In the midst of tough predictions for 2023 due to inflation and a difficult funding environment, Pliant Therapeutics closed an oversubscribed $287.5 million public offering to boost its rare disease pipeline.
On January 24, Pliant Therapeutics announced its upsized underwritten public offering of 8,333,334 shares of common stock for $30.00 per share. The company predicted the aggregate gross proceeds for the offering would total a sum of $250 million, before deductions.
On January 27, the company announced it had exceeded this target with overall aggregate gross proceeds from the offering adding up to $287.5 million before deductions. These deductions include underwriting discounts and commissions and estimated offering expenses payable by pliant.
Currently, Pliant has four drugs in its pipeline of which one drug, bexotegrast, is being developed for two rare diseases. Bexotegrast is an oral small molecule that inhibits αvβ6/αvβ1. The drug is under development for the treatment of the two rare diseases idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).
Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. In 2020, the company had raised $165.6 million when it closed its IPO. In 2023, from January 6 to February 6, Pliant saw a 75% increase in its stock price from $19.19 to $33.53 per share. The company has attributed the success of the follow-on offering to the strength of Phase IIa INTEGRIS-IPF trial data.
IPF is a condition in which the lungs become scarred, causing breathing difficulty and irreversible loss of lung function. According to 2018 data, IPF occurs in less than five individuals per 100,000 per year. According to GlobalData, there are 25 marketed drugs for IPF available in North America. GlobalData is the parent company of Pharmaceutical Technology.
PSC is similarly uncommon with only one case per 100,000 people in the United States or Europe. According to GlobalData, 29 drugs are currently marketed for managing the complications of PSC, but none can reverse liver damage associated with PSC. While norursodeoxycholic acid, a PSC drug is in Phase III of clinical trials, bexotegrast is one of 14 drugs in ongoing Phase II clinical trials.
There is no cure for IPF as all drugs available are only able to relieve symptoms and slow down progression. The standard treatments for IPF include Esbriet (pirfenidone) which is marketed by Genentech, a part of Roche, and Boehringer Ingelheim’s Ofev (nintedanib), which are used to slow disease progression. The FDA approved both drugs in 2014. In the US, the annual cost for Esbriet is $113,193 and $112,357 for Ofev.
In an email, a Pliant spokesperson told Pharmaceutical Technology, “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.
Movement in Pliant’s pipeline
On January 22, Pliant released 12-week interim data from its Phase IIa IPF clinical trial for bexotegrast. After 12 weeks, the study met its primary endpoint related to the “number of participants with treatment-related adverse events and laboratory abnormalities” for patients in the 320mg group, as there were no study-related adverse events. The company plans to release the final data in Q2 2023.
Pliant plans to use a portion of money from the public offering to “develop its ongoing and future preclinical and clinical programs including bexotegrast and PLN-101095”. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. A Pliant spokesperson said, “This successful transaction, along with existing cash, cash equivalents, loan agreement and short-term investments, provides for operations to be funded to mid-2027, a year past the expected IPF Phase 2b clinical trial readout.” The company said a Phase IIb trial initiation should be expected in mid-2023.
Public Offerings in 2023
Ernst and Young’s 2022 Global IPO report, predicts that in 2023, “IPO activity will likely remain somber through at least the first quarter, more favorable conditions seem to be set in place for global IPO activity to regain greater momentum by the second half of the year”.
According to Baker Mackenzie, a law firm brand that specialises in a range of industries including healthcare and life sciences, IPOs allow pharmaceutical companies to “access major global finance hubs and capital from a deep pool of investors around the world”.
However, elevated interest rates and increases in inflationary pressures contributed towards a significant reduction in the value and number of IPOs as companies were more wary of risky business decisions in 2022. In 2022, EY reports, financial-sponsored IPO activity fell from 77% to 93% by number and proceeds, respectively. In EY’s retrospective report, the company proposes that in 2023 companies may use a “wait and see” method to approach IPOs, as investors concentrate more on fundamentals such as revenue growth and profitability.
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