Source: sec
Source ID: 0001746473-26-000113
URL: https://www.sec.gov/Archives/edgar/data/1746473/000174647326000113/plrx-20260630.htm
Symbol: (PLRX)
Published: 2026-08-11 16:08:34 EDT
Time precision: minute
Title: 10-Q 10-Q

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
June 30, 2026
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number:
001-39303
PLIANT THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
47-4272481
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
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
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading
Symbol
Name of Each Exchange on which Registered
Common Stock, par value $0.0001 per share
PLRX
The Nasdaq Stock Market LLC
Series A Junior Participating Preferred Purchase Rights
N/A
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes
☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
As of August 7, 2026, the registrant had
61,921,897
shares of common stock, $0.0001 par value per share, outstanding.
Table of Contents
PART I.
FINANCIAL INFORMATION
6
Item 1.
Condensed Financial Statements
(Unaudited)
6
Condensed Balance Sheets (Unaudited)
6
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
7
Condensed Statements of Stockholders’ Equity (Unaudited)
8
Condensed Statements of Cash Flows (Unaudited)
10
Notes to Condensed Financial Statements (Unaudited)
11
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
21
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
27
Item 4.
Controls and Procedures
28
PART II.
OTHER INFORMATION
28
Item 1.
Legal Proceedings
28
Item 1A.
Risk Factors
28
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
71
Item 3.
Defaults Upon Senior Securities
71
Item 4.
Mine Safety Disclosures
71
Item 5.
Other Information
71
Item 6.
Exhibits
72
Signatures
73
2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or this Report, contains forward-looking statements that involve risks, uncertainties, and assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Report include, but are not limited to, express or implied statements about:
•
Our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•
The success, cost and timing of our product development activities, including preclinical studies and clinical trials of our product candidates;
•
Our plans to initiate, recruit and enroll patients in, and conduct our clinical trials at the pace that we project;
•
Our plans and strategy to obtain and maintain regulatory approvals of our product candidates;
•
Our plans and strategy to obtain funding for our operations, including funding necessary to complete further development and, upon successful development, if approved, commercialize any of our product candidates;
•
The effect and impact of new, existing and proposed laws and regulations;
•
The potential benefit of orphan drug and Fast Track designations for any of our product candidates;
•
Our ability to compete with companies currently marketing or engaged in the development of integrin-based therapeutics;
•
Our plans and strategy regarding obtaining and maintaining intellectual property protection for our product candidates and the duration of such protection;
•
Our plans and strategy regarding the manufacture of our product candidates for clinical trials and for commercial use, if approved;
•
Our ability to enter into successful new collaborations;
•
Our dependence on future collaborators for developing, obtaining regulatory approval for and commercializing product candidates in the collaboration;
•
Our receipt and timing of any milestone payments or royalties under any future research collaboration or license agreements or arrangements;
•
Our plans and strategy regarding the commercialization of any products that are approved for marketing and our ability to establish adequate pricing in the U.S. and international markets;
•
The size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in combination with others;
•
Our ability to attract and retain qualified employees and key personnel;
•
Our expectations regarding government and third-party payor coverage and reimbursement; and
•
Our expectations of obtaining a positive health technology assessment recommending our products.
These statements are based on the beliefs and assumptions of our management, which are in turn based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results and timing expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section entitled “Risk Factors” included under Part II, Item 1A in this Report. Furthermore, such forward-looking statements speak only as of the date of this Report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
3
SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS
Our business involves significant risks, some of which are summarized below. The summary risk factors listed below should be read together with the text of the full risk factors discussed in the section entitled "Risk Factors" included under Part II, Item 1A in this Report. You should carefully consider the risks described below, as well as the other information in this Report, including our financial statements and the related notes and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included under Part I, Item 2 in this Report, as well as in other documents that we file with the Securities and Exchange Commission, or the SEC. The occurrence of any of the events or developments described in this Report could have a material adverse effect on our business, financial condition, results of operations, growth prospects and stock price. In such an event, the market price of our common stock could decline. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.
Risks Related to Our Financial Position, Operations and Need for Additional Capital
•
We have incurred significant net losses since inception, and we expect to continue to incur significant net losses for the foreseeable future.
•
Our pursuit of internal and external opportunities may not deliver the benefits we expect or enhance stockholder value.
•
We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
Risks Related to Research and Development and the Biopharmaceutical Industry
•
We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
•
Our business is highly dependent on the success of our lead product candidate, PLN-101095 and any other product candidates that we advance into the clinic. All of our product candidates will require significant additional preclinical and clinical development before we may be able to seek regulatory approval for and launch a product commercially.
•
Our approach to drug discovery and development in the area of integrin-based therapeutics is unproven and may not result in marketable products.
•
Clinical development involves a lengthy, complex, and expensive process, with an uncertain outcome to support either a marketing authorization or positive pricing and reimbursement decisions.
•
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
•
We may fail to obtain and maintain certain regulatory exclusivities and orphan designations in some jurisdictions and therefore fail to secure orphan exclusivity or other exclusivity extensions in those jurisdictions.
•
Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.
•
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
•
We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than us.
•
We may fail to secure an appropriate reimbursement price or a positive health technology assessment.
Risks Related to Our Intellectual Property
•
Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
•
Our future collaborators may assert ownership or commercial rights to inventions they develop from research we support, or that we develop from our use of the tissue samples or other biological materials that they provide to us, or otherwise arising from such collaboration.
4
Risks Related to Our Reliance on Third Parties
•
We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize PLN-101095 or any other potential product candidates.
•
Because we rely on third-party manufacturing and supply vendors, including single-source vendors and vendors located in foreign jurisdictions, including China, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
•
If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
Risks Related to Managing Our Business and Operations
•
Our loss of key management personnel, or our failure to recruit additional highly skilled personnel, will impair our ability to develop PLN-101095 or other product candidates or identify and develop new product candidates, could result in loss of markets or market share and could make us less competitive.
5
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands, except number of shares and per share amounts)
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 (Note 5)
4,135
4,464
Property and equipment held for sale (Note 4)
906
1,040
Total current assets
163,142
196,448
Property and equipment, net (Note 4)
2,414
2,940
Operating lease right-of-use assets (Note 15)
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 (Note 6)
3,653
9,634
Operating lease liabilities, current (Note 15)
2,272
1,447
Total current liabilities
16,484
16,365
Operating lease liabilities, non-current (Note 15)
26,471
27,658
Long-term debt (Note 7)
—
—
Total liabilities
42,955
44,023
Commitments and Contingencies (Note 14)
Stockholders’ equity
Preferred stock, $
0.0001
par value per share;
10,000,000
shares authorized at June 30, 2026 and December 31, 2025,
300,000
shares designated as Series A Junior Participating Preferred Stock at June 30, 2026 and December 31, 2025; and
none
issued or outstanding at June 30, 2026 and December 31, 2025 (Note 8 and 10)
—
—
Common stock, $
0.0001
par value per share;
300,000,000
shares authorized at June 30, 2026 and December 31, 2025; and
61,920,154
and
61,449,290
shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively (Note 9)
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
The accompanying notes are an integral part of these condensed financial statements
6
Pliant Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except number of shares and per share amounts)
Three Months Ended June 30,
Six Months Ended June 30,
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
Comprehensive loss:
Net loss
$
(
22,371
)
$
(
43,300
)
$
(
42,411
)
$
(
99,466
)
Net unrealized loss on short-term investments
(
56
)
(
160
)
(
382
)
(
322
)
Total other comprehensive loss
(
56
)
(
160
)
(
382
)
(
322
)
Comprehensive loss
$
(
22,427
)
$
(
43,460
)
$
(
42,793
)
$
(
99,788
)
The accompanying notes are an integral part of these condensed financial statements.
7
Pliant Therapeutics, Inc.
Condensed Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except number of shares and per share amounts)
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive Loss
Accumulated
Deficit
Total
Stockholders’
Equity
Common Stock
Shares
Amount
Balance at December 31, 2025
61,449,290
$
6
$
1,040,610
$
(
15
)
$
(
859,396
)
$
181,205
Issuance of common stock under benefit plans
465,279
—
74
—
—
74
Stock-based compensation expense
—
—
4,254
—
—
4,254
Net unrealized loss on short-term investments
—
—
—
(
326
)
—
(
326
)
Net loss
—
—
—
—
(
20,040
)
(
20,040
)
Balance at March 31, 2026
61,914,569
$
6
$
1,044,937
$
(
341
)
$
(
879,436
)
$
165,166
Issuance of common stock under benefit plans
5,585
—
—
—
—
—
Stock-based compensation expense
—
—
4,187
—
—
4,187
Net unrealized loss on short-term investments
—
—
—
(
56
)
—
(
56
)
Net loss
—
—
—
—
(
22,371
)
(
22,371
)
Balance at June 30, 2026
61,920,154
$
6
$
1,049,124
$
(
397
)
$
(
901,807
)
$
146,926
The accompanying notes are an integral part of these condensed financial statements.
8
Pliant Therapeutics, Inc.
