Full Press Release Details
Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2020
SOUTH SAN FRANCISCO - November 10, 2020 - 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 third quarter 2020 financial results.
"Reflecting back on the first three quarters of 2020, I'm proud of the progress we've made despite the challenges related to the COVID-19 pandemic," said Bernard Coulie, M.D., Ph.D., Chief Executive Officer and President of Pliant Therapeutics. "We closed a successful IPO, took important steps in advancing our clinical programs across four indications, and further strengthened our leadership team. Looking ahead, with a strong cash position to advance our robust pipeline, we remain deeply committed to bringing novel treatments to people with fibrotic diseases."
COVID-19 Preparedness
Pliant continues to develop policies and procedures to enable the Company 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. Pliant 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 impacts of the pandemic become better understood.
Third Quarter 2020 Financial Results
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of av 6 and av 1 integrins that it is developing for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC. Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of av 1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies.
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, and the Quarterly Report for the second quarter of 2020 filed with the SEC on Form 10-Q on August 11, 2020 which are available on the SEC's website at www.sec.gov. Additional information will be made available in Pliant Therapeutics quarterly report on Form 10-Q for the quarter ended September 30, 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.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except number of shares and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue - related party | $ | 4,814 | $ | - | $ | 37,352 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (16,884 | ) | (10,779 | ) | (48,339 | ) | (35,626 | ) | ||||||||
| General and administrative | (4,591 | ) | (2,583 | ) | (11,642 | ) | (7,827 | ) | ||||||||
| Total operating expenses | (21,475 | ) | (13,362 | ) | (59,981 | ) | (43,453 | ) | ||||||||
| Loss from operations | (16,661 | ) | (13,362 | ) | (22,629 | ) | (43,453 | ) | ||||||||
| Interest income | 72 | 148 | 392 | 701 | ||||||||||||
| Other income (expense), net | 55 | (41 | ) | (269 | ) | (48 | ) | |||||||||
| Net loss | $ | (16,534 | ) | $ | (13,255 | ) | $ | (22,506 | ) | $ | (42,800 | ) | ||||
| Accretion to redemption value and cumulative dividends on redeemable convertible preferred stock | - | (1,375 | ) | - | (4,078 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (16,534 | ) | $ | (14,630 | ) | $ | (22,506 | ) | $ | (46,878 | ) | ||||
| Net loss per share, attributable to common stockholders: | ||||||||||||||||
| Basic | $ | (0.47 | ) | $ | (8.53 | ) | $ | (1.36 | ) | $ | (30.03 | ) | ||||
| Diluted | $ | (0.47 | ) | $ | (8.53 | ) | $ | (1.36 | ) | $ | (30.03 | ) | ||||
| Shares used in computing net loss per share attributable to common stockholders: | ||||||||||||||||
| Basic | 35,445,504 | 1,714,285 | 16,592,746 | 1,561,242 | ||||||||||||
| Diluted | 35,445,504 | 1,714,285 | 16,592,746 | 1,561,242 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (16,534 | ) | $ | (13,255 | ) | $ | (22,506 | ) | $ | (42,800 | ) | ||||
| Net unrealized gain (loss) on short-term investments | $ | 12 | $ | (10 | ) | $ | (17 | ) | $ | 1 | ||||||
| Total other comprehensive income (loss) | 12 | (10 | ) | (17 | ) | 1 | ||||||||||
| Comprehensive loss | $ | (16,522 | ) | $ | (13,265 | ) | $ | (22,523 | ) | $ | (42,799 | ) |
Pliant Therapeutics, Inc.
Condensed Balance Sheets
(In thousands, except number of shares and per share amounts)
| September 30, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 55,224 | $ | 85,807 | ||||
| Short-term investments | 238,776 | 16,966 | ||||||
| Accounts receivable | 7,131 | 7,052 | ||||||
| Tax credit receivable | 83 | 333 | ||||||
| Prepaid expenses and other current assets | 6,515 | 1,742 | ||||||
| Total current assets | 307,729 | 111,900 | ||||||
| Property and equipment, net | 4,144 | 4,079 | ||||||
| Other non-current assets | 451 | 3,085 | ||||||
| Total assets | $ | 312,324 | $ | 119,064 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,140 | $ | 1,250 | ||||
| Accrued liabilities (Note 5) | 7,886 | 6,922 | ||||||
| Total current liabilities | 11,026 | 8,172 | ||||||
| Other long-term liabilities (Note 5) | 952 | 912 | ||||||
| Total liabilities | 11,978 | 9,084 | ||||||
| Commitments and Contingencies (Note 13) | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019; | - | - | ||||||
| Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 56,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 and 56,000,000 shares issued and outstanding, at September 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $62,468 at September 30, 2020 and December 31, 2019, respectively; | - | 62,468 | ||||||
| Series B redeemable convertible preferred stock, $0.0001 par value; 0 shares and 49,501,221 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares and 49,501,221 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $75,860 at September 30, 2020 and December 31, 2019, respectively; | - | 75,860 | ||||||
| Series C redeemable convertible preferred stock, $0.0001 par value; 0 shares and 44,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares and 26,360,745 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $47,947 at September 30, 2020 and December 31, 2019, respectively; | - | 47,947 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Common stock, $0.0001 par value; 300,000,000 and 181,000,000 shares authorized at September 30, 2020 and December 31, 2019; and 35,465,715 and 1,846,024 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; | 3 | 1 | ||||||
| Additional paid-in capital | 399,162 | - | ||||||
| Accumulated deficit | (98,801 | ) | (76,295 | ) | ||||
| Accumulated other comprehensive loss | (18 | ) | (1 | ) | ||||
| Total stockholders' equity (deficit) | 300,346 | (76,295 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 312,324 | $ | 119,064 |