Pliant Therapeutics Q3 loss narrows to $24.4M
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Form Type
8-K
Rhea-AI Filing Summary
Pliant Therapeutics reported third-quarter 2026 results and updates on its oncology trial and RNA-interference delivery platform. Net loss was $24.377 million, compared with $26.301 million a year earlier. Research and development expense was $17.932 million, versus $17.938 million; general and administrative expense was $7.810 million, versus $10.331 million. As of September 30, 2026, cash, cash equivalents and short-term investments totaled $142.6 million, which the company expects to fund operations to mid-2028.
FORTIFY, a Phase 1b indication expansion trial of PLN-101095, continued enrolling ahead of schedule and will enroll up to 102 patients across three cohorts; interim data is expected in 2027. In non-human primate studies, Pliant reported more than 75% target-gene knockdown at eight weeks while avoiding liver and other non-target tissues. The company appointed David Raben, M.D., as chief medical officer and Craig Blanchette, Ph.D., as senior vice president, research (RNAi).
1 point · 0 major0 major · 0 points
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNet loss was $24.377 million, compared with $26.301 million a year earlier.
Negative
- None.
Filing Explained
At
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, or exhibit attachments filed with this report.
Key Figures
Research and development expense: $17.932 million
General and administrative expense: $7.810 million
Net loss: $24.377 million
+5 more
8 metrics
Research and development expense
$17.932 million
Three months ended September 30, 2026; $17.938 million in the same period of 2025
General and administrative expense
$7.810 million
Three months ended September 30, 2026; $10.331 million in the same period of 2025
Net loss
$24.377 million
Three months ended September 30, 2026; $26.301 million in the same period of 2025
Net loss per share, basic and diluted
($0.39)
Three months ended September 30, 2026; ($0.43) in the same period of 2025
Cash, cash equivalents and short-term investments
$142.6 million
As of September 30, 2026
FORTIFY planned enrollment
Up to 102 patients
Across three cohorts
Target-gene knockdown
More than 75% at eight weeks
Non-human primate studies of Pliant's delivery compounds
Interim data
2027
Expected for FORTIFY
Key Terms
integrin-mediated delivery platform, siRNA, immune checkpoint inhibitor (ICI)-refractory, tumor mutational burden, +2 more
6 terms
integrin-mediated delivery platform technical
"integrin-mediated delivery platform for cell- and tissue-selective extrahepatic delivery"
siRNA medical
"delivery of siRNA payloads to extrahepatic tissues"
Small interfering RNA (siRNA) is a short strand of genetic material that binds to and destroys the messenger RNA that carries instructions for making a specific protein, effectively switching that gene off. Investors care because siRNA is a platform for precise medicines: successful trials or approvals can create high-value drugs, while delivery challenges, manufacturing complexity, patent positions and regulatory risk can sharply affect a biotech company's prospects.
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.
tumor mutational burden medical
"tumors with high tumor mutational burden"
Tumor mutational burden is a measure of how many genetic changes a cancer cell carries, often expressed as the number of mutations per length of DNA. Think of it like counting typos in a book: more typos can make the abnormal cells stand out to the immune system, and cancers with higher counts sometimes respond better to certain immunotherapies. For investors, TMB can affect how well drugs perform in trials, the need for companion diagnostic tests, and the commercial potential of cancer therapies.
target gene knockdown technical
"observed >75% target gene knockdown at eight weeks"
pharmacokinetics medical
"evaluate the safety, tolerability, pharmacokinetics"
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
Earnings Snapshot
Research and development expense: $17.932 million · Guidance included
Third quarter 2026 (three months ended September 30, 2026)
Research and development expense
$17.932 million
Compared with $17.938 million in the same period of 2025
General and administrative expense
$7.810 million
Compared with $10.331 million in the same period of 2025
Net loss
$24.377 million
Compared with $26.301 million in the same period of 2025
Net loss per share, basic and diluted
($0.39)
Compared with ($0.43) in the same period of 2025
Guidance
The company expects its $142.6 million in cash, cash equivalents and short-term investments as of September 30, 2026, to be sufficient to fund operations to mid-2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was PLRX's net loss in the third quarter of 2026?
PLRX reported a net loss of $24.377 million for the three months ended September 30, 2026, compared with $26.301 million in the same quarter of 2025. Basic and diluted net loss per share was ($0.39), compared with ($0.43).
How many patients will PLRX's FORTIFY trial enroll?
FORTIFY will enroll up to 102 patients across three cohorts: non-small cell lung cancer, clear cell renal cell carcinoma, and tumors with high tumor mutational burden.
How is PLN-101095 dosed in the FORTIFY trial?
