TBIO Translate Bio Inc.

14.59
+0.19  (+1%)
Previous Close 14.4
Open 14.51
52 Week Low 6.8
52 Week High 28.09
Market Cap $1,083,219,128
Shares 74,243,943
Float 35,239,140
Enterprise Value $789,260,779
Volume 847,356
Av. Daily Volume 2,282,949
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Upcoming Catalysts

Drug Stage Catalyst Date
MRT5005
Cystic fibrosis
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
mRNA vaccine
COVID-19 vaccine
Phase 1b
Phase 1b
Phase 1 trial to commence by the end of 2020.
MRT5201
OTC deficiency
Phase 1/2
Phase 1/2
Phase 1/2 IND placed on clinical hold - January 22, 2019. Development to be discontinued - noted September 9, 2019.

Latest News

  1. -- Expanded collaboration with partner Sanofi Pasteur for all infectious diseases further unites Translate Bio's leading mRNA technology and large-scale manufacturing with Sanofi's world class vaccine development and distribution --

    -- Continued progress in advancing COVID-19 vaccine candidates supports goal to initiate first-in-human clinical trial Q4 2020 --

    -- Strong financial position to continue to invest in platform innovation and therapeutic program development --

    LEXINGTON, Mass., Aug. 06, 2020 (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…

    -- Expanded collaboration with partner Sanofi Pasteur for all infectious diseases further unites Translate Bio's leading mRNA technology and large-scale manufacturing with Sanofi's world class vaccine development and distribution --

    -- Continued progress in advancing COVID-19 vaccine candidates supports goal to initiate first-in-human clinical trial Q4 2020 --

    -- Strong financial position to continue to invest in platform innovation and therapeutic program development --

    LEXINGTON, Mass., Aug. 06, 2020 (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 second quarter ended June 30, 2020 and reviewed recent corporate achievements and updates.

    "While navigating the challenges of the COVID-19 pandemic, we continue to make progress in our preclinical programs – both in therapeutics for pulmonary diseases and in vaccine development under our collaboration with Sanofi Pasteur," said Ronald Renaud, chief executive officer of Translate Bio. "Additionally, for our Phase 1/2 clinical trial for MRT5005 for the treatment of cystic fibrosis (CF), we and the clinical sites are assessing the potential for patients to safely return to the clinic for study enrollment and dosing."

    Mr. Renaud continued, "This quarter, we also announced an important expansion of our work with Sanofi. We believe that this expanded agreement allows us to broadly develop mRNA vaccines with a leader in the vaccine space, leveraging their resources and expertise to potentially deliver novel infectious disease vaccines globally. Our two teams continue to work together to advance multiple programs towards clinical development, with a primary focus on the COVID-19 vaccine program and the initiation of a first-in-human clinical trial in the fourth quarter of this year."

    "As we enter the second half of the year, we believe we are in a strong financial position to continue to invest in platform innovation and to build on our proprietary delivery capabilities to support advancement of our therapeutic development programs," added Mr. Renaud.

    Second Quarter 2020 and Recent Updates

    • Expanded collaboration with Sanofi Pasteur to develop mRNA vaccines for all infectious diseases: In June 2020, Translate Bio and Sanofi Pasteur announced the expansion of their existing 2018 collaboration and license agreement to develop mRNA vaccines for all infectious diseases. In the third quarter, under the expanded agreement, Translate Bio received $425.0 million, consisting of a $300.0 million upfront payment and a $125.0 million common stock investment. Translate Bio will also be eligible for potential future milestones and other payments up to $1.9 billion and tiered royalties based on worldwide sales of the developed vaccines.



    • Completed $125 million public offering of common stock: In June 2020, the Company completed a public offering of 5,681,819 shares of common stock at a public offering price of $22.00 per share, for gross proceeds of $125.0 million.

