Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2024 Financial Results

Rhea-AI Summary

Pliant Therapeutics (PLRX) has announced the discontinuation of its BEACON-IPF Phase 2b trial following recommendations from both the data safety monitoring board and an outside expert panel. The trial was halted due to an imbalance in IPF-related adverse events between treatment and placebo groups, though early efficacy signals were observed in forced vital capacity endpoints.

The company continues to advance its other programs, including a Phase 1 trial of PLN-101095 in solid tumors, currently in its fourth of five planned dose cohorts, with interim data expected in Q1 2025. Additionally, PLN-101325 for muscular dystrophies is Phase 1 ready with clinical trial approval in Australia.

Financial results for Q4 2024 show R&D expenses of $38.8M (up from $33.2M YoY) and G&A expenses of $14.5M (up from $13.9M YoY). Net loss increased to $49.7M from $41.1M in the prior-year quarter. The company maintains a strong financial position with $357.2M in cash and investments, expected to fund operations beyond 12 months.

Positive

• Strong cash position of $357.2M, sufficient for >12 months operations
• Early efficacy signals observed in BEACON-IPF trial FVC endpoint
• PLN-101095 oncology trial progressing to fourth cohort
• PLN-101325 program ready for Phase 1 trials

Negative

• BEACON-IPF Phase 2b trial discontinued due to safety concerns
• Net loss increased 21% YoY to $49.7M
• R&D expenses increased 17% YoY to $38.8M
• G&A expenses rose to $14.5M from $13.9M YoY

Insights

Biotechnology Analyst

The discontinuation of Pliant's BEACON-IPF Phase 2b trial represents a significant setback for the company's lead program. Following recommendations from both the independent Data Safety Monitoring Board and an outside expert panel, the trial was halted due to an imbalance in IPF-related adverse events between treatment and placebo groups - a critical safety concern that overwhelmed the preliminary efficacy signals observed on the FVC endpoint.

While bexotegrast's development pathway becomes uncertain, Pliant's earlier-stage pipeline now takes center stage. The company's oncology program with PLN-101095, currently in Phase 1 dose-escalation with interim data expected in Q1 2025, becomes increasingly important. As a dual inhibitor of αvβ8 and αvβ1 integrins targeting TGF-β in the tumor microenvironment, this asset represents a different mechanism within Pliant's integrin-focused platform. Similarly, PLN-101325 for muscular dystrophies is Phase 1 ready with regulatory approval in Australia.

For clinical-stage biotechs, pipeline diversification provides some buffer against program failures, but the discontinuation of an advanced-stage program like BEACON-IPF typically creates a substantial development gap that earlier programs can't immediately fill. The company's ability to analyze BEACON-IPF data and potentially salvage the program with modifications will be crucial, though historically safety signals in pulmonary fibrosis trials have proven challenging to overcome.

Financial Analyst

Pliant's Q4 2024 financial results reveal accelerating cash burn alongside a significant clinical setback. R&D expenses increased 16.9% year-over-year to $38.8 million, primarily driven by the now-discontinued BEACON-IPF trial. G&A expenses rose modestly to $14.5 million. The quarterly net loss widened to $49.7 million from $41.1 million in the prior-year period, representing a 20.9% increase.

The company's $357.2 million cash position provides a substantial runway, which management indicates is sufficient for operations beyond 12 months. This buffer gives Pliant flexibility to reorient its development strategy following the BEACON-IPF discontinuation. However, investors should note that cash utilization may shift significantly as the company redirects resources from the terminated program.

The BEACON-IPF discontinuation creates substantial uncertainty around Pliant's development timeline and potential path to commercialization. For a clinical-stage biotech with no marketed products, this reset could extend the timeline to potential revenue generation. While the company maintains other pipeline assets, including the oncology program with interim data expected soon, these earlier-stage programs represent longer development horizons and additional clinical risk that may necessitate reassessment of the company's valuation.

Discontinuation of BEACON-IPF following DSMB and outside expert panel recommendation

SOUTH SAN FRANCISCO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported fourth quarter 2024 financial results.

Fourth Quarter and Recent Highlights

Bexotegrast Highlights

• BEACON-IPF discontinued following recommendation from expanded data safety monitoring board (DSMB). Following a prespecified data review and recommendation by the trial’s independent DSMB, as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial. While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed. The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development. BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg in patients with idiopathic pulmonary fibrosis (IPF).
  

Oncology Program

• Phase 1 trial of PLN-101095 in solid tumors continues to enroll, with interim data expected in the first quarter 2025. This is a Phase 1 open label trial of PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The trial is currently dosing the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Interim data from the first three cohorts is expected in the first quarter of 2025.
  

Neuromuscular Program

• PLN-101325 for treatment of muscular dystrophies. PLN-101325 is a monoclonal antibody that acts as an allosteric agonist of integrin α7β1, currently in development for treatment of muscular dystrophies. PLN-101325 is Phase 1 ready with clinical trial approval (CTA) open in Australia.
  

Corporate Highlights

• Appointment of Delphine Imbert, Ph.D. as Chief Technical Officer. Dr. Imbert brings 25 years of product development, process optimization and manufacturing experience across multiple drug modalities. Most recently, Dr. Imbert served as Senior Vice President of CMC and Technical Operations at Chinook Therapeutics.
  

Fourth Quarter 2024 Financial Results

• Research and development expenses were $38.8 million, as compared to $33.2 million for the prior-year quarter. The increase was primarily due to costs associated with the BEACON-IPF Phase 2b/3 clinical trial.
• General and administrative expenses were $14.5 million, as compared to $13.9 million for the prior-year quarter. The increase was primarily due to employee-related expenses driven by increased headcount over prior year.
• Net loss was $49.7 million as compared to $41.1 million for the prior-year quarter. The increase was due to higher operating expenses primarily attributable to costs associated with the BEACON-IPF Phase 2b/3 clinical trial and reduced interest income on short-term investments.
• As of December 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term investments of $357.2 million which the Company expects to be sufficient to fund operations for the next 12 months and beyond.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indication for the treatment of idiopathic pulmonary fibrosis, or IPF. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency in IPF. Pliant has initiated BEACON-IPF, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies.

For additional information, please visit: www.PliantRx.com. Follow us on social media X, LinkedIn, and Facebook.

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 the Company’s, the DSMB’s and the outside expert panel’s further review and analysis of data, the ability of the outside expert panel and the DSMB to reach a consensus recommendation regarding BEACON-IPF and the timing thereof; the Company’s current and future plans for bexotegrast, including with respect to the BEACON-IPF clinical trial; our plans for the future development of PLN-101325 and PLN-101095; bexotegrast’s potential to become a treatment for IPF; the anticipated timing of data and progress from our clinical studies and public announcements related thereto; discussions with regulatory authorities; and our access to future capital pursuant to the Oxford Loan Agreement and the sufficiency of such capital, together with our cash runway, to fund operations into the second half of 2026. 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 current macroeconomic and marketplace conditions 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, including the availability of additional term loans under our loan facility, 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 for the period ended December 31, 2024 which we are filing with the SEC today, 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 December 31,								Twelve Months Ended December 31,
	2024				2023				2024				2023
Revenue	$	—			$	—			$	—			$	1,580
Operating expenses:
Research and development		(38,793	)			(33,183	)			(169,310	)			(127,797	)
General and administrative		(14,527	)			(13,854	)			(59,055	)			(57,928	)
Total operating expenses		(53,320	)			(47,037	)			(228,365	)			(185,725	)
Loss from operations		(53,320	)			(47,037	)			(228,365	)			(184,145	)
Interest and other income (expense), net		4,422				6,249				21,085				24,076
Interest expense		(834	)			(321	)			(3,024	)			(1,267	)
Net loss	$	(49,732	)		$	(41,109	)		$	(210,304	)		$	(161,336	)
Net loss per share - basic and diluted	$	(0.82	)		$	(0.69	)		$	(3.47	)		$	(2.75	)
Weighted average shares used in computing net loss per share - basic and diluted		60,854,322				59,904,481				60,538,639				58,719,083

Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
	December 31,  2024				December 31,  2023
Assets
Current assets
Cash and cash equivalents	$	71,188			$	63,234
Short-term investments		284,536				431,011
Prepaid expenses and other current assets		6,540				11,257
Total current assets		362,264				505,502
Property and equipment, net		5,525				3,567
Operating lease right-of-use assets		27,243				1,211
Restricted cash equivalent		1,482				1,482
Other non-current assets		435				392
Total assets	$	396,949			$	512,154
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	5,960			$	4,531
Accrued research and development		14,363				12,456
Accrued liabilities		12,353				10,219
Lease liabilities, current		542				1,318
Total current liabilities		33,218				28,524
Lease liabilities, non-current		29,439				—
Long-term debt		30,211				10,054
Total liabilities		92,868				38,578
Stockholders’ equity
Preferred stock		—				—
Common stock		6				6
Additional paid-in capital		1,013,806				972,973
Accumulated deficit		(710,052	)			(499,748	)
Accumulated other comprehensive gain		321				345
Total stockholders’ equity		304,081				473,576
Total liabilities and stockholders’ equity	$	396,949			$	512,154

FAQ

Why did Pliant Therapeutics (PLRX) discontinue the BEACON-IPF trial?

PLRX discontinued BEACON-IPF due to an imbalance in unadjudicated IPF-related adverse events between treatment and placebo groups, following recommendations from the DSMB and external expert panel.

What is the cash position of Pliant Therapeutics (PLRX) as of Q4 2024?

PLRX reported $357.2M in cash, cash equivalents, restricted cash and short-term investments as of December 31, 2024.

How much did PLRX's net loss increase in Q4 2024 compared to the previous year?

PLRX's net loss increased to $49.7M in Q4 2024 from $41.1M in Q4 2023, primarily due to higher BEACON-IPF trial costs.

When will Pliant Therapeutics (PLRX) release interim data for PLN-101095 solid tumor trial?

PLRX expects to release interim data from the first three cohorts of the PLN-101095 trial in Q1 2025.