Atossa Plans CVRs Linked to Potential FDA Priority Review Voucher

Atossa Therapeutics has announced plans to issue contingent value rights (CVRs) to shareholders that could provide them with a share of proceeds from a potential future U.S. Food and Drug Administration (FDA) priority review voucher.

The company’s Board of Directors has approved a plan to issue one CVR for each share of Atossa common stock. The CVRs are designed to give shareholders a portion of the value generated if Atossa receives and monetizes its first qualifying rare pediatric disease priority review voucher.

Under the proposed CVR agreement, holders would collectively receive 25% of the net proceeds from a qualifying voucher monetization event. The total payment would be capped at $50 million.

Atossa is developing (Z)-endoxifen and has received two FDA rare pediatric disease designations for the drug candidate. One designation covers Duchenne muscular dystrophy, while the other is for McCune-Albright syndrome.

However, Atossa has not received a priority review voucher, and none of its product candidates have been approved. As a result, the company said there is no guarantee that shareholders will receive a payment under the CVRs.

The CVRs would be issued to shareholders of record as of a record date that will be announced by the company’s Board. Shares issued after the record date would also carry one CVR per share.

The CVRs would remain attached to Atossa common stock and would not trade separately. Anyone buying or selling Atossa shares during the term of the agreement would also buy or sell the attached CVR.

If Atossa receives and monetizes its first qualifying priority review voucher, the aggregate payment to CVR holders would equal 25% of the net proceeds after permitted deductions, subject to the $50 million limit. The payment would then be divided among eligible CVR holders.

Atossa noted that publicly disclosed priority review voucher transactions over the previous 18 to 24 months had ranged from $100 million to $220 million. The company cautioned that these previous transactions do not determine the potential value of any voucher it may receive.

The CVRs would only apply to the first qualifying voucher covered by the agreement. They would not represent ownership of the voucher or provide shareholders with additional voting or dividend rights.

The CVRs are expected to expire if Atossa does not receive a qualifying voucher by December 31, 2036, unless the company’s Board extends the deadline.

Atossa said it expects to file the CVR agreement with the U.S. Securities and Exchange Commission after the agreement is executed.

The planned CVR structure gives Atossa shareholders a potential financial interest in future priority review voucher proceeds while the company continues developing (Z)-endoxifen for rare diseases and other areas of unmet medical need.