Translate Bio Announces Second Quarter 2018 Financial Results and Highlights Recent Development and Corporate Achievements
-- Initiated Phase 1/2 clinical trial of MRT5005 in patients with cystic fibrosis --
-- Established strategic mRNA vaccines partnership with
-- Completed initial public offering raising approximately
“The first half of 2018 was transformational for
Second Quarter 2018 and Recent Highlights
- Dosed first patients in Phase 1/2 clinical trial of MRT5005: In
May 2018, Translate Bioinitiated a first-in-human clinical trial of MRT5005, an mRNA therapeutic product candidate that is designed to treat all patients with cystic fibrosis (CF) by addressing the underlying cause of the disease. The primary endpoint of the randomized, double-blind, placebo-controlled trial will be the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization. The trial is being conducted in collaboration with the Cystic Fibrosis Therapeutics Development Network.
- Established collaboration with
Sanofi Pasteurto develop mRNA vaccines for infectious diseases: In June 2018, Translate Bioannounced a multi-year research and development collaboration and exclusive licensing agreement with Sanofi Pasteurto develop mRNA vaccines for up to five undisclosed infectious disease pathogens. Under the agreement, Translate Bioand Sanofi Pasteurwill jointly conduct research and development activities to advance mRNA vaccines during an initial three-year research term. Translate Biois eligible to receive up to $805 millionin payments, which includes an upfront payment of $45 million, certain development, regulatory and sales-related milestones across several vaccine targets, and option exercise fees if Sanofi Pasteurexercises its option related to development of vaccines for additional pathogens.
- Presented preclinical data supporting ongoing clinical trial at ECFS: Translate Bio’s Chief Medical Officer, Dr.
Ann Barbier, presented preclinical in vivo data in June 2018at the 41st Annual European Cystic Fibrosis Conference(ECFS), demonstrating successful widespread delivery of hCFTR mRNA in the lungs of CFTR knock-out mice. These data support the potential use of MRT5005 as a treatment for patients with CF, regardless of their mutational status.
- Granted Orphan Drug Designation for MRT5201 for the treatment of ornithine transcarbamylase (OTC) deficiency in US and EU: In
March 2018, the U.S. Food and Drug Administrationgranted Orphan Drug Designation (ODD) to MRT5201, a first-in-class treatment designed to directly address the underlying cause of the disease by providing mRNA encoding the fully functional OTC enzyme in patients with OTC deficiency. In addition to U.S. ODD, the European Commissiongranted ODD for MRT5201 in June 2018.
- Completed initial public offering: The Company closed an initial public offering in
July 2018, raising approximately $113.4 millionin net proceeds. Translate Bioissued 9,714,371 shares of common stock, inclusive of the underwriters’ over-allotment option, at an offering price of $13.00per share.
- Relocated the corporate headquarters: In
March 2018, Translate Biorelocated to its new headquarters to accommodate a growing workforce, co-locate all employees and expand research and development footprint and in-house manufacturing capabilities. The new space expands the Company’s manufacturing facilities, allowing for continued support of large-scale manufacturing process for its lipid nanoparticle drug products.
- Strengthened leadership team: In
May 2018, Translate Bioappointed John R. Schroer, CFA, as Chief Financial Officer. With 28 years of healthcare investment experience, Mr. Schroer brings expertise in financial strategy and analysis and strong industry relationships to Translate Bio.
Anticipated Milestones Over Next 12 Months
- MRT5005 (CF): Initiate multiple-ascending dose portion of the Phase 1/2 clinical trial by year end 2018
- MRT5201 (OTC Deficiency): Initiate Phase 1/2 clinical trial in the first half of 2019
- Identify lead preclinical candidates for additional lung and liver disease targets
Second Quarter Financial Results and Financial Guidance
Operating expenses for the quarter ended
Research and development expenses were $15.2 million during the second quarter of 2018, compared to $13.5 million for the same period in 2017. The increase is primarily due to an increase in personnel-related costs and an increase in costs associated with the continued development of the Company’s product candidates.
General and administrative expenses were
In the three months ended
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the potential for Translate Bio’s corporate milestones in the first half of 2018 to enable it to advance its mission; potential benefits of, and plans relating to, the collaboration between
|TRANSLATE BIO, INC.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||15,219||$||13,506||$||27,921||$||23,127|
|General and administrative||5,991||3,125||10,769||6,099|
|Change in fair value of contingent consideration||7,852||2,324||12,760||4,599|
|Total operating expenses||29,062||18,955||51,450||33,825|
|Loss from operations||(29,062||)||(18,955||)||(51,450||)||(33,825||)|
|Other income (expense):|
|Other income (expense), net||(32||)||73||(45||)||60|
|Total other income (expense), net||59||152||136||218|
|Loss before benefit from income taxes||(29,003||)||(18,803||)||(51,314||)||(33,607||)|
|Benefit from income taxes||1,500||870||2,602||1,721|
|TRANSLATE BIO, INC.
|CONDENSED CONSOLIDATED BALANCE SHEETS
|June 30,||December 31,|
|Cash and cash equivalents||$||16,495||$||48,058|
|Prepaid expenses and other current assets||4,826||3,014|
|Total current assets||24,287||63,035|
|Property and equipment, net||9,868||6,778|
|In-process research and development||106,842||106,842|
|Deferred offering costs||3,976||511|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders'|
|Current portion of contingent consideration||2,387||1,296|
|Total current liabilities||14,364||12,085|
|Long-term portion of contingent consideration||91,382||79,713|
|Deferred tax liabilities||3,437||6,039|
|Deferred rent, net of current portion||2,023||1,329|
|Redeemable convertible preferred stock (Series A, B and C)||193,540||192,896|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||59,096||55,204|
|Accumulated other comprehensive income||-||79|
|Total stockholders' equity (deficit)||(138,414||)||(93,515||)|
|Total liabilities, redeemable convertible preferred|
|stock and stockholders’ equity (deficit)||$||166,332||$||198,547|
|Contacts for Translate Bio|
|Teri Dahlman||Maura Gavaghan|
Source: Translate Bio, Inc.