Condensed Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except number of shares and per share amounts)
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive Gain/(Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Common Stock
Shares
Amount
Balance at December 31, 2024
60,860,838
$
6
$
1,013,806
$
321
$
(
710,052
)
$
304,081
Issuance of common stock under benefit plans
525,345
—
498
—
—
498
Stock-based compensation expense
—
—
8,913
—
—
8,913
Net unrealized loss on short-term investments
—
—
—
(
162
)
—
(
162
)
Net loss
—
—
—
—
(
56,166
)
(
56,166
)
Balance at March 31, 2025
61,386,183
$
6
$
1,023,217
$
159
$
(
766,218
)
$
257,164
Issuance of common stock under benefit plans
—
—
—
—
—
$
—
Stock-based compensation expense
—
—
6,378
—
—
$
6,378
Net unrealized loss on short-term investments
—
—
—
(
160
)
—
$
(
160
)
Net loss
—
—
—
—
(
43,300
)
$
(
43,300
)
Balance at June 30, 2025
61,386,183
6
$
1,029,595
$
(
1
)
$
(
809,518
)
$
220,082
The accompanying notes are an integral part of these condensed financial statements.
9
Pliant Therapeutics, Inc.
Condensed Statements of Cash Flows
(Unaudited)
Six Months Ended June 30,
(In thousands)
2026
2025
Cash flows from operating activities
Net loss
$
(
42,411
)
$
(
99,466
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
513
895
Stock-based compensation expense
8,441
15,291
Gain on sale of property and equipment
(
94
)
—
Non-cash operating lease expense
1,677
1,628
Net amortization (accretion) on short-term investments
299
3,339
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
781
1,970
Other non-current assets
131
43
Accounts payable
1,051
(
4,580
)
Accrued liabilities
(
2,052
)
(
8,622
)
Operating lease liabilities
(
362
)
35
Net cash used in operating activities
(
32,026
)
(
89,467
)
Cash flows from investing activities
Purchase of short-term investments
(
82,216
)
(
65,756
)
Maturity of short-term investments
93,487
170,731
Purchase of property and equipment
—
(
374
)
Proceeds from sale of property, plant and equipment
119
—
Net cash provided by investing activities
11,390
104,601
Cash flows from financing activities
Proceeds from issuances of common stock under benefit plans
74
498
Net cash provided by financing activities
74
498
Net (decrease) increase in cash and cash equivalents
(
20,562
)
15,632
Cash and cash equivalents and restricted cash at beginning of period
46,927
72,670
Cash, cash equivalents and restricted cash at end of period
$
26,365
$
88,302
Supplemental disclosures of cash flow information:
Cash paid for interest
$
—
$
1,457
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents
$
24,883
$
86,820
Restricted cash
1,482
1,482
Total cash, cash equivalents, and restricted cash
$
26,365
$
88,302
Supplemental disclosures of noncash investing activities:
Purchase of property and equipment in accounts payable and accrued liabilities
$
—
$
112
The accompanying notes are an integral part of these condensed financial statements.
10
Pliant Therapeutics, Inc.
Notes to Condensed Financial Statements
(Unaudited)
1.
Organization and Description of Business
Pliant Therapeutics, Inc. (the “Company” or “Pliant” or “we” or “our” or “us”) is a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β). The Company is located in South San Francisco, California, and was incorporated in the state of Delaware in June 2015.
Bexotegrast in Idiopathic Pulmonary Fibrosis (IPF)
In March 2025, we announced that we were discontinuing the BEACON-IPF Phase 2b trial following a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board (“DSMB”), as well as a secondary review and recommendation by an outside expert panel, due to an imbalance in safety events between the treatment and placebo groups. In June 2025, we announced that we were discontinuing the development of bexotegrast in IPF as the results of BEACON-IPF demonstrated an unfavorable risk-benefit profile.
2.
Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (“SEC”), for interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the unaudited interim condensed financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited interim condensed financial statements have been prepared on the same basis as our annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of the Company's financial information. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 or for any other interim period or for any other future year.
The financial information included herein should be read in conjunction with the audited financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 11, 2026 (the “2025 10-K”).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and expenses as well as the disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, stock-based compensation expense, operating lease right-of-use (“ROU”) assets and liabilities, accruals and prepayments for research and development costs, income taxes and uncertain tax positions. The Company assesses estimates on an ongoing basis, however, actual results could materially differ from those estimates.
Significant Accounting Policies
There have been no significant changes to the accounting policies during the three and six months ended June 30, 2026, as compared to the significant accounting policies described in Note 2 of the "Notes to the Financial Statements" in the Company's audited financial statements included in its 2025 10-K.
Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03 “Disaggregation of Income Statement Expenses,” which aims to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. The guidance is effective for the Company's annual periods beginning in 2027 and interim periods beginning in the first quarter of fiscal year 2028.
3.
Financial Instruments
The Company’s short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities with original maturities beyond three months at the date of purchase. The Company has classified and accounted for its short-term investments as available-for-sale securities as the Company may sell
11
these securities at any time for reasons including, but not limited to, managing liquidity, credit risk, duration and asset allocation and such investments represent cash available for current operations. As a result, short-term investments may include securities with maturities beyond twelve months that are classified within current assets in the condensed balance sheets. The Company’s short-term investments classified as available-for-sale are carried at fair market value with unrealized gains or losses recognized in the statements of operations and comprehensive loss.
The Company’s cash equivalent Money Market Funds are classified as Level 1 in the fair value hierarchy because they are valued using quoted active market prices. The fair value of the Company’s U.S. Treasury securities, U.S. Government agency securities and corporate debt securities are classified as Level 2 because they are valued using observable inputs to quoted market prices other than Level 1 prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency and include U.S. Government agency securities, U.S. Treasury securities and corporate debt securities.
There were
no
assets or liabilities recorded at fair value to the condensed balance sheets using Level 3 inputs as of June 30, 2026 and as of December 31, 2025.
The following tables show the Company’s short-term investments and cash equivalents by significant investment category as of June 30, 2026 and December 31, 2025 (in thousands):
As of June 30, 2026
As of December 31, 2025
Adjusted
Cost
Unrealized
Gains
Unrealized
Losses
Market
Value
Adjusted
Cost
Unrealized
Gains
Unrealized
Losses
Market
Value
Money Market Funds
Level 1
$
17,141
$
—
$
—
$
17,141
$
24,811
$
—
$
—
$
24,811
U.S. Treasury securities
Level 2
17,087
—
(
109
)
16,978
8,064
2
(
1
)
8,065
U.S. Government agency securities
Level 2
2,007
—
(
11
)
1,996
1,001
—
—
1,001
Corporate debt securities
Level 2
114,521
1
(
278
)
114,244
139,941
26
(
42
)
139,925
Total financial assets
$
150,756
$
1
$
(
398
)
$
150,359
$
173,817
$
28
$
(
43
)
$
173,802
As of June 30, 2026
As of December 31, 2025
Adjusted
Cost
Unrealized
Gains
Unrealized
Losses
Market
Value
Adjusted
Cost
Unrealized
Gains
Unrealized
Losses
Market
Value
Classified as:
Cash equivalents
$
17,141
$
—
$
—
$
17,141
$
28,303
$
—
$
—
$
28,303
Short-term investments
133,615
1
(
398
)
133,218
145,514
28
(
43
)
145,499
Total
$
150,756
$
1
$
(
398
)
$
150,359
$
173,817
$
28
$
(
43
)
$
173,802
There were
no
liabilities measured at fair value on a recurring basis as of June 30, 2026 and December 31, 2025. The Company evaluates transfers between levels at the end of each reporting period and there have been no transfers between fair value measurement levels during the six months ended June 30, 2026. In addition, there were
no
assets or liabilities measured at fair value on a non-recurring basis as of June 30, 2026 and December 31, 2025.
The Company records interest income, accretion income and amortization expense on short-term investments to interest and other income (expense), net in its condensed statement of operations and comprehensive loss.
12
4.
Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
As of June 30, 2026
As of December 31, 2025
Laboratory equipment
$
7,857
$
8,563
Leasehold improvements
2,156
2,156
Furniture and fixtures
1,832
1,832
Computer equipment and software
1,105
1,105
Construction-in-progress
152
153
Total property and equipment, gross
13,102
13,809
Less: Accumulated depreciation
(
10,688
)
(
10,869
)
Total property and equipment, net
$
2,414
$
2,940
Depreciation expense was $
0.2
million and $
0.5
million for the three and six months ended June 30, 2026, respectively, and $
0.4
million and $
0.9
million for the three and six months ended June 30, 2025, respectively.
In the fourth quarter of 2025, the Company committed to a plan to sell certain laboratory equipment that was no longer required following the restructuring of operations initiated May 1, 2025. Management determined that the assets met the criteria for classification as held for sale in accordance with ASC 360, "Property, Plant and Equipment."
The Company intended to divest these assets as part of their strategic realignment of resources, focusing on the development of PLN-101095 and the drug discovery platform. The assets were measured at the lower of their carrying value or fair value less cost to sell, and reclassified to "Property and equipment held for sale" within current assets on the Balance Sheets as of December 31, 2025. Depreciation ceased to be recognized on the assets after the date of their held-for-sale classification.
Laboratory equipment held for sale: (in thousands):
As of June 30, 2026
As of December 31, 2025
Laboratory equipment held for sale
906
1,040
Total property and equipment held for sale
906
1,040
5.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
As of June 30, 2026
As of December 31, 2025
Prepaid licenses
$
567
$
763
Interest receivable
873
823
Prepaid research and development
2,366
2,114
Prepaid insurance
212
672
Other
118
92
Total prepaid expenses and other current assets
$
4,135
$
4,464
6.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
As of June 30, 2026
As of December 31, 2025
Accrued compensation and benefits
$
3,175
$
8,298
Other accrued liabilities
478
1,336
Total accrued liabilities
$
3,653
$
9,634
13
Accrued compensation and benefits consist primarily of accrued bonuses and accrued vacation. As of December 31, 2025, the amount also included accrued severance costs of $
2.5
million.
7.
