Translate Bio Announces First Quarter 2021 Financial Results and Provides Corporate Update
May 06 2021 - 4:13PM
Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company developing a new class of potentially
transformative medicines to treat or prevent debilitating or
life-threatening diseases, today announced financial results for
the first quarter ended March 31, 2021 and reviewed recent
corporate updates.
“This quarter, we continued to make important progress in
growing our team and advancing our pipeline of mRNA therapeutics
and vaccines. With interim data from our ongoing trial of MRT5005
in CF reported in March, we’ve taken critical steps toward
developing the first inhaled mRNA therapeutic to treat a genetic
lung disease,” said Ronald Renaud, chief executive officer,
Translate Bio. “Looking ahead, we anticipate completing the Phase
1/2 clinical trial of MRT5005 and continuing to advance
translational and nonclinical studies for both MRT5005 and our
next-generation CF program to support and optimize future clinical
development in CF. We also plan to advance our work in mRNA
infectious disease vaccines with our partner Sanofi Pasteur,
including reporting data from our COVID-19 program in the third
quarter of this year, and beginning a clinical trial for our
influenza program mid-year.”
Renaud continued, “We are continuing to execute on our 5-year
strategic plan, TBIO 2025, with the goal of further advancing
platform innovation and driving multiple programs into the clinic.
We believe our recent leadership appointments bring expertise in
pulmonary science, manufacturing, and operations that will be
critical to our continued growth.”
First Quarter 2021 and Recent Updates
mRNA Vaccines:
- Initiated COVID-19 mRNA vaccine clinical trial
(MRT5500) with Sanofi: In March 2021, the Company
announced the start of the Phase 1/2 clinical trial for MRT5500, an
mRNA vaccine candidate against SARS-CoV-2, the virus that causes
COVID-19. Translate Bio received a $25 million payment from Sanofi
Pasteur based on achievement of this milestone. Interim results
from this trial are expected in the third quarter of 2021.
Additionally, there is ongoing preclinical work evaluating MRT5500
as well as other constructs against the emerging SARS-CoV-2
variants to inform the incorporation of variant strains into
current or future development plans.
- Published COVID-19 mRNA vaccine preclinical
results: In April 2021, the Company announced the
peer-reviewed publication of preclinical results of its COVID-19
vaccine candidate, MRT5500, in the journal npj Vaccines.
Preclinical evaluation of MRT5500 demonstrated a favorable immune
response profile against SARS-CoV-2 and protection against the
disease in an infection challenge model.
mRNA Therapeutics:
- Reported results from second interim data analysis from
ongoing Phase 1/2 clinical trial of MRT5005 in patients with
CF: In evaluating safety and tolerability, the primary
outcome measure, data to date from the ongoing Phase 1/2 clinical
trial suggest that repeat dosing of MRT5005 was generally safe and
well tolerated. Percent predicted forced expiratory volume in 1
second (ppFEV1), a measure of lung function, was assessed as a
safety measure at pre-defined timepoints throughout the trial; no
significant change in ppFEV1 was observed. The Phase 1/2 clinical
trial is ongoing and the Company anticipates reporting the findings
from the clinical trial, including an additional multiple-ascending
dose (MAD) dose group (20 mg) and a daily dosing cohort (4 mg
once-daily for 5 days), at a future medical meeting. The Company
plans to continue with ongoing and additional translational studies
with MRT5005 and its next-generation CF candidate to support and
optimize future clinical development, including research into
dosing, formulation and nebulization.
- Advanced preclinical pulmonary
programs: The Company advanced its next-generation CF
and primary ciliary dyskinesia (PCD) programs with positive
preclinical data generated to support planned initiation of
investigational new drug application (IND)-enabling studies in the
second half of 2021.
Expansion of Leadership Team:
- Appointed Dr. Rand Sutherland as President: In
March 2021, the Company announced Dr. Rand Sutherland joined the
team as President. Dr. Sutherland brings 20 years of combined
industry, medical and academic expertise in pulmonary and rare
diseases to this role. As President of Translate Bio, Dr.
Sutherland is responsible for research and development, corporate
development and program management, including portfolio and
pipeline strategy with a focus on prioritizing and optimizing the
Company’s R&D opportunities while evaluating corporate and
business development prospects.
- Strengthened leadership team with key additions and
promotions: In April 2021, the Company announced several
key leadership appointments, including Brendan Smith as Chief
Financial Officer, Greg Troiano as Chief Manufacturing Officer, and
Jim Sullivan as Senior Vice President, Pulmonary Discovery. These
roles support the Company’s long-term strategic plan, TBIO 2025,
that emphasizes several areas for value creation across the Company
including adding key in-house quality and manufacturing
capabilities, deepening pulmonary expertise and increasing R&D
investments with a goal of advancing platform innovation and
driving multiple programs into the clinic.
