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Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results

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Pliant Therapeutics (PLRX) reported Q3 2024 financial results and provided updates on its clinical programs. The company's BEACON-IPF Phase 2b/3 trial for bexotegrast in IPF patients remains on track for full enrollment in Q1 2025, with data expected mid-2026. Q3 financial results showed R&D expenses of $47.8M (up from $32.3M YoY), G&A expenses of $14.3M (down from $15.3M YoY), and a net loss of $57.8M (increased from $41.5M YoY). The company maintains a strong cash position of $406.0M as of September 30, 2024.

Pliant Therapeutics (PLRX) ha riportato i risultati finanziari del terzo trimestre del 2024 e ha fornito aggiornamenti sui suoi programmi clinici. Il trial BEACON-IPF di fase 2b/3 per bexotegrast nei pazienti con IPF è in linea con la tabella di marcia per il completamento dell'arruolamento entro il primo trimestre del 2025, con dati attesi a metà del 2026. I risultati finanziari del terzo trimestre mostrano spese per R&S di 47,8 milioni di dollari (aumentate rispetto ai 32,3 milioni di dollari dell'anno precedente), spese generali e amministrative di 14,3 milioni di dollari (diminuite rispetto ai 15,3 milioni di dollari dell'anno precedente) e una perdita netta di 57,8 milioni di dollari (aumento rispetto ai 41,5 milioni di dollari dell'anno precedente). L'azienda mantiene una solida posizione di liquidità di 406,0 milioni di dollari al 30 settembre 2024.

Pliant Therapeutics (PLRX) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre sus programas clínicos. El ensayo BEACON-IPF de fase 2b/3 para bexotegrast en pacientes con IPF se mantiene en camino hacia el completo reclutamiento en el primer trimestre de 2025, con datos esperados para mediado de 2026. Los resultados financieros del tercer trimestre mostraron gastos de I+D de 47,8 millones de dólares (aumento respecto a los 32,3 millones de dólares del año anterior), gastos generales y administrativos de 14,3 millones de dólares (disminución respecto a los 15,3 millones de dólares del año anterior) y una pérdida neta de 57,8 millones de dólares (aumento respecto a los 41,5 millones de dólares del año anterior). La empresa mantiene una sólida posición de efectivo de 406,0 millones de dólares al 30 de septiembre de 2024.

플리안 제약 (PLRX)은 2024년 3분기 재무 결과를 보고하고 임상 프로그램에 대한 업데이트를 제공했습니다. BEACON-IPF 2b/3상 시험은 IPF 환자에게서 bexotegrast를 사용하며, 2025년 1분기까지 완전한 모집을 목표로 하고 있으며, 데이터는 2026년 중반에 예상됩니다. 3분기 재무 결과는 R&D 비용이 4,780만 달러(전년 대비 3,230만 달러에서 증가), 총무 및 관리 비용이 1,430만 달러(전년 대비 1,530만 달러에서 감소), 그리고 순손실이 5,780만 달러(전년 대비 4,150만 달러에서 증가)를 나타냈습니다. 회사는 2024년 9월 30일 현재 4억 6천만 달러의 강력한 현금 포지션을 유지하고 있습니다.

Pliant Therapeutics (PLRX) a rapporté les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur ses programmes cliniques. L' pour le bexotegrast chez les patients atteints d'IPF est sur la bonne voie pour une inscription complète au premier trimestre 2025, avec des données attendues à la mi-2026. Les résultats financiers du troisième trimestre ont montré des dépenses R&D de 47,8 millions de dollars (en hausse par rapport à 32,3 millions de dollars l'année précédente), des dépenses générales et administratives de 14,3 millions de dollars (en baisse par rapport à 15,3 millions de dollars l'année précédente) et une perte nette de 57,8 millions de dollars (augmentation par rapport à 41,5 millions de dollars l'année précédente). L'entreprise maintient une solide position de trésorerie de 406,0 millions de dollars au 30 septembre 2024.

