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Inovio Pharmaceuticals, Inc. (INO)

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  • U
    Uncle
    Count on the Advancement of DNA Medicine with Inovio Stock
    INO stock could have a breakout moment anytime as next-gen science moves forward

    By Louis Navellier and the InvestorPlace Research Staff, Editor, Growth Investor Nov 30, 2020, 3:41 pm EST

    Too often, traders tend to pigeonhole certain stocks. For example, some folks might think of Inovio Pharmaceuticals (NASDAQ:INO) as a Covid-19 vaccine company and INO stock as nothing more than a novel coronavirus stock.

    Don’t get me wrong. Inovio absolutely is part of the nationwide and global battle against the coronavirus. But there’s no need to pigeonhole INO as just a coronavirus stock.

    The company works diligently to develop DNA medicines to treat a range of infectious diseases and cancers. There’s positive news about Inovio’s development of its Covid-19 vaccine candidate, INO-4800, but there’s also good news in other departments.

    Therefore, it’s worth investigating both Inovio’s Covid-19 vaccine efforts as well as the company’s progress in other areas. That way, you can get a complete picture of this fascinating biotech company with breakout potential.

    INO Stock at a Glance

    If the market is telling us anything about INO stock, it’s that the shares are underappreciated and undervalued. You might even say that INO is one of the biotech sector’s most compelling bargains at the moment.

    INO stock achieved its 52-week high of $31.71 on June 29, but somehow the market decided that this wasn’t the right price for the stock. As a result, a gradual sell-off commenced.

    At the close of Nov. 24, INO stock settled slightly above $10 per share. Sometimes people say that they like to buy low and sell high. When the time comes to buy a stake in a promising company at a low price, however, those same traders tend to chicken out.

    If you hesitate, you might miss out on a rare opportunity with INO stock. Even if you’re only thinking relatively short-term (i.e., as a swing trader), there’s potential here. INO has a tendency to spike quickly from time to time, just like it did in mid-September. This could easily happen again if there’s good news.

    Not Just Covid-19

    I’m going to take a different approach from many commentators and veer away from the topic of Covid-19 vaccine candidates. Let’s not discount the significance of the other conditions that Inovio is working to address.

    One example is INO-3107, Inovio’s DNA medicine candidate designed to treat Recurrent Respiratory Papillomatosis (RRP). Inovio just dosed its first subject with INO-3107 in a Phase 1/2 clinical trial for this condition.

    RRP is a very unfortunate and rare ailment. Caused by certain types of human papillomavirus (HPV), RRP is incurable and causes non-cancerous tumor growths that lead to life-threatening airway obstructions.

    Usually, surgery is used to treat RRP. Furthermore, sometimes patients need multiple surgeries, which can severely impact their quality of life. The U.S. Food and Drug Administration (FDA) already granted INO-3107 Orphan Drug Designation, so it’s great to hear that there’s progress in developing this less invasive treatment.

    Advancing Other DNA Medicines

    For Inovio, INO-3107 isn’t the only DNA-based medicine that’s showing progress. It’s well documented that the FDA cleared the Covid-19 vaccine candidate, INO-4800, to proceed with Phase 2 clinical trials.

    Yet, let’s also acknowledge the progress in other areas. Encouragingly, Inovio recently announced that its DNA medicines INO-5401 and INO-9012, in combination with PD-1 Inhibitor Libtayo (cemiplimab), are under review in the treatment of newly diagnosed glioblastoma multiforme.

    This condition is a type of cancer that starts in the brain. Under certain conditions, the described combination of INO-5401 and INO-9012 appears to demonstrate a well-tolerated safety profile.

    Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, clearly sees the potential of Inovio’s work in this area:

    “We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients.”

    The Takeaway

    Yes, it is possible to take a bullish stance on INO stock because of INO-4800. Inovio’s Covid-19 vaccine candidate does hold great promise.

    However, there’s more to Inovio than INO-4800. Just as Inovio isn’t just a horse in the vaccine horse race, INO stock isn’t just a coronavirus stock. That’s why I’ve given it an “A” rating in my Portfolio Grader.
  • U
    Uncle
    mRNA-P1PR-took-4-mos 7/14-11/12. Ino-submitted 7/31, should-be-published-12/2-NEJM

    Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)

    July 14, 2020 at 5:14 PM EDT

    An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
    List of authors.
    Lisa A. Jackson, M.D., M.P.H., Evan J. Anderson, M.D., Nadine G. Rouphael, M.D., Paul C. Roberts, Ph.D., et al., for the mRNA-1273 Study Group*

    November 12, 2020
    N Engl J Med 2020; 383:1920-1931

    P1PR will likely be published online in NEJM Wed, 12/2/20. Now that P2-starts, the reviewers have no reason not to accept and publish.

