PDS Biotech licenses M9241 from Merck KGaA for $10M upfront, up to $116M milestones, 10% royalty

PDS Biotechnology Corp

Exclusive global license for M9241 (PDS0301), a tumor-targeting IL-12 fusion protein, from Merck KGaA, Darmstadt, Germany.
Upfront consideration: $5M cash plus 378,787 shares valued at $5M (based on Dec 30 close); total $10M.
Milestone payments: up to $11M development/regulatory, up to $105M commercial; 10% royalty on net sales with step-down provisions.
Phase 2 triple combination data: median OS 21 months in CPI-refractory pts (historical 3-4 mo); 63% ORR in optimal dose group.
FDA meeting scheduled to discuss registrational trial for triple combination in recurrent/metastatic HPV-positive cancers.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

PDS Biotechnology Corp entered into License Agreement with Merck KGaA, Darmstadt, Germany valued at $5.0 million (effective 2022-12-30).

Action: entry
Agreement: license
Counterparty: Merck KGaA, Darmstadt, Germany
Value: $5.0 million
Effective: 2022-12-30

Exact text from the filing

On December 30, 2022, PDS Biotechnology Corporation (the “Company”) entered into a License Agreement (the “License Agreement”) with Merck KGaA, Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merk KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein known as M9241 (the “Compound”).

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Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

PDS Biotechnology Corp entered into Share Transfer Agreement with Merck KGaA, Darmstadt, Germany valued at aggregate value of $5.0 million (effective 2022-12-30).

Action: entry
Agreement: equity purchase
Counterparty: Merck KGaA, Darmstadt, Germany
Value: aggregate value of $5.0 million
Effective: 2022-12-30

Exact text from the filing

On December 30, 2022, the Company entered into the Share Transfer Agreement with Merck KGaA, Darmstadt, Germany, pursuant to which the Company issued the Shares to Merck KGaA, Darmstadt, Germany in a private placement.

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PDS Biotechnology Corp filing history →

Source: SEC EDGAR

accession 0001140361-23-000030

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