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Pliant Therapeutics (PLRX) cuts Q2 loss, speeds FORTIFY cancer trial enrollment

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Pliant Therapeutics, Inc. reported second quarter 2026 results and provided a corporate update centered on its oncology and drug-delivery platforms. Lead asset PLN-101095, an oral dual-selective inhibitor of αvβ8 and αvβ1 integrins, is being evaluated in FORTIFY, a Phase 1a/1b trial in immune checkpoint inhibitor-refractory advanced or metastatic solid tumors.

The company highlighted that FORTIFY enrollment across three indication-expansion cohorts remains strong and ahead of schedule, with up to 102 patients planned and interim data expected in 2027. Updated Phase 1 monotherapy biomarker data showed coordinated T‑cell reactivation signals in responders, including increases in IFN‑γ, CXCL9 and granzyme‑B, suggesting a shift in the tumor microenvironment that may potentially resensitize tumors to pembrolizumab.

Pliant is advancing an integrin-targeted delivery platform for tissue-specific delivery of drug payloads, including siRNAs, and plans additional details, including initial treatment indications, in the second half of 2026. For the quarter, research and development expenses were $16.7 million and general and administrative expenses were $7.1 million, contributing to a net loss of $22.4 million, all substantially lower than the prior-year period. Cash, cash equivalents and short-term investments totaled $159.6 million as of June 30, 2026, which the company expects to fund operations into the second half of 2028.

Positive

  • Operating expenses and net loss declined significantly year-over-year, with R&D falling to $16.7 million from $32.2 million and net loss to $22.4 million from $43.3 million.
  • Cash, cash equivalents and short-term investments of $159.6 million are expected to fund operations into the second half of 2028, providing a multi‑year runway.
  • FORTIFY enrollment is progressing ahead of schedule, with interim data for PLN-101095 expected in 2027 across multiple solid tumor indications.
  • Biomarker data for PLN-101095 show coordinated T‑cell reactivation in responders, supporting the scientific rationale for combination with pembrolizumab.
  • Oncology expertise on the board was strengthened by appointing Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E., both with extensive targeted and immuno-oncology drug development experience.

Negative

  • None.

Filing Explained

On August 11, 2026, Pliant Therapeutics appointed Flavia Borellini and Robert Iannone to its board, changing the company’s board composition; the 8-K furnished the update as Exhibit 99.1 rather than treating the exhibit as filed under Section 18.

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.
Research and development expenses $16.7 million Three months ended June 30, 2026; down from $32.2 million in Q2 2025
General and administrative expenses $7.1 million Three months ended June 30, 2026; down from $13.4 million in Q2 2025
Net loss $22.4 million Three months ended June 30, 2026; improved from $43.3 million in prior-year quarter
Cash, cash equivalents and short-term investments $159.6 million Balance as of June 30, 2026; expected to fund operations into second half of 2028
Total assets $189.9 million Total assets as of June 30, 2026, versus $225.2 million at December 31, 2025
Shares used in computing net loss per share 61,919,233 Weighted-average basic and diluted shares for the quarter ended June 30, 2026
FORTIFY planned enrollment up to 102 patients Phase 1b indication expansion trial across three solid tumor cohorts
Interim FORTIFY data timing 2027 Interim data from PLN-101095 FORTIFY trial expected in 2027
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.
immune checkpoint inhibitor (ICI)-refractory medical
"in 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.
Phase 1b indication expansion trial medical
"FORTIFY, a Phase 1a/1b open-label, dose-escalation and indication expansion trial"
tumor microenvironment medical
"blocking TGF-β activation in the tumor microenvironment"
The tumor microenvironment is the immediate area surrounding a cancer cell, made up of nearby cells, blood vessels, and support structures that influence how the cancer grows and spreads. It functions like a bustling neighborhood that can either help or hinder the tumor’s development. For investors, understanding changes in this environment can signal the effectiveness of treatments and potential shifts in a cancer-related market.
siRNAs medical
"a platform to deliver drug payloads, including siRNAs, to selective tissue types"
Small interfering RNAs (siRNAs) are short strands of genetic material designed to bind and silence specific genes, like sending a targeted "mute" command to a particular instruction in a cell. Investors care because siRNA-based therapies can precisely treat diseases by turning off harmful genes, offering potential for strong clinical benefits and revenue but also carrying scientific, regulatory and manufacturing risks that affect a biotech company’s value.
Research and development expenses (Q2) $16.7 million decreased from $32.2 million in Q2 2025
General and administrative expenses (Q2) $7.1 million decreased from $13.4 million in Q2 2025
Net loss (Q2) $22.4 million improved from $43.3 million in Q2 2025
Net loss per share (Q2) $0.36 basic and diluted improved from $0.71 basic and diluted in Q2 2025
Cash, cash equivalents and short-term investments $159.6 million company expects this to fund operations into the second half of 2028

