Is Vaxart Stock Set To Decline Further?

by Trefis Team
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Vaxart stock (NASDAQ: VXRT) dropped -8% over the last five trading days and has underperformed the S&P 500 which remained roughly flat over the same period. The stock is also down by about -27% over the last month (twenty-one trading days), although it remains up by 29% year-to-date. Vaxart stock has seen a lot of volatility this year, rallying considerably in late January, in anticipation of the phase 1 data readout for the company’s tablet-based Covid-19 vaccine candidate and also due to increased attention from retail investors who were betting on small stocks with high short interest, following the GameStop short squeeze. However, the stock plummeted in early February after early-stage data indicated that the vaccine provided a lackluster antibody response against the Coronavirus. (see our updates below) Now, is Vaxart stock set to decline further or should we expect a recovery? There is a 53% chance that Vaxart stock will decline over the next month based on our machine learning analysis of trends in the stock price over the last five years. See our analysis on VXRT Stock Chances Of Rise for more details.

Overall, we think Vaxart stock looks somewhat risky at current levels of around $7.50 per share. The antibody response is the yardstick by which investors have been judging the potential efficacy of Covid-19 vaccines in phase 1 trials and Vaxart’s candidate fared badly on this front, failing to induce neutralizing antibodies in most trial subjects. In contrast, shots from Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) produced antibodies in 100% of participants in phase 1 trials. Apart from the efficacy concerns, the company’s development timeline also trails behind market leaders by multiple quarters. Vaxart has no revenue-generating products yet, with the most advanced development in its pipeline being a vaccine for seasonal influenza which is currently in phase 2 trials. Even after the big sell-off, the stock remains up by about 6x over the last 12 months.

[2/8/2021] What’s Next For Vaxart After Tough Phase 1 Readout

Biotech company Vaxart (NASDAQ: VXRT) posted mixed phase 1 results for its tablet-based Covid-19 vaccine, causing its stock to decline by over 60% from last week’s high. Although the vaccine was well tolerated and produced multiple immune responses, it failed to induce neutralizing antibodies in most subjects. Neutralizing antibodies bind to a virus and prevent it from infecting cells and it is possible that the lack of antibodies could lower the vaccine’s ability to fight Covid-19. In comparison, shots from Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) produced antibodies in 100% of participants during their phase 1 trials.

While this marks a setback for the company, there could be some hope. Most Covid-19 shots target the spike protein that is on the outside of the Coronavirus. Now, this protein has been mutating, with new Covid-19 strains found in the U.K and South Africa, possibly rending existing vaccines less useful against certain variants. However, Vaxart’s vaccine targets both the spike protein and another protein called the nucleoprotein, and the company says that this could make it less impacted by new variants than injectable vaccines. [1] Additionally, Vaxart still intends to initiate phase 2 trials to study the efficacy of its vaccine, and we wouldn’t really write off the company’s Covid-19 efforts until there is more concrete efficacy data. That being said, the risks are certainly higher for investors at this point. The company’s development trails behind market leaders by a few quarters and its cash position isn’t exactly sizeable, standing at about $133 million as of Q3 2020. The company has no revenue-generating products just yet and even after the big sell-off, the stock remains up by about 7x over the last 12 months.

See our indicative theme on Covid-19 Vaccine stocks for more details on the performance of key U.S. based companies working on  Covid-19 vaccines.

[1/22/2021] Is Vaxart Stock Worth The Risk?

Biotech company Vaxart (NASDAQ:VXRT)  stock is up by over 11x through the last 12 months rising to levels of around $7 per share, driven by the company’s efforts to develop a Covid-19 vaccine. Vaxart, which focuses on oral recombinant vaccines, is targeting a Covid-19 vaccine that can be administered via tablets, eliminating the need for an injection, while being stored at room temperatures. The relative ease of use, distribution, and transportation could make it a game-changer at the time of the pandemic, reducing strain on healthcare infrastructure and potentially speeding up vaccination efforts.

See our indicative theme on Covid-19 Vaccine stocks for more details on the performance of key U.S. based companies working on  Covid-19 vaccines.

However, Vaxart’s development lags behind industry leaders. While the likes of Moderna and Pfizer and AstraZeneca already have vaccines on the market, we don’t know yet if Vaxart’s candidate will be safe and effective on humans. Vaxart only began its phase 1 study in October with results expected this month. If the results from the safety trials are positive, the company will move into phase 2 testing and it could still be a couple of quarters before it has definitive results on the efficacy. By this time, it’s possible that developed economies such as the U.S. and the E.U. (which are more lucrative) would likely have inoculated a bulk of their populations against Covid-19.

