by DrKSSMDPhD | December 21, 2017 8:40 pm
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Long $AKAO – An astute observer on Seeking Alpha commented that Shionogi’s cefiderocol Ph3 study in carbapenem resistant G(-) pathogens has been delayed by almost a year – https://clinicaltrials.gov/archive/NCT02714595/2017_12_27/changes. Even if Cefiderocol is successful it looks like Plazo will have a head start by at least a couple of years.
Long $AKAO – An astute observer on Seeking Alpha commented that Shionogi’s cefiderocol Ph3 study in carbapenem resistant G(-) pathogens has been delayed by almost a year – https://clinicaltrials.gov/archive/NCT02714595/2017_12_27/changes. Even if Cefiderocol is successful it looks like Plazo will have a head start by at least a couple of years.
Fair enough. Why the delay? Bear in mind: the drug DOES very likely have good efficacy against CRE, and safety has thus far not been an issue (and seldom is with cephalosporins). Again, not a bad stock to be in ($AKAO) but just not the brightest flower in the garden here.
“Why the delay”: it really just goes to show how extraordinarily difficult it is to properly run a study evaluating a new drug against these MDRGN organisms. You have to screen properly for the pathogen, make sure the patients were not pre-treated inappropriately before administering the investigational drug and there’s a very tight window of opportunity in each critically ill patient. Achaogen did a great job with CARE, which is far more interpretable than either TANGO II or this Shionogi study and as a result, Plazomicin has the best shot at receiving a CRE-specific label, which would quite the competitive advantage and a strong selling point for potential commercial partners.
Yes, but your reasons speak to the issues at hand for slow trial progression…..not delay starting a trial. The points you make are really just everyday normative assumptions in ID trials. Why is there a delay starting the Shionogi trial? Very different issue I think. In fact CRE trials are cardinally undoable, truth be told.
NoTicker
Hi Doc, thanks for your comments. One can always tell which columnists possess relevant clinical experience – specifically, clinical trial experience as a PI. I would say with rare exceptions it wouldn’t be a SA author.
Thanks for the extremely valuable input you have already provided us after just one day.
/Helen
$REPH np. Just catching up on recent comments. I believe RECRO is lagging due to a possible financial overhang. There is a $100M registration statement, and may be a $45M milestone payment owed upon regulatory approval of meloxicam, plus a share of net sales (see note from Financial Statement below.) I held the stock for 3 years until recently as it appears there may be better #KSS opportunities.
Acquisition of Gainesville Facility and Meloxicam
On April 10, 2015, the Company completed the Gainesville Transaction. The consideration paid in connection with the Gainesville
Transaction consisted of $50.0 million cash at closing, a $4.0 million working capital adjustment and a seven-year warrant to purchase
350,000 shares of the Company’s common stock at an exercise price of $19.46 per share. In addition, the Company may be required to
pay up to an additional $125.0 million in milestone payments including $45 million upon regulatory approval, as well as net sales
milestones related to injectable meloxicam and a percentage of future product net sales related to injectable meloxicam between 10%
and 12% (subject to a 30% reduction when no longer covered by patent).
https://ir.recropharma.com/press-releases/detail/93/recro-pharma-secures-100-million-credit-facility
refinanced $100 mil in november
-rogerson
$ARTH.. apparently it’s open mic night at the conference.. picking up all the set up talks. (behind the scenes). conference starts now.
$STML…Newman Ferrara LLP Announces Corporate Governance Investigation of Stemline Therapeutics Inc. – STML. Newman Ferrara LLP announced today that the firm is conducting an investigation on behalf of shareholders of Stemline Therapeutics Inc. (“Stemline” or the “Company”) (STML) into potential breaches of fiduciary duty by the Company’s Board of Directors (the “Board”)….https://finance.yahoo.com/news/newman-ferrara-llp-announces-corporate-192400592.html
$STML, long – An excerpt from the legal firm”s press release reads as follows – “Newman Ferrara’s investigation focuses on decisions made by the Board, without shareholder approval, the result of which significantly diminish shareholder value and do not benefit the Company. Considering the Company’s lackluster performance since its February 2013 IPO, it is clear that the Board lacks the ability to fairly assess and oversee the Company’s direction and leadership.”
