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Agenus Inc. (AGEN)

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3.0500+0.1600 (+5.54%)
At close: 04:00PM EST
3.0300 -0.02 (-0.66%)
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  • D
    Dr Jim P. , MD
    US Army COVID-19 Vaccine Completes Phase 1 Trial | How Effective is SpFN + AGEN QS21 Vax Against Coronavirus Variants?

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    Joseph Henry, Tech Times 17 January 2022, 02:01 am

    Amid the release of several coronavirus vaccines, the US Army is preparing to launch its very own COVID-19 vax.

    Chief Medical Adviser Dr. Anthony Fauci said that the White House is investing in this universal jab that will be effective against the current and future virus variants.
    Fauci Said SpFN Vaccine Can Combat All COVID Variants
    US Army COVID-19 Vaccine Completes Phase 1 Trial | How Effective is SpFN Vax Against Coronavirus Variants?
    (Photo : United States Forces Korea via Getty Images)

    In an interview with NBC News last week, Fauci said that the government is exerting effort to develop a universal coronavirus vaccine that will protect people from different COVID-19 variants.

    While the efficiency of the vaccine depends on the variant, the Walter Reed Army Institute of Research (WRAIR) under the US Army has been developing the spike ferritin nanoparticle COVID-19 vaccine since last year.

    Last month, the researchers noted that the said vaccine showed promising results after finishing Phase 1 of clinical trials.

    WRAIR director of infectious diseases Dr. Kayvon Modjarrad said that they are working with a vaccine that could fight all variants including omicron.

    Related Article: COVID Vaccine Mandate for Workplaces Blocked by Supreme Court, Deemed Not an Occupational Hazard
    What to Know About SpFN Vaccine

    So far, the US allows the distribution of certain vaccines in the country such as Pfizer, Moderna, Johnson and Johnson.

    While many pharmaceutical firms are progressively developing a COVID-19 jab, the US is likely leaning on the new SpFN vaccine that the military scientists are working on at the moment.

    According to CNET, the SpFN vaccine has "less restrictive storage" requirements compared to Pfizer and Moderna jabs. It can last for a month at room temperature and six months at 36 to 46 degrees Fahrenheit.

    The vaccine's stability can go for up to 31 days if it will be stored in a refrigerator during the shipment process.

    The shot interval for Army's vaccine (1st and 2nd dose) is 28 days apart. The scientists said that the third shot can be injected after six months.
    How Effective is Army's Vaccine?

    The Army scientists said that the SpFN vaccine will be the "pan-coronavirus" jab which means that it can be effective to prevent spikes of multiple COVID strains.

    "Our strategy has been to develop a 'pan-coronavirus' vaccine technology that could potentially offer safe, effective, and durable protection against multiple coronavirus strains and species," Modjarrad said.
    Availability of US Army COVID Vaccine

    At the time of writing, the vaccine is still not available for public use since it needs to complete Phase 2 and 3 to evaluate if it is safe and efficient for human use.

    The usual duration of the combined phases can go for up to five years, according to scientists. However, since the pandemic continues to thrive, the US Army is urgently speeding up the phase completion.
  • H
    Harold
    So, how about this for a Tuesday morning announcement. (Or Wednesday if they’re dragging their feet on it today).

    One of the BP’s does a deal for a $300 Million cash infusion, PLUS buys 25 Million shares (just under 10% of our current Outstanding shares) for $6 each, resulting in the equivalent of an ATM for $150 million. That puts $450 Million MORE in the coffers. In return, the BP funds virtually all of clinical trials of 1181 (we supply the juice) and is in total control of the process. It becomes a 50/50 revenue sharing arrangement WORLDWIDE. Garo has funds for developing everything else the company is working on, including building and outfitting his manufacturing facility in Vacaville. The above market sale of stock is what Garo did with Betta, but I believe it was 20% above market on the bal/zal arrangement with them. BMY just did one just over a week ago with IPSC where the premium was over 100%, so anything is possible, depending on how good 1181 is and how bad BP wants it before someone else gets it. Lots of deal point minutiae that would need to be worked out, but this back-of-the-napkin hypothesizing (like first option on an outright buyout of AGEN within 5 years, etc) would be an excellent starting point for negotiations that they might have already had over the last few months.

