SOUTH SAN FRANCISCO, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), 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 2022 financial results.
“Our strong third quarter progress was highlighted by positive data from our lead candidate PLN-74809 in IPF, the further strengthening of our financial position through a successful public offering and the positive DSMB safety review of the ongoing INTEGRIS-IPF trial that added to the growing favorable safety profile of this novel drug candidate,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. “This progress sets the stage for several near-term clinical data readouts, including the 12-week and 24-week data from the INTEGRIS-IPF program in early 2023 and the first half of 2023, respectively.”
Third Quarter and Recent Highlights
PLN-74809 (bexotegrast) Highlights
Early-Stage Development Programs
Corporate Highlights
Third Quarter 2022 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 (bexotegrast), is an oral small molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 (bexotegrast) has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in PSC. Pliant is currently conducting Phase 2a trials of PLN-74809 (bexotegrast) in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.PliantRx.com and follow us on Twitter, LinkedIn, Facebook and YouTube.
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 planned INDs in our oncology and muscular dystrophy programs; anticipated progress of our clinical trials and timing of regulatory, enrollment and data disclosures; the efficacy and safety profile of our product candidates; our intended use the net proceeds from our common stock offering; the sufficiency of our cash runway to fund operations to mid-2025 and the availability of additional term loans under our loan facility;. 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, our reliance on third parties for critical aspects of our development operations, 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 Annual Report on Form 10-K filed for the year ended December 31, 2021 with the SEC on March 1, 2022, as updated by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, which we are filing with the SEC today, each available on the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
Pliant Therapeutics, Inc.
Condensed Statements of Operations
(Unaudited)
(In thousands, except number of shares and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Revenue | $ | 1,482 | $ | 1,610 | $ | 7,720 | $ | 5,573 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | (24,606 | ) | (21,052 | ) | (71,822 | ) | (58,797 | ) | |||||||
| General and administrative | (8,823 | ) | (7,671 | ) | (25,698 | ) | (19,712 | ) | |||||||
| Total operating expenses | (33,429 | ) | (28,723 | ) | (97,520 | ) | (78,509 | ) | |||||||
| Loss from operations | (31,947 | ) | (27,113 | ) | (89,800 | ) | (72,936 | ) | |||||||
| Interest and other income (expense), net | 1,332 | 68 | 1,539 | 204 | |||||||||||
| Net loss | $ | (30,615 | ) | $ | (27,045 | ) | $ | (88,261 | ) | $ | (72,732 | ) | |||
| Net loss attributable to common stockholders | $ | (30,615 | ) | $ | (27,045 | ) | $ | (88,261 | ) | $ | (72,732 | ) | |||
| Net loss per share attributable to common stockholders: | |||||||||||||||
| Basic and diluted | $ | (0.65 | ) | $ | (0.75 | ) | $ | (2.22 | ) | $ | (2.03 | ) | |||
| Shares used in computing net loss per share attributable to common stockholders: | |||||||||||||||
| Basic and diluted | 46,799,058 | 35,906,303 | 39,735,342 | 35,787,022 | |||||||||||
Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
| June 30, 2022 | December 31, 2021 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 44,617 | $ | 51,665 | |||
| Short-term investments | 315,624 | 148,931 | |||||
| Accounts receivable | 1,482 | 1,998 | |||||
| Tax credit receivable | 83 | 83 | |||||
| Prepaid expenses and other current assets | 4,159 | 6,764 | |||||
| Total current assets | 365,965 | 209,441 | |||||
| Property and equipment, net | 4,799 | 4,606 | |||||
| Operating lease right-of-use assets | 6,020 | 6,330 | |||||
| Other non-current assets | 397 | 838 | |||||
| Total assets | $ | 377,181 | $ | 221,215 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 3,206 | $ | 2,971 | |||
| Accrued liabilities | 20,306 | 11,991 | |||||
| Lease liabilities, current | 2,649 | 1,869 | |||||
| Total current liabilities | 26,161 | 16,831 | |||||
| Lease liabilities, non-current | 4,126 | 5,325 | |||||
| Term loan | 9,871 | — | |||||
| Total liabilities | 40,187 | 22,156 | |||||
| Stockholders’ equity | |||||||
| Common stock | 5 | 3 | |||||
| Additional paid-in capital | 642,795 | 414,348 | |||||
| Accumulated deficit | (303,352 | ) | (215,091 | ) | |||
| Accumulated other comprehensive loss | (2,454 | ) | (201 | ) | |||
| Total stockholders’ equity | 336,994 | 199,059 | |||||
| Total liabilities and stockholders’ equity | $ | 377,181 | $ | 221,215 | |||