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.
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, Cash Equivalents and Marketable
Securities: Cash, cash equivalents and marketable
securities were $143.1 million as of March 31, 2019 compared to
$108.0 million as 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.
About resTORbio
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 National Institutes of Health and its
potential contributions to our current and future clinical trials;
our cash position and expected cash runway, our expectations
regarding our uses of capital, expenses, future accumulated deficit
and other first quarter 2019 financial results, and our ability to
fund operations through 2020, 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: 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.
|
RESTORBIO, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(unaudited) |
(in thousands, except per share data) |
|
|
|
Three Months Ended
March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Operating expenses: |
|
|
|
|
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 |
|
$ |
(11,069 |
) |
|
$ |
(9,859 |
) |
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 |
|
|
|
|
|
|
|
RESTORBIO, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
7,181 |
|
|
$ |
7,042 |
|
Marketable securities |
|
|
135,910 |
|
|
|
100,986 |
|
Prepaid expenses and other
current assets |
|
|
1,587 |
|
|
|
1,506 |
|
Total current assets |
|
|
144,678 |
|
|
|
109,534 |
|
Restricted cash |
|
|
84 |
|
|
|
84 |
|
Property and equipment,
net |
|
|
318 |
|
|
|
321 |
|
|
|
|
|
|
Total assets |
|
$ |
145,080 |
|
|
$ |
109,939 |
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,364 |
|
|
$ |
2,989 |
|
Accrued liabilities |
|
|
1,245 |
|
|
|
2,727 |
|
Total current liabilities |
|
|
4,609 |
|
|
|
5,716 |
|
Other liabilities |
|
|
15 |
|
|
|
19 |
|
Total liabilities |
|
|
4,624 |
|
|
|
5,735 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
4 |
|
|
|
3 |
|
Additional paid-in
capital |
|
|
222,882 |
|
|
|
175,635 |
|
Accumulated deficit |
|
|
(82,462 |
) |
|
|
(71,393 |
) |
Accumulated other
comprehensive gain (loss) |
|
|
32 |
|
|
|
(41 |
) |
Total stockholders'
equity |
|
|
140,456 |
|
|
|
104,204 |
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
|
$ |
145,080 |
|
|
$ |
109,939 |
|
|
|
|
|
|
Investor Contact Michael SchaffzinStern
Investor Relations,
Inc.212-362-1200michael.schaffzin@sternir.com
Media ContactAmir KhanBiosector
2212-462-8767Amir.Khan@Syneoshealth.com
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