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, 2020.
“Following our extensive review of strategic alternatives, we
are pleased about the recently reported merger agreement between
resTORbio and Adicet Bio. The combined company will focus on the
development of Adicet’s off-the-shelf allogeneic gamma delta T cell
therapies for oncology and other indications,” commented Chen
Schor, Co-Founder, President and CEO of resTORbio. “We look forward
to completing the merger in the second half of 2020 and continuing
to work diligently with the Adicet Bio management team to achieve
that objective.”
Recent Corporate Highlights Announced
merger agreement with Adicet Bio, Inc. (“Adicet”) to advance
allogeneic gamma delta CAR-T cell therapy In April,
resTORbio, Inc. (“resTORbio”) entered into a definitive merger
agreement under which Adicet would merge with a wholly-owned
subsidiary of resTORbio in an all-stock transaction. Under the
terms of the agreement, the Adicet stockholders will become the
majority owners of resTORbio’s outstanding common stock upon the
close of the merger. Certain of resTORbio’s stockholders who
collectively own approximately 24% of the outstanding shares of
resTORbio’s common stock have entered into voting agreements,
pursuant to which they have agreed, among other things, and subject
to the terms and conditions of the agreements, to vote in favor of
the merger agreement. The proposed merger will create a combined,
publicly traded biotechnology company operating under the name,
“Adicet Bio, Inc.” The combined company will focus on the
development of off-the-shelf allogeneic gamma delta T cell
therapies focused on oncology and other indications. Adicet’s lead
product candidate, ADI-001, is a gamma delta CAR-T cell therapy
targeting CD20 antigens and is being developed for non-Hodgkin’s
lymphoma. Adicet has a strong pipeline of pre-clinical and
discovery programs based on its allogeneic gamma delta CAR-T cell
platform.
The merger agreement also contemplates a contingent value right
agreement (“CVR Agreement”) between resTORbio, a holders’
representative and rights’ representative, pursuant to which each
holder of resTORbio common stock would be entitled to one
contractual contingent value right (“CVR Right”) issued by
resTORbio, subject to the CVR Agreement, for each share of
resTORbio common stock held by such holder. A CVR Right will
entitle the holder to receive net proceeds of the
commercialization, if any, received from a third party commercial
partner of RTB101.
Announced termination of fifth cohort in Phase 1b/2a
Trial of RTB101 in Parkinson’s disease due to COVID-19 level 4
alert in New ZealandTo ensure safety of the clinical trial
participants and the study coordinators, resTORbio has decided to
terminate the study and not to enroll the fifth cohort due to the
COVID-19 level 4 alert in New Zealand, where all non-essential
services have been closed and people have been instructed to stay
home. Enrollment of four of the five planned once-weekly dosing
arms of RTB101 300 mg, sirolimus 2 mg, RTB101 300 mg in combination
with sirolimus 2 mg, and RTB101 300 mg in combination with
sirolimus 4 mg has been completed. resTORbio plans to analyze the
data from the four completed dosing arms and data from the four
completed cohorts is expected by mid-2020.
First Quarter 2020 Financial Results
- R&D Expenses: Research and
development (R&D) expenses were $4.8 million for the
three months ended March 31, 2020 compared to $8.9
million for the three months ended March 31, 2019. The
decrease was primarily due to the reduction in the number of
ongoing clinical trials.
- G&A Expenses: General and
administrative (G&A) expenses were $2.5 million for
the three months ended March 31, 2020 compared
to $2.8 million for the three months ended March 31,
2019. The decrease was primarily due to a decrease in
headcount partially offset by higher facilities-related
expenses.
- Net Loss: Net loss was $7.0 million,
or $0.19 per share, for the three months ended March
31, 2020 compared to a net loss of $11.1 million,
or $0.38 per share, for the three months ended March
31, 2019.
- Cash, Cash Equivalents and Marketable
Securities: Cash, cash equivalents and marketable
securities were $76.3 million as of March 31, 2020 compared to
$91.5 million as of December 31, 2019.
About RTB101 RTB101 is an oral, selective, and
potent TORC1 inhibitor product candidate that inhibits the
phosphorylation of multiple targets downstream of TORC1. Inhibition
of TORC1 has been observed to extend lifespan and healthspan in
aging preclinical species and to improve the function of aging
organ systems, suggesting potential benefits in several
aging-related diseases.
About resTORbio resTORbio, Inc. is a
clinical-stage biopharmaceutical company developing innovative
medicines that target the biology of aging to treat aging-related
diseases. resTORbio’s lead program selectively inhibits TORC1, an
evolutionarily conserved pathway that contributes to the decline in
function of aging organ systems. Learn more about resTORbio, Inc.
at www.resTORbio.com.
