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Restorbio, Inc. (TORC) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

Restorbio, Inc.

CIK: 1720580 Ticker: TORC

Exhibit 99.1

resTORbio Reports First Quarter 2019 Financial Results and Corporate Update

 

Initiated first Phase 3 trial, PROTECTOR 1, of RTB101 in clinically symptomatic respiratory illness; top-line data from two pivotal Phase 3 trials expected in mid-2020

 

Initiated Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson’s disease (PD)

 

Completed $50 million public offering

 

BOSTON, Massachusetts, May 15, 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 first quarter ended March 31, 2019.

 

“Our recent clinical accomplishments represent significant progress towards our goal of developing novel therapies that target key aging pathways to treat a range of aging-related diseases,” said Chen Schor, Co-Founder, President and CEO of resTORbio. “The initiation of PROTECTOR 1 and our Phase 1b/2a trial in PD bring us closer to understanding how TORC1 inhibition may improve the function of several organ systems, including improving immune and neurologic function. Our successful follow-on offering provides us with the financial strength to rapidly enroll patients in these trials and prepare to initiate PROTECTOR 2 in the fourth quarter of this year, with the goal of advancing RTB101 toward a potential New Drug Application (NDA) submission. We also remain focused on progressing our discovery efforts to develop additional TORC1 inhibitors as well as clinical candidates targeting other aging pathways.”

 

Recent Highlights and Outlook

 

Initiation of Phase 3 Program in Clinical Symptomatic Respiratory Illness: In March 2019, following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), resTORbio announced the design of its Phase 3 PROTECTOR program for RTB101 10mg once daily in clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection (RTI) based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen. resTORbio’s PROTECTOR program consists of two randomized, double-blinded, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of RTB101 10mg once daily versus placebo for 16 weeks in patients 65 years of age or older, excluding current smokers and patients with chronic obstructive pulmonary disease. The primary endpoint of both Phase 3 trials is the reduction in the percentage of elderly subjects with clinically symptomatic respiratory illness.

 

In May 2019, resTORbio announced the initiation of PROTECTOR 1, its first Phase 3 clinical trial. The Company expects to initiate PROTECTOR 2, its second Phase 3 clinical trial, in the fourth quarter of 2019, with top-line data from both trials expected in mid-2020.

 

Initiation of Phase 1b/2a Trial in PD: In April 2019, resTORbio initiated a Phase 1b/2a trial in patients with PD. The multicenter, randomized, patient and investigator blinded, placebo-controlled Phase 1b/2a trial is evaluating the safety and tolerability of RTB101 alone or in combination with sirolimus when given once weekly for 4 weeks to patients with mild to moderate PD who are already on standard-of-care therapy, including those with and without glucocerebrosidase mutations. Secondary endpoints include exposure in blood, plasma and cerebrospinal fluid (CSF), and exploratory endpoints include biomarkers in plasma and CSF, and various clinical assessments. The Company expects data from this trial in 2020.

 

Research Grant from the National Institutes of Health (NIH) to Study TORC1 inhibition and Antiviral Immunity: In May 2019, resTORbio was awarded a 5-year grant for up to $1.5 million from the NIH to study RTB101 and the regulation of antiviral immunity in the elderly.

 

Appointment of Lloyd Klickstein, M.D., Ph.D., as Chief Scientific Officer Bolsters Ongoing Drug Discovery Efforts: Dr. Klickstein brings to resTORbio a strong background in drug discovery and development for new clinical indications with high unmet medical need. resTORbio is growing its pipeline of programs targeting multiple mechanisms underlying the biology of aging, including additional TORC1 inhibitors and candidates targeting other biochemical pathways underlying the biology of aging.

 

Corporate Updates

 

 

In May 2019, resTORbio appointed Lloyd Klickstein, M.D., Ph.D., as Chief Scientific Officer.

 

In March 2019, resTORbio closed an underwritten public offering of 7.2 million shares of its common stock at a public offering price of $6.95 per share, for gross proceeds of approximately $50.0 million.


The following information was filed by Restorbio, Inc. (TORC) on Wednesday, May 15, 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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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)
Condensed Consolidated Statements Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit)
Condensed Consolidated Statements Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit) (Parenthetical)
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 - 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 Option Activity (Parenthetical) (Details)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense (Details)
Subsequent Event
Subsequent Event - Additional Information (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)
Ticker: TORC
CIK: 1720580
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-019433
Submitted to the SEC: Wed May 15 2019 4:31:35 PM EST
Accepted by the SEC: Wed May 15 2019
Period: Sunday, March 31, 2019
Industry: Pharmaceutical Preparations

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