Statera Biopharma sells rights to addiction-treatment drug, still faces delisting from Nasdaq

FORT COLLINS — For the second time in less than a month, Statera Biopharma Inc. (Nasdaq: STAB) has sold its rights to produce a drug as it seeks to shore up its financial position. 

The life-sciences company sold its rights to naltrexone, an addiction-treatment drug designed to reduce cravings for alcohol and opioids, to Florida company Immune Therapeutics Inc. The transaction is contingent on the completion of a definitive agreement.

For the rights to naltrexone, Statera will receive $2 million in cash and 5% of the outstanding Immune Therapeutics common stock. Statera will also receive payments for achievement of revenue-based milestones, new indications and royalties. In total, according to the press release announcing the transaction, the deal has the potential to generate more than $400 million in payments to Statera.

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“The agreement with Immune will enable us to strengthen our financial position with a transaction that has the potential to produce significant non-dilutive cash flow to fund our other programs,” Statera CEO Michael K. Handley said in a prepared statement. “For instance, Statera is beginning to chart a new course in the immunotherapy field by pursuing molecules that act on Toll-like Receptor pathways similar to Naltrexone. It also will help advance our new product candidates for treatment of a variety of immune-related diseases that have no cure.”

This sale came about three weeks after Statera sold the rights to produce the cancer drug Entolimod to Pennsylvania company Coeptis Therapeutics Inc. for $6 million.

Statera has endured financial and regulatory difficulties throughout the first four months of 2022. In March, it was threatened with delisting from the Nasdaq exchange, accused of defaulting on a loan and faced the resignation of multiple members of its board of directors.  

On March 23, it was informed that it was in violation of the bid price rule — the bid price for its common stock had traded below $1 per share for more than 30 days. That notice informed the company that it had until Sept. 19 to correct the issue. 

Then, on March 25, Statera received a letter from venture-capital firm Avenue Capital Group alleging that Statera had defaulted on an $11.2 million loan. The letter, which was filed with the Securities and Exchange Commission, accused Statera of failing to:

• Timely deliver monthly financial statements for certain periods.
• Obtain Avenue’s consent to repurchase certain securities from stockholders.
• Pay principal and interest when due, including on March 1, 2022.
• Maintain unrestricted cash and cash equivalents in one or more accounts subject to control agreements in favor of Avenue in the amount of at least $5 million.

Avenue also foreclosed on $4.8 million of Statera’s cash in furtherance of the allegations set out in the letter.

Two members of Statera’s board resigned that same day. 

In April, Statera’s accounting firm Turner, Stone & Co. LLP resigned, citing “information that has come to our attention” in a letter that was filed with SEC. 

And at the end of April, the company received notice from the SEC that it had missed its deadline for filing its annual financial statements, further bringing it out of compliance with Nasdaq rules.

Statera has until June 20 to submit a plan to regain compliance with the Nasdaq. If the Nasdaq accepts its plan, the company will have 180 days to come back into compliance or be delisted.