Translate Bio Announces First Quarter 2020 Financial Results and Provides Corporate Update
May 07 2020 - 4:26PM
Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company developing a new class of potentially
transformative medicines to treat diseases caused by protein or
gene dysfunction, today announced financial results for the first
quarter ended March 31, 2020 and reviewed recent corporate
achievements and updates.
“The need for novel therapies with the potential
to reach millions of people has never been more evident, and we are
committed to advancing our programs and platform during this
unprecedented time. We have kept critical areas of our business
moving forward while prioritizing the safety of our employees,”
said Ronald Renaud, chief executive officer of Translate Bio.
“We are humbled to be part of the global effort to develop a
vaccine against COVID-19 through our collaboration with Sanofi
Pasteur. Using our innovative mRNA platform and large-scale
manufacturing capacity, as well as Sanofi’s vaccine expertise, we
are working rapidly to achieve our goal of advancing a novel mRNA
vaccine to the clinic in the fourth quarter of this year.”
First Quarter 2020 and Recent
Updates
- Collaboration with Sanofi Pasteur to develop a novel
mRNA vaccine for COVID-19: Sanofi Pasteur
and Translate Bio announced a collaboration pursuing development of
a novel mRNA vaccine for COVID-19. This collaboration leverages the
original agreement from 2018 between the two companies to develop
up to five mRNA vaccines for infectious diseases. Multiple COVID-19
vaccine candidates are being evaluated in vivo for immunogenicity
and neutralizing antibody activity to support lead candidate
selection and the companies have the goal of initiating a
first-in-human clinical trial in the fourth quarter of 2020.
- Continued build-out of manufacturing capacity:
Build-out of dedicated manufacturing space through a contract
manufacturing partner is underway with the potential to accommodate
multiple 250-gram batches per month. Depending on the final human
COVID-19 vaccine dose and subject to continued investment and
third-party supplier arrangements, the Company estimates that it
could have manufacturing capacity to produce 90-360 million doses
annually by the first half of 2021.
- MRT5005 granted Rare Pediatric Disease (RPD)
designation: The U.S. Food and Drug Administration (FDA)
granted Rare Pediatric Disease (RPD) designation for MRT5005 for
the treatment of cystic fibrosis (CF). MRT5005, the first inhaled
mRNA therapeutic candidate, is designed to deliver mRNA encoding
fully functional cystic fibrosis transmembrane conductance
regulator (CFTR) protein to cells in the lung through nebulization.
- MRT5005 clinical trial interruptions due to COVID-19
pandemic response: The Company announced COVID-19
pandemic-related interruptions in enrollment and dosing in an
ongoing Phase 1/2 clinical trial of MRT5005 in patients with CF and
plans to provide updated timing on the expected interim data
readout of the additional single-ascending dose (SAD) group and the
multiple-ascending dose (MAD) portion of the clinical trial at a
later date.
- Continued focus on pulmonary programs: The
Company continued to advance its ongoing discovery efforts focused
on a next-generation CF program and additional pulmonary diseases,
including primary ciliary dyskinesia (PCD), idiopathic pulmonary
fibrosis (IPF) and pulmonary arterial hypertension (PAH). The
Company anticipates sharing more details throughout 2020.
Anticipated Milestones
- COVID-19 vaccine: advance development candidate to IND filing
with the goal of clinical trial initiation in Q4 2020 (Sanofi
Pasteur collaboration)
- Flu vaccine: advance development candidate to IND filing with
clinical trial initiation anticipated mid-year 2021 (Sanofi Pasteur
collaboration)
- MRT5005 (CF): report results from additional SAD dose group and
MAD portion of Phase 1/2 clinical trial
- Preclinical pulmonary programs: advance next-generation CF,
PCD, IPF and PAH programs toward selection of development
candidate
- Platform: identify next-generation lipid nanoparticles (LNPs)
to support liver, lung and additional disease program
development
Upcoming Events
- The Company will present and host one-on-one meetings at the
following virtual investment banking conferences:
- Bank of America Healthcare Conference 2020, May 12-15,
2020
- Jefferies Virtual Healthcare Conference, June 2-4, 2020
First Quarter 2020 Financial Results and
Financial Guidance
Translate Bio ended the first quarter of 2020
with $155.1 million in cash, cash equivalents and short-term
investments and 60,037,663 shares of common stock outstanding. The
Company expects that its existing cash, cash equivalents and
short-term investments, together with net proceeds of approximately
$36.6 million raised through common stock sales under its Open
Market Sale Agreement which settled subsequent to March 31, 2020,
will enable it to fund its operating expenses and capital
expenditure requirements into the third quarter of 2021.
