Shares of Inovio Pharmaceuticals Inc. marked a 22% drop on Tuesday, a day after the company reported a broader-than-expected loss in the second quarter and offered a limited update to its COVID-19 vaccine candidate who is currently in clinical trials.
is still 343% per year after winning early in the coronavirus pandemic over hopes for its vaccine candidate, INO-4800, one of many in trials worldwide. The Plymouth meeting, Pennsylvania-based Inovio develops immunotherapy and DNA-based vaccines for a range of diseases, including HPV, but has not yet had an approved treatment product.
The company said it expects to begin a Phase 2/3 phase of the INO-4800 in September, and is working to expand production capacity to produce at least 100 million doses by 2021.
Inovio said 38 of the 38 patients in the Phase 1 trial achieved overall immunological responses, whether through binding antibodies, neutralizing antibodies, or T cell responses. This compares with 34 of the 36 patients in the first update offered in June. Two additional patients were suspected of being infected with COVID-19 in June, but it was later discovered that they were not from COVID and data were added.
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Inovio said he expanded the clinical trial at an early stage to 40 patients out of 80 other participants, aged 18 and older. The company also added a lower dose to expand the security and immunogenicity database. The data from the phase 1 trial has been sent to a medical journal and is undergoing peer review before publication.
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Stifel analysts lowered their stock price target to $ 16 from $ 24 and reiterated a holding estimate, saying conference numbers and calls “left us (again) with more questions than answers on multiple fronts.”
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These include disclosure and public deadlines for the INO-4800 and the continuation of the “high level of immunogenicity / border security characterization of the INO-4800 P1”, analysts led by Stephen Willey wrote in a client client.
“Our reluctance to attribute any value associated with INO-4800 to our model continues and our previously reduced rate (9%) reflected improved perception: likelihood of purchasing third party funds,” the note reads. and Stifel. “We believe that these ongoing questions, coupled with an acceleration of the competitive development landscape (and difficult barriers to beating immunogenicity), force us to reconsider that assumption.”
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Late Monday, the biotech company reported a second-quarter net loss that widened to $ 128.7 million, or 83 cents a share, from a loss of $ 29.4 million, or 30 cents a share, while the FactSet consensus was for a narrowing. loss at 17 cents a share. Revenue nearly doubled to $ 267,000, but did not exceed expectations of $ 2.6 million.
Analysts Maxim Naureen Quibria and Jason McCarthy, who also assess a reserve state, took a more optimistic outlook, saying the early results look encouraging.
“Crediting additional support for the program is the demonstration of immune responses in non-human primates (NHPs) 3 months (13 weeks) after vaccination when opposed, an indicator of the animal’s ability to generate memory responses and thus the potential persistence of INO- 4800, ”they write in a note to customers.
There were only six adverse events, mostly to do with the injection site, that proved transient, they wrote. “It is important to note that the safety profile of the INO-4800 compares favorably with those on the market and other vaccine candidates currently under development for COVID-19,” they wrote.
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Inovio said he has started trials at an early stage in China and South Korea and expects to provide data in the fourth quarter. The company has received funding for trials from the Department of Defense ($ 71 million); from the Oslo-based Coalition for Epidemic Readiness Innovations ($ 17.2 million) and from the Bill & Melinda Gates Foundation ($ 5 million).
Benchmark analyst Aydin Huseynov said he is optimistic about the Phase 2/3 judgment and noted that his security profile was better than that achieved by Moderna Inc. MRNA.
Trial with 45 patients.
“We think the safety profile of any vaccine candidate to be administered to millions or billions of individuals should be extremely favorable to attracting a majority of the population (including the elderly) for a mass vaccination,” the analyst wrote.
Huseynov is awaiting readings from two other candidates for Inovio vaccines, one for cervical dysplasia and one for glioblastoma, which are expected to receive “extra attention” in the fourth trimester given developments with INO-4800.
The analyst values the shares of a buy at a price of $ 36, or more than double its current price.
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