The Sophiris Boondoggle

by DrKSSMDPhD | November 13, 2015 9:56 pm

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Source URL: https://sgumdev.stockgumshoe.com/2015/11/the-sophiris-boondoggle/


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nocitons
nocitons
6 years ago

$VSAR
Good Morning Gumborgs!
I think I saw Versartis mentioned somewhere here but I cant find it on the spreadsheet. However.

The company is developing a modified version of Growth Hormone with a longer half life, for injections in Growth Hormone Deficiency (GHD) . The modified version, Somavaratan, leads down stream to stable and durable concentrations of IGF which promotes growth in individuals with GHD.
Versartis pitch is that Somavaratan can be dosed once monthly or every 14 days or something like this, instead of the daily injections that currently is SoC.

Somavaratan is in phase 3 clinical trial VELOCITY in children with GHD, and in phase 2 in adults with GHD.

Recently Versartis announced “Confirmatory 18-Month Data From Ongoing Extension Study of Somavaratan in GHD Children”. Jay Shepard, Chief Executive Officer, commented, “We are very pleased with the 18-month data released today from our ongoing Extension Study. Somavaratan’s adverse event profile at the Phase 3 dose continues to be comparable to that of daily growth hormone therapy. Additionally, in contrast to the published literature on second year growth rates for daily rhGH that show an approximate 2 cm/yr decrease in mean height velocity, somavaratan’s annualized 18-month mean height velocity has remained stable. The 18-month data from our ongoing Extension Study of somavaratan in pediatric patients provide us with further confidence in the 3.5 mg/kg twice-monthly dosing that we are studying in our VELOCITY Phase 3 trial.”

Very encouraging I would say. Looking at the clinical trials done so far in Somavaratan its hard to not think the treatment is superior to SoC. Al other things being equal, a radical cut in the frequency of subcutaneous injections alone would be enough to transition from SoC. If Versartis can show a smaller decline in growth the 2nd year of therapy that would be a bonus.

At the moment the company has a market cap of 300 million dollars with 198 million dollars in cash as of 30 September 2015. The stock price is 10.35 and the chart looks dead, the SP has basically been in constant decline for 18 months but looks bottomed to me. The lack of near term catalysts don’t help. Catalysts at the moment look like:

*Completion of VELOCITY enrollment by mid-2016.
*Top line data on VELOCITY’s primary endpoint, 12-month height velocity, by mid-2017, potentially enabling a Biologics License Application (BLA) submission, followed by potential FDA approval by late-2018.
*Top line data on VITAL, our Phase 2 trial in AGHD, in Q3 2016.

Whats not to like here?

Best Regards
Noci

LINKs:

http://ir.versartis.com/releasedetail.cfm?ReleaseID=932247

http://ir.versartis.com/releasedetail.cfm?ReleaseID=939352

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Frenchy
Frenchy
6 years ago

$RX: Does $RX compete in any way with $BIOC? $RX is 50% off its 52 week high.

TORONTO, ONTARIO–(Marketwired – Nov. 17, 2015) – BioSyent Inc. (“BioSyent”) (TSX VENTURE:RX) today announced that its subsidiary BioSyent Pharma Inc. has commenced the Canadian launch of CYSVIEW®, a new photosensitizer for the detection and management of papillary Non-Muscle Invasive Bladder Cancer (NMIBC).

CYSVIEW® is used with blue light cystoscopy to detect papillary Non-Muscle Invasive Bladder Cancer in patients with known or suspected bladder cancer. It selectively targets tumour cells in the bladder and causes them to emit a red fluorescence against a dark blue background of healthy tissue under blue light cystoscopy. This makes the tumours easier to see and remove. Studies show that 24.9% of patients had tumours that were detected by CYSVIEW® with blue light cystoscopy which were not detected by the current standard of care.

http://web.tmxmoney.com/article.php?newsid=80677140&qm_symbol=RX

Not in $RX but long $BIOC.

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eyedoc
eyedoc
6 years ago
Reply to  Frenchy

No competition.

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Frenchy
Frenchy
6 years ago
Reply to  DrKSSMDPhD

You are too kind Doctor. You save more lives than I ever will.

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armin
armin
6 years ago

Enzo Biochem (ENZ) new 52wH after New York cleared Hepatitis C Test. Could be one for Dr. KSS?

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armin
armin
6 years ago
Reply to  DrKSSMDPhD

Helps alot. Thank you, Dr. KSS!

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derek
derek
6 years ago

Doc is there any chance you will be commenting on the ARWR presentations and results from the AASLD? They look pretty promising to me.

