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Arcturus' (ARCT) Shares Fall on COVID-19 Vaccine Study Results

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Shares of Arcturus Therapeutics Holdings Inc. (ARCT - Free Report) fell 54.2% after it released not so encouraging data from its phase I/II and preclinical study on its coronavirus vaccine candidate, ARCT-021. The company also announced that it received approval from the Singapore Health Sciences Authority to proceed with a phase II study of ARCT-021. However, shares of Arcturus have surged 289.7% year to date compared with the industry’s growth of 7.4%.

 

The phase I/II study results, together with preclinical data, indicated that ARCT-021 led to a potent immune response to SARS-CoV-2 and demonstrated a differentiated biological profile, whereby the immune response increased in the weeks following the vaccination. The preclinical data also showed that ARCT-021 resulted in highly potent cellular immunity to the virus. However, investors were disappointed as ARCT-021produced fewer neutralizing antibodies than expected.

Nevertheless, the phase I/II data demonstrated favorable tolerability.Immunogenicity was observed in 100% (44/44) of vaccinated subjects receiving 7.5 µg single dose & 5 µg single and prime-boost regimens.

In humoral immunodeficient animals depleted of B cells, ARCT-021 demonstrated protection with a single low-dose administration, further emphasizing the potential importance of the vaccine’s cellular immunity.

ARCT-021 (both single administration and prime-boost regimens)issignificantly effective in a primate challenge model. 

The company advanced ARCT-021 to a phase II study based on its phase I/II data. The phase II study will enable the selection of the optimal ARCT-021 vaccination regimen for phase III registrational studies. The company expects to obtain interim phase II data in early 2021, providing support for the anticipated initiation of a global phase III study in the second quarter of 2021.

We note that Pfizer Inc. (PFE - Free Report) and BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2, was granted emergency use authorization (EUA) by the FDA on Dec 11. Thevaccine is now approved for emergency/temporaryuse in more than 40 countries including the United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada. Moderna’s (MRNA - Free Report) coronavirus vaccine, mRNA-1273, has also been approved for emergency use in the United States and Canada.

Arcturus currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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