    Is it all that Garo has dreamed about? Probably NOT. Is the clock ticking to get a MAJOR deal before things permanently slide away from him? Probably SO.
  • H
    Harold
    Garo has a staggered board (formally called a “classified” board) the better to keep control/stymie disgruntled shareholders. The net effect is that in amy given year, only a few Directors are “up for election”. There is a movement in corporations to DEclassify their boards, to better align with accountability to Shareholders. That would mean every Director is up for election/reelection every year. BUT….we still have a classified board. So, very little accountability to the OWNERS of the corporation…that would be those of us actually owning the shares of stock.

    The good news is that the 2 most powerful board members are the only two up for reelection this year. One is the Lead Director, Tim Wright, and the other is Brian Corvese, who just happens to be the only person to be a Director on ALL THREE of Garo’s public companies…so you know he’s very tight with Garo…and is one of 3 people on the AGEN Compensation Committee. One of the other 2 on the Comp Committee is Tim Wright.

    They’ve been by Garo’s side as Directors since 2006 and 2007

    CLASS I DIRECTORS—TERM TO EXPIRE IN 2022

    Brian Corvese
    Age: 63
    President and Founder of
    Vencor Capital

    Director since 2007
    (a) Compensation Committee
    (b) Corporate Governance
    and Nominating Committee
    (c) Executive Committee
    (Chair)
    Since 1999, Mr. Corvese has been the President and Founder of Vencor Capital (“Vencor”), a private equity firm with telecommunications and technology investments in the Middle East and Mediterranean regions. Prior to working at Vencor, Mr. Corvese worked on investments in the U.S. and global equity markets as a Managing Director and partner at Soros Fund Management, the largest hedge fund in the world at the time. From 1988 to 1996, Mr. Corvese was a partner at Chancellor Capital Management (“Chancellor”), a $25 billion money management firm. While at Chancellor, Mr. Corvese was a Portfolio Manager with responsibility for investments made in basic industries, restructurings, and special situations, corporate governance investments, as well as founded and managed his own hedge fund. From 1981 to 1988, Mr. Corvese was with Drexel Burnham Lambert (“Drexel”) as an equity analyst following the chemical and specialty chemical industries and participated in a significant number of merger and acquisition activities. While at Drexel, Mr. Corvese was a member of the top chemical and specialty chemical research team, as ranked by Institutional Investor. Mr. Corvese currently serves on the Board of Directors of the National Telecommunications Corporation, based in Cairo, Egypt, and Protagenic Therapeutics based in Ontario, Canada. Mr. Corvese earned degrees in finance and political science from The University of Rhode Island and attended New York University Graduate School. With over 30 years of experience in the financial industry, Mr. Corvese brings substantial financial expertise to our Board.
    Timothy R. Wright
    Age: 63
    Chief Executive Officer of
    MiMedX Group, Inc.

    Director since 2006,
    Lead Director since 2009
    (a) Compensation Committee
    (b) Corporate Governance
    and Nominating Committee
    (Chair)
    (c) Audit and Finance
    Committee
    (d) Executive Committee
  • H
    Harold
    I was scrolling through the 2nd Quarter Earnings call from last year on August 9. It was interesting to read almost all of the answers, but I saw several that were MORe than just interesting, so I did a copy and paste for those interested. As you read each answer, try to keep from smiling too much.

    Mayank Mamtani -- B. Riley FBR Inc. -- Analyst

    Thank you for all the details. And then on the bal monotherapy PDUFA, as you prepare for that, are there any parallel to draw from, for instance, the retifanlimab recent experience with FDA or are you expecting an AdCom, by any chance?

    Steven O'Day -- Chief Medical Officer

    The question is, are we expecting a...

    Jennifer Buell -- President and Chief Operating Officer

    An AdCom?

