There are many questions that come up in this forum that could be answered by a careful listen to the analysts day presentation available still on the HALO website.
Fezz, please forget about the naysayers. The fact that they didn't already know this when you brought this up severely undermines their credibility. Don't answer them. If they can't be bothered to listen to that important presentation, or didn't understand it's many important implications, they don't deserve response here. Either they intentionally mislead or they aren't serious investors.
Please continue with your DD. And thank you for sharing. I don't always agree with your interpretations but you do come up with the occasional gem which is more than can be said about your critics.
doing great, Sudn. Thanks.
With the fire sale this past year, I more than doubled an already very large position in HALO. I am hopeful. :-)
In the early 00s, I didn't care for AF much. He didn't like some of the companies I liked. Unfortunately for me, he was usually right. Fortunately for me, I can learn from my mistakes and now I always pay close attention to his critiques.
AF likes HALO...
projected for 2015 is 100 million with 35 million in Q1, frontloaded for stocking.
Of course, you are correct. After all, my information is from your posting of quotes from the Bax cc.
Sorry about the sloppiness. So, 35 million sold in Q4 and guidance for 100 million in 2015. You have speculated the guidance may be conservative and, I agree, it seems like a surprise to the upside would not be much of a surprise. Thanks
Yes, this 'peak' is the conservative Bax peak for current indications, assuming only a modest transfer of market share from other companies. The sky is truly the limit for Hyqvia in other indications. Interestingly, the ease of home use of Hyqvia may be a big factor in opening up those other indications. That said, I think PEG revenues will likely dwarf others by the time Bax is making enough immunoglobulin to penetrate these markets. As you know, they don't have enough as it is right now.
It doesn't have to make us much. Just enough to help offset the next raise until after PEG is approved. (That, along with other Enhanze revenues, milestones, and perhaps a PEG marketing partnership for the EU or Japan.) It is in Baxter's interest to sell Hyqvia. 100 million is just the start. I'm not worried about trusting them.
I haven't been around HALO yet two years, so I don't have the cynicism born of failed attempts and misfires that you might have. I just know this company now has experienced leadership, lots of cash, more coming in at an ever faster rate, and a proprietary product that works. There is little doubt about PEG's efficacy. The main worry, as you noted, is safety. But you see, I have been around biotech, and have been an investor since Genentech started up, and I have seen some pretty toxic chemicals come to market. (The clot buster, TPA, comes to mind.) When the goal to fight a deadly cancer, toxicities are tolerated. I like the risk/reward here.
Told to check out ADXS by sudnwealth and my initial impressions are positive. Looks like a great analyst day - I will try to listen over the weekend. Please help me with my DD. Are there any other presentations or summaries that you suggest I ingest? In particular, I'd love a good breakdown of the financial plan. They will need to raise in the next year, no? Is there a positive result anticipated that might boost the SP ahead of a raise? If not, why not wait until the raise to buy here?
thanks a lot
I'm not Donjay. New to this board but have been investing in biotech almost as long as I've been going to shows. Nice to see heads here. My envelop got in. My postal money order has been cashed. Just need to here about tix... If we are lucky, will be celebrating in Chicago.
Interesting. Thanks, Sudn. But I do not hold much hope for breakthrough status in 2015. Perhaps 2016.
As you know, I am very bullish on HALO. It is my largest holding. But sometimes I feel it is my duty to put the brakes on what I consider unrealistic expectations. I think the upcoming meeting between Torley and the FDA is about what a Ph 3 will need to show. My hopes are there might be two stages with some early stage able to be combined with Ph 2 safety data to possibly qualify for breakthrough status.
At present, we have been shown some very early 202 data. The results are outstanding and the fact that this cohort had an interrupted course suggests those in the second half of the study with full uninterrupted pEG dosing will do even better. That said, we are missing consistent prospective high HA tumor identification.
The post-halt cohort of 202 didn't start enrolling until July. They are probably still enrolling the last of the 100 subjects now. It will likely be a year from now before the data is mature enough for the FDA to consider it. Remember that the subjects from the first cohort, that we were treated to some early analysis at Analyst's Day, started the trial in 2013, and even that wasn't mature.
In addition, all of these subjects had their HA status determined by a method that will not be used commercially when PEG is approved. In fact, IIRC, more than half never had their HA status determined at all for the ORR analysis. And when there is NO therapeutic effect shown for addition of PEG to chemo on those with low HA, and, likewise, NO therapeutic effect for PEG on the cohort that did not have PEG status determined, then you can conclude that new HA test will become key to final approval.
What I hope for is that the FDA tells Torley that the safety data from the Ph2 202 study will be sufficient, but that there needs only to be shown efficacy with ORR in a cohort identified prospectively with their new HA test in a small cohort inside a l
Did it cut me off? :-)
inside a larger ph 3 study that has official measured outcomes of PFS and OS. That way we might hope for breakthrough approval by late 2016. That would be a wild success.
Many other milestones along the way will continue to propel HALO upward.
