Al­most a year af­ter the FDA gave the green light to LA-based Aa­di Bio­science’s first drug, the biotech is look­ing to pri­vate in­vestors to keep it­self go­ing.

The on­col­o­gy play­er an­nounced Thurs­day that it has en­gaged with both new and ex­ist­ing in­vestors in a PIPE fi­nanc­ing — sell­ing 3.3 mil­lion shares at $12.50 a share, the biotech’s clos­ing price at Nas­daq on Wednes­day. The com­pa­ny is al­so sell­ing off pre-fund­ed war­rants to pur­chase over 2.4 mil­lion more shares at $12.4999 per pre-fund­ed war­rant.

Aa­di said in a state­ment that it ex­pects to raise $72.5 mil­lion over­all be­fore any ex­pens­es, with the fi­nanc­ing ex­pect­ed to close Mon­day.

The biotech added it would use the funds to ad­vance its Phase II reg­is­tra­tional tri­al, called PRE­CI­SION 1, study­ing a mol­e­cule tar­get­ing sol­id tu­mors in pa­tients with spe­cif­ic mu­ta­tions of genes TSC1 and TSC2. A pre­lim­i­nary read­out is ex­pect­ed some­time in H1 next year. On top of that, the biotech plans to use some of the funds to ex­pand com­mer­cial ef­forts for its one ap­proved drug, brand­ed as Fyarro and in­di­cat­ed for a rare and ag­gres­sive type of sar­co­ma, and in­crease R&D fund­ing.

The fi­nanc­ing, ac­cord­ing to Aa­di, was led by an un­named, “life sci­ences-fo­cused in­vest­ment fund” — along with ex­ist­ing in­vestors such as Avoro Cap­i­tal, Acorn Cap­i­tal Ad­vi­sors, Alerce Med­ical Tech­nol­o­gy Part­ners, Acu­ta Cap­i­tal Part­ners and KVP Cap­i­tal.

An SEC fil­ing not­ed that cer­tain undis­closed “ex­ec­u­tive of­fi­cers and se­nior man­age­ment of the Com­pa­ny” al­so joined in on the place­ment, pur­chas­ing around $750,000 in se­cu­ri­ties be­tween the ex­ecs. Aa­di’s board of di­rec­tors and its au­dit com­mit­tee were said to be made aware of the pur­chas­es by the ex­ecs, which the SEC fil­ing said was ap­proved by both the board and au­dit com­mit­tee.

“We are ex­treme­ly pleased to have the sup­port of this in­vestor group,” said Aa­di founder and CEO Neil De­sai in a state­ment. The chief ex­ec­u­tive not­ed that the funds push out Aa­di’s cash run­way a year more in­to 2025.

Per SEC doc­u­men­ta­tion, Aa­di’s Q2 re­sults said that the biotech had about $118.7 mil­lion in cash and cash equiv­a­lents at the end of the quar­ter, down from $149.0 mil­lion as of Dec. 31, 2021. At the time of the Q2 re­port, that cash was ex­pect­ed to be enough to keep Aa­di go­ing in­to 2024. Q2 rev­enue was just $3.4 mil­lion — on­ly from Fyarro sales, and Aa­di record­ed a net loss of $18.3 mil­lion.

Shares of $AA­DI went up 3% af­ter the mar­ket opened Fri­day morn­ing. Aa­di did not re­spond to queries from End­points News be­fore press time.

The FDA ap­proved Aa­di’s first drug last year, specif­i­cal­ly for pa­tients with a very rare and ag­gres­sive form of sar­co­ma that oc­curs most­ly in women. Priced at a WAC of around $468,000 a year, Fyarro was in­di­cat­ed for those with lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic ma­lig­nant perivas­cu­lar ep­ithe­lioid cell tu­mor (PECo­ma).

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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The first lab-made antibody medicine was approved in 1986 — it bound to an antigen known as CD3 on T cells and was meant to prevent kidney transplant rejection. While antibody technology improved, most antibodies were made as blocking agents, neutering clamps that attacked cells and proteins.

But then scientists got creative with their engineering. They made antibody-drug conjugates, or ADCs for short, which attached toxins or drugs to the antibodies, enabling them to kill cells. Then they made CAR-T therapies, which attached a patient’s T cell to the targeting fragment of an antibody, to destroy cancer cells.

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Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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