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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.

Opthea, a South Yarra, Aus­tralia-based biotech al­so sub­mit­ted its F-1 pa­per­work, es­ti­mat­ing a raise of up to $150 mil­lion.

Through late Au­gust, the biotech in­dus­try had raised a com­bined $11 bil­lion-plus in four dozen IPOs per in­de­pen­dent an­a­lyst Brad Lon­car, sur­pass­ing the amount from all of 2019.

Jor­dan Saxe

Fri­day’s pric­ings move the 2020 to­tal to 56 to­tal pub­lic of­fer­ings in the in­dus­try, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe. Nas­daq has count­ed $11.3 bil­lion raised for the 56 biotechs through Fri­day.

Saxe’s tal­ly al­so match­es Lon­car’s to­tal from 2018, which makes 2020 tied for the most biotech IPOs seen in any of the last four years. The boom this year is be­ing dri­ven by sev­er­al fac­tors, Saxe said, in­clud­ing the Covid-19 pan­dem­ic high­light­ing the al­ready-im­pres­sive amount of in­no­va­tion in the field, a steady in­crease of crossover in­vestors from the last few years and the fact that biotechs can pro­vide longer-term in­vest­ments than com­pa­nies re­liant on quar­ter-to-quar­ter sales num­bers.

“All of those fac­tors com­bined have added up and cre­at­ed this per­fect storm,” Saxe told End­points News. 

PMV’s move to go pub­lic comes a lit­tle over a month af­ter pulling in a $70 mil­lion Se­ries D round and hir­ing long­time biotech en­tre­pre­neur Rich Hey­man as chair­man of the board of di­rec­tors. Hey­man no­tably found­ed the biotechs Aragon and Ser­agon, each of which sold for more than $1 bil­lion in the span of 12 months back in 2013 and 2014.

Per its S-1, PMV will pri­mar­i­ly use the IPO funds to help push its lead can­di­date, PC14586, in­to a Phase I/II tri­al tar­get­ing cer­tain p53 mu­ta­tions ag­nos­tic to the tu­mor. P53 pro­teins play a piv­otal role in the body’s nat­ur­al de­fense mech­a­nism against can­cer, and PMV hopes its pro­grams can help re­store some of the func­tion lost when they mu­tate.

Pre­lude pro­vid­ed a de­tailed break­down in its fil­ing, show­ing just how they ex­pect to divvy up the IPO funds to fur­ther de­vel­op­ment. The com­pa­ny is plan­ning to spend be­tween $15 mil­lion to $20 mil­lion on each of its three lead pro­grams, in­clud­ing com­plet­ing Phase I tri­als in sol­id tu­mors, hema­to­log­i­cal ma­lig­nan­cies and some re­lapsed/re­frac­to­ry high risk can­cers. An­oth­er $30 mil­lion to $40 mil­lion will go to­ward its pre­clin­i­cal stud­ies of pro­grams com­ing up the pipeline.

Gray­bug al­so spec­i­fied how they’d use the IPO mon­ey, in­di­cat­ing about $17 mil­lion would fund tri­als for its lead pro­gram, cur­rent­ly in a Phase IIb for wet AMD. Some of the mon­ey is planned for the com­ple­tion of that tri­al, as well as start­ing up a par­al­lel Phase IIb in DME and the wet AMD Phase III should the ear­li­er study prove suc­cess­ful.

In its own fil­ing, Green­wich said that rough­ly $3 mil­lion of its raise will help com­plete man­u­fac­tur­ing of its GP2 prod­uct and en­roll the first 50 to 100 pa­tients in a Phase III tri­al. Opthea aims to be­gin two Phase III tri­als in wet AMD and ad­vance non-clin­i­cal stud­ies for a po­ten­tial com­bi­na­tion ther­a­py.

With a full quar­ter left in the year, Saxe said he doesn’t ex­pect the biotech train to slow down any­time soon. He pegged a “con­ser­v­a­tive” es­ti­mate of 65-70 biotech IPOs by New Year’s.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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