    P2 funding for 400 ppl, $50K/per, $20M must have been disbursed for P2 to start. Considered a material event, It’d show up immediately in 8-K and eventually in 10-K soon!!

    P3:6187 ppl, $309.35M. Total $330M could be announced in whole (likely) or in part as P2/3 are combined in a single FDA ClinicalTrials ID. CEO Joseph Kim might have waited for P3 hold lifted after 3PSP questions are satisfactorily answered to announce $330M.

    Inovio responds to questions about experimental Covid-19 vaccine, awaits ruling on late-stage trial
    John George, Senior Reporter
    Nov 2, 2020, 4:33pm EST
    Inovio said Monday it has responded to the Food and Drug Administration's questions about its experimental Covid-19 vaccine and the vaccine's delivery device.

    The federal agency now has 30 days to respond, from the date it received Inovio's answers, and let the Plymouth Meeting biotech company know whether it can begin late-stage testing of its INO-4800 vaccine candidate.

    Inovio declined to say exactly when it submitted its response.

    "We look forward to hearing back from the FDA in November and continue to prepare for a planned phase-II/III trial of INO-4800," Inovio said in a statement provided to the Philadelphia Business Journal. "As a reminder, the partial clinical hold by the FDA is not due to the occurrence of any adverse events related to Inovio’s ongoing expanded phase-I study of INO-4800, which has continued, and does not impact the advancement of Inovio's other product candidates in development.”

    On Sept. 28, Inovio (NASDAQ: INO) disclosed its planned phase-II/III clinical trial for INO-4800 was going to be delayed because the FDA had raised additional questions about the experimental vaccine and Inovio's Cellectra 2000 device used to deliver the vaccine.

    Inovio, one of more than 125 life sciences companies around the world working on a potential Covid-19 vaccine, had hoped to initiate the late-stage clinical trial by the end of September.

    Big Pharma companies AstraZeneca, Pfizer and Johnson & Johnson, along with small biopharm companies Moderna and Novavax, have advanced vaccine candidates into late-stage clinical testing.

    Both AstraZeneca (NYSE: AZN) and Johnson & Johnson (NYSE: JNJ) had to temporarily halt their late-stage studies because of unexplained illnesses of study participants. Regulators and independent committees overseeing the studies have since determined both trials can safely resume.

    Inovio's INO-4800 vaccine candidate is a DNA-based vaccine the company developed in a partnership with the Wistar Institute in Philadelphia and others. The vaccine's proprietary Cellectra delivery device, developed by Inovio, delivers the vaccine into the patient’s skin using an electrical pulse in a process that takes only a few seconds.

    The hand-held Cellectra device administers a brief electrical pulse to reversibly open small pores in skin-area cells. Once inside the cell, the vaccine's DNA plasmids instruct the cell to produce the targeted antigen against the virus.
  • J
    JagerMeister
    🚀 Reposting from Tom K. 🚀 Clinical Trial has 400 participants.for P2 and P3 has 6178 participants which is inline with what INOVIO had hinted to earlier 6k for 94% effectiveness for highest Covid19 risks this would mean funding at $308.9 million for P3 and 20 mill for P2 for a whopping $328.9 mill plus $71 million Cellectra and the $148 mill for the cost of the doses at 19 per dose 7.8 mil active and civilians for grand total of $547.9 mill from DoD. Shows it has not started as of Nov.24th but could mean FDA P3 lift and DoD funding announcement this week or next. https://clinicaltrials.gov/ct2/show/NCT04642638
    Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure - Full Text View.
    Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure - Full Text View.
    clinicaltrials.gov
    Bullish
  • c
    cad
    Monday, November 30, 2020
    · INO Short Interest
    Total volume = 23,130,913 (10-day average volume 12.1M). Closing at 12.22 (-0.04, -0.33%)
    Short Interest volume = 8,552,264 (36.97% of total volume, 1 out of every 2.71 shares traded today was sold short)
    Counterfeit Short Interest volume = 2,615,986 (30.59% of Short Interest volume)
    1 out of every 8.84 shares (11.31%) traded today was a counterfeit.
    After Hours Ending 5:00 PM ET: 201,132* shares traded with a range of (12.08, 12.45), last trade (at 19:59:45) was 272 shares at 12.40 (+0.18, +1.47%).
    * This number includes (some but likely not all) trades in other Exchanges and Dark Pools that occurred in the regular session but recorded after the market closed.
    Short Interest = 59,084,921 Settlement Date November 13, an increase of 2,321,441 (+4.09%) from the 56,763,480 Settlement Date October 30 (updates approximately every 15 days, last updated November 24).
    Short Interest Ratio (Days to Cover) = 2.55 (based on today's volume)
    Short Interest Ratio (Days to Cover) = 4.88 (based on 10-day average volume)
  • I
    I DON'T NEED A CRACKER
    Playing detective
    1) a scrupulous analyst puts an $8 target price
    2) then within the same week share price goes up 18%
    3) over a two day trading period volume over 40 million. Keep in mind shorts have 50+ million shorts

    It could be controlled exiting by some big time shorts that know December is not the month to hold a short position.