Long-term Debt
In March 2024 we entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”) with Oxford Finance LLC (“Oxford”) to borrow a series of term loans up to an aggregate principal amount of $
150.0
million. Pursuant to the Amended Loan Agreement, we drew an initial term loan of $
30.0
million, inclusive of $
10.0
million in principal amount previously outstanding under the initial Oxford Loan Agreement executed in May 2022.
In October 2025, we made a full voluntary prepayment of $
32.4
million to extinguish outstanding term loans. Upon prepayment, the term loans, related security interests, and all other obligations, covenants, debts and liabilities under the Amended Loan Agreement were satisfied and discharged in full.
There was
no
debt outstanding
no
r interest expense incurred during the three and six months ended June 30, 2026. Interest expense for the three and six months ended June 30, 2025 was $
0.8
million and $
1.6
million, respectively.
8.
Preferred Stock
Under the Company’s Amended and Restated Certificate of Incorporation, the Company is authorized to issue
two
classes of shares: preferred stock and common stock. The preferred stock may be issued in series, and the Company’s board of directors is authorized to determine the rights, preferences, and terms of each series. These rights, preferences and terms could include dividend rights, conversion rights, voting rights, terms of redemptions, liquidation preferences and sinking fund terms. As of June 30, 2026 and December 31, 2025, the Company was authorized to issue
10,000,000
shares of preferred stock and there was
no
outstanding preferred stock as of June 30, 2026 and December 31, 2025.
9.
Common Stock
As of June 30, 2026 and December 31, 2025, the Company was authorized to issue
300,000,000
shares of common stock at a par value of $
0.0001
per share. The Common Stock has the following rights and privileges:
Voting
The holders of shares of common stock are entitled to
one
vote for each share of common stock held at any meeting of stockholders and at the time of any written action in lieu of a meeting.
Dividends
The holders of shares of common stock are entitled to receive dividends, when declared by the Company’s board of directors. Cash dividends may not be declared or paid to holders of shares of common stock until all unpaid dividends on preferred stock have been paid in accordance with their terms.
No
dividends have been declared or paid by the Company since its inception.
Liquidation
Subject to the preferential rights of holders of preferred stock then outstanding, the holders of shares of common stock are entitled to share ratably in the Company’s remaining assets available for distribution to its stockholders in the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company.
Shares reserved for future issuance
As of June 30, 2026
As of December 31, 2025
Outstanding stock option awards
11,569,019
7,456,066
Vesting of RSUs
524,714
858,247
Shares of common stock available for future grants under the 2020 Stock Option and Incentive Plan
6,720,004
7,832,167
Shares of common stock available for future issuance under the 2020 Employee Stock Purchase Plan
1,626,484
1,692,136
Shares of common stock available for future grants under the 2022 Inducement Plan
1,425,000
1,425,000
Total shares reserved for future issuance
21,865,221
19,263,616
10.
Stockholder Rights Agreement
14
On March 12, 2025, the Company's board of directors adopted the Rights Plan and declared a dividend of
one
right (each, a “Right”) for each outstanding share of our common stock to stockholders of record at the close of business on March 25, 2025. Each Right entitles its holder, subject to the terms of the Rights Plan, to purchase from the Company one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $
0.0001
per share, of the Company at an exercise price of $
12.64
per Right, subject to adjustment. The description and terms of the Rights are set forth in the Rights Plan, dated as of March 12, 2025, by and between the Company and Computershare Trust Company, N.A., a federally chartered trust company, as rights agent. Subject to certain exceptions, Rights become exercisable and trade separately from our common stock only upon the earlier of (i) the close of business on the
tenth business day
following the public announcement of an Acquiring Person (as defined in the Rights Plan) beneficially owning
20
%, when referring to a passive investor, and
10
%, when referring to a person that is not a passive investor, or more of our common stock, and (ii) the close of business on the
tenth business day
after the commencement of a tender offer or exchange offer that, if consummated, would result in a person or group becoming an Acquiring Person. On March 3, 2026, the Company entered into an Amendment to the Stockholder Rights Agreement to extend the expiration time of the Rights for
one year
from March 11, 2026 to March 11, 2027, unless the Rights are earlier redeemed, exchanged, or terminated in accordance with the terms and conditions of the Rights Agreement.
The Rights Plan is intended to reduce the likelihood that any entity, person or group is able to gain control of the Company through open market accumulation without paying all stockholders an appropriate control premium or providing the board of directors sufficient opportunity to make informed judgments and take actions that are in the best interests of the Company and all stockholders. The Rights Plan is not intended to interfere with any merger or other business combination approved by the board of directors.
11.
Equity Incentive Plans and Stock-Based Compensation
In 2015, the Company's board of directors adopted the 2015 Equity Incentive Plan, as amended in 2018, 2019 and 2020 (the “2015 Plan”), which provided for the grant of incentive stock options, nonqualified stock options or other awards including stock appreciation rights and restricted stock awards to the Company’s employees, officers, directors, advisors, and consultants. In May 2020, the board of directors adopted the 2020 Stock Option and Incentive Plan (the “2020 Plan”) and suspended the 2015 Plan. Awards outstanding under either the 2015 Plan or 2020 Plan that are cancelled, expire or otherwise terminated subsequent to May 2020 will become available for issuance as common stock under the 2020 Plan. Additionally, the 2020 Plan is subject to automatic increases on January 1 of each year beginning January 1, 2021. The number of shares added each January 1 will be equal to the lesser of: (i)
5
% of the outstanding shares on the immediately preceding December 31 or (ii) such amount as determined by the compensation committee of the board of directors.
The 2020 Plan provides for the grant of incentive stock options, nonqualified stock options or other awards including stock appreciation rights, restricted stock awards and restricted stock units to the Company’s employees, officers, directors, advisors and consultants.
In 2022, the board of directors adopted the 2022 Inducement Plan (the “2022 Plan”), under which the Company may grant nonqualified stock options or other awards including stock appreciation rights and restricted stock awards.
Options under the 2020 Plan and Inducement Plan may be granted for periods of up to
10
years and at prices no less than the market price of the Company’s common stock on the date of grant, provided, however, that the exercise price of an incentive stock option granted to a
10
% shareholder shall not be less than
110
% of the fair value of the shares on the date of grant and the option is not exercisable after the expiration of
five years
from the date of grant.
Stock Option Repricing
On April 15, 2026, upon the recommendation of its Compensation Committee, the Board approved an option repricing (the “Repricing”), effective as of April 17, 2026 (the “Effective Date”). The Repricing was undertaken in accordance with, and as permitted by, the Company’s 2015 Plan, 2020 Plan, and 2022 Plan. Pursuant to the Repricing, effective as of the Effective Date, all outstanding vested and unvested options originally granted on or before March 1, 2025 pursuant to the 2015 Plan, the 2020 Plan, or the 2022 Plan that are held by employees as of the Effective Date, including the Company’s executive officers, were repriced to reduce the exercise price to $
1.33
per share, the closing price per share of the Company’s common stock on the Effective Date. No other changes were made to the terms and conditions of the eligible stock option awards.
In order to exercise the repriced options at the $
1.33
per share exercise price, employees are required to remain in service with the Company through the Retention Period, which begins on the Effective Date and ends on the earliest of the following: (i) the
18-month
anniversary following the Effective Date if the employee is a member of the Company’s executive leadership team, or the
12-month
anniversary following the Effective Date for all other employees; (ii) the consummation of a Corporate Transaction (as defined by the 2015 Plan); (iii) the consummation of a Sale Event (as defined by the 2020 Plan and 2022 Plan); and (iv) the employee’s (a) termination by the Company without cause (as defined in the Eligible Participant’s applicable severance plan) or due to a reduction in force, (b) death or termination due to disability, or (c) if the employee is a Vice President or above, resignation from service for good reason (as defined in the Eligible Participant’s applicable severance plan).
15
The repriced options will be subject to the original exercise price that was in effect immediately prior to the Effective Date if the employee (i) is terminated by the Company for cause (as defined in the Eligible Participant’s applicable severance plan); (ii) resigns from the Company prior to the end of the applicable Retention Period, except for good reason (as defined in the Eligible Participant’s applicable severance plan) if the employee is a Vice President or above; or (iii) elects to exercise the repriced options prior to the end of the applicable Retention Period.
Total incremental expense for the repriced options is $
2.0
million which is expected to be recognized over a weighted-average period of
1.37
years.
Incentive Stock Options and Nonqualified Stock Options
Stock options issued under either the 2015 Plan, the 2020 Plan or the Inducement Plan generally vest over
four years
and expire
ten years
from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the respective plans.
Excluding the effect of the repriced options, the Company used Black-Scholes option pricing model to estimate stock-based compensation expense for stock option awards with the following assumptions:
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Expected volatility
83.22
% -
85.89
%
88.02
% -
89.30
%
83.22
% -
87.39
%
86.82
% -
89.30
%
Risk-free interest rate
4.16
% -
4.21
%
3.98
% -
4.12
%
3.91
% -
4.21
%
3.98
% -
4.45
%
Expected dividend
—
—
—
—
Expected term (in years)
5.31
-
6.06
5.34
-
6.07
5.31
-
6.06
5.34
-
6.08
Underlying common stock fair value
$
1.14
$
1.37
- $
1.61
$
1.14
- $
1.30
$
1.37
- $
12.63
A summary of option activity under the 2015 Plan, 2020 Plan and 2022 Plan is as follows:
Number
of
Options
Weighted-
Average Exercise
Price per Share
Weighted-
Average
Remaining
Contractual
Term (in Years)
Aggregate
Intrinsic
Value
Outstanding as of December 31, 2025
7,456,066
$
15.28
5.60
$
—
Granted
5,117,500
$
1.29
Exercised
—
$
—
Forfeited
(
1,004,547
)
$
13.91
Outstanding as of June 30, 2026
11,569,019
$
9.21
7.26
$
—
Exercisable as of June 30, 2026
5,677,190
$
14.28
5.43
$
—
Vested and expected to vest as of June 30, 2026
11,569,019
$
9.21
7.26
$
—
As of June 30, 2026, there was $
18.6
million of unrecognized compensation costs, inclusive of the incremental cost of repriced options, that are expected to be recognized over a weighted-average period of
2.23
years related to stock options. Aggregate intrinsic value represents the difference between the fair value of the underlying common stock and the exercise price as of June 30, 2026.
