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Biotech / Medical : Infinity Pharmaceuticals Inc (INFI)
INFI 0.0160-4.8%Sep 29 5:00 PM EST

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From: dan.rosengold9/10/2013 6:59:30 AM
   of 19
 
Morgan Stanley Presentation (CEO+CFO)




IFI-145

· CLL: ASCO response rate after 7 cycles comparable to ibrutinib (PCYC/JNJ) after 11 cycles.

· CLL: updated data ; see if some of the nodal responses turned into partial response (nodal: 50% or more tumor shrinkage but lack of at least one supportive data; usually many nodal turns into partial response)

· CLL: Watch if there are complete responses comparable to ibrutinib at that stage (so far none; very few on ibrutinib)

· CLL: Since they already know the results and from their tone, I’m expecting strong results; comparable or better than ibrutinib.

· CLL: Infection is very common in the very heavily patients. No infection in naïve patients; Thus, infection is disease related and not drug related; No infection in iNHL too. Infections were concentrated at one site, which did not add mandatory antibiotics; now all sites do. Overall, and the Analyst agreed, side effects are pretty similar among INFI, PCYC and GILD drug.

· CLL: 25mg was as good as 75mg; needed to rush trials and not wait for the 75mg full phase 1; If 75mg is tested and people know 25mg is working as well, they can cut the pill; not good from commercial aspect.

· CLL: Phase 3 opens in Q4; ibrutinib will likely be approved by end of Q4; INFI will enroll many patients outside the USA.

· iNHL: Robust results so far; Much better than GILD; in ASH more data but started the pivotal phase 2 trials already, and do not expect ASH to have something different from what we have been seeing so far.

· Inflammation: Phase 2a results in mild Asthma soon; if good, will consider phase 2b with IFI 145 or use the new IFI-443 as next trial will be for moderate to severe patients.

· Inflammation: Large phase 2 in RA is recruiting; results by late 2014; if good will advance to phase 3 and will seek partner.



HCI-Lung cancer

· Robust phase 2 ended; awaiting results; if good will move to pivotal phase 3.



Impression

· Seems confident. If results are known to them already , It looks like:

a) We are going to see strong CLL results at ASH for IPI-145

b) Asthma: will proceeds with IFI-443

c) HCI- results could be better than current street expectations; mentioned robust trial and moving immediately to phase 3, several times.



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