Clinical-stage zsan stock biopharmaceutical startup Zosano Pharma Corporation (ZSAN) creates novel therapeutics for the alleviation of pain caused by migraine and other conditions. QtryptaTM is the company’s flagship product candidate, and it’s a transdermal microneedle patch that’s meant to administer zolmitriptan, a proven migraine medicine, through the skin. In this piece, we’ll analyze ZSAN stock’s financial and clinical indicators to determine the company’s performance and future prospects.
The State of the Economy
The last few years have been a bit of a roller coaster for ZSAN’s finances, with revenue and net income swinging wildly. Compared to 2019’s revenue of $11.1 million, 2020’s total of $4.4 million was a substantial drop. In addition, 2020’s net loss was $39.6 million, up from 2019’s $34.6 million loss. ZSAN’s cash position, however, strengthened throughout the same time frame, growing from $21.8 million in 2019 to $36.9 million in 2020. Operating expenses have also gone down, zsan stock,from $46.7 million in 2018 to an expected $38.9 million in 2020 for the company.
Effectiveness in the Clinic
The success of ZSAN’s product pipeline can have a major impact on the company’s financial performance, making the company’s clinical performance an important factor for investors to examine. Two Phase 3 trials of QtryptaTM have been completed, and the results are encouraging. The primary endpoint was met with a 64.3% pain alleviation rate at two hours post-dose in the first Phase 3 trial of the medication. QtryptaTM also showed statistical significance in the primary endpoint of a second Phase 3 trial, with 66.7% of patients experiencing relief from pain two hours after dosing. In addition, there were no major adverse effects associated with the drug’s use.
Catalysts in Potential
ZSAN may benefit from a number of different catalysts in the near future. The stock price of the company could experience a considerable increase if the QtryptaTM drug is approved by regulators. ZSAN is looking into further applications for QtryptaTM, including the treatment of cluster headaches and the management of acute agitation in patients with schizophrenia. ZSAN is also working on other product candidates, such as M207, which combines zolmitriptan and a permeability enhancer, and has the potential to bring in extra revenue.
Possible Dangers
The dangers of investing in ZSAN must be weighed by potential buyers. Regulatory approval for QtryptaTM is still needed, and the company’s financial performance has been erratic. The stock price of the corporation could drop if the drug is rejected by regulators or does not perform as expected in the market. Furthermore, ZSAN is a clinical-stage company, and unexpected outcomes from clinical studies can cause delays or even the elimination of a treatment candidate.
What’s Happened Lately
ZSAN announced in March 2021 that it had submitted a New Drug Application (NDA) to the FDA for its migraine acute treatment drug QtryptaTM. The FDA’s decision is anticipated by the firm in the fourth quarter of 2021. Approval of QtryptaTM, a transdermal patch for the acute treatment of migraine, would be a considerable improvement above the existing oral and injectable therapies for this condition.
Positive results from a pharmacokinetic study of QtryptaTM in individuals with moderate to severe hepatic impairment were also announced by ZSAN alongside the NDA filing. The trial indicated that the medicine was well-tolerated and had no significant influence on liver function, indicating that Qtrypta™ may be safe and efficacious for use in individuals with liver impairment.
Possibile Business Window
QtryptaTM could have a large market because migraine is a common and disabling neurological illness that affects millions of people throughout the world. The Migraine Research Foundation estimates that between 39 million and 1 billion people in the United States and around the world suffer from headaches. Migraines also have a significant monetary impact, costing Americans $36 billion annually in medical expenses and missed productivity.
Potentially filling a number of gaps in the current migraine therapy landscape, including the requirement for a quick-acting and easily accessible alternative, is ZSAN’s QtryptaTM. Unlike conventional therapies like injections and pills, zsan stock,the transdermal microneedle patch delivery technique is painless and simple to apply.
Difficulties and Threats
ZSAN, like any biotech in clinical development, faces a number of threats and difficulties. The possibility for clinical trial failures, which could cause major delays in product development or possibly the full failure of the project, is one of the most serious hazards. ZSAN had experienced failures in the past, including the removal of its primary product candidate, ADAM Zolmitriptan, from the market because of production problems.
Several well-established pharmaceutical companies have already developed and sold successful migraine medications, thus ZSAN also confronts substantial competition in this market. Qtrypta’sTM chances of success hinge on its ability to set itself apart from competing medicines and increase its share of the market.
Finally, ZSAN will have to deal with the intricate FDA approval process in the pharmaceutical industry. There is no assurance that QtryptaTM will get regulatory approval or be successful in the market, and the approval process can be time-consuming and costly.
The State of the Economy
ZSAN’s financial results have been inconsistent in recent years. The company lost $5.7 million in the third quarter of 2020, an increase from the $5.5 million loss reported in the third quarter of 2019. At the end of 2019, ZSAN had $17.4 million in cash and equivalents, but as of the end of February 2019 that had climbed to $33.2 million.
Additionally, investors should be aware that ZSAN’s present market worth is only under $100 million. The stock price may be more volatile and have less liquidity than stocks of larger, more established corporations.
ZSAN’s financial performance has been inconsistent, but the company’s creative product pipeline and the potential market for QtryptaTM make it an intriguing investment possibility for those who are willing to take on the risk. Before deciding to invest in ZSAN, zsan stock,potential backers should do a thorough analysis of the company’s financial and operational performance in addition to the industry’s competitive and regulatory environments.
Conclusion
Zosano Pharma Corporation (ZSAN) is a promising novel product candidate for the acute treatment of migraine that is now in the clinical trial stage. Market potential for QtryptaTM is tremendous, thanks to the company’s recent NDA submission to the FDA and encouraging clinical study findings.
Although ZSAN has shown promise in treating migraines, the company still faces a number of problems and dangers that investors should be aware of. The financial results for ZSAN are inconsistent, and the stock may see increased volatility and decreased liquidity as a result. In sum, ZSAN is a promising investment for those who can stomach the dangers. Before putting their money into a firm, investors should weigh the company’s financial and operational performance against its industry, its competitors, and the regulatory climate.