Alzheon hits an­oth­er dead end fund­ing its Alzheimer's pro­gram, pulls sec­ond IPO at­tempt

If at first you don’t suc­ceed… maybe it wasn’t such a good idea.

Alzheon has learned that the hard way as it with­draws its IPO for a sec­ond time, de­spite dras­ti­cal­ly down­siz­ing the of­fer­ing and ad­just­ing its goal from a Phase III piv­otal study to a Phase IIb for its lead drug.

Mar­tin To­lar

That wasn’t enough to woo in­vestors in­to back­ing its ul­tra-risky project of turn­ing a once-failed drug for Alzheimer’s, at a time the hu­mil­i­at­ing flop at Ax­o­vant — which es­sen­tial­ly pur­sued the same strat­e­gy — still haunts its stock.

It doesn’t help Alzheon’s odds that its pur­su­ing the amy­loid be­ta hy­poth­e­sis, which has de­feat­ed every drug thrown at it so far in a piv­otal study. Hav­ing li­censed the drug, now dubbed ALZ-801, from Mon­tre­al-based Bel­lus Health (for­mer­ly Neu­rochem) back in 2013, Alzheon made some tweaks to the once-dai­ly pill that the com­pa­ny hopes will get the drug to its tar­get more quick­ly while re­duc­ing side ef­fects in the gut.

Back in 2016, Alzheon’s CEO Mar­tin To­lar told End­points News the com­pa­ny would need more like $100 mil­lion to pay for two Phase III stud­ies for the lead drug — sub­stan­tial­ly less than what oth­er late-stage Alzheimer’s pro­grams would cost, he ar­gued, be­cause it’s tar­get­ing “pa­tients known to have risk fac­tors for amy­loid pathol­o­gy.” Un­der that plan, for­mu­lat­ed based on a post doc analy­sis, Alzheon would on­ly need to re­cruit 500 pa­tients each for its two Phase III tri­als, fo­cus­ing on a ge­net­i­cal­ly-de­fined AD pop­u­la­tion of APOE4/4 ho­mozy­gotes.

It first filed for an $80 mil­lion IPO in March 2018, on­ly to step back from it a month lat­er. The sec­ond at­tempt was launched in last Au­gust, eye­ing $30 mil­lion in pro­ceeds. At that point, ac­cord­ing to the S-1, it was run­ning on a lit­tle more than $3 mil­lion in cash and cash equiv­a­lents.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.