Here are some notes on anticipated news for Immune Pharmaceuticals (OTCQB:IMNP).
April 4: deadline to announce reverse split. Nasdaq is requiring IMNP to reverse split by April 14 in order to regain minimum bid compliance by May 1. IMNP shareholders authorized IMNP's board to reverse split in a range of 1-for-2 to 1-for-25 with a requirement that IMNP announce the reverse split 10 days before the reverse split takes effect.
Partnership Updates: AmiKet and Ceplene
March (estimate): IMNP has mentioned "ongoing business events" in conjunction with regaining Nasdaq compliance and has guided to news of partnerships in the near-term. Watch to see the track records of partnering companies and the amounts of upfront cash. Also watch for timelines for starting phase 3 trials and for taking subsidiaries public. AmiKet deal terms were announced in May 2016 but the deal has not been finalized. Under the AmiKet deal terms IMNP will receive cash as reimbursement for development expenses.
IMNP Annual Report
March 31: deadline for IMNP's 10-K for 2016. This will provide an update on IMNP's cash and recent dilution. An automatic 15-day extension is available but would risk being perceived as negative.
April (estimate): On February 3 IMNP announced $3 million in financing. If IMNP has been using $1 million per month then new financing would be needed in the April or May time frame.
Ulcerative Colitis Trial Updates
April (estimate): The clinicaltrials.gov record for IMNP's phase 2a ulcerative colitis trial previously had an estimated primary completion date of October 2016. On October 20, 2016, this estimated date was changed to April 2017. In a November 1, 2016, YouTube video the IMNP CMO said, "We're on track to complete the studies as planned and complete enrollment by the end of this year." It's pretty clear that an update is due soon for the ulcerative colitis trial. Completing the trial in April would be a good sign. Another delay would be negative.
Dupilumab FDA Decision
March 29: deadline for FDA's decision on dupilumab (from Regeneron and Sanofi) to treat moderate to severe atopic dermatitis. IMNP has said it plans to start a phase 2 trial this year using bertilimumab (an infusion) in moderate to severe atopic dermatitis. Dupilumab (an injection) would be competition in that space. Another risk for IMNP: if approved, dupilumab might be used off-label to treat bullous pemphigoid.
Competition for Bertilimumab in Bullous Pemphigoid
Unknown timing: A phase 2 trial using mepolizumab to treat bullous pemphigoid patients was completed in January. Results could be announced at any time and impact IMNP.
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