Moderna: A Firm “In Want of a Hail Mary”

Earlier than COVID-19, Moderna was in peril of hemorrhaging buyers, as persistent security considerations and different doubts about its mRNA supply system threatened its complete product pipeline. Concern attributable to the pandemic disaster made these considerations largely evaporate, although there isn’t a proof that they have been ever resolved.

These analyzing the COVID-19 disaster and its results have largely centered on how its disruptive nature has led to main shifts and recalibrations all through society and the financial system. Such disruption has additionally lent itself to quite a lot of agendas that had required an occasion of “reset” potential as a way to be realized.

Within the case of the vaccine trade, COVID-19 has led to dramatic adjustments in how federal businesses handle the approval of medical countermeasures throughout a declared disaster, how trials for vaccine candidates are carried out, how the general public perceives vaccination, and even how the time period “vaccine” is outlined.

Such shifts, although apparent, have provoked reward from some and sharp criticism from others, with the latter class being largely censored from public discourse on tv, in print, and on-line. Nonetheless, in objectively analyzing such seismic adjustments, it is clear that the majority of those shifts in vaccine growth and vaccine coverage dramatically favor pace and the implementation of recent and experimental know-how on the expense of security and thorough examine.

Within the case of vaccines, it may be argued that nobody benefitted extra from these adjustments than the builders of the COVID-19 vaccines themselves, notably the pharmaceutical and biotechnology firm Moderna.

Not solely did the COVID-19 disaster obliterate hurdles that had beforehand prevented Moderna from taking a single product to market, it additionally dramatically reversed the corporate’s fortunes. Certainly, from 2016 proper up till the emergence of COVID-19, Moderna may barely maintain it collectively, because it was shedding key executives, prime expertise, and main buyers at an alarming price.

Basically, Moderna’s promise of “revolutionizing” medication and the exceptional salesmanship and fund-raising capabilities of the corporate’s prime government, Stéphane Bancel, have been the primary forces holding it afloat.

Within the years main as much as the COVID-19 disaster, Moderna’s guarantees — regardless of Bancel’s efforts — rang more and more hole, as the corporate’s long-standing penchant for excessive secrecy meant that — regardless of practically a decade in enterprise — it had by no means been capable of definitively show that it may ship the “revolution” it had frequently assured buyers was proper across the nook.

This was compounded by main points with patents held by a hostile competitor that threatened Moderna’s potential to show a revenue on something it’d handle to take to market, in addition to main points with its mRNA supply system that led them to desert any remedy that might require multiple dose due to toxicity considerations.

The latter subject, although largely forgotten and/or ignored by media at present, ought to be a serious subject within the COVID-19 booster debate, given that there’s nonetheless no proof that Moderna ever resolved the toxicity subject that arose in multi-dose merchandise.

On this first installment of a two-part collection, the dire scenario during which Moderna discovered itself instantly previous to the emergence of COVID-19 is mentioned intimately, revealing that Moderna — very very similar to the now disgraced firm Theranos — had lengthy been a home of playing cards with sky-high valuations fully disconnected from actuality.

Half 2 will discover how that actuality would have come crashing down someday in 2020 or 2021 have been it not for the appearance of the COVID-19 disaster and Moderna’s subsequent partnership with the US authorities and the extremely uncommon processes involving its vaccine’s growth and approval.

Regardless of the emergence of real-world knowledge difficult the claims that Moderna’s COVID-19 vaccine is secure and efficient, Moderna’s booster is being rushed by means of by some governments, whereas others have just lately banned the vaccine’s use in younger adults and teenagers attributable to security considerations.

As this two-part collection will present, security considerations about Moderna have been identified properly earlier than the COVID disaster, but they’ve been ignored by well being authorities and the media through the disaster itself. As well as, as a way to stave off collapse, Moderna should maintain promoting its COVID-19 vaccine for years to come back. In different phrases, with out the approval of its booster, which has induced nice controversy even amongst the nation’s prime vaccine officers, Moderna faces a large monetary reckoning.

Whereas the COVID-19 disaster threw the corporate a lifeboat, the administration of its COVID-19 vaccine, during which the US authorities has now invested practically $6 billion, should proceed into the foreseeable future for the bailout to be actually profitable. In any other case, an organization now value $126.7 billion, with main investments from the US authorities, US navy, and ties to the world’s wealthiest people, will crumble in brief order.

A New Theranos?