Restricted Stock Units
The service-based condition for restricted stock units (“RSUs”) is generally satisfied over
three years
.
Restricted Stock Units
Weighted Average Grant Date Fair Value
Unvested and outstanding as of December 31, 2025
858,247
$
16.04
Granted
107,751
$
1.30
Released
(
405,212
)
$
19.94
Forfeited
(
36,072
)
$
5.71
Unvested and outstanding as of June 30, 2026
524,714
$
10.70
As of June 30, 2026, the Company had $
3.6
million of unrecognized stock-based compensation expense related to outstanding RSUs expected to be recognized over a weighted-average period of
1.66
years.
16
2020 Employee Stock Purchase Plan
In June 2020, the Company adopted the Company's 2020 Employee Stock Purchase Plan (the “2020 ESPP”). The 2020 ESPP provides that the number of shares reserved and available for issuance will automatically increase on January 1 of each calendar year, beginning January 1, 2021, by the least of (1)
1.0
% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, (2)
700,000
shares or (3) such lesser amount as determined by the administrator of the 2020 ESPP, which is the compensation committee of the board of directors of the Company.
Under the 2020 ESPP, eligible employees may purchase shares of our common stock through payroll deductions that cannot exceed
15
% of each employee’s salary. The 2020 ESPP provides for a
six-month
offering period. At the end of the purchase period, eligible employees are permitted to purchase shares of common stock at the lower of
85
% of the fair market value at the beginning of the offering period or
85
% of the fair market value at the end of the purchase period, subject to tax limitations on the total value of the purchase. The 2020 ESPP is considered a compensatory plan, and the Company recorded $
27.5
thousand in stock-based compensation expense for the six months ended June 30, 2026 and $
118.2
thousand for the six months ended June 30, 2025. During the six months ended June 30, 2026,
65,652
shares of common stock were issued, under the 2020 ESPP with
1,626,484
shares remaining available for issuance as of June 30, 2026.
The Company used Black-Scholes option pricing model to estimate stock-based compensation expense for the 2020 ESPP with the following assumptions:
Six Months Ended June 30,
2026
2025
Expected volatility
62.35
%
208.00
%
Risk-free interest rate
3.68
%
4.29
%
Expected dividend
—
—
Expected term (in years)
0.50
0.50
Stock-Based Compensation Expense
The following table presents the components and classification of stock-based compensation expense for the Company’s stock-based awards for the three and six months ended June 30, 2026 and 2025 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Stock options and ESPP
$
3,259
$
4,406
$
6,387
$
10,367
Restricted stock units
927
1,976
2,053
4,927
Total stock-based compensation expense
$
4,186
$
6,382
$
8,440
$
15,294
Research and development expenses
$
1,464
$
1,935
$
3,191
$
5,637
General and administrative expenses
$
2,722
$
4,447
$
5,249
$
9,657
12.
Income Taxes
For the three and six months ended June 30, 2026 and 2025, the Company did
not
record an income tax provision. The Company will continue to maintain a
100
% valuation allowance on total deferred tax assets. The Company believes it is more likely than not that the related deferred tax asset will not be realized. As a result, the Company’s effective tax rate will remain at
0
% because there are no estimated or discrete items that would impact the tax provision.
The One Big Beautiful Bill Act (“OBBBA”), enacted on July 4, 2025, introduced Internal Revenue Code (“IRC”) Section 174A, which permits the full expensing of domestic research and experimental (“R&E”) expenditures incurred in taxable years beginning after December 31, 2024. For domestic R&E expenditures incurred prior to January 1, 2025, the Company has elected to continue amortizing the remaining balances over their existing five-year periods as permitted by Rev. Proc. 2025-28.
For the three and six months ended June 30, 2026, the full expensing of current domestic R&E costs resulted in an increase in net operating loss carryforwards. However, because the Company maintains a full valuation allowance against its deferred tax assets, these changes had no impact on the effective tax rate.
17
13.
Segments
The Company operates and manages its business as
one
reportable and operating segment, which is the business of developing and commercializing novel therapies for patients. The Company’s chief executive officer, who is the chief operating decision maker (“CODM”), reviews financial information on an aggregate basis for allocating and evaluating financial performance. The Company defines its segments based on the way in which internally reported financial information is regularly reviewed by the CODM to analyze financial performance, make decisions, and allocate resources. The CODM assesses performance for the segment and decides how to allocate resources based on net loss which is also reported on the Statement of Operations and Comprehensive Loss as consolidated net loss.
All long-lived assets are maintained in the United States of America.
Our CODM is regularly provided with more detailed expense information than what is included in our Statement of Operations and Comprehensive Loss. Following our decision to discontinue development of bexotegrast, we re-prioritized development of programs formerly included in "other segment items" below. Beginning in the first quarter of 2026, significant segment expense includes the reprioritized pipeline within "Program expense - clinical trial and third-party contracting costs". Prior period amounts have been reclassified to conform to current year presentation.
The table below shows a reconciliation of the Company’s net loss, including the significant expense categories regularly provided to and reviewed by the CODM reflecting the changes made by the Company's reprioritized pipeline, as computed under U.S. GAAP, to the Company’s total net loss in the statements of operations (in thousands).
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Operating expenses:
Program expense including clinical trial and third-party contracting costs
$
9,595
$
1,292
15,180
2,728
Bexotegrast - clinical trial and third party contracting costs
(
311
)
13,359
(
1,088
)
34,948
Employee-related expenses - research and development (excluding stock-based compensation)
2,926
10,344
6,463
20,830
General and administrative costs (excluding stock-based compensation)
4,413
8,947
10,074
19,236
Other segment items
7,239
11,650
15,005
26,785
Segment loss
23,862
45,592
45,634
104,527
Reconciliation of segment loss
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
Other segment items include total stock-based compensation and research and development costs not directly associated with active, prioritized pipeline programs and other non-program costs (excluding employee-related expenses).
14.
Commitments and Contingencies
Purchase Commitments
The Company has contractual arrangements with research and development organizations and suppliers; however, these contracts are generally cancellable on
30
days’ notice and the obligations under these contracts are largely based on services performed.
18
15.
Leases
On September 28, 2023, the Company entered into a lease agreement with HCP BTC, LLC, a Delaware limited liability company (“the Landlord”) for premises consisting of approximately
100,904
square feet of office and laboratory space located at Oyster Point Blvd, South San Francisco, California (the “Oyster Point Lease”), which is being used as a single unified Company headquarters. The lease term of approximately
seven years
started in the second quarter of 2024 when the Landlord substantially completed tenant improvements and may be extended for a period of
eight years
at the then prevailing market rates for a comparable property. Future lease payments are approximately $
36.6
million which represent the non-cancellable periods of the lease. We excluded extension options that are not reasonably certain to be exercised from our lease terms. Our lease payments consist primarily of fixed rental payments for the right to use the underlying leased assets over the lease term. Our lease agreement provides us the right to sublet the premises, subject to approval by the Landlord. Additionally, the Company provided a letter of credit to the Landlord in the amount of $
1.4
million in connection with the Oyster Point Lease, which is classified as restricted cash as of June 30, 2026.
Though the Oyster Point Lease is accounted for as a single contract, the office space was occupied in March 2024 while the laboratory space was occupied in June 2024. Accordingly, the Company measured and allocated consideration to each lease component. Upon commencement of each lease component the Company recognized an aggregate right-of-use asset ("ROU") and lease liability of $
23.7
million and $
6.1
million during the quarters ended March 31, 2024 and June 30, 2024, respectively.
The undiscounted future non-cancellable lease payments of the Company's operating lease liability as of June 30, 2026 were as follows (in thousands):
Operating Lease
2026 (remainder of the year)
2,380
2027
5,897
2028
7,467
2029
8,129
2030
8,414
2031
4,278
Total undiscounted lease payments
$
36,565
Less: Present value discount
(
7,822
)
Total discounted lease payments
$
28,743
Total current operating lease liabilities
$
2,272
Total non-current operating lease liabilities
$
26,471
Total lease liability
$
28,743
The weighted-average remaining lease terms and discount rates related to the Company's operating leases were as follows:
Six Months Ended June 30,
2026
2025
Weighted-average remaining lease term (in years)
5.0
6.0
Weighted-average discount rate
9.3
%
9.3
%
Variable lease costs comprise primarily of the Company's proportionate share of operating expenses, property taxes, and insurance. Short-term lease expense and variable lease payments recorded in operating expenses were immaterial for the three and six months ended June 30, 2026 and 2025.
Lease expenses for each of the three and six months ended June 30, 2026 and 2025 are as follows (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Operating lease costs
$
1,505
$
1,505
$
3,011
3,011
Other variable costs
471
522
971
952
Total expense
$
1,976
$
2,027
$
3,982
$
3,963
19
16.
