Track topics on Twitter Track topics that are important to you
LEXINGTON, Mass., May 09, 2019 (GLOBE NEWSWIRE) -- 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, 2019 and reviewed recent corporate achievements and updates.
“This quarter, we have continued to focus on progressing our programs for rare genetic diseases while also advancing our mRNA therapeutic (MRT) platform to fuel future pipeline programs,” said Ronald Renaud, chief executive officer of Translate Bio. “We are excited to share that we have completed dosing in the single-ascending dose portion of the ongoing Phase 1/2 clinical trial for MRT5005 in patients with cystic fibrosis and anticipate reporting interim data from this trial in the third quarter of this year.”
First Quarter 2019 and Recent Updates
First Quarter 2019 Financial Results and Financial Guidance
Translate Bio ended the first quarter of 2019 with $122.6 million in cash, cash equivalents and investments and 45,294,439 shares of common stock outstanding. In May 2019, the Company raised gross proceeds of $47.5 million through a private placement of 5,582,940 shares of its common stock. The Company expects that its existing cash, cash equivalents and investments, together with the proceeds from the private placement, will enable it to fund its operations into the second half of 2020.
Translate Bio reported a net loss of $33.2 million and $21.2 million for the three months ended March 31, 2019 and 2018, respectively.
Collaboration revenue was $1.5 million in the three months ended March 31, 2019 which was derived from the collaboration and license agreement that the Company entered into with Sanofi Pasteur in 2018. There was no collaboration revenue in the three months ended March 31, 2018.
Operating expenses for the three months ended March 31, 2019 were $35.7 million, compared to $22.4 million for the same period in 2018, and were comprised of the following:
About Translate Bio
Translate 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. The Company’s MRT platform is designed to develop product candidates that deliver mRNA carrying instructions to produce intracellular, transmembrane and secreted proteins for therapeutic benefit. Translate Bio believes that its MRT platform is applicable to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease, including diseases that affect the lung, liver, eye, central nervous system and lymphatic system. The Company also believes its MRT platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology. Translate Bio’s two lead programs are being developed as treatments for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.
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; Translate Bio’s plans to report interim data from the Phase 1/2 clinical trial of MRT5005 in the third quarter of 2019; Translate Bio’s plans to conduct additional preclinical studies for MRT5201 and its plan to submit data from these studies to the FDA in the fourth quarter of 2019; Translate Bio’s plans to identify lead preclinical candidates for additional disease targets; 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; the anticipated contributions of the new members of the management team; 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: 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; Translate Bio’s ability to obtain additional preclinical data to support its IND application for MRT5201; the risk that Translate Bio may not resolve the clinical hold on MRT5201 or any other clinical hold in the near term or at all; the content and timing of decisions made by the FDA, other regulatory authorities and investigational review boards at clinical trial sites, including decisions that may arise as a result of the clinical hold on MRT5201 and 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, 2019 filed with the Securities and Exchange Commission on May 9, 2019 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.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended March 31,|
|Research and development||17,423||12,702|
|General and administrative||6,554||4,779|
|Change in fair value of contingent consideration||11,702||4,908|
|Total operating expenses||35,679||22,389|
|Loss from operations||(34,205||)||(22,389||)|
|Other income (expense):|
|Total other income (expense), net||521||77|
|Loss before benefit from income taxes||(33,684||)||(22,312||)|
|Benefit from income taxes||486||1,103|
|TRANSLATE BIO, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||62,431||$||55,199|
|Prepaid expenses and other current assets||5,247||4,474|
|Total current assets||128,857||149,602|
|Property and equipment, net||10,771||10,245|
|Right-of-use assets, net||10,769||—|
|Intangible assets, net||105,980||106,445|
|Liabilities and Stockholders' Equity|
|Current portion of deferred revenue||5,708||2,572|
|Current portion of operating lease liability||411||—|
|Total current liabilities||16,763||14,287|
|Long-term portion of contingent consideration||115,344||103,642|
|Deferred revenue, net of current portion||38,017||41,841|
|Deferred tax liabilities||—||481|
|Operating lease liability, net of current portion||12,504||—|
|Additional paid-in capital||374,113||371,257|
|Accumulated other comprehensive income||351||196|
|Total stockholders' equity||95,108||125,295|
|Total liabilities and stockholders' equity||$||277,736||$||287,651|
Contacts for Translate Bio
|Teri Dahlman||Maura Gavaghan|
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...