In September 2016, Damian Garde, the nationwide biotech reporter for the medical media firm STAT, wrote a prolonged exposé of the “ego, ambition, and turmoil” plaguing “considered one of biotech’s most secretive startups.” The article centered on the corporate Moderna, which had been based in 2010 to commercialize the analysis of Boston Youngsters’s Hospital cell biologist Derrick Rossi.

The trouble to show a revenue by creating Moderna, which intimately concerned controversial scientist and shut Invoice Gates affiliate Bob Langer in addition to Cambridge, Massachusetts–primarily based Flagship Ventures (now Flagship Pioneering), started quickly after Rossi revealed a report on the power of modified RNA to show pores and skin cells into several types of tissue.

Between the time of Moderna’s founding and Garde’s 2016 investigation, the excitement round Rossi’s analysis and its potential to create medical breakthroughs had waned, as had the excitement round its potential to make its buyers very rich.

Regardless of teaming up with pharmaceutical giants like AstraZeneca and elevating file quantities of funding, Moderna nonetheless had no product available on the market six years after its founding, and, as STAT revealed, the “firm’s caustic work atmosphere” had led to a persistent hemorrhaging of prime expertise, although little of its inner conflicts was publicly identified attributable to “its obsession with secrecy.”

Most troubling for the corporate that yr, nonetheless, was that Moderna appeared to have “run into roadblocks with its most bold initiatives.”

moderna ceo stephane bancel
Moderna CEO Stéphane Bancel

Apart from the scientific obstacles that Moderna had encountered, one main “roadblock” for the corporate, per Garde, was none aside from Stéphane Bancel, Moderna’s prime government, who nonetheless heads the corporate. In line with Garde, Bancel was squarely on the middle of lots of the firm’s controversies due, partly, to his “unwavering perception that Moderna’s science will work — and that workers who do not ‘stay the mission’ haven’t any place within the firm.”

Between 2012 and 2016, Bancel was allegedly a key issue within the resignation of no less than a dozen “extremely positioned executives,” together with those that directed Moderna’s product pipeline in addition to its vaccine initiatives.

Bancel, previous to becoming a member of Moderna, had spent a lot of his profession in gross sales and operations, not science, making a reputation for himself at pharmaceutical large Eli Lilly earlier than heading a French diagnostics agency referred to as bioMérieux. His efficiency there, in addition to his ambition, caught the eye of Flagship Ventures, a Moderna cofounder and prime investor, which then related him with the corporate he would go on to guide.

Though missing a background in mRNA and the science behind its use as a therapeutic, Bancel has made up for it by changing into Moderna’s salesman par excellence. Underneath his management, Moderna grew to become “loath to publish its work in Science or Nature, however enthusiastic to herald its potential on CNBC and CNN.”

In different phrases, beneath Bancel, the corporate got here to advertise its science by means of media publicity and public relations moderately than by publishing precise knowledge or scientific proof. When two of its vaccine candidates entered section 1 human trials in 2016 (trials that finally went nowhere), the corporate declined to record them on the general public federal registry

The choice to not record, which deviates from frequent observe by Moderna’s opponents and different extra conventional vaccine firms, meant that the data on the security of those vaccine candidates would seemingly by no means be publicly accessible after the trial’s conclusion. Moderna additionally refused to publicly touch upon what ailments these vaccines have been meant to focus on.

Such secrecy grew to become commonplace at Moderna after Bancel took the helm, with the corporate having revealed no knowledge “supporting its vaunted know-how” by the point STAT’s 2016 exposé was revealed. Insiders in addition to buyers that had dedicated tens of millions to the corporate have been solely granted “a peek” on the firm’s knowledge.

In line with former Moderna scientists who spoke to STAT, the corporate was “a case of the emperor’s new garments.” Former workers additional charged that Bancel was truly “working an funding agency” and “then hop[ing] it additionally develops a drug that is profitable.”

Maybe because of this Bancel was deemed the perfect government to steer Moderna. As an bold salesman working a extremely overvalued firm, he would prioritize the corporate’s picture and its funds no matter any points with the science underpinning all of it. Maybe it was for that cause that Bancel, per former workers, “made it clear [from the beginning] that Moderna’s science merely needed to work. And that anybody who could not make it work did not belong.”

As STAT famous in 2016, the individuals who have been tasked with making “the science work” have been those that most steadily resigned, which led to Moderna shedding two heads of chemistry inside a single yr, adopted shortly by shedding its chief scientific officer and its head of producing. Many prime executives, together with the heads of its most cancers analysis and uncommon illness analysis branches, ended up lasting fewer than eighteen months of their respective positions.

