Three biotechs – Turning Point Therapeutics Inc., Hookipa Pharma Inc. and Trevi Therapeutics Inc. – are gearing up to join the public sector. Turning Point and Hookipa both set terms, aiming to raise $125.8 million and $100.5 million at the midpoint of their respective ranges, while Trevi filed for an IPO, aiming to raise as much as $86.25 million.
Should all three price, they would add to the 14 biopharmas that have raised $1.47 billion in IPOs so far this year, according to BioWorld Snapshots.
San Diego-based Turning Point, a clinical-stage company whose pipeline of tyrosine kinase inhibitors (TKI) targets numerous genetic drivers of cancer in both TKI-naïve and TKI-pretreated patients, plans to offer nearly 7.4 million shares of its common stock at a range of $16 to $18 a share. The company intends to list its common stock on Nasdaq under the symbol TPTX. Some affiliates of the company directors and other principal stockholders may buy about $50 million of the common stock at the IPO price. The joint book-running managers are Goldman Sachs and Co. Ltd., SVB Leerink, Wells Fargo Securities and Canaccord Genuity.
Turning Point, which filed as an emerging growth company, was founded in 2013. Its lead drug candidate, repotrectinib (TPX-0005), is in a phase I/II trial called TRIDENT-1 for the treatment of patients with ROS1-positive advanced non-small-cell lung cancer (NSCLC) and patients with ROS1-positive, NTRK-positive or ALK-positive advanced solid tumors. Phase I is nearly complete, and the company plans to initiate a multicohort phase II in the second half of 2019. That will be a registrational trial for potential approval in ROS1-positive advanced NSCLC and NTRK-positive advanced solid tumors.
In addition to repotrectinib, the company pipeline includes two multitargeted kinase inhibitors – TPX-0046 (an RET/SRC inhibitor) and TPX-0022 (a MET/CSF1R/SRC inhibitor) – plus a series of next-generation ALK inhibitors. It also anticipates submitting INDs and initiating clinical trials for TPX-0046 and TPX-0022 in 2019.
Seeking a market HOOK
New York-based Hookipa Pharma, a clinical-stage biopharma developing immunotherapeutics targeting infectious diseases and cancers, plans to offer about 6.6 million shares of its common stock at a range of $14 to $16 a share. The company plans to list its common stock on Nasdaq under the symbol HOOK. The joint book-running managers are Bank of America Merrill Lynch, SVB Leerink and RBC Capital Markets. The co-manager is Kempen and Co.
Hookipa's Vaxwave and Therat is designed to elicit patients' response of antigen-specific killer T cells and antibodies that activate immune defenses against infectious diseases and cancers. Hookipa's lead infectious disease product candidate, HB-101, is in a randomized, double-blinded phase II trial in cytomegalovirus-negative patients awaiting kidney transplantation from cytomegalovirus-positive donors. Its lead oncology product candidates, HB-201 and HB-202, are being developed to treat human papillomavirus-positive cancers. The company plans to file an IND with the FDA for HB-201 and HB-202 in the first half of 2019 and 2020, respectively.
It has also has entered a strategic partnership with Gilead Sciences Inc. to build a pipeline of additional infectious disease product candidates. (See BioWorld, June 7, 2018.)
Hookipa co-founder Rolf Zinkernagel received the Nobel Prize in Physiology or Medicine in 1996 for his arenavirus-based work on how CD8-positive T cells recognize virus-infected cells. The company's first technology, Vaxwave, is a replication-defective arenavirus that induces an immune response for prophylactic use against infectious disease. Its second technology, Therat, is a replication-attenuated arenavirus that also produced an immune response. In preclinical studies, Therat reprogrammed the immune system so that more than half of the body's CD8-positive T cells focused on a specific cancer antigen target without observed serious adverse events.
Trevi advancing pruritus program
New Haven, CT-based Trevi Therapeutics, an emerging growth company of 15 employees and founded in 2011, plans to raise about $86.25 million in its IPO. It intends to list on Nasdaq under the symbol TRVI. The joint book-running managers are SVB Leerink, Stifel, BMO Capital Markets and Needham and Co.
Trevi is clinical-stage company focused on developing and commercializing nalbuphine ER to treat chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis and levodopa-induced dyskinesia in patients with Parkinson's disease. It is conducting a phase IIb/III trial of nalbuphine ER, the PRISM trial, in patients with severe pruritus associated with prurigo nodularis and expects top-line data in the first half of 2020. Should the trial be successful, the company expects to use the PRISM trial and an additional phase III trial to submit an NDA and an MAA for the drug.