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, 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. ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements) The unaudited condensed financial statements for Q1 2023 reflect significant asset and equity growth from a public offering, alongside an increased net loss due to higher operating expenses [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2023, total assets significantly increased to **$597.9 million** from **$350.6 million** at December 31, 2022, primarily due to a public offering, while stockholders' equity grew to **$561.9 million** Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $102,527 | $33,685 | | Short-term investments | $474,787 | $297,502 | | **Total Assets** | **$597,881** | **$350,613** | | **Liabilities & Equity** | | | | Total liabilities | $35,961 | $37,271 | | Total stockholders' equity | $561,920 | $313,342 | | **Total Liabilities and Stockholders' Equity** | **$597,881** | **$350,613** | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) For Q1 2023, the company reported a net loss of **$37.5 million**, an increase from **$28.1 million** in Q1 2022, primarily driven by higher research and development and general and administrative expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenue | $1,332 | $1,249 | | Research and development | $(29,273) | $(20,881) | | General and administrative | $(14,154) | $(8,579) | | Loss from operations | $(42,095) | $(28,211) | | **Net loss** | **$(37,548)** | **$(28,100)** | | Net loss per share, basic and diluted | $(0.67) | $(0.78) | [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity significantly increased to **$561.9 million** as of March 31, 2023, primarily driven by **$269.9 million** in net proceeds from a public common stock offering - In January 2023, the company completed a public offering of common stock, resulting in net proceeds of approximately **$269.9 million**[37](index=37&type=chunk)[27](index=27&type=chunk) - Stock-based compensation expense for the quarter was **$11.9 million**[27](index=27&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For Q1 2023, net cash used in operating activities was **$30.3 million**, while financing activities provided **$273.3 million** from a public offering, leading to a net increase in cash of **$68.8 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,276) | $(20,498) | | Net cash (used in) provided by investing activities | $(174,208) | $1,531 | | Net cash provided by (used in) financing activities | $273,326 | $(153) | | **Net increase (decrease) in cash** | **$68,842** | **$(19,120)** | - The company received **$270.3 million** in proceeds from the sale of common stock in a public offering during the quarter[33](index=33&type=chunk) [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Key disclosures include the January 2023 public offering raising **$269.9 million**, the termination of the Novartis collaboration for PLN-1474, and details on the **$10.0 million** long-term debt and **$11.9 million** stock-based compensation expense - In January 2023, the company completed a public offering raising approximately **$269.9 million** in net proceeds[37](index=37&type=chunk) - Novartis exercised its right to terminate the collaboration agreement for PLN-1474, effective April 18, 2023, with all rights and licenses reverting to Pliant[57](index=57&type=chunk) - The company has a **$10.0 million** term loan with Oxford Finance, with an effective interest rate of **12.69%**[53](index=53&type=chunk)[55](index=55&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $4,848 | $1,914 | | General and administrative | $7,075 | $1,617 | | **Total** | **$11,923** | **$3,531** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the increased net loss of **$37.5 million** in Q1 2023, the strengthened financial position with **$577.3 million** in cash, and key clinical developments including positive bexotegrast data and the Novartis collaboration termination - The company's lead product candidate, bexotegrast, showed positive data in a Phase 2a trial for IPF, with a Phase 2b trial expected to start in mid-2023[92](index=92&type=chunk)[95](index=95&type=chunk) - The collaboration with Novartis for PLN-1474 was terminated in April 2023, with global rights returning to Pliant[93](index=93&type=chunk)[99](index=99&type=chunk) - As of March 31, 2023, the company had **$577.3 million** in cash, cash equivalents, and short-term investments, believed to be sufficient to fund operations into the second half of 2026[116](index=116&type=chunk)[120](index=120&type=chunk) Comparison of Operating Results (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | $ Change | | :--- | :--- | :--- | :--- | | Revenue | $1,332 | $1,249 | $83 | | Research and development | $(29,273) | $(20,881) | $(8,392) | | General and administrative | $(14,154) | $(8,579) | $(5,575) | | **Net loss** | **$(37,548)** | **$(28,100)** | **$(9,448)** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$577.3 million** in cash and investments, with a hypothetical 100 basis point change not expected to materially affect financial statements - The company's primary market risk is interest rate sensitivity on its **$577.3 million** of cash, cash equivalents, and short-term investments[134](index=134&type=chunk) - The