Arcturus Gets Approval For Covid-19 Vaccine Phase 2 Study; Shares Plunge 38%

Arcturus Therapeutics Holdings on Dec. 28 announced that the Singapore Health Sciences Authority approved the start of the Phase 2 clinical study of its COVID-19 vaccine candidate ARCT-021. Shares plunged 38% in Monday’s after-hours trading.

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Arcturus Therapeutics (ARCT) said that the approval was based on Phase 1/2 data, which showed favorable tolerability of the vaccine candidate and immunogenicity in all the 44 vaccinated individuals receiving 7.5 µg single dose & 5 µg single and prime-boost regimens.

The Phase 2 study will build upon the Phase 1/2 study results and supportive preclinical data. It will include both single dose and prime-boost regimens in up to 600 participants.

“We are pleased to advance ARCT-021 into a Phase 2 study based upon our promising Phase 1/2 data, which continues to support the potential for Arcturus’ STARR self-replicating mRNA technology to provide a highly effective, and differentiated clinical profile, including a single dose regimen,” said Arcturus Therapeutics Chief Development Officer, Steve Hughes.

On Dec. 23, Roth Capital analyst Elemer Piros double downgraded ARCT’s rating from Buy to Sell as he is awaiting further information on the vaccine program and after shares exploded 750% year-to-date. The analyst left the price target unchanged at $77 (16.7% downside potential).

While there could be a number of advantages to Arcturus’ Covid vaccine, including a lower dose, potential single dose and storage advantage, the efficacy bar is “significant” at over 90%, noted Piros. (See ARCT stock analysis on TipRanks)

From the rest of the Street, the stock scores an analyst consensus of a Strong Buy based on 7 Buys and Roth Capital’s Sell. The average analyst price target of $110.63 implies upside potential of 19.7% to current levels.