resTORbio Reports Second Quarter 2018 Financial Results
Phase 2b results identify dose and patient population for pivotal program with RTB101
Initiation of pivotal program with RTB101 expected in the first half of 2019
“We have made great strides in advancing RTB101, our TORC1 inhibitor, for enhancing immune function and reducing the incidence of respiratory tract infections (RTIs),” said
Recent Highlights and Outlook
Positive Topline Results from Phase 2b Trial: In
Analyses of Phase 2b Study to Inform Trials in Additional Aging-Related Diseases: The Company intends to leverage learnings from its Phase 2b clinical trial, together with preclinical data, to further develop RTB101 for the treatment of additional aging-related indications where TORC1 inhibition may have therapeutic benefit. Additional data from the Phase 2b clinical trial on the incidence of urinary tract infections and a potential efficacy signal for heart failure based on echocardiograms are expected in the second half of 2018.
Initiation of Phase 2 Trial in Parkinson’s Disease Expected by the First Quarter 2019: Selective and broad inhibition of TORC1 has been shown to extend lifespan and ameliorate several aging-related diseases in preclinical studies, including neurodegenerative diseases. Neurodegenerative diseases, including Parkinson’s disease, are associated with accumulation of aggregated proteins that may contribute to neuronal death. Inhibition of TORC1 with RTB101 in combination with rapalogs, such as everolimus or sirolimus, induces autophagy, the process in which a cell breaks down and recycles damaged aggregated proteins and cellular components. Therefore, 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 proof-of-concept trial in patients with Parkinson’s disease by the first quarter 2019.
Positive Phase 2a Results Published in Science Translational Medicine: Data from resTORbio’s Phase 2a clinical trial of RTB101 alone and in combination with everolimus were published in the journal Science Translational Medicine in
June 2018, resTORbio announced the appointment of Kerry Russell, M.D., Ph.D., as Vice President of Clinical Development.
May 2018, resTORbio hosted a key opinion leader symposium on the potential of TORC1 inhibition to treat multiple aging-related diseases, as well as the unmet medical need for reducing the incidence of respiratory tract infections.
Second Quarter 2018 Financial Results
- R&D Expenses: R&D expenses were
$11.8 millionfor the three months ended June 30, 2018compared to $3.4 millionfor the three months ended June 30, 2017. The increase was primarily attributable to the Company’s Phase 2b study.
- G&A Expenses: General and administrative expenses were
$2.3 millionfor the three months ended June 30, 2018compared to $0.6 millionfor the three months ended June 30, 2017. The increase was primarily attributable 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
$13.6 million, or $0.48per share, for the three months ended June 30, 2018compared to a net loss of $4.1 million, or $0.94per share, for the three months ended June 30, 2017.
- Cash Position: Cash, cash equivalents and marketable securities were
$125.9 millionas of June 30, 2018. The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2018will be sufficient to fund its operating expenses through 2020.
resTORbio, Inc. is a clinical stage biopharmaceutical company targeting TORC1 and other biological pathways that regulate aging to develop innovative medicines with the potential to extend healthy lifespan. resTORbio’s lead program is selectively targeting TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiovascular and central nervous systems.
Forward Looking Statements:
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. 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 plans to develop and commercialize RTB101 alone or in combination with everolimus, 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 alone or in combination with everolimus, including the timing of the initiation and anticipated results of these trials, the intended regulatory path for our product candidates and interactions with regulatory authorities, and our cash position and expected runway, constitute forward-looking statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions. 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: the delay of any planned clinical trials and/or development of RTB101, either alone or in combination with everolimus; 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; 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
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|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||11,845||$||3,420||$||19,951||$||6,714|
|General and administrative||2,268||637||4,362||700|
|Total operating expenses||14,113||4,057||24,313||7,414|
|Loss from operations||(14,113||)||(4,057||)||(24,313||)||(7,414||)|
|Other income, net||522||—||863||—|
|Net loss per share —basic and diluted||$||(0.48||)||$||(0.94||)||$||(0.95||)||$||(2.09||)|
|Weighted-average number of common shares used
in net loss per share —basic and diluted
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||125,923||$||53,349|
|Prepaid expenses and other current assets||2,449||876|
|Deferred offering costs||—||929|
|Total current assets||128,372||55,154|
|Property and equipment, net||324||39|
|Liabilities, redeemable convertible preferred stock and stockholders'
|Total current liabilities||11,591||5,502|
|Redeemable convertible preferred stock||—||81,620|
|Stockholders' equity (deficit):|
|Additional paid-in capital||174,420||1,849|
|Accumulated other comprehensive loss||(30||)||—|
|Total stockholders' equity (deficit)||117,164||(31,929||)|
|Total liabilities, redeemable convertible preferred stock and stockholders'