Investors are likely to focus on pipeline updates when clinical-stage biopharmaceutical company, Zosano Pharma Corporation ZSAN, reports earnings results for the first quarter of 2022.

The company's surprise history has been mixed so far, with its earnings beating the Zacks Consensus Estimate in one of the trailing four quarters, meeting the same twice and missing once. In the last-reported quarter, Zosano delivered an earnings beat of 14.29%.

Shares of Zosano have plunged 88.4% year to date compared with the industry's decrease of 20.1%.

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Let's see how things are shaping up for the quarter to be reported.

Factors at Play

In the absence of a marketed product in its portfolio, investors' focus will be on the updates related to Zosano's pipeline development.

The company's lead product candidate, M207, is a proprietary formulation of zolmitriptan. It is designed to be delivered via its transdermal microneedle system technology as an acute treatment for migraine.

Zosano submitted a new drug application ("NDA") for M207 to the FDA in December 2019. Subsequently, the company received a Complete Response Letter ("CRL") from the regulatory body with respect to the NDA in October 2020. The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA's discipline review letter. Back then, the FDA had recommended that the company should conduct a repeat bioequivalence study between the lots used during the development.

Based on feedback from the FDA, Zosano conducted an additional pharmacokinetic ("PK") study on M207 for inclusion in the NDA resubmission package.

In January 2022, Zosano resubmitted the NDA for M207 and subsequently received a response letter from the FDA related to the same in February. In this response letter, the regulatory body stated that it did not consider the resubmitted NDA for M207 to be a complete response to the deficiencies identified previously in the CRL.

Investors will be keen to get an update on the company's plans to evaluate the next steps of development for M207 at the upcoming earnings call.

Operating expenses are likely to have decreased in the to-be reported quarter on lower professional service fees and employee expenses, as well as a reduction in material purchases.

Earnings Whispers

Our proven model does not conclusively predict an earnings beat for Zosano this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. However, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.