The company IPOed at $10.00 per share and currently trades at $13.90.
Shareholders don’t run companies; management does! Outside-firm lawyers don’t run companies and in the case of a company involved in sophisticated biotechnology have no as-yet-evidence-disclosed basis for judgment-substitution for that of management’s. Since no diminution of share price for original subscribers, and thus no loss versus today’s price, it seems a rather novel basis for a lawsuit that damages are in order because the higher price hasn’t risen to a greater extent. The fee business in lawerdom must be slow these days.
$several tickers
Finally back from New Year in the rural village and have enough internet connection to contribute again:
Personal report for 2017: my total portfolio, which is 90-95% KSS at any given time, multiplied by about 2.5 during the year. I was very lucky not to get into AUPH first time round until it was down to $2.30 ish, so that helped.
ABVX was also a big winner, and most of the rest is currently unrealised gains in APTO, BLPH and HALO calls.
Overall, an amazing result, especially considering how many TIB events we’ve had to endure too. Many, many thanks, Doc. I have not yet contributed to expenses, but have every intention of doing so.
Most amazing is that I confidently expect 2018 to surpass it…
Lumpified, that’s awesome. Well done. Only thing that I did right close to your level was $BLPH ow, up about 250%, but only in my Roth which is over half of my BLPH. You smoked it, I got hammered on $CUR, $ABIO and down on several others. But waiting on good upswings in $APTO, _$ARTH, and others.
Again, well done.
#NEW #ZKSS#BioTech Trhread: Dr. KSS Posts from Biotech Showcase 2018, San Francisco 14 COMMENTS READ MORE ThankYOU #ZKSS!
https://www.stockgumshoe.com/2018/01/dr-kss-posts-from-biotech-showcase-2018-san-francisco/ Long #Gr8Gummune! Sharing and Caring! #JOINus… ~ 😉 #GimpySoGiAm 😉
SoGiAm,. Sorry to hear about your slip and fall. For those of you who aren’t used to cold, snow and ice. One of the things I learned up here is to walk more safely in snow and ice is to walk like a Penguin. Short steps, feet pointed out and walk keeping your feet out. It increases your stability side to side, and waddle a little. It looks silly but works.
John
$EBIO $LPTX $HALO
I finally mananged to listen to the replay of the latest conference call. As ever, an extraordinary amount of information, so graciously imparted.
I heard Doc say of both LPTX and EBIO that he was going to check some details with Cleveland. He said that LPTX was a potential candidate for the 12, but I couldn’t hear if he said the same about EBIO or not. Anyone? Small position in both, btw.
The was also one question from a listener which I think Doc didn’t quite hear: about a possible price target for HALO in the event of a buyout NOT happening this year. Anyone care to speculate?
I believe $EBIO was a candidate for the 12 (sp). Btw, harsh day on the exchanges for some of my stocks. $SRRA, $MRTX, $BLPH, $ARTH AND $CWBR all down about 10% on nothing new that I can find,.
NoTicker
Investors quite often defer tax gains till the next year….thus last year’s big gainers could become New Yesrs’s losers, temporarily at least. That’s what I’ve observed and what I believe.
Yes, I got hit hard today, a lot of red. However, last week, I think on the third, every stock I had went up, except one which closed unchanged.
John
$TNDM-np
I think it was Glenn that brought this to our attention. It had a great day today….
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#KSS Expense Funding
One of the most important parts of the January Conference call
“Generosity has moved me to tears.”
January Conference Call Listen to 1:50:48 to 1:53:49
https://fccdl.in/NpIZTDFf2
Checks are still rolling in. I have decided to reopen to allow further contributions.
1) By Check: Make out to Dr. KSS MD PHD
Mail to:
Dr. KSS MD PHD
3104 E. Camelback Road #1010
Phoenix, Arizona 85016
2) By Amazon Gift Card Email To privatekss@gmail.com
Thank You !
