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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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