Also in December 2017, we reported results from our investigation in healthy volunteers of
PTI-808
as a single agent as well as
co-administration
of
PTI-428,
PTI-808
and
PTI-801. Our
combination study protocols for trials in CF patients have been reviewed by key patient advocacy and applicable regulatory authorities where the trials will be conducted.
In January 2018, we announced that our triple combination clinical study protocol received endorsement and a high strategic fit score from the Therapeutics
Development Network (TDN) and the Clinical Trial Network (CTN). Our double combination protocol has also received the endorsement of the TDN. The TDN and CTN are the drug development arms of the Cystic Fibrosis Foundation (CFF) and the European CF
Society (ECFS), respectively.
The CFF and ECFS are the most impactful CF patient advocacy organizations and shepherd the execution of clinical trials in
the United States and Europe, respectively. Both organizations have well established processes to evaluate submitted study protocols based on scientific merit, study design, feasibility and the overall clinical research priorities of the CF
community. Protocols are reviewed by a selected group of experienced CF physician investigators, research coordinators, biostatisticians, people with CF and other specialists.
In the United States, upon the protocol endorsement, the TDN provides access to 89 accredited care centers with demonstrated expertise in clinical research,
and supports study participant recruitment and execution of studies. Since its founding in 1998, the TDN has conducted more than 130 clinical studies for CF, including studies of CFTR modulators. Similarly, in Europe, the CTN provides access for
endorsed studies to 43 large and experienced CF centers located in 15 different countries, including the U.K. The TDN and the CTN have established a strong partnership for endorsed studies conducted in both the U.S. and Europe.
We have commenced dosing CF patients for a double combination study consisting of
PTI-801
and
PTI-808,
and plan to report initial data by
mid-year
2018.
Corporate Information
We were
incorporated in Delaware on December 13, 2006 under the name Proteoguard, Inc. and subsequently changed our name to Proteostasis Therapeutics, Inc. on September 17, 2007. Our principal executive offices are located at 200 Technology
Square, 4th Floor, Cambridge, Massachusetts 02139, and our telephone number is (617)
225-0096.
Our website address is www.proteostasis.com. We do not incorporate the information on or accessible through our
website into this prospectus supplement, and you should not consider any information on, or that can be accessed through, our website a part of this prospectus supplement.
This prospectus contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names
referred to in this prospectus, including logos, artwork, and other visual displays, may appear without the
®
or symbols, but such references are not intended to indicate, in any way,
that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies trade names or trademarks to
imply a relationship with, or endorsement or sponsorship of us by, any other companies.
On February 17, 2016, we completed our initial public
offering. We qualify as an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other
requirements that are otherwise applicable generally to public companies. We would cease to be an emerging growth company on the date that is the earliest of: (i) the last day of the fiscal year in which we have total annual gross revenues of
$1.07 billion or more; (ii) December 31, 2021; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large
accelerated filer under the rules of the SEC.