Pliant Therapeutics (PLRX) hat die finanziellen Ergebnisse des dritten Quartals 2024 bekannt gegeben und Updates zu seinen klinischen Programmen bereitgestellt. Die BEACON-IPF Phase 2b/3 Studie für Bexotegrast bei IPF-Patienten liegt im Zeitplan für die vollständige Rekrutierung im ersten Quartal 2025, die Daten werden Mitte 2026 erwartet. Die finanziellen Ergebnisse des 3. Quartals zeigten F&E-Ausgaben von 47,8 Millionen USD (ein Anstieg von 32,3 Millionen USD im Vergleich zum Vorjahr), allgemeine und administrative Ausgaben von 14,3 Millionen USD (ein Rückgang von 15,3 Millionen USD im Vergleich zum Vorjahr) und einen Nettoverlust von 57,8 Millionen USD (ein Anstieg von 41,5 Millionen USD im Vergleich zum Vorjahr). Das Unternehmen hält zum 30. September 2024 eine starke Liquiditätsposition von 406,0 Millionen USD aufrecht.

Positive
  • Strong cash position of $406.0M providing runway for operations
  • BEACON-IPF Phase 2b/3 trial enrollment progressing on schedule
  • Reduction in G&A expenses from $15.3M to $14.3M YoY
Negative
  • Net loss increased by 39% to $57.8M compared to prior year
  • R&D expenses increased significantly by 48% to $47.8M YoY

Insights

The Q3 2024 financial results reveal significant R&D investment acceleration, with expenses increasing 47.9% year-over-year to $47.8M, primarily driven by the BEACON-IPF Phase 2b/3 trial. The net loss widened by 39.3% to $57.8M, reflecting the company's aggressive clinical development strategy.

With $406M in cash and equivalents, PLRX maintains a strong liquidity position providing approximately 18-24 months of runway at current burn rates. This buffer should comfortably support operations through the critical BEACON-IPF trial data readout in mid-2026. The 6.5% reduction in G&A expenses to $14.3M demonstrates disciplined cost management in non-core areas.

The BEACON-IPF trial's progression represents a important milestone for bexotegrast in IPF treatment. The trial's robust design, evaluating two dose levels (160mg and 320mg) across 360 patients, will provide comprehensive efficacy data. The publication of Phase 2a PET imaging results in AJRCCM, a prestigious peer-reviewed journal, validates the drug's mechanism showing dose-dependent αvβ6 integrin receptor occupancy.

The expansion of PLN-101325 beyond muscular dystrophies and the advancement of PLN-101095 in solid tumors demonstrate pipeline diversification. The third cohort completion in the PLN-101095 trial positions the company for preliminary data in early 2025, potentially opening new therapeutic opportunities in oncology.

BEACON-IPF Phase 2b trial on track for full enrollment in the first quarter of 2025 with data anticipated in mid-2026

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical 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 third quarter 2024 financial results.

“A highlight to this quarter’s progress was the continued strong execution of our BEACON-IPF Phase 2b/3 trial which is enrolling well and on track to complete enrollment in the first quarter of 2025,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “We are pleased with the interest from the global physician and patient communities in participating in BEACON-IPF and look forward to sharing data in mid-2026. Additionally, we made progress across the portfolio with the goal of bringing potential therapies to patients.”

Third Quarter and Recent Highlights

Bexotegrast Highlights

  • Enrollment remains on track in BEACON-IPF, a pivotal adaptive Phase 2b/3 trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The BEACON-IPF Phase 2b/3 trial 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. The Phase 2b portion of BEACON-IPF will enroll 360 patients with IPF. Enrollment in this portion of this trial is expected to be complete in the first quarter of 2025 with data anticipated in mid-2026.
  • Results from Phase 2a PET imaging target engagement trial published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). Also known as the “Blue Journal,” AJRCCM is a leading peer-reviewed journal published by the American Thoracic Society. The publication reviews the previously reported positive results from an open-label trial in which bexotegrast showed dose-dependent αvβ6 integrin receptor occupancy in lungs of patients with IPF.

Pipeline Programs

  • Phase 1 trial of PLN-101095 in solid tumors is progressing with dosing of the third of five cohorts. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The Company has completed enrollment in the third of five cohorts in the Phase 1 open-label, dose-escalation trial. In this trial, PLN-101095 is being tested as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in early 2025.
  • PLN-101325 applications beyond muscular dystrophies. PLN-101325 is a monoclonal antibody that acts as an allosteric agonist of integrin α7β1, currently in development for treatment of muscular dystrophies. The Company is currently generating additional evidence in support of potential expansion of the scope of PLN-101325 prior to initiating a Phase 1 trial.

