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Restorbio, Inc. (TORC) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Restorbio, Inc.

CIK: 1720580 Ticker: TORC

Exhibit 99.1

resTORbio Reports Third Quarter 2019 Financial Results and Corporate Update

 

Top-line data from PROTECTOR 1 study expected by early first quarter of 2020

 

RTB101 Phase 2b data demonstrating upregulation of innate antiviral immunity presented at IDWeek 2019

 

BOSTON, Massachusetts, November 5, 2019

 – resTORbio, Inc. (Nasdaq: TORC), a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2019.

 

“We made significant progress advancing our clinical programs during the third quarter of 2019. In July, we completed patient recruitment in our Phase 3 PROTECTOR 1 study, the first of two studies in the pivotal PROTECTOR program of our lead candidate RTB101 for improving immune function and reducing the incidence of clinically symptomatic respiratory illness in older adults. Furthermore, we recently presented encouraging data from our Phase 2b trial of RTB101 at IDWeek 2019 showcasing its ability to upregulate anti-viral immunity in older adults and thereby reduce the incidence of illness associated with respiratory tract infections,” said Chen Schor, Co-Founder, President and CEO of resTORbio. “Additionally, our Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson’s disease is on track to report data next year. We look forward to continuing our efforts to address aging-related diseases.”

 

Recent Corporate Highlights

 

Data from PROTECTOR 1 Trial in Clinically Symptomatic Respiratory Illness Expected by Early First Quarter of 2020: Following early completion of enrollment of 1,024 subjects in PROTECTOR 1 trial, the Company expects to report top-line data by early first quarter of 2020. The PROTECTOR 2 trial, resTORbio’s second Phase 3 clinical trial, is planned to begin in the fourth quarter of 2019, with top-line data from the trial expected in mid-2020.

 

The PROTECTOR Phase 3 program includes two randomized, double-blind, placebo-controlled clinical trials that will evaluate the safety and efficacy of RTB101 10mg given once daily for 16 weeks during winter cold and flu season to subjects 65 years of age and older, excluding current smokers and individuals with chronic obstructive pulmonary disease. The primary endpoint of both trials is the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection, or RTI, based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.

 

Presented Phase 2b Data on RTB101 in Late Breaking Session at IDWeek 2019: In October 2019, resTORbio presented additional data from its randomized, double-blind, placebo-controlled Phase 2b trial of RTB101 for reducing the incidence of RTIs at the Infectious Disease Society of America’s IDWeek. The data highlighted RTB101’s potential to reduce the incidence of RTIs caused by multiple different viruses via upregulation of pan-antiviral immunity. In addition, in post-hoc analyses, RTB101 10mg once daily was observed to reduce the time to alleviation of moderate to severe RTI symptoms by an average of five days as compared to placebo (p=0.025) and to reduce the rate of all-cause hospitalization by 56% (p=0.047). Overall, RTB101 was well-tolerated with adverse events balanced between the RTB101 10mg once daily and placebo treatment arms.  

 

Phase 1b/2a Trial in Parkinson’s Disease (PD) is Progressing with Data Expected in 2020: Preclinical studies suggest that inhibition of TORC1 may be of potential therapeutic benefit in a number of aging-related neurodegenerative diseases such as PD by stimulating the clearance of misfolded protein aggregates that cause neuronal toxicity. resTORbio’s multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a trial is evaluating the safety and tolerability of RTB101 alone or in combination with sirolimus in patients with mild to moderate PD who are already on standard-of-care therapy, including those with and without glucocerebrosidase mutations. The Company expects data from this trial in 2020.


The following information was filed by Restorbio, Inc. (TORC) on Tuesday, November 5, 2019 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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Document And Entity Information
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statement Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit)
Condensed Consolidated Statement Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit) (Parenthetical)
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
Commitments And Contingences (Tables)
Commitments And Contingencies - Commitment And Contingencies - Summary Of Obligations Future Minimum Lease Payments (Details)
License Agreements
License Agreements - Additional Information (Details)
Marketable Securities
Marketable Securities (Tables)
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)
Preferred Stock And Common Stock
Preferred Stock And Common Stock (Tables)
Preferred Stock And Common Stock - Additional Information (Details)
Preferred Stock And Common Stock -Schedule Of Number Of Shares Of Common Stock Reserved For Future Issuance (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)
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-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 - 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: 0001564590-19-040353
Submitted to the SEC: Tue Nov 05 2019 4:02:30 PM EST
Accepted by the SEC: Tue Nov 05 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations

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