    Anticipated Milestones

    • COVID-19 vaccine: advance development candidate to Investigational New Drug (IND) filing with the goal of clinical trial initiation in Q4 2020 (Sanofi Pasteur collaboration)
    • Flu vaccine: advance development candidate to IND filing with clinical trial initiation anticipated mid-year 2021 (Sanofi Pasteur collaboration)
    • MRT5005 (CF): report results from additional single-ascending dose group and multiple-ascending dose portion of Phase 1/2 clinical trial
    • Preclinical pulmonary programs: advance next-generation CF, Primary Ciliary Dyskinesia, Idiopathic Pulmonary Fibrosis and Pulmonary Arterial Hypertension programs toward selection of development candidate
    • Platform: identify next-generation lipid nanoparticles (LNPs) to support liver, lung and additional disease program development

    Upcoming Events

    • The Company will participate in the following virtual investment banking conferences:

           - Citi's 15th Annual BioPharma Virtual Conference, September 9-10, 2020

           - SVB Leerink CybeRx Series: Vaccine Forum, September 23-24, 2020

           - SVB Leerink CybeRx Series: Rare & Genetics, October 1, 2020
    • The Company will give a presentation at the North American Cystic Fibrosis Conference, October 21-23, 2020, during a session entitled: Novel Nucleic Acid Strategies to Treat the Fundamental CF Defect

    Second Quarter 2020 Financial Results and Financial Guidance

    Translate Bio ended the second quarter of 2020 with $292.2 million in cash, cash equivalents and short-term investments and 69,359,509 shares of common stock outstanding. The Company expects that its existing cash, cash equivalents and short-term investments, together with the upfront payment and common stock equity investment of approximately $425.0 million from Sanofi received in the third quarter of 2020, will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 36 months.

    Translate Bio reported a net loss of $36.3 million and $27.8 million for the three months ended June 30, 2020 and 2019, respectively.

    Collaboration revenue was $16.3 million and $1.2 million for the three months ended June 30, 2020 and 2019, respectively, which was derived from the collaboration with Sanofi. The increase was related to increased activities for the vaccine program in the three months ended June 30, 2020 compared to the same period in 2019.

    Operating expenses for the three months ended June 30, 2020 were $53.0 million, compared to $29.4 million for the same period in 2019, and were comprised of the following:

    • Research and development expenses of $29.0 million during the second quarter of 2020, compared to $16.6 million for the same period in 2019. The increase is primarily due to continued development of the Company's vaccine and discovery programs as well as an increase in personnel-related costs, partially offset by a decrease in expenses related to the Company's MRT5201 and MRT5005 programs.

       
    • General and administrative expenses of $8.6 million during the second quarter of 2020, compared to $7.9 million for the same period in 2019.

       
    • Operating expenses of $15.3 million for change in the fair value of contingent consideration related to future potential milestone and earnout payment obligations. The expense recognized was primarily attributed to an increase in the fair value of the contingent consideration liability due to the time value of money due to the passage of time and a decrease in the discount rate.

    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 is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio's lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company is also pursuing the development of mRNA vaccines for infectious diseases under a collaboration with Sanofi Pasteur. The Company also believes its technology is applicable to a broad range of diseases, including diseases that affect the liver. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies for infectious disease and other diseases. 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 and benefit patients; Translate Bio's plans to resume enrollment and dosing its paused Phase 1/2 clinical trial of MRT5005; 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, the anticipated IND filing with clinical trial initiation for a flu vaccine in mid-year 2021, and the development of mRNA vaccines and the delivery of infectious vaccines globally; Translate Bio's plans to advance its pipeline of mRNA therapeutics and validate targets for additional pulmonary diseases;  Translate Bio's plans to advance its additional disease program 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 Translate Bio and Sanofi; uncertainties relating to the discovery and development of vaccine candidates based on mRNA, and specifically as it relates to the novel coronavirus, COVID-19; the content and timing of decisions made by the FDA, 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 quarterly period ended June 30, 2020 filed with the Securities and Exchange Commission on August 6, 2020 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.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (IN THOUSANDS)
    (UNAUDITED)
             
