Sarasota biotech company noncompliant with NYSE listing standards

A Sarasota biotech company received notice from the New York Stock Exchange this week that it is out of compliance with the organization’s listing standards.

Oragenics is not in compliance with the NYSE requirements that stockholders’ equity total at least $4 million if the company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years and $6 million in its five most recent fiscal years, according to a statement. 

(Oragenics, in a Monday SEC filing on the situation, listed 1990 Main St., Sarasota, in the Regus shared and co-work office space, as the address of its principal executive officers. That's a change from previous corporate filings that listed the corporate address in Tampa. Oragenics was founded in 1996.)

The company, which develops intranasal pharmaceuticals for neurological disorders reported a stockholders’ equity of $3.2 million as of Dec. 31, 2023, and losses from continuing operations and/or net losses in its five most recent fiscal years that ended Dec. 31, 2023, according to a statement from Oragenics.

By May 18, Oragenics must submit a plan addressing how it intends to regain compliance with the NYSE standards, and the company reports as of April 19 it has begun preparing its plan for submission.

Should the NYSE accept the plan, Oragenics will continue to be listed, subject to continued periodic review by the NYSE staff, the company says in a statement. If the plan is not submitted or not accepted by the NYSE or if the plan is accepted and the company is not compliant with continued listing standards by Oct. 18, 2025, it will be subject to delisting procedures.

Oragenics is a “development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases,” including drug candidates for treating mild traumatic brain injury (also known as concussion) and Niemann Pick Disease, the statement says.

“The Company is committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements,” according to the statement from Oragenics. “However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe.”

Its notification of noncompliance does not have an immediate impact on the listing of the company's share's of common stock, par value $0.001 per share, which will continue to be listed and traded on the NYSE American under the symbol OGEN with the addition of ".BC" to indicate its status is below compliance, the statement says.

The company announced in early April that it had raised $2.1 million in a public offering and $890,000 in a private transaction, plus it acquired a platform to treat concussions and added new board members. In February, it parted ways with its CEO.

“We are excited about the progress the company has made in the past several months,” says Oragenics President Michael Redmond, the company’s interim principal executive officer, in an April 1 statement. “We are creating a team with the experience and drive to further our neurological drug candidates through clinical trials during 2024.”

Despite its progress, the annual report filed with the Securities and Exchange Commission contained an opinion from an independent registered accounting firm stating that the company's ability to continue was a "going concern."

The annual report shows that for 2022 and 2023, the company incurred net losses of about $14 million and $21 million, respectively, with an accumulated deficit as of the end of 2023 estimated to be $206 million.

"Our ability to fund our operations is dependent upon funding from grants and/or equity financing," the annual report says. "If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, pivot, reduce the scope of, or eliminate some or all of our operations, or downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations, and ability to operate as a going concern. Our management believes that, given the significance of these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financials statements are issued."

The company projected it would be able to continue through at least the second quarter of 2024 without needing additional financing, based on its cash on hand.