Pharmaceutical and biotech IPOs have been leading the IPO market for many months now, as most investors are probably aware. Even in the face of this recent sell-off in the market, healthcare-related IPOs have done quite well. In fact, just yesterday, SI-BONE's up-sized deal priced at the high end of the expected price range.
But, there is some evidence now that the IPO market is starting to crack. Most notably, SolarWinds (SWI) -- a high quality cloud software IPO -- just drastically slashed the terms of its IPO. Additionally, Riley Exploration and Valtech both postponed their deals. So, with conditions taking a turn for the worse, even a pharmaceutical IPO had trouble drawing much interest.
Specifically, its IPO priced at $5, far below the $12-$14 projected range. The deal was up-sized to 9.2 million shares from 5.0 million, but, it still generated $19 million, or 29%, less in proceeds than anticipated. One bad pricing isn't enough to suggest that pharmaceutical IPOs hot streak has come to an end. However, when considering the other news in the IPO market this week, the signs aren't encouraging at the moment.
As for PHAS' IPO, it was led by Citigroup, Cowen, and Stifel. The stock is set to open for trading later this morning on the Nasdaq.
PHAS is a clinical-stage biopharma focused on therapies to treat orphan diseases, with an initial focus on cardiopulmonary (heart and lungs) indications. It currently has two clinical-stage product candidates: PB2452, a ticagrelor reversal agent, and PB1046 for the treatment of PAH.
Its lead candidate, PB2452, is a reversal agent for the antiplatelet drug ticagrelor. PHAS is developing a treatment for patients on ticagrelor who are experiencing a major bleeding event or those who require urgent surgery. Ticagrelor is an antiplatelet therapy widely prescribed to reduce the rates of death, heart attack and stroke in patients with acute coronary syndrome (ACS).
In PhaseBio's Phase 1 clinical trial, PB2452 achieved rapid and complete reversal of ticagrelor's antiplatelet activity, which has the potential to bring life-saving therapeutic benefit to these patients by increasing the safety of ticagrelor. PHAS believes the availability of a reversal agent could expand ticagrelor's use by mitigating concerns regarding bleeding risk and uniquely position ticagrelor as the only oral antiplatelet drug with a reversal agent.
PHAS intends to conduct a Phase 2a clinical trial of PB2452 in healthy older subjects in 1H19. Older adults exhibit more variability in drug response to ticagrelor and higher levels of baseline platelet reactivity compared to younger subjects, and they resemble the patient population most likely to be treated with ticagrelor. Upon completion of the Phase 2a trial, PHAS intends to request a meeting with the FDA to review the clinical profile of and confirm the regulatory pathway for PB2452. Subject to discussions with the FDA, PHAS intends to initiate a Phase 2 trial of PB2452 in healthy older adults in 2H19.
The company plans to initiate an international Phase 3 trial in patients on ticagrelor who are experiencing a major bleeding event or require urgent surgery. If considered appropriate by the FDA, PHAS intends to pursue accelerated approval, which would allow PHAS to submit a biologics license application (BLA) prior to completion of the Phase 3 trial based on biomarker data from an initial subset of the Phase 3 patients.
Finally, as is the case with most clinical-stage biopharmas, PHAS has no products that are approved for commercial sale. It also has no financials at this point and it expects losses to continue for the next several years. Investors will be focusing mostly on any developments on the clinical trial front.