Trimel Pharmaceuticals Funding ahead of key drivers in H114
CompleoTRT dose and PDUFA date clarified
Trimel decided, following discussions with FDA officials, to focus its CompleoTRT (a testosterone replacement therapy) regulatory submission on a three-times daily (TID) dosing schedule. FDA officials had raised questions over the drug’s ability to normalise testosterone in a Phase III study (n=306) when used twice-daily (BID), whereas the TID data were more robust. This pushed the PDUFA target action date back to 28 May 2014 (from 28 February), but in our view improves the product’s likelihood of gaining approval. While a TID label could affect convenience vs current topical TR products (generally dosed once-daily), once CompleoTRT is approved, a process to extend the label to BID dosing could be initiated.
Out-licensing deal likely to hinge on FDA decision
Added clarity on the CompleoTRT approval strategy should improve Trimel’s prospects in partnering discussions, although we believe a transaction is more likely to occur after FDA approval (given de-risking benefits for a potential licensee).
Tefina ambulatory study results in late Q214
Trimel recently completed recruitment for the 240-patient, 84-day Tefina ambulatory Phase II study in anorgasmia/female orgasmic disorder (FOD). Positive results in Q214 could lead to partnership discussions and future trials. While there is little clarity on acceptable FDA endpoints for FOD, the FDA’s recent guidance to Sprout Pharmaceuticals for a re-submission of a previously rejected FSD drug candidate, flibanserin, signals a potentially more flexible stance by the regulator on FSD drugs.
Valuation: Recovering EV of C$101m
Trimel’s shares have now recovered the losses suffered in October 2013 when the FDA queried the CompleoTRT NDA. We estimate that after the capital raise and a US$4.25m payment to M&P Patent to settle their legal disputes, current net cash (pro forma) is ~US$17.5m. This should be sufficient to fund operations into Q414, and provide the flexibility to assess different out-licensing options for CompleoTRT.
Trimel is raising C$10.5m in equity (C$0.711/share) following an 80% share price gain since the US regulatory pathway for CompleoTRT was resolved and agreement disputes with M&P were settled. Further potential returns in H114 will be geared towards the results of the Tefina Phase II ambulatory trial (Q214) and the FDA’s decision (PDUFA date 28 May) on CompleoTRT.
12/11 0.0 (26.01) (0.39) 0.0
12/12 0.0 (28.13) (0.32) 0.0
12/13e 0.0 (28.60) (0.23) 0.0
12/14e 5.12 (21.13) (0.08) 0.0
Source: Bloomberg. Note: *Does not reflect February 2014 private placement.