On August 8, 2022 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported second quarter 2022 financial results (Press release, Pliant Therapeutics, AUG 8, 2022, View Source [SID1234617784]).
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"A highlight to our team’s progress in 2022 is the positive safety and efficacy data from the INTEGRIS-IPF Phase 2a trial. The trial met its primary endpoint demonstrating that PLN-74809 was well tolerated over a 12-week treatment period, and delivered compelling efficacy results demonstrating a clear dose dependent treatment effect in patients with IPF," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "These data reflect the significant preclinical and clinical derisking conducted that allows for PLN-74809’s late-stage development and moves this program closer to potentially assisting patients in need."
Second Quarter and Recent Highlights
PLN-74809 Highlights
INTEGRIS-IPF Phase 2a trial results showed PLN-74809 was well tolerated with dose-dependent treatment effects on forced vital capacity (FVC) and quantitative lung fibrosis (QLF) in patients with idiopathic pulmonary fibrosis (IPF). Exploratory endpoints a showed a dose-dependent treatment effect on FVC and QLF versus placebo in all PLN-74809 dose groups, both with and without standard of care therapy. In addition, a dose-dependent reduction in the proportion of patients with percent-predicted FVC (FVCpp) decline of ≥ 10%, a risk factor associated with increased mortality in IPF patients, was observed across all treatment groups.
INTEGRIS-IPF Phase 2a trial of PLN-74809 at 320 mg completed enrollment in patients with IPF. Enrollment is complete in the randomized, double-blind, placebo-controlled trial evaluating PLN-74809 at a once daily dose of 320 mg administered for at least six months and up to 48 weeks in approximately 28 patients with IPF. The trial will evaluate primary and secondary endpoints of safety, tolerability, and pharmacokinetics. Exploratory efficacy endpoints will include effect on FVC and QLF imaging as well as biomarkers. Interim 12-week data is anticipated in early 2023.
INTEGRIS-PSC Phase 2a data anticipated in the first half of 2023. This 12-week randomized, dose-ranging, double-blind, placebo-controlled trial is evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in primary sclerosing cholangitis (PSC) patients. The trial is also evaluating exploratory endpoints including fibrosis biomarkers such as PRO-C3 and ELF, changes in ALP, and liver imaging. Topline data from this trial is expected in the first half of 2023.
FDA Fast Track designation received for PLN-74809 for the treatment of PSC. FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans, and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.
Early-Stage Development Programs
Advancement of integrin target in fibrosis under strategic collaboration. A fibrosis-directed integrin target moved into development as part of Pliant’s 2019 research and development collaboration with Novartis. Pliant earned a $4.0 million milestone payment and research funding in support of the development work.
Oncology and muscular dystrophy programs progressing through Investigational New Drug (IND) enabling studies. IND application submissions for both programs expected by the end of 2022.
Corporate Highlights
Underwritten public offering raised approximately $215.7 million in net proceeds. In July 2022, the Company closed a public offering of $230.0 million of common stock including the underwriter’s exercise in full of their overallotment option to support development of ongoing and future preclinical and clinical programs including PLN-74809.
Loan facility agreement with Oxford Finance LLC provides up to $100 million of non-dilutive financing. The agreement provides support for the continued clinical development of PLN-74809 in the lead indications of IPF and PSC. The Company drew $10.0 million at closing of an initial $25.0 million tranche. Following the achievement of a development milestone, the Company now has access to the second $25.0 million tranche.
Second Quarter 2022 Financial Results
Research and development expenses were $26.3 million, as compared to $19.2 million for the prior-year quarter. The increase was due primarily to employee related expenses and higher costs related to the advancement of preclinical programs and ongoing Phase 1/2 clinical trials.
General and administrative expenses were $8.3 million, as compared to $5.5 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
Net loss of $29.5 million as compared to $22.8 million for the prior-year quarter due to an increase in operating expenses partially offset by an increase in collaboration revenue resulting from a $4.0 million target validation fee earned under the Novartis collaboration during the quarter.
As of June 30, 2022, the Company had cash, cash equivalents and short-term investments of $163.6 million. With the aggregate net proceeds from the public offering of approximately $215.7 million, the Company had pro-forma cash, cash equivalents and short-term investments of $379.8 million as of June 30, 2022. With current cash and full utilization of our loan facility, the Company expects to be able to fund operations to mid-2025.