While Vaxart’s market cap of under $800 million makes it look like a reasonable value, the risks are also sizeable as the company doesn’t have any revenue-generating products just yet. Vaxart’s pipeline consists of five other vaccines, with the most advanced candidate being an influenza vaccine in phase 2 trials, with most of its other candidates in the pre-clinical stage. The stock is also extremely volatile. At one point in 2020, the stock went to as high as $17, driven by news that the company had joined the federal government’s Operation Warp speed, which turned out to be false, causing it to correct significantly. Overall, Vaxart remains a very high risk, high reward type bet.

[1/12/2021] Novavax

Vaccine developer Novavax (NASDAQ: NVAX) is seen as a key player in the Coronavirus vaccine space. Here’s a quick overview of what has been happening with the company over the last few weeks. Firstly, Novavax initiated a phase 3 study for its Covid-19 vaccine candidate in the U.S. and Mexico towards the end of December, after facing multiple delays. The company also has an ongoing phase 3 trial in the U.K, which commenced in September. Data from the U.K. trial is expected within the next few weeks and the results will be closely watched considering that a much more contagious strain of the coronavirus has been spreading in the country. This should allow Novavax to gauge how its shot fares against these mutations. Separately, Novavax also signed an agreement to supply 51 million doses of its vaccine candidate to Australia. The vaccine is currently being evaluated under phase 1/2 trials in Australia. Novavax stock had a decent week, rising by about 4% over the last week, although it remains down by about 10% over the last month. See our indicative theme of  Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up about 3x over the last 2 years.

[1/4/2021]

Vaccine specialist Novavax (NASDAQ: NVAX) – which is seen as a key player in the Covid-19 vaccine space – saw its stock price decline by about 20% over December. Here are a few possible reasons for the decline.

Covid-19 vaccines by Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) received emergency approval from the U.S. FDA in December and inoculation drives have already begun in the U.K and the U.S. with these countries looking to get their citizens vaccinated as quickly as possible. For instance, the U.S. says that every American who wants a Covid-19 vaccine should have one by June. This likely means that demand for the Novavax vaccine – which is only likely to be available, subject to approval, in Q1 2021 or later – will be somewhat limited in the country. While Novavax has supply agreements with the U.S. and Australia, the company might not see much upside in developed markets.

Novavax announced that it was commencing phase 3 clinical trials for its novel coronavirus vaccine in the U.S. and Mexico last week. While this is good news, considering that Novavax saw multiple delays in starting late-stage U.S. studies amid manufacturing challenges, there are concerns whether the company will be able to meet its target of signing up 30k volunteers when there are two highly effective vaccines already available in the market. For example, prospective volunteers might be concerned that they are given a placebo or that Novavax’s candidate could be less protective or even if their involvement in the trial could impact their ability to take another vaccine.

See our indicative theme on Covid-19 Vaccine stocks for more details on the performance of key U.S. based companies working on  Covid-19 vaccines.

[Updated 12/23/2020] What Are The Risks For Novavax?

Vaccine specialist Novavax (NASDAQ: NVAX) has seen its stock price soar by roughly 25x year to date. While part of the gains were driven by encouraging results for phase 3 trials of the company’s NanoFlu flu vaccine back in March, a bulk of the price appreciation is due to the company’s development of a Covid-19 vaccine candidate. While we discussed some of the merits of the Novavax vaccine in our previous update (see below), in this note, we take a look at some of the key risks that it could face.

While Novavax entered the Covid vaccine race in the Spring, along with Moderna and Pfizer/BioNtech who have now started rolling out their vaccines, the company has faced delays in its timeline. The first readouts from its phase 3 trials are expected around Q1 2021 – likely one quarter behind the front runners. Only after these results are available will the company be able to file for emergency approval and rollout its vaccine. While this may not be a big deal considering that there’s enough room for multiple Covid vaccines, Novavax might miss out on relatively more lucrative orders from developed markets. For instance, the U.S. is now expected to increase its order for Pfizer’s vaccine to another 100 million doses.

Margins for the vaccine could also be a concern. Novavax’s vaccine is based on subunits – essentially using a fragment of the virus – and the manufacturing process is apparently more complex compared to the method used in messenger RNA vaccines including Moderna’s.  This could potentially make the Novavax vaccine more expensive to manufacture. Based on a supply agreement with the U.S. government, the Novavax vaccine will be priced at about $16 per dose, below the $19.50 for Pfizer’s vaccine and as much as $37 per dose for Moderna’s. The potentially more complex manufacturing process and lower prices could mean that margins might be lower.