      Three Months Ended June 30, Six Months Ended June 30,
       2020   2019   2020   2019 
    Collaboration revenue $16,319  $1,174  $20,974  $2,648 
    Operating expenses:        
    Research and development  29,002   16,625   50,442   34,048 
    General and administrative  8,601   7,850   16,060   14,403 
    Change in fair value of contingent consideration  15,347   4,889   5,895   16,591 
    Total operating expenses  52,950   29,364   72,397   65,042 
    Loss from operations  (36,631)  (28,190)  (51,423)  (62,394)
    Interest income  343   358   853   878 
    Loss before benefit from income taxes  (36,288)  (27,832)  (50,570)  (61,516)
    Benefit from income taxes           486 
    Net loss $(36,288) $(27,832) $(50,570) $(61,030)
             





    TRANSLATE BIO, INC.
    CONSOLIDATED BALANCE SHEETS
    (IN THOUSANDS)
    (UNAUDITED)
       June 30, December 31,
        2020   2019 
    Assets      
    Current assets:   
    Cash and cash equivalents$272,193  $84,580 
    Short-term investments 20,029   104,098 
    Collaboration receivables 15,131   4,596 
    Prepaid expenses and other current assets 7,918   9,391 
    Restricted cash 950   950 
    Total current assets 316,221   203,615 
    Property and equipment, net 15,154   12,539 
    Right-of-use assets, net 10,130   10,400 
    Goodwill   21,359   21,359 
    Intangible assets, net 81,280   85,536 
    Other assets  10,134   2,752 
    Total assets$454,278  $336,201 
          
    Liabilities and Stockholders' Equity   
    Current liabilities:   
    Accounts payable$12,912  $15,968 
    Accrued expenses 11,126   7,072 
    Current portion of deferred revenue 27,109   18,100 
    Current portion of operating lease liability 619   530 
    Total current liabilities 51,766   41,670 
    Contingent consideration 109,550   103,655 
    Deferred revenue, net of current portion 9,818   25,256 
    Operating lease liability, net of current portion 11,751   12,084 
    Total liabilities 182,885   182,665 
          
    Stockholders' equity:   
    Common stock 69   60 
    Additional paid-in capital 680,850   512,231 
    Accumulated deficit (410,066)  (359,496)
    Accumulated other comprehensive income 540   741 
    Total stockholders' equity 271,393   153,536 
    Total liabilities and stockholders' equity$454,278  $336,201 
          



    Contacts for Translate Bio

     
    Investors Media
    Teri DahlmanMaura Gavaghan
    617-817-8655617-233-1154

    Primary Logo

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  2. LEXINGTON, Mass., July 20, 2020 (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 the closing of a previously announced expansion of the collaboration and licensing agreement with Sanofi Pasteur to develop mRNA vaccines for all infectious disease pathogens, following notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the agreement, Translate Bio will receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9…

    LEXINGTON, Mass., July 20, 2020 (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 the closing of a previously announced expansion of the collaboration and licensing agreement with Sanofi Pasteur to develop mRNA vaccines for all infectious disease pathogens, following notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the agreement, Translate Bio will receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones and other payments as well as tiered royalties on worldwide sales of developed vaccines. In turn, Sanofi received exclusive worldwide rights for infectious disease mRNA vaccines.  Sanofi will pay for all costs during the collaboration term.

    About the Sanofi Pasteur and Translate Bio collaboration

    In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens. This agreement was first expanded in March 2020 to include the collaborative development of a novel mRNA vaccine for COVID-19. The July 2020 expansion agreement covers the development of mRNA vaccines broadly for all infectious diseases. This collaboration brings together Sanofi Pasteur's leadership in vaccines and Translate Bio's mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018. Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs including screening, optimization and production of mRNA and LNP formulations across multiple targets.