company's **$10.0 million** term loan has a capped interest rate exposure of **2.0%**[134](index=134&type=chunk) - A hypothetical **10%** change in interest rates is not expected to have a material impact on the condensed financial statements[135](index=135&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of March 31, 2023[138](index=138&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2023, that materially affected, or are reasonably likely to materially affect, internal controls[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not a party to any material legal proceedings or claims, while acknowledging the possibility of future matters - The company is not currently party to any material legal matters or claims[141](index=141&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant financial, R&D, regulatory, intellectual property, third-party reliance, operational, and stock-related risks, including a history of losses and dependence on its lead candidate bexotegrast [Risks Related to Our Financial Position and Need for Additional Capital](index=28&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section details financial risks, including a **$376.0 million** accumulated deficit, the need for substantial additional capital, and restrictive covenants in the Oxford Loan Agreement - The company has incurred significant net losses since inception, with an accumulated deficit of **$376.0 million** as of March 31, 2023[144](index=144&type=chunk) - Substantial additional capital will be required to fund operations, and failure to raise capital could force delays or elimination of research programs[147](index=147&type=chunk) - The Oxford Loan Agreement contains covenants that restrict the company's ability to incur additional debt, make certain investments, and pay dividends, among other things[156](index=156&type=chunk) [Risks Related to Research and Development and the Biopharmaceutical Industry](index=32&type=section&id=Risks%20Related%20to%20Research%20and%20Development%20and%20the%20Biopharmaceutical%20Industry) The company's business is highly dependent on the success of its lead candidate bexotegrast, facing risks from its unproven drug discovery approach, the long and uncertain clinical development process, and challenges in patient enrollment for orphan indications - The business is highly dependent on the success of its lead product candidate, bexotegrast, which requires significant additional development[161](index=161&type=chunk) - The company's approach to drug discovery in fibrotic diseases by targeting integrins is unproven and may not result in marketable products[164](index=164&type=chunk) - The company faces potential difficulties in enrolling patients for its clinical trials in orphan indications like IPF and PSC, which have small patient populations[182](index=182&type=chunk) [Risks Related to Our Intellectual Property](index=47&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on its ability to protect intellectual property, facing risks of patent invalidation, trade secret misappropriation, and costly third-party infringement litigation that could block commercialization - The company's success depends on its ability to protect its intellectual property, but the patenting process is expensive, time-consuming, and uncertain[245](index=245&type=chunk)[246](index=246&type=chunk) - The company may face third-party claims of intellectual property infringement, which could lead to costly litigation, substantial damages, or prohibitions on selling product candidates[263](index=263&type=chunk)[264](index=264&type=chunk) - The company relies on trade secrets and confidentiality agreements, which may not provide adequate protection against misappropriation or independent development by competitors[260](index=260&type=chunk) [Risks Related to Our Reliance on Third Parties](index=57&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company heavily relies on third parties for critical functions, including CROs and single-source manufacturers, with the Novartis collaboration termination highlighting partnership risks and potential delays from third-party failures - The termination of the Novartis collaboration agreement in April 2023 highlights the risks of relying on partners for development and commercialization[300](index=300&type=chunk)[301](index=301&type=chunk) - The company relies on third parties to conduct preclinical studies and clinical trials, with limited control over their performance and compliance with regulations like GCP[303](index=303&type=chunk)[304](index=304&type=chunk) - The company relies on single-source third-party suppliers, including some located in China, to manufacture its drug candidates, creating a risk of supply interruption due to business or geopolitical events[311](index=311&type=chunk) [Risks Related to Managing Our Business and Operations](index=61&type=section&id=Risks%20Related%20to%20Managing%20Our%20Business%20and%20Operations) Operational risks include potential COVID-19 disruptions, challenges in managing growth, dependence on key personnel, concentration in an earthquake-prone area, and the need to comply with evolving global data protection laws - The COVID-19 pandemic could continue to adversely impact the business, including preclinical studies and clinical