tag:blogger.com,1999:blog-79047378448030488292024-02-16T15:34:16.320+11:00Branko's Investment IdeasAnonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.comBlogger132125tag:blogger.com,1999:blog-7904737844803048829.post-66981945095380804172017-11-15T23:20:00.000+11:002017-11-15T23:20:46.258+11:00Newly diagnosed Glioblastoma (GBM) survival prospects<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-1IqlDe2hMe9taX_Wg8GCKhlFYS0xNFmL3fDrVQHhgq5UsNZPQ4VPD6uDos7NW9-noPWJkH2ELvEoSWl9g8XR-cuSdz07hV7XOBbuVaw9juQhjbFLyifKB37W_5aXXFHddt6WI7WFs7A/s1600/nGBM+OS+comparison.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="490" data-original-width="1232" height="158" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-1IqlDe2hMe9taX_Wg8GCKhlFYS0xNFmL3fDrVQHhgq5UsNZPQ4VPD6uDos7NW9-noPWJkH2ELvEoSWl9g8XR-cuSdz07hV7XOBbuVaw9juQhjbFLyifKB37W_5aXXFHddt6WI7WFs7A/s400/nGBM+OS+comparison.PNG" width="400" /></a></div>
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This is a survival comparator chart of various treatments of patients with newly diagnosed GBM.<br />
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UCLA's patient survival curve has a thick tail meaning a larger proportion of their patients have better long-term survival prospects. The beginning of their curve is similar to Stupp's curve (standard of care). </div>
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Optune, a medical device, has the strongest survival curve other than the 4 to 5 year time period where UCLA is stronger.</div>
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The treatments on the chart all have unique inclusion/exclusion trial criteria so it’s not quite comparing apples to apples but it still can be used as a guide of what we can expect. I adjusted UCLA's curve by moving it all back 3 months to simulate measuring survival from the beginning of treatment rather than beginning of diagnosis.</div>
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<b></b><i></i><u></u><sub></sub><sup></sup><strike></strike>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com10tag:blogger.com,1999:blog-7904737844803048829.post-18669794994754919632017-07-06T17:20:00.000+10:002017-10-02T16:36:35.033+11:00My Northwest Biotherapeutics (NWBO) Overall Survival Endpoint Estimates<div class="separator" style="clear: both; text-align: center;">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtrJpsbTjOMFefWhw9Np5coYeLa9fsAn0C9X6MimO6GEk_qctcqQ7Y1Jg43BdprJ-dvYe3FaR90t3xcJP9P8K74U6zEC6405_uKZ03QrJDaQsMB0LtjtXRCDyWl1fGYjqUHcSE8AvgyuY/s1600/NWBO+P3+OS+estimate.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="490" data-original-width="1203" height="162" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtrJpsbTjOMFefWhw9Np5coYeLa9fsAn0C9X6MimO6GEk_qctcqQ7Y1Jg43BdprJ-dvYe3FaR90t3xcJP9P8K74U6zEC6405_uKZ03QrJDaQsMB0LtjtXRCDyWl1fGYjqUHcSE8AvgyuY/s400/NWBO+P3+OS+estimate.PNG" width="400" /></a></div>
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*** Updated Oct'17 - added Rintega as a Control Arm modelled<br />
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These are the results of my modelling work on Overall Survival (OS) for Northwest Biotherapeutics (NWBO) Phase3 trial. I did this analysis after NWBO presented new Phase3 trial information at this year’s ASCO event. <br />
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The results show a best theoretical treatment median survival range between 25 to 27 months versus 18 to 25 months for the control or placebo group. The trial Blended survival curve has a median 25 month survival. <br />
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By my model, there can be up to a 9 month treatment survival benefit. However, I am expecting a lower treatment survival benefit of around 5 months. In this trial patients cross-over to treatment at disease progression so Control patients can gain OS benefit if this treatment has efficacy in recurrent GBM patients. I expect this cross-over effect to be small and not substantial.<br />
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The actual statistical significance threshold is unknown for this secondary endpoint but I intuitively expect a 2 to 3 month treatment benefit will be adequate. The company has not disclosed the amount of alpha this endpoint has been allocated. The company has stated their trial’s endpoints are independently powered and that 0.02 alpha has been allocated to their primary endpoint of PFS. So their OS secondary endpoint should have between 0.03 to 0.05 alpha.<br />
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The Blended survival efficacy curve is a theoretical point where both treatment and control curves lie exactly on top of each other meaning there is no difference in efficacy. My Blended curve has a 25 month median survival which is unusually high for a GBM trial. To date, no large drug clinical trial has produced a patient survival figure higher than 20 months (Celldex’s failed Rintega trial). The SOC expected median survival ranges from 14 to 17 months.<br />
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<![endif]--><u><b>Assumptions:
</b></u><br />
<div class="MsoListParagraphCxSpMiddle" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
· <br />
* 233 OS events reached in July 2017<br />
* Last patient enrolled in Nov 2015 <br />
* 6 patients lost-to-follow-up <br />
* 248 PFS events reached in Dec 2016 <br />
* 12 patients PFS evented post Dec 2016 <br />
* My Control group efficacy curve is derived from Stupp's Dose-Dense Study<span style="font-family: "symbol"; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";"> </span></span></span></div>
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<br />
<br />
<br />
<b>Other Control Arm KM curves modeled -</b><br />
<b><br /></b>
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<br />
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<span style="font-size: xx-small;">Disclosure - I am long NWBO. I do not short stocks</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com4tag:blogger.com,1999:blog-7904737844803048829.post-20509403279249444022017-06-09T23:19:00.000+10:002017-06-22T10:54:35.295+10:00Northwest Bio (NWBO) has a real chance of hitting its Primary Endpoint<div class="separator" style="clear: both; text-align: center;">
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<span style="font-size: xx-small;"> **chart update 22nd Jun'17</span><br />
<br />
I re-ran my DCVax-L Progression Free Survival (PFS) model with updated assumptions from last week's<span style="background-color: cyan;"></span><span style="background-color: #eeeeee;"> <span style="color: cyan;"><a href="https://www.nwbio.com/dcvax-novel-personalized-immune-therapies-solid-tumors/" target="_blank">ASCO presentation</a></span>. </span><br />
<br />
My model now gives DCVax-L a 14 month mPFS vs 7 months for its placebo thereby providing a 6 month treatment advantage (measured from time of treatment).