Anticipated 2021 Milestones
mRNA Vaccines:
- COVID-19 Vaccine (MRT5500): Report interim
results from the ongoing Phase 1/2 clinical trial in the third
quarter of 2021 (Sanofi Pasteur collaboration)
- Influenza Vaccine: Advance lead lipid
nanoparticle (LNP)/mRNA formulations to begin clinical
proof-of-technology trial mid-year 2021 (Sanofi
Pasteur collaboration)
- Additional Vaccine Programs: Advance ongoing
preclinical studies for targets against additional viral and
bacterial pathogens
mRNA Therapeutics:
- CF Clinical Program (MRT5005): Complete
enrollment and dosing for the ongoing Phase 1/2 clinical trial and
report data at a future medical meeting, including the 20 mg MAD
group and a daily dosing cohort assessing 4 mg once-daily for 5
days
- CF Discovery Program (Next-generation CF):
- Advance lead candidate into IND-enabling studies in the second
half of 2021
- Continue ongoing and additional translational studies with
MRT5005 and a next-generation CF candidate to support and optimize
future clinical development, including research into dosing,
formulation and nebulization
- Primary Ciliary Dyskinesia (PCD): Advance lead
candidate into IND-enabling studies in the second half of 2021
- Additional Pulmonary: Conduct preclinical
studies to validate targets, including pulmonary arterial
hypertension and respiratory infectious diseases
- Liver: Progress efforts to identify
next-generation LNPs to enable advancement of Company's
liver-directed therapeutic portfolio
- mRNA Platform:
- Delivery: Identify next-generation LNPs to support additional
disease program development
- Next Wave Areas: Explore new areas for application of mRNA
technology including therapeutic antibodies and protein
degradation
Upcoming Scientific Presentations
- Preclinical Presentation in Primary Ciliary Dyskinesia at the
American Thoracic Society (ATS) 2021 International Conference: A
Messenger RNA (mRNA)-Based Therapeutic Designed to Treat Primary
Ciliary Dyskinesia (Abstract #A1138), Mini Symposium, May 18 from
10:00– 11:30 am ET
Upcoming Investor Events
- Jefferies Virtual Healthcare Conference, June 1–3
- 42nd Annual Goldman Sachs Global Healthcare Conference, June
8–10
- 2nd Annual SVB Leerink CyberRx Series: Vaccine Forum, June
21–22
- William Blair Biotech Focus Conference 2021, July 14–15
First Quarter 2021 Financial Results and Financial
Guidance
Translate Bio ended the first quarter of 2021 with $654.8
million in cash, cash equivalents and investments and 75,217,672
shares of common stock outstanding. The Company expects that its
existing cash, cash equivalents and investments will enable it to
fund its operating expenses and capital expenditure requirements
through 2023.
Translate Bio reported a net income of $26.5 million and a net
loss of $14.3 million for the three months ended March 31, 2021 and
2020, respectively.
Collaboration revenue was $34.6 million and $4.7 million for the
three months ended March 31, 2021 and 2020, respectively, which was
derived from the Sanofi Pasteur collaboration. Revenue is recorded
as a percentage of the estimated transaction priced based on the
extent of progress towards completion. Activities for the vaccine
program increased in the three months ended March 31, 2021 compared
to the same period in 2020, resulting in a larger percent of the
transaction price recognized.
Operating expenses for the three months ended March 31, 2021
were $8.0 million, compared to $19.4 million for the same period in
2020, and were comprised of the following:
- Research and development expenses of $41.1 million during the
first quarter of 2021, compared to $21.4 million for the same
period in 2020. The increase is primarily due to continued
development of the Company’s discovery and vaccine programs as well
as increases in occupancy and personnel-related costs.
- General and administrative expenses of $10.8 million during the
first quarter of 2021, compared to $7.5 million for the same period
in 2020. The increase is primarily due to increases in recruiting
fees, consulting and legal costs and an increase in
personnel-related costs.
- Change in fair value of contingent consideration of $44.0
million related to future potential milestone and earnout payment
obligations. This decrease was primarily driven by revisions to the
clinical development plan for MRT5005.
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 with a lead
pulmonary candidate 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 also believes its technology may apply broadly to a
wide 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 protein degradation.
