Pliant Therapeutics(PLRX) - 2025 Q1 - Quarterly Results

Corporate Update and First Quarter 2025 Financial Results Overview Recent Developments and Program Highlights Pliant Therapeutics updated on clinical programs, including BEACON-IPF trial close-out and promising Phase 1 PLN-101095 oncology data Bexotegrast Program Updates BEACON-IPF Phase 2b/3 trial close-out continues, with topline data expected in Q2 2025; Phase 2a PET imaging trial results published - BEACON-IPF Phase 2b/3 trial close-out activities are ongoing, with topline data anticipated in the second quarter of 2025[1][2][7] - Results from a Phase 2a positron emission tomography (PET) imaging trial, reporting positive findings on collagen deposition in IPF patients, were published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM)[7] Oncology Program (PLN-101095) Updates Interim Phase 1 data for PLN-101095 with pembrolizumab demonstrated antitumor activity and confirmed partial responses in solid tumors, with good tolerability - Interim Phase 1 data for PLN-101095 in combination with pembrolizumab showed antitumor activity with confirmed partial responses in solid tumors resistant to immune checkpoint inhibitors[2][4] - Three of six patients treated at the 1000 mg BID dose (non-small cell lung cancer, cholangiocarcinoma, and melanoma) experienced confirmed partial responses with tumor size reductions of 74%, 48%, and 42%, respectively[4] - PLN-101095 was generally well tolerated across all doses tested, and the trial is currently enrolling the fourth of five potential cohorts[4] Corporate Strategic Realignment Pliant Therapeutics announced a strategic realignment, including a 45% workforce reduction, to extend its cash runway and support clinical trials - A strategic realignment of workforce and operations was announced on May 1, 2025, including an approximately 45% reduction in workforce and other cost-saving actions[5] - The realignment is expected to extend the cash runway to support the execution of clinical trials, including late-stage trials, and is anticipated to be substantially completed by the second quarter of 2025[1][5] First Quarter 2025 Financial Highlights Pliant Therapeutics reported a net loss of $56.2 million for Q1 2025, driven by higher operating expenses, while maintaining a strong cash position of $307.1 million Key Financial Highlights (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) | | :----------------------------- | :-------------------- | :-------------------- | :----------- | | Research and development expenses | $43.4 | $37.1 | +$6.3 | | General and administrative expenses | $15.5 | $15.2 | +$0.3 | | Net loss | $56.2 | $47.0 | +$9.2 | | Cash, cash equivalents and short-term investments (as of March 31) | $307.1 | N/A | N/A | - The increase in research and development expenses was primarily due to the acceleration of close-out activities for the BEACON-IPF study and increased employee-related expenses[11] About Pliant Therapeutics, Inc. Company Overview and Product Pipeline Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on fibrotic diseases, with lead candidate bexotegrast for IPF and other programs in oncology and muscular dystrophies - Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on fibrotic diseases[8] - Bexotegrast (PLN-74809), the lead product candidate, is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins in development for idiopathic pulmonary fibrosis (IPF)[8] - Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency in IPF[8] - The pipeline includes PLN-101095 (Phase 1 for solid tumors resistant to immune checkpoint inhibitors) and PLN-101325 (Phase 1 for muscular dystrophies)[8] Condensed Financial Statements Condensed Statements of Operations For Q1 2025, Pliant Therapeutics reported a net loss of $56.2 million, an increase from the prior year, primarily due to higher R&D expenses Condensed Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $(43,436) | $(37,146) | | General and administrative | $(15,499) | $(15,246) | | Total operating expenses | $(58,935) | $(52,392) | | Loss from operations | $(58,935) | $(52,392) | | Interest and other income (expense), net | $3,568 | $5,882 | | Interest expense | $(799) | $(445) | | Net loss | $(56,166) | $(46,955) | | Net loss per share - basic and diluted | $(0.92) | $(0.78) | | Shares used in computing net loss per share | 61,222,676 | 60,180,921 | Condensed Balance Sheets As of March 31, 2025, total assets decreased to $344.8 million from $396.9 million, mainly due to reduced short-term investments, while total liabilities also decreased Condensed Balance Sheets (Unaudited, in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $91,936 | $71,188 | | Short-term investments | $213,709 | $284,536 | | Total current assets | $311,191 | $362,264 | | Total assets | $344,770 | $396,949 | | Total current liabilities | $28,203 | $33,218 | | Total liabilities | $87,606 | $92,868 | | Total stockholders' equity | $257,164 | $304,081 | Forward-Looking Statements Disclaimer and Risk Factors This section disclaims forward-looking statements, highlighting various risks and uncertainties that could cause actual results to differ materially - Statements regarding future events, conditions, or circumstances are identified as forward-looking statements, subject to risks and uncertainties[10] - Risks include those related to the development and commercialization of product candidates, delays in trials, macroeconomic conditions, reliance on single-source third parties, and capital requirements[10] - These and additional risks are discussed in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of the company's Quarterly Report on Form 10-Q for the period ended March 31, 2025[10] - Pliant Therapeutics does not undertake any obligation to update forward-looking statements[10] Investor and Media Contact Contact Information This section provides the contact details for investor relations and corporate communications at Pliant Therapeutics - Contact for Investor and Media: Christopher Keenan, Vice President, Investor Relations and Corporate Communications[11] - Email: ir@pliantrx.com[11]