This trial requires a 4 to 5 month treatment advantage to demonstrate statistical significance.<br />
<br />
Previously my model gave DCVax-L a 16 month mPFS vs 6 months for placebo. The main reason for my now lower estimated PFS number is that I
increased the efficacy curve of the placebo arm. I made this change
based on Dr Bosch’s statement at ASCO that ~90% of all trial patients have received DCVax-L treatment either upfront or at cross-over. Previously, around December 2016, Principle Investigator, Dr. Linda Liau stated 86% of patients have received DCVax-L treatment. So it can be inferred that during the past 6 months ~12 additional placebo patients may have experienced PFS events. It is possible Dr. Bosch's ~90% figure is the same as Dr. Liau's 86%, in this case the trial's chance of success improves significantly. <br />
<br />
Changes to my modal -
<br />
* updated enrollment ramp numbers (extrapolated from ASCO slide)
<br />
* broke-down my K-M curve points into 6 month increments
<br />
* added 6 patients as Lost to Follow-up (LTFU)
<br />
* made Dec’16 the date 248 PFS events hit
<br />
* assumed 16 placebo had not evented at Dec’16<br />
<br />
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<br />
<br />
<br />
<br />
<br />
<br />
<br />
Highlights from ASCO presentation:<br />
<br />
DCVax-L Program -<br />
* Efficacy determination is made by a central review process<br />
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11713">
* 90% of pts received L (LL said 86%?)</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11714">
* trial is powered both for PFS and OS independently </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11715">
* ~3 month period btw screening and treatment </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11716">
* pseudo progressors not mentioned in exclusion criteria </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11717">
* 80-80% cell purity required to produce vaccine </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11830">
* a few patients were lost to follow-up </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11831">
* enrollment midpoint hit in May2014 </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11833">
* fully enrolled in November2015 </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11834">
* 231 pts have evented </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11835">
* OS 233 event expected to be hit around mid July </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11869">
* preliminary analysis publication of results is in the works</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11954">
* 7 SAEs related to L or placebo </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11955">
* 132 SAEs related to GBM or SOC </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_11956">
* SOC expected OS 15 -17 mths from diagnosis</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12082">
<br clear="none" /></div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12082">
DCVax-L Information Arm: <br />
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12229">
* Dr B said most indeterminate patients are probably rapids with a few pseudos (LL said the opposite) </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12270">
* mOS of this group was 21.5 mths </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12355">
* 24% > 48 mths OS </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12356">
* 40% > 35 mths OS</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12356">
</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12356">
<br />
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12358">
DCVax-Direct Highlights: </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12709">
* Sarcoma Phase2 trial to open in several months </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12710">
* plan to expand this trial for pediatric patients </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12711">
* Phase 2 trials to include CI in indications where they are approved already </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12844">
* 7 of 8 PH1 sarcoma pts exceeded their expected survival times </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12845">
* PH1 survival times 18% > 30 mths, 23% > 24 mths </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12846">
* 59% exceeded their expected survival time by an average of 11 mths </div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_12847">
* 4 SAEs
* Direct is manufactured in an automated system</div>
<div dir="ltr" id="yiv8827491819yui_3_16_0_1_1496720213182_14763">
<br clear="none" /></div>
</div>
</div>
NWBO is in a very distressed financial state. The company has ~$6.5M debts due in late June. Investors may suffer substantial dilution when this debt is settled.<br />
<br />
<span style="font-size: x-small;">Disclosure - I am long NWBO, I do not short stocks.</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-1270596884812407322017-04-26T10:54:00.000+10:002017-06-10T00:48:32.864+10:00Northwest Bio (NWBO) may become the biggest biotech winner of 2017 with positive Phase3 data in the coming months. Understand the risks it may also be a 0.<div class="separator" style="clear: both; text-align: center;">
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<br />
<span style="font-size: x-small;">Disclosure - I am long NWBO. I do not short stocks</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-8589967457746525112017-02-17T23:42:00.000+11:002017-02-18T12:52:28.283+11:00Northwest Bio (NWBO) improves fundamentals<!--[if gte mso 9]><xml>
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<![endif]-->Northwest Biotherapeutics (NWBO) significantly improved its fundamentals last week by announcing the lifting of a clinical hold from its lead DCVax-L Phase 3 trial for Glioblastoma (GBM). Also announced was the Phase 3 had reached the threshold number of Progression Free Survival (PFS) events, and the trial was several months away from reaching the threshold number of Overall Survival (OS) events. This trial is now fully enrolled with 331 patients and moving forward towards data lock. <br />
<br />
These recent positive developments have significantly improved the outlook for NWBO and reduced their risks. After the partial clinical hold was instated in August 2015, NWBO’s trial was perceived to be very troubled. There were perceptions the partial hold would not get lifted and as a result the trial could not complete enrollment and reach its endpoints. There were also doubts NWBO could remain solvent while waiting for the trial to complete.<br />
<br />
The latest announcement removes most of those risks. Whatever problem caused the partial hold, while still unknown, cannot now be a problem since the partial hold was lifted. The Phase 3 trial is now fully enrolled and within months of data-lock so the risks the company becomes insolvent and their trial never finishing are also gone. <br />
<br />
NWBO is a small biotechnology company in the Immuno-Oncology space. They have two promising vaccine candidates for treating solid tumor cancers. DCVax-L is their lead candidate. Their other candidate is DCVax-Direct for treating various inoperable cancers; this program has completed portion1 of a Phase 1/2 trial and is expected to begin the portion 2 in the near future.<br />
<br />
NWBO’s approach to treating cancer is exciting and can theoretically be used to treat ALL solid cancers. They claim their dendritic cell vaccine platform aspires to educate and direct the human immune system to identify, find, and destroy all cancer cells. NWBO’s vaccines are also meant to leave behind an immune memory so when cancer cells try returning they are also destroyed. Other immunotherapy companies fight cancer by targeting a single or several know cancer cells. <br />
<br />
The partial clinical hold, instated 18 months ago, was probably the main cause for NWBO’s share price collapse. The company’s market cap dropped from a lofty +$900M to today’s $65M, thereby pricing the Phase 3 trial as a complete failure. Despite the recent positive announcements NWBO's share price remained unchanged. Given the improved fundamentals I see this stock as excessively under-valued. <br />
<br />
Unfortunately, the latest announcement does not explain what the partial clinical hold was about. This hurts NWBO management’s credibility and probably keeps new investors away. This perceived management lack of transparency is damaging for NWBO and undoubtedly suppressing its stock’s share price. NWBO had previously said they will not discuss the nature of the partial hold while they are in on-going dialog with regulators. I suspect the dialog with regulators has not completed so there may be good reasons and justification for the continued silence. <br />
<br />
NWBO stated they are several months from data-lock in this Phase 3. After data-lock there should be no reason to withhold the partial hold explanation. An explanation would improve investor confidence.<br />
<br />
It’s unlikely there ever were serious problems with this trial because during the clinical hold period the trial remained on-going, it was not halted by the FDA. Patients continued to receive their vaccine treatments which would not have been allowed by the FDA had there actually been serious problems. <br />
<br />
Another perceived risk with this Phase 3 trial is whether DCVax-L has a chance of showing statistically significant efficacy. I believe it can and rate DCVax-L as having a high likelihood of success. DCVax-L produced very promising results in earlier clinical studies showing both strong signals of efficacy and an excellent safety profile without chemo/radiation type side-effects. Those studies however were small in size and were susceptible to patient selection bias.<br />
<br />
DCVax-L has also shown enough promise for foreign regulators to approval it for compassionate use in Germany and its being considered for early approval in the UK. According to NWBO’s latest 8K, a substantial number of patients have already been treated on a compassionate basis under an Expanded Access Protocol. <br />
<br />
I have run several analyses to try and predict the efficacy of this Phase 3 trial based on assumptions I have created from my knowledge of the trial. My analysis results give DCVax-L a strong possibility of showing statistically significant efficacy on their PFS primary endpoint. My model below gives DCVax-L 16 month PFS versus 6 months for placebo, a 10 month treatment benefit.<br />
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DCVax-L is further validated by being included in combination trials with FDA approved Checkpoint Inhibitors (CI). At least two Phase 2 combination trials are planned for 2017. Already announced is a trial with Merck’s (MRK) Keytruda for colorectal cancer. And the second, unannounced but listed on clinicaltrials.gov, is a trial with Bristol-Myers’ (BMY) Opdivo for recurrent GBM. Both these trials are no longer at risk of being delayed by the partial clinical hold. <br />
<br />
For the risk-averse investor this stock at $65M market cap now presents a tremendous near-term, risk/reward profile. <br />
<br />
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<br />
<u>Other Risks: </u><br />
* Should this Phase 3 trial fail, it may become very difficult for NWBO to remain solvent.<br />
* NWBO will require more funding around mid-2017 and it may come under dilutive terms. <b><br />ADDED - Additional funding may be required before 10th of March 2017 should the company be required to repurchase 11M in Convertible Senior Notes</b><br />
* There is uncertainty about the intentions of NWBO’s major stakeholder Neil Woodford. His relationship with NWBO appears hostile or strained at best. <br />
* NWBO continues to be targeted in the media despite its very low valuation. <br />
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<br />
<span style="font-size: x-small;">Disclosure:<br /> I am long NWBO. I do not short stocks.</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com2tag:blogger.com,1999:blog-7904737844803048829.post-35531582236012815422017-02-12T22:22:00.000+11:002017-04-19T12:12:10.410+10:00My Northwest Biotherapeutics (NWBO) PFS estimated Kaplan-Meier Chart Below is a copy of <a href="https://twitter.com/KrstevskiBranko/status/815240511116017664" target="_blank">my analysis on NWBO's Phase3 clinical trial</a> that I posted on Twitter back at the beginning of January 2017.<br />
My analysis predicted a likely positive outcome for the trial's primary endpoint of Progression Free Survival (PFS).<br />
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<u>Assumptions -</u><br />
* 248 Progression Free Survival (PFS) events for primary endpoint have NOT been reached as of Dec'16.