resTORbio Forward Looking
Statements This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements
regarding: the proposed merger agreement with Adicet and the
structure, expected timing and completion of the proposed merger,
future product development plans and projected timelines for the
initiation and completion of preclinical and clinical trials; the
potential for the results of ongoing preclinical or clinical trials
and the efficacy of either our or Adicet’s product candidates; the
combined company’s future financial performance, results of
operations or sufficiency of capital resources to fund operating
requirements; expectations of the potential impact of COVID-19 on
strategy, future operations, and the timing of clinical trials and
timing related to Adicet’s future clinical trials; the safety,
efficacy and regulatory, and clinical progress of our product
candidates, including RTB101 alone or in combination with
sirolimus; our expectations around the timing of our data
announcement from the four completed cohorts; our ability to
replicate results achieved in our clinical trials in any future
trials; financial plans and projections; our expectations regarding
our uses of capital, expenses, future accumulated deficit and other
first quarter 2020 financial results; and the potential payment of
proceeds pursuant to the CVR Agreement. 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
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,
including the timing of the initiation and anticipated results of
these trials, our ability to replicate results achieved in our
clinical trials in any future trials, the timing of the closure of
the merger transaction with Adicet and our ability to maximize any
benefits in connection with such merger constitute forward-looking
statements. The use of words such as, but not limited to,
“believe,” “expect,” “estimate,” “project,” “intend,” “future,”
“potential,” “continue,” “may,” “might,” “plan,” “will,” “should,”
“seek,” “anticipate,” or “could” and other similar words or
expressions are intended to identify forward-looking
statements. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, our clinical
results and other future conditions. New risks and uncertainties
may emerge from time to time, and it is not possible to predict all
risks and uncertainties. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Such forward-looking statements are subject to a number of
material risks and uncertainties including but not limited to: (i)
risks associated with resTORbio’s ability to obtain the stockholder
approval required to consummate the proposed merger transaction and
the timing of the closing of the proposed merger transaction,
including the risks that a condition to closing would not be
satisfied within the expected timeframe or at all or that the
closing of the proposed merger transaction will not occur; (ii) the
outcome of any legal proceedings that may be instituted against the
parties and others related to the merger agreement; (iii)
unanticipated difficulties or expenditures relating to the proposed
merger transaction, the response of business partners and
competitors to the announcement of the proposed merger transaction,
and/or potential difficulties in employee retention as a result of
the announcement and pendency of the proposed merger transaction;
(iv) the length of time necessary to consummate the proposed
transaction may be longer than anticipated; (v) resTORbio’s
continued listing on the Nasdaq Global Market until closing of the
proposed merger transaction; (vi) the combined company’s listing on
the Nasdaq Global Market after closing of the proposed merger
transaction; (vii) the adequacy of the combined company’s capital
to support its future operations and its ability to successfully
initiate and complete clinical trials; (viii) the nature, strategy
and focus of the combined company; (ix) the difficulty in
predicting the time and cost of development of resTORbio’s product
candidates; (x) the executive management and board structure of the
combined company; (xi) the risk that any potential payment of
proceeds pursuant to the CVR Agreement may not be distributed at
all or result in any value to resTORbio’s stockholders; and (xii)
those risks detailed in resTORbio’s most recent Annual Report on
Form 10-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the SEC. Any forward-looking statement
speaks only as of the date on which it was made. Neither we, nor
our affiliates, advisors or representatives, undertake any
obligation to publicly update or revise any forward-looking
statement, whether as result of new information, future events or
otherwise, except as required by law.
|
RESTORBIO, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(unaudited) |
(in thousands, except per share data) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
4,841 |
|
|
$ |
8,852 |
|
General and administrative |
|
|
2,539 |
|
|
|
2,839 |
|
Total operating expenses |
|
|
7,380 |
|
|
|
11,691 |
|
Loss from operations |
|
|
(7,380 |
) |
|
|
(11,691 |
) |
Other income, net |
|
|
349 |
|
|
|
631 |
|
Loss before income taxes |
|
|
(7,031 |
) |
|
|
(11,060 |
) |
Income tax expense |
|
|
7 |
|
|
|
9 |
|
Net loss |
|
$ |
(7,038 |
) |
|
$ |
(11,069 |
) |
Net loss per share —basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.38 |
) |
Weighted-average number of common shares used in net loss per share
—basic and diluted |
|
|
36,445 |
|
|
|
29,015 |
|
|
|
|
|
|
|
RESTORBIO, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
76,343 |
|
|
$ |
91,473 |
|
Prepaid expenses and other current assets |
|
|
1,238 |
|
|
|
1,780 |
|
Total current assets |
|
|
77,581 |
|
|
|
93,253 |
|
Restricted cash |
|
|
245 |
|
|
|
245 |
|
Property and equipment, net |
|
|
380 |
|
|
|
414 |
|
Total assets |
|
$ |
78,206 |
|
|
$ |
93,912 |
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,210 |
|
|
$ |
6,716 |
|
Accrued liabilities |
|
|
1,355 |
|
|
|
5,483 |
|
Total current liabilities |
|
|
2,565 |
|
|
|
12,199 |
|
Other liabilities |
|
|
24 |
|
|
|
15 |
|
Total liabilities |
|
|
2,589 |
|
|
|
12,214 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
236,751 |
|
|
|
235,777 |
|
Accumulated deficit |
|
|
(161,170 |
) |
|
|
(154,132 |
) |
Accumulated other comprehensive income |
|
|
32 |
|
|
|
49 |
|
Total stockholders' equity |
|
|
75,617 |
|
|
|
81,698 |
|
Total liabilities and stockholders' equity |
|
$ |
78,206 |
|
|
$ |
93,912 |
|
|
|
|
|
|
Investor ContactJanhavi MohiteStern Investor
Relations, Inc.212-362-1200janhavi.mohite@sternir.com
Media ContactLauren
ArnoldMacDougall617-694-5387larnold@macbiocom.com
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