It’s estimated that 90% of retail investors lose money. We help you beat those odds with concise research, education, and more. Click here to see our offerings.
Background
Old News
Latest Developments
Upcoming Catalyst
Technicals/Notes
Background
- A commercial-stage biotech company focused on developing/commercializing cancer treatments in the United States, Europe, and other international markets
- The company’s developmental strategy involves targeting specific subsets of cancer patient populationsÂ
- Lead asset Rubraca = FDA approved for castration-resistant prostate cancer (mCRPC) as well as sub-populations of ovarian, fallopian tube, or primary peritoneal cancer
- Clinical stage assets=  lucitanib and LuFAP-2286 (licensed from 3B pharma) are in P2 and P1 of development, respectively
- Has partnered programs with Bristol-Myer Squibb and investigator-initiated studiesÂ
Old News
- Rubraca became the first drug of its class approved to treat prostate cancer; 5/15/20
- Announced a debt-exchange transaction whereby $65M in debt was exchanged for ~13M shares as well as newly issued 4.5% convertible notes due in 2024;Â 11/5/20
- Shared real-world efficacy/safetyÂ
data for Rubraca in mCRPC patients at a medical conference (ASCO); 2/11/21 - Reported financial results for 4Q/FY20; 2/23/21 Â
- Net rev for 4Q20 exceeded $43M (+10% YoY)
- Net rev for FY20 exceeded $164M (+15% YoY)
- Net loss for FY20= $369M
- Ended 2020 with over $240M in cash paving an operating runway into 2023
- Reported that the P3 ARIEL4 study hit its primary endpoint of improving progression-free survival in later-line Ovarian cancer compared to chemotherapy; 3/19/21
- This data was met with great enthusiasm prompting a short squeeze that day
- Safety data were consistent with previous studies
Latest Developments
- Announced a $75M ATM-offering facility through J.P. Morgan and BofA Securities; 5/17/21
- Highlighted new data in 4 abstracts presented at a medical conference (ASCO) for Rubraca and/or Lucitanib;Â 6/4/21
- Opened enrollment in its P1/2 study of FAP-2286 in FAP+ cancer patients at its first site (The University of Alabama at Birmingham); 6/23/21
- FAP-2286= the first drug of its class to enter clinical testing
- A retrospective study looking at treatment with FAP-2286 in named-patient use was published in The Journal of Nuclear Medicine; 6/28/21
- Investigators noted high uptake and long retention in primary and metastatic tumors with an acceptable toxicity profile
- The data warranted further investigation
- Appointed Dr. Ronit Simantov to its BOD; 7/12/21
- Dr. Ronit is an industry veteran who served as VP, Oncology Global Medical Affairs at PfizerÂ
- Highlights from 1Q21 earnings; 5/5/21
- Beat expectations causing the stock to rally that day
- Â Product rev for 1Q21= $38M (-~11% YoY and QoQ)
- The decrease in rev was attributed to COVID-19 headwinds
- Maintained US market share despite this impact
- P3 ATHENA data for Rubraca as a first-line maintenance treatment in ovarian cancer is expected in 2H21
- Strong financial position with $190M in cash as of 3/31/21 plus access to additional capital paving a runway well into 2023
- Reduced its operating expenses by $28M compared to 1Q20
- Net loss was still quite high for our liking at $66M during 1Q21
Upcoming Catalyst
- P3 ATHENA data (2H21)
- A potential regulatory filing for Rubraca (2H21)
- Interim P1b/2 combo data of Lucitanib+Opdivo (2H21)
Technicals/Notes
- In the earnings report, investors will be looking to see how impactful COVID-19 continues to be on their commercial operationsÂ
- While the commercial performance to date has been robust, it’s vital that the company continues growing its top and bottom lines (a net loss of $369M in 2020 is huge)
- If the P3 ATHENA data hits the mark the stock price could return to double digits. Conversely, if the data fails to impress the stock will continue to struggle