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newby3867
newby3867
6 years ago

ATNM submits Iomab-B INDA application to FDA.
http://finance.yahoo.com/news/actinium-submits-iomab-b-ind-230000851.html

Cheers,Glenn

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Lannas
Lannas
6 years ago
Reply to  newby3867

The $WAIT is over, up 20% after hours 🙂
Long $ATNM

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chibana
chibana
6 years ago
Reply to  Lannas

Team,
$ATNM great news! Short interest has been up sharply over the last six weeks so it will be interesting to see if share value can maintain a good steady climb. Hopefully we will soon get some positive news reference Phase 2 for Actimab-A prior to the 22 Dec 2015 annual meeting. The American Society of Hematology annual meeting on 7 Dec 2015 would be a superb forum to announce Phase 2 for Actimab-A. Long $ATNM.
V/R
Tom

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newby3867
newby3867
6 years ago

Bluebird (BLUE) getting its mojo back after this data release yesterday with Celgene.Wedbush went as far as putting a 165.00 price target on them.

https://ash.confex.com/ash/2015/webprogram/Paper87396.html

http://www.fool.com/investing/general/2015/11/17/why-bluebird-bio-inc-is-soaring-today.aspx?source=eogyholnk0000001&utm_source=yahoo&utm_medium=feed&utm_campaign=article

Cheers,Glenn

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newby3867
newby3867
6 years ago
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newby3867
newby3867
6 years ago

More inside buys for TRXC. I believe insiders gearing up for something positive.
http://ir.transenterix.com/secfiling.cfm?filingid=1209191-15-80799&CIK=876378

Cheers,Glenn

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newby3867
newby3867
6 years ago

OGEN announces successful completion of Pre-IND meeting with FDA with OG253.
http://finance.yahoo.com/news/oragenics-announces-successful-completion-pre-131500260.html

Cheers,Glenn

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fsgdu77077
fsgdu77077
6 years ago

Can we keep the discussion within one thread? Either one is fine with me.
http://www.sgumdev.stockgumshoe.com/2015/11/the-sophiris-boondoggle/comment-page-1/#comment-4563118

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gambly1
gambly1
6 years ago

As a $SPHS long (former and current) I have to correct one thing that you posted. You said:

“On 15 December 2014, Sophiris announced that 12-week data had not attained significance. ”

…And that is technically not correct. What they did say was that the threshold that was pre-defined for the admin interim result did not achieve the 2.0 point IPSS difference that would allow them to most likely go ahead with the second phase 2 trial. The PR was widely interpreted as not reaching statistical significance, but the PR does not specify that. Further, the primary endpoint of the trial was to try to reach statistical significance, not to reach the 2.0 point IPSS difference that the admin interim had failed to reach. I reached out to the company and clarified this through phone conversations, that success was defined as reaching statistical significance.

I did sell half my position (200K shares) at varying prices from 3.80 down to 1.90’s, which I had bought at about 50-60c nearly a year ago. I am still holding 200K shares which I believe will reach perhaps 5$ by mid 2016, although I think I may sell 1/2 of that if it reaches the high 3$ mark sooner. Time will tell.

gambly1

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gambly1
gambly1
6 years ago
Reply to  gambly1

sorry, I meant “…go ahead with the second P3 trial”. Anyway, time will tell what happens to SPHS this year, and I won’t post again unless the stock hits below 1$ or high 3$, if I sell.

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gambly1
gambly1
6 years ago
Reply to  gambly1

I think if you refer to the 8K it states more details about the 2.0 IPSS point difference:

http://investor.sophiris.com/secfiling.cfm?filingID=1437749-14-22077&CIK=1563855

“The Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved…[SNIP]…The IDMC completed the planned, protocol-specified administrative analysis of efficacy based on the International Prostate Symptom Score (IPSS) change from baseline to Week 12 for all 479 patients dosed in the study. The protocol-specified administrative analysis of efficacy threshold at 12 weeks is defined as an IPSS treatment effect of ≥ 2.0 points favoring PRX302 over vehicle-only (i.e.average IPSS total score change from baseline (CFB) for PRX302 minus IPSS CFB for vehicle-only). “

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stephencmyers
stephencmyers
6 years ago
Reply to  gambly1

Gambly1 – You are either a shill for the company or heavily in debt with stock to this company. Between your posts here on Stock Gumshoe, on StockTwits, Yahoo Finance, and also apparently posting under gambler2075, Joe Gambler, you are busy!

Good luck to you!

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gambly1
gambly1
6 years ago
Reply to  DrKSSMDPhD

FDA did not expressly state they wanted 2.0 IPSS points for approvability for injectables. I talked to Peter Slover at Sophiris, and you can as well… that the FDA has not decided what the IPSS requirement is for PRX-302 specifically. You should call them to confirm this. The IPSS requirement of 2.0 IPSS points above placebo was the level required for oral drugs. When I talked to Mr. Slover, he said that FDA would decide, based on the efficacy/side effect profile for PRX, and make that decision if they needed 2.0 IPSS points or not. The fact that they posted that they feel that, if they get another stat sig P3 trial, and replicate the results, it would be enough for registration, means that IMO they have talked to FDA and FDA has confirmed that their trial counts for one of 2 successful P3 results needed to eventually file BLA.

Anyway, I feel that, just as people were running me off the message board when I was posting about SPHS before P3 data, that people here are extremely skeptical of my SPHS positions. Yes, I am gambly1 on stocktwits, and gambler2075 on yahoo.

I’ll stop posting on SPHS after this reply, but will be back either sub 1$ or when I sell.

gambly1

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herbalix
6 years ago
Reply to  gambly1

Good luck Gambly1!

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alanh
6 years ago
Reply to  gambly1

Gambly: I think a world of investors owe you a huge debt of gratitude for helping them to make a fortune, while expecting nothing in return. You are too generous by half.

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sheldon
sheldon
6 years ago

British sarcasm is often lost on those from outside the Empire.

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Lynn Clark, Stock Gumshoe
Admin

This thread has been closed and the biotech discussions with Dr. KSS have moved to his new article. Dr. KSS’s most recent article can always be found on his author page here

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