Bob Duggan, Summit Therapeutics CEO (via Summit Investments)

Look­ing to climb out of bear mar­ket and FDA hur­dles, Sum­mit of­fers up $100M worth of stock

While the road has cer­tain­ly been rocky for bil­lion­aire Bob Dug­gan’s biotech amidst a bear mar­ket and FDA trou­bles, Sum­mit Ther­a­peu­tics is still look­ing to forge ahead with a new stock of­fer­ing.

Sum­mit an­nounced on Mon­day that it has kicked off a pre­vi­ous­ly an­nounced rights of­fer­ing of up to $100 mil­lion of its com­mon stock. Ac­cord­ing to the com­pa­ny, the sub­scrip­tion rights will ex­pire if they are not ex­er­cised be­fore Aug. 8.

Sum­mit es­ti­mates the price per share at $1.08. The orig­i­nal an­nounce­ment of the of­fer­ing in June said that Dug­gan owns around 70% of Sum­mit’s com­mon stock be­fore the rights of­fer­ing, and COO Maky Zan­ganeh owns 6.5% of the com­mon stock. Dug­gan, a long-time in­dus­try backer, touts hav­ing been the largest in­vestor in his pre­vi­ous com­pa­ny, Phar­ma­cyclics, which he sold to Ab­b­Vie for $21 bil­lion in 2015, in­clud­ing the blood can­cer drug Im­bru­vi­ca.

Maky Zan­ganeh

Both Dug­gan and Zan­ganeh have in­di­cat­ed they in­tend to par­tic­i­pate in the rights of­fer­ing but have not in­di­cat­ed a min­i­mum lev­el of par­tic­i­pa­tion or made any for­mal bind­ing com­mit­ments to any pur­chas­es.

The an­nounce­ment has brought the biotech’s share price $SMMT up al­most 1%, but more con­fi­dence will be need­ed in the long run as the com­pa­ny is look­ing at a 60% drop since ear­ly Jan­u­ary as it sits just above the pen­ny stock zone.

This is not the first time that Sum­mit has of­fered up a sub­stan­tial piece of the com­pa­ny to in­vestors. In 2020, as the Covid-19 head­winds were hit­ting the biotech world, Dug­gan agreed to pur­chase up to an­oth­er 15 mil­lion shares to raise $50 mil­lion and help Sum­mit as­sist in fin­ish­ing its piv­otal Phase III tri­al of its lead an­tibi­ot­ic, ri­dini­la­zole, for C. dif­fi­cile treat­ment, and launch it in the US.

Sum­mit has been fac­ing sev­er­al head­winds this past year. When it an­nounced its in­tent to com­bine two Phase III stud­ies for ri­dini­la­zole in­to one tri­al that changed the pri­ma­ry end­point, the FDA did not orig­i­nal­ly agree with the new end­point and raised ques­tions about its on­go­ing de­vel­op­ment. But Dug­gan did man­age to stand his ground against the US reg­u­la­tor. Last week, Sum­mit and the FDA held a meet­ing, with the new path like­ly in­volv­ing at least one ad­di­tion­al clin­i­cal tri­al.

Sum­mit is not the on­ly biotech go­ing down the route of pub­lic com­pa­nies at­tempt­ing to raise cash af­ter da­ta drops. Last week, Pli­ant Ther­a­peu­tics, on the back of ear­ly da­ta for its TGF-β in­hibitor in id­io­path­ic pul­monary fi­bro­sis, an­nounced that it is look­ing to sell $150 mil­lion worth of its stock in a pub­lic of­fer­ing, and an op­tion for un­der­writ­ers to pur­chase $22.5 mil­lion more.

Day One Bio­phar­ma­ceu­ti­cals, af­ter re­cent­ly show­ing that a for­mer Take­da drug worked well in treat­ing kids with a cer­tain form of brain can­cer, al­so bumped up its pub­lic of­fer­ing to $150 mil­lion as more in­vestors came knock­ing.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.