Yes, really intrigued about the 12-month preliminary findings from the phase I/IIa dose finding trial of GALE-301 (a folate binding protein vaccine) in ovarian and endometrial cancer patients to prevent recurrence.... "In the optimal 1000 mcg vaccine dose group (VG), the clinical recurrence rate is 13.3% versus 55% in the control group (CG) (p=0.02), providing for a two-year Disease Free Survival estimate of 85.7% (VG) versus 33.6% (CG), p
Same here Fraz. Didn't get them as good as a $1.34/share though (1.45 instead). MD Anderson and Mittendorf's backing (and now NIH) keeps me committed to Gale.
"If I'm SNY why not simply wait until MNKD gets into serious financial straights then snag the company for a song?"
To my knowledge, there's nothing preventing MNKD to enter into a buyout agreement with Sanofi's competition at anytime. If you believe in the science, and that Afrezza (and Technosphere) has blockbuster potential; then reliable and ethical partnering relationships yields the next best thing to "exclusive rights of purchase." IMO, Sanofi will prevent at all costs potential circumstances that could invite a bidding war among competitive interests.
Yes, really interesting commercial. IMO, whether for Neuvax or FBP, all very good for Gale and the entire "vaccine--checkpoint inhibitor" combo immunotherapy platform.
You're correct that data to be presented at ESMO is for the Phase I/IIa FBP (E39+GM-CSF) trial. The key point to take away is that upcoming ESMO data is "more developed" than what was presented at ASCO earlier this year. If you compare the pre-published ESMO abstract with earlier released ASCO data, you will find distinctions between the two. IMO, the ESMO presentation will serve as a positive catalyst, providing increased pps momentum (and support) going forward until announcement of interim Nuevax results. Also, FBP significantly strengthens the pipeline and serves to reduce overall investor risk; thereby attracting greater IO interest.
Agreed. Bondholders (2017/18) should be very nervous about debt being "unsecured" in today's challenging oil pricing environment and will undoubtedly push negotiations towards a "secured" status. I suspect bondholders/Exxi are currently splitting hairs over extension and interest reduction details. Now that the Federal Reserve decision (not to raise rates) is established, this should lend some underlying pricing support going forward; thereby helping to move negotiations along.
Well, then it's a darn good thing that the 2017 "unsecured" bond debt isn't due for another two years, and the 2018 due in three years. Not too shabby, that gives EXXI two more years to burn thru their $800+ million in cash before bondholders can get anything over interest payments. If bondholders are smart, they'll negotiate for something before then ... probably some form of "secure" debt position in exchange for extension. IMO, seems like EXXI is holding a pretty good negotiating hand.
Glad to see this press release giving updated proved reserve valuation, especially with impending restatement of financials (due to change in derivative accounting method). Noteworthy points from press release ...
"Our proved reserves decreased primarily due to production of 22 million barrels of oil equivalent ("MMBOE") during fiscal year 2015, as well as the divestiture of non-core assets, price-based adjustments, and our reduced capital expenditures due to the current low commodity price environment, ... Our Fiscal Year 2015 reserve additions of 17 MMBOE demonstrate our ability to continue to replace our reserves organically while upgrading our portfolio by delivering on the divesture of our higher cost, non-core properties... The reserves that we lost to price and reduced forecasted capital expenditures over the next five years don't simply go away; those hydrocarbons are still in the ground and as prices recover we expect to once again realize the value of those barrels ... The company has proved "and" probable reserves totaling 265.7 MMBOE, with a present value of $4.5 billion.... "
"The reserves are reported as of June 30, 2015 and "do not" include the reserves, or present value attributed to the M21K, LLP acquisition which closed August 11, 2015. At the time of closing, the proved reserves associated with the M21K, LLP assets were estimated at 13 MMBOE with a present value of $82 million at strip prices. The company is working with reserve auditors to complete those estimates. The reserves associated with the M21K, LLP acquisition have never been included in the company's reserves."
Roche is involved with Gale in the NeuVax+Herceptin Phase 2b clinical trial which is not blinded. Roche scientists should have the inside track on progress. " ...Excellent point orchids!
buyvalue, well said! All this hype about BK, Chapter 11 Reorg, restating accounting is completely uninformed and demonstrates total absence of DD research w/r/t Exii. Yes, risk is undoubtedly considerable for any oil/gas play today; however, IMO Exxi has a lot going for it when compared to other highly leveraged oil/gas companies.
Agreed. Not sure why everyone keeps splitting hairs about possible BK and Chapter 11 reorganization to cover "unsecured" bond debt that's not due until late 2017 and 2018 ... with over $800M in liquidity. It seems to me that bondholders with "unsecured" debt would want to negotiate "now" ... than run the risk of waiting 2 years for a BK/Chapter 11 reorganization to redistribute assets. As "unsecured" debt holders aren't they already near the bottom of the BK food chain (one tier above preferred stockholders)? It seems reckless to me to not want to negotiate. In two years, the company may not even have the cash reserves available (like they do now) to get some of their money back. Appears like Exxi is in a pretty decent negotiating position than people are recognizing, especially if everything checks out with the restating of earnings resulting from non-cash accounting adjustments.
Per CNBC press release:
"While these non-cash adjustments impact revenues, net income (loss) and net income (loss) per common share for each period, as well as total stockholders' equity, these adjustments do not impact the economics of the hedge transactions or net cash flows from operating, investing or financing activities, nor do they affect the Company's liquidity or adjusted earnings before interest, taxes, depreciation, and amortization ("EBITDA") for each such period."
"Down 14 cents from Tuesday's open"
Not bad, considering the downgrade and negative articles. This coming week expect pps to rebound back closer to $4. Next good news release should propel pps over $4. Spread is getting lesser and lesser for shorts to manipulate. Days are numbered.
Yup, good catch ... another tweak in the data.
ASCO ... Delayed Type hypersensitivity Reaction (DTH) increased pre- to post-vax (5.9mm+1.5 v 12.3mm+8.1, p = 0.06). DTH increase was larger in 1000 mcg pts (4mm v 13.5 mm, p = 0.039) v
Agreed, the difference between ASCO and ESMO abstracts is the reported 2 year Disease Free Survival (DFS) estimate. At ASCO is was reported as 19.2% (CG) v 85.7% (1000 mcg pts) (p = 0.09). For ESMO, 2 year DFS estimate is now reported as 24.8% (CG) v 91.7% (1000 mcg pts) (p=0.02). All other reported information appears unchanged.
Gale-301 serves as a significant investor risk minimizer (more so than Abstral and Zuplenz sales); and as such, is a powerful magnet to attract increased Institutional interest and ownership... sooner than later. I expect increased trading volume prior to the additional data readout of Gale-301 at the upcoming ESMO; then gradual, steady pps growth prior to Neuvax 70th event.
9) We should be hearing about another $25M manufacturing/supply milestone payment from SNY real soon ...
10) The refinancing debt deal will be resolved by October, or sooner.
If someone is challenged in using the Afrezza inhaler, God help them if they ever have to use a needle! The competition is grasping for straws now!