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Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

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Pliant Therapeutics (Nasdaq: PLRX) reported a Q1 2026 net loss of $20.0 million, down from $56.2 million, with research and development expenses cut to $13.6 million and general and administrative expenses to $8.2 million. Cash and investments totaled $172.4 million, expected to fund operations into the second half of 2028.

The first participant was dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095 in ICI-refractory tumors. Updated Phase 1 data showed one confirmed complete response and two confirmed partial responses in combination with pembrolizumab, with PLN-101095 generally well tolerated.

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AI-generated analysis. Not financial advice.

Positive

  • Research and development expenses fell to $13.6 million from $43.4 million year-over-year
  • General and administrative expenses decreased to $8.2 million from $15.5 million year-over-year
  • Net loss narrowed to $20.0 million from $56.2 million year-over-year
  • Cash, cash equivalents and short-term investments of $172.4 million fund operations into second half of 2028
  • First participant dosed in FORTIFY Phase 1b indication expansion trial of PLN-101095
  • Phase 1 PLN-101095 data reported one confirmed complete response and two confirmed partial responses with pembrolizumab

Negative

  • Company continues to operate at a quarterly net loss of $20.0 million
  • Termination of bexotegrast development in IPF in 2025 contributed to reduced operating expenses
  • Decreased headcount drove lower personnel-related expenses, indicating workforce reductions

Key Figures

R&D expenses: $13.6M G&A expenses: $8.2M Net loss: $20.0M +5 more
8 metrics
R&D expenses $13.6M Q1 2026, vs $43.4M prior-year quarter
G&A expenses $8.2M Q1 2026, vs $15.5M prior-year quarter
Net loss $20.0M Q1 2026, vs $56.2M prior-year quarter
Cash & investments $172.4M Balance as of March 31, 2026; expected runway into H2 2028
PLN-101095 dose 1,000 mg twice daily FORTIFY Phase 1b monotherapy for 14 days before pembrolizumab
Clinical responses 1 CR, 2 confirmed PRs, 1 unconfirmed PR Phase 1 PLN-101095 + pembrolizumab in solid tumors
IFN-γ increase >2-fold at Week 10 Maintained in all responders; no meaningful rise in non-responders
ATM capacity $50,000,000 At-the-market offering limit under Leerink Partners Sales Agreement

Market Reality Check

Price: $1.2200 Vol: Volume 208,182 vs 20-day ...
low vol
$1.2200 Last Close
Volume Volume 208,182 vs 20-day average 499,986 (relative volume 0.42) ahead of the earnings update. low
Technical Shares at 1.22 were trading below the 200-day MA of 1.42 and 37.44% under the 52-week high of 1.95 before this report.

Peers on Argus

Pre-news, PLRX was down 1.61% with mixed peer moves: sector names like SAVA (+8....
1 Up

Pre-news, PLRX was down 1.61% with mixed peer moves: sector names like SAVA (+8.68%) and ATOS (+3.32%) up while SRZN (-6.43%) and HLVX (-0.48%) were lower. Momentum scans only flagged one peer (IFRX, modestly up), supporting a stock-specific rather than sector-wide move.

Previous Earnings Reports

5 past events · Latest: Mar 11 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Mar 11 Q4 2025 earnings Positive +6.0% Strong PLN-101095 data, accelerated plans, and cash runway into H2 2028.
Nov 06 Q3 2025 earnings Positive +4.6% Positive interim oncology data, lower R&D and G&A, and solid cash balance.
Aug 07 Q2 2025 earnings Negative -1.2% Discontinuation of bexotegrast in IPF despite cost reductions and cash strength.
May 08 Q1 2025 earnings Negative -3.4% Large workforce reduction and higher net loss alongside early oncology progress.
Mar 03 Q4 2024 earnings Negative -2.2% BEACON-IPF trial discontinuation due to safety concerns despite ongoing programs.
Pattern Detected

Earnings updates with oncology progress and cost controls have typically seen positive next-day reactions.

Recent Company History

Over the last five earnings-related updates from Mar 2025 through Mar 2026, Pliant shifted from an IPF-centric story to one led by oncology candidate PLN-101095 and pipeline diversification. Multiple quarters highlighted reduced R&D and G&A versus prior periods, lower net losses, and sizeable cash balances. IPF program discontinuations and workforce realignment were offset by advancing oncology data and extended runway. Today’s Q1 2026 results continue that trend of leaner operating expenses and a multiyear cash runway.

Historical Comparison

+0.8% avg move · Earnings releases for PLRX over the past five events saw an average next-day move of 0.76%, often po...
earnings
+0.8%
Average Historical Move earnings

Earnings releases for PLRX over the past five events saw an average next-day move of 0.76%, often positive when oncology updates and cost controls were highlighted.

Same-tag history shows a pivot from IPF setbacks toward advancing PLN-101095 and tighter cost structure, with repeated emphasis on multi-year cash runway.

