One new IPO filing, three newly priced upsized IPOs and the revival of a once-postponed offering added fuel to an explosion of June fundraising, bringing the total number of IPOs on U.S. markets this month to 14, so far. Specialty pharma Aquestive Therapeutics Inc. is the latest to arrive, filing to raise up to $69 million. Meanwhile, immuno-oncology specialist Forty Seven Inc., kidney disease-focused Tricida Inc., and messenger RNA drug developer Translate Bio Inc. all increased their fundraising targets. Not to miss the moment, oral formulations expert Entera Bio Ltd. took its offering, earlier postponed, off ice.

So far this year, there have been a total of 39 IPOs, of which 36 were on U.S. exchanges, according to data compiled by BioWorld Snapshots. Altogether, the offerings have raised a stunning $3.9 billion, including more than $1.6 billion in June alone. Eleven more offerings, including Aquestive, are on deck.

Filing for film

With plans to raise up to $69 million, Aquestive is the newest, but also one of the smaller offerings on tap. Perhaps better known through its former incarnation, Monosol Rx LLC, Warren, N.J.-based Aquestive is looking to fill perceived shortcomings of available therapies for diseases of the central nervous system with its Pharmfilm formulations of already-known drugs. By summer's end, investors will have some insight into the strategy's odds in the form of an FDA decision on whether or not to approve its Lennox-Gastaut syndrome therapy, an oral soluble film formulation of clobazam. The PDUFA date for that program, Sympazan, is due Aug. 31.

Two other Aquestive programs are also nearing milestones: Libervant (AQST-203), a buccally administered soluble film formulation of diazepam that's intended for treating recurrent epileptic seizures; and AQST-117, an oral soluble film formulation of riluzole for the treatment of amyotrophic lateral sclerosis. By year-end, the company expects to submit new drug applications to the FDA for both drugs.

Funds from the IPO are slated to support pre-launch commercialization investments for all three programs. In addition, Aquestive said it would invest in trials for AQST-108, a sublingual film formulation of epinephrine for the treatment of anaphylaxis, and AQST-305, a buccal film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors, and the identification of new pipelines candidates.

According to the company, Libervant would provide an alternative for Diastat (diazepam rectal gel), which it said is the current standard-of-care rescue therapy for patients with epilepsy; Sympazan would offer an alternative to Onfi (clobazam), currently available in either tablet form or liquid suspension; and AQST-117 would present an alternative to Rilutek (riluzole), which is currently available only in tablet form.

Aquestive is also carrying a portfolio of commercialized and development-stage partnered products, including Suboxone, a sublingual film formulation of buprenorphine and naloxone. It has produced 1.1 billion doses of Suboxone in the last four years, it said.

As of March 31, the company had $16.5 million in cash and cash equivalents and an accumulated deficit of $116 million. As with most companies dealing in reformulation of known drugs, it has a number of issues in litigation. It settled one in May, with Par Pharmaceuticals Inc., of Woodcliff Lake, N.J., that will allow Par and Intelgenx Technologies Corp., of Montreal, to launch their proposed generic version of Suboxone (buprenorphine and naloxone sublingual film) in 2023.

Aquestive, which filed for its offering confidentially on April 2, plans to list on Nasdaq under the symbol AQST. BMO Capital Markets and RBC Capital Markets are acting as joint book-running managers for the offering.

Putting the brakes on CKD

Evidence of the healthy demand for new issues was clearest in Tricida's $222.3 million offering, which saw shares (NASDAQ:TCDA) quickly snapped up Thursday for as much as $31.20 each, a significant increase from their upsized initial offering price of $19 per share. The South San Francisco-based company had already rolled out the biggest raise of this round-up, seeking plentiful support for its development and commercialization of TRC-101, a non-absorbed, orally dosed polymer drug designed to treat metabolic acidosis in patients with chronic kidney disease. There are no FDA-approved therapies for the chronic treatment of metabolic acidosis.

It priced 11.7 million shares at $19 each, pre-empting an earlier plan to raise $175 million by offering 10.3 million shares at a proposed range of $16 to $18 per share.

