Full Press Release Details
Pliant Therapeutics Provides Corporate Update and
Reports Fourth Quarter and Full Year 2020 Financial Results
- PLN-74809 Phase 2a PET Imaging Trial Resumed, with Preliminary Data Expected First Half of 2021
- PLN-74809 Phase 2a 12-week trials in IPF and PSC Gained Momentum in the Fourth Quarter, Currently on Track to Complete Enrollment by the End of 2021 and First Half of 2022, Respectively
SOUTH SAN FRANCISCO - March 16, 2021 - Pliant Therapeutics, Inc. (Nasdaq: PLRX) (the Company), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today provided a corporate update and reported fourth quarter and full year 2020 financial results.
"We entered 2021 in a strong position resulting from our team's execution throughout the fourth quarter despite the challenges of the evolving backdrop of the COVID-19 pandemic," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "Our focus remains on continuing to actively drive our lead Phase 2a programs in IPF and PSC towards near term data readouts, to advance our earlier-stage oncology and muscular dystrophy portfolio towards the clinic while also leveraging our robust discovery engine to create a broad and differentiated product portfolio focused on delivering novel treatments to areas of unmet medical need."
Fourth Quarter and Recent Highlights
COVID-19 Preparedness
The Company continues to develop and maintain policies and procedures to enable us to operate safely and productively during the COVID-19 pandemic. The Company has experienced delays in clinical trial operations which have impacted and may further impact the expected timing of data readouts. The Company is working closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines. The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the long-term impacts of the pandemic become better understood.
Fourth Quarter 2020 Financial Results
About Pliant Therapeutics, Inc.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning 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. These statements include those regarding our product candidates, including their development and therapeutic potential, the advancement of our clinical and preclinical pipeline, including the timing, enrollment and results of our clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical trials, clinical supply and plans, our collaboration with Novartis for PLN-1474 and the intended benefits of such collaborations, and our financial position and cash runway. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our prospectus dated June 3, 2020 as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, the Quarterly Report for the second quarter of 2020 filed with the SEC on Form 10-Q on August 11, 2020, and the Quarterly Report for the third quarter of 2020 filed with the SEC on Form 10-Q on November 10, which are available on the SEC's website at www.sec.gov. Additional information will be made available in Pliant Therapeutics Annual Report on Form 10-K for the year ended December 31, 2020 forward looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
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Pliant Therapeutics, Inc.
Pliant Therapeutics, Inc.
Condensed Statements of Operations
(In thousands, except number of shares and per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue - related party | $ | 4,465 | $ | 57,052 | $ | 41,817 | $ | 57,052 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (17,854 | ) | (11,727 | ) | (66,193 | ) | (47,353 | ) | ||||||||
| General and administrative | (5,627 | ) | (3,103 | ) | (17,269 | ) | (10,930 | ) | ||||||||
| Total operating expenses | (23,481 | ) | (14,830 | ) | (83,462 | ) | (58,283 | ) | ||||||||
| (Loss) income from operations | (19,016 | ) | 42,222 | (41,645 | ) | (1,231 | ) | |||||||||
| Interest income | 86 | 115 | 478 | 816 | ||||||||||||
| Other expense, net | (97 | ) | (168 | ) | (366 | ) | (216 | ) | ||||||||
| Net (loss) income | $ | (19,027 | ) | $ | 42,169 | $ | (41,533 | ) | $ | (631 | ) | |||||
| Accretion to redemption value and dividends on redeemable convertible preferred stock | - | (2,147 | ) | - | (6,225 | ) | ||||||||||
| Less: Undistributed earnings to preferred shareholders | - | (13,789 | ) | - | - | |||||||||||
| Net (loss) income attributable to common stockholders | $ | (19,027 | ) | $ | 26,233 | $ | (41,533 | ) | $ | (6,856 | ) | |||||
| Net (loss) income per share, attributable to common stockholders: | ||||||||||||||||
| Basic | $ | (0.54 | ) | $ | 15.82 | $ | (1.95 | ) | $ | (4.22 | ) | |||||
| Diluted | $ | (0.54 | ) | $ | 1.50 | $ | (1.95 | ) | $ | (4.22 | ) | |||||
| Shares used in computing net (loss) income per share attributable to common stockholders: | ||||||||||||||||
| Basic | 35,495,414 | 1,658,559 | 21,344,236 | 1,623,358 | ||||||||||||
| Diluted | 35,495,414 | 17,527,829 | 21,344,236 | 1,623,358 |
Pliant Therapeutics, Inc.
Condensed Balance Sheets
| December 31, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 50,882 | $ | 85,807 | ||||
| Short-term investments | 226,012 | 16,966 | ||||||
| Accounts receivable | 9,279 | 7,052 | ||||||
| Tax credit receivable | 83 | 333 | ||||||
| Prepaid expenses and other current assets | 4,498 | 1,742 | ||||||
| Total current assets | 290,754 | 111,900 | ||||||
| Property and equipment, net | 4,321 | 4,079 | ||||||
| Other non-current assets | 451 | 3,085 | ||||||
| Total assets | $ | 295,526 | $ | 119,064 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,023 | $ | 1,250 | ||||
| Accrued liabilities | 9,576 | 6,922 | ||||||
| Total current liabilities | 11,599 | 8,172 | ||||||
| Other long-term liabilities | 866 | 912 | ||||||
| Total liabilities | 12,465 | 9,084 | ||||||
| Series A redeemable convertible preferred stock | - | 62,468 | ||||||
| Series B redeemable convertible preferred stock | - | 75,860 | ||||||
| Series C redeemable convertible preferred stock | - | 47,947 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 3 | 1 | ||||||
| Additional paid-in capital | 400,918 | - | ||||||
| Accumulated deficit | (117,828 | ) | (76,295 | ) | ||||
| Accumulated other comprehensive loss | (32 | ) | (1 | ) | ||||
| Total stockholders' equity (deficit) | 283,061 | (76,295 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 295,526 | $ | 119,064 |