Regulatory & Risk Context

Active S-3 Shelf · $300,000,000
Shelf Active
Active S-3 Shelf Registration 2026-03-30
$300,000,000 registered capacity

An effective S-3 shelf filed on 2026-03-30 allows Pliant to offer up to $300,000,000 in various securities, including an at-the-market program to sell up to $50,000,000 of common stock for general corporate and R&D purposes. No usage has been recorded yet in the provided context.

Market Pulse Summary

This announcement combined a detailed Q1 2026 financial update with further validation of oncology c...
Analysis

This announcement combined a detailed Q1 2026 financial update with further validation of oncology candidate PLN-101095. R&D and G&A fell sharply versus the prior-year quarter, cutting net loss to $20.0M, while cash of $172.4M is expected to fund operations into H2 2028. Investors may watch upcoming FORTIFY Phase 1b data, continued IFN-γ and PD-L1 biomarker trends, and any usage of the $300M shelf or $50M ATM.

Key Terms

phase 1b, integrins, immune checkpoint inhibitor, pembrolizumab, +3 more
7 terms
phase 1b medical
"First participant dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095"
"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.
integrins medical
"dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance"
Integrins are proteins on the surface of cells that act like molecular Velcro and signal relays, helping cells stick to their surroundings and communicate with their internal machinery. Investors care because drugs or diagnostics that target integrins can alter disease processes such as inflammation, blood clotting, and cancer spread, so advances, trial results, or regulatory actions involving integrins can materially affect a biotech company’s development prospects and valuation.
immune checkpoint inhibitor medical
"in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors"
An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.
pembrolizumab medical
"antitumor activity in combination with pembrolizumab, an FDA-approved ICI"
A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.
pd-l1 medical
"all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ"
PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.
at-the-market offering financial
"The prospectus also includes an at-the-market offering under a Sales Agreement with Leerink Partners LLC"
An at-the-market offering is a method companies use to sell new shares of stock directly into the open market over time, rather than all at once. This allows them to raise money gradually, similar to selling small pieces of a product instead of a large batch. For investors, it means the company can access funding more flexibly, but it may also increase the supply of shares and influence the stock’s price.
shelf registration regulatory
"Pliant Therapeutics, Inc. has filed a shelf registration to offer up to $300,000,000 of securities"
Shelf registration is when a company gets permission ahead of time to sell new stocks or bonds over a period of time instead of all at once. It matters to investors because it lets a company raise money quickly when needed, but it can also change the value of existing shares if many new ones are sold.

AI-generated analysis. Not financial advice.

First participant dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095

Oral presentation at AACR 2026 featured updated data from Phase 1 trial of PLN-101095 showing deepening of confirmed responses in checkpoint inhibitor-refractory solid tumors

PLN-101095 spotlighted as novel IO approach as part of AACR's 2026 Highlights Plenary Session

SOUTH SAN FRANCISCO, Calif., May 11, 2026 (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 first quarter 2026 financial results.

“In the first quarter, our team showcased its clinical development capabilities, initiating FORTIFY, the Phase 1b trial of PLN-101095, ahead of schedule and dosing the first patient in April,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “We were excited to highlight encouraging recent data from the Phase 1a trial of PLN-101095 at AACR showing deepening responses and increasing time on treatment. The team continues to make progress on pipeline programs emerging from Pliant's proprietary integrin platform while evaluating opportunities to expand our clinical-stage pipeline.”

Oncology Program
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. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

  • FORTIFY, a Phase 1b indication expansion trial, enrolling and dosing patients. In April, the Company announced the dosing of its first participant in the FORTIFY Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma and a subset of tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

  • Oral presentation at AACR of updated Phase 1 data from PLN-101095 highlighted deepening of confirmed responses. In April, at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) 2026 Annual Meeting, the Company announced positive updated data from its Phase 1 trial of PLN-101095. Results showed that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab, an FDA-approved ICI. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported. These clinical responses were observed in patients with cholangiocarcinoma, NSCLC, melanoma and head and neck squamous cell carcinoma, respectively. All responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. Additionally, PLN-101095 was spotlighted as a novel immunotherapy approach as part of AACR’s 2026 Annual Meeting Highlights Plenary Session.

Integrin-Targeted Delivery Platform

  • Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads.