Defined Contribution Plan
The Company sponsors a defined contribution plan under Section 401(k) of the Internal Revenue Code covering substantially all full-time U.S. employees. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. The Company made contributions to the plan of $
0.1
million and $
0.5
million for the three and six months ended June 30, 2026, respectively, and $
0.3
million and $
1.0
million for three and six months ended June 30, 2025 respectively.
17.
Net Loss Per Share Attributable to Common Stockholders
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented, because including them would have been antidilutive:
Six Months Ended June 30,
2026
2025
Options to purchase common stock
11,569,019
9,037,076
Restricted stock units
524,714
1,060,650
Total
12,093,733
10,097,726
18.
Restructuring of Operations
On May 1, 2025, we announced a reduction in workforce that impacted approximately
45
% of our then-current employees. The restructuring plan was completed in the third quarter of 2025 and amounted to $
3.8
million.
In December 2025, we initiated an additional restructuring plan totaling $
2.5
million. The restructuring plan was completed on December 15, 2025 and the entire cost, consisting of severance and a benefits continuation payment was accrued within Accrued Compensation and Benefits as of December 31, 2025 and settled in cash during the three months ended March 31, 2026.
20
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with our condensed financial statements and related notes appearing elsewhere in this Report, as well as our audited financial statements and related notes included in our 2025 10-K. This discussion and analysis contains forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intention, beliefs and projections. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in the section titled “Risk Factors” under Part II, Item 1A of this Report and under Part I, Item 1A of our 2025 10-K. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will” or the negative of these terms or other similar expressions.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate we have conducted exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Overview
We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β). We have applied our deep understanding of integrin biology, along with our medicinal chemistry and translational medicine expertise to develop a proprietary drug discovery platform that we believe has broad applicability across multiple areas of disease.
Our wholly owned lead product candidate, PLN-101095, is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors. In 2025, we announced positive data from a Phase 1 open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with the immunotherapy pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. We also continue to explore the full potential of our drug discovery platform consisting of a proprietary library of over 15,000 integrin binding molecules, focusing on integrin-based target-mediated drug delivery.
Since inception, we have had significant operating losses. Our net loss was $22.4 million and $43.3 million for the three months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $901.8 million and cash, cash equivalents, and short-term investments of $159.6 million. We expect to continue to incur net losses for the foreseeable future as we:
•
perform research and development activities to identify and develop product candidates;
•
advance product candidates into and through clinical development;
•
require the manufacture of supplies to support research and development, preclinical studies and clinical trials;
•
seek regulatory approvals for any product candidates that successfully complete clinical trials;
•
maintain, expand and protect our intellectual property portfolio; and
•
invest in or in-license other technologies or product candidates.
Second Quarter and Recent Developments
Oncology
Program
•
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
21
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.
Components of Operations
Operating Expenses
Research and Development
Our research and development expenses consist of expenses incurred in connection with the development of our product candidates. Research and development expenses include:
•
employee-related expenses, which include salaries, benefits and stock-based compensation for our research and development personnel;
•
expenses incurred under agreements with third-party contract organizations for pre-clinical studies, clinical trials and consultants that conduct research and development activities on our behalf;
•
costs associated with the manufacture of supplies to support research and development, preclinical studies and clinical trials;
•
depreciation of laboratory equipment and costs of equipment and supplies;
•
facilities expenses, which include expenses for rent and other facility related costs; and
•
other expenses and other allocations associated with research and development.
The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025 (in thousands):
Three Months Ended June 30,
2026
2025
$ Change
Employee related expenses
$
4,390
$
12,279
$
(7,889)
Outside and consulting services for preclinical studies and research and development activities by third-party contract organizations
595
4,087
(3,492)
Clinical trials expenses
8,779
11,291
(2,512)
Depreciation of lab equipment and costs of equipment and supplies
449
1,291
(842)
Facilities expenses
1,415
1,742
(327)
Other expenses and other allocations
1,098
1,508
(410)
Total research and development expenses
$
16,727
$
32,198
$
(15,471)
We expense all research and development costs in the periods in which they are incurred. We do not allocate our internal costs by product candidates or by preclinical programs as these are in early stages of clinical trials or development, and any such allocation would involve significant estimates and judgments and, accordingly, would be imprecise. Where appropriate, we allocate our third-party research and development expense by product candidate or preclinical program. These expenses primarily relate to outside consultants, clinical research organizations and contract manufacturing organizations. When we refer to the research and development expenses associated with a specific product candidate or preclinical program, these refer exclusively to the allocated third-party expenses associated with that product candidate.
22
Following the discontinuation of bexotegrast development, our current quarter results are reflective of the re-prioritized development pipeline and research and development expenses should be relatively consistent in the near term, increasing commensurate with the progress of our phase 1b trial. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
General and Administrative
Our general and administrative expenses consist primarily of salaries, benefits and stock-based compensation for our general and administrative personnel, allocated facilities costs, insurance and other expenses for outside professional services, including legal, marketing, investor relations, human resource and accounting services. We expect general and administrative expenses to remain relatively consistent for the foreseeable future. In addition, if we obtain regulatory approval for any of our product candidates and do not enter into a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.
Interest and Other Income (Expense), net
Our interest and other income (expense), net consists of interest, accretion income and amortization expense on cash, cash equivalents, and short-term investments, and realized gains and losses on short-term investments.
Interest Expense
Our interest expense was derived from a term loan executed under the Amended Loan Agreement with Oxford Finance LLC that was terminated in October 2025.
Financial Operations Overview
Comparison of the three months ended June 30, 2026 and 2025 (in thousands)
Three Months Ended June 30,
2026
2025
$ Change
Operating expenses:
Research and development
$
(16,727)
$
(32,198)
$
15,471
General and administrative
(7,135)
(13,394)
6,259
Total operating expenses
(23,862)
(45,592)
21,730
Loss from operations
(23,862)
(45,592)
21,730
Interest and other income (expense), net
1,491
3,101
(1,610)
Interest expense
—
(809)
809
Net loss
$
(22,371)
$
(43,300)
$
20,929
Research and development expenses
The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025 (in thousands):
23
Three Months Ended June 30,
2026
2025
$ Change
Program-specific external expenses:
Program expense including clinical trial and third-party contracting costs
$
9,595
$
1,292
$
8,303
Bexotegrast - clinical trial and third party contracting costs
(311)
13,359
(13,670)
R&D non-program spend
90
727
(637)
Total program-specific external expenses
9,374
15,378
(6,004)
Unallocated internal expenses
Employee-related expenses
4,390
12,279
(7,889)
Depreciation of lab equipment and costs of equipment and supplies
450
1,291
(841)
Facilities expenses
1,415
1,742
(327)
Other expenses and other allocations
1,098
1,508
(410)
Total unallocated internal expenses
7,353
16,820
(9,467)
Total research and development expenses
$
16,727
$
32,198
$
(15,471)
Research and development expenses for the three months ended June 30, 2026 decreased $15.5 million, primarily due to discontinuing development of bexotegrast in IPF and lower employee-related expenses, driven by a reduction in headcount resulting from our 2025 restructuring activities. These decreases were partially offset by an $8.3 million increase in expense primarily associated with development of PLN-101095.
General and Administrative Expenses
General and administrative expenses for the three months ended June 30, 2026 decreased $6.3 million, primarily due to a decrease in employee related costs driven by reduced headcount resulting from our 2025 restructuring activities.
Interest and Other Income (Expense), Net
Interest and other income (expense), net decreased $1.6 million due to lower investment balances due to continued funding of operating activities.
Interest Expense
Interest expense for the three months ended June 30, 2026 decreased $0.8 million due to full repayment of the Amended Loan Agreement in 2025.
Comparison of the six months ended June 30, 2026 and 2025 (in thousands)
Six Months Ended June 30,
2026
2025
$ Change
Operating expenses:
Research and development
$
(30,311)
$
(75,634)
$
45,323
General and administrative
(15,323)
(28,893)
13,570
Total operating expenses
(45,634)
(104,527)
58,893
Loss from operations
(45,634)
(104,527)
58,893
Interest and other income (expense), net
3,223
6,669
(3,446)
Interest expense
—
(1,608)
1,608
Net loss
$
(42,411)
$
(99,466)
$
57,055
Research and development expenses
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):
24
Six Months Ended June 30,
2026
2025
$ Change
Program-specific external expenses:
Program expense including clinical trial and third-party contracting costs
$
15,180
$
2,728
$
12,452
Bexotegrast - clinical trial and third party contracting costs
(1,088)
34,948
(36,036)
R&D non-program spend
902
1,675
(773)
Total program-specific external expenses
14,994
39,351
(24,357)
Unallocated internal expenses
Employee-related expenses
9,654
26,467
(16,813)
Depreciation of lab equipment and costs of equipment and supplies
1,003
2,684
(1,681)
Facilities expenses
2,820
3,619
(799)
Other expenses and other allocations
1,840
3,513
(1,673)
Total unallocated internal expenses
15,317
36,283
(20,966)
Total research and development expenses
$
30,311
$
75,634
$
(45,323)
Research and development expenses for the six months ended June 30, 2026 decreased $45.3 million, primarily due to discontinuing development of bexotegrast in IPF and lower employee-related expenses, driven by a reduction in headcount resulting from our 2025 restructuring activities. These decreases were partially offset by a $12.5 million increase in expense primarily associated with development of PLN-101095.
General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2026 decreased $13.6 million, primarily due to a decrease in employee related costs driven by reduced headcount resulting from our 2025 restructuring activities.
Interest and Other Income (Expense), Net
Interest and other income (expense), net decreased $3.4 million due to lower investment balances due to continued funding of operating activities.
