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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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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