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Don't believe so. Because if that was the case, then Moderna would have gone after Genevant for the two patents. 069 and the other patent are owned by Arbutus. Othewise the case would have been Moderna Versus Genevant for the court document.
Arbutus Biopharma fireside chat at H.C. Wainwright HBV Virtual Conference October 13, 2021 at 1:00 p.m. EST. Looking forward to some type of update on pipelines possibly other news by then.
https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-participate-october-investor-conferences
Not enough. In the court filings, it was stated that both parties spoke to each other in an attempt to settle it before the hearing and that was unsuccessful. It is likely that Moderna offered very low and Arbutus rejected it. Good for Arbutus, because if it wins 069 and the other patent, it can then ask for more. If it goes to Court (And Arbutus does hypothetically win on the patent dispute with PTAB) then Moderna is in even worse shape. IMO Moderna should have settled before the hearing, to settle after it's gonna cost them more. Because then Arbutus May have two favorable patents won, and they could ask for as much as they like in royalties.
In essence, I watched the video about the case. Bottom-line it's favorable for Arbutus Biopharma. There are two paths now:
1.) Rubber stamp of approval for protecting Arbutus' patent which could take 3 to 10 days
2.) Few weeks to few months for all 3 judges to favor Arbutus writing their opinion on why they chose to do so and what they think about the case itself.
As far reversal, based on what I heard on the hearing Moderna had not other valid argument other than " They are going to sue us" if you rule in their favor. I would have hoped they had a way to argue on the merits of the LNP technology but likely they know they stole IP.
Also all 3 judges used to be proponents of protecting patents and siding with patent companies on IP. It's very unlikely that Moderna will will on this appeal. That's just my opinion on it.
Downside would be if AB-836 Capsid inhibitor data isn't good in 2nd half 2201, or if triple combination data for 1 of the 4 studies is bad.
The only triple combo that has started so far was with Assembly biosciences back at the beginning of 2021. It will be AB-729 + Assembly's drug vebicorvir + Nrtl standard therapy for Hep B patients. Estimate by Assembly is 2022 they will reveal interim data. Not sure exactly when, but my guess would be 1st half of 2022.
Maybe downside if Federal appeals court sides with Moderna, but the Federal appeals court very rarely reverses the decision of the PTAB. For the appeals court to reverse a decision by the PTAB there would have to be very strong evidence to reverse it. In other words if Moderna can prove that it didn't copy the molecular structure of patent "069". If Moderna can't do that in court, then its in trouble. It's a huge gamble really, but the PTAB already had its initial ruling in 2020. That's why Moderna is going to the Federal appeals court, in hopes that it reverses the PTAB ruling.
"https://www.reuters.com/article/us-moderna-patent/moderna-loses-challenge-to-arbutus-patent-on-vaccine-technology-idUSKCN24O2XY"
It would have to take a miracle for Moderna to persuade the Federal appeals court to reverse the PTAB's initial ruling.
You have to know, that Arbutus Biopharma didn't initiate anything with its patent. Moderna poked the hornets nest by trying to invalidate "069". Maybe Moderna knew there might be a future problem if patent "069" remained in place.
October 7, 2021 is oral arguments in Court of federal appeals, doubt a decision would be made immediately. My theory for ABUS is that Moderna would strike a deal before that date. Unless they are fighting it, but that's quite shocking. I would think they would want to do so before the PTAB validates "069". If "069" is validated then Moderna has no recourse other than fighting it in court or make a deal after. But at that point, Arbutus could sue for 100% damages and take all of Moderna's money. Whereas now, Moderna could get away with keeping 60% or doing a 50%/50%. If ABUS wins in court afterwards it gets everything all the revenues Moderna makes.
