Tiny No­van is not just low on funds, its in­vestors are al­so scrap­ing the bar­rel for some con­fi­dence.

The Mor­risville, North Car­oli­na-based drug de­vel­op­er’s stock $NOVN plunged in­to pen­ny stock ter­ri­to­ry af­ter the com­pa­ny re­vealed two late-stage stud­ies test­ing its drug, SB206, failed in pa­tients with mol­lus­cum con­ta­gio­sum, a con­ta­gious skin in­fec­tion that af­fects about 2 mil­lion in the Unit­ed States.

G. Kel­ly Mar­tin

The top­i­cal an­tivi­ral gel is be­ing test­ed against a ve­hi­cle in two tri­als — with each en­rolling 340 sub­jects aged 6 months and old­er. The main goal for ei­ther study is the pro­por­tion of pa­tients with com­plete clear­ance of all treat­able mol­lus­cum le­sions at week 12. Large­ly af­fect­ing chil­dren, mol­lus­cum con­ta­gio­sum is char­ac­ter­ized by up to 100 le­gions — these are small, raised, and usu­al­ly white, pink, or flesh-col­ored with a dim­ple or pit in the cen­ter, and can be­come itchy, sore, red, and/or swollen.

The drug did not meet the pri­ma­ry end­point in ei­ther tri­al — B-SIM­PLE1 or B-SIM­PLE2.

But some sta­tis­ti­cal wiz­ardry has con­vinced No­van oth­er­wise.

No­van plans to use B-SIM­PLE2 as one of its con­fir­ma­to­ry tri­als for a mar­ket­ing ap­pli­ca­tion, pend­ing dis­cus­sions with the FDA. It al­so ex­pects to con­duct an­oth­er late-stage study (slat­ed to kick­off in April 2020) to sup­port the ex­ist­ing dataset, the com­pa­ny said, adding that its time­line for an NDA sub­mis­sion re­mains the sec­ond quar­ter of next year.

Paula Brown Stafford

The com­pa­ny’s stock was oblit­er­at­ed on Fri­day morn­ing. Shares cratered near­ly 73% to 85 cents.

The com­pa­ny’s pipeline, which in­cludes a range of oth­er der­ma­tol­ogy tar­gets, is en­gi­neered to har­ness the ther­a­peu­tic po­ten­tial of ni­tric ox­ide, a nat­u­ral­ly oc­cur­ring com­pound. When a threat is de­tect­ed by the body, white blood cells in the im­mune sys­tem en­gulf in­vad­ing pathogens by re­leas­ing a burst of ni­tric ox­ide to de­stroy the per­pe­tra­tor.

Fi­nan­cial­ly, No­van is in trou­ble. As of Sep­tem­ber 30, 2019, the com­pa­ny had around $22.5 mil­lion in cash — funds that should keep the lights on in­to the first quar­ter. But in or­der to keep de­vel­op­ing SB206 and sus­tain the com­pa­ny, man­age­ment is in search for a life­line — ex­plor­ing fi­nan­cial and strate­gic op­tions.

The No­van an­nounce­ment has so­lid­i­fied the po­si­tion of ri­val Ver­ri­ca $VR­CA, whose top­i­cal agent of can­tharidin is up for FDA ap­proval for pa­tients with mol­lus­cum con­ta­gio­sum by Ju­ly 13.

“(C)on­sid­er­ing the re­strict­ed cash on hand and the lack of con­vinc­ing com­pet­i­tive da­ta, we con­sid­er the sin­gu­lar threat to Ver­ri­ca’s VP-102 now es­sen­tial­ly elim­i­nat­ed,” Cowen’s  Ken Cac­cia­tore wrote in a note. “These re­sults are fur­ther con­fir­ma­tion that VP-102’s long term op­por­tu­ni­ty should be as­sured.”

Last month, No­van said its CEO and phar­ma vet­er­an Kel­ly Mar­tin — for­mer chief of Ma­lin Corp and Elan — is step­ping away in Feb­ru­ary. COO Paula Brown Stafford will take over the reins.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.