Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing such as cystic fibrosis, today reported financial results for the third quarter ended September 30, 2016.

Revenue was $1.7 million for the three months ended September 30, 2016, compared to $1.2 million for the three months ended September 30, 2015. The increase was the result of an increase in revenue recognized from the Company’s collaboration with Astellas.

Research and development expenses were $9.2 million for the three months ended September 30, 2016, compared to $6.3 million for the three months ended September 30, 2015. The increase was primarily due to an increase of $2.6 million related to activities supporting the Company’s Phase 1 clinical trials of PTI-428 which commenced during the first quarter of 2016.

General and administrative expenses were $3.3 million for the three months ended September 30, 2016, compared to $1.5 million for the three months ended September 30, 2015. The increase was primarily due to a $0.8 million increase in personnel-related costs, a $0.6 million increase in professional fees and a $0.3 million increase in occupancy and other facility-related costs.

Net loss was $10.8 million for the three months ended September 30, 2016, compared to $7.1 million for the three months ended September 30, 2015. The increase in net loss was primarily attributable to the increase in operating expenses noted above.

Cash, cash equivalents and short-term investments were $100.2 million as of September 30, 2016, including the proceeds from the Company’s follow-on public offering in the third quarter of 2016. In September 2016, the Company closed its follow-on public offering of 5,750,000 shares of its common stock at a public offering price of $13.00 per share. The net proceeds from the offering were $69.5 million, after deducting the underwriting discount and expenses associated with the offering payable by the Company.

Based on the Company’s current operating plan, the Company expects its cash, cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditures requirements through the second quarter of 2018.

About Proteostasis Therapeutics, Inc.

Proteostasis Therapeutics, Inc. is a biopharmaceutical company dedicated to the discovery of groundbreaking therapies to treat diseases caused by dysfunctional protein processing, such as cystic fibrosis (CF). Headquartered in Cambridge, MA, the Proteostasis Therapeutics team focuses on identifying therapies that modulate the proteostasis imbalance in cells and restore protein function. Proteostasis Therapeutics is currently enrolling eligible adults with CF to participate in its Phase 1 clinical trials of PTI-428. In addition to its multiple programs in cystic fibrosis, Proteostasis Therapeutics has formed collaborations with Biogen to research and identify therapeutic candidates for neurodegenerative disease and with Astellas Pharma, Inc. to research and identify therapies targeting the Unfolded Protein Response (UPR) pathway. For more information, visit www.proteostasis.com.

Safe HarborTo the extent that statements in this release are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as “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 release include, without limitation, statements regarding the sufficiency of our cash balances to fund our operating and capital expenses through an expected date.  Forward-looking statements made in this release 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, uncertainties inherent in the execution and completion of clinical trials, in the timing of availability of trial data, in the actions of regulatory agencies, and those set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, 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.

   
PROTEOSTASIS THERAPEUTICS, INC.  
   
BALANCE SHEETS  
(In thousands, except share and per share amounts)  
(Unaudited)  
   
    September 30,     December 31,  
    2016     2015  
Assets                
Current assets:                
Cash and cash equivalents   $ 43,828     $ 13,844  
Short-term investments     56,412        
Accounts receivable     445       918  
Other current assets     2,388       180  
Total current assets     103,073       14,942  
Property and equipment, net     342       566  
Deferred offering costs           2,744  
Other assets     81       144  
Restricted cash     294       294  
Total assets   $ 103,790     $ 18,690  
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)                
Current liabilities:                
Accounts payable   $ 2,809     $ 3,330  
Accrued expenses     4,182       2,248  
Deferred revenue     4,683       4,076  
Deferred rent     196       182  
Total current liabilities     11,870       9,836  
Deferred revenue, net of current portion     1,666       4,265  
Deferred rent, net of current portion     139       287  
Preferred stock warrant liability           110  
Derivative liability     142       2  
Total liabilities     13,817       14,500  
Commitments and contingencies (Note 9)                
Convertible preferred stock, (Series A and B), $0.001 par value; 0 and 110,057,398  shares authorized as of September 30, 2016 and December 31, 2015, respectively;  0 and 104,854,769 shares issued and outstanding as of September 30, 2016 and  December 31, 2015, respectively; aggregate liquidation preference of $0 and  $149,392, respectively, as of September 30, 2016 and December 31, 2015           112,292  
Stockholders’ equity (deficit):                
Preferred stock, $0.001 par value; 5,000,000 and 0 shares authorized  as of September 30, 2016 and December 31, 2015, respectively; no shares issued  and outstanding as of September 30, 2016 and December 31, 2015            
Common stock, $0.001 par value; 125,000,000 and 170,000,000 shares authorized  as of September 30, 2016 and December 31, 2015, respectively; 24,945,125 and  571,137 shares issued and outstanding as of September 30, 2016 and December  31, 2015, respectively     26       1  
Additional paid-in capital     237,989       12,115  
Accumulated other comprehensive loss     (9 )      
Accumulated deficit     (148,033 )     (120,218 )
Total stockholders’ equity (deficit)     89,973       (108,102 )
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)   $ 103,790     $ 18,690  
 
PROTEOSTASIS THERAPEUTICS, INC.  
   
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS  
(In thousands, except share and per share amounts)  
(Unaudited)  
   
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2016     2015     2016     2015  
Revenue   $ 1,715     $ 1,201     $ 4,324     $ 3,078  
Operating expenses:                                
Research and development     9,218       6,258       23,498       16,737  
General and administrative     3,266       1,523       8,682       4,553  
Total operating expenses     12,484       7,781       32,180       21,290  
Loss from operations     (10,769 )     (6,580 )     (27,856 )     (18,212 )
Interest income     36             56        
Interest expense           (189 )           (599 )
Other expense, net     (38 )     (281 )     (15 )     (598 )
Net loss     (10,771 )     (7,050 )     (27,815 )     (19,409 )
Modification of Series A preferred stock           174             10,739  
Accruing dividends on preferred stock           (2,459 )     (1,378 )     (6,698 )
Net loss attributable to common stockholders   $ (10,771 )   $ (9,335 )   $ (29,193 )   $ (15,368 )
Net loss per share attributable to common stockholders—basic and diluted   $ (0.54 )   $ (16.77 )   $ (1.75 )   $ (28.05 )
Weighted average common shares outstanding—basic and diluted     20,073,685       556,567       16,672,368       547,816  
                                 
Media Contact: 
Katie Engleman, Pure Communications, Inc.

(910) 509-3977 
katie@purecommunicationsinc.com

Investor Contact:
Luke Heagle, Pure Communications, Inc.
(910) 726-1372
luke@purecommunicationsinc.com
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