Translate Bio reported a net loss of $14.3
million and $33.2 million for the three months ended March 31, 2020
and 2019, respectively.
Collaboration revenue was $4.7 million and $1.5
million for the three months ended March 31, 2020 and 2019,
respectively, which was derived from the collaboration with Sanofi.
The increase was related to increased activities for the vaccine
program in the three months March 31, 2020 compared to the same
period in 2019.
Operating expenses for the three months ended
March 31, 2020 were $19.4 million, compared to $35.7 million for
the same period in 2019, and were comprised of the following:
- Research and development expenses of $21.4 million during the
first quarter of 2020, compared to $17.4 million for the same
period in 2019. The increase is primarily due to continued
development of the Company’s discovery and vaccine programs as well
as an increase in personnel-related costs, partially offset by a
decrease in its MRT5201 program.
- General and administrative expenses of $7.5 million during the
first quarter of 2020, compared to $6.6 million for the same period
in 2019. The increase is primarily due to an increase in
personnel-related costs.
- Operating income of $9.5 million for change in the fair value
of contingent consideration related to future potential milestone
and earnout payment obligations. The operating income was
attributed to an decrease in the fair value of the contingent
consideration liability primarily due to an increase in the
discount rate, partially offset by an increase in the fair value
due to the continued progress of the MRT5005 program and the time
value of money due to the passage of time.
About Translate BioTranslate
Bio is a clinical-stage mRNA therapeutics company developing a new
class of potentially transformative medicines to treat diseases
caused by protein or gene dysfunction. Translate Bio is
primarily focused on applying its technology to treat pulmonary
diseases caused by insufficient protein production or where the
reduction of proteins can modify disease. Translate Bio’s
lead program is being developed as a treatment for cystic fibrosis
(CF) and is in a Phase 1/2 clinical trial. The Company also
believes its technology is applicable to a broad range of diseases,
including diseases that affect the liver. Additionally, the
platform may be applied to various classes of treatments, such as
therapeutic antibodies or vaccines in areas such as infectious
disease and oncology. For more information about the Company,
please visit www.translate.bio or on Twitter at @TranslateBio.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include, but are not limited to, those regarding:
the potential for MRT5005 to address the underlying cause of CF and
benefit patients; Translate Bio’s plans to update its timing to
report data from the additional SAD dose group and MAD portion of
the Phase 1/2 clinical trial of MRT5005; Translate Bio’s plans to
advance its pipeline of mRNA therapeutics and validate targets for
additional pulmonary diseases; Translate Bio’s expectations
with respect to its collaboration with Sanofi, including the
anticipated advancement towards an IND filing and initiating
clinical trials for a COVID-19 vaccine in Q4 2020 and the
anticipated IND filing for a flu vaccine in mid-year 2021;
Translate Bio’s plans to advance its preclinical pulmonary programs
and platform; the period in which Translate Bio expects
that its existing cash, cash equivalents and investments will
enable it to fund its operations; Translate Bio’s beliefs regarding
the broad applicability of its MRT platform; and Translate Bio’s
plans, strategies and prospects for its business, including its
lead development programs. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from current expectations
and beliefs, including but not limited to: the current and
potential future impacts of the COVID-19 pandemic on the Company’s
business, financial condition, operations and liquidity; Translate
Bio’s ability to advance the development of its platform and
programs under the timelines it projects, demonstrate the requisite
safety and efficacy of its product candidates and replicate in
clinical trials any positive findings from preclinical studies; the
successful advancement of the collaboration agreement between
Translate Bio and Sanofi; uncertainties relating to the discovery
and development of vaccine candidates based on mRNA, and
specifically as it relates to the novel coronavirus, COVID-19; the
content and timing of decisions made by the FDA, other
regulatory authorities and investigational review boards at
clinical trial sites, including decisions as it relates to ongoing
and planned clinical trials; Translate Bio’s ability to obtain,
maintain and enforce necessary patent and other intellectual
property protection; the availability of significant cash required
to fund operations; competitive factors; general economic and
market conditions and other important risk factors set forth under
the caption “Risk Factors” in Translate Bio’s Quarterly Report on
Form 10-Q for the quarterly period ended March 31, 2020 filed with
the Securities and Exchange Commission on May 7, 2020 and in any
other subsequent filings made by Translate Bio. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and Translate Bio specifically disclaims any
obligation to update any forward-looking statement, whether as a
result of new information, future events or otherwise.