The abrupt resignations weren’t unique to Moderna’s science-focused government positions both, because the chief info officer and prime monetary government function have been additionally affected. Bancel finally sought recommendation from the human sources departments of Fb, Google, and Netflix on worker retention.

Notably telling was the abrupt and mysterious resignation of Moderna’s head of analysis and growth, Joseph Bolen, after about two years on the firm. An organization insider on the time instructed STAT that the one cause Bolen would have resigned was if “there was one thing improper with the science or the personnel.”

In different phrases, Bolen both left as a result of the science underpinning Moderna’s large valuation didn’t stay as much as the hype or Bancel had compelled him out, with the extra chance that each have been key in Bolen’s resignation.

Hypothesis on the time pointed the finger at Bancel, although it isn’t clear why the rift between the 2 males emerged. Bancel asserted that he tried to persuade Bolen to remain, although there have been contrasting assertions from nameless workers, and that Bolen had “voted himself off the island.”

Regardless of the precise reason behind the resignation of the top of R & D, it solely added to the mystique round Moderna’s inside workings and its potential to ship on its promise to “revolutionize” medication. It additionally reveals quite a lot of similarities between Moderna and the now-disgraced firm Theranos.

Theranos, whose former prime government, Elizabeth Holmes, is now on trial for fraud, was identified for its excessive tradition of secrecy that saved buyers and enterprise companions at the hours of darkness, compelled nondisclosure agreements on everybody who got here in touch with the corporate, and saved workers “siloed” by means of an especially strict need-to-know coverage.

Like Moderna, Theranos had been praised as revolutionary and poised to “change the medical trade endlessly.” Equally, its prime government had no skilled health-care or science expertise, but each fired or compelled the resignations of workers who disagreed with their perspective or have been unable to supply “optimistic” outcomes.

Each firms additionally did not publish any proof in peer-reviewed journals that the science behind their multibillion-dollar valued firms was extra than simply fantasy and a well-devised gross sales pitch.

Arguably, probably the most vital distinction between Moderna and Theranos is that Moderna, whose quite a few points and challenges solely got here to mild after the collapse of Theranos had begun, has by no means confronted the identical diploma of scrutiny from the US authorities or mainstream investigative journalists.

There are lots of potential causes for this, together with Moderna’s shut relationship with the US Division of Protection by means of the Protection Superior Analysis Tasks Company (DARPA), or concern that its publicity post-Theranos would deliver scrutiny to any firm current on the intersection of Silicon Valley and the health-care trade.

Nonetheless, such a reckoning would seemingly have been inevitable for Moderna had it not been for the COVID-19 disaster, which couldn’t have come at a extra handy time for the corporate.

Moderna’s “Software program” Encounters Bugs

Most of the issues with Moderna that Garde recognized in 2016 continued to plague the corporate proper up till the start of the COVID-19 disaster. Chief amongst these was Moderna’s wrestle to show that its know-how labored and that it was secure.

Issues in regards to the security and efficacy of the corporate’s merchandise, which have been publicly reported starting in 2017, evaporated within the wave of panic surrounding COVID-19 and the simultaneous “Warp Pace” race for a vaccine that might “finish the pandemic.”

But, there may be little, if any, proof that these once-well-recognized considerations have been addressed previous to the US authorities’s emergency use authorization of Moderna’s COVID-19 vaccine and its now widespread use in lots of nations all over the world. On the contrary, there may be proof that these considerations have been lined up each previous to and through the growth of its vaccine.

moderna office in cambridge massachusetts
Moderna’s workplace in Cambridge, Massachusetts

The stories that emerged in January 2017 famous that Moderna had “run into troubling security issues with its most bold remedy” and that the corporate was “now banking on a mysterious new know-how to maintain afloat.”

The “bold remedy” in query was meant to deal with Crigler-Najjar syndrome and “was to be the primary remedy utilizing audacious new know-how that Bancel promised would yield dozens of medication within the coming decade.” Bancel had particularly used the Crigler-Najjar remedy as a serious promoting level to buyers, notably in 2016 when he touted it on the JP Morgan Healthcare Convention.

