plrx-20230930

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 September 30, 2023


☐			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.)
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

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

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 November 3, 2023, the registrant had 59,895,958 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	6
	Condensed Statements of Operations and Comprehensive Loss	7
	Condensed Statements of Stockholders’ Equity	8
	Condensed Statements of Cash Flows	10
	Notes to Condensed Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	27

PART II.	OTHER INFORMATION	27

Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	74
Item 3.	Defaults Upon Senior Securities	74
Item 4.	Mine Safety Disclosures	74
Item 5.	Other Information	74
Item 6.	Exhibits	75
Signatures		76

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, 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 and clinical trials of our lead product candidate, bexotegrast (PLN-74809) and our other product candidates;

•Our estimates regarding the impact of challenging macroeconomic and marketplace conditions, including the effects of health epidemics and pandemics, such as COVID-19, on our business and operations, and our ability to manage such impacts;

•Our or our future collaborators' 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 potential benefit of orphan drug and Fast Track designations for bexotegrast;

•Our ability to compete with companies currently marketing or engaged in the development of treatments for fibrosis;

•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 dependence on current and 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; and

•Our expectations regarding government and third-party payor coverage and reimbursement.

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.

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 "Part II, Item 1A. Risk Factors" 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 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” 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 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 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, bexotegrast 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 fibrotic diseases 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 bexotegrast or any other 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.

Risks Related to Our Intellectual Property

•Our success depends in part on our ability to obtain patent term extensions and 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 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 which they provide to us, or otherwise arising from the collaboration.

Risks Related to Our Reliance on Third Parties

•We previously entered into a collaboration agreement, as amended, with Novartis Institutes for Biomedical Research, Inc., or Novartis, for the development of PLN-1474, which was terminated in April 2023, and may

in the future seek to enter into collaborations with third parties for the development and commercialization of other product candidates. If we fail to enter into such collaborations, or if our collaborations are not successful, we may be unable to continue development of such product candidates, we would not receive any contemplated milestone payments or royalties, and we could fail to capitalize on the market potential of such product candidates.

•We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials and for tissue samples and other materials required for our research and development activities.

•We rely on single-source third party suppliers located in foreign jurisdictions, including China, to manufacture our drug candidates. An interruption in this supply, caused by a business interruption or geopolitical events, could materially disrupt our research and development activities.

Risks Related to Managing Our Business and Operations

•The effects of health epidemics and pandemics, such as the COVID-19 could adversely impact our business, including our preclinical studies and clinical trials.

•Our loss of key management personnel, or our failure to recruit additional highly skilled personnel, will impair our ability to develop current product candidates or identify and develop new product candidates, could result in loss of markets or market share and could make us less competitive.

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)


	September 30, 2023		*December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	57,679	$	33,685
Short-term investments	465,933		297,502
Accounts receivable	—		1,983
Tax credit receivable	83		83
Prepaid expenses and other current assets (Note 5)	10,640		7,058
Total current assets	534,335		340,311
Property and equipment, net	3,969		4,486
Operating lease right-of-use assets	1,768		5,422
Other non-current assets	392		394
Total assets	$	540,464	$	350,613
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	3,360	$	1,580
Accrued research and development	13,664		11,218
Accrued liabilities (Note 6)	8,310		8,658
Lease liabilities, current	2,061		2,457
Total current liabilities	27,395		23,913
Lease liabilities, non-current	—		3,429
Long-term debt (Note 7)	10,021		9,929
Total liabilities	37,416		37,271
Stockholders’ equity
Common stock, $0.0001 par value; 300,000,000 shares authorized at September 30, 2023 and December 31, 2022; and 59,890,980 and 48,941,254 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively;	6		5
Additional paid-in capital	963,588		653,707
Accumulated deficit	(458,639)		(338,412)
Accumulated other comprehensive loss	(1,907)		(1,958)
Total stockholders’ equity	503,048		313,342
Total liabilities and stockholders’ equity	$	540,464	$	350,613

*The condensed balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date.

The accompanying notes are an integral part of these condensed financial statements

Pliant Therapeutics, Inc.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except number of shares and per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Revenue	$	—	$	1,482	$	1,580	$	7,720
Operating expenses:
Research and development	(32,339)		(24,606)		(94,614)		(71,822)
General and administrative	(15,346)		(8,823)		(44,074)		(25,698)

SEC Form 10-Q filed by Pliant Therapeutics Inc.