PDSB - Merck KGaA to license potential tumor drug to PDS in cash stock transaction

PDS Biotechnology ( NASDAQ: PDSB ) said it signed a licensing agreement with Merck KGaA ( OTCPK:MKGAF ) ( OTCPK:MKKGY ) for tumor drug candidate M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301.

Under the agreement, PDS Biotech will receive from Merck KGaA an exclusive license to M9241 and take responsibility for future development, commercialization and manufacturing of M9241.

Merck KGaA will receive $5M cash upfront and will be entitled to up to $11M in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105M in commercial milestones, and a 10% royalty on future sales of M9241.

Merck KGaA will receive ~378.78K common shares of PDS worth $5M.

"Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy," said PDS CEO Frank Bedu-Addo.

PDS noted that M9241 was studied in a novel triple combination in a phase 2 trial in combination with PDS0101, a Versamune-based HPV16-targeted immunotherapy, and bintrafusp alfa, to treat checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

PDSB -1.89% to $12.95 premarket Jan. 3

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