Three months af­ter bring­ing on a new CEO, In­ovio has reached a set­tle­ment with in­vestors over ac­cu­sa­tions that it ex­ag­ger­at­ed progress on its Covid-19 vac­cine can­di­date.

The biotech, once claim­ing to be at the heart of Op­er­a­tion Warp Speed, has agreed to shell out $44 mil­lion in a mix of cash and stock to end a class ac­tion law­suit in which in­vestors al­leged that the com­pa­ny mis­rep­re­sent­ed its ef­forts on INO-4800, caus­ing the biotech’s share price to plunge.

The case dates back to March 2020, when Patrick Mc­Der­mid filed an ini­tial com­plaint. Al­most half a mil­lion pages of doc­u­ments and more than a dozen de­po­si­tions lat­er, the par­ties start­ed look­ing to re­solve the case in Ju­ly 2021, bring­ing in a me­di­a­tor of se­cu­ri­ties class ac­tions and fail­ing. A sec­ond ne­go­ti­a­tion in Feb­ru­ary this year al­so failed.

Ac­cord­ing to court doc­u­ments, the me­di­a­tor, Gre­go­ry Lind­strom, then is­sued a “me­di­a­tor’s pro­pos­al” on May 18, which was ac­cept­ed by all par­ties. The set­tle­ment to­tals $30 mil­lion in cash plus 7 mil­lion shares of $INO at $2 a share. The com­pa­ny’s stock is cur­rent­ly trad­ing at $2.56 a share.

Joseph Kim

An In­ovio spokesper­son told End­points News on Wednes­day that the biotech does not com­ment on on­go­ing lit­i­ga­tion. It’s al­so worth not­ing that the set­tle­ment still has to be ap­proved by a judge be­fore it can go in­to ef­fect and the law­suit of­fi­cial­ly ends.

This new de­vel­op­ment takes place af­ter new CEO Jacque­line Shea an­nounced last month that 18% of the com­pa­ny’s full-time staffers will be let go, plus 86% of all con­trac­tors in a bid to re­duce op­er­a­tional ex­pens­es and ex­tend its cash run­way in­to Q3 of 2024. The pre­vi­ous CEO, Joseph Kim, left the com­pa­ny in May af­ter steer­ing the com­pa­ny for years and claim­ing in the ear­ly days of the pan­dem­ic that In­ovio had “de­vel­oped a vac­cine in a mat­ter of hours.”

Kim was among a se­lect group of CEOs who met with Pres­i­dent Don­ald Trump ear­ly in the Covid-19 pan­dem­ic to dis­cuss the de­vel­op­ment of vac­cines and ther­a­peu­tics against the coro­n­avirus. How­ev­er, In­ovio en­coun­tered hur­dle af­ter hur­dle with its vac­cine can­di­date, in­clud­ing a clin­i­cal hold, fund­ing with­draw­al and a stand­off with con­tract man­u­fac­tur­er VGXI. INO-4800 re­mains in clin­i­cal tri­als, but In­ovio has said it will fo­cus on test­ing it as a boost­er to oth­er vac­cines rather than a pri­ma­ry se­ries vac­cine op­tion.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.