Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (2024)

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  • J

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (1)

    Goldman Sachs analyst Madhu Kumar reinstates coverage on Dynavax Technologies (NASDAQ: DVAX) with a Buy rating and a price target of $38.00.
    The analyst commented, "While we are long-term bullish on the opportunity for hepatitis B virus (HBV) vaccine Heplisav-B to prove best-in-class in that space, with the recent CDC ACIP positive recommendation for universal HBV vaccination likely over time to expand the TAM, we see near-term value creation from the company's multiple COVID-19 vaccine partnerships for its adjuvant CpG 1018. In particular, we would highlight the SCB-2019 program with Clover Biopharma as an under-appreciated COVID-19 vaccine, given its broad capacity for protection and a potential best-in-class tolerability profile, leaving open a substantial opportunity for both ROW pandemic and booster endemic uptake."

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (2)

    TAIPEI (Taiwan News) — Local vaccine developer Medigen Vaccine Biologics Corporation announced Wednesday (June 9) that phase 2 clinical trials of its COVID-19 vaccine had been completed, leading to trading in its shares on the Taiwan Stock Exchange being suspended the following day.
    Medigen’s stocks suffered a rocky week, beginning with sharp declines followed by steep rises as Taiwan's need for vaccines becomes ever more paramount. All vaccines in Taiwan have so far have been imported despite politically motivated problems caused by China.
    Earlier reports said Medigen and a local competitor, United Biomedical, might produce a total of 10 million vaccines to be ready in July.
    At a news conference scheduled for Thursday (June 10), Medigen will announce the results of its clinical trials and hand the relevant information to the Food and Drug Administration (FDA) to apply for emergency use authorization (EUA), CNA reported.
    The Taiwanese company was planning to “unblind” the second-phase trial process, allowing participants to know whether they received the real new vaccine or a placebo, according to the report. More than 3,700 people were recruited as volunteers to serve in the trials.

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (3)

    Okay, from the most recent 10-K filed February 25th, 2021. My focus here is to think about the potential revenue that will be included in earnings for Q1 2021. We know from previous posts that I am usually right about things, and mainly that is because I use the actual words and numbers that the company provides. I recommend that everyone try that...lol. Anyway, here we go:
    Full 2020 revenue from Heplisav: $36,030,000
    Full 2020 revenue from CpG 1018: $3,277,000
    Total 2020 revenue from Heplisav and CpG 1018 = $39,307,000
    For comparison - Total 2019 revenue from Heplisav and CpG 1018 (none) = $34,644,000
    The good news here is that Heplisav increased - even with the pandemic headwinds in 2020...and obviously CpG 1018 started to create new revenue.

    Next, I will highlight just the research and development expenses between 2018 and 2020. These numbers have been talked about, but they don't seem to get the recognition they deserve, especially considering the fact that revenue has actually increased while R&D expenses have drastically gone down. For those following, the idea in business is to receive more revenue than outgoing expenses. It took a while, and it's nice to see all the planning and effort to decrease spending that Ryan Spencer/Dynavax Team and the Board have been working on since 2019 paying off.

    Total R&D expenses for 2018: $74,951,000
    Total R&D expenses for 2019: $62,331,000
    Total R&D expenses for 2020: $28,607,000

    Obviously there are reasons for the savings - among them winding down SD-101. These savings were part of the plan, and a 54% decrease in R&D expense is incredible year over year, especially with overall revenue increasing year over year. So, in my opinion, this is all positive - and barely takes CpG 1018 into consideration.

    Now, speaking about potential earnings for Q1 2021. From the latest 10-K released on February 25th, 2021 - there is a mention of $37.1Mill of deferred revenue that came in Q4 2020:

    "Pursuant to our supply agreement with Valneva, in the fourth quarter of 2020, we received payments from Valneva totaling $20.0 million and issued an invoice to Valneva for $17.1 million for advanced payment to purchase specified quantities of CpG 1018 adjuvant in the first half of 2021. We recorded the total amount of $37.1 million as deferred revenue in our consolidated balance sheets as of December 31, 2020."

    Dynavax also explains how they count revenue in the 10-K:

    "We also sell our novel adjuvant, CpG 1018, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables."

    So, if one believes that there have been CpG 1018 deliveries to Valneva in Q1, than some, or all, of that $37.1Mill would likely be counted as revenue for Q1 2021...on top of any revenue that was accrued with delivery of additional CpG 1018 to Valneva or any other partner.

