Breaking Down VBI Vaccines' Pipeline: Descriptions And Catalysts

Clarus Ventures, by way of its Clarus Lifesciences fund, just reported a 6.72% position in VBI Vaccines Inc. (VBIV). The filing, available here, details a 2.7 million share count, and positions Clarus, which has a history of success in the healthcare space and manages $1.78 billion, as one of the company's leading institutional backers. It's far from the only example of smart money with a stake in VBI, however. The company counts Perceptive Advisors as an institutional backer, having reported a $23.6 million financing, the most recent iteration of this relationship, back in December. Biotech entrepreneur Dr. Phillip Frost, Chairman and CEO of Opko Health Inc. (NASDAQ:OPK ) and biotech investor through his own Frost Gamma Investments Trust, holds a 17% stak.

This is a company with strong institutional interest, and a retail base that is expanding rapidly. VBI is up more than 30% year to date. If the company's operational strategy plays out as planned, however, this 30% could be just the beginning of a longer term upside revaluation. VBI has a pipeline that spans numerous multi billion-dollar target markets, and a portfolio of proprietary technologies, each of which could be a game changer in its field. In other words, the company has multiple shots at some very rewarding goals, and a hit on any one would justify a market capitalization far in excess of that which it currently holds.

Even with this being the case, however, the company remains somewhat under the radar.

Here's a look at VBI's pipeline, and a discussion of why it deserves more retail attention than it's currently drawing.

The company's lead commercial asset is called Sci-B-Vac, and it's a third generation hepatitis B vaccine. The drug is a third generation vaccine, designed using the company's eVLP platform. It's built to improve on the immunogenicity of the current standard of care vaccines in the space (such as GlaxoSmithKline PLC (GSK)'s Engerix B), and it's currently approved in a number of countries globally, including VBI's native Israel. It's not approved in the US or Europe, however, and these are the company's primary target markets right now. An approval in both would open up a $1 billion preventative vaccination market to VBI, and the company took a big step towards this end with recent announcement that it has received EMA support in Europe to proceed with a phase III that will underpin an approval application in the region on completion. A concurrent phase III is planned in the US, and this should kick off at some point early second half 2017. This is a drug that has a safety and efficacy track record in over 22 clinical studies in more than 4,000 children and adults, and has demonstrated safety and efficacy in over 300,000 patients in currently licensed markets. In other words, it should have no problem hitting its endpoints (which are rooted in seroprotection) in the US and European pivotals, and by proxy, should have a clean run through to commercialization in the two respective markets.

VBI's lead development asset (separating commercial and development here for the sake of clarity – Sci-B-Vac is technically commercial and development stage) is a cytomegalovirus (CMV) vaccine called VBI-1501A. CMV infection is a major problem in the US, where annually, approximately 5,000 infants will develop permanent problems due to infection. These include deafness, blindness, and mental retardation. There's no vaccine available right now, and nothing promising in development outside of VBI's pipeline. 1501A employs the same eVLP technology that the company used to produce Sci-B-Vac, and is a highly immunogenic vaccine that (based on preclinical investigation) is able to elicit an immune response that is comparable to or better than a natural infection by closely mimicking the structure of the target CMV virus.

Enrollment in a phase I study of CMV in the US completed back in September 2016, and the company expects to release preliminary results from the study at some point during the first half of this year (read: second quarter 2017). There's immediate upside potential on this catalyst, if the data reads as positive, and implies a degree of seroprotection across the 128 patients in the study.

The second development asset is called VBI-1901, and rather than a preventative vaccine (like 1501A and Sci-B-Vac) is a reactive vaccine therapy, which the company is using to target glioblastoma multiforme (GBM). GBM is an aggressive brain cancer that basically has no current effective treatment (surgical resection, radiotherapy are standards of care, but both extend survival by weeks and months, not months and years).

VBI has taken a body of research that suggests GBM tumors are susceptible to infection by CMV, and used this to underpin 1901's MOA. Basically, the drug employs the expression of CMV antigens by tumor cells to selectively target the cells for immunotherapy activation. A pre-IND meeting with the FDA back at the end of October 2016 yielded a positive response from the agency, and VBI expects to file an IND to initiate a Phase I/IIa clinical trial in patients with GBM during the second quarter of this year. Further, the FDA has stated that it will consider a Fast Track designation for 1901 at the time of the IND submission. Trial initiation and the Fast Track designation both have the potential to inject some upside momentum into the company on announcement.

Outside of the eVLP platform, VBI has also developed a way to modify currently available vaccines so as to equip them for removal from the cold chain. For those not familiar with the cold chain concept, the term describes the necessity for vaccination formulations to be kept at a steady temperature (generally accepted as between 4 and 8 Celsius) to avoid degradation. This necessity is expensive, and spans the full distribution chain associated with vaccines, with estimates suggesting it adds 20% on to the cost of vaccines to the end user.

With VBI's platform, called LPV, vaccines that would otherwise need to maintain a temperature within the above mentioned bracket can be removed from the chain, while maintaining stability, potency, and safety. The platform is currently the foundation of a number of collaboration efforts between VBI and other companies, with the two most noteworthy near term being strategic partnerships with Sanofi (SNY) and GlaxoSmithKline. Very little is available as to exactly what these partnerships entail, but a reasonable conclusion is that they are in place to allow Sanofi and GSK to investigate the potential of the LPV platform when applied to the vaccines each already has o the market. Both companies are giants in the vaccine space, and if VBI can prove that it can reduce the cost associated with vaccine transportation and storage by applying its technology to the two companies' commercial vaccines, there's a massive potential impact on VBI's standing in the space, and by proxy, valuation.

With all this noted, there are still some risks worth pointing out in the interest of balance.

Outside of Sci-B-Vac, the company's pipeline is very much early stage, with one phase I study and the rest pre-clinical as things stand. There's a long way to go before VBI can start generating revenues from its GBM and CMV vaccines. The income stream from Sci-B-Vac mitigates this somewhat, but far from negates it as a risk factor.

Coupled with this is the potential for equity issue. VBI is going to need to raise development capital if it is to fund its pipeline through to commercial maturation. The raise detailed in the introduction to this piece extends runway somewhat, but only $10.6 million derives from equity issue, and the remaining $13 million comes on the back of a secured debt issue. The capital should fund through to the completion of the hepatitis studies (and in doing so, could carry Sci-B-Vac to US and European commercialization) but there's going to be a gap between the drug getting a regulatory green light and the company starting to generate revenues from any US and European approvals. Any further equity issue (which is almost inevitable, if VBI wants to continue to develop its pipeline while it kicks off a commercialization run for Sci-B-Vac) is going to impact the holdings of early investors, and while not prohibitive to an exposure, should be taken into consideration. As should the potential burden of a debt rooted alternative, like we've already seen with the Perceptive issue. 

Disclosure: I do not own shares in any of ...

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