Its decision time for Point Biopharma investors. Having dragged out the Eli Lilly buyout, investors now have phase 3 radiopharmaceutical data to compare to Novartis’ results—and days to choose whether to cash out or reject the existing offer.
In October, Lilly agreed to pay $1.4 billion to buy Point for a R&D pipeline featuring the prostate-specific membrane antigen targeted radioligand therapy PNT2002. The offer represented an 87% premium over Point’s closing stock value the day before but most investors have chosen to hold on to their shares, forcing Lilly to repeatedly extend its offer.
The reticence of investors to sell up seems to stem from the potential for PNT2002 to perform better in the phase 3 SPLASH trial than Pluvicto, a product that Novartis recently linked to improved progression-free survival (PFS) but numerically worse overall survival (OS) in a separate study.
Now, Point investors have their answer. Based on a cross trial comparison, the efficacy of PNT2002 is in the same ballpark as Pluvicto, for better and worse. On OS, the hazard ratio was 1.11, compared to 1.16 in Novartis’ trial. That is what Lilly expected.
“So if the Point study reads out, and it has a primary endpoint hazard ratio in the range of Novartis’, which I think is very reasonable to assume—that is what we underwrote for our deal, we’ve already valued that,” Jake Van Naarden, president of Lilly’s Loxo oncology unit, told Fierce Biotech recently.
On PFS, Point’s candidate looks numerically worse than Pluvicto, with the caveat that comparing data from different trials can give misleading impressions. Median PFS in the PNT2002 cohort was 9.5 months, versus 6 months in the control arm. The figures for the Pluvicto study were 12 months and 5.6 months.
Lilly put out its own statement about Point this morning, telling investors that the offer has been extended until 5 pm ET on Friday, December 22. As of close of business on Friday, December 15, investors had tendered 22.81% of Point’s stock. The figure has fallen throughout the saga, sliding from 26.45% in mid-November to 24.75% at the start of this month.
Investors now have more data, including some evidence PNT2002 may have a safety and tolerability edge over Pluvicto, to inform their decisions about whether to accept the offer. The initial stock reaction suggests investors may now see Lilly’s offer as the best option. In pre-market trading, Point’s stock fell 11% to $12.47, pennies below the buyout bid price.
William Blair analysts said the SPLASH study underperformed and physicians will likely see Point’s offering as inferior to Pluvicto. After looking at the latest readout, the firm says has PNT2002 has an “uncompetitive clinical profile.”
“Sharing the same survival trend as Pluvicto effectively removes a potential bull thesis in which PNT2002 could potentially be on the market before Pluvicto in the disease setting,” the analysts wrote in a Monday morning note. Now, Point plans to collect more OS data in 2024 before submitting a new drug application for regulartory review.
As for safety, William Blair’s team is not sure Point can prove the safety edge as Pluvicto has a numerically lower frequency of high-grade adverse events when compared to alternate novel hormone therapy as well.
“We view the efficacy of the PNT2002 regimen as likely less active than Pluvicto, while the tolerability profile did not exhibit material advantages,” William Blair wrote.