Marshall Fordyce, Vera CEO

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

Ve­ra Ther­a­peu­tics took a big risk at the start of the year, piv­ot­ing away from its gene edit­ing mis­sion state­ment to chase a lead kid­ney drug in­stead — and they dou­bled down with an IPO just months lat­er. But in­vestors don’t seem im­pressed with Ve­ra’s promise, and now the biotech is look­ing at a far more scaled-back of­fer­ing.

On Fri­day, Ve­ra priced its 4.35-mil­lion-share IPO at $11 per share, well be­low its tar­get­ed range of $14 to $16 and good for $47.58 mil­lion in pro­ceeds. The biotech will start trad­ing Mon­day un­der the tick­er $VE­RA.

In its ini­tial S-1 fil­ing with the SEC seek­ing as much as $86.25 mil­lion, Ve­ra said it would use be­tween $30 mil­lion and $35 mil­lion to com­plete its Phase IIb clin­i­cal tri­als, and an­oth­er $15 mil­lion to $20 mil­lion to ini­ti­ate a Phase IIb or Phase III tri­al for pa­tients with lu­pus nephri­tis. The com­pa­ny said the pro­ceeds would be able to fund op­er­a­tions for the next 18 months.

Ve­ra got its start as Tru­code Gene Re­pair, and orig­i­nal­ly in­tend­ed to com­pete with CRISPR com­pa­nies with a new form of gene edit­ing. It was a dark horse in the race to bring gene ther­a­py cures for sick­le cell dis­ease, a dis­ease that af­fects 100,000 Amer­i­cans and leaves them with sick­le-shaped red blood cells that clog blood ves­sels. Tru­code launched in Sep­tem­ber 2019, but just five months lat­er, it filed a new trade­mark and do­main name, and an­nounced that they’d piv­ot to fo­cus ef­forts on at­aci­cept, a 20-year-old mol­e­cule in de­vel­op­ment for kid­ney dis­ease. The Jan­u­ary “re-launch” came with an $80 mil­lion Se­ries C led by Abing­worth.

In Jan­u­ary, CEO Mar­shall Fordyce told End­points News that his com­pa­ny didn’t move on from the gene edit­ing be­cause of a fail­ure in tech­nol­o­gy, but rather, “a mat­ter of com­par­ing op­por­tu­ni­ties.”

“We’re fo­cused on de­vel­op­ment and com­mer­cial­iza­tion and mov­ing tech­nolo­gies down the de­vel­op­ment pipeline, and that’s re­al­ly what’s dri­ven our think­ing,” he said.

Fordyce is a 15-year vet­er­an of biotech, who pre­vi­ous­ly served as Gilead’s se­nior di­rec­tor of clin­i­cal re­search. There, he con­tributed to the ap­proval of sev­en drugs, and over­saw the teno­fovir alafe­namide de­vel­op­ment pro­gram, which even­tu­al­ly led to 5 new drugs and $12 bil­lion in sales in 2019.

At­aci­cept is a fu­sion pro­tein to treat IgA nephropa­thy that re­cent­ly went through Phase IIa tri­als suc­cess­ful­ly. IgAN, al­so known as Berg­er’s dis­ease, can lead to in­flam­ma­to­ry tis­sue dam­age and kid­ney fail­ure. Its his­to­ry dates back to 2001, when Seat­tle biotech Zy­mo­Ge­net­ics, which is now de­funct, signed a deal to de­vel­op the drug with Serono.

In 2009, the drug was li­censed to Mer­ck KGaA, but most of the tri­als came up short for the treat­ment of mul­ti­ple scle­ro­sis, lu­pus and rheuma­toid arthri­tis. Last No­vem­ber, short­ly af­ter the Ger­man phar­ma an­nounced the suc­cess­ful Phase IIa da­ta for pa­tients with IgAN, Ve­ra li­censed the drug for a 10% eq­ui­ty stake and about $733 mil­lion in mile­stones.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.