May 3, 2016 8:59am

After releasing data from ongoing trial and announcing agreements with immunotherapy participants.



NWBO’s data from ongoing follow-up of patients in P1 portion of the DCVax-Direct trial showed 20 of 40 patients have exceeded 12 months overall survival, 13 of 40 patients exceeded 18 months, at least 10 of those 13 patients (with 2 of the 13 currently unknown) are still alive at OS times up to 29 months to date, with majority having exceeded 20 months

Reached “conceptual agreements” involving leading participants in immunotherapy field with three different sets of parties, in regard to three different combination treatments, for three different cancers in three different P2 trials

Is establishing Scientific Advisory Board, reached agreement with initial members of SAB, including experts in immunotherapy, oncology from both US and Europe; initial members in process of completing internal institutional approvals …


The Bottom Line: As I mentioned in last night’s post, NWBO Is in talks with Nasdaq Staff about two potential approaches to remedy non-compliance on some stock issuances:

  • NWBO received a letter from the staff of The NASDAQ Stock Market LLC indicating that they had reviewed certain stock issuances by NWBO to Cognate BioServices and determined that those issuances did not comply with Nasdaq Rules.
  • Certain stock issuances by NWBO to Cognate during 2015 and 2014 should be aggregated for purposes of applying NASDAQ rules, and that the aggregate total of the stock issuances in 2015 and 2014 should be measured against NWBO's stock outstanding in January 2014. The Letter further indicated that when the aggregated 2015 and 2014 stock issuances were measured against the stock outstanding in January 2014, the issuances exceeded 20% of NWBO's common stock outstanding in January 2014 before the issuances.
  • Although the shares issued to Cognate were unregistered, non-tradable shares, and were also subject to multi-year vesting and lock-up restrictions (and an independent economic analysis by a major firm determined that the actual value of the shares was far lower), the applicable price per share for purposes of the Nasdaq rules is the market price of tradable shares. Some of NWBO's issuances to Cognate were below the market prices, and the most favored nation adjustments also resulted in issuances below the market prices.
  • NASDAQ rule 5635(d) requires that a company obtain shareholder approval prior to the issuance, in a transaction not involving a public offering, of common shares or securities exercisable for common shares equal to 20% or more of the common shares outstanding before the issuance for less than the greater of book or market value. The Nasdaq Staff determined that the aggregated issuances by NWBO to Cognate were … not in compliance with this rule.

NWBO closed at $1.34 and is trading UP +$0.05 to $1.39 after the pre-open +$0.20 or +14.93% to $1.54