<br />
* All Placebo patients have PFS evented (per L Liau SSF video).<br />
* 331 patients enrolled in trial with a 2:1 treatment to placebo ratio<br />
* Enrollment Ramp ->
91 patients between Oct'14 & Oct'15,
70 patients between Jan'14 & Sep'14, and 170 patients between Dec'13 & 2011 (thx to ihubbers RKM & FLP44 for sharing)<br />
* Last patient enrolled Oct'15<br />
* Placebo will perform similar to Stupp (Dose-Dense) Study but without the long survival tail because pseudo Progression patients were excluded from NWBO's study.<br />
* pseudo Progression patients mostly make-up the long tail survivors in GBM, they make-up ~25% of the GBM population.<br />
* NWBO's study population has better patient prognostics including more tumor resection & higher patient KPS but its PFS measure begins later.<br />
* A 4 to 5 month efficacy benefit is required to show statistical significance<br />
* After crunching through the numbers, NWBO's Phase3 trial gets a positive figure of <b>16 month PFS vs 6 months</b> for placebo.<br />
<br />* my PFS measurements are from time of treatment.<br />
<span style="font-size: x-small;"><span style="font-family: "calibri" , "sans-serif"; line-height: 115%;">Disclosure - I am long NWBO. I do not short stocks.</span></span><br />
<br />Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-21467579557077811092017-01-10T23:56:00.000+11:002018-04-02T14:31:48.432+10:00My 2017 & 2018 top stock recommendations - NWBO & TGTX<div id="yiv5832301172yui_3_16_0_ym19_1_1482911099188_5861">
For investors who can tolerate high risk I am
recommending biotech stocks Northwest Biotherapeutics (NWBO) and TG Therapeutics (TGTX). Both companies are developing cancer
treatments that are showing very promising efficacy with excellent safety profiles. Both
these stocks have an enormous market potential while their current share prices are beaten down in
value. With clinical successes in 2017 & 2018 both these stocks have potential to become multi-baggers.</div>
Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com4tag:blogger.com,1999:blog-7904737844803048829.post-89652896128580852502016-10-25T10:02:00.000+11:002016-11-15T09:02:48.318+11:00Another look at Northwest Bio's (NWBO) Phase 3 trial - still predicts successBelow is my analysis for trying to predict the outcome of Northwest Bio's (NWBO) Phase 3 trial. I ran this analysis after learning that NWBO have changed their trial's estimated primary completion date at clinicaltrials.gov. The date was moved back from Sept'16 to Nov'16. Now suggesting NWBO believes their trial will reach its primary completion date in Nov'16. I added this new date as an assumption in my model and then re-ran the analysis. <br />
<br />
My analysis now gives NWBO's DCVax-L a 14 month mPFS vs 8 month for its control. This gives DCVax-L a <b>6 month benefit</b> which is larger than the 4 month
benefit required to show statistical significance.<br />
<br />
This new analysis uses an 8 month SOC PFS assumption and an enrollment ramp assumption (generated by i-hubbers Flipper44 & Rkmatters).<br />
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<i>I created this simple model to try and predict how NWBO’s Phase 3 clinical trial is performing. </i><br />
<i>I
consider this model at best a “rough-estimate”, <a href="https://www.linkedin.com/in/branko-krstevski-307278aa?trk=nav_responsive_tab_profile" target="_blank">from an engineer’s perspective</a> (not a mathematician). </i><br />
<i><br /></i>
<i>I used the <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3816958/">Dose-Dense Temozolomide for newly diagnosed Glioblastoma study</a>
(D-D) as a foundation for this model. NWBO’s vaccine (DCVax-L) is
getting compared to today’s SOC which is this D-D study (Arm1). The D-D
study examined an increased chemotherapy dosing schedule to the original Stupp SOC. This study showed no efficacy statistical difference between the two treatments. </i><br />
<i><br /></i>
<i>My model begins by assuming NWBO’s vaccine is ineffective, meaning that it
has the same efficacy as the D-D study. The model uses the D-D study’s
Kaplan-Meier chart (K-M) to estimate when NWBO’s trial can be expected
to reach its primary completion date. Note, NWBO’s trial has not reached its
primary completion dated, it is “on-going” and “nearing completion” according to
the company’s more recent statements. In early Oct'16 the trial's primary completion date was moved to Nov'16 suggesting the company expects 248 PFS events to occur around that date. </i><br />
<i><br /></i>
<i>I made a change
to the D-D K-M chart so that it better represents NWBO’s trial patient
population. The D-D study included a class of patients know as pseudo
progressive (psPD) whereas the NWBO trial has excluded these patients.
PsPD patients are believed to be the best GBM survivors and can make-up
over <a href="http://www.ncbi.nlm.nih.gov/pubmed/18484594">20% of the entire GBM population</a>.
So for my analysis I have disregarded the 15% longest survivors from
the D-D study, assuming they will mainly be psPD patients. </i><br />
<i><br /></i>
<i>I used publicly shared enrollment ramps from i-hubbers Rkmatters & Flipper44. With the enrollment ramp information and the PFS rates from the D-D K-M chart I was able to determine patient expected survival times. Using those survival time, I could then calculated the expected trial primary completion date, 248 PFS events. This would be the point at which the trial would end
had all patients only received SOC treatment, note the trial has not reached its completion date as of Oct'16. </i><br />
<i><br /></i>
<i>Should NWBO's trial reach its primary completion date in November 2016, my model gives NWBO a 14 month advantage over the D-D study. </i><br />
<i><br /></i>
<i>However
NWBO’s advantage is made-up from two portions, its treatment (DCVax-L) and
its control. </i><br />
<br />
<i>To determine the benefit from the treatment portion of the trial an assumption was made about the benefit from the control portion. </i><i>I have given NWBO's control an 8 months median PFS time which is longer than the </i><i><i>D-D study's 5.5 months</i>. </i><br />
<br />
<i>My reasoning for expecting longer PFS in NWBO's trial is based on the fact their patients have better outcome prognostics ie more tumor removed, higher KPS etc. </i><br />
<br />
<i>NWBO control patients are likely to see survival times closer to the Celldex's Rintega nGBM trial where all patients received complete tumor resections. Unfortunately Celldex has not shared their trial's K-M PFS data but they have shared their overall survival data. Rintega patient's median overall survival improved by around 40% from historical studies, 21months vs 15 months. Assuming PFS also improves by a similar 40% then NWBO's control can expect to have an 8 month mPFS (5.5 x 1.4 = ~8).</i><br />
<br />
<i><i>Using NWBO’s trial randomization ratio and an 8 months mPFS assumption for its control </i>I was able to calculated the likely DCVax-L mPFS benefit (1/3 * 8 + 2/3 * DCVax-L = 12). </i><br />
<i><br /></i>
<i>My model gives <b>DCVax-L a 14 months mPFS</b> vs 8 months for its control. So DCVax-L has a 6 month benefit which is larger than the 4 month benefit required to show statistical significance.</i><br />