But, workers of Alexion, the corporate co-developing the drug with Moderna, blew the whistle on the undertaking in 2017, revealing that it “by no means proved secure sufficient to check in people” and that the failure of this remedy and the know-how platform it sought to make use of had been answerable for prompting Moderna to desert the category of drug therapies that, for years, had justified its sky-high valuation and attracted a whole bunch of tens of millions in investor money.

Because of the issue with the Crigler-Najjar drug, media retailers asserted that Moderna was now “in want of a Hail Mary” that might maintain its valuation from imploding and its buyers from fleeing. The persistence of issues first famous within the 2016 STAT investigation, akin to Moderna’s failure to publish significant knowledge supporting its mRNA know-how, have been solely exacerbating the corporate’s more and more precarious place.

Certainly, not lengthy earlier than the indefinite delay of the Crigler-Najjar remedy, Bancel had dismissed questions on Moderna’s promise by portray mRNA as a straightforward approach to shortly develop novel therapies for quite a lot of ailments. He said that “mRNA is like software program: You possibly can simply flip the crank and get loads of merchandise going into growth.”

If that have been the case, why did the corporate haven’t any merchandise available on the market after practically seven years, and why had its most touted undertaking skilled such obstacles? Clearly, in line with Bancel’s “software program” metaphor, Moderna’s know-how had encountered bugs, bugs that have been doubtlessly ineradicable.

It seems that the Crigler-Najjar drug remedy that Moderna had guess on so closely had failed due to the lipid nanoparticle supply system it used to move mRNA into cells. Crigler-Najjar had been chosen as a goal situation as a result of Moderna scientists deemed it to be “the lowest-hanging fruit.”

First, the syndrome is attributable to one particular genetic defect; second, the affected organ, the liver, is among the many best to focus on with nanoparticles; and third and most essential for the corporate, treating the illness with mRNA would require frequent doses, guaranteeing a gradual stream of revenue for the corporate.

Thus, given the primary two motives behind the corporate’s give attention to Crigler-Najjar, if Moderna could not develop a remedy for that situation, it meant they would not be capable to develop a remedy for different situations that, for instance, have been attributable to a number of genetic defects or affected a number of organs or these extra immune to nanoparticle-based therapies.

In different phrases, that “Moderna couldn’t make its remedy [for Crigler-Najjar] work” meant that it was unlikely to make therapies of that complete class work both.

Certainly, media stories on the indefinite delay of this specific remedy famous that “the indefinite delay on the [Moderna] Crigler-Najjar undertaking alerts persistent and troubling security considerations for any mRNA remedy that must be delivered in a number of doses.”

This subject would quickly lead Moderna to solely pursue therapies that might be delivered as a single dose — that’s, till the emergence of COVID-19 and the appearance of the COVID-19 vaccine booster debate. It’s also value mentioning that, as a result of excessive rarity of Crigler-Najjar syndrome, even when the remedy had been efficiently taken to market by Moderna, it might have been unlikely to herald sufficient cash to maintain the corporate.

The precise drawback Moderna encountered with the Crigler-Najjar remedy was associated to the lipid nanoparticle supply system it was utilizing. In line with former Moderna workers and their collaborators at Alexion, “The secure dose was too weak, and repeat injections of a dose robust sufficient to be efficient had troubling results on the liver [the target organ of this particular therapy] in animal research.”

This was a problem Moderna had apparently run into with its nanoparticle supply system in different instances too, in keeping with stories revealed on the time. Per STAT, the supply system employed by Moderna had persistently “created a frightening problem: Dose too little, and you aren’t getting sufficient enzyme to have an effect on the illness; dose an excessive amount of, and the drug is just too poisonous for sufferers.”

Moderna tried to offset the unhealthy press over having to delay the Crigler-Najjar drug with claims that that they had developed a brand new nanoparticle supply system referred to as V1GL that “will extra safely ship mRNA.” The claims got here a month after Bancel had touted one other supply system referred to as N1GL to Forbes.

In that interview, Bancel instructed Forbes that the supply system that they had been utilizing, licensed to them by Acuitas, “was not excellent” and that Moderna had “stopped utilizing Acuitas tech for brand spanking new medication.” Nonetheless, as can be explored intimately on this report in addition to Half II of this collection, it seems that Moderna continued to depend on the Acuitas-licensed know-how in subsequent vaccines and different initiatives, together with its COVID-19 vaccine.