trials, through delays and disruptions[324](index=324&type=chunk) - The company is highly dependent on its key management and scientific personnel, and competition for skilled employees is intense[331](index=331&type=chunk)[332](index=332&type=chunk) - The company is subject to evolving global data protection laws (e.g., HIPAA, CCPA, GDPR), and failure to comply could result in significant penalties and harm business operations[366](index=366&type=chunk)[367](index=367&type=chunk)[376](index=376&type=chunk) - Current operations are concentrated in South San Francisco, California, exposing the company to risks from earthquakes or other natural disasters[334](index=334&type=chunk) [Risks Related to Our Common Stock](index=65&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Risks for common stock investors include high price volatility, no foreseeable dividends, significant insider control, potential dilution from future equity issuances, and anti-takeover provisions - The trading price of the company's common stock is likely to be highly volatile[344](index=344&type=chunk) - Executive officers, directors, and principal stockholders hold a significant portion of the stock and can exert significant control over matters subject to stockholder approval[348](index=348&type=chunk) - Anti-takeover provisions in the company's charter documents and under Delaware law could delay or prevent a change of control[351](index=351&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2023, the company reported no unregistered sales or repurchases of its equity securities - There were no unregistered sales of equity securities in the quarter[397](index=397&type=chunk) - There were no repurchases of company equity securities in the quarter[398](index=398&type=chunk) [Item 3. Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable as the company has not defaulted upon any senior securities - Not applicable[399](index=399&type=chunk) [Item 4. Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[400](index=400&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) There is no other information to report for this period - None[401](index=401&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and required CEO and CFO certifications

Summary of Client Therapeutics Conference Call Company and Industry - **Company**: Client Therapeutics - **Industry**: Pharmaceutical, specifically focusing on treatments for idiopathic pulmonary fibrosis (IPF) Core Points and Arguments 1. **Clinical Trial Overview**: The conference call presented data from the INTEGRIS IPF Phase 2a clinical trial evaluating bexodograft (formerly PLN 74809) in patients with IPF, focusing on a 320 mg dose cohort [2][6][9] 2. **Therapeutic Potential**: Bexodograft is a dual selective inhibitor of alpha v beta six and alpha v beta one integrins, currently in development for IPF and primary sclerosing cholangitis [5][6] 3. **Results from the Trial**: - The 24-week results exceeded expectations, showing long-term safety and durable improvement in patients with IPF [6][9] - 89% of patients treated with bexodograft maintained an increase in forced vital capacity (FVC) at week 24 compared to baseline [15][21] - Bexodograft-treated patients were twice as likely to show stabilization or improvement of fibrosis compared to placebo [16][22] - Cough severity, a common symptom in IPF, was reduced in the bexodograft group, while it worsened in the placebo group [17][23] 4. **Safety Profile**: The treatment was well tolerated, with no drug-related serious adverse events reported, and the most common adverse event was diarrhea, comparable to placebo [15][19] 5. **Future Development Plans**: The next phase, BEACON IPF, will evaluate two doses (320 mg and 160 mg) over 52 weeks, with a focus on the change in absolute FVC as the primary endpoint [24][25] 6. **Secondary Endpoints**: The study will also assess time to disease progression, respiratory-related hospitalizations, and quality of life measures related to cough [26] Important but Potentially Overlooked Content 1. **Patient Demographics**: The baseline demographics were similar between treatment and placebo groups, with minor differences in female distribution noted [18][19] 2. **Biomarker Changes**: Changes in circulating biomarkers (integrin beta six and pro C3) suggested a reduction in disease progression, supporting the efficacy of bexodograft [23][70] 3. **Comparison with Existing Treatments**: The results suggest that bexodograft may offer better tolerability and efficacy compared to existing treatments, which typically slow disease progression rather than stabilize it [36][38] 4. **Regulatory Considerations**: The data from the INTEGRIS trial may support the drug's potential as a new standard of care, especially if it demonstrates sustained benefits in larger studies [86][108] This summary encapsulates the key points discussed during the conference call, highlighting the promising data from the INTEGRIS trial and the future direction for Client Therapeutics in the treatment of IPF.

MARCH 2023 Disclaimers This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of u ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-K _____________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ¨ 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 _________________ ...

