It’s only Tuesday, and we’ve already seen a number of small cap biotech companies soar on better than expected trial data. GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) is up more than 120% after meeting its primary endpoint in a CBD epilepsy trial, and Celator Pharmaceuticals Inc (NASDAQ:CPXX) sits 355% higher premarket than it did at the Monday close, on positive phase III topline in an acute myeloid leukemia indication. Here are two more small cap biotechs with near term catalysts that could be the next triple digit gainers in the space.
First up, Minerva Neurosciences Inc (NASDAQ:NERV). This one just announced its fourth quarter, 2015, and full year financials – neither of which came out as particularly inspiring. A loss across both periods is hardly representative of the company’s longer term potential, however, and markets seem to recognize this – it’s up close to 4% across Monday’s session. Why did it make this list? Because alongside its financials, Minerva alos noted a couple of key, near term data releases that could see it pick up a boost to its market capitalization if the data comes out positive.
The first is a phase IIa trial in major depressive disorder. The drug is an antagonist of two receptors – 5-HT1A and 5-HTT – that are key to the neurological impact of mood altering depression, and also serves to antagonize (and in turn, both facilitate and increase the level of) serotonin and dopamine reuptake. It’s early days, but phase I and preclinical suggested both tolerability and a certain level of efficacy, so a reiteration of both of these qualities in the ongoing phase IIa should give the company a running start as it moves into late stage development and a potential pivotal initiation before the close of the year.
Minerva expects to report topline from the IIa during the second quarter of the year, so keep an eye on its reports between April-June for insight into the drug’s performance.
The company has also stated it expects near term data from a second phase II trial, tis time a phase IIb, in its lead candidate – MIN-101 in a schizophrenia indication. This one’s a twelve-week evaluation period that just completed a 244 patient enrollment panel, with primary endpoint of evaluating efficacy at various dosing regimens. Schizophrenia is a notoriously difficult condition in which to demonstrate consistent and – more importantly – replicable – results, so a solid efficacy readout could be a big boost for Minerva going forward, and would pave the way for a solid phase III, or a potential NDA based on the IIb data (if it’s strong enough). This one’s also scheduled for topline release during the second quarter of this year, meaning the period could be a big one for Minerva and its shareholders. One to watch.
Next up, BioSpecifics Technologies Corp. (NASDAQ:BSTC). Just as with Minerva, BioSpecifics just reported its fourth quarter financials, but in this instance, the company posted a profit across the period. Again, however, that’s secondary to the concurrent update it gave regarding its ongoing operations – specifically, a data release for a phase II in its lead pipeline candidate, XIAFLEX, in a human lipoma indication. Human lipomas are essentially benign tumors that lead to lumps in a patient’s skin, which form as the result of over-proliferation of fat cells. Physicians will generally recommend removal, as they have the potential to become cancerous if left unattended.
If topline comes out positive, healthcare incumbent Endo International plc – Ordinary Shares (NASDAQ:ENDP) has an option to pick up the continued development of the drug, so keep an eye on how this plays out for further upside potential.
Just as with the Minerva data, BioSpecifics expects to put out topline from the phase II during the second quarter of 2016, so look for an April-June release to serve as an upside catalyst if the drug can meet its primary endpoint of lipase reduction.
Secondaries of safety and efficacy will also come in to play, as will an ongoing trial of the same drug in a canine lipoma indication – essentially the same trial, same administration, but for the same condition in dogs. The aforementioned Endo has full control over the canine trial, but any success will likely filter through to BioSpecifics’ market capitalization as collateral exposure.