In a first for up­start syn­thet­ic bi­ol­o­gy field, Zymer­gen files for $100M IPO

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

Five years af­ter the syn­thet­ic bi­ol­o­gy com­pa­ny Zymer­gen raised $174 mil­lion from in­vestors by piquing in­ter­est in de­sign­er mi­crobes, the com­pa­ny has filed for an IPO.

The com­pa­ny pen­ciled in a $100 mil­lion raise, al­though that fig­ure has be­come a place­hold­er over the last year for life sci­ences com­pa­nies that have their eyes on much larg­er troves.

Zymer­gen so far has spe­cial­ized in en­gi­neer­ing mi­crobes for new ma­te­ri­als, in­clud­ing elec­tron­ics and in­sect re­pel­lent, or for man­u­fac­tur­ing chem­i­cals and fu­els. But they’ve al­so qui­et­ly been in­volved in drug de­vel­op­ment and man­u­fac­tur­ing bi­o­log­ics and their IPO haul, which could be sig­nif­i­cant, rep­re­sents a ma­jor mile­stone for a syn­thet­ic bi­ol­o­gy field that has been try­ing to re­make cor­ners of the bio­phar­ma in­dus­try.

The amount they ul­ti­mate­ly raise could pro­vide a bench­mark for the next wide­ly an­tic­i­pat­ed syn­thet­ic bi­ol­o­gy IPO: Gink­go Bioworks, which has played a much more di­rect role in drug de­vel­op­ment, team­ing with Roche, Mod­er­na and Syn­log­ic. CEO Ja­son Kel­ly has said in the past that the com­pa­ny, which was val­ued at $4 bil­lion in 2019 and dubbed as “a mag­net for VC mon­ey” by the Boston Globe, has plans to do just that.

Zymer­gen’s first prod­uct, a film that al­lows cus­tomers to make fold­able touch­screens, was launched in De­cem­ber 2020. Board mem­ber and No­bel Prize win­ner Steven Chu told the Fi­nan­cial Times in 2016 that iden­ti­fy­ing groups of genes in­side mi­croor­gan­isms is the key to cre­at­ing new or­gan­isms.

The com­pa­ny ar­gues that “bio­fac­tur­ing” cre­ates bet­ter prod­ucts cheap­er, faster and more sus­tain­ably than tra­di­tion­al chem­istry.

“Our goal is to make our bio­mol­e­cules by fer­men­ta­tion, which we be­lieve is a safer process than mak­ing prod­ucts with petro­chem­istry,” the doc­u­ments stat­ed. “Us­ing new tools and build­ing blocks de­rived from na­ture, we be­lieve we can man­u­fac­ture high-per­for­mance ma­te­ri­als more clean­ly and with less waste.”

Zymer­gen has yet to make any ma­jor pub­lic in­roads in­to bio­phar­ma, but they say on their web­site in a sec­tion la­beled “emerg­ing ar­eas” that they are ac­tive­ly us­ing their ge­net­ic li­braries, high-through­put sys­tems and oth­er tech­nolo­gies to de­vel­op drugs for on­col­o­gy and in­fec­tious dis­eases. The idea is to cut the length of time it takes to get a can­di­date in­to clin­i­cal tri­als and make it eas­i­er to man­u­fac­ture those can­di­dates if they prove ef­fec­tive.

The com­pa­ny said in the IPO fil­ing that the pro­ceeds from in­vestors would pri­mar­i­ly be used for work­ing cap­i­tal, and ex­pect that to take the shape of com­mer­cial­iz­ing al­ready ex­ist­ing prod­ucts and fur­ther­ing the de­vel­op­ment of the bio­fac­tur­ing plat­form and tech­nol­o­gy.

“We do not cur­rent­ly have spe­cif­ic planned us­es for the pro­ceeds of this of­fer­ing,” the com­pa­ny said in their S-1 form.

In 2016, Zymer­gen took away an in­vest­ment of $130 mil­lion in its Se­ries B.

En­ti­ties af­fil­i­at­ed with SVF Ex­cal­ibur (Cay­man) Lim­it­ed own the most shares be­fore the of­fer­ing, with near­ly 33%. En­ti­ties af­fil­i­at­ed with True Ven­tures IV own 10.4% of shares, and those af­fil­i­at­ed with Gam­nat Pte. Ltd. own 5.5%. Co-founders Josh Hoff­man and Zach Ser­ber own 3.7% and 3.5%, re­spec­tive­ly.

The com­pa­ny has ac­quired an ac­cu­mu­lat­ed deficit of $511.5 mil­lion and $773.7 mil­lion as of Dec. 31, 2019 and 2020.

“We have a his­to­ry of op­er­at­ing loss­es and we do not ex­pect to be prof­itable for the fore­see­able fu­ture,” the S-1 re­port said.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Voting in the 2020 election (AP Images)

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We oppose all attempts to introduce laws that reduce the rights of US citizens to vote or that restrict them from exercising that right. The right to vote is fundamental to democracy. States that have enacted, or are proposing to enact, legislation to restrict voting are undermining our democracy and posing a threat to our nation. As leaders of the life sciences industry, we stand for what we believe is right for our country, our enterprises, our employees and those who benefit from our work. We join the first groups of business leaders who have challenged these laws and will continue to make our collective voices heard on this matter.

Sajith Wickramasekara, Benchling via YouTube

Meet Bench­ling, the lat­est uni­corn seek­ing to rev­o­lu­tion­ize the way sci­en­tists do work with the help of the cloud

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added to mix-and-match study in the UK

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amy­lyx to move for­ward with ALS pro­gram in Eu­rope, but FDA wants an­oth­er look; Hu­ma­cyte adds $50M in debt fi­nanc­ing

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Barbara Weber, Tango Therapeutics CEO (Tango)

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

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

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.