Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

Rhea-AI Summary

Pliant Therapeutics (Nasdaq: PLRX) provided a corporate update and reported third quarter 2025 results on Nov 6, 2025. The company completed enrollment in the Phase 1 open-label trial of PLN-101095 in solid tumors; interim data showed a 50% objective response rate in one dose cohort and full trial data, including the two highest dose cohorts, are expected by the end of 2025. Close out activities for the BEACON‑IPF Phase 2b/3 trial are expected to finish in Q4 2025, with full results planned for future publication. In October the company completed a voluntary prepayment of its March 11, 2024 loan with Oxford Finance. Q3 2025 results: R&D $17.9M (prior $47.8M), G&A $10.3M (prior $14.3M), Net loss $26.3M (prior $57.8M), and Cash & short-term investments $243.3M as of Sept 30, 2025.

Positive

• PLN-101095 Phase 1 completed enrollment
• Interim 50% objective response rate in a dose cohort
• Cash balance $243.3M as of Sept 30, 2025

Negative

• Discontinuation and close out of BEACON‑IPF program
• R&D expenses declined from $47.8M to $17.9M indicating program wind-down

Insights

Oncology development analyst

PLN-101095 shows promising early activity; full Phase 1 data due by end of 2025 will be determinative.

PLN-101095 completed enrollment across five dose cohorts in a Phase 1 open-label trial testing monotherapy and pembrolizumab combinations in checkpoint‑resistant solid tumors. An interim cohort reported a 50% objective response rate and tolerability, which signals a potential biological effect in a difficult-to-treat population.

The program’s near-term value depends on the completeness and consistency of the remaining cohorts, safety at higher doses, and durability of responses; those factors remain unknown until full data are released. Watch for the full dataset, including the two highest dose cohorts, expected by Q4 2025, to assess dose‑response, safety, and response durability.

Corporate finance analyst

Discontinuation of BEACON‑IPF cut costs and left the company with a sizeable cash runway of $243.3 million.

BEACON‑IPF close‑out in Q4 2025 and voluntary prepayment of the Oxford Finance loan materially reduced ongoing R&D and interest burden. R&D fell to $17.9 million and G&A to $10.3 million, producing a narrower net loss of $26.3 million for the quarter.

Key near-term items are completion of BEACON‑IPF close-out and publication timing, plus the Phase 1 dataset for PLN-101095 by Q4 2025, which will influence capital allocation decisions; monitor cash burn against milestones and any financing or partnering announcements over the next 6–12 months.

Oncology program advancing with data expected in the fourth quarter 2025

BEACON-IPF close out activities to be completed in the fourth quarter 2025

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported third quarter 2025 financial results.

“During the third quarter, our team continued to advance our portfolio while winding down activities surrounding the BEACON-IPF trial,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “Looking ahead, we continue to evaluate a range of opportunities to create shareholder value.”

Third Quarter and Recent Developments

Oncology Program

• Phase 1 open-label trial of PLN-101095 in solid tumors has completed enrollment. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March of 2025 we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment of all five dose cohorts. Data from the trial, including the two highest dose cohorts, is expected by the end of 2025.
  
  

Bexotegrast

• BEACON-IPF close out activities to be completed in fourth quarter. Close out activities from the BEACON-IPF Phase 2b/3 clinical trial are expected to be completed in the fourth quarter of 2025 with full results from the trial to be submitted for future publication.
  
  

Corporate Highlights

• In October, the Company announced that it completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the March 11, 2024 Loan Agreement with Oxford Finance LLC.
  
  

Third Quarter 2025 Financial Results

• Research and development expenses were $17.9 million as compared to $47.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF.
• General and administrative expenses were $10.3 million as compared to $14.3 million for the prior-year quarter. The decrease was primarily due to lower personnel-related costs resulting from the strategic restructuring of our workforce.
• Net loss was $26.3 million as compared to $57.8 million for the prior-year quarter. The decrease was primarily attributable to the discontinuation of BEACON-IPF coupled with the decrease in personnel-related costs resulting from the strategic restructuring of our workforce.
• As of September 30, 2025, the Company had cash, cash equivalents and short-term investments of $243.3 million.
  
  

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. The Company’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of α_vß₈ and α_vß₁ 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. Pliant’s early-stage platform includes preclinical research focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules. 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 close-out of the BEACON-IPF study, the anticipated timing of data from our ongoing Phase 1 trial of PLN-101095, the cost savings expected to result from our strategic restructuring, our ongoing evaluation of business opportunities and our ability to maintain core capabilities in support of Pliant’s next steps. 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 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, geopolitical and marketplace conditions on our business, operations, clinical supply and plans, our reliance on single-source third parties located in foreign jurisdictions, including China, 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 Quarterly Report on Form 10-Q for the period ended September 30, 2025 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 September 30,
		2025				2024
Operating expenses:
Research and development	$	(17,938	)		$	(47,754	)
General and administrative		(10,331	)			(14,260	)
Total operating expenses		(28,269	)			(62,014	)
Loss from operations		(28,269	)			(62,014	)
Interest and other income (expense), net		2,783				5,128
Interest expense		(815	)			(877	)
Net loss	$	(26,301	)		$	(57,763	)
Net loss per share - basic and diluted	$	(0.43	)		$	(0.95	)
Shares used in computing net loss per share - basic and diluted		61,406,475				60,730,935

Pliant Therapeutics, Inc. Condensed Balance Sheets (Unaudited) (In thousands)
	September 30, 2025				December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	93,732			$	71,188
Short-term investments		148,065				284,536
Prepaid expenses and other current assets		3,791				6,540
Total current assets		245,588				362,264
Property and equipment, net		4,344				5,525
Operating lease right-of-use assets		24,794				27,243
Restricted cash		1,482				1,482
Other non-current assets		392				435
Total assets	$	276,600			$	396,949
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	485			$	5,960
Accrued research and development		7,779				14,363
Accrued liabilities		8,173				12,353
Operating lease liabilities, current		1,187				542
Total current liabilities		17,624				33,218
Operating lease liabilities, non-current		28,231				29,439
Long-term debt		30,439				30,211
Total liabilities		76,294				92,868
Stockholders’ equity
Preferred stock		—				—
Common stock		6				6
Additional paid-in capital		1,036,085				1,013,806
Accumulated deficit		(835,819	)			(710,052	)
Accumulated other comprehensive gain		34				321
Total stockholders’ equity		200,306				304,081
Total liabilities and stockholders’ equity	$	276,600			$	396,949

FAQ

What did Pliant (PLRX) announce about PLN-101095 on Nov 6, 2025?

Pliant said the Phase 1 open-label trial of PLN-101095 completed enrollment and full data, including two highest dose cohorts, are expected by the end of 2025.

When will Pliant report full PLN-101095 results for PLRX?

The company expects to report full Phase 1 data, including the top two dose cohorts, by end of 2025.

What is the significance of the 50% objective response rate reported by Pliant (PLRX)?

An interim cohort in the PLN-101095 trial showed an objective response rate of 50%, indicating initial clinical activity in patients resistant to checkpoint inhibitors.

What is the status and timing for BEACON-IPF results for PLRX?

Close out activities for the BEACON‑IPF Phase 2b/3 trial are expected to be completed in Q4 2025, with full results to be submitted for future publication.

How did Pliant's Q3 2025 financials affect PLRX cash and losses?

Q3 2025 net loss was $26.3M (vs $57.8M prior year) and cash, cash equivalents and short-term investments totaled $243.3M as of Sept 30, 2025.