By a: “ Most interesting info from earning call:
Dosing 4800 phase 3 and Dr Kim confirmed that WHO trial may expand to next generation Covid vaccine. If I recall correctly, FDA allows to bridge the next version of vaccine to the phase 3 trial of current vaccine, so WHO can do the same or even more flexible to speed up the the next generation vaccine.
An awesome scenario for INO would be getting EUA for 4802 in Q1 2022. It is possible by starting phase 1/2 of 4802 later this month or early next month.
1. Do phase 1 of 4802 in Columbia and Philippine later this month or next month. INO completed pre-clinical trial and published the result. INO may be waiting funding to next phase, but it may be smarter to fund itself to speed up the process. The cost of doing phase 1 in Columbia or Philippine is not expensive.
2. In the mean time, INO 4800 phase 3 trials continues
3. Early phase 3 4800 and phase 1 4802 readouts in Jan
4. From the early results of both 4800 and 4802, WHO would fund and start an express 4802 phase 3 trial (skip phase 2, and smaller scale phase 3?), and allows to use phase 3 data of 4800 to partially support 4802.
5. From Jan to Mar, expect to receive EUA from China and some countries participated in the trials.
6. In a wonderful scenario, China and some countries may grant EUA for INO 4802 in Feb to Apr.
INO 4802 would be the first pan covid vaccine to receive EUA.
Certainly, PFE, MRNA, NVAX has been actively developing pan covid vaccine. mRNA has more advantage in speed, but due to the nature of their vaccines, their scientists may still not be able to resolve increasing side effects with boosters in short time. It may take even more time for NVAX to have pan covid vaccine.
The big advantage of INO is to give booster without concerning increasing side effects as it was confirmed from phase 1,2, booster trials while MRNA, PFE vaccines recorded increasing side effects after second doses from their trials.
Imagine 4802 get EUA and the newer Covid variants beat current vaccine badly. INO 4802 would be the game changer and take most of entire Covid market. As Dr Kim had mentioned last call, mRNA had good time, but INO DNA time will come. I think INO 4802 will not play as an support role of providing booster, but as central role of main vaccine against new Covid variants. With increasing covid cases in EU, Asia, and lack of vaccine in other parts of the world, new variants will come just a matter of time, and how dangerous they are.”
By StockHound “ 1. We beat earnings estimates, great, but we still took a loss of -.29 however was less that last earnings and expected.
2. Our burn rate was around $60M, which was as expected.
3. We still have $394 in cash, cash equivalents and short term investments
4. Even more countries are expected to join the P3 INNOVATE trial. This in itself is a mystery, why didn't INO provide clear P3 protocols, more specifically around number of participants. Their P3 trial seems likes its an open book, allowing more countries to come and participate at will. I feel, since the WHO solidarity trial is running parallel with INNOVATE and both have the same design and endpoints, it really doesn't matter who finishes first, the data will likely be the same. Inovio is using their INNOVAITE trial to lock down countries for future EUA, advanced orders and eventually full licensing. They can slow step their part of the P3 focusing on their future market while Solidarity powers through with their few select sites. this way, they get the data at rapid speed and a wide range of potential clients.
5. Stright from the man himself, Kim confirmed P3 dosing for INNOVATE has started.
6. Africa to soon follow in P3 INNOVATE
7. LOL, 99% of the P1 participant pool for 4800 opted for the booster dose. If this doesn't tell you something, you need to open your eyes.
8. VGX-3100 with Quigan biomarker data due by EOY
9. INO-5401 data due end of THIS WEEK, they seem very excited for the data
10. Everyone one of the analysts congratulated Kim on his recent successes and FDA hold lift, upgrades to follow?
11. Oppenhimer analyst Hartaj Singh asked what Inovio's plans are to launch INO-4802 as a booster after INO-4800 has launched. This is a forward thinking statement, showing his strong confidence that INO-4800 will go to market. Sounds like a done deal.
12. Columbia outreached to Inovio, not the other way around. These countries see the true data and is now approaching INO to be included in P3, this connects back to my #4.
13. Regarding the IP for the Cellectra 3PSP device, Kim says there is no overlap with the US government as they had previously help fund the development and scale up. He did say "I don't believe there is" which is a weak statement. Will need to keep a closer eye on this.
14. Kim said it's a board range when saying the data is due in the 1st half of 2022 because of the Interim data endpoints. The data could be sooner based on if the endpoints are met sooner.
15. Kim said INO is the LEADER of the 2nd generation vaccines
16. Getting India on board in P3 was very significant as they have already reviewed and developed an approval process for another DNA vaccine. It will be quicker to get approval there than anywhere else at the point.
17. They are still preparing to scale up 3PSP production once advanced orders are made
18. Kim's closing words were that they feel INO is in a transitional period going to a commercialization in the next several quarters. In my words, 6-9 months we'll be on the market. Anything can happen in the interim, funding, orders, data, etc. “