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<span style="font-family: "calibri" , "sans-serif"; font-size: xx-small; line-height: 115%;"><span style="mso-spacerun: yes;">Disclosure - I am long NWBO. I do not short stocks.</span></span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com1tag:blogger.com,1999:blog-7904737844803048829.post-66056055639479044282016-10-04T22:03:00.001+11:002016-10-04T22:03:31.917+11:00My small cap Healthcare investment ideasHere are some Healthcare investment ideas from my Fund holdings as at the end of September 2016:<br />
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Note - most of these stocks are very risky. My fund is down 33% ytd with a 9.2% annualized 10 year return.Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com1tag:blogger.com,1999:blog-7904737844803048829.post-58255569187167440422016-09-16T09:46:00.001+10:002016-09-16T09:46:46.274+10:00Novavax (NVAX) Phase 3 RSV Flu trial fails to meet its endpoints Today, NVAX announced its lead Phase 3 RSV vaccine trial <a href="http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArticle&ID=2202271" target="_blank">failed to meet its endpoints</a>.<br />
The company says its trial experienced low vaccine attack-rates which hurt its results.<br />
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<br />
NVAX's cash value is approximately $1.20<br />
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<span style="font-size: x-small;">Disclosure - I am long NVAX, I do not short stocks </span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-66152992517844473762016-09-08T17:21:00.001+10:002016-10-25T10:03:45.563+11:00My model predicts success for Northwest Biotherapeutics (NWBO) Phase 3 trial<br />
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<br />
I created this simple model to try and predict how NWBO’s Phase 3 clinical trial is performing. <br />
I consider this model at best a “rough-estimate”, from an engineer’s perspective (not a mathematicians). This model does not account for an enrollment ramp. <br />
<br />
I used the <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3816958/">Dose-Dense Temozolomide for newly diagnosed Glioblastoma study</a> (D-D) as a foundation for this model. NWBO’s vaccine (DCVax-L) is getting compared to today’s SOC which is this D-D study (Arm1). The D-D study examined an increased chemotherapy dosing schedule to SOC but ultimately showed no statistical difference between the two treatments. <br />
<br />
My model begins by assuming NWBO’s vaccine is ineffective, meaning that it has the same efficacy as today’s SOC. The model uses the D-D study’s Kaplan-Meier chart (K-M) to estimate when NWBO’s trial can be expected to reach its completion date. Note, NWBO’s trial has not reached its completion dated, it is “on-going” and “near completion” according to the company’s more recent statements. <br />
<br />
I made a change to the D-D K-M chart so that it better represents NWBO’s trial patient population. The D-D study included a class of patients know as pseudo progressive (psPD) whereas the NWBO trial has excluded these patients. PsPD patients are believed to be the best GBM survivors and can make-up over <a href="http://www.ncbi.nlm.nih.gov/pubmed/18484594">20% of the entire GBM population</a>. So for my analysis I have disregarded the 20% longest survivors from the D-D study, assuming they will mainly be psPD patients. <br />
<br />
Then I calculated the required PFS rate to reach trial completion. Using that PFS rate, I then extrapolated from the D-D K-M chart to get an expected survival time. Using that survival time, I then estimated a trial completion date. This is the point at which the trial would end had all patients only received SOC treatment. <br />
<br />
As of September 2016, my model gives NWBO a 3 month advantage over SOC. <br />
<br />
However NWBO’s advantage is made-up from two parts, its treatment (DCVax-L) and its control. Assuming the trial’s control has no advantage then the treatment’s advantage increases. I used NWBO’s trial randomization ratio to allocate proportions.<br />
<br />
My model then gives DCVax-L a greater than 4 month advantage verse SOC thereby reaching a demonstrable efficacy level. <span style="font-family: "calibri" , "sans-serif"; font-size: 11.0pt; line-height: 115%;"><span style="mso-spacerun: yes;"><br /><br /><br />Disclosure - I am long NWBO. I do not short stocks.</span></span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com6tag:blogger.com,1999:blog-7904737844803048829.post-48905026599048516952016-08-16T12:48:00.002+10:002016-08-22T23:02:05.711+10:00Omeros Corp (OMER) -> a de-risked revenue producing small biotech<div class="MsoNormal">
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Below is my OMER valuation model with assumptions –> showing over 200% upside potential<br />
<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsB7psENmDleBFRPlPm7_ql3KkmWWXi_KsSpMZlbM6T-iH4DwmgipBKtyCVSnjmYfKvxpfFzGWHXlwXJsm3r08d2GWpzEawH_QFA675j7pDfH1s0fIUdI5Wrm-eYqhGz0wVvRDFK4W0dg/s1600/omer+valuation+aug16v2.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsB7psENmDleBFRPlPm7_ql3KkmWWXi_KsSpMZlbM6T-iH4DwmgipBKtyCVSnjmYfKvxpfFzGWHXlwXJsm3r08d2GWpzEawH_QFA675j7pDfH1s0fIUdI5Wrm-eYqhGz0wVvRDFK4W0dg/s400/omer+valuation+aug16v2.GIF" width="351" /></a></div>
<br />
<br />
<span style="font-size: x-small;">Disclosure - OMER is a holding of <a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781" target="_blank">my Marketocracy Fund</a>. I do not short stocks.</span></div>
Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-91675666254558902692016-07-11T23:23:00.002+10:002016-07-17T23:53:32.293+10:00Here are more Healthcare investment ideas from my Fund holdings<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjtVwzvRcrgGZPaoqDUZGOez0UUWieY3CjfmzV9qMRhQuRZaq3y3llz017uGN298SiUDJ1HoOadVY0jFlu9gTDWpwVTnH-C4fDpEESewdWmiEdwCkYdM_lWL9Pjs5XSJKh434MQzG3wPMw/s1600/bk11+fund+july+2106.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjtVwzvRcrgGZPaoqDUZGOez0UUWieY3CjfmzV9qMRhQuRZaq3y3llz017uGN298SiUDJ1HoOadVY0jFlu9gTDWpwVTnH-C4fDpEESewdWmiEdwCkYdM_lWL9Pjs5XSJKh434MQzG3wPMw/s400/bk11+fund+july+2106.GIF" width="222" /></a></div>
<br />
Note -most of these stocks are very risky.<br />
My Fund is down 30% ytd with a 10.3% annualized 10 year returnAnonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-74697288969287948862016-07-06T22:35:00.003+10:002016-07-17T23:54:22.748+10:00Here are some investment ideas from my July 2016 Healthcare Watchlist<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLjEdiNwApNwh_O-rJmw4jS8ekb4dVtlJO-BXBPTeXTslfIreA4kcFRoCMUlz9FMO2_Labe9ZNJ3_YoWCu5PT_B2EzHBM1ruDdHGOIpylH6S8n-A3xQYSbEm-xJzy3tlZuaeAX_Xa1MdI/s1600/watchlist+july+2016.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLjEdiNwApNwh_O-rJmw4jS8ekb4dVtlJO-BXBPTeXTslfIreA4kcFRoCMUlz9FMO2_Labe9ZNJ3_YoWCu5PT_B2EzHBM1ruDdHGOIpylH6S8n-A3xQYSbEm-xJzy3tlZuaeAX_Xa1MdI/s400/watchlist+july+2016.GIF" width="182" /></a></div>
<br />Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-89427808043886774732016-07-03T01:45:00.000+10:002016-07-17T23:55:32.994+10:00Marketocracy's Fund Managers Report Card for 1H16 -> C+2016 is shaping-up as a good year for Marketocracy's Fund Managers. According to data just released, a majority 58% of managers (15 of 26) are beating the S&P500 benchmark .<br />
<br />
The second quarter was particularly strong for managers as they averaged returns of 4.51% verses 1.90% for the S&P500 index.<br />
<br />
However on
average managers lagged the performance of the S&P500 over the first half of 2016.