|
|
|
|
|
TRANSLATE
BIO, INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
Collaboration revenue |
$ |
4,654 |
|
|
$ |
1,474 |
|
|
Operating
expenses: |
|
|
|
|
Research and development |
|
21,439 |
|
|
|
17,423 |
|
|
General and administrative |
|
7,458 |
|
|
|
6,554 |
|
|
Change in fair value of contingent consideration |
|
(9,452 |
) |
|
|
11,702 |
|
|
Total operating expenses |
|
19,445 |
|
|
|
35,679 |
|
|
Loss from
operations |
|
(14,791 |
) |
|
|
(34,205 |
) |
|
Interest
income, net |
|
509 |
|
|
|
521 |
|
|
Loss before
benefit from income taxes |
|
(14,282 |
) |
|
|
(33,684 |
) |
|
Benefit from
income taxes |
|
— |
|
|
|
486 |
|
|
Net
loss |
$ |
(14,282 |
) |
|
$ |
(33,198 |
) |
|
|
|
|
|
|
TRANSLATE
BIO, INC. |
CONSOLIDATED
BALANCE SHEETS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
March
31, |
December
31, |
|
|
2020 |
|
|
|
2019 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
97,468 |
|
|
$ |
84,580 |
|
Short-term investments |
|
57,627 |
|
|
|
104,098 |
|
Collaboration receivables |
|
6,228 |
|
|
|
4,596 |
|
Deferred offering costs |
|
177 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
6,744 |
|
|
|
9,391 |
|
Restricted cash |
|
950 |
|
|
|
950 |
|
Total current assets |
|
169,194 |
|
|
|
203,615 |
|
Property and equipment, net |
|
13,781 |
|
|
|
12,539 |
|
Right-of-use assets, net |
|
10,268 |
|
|
|
10,400 |
|
Goodwill |
|
21,359 |
|
|
|
21,359 |
|
Intangible assets, net |
|
84,844 |
|
|
|
85,536 |
|
Other assets |
|
5,796 |
|
|
|
2,752 |
|
Total assets |
$ |
305,242 |
|
|
$ |
336,201 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
6,297 |
|
|
$ |
15,968 |
|
Accrued expenses |
|
7,478 |
|
|
|
7,072 |
|
Current portion of deferred revenue |
|
26,760 |
|
|
|
18,100 |
|
Current portion of operating lease liability |
|
573 |
|
|
|
530 |
|
Total current liabilities |
|
41,108 |
|
|
|
41,670 |
|
Contingent consideration |
|
94,203 |
|
|
|
103,655 |
|
Deferred revenue, net of current portion |
|
15,328 |
|
|
|
25,256 |
|
Operating lease liability, net of current portion |
|
11,931 |
|
|
|
12,084 |
|
Total liabilities |
|
162,570 |
|
|
|
182,665 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Common stock |
|
60 |
|
|
|
60 |
|
Additional paid-in capital |
|
515,535 |
|
|
|
512,231 |
|
Accumulated deficit |
|
(373,778 |
) |
|
|
(359,496 |
) |
Accumulated other comprehensive income |
|
855 |
|
|
|
741 |
|
Total stockholders' equity |
|
142,672 |
|
|
|
153,536 |
|
Total liabilities and stockholders' equity |
$ |
305,242 |
|
|
$ |
336,201 |
|
|
|
|
|
Contacts for Translate Bio
Investors |
|
Media |
Teri Dahlman |
|
Maura Gavaghan |
tdahlman@translate.bio |
|
mgavaghan@translate.bio |
617-817-8655 |
|
617-233-1154 |
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