Arbutus Catalysts for 2nd half of 2021 as follows;
1.) AB-836 capsid inhibitor data in phase 1a/1b study for Hep B patients expected 2nd half 2021
2.) Results from phase 1a/1b study using AB-729 90 mg multi dose in Hep B patients 12 week dosing interval expected 2nd half of 2021
3.) Results from phase 1a/1b study using AB-729 90 mg multi dose in Hep B HBV DNA positive patients 8 week dosing interval expected 2nd half of 2021
4.) Initiation of phase 2 triple combination study using AB-729 multi-dose 60 mg, Peg Interferon , plus standard of care Nrtl therapy treating patients with Hepatitis B expected 2nd half of 2021
5.) Not guaranteed but possible patent dispute settlement between Arbutus and Moderna on "069" patents. Court case October 7, 2021 for oral arguments.
Moderna can go argue orally that day if it wants, but I don't believe it will risk losing 100% of its revenues for Covid-19 vaccine in the hopes that the Federal appeals court reverses the PTAB ruling from 2020, where Arbutus was claimed victor in that 069 patent dispute. Just my opinion, I believe Moderna will do everything it can to avoid having to let a court decide on patent 069 validation. It is not court yet or lawsuit yet, but if the PTAB and Federal appeals court claim 069 patent to be valid for ABUS, then Moderna is done for. It knows that Arbutus will seek a lawsuit at that point shortly thereafter, it is even written in the document Moderna filed to the court. It's in Moderna's best interest to make a deal before the Federal Appeals court decides.
Catalysts of Arbutus for 2022:
1.) Initiation of phase 2 triple combination study using AB-729, Antios' proprietary active site polymerase inhibitor nucleotide, ATI2173, and a Nucleoside analogue for the treatment of Hepatitis B expected 2022
2.) Initiation of phase 2 triple combination study using AB-729 with Vaccitech's Immune modulating treatment VTP-300, plus nucleoside analogue for the treatment of patients with Hepatitis B expected 2022
3.) Assembly Biosciences will give update on partnered with Arbutus phase 2 triple combination for Hepatitis B; This includes AB-729 + Assembly's Vebicorvir + nucleoside analogue for treatment of patients with Hepatitis B expected 2022
4.) Possible updates in 2021/2022 on oral pan corona virus antiviral drug for Covid-19 to also be able to fight any future strains as well.
you normally just buy the stock and have the mindset of letting it sit for 5 to 10 years. Biotechs just take time to rise. You remember PCYC? Pharmacyclics? For 10 years it traded at around $1 per share, reached about I believe $264 per share on a buyout. With biotechs you have to have a 5 to 10 year investment horizon. It doesn't always work out though as they are risky, but typically it takes years before the stock really gets moving. Arrowhead Pharmaceuticals sat at $3 per share for years before moving up I remember seeing it.
The Chief Scientific Officer of Arbutus Michael Sofia started Pharmasset and found the cure for Hepatitis C Sovaldi. Gilead Sciences bought pharmasset for $12 billion I believe. Anyways the main thing is he's an expert in antiviral drugs, thus why they are researching pan corona virus oral antiviral drug with Proteos and Xchem. Their oral drug is intending to treat current Covid-19 and any future strain that comes after that.
As far as AB-729 that falls under the assets for RNA interference drugs from Tekmira. Ian M. disovered the LNP for all RNAi companies you see now like Alnylam, Arrowhead, Dicerna etc which use the LNP GalNac or LNP to deliver the RNAi material into cells. Without the LNP tech they would not be able to get the drug to reach the cells.
Thus, Moderna uses LNP to do so for its products, including the MRNA Covid-19 vaccine it has now. It claims that its molar ratios for the patents are out of range, but the PTAB has already ruled in Arbutus favor once in 2020. Now it's on appeal in Federal court for oral arguments set for October 7, 2021. Federal appeals court doesn't normally reverse the ruling of the PTAB, so this is bad news for Moderna and great new for Arbutus Biopharma ABUS.
You think that's good for ABUS? Wait till you see what's coming nextt.
