The pan­dem­ic IPOs keep rolling, as Gen­er­a­tion, Avid­i­ty, Vax­cyte each claim 200M+

If it wasn’t al­ready, biotech’s pan­dem­ic IPO boom is in full swing.

Af­ter a week that saw the largest Chi­nese biotech IPO in his­to­ry and an­oth­er $154 mil­lion for a com­pa­ny that emerged on­ly last Sep­tem­ber, four dif­fer­ent biotechs raised over $200 mil­lion. Each of them up­sized their of­fer­ings or priced at the top end — or more — of their orig­i­nal range.

Col­lec­tive­ly, they raised $926 mil­lion, or an av­er­age of $231 mil­lion per com­pa­ny.

The new rais­es are part of a broad­er trend, as in­vestors have flocked to biotech stocks as is­lands of sta­bil­i­ty in an in­creas­ing­ly rocky and pan­dem­ic-strick­en stock mar­ket. Large­ly, that’s meant bal­loon­ing val­u­a­tions for pub­lic com­pa­nies, such as Mod­er­na and Vir, who are mak­ing treat­ments or vac­cines for Covid-19.

But the com­pa­nies go­ing pub­lic this week don’t have large Covid-19 pro­grams. They con­sist of a Chi­nese can­cer de­tec­tion com­pa­ny and three com­pa­nies that are still pre­clin­i­cal, a stage when it used to be rare for com­pa­nies to go pub­lic, let alone raise vast cap­i­tal. The new rounds are a con­tin­u­a­tion of that trend, glimpses of which were seen be­fore the out­break hit the US, as the mar­ket showed an ap­petite for such ear­ly-stage ven­tures.

Six pre­clin­i­cal biotechs have now raised over $150 mil­lion in 2020, com­pared with just two over the pre­vi­ous three years, ac­cord­ing to num­bers from Re­nais­sance Cap­i­tal. That in­cludes David Liu’s Beam Ther­a­peu­tics, which raised $180 mil­lion on a base pair edit­ing plat­form in Feb­ru­ary, Jim Wil­son’s Pas­sage Bio, and Ver­sant’s Black Di­a­mond Ther­a­peu­tics.

Ge­off Mc­Do­nough Gen­er­a­tion

Gen­er­a­tion Bio was the first com­pa­ny to go pub­lic this week, grab­bing $200 mil­lion in a twice-up­sized of­fer­ing. Run by Gen­zyme vet Ge­off Mc­Do­nough, it’s de­vel­op­ing gene ther­a­pies that can be de­liv­ered by lipid nanopar­ti­cles in­stead of vi­ral vec­tors. The idea is that the nanopar­ti­cles can last as long as the now-com­mon ade­no-as­so­ci­at­ed virus­es, while be­ing eas­i­er to scale and sell for less than the cur­rent mul­ti-mil­lion dol­lar price tags for gene ther­a­pies.

In Jan­u­ary, the com­pa­ny raised $110 mil­lion, bring­ing their to­tal to $235 mil­lion. At the time, Mc­Do­nough told End­points News they might look for an IPO in 12 to 18 months to fund their clin­i­cal work.

Avid­i­ty Bio­sciences, an Eli Lil­ly-backed an­ti­sense biotech, priced at $14 to $16, up­sized the range to $17 to $18, and then priced at the high end of that, earn­ing $259 mil­lion in the end. The com­pa­ny works on mus­cle dis­or­ders, par­tic­u­lar­ly my­oton­ic mus­cu­lar dy­s­tro­phy. They com­bine an­ti­sense oligonu­cleotides — an old way of drug­ging RNA — with hom­ing an­ti­bod­ies to cre­ate what they call an­ti­body oligonu­cleotides con­ju­gates. The idea is that the an­ti­body will guide the an­ti­sense to se­quences that were pre­vi­ous­ly dif­fi­cult to tar­get. Their last round was in No­vem­ber, for $100 mil­lion.

Vax­cyte filed for its IPO ex­act­ly two months af­ter it raised $110 mil­lion in a Se­ries D, and end­ed up rais­ing $249 mil­lion. At the time of the last raise, it was known as SutroVax — a holdover from its days as a spin­out of Sutro Bio­phar­ma — but they changed their name and lo­go in ad­vance of fil­ing for what was orig­i­nal­ly sten­ciled as a $100 mil­lion IPO.

There may be no bet­ter time to go pub­lic as a vac­cine com­pa­ny, and the re­turn of vac­cines to the cen­ter of pub­lic at­ten­tion may have boost­ed their over­all raise, but Vax­cyte is work­ing on a far dif­fer­ent mar­ket and type of in­oc­u­la­tion than coro­n­avirus. The com­pa­ny is try­ing to cre­ate a fol­low-up to Pre­vnar13, the Pfiz­er pneu­mo­nia vac­cine that’s earned over $30 bil­lion in one of the few block­buster vac­cine mar­kets. Vax­cyte’s lead prod­uct is meant to guard against 24 strains of bac­te­ria, in­stead of Pre­vnar’s 13, and is com­pet­ing against ex­per­i­men­tal in­oc­u­la­tions at Pfiz­er and else­where.

In the fi­nal large raise, Il­lu­mi­na-part­nered Burn­ing Rock Biotech, a DNA-se­quenc­ing based can­cer de­tec­tion com­pa­ny, earned $223 mil­lion, pric­ing a dol­lar above their orig­i­nal $13.50 to $15.50 range. They got to ring the open­ing bell to­day at the Nas­daq.

And on a small­er note, AI-fo­cused Chi­nese biotech, Lantern Phar­ma had an ever-so-slight­ly up­sized IPO. They filed for $25 mil­lion and raised $26 mil­lion.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”