    I think it'd be fair to think that Heplisav revenue would be lower in Q1 as covid vaccines prioritized any other type of vaccine program for most doctors and hospitals...but there would still be some revenue.

    In conclusion, my point is that the highest year of revenue for Dynavax, including every possible avenue for revenue outside of Heplisav and CpG 1018, was in 2020 with $46,551,000. It is very possible that Q1 2021 could beat that number just in one quarter...and if not in Q1, then Q1 + Q2 should definitely do it. A company that has rising revenue and lower expenses is always a good look - and one with the potential that Dynavax has for this upcoming year is amazing. The current market cap of $1.1Billion is where Dynavax has been many times before without CpG 1018, so thinking that market cap could/would be higher this year is very reasonable. Onward and upward is what I think.

    If anyone feels this info is useful, feel free to use it. All numbers and items quoted were taken directly from the Dynavax 10-K released February 25th, 2021.

  • A

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (4)

    Why Small-Cap Biotech Stocks are a Speculator’s Best Friend (INMD, ATRX, DVAX, SAVA, ICPT, IMGN, IBB)...

    Dynavax Technologies Corp. (Nasdaq:DVAX) operates as a biopharmaceutical company that engages in the discovery, development, and commercialization of novel vaccines and immuno-oncology therapeutics.

    The company’s product includes HEPLISAV-B, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

    Dynavax Technologies Corp. (Nasdaq:DVAX) recently reported financial results for the third quarter ended September 30, 2021, including revenues of $108.3 million, and news of HEPLISAV-B net product revenue of $22.7 million, CpG 1018 adjuvant product revenue of $84.3 million, and an increase in 2021 full-year CpG 1018 revenue guidance to between $375 and $425 million.

    “This quarter we continued to make strong progress with both our lead commercial vaccine, HEPLISAV-B, and our CpG 1018 vaccine adjuvant platform,” commented Ryan Spencer, Chief Executive Officer of Dynavax. “Our belief in the significant value of both assets is reinforced by the continued growth in market share and revenue for HEPLISAV-B along with multiple positive data readouts for adjuvanted COVID-19 vaccine candidates demonstrating the capabilities of CpG 1018 to help drive efficacy and high levels of antibodies while maintaining a favorable tolerability profile. Strong execution on a thoughtful, timely strategy has resulted in $244 million in year-to-date total revenue and $215 million in cash flow from operations, generating approximately $414 million in cash and equivalents at the end of this quarter which further enables our ability to continue to make investments which we believe will drive long-term value.”

    The stock has suffered a bit of late, with shares of DVAX taking a hit in recent action, down about -22% over the past week. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -8%.

    Dynavax Technologies Corp. managed to rope in revenues totaling $52.8M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 1877.8%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($345.8M against $204.6M).

    GL

    A1

  • Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate
    February 1, 2021 1:00 AM
    •Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
    •The Coalition for Epidemic Preparedness Innovations (CEPI) continues to support Clover's COVID-19 vaccine candidate and will fund its development through licensure.
    EMERYVILLE, Calif. and CHENGDU, China , Feb. 1, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company committed to developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced the plan to initiate a global Phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure.

    In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand.

  • T

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (6)

    Contemplating Market Cap - DVAX is roughly a 2 Billion dollar company right now. Revenue is project at $300 Million to $400 Million in 2021. The 2022 projections are still in development based on the status with Clover, BioE, and Valneva. If all three are successful and announce favorable rollout plans and dose volumes in 2022...DVAX could announce revenue projections over $2 Billion in 2022.

    Here's where it gets tricky in trying to determine a company value. The pandemic at some point will become endemic...with booster shots necessary in an ongoing manner is the current assumption. Therefore, you could see a slowing of revenue in 2023 based on where the various countries are in regard to their pandemic success.

    If you then factor in a sizable increase in Heplisav sales for 2022 and 2023 and you can project that this will partially offset the loss of revenue for Covid vaccines. Regardless, I would project a large revenue shortfall in 2023 based on the curve of how Covid should respond to a successful 2022 vaccination rate in third world countries.

    The real conundrum is how to value an asset like CPG 1018. If DVAX is successful in other vaccines beyond COVID (both internal & external)...then CPG will drive market cap multiples based on its potential with other vaccines for other conditions in 2023 and beyond.