Translate Bio is also pursuing the development of mRNA vaccines for
infectious diseases under a collaboration with Sanofi Pasteur. 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: Translate Bio’s plans to
complete and report data from its Phase 1/2 clinical trial of
MRT5005 for CF at a future medical meeting; plans to report interim
data from its Phase 1/2 clinical trial of MRT5500 for COVID-19 in
the third quarter of 2021; plans to commence clinical trials for an
influenza vaccine mid-year 2021; plans to advance lead candidates
for next-generation CF and PCD programs in the second half of 2021;
plans to further advance platform innovation and drive multiple
programs into the clinic; the goals and objectives of the TBIO 2025
long-term strategic plan; Translate Bio’s expectations with respect
to its recent leadership appointments; the potential for mRNA-based
therapeutics to apply to the treatment of many diseases caused by
protein or gene dysfunction; Translate Bio’s beliefs regarding the
broad applicability of its technology; Translate Bio’s plans to
advance its pipeline of mRNA therapeutics and validate targets for
additional pulmonary diseases and advance its liver-directed
therapeutic portfolio; and the period in which Translate Bio
expects that its existing cash, cash equivalents and investments
will enable it to fund its operating expenses and capital
expenditure requirements. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “forward,” “intend,”
“may,” “milestone,” “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 Translate Bio’s business, financial condition,
operations and liquidity; Translate Bio’s ability to advance the
development of its platform and programs, including without
limitation, 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; 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; 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 three months ended March 31, 2021 filed
with the Securities and Exchange Commission on May 6, 2021 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.
Investor Relations |
Media Relations |
Teri Dahlman |
Maura Gavaghan |
Tel.: +1 (617) 817-8655 |
Tel: +1 (617) 233-1154 |
tdahlman@translate.bio |
mgavaghan@translate.bio |
TRANSLATE
BIO, INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Collaboration revenue |
|
$ |
34,600 |
|
|
$ |
4,654 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
41,140 |
|
|
|
21,439 |
|
|
General and administrative |
|
|
10,817 |
|
|
|
7,458 |
|
|
Change in fair value of contingent consideration |
|
|
(43,979 |
) |
|
|
(9,452 |
) |
|
Total operating expenses |
|
|
7,978 |
|
|
|
19,445 |
|
|
Income
(loss) from operations |
|
|
26,622 |
|
|
|
(14,791 |
) |
|
Other
income, net |
|
|
154 |
|
|
|
509 |
|
|
Income
(loss) before income tax provision |
|
|
26,776 |
|
|
|
(14,282 |
) |
|
Income tax
provision |
|
|
(254 |
) |
|
|
— |
|
|
Net income
(loss) |
|
$ |
26,522 |
|
|
$ |
(14,282 |
) |
|
|
|
|
|
|
|
TRANSLATE
BIO, INC. |
|
|
CONSOLIDATED
BALANCE SHEETS |
|
|
(IN
THOUSANDS) |
|
|
(UNAUDITED) |
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
|
|
|
|
2021 |
|
2020 |
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
155,746 |
|
|
$ |
342,027 |
|
|
|
|
Investments |
|
499,007 |
|
|
|
312,001 |
|
|
|
|
Collaboration receivables |
|
23,240 |
|
|
|
26,598 |
|
|
|
|
Prepaid expenses and other current assets |
|
16,721 |
|
|
|
11,741 |
|
|
|
|
Restricted cash |
|
4,826 |
|
|
|
4,826 |
|
|
|
|
|
Total current assets |
|
699,540 |
|
|
|
697,193 |
|
|
|
Property and equipment, net |
|
16,563 |
|
|
|
15,372 |
|
|
|
Right-of-use assets, net |
|
71,154 |
|
|
|
72,957 |
|
|
|
Goodwill |
|
|
|
21,359 |
|
|
|
21,359 |
|
|
|
Intangible assets, net |
|
77,106 |
|
|
|
79,127 |
|
|
|
Other assets |
|
|
4,918 |
|
|
|
3,928 |
|
|
|
|
|
Total assets |
$ |
890,640 |
|
|
$ |
889,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
17,068 |
|
|
$ |
8,839 |
|
|
|
|
Accrued expenses |
|
16,240 |
|
|
|
13,202 |
|
|
|
|
Current portion of deferred revenue |
|
72,373 |
|
|
|
67,563 |
|
|
|
|
Current portion of operating lease liability |
|
12,084 |
|
|
|
11,733 |
|
|
|
|
Income tax liability |
|
254 |
|
|
|
— |
|
|
|
|
|
Total current liabilities |
|
118,019 |
|
|
|
101,337 |
|
|
|
Contingent consideration |
|
108,251 |
|
|
|
152,230 |
|
|
|
Deferred revenue, net of current portion |
|
226,876 |
|
|
|
228,659 |
|
|
|
Operating lease liability, net of current portion |
|
48,604 |
|
|
|
50,953 |
|
|
|
|
|
Total liabilities |
|
501,750 |
|
|
|
533,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock |
|
75 |
|
|
|
75 |
|
|
|
|
Additional paid-in capital |
|
775,499 |
|
|
|
769,965 |
|
|
|
|
Accumulated deficit |
|
(386,761 |
) |
|
|
(413,283 |
) |
|
|
|
Accumulated other comprehensive income |
|
77 |
|
|
|
— |
|
|
|
|
|
Total stockholders' equity |
|
388,890 |
|
|
|
356,757 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
890,640 |
|
|
$ |
889,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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