Last 10Q listed only $12.5M cash
"Our quarterly cash for burn has been approximately $2 to $4 million per quarter in fiscal 2015 and for the first three quarters of fiscal 2016 and we expect our cash burn to increase the remainder of fiscal 2016 in connection with the continued enrollment of patients in Phase III program and the ongoing development of our sustained release platform technology. The Company does not have a bank line of credit or other fixed source of capital reserves. Should it need additional capital in the future, the Company will be primarily reliant upon private or public placement of its equity or debt securities, or a transaction with a pharmaceutical partner"
At $6M/Q they run out of cash end Q4. The deal has been "ongoing" for over a year. That is longer than usual, even for a major deal, but not unheard of. A "quiet" change in 1501 which everyone knows is a validation study for Phase 3 design doesn't have full results until 2017. Why the change? Why hide the change at a CC only to report it the next day in a 10Q? Why not report on the results vs Lucentis which are already done? It might be demanded from a partner to derisk Phase 3 before they invest.
They can't run Phase 3 with no cash and cash runs out before 1501 validation. Therefore dilution, even at these levels, is extremely possible. That was the primary cause for the recent downgrade.
Of course yet another 10% drop isn't a reason to celebrate. As stated in the other thread, I view it as neutral. The ONLY thing that matters is POSITIVE FDA GUIDANCE. That doesn't mean it's cleared for BLA filing. It could mean (and may likely be the case) that yet another Phase III is needed. It's only smart to take financing ahead of that decision.
No one knows what the FDA will decide. I described similar subgroup submissions in prior posts. It is important to remember that Ampion has helped many patients where ALL PRIOR TREATMENTS FAILED or had serious side effects. Unfortunately, that is not statistically significant, but it IS a factor in FDA decisions.
It will be interesting to find out who bought in and how much biotech experience they have. I am assuming that the meeting has not yet happened (per 3-day SEC reporting rule).
Hand trial is Phase 1, 4wk primary on safety only. They did not list any pain measure as 2ndary. At 4wks it couldn't beat saline anyway (see PLoS One plot).
Depressing at first glance, but we knew money had to be raised, regardless of FDA guidance. However, one would think it would be easier if guidance was positive. As I read it, an institutional investor has already signed on. They do significant due diligence, therefore think the stock is undervalued and a reasonable risk.
Monday could be bad. PR's released on Friday after market close are almost always bad news. Since the money will keep them alive and is used to fund a new (but very small) Phase 2, there is and will be NO buyout for the near term. The drug works, but it will be another year before news.
This is a small trial, but it's clear that even after eliminating R&D they are continuing R&D w/o a partner. The stock will probably get killed as hope of a quick return are now completely gone.
With the proceeds from the offering, the Company plans to conduct a second Phase 2 clinical trial of topsalysin for the treatment of localized prostate cancer. Consistent with its recently completed proof of concept trial, this new trial will utilize previously obtained MRI images of a patient's prostate mapped to real time 3D ultrasound to target the delivery of topsalysin directly into and around a pre-identified clinically significant tumor. The primary objectives of the trial will be safety and tolerability of topsalysin when used to focally treat a targeted clinically significant tumor with potential efficacy assessed by targeted biopsy of the treated area, six months after treatment. The Company expects that this clinical trial will enroll approximately 40 patients at two or more trial sites and the Company is exploring potential trial sites in the United States. The Company expects to have six month biopsy data from the trial in the second half of 2017.
Also noted that OrthoTrophix just started a 2nd Phase 2 with multiple dosing (4 shots/wk for 4 wks!). It only included patients from the 1st Phase 2. It uses the maximum dose from the 1st trial. It is similar to what AMPE tried with the multiple dosing in STEP and STRIDE. So, it could mean that a small effect was seen and no SAEs at maximum dose, so they are trying to maximize the effect. If nothing is reported within next month from the 1st trial, it's probably safe to assume it was similar to STEP = no substantial, measurable effect.
Besides the obvious FDA guidance statement for Ampion, which the company stated would likely be Q3 (my est. is mid-Sept) the other Q3 event that is worth noting is TPX-100 (Phase 2, non-stem-cell regeneration). Last patient visit was Apr with results scheduled for mid-2016. FLXN should have NDA filed for Zilretta by Q4.
Pretty decent volume, minimal price change. We are getting close to the end of the game.
