Weath­er­ing the storm: An­oth­er biotech braves Covid-19 in up­sized IPO

Zen­tal­is isn’t the on­ly biotech to de­fy ex­pec­ta­tions as fi­nan­cial mar­kets across the globe roil from the shock of the coro­n­avirus pan­dem­ic. Keros Ther­a­peu­tics has man­aged to ex­e­cute an IPO, hit­ting the top end of its pric­ing range and sell­ing more shares than orig­i­nal­ly en­vi­sioned, as it shep­herds its lead drug in­to mid-stage de­vel­op­ment.

The Lex­ing­ton, Mass­a­chu­setts-based com­pa­ny’s pipeline of drugs tar­get a fam­i­ly of pro­teins called trans­form­ing growth fac­tor-be­ta (TGF-β), sig­nal­ing path­ways that reg­u­late blood cell and platelet pro­duc­tion, and growth, re­pair, and main­te­nance of mus­cle and bone.

The com­pa­ny’s ear­ly-stage lead drug, KER-050, is un­der de­vel­op­ment for the treat­ment of low blood cell counts, or cy­tope­nias, in­clud­ing ane­mia and throm­bo­cy­tope­nia. Phase II tri­als are planned in pa­tients with myelodys­plas­tic syn­dromes (MDS), and those suf­fer­ing from myelofi­bro­sis. Its sec­ond drug, KER-047, is in a Phase I study, and is be­ing de­vel­oped for use in pa­tients suf­fer­ing from ane­mia re­sult­ing from el­e­vat­ed lev­els of a key reg­u­la­tor of iron ab­sorp­tion and re­cy­cling, as well as a rare mus­cu­loskele­tal dis­or­der called FOP. Keros al­so has a pre­clin­i­cal prod­uct be­ing de­vel­oped for bone loss and PAH.

Keros has raised $96 mil­lion, hand­some­ly beat­ing its $80 mil­lion tar­get, hav­ing of­fered 6 mil­lion shares for $16 a pop. Pre­vi­ous­ly, the biotech had planned to of­fer 5 mil­lion shares in the range of $14 to $16 each. The stock KROS made its de­but on Wednes­day.

Keros, which raised $56 mil­lion in a Se­ries C round last month, is one of a hand­ful of biotechs that got their pre-IPO road­show “test of the wa­ters” meet­ings done be­fore the coro­n­avirus out­break hit, so the on­ly thing left was road­shows, which are easy to ex­e­cute vir­tu­al­ly — in­deed road­shows have al­ways had vir­tu­al com­po­nents even be­fore the pan­dem­ic, said Jor­dan Saxe, se­nior man­ag­ing di­rec­tor of list­ing ser­vices at Nas­daq, in an in­ter­view with End­points News.

Saxe has pre­dict­ed 30 to 35 biotech IPOs this year, rais­ing about $3.5 bil­lion, ver­sus last year’s har­vest of $5 bil­lion. How­ev­er, in com­par­i­son to the fi­nan­cial cri­sis of 2008, it is still a big num­ber.

In re­cent days, ven­ture cap­i­tal firms have re­port­ed record fund­ing. Be­tween Flag­ship Pi­o­neer­ing, ARCH Ven­tures, Deer­field and ven­Bio, near­ly $4 bil­lion in fund­ing has been ear­marked for the life sci­ences. In fact, the first quar­ter of 2020 was the sin­gle largest quar­ter ever for bio­phar­ma ven­ture fund­ing in the Unit­ed States, hit­ting $5.5 bil­lion in ag­gre­gate fund­ing across 171 fi­nanc­ing rounds, not­ed At­las Ven­ture’s Bruce Booth in a blog post, cit­ing Pitch­book da­ta.

So what is so ap­peal­ing, so re­deem­ing about biotech? Un­like most oth­er sec­tors, which are de­pen­dent on the sale of prod­ucts and ser­vices, the bio­phar­ma in­dus­try makes med­i­cines, which we all need come rain or come shine. Apart from time­line de­lays to clin­i­cal tri­als and reg­u­la­to­ry sub­mis­sions, fun­da­men­tals re­main strong, and in many ar­eas, the in­dus­try is con­sid­ered key, so lab work is con­tin­u­ing.

“While typ­i­cal in­dus­tries are of­ten af­fect­ed by acute changes in con­sumer de­mand (and spikes in un­em­ploy­ment), this isn’t re­al­ly the case with bio­phar­ma: there are plen­ty of un­met needs of pa­tients where in­no­v­a­tive new ther­a­peu­tics can have a mean­ing­ful im­pact,” Booth said. “Loss-mak­ing bio­phar­ma is where many of these new drugs are dis­cov­ered and/or de­vel­oped to­day: com­pa­nies that get fund­ed, and val­ued, based on da­ta which ac­crues over years, not weeks and months. That dis­con­nect from con­ven­tion­al eco­nom­ic cy­cles is one of the rea­sons why bio­phar­ma tends to out­per­form oth­er sec­tors dur­ing fi­nan­cial re­ces­sions.

Ad­di­tion­al re­port­ing by Am­ber Tong.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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