    I've always thought DVAX was a great acquisition target for Merck or GSK as they have huge vaccine businesses and DVAX would fold nicely into their suite of products and services. It's determining fair value that is difficult with COVID, hopefully, becoming a booster type of product.

    Is a $4 Billion market cap and subsequent $39 price target a fair acquisition price knowing that revenue will decelerate in 2023. The company could also have over $1 Billion in cash by the end of 2022...so you are really paying for a $3 Billion market cap.

    Anyone else have any thoughts on how to value this company and how they are projecting this?

  • L

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (7)

    Good update on Valneva’s covid vaccine = good for DVaX.

    •Commences recruitment of Adolescents into Phase 3 trial “Cov-Compare”
    •Enrolls participants in the Phase 1/2 Booster Trial

    Saint-Herblain (France), September 23, 2021 – Valneva SE, (Nasdaq: VALN) announced that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301, “Cov-Compare”) for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults.

    The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial. This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.
    Recruitment of adolescents, aged 12 to 17 years, has commenced in the United Kingdom as part of Valneva’s pivotal Cov-Compare Phase 3 trial (VLA2001-301). An initial cohort of adolescents will be enrolled in an open label, non-randomized format. Subject to safety review, remaining participants will be randomized to receive two doses of either VLA2001 or a placebo 28 days apart, followed by a booster dose seven months after enrolling into the study. Approximately 660 participants will be recruited for this trial. Participants randomized to the placebo arm will have the opportunity to receive a course of VLA2001 following the initial safety assessment. A further expansion of the study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

    Valneva has also commenced booster vaccinations as a continuation of the Phase 1/2 VLA2001-201 trial for which the Company reported positive topline data in April 20211. The booster shot will be provided to each volunteer six months after initial vaccination.
    Valneva is conducting several clinical trials of VLA2001.

    In addition to Cov-Compare and VLA2001-201, VLA2001 is being evaluated in elderly volunteers in study VLA2001-304 in New Zealand as well as in a small, policy-led trial sponsored by University Hospital Southampton NHS Foundation Trust which is not part of Valneva’s regulatory package.

    Valneva continues discussions with the European Commission regarding a potential VLA2001 supply contract. The Company is also actively pursuing opportunities to make VLA2001 available to other customers, subject to positive Cov-Compare data and regulatory approval.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Our teams at Valneva remain fully committed to carry out VLA2001’s development plan and bring our inactivated vaccine to all patient groups who could benefit. We continue to receive messages on a daily basis from people across the world who are waiting for an inactivated vaccine so we continue to believe that our differentiated vaccine candidate could contribute to the ongoing fight against the COVID-19 pandemic. We’re confident that many countries, and regulators, will want to have the opportunity to consider our inactivated COVID-19 vaccine.”

  • a

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (8)

    Love the short stats....
    For those who are wondering what it takes to create a squeeze....here goes.
    An orderly rise in a stocks price will not create a squeeze itself. There needs to be a couple of other factors present. One is rising buy volume which indicates that people are hanging on to their shares and not allowing those who have taken a short position off the hook. By this I mean, closing a short position requires the purchase of stock to close out the opening trade. If shares are bought at higher prices and held, it forces the shorts to hold.....and wait for a better exit price (lower price) or to capitulate and buy the shares anyway.
    This leads to a somewhat self-fulfilling prophecy......DVAX goes up because folks are buying it (this time it's for all the right reasons). And folks are buying it because it continues to rise. Good or bad, the sentiment improves markedly and more folks get in. Then analysts (Goldman) find religion and increase price targets and/or ratings changes to "buys". This can lead to wider ownership and yet more volume. As the bull case builds and awareness spreads, those caught short (specifically those who have shorted before and made money doing so) are forced to buy to cover or to double down.....or just keep waiting. IMO we are in the "just keep waiting phase" where the shorts cannot believe "it's different this time" and refuse to acknowledge the data points indicating exactly that.
    Then there needs to be some catalyst.....as an example.....a large block trade by a hedge fund...entry to an index....material development by DVAX that adds to an already good story getting better. This is where panic can override rational thought. Volume takes off, the price breaks through a multi-year resistance level and the shorts are forced to get out. The squeeze happens when the shorts decide that it's "buy at the market" time and there just isn't a lot of available liquidity...or shares. Small caps like DVAX could take a week or more to cover.....therein creates the squeeze.
    Every day the shorts remain short, they are losing money. Many times it's borrowed money. So there is a cost just to put the position on. And it's not cheap.
    Many times short squeezes put in highs that are at absurd levels and the stock can languish for quite some time. Check out AMC, GME etc.....you really had to sell out to make real money.......as long as you were there early.

