Read the entire 10-Q yesterday. Gratified to see that the company is prioritizing initiatives that will generate the most strategic value. Just putting all my thoughts in one place:
“The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.” [1] Not one, but multiple combo trials. The company’s willingness to put this in their Q means discussions are advanced. My view is that successful combos can get NW to a $10B+ valuation.
“…buildout of Phase 1B of the Sawston facility, which had been underway since last year, has been completed.” [1] Revenue ramp post approval requires capacity. Confidence.
“Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including optimizing yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.” [1] NW strategic value is driven by two factors. One, the possible use in combination settings, and the associated franchise value enhancement to existing big pharma therapies. Two, the ability to scale significantly and economically. The use of the phrase “optimizing yields” indicates to me that NW has made substantial progress in this important area.
“Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action …. The Company is pursuing further analyses by independent experts, and plans to present further information at an appropriate future conference.” [1] Understanding why a therapy works is as important as trial results showing effectiveness. I’m very interested in what further analyses will be presented.
"The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive." [1] Wish I knew how many are still alive but doubtful that they would write this if it were just a few. Minimum 8-year long tail given last enrollment was in 2015.
The company continues to creatively finance. Finding hundreds of millions of dollars to finance clinical trials is incredibly difficult and the NW team is among the best I’ve seen. It’s a long road yet the base of company supporters (count me among them) -- willing to invest additional funds -- has grown over time. Very good sign.
“We received $4.1 million from issuance of non-dilutive funding agreements during the six months ended June 30, 2023.” [2] “These agreements are accounted for under ASC 470 and are recognized as contingent payment obligations on the Company’s condensed consolidated balance sheet. The Company’s payment obligations only apply when such are received by the Company.” [3] Ergo: These are not convertible into shares (e.g., non-dilutive). Rather they are a derivative of some other economic event or cash flow stream. This minimizes shareholder dilution and better manages the company’s cash flow.
Northwest Biotherapeutics Inc. v. Canaccord, et al. is going better than I would have expected. It’s possible the company will receive a large settlement that will minimize dilution.
[1] pg 26
[2] pg 31
[3] pg 24
AI
