Biotech Values

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IFRX IPOs 7.7M* shares @$15—insiders buy 40% of IPO shares:

Good move by insiders as IFRX now trading at $28. Some notes from Leerink...

• IFX-1 for HS is on-track for Ph.IIb trial initiation in 1Q18. Recall, the company recently received FDA clearance for its IND application, which allows IFRX to start in 1Q18 the Ph.IIb clinical trial for its lead program evaluating IFX-1 (anti-C5a antibody) in patients suffering from moderate severe hidradenitis suppurativa (HS). The Ph.IIb trial will be a randomized, double-blind, placebo-controlled, multicenter global study (~50 trial sites), which is expected to enroll ~175 patients (n=35/ cohort) with the aim of assessing the safety/ tolerability and efficacy of IFX-1 in HS patients as measured by the Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 wks of treatment.

Ph.IIa data suggest IFX-1 could be more effective than Humira (adalimumab). Currently, the only FDA approved therapy for moderate-severe HS is ABBV’s Humira. However, previous data showed that ~50% of the targeted moderate-severe HS patients responded in ABBV’s Ph.3 Pioneer I/II clinical trials after 7 weeks of treatment (Humira, n=316; placebo, n=317), illustrating the significant unmet medical need in this highly morbid autoimmune skin condition.

In contrast, Ph.IIa data reported by IFRX showed a 75% response rate (n=9/12) in week 8 and an 83% response rate in week 20 (n=10/12) in refractory moderate-severe HS patients exposed to IFX-1 (see our initiation HERE), even though many of these patients had failed antitumor necrosis factor (TNF) drugs, like Humira, previously. In addition,IFX-1 was also well tolerated with a favorable safety profile (i.e., no adverse events or infusion-related allergic or anaphylactic reactions).

Taken together, we are optimistic that the previously observed efficacy with IFX-1 in HS could present a differentiated product profile in the upcoming Ph.IIb study and beyond.

• IFRX's allure is a novel C5a inhibitor, we currently estimate peak WW sales of ~€2B for IFX-1 in HS. C5a is a prevailing pro inflammatory mediator whose dysregulation results in the moderate-severe progression of HS. IFRX has been able to differentiate itself from other complement inhibitors with IFX-1, a potent and selective first-in-class anti-C5a inhibitor. Physicians have been eager forsuch a compound because it has direct action against neutrophils without dampening other necessary noninflammatory actions of the immune system. Since the patients studied by IFRX thus far have been mostly refractory moderate-severe HS patients, we model penetration solely within this estimated 100,000 population each in the US and Europe (EU). By our estimates, this could generate peak WW sales of ~ €2B by 2030E,but since IFRX is not strictly enrolling refractory moderate-severe HS patients in Ph.IIb, it's possible that IFRX penetrates the first line setting as well.