Ali­gos Ther­a­peu­tics, de­vel­op­ing sev­er­al dif­fer­ent hep B and NASH treat­ments, files for $100M IPO raise

An­oth­er biotech filed to go pub­lic late Fri­day as the 2020 IPO par­ty rages on.

Ali­gos Ther­a­peu­tics, fo­cus­ing on chron­ic he­pati­tis B and NASH, sub­mit­ted its S-1 pa­per­work to the SEC with a goal of rais­ing $100 mil­lion. The com­pa­ny’s lead can­di­date is known as a STOPS mol­e­cule, or an S-anti­gen trans­port-in­hibit­ing oligonu­cleotide poly­mer, and start­ed a Phase I study for CHB in Au­gust.

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

Af­ter four oth­er biotechs priced their shares last Fri­day, the to­tal num­ber of in­dus­try IPOs in 2020 reached 56, Nas­daq’s head of health­care list­ings Jor­dan Saxe told End­points News at the time. Nas­daq has count­ed $11.3 bil­lion raised for those 56 biotechs through Fri­day. Saxe’s tal­ly al­so match­es Lon­car’s to­tal from 2018, which made 2020 tied for the most biotech IPOs seen since at least 2017.

The the­o­ry be­hind the lead pro­gram, dubbed ALG-010133, is that sup­press­ing the S-anti­gen in the he­pati­tis B virus can boost the pa­tients’ com­pro­mised im­mune sys­tems and im­prove vi­ral clear­ance in chron­ic he­pati­tis B. Ali­gos’ Phase I study will mea­sure safe­ty and an­tivi­ral ac­tiv­i­ty in up to 12 week­ly dos­es, both in healthy vol­un­teers and vi­ro­log­i­cal­ly sup­pressed pa­tients with CHB.

Ac­cord­ing to a state­ment at the time, ALG-010133 will first be eval­u­at­ed as a monother­a­py but Ali­gos said it has seen some po­ten­tial that it could be used in com­bi­na­tion ther­a­pies.

Topline re­sults for some co­horts are ex­pect­ed in the sec­ond half of 2021, and the first pa­tients were dosed at a tri­al site in New Zealand. Oth­er sites across Asia and Eu­rope have not be­gun dos­ing as of yet.

Ali­gos has three oth­er pre­clin­i­cal pro­grams try­ing to hit the chron­ic he­pati­tis B in­di­ca­tion, each with dif­fer­ent mech­a­nisms of ac­tion. The first is with cap­sid as­sem­bly mod­u­la­tors, which are small mol­e­cules that in­ter­fere with HBV cap­sid dis­as­sem­bly and vi­ral repli­ca­tion. This pro­gram, called ALG-000184, is ex­pect­ed to be­gin clin­i­cal tri­als be­fore the end of the year.

The com­pa­ny’s oth­er two CHB pre­clin­i­cal pro­grams both can in­hib­it the virus’s mR­NA that en­codes S-anti­gens, Ali­gos says. These two meth­ods are through an an­ti­sense oligonu­cleotide, as well as a small in­ter­fer­ing RNA. Ad­di­tion­al­ly, the biotech’s NASH pro­gram — al­so in pre­clin­i­cal stud­ies — is a THB-be­ta ag­o­nist.

Ali­gos’ S-1 did not give much de­tail about how it ex­pects to divvy up the funds from the IPO raise, on­ly that the mon­ey would main­ly go to­wards fund­ing these five pro­grams.

Al­so on Fri­day, a 5AM Ven­tures-backed blank check com­pa­ny filed to go pub­lic, seek­ing an $80 mil­lion raise. The com­pa­ny, called 5:01 Ac­qui­si­tion, is not plan­ning on op­er­at­ing like a nor­mal SPAC in that it’s not of­fer­ing war­rants that would be­come ex­er­cis­able fol­low­ing com­ple­tion of the ini­tial busi­ness com­bi­na­tion, per Re­nais­sance Cap­i­tal.

5:01 Ac­qui­si­tion did not spec­i­fy with which biotech it plans to con­duct a re­verse merg­er.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.