Not only a federal appeals court oral argument hearing October 7, 2021, but a patent is expected to be given October 12, 2021. It's on the official PTAB patent site USPTO
The Patent Office website was updated this morning to show that an "Issue Notification" has been mailed to $ABUS for the new patent application that was recently allowed. That means that the new application will issue as a patent in the next few weeks. $MAAC https://t.co/QW6EAazsDV pic.twitter.com/wpuZ3hEgTj
— Patent Pundit (@PunditPatent) September 22, 2021
Multiple catalysts expected in the 2nd half of 2021. About 4 to 5 catalysts incoming results from HBV and trial initiations for AB-729.
Also conference in a week and half likely new slides and data update possible there too. Also expecting update on AB-836 capsid inhibitor results for phase 1a/1b study.
Federal appeals court hearing between Arbutus and Moderna for oral arguments is October 7, 2021. I believe the stock should start to climb heading into this event. Best of luck to all ABUS shareholders.
Not only that, but we got multiple catalysts coming soon in just days/weeks
We are still waiting for 2nd half 2021 readout of 90 mg multi-dose AB-729 in both hep B patients and HBV DNA positive patients, data for AB-836 capsid inhibitor in Hep B patients, and trial initiation announcement for AB-729 plus PEG interferon alpha, plus Nrtl SOC therapy . All these catalysts are expected any day now in 2nd half 2021. My guess is that pre-market Monday we get some news on one of these catalysts, or other possible update. Also a bonus would be an update for the pan corona virus oral drug it is working on as well with 2 other companies.
Arbutus Biopharma has soared, likely to get bought out or high level royalties from Moderna for Covid vaccine. This is a goldmine stock in the making. Even better there are 4 to 5 catalysts expected in the 2nd half of 2021. Multiple data readouts and trial initiations. Good things to come I expect ABUS to continue its climb.
https://seekingalpha.com/news/3738496-arbutus-rises-15-on-apparent-patent-fight-win-with-moderna
Looks like you were way off base lol. Going to be trading much higher now. I hope many listened to me, you would be raking in money right now with ABUS.
Nice, every 8 weeks data for Hepatitis B is superb. Buyout material for sure in a year or so for ABUS.
https://www.globenewswire.com/news-release/2020/12/10/2142964/0/en/Arbutus-Announces-Robust-HBsAg-Decline-Data-with-AB-729-Dosed-at-60-mg-Every-8-Weeks-in-Chronic-Hepatitis-B-Subjects.html
The MRNA vaccine is a part of the volume, I think the other is that ABUS is expecting additional Hep B data any day now before the end of 2020 which is a major catalyst.
What some on here on this board don't understand is that ABUS can move on to dose once every 8 weeks or possibly once every 12 weeks. They claim there was nothing proven, on the contrary this was proven. In addition, 3 patients are still experiencing declines in Hep B surface antigens with no plateau seen to date in multi-dose 60 mg.
Arbutus is the best Long-term Biotech to own. Why?
1.) Because has chance to dose AB-729 once every 8 or once every 12 weeks. Future combinations could prove to be cures. Either all oral combo or AB-729 with other drugs
2.) ABUS collects payments from Alnylam for onpattro and has several other licensees for technology. Also may end up getting royalties through genevant for Pfizer/Biontech vaccine sales and Moderna Vaccine sales
3.) Pan coronavirus antiviral drug being developed. With Sofia having knowledge in antivirals company is working on a potential antiviral drug that could not only target the current coronavirus but any other type that mutates in the future. I consider this a long-term play on spike coronaviruses or any other viruses that may arise/mutate.
4.) PD-L1 1st generation. If you look at the pipeline the goal is to develop the company's own PD-L1 drug. Well it will be attempted with the Hepatitis B combination, but it could also become a multi-billion dollar drug targeting cancer like Keytruda, Opdivo, Avelumab, Tecentriq etc.
Based on everything this company currently shows in Hepatitis B with AB-729 and so much potential I believe it is a future buyout candidate at around $20 per share or higher. It's just that investors have to be patient with this one to achieve that goal. Even if it takes 2 years, which nobody knows, I feel ABUS will eventually be bought out.