Managers returned 0.92% vs 2.69%.<br />
<br />
<br />
The best performing 2016 Marketocracy managers:<br />
#1 Bruce Pile with 27.77% <span style="font-size: x-small;">(@ a 15yr annual return of 7.5%)</span> <br />
#2 Chris Rees with 19.11% <span style="font-size: x-small;">(@ a 15yr annual return of 8.2%) </span><br />
#3 Rex Jacobsen with 13.94% <span style="font-size: x-small;">(@ a 14yr annual return of 11.2%) </span><br />
<br />
<br />
<br />
The best long-term Marketocracy performers <span style="font-size: x-small;">(since their fund inception)</span>:<br />
#1 Todd Hagopian <span style="font-size: x-small;">(28.0% </span><span style="font-size: x-small;">annual return over 5 years)</span> <br />
#2 Justin Uyehara <span style="font-size: x-small;">(25.6% annual return over 13 years) </span><br />
#3 Sam Miklosko <span style="font-size: x-small;">(20.8% annual return over 7 years) </span><br />
<br />
<br />
<br />
<span style="font-size: small;">Below is a detailed look at all the managers' 2016 performances:</span><br />
<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgyR3cfbkBRMhNxUprrX1mqJ7n-V6lyLAuUF9wLYTwPYvBhiPdb8SsnCrAFXqXXvJ8J2mL9qXpa6r9rcCBhRXcHBfRcF8eRkLQI9_93hqJiIBFuBmBKmcSMH8DXt7gUnVAhjcl-bLxuU4Q/s1600/masters+ranks+1H16.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgyR3cfbkBRMhNxUprrX1mqJ7n-V6lyLAuUF9wLYTwPYvBhiPdb8SsnCrAFXqXXvJ8J2mL9qXpa6r9rcCBhRXcHBfRcF8eRkLQI9_93hqJiIBFuBmBKmcSMH8DXt7gUnVAhjcl-bLxuU4Q/s400/masters+ranks+1H16.GIF" width="248" /></a></div>
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<br />
<b>My Fund:</b><br />
My
small-cap focused Healthcare Fund is performing poorly year to date. I am at the bottom of the rankings list, highlighted in yellow.<br />
<br />
My fund is down a large 34.45% ytd. It lags the returns of equivalent benchmarks such as the IBB down 20% and the XBI down 18%. My fund's longer-term performance remains strong having returned 10% annualized over the past 10 years. <br />
<br />
The recent biotech sector sell-off had a very adverse affect on my fund. I primarily hold small-cap stocks
which unfortunately were among the worst affected in the sell-off. Heavy losses from my larger core-holdings also significantly contributed to my under-performance. My positions in Northwest Biotherapeutics (NWBO) and TG Therapeutics (TGTX) fell 94% and 61% respectively over the past 12 months.<br />
<br />
I continue to hold both these stocks because I believe their recent sell-off was over-done and the stocks are now under-valued. Both stocks have late-stage cancer treatment candidates that offer tremendous promise with block-buster market potential. Important catalysts, later this year, have the potential to sharply shift investor sentiment in both of these stocks. <br />
<br />
The biotech sector is showing signs of a recovery which is encouraging. I remain
optimistic about being invested in this space despite the rocky past 12 months. Over the longer-term I believe this sector will continue to be prosperous. <br />
<br />
<br />
<br />
<span style="font-size: x-small;">Disclosure -<a href="http://marketocracy.com/managers.php?type=composites" target="_blank"> Marketocracy Funds</a> are available for investment through SMAs.<a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781" target="_blank"></a><br />I do not short stocks.</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-20787780305823741462016-06-23T13:19:00.000+10:002016-09-16T09:37:50.070+10:00Novavax (NVAX) is nearing a pivotal PH3 data read-out -> updated - P3 failed to meet its endpoints Novavax's lead vaccine candidate is for the indication of RSV Flu in older adults. This program is at a Phase 3 stage in clinical development. A data read-out is anticipated in 3Q16. I am expecting a positive result here which will be transformational for this small biotech company. A positive Phase 3 result here will help validate NVAX's vaccine platform technology from which its other vaccine candidates are also built, de-risking the stock..<br />
<br />
My price target for NVAX is $13 - $16 which presents around 150% upside.<br />
<br />
Below is my valuation model with assumptions. It only considers NVAX's lead vaccine candidate, RSV F for older adults. <br />
<br />
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For my model, I have chosen a conservative vaccine sales price of $80 which less than similar vaccines like Pneumovax and Prevnar which sell for around $100 and $200. Using a market penetration rate of 40% and an 80% likelihood of clinical success and then discounting 50% I calculate peak sales at over $600M. Applying an x8 Price to Sales ratio gives NVAX a Market Cap of $5.0B which is well above its current $1.8B valuation. Note my model only considers NVAX's lead indication. </div>
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I see NVAX as a very attractive investment idea. <br />
The company has a
promising vaccine platform that has been used to produce several different vaccine candidates. These candidates have produced positive clinical data and
have received FDA Fast Track designations .<br />
NVAX's vaccine candidates are for the following indications; RSV Flu (elderly, maternal, &
pediatric), seasonal influenza, RSF/seasonal Flu combo, Ebola, Avian flu (H7N9), and MERS. <br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYEhGs4R_a0Ahr6ZL6ePj_WoPHBUS157dSRz5Cr7ZCBHL7zgmfDuyN154yyPfKbOQAll8cKNsH3WuwZpb5MH3AZjPuDEkTTfl8hTqfYxTmuzc908K6uM4Syp6IBDO1HgLwkjW4uzMtMQ4/s1600/nvax+pipline.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYEhGs4R_a0Ahr6ZL6ePj_WoPHBUS157dSRz5Cr7ZCBHL7zgmfDuyN154yyPfKbOQAll8cKNsH3WuwZpb5MH3AZjPuDEkTTfl8hTqfYxTmuzc908K6uM4Syp6IBDO1HgLwkjW4uzMtMQ4/s400/nvax+pipline.GIF" width="400" /></a></div>
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NVAX’s most lucrative vaccine candidate is for the RSV indication. Currently there are no FDA approved vaccine's for this indication making this space an area of unmet need. RSV Flu is a common respiratory disease,
according to the company, severe cases put a large burden on the healthcare system with over 200k
hospital admissions and causing 16k deaths. The total cost burden on major markets NVAX estimates at approximately $88B.<br />
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NVAX is leading the race to provide a treatment for this RSV Flu indication. Other companies addressing this indication are GSK and Medimmune with candidates at the Phase2 clinical stage. NVAX's vaccine is the first to demonstrate efficacy in this indication. In Phase2 testing, their vaccine's immunization efficacy was measured at 41% with p=0.041. These results compare very favorably to approved vaccine Prevnar which showed a lower immunization efficacy of 31% with p=0.008.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiNinaOrzIitoltrRrW8sVGAeL8TJvTwRvnsVV4a_Dw0XhSgzEfkHUIwqK_YyDe-i_XGPDMDX4Ab32cR4XR3NRDcXHTt908A5v9GGV-Sm__m4oGIwuyFBwiAwweqKoTlADr01vAJVf6WPo/s1600/nvax+efficacy+comparison.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="292" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiNinaOrzIitoltrRrW8sVGAeL8TJvTwRvnsVV4a_Dw0XhSgzEfkHUIwqK_YyDe-i_XGPDMDX4Ab32cR4XR3NRDcXHTt908A5v9GGV-Sm__m4oGIwuyFBwiAwweqKoTlADr01vAJVf6WPo/s400/nvax+efficacy+comparison.GIF" width="400" /></a></div>
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NVAX has benefited from funding support from organizations like BARDA and the Gates Foundation. They are now in a strong financial position with over $430M in cash. These reserves will be adequate to advance their various vaccine candidates well into the future. <br />
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I estimate NVAX's vast pipeline of vaccines may eventually yield well over $1B
in peak sales. Its current low Market Cap of $1.8B lies well below its true potential and now offers investors a very attractive entry point.</div>
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Disclosure - NVAX is a core holding of my <a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781" target="_blank">Marketocracy fund</a>. I do not short stocks </div>
Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com2tag:blogger.com,1999:blog-7904737844803048829.post-21034492099095957962016-05-31T23:04:00.002+10:002016-05-31T23:19:13.447+10:00ResApp Health (RAP.AX) - Not at its peak after a 1500% rise over the past 9 monthsResApp is a small Australian company developing an exciting iPhone App to detect respiratory disease. <br />
This App aims to compete against today's respiratory disease diagnostic tools such as the stethoscope, imaging (x-ray/CT scan), blood and or sputum test. <br />