[Updated 12/2/2020] Does Novavax Covid Vaccine Still Matter?

Novavax (NASDAQ: NVAX) stock saw some volatility after the company said that it had rescheduled its Phase-3 clinical trial in the US, indicating that it could begin in the coming weeks, instead of starting in November. This marks the second time that the company has delayed its U.S. trials, amid some challenges with scaling up production. While the company currently has late-stage trials underway in the U.K, with a readout expected in Q1 2021, Novavax significantly trails frontrunners Pfizer and Moderna who have shown extremely high efficacy rates of roughly 95% and have already applied for emergency approval with the U.S. FDA. Considering that the Novavax vaccine could be at least one quarter behind the frontrunners, will there be a place in the market for the Novavax vaccine even if it proves safe and effective and wins regulatory approval? We believe the answer is yes, for multiple reasons.

While the Novavax vaccine might arrive later than expected, it still holds promise. Firstly, based on data from early trials there are indicators that it might be highly effective. For example, the antibody responses for the Novavax vaccine were meaningfully stronger than other vaccines that have been reported at that time, per data from its Australian trials that were available in August. [2] The vaccine should also be easier to distribute, as it only needs to be stored at refrigerated temperatures, unlike Pfizer’s vaccine which needs to be stored at ultra-cold temperatures.  Novavax’s vaccine might also be more reasonably priced. Based on a supply deal with the U.S. government, the vaccine’s price is estimated to be about $16 per dose, compared to as much as $37 per dose for Moderna’s vaccine and $19.50 for Pfizer’s. If all goes well, Novavax could also scale up production fairly quickly. In September Novavax reached an agreement with the Serum Institute of India, one of the largest vaccine manufacturers in the world, boosting the company’s capacity to as much as 2 billion doses a year starting from mid-2021. [3]

Novavax’s vaccine could also emerge popular in low and middle-income markets. While the Oxford-AstraZeneca’s vaccine – which is likely to be priced at a few dollars per dose – is seen as key to fighting the pandemic in emerging markets, it now faces questions regarding the way phase 3 trials were handled, potentially resulting in delays and apprehension among governments. This could make the Novavax vaccine – which can be produced at scale and easily distributed – popular if the pricing is suitably adjusted.

[Updated 11/4/2020] Covid-19 Vaccine stocks

Our indicative theme of Covid-19 Vaccine stocks – which includes a diverse set of U.S.-based pharma and biotech companies developing Covid vaccines – is up by about 560% year-to-date, on an equally weighted basis, compared to the S&P 500 which has gained just about 4% over the same period. While most vaccine stocks declined last week, amid a broader sell-off in the markets, they are likely to come back into the spotlight as efficacy data from late-stage trials is expected from frontrunners Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) in the coming weeks. Below is a bit more on the companies in our theme of Coronavirus Vaccine stocks and their relative performance.

Novavax (NVAX), a vaccine development company, began late-stage trials of its Covid vaccine in the U.K in September, and large-scale phase 3 trials are due to begin in the U.S. and Mexico this month. While the company doesn’t have any other products on the market yet, its flu vaccine NanoFlu could be ready for potential FDA approval. The company has received about $1.6 billion in funding from the Federal government. The stock has soared 2,000% year-to-date.

NVAX

Moderna (MRNA) , a clinical-stage biotech company, is carrying out phase 3 trials of its Covid-19 vaccine, completing enrollment of 30,000 participants. The company is likely to have data on whether its vaccine works or not by this month, and has noted that it would seek emergency approval from the FDA if the vaccine is at least 70% effective. The stock is up 253% this year.

Johnson & Johnson (JNJ): Unlike most other vaccine candidates, which are likely to require two shots, J&J is targeting a single-dose vaccine. While the company had to pause trials in mid-October after an illness was reported in a volunteer, the company is now preparing to resume trials.  The stock is down by -5.1% this year.

Pfizer (PFE) is working with German partner BioNTech on a Covid-19 vaccine. The company is likely to have efficacy data from late-stage trials available shortly. The company could supply about 40 million doses in the United States in 2020 if the data is positive and regulators approve the vaccine. The stock is down by about -7.6% this year.

While Vaxart stock may have moved, 2020 has created many pricing discontinuities which can offer attractive trading opportunities. For example, you’ll be surprised how the stock valuation for Alphabet vs. Vertex Pharmaceuticals shows a disconnect with their relative operational growth. You can find many such discontinuous pairs here.

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Notes:
  1. Vaxart Press Release []
  2. Will a small, long-shot U.S. company end up producing the best coronavirus vaccine?, Science []
  3. Novavax Press Release []
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