Summary of Pliant Therapeutics (PLRX) FY Conference Call - January 10, 2023 Company Overview - **Company**: Pliant Therapeutics - **Focus**: Development of novel treatments for fibrotic diseases with an industry-leading fibrosis platform [2][3] Key Programs and Developments 1. **Bexotogast (formerly PLN74809)** - Currently in Phase 2A trials for Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC) [3][4] - Phase 2A data showed it was well tolerated with a clear anti-fibrotic effect, evidenced by an 80% reduction in FVC decline [23][24] - Expected interim data for 12-week treatment in early Q1 2023 and final data in Q2 2023 [7][31] 2. **PLN101095** - A potential first-in-class selective integrin small molecule inhibitor targeting immune checkpoint inhibitor resistance [4] - IND submitted late last year, with Phase I trials expected to start in Q2 2023 [4][39] 3. **PLN101325** - An allosteric activator aimed at muscle diseases and fibrosis, with an IND filing expected by the end of 2023 [5][6] 4. **PLN1474** - Focused on treating NASH-associated liver fibrosis, owned by Novartis, entering Phase II testing [6] Financial Position - **Cash Position**: $360 million at the end of Q3 2022, including $230 million from a follow-on financing [5] Market Landscape and Competitive Positioning - Current IPF market dominated by Asbriet and OFEV, generating over $3 billion in revenue in 2020 [9] - Asbriet went generic in 2022, and OFEV will lose exclusivity in 2025, creating a significant opportunity for new treatments [9] - Bexotogast offers advantages such as: - Direct anti-fibrotic effect through TGF beta inhibition [10] - Once-daily dosing compared to multiple daily doses for existing treatments [10] - Better tolerability with no GI side effects reported [10][28] Clinical Data Highlights - Bexotogast demonstrated a 15 mL decrease in FVC decline compared to placebo, with a notable improvement in the 80 mg dose group [24][25] - Safety profile showed no significant adverse events or discontinuations due to the drug [22][23] - The drug's mechanism involves blocking integrins selectively upregulated in fibrotic tissue, leading to reduced pro-fibrotic gene expression [13][14] Upcoming Milestones - Anticipated data releases for bexotogast in both IPF and PSC throughout 2023 [7][33] - Phase IIb study for bexotogast expected to start mid-2023, with a focus on both monotherapy and combination therapy [58][61] Regulatory Considerations - Ongoing discussions with the FDA regarding the design of the Phase IIb study, which will include a significant portion of patients not on standard care [58][61] - The potential for using validated biomarkers as co-primary endpoints in PSC trials, given the challenges of histological assessments [66][68] Conclusion - Pliant Therapeutics is well-positioned in the fibrotic disease market with promising clinical data and a strong financial foundation, aiming to address significant unmet needs in IPF and PSC treatments [2][5][9]

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, 2022 ☐ 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 o ...

| --- | --- | |-----------------------------|-------| | | | | | | | | | | | | | | | | Developing Novel Treatments | | | for Fibrotic Diseases | | | Corporate Presentation | | | SEPTEMBER 2022 | | © 2022 PLIANT THERAPEUTICS Disclaimers This presentation has been prepared by Pliant Therapeutics, Inc. ("we," "us," "our," "Pliant" or the "Company"). The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the ...

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, 2022 ☐ 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. ...

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Financial Statements](index=7&type=section&id=Item%201.%20Condensed%20Financial%20Statements) Presents unaudited condensed financial statements for Q1 2022 and 2021, detailing a **$28.1 million net loss** and **$178.3 million in cash and investments** [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $32,545 | $51,665 | | Short-term investments | $145,735 | $148,931 | | **Total Assets** | **$197,022** | **$221,215** | | **Liabilities & Equity** | | | | Total liabilities | $23,229 | $22,156 | | Total stockholders' equity | $173,793 | $199,059 | | **Total Liabilities and Stockholders' Equity** | **$197,022** | **$221,215** | - Total assets decreased from **$221.2 million** at the end of 2021 to **$197.0 million** as of March 31, 2022, primarily due to a decrease in cash and cash equivalents used to fund operations[24](index=24&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Revenue | $1,249 | $2,174 | | Research and development | ($20,881) | ($18,527) | | General and administrative | ($8,579) | ($6,566) | | **Loss from operations** | **($28,211)** | **($22,919)** | | **Net loss** | **($28,100)** | **($22,856)** | | **Net loss per share (Basic & Diluted)** | **($0.78)** | **($0.64)** | - The company's net loss increased to **$28.1 million** in Q1 2022 from **$22.9 million** in Q1 2021, driven by lower revenue from its collaboration agreement and higher operating expenses, particularly in R&D and G&A[27](index=27&type=chunk) [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statement of