    DVAX has a real product in Heplisav that is gathering momentum after a few stops and starts......and a real answer to Covid. It isn't a specific vaccine right? It's a building block that augments a vaccine's efficacy. I'm no MD but I would rather sell tools and hammers to contractors than build a deck. Wouldn't this adjuvant have additional applications?
    I hope this helps......

  • K

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (9)

    Remember couple of things....
    1. Revenue has just started for Covid-Vaccines true value not reflected yet.
    2. Variants will continue to necessitate future development and companies that have used our adjuvant will be locked into using it on follow on versions that will be tailored each year to combat new variants. This means money train will continue for the foreseeable future.
    3. We have pricing power in the EU and Asia so better margins and more revenue in these countries and we are the low cost provider for the rest of the world with Biological E. That will bring down our cost of goods allow us to get better pricing on raw materials and manufacturing. Remember vaccines are cyclical they travel the world on differnt cyles like the flu. So we will have a steady stream of income throughout the year.
    4. Heplisav B has a much bigger sales force now and we are on the cusp of Universal Vaccination for Hepatitis B in the US that will make the market much bigger.
    5. We have a best in class vaccine with Heplisav B and should benefit with growing market share as Doctors are mandated to vaccinate for Hepatitis B.
    6. We also have a growing pipeline TDAP, Flu and potentially a US Covid vaccine long term.
    The shorts only have financial muscle to try and move the share price...they have been wrong every step of the way! Bain and Goldman have been correct in their analysis of the company! Can't wait for this to hit $40!

    P.S. I wish we didn't have to go through this battle with shorts but that's what makes a market. They will lose all their money in the end.

  • e

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (10)

    I love that the headlines are talking about the $.24c 'loss', keeping the share price down until people figure it out. Here is the profitability facts, but that's not really the best part of the story as indicated by reading the filing and listening to the call (on top of the actual numbers) "Dynavax Technologies (DVAX) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.05 per share. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.

    This quarterly report represents an earnings surprise of 20%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.04 per share when it actually produced earnings of $0.02, delivering a surprise of 150%.

    Over the last four quarters, the company has surpassed consensus EPS estimates four times.

  • n

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (11)

    Briefly, for those of you new to this investment opportunity; This is a solid and now profitable biotech:

    1. They own completely HEPLISAV-B, which likely will become a billion dollar vaccine for Hep B as this Dynavax product provides more protection, to all groups, with only two doses over one month v. three doses over six months for Merck and GSK's old products. DVAX is building market share and the market is set to explode when the ACIP recommends hepatitis B vaccination for all adults, as they are now expected to do by the end of this year, rather than the current groups (doctors and other workers and those exposed to blood, including diabetics).
    2. The secret sauce that makes HEPLISAV-B superior is the adjuvant it contains, CpG1018, which DVAX is exploiting through partners who are developing COVID vaccines, including Clover in China with Phase 3 data this month, Medigen in Taiwan, already conditionally approved, BioE in India with phase 3 data soon, and Valneva in Europe. The recent drop in price was due to Valneva getting into a dispute with UK, but they already have paid DVAX for the component in at least 100M doses and they likely will replace them with a EU deal. So perhaps a good time to get in.
    3. DVAX has $350M and is profitable, with a sharply increasing growth curve
    4. An attractive "bolt-on" takeout opportunity for Pfizer or Sanofi, or Moderna or Novavax. NVAX is worth $18B without an approved vaccine. DVAX is less than $2B with approved Heplisav-B, and existing salesforce and commercial infrastructure and 4 Covid vaccines in play as well as flu and pertussis programs.

  • Y

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (12)

    TODAYS NEWS!
    EMERYVILLE,Calif., May 27, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in Germany with an expected launch in the fourth quarter of 2021.

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (13)

    French vaccine biotech Valneva files for a $100 million US IPO
    April 9, 2021. (https://www.renaissancecapital.com/IPO-Center/News/80620/French-vaccine-biotech-Valneva-files-for-a-$100-million-US-IPOVALN)
    Valneva, a commercial-stage French biotech developing vaccines for infectious diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering. The company is currently listed on the Euronext Paris (VLA).