    Steven O'Day -- Chief Medical Officer

    AdCom. Okay. I think between now and the PDUFA date, you can expect that we are going to do a lot of work in communication with the agency. There are mandated inspections in the process and we're going through all of that right now. And I think out of respect to the process, we will not disclose the details.

    Mayank Mamtani -- B. Riley FBR Inc. -- Analyst

    Okay. Fair enough. And then maybe for Jen and Garo, I have a follow-up for you. But maybe, Jen, are you able to comment on sort of the patients dosed across solid tumors and COVID-19 ARDS? And what sort of territories have you been enrolling for the iNKT, any color there?

    Jennifer Buell -- President and Chief Operating Officer

    Hi, Mayank. We can't say too much right now for obvious reasons given where we are in the process. But rest assure, we'll be aggressive with data releases as we have always been at across the portfolio.

    Mayank Mamtani -- B. Riley FBR Inc. -- Analyst

    Great. Thank you. And maybe for Garo. Garo, as you look at scaling up a lot across R&D, G&A capex, great to see this Vacaville facility coming online here in California, expanding your XOMA antibody efforts. But I'm just curious, like how should we think about this going forward, especially if QS-21 adjuvant becomes something that would require investment? How would you think about expanding capex and obviously continuing to fund the R&D pipeline here?

    Garo H. Armen -- Chairman and Chief Executive Officer

    Okay. So let me address that in several ways. And I don't mean to be complex about my answer, but just bear with me. Now if you look at the history, Mayank, of how we have managed our expenditures versus our cash balance, it has been done in a very orderly way. Meaning, at any given quarter, we have managed our cash outflows and cash inflows very well. Of course, the Bristol transaction that brought in $200 million and is expected to deliver another milestone this year in terms of cash infusion, has provided a bit of a jump into our cash balances. And I expect that in the second half of the year, we will have additional jumps in our cash balances.

    Now where do they come from? Several sources, in addition to corporate transactions, milestones, project financing transactions. In addition to those, we expect to fund some of our separated subsidiaries by means of outside capital infusion, and that will certainly reduce some of our cash, this cash burn associated with those businesses. That includes, for example, our MiNK Therapeutics asset, it also includes our QS-21 and related assets.

    You can also expect to see some asset sales possibly in the second half of this year. And so if you add all those things, relative to unusual items that will occur from time to time that will represent jumps, I cannot promise you on a quarter-to-quarter basis what the impact of that will be, but I expect that we'll be able to manage our cash position so that we are left with a substantial cushion at the end of each period. So other than that, unfortunately, I cannot give you any more specific dollar guidance.

    Mayank Mamtani -- B. Riley FBR Inc. -- Analyst

    No, that's helpful color. Thanks again for taking our questions.

    Operator

    [Operator Instructions] Our next question comes from the line of Matt Philips from William Blair. Your line is open. Please go ahead.

    Matt Phipps -- William Blair & Co. -- Analyst

    Good morning. Thanks for taking my questions. Just a few. Do you guys have any update on the timing of the bal-zal filing? Just right now you can give a little bit more clarity on ahead of the PDUFA for bal or do we have to really wait for that PDUFA to clear?

    Garo H. Armen -- Chairman and Chief Executive Officer

    I think on the bal-zal filing, Matt, we've said that we'll provide guidance in the second half of this year. Of course, it's going to be a function of us disclosing the data, the final data from that combination trial at ESMO, and then deliberations with the FDA. So bear with us. Once we get some clarity through both processes, we'll give you a definition on the path forward. But with regard to the PDUFA date, what was the question again?
  • p
    peter
    I honestly can't recall running up against anything like I have with Agenus in biotech. It is clear with 99%+++ certainty that bal works as well for better than KEYTRUDA in cervical cancer. It is also clear that zal/bal works better than bal and KEYTRUDA and it is likely that lives are being saved by the combination based on the published spider plot. However, both drugs sit fallow because of FDA capriciousness and what is either a lack of funds to file the zal/bal PDUFA or the concern that it might not work as well in failed combination chemo/pembro patients. I say get it approved and let the clinicians figure out if it works while we run a confirmatory trial. Women are dying unnecessarily.
  • S
    Steve-RationallyBullishOn1181
    I've posted this before, but it is worth repeating. If you are a shareholder and upset with Agenus management, you should create a letter detailing your concerns. Then take that letter and post it to an online website where other shareholders can sign the letter. Then take that letter with 50+ signatures, and deliver it to the Agenus board of directors. Trust me, you will feel far better doing something like that than just coming here every day and screaming into the abyss that is an online message board, and you will have a far greater chance of seeing your concerns addressed doing things that way.
  • a
    ageninrussia
    FYI, we’re three months in to garos comment where he said to expect a significant cash infusion 3-5 months from now
  • a
    ageninrussia
    Garo-3-5 months big deal coming. , next level

