Translate Bio Announces Third Quarter 2020 Financial Results and Reviews Recent Progress
November 05 2020 - 4:20PM
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 third
quarter ended September 30, 2020 and reviewed recent corporate
achievements and updates.
“We continue to leverage our mRNA and lung delivery capabilities
to advance our technology with a focus on addressing unmet needs in
CF and other pulmonary diseases. With the resumption of enrollment
and dosing in the Phase 1/2 clinical trial of MRT5005, and
promising preclinical data from our next-generation CF program, we
continue to demonstrate our commitment to developing a treatment
for all patients with CF, particularly those non-amenable to
modulator treatments,” said Ronald Renaud, chief executive officer
of Translate Bio.
Mr. Renaud continued, “We have also made important progress in
our mRNA infectious disease vaccine programs under our
collaboration with Sanofi Pasteur. We were pleased to share initial
positive preclinical data from the COVID-19 vaccine program and are
working to advance the lead mRNA vaccine candidate, MRT5500, into
the clinic.”
Third Quarter 2020 and
Recent Updates
- Expanding research and
development footprint: In November 2020, the Company
entered into a lease agreement for new office and laboratory space
in order to expand its research and development footprint and build
upon internal capabilities with a continued focus on advancing
platform innovation and driving multiple programs towards clinical
development.
- Reported
positive preclinical data
for MRT5500, lead
COVID-19 mRNA vaccine
candidate, now anticipated to
begin Phase 1/2 clinical trial in first quarter 2021: In
October 2020, Translate Bio and Sanofi Pasteur announced
preclinical results for MRT5500, an mRNA-based vaccine candidate
against SARS-CoV-2, the virus that causes COVID-19. In preclinical
studies, MRT5500 induced potent neutralizing antibodies against
SARS-CoV-2 at levels significantly higher than those observed in a
panel of samples from COVID-19 patients. These data supported the
selection of MRT5500 for clinical development. A Phase 1/2 clinical
trial was anticipated to begin in the fourth quarter of 2020, and
is now expected to begin in the first quarter of 2021 due to a
delay in the manufacturing of clinical trial material.
- Presented data from mRNA clinical and preclinical
product candidates for treatment of CF
at NACFC: In October 2020,
Translate Bio gave oral and poster presentations at the 34th Annual
North American Cystic Fibrosis Conference (NACFC) which underscored
the remaining unmet need in the treatment of CF, reviewed
encouraging clinical data shared to date for the Company’s lead
program, MRT5005, and described preclinical data for a
next-generation CF program which applies advances in mRNA science,
lipid nanoparticle (LNP) chemistry, and investigation of the cystic
fibrosis transmembrane conductance regulator (CFTR) biology.
Preclinical data presented from the next-generation CF program
demonstrated that the design of novel mRNA sequences encoding
wild-type and rationally engineered CFTR protein produced active
ion channels and enhanced protein expression when compared to
reference experiments in vitro. Preclinical studies are ongoing to
select the optimal mRNA sequence and LNP for the Company’s
next-generation CFTR product candidate.
- Resumed dosing and
enrollment in Phase 1/2 clinical trial for MRT5005 for the
treatment of CF: In
September 2020, Translate Bio announced that enrollment and dosing
in its Phase 1/2 clinical trial for MRT5005 in CF resumed, with
multiple clinical sites open for enrollment. In March 2020, the
Company had announced a pause to enrollment and dosing in the
clinical trial as a consequence of the COVID-19 pandemic. The
Company 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.
Anticipated Milestones
- MRT5500 (COVID-19 vaccine): Initiate Phase 1/2 clinical trial
in Q1 2021 (Sanofi Pasteur collaboration)
- Flu vaccine: Advance lead LNP/mRNA formulation to clinical
proof of technology trial anticipated to begin mid-year 2021
(Sanofi Pasteur collaboration)
- MRT5005 (CF): Report results from additional SAD dose group and
MAD portion of the ongoing Phase 1/2 clinical trial
- Preclinical pulmonary programs: Advance next-generation CF,
primary ciliary dyskinesia, idiopathic pulmonary fibrosis and
pulmonary arterial hypertension programs toward selection of
development candidates
- Platform: Identify next-generation LNPs to support liver, lung
and additional disease program development
Upcoming Events
- The Company will give presentations on its infectious disease
vaccine and therapeutic pulmonary programs at the 8th International
mRNA Health Conference taking place virtually November 9-10,
2020.
