Proteostasis Therapeutics, Inc. (NASDAQ:PTI) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
In contemplation of its previously-announced move to a new headquarters location in Boston, MA, Proteostasis Therapeutics, Inc. (the “Company”) and its current landlord amended the lease for the Company’s existing office space (located at 200 Technology Square, Cambridge, Massachusetts) to accelerate the expiration date of the lease to May3, 2018 (the term was originally scheduled to expire on May31, 2018). The amendment, effective as of April13, 2018, also defined the terms of surrender of the existing space.
The foregoing description of the amendment to the lease does not purport to be complete and is qualified in its entirety by reference to such agreement, which the Company intends to file as an exhibit to its next periodic report filed under the Securities Exchange Act of 1934, as amended, that corresponds to the period in which the lease amendment was executed.
On April17, 2018, Proteostasis Therapeutics, Inc. announced that the study protocol to investigate PTI-428 in CF patients on background SymdekoTM therapy has received endorsement from the Therapeutics Development Network (TDN), the drug development arm of the Cystic Fibrosis Foundation (CFF). The Phase 2 study is designed to investigate the safety, tolerability and pharmacokinetics (PK) of multiple doses of PTI-428 in a 28-day dosing study. The Company plans to start dosing Cystic Fibrosis patients in the third quarter of this year and aims to share initial results in early 2019.
To the extent that statements in this Form 8-K are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “aim,” “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements made in this Form 8-K include, without limitation, statements regarding expected timing of the initiation of, patient enrollment in, data from, and the completion of, our clinical studies and cohorts for PTI-428 and the expected benefits of TDN endorsement. Forward-looking statements made in this Form 8-K involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, the possibility final or future results from our drug candidate trials (including, without limitation, longer duration studies) do not achieve positive results or are materially and negatively different from or not indicative of the preliminary results reported by the Company (noting that these results are based on a small number of patients and small data set), uncertainties inherent in the execution and completion of clinical trials (including, without limitation, the possibility FDA protocol comments delay or do not permit trial commencement, or the FDA requires us to run cohorts sequentially or conduct additional cohorts or pre-clinical or clinical studies), in the enrollment of CF patients in our clinical trials in a competitive clinical environment, in the timing of availability of trial data, in the results of the clinical trials, in possible adverse events from our trials, in the actions of regulatory agencies, in the endorsement, if any, by therapeutic development arms of CF patient advocacy groups (and the maintenance thereof), and those set forth in our Annual Report on Form 10-K for the year ended December31, 2017 and our other SEC filings. We assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Symdeko™ is a trademark of Vertex Pharmaceuticals Incorporated.
The above information is not an admission as to the materiality of any information therein. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.
About Proteostasis Therapeutics, Inc. (NASDAQ:PTI)
Proteostasis Therapeutics, Inc. is a biopharmaceutical company. The Company is engaged in discovery and development of therapeutics that treat diseases caused by an imbalance in the proteostasis network, a set of pathways that control protein biosynthesis, folding, trafficking and clearance. It has developed the Disease Relevant Translation (DRT) technology platform, a drug screening approach for identifying highly translatable therapeutics based on predictive and functionally pertinent phenotypic assays and disease relevant models. Using this platform, it has identified a new class of small molecules, amplifiers that modulate proteins in the proteostasis network. It is developing and intend to commercialize its lead amplifier of CFTR protein, PTI-428, to improve CFTR protein function. It also focuses on developing PTI-NC-733, PTI-130, Usp14 program and unfolded protein response (UPR) program. PTI-130 is a small molecule amplifier.