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I ran a Times Revenue Multiple valuation model for this stock using their research data and got a <b>share price target of $0.85 - $0.66</b>. This presents an attractive over <b>150% upside from today's price</b>. <br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRunacFP-dlEfcyf5O3a6OQy5iisfUwUwEJfBPMwNs3yBrkUP9RCaxkdM7pdpaRj9Hgk6_VQENxBs4WIWJdrIVbZJ5wgnpsR1_JxZu475BIeUdxS6lBtgkP72UXW3l2t91fvbOWtB-094/s1600/rap.ax+valuation+model.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="203" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRunacFP-dlEfcyf5O3a6OQy5iisfUwUwEJfBPMwNs3yBrkUP9RCaxkdM7pdpaRj9Hgk6_VQENxBs4WIWJdrIVbZJ5wgnpsR1_JxZu475BIeUdxS6lBtgkP72UXW3l2t91fvbOWtB-094/s400/rap.ax+valuation+model.GIF" width="400" /></a></div>
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Clinical results to date suggest this App has a very high chance of winning FDA approval. This App was able to correctly detect lower respiratory tract involvement in 97% of cases initially missed by experienced clinicians using a stethoscope. The App was also able to differentiate between viral and bacterial pneumonia with around 90% accuracy.<br />
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MD take-up of this new diagnostic tool will likely be modest since doctors have used the stethoscope for a very long time. However the uptake in the telehealth market will likely be very high. For my modeling I have given 10% market penetration by MDs and 80% by telehealth markets. <br />
Coming catalysts include an imminent telehealth partnership announcement, an initiation this quarter of a pivotal clinical study, and a FDA decision in Q4'16. <br />
The risks with this investment include the potential for a similar App competitor to emerge.<br />
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Below are information slides from ResApp's last investor presentation:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSbBE6YCrPeOHQO1wybONapPejGD3E2urD-QMa_meVy1E2nDbGbg7G_ve0T1jsEPcGnTSBrfPqgEgowrWhncNLLN2h_2Mxv8iEfl7-VF-vUjmWOTWnf2jcAthjXTt-MFj6MF3YOfcR3Sk/s1600/rap+tech+slide.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="233" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSbBE6YCrPeOHQO1wybONapPejGD3E2urD-QMa_meVy1E2nDbGbg7G_ve0T1jsEPcGnTSBrfPqgEgowrWhncNLLN2h_2Mxv8iEfl7-VF-vUjmWOTWnf2jcAthjXTt-MFj6MF3YOfcR3Sk/s400/rap+tech+slide.GIF" width="400" /></a></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgN0TW4L80K1fCsnPjWB6pJiG_XWHPmIeTV2PoFIO5hyp2nbToPpaXDr2T5Ov9UH7AMELvIewbsKUZrIwZBbTiqo-sSfzEaibbiiDAbnSWBeGmEecodQZ_kuHedhm5ld4btc4OQxCzO4eM/s1600/rap+summary+slide.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="228" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgN0TW4L80K1fCsnPjWB6pJiG_XWHPmIeTV2PoFIO5hyp2nbToPpaXDr2T5Ov9UH7AMELvIewbsKUZrIwZBbTiqo-sSfzEaibbiiDAbnSWBeGmEecodQZ_kuHedhm5ld4btc4OQxCzO4eM/s400/rap+summary+slide.GIF" width="400" /></a></div>
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This is ResApp's 12-month share price chart -<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqqbTNXCAP1qvXV8Y6bhLVBT2YBtmT-IdubwcYr7wqN0tg34NxJykMF-8R9RDIxTMyJr9_PDTlcAIK1cVa1XHzkdIhhUrouNGMjd_Aa2aWfvT73cIbhMP2R88E9tkUeSfvgzVOWnv4mNE/s1600/rap+12m+chart.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="272" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqqbTNXCAP1qvXV8Y6bhLVBT2YBtmT-IdubwcYr7wqN0tg34NxJykMF-8R9RDIxTMyJr9_PDTlcAIK1cVa1XHzkdIhhUrouNGMjd_Aa2aWfvT73cIbhMP2R88E9tkUeSfvgzVOWnv4mNE/s400/rap+12m+chart.GIF" width="400" /></a></div>
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This investment should only be considered by risk adverse investors. Considering the already staggering share price increase large price retractions are possible.<br />
My pricing model says there is still significant upside potential here.<br />
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<span style="font-size: x-small;"><br />Disclosure - I have no position in this stock but may initiate a long position in the coming weeks</span><br />
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<br />Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-8291217611484887412016-05-28T22:17:00.000+10:002016-05-28T22:17:39.803+10:00Dipexium Pharmaceuticals (DPRX) - High likelihood of clinical success with big upside<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgYUv28UZ6WCtFt6NJjavRJckOf0nwSESi5qYGCuDVjwooq2bvsh5pvoQUcWIWTp76I4awDs0F9pTFBS3NM4zDUFCHFkR6x4o5F4XJmNkCQ1ZGCfN5OvhPU6TomRKvqEqe9c-eyIfYgzoE/s1600/dprx+valuationr1.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="245" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgYUv28UZ6WCtFt6NJjavRJckOf0nwSESi5qYGCuDVjwooq2bvsh5pvoQUcWIWTp76I4awDs0F9pTFBS3NM4zDUFCHFkR6x4o5F4XJmNkCQ1ZGCfN5OvhPU6TomRKvqEqe9c-eyIfYgzoE/s400/dprx+valuationr1.GIF" width="400" /></a></div>
<span style="font-size: x-small;"><br /></span>
<span style="font-size: x-small;">Disclosure - I have no position but may initiate one before PH3 results</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-80868400838960131752016-05-14T00:40:00.001+10:002016-08-16T12:32:08.957+10:00My CorMedix (CRMD) valuation model shows up to 160% upside<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8xL21jhB55Wk_BFti3UJhsxKqKQBCFDSgJykaXZ5wPbT54DprrmwnBUWcUFK4mVqtpYcRv9cU0spYT6_LRqj6wk9Wxz0gq1uiUcAdjgW2SyX_DwOQOF3bNmlPTWdsO2yCdVk_-BZcP3E/s1600/crmd+valuation+may2016a.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="245" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8xL21jhB55Wk_BFti3UJhsxKqKQBCFDSgJykaXZ5wPbT54DprrmwnBUWcUFK4mVqtpYcRv9cU0spYT6_LRqj6wk9Wxz0gq1uiUcAdjgW2SyX_DwOQOF3bNmlPTWdsO2yCdVk_-BZcP3E/s400/crmd+valuation+may2016a.GIF" width="400" /></a></div>
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I have no position in CRMD but may open a long position.Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-89980544040463782762016-05-11T22:31:00.000+10:002016-05-11T22:31:07.921+10:00Acadia Pharmaceuticals wins FDA approval and sets its drug priceThe FDA has approved Nuplazid, Acadia atypical anti-psychotic drug for treating Parkinson's Disease Psychosis. Nuplazid is set for commercial launch in the US this June with a price tag of $1,950 per month.<br />
<br />
In light of these recent developments I have updated my Acadia valuation. My new price target for ACAD is $48-$63 per share which presents over 100% upside.<br />
<br />
I used the Times Revenue Multiple Valuation method.<br />
Below is my model with assumptions:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbHYGIIzMhP8VnvaUk3q03yD75dOvqk4RzgvGGF18onuHZOZlL9PlI_iN_u6kW20nXDxvxMBSSLICHaN-rKRH8-ZCSMQh767AUtOAa88XmpfhDaR1-layCVfwrljJM46Co45v5wiAU2iw/s1600/acad+valuation+2016+may.GIF2.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="251" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbHYGIIzMhP8VnvaUk3q03yD75dOvqk4RzgvGGF18onuHZOZlL9PlI_iN_u6kW20nXDxvxMBSSLICHaN-rKRH8-ZCSMQh767AUtOAa88XmpfhDaR1-layCVfwrljJM46Co45v5wiAU2iw/s400/acad+valuation+2016+may.GIF2.GIF" width="400" /></a></div>
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<br />
I wrote about ACAD and its drug candidate back in <a href="http://askthebranko.blogspot.com.au/2015/04/acadia-pharmaceuticals-acad-still.html" target="_blank">April 2015</a>. <br />
<br />
I continue to view ACAD as an excellent long-term investment opportunity.<br />
<br />
<br />
<br />
<span style="font-size: x-small;">Disclosure - ACAD is a core holding of <a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781" target="_blank">my Marketocracy Fund</a>. I do not short stocks.</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-76948100678727491782016-04-27T13:34:00.000+10:002016-04-27T13:34:02.317+10:00My Neuren Pharma valuation model after their negative PH2 TBI results<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjzV5XND-dYA-cEj6dsPC6Q0Mgroxv61RNCPdD2ZNvtk8fWnPZeQJ49IXOYWrYZPHFO0JnErmFlblx3BsjwzjCov58XCCsGcodgnSSo6ArntuJos3dNZwsVB7KB-2eA_W6DAD9bBifDEZc/s1600/neuren+valuation+aprilv2+2016.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="233" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjzV5XND-dYA-cEj6dsPC6Q0Mgroxv61RNCPdD2ZNvtk8fWnPZeQJ49IXOYWrYZPHFO0JnErmFlblx3BsjwzjCov58XCCsGcodgnSSo6ArntuJos3dNZwsVB7KB-2eA_W6DAD9bBifDEZc/s400/neuren+valuation+aprilv2+2016.GIF" width="400" /></a></div>
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<a href="http://www.neurenpharma.com/IRM/PDF/1590/ResultsofPhase2trialinmoderatetosevereTBI" target="_blank">This is Neuren's PH2 TBI results Press Release</a><br />
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<br />
<br />
<span style="font-size: xx-small; line-height: 115%;">Disclosure – NEU.AX
is a very small AU/NZ biopharma company that carries substantial risk.
