ZSAN : Zosano Pharma Corporation Stock Analysis and Research Report

2017-11-09 - by Asif, Contributing Analyst

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Zosano Pharma Corporation and its subsidiary is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microarray (ADAM) technology. The company recently announced positive results from its ZOTRIP study that evaluated M207, which is its proprietary formulation of zolmitriptan delivered via its ADAM technology, as an acute treatment for migraine. Zosano Pharma is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company anticipate that many of its current and future development programs may enable it to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization.

ADAM is its proprietary, investigational technology platform designed to offer rapid drug absorption into the bloodstream, which can result in an improved pharmacokinetic profile compared to original dosage forms. ADAM consists of an array of drug-coated titanium microprojections mounted on an adhesive backing that is pressed on to the skin using a reusable handheld applicator. The microprojections penetrate the stratum corneum and allow drug to be absorbed into the microcapillary system of the skin. The company focus on developing products based on its ADAM technology for indications in which rapid onset, ease of use and stability offer significant therapeutic and practical advantages, for markets where there is a need for more effective therapies.

The company's development efforts are focused on its product candidate, M207. M207 is its proprietary formulation of zolmitriptan delivered utilizing its ADAM technology. Zolmitriptan is one of a class of serotonin receptor agonists known as triptans and is used as an acute treatment for migraine. Migraine is a debilitating neurological disease, symptoms of which include moderate to severe headache pain, nausea and vomiting, and abnormal sensitivity to light and sound. The objective of M207 is to provide faster onset of efficacy and sustained freedom from migraine symptoms by delivering rapid absorption while avoiding GI tract. In July 2016, the company announced the dosing of the first subject in the M207 pivotal efficacy trial, known as the ZOTRIP trial.

In February 2017, the company announced the completion and results of its ZOTRIP pivotal efficacy trial for M207. The company's ZOTRIP trial was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. The ZOTRIP trial results demonstrated that the 3.8mg M207 dose achieved statistically significant pain freedom and most bothersome symptom freedom at two hours. While the 1.0mg and 1.9mg doses of M207 demonstrated statistical significance in pain freedom at two hours, they did not achieve statistical significance in freedom from most bothersome symptoms at two hours.

Zosano Pharma has no product sales to date, and the company will not have product sales unless and until the company receive approval from the United States Food and Drug Administration (“FDA”) or equivalent foreign regulatory bodies, to market and sell M207 or any other product candidates. Accordingly, its success depends not only on the development, but also on its ability to finance the development of these product candidates. The company will require substantial additional funding to complete development and seek regulatory approval for these product candidates. Additionally, the company currently have no sales, marketing or distribution capabilities and thus its ability to market its product candidates in the future will depend in part on its ability to develop such capabilities either alone or with collaboration partners.

M207 Clinical Trial

The company met with the FDA in May 2017 to discuss parameters of its required long term safety study, primarily the dose of M207 Zosano Pharma is advancing and the study design. Consistent with FDA feedback, the safety study will seek to enroll subjects who historically had experienced two to eight migraines per month, with the goals of 150 subjects completing at least six months dosing and 50 subjects completing 12 months of dosing. The safety study is planned to be open-label, with investigator visits at months one, two, three, six, nine and twelve to record adverse events. The primary objective of the safety study is to measure adverse events and local tolerability during repeated administration. Other endpoints are electrocardiography, and laboratory parameters, as well as percentage of headaches with pain-free response.

The company will require additional financing to complete this safety study. While Zosano Pharma is pursuing clinical development and regulatory approval of its M207 product candidate through commercialization, the company remain open to opportunities with potential strategic partners to ensure its product candidate will receive the best chance of commercial success.

In March 2017, the company closed an underwritten public offering pursuant to a registration statement on Form S-1 of 19,550,000 shares of its common stock sold at a price of $1.50 per share, including 2,550,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. The proceeds from the offering were $29.3 million, and the net proceeds to it, after deducting underwriting discounts, commissions and reimbursable costs of approximately $2.2 million and offering expenses of approximately $0.5 million, were approximately $26.6 million.

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