Pliant Therapeutics (PLRX) narrows Q1 2026 loss as PLN-101095 shows early responses
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Pliant Therapeutics reported first quarter 2026 results and highlighted progress in its oncology and delivery platforms. The company’s lead program, PLN-101095, advanced with first patient dosed in FORTIFY, a Phase 1b indication expansion trial in checkpoint inhibitor-refractory solid tumors, with interim data expected in 2027.
Updated Phase 1 data for PLN-101095 presented at AACR 2026 showed one confirmed complete response, two confirmed partial responses and one unconfirmed partial response in heavily pretreated patients, with biomarker changes consistent with enhanced immune activity and a generally well tolerated safety profile. Pliant is also advancing an integrin-targeted delivery platform for tissue-specific siRNA delivery.
Financially, first quarter 2026 research and development expenses were $13.6 million and general and administrative expenses were $8.2 million, both sharply lower than the prior-year period. Net loss narrowed to $20.0 million, or $0.32 per share, and the company ended March 31, 2026 with $172.4 million in cash, cash equivalents and short-term investments, which it expects to fund operations into the second half of 2028.
Positive
- Net loss narrowed significantly to $20.0 million from $56.2 million year over year, driven by a steep reduction in operating expenses after portfolio restructuring and headcount reductions.
- Strong cash runway with $172.4 million in cash, cash equivalents and short-term investments as of March 31, 2026, expected to fund operations into the second half of 2028.
Negative
- None.
Insights
Pliant sharply reduced its cash burn while advancing PLN-101095 with early but encouraging Phase 1 data.
Pliant is repositioning around PLN-101095 in oncology after ending bexotegrast in IPF in 2025. The FORTIFY Phase 1b expansion trial is enrolling NSCLC, high tumor mutational burden tumors and clear cell renal cell carcinoma, with combination dosing after a short monotherapy lead-in.
Updated Phase 1 data showed one complete response and two partial responses in a heavily pretreated, checkpoint-refractory population, plus biomarker shifts in IFN-γ and PD-L1 that align with immune activation. Safety was generally acceptable across doses tested, supporting continued development at 1,000 mg twice daily plus pembrolizumab.
On the financial side, quarterly operating expenses fell from $58.9M to $21.8M, narrowing net loss to $20.0M or $0.32 per share. Cash and investments of $172.4M are expected to fund operations into the second half of 2028, giving multiple years of runway to generate FORTIFY interim data and progress the integrin-targeted delivery platform.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Research and development expenses: $13.6 million
General and administrative expenses: $8.2 million
Net loss: $20.0 million
+4 more
7 metrics
Research and development expenses
$13.6 million
Three months ended March 31, 2026 vs $43.4 million in 2025
General and administrative expenses
$8.2 million
Three months ended March 31, 2026 vs $15.5 million in 2025
Net loss
$20.0 million
Three months ended March 31, 2026 vs $56.2 million in 2025
Net loss per share
$0.32
Basic and diluted for Q1 2026 vs $0.92 in Q1 2025
Cash and investments
$172.4 million
Cash, cash equivalents and short-term investments as of March 31, 2026
Total operating expenses
$21.8 million
Q1 2026 total operating expenses vs $58.9 million in Q1 2025
Shares used in EPS
61,803,467 shares
Shares used in computing basic and diluted net loss per share, Q1 2026
Key Terms
Phase 1b indication expansion trial, immune checkpoint inhibitor (ICI)-refractory, integrin-based therapeutics, dose-escalation, +2 more
6 terms
Phase 1b indication expansion trial medical
"First participant dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095"
immune checkpoint inhibitor (ICI)-refractory medical
"patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors"
Immune checkpoint inhibitor (ICI)-refractory describes cancers that no longer respond to treatments designed to help the immune system recognize and attack tumors. When a cancer becomes ICI-refractory, it’s similar to a lock that no longer opens with the key, meaning the usual therapy no longer works. This situation matters to investors because it can impact the effectiveness and market potential of new or existing cancer treatments.
