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)
“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
Recent Highlights and Outlook
Initiation of Phase 3 Program in Clinical Symptomatic Respiratory Illness: In
Initiation of Phase 1b/2a Trial in PD: In
Research Grant from the
May 2019, resTORbio appointed Lloyd Klickstein, M.D., Ph.D., as Chief Scientific Officer.
March 2019, resTORbio closed an underwritten public offering of 7.2 million shares of its common stock at a public offering price of $6.95per share, for gross proceeds of approximately $50.0 million.
First Quarter 2019 Financial Results
- R&D Expenses: Research and development (R&D) expenses were $8.9 million for the three months ended March 31, 2019 compared to $8.1 million for the three months ended March 31, 2018. The increase was primarily due to the initiation of the Phase 1b/2a for Parkinson’s disease and preparation for the Phase 3 clinical program for clinical symptomatic respiratory illness.
- G&A Expenses: General and administrative (G&A) expenses were $2.8 million for the three months ended March 31, 2019 compared to $2.1 million for the three months ended March 31, 2018. The increase was primarily due to an increase in headcount as well as increased operating costs as a result of the Company’s transition from a private company to a public company, including legal, accounting, insurance and investor relations expenses.
- Net Loss: Net loss was $11.1 million, or $0.38 per share, for the three months ended March 31, 2019 compared to a net loss of $9.9 million, or $0.46 per share, for the three months ended March 31, 2018.
Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $143.1 millionas of March 31, 2019compared to $108.0 millionas of December 31, 2018. The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2019 will be sufficient to fund its operating expenses through 2020.
resTORbio, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases. resTORbio’s lead program selectively inhibits TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiovascular and central nervous systems. Learn more about resTORbio, Inc. at https://www.restorbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 growth as a company and the anticipated contribution of our executives to our operations and progress, our ability to expand our drug discovery capabilities to develop additional TORC1 inhibitors, the timing and anticipated results from our Phase 3 PROTECTOR program for RTB101, the timing and anticipated results of Phase 1b/2a clinical trial of RTB101 in combination with sirolimus in Parkinson’s disease, our plans to develop RTB101 alone or in combination with rapalogs, including the therapeutic potential and clinical benefits thereof and the potential patient populations that may be addressed by our product candidates, our ongoing and future clinical trials for RTB101 the intended regulatory path for our product candidates and interactions with regulatory authorities, our ability to replicate results achieved in our clinical trials in any future trials, our expected use of the research grant from the
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: our Phase 3 PROTECTOR program for RTB101, our Phase 1b/2a clinical trials of RTB101 either alone or in combination with a rapalog, such as everolimus or sirolimus; 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; uncertainties related to the results of our clinical trials predictive of future results in connection with future trials; the timing and outcome of our planned interactions with regulatory authorities; 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, Inc. with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our 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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended
|Research and development||$||8,852||$||8,106|
|General and administrative||2,839||2,094|
|Total operating expenses||11,691||10,200|
|Loss from operations||(11,691||)||(10,200||)|
|Other income, net||631||341|
|Loss before income taxes||(11,060||)||(9,859||)|
|Income tax expense||9||—|
|Net loss per share —basic and diluted||$||(0.38||)||$||(0.46||)|
|Weighted-average number of common shares used in net loss per share —basic and diluted||29,015||21,523|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||7,181||$||7,042|
|Prepaid expenses and other current assets||1,587||1,506|
|Total current assets||144,678||109,534|
|Property and equipment, net||318||321|
|Liabilities and stockholders' equity|
|Total current liabilities||4,609||5,716|
|Additional paid-in capital||222,882||175,635|
|Accumulated other comprehensive gain (loss)||32||(41||)|
|Total stockholders' equity||140,456||104,204|
|Total liabilities and stockholders' equity||$||145,080||$||109,939|
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