- Myrexis reported 4th fiscal quarter and full year (end 6/30/11) results on 9/8/11 - click here for PR.
- Additional details on the company and pipeline can be found on the MYRX research page.
- My notes from 6/30 quarterly conference calls of other biotech and pharmaceutical companies can be found on the Past Events page.
- Keep reading below for my complete notes:
- Chairman on Lollini - we were planning to look at external candidates, but he "quickly emerged as an effective CEO at a time when MYRX needed effective leadership." New CEO mentioned "shareholders" more in two paragraphs than in all previous calls combined by old CEO it seemed. But said "longterm" business strategy, so I don't see an "exploration of strategic alternatives"
- The company reviewed all of its clinical/preclinical programs in fiscal 4q2011. Review committee consisted of independent directors plus internal/external resources
- We are not actively exploring in-licensing opportunities/acquisitions at this time [aka, we will not have another JAV-like debacle]
- Next step - align resources with development objectives [aka, more layoffs in addition to those done in March 2011]
- Strategic decision to suspend any further development of Azixa- not based on any single factor - mentioned more advanced competitors. Completing the ongoing phase 2b trial would require disproportional commitment of time and resources vs its likelihood of technical and regulatory success compared other programs in the objective of building value for shareholders
- We will direct resources to HSP90, nampt, and IKKe programs - these need less investment, and collectively offer great opportunity for shareholders
- MPC-3100/MPC-0767 HSP90 inhibitors block the process by which cells tolerate the presence of oncoproteins
- MPC-9528/MPC-8640 cancer metabolism inhibitors
- oral anti-interferon - IKK epsilon inhibitors for autoimmune diseases
- We will advance these programs thru development by building value and partnering as appropriate. We have all worldwide rights to each program [This was not true of Azixa, licensed from Epicept]
- MPC-3100 - unique structure, very specific binding to HSP90. Preclinical efficacy against all solid and hematologic tumors studied, with results as good or better than the standard of care comparators used
- We recently completed a 26 patient single and multiple ascending dose phase 1 trial, will report results 4q2011. We were able to treat with continuous daily dosing. Saw good oral absorption and PK, well tolerated with low side effect burden [It is a bit of a red flag to me that the trial is done and no top-line readout was provided with this PR...I suspect a lack of or minimal efficacy signal]
- We have initiated IND-enabling studies on MPC-0767, an alanine produg of MPC-3100 - enhanced solubility, easier to formulate. MPC-3100 is only detecbale plasma metabolite. We plan to move quickly into single phase 1 relative bioavailability study in healthy volunteers in 1q2012, and we have discussed this plan with FDA [this is new, as of last update the meeting had yet to take place]
- We are now trying to identify optimal cancer indications and combo regimens to advance one or both of these in clinical development. Also now exploring combinations with targeted agents that are in devleopment but not yet approved
- CMI - multiple compounds that have flexible dosing and encouraging results across multiple tumor types, have seen synergy in combination with DNA-damaging and other agents. Mentioned CRC
- 6/2011 - addl data presented for MPC-9528 and structurally disinct inhibitors. These offer oral administration, dramatic tumor regression in animals with multiple cancer types.
- MPC-8640 is prodrug of MPC-9528 - IND-enalbing studies ongoing, has improved solubiity and PK properties
- We are also exploring simple companion diagnostics to use with these cancer metabolism inhibitor compounds
- We have developed an extensive portfolio of IKKe potent/selective inhibitors.
- Our objective is to devleop compounds for RA, SLE, psoriasis
- 4/2011 presented data from a lead compound
- We hope to identify one or more potenial IND candidates. Currently conducting preclinical studies with multiple molecules/diseases.
- Management will assess resources to ensure alignmment with objectives.
- Financial summary from newly promoted CFO (ne CEO was former CFO):
- Net cash used $33.6m for fy2011 vs $40m fy2010
- 6/30/2011 had $115.9m cash balance
- F4q r&d expenses were $3.6m down from $6.9m F4q2010
- FY2011 R&D expenses of $22.3m down 21% y/y
- We expect R&D expenses will fluctuate over the next few years. Expect decreased development expenses due to 3/2011 restructuring.
- We believe we have adequate funds for current and planned operations thru at least 6/30/2014 without new cash inflows from partnering, etc [added one year to cash runway guidance by killing Azixa program]
1) Azixa suspension - effect on operating burn going forward? Quarterly burn was $7-8m. It is hard to predict going forward due to uncertainty of timing and cost of clinical trials. Spend might decline a bit from projections in near quarters. But will be spending acceleration in other programs.
Azixa phase 2b costs were estimated at $12m or so. - some of this savings may be offset by increased spend on other programs
Seems like a less immediate effort to partner assets? specifically CMI and OAI? um, Yes. Partnering remains key element. We will continue to engage in discussions about all of our programs. But we want to advance them thru development to build value and then will partner as appropriate.
Azixa- will you be returning rights to Epicept? We continue to believe it has promise and that a trial in newly-diagnosed glioblastoma (GBM) has potential to demonstrate therapeutic benefit. We will try to find an opportunity to move the program forward thru cooperative development or partnering. At the present time don't expect to see any reversion of rights. [Don't hold your breath on a new partner. I wonder how long MYRX can dither around with Azixa before contractually have to give it back?]
HSP90 inhibitor program. You mentioned a phase 2 combo study with agent not yet approved. But there are two recently approved targeted BRAF and ALK inhibitors - will you pursue this? That is certianly something we will be looking at.
Is a combo with JAK2 re myeloproliferative diseases still on table? Yes [don't recall when this had bene publicly discussed before...]
So the pre-IND meeting re prodrug MPC-0767 has occurred? Yes it did
Guidance on timeline for the start of HSP90 phase 2 combo study? Probably mid-year 2012
Cancer metabolism inhibitor program- will you file an IND regardless of partnering? Yes.
2) More detail on strategy for hsp90 prodrug? One key challenge w/ MPC-3100 was pill burden/formulation. Prodrug allows dramatically reduced burden for equivalent dose, and is more commercially viable. Same active compound, don't expect any diference in PK or toxicity or efficacy profile