Corporate Highlights

  • Appointment of Gary Palmer, M.D. as Senior Vice President of Medical Affairs. Dr. Palmer brings over 25 years of global leadership experience in medical affairs from biopharmaceutical companies of various sizes and stages, and across multiple therapeutic areas including pulmonary medicine, immunology and neurology. Most recently, Dr. Palmer served as Senior Vice President of Global Medical Affairs, Immunology and Neuroscience at Bristol Myers Squibb.

Third Quarter 2024 Financial Results

  • Research and development expenses were $47.8 million, as compared to $32.3 million for the prior-year quarter. The increase was primarily driven by BEACON-IPF, a Phase 2b/3 trial of bexotegrast in patients with IPF.
  • General and administrative expenses were $14.3 million, as compared to $15.3 million for the prior-year quarter. The decrease was primarily due to professional service expenses.
  • Net loss of $57.8 million as compared to $41.5 million for the prior-year quarter. The increase was primarily due to higher operating expenses driven by BEACON-IPF.
  • As of September 30, 2024, the Company had cash, cash equivalents and short-term investments of $406.0 million.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a late-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, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting 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, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies.

For additional information, please visit: www.PliantRx.com. Follow us on social media X, LinkedIn, and Facebook.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our ability to complete enrollment in BEACON-IPF in the first quarter of 2025; our plans for the future development of bexotegrast, PLN-101325 and PLN-101095, including the potential expansion of PLN-101325 into additional indications in organ systems outside of muscle; bexotegrast’s potential to become a treatment for IPF or PSC; the anticipated timing of data and progress from our clinical studies and public announcements related thereto; and discussions with regulatory authorities. 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 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 Quarterly Report on Form 10-Q for the period ended September 30, 2024 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 September 30,
  2024   2023 
Revenue$  $ 
Operating expenses:   
Research and development (47,754)  (32,339)
General and administrative (14,260)  (15,346)
Total operating expenses (62,014)  (47,685)
Loss from operations (62,014)  (47,685)
Interest and other income (expense), net 5,128   6,515 
Interest expense (877)  (317)
Net loss$(57,763) $(41,487)
Net loss per share - basic and diluted$(0.95) $(0.70)
Shares used in computing net loss per share - basic and diluted 60,730,935   59,688,451 


Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
 
 September 30,
2024
 December 31,
2023
Assets   
Current assets   
Cash and cash equivalents$79,616  $63,234 
Short-term investments 324,897   431,011 
Prepaid expenses and other current assets 5,518   11,257 
Total current assets 410,031   505,502 
Property and equipment, net 5,671   3,567 
Operating lease right-of-use assets 28,054   1,211 
Restricted cash 1,482   1,482 
Other non-current assets 427   392 
Total assets$445,665  $512,154 
Liabilities and stockholders’ equity   
Current liabilities   
Accounts payable$6,890  $4,531 
Accrued research and development 23,025   12,456 
Accrued liabilities 9,715   10,219 
Operating lease liabilities, current 322   1,318 
Total current liabilities 39,952   28,524 
Operating lease liabilities, non-current 29,752    
Long-term debt 30,139   10,054 
Total liabilities 99,843   38,578 
Stockholders’ equity   
Preferred stock     
Common stock 6   6 
Additional paid-in capital 1,005,288   972,973 
Accumulated deficit (660,320)  (499,748)
Accumulated other comprehensive gain 848   345 
Total stockholders’ equity 345,822   473,576 
Total liabilities and stockholders’ equity$445,665  $512,154 
    

FAQ

When will Pliant Therapeutics (PLRX) complete enrollment for the BEACON-IPF Phase 2b trial?

Pliant Therapeutics expects to complete enrollment for the BEACON-IPF Phase 2b trial in the first quarter of 2025.

What was Pliant Therapeutics' (PLRX) net loss in Q3 2024?

Pliant Therapeutics reported a net loss of $57.8 million in Q3 2024, compared to $41.5 million in the prior-year quarter.

How much cash does Pliant Therapeutics (PLRX) have as of Q3 2024?

Pliant Therapeutics had $406.0 million in cash, cash equivalents and short-term investments as of September 30, 2024.

When will PLRX release data from the BEACON-IPF Phase 2b trial?

Pliant Therapeutics anticipates releasing data from the BEACON-IPF Phase 2b trial in mid-2026.

Pliant Therapeutics, Inc.

NASDAQ:PLRX

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761.89M
59.06M
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111.68%
11.86%
Biotechnology
Pharmaceutical Preparations
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United States of America
SOUTH SAN FRANCISCO