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James.Roberts


Inovio Pharmaceuticals: Financial Performance and Potential Impact of Phase 3 Trial

2023-07-30

Inovio, a company specializing in DNA medicines, recently held a call meeting to provide updates on their clinical development candidates and discuss future research and development plans. During the meeting, the progress made by Inovio in the clinical development of their key candidates and their commitment to advancing their pipeline and exploring new ways to develop their DNA medicines were discussed.

One of the most interesting topics from the meeting was the potential impact of the Phase 3 trial on the company's cash burn. Li Chen from H.C. Wainwright asked whether starting the Phase 3 trial would increase the quarterly cash burn. In response, Peter Kies, the Chief Financial Officer, stated that the anticipated increase in cash burn is already factored into their current financial plans. This suggests that the company has taken into account the additional expenses associated with the trial and has made provisions to cover them.

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Kies also mentioned that they believe they have sufficient funds to complete the trial, indicating the company's confidence in its ability to finance the Phase 3 trial without running out of funds. However, he did mention that they are still working through the details with the feedback from the FDA, suggesting that there may be some uncertainties or adjustments that need to be made.

The meeting provided insight into the financial planning and funding capabilities of the company. It showed that they have considered the potential increase in cash burn and have taken steps to ensure they have enough funds to complete the trial. This analysis is important for investors and stakeholders as it gives them confidence in the company's ability to manage its finances and execute its clinical trials successfully.

In terms of the market outlook, the company's financial performance for the first quarter of 2023 showed a net loss of $0.16 per share, a decrease compared to the previous year. Despite this, the company has a cash position of $223.8 million and projects maintaining a cash runway until the first quarter of 2025. The company also briefly mentioned their existing ATM at the market offering program and potential capital raise activities, indicating that they may be exploring options to raise additional funds.

In terms of product development, the company presented combined Cohort 1 and Cohort 2 data for their product INO-3107, which shows potential as a therapeutic option for patients suffering from Respiratory Papillomatosis (RRP). The CEO expressed encouragement about the data set and interactions with the FDA, indicating the potential for INO-3107 to provide clinical benefit to patients with RRP. The Chief Medical Officer provided further details on the data set and the company's plans for INO-3107.

Overall, while the market outlook was not explicitly stated, the company's financial performance, cash position, potential capital raise activities, and positive developments in product data suggest a mixed outlook for the company.

The company's plans for their product candidate, INO-3107, include further development for recurrent respiratory papillomatosis (RRP). They have received feedback from the FDA on their proposed Phase 3 plans and have applied for Orphan Drug Designation with the European Commission. The company believes that INO-3107 has the potential to provide clinical benefit to patients with RRP.

The company's outlook for the quarter/year is that they are focused on managing their cash. They reported an improvement in net loss for the first quarter of 2023 compared to the same period in 2022. They have a significant amount of cash on hand as of the end of the first quarter, and their cash runway is projected to last until the first quarter of 2025. The projected cash burn estimate for the second quarter of 2023 is approximately $33 million. It is important to note that these projections do not include any funds that may be raised through the company's existing ATM at the market offering program or other capital raise activities.

The participants of the call included Thomas Hong, the Manager of Investor Relations; Jackie Shea, the President and Chief Executive Officer; Mike Sumner, the Chief Medical Officer; Peter Kies, the Chief Financial Officer; an unknown speaker from RBC Capital Markets, an analyst; Hartaj Singh from Oppenheimer and Company, an analyst; and Li Chen from H.C. Wainwright, also an analyst.

In conclusion, the meeting provided insights into Inovio's progress in the clinical development of their key candidates. The company plans to present and publish their work at medical conferences and journals, as well as provide updates on regulatory and development activities. With a focus on advancing their pipeline and exploring new ways to develop DNA medicines, Inovio aims to deliver on the promise of these innovative treatments for patients globally.

The financial condition of Inovio, a company focused on advancing candidates in their pipeline for various diseases, has shown improvements in operating expenses and revenues. In the first quarter of 2023, the company experienced a 39% decrease in total operating expenses compared to the same period in 2022. Research and development expenses also decreased by 46% in the first quarter of 2023, primarily due to lower drug manufacturing and clinical trial expenses. General and administrative expenses decreased by 13% in the same period. However, the company's revenues for the first quarter of 2023 were $115,000, down from $199,000 in the same period in 2022. This resulted in a net loss of $40.6 million for the first quarter of 2023, a 49% decrease from the prior period in the prior year.