- Despite repeatedly telling investors that it would file for approval, Nymox has never filed a marketing application in the US and withdrew the application it filed in Europe.
- Nymox has most recently claimed it would file for approval in 1H20 but we are skeptical.
- Resume of former employee validates concerns: we believe NYMX was never close to filing an NDA or an adequate MAA, and will likely be unable to file anytime soon.
Nymox Corp (NASDAQ: NYMX) has been developing NX-1207 for the treatment of benign prostatic hyperplasia (BPH) for the last 20 years. In 2014, two pivotal Phase III trials missed their primary endpoint. Instead of conducting another set of trials in consultation with the FDA and EMA, Nymox has pursued tangents for the last 5 years – reporting data from long-term extension studies (extremely unlikely to be accepted by FDA as adequate evidence of efficacy), and claiming that approval filings would be made in near future all while raising ~$35M through private placements.
Management Responds to Our Questions with Identical Talking Points
We presented our concerns and questions to Nymox CFO Erik Danielsen twice. During our first conversation in early 2019, Danielsen told us that Nymox was busy working alongside experts on the large and complex tasks involved with filing an NDA and MAA. When asked why Nymox had repeatedly missed its filing timelines in the past, he told us this should be expected since Nymox was a small company and that regulatory filings shouldn’t be rushed. We asked why Nymox has only ever done private placements and he answered by describing a recent conversation he had with a banker:
“I just got off the phone with a Wall Street banker who wanted to raise money for us. We have bankers calling us all the time. He proposed a deal with 100% warrant coverage. We said no. We’d rather raise money with our loyal shareholders.”
He told us Nymox shares were a great value since other biotechs that have completed Phase III trials in large indications were worth “billions of dollars.”
When we next spoke with him last month he again told us of a recent (“an hour ago”) conversation with a banker who proposed a 100% warrant coverage secondary offering. He also repeated the excuses for missing filing guidance and again said that Nymox was working with experts and shares were cheap when compared with other biotechs that have completed Phase III trials.
Danielsen’s identical talking points only added to our suspicion that Nymox was not being completely transparent with investors about the true regulatory status of NX-1207, but we lacked compelling direct evidence – until now.
New Evidence: Employee Resume
We recently found an employee resume that we believe substantiates concerns about Nymox’s claims. Below is an excerpt:
Several things should be very concerning to Nymox investors:
- This temporary employee was apparently the only person in Clinical Operations, and they were only employed for six months. This during a time when Nymox claimed it was working on an NDA, and years after Nymox claimed it filed for decentralized approval in Europe.
- The employee was tasked with creating an electronic Trial Master File (eTMF) “from scratch”. A TMF is defined by the European Medicines Agency as a “collection of essential documents that facilitates the conduct and management of the clinical trial and allows that the integrity of the trial data and the compliance of the trial with GCP can be evaluated.” It’s explicitly required by the EMA as part of a marketing application. More background on TMFs can be found here. The FDA requires healthcare companies to maintain compliance with standards set by the International Conference on Harmonization Good Clinical Practice (ICH GCP), in which there is an expectation of maintaining a TMF. From FDA guidance: “Trial master files should be established at the beginning of a trial, both at the investigator’s site and at the sponsor’s office.” The FDA further recommends, “Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region…”
- The employee notes that 11 years of trial records were “contained in storage boxes with no organization.” Recall this was 16 months after Nymox claimed it filed for approval in five European countries. Were these applications actually filed? If so, a TMF would have already been built and the trial records would have already been organized. The only evidence of the European filing is a May 2017 Nymox press release and a September 2017 press release announcing its validation. We’ve presented Nymox with our findings and asked for corroborating evidence of a European filing but as of publication haven’t received a response.
- In July 2018, Nymox said in a press release it “expects to file for approval in the US later in 2018.” It’s difficult to reconcile this statement if records sat unorganized in storage boxes and management only hired someone – a single person – in September 2018 to create a TMF. Nymox management next updated investors in October 2018, when it said “preparatory work for regulatory filings on track.” We asked Nymox to comment on these inconsistencies but have yet to receive a response.
- The employee notes creating a TMF “from scratch” with “intent of filing an NDA in the future”. It’s curious an MAA isn’t mentioned. Not only is it unsettling that Nymox didn’t have a TMF in place and hadn’t even begun the process of assembling one before this person was hired, it’s also concerning that the only apparent person in Clinical Operations – the only employee creating the TMF – doesn’t mention an MAA.
- The employee worked in the “Quality Assurance” office Nymox opened in Irvine, CA in August 2018. The person who answers the phone at Nymox’s Montreal office gave us a number to the Irvine office which we have called multiple times. Nobody has ever answered, and the number doesn’t go to voicemail.
We’ve reached out to the employee in case they were willing to discuss their experience at Nymox but haven’t heard back.
This Time Is Different?
Nymox’s last private placement was done 13 months ago. This is the longest period of time Nymox has gone without selling new shares since 2003. And Nymox’s largest benefactor, 84-year old movie producer James Robinson, was a consistent buyer of private placement and open market shares but hasn’t bought any stock since July 2019. Taken together with Nymox now guiding towards US and EU filings in 1H20, we believe the larger investors have signaled an unwillingness to provide further funding until Nymox files.
At the same time, we believe this guidance has caused the stock to more than double off of its 4Q19 lows. Shareholders should ask themselves why this time would be any different, especially when the only employee involved in putting together a basic component of a regulatory filing describes an operation likely nowhere near filing and in any case incapable of producing an adequate one.