    Or rumors of a buyout and FDA News are coming quickly.

    Very suspicious indeed.
  • C
    Craig
    Answer from email this morning to Walter Reed Army Institute:

    Good Afternoon,

    At the moment, the study is not active. However, it will be in the near future. What we can do is add you to our waiting list then contact you once, we start recruiting for it.

    Best,

    Jaquane Clanton
    Recruiter
    Walter Reed Army Institute of Research
    Clinical Trials Center
    503 Robert Grant Avenue, Room 2W105
    Silver Spring, MD 20910
    301-319-9333 (office)
    301-319-9660 (front desk)
    866-428-2788 (recruitment line)
    Bullish
  • A
    Anthony
    It is becoming crystal clear, as the initial leading contenders flail, there is plenty of room for Inovio as a Covid 19 vaccine provider. Once FDA approval is given for phase 3 for a DNA candidate, as well as the progress of our additional trials for cervical and brain cancers, shareholders in my opinions will welcome the Roaring Twenties.
    Would like to hear from InovioThinkTank on their efforts to converse/contact the FDA as well as the media in regards to Inovio and it’s progress, it was mentioned daily efforts are extended, Thank You.

    Would love to see Dr Fauci asked point blank about Inovio.

    Happy Monday.
    Sister in Law out of Hospital, still on Oxygen. My 83 year old mom with one lung lost a very special friend to Covid yesterday.
    Bullish
  • T
    Tom K
    Got this message from the FDA about the clinical trials.

    Dear Tom,

    Thank you for your interest in INOVIO’s Phase 2/3 clinical trial. Please note that recruitment has not yet started for NCT04642638 trial. We encourage you to review www.clinicaltrials.gov for updates on the active locations.

    https://clinicaltrials.gov/ct2/show/NCT04642638#contacts

    Sincerely,
    Clinical Trials Team at Inovio
    Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure - Full Text View.
    Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure - Full Text View.
    clinicaltrials.gov
  • A
    Adrienne
    for those that use Fintel your be happy to hear that they fixed the bug. Institutional ownership at just shy of 55% NOT the 72% mentioned the past few days. Still up though. (as of end of quarter or filing period as some update more frequantley) Pay particular attention to XBI (State St ETF) one of it not the largest Bio ETF. 4.8m shares held as of 9/30 Now 5.4m as of Friday. They update daily on their website.
  • M
    Michael
    Remember the press release from MRNA today.

    ( 100% SUCCESS RATE FOR SEVERE CASES; )

    " Of the 196 volunteers who contracted COVID-19 in the more than 30,000-person
    trial, 185 had received a placebo versus 11 who got the vaccine. The company reported
    30 severe cases - all in the placebo - which means the vaccine was 100% effective at
    preventing severe cases."

    The 100% success rate was based on the mere 185 participants who received the placebo.
    This press release is purely hype.
  • G
    G
    My posts came now two weeks ago.. I told the whole bd what was about to happen.. I stand by it.. When the fake analyst came out and said INO was a little too late possibly to enter the race, I let everyone know that was the Signal for the real investor.. and it is 100%...

    BUY BUY BUY

    Come June 2021 this is over $40.. maybe over $100 with such a small float..

    Do not miss out on the future.. DNA only room temp vaccine, backed by Bill Gates, WHO, CEPI, DOD
    They know what they are doing.. this is the GREAT RESET

    You can't stop it.. you can pray and God hears, but His will must come.. judgement has begun and the White Horse is begun riding..

    And Vaccines are in and will be in for a long time.. these are not just life saving for those who believe in the pandemic. these are life changing and will so do for the Billions around the world.

    This is the only DNA
    thus the World Awaits.. and in the long run this will be the big winner.

    Next year there will be more viruses.. only INO has the ability to discover, program and produce by 2022 whichever new strand is needed.. and maintain room temp for easy shipment..

    Hold on LONGS this is an excellent investment

    Get some whole shares, and get some Calls for 2022, and 2023.

    Buy on any pull back.. you will see some up / down but you will not be disappointed come June 2021

    GO INO
    Bullish
  • B
    Bret
    Shorts are out spinning as they do

    Hard to deny the bullish premarket behavior breaking through $13 handily then consolidating at $12.55ish and moving higher

    Broader market moving off lows (way off) nasdaq higher premarket (tech has bcome safe haven)

    Inovio and Covid plays also a bit safe haven..esc

    Shorts are watching without question it seems that it will be difficult for them to have much of an impact without negative news.