Former Moderna workers and people near their product growth have been uncertain on the time that these new and supposedly safer nanoparticle supply programs have been of any consequence. In line with three former workers and collaborators near the method who spoke anonymously to STAT, Moderna had lengthy been “toiling away on new supply applied sciences in hopes of hitting on one thing safer than what it had.”

All of these interviewed believed that “N1GL and V1GL are both very current discoveries, simply within the earliest levels of testing — or else new names slapped on applied sciences Moderna has owned for years.” All spoke anonymously attributable to having signed nondisclosure agreements with the corporate, agreements which can be aggressively enforced.

One former worker, commenting on the alleged promise of N1GL and V1GL, said that these platforms “must be a miraculous, Hail Mary type of save for them to get to the place they must be on their timelines … Both [Bancel] is extraordinarily assured that it’ll work, or he is getting type of jittery that, with an absence of progress, he must put one thing on the market.”

stephen hoge melissa moore
Stephen Hoge, Moderna’s president, and Melissa Moore, Moderna’s CSO for Platform Analysis Supply: Moderna

Plainly these former workers who believed that N1GL and V1GL have been new names placed on current know-how and that Bancel was overselling their promise have been appropriate, as Moderna seems to have returned to the troubled lipid nanoparticle supply system it had licensed from Acuitas for subsequent therapies, together with its COVID-19 vaccine.

As can be explored on this report and Half II of this collection, there isn’t a proof that Moderna ever bought their “Hail Mary” save when it got here to buying the rights for or creating a secure mRNA supply system.

On prime of the much-touted guarantees of N1GL and V1GL as safer therapies, Moderna moreover vowed to create “new and higher formulations” for the Crigler-Najjar remedy that might doubtlessly make it to human trials at a later time. This helped to stave off extra unhealthy press, however just for just a few weeks.

One month after the troubles with the Crigler-Najjar remedy have been publicly reported, the top of Moderna’s oncology division, Stephen Kesley, left the corporate. This was simply as Moderna was shifting towards its first human trials for its most cancers remedy, which compelled “a senior management group with little expertise in creating medication to type out the corporate’s future within the area.”

Simply weeks earlier than Kesley’s departure, Bancel had boldly claimed in a bid to woo new buyers on the JP Morgan Healthcare Convention, held in January 2017 in San Francisco, that oncology was Moderna’s “subsequent massive alternative after vaccines.”

The identical month as Kesley’s departure, Moderna was in a position to attract media consideration elsewhere, as for the very first time they revealed knowledge in a peer-reviewed journal. In Cell, its scientists revealed knowledge on an animal trial for its Zika vaccine candidate that positively demonstrated each efficacy and security in mice.

Whereas animal trial outcomes don’t essentially translate into equal leads to people, the outcomes have been deemed to “bode properly” for Moderna’s deliberate medical trial of that vaccine candidate in people. As well as, the outcomes have been just like the animal trial outcomes revealed by Moderna competitor BioNTech for his or her mRNA vaccine candidate for Zika a month earlier.

Nonetheless, for Moderna, the optimistic information was muted by a detrimental ruling on a authorized dispute that threatened Moderna’s potential to ever flip a revenue on the Zika vaccine or some other mRNA vaccine it developed, a menace that Moderna’s opponents, akin to BioNTech, did not need to cope with.

That ruling, mentioned in better element later on this report, significantly restricted Moderna’s use of the lipid nanoparticle supply system licensed to it by means of Acuitas and instantly threatened the corporate’s potential to create a for-profit product utilizing mental property tied to the related patents.

It could additionally kick off a years-long authorized dispute that has steered at varied occasions that the guarantees of V1GL and N1GL have been both fully invented or significantly exaggerated, as former Moderna workers and collaborators had said.

Not lengthy afterward, in July 2017, Moderna was hit with yet one more wave of unhealthy press as their accomplice within the Crigler-Najjar enterprise, Alexion, reduce ties with the corporate fully. Moderna downplayed Alexion’s choice and claimed it had acquired “intensive information” that might permit it to proceed to develop the troubled remedy by itself.

Nonetheless, Alexion’s choice got here at an inopportune time for the corporate, as considered one of Moderna’s prime buyers had simply two weeks earlier slashed its valuation of the corporate by virtually $2 billion, allegedly as a result of Moderna had “struggled to stay as much as its personal hype.” Studies started to flow into claiming that “Moderna’s buyers may be shedding religion within the firm’s future.”

Certainly, the Crigler-Najjar syndrome drug was not the one one which, at that time, had confirmed “too weak or too harmful to check in medical trials,” in keeping with former workers and companions.

