Cellectar Biosciences (CLRB) is a late-stage medical biotech firm (not a “damaged biotech”) that lately reported constructive information for his or her lead therapeutic, Iopofosine I 131, for the therapy of Waldenstrom’s macroglobulinemia (“WM”), which is an unusual gradual rising kind of non-Hodgkin lymphoma. WM usually inflicts these over the age of 60 and people with WM succumb to the most cancers inside 5-10 years. Whereas I attempt to keep away from science performs round right here, the outcomes have been fairly exceptional and supply hope for these with WM who’ve unsuccessfully tried two prior traces of remedy. The FDA has granted Iopofosine each orphan drug and quick observe designations, Cellectar plans to file a brand new drug utility (NDA) within the second half of this yr with an accelerated 6 month approval timeline.
One of many advantages of remedies for uncommon ailments is the affected person inhabitants tends to be tightly concentrated inside specialised well being care communities and as a result of R&D improvement prices, extraordinarily excessive pricing is norm in orphan medicine to recoup that funding over a small affected person inhabitants. Cellectar is within the strategy of transitioning from a medical stage biotech to a industrial one (assuming FDA approval), they’re outsourcing a lot of the manufacturing and solely spending $25MM to face up a gross sales and industrial assist workforce. Absolutely the variety of sufferers is comparatively small, however once more, this can be a excessive priced remedy (a fast google search, the median orphan drug prices $200k+ yearly).
Doing a little bit again of the envelope math (full warning, this could possibly be wildly off), if 1500 new sufferers are recognized with WM yearly and 80% finally obtain a third line therapy, then CLBR’s annual affected person market section is about 1200 folks. If 2/3rds of these find yourself taking Iopofosine at $250k (made up quantity, barely above the median orphan drug, I have not seen administration point out pricing wherever, please right me if they’ve) a bit, that is $200MM in annual income. Moreover, Cellectar is working a Section 2 examine for Iopofosine in sufferers with a number of myeloma (“MM”) and central nervous system lymphoma, plus a Section 1b examine is simply kicking off for pediatric sufferers with mind tumors. In the event that they’re capable of repeat the success in WM, this might change into a a lot bigger income alternative.
Cellectar has a messy and complicated capital construction. In September, they raised capital by way of a personal placement for $24.5MM by promoting Sequence E-1 convertible most popular inventory that converts to inventory at a strike worth of $1.82/share (CLRB presently trades for ~$3.40/share), stapled to the Sequence E-1 prefs have been two tranches of warrants, designed to behave as milestone funds to supply funding for Cellectar put up constructive WM examine outcomes and the second tranche put up FDA approval. The tranche A (train deadline 10 days put up constructive information, or 1/19) has a strike worth of $3.185/share and if totally exercised, will herald $44.1MM to Cellectar. The second tranche, tranche B, has an train worth of $4.7775/share and would herald $34.3MM if CLRB receives FDA approval and the warrants are utterly exercised. This personal placement was designed to be sufficiently big to get the corporate to its industrial part the place it might doubtlessly be self funding. CLRB does have extra warrants, one tranche, the “2022 frequent” is within the cash with a $1.96 strike and expires in 2027, the others are all properly out of the cash and might typically be ignored.
Above is my try on the share depend math and proforma money assuming the tranche A & B warrants are totally exercised (to be extra conservative, you possibly can take extra burn under consideration because the FDA approval trigging the tranche B warrants will not come till someday within the first half of 2025). However I get a present proforma enterprise worth within the mid-$80MMs for a remedy that would do $200+MM in annual gross sales, that appears low cost to me.
Disclosure: I personal shares CLRB
