On September 17th, Translate Bio, Inc. (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, announced the pricing of its underwritten public offering of 9,000,000 shares of its common stock. The company is trying to raise $90 million, before deducting underwriting discounts and commissions and offering expenses it will pay, by selling shares through a public offering of $10.00 per share.
Translate Bio’s lead program is an inhaled mRNA therapeutic
Translate Bio has also granted the underwriters a 30-day option to purchase up to 1,350,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. Citigroup, Jefferies and SVB Leerink are joint book-running managers for the offering. The shares were being offered by Translate Bio following an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on July 3, 2019 and declared effective by the SEC on July 19, 2019.
Translate Bio’s lead program is an inhaled mRNA therapeutic in an ongoing Phase 1/2 clinical trial in patients with cystic fibrosis. Its preclinical programs are focused primarily on targets in additional pulmonary diseases and include infectious disease targets for vaccine applications. Other discovery efforts include next-generation delivery programs for applications in diseases affecting the liver.
September, a full month for Translate Bio
September started well for Translate Bio. On September 9th the company announced that the development of pulmonary disease programs is becoming a priority. This includes the ongoing development of MRT5005, Translate Bio’s clinical candidate for the treatment of CF, as well as the evaluation of targets in additional pulmonary diseases.
Preclinical research efforts are focused on additional pulmonary diseases, including primary ciliary dyskinesia (PCD), pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
The Company’s prioritization of pulmonary diseases is motivated by the previously reported positive single-ascending dose Phase 1/2 data from the CF program, which employs its proprietary lung delivery platform. MRT5005, a first-in-class mRNA therapeutic, is supposed to address the underlying cause of CF regardless of genetic mutation. The drug delivers mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to cells in the lung through nebulization. The multiple ascending dose portion of the clinical trial is ongoing with data expected in 2020.
At this time, the Company has decided against continued development of MRT5201, a liver-targeted treatment for OTC deficiency.
A multi-year strategic manufacturing agreement
Pricing of its shares was made public only days later. On September 12th, the company announced a multi-year strategic manufacturing agreement with Albany Molecular Research, Inc. (AMRI), a best-in-class, global clinical development manufacturing organization. The aim of the collaboration was to support the planned expansion of Translate Bio’s current Good Manufacturing Practices (cGMP) clinical mRNA manufacturing capabilities.
According to the five-year agreement, AMRI has to build new, dedicated cGMP clinical manufacturing suites adjusted to Translate Bio’s manufacturing needs. This allows for greater control and flexible access to AMRI’s purpose-built cGMP manufacturing capacity, experience and expertise to advance Translate Bio’s preclinical and clinical-stage programs.
“At Translate Bio, we recognize the importance of developing scalable manufacturing processes in this innovative field and have made this a priority from the inception of our mRNA therapeutic (MRT) platform,” said Ronald Renaud, Chief Executive Officer, Translate Bio. “We are excited to build upon our successful experience with AMRI, a demonstrated leader in drug manufacturing, with this agreement that supports the advancement of our manufacturing efforts as we work to develop first-in-class mRNA medicines for genetic diseases.”
This offering is being made solely by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC.
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. Translate Bio’s mRNA therapeutic platform (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 is primarily focused on applying its MRT platform to pulmonary diseases caused by insufficient protein production or where the production of proteins can modify disease. Translate Bio also believes that its technology is applicable to a broad range of diseases, including diseases that affect the liver, eye and central nervous system. Additionally, the MRT platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology.