Translate Bio Announces First Quarter 2020 Financial Results and Provides Corporate Update
-- Pursuing development of mRNA vaccine against COVID-19 through expanded collaboration with
-- Existing large-scale manufacturing capacity expected to help meet needs of pandemic --
-- In vivo testing ongoing for multiple COVID-19 vaccine candidates to support lead candidate selection; goal to initiate first-in-human clinical trial Q4 2020 --
“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
First Quarter 2020 and Recent Updates
- Collaboration with
Sanofi Pasteurto develop a novel mRNA vaccine for COVID-19: Sanofi Pasteurand Translate Bioannounced 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.
- COVID-19 vaccine: advance development candidate to IND filing with the goal of clinical trial initiation in Q4 2020 (
- Flu vaccine: advance development candidate to IND filing with clinical trial initiation anticipated mid-year 2021 (
- 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
- The Company will present and host one-on-one meetings at the following virtual investment banking conferences:
Bank of America Healthcare Conference2020, May 12-15, 2020 Jefferies Virtual Healthcare Conference, June 2-4, 2020
First Quarter 2020 Financial Results and Financial Guidance
Collaboration revenue was
Operating expenses for the three months ended
- Research and development expenses of
$21.4 millionduring the first quarter of 2020, compared to $17.4 millionfor 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 millionduring the first quarter of 2020, compared to $6.6 millionfor the same period in 2019. The increase is primarily due to an increase in personnel-related costs.
- Operating income of
$9.5 millionfor 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.
Cautionary Note Regarding Forward-Looking Statements
This 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
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
|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|
|CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||97,468||$||84,580|
|Deferred offering costs||177||—|
|Prepaid expenses and other current assets||6,744||9,391|
|Total current assets||169,194||203,615|
|Property and equipment, net||13,781||12,539|
|Right-of-use assets, net||10,268||10,400|
|Intangible assets, net||84,844||85,536|
|Liabilities and Stockholders' Equity|
|Current portion of deferred revenue||26,760||18,100|
|Current portion of operating lease liability||573||530|
|Total current liabilities||41,108||41,670|
|Deferred revenue, net of current portion||15,328||25,256|
|Operating lease liability, net of current portion||11,931||12,084|
|Additional paid-in capital||515,535||512,231|
|Accumulated other comprehensive income||855||741|
|Total stockholders' equity||142,672||153,536|
|Total liabilities and stockholders' equity||$||305,242||$||336,201|
Source: Translate Bio, Inc.