I picked up some last week. My MO is to average into new stocks over a few months, so I will likely be buying more. My two largest holding are HALO and NVAX. Another half dozen round out the fotd biotech fund. ADXS is rising but, heck, I haven't even got thru that 2.5 hour analyst day presentation yet... My day job, and my kids, are keeping me too busy right now.
Breakthrough status is rare, but becoming more frequent in the past year. It is a MUCH better status than fast track because it will allow for FDA approval on less than completed Ph3 data. That could save years in development. Fast Track status only gets you priority reviews and the ability to work more closely with the FDA on trial design.
I believe that fezz is correct that PEG could qualify for Breakthrough status. I am just qualifying his comments to opine that the FDA will require HALO to first show efficacy in a cohort prospectively chosen with the new HA test - and that will take at least another 18 mos, probably longer.
(Reuters) - An experimental therapeutic vaccine from Danish drugmaker Bavarian Nordic helped significantly extend survival in patients with advanced prostate cancer, according to results of a small early-stage trial conducted by the U.S. National Cancer Institute.
Patients were treated with the company's Prostvac vaccine, in addition to escalating doses of Bristol-Myers Squibb Co's Yervoy, an approved injectable treatment for advanced melanoma that works by taking the brakes off the body's immune system.
On average, patients taking both drugs survived 31.3 months, compared with a predicted survival period of 18.5 months that had been based on historical survival data for older chemotherapy treatments.
Among the 15 patients who received the highest 10 milligram dose of Yervoy in combination with Prostvac, 20 percent remained alive at 80 months.
Data from the combination trial were especially impressive, considering that Yervoy had previously failed in Bristol-Myers' own trials to prolong survival in patients with advanced prostate cancer.
Yervoy and an emerging group of immuno-oncology drugs called PD-1 inhibitors from Bristol-Myers, Merck & Co and other drugmakers are expected to have greatest effectiveness when used in combination. The PD1-inhibitors make cancer cells more visible to the immune system, removing their natural camouflage.
Prostvac is a prostate cancer vaccine regimen consisting of a recombinant vaccinia vector as a primary vaccination, followed by multiple booster vaccinations employing a recombinant fowlpox vector. Both vectors contain the transgenes for prostate-specific antigen (PSA) and multiple T-cell co-stimulatory molecules (TRICOM). The PSA-TRICOM vaccines infect antigen-presenting cells (APCs) and generate proteins that are expressed on the surface ..
March 4, 2015 |
Determined to stay ahead of the growing pack of rivals in immuno-oncology, Bristol-Myers Squibb ($BMY) has swooped in with $60 million upfront to gain an option on Bavarian Nordic's Phase III therapeutic prostate cancer vaccine Prostvac, ready to shell out an additional $915 million-plus in milestones if it takes the next step to license and ultimately commercialize the therapy. In the meantime, Bristol-Myers--which has now committed up to $2.6 billion in three new cancer R&D deals over the past two weeks--and its new partner are hatching plans for a slate of combination studies.
If Bristol-Myers does take the next step, it will be on the hook for another $80 million payment, more than $230 million in development milestones if the therapy tops its Phase II efficacy results, $110 million in regulatorymilestones and $495 in sales milestones. The Danish biotech will manufacture Prostvac and also stands to earn a double-digit royalty.
More from the same article. This deal shines a light on the value of cancer vaccines in the new era of checkpoint inhibition. Cancer vaccines are back in and ADXS has the goods:
Bristol-Myers' deal today could go a long way toward reviving expectations for cancer vaccines, which have experienced a multitude of setbacks in the clinic at Merck KGaA and elsewhere. The pioneering cancer vaccines just haven't had the efficacy punch needed to prove their value. But with checkpoint inhibitors like Bristol-Myers' leading program for Opdivo stealing the limelight in cancer R&D, leaders in the field are demonstrating a renewed interest in matching a therapy that can jump-start an immune attack on specific cancer cells with new therapies that are taking the brakes off an immune system assault.
Obviously, we've been looking for a partner for some time," Bavarian Nordic CEO Paul Chaplin tells FierceBiotech. In the early days the field's risky profile had an effect. But with the arrival of checkpoint inhibitors and the booming market for collaborations, the pendulum swung in Bavarian Nordic's favor, particularly as new data rolled in on Prostvac's efficacy.
"The world has changed," adds Chaplin, pointing to the large percentage of cancer patients who don't respond to the checkpoint drugs and could well benefit substantially by adding a cancer vaccine. "I think we became quite popular in the last 18 months."
Bristol-Myers already has a mid-stage combination study underway with Prostvac and Yervoy to test that theory. More combo studies are being planned, according to today's announcement. And just days ago Bristol-Myers and Aduro noted that they had begun a midstage study of a combination therapy that includes Opdivo and GVAX, one of the failed cancer vaccines that has now come back into the spotlight.
I appreciate you pointing me here. ADXS is already my third largest biotech position. Despite the run-up, it is still a great value.