While its potential returns may be high its losses may also be high.<br />
I am long NEU.AX.<br />I do not short stocks.</span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-47286618690596745682016-04-20T12:27:00.000+10:002016-04-20T12:27:26.144+10:00Neuren Pharmaceuticals (NEU.AX) - Awaiting TBI Phase 2 resultsClinical results are now imminent for Neuren's Phase2 trial in TBI (Traumatic Brain Injury - moderate to severe). Positive results in this indication would significantly boost Neuren's market value. This indication has a large 1 million US & EU potential patient population and its without an FDA approved disruptive drug. <br /><br />
Below is my Valuation Model with assumptions. It shows NEU.AX undervalued by as much as 200%.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsJvGt6L0aCVcxUMBi2_kLc_GgYTjUPoEl4-LKqE1xIOk2piHuQyG2l1g3oqTeJPXIx_VQMOuX9rgEbpATA2jFdl0SV7vKMJxIPQurpT6xHmfAMTBHerkX0sRb0UUNfSfeOlvbNI8VKM4/s1600/neuren+valuation+april+2016.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="235" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsJvGt6L0aCVcxUMBi2_kLc_GgYTjUPoEl4-LKqE1xIOk2piHuQyG2l1g3oqTeJPXIx_VQMOuX9rgEbpATA2jFdl0SV7vKMJxIPQurpT6xHmfAMTBHerkX0sRb0UUNfSfeOlvbNI8VKM4/s400/neuren+valuation+april+2016.GIF" width="400" /></a></div>
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Last year, I wrote about Neuren's drug <a href="http://askthebranko.blogspot.com.au/2015/07/neuren-pharmaceuticals-neuax-my.html" target="_blank">here</a>.<br />
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This next slide is from Neuren's latest investor presentation:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhatfuPFOEYB4kqTFUoLjhwlpYiE1K-psL2z-cvtNhkYy5g3B6MB7O2FLcuNfo_4x2CZpNN3LQtQhL8HvOYEHsSWqUNg4eLzARbOWe8zqe7pN23ExCVufHYL1TL12nNzbjbldKxxzcCkgg/s1600/neuren+milestones+and+pipeline.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="281" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhatfuPFOEYB4kqTFUoLjhwlpYiE1K-psL2z-cvtNhkYy5g3B6MB7O2FLcuNfo_4x2CZpNN3LQtQhL8HvOYEHsSWqUNg4eLzARbOWe8zqe7pN23ExCVufHYL1TL12nNzbjbldKxxzcCkgg/s400/neuren+milestones+and+pipeline.GIF" width="400" /></a></div>
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<br />
The status of Neuren's second TBI trial (mild or concussion) has become uncertain. This latest investor presentation does not provide a program timeline update, results were expected in 2Q16. The presentation states enrollment is proving difficult and the trial is under review. <br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiU5KR8y80go6uXSD23qB-aWr3wHIvQM41bxiQp0leaQrj4GBvIspVEduagjAbJy0f4TAaJpCFsHIWrvkXzpMxM2fhvsVrWkkFBsB7z4DEytCIhnWxO9zJSP7ES2XdTDwJ2qqT2mXxpUlY/s1600/neu+concusion.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="292" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiU5KR8y80go6uXSD23qB-aWr3wHIvQM41bxiQp0leaQrj4GBvIspVEduagjAbJy0f4TAaJpCFsHIWrvkXzpMxM2fhvsVrWkkFBsB7z4DEytCIhnWxO9zJSP7ES2XdTDwJ2qqT2mXxpUlY/s320/neu+concusion.GIF" width="320" /></a></div>
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<span style="font-size: xx-small; line-height: 115%;">Disclosure – NEU.AX
is a very small AU/NZ biopharma company that carries substantial risk.
While its potential returns may be high its losses may also be high.<br />
I am long NEU.AX.<br />I do not short stocks. <span style="mso-spacerun: yes;"></span></span>Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-36524311114667047352016-04-18T15:00:00.002+10:002016-04-18T15:00:48.576+10:00Argos Therapeutics (ARGS) - my price target is $19-$13<div class="separator" style="clear: both; text-align: center;">
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Below is my valuation model with assumptions – </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsJm7s8P3X9Yo4ZchK3gDsVA9sz73olqXNd-jDZooh7wFPFXZ1dHbCT008NCUoplhXHKbBfVdq6ATOx7tlNkwir5fVNd8BRrKQ9RkZDXL1gZ7LAAJwSe9ztwTlAEuByG7x4aGN-7utpuU/s1600/args+valuation+apr2016.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="268" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsJm7s8P3X9Yo4ZchK3gDsVA9sz73olqXNd-jDZooh7wFPFXZ1dHbCT008NCUoplhXHKbBfVdq6ATOx7tlNkwir5fVNd8BRrKQ9RkZDXL1gZ7LAAJwSe9ztwTlAEuByG7x4aGN-7utpuU/s400/args+valuation+apr2016.GIF" width="400" /></a></div>
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This is their 12 month chart -</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEivOHvirhp3tTvp1-iaj1X-ZjP1gKVcPGsLEGozhQUTx8ceIo5pptaSxD7AOeU7BQJlKm64FxOCnWtjtywP_eEaeiBxWJHaBuuAyuJwdUpWnpGBjwLCnaE5KrhGEzbf0d-QVl1r9GSLoec/s1600/args+chart.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="275" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEivOHvirhp3tTvp1-iaj1X-ZjP1gKVcPGsLEGozhQUTx8ceIo5pptaSxD7AOeU7BQJlKm64FxOCnWtjtywP_eEaeiBxWJHaBuuAyuJwdUpWnpGBjwLCnaE5KrhGEzbf0d-QVl1r9GSLoec/s400/args+chart.GIF" width="400" /></a></div>
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This is their Phase3 ADAPT trial design -<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhWq1NFQ9T0J0kAxTr80z4aup42tSBdjkeBn1qo3FbegygIGy2Uw-FUhyalI5nvhp76SimKG2fOhCcpzTx1wHdhhYfkltON05IEFKvutPsgQbHFAjp_KZ6EAsgBgyXx8GSgQDLNXtG-XT0/s1600/argos+adapt.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="301" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhWq1NFQ9T0J0kAxTr80z4aup42tSBdjkeBn1qo3FbegygIGy2Uw-FUhyalI5nvhp76SimKG2fOhCcpzTx1wHdhhYfkltON05IEFKvutPsgQbHFAjp_KZ6EAsgBgyXx8GSgQDLNXtG-XT0/s400/argos+adapt.GIF" width="400" /></a></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvu96W7FfwuzpmAAK73HaHBM9BY3BEqSKhw_OVY28KGxQBuL9aMBfn1nu4lpfcMdUEAAqk9swzJFORhTK8Iyk6E0Masyl26hrjlFbEsHy2w08kji1kr2LqUP-Ay-RfJLjnQwXEamBD1Jo/s1600/argos+pipeline.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="301" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvu96W7FfwuzpmAAK73HaHBM9BY3BEqSKhw_OVY28KGxQBuL9aMBfn1nu4lpfcMdUEAAqk9swzJFORhTK8Iyk6E0Masyl26hrjlFbEsHy2w08kji1kr2LqUP-Ay-RfJLjnQwXEamBD1Jo/s400/argos+pipeline.GIF" width="400" /></a></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhOFpl4vB4SSTGHjVVA5LHkW6DtZ_xjK8RLx5s0Wux87m5iYkygL9BcrjZGxKmDxzF1acMwdyyOLzPOBVsEykFVqHtdrVXer3eeuQn9taon_rLtDqzHUqwR9cBtnAwchJkCiV39a4_8400/s1600/argos+milestones.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="301" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhOFpl4vB4SSTGHjVVA5LHkW6DtZ_xjK8RLx5s0Wux87m5iYkygL9BcrjZGxKmDxzF1acMwdyyOLzPOBVsEykFVqHtdrVXer3eeuQn9taon_rLtDqzHUqwR9cBtnAwchJkCiV39a4_8400/s400/argos+milestones.GIF" width="400" /></a></div>
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<span style="font-size: x-small;"><span style="font-size: x-small;">Disclosure - ARGS is a holding of <a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781" target="_blank">my Marketocracy Fund</a>.<br />I do not short stocks.</span></span><br />
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<br />Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-90584045362091045442016-04-05T00:10:00.000+10:002016-07-17T23:56:33.269+10:00Medical Stocks Watchlist - Apr 2016<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWWsqI5k6bqMpra9UXBo6JrDcDMeqMd0gahEdBTpd8Q7VEs1lqifCt5bQpPOTouTpzokL8ht4MiOzF0CRZcR5UNYfDHE1o-WzPp51yHTLiy4a3BPmum1_8A24hODgxSOift4IUzw18m3U/s1600/watchlistapril2016.GIF" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWWsqI5k6bqMpra9UXBo6JrDcDMeqMd0gahEdBTpd8Q7VEs1lqifCt5bQpPOTouTpzokL8ht4MiOzF0CRZcR5UNYfDHE1o-WzPp51yHTLiy4a3BPmum1_8A24hODgxSOift4IUzw18m3U/s400/watchlistapril2016.GIF" width="151" /></a></div>
<br />Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0tag:blogger.com,1999:blog-7904737844803048829.post-20370580156858801992016-03-24T00:14:00.001+11:002016-03-24T00:14:10.690+11:00Northwest Biotherapeutics (NWBO) - huge upside potential with high risk<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmHCKX5LobU_ltuhnTlAooGLHnYH11Iq0xYQQbt2-u1nT3HURG8yz4BM8vbMQlhzaMoalxMtv3JDujy3i-cg8Ajo5ZH7bdEoyG23ZihX5J6TmY5yi-CqSAszu3szXcj9eqBDl035N0RTo/s1600/NWBO+Valuation+mar2016.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmHCKX5LobU_ltuhnTlAooGLHnYH11Iq0xYQQbt2-u1nT3HURG8yz4BM8vbMQlhzaMoalxMtv3JDujy3i-cg8Ajo5ZH7bdEoyG23ZihX5J6TmY5yi-CqSAszu3szXcj9eqBDl035N0RTo/s400/NWBO+Valuation+mar2016.PNG" width="400" /></a></div>
