Bil­lions of dol­lars worth of SPACs are rid­ing on the biotech IPO boom

Bil­lion­aire hedge fund man­ag­er Bill Ack­man’s push to raise $4 bil­lion for his blank check com­pa­ny, Per­sh­ing Square Ton­tine Hold­ings, is cast­ing a spot­light on the SPACs. And amid a his­toric SPAC boom, biotechs are set­ting sev­er­al records on what some ob­servers say is shap­ing up to be a third ma­jor track — be­sides IPO and M&A — to go pub­lic.

Jay Heller

“SPACs were ap­prox­i­mate­ly 3% of the IPO mar­ket back in 2014, now they are al­most 35% of all new list­ings,” Jay Heller, the Nas­daq’s head of cap­i­tal mar­kets, told End­points News.

Even though bio­phar­ma ap­pears large­ly un­scathed by the volatil­i­ty in the broad­er pub­lic mar­ket, see­ing in­stead a his­toric run of de­buts, SPACs have still emerged as an al­ter­na­tive ve­hi­cle that can off­set some risks.

Es­tab­lished more than three decades ago, SPACs, or spe­cial pur­pose ac­qui­si­tion com­pa­nies, are es­sen­tial­ly clean­er re­verse merg­er shells for pri­vate com­pa­nies look­ing to make a quick flip to the pub­lic mar­ket. The way it works: An in­vest­ment firm would cre­ate a cor­po­ra­tion and file for an IPO based on noth­ing but its rep­u­ta­tion for pick­ing out win­ner op­por­tu­ni­ties — and the team has two years to do so af­ter rais­ing the cap­i­tal, sole­ly re­served for buy­ing out an ex­ist­ing com­pa­ny.

While it’s had a check­ered past tied with fraud­u­lent out­fits, blue chip spon­sors from RTW In­vest­ments to Per­cep­tive Ad­vi­sors are in­creas­ing­ly set­ting up their own SPACs.

For both in­vestors and com­pa­nies (as well as their orig­i­nal back­ers), it saves time and trou­ble ne­go­ti­at­ing terms or set­ting a price — al­though ex­ist­ing share­hold­ers do have the right to vote down a merg­er last minute.

Jonas Gross­man

“We pre­dict­ed at least six biotech fo­cused SPACs this year and we are al­most there,” said Jonas Gross­man, the pres­i­dent of Chardan.

Chardan raised $70 mil­lion to cre­ate its own SPAC, Chardan Health­care Ac­qui­si­tion, back in 2018. It then ze­roed in on Bio­mX, an Is­raeli mi­cro­bio­me-fo­cused biotech, as a merg­er tar­get, bring­ing the first and on­ly biotech SPAC com­bi­na­tion of 2019.

Since then, RTW’s Health Sci­ences has com­bined with Im­muno­vant, Per­cep­tive’s Arya Sci­ences has merged with Im­mat­ics, EcoR1’s Panacea has priced its $125 mil­lion IPO, and LifeSci Ac­qui­si­tion Corp has raised $60 mil­lion. Chardan it­self has pooled $85 mil­lion for a sec­ond SPAC.

Last week, Ther­a­peu­tics Ac­qui­si­tions — a SPAC spon­sored by RA Cap­i­tal — marked an­oth­er first by an IPO by sell­ing $118 mil­lion worth of com­mon shares rather than units. Prac­ti­cal­ly, it means that the of­fer­ing didn’t in­clude any trad­able war­rants, which used to be a fix­ture in such pub­lic list­ings.

The com­pa­ny had ini­tial­ly struc­tured the IPO based on units, Heller of Nas­daq not­ed, con­sist­ing of one share of Class A com­mon stock and one-third of one re­deemable war­rant.

“They were prob­a­bly able to re­struc­ture the deal be­cause of strong in­vestor de­mand,” he wrote. “The af­ter­mar­ket trad­ing of this se­cu­ri­ty will be a test to see if this will be adopt­ed by fu­ture SPACs.”

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.

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.

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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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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