Last10K.com

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

Restorbio, Inc.

CIK: 1720580 Ticker: TORC

Exhibit 99.1

resTORbio Reports Second Quarter 2019 Financial Results and Corporate Update

 

– Quarter highlighted by initiation and early completion of enrollment of Phase 3 PROTECTOR 1 trial; topline data expected by early first quarter of 2020 –

BOSTON, MA, August 14, 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 reported financial results for the second quarter ended June 30, 2019 and provided a corporate update.

“We believe our significant clinical progress year-to-date positions us well for the second half of 2019 and into 2020,” said Chen Schor, co-founder, president and CEO of resTORbio. “The interest from patients and investigators in our PROTECTOR 1 trial combined with the focused execution by our highly experienced team, enabled us to complete enrollment ahead of previously disclosed clinical timelines. We now expect topline data from this study by early first quarter of 2020. PROTECTOR 2 is planned to begin in the fourth quarter of this year, in conjunction with the cold and flu season in the northern hemisphere. We continue to move quickly to develop RTB101 as the first potential medicine to enhance immune function and thereby reduce the incidence of illness associated with respiratory tract infections. In parallel, our Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson’s disease continues to enroll patients. Beyond our clinical efforts, we continue to generate data that we believe further support the mechanism of action of RTB101. We are also leveraging our deep understanding of aging biology and TORC1 to evaluate new potential product candidates.”

 

Second Quarter and Recent Highlights and Outlook

 

RTB101 Phase 3 PROTECTOR Program in Clinically Symptomatic Respiratory Illness Advancing Ahead of Previously Disclosed Clinical Timelines: During the second quarter, resTORbio initiated a global Phase 3 PROTECTOR program in adults 65 years of age and older, excluding current smokers and chronic pulmonary disease (COPD) patients. The program consists of two randomized, double-blind, placebo-controlled clinical trials to evaluate the safety and efficacy of RTB101 10 mg given orally once daily for 16 weeks during winter cold and flu season. The primary endpoint of both trials is the reduction in the percentage of patients with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection (RTI) based on prespecified diagnostic criteria.

 

In July 2019, the company announced early completion of enrollment of 1,024 patients in PROTECTOR 1, its first Phase 3 trial of RTB101 in clinically symptomatic respiratory illness. Topline data from PROTECTOR 1 is now anticipated by early first quarter of 2020. PROTECTOR 2, the second Phase 3 trial, is planned to begin in the fourth quarter of 2019, with topline data expected in mid-2020.

 

Additional Phase 2b Proof-of-Concept Data for RTB101 Presented at the American Thoracic Society (ATS) International Conference: In a press release dated May 20, 2019, resTORbio announced presentation of additional data at ATS from a prespecified analysis of its Phase 2b trial of RTB101 in patients 65 years of age and older with asthma. RTIs are one of the most common causes of asthma exacerbations, and the majority of RTIs are caused by many different types of viruses, most of which lack current treatments. Among Phase 2b participants 65 years of age and older with asthma, RTB101 10 mg once daily was observed to reduce the rate of laboratory-confirmed RTIs by 78.7% (p=0.001) and the rate of all RTIs (with or without laboratory confirmation) by 66.4% (p=0.003) as compared to placebo. RTB101 10 mg once daily was also observed to reduce the incidence of RTIs caused by multiple different viruses, including rhinovirus, the most common viral cause of asthma exacerbations.

 

Phase 1b/2a Dose Escalation Trial in Parkinson’s Disease (PD) Ongoing, with Data Expected in 2020: Inhibition of TORC1 has been shown to extend lifespan and ameliorate a number of aging-related diseases across multiple preclinical species, including preclinical models of neurodegenerative diseases such as PD.

 

In April 2019, resTORbio initiated a Phase 1b/2a trial in patients with PD. The multicenter, randomized, double-blind, placebo-controlled trial is evaluating the safety and tolerability of RTB101 alone or in combination with


The following information was filed by Restorbio, Inc. (TORC) on Wednesday, August 14, 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.

View differences made from one quarter to another to evaluate Restorbio, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Restorbio, Inc..

Continue

Assess how Restorbio, Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Restorbio, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

Continue

Tools

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

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)
Subsequent Event - Additional Information (Details)
Subsequent Events
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)

Material Contracts, Statements, Certifications & more

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

Ticker: TORC
CIK: 1720580
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-032151
Submitted to the SEC: Wed Aug 14 2019 4:32:29 PM EST
Accepted by the SEC: Wed Aug 14 2019
Period: Sunday, June 30, 2019
Industry: Pharmaceutical Preparations

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/torc/0001564590-19-032151.htm