The persistent subject, which once more lay with the nanoparticle supply system Moderna had licensed from Acuitas, had compelled the corporate, starting with the delay of the Crigler-Najjar remedy, to “prioritize vaccines, which might be dosed simply as soon as and thus keep away from the security issues which have plagued extra bold initiatives.”

But, these single-dose “vaccines” or therapies have been thought-about not as profitable because the drug therapies Moderna had lengthy promised and that underpinned its multibillion-dollar valuation, thereby forcing the corporate to “guess massive on a loss-leader.” Additionally problematic was that Moderna lagged behind its mRNA vaccine opponents and that the supposed promise of its know-how to supply viable vaccines was solely “confirmed” at that time by a single, small trial.

That trial, as famous by the Boston Enterprise Journal, was an “early-stage human trial that was primarily meant to evaluate the security of an avian flu vaccine.” Moderna had claimed, regardless of the trial being designed to evaluate security, that it had “offered proof that the vaccine is efficient, with no main negative effects” as properly.

Moreover, as can be mentioned in a later part of this report, the authorized dispute over the Acuitas-licensed lipid nanoparticle system threatened Moderna’s potential to ever activate a revenue on any mRNA vaccine it managed to get by means of trials and the federal approval course of, making the corporate’s future seem fairly grim.

Regardless of Optimistic Press, Lingering Questions Remained

In September 2017, at a closed-door investor occasion meant to stop extra main buyers from devaluing the corporate or leaping ship, Moderna offered extra perception into a just lately revealed press launch on the trial outcomes of a remedy meant to regrow coronary heart tissue by boosting manufacturing of a protein often known as VEGF.

The press launch, which generated optimistic media headlines, famous that the remedy had been confirmed secure in a examine with a pattern measurement of 44 sufferers. Nonetheless, neither the press launch nor the info Moderna disclosed to buyers on the closed-door assembly revealed how a lot protein the remedy induced sufferers to supply, leaving its efficacy a thriller.

Certainly, media stories on the investor assembly famous that “since Moderna didn’t launch that essential knowledge level, outsiders cannot choose how a lot therapeutic potential there could also be.”

The outcomes, although they appeared to mitigate the considerations over the security of Moderna’s know-how, did not encourage confidence in lots of attendees. A number of attendees later instructed reporters that they “weren’t overly impressed” with Moderna’s presentation, which solely “underlined lingering questions on whether or not it could possibly stay as much as its personal hype.”

One of many points right here, but once more, is that Moderna’s valuation was and is underpinned by its promise to supply merchandise for uncommon ailments that require repeated injections over a affected person’s lifetime. The VEGF remedy promoted by Moderna at this assembly was meant to be a one-time-only injection, and, thus, proof of its security didn’t resolve the issue of none of Moderna’s multi-dose merchandise having confirmed secure sufficient to check on people.

The closed-door investor occasion made it clear that Moderna was aiming to keep away from that persistent drawback by prioritizing single-dose vaccines. As STAT famous on the time:

“The presentation to buyers additionally made clear that Moderna is prioritizing vaccines. They’re simpler to develop from mRNA as a result of sufferers want only one dose, which eliminates among the issues of safety which have plagued extra bold initiatives akin to therapies for uncommon ailments.”

The pivot to vaccines remained a sore level with many buyers, nonetheless, as vaccines are seen as “low-margin product[s] that may’t generate wherever close to the earnings seen in additional profitable fields like uncommon ailments and oncology.” These, as beforehand talked about, are the very fields on which Moderna’s large valuation had been primarily based however for which it had been unable to supply secure and efficient therapies.

Moderna was clearly conscious of those considerations amongst its present and potential investor base and tried to talk promisingly of its oncology-related efforts at this similar occasion. Nonetheless, it was silent on trial timing and different key knowledge factors, sustaining the corporate’s long-standing popularity for secrecy in the direction of each insiders and most people.

It’s definitely telling that Moderna remained so secretive about key knowledge at an occasion not solely closed to the general public and the press, however meant to reassure current buyers and to entice new ones. If Moderna declined to indicate essential knowledge to buyers at a time when it was desperately searching for to maintain them onboard, it implies that the corporate both had one thing to cover or nothing to indicate.

