 inhibition in ameliorating aging-related diseases such as neurodegenerative diseases, and look forward to expanding our pipeline with the initiation of a Phase 2a trial in Parkinson’s disease by the end of the first quarter of 2019.”

 

Recent Highlights and Outlook

 

Additional Positive Results from Phase 2b Trial Support Planned Pivotal Phase 3 Program in RTIs: In October 2018, resTORbio announced additional positive results from its dose-ranging Phase 2b trial of RTB101 in RTIs. The results supported and expanded upon topline results from the Phase 2b trial previously announced in July 2018, in which RTB101 10 mg QD demonstrated a statistically significant 30.6% reduction in the percentage of patients with laboratory-confirmed RTIs during the 16-week treatment period compared to placebo (p=0.025).

 

During the 16-week treatment period, RTB101 10 mg QD decreased the severity of laboratory-confirmed RTI symptoms compared to placebo, with a 52.1% reduction in the percentage of patients with severe laboratory-confirmed RTI symptoms (odds ratio (OR)=0.437; p=0.034). During the 16-week treatment period and the additional 8-week follow-up period off study drug (for a total of 24 weeks), RTB101 10 mg QD decreased the incidence of laboratory-confirmed RTIs compared to placebo, with a 27.5% reduction in the percentage of patients with laboratory-confirmed RTIs (OR=0.623; p=0.030).

 

Detailed results from this Phase 2b trial will be submitted for presentation at upcoming medical meetings, and the Company plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019.

 

Pre-specified Analyses from Phase 2b Trial Demonstrate Potential of RTB101 in Other Infections: The Phase 2b trial results reported in October 2018 also demonstrated from pre-specified analyses that treatment with RTB101 decreased the incidence of all infections and UTIs. RTB101 10 mg QD decreased the incidence of all infections during the 16-week treatment period compared to placebo, with a 23.6% reduction in the percentage of patients with any infection (OR=0.653; p=0.032). RTB101 10 mg twice daily decreased the incidence of UTIs during the 16-week treatment period compared to placebo, with a 74.6% reduction in the percentage of patients with one or more UTIs (OR= 0.211; p=0.027). The Company is developing its clinical strategy for RTB101 in UTIs, including dose selection.

 

Initiation of Phase 2 Trial in Parkinson’s Disease Expected by the End of the First Quarter of 2019: Selective and broad inhibition of TORC1 has been shown to extend lifespan and ameliorate several aging-related diseases in preclinical studies, including neurodegenerative disease. TORC1 inhibition with RTB101, in combination with rapalogs, such as sirolimus or everolimus, may induce autophagy, the process by which cells break down and recycle damaged aggregated proteins and cellular components. As neurodegenerative diseases such as Parkinson’s disease are associated with the accumulation of aggregated toxic proteins, the induction of autophagy with RTB101 in combination with rapalogs may have potential therapeutic benefit for patients with Parkinson’s disease. The Company plans to initiate a Phase 2a trial in patients with Parkinson’s disease by the end of the first quarter of 2019.

 


The following information was filed by Restorbio, Inc. (TORC) on Tuesday, November 13, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Accrued Liabilities
Accrued Liabilities (Tables)
Accrued Liabilities - Summary Of Accrued Liabilities (Details)
Commitment And Contingencies - Additional Information (Details)
Commitments And Contingences
License Agreements
License Agreements - Additional Information (Details)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Additional Information (Details)
Marketable Securities - Schedule Of Fair Value And Amortized Cost Of Company's Available-For-Sale Securities By Contractual Maturity (Details)
Marketable Securities - Schedule Of Fair Value Marketable Securities By Type Of Security (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Schedule Of Potentially Dilutive Securities Excluded From Computation Of Diluted Net Loss Per Share (Details)
Organization
Organization - Additional Information (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Details)
Property And Equipment, Net - Summary Of Property And Equipment, Net (Details)
Redeemable Convertible Preferred Stock And Common Stock
Redeemable Convertible Preferred Stock And Common Stock (Tables)
Redeemable Convertible Preferred Stock And Common Stock - Additional Information (Details)
Redeemable Convertible Preferred Stock And Common Stock -Schedule Of Number Of Shares Of Common Stock Reserved For Future Issuance (Details)
Related Party Transactions
Related Party Transactions - Additional Information (Details)
Research Funding Agreement - Additional Information (Details)
Research Funding Agreements
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Assumptions To Estimate Fair Value Of Stock Options For Employees And Non-Employees Using Black-Scholes Option Pricing Model (Details)
Stock-Based Compensation - Summary Of Restricted Stock Activity (Details)
Stock-Based Compensation - Summary Of Restricted Stock Units Activity (Details)
Stock-Based Compensation - Summary Of Stock Option Activity (Details)
Stock-Based Compensation - Summary Of Stock Option Activity (Parenthetical) (Details)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Estimated Useful Lives Of Property And Equipment (Details)
Summary Of Significant Accounting Policies - Summary Of Assets Measured At Fair Value On Recurring Basis (Details)

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Restorbio, Inc. provided additional information to their SEC Filing as exhibits

Ticker: TORC
CIK: 1720580
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-18-029327
Submitted to the SEC: Tue Nov 13 2018 4:32:01 PM EST
Accepted by the SEC: Tue Nov 13 2018
Period: Sunday, September 30, 2018
Industry: Pharmaceutical Preparations

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