Thank you to you Cleveland for making this kind of donation possible! I bet we’re all moved by Doc’s everlasting interest and devotion in helping us so being able to help back even a little feels like being part of something bigger.
All the best!
yours, Finn
NEW #ZKSS#BioTech Trhread: Dr. KSS Posts from Biotech Showcase 2018, San Francisco 14 COMMENTS READ MORE ThankYOU #ZKSS!
https://www.stockgumshoe.com/2018/01/dr-kss-posts-from-biotech-showcase-2018-san-francisco/ Long #Gr8Gummune! Sharing and Caring! #JOINus… ~ #GimpySoGiAm
$HTBX fp – Currebt report , 2 amendments esit in and 6 Form 4s
https://ir.heatbio.com/sec-filings-email/content/0001553350-18-000034/htbx_8k.htm
Item 1.01. Entry into a Material Definitive Agreement.
On January 8, 2018, Heat Biologics, Inc. (the “Company”) approved an amendment, effective January 1, 2018, to its employment agreement with Jeff T. Hutchins, Ph.D., initially effective as of January 1, 2017 (the “Hutchins Amendment”). The Hutchins Amendment clarified that Dr. Hutchins is eligible for an annual incentive bonus, which bonus may be paid in cash, equity or a combination thereof, and that any such bonus will be awarded in the sole and absolute discretion of the Board of Directors of the Company (the “Board”), a committee of the Board or both. Dr. Hutchins serves as the Chief Scientific and Operating Officer of the Company.
In addition, on January 8, 2018, the Company approved an amendment, effective January 1, 2018, to its employment agreement with Ann Rosar, initially effective as of April 5, 2016, as amended and effective as of January 1, 2017, to increase Ms. Rosar’s annual base salary from $225,000 to $260,000. Ms. Rosar serves as the Company’s Vice President of Finance, Controller and Secretary.
The information contained in this Item 1.01 regarding the Hutchins Amendment and the Rosar Amendment is qualified in its entirety by the copy of each of these agreements attached to this Current Report on Form 8-K as Exhibits 10.1 and 10.2, respectively, and are incorporated herein by reference.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
See Item 1.01 for a description of the Hutchins Amendment and the Rosar Amendment. The information set forth in Item 1.01 is hereby incorporated by reference into this Item 5.02.
On January 8, 2018, the Board awarded the executive officers of the Company (Jeff Wolf, Chief Executive Officer, Ms. Rosar, Vice President of Finance, and Dr. Hutchins, Chief Scientific and Operating Officer) annual incentive bonuses for 2017. Mr. Wolf and Ms. Rosar each received bonuses consisting of cash and equity awards that are consistent with the terms of their respective employment agreements with the Company. For 2017, Dr. Hutchins received a cash bonus of $77,361 as well as options to purchase 296,471 shares of the Company’s common stock (the “Common Stock”), which options are exercisable for a period of ten years from the grant date, vest monthly on a pro rata basis over a four-year period commencing on February 1, 2018 and have an exercise price of $0.40 per share.
n addition, on January 8, 2018, the Board awarded the following equity compensation to the non-executive members of the Board and its Committees: John K.A. Prendergast, Ph.D., was awarded options to purchase 190,588 shares of the Common Stock, John Monahan, Ph.D., was awarded options to purchase 95,294 shares of the Common Stock, and Edward B. Smith, III was awarded options to purchase 95,294 shares of the Common Stock. Each option issued to a non-executive member of the Board is exercisable for a period of ten years from the grant date and vest in full on the one-year anniversary of the date of grant and have an exercise price of $0.40 per share.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit Number
Description
10.1
Amendment to Employment Agreement between Heat Biologics, Inc. and Jeff T. Hutchins, effective as of January 1, 2018
10.2
Amendment to Employment Agreement between Heat Biologics, Inc. and Ann Rosar, effective as of January 1, 2018
$AUPH Dr KSS I would appreciate your perspective on when Aurinia might file for a patent extension on Voclosporin. How many patents do they need to extend, and are there any reasons to believe they might not get those extensions? How long does it take from the point of filing the request to extend the patent to get a ruling, typically?