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FAQ

How did Pliant Therapeutics (PLRX) perform financially in Q2 2026?
Pliant reported a Q2 2026 net loss of $22.4 million, improved from $43.3 million a year earlier, on total operating expenses of $23.9 million versus $45.6 million. R&D and G&A costs both declined substantially year-over-year.

What is Pliant Therapeutics’ (PLRX) cash runway as of June 30, 2026?
As of June 30, 2026, Pliant held $159.6 million in cash, cash equivalents and short-term investments. The company expects this capital to be sufficient to fund operations into the second half of 2028.

What progress did Pliant Therapeutics (PLRX) report on the FORTIFY trial?
Pliant stated that FORTIFY enrollment remains strong and ahead of schedule. The Phase 1a/1b trial will enroll up to 102 patients across NSCLC, clear cell renal cell carcinoma and high tumor mutational burden tumors, with interim data expected in 2027.

What new PLN-101095 biomarker data did Pliant Therapeutics (PLRX) share?
Updated data showed that PLN-101095 monotherapy in responders increased IFN‑γ, CXCL9 and granzyme‑B, indicating a T‑cell reactivation cascade. This biomarker pattern suggests a tumor microenvironment shift that could potentially resensitize tumors to pembrolizumab.

What is Pliant Therapeutics’ (PLRX) integrin-targeted delivery platform?
Pliant is developing an integrin-targeted drug-delivery platform that uses cell-specific integrin receptors to deliver payloads, including siRNAs, to selective tissues such as skeletal muscle. Preclinical proof-of-concept studies are ongoing, with more details planned in the second half of 2026.

What were Pliant Therapeutics’ (PLRX) key operating expenses in Q2 2026?
In Q2 2026, Pliant reported research and development expenses of $16.7 million and general and administrative expenses of $7.1 million. Both categories decreased markedly from $32.2 million and $13.4 million, respectively, in the prior-year quarter.
0001746473FALSE00017464732026-08-112026-08-110001746473plrx:CommonStockParValue0.0001PerShareMember2026-08-112026-08-110001746473plrx:SeriesAJuniorParticipatingPreferredPurchaseRightsMember2026-08-112026-08-11

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): August 11, 2026
__________________________________________
PLIANT THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
__________________________________________
Delaware001-3930347-4272481
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
331 Oyster Point Blvd., South San Francisco, CA
94080
(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
Common Stock, par value $0.0001 per sharePLRXThe Nasdaq Stock Market LLC
Series A Junior Participating Preferred Purchase RightsN/AThe Nasdaq Stock Market LLC
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 August 11, 2026, Pliant Therapeutics, Inc. (the "Company") issued a press release announcing the Company’s financial results for the second quarter ended June 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 August 11, 2026
104Cover 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: August 11, 2026
By:/s/ Keith Cummings
Keith Cummings, M.D., MBA
Chief Financial Officer




Exhibit 99.1
image_0a.jpg
Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results
FORTIFY, a Phase 1b indication expansion trial of PLN-101095,
experiencing strong enrollment

Appointed seasoned oncology drug development leaders
Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to Board of Directors

SOUTH SAN FRANCISCO, CA., August 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 second quarter 2026 financial results.

“In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “With the appointments of Flavia and Robert to the board, Pliant now has deep global oncology drug development and commercialization expertise at this important time for our oncology program. We continue to make progress on our proprietary integrin-targeted drug-delivery platform and look forward to sharing more information on the platform soon.”
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 (NCT0670706), 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.

