CureVac N.V. (NASDAQ:CVAC) is in the process of developing an avian influenza [H5N1] vaccine with its partner GSK plc (GSK) aka GlaxoSmithKline. The significance of this is that there have been a few cases of avian flu noted in Australia and the United States. It is too early to tell right now, but if there is an eventual outbreak, then this company could possibly be in a position to help out with a working vaccine.
CureVac is even in the process of developing a season influenza vaccine as well. Interim data showed the vaccine to do better than comparative vaccines in terms of targeting influenza A, but not so much so for influenza B. Thus, it is going to optimize this program to see if it can do better for targeting influenza B in another phase 2 study.
The seasonal influenza program needs work in terms of targeting influenza B and there is no assurance that an avian influenza pandemic will occur. If this is the case, then what else is in CureVac's pipeline for investors to look forward to? This would be in terms of developing an mRNA cancer vaccine candidate for surgically resected glioblastoma. Part A of a phase 1 study completed, with patients starting to be enrolled for Part B in mid-2024. It is said that the first data readout of this study is expected in the 2nd half of 2024. This is another shot on goal for investors to look forward to.
Regarding the Covid-19 program that is winding down, like many other pharmaceutical companies have done. Having said that, Q2 of 2024 will see the end of contract provisions as part of the CVnCov program, and that cash burn going forward will be lowered.
Avian Influenza Vaccine Advancement Could Mean Possibility Of Added Protection
As I stated above, CureVac along with its partner GlaxoSmithKline are advancing an avian influenza [H5N1] vaccine. The thing is that the company is not waiting until such a pandemic hits. Instead, it is being proactive and has already initiated a phase 1 study for this program. Matter of fact, this study was already initiated back on April 24th of 2024. The goal is to evaluate influenza A [H5N1] as a pre-pandemic vaccine in two different patient populations, as follows:
- Healthy younger adults, ages 18 to 64
- Healthy older adults, ages 65 to 85.
It honestly remains to be seen what happens with this study, which is why I would still consider this program an unknown. Why is that? That's because the intended goal is to escalate 5 dosing levels. However, what I do like about the study design for such an early study is that such dosing will be compared to a placebo control. The primary measure, which is always indicated for dose-escalation portions of studies, is safety. From there, immunogenicity [ability to provoke immune response] and reactogenicity [expected adverse reactions for vaccines] will be evaluated.
The candidate being advanced as a prophylactic vaccine for avian influenza is a monovalent type utilizing CureVac's proprietary second-generation mRNA backbone and has the influenza A H5-antigen in place.
The big question becomes whether there is a need for such a prophylactic vaccine. This honestly remains to be seen. However, avian influenza is starting to pop up in a few places. For instance, it first appeared in March 2024, where one child contracted the disease. Then, there was another case found in a Michigan farm worker.
The common consensus among experts, though, is that a bird flu pandemic remains low. Still, it is highly important for countries across the globe to be ready in case of an outbreak. Especially, when you consider that the avian influenza [H5N1] virus has already been known to spread from animals to humans. This makes the virus adaptable, and you can never ever predict when such a strain can mutate, either.
The ability for CureVac to partner with GlaxoSmithKline is based on a long-term partnership starting back in July 2020. The goal was for both companies to jointly use CureVac's mRNA technology to develop new products for infectious disease targets. Not only that, but since then, most emphasis has been placed on using the second-generation mRNA technology I noted above for them. The Avian Flu influenza [H5N1] program has already received Fast Track Designation from the FDA. It also has the seasonal influenza program it is pushing forward.
As I stated above, it saw some good preliminary safety data. Plus, it also was able to show that this other vaccine was able to elicit strong overall antibody titer. However, antibody titer superiority over licensed cancer vaccine candidates was only observed when targeting the influenza A strain and not the influenza B strain. More work is needed with this vaccine candidate. Dose optimization is currently being deployed for a phase 2 study; thus, it remains to be seen if this program continues to advance in the pipeline. Regardless, this is another shot on goal for investors to keep an eye on.
Financials
According to the 6-K SEC Filing, CureVac had cash and cash equivalents of €402.5 million as of December 31st, 2023. This company is in good shape in terms of its cash. That's because, as I noted in the beginning above, it is starting to wind down its Covid-19 vaccine business.
Thus, the remaining costs as part of this program will only happen in Q2 of 2024. From there, cash burn will be much lower. Its cash runway is expected into Q4 of 2025 because of all the cost-cutting measures it has been able to achieve.
Risks To Business
There are several risks that investors should be aware of before investing in CureVac. The first risk to consider would be regarding the development of the avian influenza [H5N1] vaccine with GlaxoSmithKline. First, this product is being prepared as part of pandemic readiness. There is no way of knowing whether an avian influenza pandemic will occur. Secondly, this program is still in early-stage testing, as only a phase 1/2 study was just initiated in April 2024. Much more testing will be needed to see if this vaccine can elicit significant immune response against such a virus.
A second risk to consider would be regarding the seasonal influenza vaccine that it is developing. It was able to do well regarding targeting influenza A. However, there is more work to be done when targeting influenza B. That is, additional optimization is needed in a larger phase 2 study.
A third risk to consider would be in terms of the advancement of CVGBM, which is an mRNA cancer vaccine being developed to treat patients with surgically resected glioblastoma. Part A of the phase 1 study had completed and Part B is underway. It is expected that the first data readout, from this phase 1 study, will be released in the 2nd half of 2024. There is no assurance that the data will turn out to be good.
The fourth and final risk to consider would be with ongoing patent litigation. It was able to settle such litigation with Acuitas over patents. However, the litigation against Pfizer (PFE)/BioNTech (BNTC) will proceed as planned. This is going to cover 4 patent families, now covering 7 U.S. patents. A trial for such patents is expected to begin in Q2 of 2025. There is no assurance that CureVac will ultimately end up being successful in court. Thus, this would have a huge negative impact on the company and its stock price.
Conclusion
CureVac N.V. stock continues to be a hold based on the possibility of an avian influenza outbreak. The thing about it, though, is that it has other vaccines being developed in its pipeline. For instance, it is also advancing a seasonal influenza vaccine, which might end up targeting both influenza A & B variants. Another promising program would be the development of the CVGBM vaccine being developed to target patients with surgically resected glioblastoma. If positive data is reported later this year, this would open the door towards oncology development.
In addition, there is another avenue for CureVac to dive into the oncology space. In April 2024, it entered into a strategic co-development and licensing agreement with The University of Texas MD Anderson Cancer Center. The purpose of this is to advance off-the-shelf mRNA-based cancer vaccines to target both hematological [blood cancer] and solid tumors indications.
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This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