    Positive news would send this 20-40% higher very quickly

    Stable to higher IMO
    Bullish
  • J
    JagerMeister
    🧑‍🎄Early Christmas 🎄 ? EUA could be granted to DoD by the FDA at anytime.. Remember Inovio has stated many times they plan to apply for EUA they never stated that it could be for the DoD. Remember DoD-ADM manufacturing is in contract with Inovio and Biology Bioservices. Setup supports 4 distant products at once. Has capacity for full production of FDa approved products. Its fully funded and now with Peer Review and Ino4800 in P2 they already complete with 1million doses. Think about?🤔
    Bullish
  • C
    Craig
    So Inovio is working with these guys to:

    The company has partnered with Advaccine and the International Vaccine Institute for trials of the vaccine candidate in China and South Korea, respectively.

    Furthermore, the company is working with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia to test INO-4800’s non-clinical efficacy.
    Bullish
  • D
    Damian
    When Inovio eventually publishes a press release about the publication of its phase I INO-4800, it needs to make a statement in the PR about the peer review process itself. The global pandemic has revealed the dichotomy organizations face between publishing peer review and publishing by preprint and press release. For medicine to progress, the former requires patience, while the latter requires faith.

    AZN/Oxford’s preliminary announcement about its phase III data is confusing and highly questionable. To address this, AZN has said it will soon publish their phase III clinical trial as a peer-reviewed article in the Lancet. The Lancet is able to conduct and publish full peer review of selected articles within a couple weeks of receiving a manuscript, even with revisions. This is the way peer review and PR should be balanced, separated by only weeks of disclosure.

    NEJM however, or whatever journal to which Inovio has submitted their phase I Cov-2 vaccine clinical trial data, will have taken about 6 months to publish. This is wrong. Inovio needs to state this, emphasizing that investors of some companies should not need to be patient while investors of other companies should not need to have faith. Science simply needs to be communicated more quickly and more accurately.

    Here is how their PI peer review announcement should be written:

    INOVIO (NASDAQ:INO) today announced the publication of the phase I clinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating an outstanding safety profile, robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal new England Journal of Medicine titled …

    Inovio has consistently published its clinical data to peer reviewed journals only to ensure there is little question about the validity of its science. Regretfully, when publication occurs six months and much longer after an article is written, the value of the data to the medical community is lessened and the accuracy of the statements can be misleading. For this reason, Inovio will no longer publish clinical trial data only by peer review. Inovio’s clinical data will be published when written via pre-print servers, as well as by peer reviewed journals. Inovio looks forward to a better balance of providing details of its clinical programs as quickly and as accurately as possible for investors and the medical community.
  • C
    Craig
    What triggers a short squeeze?
    A short squeeze can occur when there is a lack of supply and an excess of demand for the stock due to short sellers covering (liquidating) their positions. Short squeezes result when short sellers of a stock move to cover their positions, purchasing large volumes of stock relative to the market volume.
    Bullish
  • K
    Ken
    A lot of the volitility Pre M is due to news of Moderna applying for emergency use. On balance, we're doing very well. Modena got to the stage it's at because of golf club deals - not science. Look at Moderna board selling off their stock for a more accurate assessment...
    Bullish
  • G
    G
    1- WHO makes INO the real long term winner.. 2 -Why INO will not be the first intentionally to receive FDA.3- WHAT is the Reason

    1- Temperature matters - In many societies getting a vaccine to a cold storage is not a problem, but for most citizens of earth it makes a big difference. Read the attached document from 1998 which helps you understand how critical vaccines that are resilient to ambient matters. Please tell the world other than INO which vaccine(s) will have this advantage.

    2- FDA approval for a messenger or molecular RNA vaccine or medicine has never been approved and you do not want to be the first to the market to get approval unless your a PFE. And they will open the door to move mRNA technology through the door. After will follow MRNA and then others. When INO is ready they will not have to hurdles to pass.

    3- What is the reason, well listen closely the dates explain the timing .. we are being told mass rollout will be by late spring.. who will this include.. MRNA, PFE, AZN, and yes a few others, but which one is already ready with room temp availability, and you have the WHAT.. INO has always been the mRNA future for the rest of the world and more importantly the device used to inject allows for other particles such as nanodust / smartdust which will allow us worldwide to monitor the success and needs of the world. 24/7 blood checks, and more..

    No I am not a conspiracist I am just in the know and this will be one of the greatest pharmaceuticals in the world with military delivery all over the world in the 2021 year.

    Watch

    It still has time to cook but soon by March this is a 17 - 21 dollar stock with out question.. but lately stocks are running up so fast it could be that next week

    https://apps.who.int/iris/bitstream/handle/10665/64980/WHO_GPV_98.07.pdf;jsessionid=4A151A2AA108392B09D4C45D31937221?sequence=1
    Bullish