Of course it does. ADXS drugs Lm restore sensitivity to checkpoint inhibitors like Keytruda and Opdivo. ADXS-PSA being combined with keytruda has already shown to increase median overall survival compared to chemotherapy. It was even better in those prostate cancer patients with visceral metastases 16.4 months versus 9 months or so. I expect an advancement of ADXS-PSA to phase 3 with Merck.
Blueeyedcatch I agree on that. I see Merck forming a partnership with ADXS. The way I see it is like this.
First, it will form a partnership with upfront cash/milestone payments for ADXS-PSA. It's already in collaboration as a keynote study and is a phase 3 ready asset. That means most of the hardwork has already been done. Merck just has to take it through the finish line.
Second, there was an article that was linked the other day about the good data that was achieved in NSCLC using ADXS-503. Being that Merck makes 70% of its Keytruda revenue in NSCLC, it needs to keep this market. If adding ADXS-503 enhances keytruda, that will be a godsend for Merck.
Which is why I predict that Merck will not only partner with ADXS in the short-term, but ultimately it will buy it out in a large deal.
There is always a risk in biotechs, but based on the data for ADXS-PSA it is either going to phase 3 or going to get a partnership with Merck for upfront cash. Even then, there is also a chance for Merck wanting to gets its hands on HOT for NSCLC. So multiple chances. I believe there will be a positive announcement next week. Plus we got additional catalysts coming this month.
ADXS is green now. There is a CC on earnings and a business update at 11:00 a.m.. More than likely good ADXS-PSA update. I'm expecting a partnership announcement or another partnership with HOT. Either way, I view today's announcement as good news.
They didn't say a CC to announce earnings. Read the wording
"announced today that it will release financial results for the second quarter ended April 30, 2020 before the market opens on Thursday, June 11, 2020. The company will host a conference call at 11:00am EDT on the same day to provide a business update."
The company will host a conference call the same day to provide a business update being the key thing.
https://finance.yahoo.com/news/advaxis-host-second-quarter-financial-120010489.html
ADXS bounced from the low today at .69 but went right back up. It's holding this level well. Just need the ADXS-PSA next steps expected 1st half 2020.
Correct currently Merck's Keytruda is with chemotherapy to treat patients with lung cancer. Either primarily with chemotherapy or alone as a monotherapy to treat NSCLC.
There are many biotechs looking to target NSCLC including Bristol-Myers Squibb but they are all in the clinic at the moment. MY interest is that Advaxis Lm listeria tech (HOT) and non-HOT diminishes the tumor microenvironment, that allows Keytruda to be boosted (or work 100X better) because of that. In essence, Advaxis' tech creates a weakness in cancer for Keytruda to exploit.
Therefore, my focus is that ADXS-PSA, ADXS-503 already have shown to boost the effects of Keytruda. Merck is always wanting to find something that boosts its multibillion dollar drug Keytruda.
Well, Blue my logic on it is that Merck will do well to watch ADXS. This is what I expect in the short-term for ADXS.
1.) Merck advances ADXS-PSA with Keytruda to phase 3 study and funds it (possibly partnership with milestone payments/upfront payment not totally guaranteed but highly likely)
2.) ADXS-PSA gets accelerated approval and moves to complete/submit phase 2 for FDA approval
3) Merck buys ADXS. Why?
Because ADXS-PSA boosts Keytruda in mCRPC and the prostate cancer market which is a $13B market opportunity. Since ADXS-PSA is ready to move phase 3 that would be huge.
Another reason why is ADXS-503? Well why is that special? That's because Merck gets roughly about 65% of its revenues with keytruda in the Non-small cell lung cancer market. ADXS-503 combined with Keytruda has already shown to boost keytruda in NSCLC. Those patients in the study had failed monotherapy Keytruda and 4 prior lines of treatments before being given combo of ADXS-503 and keytruda. There was 1 PR and 1 SD tumor shrinkage.
ADXS-504 is another prostate cancer drug but the HOT version like ADXS-503. However, ADXS-504 is targeting front-line prostate cancer therapy before a patient is given anything else.