Interest Expense
Interest expense for the six months ended June 30, 2026 decreased $1.6 million due to full repayment of the Amended Loan Agreement in 2025.
Liquidity and Capital Resources
Overview
As of June 30, 2026, we had $159.6 million of cash, cash equivalents and short-term investments. Our short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities.
On March 30, 2026 we entered into a Sales Agreement with Leerink Partners LLC (the "Leerink Sales Agreement"), as sales agent, pursuant to which we may issue and sell shares of common stock in an "at-the-market" offering. On March 30, 2026 we filed a registration statement on Form S-3 (File No. 333-294737) which included an "at the market offering" prospectus covering the offering, issuance and sale of up to $50.0 million of common stock under the Leerink Sales Agreement and a base prospectus registering the offer and sale of up to $300.0 million of debt securities, common stock, preferred stock, units and/or warrants. As of the date of this Report, we have not issued any shares pursuant to any at-the-market offerings, including pursuant to the Leerink Sales Agreement, but may do so at a future date.
In October 2025, we completed a voluntary prepayment of our Amended Loan Agreement with Oxford for $32.4 million, representing all outstanding principal, accrued and unpaid interest, fees, costs and expenses. Upon prepayment, all obligations, covenants, debts and liabilities under the Amended Loan Agreement were satisfied and discharged in full.
We believe that our existing capital resources will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for the next 12 months and beyond. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may
25
change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned.
Funding Requirements
Our primary use of cash is to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Our future funding requirements will depend on many factors, including the following:
•
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates;
•
the clinical development plans we establish for these product candidates;
•
the timelines of our clinical trials and the overall costs to conduct and complete the clinical trials, which may be impacted by health epidemics and pandemics, such as COVID-19;
•
the number and characteristics of product candidates that we develop;
•
the outcome, timing and cost of meeting regulatory requirements established by the FDA, and other comparable foreign regulatory authorities including but not limited to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA);
•
whether we enter into any collaboration agreements and the terms of any such agreements;
•
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
•
the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
•
the effect of competing technological and market developments;
•
the cost and timing of completion of commercial-scale outsourced manufacturing activities;
•
the cost and timing of achieving favorable pricing and reimbursement agreements with the pricing authorities in each market of interest, including of securing a positive recommendation after undergoing a health technology assessment by health technology authorities;
•
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own; and
•
the cost of operating as a public company.
Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all. In addition, the discontinuation of our development of bexotegrast in IPF may intensify the risk that we will be unable to access capital on favorable terms, or at all, as and when needed. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
Cash Flows
Comparison of the six months ended June 30, 2026 and 2025
The following summarizes our cash flows for the periods indicated (in thousands):
26
Six Months Ended June 30,
2026
2025
Net cash used in operating activities
$
(32,026)
$
(89,467)
Net cash provided by investing activities
11,390
104,601
Net cash provided by financing activities
74
498
Net increase in cash and cash equivalents
$
(20,562)
$
15,632
Cash Used in Operating Activities
Net cash used in operating activities decreased $57.4 million, primarily due to the discontinuation of the BEACON-IPF study in 2025 and the related restructuring of operations that reduced workforce and refocused development efforts toward PLN-101095, which is in an earlier, less capital-intensive phase of development.
Cash Provided by Investing Activities
Net cash provided by investing activities decreased $93.2 million compared to the same period of the prior year due to declining marketable securities balances resulting from continued funding of operations and thus less overall maturities coupled with a higher relative volume of marketable securities purchases compared to the prior year period.
Cash Provided by Financing Activities
Net cash provided by financing activities decreased $0.4 million, as lower headcount and a decreased stock price yielded smaller proceeds associated with our Employee Stock Purchase Plan during the six months ended June 30, 2026.
Contractual Obligations and Other Commitments
At June 30, 2026, we have a non-cancelable operating lease for office and laboratory space through March 31, 2031. Refer to Note 14 and Note 15 to our financial statements appearing elsewhere in this Report for a discussion of material obligations and commitments.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements or holdings in any variable interest entities.
Critical Accounting Polices and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates from those described in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2025 10-K.
Recent Accounting Pronouncements
See Note 2 to the Notes to Condensed Unaudited Financial Statements of this Report for more information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The primary objectives of our investment activities are to ensure liquidity and to preserve capital. We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. We had cash and cash equivalents, restricted cash and short-term investments of $159.6 million as of June 30, 2026 which consisted of bank deposits, highly liquid money market funds and short-term investments in U.S. treasury securities, U.S. government agency securities and corporate debt securities. Due to the short-term maturities of our cash equivalents and short-term investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents or short-term investments.
To minimize the risk, we maintain our portfolio of cash equivalents and short-term investments in institutional market funds that are composed of U.S. Treasury and U.S. Treasury-backed repurchase agreements or short-term U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities. We do not believe
27
that inflation, interest rate changes, or exchange rate fluctuations had a significant impact on our results of operations for any periods presented herein. A hypothetical 10% change in interest rates during the periods presented would not have had a material impact on our condensed financial statements.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of June 30, 2026, management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2026, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.
Changes in Internal Control over Financial Reporting
There was no change in our internal controls over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the quarter ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
As of the date of this filing, we are not party to any material legal matters or claims. We may become party to legal matters and claims arising in the ordinary course of business. We cannot predict the outcome of any such legal matters or claims, and despite the potential outcomes, the existence thereof may have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
Our business faces significant risks. If any of the events or circumstances described in the following risks actually occurs, our business may suffer, the trading price of our common stock could decline and our financial condition or results of operations could be harmed. These risks should be read in conjunction with the other information set forth in this Report. The risks and uncertainties described below are not the only ones we face. There may be additional risks faced by our business. Other events that we do not currently anticipate or that we currently deem immaterial may also adversely affect our financial condition or results of operations. In addition, we cannot assure investors that our assumptions and expectations will prove to be correct. Important factors could cause our actual results to differ materially from those expressed or implied by forward-looking statements. See "Special Note Regarding Forward-Looking Statements" elsewhere in this Report.
RISK FACTORS
Risks Related to Our Financial Position, Operations and Need for Additional Capital
We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.
We have incurred significant net losses since our inception and have financed our operations principally through equity and debt financing and our prior collaboration with Novartis Institute for Biomedical Research, Inc., or Novartis. We continue to incur significant research and development and other expenses related to our ongoing operations. Our net loss was $22.4 million and $42.4 million for three and six months ended June 30, 2026, respectively, and $43.3 million and $99.5 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $901.8 million. We have devoted substantially all of our resources and efforts to research and development, and we expect that it will be at least several years, if ever, before we generate revenue from product sales. Even if we receive marketing approval for and commercialize one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to further develop and, if approved, market additional potential product candidates.
We expect to continue to incur significant losses for the foreseeable future as we:
•
advance our product candidates through clinical development, and, if successful, later-stage clinical trials;
28
•
discover and develop new product candidates;
•
advance our preclinical development programs into clinical development;
•
further develop manufacturing processes and manufacture our product candidates;
•
seek regulatory approvals for any product candidates that successfully complete clinical trials;
•
commercialize PLN-101095 and any other future product candidates, if approved;
•
increase the amount of research and development activities to identify and develop product candidates;
•
hire additional clinical development, quality control, scientific and management personnel;
•
establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly with third parties;
•
maintain, expand and protect our intellectual property portfolio;
•
invest in or in-license other technologies or product candidates; and
•
continue to build out our organization to engage in such activities.
To become and remain profitable, we must develop and eventually commercialize products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing, marketing, and selling products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in any or all of these activities and, even if we do, we may never generate revenue that is significant enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business, or continue our operations.
Our pursuit of internal and external opportunities may not deliver the benefits we expect or enhance stockholder value.
We are continually evaluating a broad range of opportunities designed to create stockholder value. There can be no assurance regarding the results or outcome of any opportunities we may pursue. It is possible that we may not identify or pursue opportunities, that such opportunities pursued may not be attractive, or that such opportunities may not ultimately be consummated. Further, any strategic transaction or other opportunity that is consummated ultimately may not deliver the benefits we expect or enhance stockholder value.
We will require substantial additional capital to fund our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive, and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception. We expect to incur significant expenses in connection with our ongoing activities, particularly as we conduct clinical trials of PLN-101095 and any future product candidates that we may develop, seek regulatory approvals for our product candidates and launch and commercialize any products for which we receive regulatory approval. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations, and such funding may be more difficult to obtain given the early stages of our current programs as well as financial, economic and market conditions and other factors, over which we may have limited or no control. If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce, or eliminate one or more of our research and drug development programs or future commercialization efforts.
As of June 30, 2026, we had approximately $159.6 million in cash, cash equivalents, restricted cash and short-term investments. Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for the next 12 months and beyond. However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital in order to complete clinical development of PLN-101095 and any other programs. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development, marketing, and commercialization activities. Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to:
29
•
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates;
•
the clinical development plans we establish for product candidates;
•
the timelines of our clinical trials and the overall costs to conduct and complete the clinical trials, including any increased costs due to disruptions caused by marketplace conditions, including the effects of health epidemics and pandemics or other geopolitical conditions, such as recent military actions against Iran;
•
the cost and capital commitments required for developing manufacturing processes for our product candidates and manufacturing our product candidates at clinical and commercial scales;
•
the number and characteristics of product candidates that we develop;
•
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, and other comparable foreign regulatory authorities;
•
whether we are able to enter into future collaboration agreements and the terms of any such agreements;
•
the ability to and timing of achieving a favorable pricing and reimbursement decision by the pricing authorities in the markets of interest;
•
the ability to secure a position recommendation following the health technology assessment by the health technology bodies in the relevant market;
•
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
•
the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
•
the effect of competing technological and market developments;
•
the cost and timing of completion of commercial-scale outsourced manufacturing activities; and
•
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own.
