The Delta variant has demonstrated a likely course for our Covid future – a new endemic piece of the global human microbiome puzzle. It’s not the news we wanted. But it could have turned out a lot worse.
Covid is amenable to vaccine solutions, even if we may have to come up with modified versions each year. On balance, that should be good news because it means we can find a way back to normal life, even if it implies a half-hour trip to the pharmacy each year.
But there are realistic questions to ask given this potential state of affairs and the fact that the current dominant vaccine solutions are expensive to produce, difficult to transport, difficult to store, and increasingly subject to social rejection due to their newness and humanity’s cultural unfamiliarity with mRNA vaccines.
While they represent remarkable technological solutions, the mRNA vaccines may not ultimately be the long-term answer to an endemic transmogrifying viral foe that demands frequent dosing of billions of people on a budget.
With that in mind, we take a look at some of the more interesting recent catalysts in the vaccine space, which includes Moderna Inc (NASDAQ:MRNA), Dyadic International, Inc. (NASDAQ:DYAI), Novavax, Inc. (NASDAQ:NVAX), Johnson & Johnson (NYSE:JNJ), AstraZeneca plc (NASDAQ:AZN), BioNTech SE – ADR (NASDAQ:BNTX), and Pfizer Inc. (NYSE:PFE).
Moderna Inc (NASDAQ:MRNA) has become the poster boy for the revolution in the vaccine space catalyzed by our collective scientific response to the Covid pandemic. In the past, it often took 10 years or more to develop a vaccine. MRNA did it reportedly in two days. The rest was testing.
The company engages in the development of transformative medicines based on messenger ribonucleic acid (mRNA). Its product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics.
Moderna Inc (NASDAQ:MRNA) recently announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada including access to Moderna’s mRNA development engine. The goals of this MoU are to build the foundation to support Canada with direct access to rapid pandemic response capabilities and to provide access to Moderna’s vaccines in development for respiratory viruses.
“I would like to thank the Government of Canada for the partnership they have built with us and for their faith in our data, science and early confidence in our mRNA platform in addressing the COVID-19 pandemic. We recently announced data from the final analysis of the Phase 3 COVE study demonstrating that vaccination with the Moderna COVID-19 vaccine showed 93% efficacy, with this efficacy remaining durable six months after administration of the second dose,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As a company, we are committed to global public health. While we are still responding to this pandemic, we also want to ensure we and society learn from it. As Moderna expands internationally, we are delighted to bring mRNA manufacturing to Canada. We believe that this innovative business model will have global impact and implications.”
While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action MRNA shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -8% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities. Shares of the stock have powered higher over the past month, rallying roughly 56% in that time on strong overall action.
Moderna Inc (NASDAQ:MRNA) managed to rope in revenues totaling $4.4B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 6462.1%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($8B against $8.8B, respectively).
Dyadic International, Inc. (NASDAQ:DYAI) is exploding higher this week and should be noted for investors interested in this space. The company has a unique approach to its vaccine platform and is making great strides toward global recognition even as it probably has received the least attention from retail investors of any credible front-line player in the Covid vaccine space – a fact that could make it ultimately the most interesting name on this list.
The company has a special edge with its fungal-based C1 technology platform, which uses a different vector for producing more vaccine volume faster and cheaper, and its vaccine solution (now starting human testing) is easier to store, produce, transport, and distribute, and cheaper to manufacture quickly, than the mRNA solutions.
Dyadic International, Inc. (NASDAQ:DYAI) recently announced, along with Sorrento Therapeutics, Inc. (NASDAQ:SRNE), the signing of a binding term sheet to enter into an exclusive license agreement to develop and commercialize vaccines, therapeutics, and diagnostics for coronaviruses, including Dyadic’s lead COVID-19 vaccine candidate, DYAI-100, produced using Dyadic’s proprietary and patented C1-cell protein production platform. The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.
Sorrento Chairman and CEO, Dr. Henry Ji, commented, “We look forward to continuing our collaboration with Dyadic, which began last year, initially with a goal of developing and commercializing a protein-based COVID-19 vaccine that can be rapidly manufactured in large quantities in our existing cGMP facilities, and stored and transported at room temperature, in order to increase access and affordability to underserved populations globally.” Dr Ji. continued, “Over the past six months we have carried out several promising preclinical animal studies using the C1-produced RBD antigen in Dyadic’s lead COVID-19 vaccine candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine that will provide protection across the variants of concern, including Delta, and in addition, apply the C1 protein production platform broadly across our current and future coronavirus programs.”
Mark Emalfarb, Dyadic’s President and Chief Executive Officer noted, “We are delighted to have executed a binding term sheet with Sorrento Therapeutics to license the C1 technology for the development and commercialization of coronavirus vaccines, therapeutics, and diagnostics, including COVID-19. This marks a significant milestone in our corporate development efforts as we expect the license agreement we will enter into to enable us to monetize our internal COVID-19 development efforts with a partner that has the resources and expertise to advance vaccines, therapeutics, and diagnostics both clinically and commercially.”
This is huge game-changing news for DYAI, and the stock should be on the radar for market participants searching for value in the Covid space.
Dyadic International, Inc. (NASDAQ:DYAI) managed to rope in revenues totaling $461K in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 46%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($27.2M against $2.6M).
Novavax, Inc. (NASDAQ:NVAX) focuses on the discovery, development and commercialization of vaccines to prevent infectious diseases. NVAX has gained attention as a potential producer of a traditional vaccine solution – non-mRNA – that could work against Covid, like DYAI. But the stock has been bid up to nose-bleed levels in recent action.
The company provides vaccines for COVID-19, seasonal flu, respiratory syncytial virus, Ebola, and Middle East respiratory syndrome.
Novavax, Inc. (NASDAQ:NVAX) recently announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers. Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant were more than 6-fold higher than the primary vaccination series. Complete data from the study will be submitted to a peer review publication and posted to a preprint server.
“The strong results from this study reinforce our confidence in the potential for a booster dose of NVX-CoV2373 to provide broad protection against disease, including from known and emerging variants,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “Given the evidence that natural and vaccine-induced immunity wanes over time, the continuation of our proactive clinical development program will be critical to understanding and demonstrating the effectiveness of our recombinant nanoparticle COVID-19 vaccine.”
The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 5% in that timeframe. Shares of the stock have powered higher over the past month, rallying roughly 32% in that time on strong overall action.
Novavax, Inc. (NASDAQ:NVAX) managed to rope in revenues totaling $298M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 738.6%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($2.1B against $1.7B).