This morning, Eli Lilly (LLY) acquired Point Bio (PNT) for $12.50/share, an 87% premium. The $1.4B price tag gives Lilly a strong presence in radiopharmaceuticals for solid tumor cancers. We wrote about the radiopharmaceutical space here, and are now starting to see some of the catalyst play out.
A Low-Risk Acquisition for Lilly
Point had $400M in cash so Lilly’s net acquisition price is $1B. For this $1B, Lilly gets:
- PNT2002 milestones/royalties
- manufacturing capabilities
- PNT2004, FAP-alpha asset
PNT2002 milestones/royalties
PNT2002 is a Lu-177 labelled anti-PSMA molecule for prostate cancer targeting pre-chemo patients who have undergone androgen deprivation. PNT2002 will report Phase 3 topline data in Q4 2023.
Point Biopharma (PNT) handed PNT2002 over to Lantheus (LNTH) in exchange for $250M upfront, $250M on FDA approval, up to $1.55B in milestones and a 20% royalty (details below). As part of the agreement, Point will fund and complete the phase 3, following which Lantheus will file the NDA and commercialize the drug due to their extensive diagnostic distribution in the radiopharmaceutical space.
It is believed that PNT2002 will report positive Phase 3 data and be set for FDA approval by late 2024. Expectations for PNT2002’s Phase 3:
- Median radiographic progression free survival (rPFS) of at least 11.5months
- At least 40% of patients with PSA declines by 50% or more.
- OS of at least 15 months
PNT2002 is the main challenger to Novartis’ blockbuster radiopharmaceutical Pluvicto. More on this below. Although LNTH will get the majority of the sales upside with PNT2002 after licensing from PNT, Lilly will be subject to milestones/royalty amounts above.
Manufacturing capabilities
Lilly’s most important get in this acquisition is Point’s manufacturing capabilities and supply chain with isotopes. Supply problems have burdened radiopharmaceuticals, largely because it is still a new area with non-commoditized business practices that lack back-up production capacity. The field also deals with nuclear isotopes in healthcare, which requires highly technical expertise.
Novartis’ Pluvicto and Lutathera have seen their sales be capped as a result of supply constraints limiting existing patient doses and also delaying treatment for potential new takers. With Point’s acquisition, Lilly is getting ahead of this problem.
PNT2004, FAP-alpha asset
PNT2004 is a molecule that targets the Fibroblast Activation Protein (FAP) with Lutetium-177. The molecule will attack solid tumors with FAP expression and is expected to have Phase 1 data in 1H 2024. This is a promising, albeit early, target for radiopharmaceuticals after Clovis (now Novartis’ FAP-2286) reported promising preliminary data for the LuMIERE trial.
Radiopharmaceutical Sector Update
Novartis remains the leader in the radiopharmaceutical space with their blockbuster Pluvicto continuing strong growth. In Q2 2023, Pluvicto reported 14% QoQ growth staying on pace to hit billion-dollar sales for 2023. Novartis is also continuing to ramp up manufacturing with 2 sites approved and a third expected shortly, easing up supply chain issues.
RayzeBio (RYZB) took advantage of the radiopharmaceutical momentum and IPO-ed in mid-September 2023, raising an upsized $358M at $18/share, opening at $24 and now trading at $20. Their lead program is RYZ101 (225Ac-DOTATATE) targeting SSTR2 with an ongoing Phase 3 enrolling in GEP-NETs. This is challenging Novartis' already commercial Lutathera. RYZB reported preliminary Phase 1b data in which they confirmed ORR of 29% with no dose limiting toxicities as of June 30, 2023. The Company will report an update on this data by 1H 2024.
Upcoming Radiopharmaceutical Catalysts
Aside from PNT2002 Phase 3 data expected Q4 2023, the ongoing launch of Novartis’ Pluvictro and RayzeBio, these are a few other company catalysts to watch:
Fusion Pharma (FUSN)
FPI-2265 (225Ac-PSMA) in mCRPC patients. Fusion has ongoing Phase 2 with data update expected in Q1 2024 on 20 to 30 patients, including safety and efficacy where PSA50 responses should be between 40-60%. FUSN is trading at about $0 EV and with near term catalyst in Q1 2024.
Actinium Pharma (ATNM)
ATNM’s actimab-A uses a CD33 targeting antibody and actinium 225 as the radioactive agent to target acute myeloid leukemia (AML). In combination with chemo regimen CLAG-M, actimab-A demonstrated a 67% ORR and 12-month median OS. ATNM will give an update on strategy to move this therapy into pivotal trials by year end 2023.
ATNM will also report proof of concept Phase 1/2 that is combining their actimab-A + venetoclax, a small molecule Bcl-2 inhibitor, for patients with AML. Actimab-A + venetoclax combination has been well tolerated with responses, including a CR and a partial response in early dose escalation cohorts. Proof of concept data is expected 2H 2023 and should demonstrate complete response rates of at least 50%. ATNM trades at a $70M enterprise value with several catalysts by year end and a Phase 3 asset that conditions patients for bone-marrow transplant.
Cellectar Biosciences (CLRB)
CLRB is using Iopofosine I-131, a first-in-class targeted radiotherapeutic, in a pivotal clinical trial for Waldenstrom’s macroglobulinemia (WM). Unlike other radiopharmaceuticals, CLRB’s approach is not as targeted, using phospholipids to target lipid rafts found on the surface of cancer cells. This approach is mostly limited to bone marrow and blood cancers. Top line data for CLRB’s pivotal trial in WM is expected in Q4 2023.
Interesting to note that last month, September 2023, CLRB closed a financing with several institutional investors for up to $103M. The Company only received $24.5M at the deal closing through preferred stock convertible to common shares at $1.82 and will receive the remaining:
- $44M upon top-line WM data. Preferred shares would be converted at $3.19
- $34M upon FDA approval of Iopofosine I 131. Preferred shares would be converted at $4.78.
CLRB is currently trading in the $2.70 range. The institutional investors that participated in the above financing have already seen some of the upcoming Q4 2023 data under NDA. If Q4 data is positive, CLRB could see a run, but will ultimately be seeing a cap near $3.19 due to the $44M supply of shares that are being converted from this September preferred round.
Overview of public radiopharmaceutical companies
Disclosure: PropThink contributors do not hold positions in any of the companies mentioned
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