    Valneva has successfully licensed and commercialized a portfolio of traveler vaccines, composed of IXIARO (also marketed as JESPECT in Australia and New Zealand) for the prevention of Japanese encephalitis in travelers and military personnel and DUKORAL for the prevention of cholera. Its clinical portfolio contains lead program VLA15, a vaccine targeting Borrelia (Lyme disease) under development in collaboration with Pfizer, which is currently in Phase 2 trials.

    The Saint-Herblain, France-based company was founded in 1999 and booked $131 million in sales for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol VALN. Valneva filed confidentially on January 15, 2021. Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co are the joint bookrunners on the deal. No pricing terms were disclosed.

    Valneva, a commercial-stage French biotech developing vaccines for infectious diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.

    Valneva, a commercial-stage French biotech developing vaccines for infectious diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.

    www.renaissancecapital.com

  • i

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (14)

    from a value perspective I look at it like this...

    NVAX = no revenue

    DVAX = revenues are the strongest in the stock’s history

    NVAX = focused on Covid play (main source of income)

    DVAX = focused on Hepislav-B a potential 600+ million dollar market in the US alone and multiple billions annually with worldwide ACIP approval, with a bonus on the side of CPG1018/Covid play, TDAP/Pertussis, and pot universal flu vaccine with Mt. Sinai collaboration.

    NVAX = over $200 a share which does not leave a lot of opportunity even if stock rises to $300 you only stand to make a 50% profit and some MAJOR news would have to happen to even move it to $300 in the first place.

    DVAX = under $15 a share, potential to reach $30, $50, $100+ which means 100% - 700% profits.

    NVAX = investors already aware, some dumping their positions in frustration over delays.

    DVAX = investors are just starting to become aware of DVAX and its contributions

  • b

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (15)

    ... possibly the news we have all been waiting for. Premarket is up...
    This should propel DVAX to new high's adding to yesterday's gains.
    This is the beginning of the climb... when they report earning in August... put on your seat belt...

    Clover to procure CpG 1018 adjuvant from Dynavax for use in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)

    Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021CHENGDU, China and EMERYVILLE, Calif., June 30, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats, and Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax.

  • m

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (16)

    Just a few quotes from earnings call last year (September 2020) - a reminder of the less talked about sleeping giant in these DVAX forums HEPLISAV-B:

    “While the efforts of development adjuvanted vaccine for COVID-19 is a key priority, we continue to drive our business forward for the growth of sales of HEPLISAV-B, which we believe will become the standard-of-care adult hepatitis B vaccine in the U.S. with a potential future market opportunity exceeding $600 million in net sales.”
    “It has been approved by the FDA and it offers protection in just one month, compared to six months for the competitor products. On top of the speed of protection, it has demonstrated higher rates of protection in head-to-head clinical studies compared to the three-dose six-month regimen of the current market leader. HEPLISAV-B's two-dose one-month regimen with the corresponding improvement in compliance and higher levels of protection gives us confidence HEPLISAV-B will become the standard-of-care for adult hepatitis B vaccination in the U.S.”
    “The Department of Defense saw an increase in utilization in the third quarter (2020) compared to the same period last year. The third quarter historically has represented the period of highest utilization in this segment, due to a surge in new recruits over the summer months. In addition to the third-quarter surge several bases used in the fiscal-year budget surplus to stock in doses at the end of September for use in the fourth quarter, which resulted in strong demand in the DOD segment in the third quarter.”

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (17)

    A great reminder for fellow dvax followers from years back that may be looking to catch up - not only is there this amazing covid news with CpG 1018 and obviously Heplisav European approval, but the post marketing study that was required following the 2017 Heplisav approval - the one to check for acute myocardial infarction against Engerix - those results finally came out a few weeks ago and they are great! Over 30,000 patients on each side were given Heplisav and Engerix and the study not only confirmed the safety profile for Heplisav, and by extension CpG 1018...but the rate of acute myocardial infarction was actually higher on the Engerix side! So you could not have had better results for that. The only reason I mention it as it was such a big deal when Heplisav was approved, and now you have clear results and Europe approved. Per CEO Ryan Spencer, Germany will be open for business for Heplisav by the end of the year.

    -----
    from April 27th, 2021 press release:

    The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the occurrence of AMI in approximately 31,000 patients who received HEPLISAV-B® and approximately 38,000 patients who received Engerix-B. The AMI rate per 1000 person years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results provide evidence there is no increased risk of AMI associated with vaccination with HEPLISAV-B compared to Engerix-B. The study was conducted by Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness.

