With Moderna Inc. leading the charge with its work on a COVID-19 vaccine, the market is feeling its oats as companies go after money sitting on the sidelines. One of the biggest financings to price this week is San Diego-based Turning Point Therapeutics Inc.’s underwritten public offering of common stock at $60 per share for gross proceeds expected at about $325 million.
The company is building on the markets’ dramatic price surge in April that saw the BioWorld Drug Developers Index record an almost 20% increase that ends the period down 11% year-to-date.
Other biopharmas set for raising money in public or private financings this week include Abivax SA, Apeiron Biologics, Bluebird Bio Inc. (an underwritten public offering of common stock shares at $55 each for about $500 million), Citius Pharmaceuticals Inc. (a registered direct offering of common stock with gross proceeds expected to be about $7.5 million), Diffusion Pharmaceuticals Inc. (a $12 million registered direct offering of common stock at $1.05 per share), Midatech Pharma plc and SQZ Biotechnologies Co. (bringing in a $65 million series D preferred stock financing).
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, raised $167 million from its IPO in April 2019. Its lead drug candidate, repotrectinib, is a kinase inhibitor targeting ROS1 and TRK oncogenic drivers of non-small-cell lung cancer (NSCLC) and advanced solid tumors.
Turning Point’s offering is expected to close on Thursday, May 21. The company stock (NASDAQ:TPTX) dipped 12.75% on Tuesday to close at $55.75 per share.
Goldman Sachs & Co. LLC, SVB Leerink and Guggenheim Securities are joint book-running managers. Wedbush Pacgrow is lead manager and H.C. Wainwright & Co. is co-manager for the offering.
It’s been a big two weeks for the company. On May 12, repotrectinib was granted fast track designation by the FDA for treating ROS1-positive advanced NSCLC patients who have not been previously treated with a ROS1 TKI. That follows the FDA’s action in January, when repotrectinib was granted fast track designation for treating ROS1-positive advanced NSCLC patients who had been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI, a setting where there are currently no approved targeted therapies.
Repotrectinib is in the ongoing phase I/II TRIDENT-1 trial of patients with ROS1+ advanced NSCLC and patients with NTRK+ advanced solid tumors. The phase II registrational portion of TRIDENT-1 began in June 2019 and the phase II portion is set for up to 120 sites in North America, Europe and Asia-Pacific regions with about 320 patients enrolled.
Repotrectinib has demonstrated CNS activity among patients with ROS1+ advanced NSCLC who are ROS1 TKI-naïve, with an intracranial objective response rate (IC-ORR) of 100% (3 of 3 patients, 95% CI: 29–100) with durations of response, as of the July 22, 2019, data cutoff, of 14.8+, 17.6+ and 23.1 months. All three of those patients remained on treatment as of April 6, for 26+, 28.5+ and 34.2+ months, respectively.
Turning Point said on May 18 that preclinical data published in Clinical Cancer Research showed repotrectinib demonstrated in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors against ROS1 and the ROS1 G2032R solvent-front mutation. The CNS activity of repotrectinib was studied in an in vivo model and demonstrated significant reduction of metastatic brain lesions with longer survival compared to a proxy chemical compound for entrectinib.
There are also management changes afoot at Turning Point, as it appointed Siegfried Reich on March 2 as executive vice president and chief scientific officer.