Rare Daily Staff

NewLink Genetics and Lumos Pharma have agreed to merge to form a new company focused on developing therapies to treat patients with rare diseases.

The merger will combine the Lumos management team’s deep experience in rare diseases and endocrinology with NewLink’s expertise in drug development and its solid financial position. The combined company will have about $80 million in cash to advance clinical development of LUM-201, Lumos Pharma’s lead candidate. LUM-201 is a potential oral therapy for pediatric growth hormone deficiency (PGHD) and other rare endocrine disorders.

The mmerged company will assume the Lumos Pharma name and be led by Richard Hawkins, the current CEO of Lumos Pharma. It expects to initiate a phase 2b clinical trial in mid-2020 that will evaluate LUM-201 for children with PGHD compared to the current standard of care: daily injections of recombinant human growth hormone (rhGH).

Current therapies for PGHD consist of injectable treatments of rhGH or its derivatives. LUM-201 would potentially represent the first orally administered therapeutic for PGHD, with the aim to supplant a prolonged treatment regimen of daily injections. LUM-201 causes the secretion of growth hormone (GH), providing a differentiated mechanism of action to treat PGHD.

LUM-201 has orphan drug designation for the treatment of growth hormone deficiency in the United States and European Union.

“Working toward the development and commercialization of novel therapies for rare diseases remains the cornerstone of Lumos Pharma’s strategy,” said Rick Hawkins, CEO of Lumos Pharma. “As we advance LUM-201 for PGHD through later stages of clinical development, we believe there is an established regulatory path to approval and the

opportunity for LUM-201 to become the world’s first oral therapeutic for pediatric growth hormone deficiency. Other target indications for LUM-201 have potential for development, supporting expanded market opportunity for this drug candidate. With exciting prospects for the clinic, we are optimistic about what this combined company will achieve.”

In addition to its development of LUM-201, the combined company expects to evaluate other opportunities to acquire or in-license assets addressing rare diseases to grow its pipeline and expects to continue to evaluate NewLink’s oncology portfolio to determine value creation opportunities.

Under the terms of the merger agreement, NewLink will issue Lumos Pharma stockholders NewLink common stock in exchange for their shares in Lumos with Lumos stockholders owning approximately 50 percent of NewLink. Immediately following the closing of the merger, Lumos Pharma will become a wholly-owned subsidiary of NewLink, and NewLink will be renamed “Lumos Pharma, Inc.,” and will trade on Nasdaq under the symbol “LUMO.”

The management of the combined company is expected to include John McKew, chief scientific officer of Lumos Pharma as chief scientific officer of the combined company; Eugene Kennedy, chief medical officer of NewLink as chief medical officer of the combined company; and Carl Langren, chief financial officer of NewLink as chief financial officer of the combined company. Nick Vahanian, president and co-founder of NewLink, is retiring.

Photo: Rick Hawkins, CEO of Lumos Pharma

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