Decoding ORR: What RECIST v1.1 Means for Investors
Investors will often see ORR quoted or displayed for oncology clinical trial results for solid tumors Here's what the CRs/PRs/SDs mean at a high level These are assessed on scans I'm using RECIST v1.1 definitions #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/eZb86TcoLL
Plan Biotech Catalysts Ahead to Capture Stock Moves
Investors should know WHAT will move a stock and WHEN, especially in biotech with the outsized moves. Build your catalyst calendar ahead of time. You won't have time to thoughtfully analyze the data when it hits #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/2RGMVrR2lG
Know the FDA Process: Key to Biotech Investing
Investors should understand the #FDA regulatory process well. Here is a quick summary At each step investors should ask themselves if the company is developing things in a way that will satisfy the FDA Until a drug is approved the FDA is...
Probability of Success Integrates Development Risk Into Biotech Valuations
Incorporating Probability of Success (PoS) is a unique aspect of #biotech valuation investors must be aware of. It tries to factor development risk into revenue and cost assumptions. Here is a table of PoS values: #learnbiotechinvesting #investing #BiotechPrometheus https://t.co/GA3LVSmWFZ
Consider Fully Diluted Shares for True Market Cap
Investors should look at fully diluted shares outstanding #FDSO when looking at the market cap of a company. Dilutive securities, including options, warrants, converts, etc, can have a meaningful impact on the actual market cap of a company #learnbiotechinvesting #biotech #investing...
Assess Management Reputation to Uncover Hidden Risks
A key variable for investors is management reputation A lot that happens inside a company that is critical for success is outside of public view Investors must ask themselves if they believe management is giving an accurate assessment, both good &...
Probability‑Adjusted DCF: Essential Tool for Valuing Pre‑Profit Biotechs
When thinking about valuing #biotechs, especially those which are not yet profitable, a probability adjusted discounted cash flow model is perhaps the most important methodology Though it too has drawbacks #DCF #PoS #learnbiotechinvesting #investing #BiotechPrometheus https://t.co/1sfTMkZ6kO
Black‑Box Warnings Can Slash Drug Revenues—Investors Beware
Approved drugs can have a "black box" (aka boxed) warning, the highest safety-related warning that FDA can put on an approved drug Usually applied to multiple drugs in the same class it can hamper revenue potential if alternatives exist Investors should be...
Biotech Gains as Pharma Approval Success Diverges
Pharma has varying levels of success developing drugs. That's a boon for biotech Here are the biopharma companies ranked by likelihood of first approval (LoA%) from 2006-2022 $AMGN, $NVO, #Eisai top the list $GSK, #Astellas, $ABBV are at the bottom #learnbiotechinvesting #BiotechPrometheus
Understanding ORR and RECIST v1.1 Response Metrics
Investors will often see ORR quoted or displayed for oncology clinical trial results for solid tumors Here's what the CRs/PRs/SDs mean at a high level These are assessed on scans I'm using RECIST v1.1 definitions #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/1YAoHGXujW
Accelerated & Breakthrough Save Time; Fast Track Doesn't
How much time do FDA expedited designations save? Accelerated approval and Breakthrough status save a statistically significant amount of time. But Fast track does not Investors should keep this in mind #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/tmxBBt7Izi
Biotech Pre‑funded Warrants Raise Cash, Delay Dilution
Since most biotechs aren't profitable they often use warrants (including pre-funded) to raise capital while mitigating short term dilution But what is a warrant and what are their implications? #learnbiotechinvesting #biotech #investing #BiotechPrometheus A warrant is a security that gives the...
Plan Biotech Catalysts Early to Capture Stock Moves
Investors should know WHAT will move a stock and WHEN, especially in biotech with the outsized moves. Build your catalyst calendar ahead of time. You won't have time to thoughtfully analyze the data when it hits #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/iFc6oc4jll
Oncology M&A: Early‑Stage Deals Still Command Higher Multiples
In #oncology #M&A higher 5-yr forward revenue multiples occur for earlier stage companies, though P3 is an exception Recently multiples have declined reflecting lower valuations, later stage acquisitions, and smaller market opportunities What are some other reasons? #learnbiotechinvesting #biotech #investing #BiotechPrometheus
Phase 3 Data More Reliable; P2 Placebos Often Variable
Another reason a P3 study can fail while a P2 was successful is that P2 placebo groups, with narrower eligibility criteria & fewer patients, often have more variable placebo-adjusted effects Use Phase 3 data, often on drug labels, to make comparisons;...
