Jupiter Neurosciences (NASDAQ: JUNS) has signed a definitive license agreement with PharmAla Biotech Holdings Inc. for perpetual exclusive U.S. rights to ALA-002, a patented non-racemic MDMA formulation, in a deal valued at up to $100 million including milestone payments.

The upfront payment totals $3.3 million, comprising $1.5 million in cash and $1.8 million in JUNS common stock subject to a 120-day lock-up. Additional payments include $3.3 million upon Phase 3 first patient enrollment, $20 million upon U.S. NDA approval, and commercial milestones of $10 million, $30 million, and $33.3 million tied to cumulative U.S. net sales of $333 million, $1 billion, and $2 billion, respectively. A 3% royalty on net sales commences after the third commercial milestone is reached.

ALA-002 has received Novel Chemical Entity designation from the FDA, which provides a five-year data exclusivity period upon approval. PharmAla will continue to manufacture ALA-002 for Jupiter under commercial terms to be negotiated.

Jupiter's existing pipeline includes JOTROL, a resveratrol formulation currently in a Phase IIa trial for Parkinson's disease. The addition of ALA-002 expands the company to two clinical-stage CNS programs.

PharmAla will retain rights to ALA-002 outside the United States.

"This agreement significantly expands our CNS strategy by adding a differentiated clinical-stage asset that complements our Parkinson's disease program," said Christer Rosén, Chairman and Chief Executive Officer of Jupiter Neurosciences. "Our focus is now disciplined clinical execution, prudent capital allocation and advancing both programs toward meaningful value-creating milestones, while recognizing the inherent risks of clinical development."

Nicholas Kadysh, Founding Chief Executive Officer of PharmAla Biotech Holdings, said Jupiter's focus on CNS disorders makes the partnership "a strong strategic fit for both companies."

The information above is based on a press release issued by Jupiter Neurosciences.