We have previously borrowed and may in the future borrow additional capital from institutional and commercial banking sources to fund future growth or potentially pursuant to new arrangements with different lenders. In addition, we have sought and expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. However, we cannot be certain that additional funding will be available on acceptable terms, or at all. Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. If we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Further, to the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted. In addition, any debt financing may subject us to fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish certain valuable intellectual property or other rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. We also may be required to seek collaborators for any of our product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves. Market volatility resulting from challenging financial markets factors, including the effects of health epidemics and pandemics could also adversely impact our ability to access capital as and when needed. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.
The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
Our quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:
30
•
the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
•
our ability to successfully recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;
•
our ability to obtain marketing approval for our product candidates, and the timing and scope of any such approvals we may receive;
•
the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time;
•
the cost of manufacturing our product candidates, which may vary depending on the difficulty of manufacture, quantity of production and the terms of our agreements with manufacturers;
•
our ability to attract, hire and retain qualified personnel;
•
expenditures that we will or may incur to develop our product candidates;
•
the level of demand for our product candidates should they receive approval, which may vary significantly;
•
the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates;
•
general market conditions or extraordinary external events, such as recessions, inflationary and labor market pressures, changes in domestic policies, volatility and uncertainty, as well as potential volatility in the global trade markets or interest rates;
•
the changing and volatile U.S. and global economic and political environments; and
•
future accounting pronouncements or changes in our accounting policies.
The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.
Risks Related to Research and Development and the Biopharmaceutical Industry
We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
We have no products approved for commercial sale and have not generated any revenue from product sales to date. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and performing research and development of our product candidates and our technology related to transforming growth factor beta, or TGF-β, signaling and integrin biology, medicinal chemistry, translational screening technologies, and clinical insights to discover and develop integrin-based therapeutics. Our approach to the discovery and development of product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value. We have not yet demonstrated the ability to progress any product candidate through clinical trials, obtain regulatory approval, manufacture a product at commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. Consequently, we expect our operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control, and predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing drug products.
Our business is highly dependent on the success of the product candidates that we advance into the clinic. PLN-101095, our lead program, and our other product candidates will require significant additional development before we may be able to seek regulatory approval for and commercially launch a product.
We a
re currently conducting a Phase 1 clinical trial of PLN-101095 in solid tumors
. We have no products that are approved for commercial sale and may never be able to develop marketable products. If PLN-101095 or any of our other product candidates encounter safety or efficacy problems, development delays, regulatory issues or other problems, our
31
development plans and business would be significantly harmed. For example, in March 2025, we announced that we were discontinuing the BEACON-IPF Phase 2b trial and in June 2025, we announced that we were discontinuing the development of bexotegrast in idiopathic pulmonary fibrosis, or IPF.
Before we can generate any revenue from sales of PLN-101095 or any of our other product candidates, we must undergo additional preclinical and clinical development and regulatory review and obtain marketing approval in one or more jurisdictions. In addition, if one or more of our product candidates are approved, we must ensure access to sufficient commercial manufacturing capacity and conduct significant marketing efforts in connection with any commercial launch. These efforts will require substantial investment, and we may not have the financial resources to continue development of PLN-101095 or any of our other product candidates.
We may experience setbacks that could delay or prevent regulatory approval of, or the extent of regulatory protection or our ability to commercialize, our product candidates, including:
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negative or inconclusive results from our preclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;
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product-related side effects experienced by subjects in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates;
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delays in submitting investigational new drug, or IND, applications or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
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conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
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delays in enrolling subjects in clinical trials, including due to operational challenges, competition with other clinical trials, the effects of health epidemics and pandemics or geopolitical events, such as recent military action against Iran;
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high drop-out rates or screening failures of subjects from clinical trials;
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inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials;
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challenges manufacturing our product candidates to regulatory requirements in a cost effective manner;
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greater than anticipated clinical trial costs;
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inability to compete with other therapies;
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failure to secure or maintain orphan designation in some jurisdictions;
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poor efficacy of our product candidates during clinical trials;
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unfavorable FDA or other regulatory agency inspection and review of a clinical trial site;
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failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
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delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or
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varying interpretations of data by the FDA and similar foreign regulatory agencies.
We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and our manufacturing, marketing, distribution and sales efforts or that of any future collaborator.
Our approach to drug discovery and development of integrin-based therapeutics is unproven and may not result in a marketable product.
Our approach to discover and develop integrin-based therapeutics is a novel approach in a rapidly developing field, and there can be no assurance that we will not experience currently unknown problems or delays in developing PLN-101095 or our other product candidates, that such problems or delays will not result in unanticipated costs, or that any such development problems can be solved. As a result, we may never succeed in developing a marketable integrin-based product.
Clinical development involves a lengthy, complex, and expensive process, with an uncertain outcome.
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To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. In particular, the general approach for FDA approval of a new drug is dispositive data from two well-controlled, Phase 3 clinical trials of the relevant drug in the relevant patient population. Phase 3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete. A product candidate can fail at any stage of testing, even after observing promising signals of activity in earlier preclinical studies or earlier stage clinical trials. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. For example, in March 2025, we announced that we were discontinuing the BEACON-IPF Phase 2b trial, and in June 2025, that we were discontinuing development of bexotegrast in IPF. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A large number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials or divergent conclusions by the FDA, other regulatory agencies, institutional review boards, or IRBs, data safety monitoring boards, or DSMBs, or others in connection with such findings.
Most product candidates that commence clinical trials are never approved as products and there can be no assurance that any of our future clinical trials will ultimately be successful or support further clinical development of any of our product candidates. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:
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preclinical studies or clinical trials may show the product candidates to be less effective than expected (e.g., a clinical trial could fail to meet its primary endpoint(s)) or to have unacceptable side effects or toxicities;
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failure to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful;
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failure to receive the necessary regulatory approvals;
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development of competing products in the same disease state;
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manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make a product candidate uneconomical;
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failure or inability to perform by our third-party vendors, including vendors in foreign jurisdictions such as China; and
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the proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being commercialized.
In addition, differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials. Further, as we rely on novel technologies including sophisticated imaging technologies to generate data relating to our clinical endpoints, there is an increased risk that we may not properly measure, analyze or interpret this data. Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products. Additionally, some of our trials are open label studies, where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most typically, open label clinical trials test only the investigational product candidate and sometimes do so at different dose levels. For example, PLN-101095 is currently being evaluated in an ongoing first-in-human Phase 1 dose-escalation open label trial where patients are either receiving PLN-101095 alone or in combination with the immunotherapy pembrolizumab. Open label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open label clinical trials are aware of when they are receiving treatment. In addition, open label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. Therefore, it is possible that positive results observed in open label trials will not be replicated in later placebo-controlled trials.
In addition, the standards that the FDA and comparable foreign regulatory authorities use when regulating us require judgment and can change, which makes it difficult to predict with certainty how they will be applied. Although we are currently focusing our efforts on development of small molecule drug products, if we were to also commence the development of biological products in the future we could be subjected to additional regulatory requirements. Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government
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regulations or changes in regulatory policy as a result of judicial challenges. Examples of such regulations and changes include future legislation or administrative action, or changes in FDA policy during the period of product development and FDA regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support approval. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain approval of any product candidates that we develop.
We must comply with numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, and if approved for marketing, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities outside the United States and vice versa.
Successful completion of clinical trials is a prerequisite to submitting a marketing application to the FDA and similar marketing applications to comparable foreign regulatory authorities, for each product candidate and, consequently, the ultimate approval and commercial marketing of any product candidates. We may experience negative or inconclusive results, which may result in our deciding, or our being required by regulators, to conduct additional clinical studies or trials or abandon some or all of our product development programs, which could have a material adverse effect on our business.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of PLN-101095 or any other product candidates.
We may experience delays in initiating or completing clinical trials. We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that could delay or prevent our ability to receive marketing approval or commercialize PLN-101095 or any other product candidates, including:
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regulators, IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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the FDA or other comparable regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels and dose selection administered in our planned clinical trials, which may delay or prevent us from initiating our clinical trials with our originally intended trial design or impact our ability to demonstrate favorable safety or efficacy traits;
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we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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the number of subjects required for clinical trials of any product candidates may be larger than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate, or we may have enrollment issues due to disruptions related to uncertainty caused by geopolitical events (such as recent military action against Iran) or health pandemics;
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators;
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we may experience delays or interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service providers on whom we rely;
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additional delays and interruptions to our clinical trials could extend the duration of the trials and increase the overall costs to finish the trials as our fixed costs are not substantially reduced during delays;
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we may elect to, or regulators, IRBs, DSMBs, or ethics committees may require that we or our investigators suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
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we may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a given clinical trial; and
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the FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
Our product development costs will increase if we experience additional delays in clinical testing or in obtaining marketing approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. If we do not achieve our product development goals in the timeframes we announce and expect, the approval and commercialization of our product candidates may be delayed or prevented entirely. In addition, significant clinical trial delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business and results of operations. Any delays in our clinical development programs may harm our business, financial condition, and results of operations significantly.
Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of PLN-101095 or any of our other product candidates.