Cash Flows (in thousands) | Activity | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,498) | ($13,665) | | Net cash provided by investing activities | $1,531 | $12,232 | | Net cash (used in) provided by financing activities | ($153) | $1,370 | | **Net decrease in cash and cash equivalents** | **($19,120)** | **($63)** | - Cash used in operating activities increased to **$20.5 million** in Q1 2022 from **$13.7 million** in Q1 2021, primarily due to a higher net loss and changes in operating assets and liabilities[36](index=36&type=chunk) [Notes to Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - Under the Novartis collaboration agreement for PLN-1474, the company recognized **$1.2 million** in revenue for R&D services in Q1 2022, down from **$2.2 million** in Q1 2021. A total of **$391.0 million** in potential contingent payments remain eligible for achievement[53](index=53&type=chunk)[54](index=54&type=chunk) - Total stock-based compensation expense was **$3.5 million** for Q1 2022, an increase from **$2.6 million** in Q1 2021. As of March 31, 2022, there was **$32.6 million** of unrecognized compensation cost related to stock options[76](index=76&type=chunk) - Subsequent to the quarter end, in May 2022, the company entered into a term loan facility with Oxford Finance LLC for up to **$100.0 million**, receiving an initial term loan of **$10.0 million** at closing[91](index=91&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 financial results, highlighting a **$28.1 million net loss**, PLN-74809 progress, and liquidity extending to mid-2024 [Overview and Recent Highlights](index=22&type=section&id=Overview%20and%20Recent%20Highlights) - The company is a clinical-stage biopharmaceutical firm focused on novel therapies for fibrosis by inhibiting integrin-mediated activation of TGF-β. Its lead product candidate is **PLN-74809** for **idiopathic pulmonary fibrosis (IPF)** and **primary sclerosing cholangitis (PSC)**[96](index=96&type=chunk) - Data readout for the **INTEGRIS-IPF Phase 2a trial** is anticipated in **mid-2022**. All patients have completed the 12-week treatment[100](index=100&type=chunk) - **PLN-74809** received **FDA Fast Track designation** for **IPF** and **EMA Orphan Drug designation** for **PSC**[104](index=104&type=chunk) - The company secured a **$100 million** loan facility from Oxford Finance, extending its cash runway to **mid-2024**. An initial **$10 million** was drawn at closing[103](index=103&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Item | Q1 2022 | Q1 2021 | $ Change | | :--- | :--- | :--- | :--- | | Revenue | $1,249 | $2,174 | ($925) | | Research and development | ($20,881) | ($18,527) | ($2,354) | | General and administrative | ($8,579) | ($6,566) | ($2,013) | | **Net loss** | **($28,100)** | **($22,856)** | **($5,244)** | - Revenue decreased by **$0.9 million** year-over-year, primarily due to the substantial completion of R&D services for PLN-1474 under the Novartis agreement in Q1 2021[114](index=114&type=chunk) - R&D expenses increased by **$2.4 million**, mainly due to costs for advancing preclinical programs and higher employee-related expenses, partially offset by lower clinical trial manufacturing costs for PLN-74809 compared to the prior year[115](index=115&type=chunk) - G&A expenses increased by **$2.0 million**, primarily driven by higher employee-related costs, including salaries and stock-based compensation[117](index=117&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2022, the company had **$178.3 million** in cash, cash equivalents, and short-term investments[120](index=120&type=chunk) - Management believes existing capital, combined with proceeds from the Oxford Loan Agreement, will be sufficient to fund operations into the **middle of 2024**[121](index=121&type=chunk) - Operations have been financed primarily through preferred stock sales, the Novartis collaboration, and the IPO. In May 2022, the company secured a loan agreement with Oxford Finance for up to **$100.0 million**[122](index=122&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$178.3 million** cash and investments, with no material impact from a 100 basis point rate change - The company's primary market risk is interest rate sensitivity on its portfolio of cash, cash equivalents, and short-term investments, which totaled **$178.3 million** as of March 31, 2022[137](index=137&type=chunk) - Due to the short-term maturities of its investments, the company does not believe an immediate **100 basis point** change in interest rates would materially affect the fair market value of its portfolio[137](index=137&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of March 31, 2022, the company's disclosure controls and procedures were **effective** at a reasonable assurance level[139](index=139&type=chunk) - There were **no material changes** to the company's internal control over financial reporting during the quarter ended March 31, 2022[140](index=140&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or claims as of the filing date - The company is **not currently party to any material legal proceedings or claims**[142](index=142&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Details