•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. Interim data is expected in 2027.

•Oral presentation at AACR of updated PLN-101095 Phase 1 data highlights monotherapy biomarker data showing a coordinated T-cell reactivation cascade in responders. In July, at the American Association for Cancer Research’s (AACR) Drug Discovery and Development conference, the Company reviewed encouraging PLN-101095 Phase 1 monotherapy biomarker data. As previously reported, all responding patients showed large increases in plasma interferon gamma (IFN-γ), a modulator of anti-tumor immunity, after 14 days of monotherapy with PLN-101095. Updated data show that blocking of αvβ8 by PLN-101095 also resulted in increases in CXCL9, a recruiter of T cells, and granzyme-B, a marker for cytotoxic arming in responding patients. Increased IFN-γ, CXCL9 and granzyme-B after PLN-101095 monotherapy signals a shift in the tumor microenvironment that could potentially resensitize tumors to pembrolizumab. Importantly, no non-responders experienced increases in these biomarkers.



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. Pliant plans to provide additional detail on the platform and path forward, including initial treatment indications, in the second half of 2026.

Corporate Highlights
•Appointed Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to the Company’s Board of Directors. Dr. Borellini brings more than 25 years of executive management experience in the biopharmaceutical industry with a focus on the global development of targeted oncology drugs from preclinical to commercial stage. Dr. Iannone, who currently serves as Executive Vice President, Research and Development and Chief Medical Officer at Jazz Pharmaceuticals, brings more than two decades of executive drug development and regulatory leadership, including the approval of several targeted and immuno-oncology medicines.

Second Quarter 2026 Financial Results
•Research and development expenses were $16.7 million, as compared to $32.2 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 $7.1 million, as compared to $13.4 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 $22.4 million as compared to $43.3 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 June 30, 2026, the Company had cash, cash equivalents and short-term investments of $159.6 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; 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 June 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 June 30, 2026
Six Months Ended June 30, 2026
2026
2025
2026
2025
Operating expenses:
Research and development
$
(16,727)
$
(32,198)
$
(30,311)
$
(75,634)
General and administrative
(7,135)
(13,394)
(15,323)
(28,893)
Total operating expenses
(23,862)
(45,592)
(45,634)
(104,527)
Loss from operations
(23,862)
(45,592)
(45,634)
(104,527)
Interest and other income (expense), net
1,491 
3,101 
3,223 
6,669 
Interest expense
— 
(809)
— 
(1,608)
Net loss
$
(22,371)
$
(43,300)
$
(42,411)
$
(99,466)
Net loss per share - basic and diluted
$
(0.36)
$
(0.71)
$
(0.69)
$
(1.62)
Shares used in computing net loss per share - basic and diluted
61,919,233 
61,386,183 
61,861,670 
61,304,881 



Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
June 30,
2026
December 31,
2025
Assets
Current assets
Cash and cash equivalents
$
24,883 
$
45,445 
Short-term investments
133,218 
145,499 
Prepaid expenses and other current assets
4,135 
4,464 
Property and equipment held for sale
906 
1,040 
Total current assets
163,142 
196,448 
Property and equipment, net
2,414 
2,940 
Operating lease right-of-use assets
22,289 
23,966 
Restricted cash
1,482 
1,482 
Other non-current assets
554 
392 
Total assets
$
189,881 
$
225,228 
Liabilities and stockholders’ equity
Current liabilities
Accounts payable
$
1,531 
$
480 
Accrued research and development
9,028 
4,804 
Accrued liabilities
3,653 
9,634 
Lease liabilities, current
2,272 
1,447 
Total current liabilities
16,484 
16,365 
Lease liabilities, non-current
26,471 
27,658 
Total liabilities
42,955 
44,023 
Commitments and Contingencies
Stockholders’ equity
Preferred stock
— 
— 
Common stock
6 
6 
Additional paid-in capital
1,049,124 
1,040,610 
Accumulated deficit
(901,807)
(859,396)
Accumulated other comprehensive loss
(397)
(15)
Total stockholders’ equity
146,926 
181,205 
Total liabilities and stockholders’ equity
$
189,881 
$
225,228 

Source: View Original Filing on SEC EDGAR

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