If significant adverse events or other side effects are observed in any of our ongoing or future clinical trials, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts altogether. For example, in March 2025, we announced that we were discontinuing the BEACON-IPF Phase 2b trial following a prespecified data review and recommendation by the trial’s independent DSMB, as well as a secondary review and recommendation by an outside expert panel due to an imbalance in safety events between treatment and placebo groups. We subsequently announced in June 2025 that we were discontinuing development of bexotegrast in IPF. We may also encounter unexpected drug-drug interactions in our ongoing or planned trials, and may be required to further test our candidates, including additional drug-drug interaction studies, which may be expensive, time consuming and result in delays to our programs.
Some potential therapeutics developed in the biopharmaceutical industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:
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the patient eligibility and exclusion criteria defined in the protocol;
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the size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;
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the willingness or availability of patients to participate in our trials;
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the proximity of patients to trial sites;
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the design of the trial;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating or other studies enrolling for similar diseases;
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the availability of competing commercially available therapies and other competing product candidates’ clinical trials;
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our ability to obtain and maintain patient informed consents; and
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the risk that patients enrolled in clinical trials will drop out of the trials before completion.
Our clinical trials compete with other clinical trials for product candidates that are in the same therapeutic areas as PLN-101095 or our other product candidates, and this competition will reduce the number and types of patients available to us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials
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at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.
Additionally, the FDA may modify or enhance trial requirements, which may affect enrollment. For example, the FDA has published guidance documents and rulemaking on informed consent. The FDA’s guidance and rulemaking may present new or evolving requirements for informed consent which may affect recruitment and retention of patients in clinical trials. Also, we may have enrollment issues due to clinical site disruptions related to uncertainty caused by geopolitical events (such as recent military action against Iran) or health pandemics. Effects on recruitment and retention of patients or site disruptions may hinder or delay a clinical trial and could cause a significant setback to an applicable program.
The design or execution of our ongoing and future clinical trials may not support marketing approval.
The design or execution of a clinical trial can determine whether its results will support marketing approval, and flaws in the design or execution of a clinical trial may not become apparent until the clinical trial is well advanced.
Additionally, in some instances, there can be significant variability in safety or efficacy results between different trials with the same product candidate due to numerous factors, including differences in trial protocols, size and type of the patient populations, variable adherence to the dosing regimen or other protocol requirements and the rate of dropout among clinical trial participants. We do not know whether any clinical trials we conduct will demonstrate consistent or adequate efficacy and safety to obtain marketing approval to market PLN-101095 or our other product candidates. For example, in March 2025, we announced that we were discontinuing the BEACON-IPF Phase 2b trial and in June 2025, that we were discontinuing our development of bexotegrast in IPF.
Further, the FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether marketing approval will be obtained for PLN-101095 or any of our other product candidates. Our product candidates may not be approved even if they achieve their primary endpoints in future Phase 3 clinical trials or registrational trials. The FDA or comparable foreign regulatory authorities may disagree with our trial designs and our interpretation of data from preclinical studies or clinical trials. Moreover, clinical data are often susceptible to varying interpretations and analyses, including by the FDA, comparable foreign regulatory authorities, IRBs or DSMBs interpreting such data. Further, requirements regarding clinical trial data may evolve and the FDA has published draft guidance on unification of standards for clinical trial data. Changes to data requirements may cause the FDA or comparable foreign regulatory authorities to disagree with data from preclinical studies or clinical trials, and may require further studies.
In addition, any of these regulatory authorities may change requirements for the approval of a product candidate even after reviewing and providing comments or advice on a protocol for a pivotal Phase 3 or registrational clinical trial. Further, any of these regulatory authorities may also approve a product candidate for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post-marketing clinical trials. The FDA or comparable foreign regulatory authorities may not approve the labeling claims that we believe would be necessary or desirable for the successful commercialization of PLN-101095 or our other product candidates, if approved.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our future clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of PLN-101095 or our other product candidates.
We may be unable to obtain and maintain orphan drug designation for our product candidates and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
Regulatory authorities in some jurisdictions, including the United States and other major markets, may designate drugs intended to treat conditions or diseases affecting relatively small patient populations as orphan drugs.
Generally, if a product candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or foreign regulatory authorities from approving another marketing application for a product that constitutes a similar medicinal product treating the same indication for that marketing exclusivity period, except in limited circumstances. The applicable period is seven years in the United States and ten years in the EEA. The exclusivity in the EEA can be reduced to a period of six years if the orphan designation criteria are no longer met after the fifth year, including if the product is sufficiently profitable so that market exclusivity is no longer justified. Proposed amendments to European Union regulations regarding orphan medicines are under consideration which, if approved, could reduce the ten-year marketing exclusivity period.
Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.
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Even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because different drugs with different active moieties can be approved for the same condition in the United States or EEA. Even after an orphan drug is approved, the FDA or EMA, as applicable, may subsequently approve another drug with the same active moiety for the same condition if the FDA concludes that the latter drug is not a similar medicinal product or is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
A Fast Track designation by the FDA, even if granted for current or future product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that PLN-101095 or our other product candidates will receive marketing approval.
We may seek Fast Track designation for PLN-101095 or our other future product candidates. If a drug product is intended for the treatment of a serious or life-threatening disease or condition and it demonstrates the potential to address unmet medical needs for such a disease or condition, the drug sponsor may apply for FDA Fast Track designation for a particular indication. We may seek Fast Track designation for our product candidates, but there is no assurance that the FDA will grant this designation to any of our proposed product candidates. Marketing applications submitted by sponsors of products in Fast Track development may qualify for priority review under the policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant Fast Track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures or pathways and receiving a Fast Track designation does not provide assurance of ultimate FDA approval. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, the FDA may withdraw any Fast Track designation at any time.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates progress through preclinical to late-stage clinical trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield, manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause PLN-101095 or one of our other product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates and generate revenue.
In addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials. Even if we obtain marketing approval for PLN-101095 or any of our other product candidates, there is no assurance that our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential future demand. Additionally, if we advance a biological candidate into IND-enabling studies, the manufacturing processes for biological products is more complex and expensive than with small molecule products and additional manufacturing suppliers may be needed to manufacture clinical supplies for these programs. If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.
Additionally, the actual cost to manufacture and supply our product candidates could be greater than we expect and could materially and adversely affect the commercial viability of our product candidates. Excessive manufacturing costs could make our product candidates too expensive to compete with alternative products or therapies, or might result in third-party payors declining to cover our products or setting coverage levels too low for us or a strategic collaborator to earn a profit from the commercialization of one or more of our products.
We may not be successful in our efforts to identify or discover additional product candidates in the future.
Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for a number of reasons, including:
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our inability to design such product candidates with the pharmacological properties that we desire or attractive pharmacokinetics; or
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potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be medicines that will receive marketing approval and achieve market acceptance.
Research programs and efforts to identify new product candidates require substantial technical, financial, and human resources. While we continue to evaluate a range of opportunities to create stockholder value, if we are unable to identify suitable compounds for preclinical and clinical development or other opportunities to create stockholder value, we may experience harm to our business, financial position and stock price.
Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
We have limited financial and human resources and intend to initially focus on research programs and product candidates for a limited set of indications. As a result, we may forgo or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. In addition, we seek to accelerate our development timelines, including by initiating certain clinical trials of our product candidates before earlier-stage studies have been completed. This approach may cause us to commit significant resources to prepare for and conduct later-stage trials for one or more product candidates that subsequently fail earlier-stage clinical testing. Therefore, our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities or expend resources on product candidates that are not viable.
There can be no assurance that we will ever be able to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, which could materially adversely affect our future growth and prospects. We may focus our efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful.
If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of PLN-101095 or our other product candidates.
We face an inherent risk of product liability as a result of testing any of PLN-101095 or our other product candidates in clinical trials and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
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inability to bring a product candidate to the market;
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decreased demand for our products;
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injury to our reputation;
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withdrawal of clinical trial participants and inability to continue clinical trials;
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initiation of investigations by regulators;
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fines, injunctions or criminal penalties;
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costs to defend the related litigation;
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diversion of management’s time and our resources;
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substantial monetary awards to trial participants;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenue;
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exhaustion of any available insurance and our capital resources;
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inability to commercialize any product candidate, if approved; and
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decline in our share price.
Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop. We will need to obtain additional
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insurance for clinical trials as PLN-101095 and our other product candidates continue clinical development and as additional product candidates may enter the clinic. However, we may be unable to obtain, or may obtain on unfavorable terms, clinical trial insurance in amounts adequate to cover any liabilities from any of our clinical trials. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.
We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than us.
The development and commercialization of new drug products is highly competitive. We may face competition with respect to PLN-101095 and any other product candidates that we seek to develop or commercialize in the future from major biopharmaceutical companies, specialty biopharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.
Many of our current or potential competitors, such as AbbVie Inc., Bicara Therapeutics Inc., Incyte Corporation, and Pfizer Inc., either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.
Mergers and acquisitions in the biopharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, more convenient or less expensive than any products that we may develop. Furthermore, products currently approved for other indications could be discovered to be effective treatments as well, which could give such products significant regulatory and market timing advantages over product candidates that we may identify. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, products or technologies developed by our competitors may render our potential product candidates uneconomical or obsolete and we may not be successful in marketing PLN-101095 or any other product candidates we may develop against competitors. The availability of competitive products could limit the demand, and the price we are able to charge, for any products that we may develop and commercialize.
The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
In June 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA, the U.S. Department of Health and Human Services, or HHS, Centers for Medicare and Medicaid Services, or CMS, and other agencies with significant oversight of the biopharmaceutical industry.
The new framework may increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies may be subject to increased litigation and judicial scrutiny.
In addition, federal agency activities, priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments. For example, the current U.S. presidential administration has committed to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agenc