0001746473FALSE00017464732024-02-272024-02-27

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________________________________________
FORM 8-K
__________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2024
__________________________________________
PLIANT THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
__________________________________________
Delaware001-3930347-4272481
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
   
260 Littlefield Avenue,
South San Francisco, CA
 94080
(Address of Principal Executive Offices) (Zip Code)
Registrant’s Telephone Number, Including Area Code: (650) 481-6770
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
__________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class 
Trading
Symbol(s)
 Name of each exchange on which registered
Common Stock, par value $0.0001 per share PLRX The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02    Results of Operations and Financial Condition.
On February 27, 2024, Pliant Therapeutics, Inc. (the "Company") issued a press release announcing the Company’s financial results for the fourth quarter ended December 31, 2023. A copy of this press release is furnished as Exhibit 99.1 to this report.
The information in this Current Report on Form 8-K including the exhibits furnished herewith shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (as amended, the "Exchange Act") or otherwise subject to the liabilities of that Section, and shall not be or be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01     Financial Statements and Exhibits.
(d) Exhibits. 
Exhibit
No.
 Description
 
104Cover Page Interactive Data File (embedded within the Inline XBRL document).
1

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 PLIANT THERAPEUTICS, INC.
   
Date: February 27, 2024
By:/s/ Keith Cummings
  Keith Cummings, M.D., MBA
  Chief Financial Officer


2

Exhibit 99.1
image_0a.jpg

Pliant Therapeutics Provides Corporate Update and
Reports Fourth Quarter 2023 Financial Results
Positive interim 12-week safety and efficacy data reported from Phase 2a INTEGRIS-PSC trial in patients with PSC

Enrollment continues in BEACON-IPF, a Phase 2b trial in patients with IPF
SOUTH SAN FRANCISCO, CA., February 27, 2024 - Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported fourth quarter 2023 financial results.

“The progress made by our teams during the fourth quarter of 2023 position us well for executing upon our 2024 milestones including the recent positive data from the INTEGRIS-PSC trial that support the late-stage development of bexotegrast in this important indication," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. “In 2024, our focus will be on the advancement the BEACON-IPF late-stage program, gathering clarity on next steps for a late-stage PSC program and providing updates to our early-stage portfolio including from our oncology and muscular dystrophy programs."

Fourth Quarter and Recent Highlights
Bexotegrast Highlights
•Positive safety and efficacy data from 320 mg dose cohort of INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC). At a once-daily dose of 320 mg, bexotegrast was well tolerated over 12 weeks of treatment with no drug-related severe or serious adverse events. At the 320 mg dose, bexotegrast reduced both Enhanced Liver Fibrosis (ELF) scores and PRO-C3 levels and showed improvements in hepatocyte function and bile flow by contrast MRI imaging relative to placebo at Week 12. Twenty-four-week data from the 320 mg dose group is expected in mid-2024.
•Enrollment continues in BEACON-IPF, a Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg. BEACON-IPF is expected to enroll approximately 270 patients with IPF.
Pipeline Programs
•Phase 1 trial of PLN-101095 in solid tumors is enrolling. This is a Phase 1 open label trial of PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The trial is currently dosing the third of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in late 2024.
•Muscular dystrophy program on track for regulatory filing in the first quarter of 2024. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1. Filing for first-in-human clinical studies in Duchenne muscular dystrophy (DMD) is expected in the first quarter of 2024.



Fourth Quarter 2023 Financial Results
•Research and development expenses were $33.2 million, as compared to $25.1 million for the prior-year quarter. The increase was due primarily to higher employee-related expenses and increased clinical and manufacturing-related costs associated with our lead program, bexotegrast.
•General and administrative expenses were $13.9 million, as compared to $14.3 million for the prior-year quarter. The decrease was primarily due to a decrease in stock-based compensation as we achieved a clinical development milestone in the fourth quarter of 2022 that triggered the vesting of certain performance based awards.
•Net loss was $41.1 million as compared to $35.1 million for the prior-year quarter. The increase was due to higher operating expenses coupled with a decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $495.7 million which the Company expects, together with funds available under the Oxford Loan Agreement, to be sufficient to fund operations into the second half of 2026.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, a Phase 2b trial of bexotegrast in IPF. Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 integrin for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant has initiated a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition to clinical-stage programs, Pliant currently has a preclinical program targeting muscular dystrophies. For additional information, please visit: www.PliantRx.com. Follow us on social media: X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast, PLN-101325 and PLN-101095; bexotegrast’s potential to become a treatment for IPF or PSC; the anticipated timing of data and progress from our clinical studies; discussions with regulatory authorities and the sufficiency of our cash runway to fund operations into the second half of 2026. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the impact of current macroeconomic and marketplace conditions, including the effects of health epidemics and pandemics, such as COVID-19, on our business, operations, clinical supply and plans, our reliance on third parties for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, including the availability of additional term loans under our loan facility, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the period ended December 31, 2023 which we are filing with the SEC today, available on the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com


Pliant Therapeutics, Inc.
Condensed Statements of Operations
(Unaudited)
(In thousands, except number of shares and per share amounts)
Three Months Ended December 31,Twelve Months Ended December 31,
2023202220232022
Revenue$— $1,965 $1,580 $9,685 
Operating expenses:
Research and development(33,183)(25,114)(127,797)(96,936)
General and administrative(13,854)(14,251)(57,928)(39,949)
Total operating expenses(47,037)(39,365)(185,725)(136,885)
Loss from operations(47,037)(37,400)(184,145)(127,200)
Interest and other income (expense), net6,249 2,657 24,076 4,670 
Interest expense(321)(317)(1,267)(791)
Net loss$(41,109)$(35,060)$(161,336)$(123,321)
Net loss attributable to common stockholders$(0.69)$(0.72)$(2.75)$(2.94)
Net loss per share, attributable to common stockholders - basic and diluted59,904,481 48,783,242 58,719,083 42,015,908 



Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
 December 31,
2023		December 31,
2022
Assets
Current assets
Cash and cash equivalents$63,234 $33,685 
Short-term investments431,011 297,502 
Accounts receivable— 1,983 
Tax credit receivable— 83 
Prepaid expenses and other current assets11,257 7,058 
Total current assets505,502 340,311 
Property and equipment, net3,567 4,486 
Operating lease right-of-use assets1,211 5,422 
Restricted cash1,482 — 
Other non-current assets392 394 
Total assets$512,154 $350,613 
Liabilities and stockholders’ equity
Current liabilities
Accounts payable$4,531 $1,580 
Accrued research and development12,456 11,218 
Accrued liabilities10,219 8,658 
Lease liabilities, current1,318 2,457 
Total current liabilities28,524 23,913 
Lease liabilities, non-current— 3,429 
Long-term debt10,054 9,929 
Total liabilities38,578 37,271 
Stockholders’ equity
Preferred Stock— — 
Common stock6 5 
Additional paid-in capital972,973 653,707 
Accumulated deficit(499,748)(338,412)
Accumulated other comprehensive gain (loss)345 (1,958)
Total stockholders’ equity473,576 313,342 
Total liabilities and stockholders’ equity$512,154 $350,613 

v3.24.0.1
Cover
Feb. 27, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Feb. 27, 2024
Entity Registrant Name PLIANT THERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-39303
Entity Tax Identification Number 47-4272481
Entity Address, Address Line One 260 Littlefield Avenue,
Entity Address, City or Town South San Francisco,
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code 650
Local Phone Number 481-6770
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol PLRX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001746473
Amendment Flag false
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