- The Company will participate in the following virtual investor
conferences:
- Jefferies Virtual London Healthcare Conference, November 17-19,
2020
- Evercore ISI HealthCONx Conference, December 1-3, 2020
Third Quarter
2020 Financial Results and Financial
Guidance
Translate Bio ended the third quarter of 2020 with $674.1
million in cash and cash equivalents and 74,251,559 shares of
common stock outstanding. The Company expects that its existing
cash and cash equivalents will be sufficient to fund its operating
expenses and capital expenditure requirements through 2023.
Translate Bio reported a net income of $17.3 million and a net
loss of $21.2 million for the three months ended September 30, 2020
and 2019, respectively.
Collaboration revenue was $66.4 million and $1.3 million for the
three months ended September 30, 2020 and 2019, respectively, which
was derived from the collaboration with Sanofi. The increase was
primarily related to increased activities for the vaccine program
as well as a cumulative catch-up of revenue resulting from entering
into the expanded Sanofi agreement and the related increase in the
transaction price.
Operating expenses for the three months ended September 30, 2020
were $49.7 million, compared to $22.9 million for the same period
in 2019, and were comprised of the following:
- Research and development expenses of $26.3 million during the
third quarter of 2020, compared to $17.3 million for the same
period in 2019. The increase is primarily due to continued
development of the Company’s vaccine program associate with the
Sanofi collaboration and discovery program as well as an increase
in personnel-related costs, partially offset by a decrease in
expenses related to the Company’s MRT5005 and MRT5201
programs.
- General and administrative expenses of $9.2 million during the
third quarter of 2020, compared to $6.9 million for the same period
in 2019. The increase is primarily due to costs related to entering
into the expanded Sanofi agreement.
- Operating expenses of $14.2 million for change in the fair
value of contingent consideration related to future potential
milestone and earnout payment obligations. The expense recognized
was primarily attributed to an increase in the fair value of the
contingent consideration liability due to the time value of money
due to the passage of time and a decrease in the discount
rate.
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, or to prevent infectious diseases by
generating protective immunity. 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 pulmonary candidate is
being evaluated as an inhaled treatment for cystic fibrosis (CF) in
a Phase 1/2 clinical trial. Additional pulmonary diseases are being
evaluated in discovery-stage research programs that utilize a
proprietary lung delivery platform. Translate Bio believes that
mRNA can be delivered to target tissues via multiple routes of
administration and, consequently, its technology may apply broadly
to a wide range of diseases, including diseases that affect the
liver. Translate Bio is also pursuing the development of mRNA
vaccines for infectious diseases under a collaboration with Sanofi
Pasteur.
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 provide updated timing on the expected
interim data of the Phase 1/2 clinical trial of MRT5005; Translate
Bio’s expectations with respect to its collaboration with Sanofi,
including the anticipated initiation of a Phase 1/2 trial for
MRT5500 in the first quarter of 2021 and the advancement of lead
LNP/mRNA formulation for the flu vaccine to a clinical proof of
technology trial to begin mid-year 2021; Translate Bio’s plans to
advance its pipeline of mRNA therapeutics and validate targets for
additional pulmonary diseases; Translate Bio’s plans to advance its
additional disease program programs and platform; Translate Bio’s
plans to expand its research and development footprint and build
upon internal capabilities; the period in which Translate
Bio expects that its existing cash and cash equivalents will
enable it to fund its operating expenses and capital expenditure
requirements; 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 risk of