    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 is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio's lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad 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 vaccines in areas such as infectious disease and oncology. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio. (updated)

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Translate Bio 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 expectations with respect to the benefits of its collaboration with Sanofi; the potential of Translate Bio's mRNA platform; the amount and receipt of future potential milestone, royalty and other payments under its collaboration with Sanofi; and 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 and continued development of mRNA vaccines for the treatment of infectious diseases. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "forward," "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 Translate Bio'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 Translate Bio and Sanofi;  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 fiscal quarter ended March 31, 2020 filed with the Securities and Exchange Commission on May 7, 2020 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.

    Contacts for Translate Bio

    Teri DahlmanMaura Gavaghan
    617-817-8655617-233-1154

    Primary Logo

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  3. LEXINGTON, Mass., June 25, 2020 (GLOBE NEWSWIRE) -- Translate Bio, Inc. (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 the pricing of its underwritten public offering of 12,506,811 shares of its common stock at a public offering price of $22.00 per share. In the offering, Translate Bio will issue and sell 5,681,819 shares and an existing stockholder, Shire Human Genetic Therapies, Inc. (Shire), a subsidiary of Takeda Pharmaceutical Company Limited, will sell 6,824,992 shares. The gross proceeds to Translate Bio from the offering, before deducting underwriting discounts and commissions…

    LEXINGTON, Mass., June 25, 2020 (GLOBE NEWSWIRE) -- Translate Bio, Inc. (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 the pricing of its underwritten public offering of 12,506,811 shares of its common stock at a public offering price of $22.00 per share. In the offering, Translate Bio will issue and sell 5,681,819 shares and an existing stockholder, Shire Human Genetic Therapies, Inc. (Shire), a subsidiary of Takeda Pharmaceutical Company Limited, will sell 6,824,992 shares. The gross proceeds to Translate Bio from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Translate Bio, are expected to be approximately $125.0 million. Translate Bio will not receive any proceeds from the sale of the shares by Shire. In addition, Translate Bio has granted the underwriters a 30-day option to purchase up to 1,876,021 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on June 30, 2020, subject to the satisfaction of customary closing conditions.

    Goldman Sachs & Co. LLC, SVB Leerink and Evercore ISI are acting as joint book-running managers and H.C. Wainwright & Co. and Roth Capital Partners are acting as co-lead managers for the offering. 

    The shares are being offered pursuant to an effective shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the Securities and Exchange Commission (SEC) on June 24, 2020.

    This offering is being made only 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 is available on the SEC's website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526 or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at .

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio's lead program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad 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 vaccines in areas such as infectious disease and oncology.

    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 expected closing of the offering and anticipated proceeds from the offering.  The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "hope," "may," "plan," "possible," "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: risks and uncertainties related to the satisfaction of customary closing conditions related to the public offering, the impact of general economic, industry or political conditions in the United States or internationally including the ongoing COVID-19 pandemic and other important risk factors set forth under the caption "Risk Factors" in the preliminary prospectus relating to the offering, Translate Bio's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, and in any other subsequent filings made with the SEC 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, except as required by law.

    Contacts for Translate Bio

    InvestorsMedia
    Teri Dahlman



    617-817-8655 



     
    Maura Gavaghan



    617-233-1154

    Primary Logo

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  4. LEXINGTON, Mass., June 24, 2020 (GLOBE NEWSWIRE) -- Translate Bio, Inc. (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 that it has commenced an underwritten public offering of $125.0 million of its common stock. In addition, Shire Human Genetic Therapies, Inc. (Shire), a subsidiary of Takeda Pharmaceutical Company Limited, is offering 6,824,992 shares of Translate Bio's common stock in the offering. Translate Bio will not receive any proceeds from the sale of the shares by Shire. Translate Bio also intends to grant the underwriters a 30-day option to purchase up to an additional…

    LEXINGTON, Mass., June 24, 2020 (GLOBE NEWSWIRE) -- Translate Bio, Inc. (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 that it has commenced an underwritten public offering of $125.0 million of its common stock. In addition, Shire Human Genetic Therapies, Inc. (Shire), a subsidiary of Takeda Pharmaceutical Company Limited, is offering 6,824,992 shares of Translate Bio's common stock in the offering. Translate Bio will not receive any proceeds from the sale of the shares by Shire. Translate Bio also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the base shares of common stock offered in the public offering.