    2-5 years, huge , your money is safe with me Mark

    Also garo, go look at what he promises in quarterly calls and never delivers
  • M
    Manny
    This is unacceptable....clearly urgent action is needed......mgmt misled investors about registrational trials by YE.......after a slew of spewing out misinformation in 2021. Combo strategy for Bal/Zal, lighting speed, more partnership, release of iNKT data, initiation of trials. This is unacceptable business practices for any publicly held company.
  • T
    TraderE
    Anyone know the address of the California property Garo bought, then sold 1/3 of? Sale details were never mentioned in any PR's Why? I'd like to look up who the "buyer" was.
  • P
    PaulN1958
    As with Many Long Term Investors, I am down significantly.

    I hope AGEN's Portfolio/Pipeline is as good as Garo is say; but if so, why hasn't he brought home Partners for 1181?

    And when you look at AGEN's Max Chart; in 28 years; Garo, and the Board of directors, have failed to produce a Return on Investment for the Long Term Investors.

    If by the next Proxy Vote; If Garo, and the Board of Directors; is unable to bring home the needed Partnerships and or unable to nurture Investor Confidence; I believe they have failed Investors, and I believe we all must vote for change.
  • b
    bmcgoo_03
    We're at a turning point. Lots of frustration here.
    Pazdur is head of the cancer wing at the FDA. He's made it clear that he's shutting down Accelerated Approval for PD1s....like our Bal.
    He came out with some sort of statement or interview on Endpoints around the time of our Bal PDUFA date.
    Apparently, they had a number of Accelerated Approval applications from small biotech companies for PD1s. I got the impression that they just didn't want to review all of them.
    He said these single arm trials didn't have enough patients (our Bal trial for 2L Cervical is the largest, to date)
    He said the results were incremental at best. Used to be...the FDA approved drugs if they were "non-inferior".
    When did that standard change ??
    So...what drugs get approved using Accelerated Approval ?? Orphan drugs with limited markets ??
    Indications not addressed by Big Pharma ??
    The timeline....AGEN's Bal had a 10 month head start on MRK's Keytruda application for Cervical.
    We got a 6 month speed bump in June. "We'd like to see the data mature." Ok.....
    Keytruda got approved 4 months early for 1L Cervical and 2L Cervical....with no data on 2L Cervical.
    We got a phone call telling us that we should withdraw our application because we no longer fit the criteria for Accelerated Approval in light of the 2L Cervical approval for Keytruda.
    We would have to do a 100 million dollar head-to-head P3 with Keytruda to get 2L approval.
    So...what does all of this mean, going forward ??
    It means that the only way we get 1181 to market is that we have to do head-to-head P3s with
    approved Big Pharma I/O drugs and prove 1181 is better.
    That will take BIG money. So...we have to partner with Big Pharma for 1181....no question.
    In effect, Pazdur...with this administrative decision, has shut the door on small biotech in favor of
    the Big Boys.
    What about the patients ?? What about innovation ??? What about the FDA's own policies and procedures. The FDA does two things: rule on safety and efficacy......period. That's no longer true. The rules have been changed by a non-elected bureaucrat.
  • P
    Pat
    Los Angeles Capital Management LLC Sells 238,798 Shares of Agenus Inc. (NASDAQ:AGEN)

    Los Angeles Capital Management LLC reduced its position in Agenus Inc. (NASDAQ:AGEN) by 77.8% during the 3rd quarter, according to the company in its most recent 13F filing with the Securities & Exchange Commission. The firm owned 68,073 shares of the biotechnology company’s stock after selling 238,798 shares during the quarter. Los Angeles Capital Management LLC’s holdings in Agenus were worth $357,000 at the end of the most recent quarter.