Either the FDA provides a cost-effective path for development with KL4 (or any OAK class(es)) or it is indeed dead. Outside of the unlikely acceptance of current KL4 data as "adequate" for a BLA, the other positive outcome would be a small confirmatory trial, especially with a rolling submission to expedite review.
Worth reminding folks of all the treatments in front of PRX302. Not all are targeting the same PC stage.
ARN509 was suggested as a comparable for valuing SPHS due to JnJ b/o. However, note that it is ORAL, not injection. Substantially less expense involved and much higher patient interest than needles in the in you-know-where. Efficacy and ASE are needed for 1:1 comparison, but this is obviously what Oppenheimer and consultants are dealing with in trying to identify interested parties.
Exactly. Facts do appear to be either missing or consistently buried among the trash. I'm surprised the old Yahoo msg boards are still working. Most browsers are forced to point to the new "Conversations". Still loaded with some trash but less so.
Other than the "Is Sophiris Bio Inc. (SPHS) Primed for Acquisition?" article referenced, is there any other source of substantive comments? Analysts can be superficial, but Maxim asked probing questions at the PC CC (actually, the only one asking questions).
Also: Pharmacy and Therapeutics review article (P T. 2015 Aug; 40(8): 530) summarized several PC compounds already at Phase 3: Yervoy, Custirsen, ProstVac, Tasquinimod, ARN501, ProstAtak, ODM201, DCVAC/PCa. How does PRX302 compare with Phase 1/2A results from all of these?
This is hardly a field without alternatives, especially local ablasion therapy. So deriving a reasonable value of PRX302 at this stage is not some simple-minded "Company X just paid $Y Billions for a Phase 3 PC drug" BS.
The BPH results seemed marginal (1pt above placebo, nominal p value) in which SPHS SEC filings state the FDA requires 2-3pts for approval. Again, MANY alternatives exist for BPH. So the real value to a partner would be for treatment of prostate cancer.
"Is Sophiris Bio Inc. (SPHS) Primed for Acquisition?" is worth a more in depth discussion. ESPECIALLY the counterpoints made by a KOL. All pharma companies use internal and KOLs to determine merit.
Comparisons to ARN509 are interesting but that was Phase 2 not 2A. There can be NO comparison to MDVN since XTANDI is already FDA-approved. PRX302 is years away and requires 100M or more investment to even get ready for Submission.
So, we wait for the company to give SOME indication that there is at least SOME interest from SOME pharma partner for PC.
Forget BPH. 1pt IPSS does not meet the minimum FDA criteria for 2-3 pts as SPHS has stated in it's own SEC filings.
not to keep posting on the warrant thread, but it is a substantive discussion. Let's hope the analysts comment on both size of offering, warrants, projected use AND relative valuation vs Phase II results of MDVN.
Obviously only a fool would believe this commands MDVN value. What is important is to compare results (if at ALL possible at this stage) with Phase 1 and Phase 2 results for enzalutamide. To conduct a double blind, placebo controlled trial with a few hundred patients to even collect comparable data appears to be well out the reach of SPHS.
Also, there are different target populations. Would be nice to have a substantive discussion around that though most of those msgs will be buried here. Perhaps under the new Yahoo format.
So it's momentum, then leveraged money leaving with no major buyers? Makes sense as momo drove it up. Still hope the company would clarify if strategy has changed. I doubt it but it would be good to know the true interest of potential partners. No commentary on this board objectively evaluating it.
Obviously this was not received well. Company silence may be to blame. Warrants at 4 arent worth it as this is getting demolished. No rationale evident.
Issuing stock for clinical development is routinely done. There is always a drop, but stronger companies have the stock rebound shortly after.
Today's action shows little demand for this offering. Not good folks. We also have to hear from the analysts.
Good trade. I'm in since the PC data seems interesting enough for a partner, possibly a b/o. The b/o had seemed more likely, though still think it is a Q4 event, but this new raise brings up the question of what the cash is for. The statement saying it's for clinical work could be just from the original shelf. Some clarification that parties are interested and that the company has no intention of spending this money on BLA BPH filing or Phase II PC work would go a long way in bringing this back up. So would a major biotech investor (not just some index fund like Vanguard).
We have our answer already: From San Diego Business Journal
"In a regulatory form filed with the Securities and Exchange Commission, Sophiris disclosed that the proceeds would fund a new clinical trial and development efforts for its lead product candidate, topsalysin, and for working capital and general corporate purposes."