One mi­cro­cap biotech is charg­ing head­first in­to treach­er­ous IPO wa­ters, jump­ing to Nas­daq with mod­est raise

It’s a tough mar­ket right now for biotech IPOs, but one small com­pa­ny is tak­ing the pub­lic leap Fri­day with a mod­est ini­tial of­fer­ing.

Blue Wa­ter Vac­cines raised $20 mil­lion in its IPO, pric­ing shares at $9 apiece late Thurs­day af­ter­noon. The Cincin­nati-based com­pa­ny will use the mon­ey pri­mar­i­ly to ad­vance a slate of pre­clin­i­cal pro­grams to­ward IND stud­ies and boost man­u­fac­tur­ing ca­pa­bil­i­ties, it re­port­ed in its S-1 fil­ing.

When Blue Wa­ter de­buts Fri­day on Nas­daq, it will trade un­der the tick­er $BWV.

Long gone are the days of 2020 when the biotech IPO mar­ket was boom­ing, a pe­ri­od that stretched well in­to the first half of 2021 and saw rough­ly 200 com­pa­nies go pub­lic. The bull mar­ket helped bring in about $30 bil­lion in new cash, as in­vestors set their sights on the life sci­ences hop­ing to find the next pan­dem­ic suc­cess like Mod­er­na.

Dur­ing that pe­ri­od, it was not un­com­mon to see three or four biotechs price their IPOs every week. Some were so busy that 10 biotechs de­buted in a sin­gle week last Feb­ru­ary, and rais­es top­ping the $200 mil­lion mark were aplen­ty.

How­ev­er, the sec­tor has come down from that high in a stark fash­ion, as the biotech XBI has shaved more than 40% from that Feb­ru­ary 2021 peak. And al­ready this year, the fig­ure lost 20% of val­ue in Jan­u­ary alone, though it has sta­bi­lized around that lev­el so far this month.

The shift has led some to spec­u­late that VCs were per­haps overea­ger in push­ing their in­vest­ments pub­lic to cap­i­tal­ize on the boom­ing mar­ket, even if many such biotechs had not yet reached the clin­ic. RA Cap­i­tal Man­age­ment, a no­table pres­ence in the crossover space, shep­herd­ed sev­er­al such biotechs to Nas­daq dur­ing the pan­dem­ic.

Two no­table ex­am­ples, Janux Ther­a­peu­tics and Tyra Bio­sciences, are each down 35% from their IPO prices last June and Sep­tem­ber, re­spec­tive­ly.

And at least one biotech, con­cerned over the ever-ethe­re­al “mar­ket con­di­tions,” elect­ed to go af­ter an­oth­er pri­vate megaround rather than jump to Nas­daq ear­li­er this week. It re­mains to be seen if oth­er com­pa­nies will fol­low Kally­ope’s lead, but the ram­i­fi­ca­tions could be felt through­out the sec­tor.

With Blue Wa­ter seem­ing­ly buck­ing the trend Fri­day, mi­cro­cap IPOs may end up able to weath­er the storm giv­en the low­er mar­ket ex­pec­ta­tions. The biotech priced at the mid­point of its range and of­fered 2.2 mil­lion shares.

Like many of its new­ly pub­lic coun­ter­parts, Blue Wa­ter does not have any pro­grams in the clin­ic just yet. It’s de­vel­op­ing sev­er­al dif­fer­ent vac­cine can­di­dates rang­ing from a uni­ver­sal flu shot to a stand­alone, long-last­ing H1 flu shot. The com­pa­ny is al­so re­search­ing a norovirus/ro­tavirus vac­cine, a norovirus/malar­ia vac­cine and a Strep­to­coc­cus pneu­mo­ni­ae vac­cine.

In ad­di­tion to pre­clin­i­cal re­search and IND stud­ies for all pro­grams, some of the cash will al­so be used to fund Phase I stud­ies for the flu shots and the Strep­to­coc­cus pneu­mo­ni­ae vac­cine, the biotech re­port­ed to the SEC.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el's Tony Coles is still count­ing his mon­ey as a ri­val's boost helps fu­el a po­ten­tial $609M wind­fall

These days in biotech, you never want to miss a chance to raise money for public companies. As much money as possible.

That survival strategy was in full view over the last 24 hours as Cerevel $CERE announced a major stock/debt raise, then upped the ante with a bigger debt load than initially planned.

The tally: $238 million – net — with a shot at boosting that to $274 million from the stock sale, provided the underwriters come back for more. And there’s $335 million from the debt, provided their first round buyers come back for an added bite. Rounding up, that’s $609 million with the add-on. Even without the add-ons, though, it’s still $530 million in the bank.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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