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<br />
<b>The Risks -</b><br />
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NWBO has suffered from the current biotech sell-off and may continue to drop in value should this sector continue to drop. <br />
NWBO like other small biotech companies will require more funding and may continue raising capital under dilutive terms. <br />
There is uncertainty with the timeline of the NWBO’s DCVax-Direct Phase 2 trials. <br />
There
is also uncertainty what direction major stakeholder Neil Woodford will
now take that his relationship with NWBO management appears strained. <br />
NWBO is increasingly targeted in the media despite its very low valuation.<br />
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<br />
<br />
Below is in article format from <a href="http://www.forbes.com/sites/kenkam/#71307272749c" target="_blank">my interview with Forbes.com</a>.<br />
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2015 was a very damaging year for Northwest Biotherapeutics (NWBO). Since I nominated NWBO as a best investment idea for Forbes.com the stock has dropped 75% of its value, down from$7 to $1.50. The stock initially rose to over $12 in July 2015 before then dropping steadily to today’s all-time lows. <br />
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NWBO is a small biotechnology company and like most of its peers carries a very risky profile. Small biotechnology companies are lightly traded and can easily be misunderstood so they are susceptible to wild share-price volatility. <br />
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I don’t believe NWBO’s current low valuation is justified. Most of its sell-off can be attributed to perceived troubles with its lead Phase 3 clinical trial. I don’t agree this trial is in real trouble and expect to see a recovery once its suspension is lifted and management explains what happened.<br />
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NWBO is working on ways to make the body's immune system more effective in fighting cancer. They have two promising vaccine candidates for treating solid tumor cancers.<br />
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DCVax-L is their lead candidate for treating newly diagnosed Glioblastoma (GBM) patients; this program is at an advanced Phase 3 stage.<br />
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DCVax-Direct, their second candidate, is for treating various inoperable cancers. This program is at an advanced Phase 1/2 stage.<br />
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NWBO’s approach to treating cancer is exciting and unique because, they claim their personalized dendritic cell vaccine platform can educate and direct the human immune system to identify, find, and destroy <i>all</i> cancer cells' antigens.<br />
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Cancers are known to each carry hundreds to thousands of different antigens so it makes sense that attacking all of them is your best approach at defeating the cancer.<br />
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There are other companies developing dendritic cell based vaccines but their treatments are designed to attack a single or several cancer cell antigens so their approaches will likely have limited successes with the fight against cancer.<br />
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Celldex’s (CLDX) recently failed GBM vaccine Rintega targeted a single cancer antigen. Immunocellular Therapeutics’s (IMUC) GBM vaccine ICT-107 targets 6 cancer antigens and will likely fare better than Rintega.<br />
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NWBO’s major problem began in August 2015 when new patient screening was temporarily suspended for its lead Phase 3 trial while a regulatory review was taking place.<br />
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Management unfortunately cannot say much about this trial while regulators are investigating. But leaving investors' questions unanswered has caused many to assume the worst and the stock has continued to decline in value.<br />
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Nevertheless, I think the Phase 3 trial is unlikely to have serious problems since regulators are allowing NWBO to continue to treat patients while they are reviewing it. Regulators typically halt troubled trials while reviews take place.<br />
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NWBO have performed very strongly in past studies. In a Phase 1/2 of 21 patients, DCVax-L produced excellent safety and efficacy data; no chemo/radiation like side effects with around 24 months of Progression Free Survival (PFS), that’s a 3-fold improvement on historical standard of care (SOC). To meet its Phase 3 primary endpoint DCVax-L has to improve PFS by 4 months. I think DCVax-L has a high probability of clinical success. <br />
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Some patient data is also available from DCVax-L‘s Phase 3 trial and it is also very encouraging. NWBO is running a Phase 3 “Info Arm” for progressive GBM patients that are not eligible for their main Phase 3 trial. Median Overall Survival of 25 of these patients (rGBM) is 8 months better than the expected SOC survival.<br />
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Two European medical bodies have also been impressed with NWBO’s clinical data. The German FDA equivalent has already approved DCVax-L for compassionate use even before final Phase 3 results. The UK medical board is also considering early approval of DCVax-L. <br />
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I continue to view NWBO as an attractive long-term investment. I am
very encouraged by their clinical results so far but the risks with this
investment have dramatically increased over the past 7 months so while I
continue to hold the stock I am not adding to my position until
management can answer some of my questions.<br />
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There may be good legal reasons for management to remain quiet
considering the regulatory situation. But there is no doubt that
management's silence has shaken investors' confidence and severely
damaged their share price. Here's what I would like to know before I
think about adding to my position. <br />
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1. How many patients are enrolled in the DCVax-L Trial? <br />
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2. How many patients have been treated in European compassionate trials?<br />
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3. Are the compassionate trials suspended?<br />
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4. What is the timeline for DCVax-Direct?<br />
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My price target for NWBO is $11-$16 which makes this stock a 10-bagger candidate. In my pricing model I have only considered DCVax-L for GBM patients. I have given the vaccine between 55% and 75% chance of clinical success and a 40% market penetration. I estimate peak sales near $250M in the US and EU. Then using a price/sales multiple of 8 and discounting I get a market cap close to $2B which is in-line with valuations for its Immunotherapy peers like KITE $2.6B, BLUE $2.0B, & JUNO $4.4B. <br />
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At today’s valuation of $140M, NWBO is heavily over-sold but with high risks.<br />
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This is the <a href="http://www.forbes.com/sites/kenkam/#71307272749c" target="_blank">link to my interview in Forbes.com</a><br />
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Disclosure - NWBO is a core holding of <a href="https://791branko.mytrackrecord.com/?page=04-00-00-001&member=781">my Marketocracy Fund</a>. <br />
I do not short stocks.Anonymoushttp://www.blogger.com/profile/16640002248231948890noreply@blogger.com0