Proteostasis Therapeutics (PTI): results from the Phase 2 study

• Dec 22, 2020:  Proteostasis will be renamed Yumanity Therapeutics, Inc. and Yumanity's common stock will commence trading on the Nasdaq Capital Market on a post-reverse stock split basis under the new symbol "YMTX" on, December 23, 2020.
• Dec 19, 2022:  Kineta, Inc. completes reverse merger with Yumanity Therapeutics; commences trading on The Nasdaq Capital Market under the ticker symbol “KA” on December 19, 2022. Immediately prior to the merger, Yumanity effected a reverse stock split of its common stock at a ratio of one share for every seven shares.

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Shares of Proteostasis Therapeutics  fell on Tuesday after the biopharmaceutical company shared mixed findings from a mid-stage study for its experimental triple combination cystic fibrosis therapy. Proteostasis still plans to launch a Phase 3 trial next year. It is also conducting a personalized medicine study for patients with cystic fibrosis. The company held a call with investors on Tuesday morning to discuss the findings. Shares of Proteostasis have gained 34% year-to-date, while the S&P 500 (SPX) is up 27%.

 

Proteostasis Therapeutics (PTI): Breakthrough Therapy Designation for PTI-428 in Cystic Fibrosis

 

Proteostasis Therapeutics announces that the FDA has granted Breakthrough Therapy Designation for PTI-428, the Co's cystic fibrosis transmembrane conductance regulator (CFTR) amplifier
FDA granted the Breakthrough Therapy Designation for PTI-428 for the treatment of CF in homozygous patients for the F508del mutation who are receiving Orkambi as background therapy. The designation was based on the results from a recent Phase 2, randomized, placebo controlled study of PTI-428, in 24 CF subjects on background treatment with Orkambi and who were treated with either 50 mg PTI-428 once daily or placebo for 28 consecutive days. The study results showed that treatment with PTI-428 led to mean absolute improvement in percent predicted forced expiratory volume in 1 second (ppFEV1) of 5.2 percentage points.

Proteostasis Therapeutics (PTI) : positive study results across all three of the company's CF pipeline programs

Headquarters: Massachusetts
Founded: 2006
proteostasis.com

 

Proteostasis Therapeutics commences 7 mln common stock offering 

Proteostasis Therapeutics announced positive study results across all three of the company's CF pipeline programs;  

• Results of PTI-428 Meet Efficacy Endpoint in 28-day Study in CF Patients on Background Orkambi - Proteostasis announced that it has completed its Phase 2 study designed to evaluate the efficacy, safety, and tolerability of 50 mg once-a-day of PTI-428 over a 28-day treatment of CF patients on background Orkambi (lumacaftor/ivacaftor). The addition of PTI-428 to Orkambi demonstrated mean absolute improvements in ppFEV1 of 5.2 percentage points from baseline compared to placebo 
• The two registrational phase 3 studies of Orkambi, TRAFFIC and TRANSPORT, showed that magnitude of response to Orkambi varied according to patient lung function at screening, suggesting that the overall efficacy was mainly driven by the subgroup with baseline ppFEV1 below 70% (+3.3 percentage points) while the changes in the group with FEV1 =70% were not statistically significant.
• Preliminary Ad Hoc Analysis of PTI-801 in Ongoing 14-day Study in CF Patients on Background Orkambi - The Company has also shared initial data from the first five subjects (four PTI-801 treated and one placebo) of the first dose level tested in the 14-day dosing study of PTI-801 in CF patients on background Orkambi therapy.

Description

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.

Key stats and ratios

	Q3 (Sep '17)	2016
Net profit margin	-899.68%	-444.08%
Operating margin	-908.06%	-446.74%
EBITD margin	-	-443.09%
Return on average assets	-91.17%	-67.80%
Return on average equity	-125.11%	-
Employees	71

Proteostasis Therapeutics (PTI) began trading on the Nasdaq on 11 Feb 2016

CAMBRIDGE, Mass., Feb. 18, 2016 (GLOBE NEWSWIRE) -- Proteostasis Therapeutics, Inc. today announced the closing of its initial public offering of 6,250,000 shares of common stock at a public offering price of $8.00 per share. All of the shares sold in the offering were offered by Proteostasis Therapeutics, Inc. The company’s shares began trading on the NASDAQ Global Market on February 11, 2016 under the ticker symbol “PTI.” The gross proceeds from the offering are $50.0 million, before deducting underwriting discounts and commissions and expenses associated with the offering payable by the company.

Leerink Partners and RBC Capital Markets acted as joint book-running managers. Baird and H.C. Wainwright & Co. acted as co-managers.