More da­ta, more dol­lars: Three biotechs post of­fer­ings af­ter tri­al read­outs

The pat­tern goes as fol­lows: roll out the da­ta first, and then go to in­vestors and ask for more mon­ey.

Three biotechs played right in­to that strat­e­gy on Tues­day.

The first was Jasper Ther­a­peu­tics, which kicked things off Tues­day af­ter­noon by an­nounc­ing it plans on sell­ing shares via a pub­lic of­fer­ing. Jasper elab­o­rat­ed Wednes­day morn­ing, dis­clos­ing it would sell 60 mil­lion shares of stock at $1.50 each, for around $90 mil­lion. The stock $JSPR ticked up more than 10% af­ter the open­ing bell.

While the state­ment said the biotech in­tends to use the pro­ceeds for gen­er­al ex­pens­es, work­ing cap­i­tal and cap­i­tal ex­pen­di­tures, an SEC fil­ing al­so not­ed Jasper may use a por­tion of the fi­nanc­ing to “ac­quire or in­vest in oth­er busi­ness­es, prod­ucts and tech­nolo­gies that are com­ple­men­tary to our own.” How­ev­er, there are no cur­rent plans to do just that.

This an­nounce­ment comes af­ter a pos­i­tive da­ta read­out ear­li­er in Jan­u­ary, where Jasper’s an­ti-c-KIT mon­o­clon­al an­ti­body, known as briquil­imab, was test­ed in a tri­al along­side an ex­ist­ing bone mar­row trans­plan­ta­tion reg­i­men for three pa­tients with sick­le cell dis­ease. The goal of the tri­al was to see if adding the an­ti­body would lead to a high­er per­cent­age of stem cell en­graft­ment with­out in­creased tox­i­c­i­ty. All pa­tients treat­ed were suc­cess­ful­ly en­graft­ed, Jasper said at the time, and had no ad­verse ef­fect re­lat­ed to briquil­imab.

Next up is pen­ny-stock Ve­rastem On­col­o­gy, which put out word less than 90 min­utes af­ter Jasper on Tues­day that it was rais­ing $60 mil­lion in a pri­vate place­ment of­fer­ing. How it’s get­ting the mon­ey, ac­cord­ing to a state­ment, is by sell­ing 2.1 mil­lion shares of pre­ferred stock to af­fil­i­ates of ven­ture cap­i­tal firm BVF Part­ners.

That place­ment came af­ter re­leas­ing ini­tial tranch­es of da­ta ear­li­er Tues­day from an on­go­ing Phase II study look­ing at a com­bi­na­tion treat­ment in pa­tients with re­cur­rent and heav­i­ly pre-treat­ed LGSOC, or low-grade serous ovar­i­an can­cer. Out of 29 pa­tients that could be eval­u­at­ed, Ve­rastem re­port­ed an ORR of 28%.

Last­ly was Pre­ci­gen, which re­port­ed sev­er­al hours af­ter the oth­er com­pa­nies on Tues­day night that it would be rais­ing $75 mil­lion via a pub­lic of­fer­ing.

The biotech said it would be sell­ing more than 42 mil­lion shares of com­mon stock at $1.75 each, giv­ing un­der­writ­ers 30 days to buy an­oth­er 6.4 mil­lion shares at that price and clos­ing Fri­day. Per an SEC fil­ing, Pre­ci­gen plans to use the funds for “gen­er­al cor­po­rate pur­pos­es,” which may in­clude clin­i­cal tri­als, fur­ther R&D, work­ing cap­i­tal, and more.

Just like Jasper and Ve­rastem, the of­fer­ing comes on the heels of a da­ta read­out. Ear­li­er that day, Pre­ci­gen an­nounced pos­i­tive Phase I da­ta for an in­ves­ti­ga­tion­al im­munother­a­py in pa­tients with re­cur­rent res­pi­ra­to­ry pa­pil­lo­mato­sis, a dis­ease of the up­per res­pi­ra­to­ry tract where re­cur­rent, wart-like growths ap­pear on the sur­face of the vo­cal cords or the sur­round­ing tis­sue. It is caused by in­fec­tion from HPV-6 or HPV-11. Pa­tients have no ap­proved ther­a­py, as growth-re­moval surgery is the cur­rent stan­dard of care.

Clin­i­cal da­ta from the Phase I showed the im­munother­a­py re­duced the need for surg­eries in pa­tients at the high­er of two dose lev­els. Half of those in that high­er dose group showed no need for surg­eries for 12 months af­ter fin­ish­ing treat­ment with the im­munother­a­py can­di­date.

De­spite the da­ta, the share price of $PGEN opened Wednes­day morn­ing down al­most 30%.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.