    "These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," commented Robert Janssen, MD, Chief Medical Officer. "We are pleased to collaborate with Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness and appreciate their rigorous conduct of this study."

  • m

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (18)

    Dynavax and Biological E Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Biological E's COVID-19 Vaccine Candidate
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    July 6, 2021 - 8:00 am
    EMERYVILLE, Calif. and HYDERABAD, India, July 6, 2021 -- Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAX™ later this year.
    (PRNewsfoto/Dynavax Technologies)

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (19)

    Valneva Commences Manufacturing of its Inactivated, Adjuvanted COVID-19 Vaccine, Completes Phase 1/2 Study RecruitmentVaccine production initiated to optimize timeline for potential deliveries

    Phase 1/2 clinical study now fully enrolled; initial data read out expected in April 2021
    Saint-Herblain (France), January 28, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies, in order to optimize the timeline for potential deliveries of the vaccine. The Phase 1/2 clinical study is now fully enrolled and is expected to report initial results in April 2021.

    VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. A total of 150 healthy adults aged 18 to 55 years have been recruited for the Phase 1/2 study which commenced mid December 20201.

    Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are extremely pleased to have achieved these two important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly. I would like to thank the UK Vaccines Taskforce and National Institute for Health Research who have played vital roles in the rapid recruitment and enrollment of the volunteers for the clinical study. We believe that our vaccine, assuming successful development, can make a major contribution in the UK and beyond.”

    In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its COVID-19 vaccine VLA20012. Under this partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. Valneva also announced in January 20213 it is in advanced discussions with the European Commission for the supply of up to 60 million doses of VLA2001.

  • D

    Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (20)

    My quick take away - if one were to believe guidance for Q2 and 2020 was baked in due to Covid-19, then earnings look great year over year. Also, with r&d down 75% ($4.6Mill compared to $21.2Mill), it's like a dream compared to the money pit that was/is SD-101 (taking nothing away from the true value/benefit of SD-101, which continues to show promise). As they explained, "despite the short-term disruptions of this year, Dynavax’s long-term value proposition remains intact with the added potential to accelerate the utilization of CpG 1018 globally.” Here are a few interesting items from the 10-Q - term loan amount (my favorite topic), warrant conversion price info (if exercised), and ATM proceeds from Q1 with a little Q2 already thrown in.

    "Liquidity and Financial Condition
    As of March 31, 2020, we had cash, cash equivalents and marketable securities of $129.5 million. As of March 31, 2020, the principal amount of our term loan was $180.9 million, including paid-in-kind interest. The term loan has a maturity date of December 31, 2023, unless earlier prepaid."

    "On March 11, 2020, we entered into a warrant exchange agreement with Bain Life Sciences Funds pursuant to which we agreed that we would, upon future notice from Bain Life Sciences Funds, exchange all or a portion of the common stock warrants held by Bain Life Sciences Funds for warrants to purchase a new Series C convertible preferred stock (“Series C Warrants”). Each share of Series C convertible preferred stock would be convertible into 1,000 shares of common stock, with a conversion price of $4.50 and would have substantially identical rights to our Series B Convertible Preferred Stock. As of March 31, 2020, Bain Life Sciences Funds have not exercised their rights to exchange common stock warrants with Series C Warrants.

    On November 3, 2017, we entered into an At Market Sales Agreement (“2017 ATM Agreement”) with Cowen and Company, LLC (“Cowen”) under which we may offer and sell from time to time at our sole discretion, shares of our common stock having an aggregate offering price up to $150 million through Cowen as our sales agent. We pay Cowen a commission of up to 3% of the gross sales proceeds of any common stock sold through Cowen under the 2017 ATM Agreement. For the three months ended March 31, 2020, we received net cash proceeds of $14.2 million resulting from sales of 2,908,875 shares of our common stock. As of March 31, 2020, we have $104.0 million remaining under the 2017 ATM Agreement. Subsequent to March 31, 2020
    and through May 1, 2020, we sold 4,584,591 shares of common stock for net proceeds of $15.9 million under the 2017 ATM Agreement."

    "We currently anticipate that our cash, cash equivalents and short-term marketable securities as of March 31, 2020, and anticipated revenues from HEPLISAV-B will be sufficient to fund our operations for at least the next 12 months from the date of this filing."

Dynavax Technologies Corporation (DVAX) stock forum & discussion – Yahoo Finance (2024)

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