Four biotechs haul in $303M+ from a fresh burst of IPOs

De­spite the longest-ever US gov­ern­ment shut­down sub­du­ing IPO ac­tiv­i­ty in the first-quar­ter — health­care IPOs dom­i­nat­ed, ac­count­ing for 70% of the 20 IPOs in the re­gion, ac­cord­ing to ac­count­ing firm Ernst & Young. In­ter­est in the sec­tor has far from cooled — with four drug de­vel­op­ers fo­cus­ing on a range of con­di­tions from the ever-pop­u­lar im­muno-on­col­o­gy to fail­ure-friend­ly Alzheimer’s — set to make their pub­lic de­buts on Thurs­day.

Lieping Chen

In March, Yale spin­out NextCure laid out the blue­print for its im­muno-on­col­o­gy re­search in Na­ture Med­i­cine, af­ter se­cur­ing $40 mil­lion up­front in an R&D col­lab­o­ra­tion with Lil­ly and bring­ing its cash haul to a cool $180 mil­lion. The com­pa­ny — found­ed in 2015 by Lieping Chen, a not­ed I/O re­searcher be­hind Am­plim­mune, a com­pa­ny bought out by As­traZeneca five years ago — has now raised $75 mil­lion in an IPO. The com­pa­ny, which is poised to trade un­der the sym­bol $NXTC, of­fered 5 mil­lion shares at $15 — the mid­point of its range of $14 to $16. The Beltsville, Mary­land-based drug de­vel­op­er is fo­cus­ing on PD-L1-neg­a­tive tu­mors to help the scores of pa­tients for whom check­point in­hibitors don’t work. Its lead ex­per­i­men­tal drug — NC318 — tar­gets an im­munomod­u­la­to­ry re­cep­tor called Siglec-15 and is cur­rent­ly be­ing test­ed in a Phase I/II tri­al in pa­tients with ad­vanced or metasta­t­ic sol­id tu­mors.

Steve Dominy

With the field of Alzheimer’s drug de­vel­op­ment lit­tered with fail­ure and the amy­loid-be­ta hy­poth­e­sis all but dead, a fresh ap­proach to treat­ing the mem­o­ry-wast­ing dis­ease has gar­nered in­ter­est in Cor­texyme. The South San Fran­cis­co-based biotech is bet­ting that Por­phy­romonas gin­gi­valis — a bac­te­r­i­al pathogen as­so­ci­at­ed with chron­ic pe­ri­odon­ti­tis — could be vi­tal to com­bat­ing Alzheimer’s-re­lat­ed neu­rode­gen­er­a­tion, based on the find­ings of  UCSF psy­chi­a­trist Steve Dominy. Cor­texyme’s lead ex­per­i­men­tal drug is de­signed to in­hib­it gingi­pains — the tox­ic pro­tease se­cret­ed by P. gin­gi­valis — and is be­ing eval­u­at­ed in Phase II/III study. Backed by Pfiz­er (14.71%) and Take­da (12.32%), the com­pa­ny has now raised $75 mil­lion in an IPO. The com­pa­ny, which is set to trade un­der the sym­bol $CRTX, of­fered 4.4 mil­lion shares at $17 — the mid­point of its range of $16 to $18.

With car­dio­vas­cu­lar dis­eases im­pli­cat­ed in an es­ti­mat­ed third of all deaths, drug­mak­ers (and in­vestors) are al­ways on the hunt for new treat­ments. Cana­di­an biotech Mile­stone Phar­ma­ceu­ti­cals’ sole as­set is a nasal spray for­mu­la­tion of a cal­ci­um chan­nel block­er, which has been craft­ed to treat a rapid heart rate con­di­tion that is usu­al­ly treat­ed with in­tra­venous in­fu­sions in the ER. The hope is the rapid-on­set drug (cur­rent­ly in late-stage de­vel­op­ment) can help pa­tients re­solve sud­den episodes of parox­ys­mal supraven­tric­u­lar tachy­car­dia — which are of­ten ac­com­pa­nied by pal­pi­ta­tions, chest pres­sure, pain, short­ness of breath and faint­ing — on their own. The drug, etri­pamil, is al­so be­ing eval­u­at­ed for atri­al fib­ril­la­tion and angi­na. Ven­ture in­vestors col­lec­tive­ly claim more than 80% of the com­pa­ny, which raised $82.5 mil­lion in an up­sized IPO. The drug de­vel­op­er, set to trade as $MIST, of­fered 5.5 mil­lion shares at $15, sell­ing an ad­di­tion­al 500,000 shares at the mid­point of the range of $14 to $16.

Bill Hin­shaw

About a year af­ter en­tic­ing No­var­tis ex­ec­u­tive Bill Hin­shaw to run its op­er­a­tions, Flag­ship Pi­o­neer­ing-backed Ax­cel­la Health is tak­ing its pre­clin­i­cal pipeline of meta­bol­ic mod­u­la­tors — based on sci­ence that sug­gests amino acids can re­store health across a net­work of dys­reg­u­lat­ed path­ways — on to the pub­lic mar­ket. The com­pa­ny’s lead ex­per­i­men­tal drug is be­ing de­vel­oped for he­pat­ic en­cephalopa­thy, which are neu­ropsy­chi­atric ab­nor­mal­i­ties as­so­ci­at­ed with pa­tients suf­fer­ing from liv­er dys­func­tion, typ­i­cal­ly chron­ic liv­er dis­ease. The Cam­bridge, Mass­a­chu­setts-based biotech — set to trade un­der the sym­bol $AXLA — raised $71 mil­lion by of­fer­ing 3.6 mil­lion shares at $20, the low end of the range of $20 to $22.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.