Geron Corp. (GERN 6.46%), a small-cap cancer company, released its fourth-quarter and full-year earnings after the bell last Friday. While earnings for developmental-stage biotechs like Geron are generally meaningless, the company did update investors on the progress of the collaboration with Johnson & Johnson's (JNJ -0.46%) biotech subsidiary Janssen. The two companies are presently developing the first-in-class telomerase inhibitor, imetelstat, for a basket of blood-based cancers.
Oddly enough, though, Geron decided to bury the most important of these clinical updates deep in the press release, and it also left out another major regulatory update altogether.
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Burying the lede
Turning to the specifics, Geron noted -- two-thirds of the way through the press release -- that imetelstat's mid-stage myelofibrosis (MF) trial in patients that are relapsed or refractory to Incyte's (INCY 0.98%) JAK1/2 inhibitor, Jakafi (ruxolitinib), had not yet reached the median overall survival rate at a "median follow up of approximately 19 months," per a January cut-off date.
That extremely encouraging update should have been front and center in the press release, as the prognosis for patients that discontinue Incyte's ruxolitinib is exceptionally poor. One recent study, for instance, noted that median overall survival rate for this patient population came in at a mere 14 months. So, imetelstat appears to be in unprecedented territory for advanced MF in terms of overall survival, although other confounding factors could admittedly be contributing to this elongated survival curve in a significant manner as well.
Geron also decided to skip over a key regulatory issue in the press release. Per the company's latest 10-K filed with the SEC:
In October 2017, Janssen submitted to the FDA data from the aforementioned internal reviews, as well as additional efficacy and safety data, including information about deaths and overall survival in IMbark, in response to an FDA information request regarding the benefit-risk profile of imetelstat in relapsed or refractory MF and justification for continued treatment of patients enrolled in the trial. Since that submission, the FDA has not requested any additional information regarding IMbark, nor has the FDA requested any changes to the trial.
Given that the short interest in Geron's shares has risen significantly since this potentially game-ending news first hit the wires in late 2017, I find it rather perplexing that the company didn't highlight or even mention the Food and Drug Administration's lack of a response in its Q4 press release.
Why should investors care?
Taken together, these two issues, if featured prominently in the press release, would have probably propelled Geron's shares upwards in a big way in after-hours trading on Friday. Geron's collaboration with J&J, after all, is entirely dependent on the outcome of imetelstat's MF trial known as IMbark, and things seem to be trending in the right direction.
So why did Geron decide to play it safe and forgo a possible double-digit bump to its valuation? My guess (and it's purely a guess) is that J&J is not being particularly transparent with Geron about their views toward imetelstat's progress to date.
If Geron's management, for instance, felt confident that J&J was, in fact, pleased with the progress so far, then they probably wouldn't have put out such a tepid press release that literally glossed over the most critical clinical developments over the last six months. Something doesn't add up here.
Red flags?
On the bright side, there are myriad reasons why J&J might be playing it close to the chest -- even with their development partner. Leaks can and do happen in pharma all the time, and MF is a highly coveted indication that's receiving a fair amount of attention right now.
So, I think the real take home point here is that even Geron doesn't seem to know what comes next in regards to J&J's plans. The biotech, after all, didn't do any favors for its long-suffering shareholders by issuing a bland earnings release after the market close on Friday.
I could be wrong and Monday's scheduled conference call could be a major surprise, but this earnings release appears to indicate that Geron won't know all that much until IMbark officially wraps up later this year.