Patients receive 1,000 mg twice daily as monotherapy for 14 days, after which pembrolizumab is added as combination therapy.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): November 12, 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 November 12, 2026, Pliant Therapeutics, Inc. (the "Company") issued a press release announcing the Company’s financial results for the second quarter ended September 30, 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 November 12, 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: November 12, 2026 | By: | /s/ Keith Cummings | ||||||
| Keith Cummings, M.D., MBA | ||||||||
| Chief Financial Officer | ||||||||
Exhibit 99.1
Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2026 Financial Results
FORTIFY, a Phase 1b indication expansion trial of PLN-101095, continues strong enrollment
Pliant’s proprietary selective, targeted, integrin-mediated delivery platform
demonstrates encouraging initial preclinical results
demonstrates encouraging initial preclinical results
Strengthened leadership team with appointments of David Raben, M.D., as Chief Medical Officer and Craig Blanchette, Ph.D., as Senior Vice President, Research (RNAi).
SOUTH SAN FRANCISCO, CA., November 12, 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 third quarter 2026 financial results.
“The third quarter reflected continued strong execution across the Organization, including robust FORTIFY enrollment and compelling proof-of-concept data generated from our integrin-mediated drug delivery platform,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “FORTIFY continues to enroll ahead of schedule, with a number of European sites onboarded during the quarter. In addition, we continue to explore the potential of our proprietary drug delivery platform with cross-species preclinical data demonstrating successful selective delivery of siRNA payloads to extrahepatic tissues. With emerging data continuing to inform our next steps, potential therapeutic applications and paths forward, we will provide a comprehensive overview of the program in the coming months.”
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 FORTIFY, a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT06270706), to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
•Strong enrollment continues in FORTIFY, a Phase 1b indication expansion trial. FORTIFY will enroll up to 102 patients across three cohorts including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC) and tumors with high tumor mutational burden. Patients are treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab is added as combination therapy. Enrollment remains strong, progressing ahead of schedule with active sites in the United States and Spain with additional countries onboarding in the next several months. Interim data is expected in 2027.
•Presentations at Annual Meeting of the Society for Immunotherapy of Cancer (SITC) highlight PLN-101095 Phase 1 biomarker data and mechanism of action.
◦Researchers from Pliant presented new biomarker data from the Phase 1 trial showing that early induction of immune activation biomarkers during PLN-101095 monotherapy was associated with subsequent clinical response following pembrolizumab initiation. These findings support the
hypothesis that TGF-β pathway inhibition promotes immune activation, T-cell recruitment into the tumor microenvironment, and enhanced cytotoxic effector function.
◦Researchers from the National Cancer Institute presented data demonstrating that the blockade of integrins αvβ8 and αvβ1 in combination with anti-PD-1 reduced TGF-β signaling leading to modulation of fibroblastic cell populations in the tumor microenvironment and increased infiltration and activation of cytotoxic CD8+ T cells. This resulted in an improvement in anti-tumor activity and survival.
Selective, Targeted, Integrin-mediated Delivery Platform
Utilizing our fully annotated library of 15,000+ integrin binding molecules, as well as our biological knowledge of cell-specific integrin receptor expression, Pliant has created a selective, targeted integrin-mediated delivery platform for cell- and tissue-selective extrahepatic delivery of drug payloads, including RNAi. The platform has broad applicability across multiple disease areas utilizing a variety of drug payloads.
•Tissue Specificity, Potency and Durability – Pliant has initiated multiple RNAi delivery programs targeting specific tissues through unique integrin expression profiles. The most advanced compounds to date selectively target skeletal and skeletal/cardiac muscle, respectively. In non-human primate studies, we have observed >75% target gene knockdown at eight weeks while avoiding liver and other non-targeted tissues.
•Plug-and-Play Compatibility – Pliant's integrin-directed small molecule delivery compounds can be loaded with RNAi payloads directed at any gene of interest. This allows a single compound to serve as the basis for rapid development of tissue-specific therapies to a broad array of indications. Additionally, while initial efforts are directed at RNAi, the platform is potentially capable of delivering a variety of therapeutic payloads.
•Initial Indications – Based on early findings showing the successful selective delivery of Pliant’s skeletal and cardiac muscle compounds, the Company plans to accelerate development with initial therapeutic programs focused in areas of high unmet need including neuromuscular diseases and rare cardiomyopathies where gene suppression modalities show promise.
Pliant plans to share additional details regarding muscle and cardiac, as well as other RNAi programs, including detailed preclinical data and specific indication and gene targets for development over the coming months.
A presentation on the platform, including preclinical data, titled "Pliant’s Selective Targeted Integrin-Mediated Drug Delivery Platform" can be found in the "Investors & Media" section of Pliant's website at www.PliantRx.com.