First Quarter 2026 Financial Results

  • Research and development expenses were $13.6 million, as compared to $43.4 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
  • General and administrative expenses were $8.2 million, as compared to $15.5 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
  • Net loss was $20.0 million as compared to $56.2 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
  • As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of $172.4 million which the Company expects to be sufficient to fund operations into the second half of 2028.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. Pliant’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of ICI-refractory advanced or metastatic solid tumors. PLN-101095 is being investigated in FORTIFY, a Phase 1b indication expansion trial enrolling patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Pliant’s preclinical research is focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules with programs focused on delivering siRNAs to skeletal muscle cells, adipocytes, and renal cells. For additional information, please visit: www.PliantRx.com. Follow Pliant on social media at 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 express or implied statements regarding ongoing clinical trial development of PLN-101095, including timing of enrollment and data; the potential benefits of PLN-101095; and Pliant’s plans for the continued development of PLN-101095 among others, including its integrin-based drug delivery platform. Because such statements deal with future events and are based on Pliant’s 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 Pliant’s product candidates, including any delays in Pliant’s ongoing or planned preclinical or clinical trials, the impact of current macroeconomic, geopolitical and marketplace conditions on Pliant’s business, operations, clinical supply and plans, Pliant’s reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of Pliant development operations, the risks inherent in the drug development process, the risks regarding the accuracy of Pliant’s estimates of expenses and timing of development, its capital requirements and the sufficiency of its cash to support Pliant’s planned operations, and Pliant’s ability to obtain and maintain intellectual property protection for Pliant’s product candidates. These and additional risks are discussed in the sections titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Pliant’s Quarterly Report on Form 10-Q for the period ended March 31, 2026, which Pliant is filing with the Securities and Exchange Commission (SEC) today, and which will be 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 March 31,
 2026
 2025
Operating expenses:   
Research and development$(13,584) $(43,436)
General and administrative (8,188)  (15,499)
Total operating expenses (21,772)  (58,935)
Loss from operations (21,772)  (58,935)
Interest and other income (expense), net 1,732   3,568 
Interest expense    (799)
Net loss$(20,040) $(56,166)
Net loss per share - basic and diluted$(0.32) $(0.92)
Shares used in computing net loss per share - basic and diluted 61,803,467   61,222,676 
        


Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
 
 March 31,
2026
 December 31,
2025
Assets   
Current assets   
Cash and cash equivalents$22,190  $45,445 
Short-term investments 148,702   145,499 
Prepaid expenses and other current assets 3,132   4,464 
Property and equipment held for sale 906   1,040 
Total current assets 174,930   196,448 
Property and equipment, net 2,664   2,940 
Operating lease right-of-use assets 23,131   23,966 
Restricted cash 1,482   1,482 
Other non-current assets 389   392 
Total assets$202,596  $225,228 
Liabilities and stockholders’ equity   
Current liabilities   
Accounts payable$362  $480 
Accrued research and development 4,141   4,804 
Accrued liabilities 4,143   9,634 
Lease liabilities, current 1,713   1,447 
Total current liabilities 10,359   16,365 
Lease liabilities, non-current 27,071   27,658 
Long-term debt     
Total liabilities 37,430   44,023 
Commitments and Contingencies   
Stockholders’ equity   
Preferred stock     
Common stock 6   6 
Additional paid-in capital 1,044,937   1,040,610 
Accumulated deficit (879,436)  (859,396)
Accumulated other comprehensive loss (341)  (15)
Total stockholders’ equity 165,166   181,205 
Total liabilities and stockholders’ equity$202,596  $225,228 

FAQ

What were Pliant Therapeutics (NASDAQ: PLRX) Q1 2026 financial results?

Pliant reported a Q1 2026 net loss of $20.0 million, significantly reduced from $56.2 million a year earlier. According to Pliant, research and development expenses were $13.6 million and general and administrative expenses were $8.2 million, reflecting lower headcount and program changes.

How much cash does Pliant Therapeutics (PLRX) have after Q1 2026?

Pliant ended Q1 2026 with $172.4 million in cash, cash equivalents and short-term investments. According to Pliant, this balance is expected to fund operations into the second half of 2028, providing a multi-year runway for ongoing clinical and platform activities.

What is the FORTIFY Phase 1b trial of PLN-101095 at Pliant Therapeutics?

FORTIFY is a Phase 1b indication expansion trial evaluating PLN-101095 in advanced ICI-refractory solid tumors. According to Pliant, the open-label trial enrolls cohorts in NSCLC, clear cell renal cell carcinoma and high tumor mutational burden tumors, with 14 days of monotherapy before adding pembrolizumab.

What clinical results did Pliant Therapeutics report for PLN-101095 in 2026?

Pliant reported Phase 1 data showing one confirmed complete response and two confirmed partial responses with PLN-101095 plus pembrolizumab. According to Pliant, responses occurred in several tumor types and were associated with increased plasma IFN-γ and PD-L1, with PLN-101095 generally well tolerated.

When is interim data from Pliant Therapeutics' FORTIFY trial of PLN-101095 expected?

Interim data from the FORTIFY Phase 1b trial are expected in 2027. According to Pliant, enrollment is underway in three indication cohorts, with patients receiving PLN-101095 monotherapy for 14 days before pembrolizumab combination therapy to assess safety and preliminary anti-tumor activity.

How did program changes affect Pliant Therapeutics (PLRX) expenses in Q1 2026?

Program changes significantly reduced operating expenses in Q1 2026 for Pliant. According to Pliant, completing BEACON-IPF close-out activities and terminating bexotegrast development in IPF in 2025, along with lower personnel-related costs from reduced headcount, drove declines in R&D and G&A expenses.