integrin-based therapeutics medical
"a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics"
Integrin-based therapeutics are drugs or biologic treatments that target integrins, which are proteins on cell surfaces that act like Velcro and signaling switches to help cells stick to each other and respond to their environment. By blocking or activating these proteins, such therapies can change inflammation, tissue repair, cancer spread or clotting, so investors watch them as potential high-impact treatments that can create new markets, move clinical-stage valuations, and carry clinical and regulatory risk.
dose-escalation medical
"a Phase 1a/1b open-label, dose-escalation and indication expansion trial"
Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.
integrin-targeting drug-delivery platform medical
"this integrin-targeting drug-delivery platform has the potential for broad applicability"
short-term investments financial
"the Company had cash, cash equivalents and short-term investments of $172.4 million"
Short-term investments are financial assets purchased with the goal of turning them back into cash within about a year, including things like Treasury bills, money market funds, and short-duration bonds. They matter to investors because they provide a lower-risk, more accessible place to park money than stocks or long-term bonds—like a nearby savings box that earns some interest while staying ready for immediate needs or opportunities.
Earnings Snapshot
Net loss: $20.0 million
Q1 2026
Net loss
$20.0 million
vs $56.2 million in prior-year quarter
R&D expenses
$13.6 million
vs $43.4 million in prior-year quarter
G&A expenses
$8.2 million
vs $15.5 million in prior-year quarter
Net loss per share
$0.32
vs $0.92 in prior-year quarter
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________________________________________
FORM 8-K
__________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 11, 2026
__________________________________________
(Exact name of Registrant as Specified in Its Charter)
__________________________________________
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (650 ) 481-6770
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
__________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2026, Pliant Therapeutics, Inc. (the "Company") issued a press release announcing the Company’s financial results for the first quarter ended March 31, 2026. A copy of this press release is furnished as Exhibit 99.1 to this report.
The information in this Current Report on Form 8-K including the exhibits furnished herewith shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (as amended, the "Exchange Act") or otherwise subject to the liabilities of that Section, and shall not be or be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||||||
99.1 | Press Release issued by the Company dated May 11, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| PLIANT THERAPEUTICS, INC. | ||||||||
Date: May 11, 2026 | By: | /s/ Keith Cummings | ||||||
| Keith Cummings, M.D., MBA | ||||||||
| Chief Financial Officer | ||||||||
Exhibit 99.1
Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results
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
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, CA., May 11, 2026 - 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
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
How did Pliant Therapeutics (PLRX) perform financially in Q1 2026?
Pliant reported a net loss of $20.0 million for Q1 2026, significantly improved from $56.2 million a year earlier. Operating expenses fell to $21.8 million, reflecting lower R&D and G&A after terminating bexotegrast development and reducing headcount.
What were Pliant Therapeutics’ operating expenses in the first quarter of 2026?
First quarter 2026 operating expenses at Pliant totaled $21.8 million, down from $58.9 million in the prior-year quarter. Research and development expenses were $13.6 million and general and administrative expenses were $8.2 million, both reduced primarily due to lower personnel-related costs.
What is Pliant Therapeutics’ cash runway as of March 31, 2026?
As of March 31, 2026, Pliant held $172.4 million in cash, cash equivalents and short-term investments. The company expects this capital to fund operations into the second half of 2028, providing multiple years of runway for clinical and platform development.
What progress did Pliant Therapeutics report on PLN-101095 and the FORTIFY trial?
Pliant dosed the first participant in FORTIFY, its Phase 1b indication expansion trial of PLN-101095, in April 2026. The open-label study enrolls NSCLC, high tumor mutational burden tumors and clear cell renal cell carcinoma, with interim data expected in 2027.
What clinical data for PLN-101095 were presented at AACR 2026?
At AACR 2026, Pliant shared updated Phase 1 data showing one confirmed complete response, two confirmed partial responses and one unconfirmed partial response with PLN-101095 plus pembrolizumab. Responders showed sustained IFN-γ and PD-L1 increases and the regimen was generally well tolerated.
What is Pliant Therapeutics’ integrin-targeted delivery platform?
Pliant is developing an integrin-targeted delivery platform that uses cell-specific integrin receptors to deliver drug payloads, including siRNAs, to selected tissues. Current preclinical programs focus on skeletal muscle and other tissues, with proof-of-concept studies ongoing across multiple potential disease areas.