Here's a summary of what was covered during this morning's teleconference call, provided for those who didn't have the opportunity to participate. Topics are provided in no particular order.
Bulk Production
A considerable increase in demand for TPM has been forecast for 2016/17, coming from both existing and new customers. Expansion of production capacity is expected to be completed in Q3 2016.
Both Greg Moses and Roksan Libinaki are actively looking for new customers.
Animal Trials
Current trial design has been guided by external animal experts and potential partners to ensure that the data generated will be as attractive as possible to prospective partners. Murdoch noted that different jurisdictions being targeted (US and EU) have different requirements.
Oxymorphone Patch
If tesa Labtec successfully resolves the Oxy-M formulation issues it is likely that further tests such as toxicology will need to be completed before an IND can be submitted.
Oxycodone Patch
Results of the current trial are hoped for at the end of this year or early next year. There has been a new burst of interest by prospective partners regarding Oxy-C in anticipation of forthcoming trial results. Murdoch will be attending the JP Morgan partnering conference in the US in January and hopes to have Oxy-C data ready to share at that conference. He also added that he had just received some “encouraging” information that there may now be less than four patients left to recruit in the current trial.
The company has already considered its post-trial direction according to various trial outcome scenarios. Direction after trial failure would be dependent on analysis of data before deciding whether it would be worthwhile to proceed further – was the problem an issue of safety, numbers required for statistical significance etc.? If the trial is a success, advancement of deal negotiation with different partners is expected, but Murdoch cautioned that perspective is needed with respect to timeframes for negotiation, citing the example of Spinifex’s substantial post-Phase 2 deal which took 2 years to negotiate. Trial success would also encourage the company to investigate the Oxy-C patch in another indication.
TPM Injectable
POH’S agreement with Mylan covers both R&D and commercialisation. The company is currently in active discussions with Mylan re the final data required for submission of a drug approval application to the FDA. This is anticipated in the “near future”. Murdoch gave a reminder that FDA approval process takes ~ 12 months from submission before a decision is reached. POH is currently also in discussion with Mylan with respect to identifying other suitable TPM injectable options. Selection is dependent on market attractiveness of the injectable as well as the ability of TPM to optimise/solve problems of the injectable.
Diclofenac Gel
The company has received lots of very positive feedback from those who have tried Voveran TPM gel. The market for diclo gel outside of India remains highly competitive with multiple strength/delivery options. GSK now controls direction of consumer health products and Voltaren gel and has a "different approach" to Novartis.
Australian based trials
Although recruitment may be slower in Australia, it has been chosen for early stage trials for various reasons including its homogenous population. Slow recruitment is primarily the result of the sharp narrowing down of candidate patients due to the need to meet very specific criteria for the trial. Murdoch said that going abroad for such a trial might not necessarily reduce the trial timeline but would likely increase the cost. Guidance on discussions
The company is constantly talking with prospective partners. Murdoch identified three deal stages – initial approach, due diligence and contractual/financial. He said that there are currently a variety of groups at each of those three stages. A number are currently well into due diligence.
Cash Runway
Murdoch stressed his sharp focus on advancing current projects to revenue-generating phase while keeping costs as tight as possible. Having come from big pharma himself, he noted that large companies will always use time/cash pressures to tighten the screws on small companies during deal negotiation.
Definition of Near Term Deals and Low Hanging fruit
Short term means within 12 months. Medium term means within 2+ years. Low hanging fruit refers to lower level of clinical/development risk of a product and its closer proximity to revenue generation. Products using bulk TPM/Vital ET are therefore considered the lowest hanging fruit. The OxyC. patch is said to be entering the territory
BioElixia
The company is still in discussions.
Director buying
The company is aware of strong shareholder sentiment on this issue. In the 5 months that the current Board has been in place, Murdoch said that there has not been an appropriate window for buying. Murdoch said that he will not mandate that directors buy shares in the company. It very much remains in discussion and he stressed that the fact that there has been no buying since the AGM should not be seen as a reflection of directors holding a negative view.
POH Price at posting:
1.4¢ Sentiment: Hold Disclosure: Held
(20min delay)