    A number of other hedge funds have also recently added to or reduced their stakes in the business. Lindbrook Capital LLC bought a new position in Agenus in the 3rd quarter valued at about $42,000. Advisor Group Holdings Inc. increased its holdings in Agenus by 12.7% in the 3rd quarter. Advisor Group Holdings Inc. now owns 29,849 shares of the biotechnology company’s stock valued at $158,000 after buying an additional 3,370 shares during the period. Chilton Capital Management LLC grew its holdings in shares of Agenus by 26.6% during the 3rd quarter. Chilton Capital Management LLC now owns 21,175 shares of the biotechnology company’s stock valued at $111,000 after purchasing an additional 4,450 shares during the last quarter. Barnett & Company Inc. bought a new stake in shares of Agenus during the 3rd quarter valued at approximately $26,000. Finally, Deutsche Bank AG grew its holdings in shares of Agenus by 3.6% during the 3rd quarter. Deutsche Bank AG now owns 141,052 shares of the biotechnology company’s stock valued at $741,000 after purchasing an additional 4,877 shares during the last quarter. 46.75% of the stock is currently owned by hedge funds and other institutional investors.
  • S
    Steve-RationallyBullishOn1181
    There are around 800 publicly traded biotech companies listed on US exchanges.....more than 700 of them have posted negative stock returns over the last year. I look at that and can't help but think that our problem is more a "biotech" issue than a "Garo" issue.
  • p
    peter
    Humans have lost their collective minds with crypto currency IMO. Massive amounts of energy are needed to "mine" the coins which have no real utility value. No use in electronics or medicine or even jewelry like gold and silver. So we are burning up all this energy to create nothing of real use.
    Maybe I'm too old but I just don't see it.
  • m
    mary
    @peter You can’t blame it mostly on the XBI. The XBI accounts for roughly 6 percent of agenus’s outstanding shares and a total of roughly 12 percent of all ETF’s combined.
    Small caps with no revenue are getting sold off no matter what the future potential looks like. At the moment, this market is more about emotions than it is fundamentals. We need to either have conviction or simply move on to something else. I for one am still sticking around
  • P
    Pat
    Vice President, Senior Corporate Counsel, $103K - $281K Agenus, Lexington, MA

    Doubtful at this pay......Average Base Salary Estimate $169,896

    Job Summary:

    Agenus Legal is building our Dream Team and are seeking an experienced biotechnology lawyer with a broad skillset to meaningfully contribute on strategy and execution as Agenus prepares to launch its first commercial product and advances its extensive clinical development pipeline.

    The successful candidate will have a solid understanding of the business of a biotech company and 10+ years of broad legal experience, with at least 5 years of biotechnology experience, including some or all of the following: business development initiatives, commercial contracting, healthcare compliance, advertising and promotional review, corporate governance, privacy, SEC and Nasdaq compliance and clinical contracting. The Corporate Counsel, Executive Director will report directly to the Chief Legal Officer
  • S
    SG
    As we wait for the moad, I wanted to share 2 companies that imo has a lot of potential, dmtk is a company that has a melanoma test that is based on genomics and avoids biopsy. Grts is a vaccine for Covid using a mRNA amplification process and uses spike and central epitomes to avoid breakthrough for future variant along with oncology pipeline. Hopefully this will help offset some of the downside pressures from Agen and xbi sell off so good luck longs as we wait for 1181 deals
  • C
    Charles
    AOC urge followers to take precautions to avoid illness and reduce spread.. so don’t party without mask in crowded places in Miami 😀
  • P
    PaulN1958
    Garo; you are the CEO, and the Chairman of the Board of Directors.

    Please be good enough; such that if you and your team are unable to bring home the Needed Partnerships; Please, bring in someone who can.

    Please.
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