adverse current and potential future impacts of the COVID-19
pandemic on the Company’s business, financial condition, operations
and liquidity; the risk that Translate Bio is not able 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; whether or not Translate Bio is
able to successfully advance the collaboration agreement with
Sanofi; uncertainties relating to the successful 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 U.S. Food and Drug
Administration, other regulatory authorities and investigational
review boards at clinical trial sites, including decisions as it
relates to ongoing and planned clinical trials; uncertainties
related to Translate Bio’s ability to obtain, maintain and enforce
necessary patent and other intellectual property protection;
whether or not the significant cash required to fund operations
will be available; competitive factors; uncertainties and risks
related to 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 September 30, 2020 filed with the Securities and
Exchange Commission on November 5, 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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Collaboration revenue |
|
$ |
66,446 |
|
$ |
1,266 |
|
|
$ |
87,420 |
|
|
$ |
3,914 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
26,344 |
|
|
17,295 |
|
|
|
76,785 |
|
|
|
51,343 |
|
General and administrative |
|
|
9,163 |
|
|
6,881 |
|
|
|
25,223 |
|
|
|
21,284 |
|
Change in fair value of contingent consideration |
|
|
14,190 |
|
|
(19,834 |
) |
|
|
20,085 |
|
|
|
(3,243 |
) |
Impairment of intangible asset |
|
|
— |
|
|
18,559 |
|
|
|
— |
|
|
|
18,559 |
|
Total operating expenses |
|
|
49,697 |
|
|
22,901 |
|
|
|
122,093 |
|
|
|
87,943 |
|
Income
(loss) from operations |
|
|
16,749 |
|
|
(21,635 |
) |
|
|
(34,673 |
) |
|
|
(84,029 |
) |
Other
income, net |
|
|
595 |
|
|
408 |
|
|
|
1,447 |
|
|
|
1,286 |
|
Income
(loss) before benefit from income taxes |
|
|
17,344 |
|
|
(21,227 |
) |
|
|
(33,226 |
) |
|
|
(82,743 |
) |
Benefit from
income taxes |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
486 |
|
Net income
(loss) |
|
$ |
17,344 |
|
$ |
(21,227 |
) |
|
$ |
(33,226 |
) |
|
$ |
(82,257 |
) |
|
|
|
|
|
|
|
|
|
TRANSLATE
BIO, INC. |
CONSOLIDATED
BALANCE SHEETS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
|
|
September
30, |
December
31, |
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
674,050 |
|
|
$ |
84,580 |
|
|
|
Short-term investments |
|
— |
|
|
|
104,098 |
|
|
|
Collaboration receivables |
|
25,139 |
|
|
|
4,596 |
|
|
|
Prepaid expenses and other current assets |
|
10,822 |
|
|
|
9,391 |
|
|
|
Restricted cash |
|
950 |
|
|
|
950 |
|
|
|
|
|
Total current assets |
|
710,961 |
|
|
|
203,615 |
|
Property and equipment, net |
|
15,044 |
|
|
|
12,539 |
|
Right-of-use assets, net |
|
75,650 |
|
|
|
10,400 |
|
Goodwill |
|
|
|
21,359 |
|
|
|
21,359 |
|
Intangible assets, net |
|
81,280 |
|
|
|
85,536 |
|
Other assets |
|
|
4,334 |
|
|
|
2,752 |
|
|
|
|
|
Total assets |
$ |
908,628 |
|
|
$ |
336,201 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
6,815 |
|
|
$ |
15,968 |
|
|
|
Accrued expenses |
|
11,766 |
|
|
|
7,072 |
|
|
|
Current portion of deferred revenue |
|
93,164 |
|
|
|
18,100 |
|
|
|
Current portion of operating lease liability |
|
12,279 |
|
|
|
530 |
|
|
|
|
|
Total current liabilities |
|
124,024 |
|
|
|
41,670 |
|
Contingent consideration |
|
123,740 |
|
|
|
103,655 |
|
Deferred revenue, net of current portion |
|
242,047 |
|
|
|
25,256 |
|
Operating lease liability, net of current portion |
|
53,151 |
|
|
|
12,084 |
|
|
|
|
|
Total liabilities |
|
542,962 |
|
|
|
182,665 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock |
|
74 |
|
|
|
60 |
|
|
|
Additional paid-in capital |
|
758,314 |
|
|
|
512,231 |
|
|
|
Accumulated deficit |
|
(392,722 |
) |
|
|
(359,496 |
) |
|
|
Accumulated other comprehensive income |
|
— |
|
|
|
741 |
|
|
|
|
|
Total stockholders' equity |
|
365,666 |
|
|
|
153,536 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
908,628 |
|
|
$ |
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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