Point Biopharma: Interesting, Novel Radiotherapy Developer (NASDAQ:PNT)

POINT Biopharma Global Inc. (NASDAQ:PNT) is a clinical-stage company developing radioligands targeting cancer. Its pipeline:

PNT has a major collaboration deal with Lantheus Holdings, Inc. (LNTH), the diagnostic major – a deal that gave it a new cash lifeline and consists of PNT2002 and PNT2003. What remains is PNT2004, and the company’s self-owned CanSEEK technology, which has been sub-licensed from both Bach Biosciences and Avacta, and it was originally developed by Dr. William Bachovchin of Tufts University. The technology is described as follows:

[CanSEEK] aims to minimize radiopharmaceutical toxicity caused by off-target delivery by only activating a radiopharmaceuticals’ targeting moiety, such as its ligand, after it has encountered FAP-α in the tumor microenvironment (TME).

Fibroblast activation protein alpha (FAP-alpha) is often highly expressed in a variety of solid tumors but rarely found in healthy tissues, making it a good target for oncology therapies. The associated product is PNT2004.

This therapy is called Radioligand Therapy or RLT, and it is already FDA-approved for prostate cancer (Pluvicto from Novartis), the second most common cancer in men. It requires different types of radioactive substances, like lutetium-177 and actinium-225, and Point Biopharma has lined up suppliers for these, while also having its own cGMP manufacturing plant in Indianapolis, Indiana. Since some of the substances have a working life of just a few days, they cannot be used off-the-shelf but need to be manufactured for specific patients just when they need them. The company claims the capability to supply anywhere in the U.S. within 12 hours, and to the EU/UK within 48 hours.

The company’s self-owned lead candidate is PNT2004, which it licensed in 2020 and brought to the clinic within 2 years. This asset is now running a phase 1 trial in various solid tumors. However, its most advanced candidate seems to be PTN2002, which is being developed by Lantheus in a phase 3 trial in pre-chemo prostate cancer patients. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis’ own imaging solution, Locametz, for Pylarify, when selecting their patients. Lantheus already has 1095, an RLT targeting PSMA. However, PNT2004 will be its most advanced candidate, and it will be used along with Pylarify. Trial data is expected in mid-2023, and that will validate Point’s point.

That may be so, but the Lantheus deal did not go down well with Point shareholders. The stock went down 35% on the news. People feel Point was shortchanged. The deal gave them $260mn in an upfront payment, and also $1.8bn in milestone potential, however, as Evaluate describes it, the milestone part is convoluted, needing not only own product approval – in which Point may have some control; but also depending on the number of competing products at the time, which is not exactly in Point’s control. Investors may have also disliked Point giving up both its lead candidates for what they consider too small a sum. They may also have preferred that Lantheus pay for some of the trial costs. This phase 3 trial, dubbed SPLASH, will be done by Point, and will read out mid-2023. Lantheus will take up the NDA application part after the trial.

The second program that Lantheus licensed is PNT2003, which targets neuroendocrine tumors through SSTR. This is the same pathway taken by Novartis’ other approved RLT product, Lutathera, and it sells $500mn a year. Point claims, however, that their in-house manufacturing capabilities surpass even Novartis’, and that will be a major point of difference between these otherwise similar products. Another point is that PNT2002 targets a somewhat earlier line of setting than Novartis does, while PNT2003 targets an area where Lutathera has not been approved, namely rare lung and ovary NETs.

Financials

PNT has a market cap of $796mn and a cash balance of $291mn to September 30, 2022, and to which must be added another $260mn they received from Lantheus. Research and development expenses were $20.8 million for the three months ended September 30, 2022, while general and administrative expenses were $3.8 million. That gives them a cash runway of over 20 quarters. Since Lantheus will pick up some regulatory costs, I think their cash runway is pretty strong.

Bottom Line

POINT Biopharma Global Inc. is a leader in an emerging field which has seen solid traction with the Novartis products. POINT Biopharma Global Inc. has a better manufacturing facility, and while they do not claim to have much clinical data, radiotherapy is a tested field of science, and adding a ligand to it all will surely not hinder anything. Bottom line, I am hopeful of POINT Biopharma Global Inc. and may consider a small position at some point.

Editor’s Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

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