    Goldman Sachs & Co. LLC, SVB Leerink and Evercore ISI are acting as joint book-running managers and H.C. Wainwright & Co. and Roth Capital Partners are acting as co-lead managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The shares are being offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the Securities and Exchange Commission (SEC) on June 24, 2020.

    This offering is being made only 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 will be filed with the SEC and, when filed, will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526 or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio's lead program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad 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 vaccines in areas such as infectious disease and oncology.

    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 Translate Bio's plans to consummate its proposed public offering and the anticipated final terms, timing and completion of the proposed offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "hope," "may," "plan," "possible," "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: risks and uncertainties related to whether or not Translate Bio will be able to raise capital through the sale of shares of common stock, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering, the impact of general economic, industry or political conditions in the United States or internationally including the ongoing COVID-19 pandemic and other important risk factors set forth under the caption "Risk Factors" in the preliminary prospectus supplement to be filed with the SEC, in Translate Bio's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 and in any other subsequent filings made with the SEC by Translate Bio. There can be no assurance that Translate Bio will be able to complete the proposed public offering on the anticipated terms, or at all. 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, except as required by law.

    Contacts for Translate Bio

    InvestorsMedia
    Teri Dahlman



    617-817-8655

    Maura Gavaghan



    617-233-1154

    Primary Logo

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  5. Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas

    • The two companies will build upon their existing collaboration
      to pursue novel mRNA vaccines aimed at broadly addressing
      current and future infectious diseases
    • Translate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccines
    • Sanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technology
    • The expanded collaboration brings together Translate Bio's leading mRNA technology and manufacturing…

    Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas

    • The two companies will build upon their existing collaboration

      to pursue novel mRNA vaccines aimed at broadly addressing

      current and future infectious diseases
    • Translate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccines
    • Sanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technology
    • The expanded collaboration brings together Translate Bio's leading mRNA technology and manufacturing with Sanofi's world class vaccine development and distribution

    PARIS and LEXINGTON, MASS. - June 23, 2020 - Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ:TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.

    The expansion of this agreement will further unite Translate Bio's expertise and knowledge from more than 10 years of mRNA research and development with Sanofi's leadership in vaccine research and development. Under the expansion agreement, Translate Bio will receive a total upfront payment of $425 million, consisting of a $300 million cash payment and a private placement common stock investment of $125 million at $25.59 per share representing a 50 percent premium to the 20-day moving average share price prior to signing. Translate Bio will also be eligible for potential future milestones and other payments up to $1.9 billion, including $450 million of milestones under the 2018 agreement. Of these potential milestones and other payments, approximately $360 million are anticipated over the next several years, inclusive of COVID-19 vaccine development milestones. In addition, Translate Bio is also eligible to receive tiered royalty payments based upon worldwide sales of the developed vaccines. Sanofi Pasteur will pay for all costs during the collaboration term. Under this agreement Sanofi Pasteur will receive exclusive worldwide rights for infectious disease vaccines.

    "As all eyes are on prevention of infectious disease through vaccines, this is a pointed moment in time where we are called upon to seek innovative ways to protect public health," said Thomas Triomphe, Executive Vice President, Sanofi Pasteur. "We are excited by the novel technology and expertise Translate Bio brings, and we believe that adding this mRNA platform to our vaccines development capabilities will help us advance prevention against current and future infectious diseases."