All these points above are why Merck will eventually acquire ADXS in my opinion. I don't think it will happen right away.
The first thing to drop will be ADXS-PSA partnership or advancement to phase 3.
However based on what I laid out above Advaxis will eventually be bought out. Not right away, but it will eventually will be if ADXS-503 and ADXS-504 deliver in the clinic.
ADXS-503 already has been delivering good data. ADXS-PSA is already golden goose passed phase 2 study in patients with mCRPC.
It will be fine. If one is a long-term investor the major update is on ADXS-PSA "next steps" expected 1st half of 2020. If it is announced that Merck funds the phase 3, gains accelerated approval, or Merck generates a license agreement, the stock goes to $3 or $4 per share instantly. It's risky sure, but with ADXS-PSA data released already my bet is on partnership with Merck for ADXS.
ADXS-PSA has already boosted Keytruda in mCRPC.
40+ patients saw a median OS of 33.7 months and not yet reached.
Visceral metastasis was 16.4 months for ADXS-PSA + Keytruda and then for chemotherapy combination it was 11.3 months.
Merck will likely advance ADXS-PSA to a phase 3 IMO.
I still see good things coming from ADXS. New data out on ADXS-503 and Keytruda will eventually get bought out or partnered with Merck it's inevitable.
https://www.globenewswire.com/news-release/2020/05/14/2033458/0/en/Advaxis-Announces-Updated-Positive-Clinical-and-Biomarker-Data-from-Ongoing-Phase-1-2-ADXS-503-Trial-in-NSCLC.html
I agree with everything you said, ADXS is in good shape.
It says is plainly in the 8-K SEC form that was filed by ADXS.
Shares can be sold from time to time at Advaxis Discretion at any price. This is not something they are going to use right away in one big dilution. Later on they can say for example sell $1 million worth or $2 million worth of shares. The projection now for CAsh is Q3 2021. Logic is there is no dilution in the near term. That ATM is just a rehash of upping the filing in case they eventually need to use it.
Also look in the SEC form. It states there is no assurance that it will even be used.
https://www.sec.gov/Archives/edgar/data/1100397/000149315220008067/ex1-1.htm
There is no new dilution for ADXS, don't listen to trolls. CAsh was just updated to Q3 of 2021. Lots of new updates in 1st half 2020 and 2nd half of 2020.
Announcement of ADXS-PSA next steps 1st half 2020.
New slides
https://www.advaxis.com/static-files/a8e57f20-9bd1-416c-8532-3c2595e53756
Some good movement for ADXS lately. Lots of catalysts expected 1st half 2020 and only 2 months left to release them. Got possible AXAL data, next steps for ADXS-PSA possibly phase 3 study advancement and a lot of clinical data. I expect the stock to reach 1+ in coming days.
Lots of catalysts coming for ADXS. More than likely update on next steps for ADXS-PSA with Merck. Phase 3 or partnership takes this stock over $1
Management gave themselves options and a huge increase. I think we got good data coming in the next few weeks for ADXS.
Really good close for ADXS, volume pouring in. I believe that there is news on the way soon. GL to all
I'm glad you like them. I appreciate your kind words sir.
What are you rambling on about? They got the notice they have until October 2020 to get over $1 per share for 10 consecutive days to avoid possible Delist. Even then if you read the filing, which I highly doubt, it states that if the company doesn't get over $1 per share by then it can transfer to the other NASDAQ market and get another 180 days. With all the catalysts ADXS has coming it will be north of $1 way before then.
Good article for Advaxis ADXS talking about the pipeline.
https://seekingalpha.com/article/4332116-advaxis-is-one-biotech-should-be-on-your-radar-targeting-large-nsclc-and-prostate-cancer-drug
You are right, that's why I bought a lot of ADXS during that day! I think Ken Berlin hinted at a partnership with Merck for ADXS-PSA.
Soon TRIL will gap higher. Best in class CD47 product to date, nothing else beats it in this space so far.