CAMBRIDGE, Mass., Nov. 10, 2016 (GLOBE NEWSWIRE) -- 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 Harbor
To 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 | ||||||||||||