Tricida plans to submit an NDA for TRC-101 in the second half of 2019, seeking approval through the FDA's accelerated approval program.

Prior to the offering, the company's largest stakeholders included Orbimed, entities associated with Sibling Capital, and Longitude Venture Partners. Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Cowen and Co. LLC acted as joint book-running managers for the offering.

Tricida shares ended Thursday at $26, up 36.8 percent.

In contrast to Tricida's success, two other ambitious upsizers, Forty Seven and Translate Bio, met with a chillier reception from investors.

Menlo Park, Calif.-based Forty Seven, founded by a quartet of CD47 experts, moved to raise about $112.6 million through the sale of a little more than 7 million shares priced at $16 per share. Plans for the proceeds include supporting the further clinical development of its lead candidate, 5F9, through completion of existing phase I monotherapy and planned PD-L1 combination trials. So far, the company said, the candidate has demonstrated "promising activity" in six phase Ib/II trials in which it has treated more than 190 relapsed or refractory cancer patients with solid or hematologic tumors. But that didn't seem to be enough to drive enthusiasm for the shares (NASDAQ:FTSV), which fell nearly 6 percent to $15.05 by Thursday's close. (See BioWorld Today, July 26, 2016.)

Pas d'amour pour mRNA?

Translate Bio, a Lexington, Mass.-based company developing mRNA therapeutics to treat diseases caused by protein or gene dysfunction, also moved to upsize its offering, choosing to sell about 9.4 million shares of its common stock (NASDAQ:TBIO) instead of the originally planned 7.7 million shares. The final offering was priced at $13 per share, the midpoint of the initially contemplated range. But investors seemed to find $11.52 a better approximation of the company's share value, as the stock closed down 11.4 percent on its first day of trading.

Sanofi SA, of Paris, expressed its confidence in the company's mRNA therapeutics platform earlier this month, with an $805 million R&D deal focused on development of five mRNA vaccines for five infectious pathogens. (See BioWorld, June 12, 2018.)

Translate emerged in early 2017 as a relaunch of Cambridge, Mass.-based Rana Therapeutics Inc., which raised $20.7 million in a series A round in 2012, and then $55 million in a series B in 2015. Rana had just acquired the MRT platform from Shire Human Genetic Therapies Inc., a subsidiary of Shire plc. (See BioWorld Today, July 23, 2015, and Jan. 5, 2017.)

Prior to completion of the offering, Translate Bio's biggest shareholders were Shire Human Genetic Therapies Inc., Fidelity funds and investment advisor The Baupost Group LLC. Citigroup Global Markets Inc., Leerink Partners LLC, Evercore Group LLC acted as joint book-running managers for the offering.

A more modest offering

Not to be left out, Entera Bio, of Jerusalem, revived its plans for an IPO after initially postponing in January. The company, which is developing an oral formulation of parathyroid hormone (PTH) for hypoparathyroidism and osteoporosis, had originally filed to raise up to $50 million, but eventually sought to raise a more modest $11.2 million through the sale of 1.4 million units, with each unit consisting of one ordinary share (NASDAQ:ENTX) and one warrant to purchase half of an ordinary share, at a combined price of $8 per unit. (See BioWorld, Nov. 13, 2017.)

Out of the gate, Entera's shares fell 21.5 percent to close at $6.28 on Thursday, significantly below the exercise price of its warrants: $8.40 per share. Maxim Group LLC is acting as sole book-running manager, having replaced earlier plans to go with Oppenheimer & Co.

Entera's lead oral PTH product candidate, EB-612, has completed a phase IIa trial for hypoparathyroidism, a rare condition in which the body fails to produce sufficient amounts of PTH. The FDA and EMA have both granted EB-612 orphan status for the treatment of hypoparathyroidism. With its new funds, the company will prepare EB-612 for advanced clinical studies and ultimately for regulatory approval, it said.

Major shareholders of Entera include D.N.A Biomedical Solutions Ltd., the Centillion Fund and Capital Point Ltd.