significant business risks across financial, R&D, IP, and operational areas, emphasizing a history of losses and dependence on lead candidate PLN-74809 [Risks Related to Financial Position and Need for Additional Capital](index=29&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company has a history of significant net losses, with a net loss of **$28.1 million** for Q1 2022 and an accumulated deficit of **$243.2 million** as of March 31, 2022, and expects to continue incurring losses[145](index=145&type=chunk) - **Substantial additional capital** will be required to finance operations. Failure to raise capital when needed could force delays or elimination of research and development programs[148](index=148&type=chunk) - The Oxford Loan Agreement contains **restrictive covenants** that could adversely affect business operations and financial conditions. A default could lead to **foreclosure** on substantially all company assets[153](index=153&type=chunk) [Risks Related to Research and Development and the Biopharmaceutical Industry](index=33&type=section&id=Risks%20Related%20to%20Research%20and%20Development%20and%20the%20Biopharmaceutical%20Industry) - The company has a **limited operating history** (incorporated in 2015) with **no products approved for sale**, making it difficult to evaluate its prospects[161](index=161&type=chunk) - The business is **highly dependent** on the success of its lead product candidate, **PLN-74809**, which requires significant additional clinical development[162](index=162&type=chunk) - The company's approach to treating fibrotic diseases by inhibiting integrins is **unproven** and may not result in marketable products[166](index=166&type=chunk) - Clinical development is a **lengthy, complex, and expensive process** with an **uncertain outcome**, and the company may experience **delays** or be unable to complete the development of its product candidates[170](index=170&type=chunk)[176](index=176&type=chunk) [Risks Related to Intellectual Property](index=49&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to **obtain and maintain patent, trademark, and trade secret protection** for its technologies and product candidates, which is a **difficult and costly process**[253](index=253&type=chunk) - **Third-party claims of intellectual property infringement** could prevent or delay product development and commercialization efforts, leading to **expensive litigation** and **potential damages**[270](index=270&type=chunk) - If the company is **unable to protect the confidentiality of its trade secrets**, such as its techniques for testing live tissue samples, its **competitive position could be harmed**[265](index=265&type=chunk) [Risks Related to Reliance on Third Parties](index=59&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company **relies on its collaboration with Novartis** for the development of PLN-1474. If this collaboration is **unsuccessful or terminated**, the **development of this candidate could be halted**[304](index=304&type=chunk)[305](index=305&type=chunk) - The company **depends on third parties**, such as Contract Research Organizations (CROs), to conduct preclinical studies and clinical trials. Failure by these parties to perform their duties could **delay or prevent regulatory approval**[307](index=307&type=chunk) - The company **relies on third-party contract manufacturers** for its product supply. Any interruption, quality issues, or failure to comply with cGMP could **disrupt development and commercialization**[315](index=315&type=chunk) [Risks Related to Managing Business and Operations](index=63&type=section&id=Risks%20Related%20to%20Managing%20Our%20Business%20and%20Operations) - The COVID-19 pandemic has caused and could continue to cause **disruptions to business operations**, including **delays in clinical trial enrollment** and **supply chain interruptions**[329](index=329&type=chunk) - The **loss of key management personnel** or failure to recruit additional skilled personnel could **impair the company's ability to develop its product candidates**[338](index=338&type=chunk) - Current operations are **concentrated in South San Francisco, California**, a region **susceptible to earthquakes and other natural disasters**, which could **disrupt business**[341](index=341&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities and no material change in the planned use of IPO proceeds during the period - There were **no unregistered sales of equity securities** in the quarter[404](index=404&type=chunk) - There has been **no material change** in the planned use of proceeds from the company's initial public offering[405](index=405&type=chunk) [Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company [Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company [Other Information](index=77&type=section&id=Item%205.%20Other%20Information) No other material information is reported in this section [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and Sarbanes-Oxley certifications - Lists exhibits filed with the report, including **corporate governance documents** and **CEO/CFO certifications** under **Sarbanes-Oxley Sections 302 and 906**[411](index=411&type=chunk)