    "The expansion of our collaboration with Sanofi Pasteur validates the progress we've made in the development of mRNA vaccines for infectious diseases since our work together began in 2018 and also speaks to the potential of our mRNA platform. We are excited to work with Sanofi in this broadened capacity with the goal of ultimately delivering vaccines on a global scale, a need underscored by the current pandemic," said Ronald Renaud, Chief Executive Officer of Translate Bio. "Translate Bio will also be well positioned financially to continue to build upon our internal capabilities with a focus on advancing innovations in platform discovery and on the development of ongoing and additional preclinical therapeutic programs as we aim to bring multiple programs towards clinical development."

    Under the collaboration, Translate Bio is using its mRNA platform to discover, design and manufacture vaccine candidates and Sanofi Pasteur is providing its deep vaccine expertise to advance vaccine candidates into and through further development. Translate Bio will also transfer technology and processes to allow Sanofi Pasteur to develop and manufacture mRNA vaccines for infectious diseases.

    The teams are currently evaluating multiple COVID-19 vaccine candidates 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.

    The companies are also advancing an mRNA vaccine development candidate against influenza through preclinical studies with clinical trial initiation anticipated in mid-year 2021. Additional mRNA vaccine development programs under the collaboration include another viral pathogen and a bacterial pathogen.

    The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. For more information regarding the financial and other terms of the agreement, please refer to the Current Report on Form 8-K which will be filed by Translate Bio with the U.S. Securities & Exchange Commission on June 23, 2020.

    Evercore acted as financial advisor to Translate Bio for the expansion of the collaboration agreement.

    About mRNA Vaccines 

    Vaccines work by mimicking disease agents to stimulate the immune system; building up a defense mechanism that remains active in the body to fight future infections. mRNA vaccines offer an innovative approach by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential to induce a protective immune response. mRNA vaccines also represent a potentially innovative alternative to conventional vaccine approaches for several reasons - their high potency, ability to initiate protein production without the need for nuclear entry, capacity for rapid development and potential for low-cost manufacture and safe administration using non-viral delivery. This approach potentially enables the development of vaccines for disease areas where vaccination is not a viable option today. Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process offering maximum flexibility and efficiency in development.

    About the Sanofi Pasteur and Translate Bio collaboration

    In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens. This agreement was first expanded in March 2020 to include the collaborative development of a novel mRNA vaccine for COVID-19. This collaboration brings together Sanofi Pasteur's leadership in vaccines and Translate Bio's mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018. Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs including screening, optimization and production of mRNA and LNP formulations across multiple targets.

    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 is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio's lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad 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 vaccines in areas such as infectious disease and oncology. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.

     



    About Sanofi



     



    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.



     



    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.



     



    Sanofi, Empowering Life



     





    Media Relations Contact for Sanofi

    Nicolas Kressmann

    Tel.: +1 (732) 532 53-18





     



    Media Relations Contact for Translate Bio

    Maura Gavaghan

    Tel: +1 (617) 233-1154



    Investor Relations Contact for Sanofi

    Felix Lausher

    Tel.: +33 (0)1 53 77 45 45





     



    Investor Relations Contact for Translate Bio

    Teri Dahlman

    Tel: +1 (617) 817-8655



     



    Sanofi Forward-Looking Statements

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions,  cost containment initiatives and subsequent changes thereto, and  the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.



     





    Translate Bio 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:  Translate Bio's expectations with respect to the benefits of its collaboration with Sanofi; the potential of Translate Bio's mRNA platform; Translate Bio's expectations regarding its financial positioning after giving effect to the amended transaction with Sanofi; and the anticipated initiation of clinical trials for the COVID-19 vaccine in the fourth quarter of 2020 and for the flu vaccine in mid-year 2021; the timing and amount of future potential milestone and royalty payments under its collaboration with Sanofi; 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 and continued development of mRNA vaccines for the treatment of infectious diseases.. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "forward," "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 Translate Bio'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 Translate Bio and Sanofi;  the content and timing of decisions made by the FDA, 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 fiscal quarter ended March 31, 2020 filed with the Securities and Exchange Commission on May 7, 2020 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.



     

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