A presentation on the platform, including preclinical data, titled "Pliant’s Selective Targeted Integrin-Mediated Drug Delivery Platform" can be found in the "Investors & Media" section of Pliant's website at www.PliantRx.com.
Corporate Highlights
•Appointment of David Raben, M.D., as Chief Medical Officer. Dr. Raben is a leader in targeted immuno-oncology drug development and brings three decades of academic and biopharmaceutical oncology expertise. Most recently, Dr. Raben served as Chief Medical Officer at Bicara Therapeutics.
•Appointment of Craig Blanchette, Ph.D., as Senior Vice President, Research (RNAi). Dr. Blanchette is a recognized leader in RNAi drug discovery with a track record of advancing novel delivery platforms and therapeutics. Dr. Blanchette brings more than two decades of drug discovery and development expertise, having most recently served as Chief Scientific Officer at Switch Therapeutics.
Third Quarter 2026 Financial Results
•Research and development expenses were $17.9 million in the current and prior-year quarter. Expenses remained consistent as increased spending on PLN-101095 development in the current period was offset by decreased costs resulting from the termination of bexotegrast development in IPF and reduced personnel-
related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $7.8 million, as compared to $10.3 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 $24.4 million as compared to $26.3 million for the prior-year quarter. The decrease was primarily due to 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 September 30, 2026, the Company had cash, cash equivalents and short-term investments of $142.6 million which the Company expects to be sufficient to fund operations to mid-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 1a/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, as well as other tissue types.
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; and plans for its integrin-based drug delivery platform, including timing of additional details, including initial treatment indications; among others. 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 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 studies 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 September 30, 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, as well as other risks or uncertainties set forth in Pliant’s future SEC filings. 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, 2026 | Nine Months Ended September 30, 2026 | ||||||||||||||||||||||
2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | $ | (17,932) | $ | (17,938) | $ | (48,243) | $ | (93,572) | |||||||||||||||
General and administrative | (7,810) | (10,331) | (23,133) | (39,224) | |||||||||||||||||||
Total operating expenses | (25,742) | (28,269) | (71,376) | (132,796) | |||||||||||||||||||
Loss from operations | (25,742) | (28,269) | (71,376) | (132,796) | |||||||||||||||||||
Interest and other income (expense), net | 1,365 | 2,783 | 4,588 | 9,452 | |||||||||||||||||||
Interest expense | — | (815) | — | (2,423) | |||||||||||||||||||
Net loss | $ | (24,377) | $ | (26,301) | $ | (66,788) | $ | (125,767) | |||||||||||||||
Net loss per share - basic and diluted | $ | (0.39) | $ | (0.43) | $ | (1.08) | $ | (2.05) | |||||||||||||||
Shares used in computing net loss per share - basic and diluted | 61,943,959 | 61,406,475 | 61,889,401 | 61,339,118 | |||||||||||||||||||
Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
September 30, 2026 | December 31, 2025 | ||||||||||
Assets | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | 26,568 | $ | 45,445 | |||||||
Short-term investments | 114,516 | 145,499 | |||||||||
Prepaid expenses and other current assets | 2,725 | 4,464 | |||||||||
Property and equipment held for sale | 400 | 1,040 | |||||||||
Total current assets | 144,209 | 196,448 | |||||||||
Property and equipment, net | 2,183 | 2,940 | |||||||||
Operating lease right-of-use assets | 21,435 | 23,966 | |||||||||
Restricted cash | 1,482 | 1,482 | |||||||||
Other non-current assets | 568 | 392 | |||||||||
Total assets | $ | 169,877 | $ | 225,228 | |||||||
Liabilities and stockholders’ equity | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | 3,067 | $ | 480 | |||||||
Accrued research and development | 8,002 | 4,804 | |||||||||
Accrued liabilities | 4,397 | 9,634 | |||||||||
Lease liabilities, current | 2,455 | 1,447 | |||||||||
Total current liabilities | 17,921 | 16,365 | |||||||||
Lease liabilities, non-current | 25,324 | 27,658 | |||||||||
Total liabilities | 43,245 | 44,023 | |||||||||
Commitments and Contingencies | |||||||||||
Stockholders’ equity | |||||||||||
Preferred stock | — | — | |||||||||
Common stock | 6 | 6 | |||||||||
Additional paid-in capital | 1,053,340 | 1,040,610 | |||||||||
Accumulated deficit | (926,184) | (859,396) | |||||||||
Accumulated other comprehensive loss | (530) | (15) | |||||||||
Total stockholders’ equity | 126,632 | 181,205 | |||||||||
Total liabilities and stockholders’ equity | $ | 169,877 | $ | 225,228 | |||||||