- 2018-05-02 RELISTOR® Injection Protected from Generic Competition Until 2024
- 2018-06-26 Completes Enrollment of Phase 2/3 Clinical Trial of PSMA-Targeted PET/CT Imaging Agent PyL™ in Prostate Cancer
-- 4Q18 P2/3 Data & Initiate 2nd P3
- 2018-07-30 FDA Approval for AZEDRA
- 2018-08-10 Closing Offering 9M @ $8.25/sh w/o Warrants!
-- Not even used any Warrants nor discount to lure investors in
- 2018-09-12 Ph3 Trial of 1404 failed 1 of 2 co-primary endpoints
- 2018-09-14 New Company Presentation Slides
- 2018-09-17 Addition of AZEDRA to NCCN Guidelines
-- The first and only FDA approved treatment of patients 12 and older with iobenguane scan positive, locally unresectable and metastatic pheochromocytoma or paraganglioma.
+++
Cash position now around $80M + $70M from offering = $150M,
maybe reduce $20M max for 3Q18 -> $130M
Liabilities Current $14.75M, Total $80M
Debt Current $5M, Total $48M
+++
Pipeline
Azedra Economics, having ODD
- US population 350M: 2-8 per million, leading to 700 - 2800 pts
- Addressable 15% 105 - 420 pts, up to 35% 245 - 980 pts.
- Plus recurrence of additional 16% 112 - 448 pts.
- Total min 217 - 1428 pts, 822 pts avg
"$147,000 for one therapeutic dose, bringing the total cost of treatment to just under $300,000", see https://www.fiercepharma.com/pharma/progenics-snags-fda-nod-for-300k-cancer-fighter-azedra
20% discounted WAC (2x $147k) = $235k per treatment:
- $51M for 217 pts - $336M for 1428 pts, $193M for 822 pts avg
This range matches well with w/ http://rjhealthsystems.com/2018/08/17/azedra-progenics-pharmaceuticals-inc-fda-approval-for-rare-tumors-of-the-adrenal-gland/
Catalysts
- Azedra Sales
- PyL ph2/3 data, initiated 2nd ph3
- PSMA-TTC ph1 by year-end (Bayer)
- PSMA-CADx Using 1404 data to develop & validate
Also
- Selling Azedra Ex-US Rights?
- Some rumors about selling Relistor to licensing partner?
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