Moderna’s more and more troubled inner scenario, regardless of its persistently rosy PR, escalated a month later when stories emerged of the abrupt resignations of its head of chemistry, the chief of its cardiovascular division, and the top of its uncommon ailments division. These resignations, which occurred towards the tip of 2017, adopted the high-profile resignations the corporate suffered that have been talked about within the 2016 STAT exposé by Damian Garde.

A couple of months later, in March 2018, the chief scientific officer of Moderna’s vaccine enterprise, Giuseppe Ciaramella, additionally left.

This resignation signaled additional inner troubles on the firm, much more as a result of Moderna had just lately and really publicly pivoted to vaccines; and Ciaramella, along with main vaccine growth at this vital juncture, had been the primary Moderna government to counsel that the corporate’s know-how might be helpful in creating vaccines, a suggestion that the corporate was now betting the whole lot on.

One can not help however marvel if Bancel’s tendency to power out workers and executives who “could not make the science work” was a consider any of those high-profile resignations, together with that of Ciaramella.

A Years-Lengthy Authorized Snafu

Up to now, this report has largely centered on how Moderna’s excessive secrecy seems to have been used to obfuscate and mitigate main points with its know-how and product pipeline and the way these points have been reaching a climax following the corporate’s IPO and instantly previous to the COVID disaster.

Nonetheless, the problem of making merchandise that work and might be confirmed to work in medical settings is however considered one of no less than two main points dealing with Moderna as an organization. Certainly, throughout the identical timetable explored above, Moderna was embroiled in aggressive disputes associated to mental property and patents.

Notably, these similar authorized points cope with the lipid nanoparticle system that was additionally reportedly on the root of Moderna’s security and product-pipeline points.

As talked about earlier, the lipid nanoparticle supply system utilized in many Moderna therapies was licensed to them by Acuitas. Acuitas, nonetheless, had licensed that system from a separate firm, Arbutus, which sued in 2016 claiming that Acuitas’s sublicense to Moderna was unlawful. Arbutus received the case, which result in a short lived injunction in 2017 that stopped Acuitas from additional sublicensing the lipid nanoparticle know-how.

A settlement reached between Acuitas and Arbutus in 2018 terminated Acuitas’s license and restricted Moderna’s use of the know-how to 4 vaccine candidates that focused already recognized viruses.

Moderna’s Bancel instructed Forbes in 2017 that the Acuitas/Arbutus system was barely mediocre and that Moderna was creating its personal improved supply system that might not infringe on Arbutus’s mental property (the aforementioned N1GL and V1GL programs).

Nonetheless, quickly after Bancel made these claims, Arbutus’s management challenged them, stating that the corporate had reviewed all of Moderna’s patents, publications, and shows relating to these “new” supply programs and had discovered nothing that did not contain their very own mental property.

Even former Moderna workers, as talked about beforehand, have been very uncertain that N1GL and V1GL have been any totally different than the Acuitas/Arbutus system, that means that — regardless of Bancel’s claims — Moderna had unresolved authorized woes associated to those nanoparticles that, together with the toxicity points, was stalling Moderna product candidates.

You will need to notice at this level that, whereas solely Moderna has been locked in a authorized battle with Acuitas/Arbutus for years over LNP mental property, the opposite essential producers of mRNA COVID-19 vaccines, Pfizer/BioNTech and CureVac, additionally use main features of the identical Arbutus-derived know-how. Nonetheless, BioNTech licensed the LNPs in such a manner as to keep away from the problems which have entangled Moderna for years.

Moderna’s authorized dispute, along with the already mentioned issues of safety, significantly threatened Moderna’s potential to outlive as an organization. Having already been compelled to choose the vaccines market and reject the extra profitable and “revolutionary” mRNA therapies it had lengthy promised, Moderna was steadily shifting towards a place the place it had “no proper to promote” vaccine merchandise that relied on the Arbutus-patented and Acuitas-sublicensed know-how.

This example has positioned strain on Moderna to barter a brand new license with Arbutus instantly, negotiations during which the corporate would have little or no leverage.

For the reason that first authorized case in 2016, Moderna and Arbutus have remained locked in disputes in regards to the nanoparticles and who owns them. Moderna challenged three Arbutus patents with the US Patent and Trademark Workplace, with blended outcomes.

But, concurrently, Moderna additionally claimed that its tech was “not lined by the Arbutus patents,” which prompted quite a few observers and reporters to ask questions akin to — “In that case, why did [Moderna] provoke the authorized motion towards Arbutus to start with?”

Moderna answered that question by claiming that it focused Arbutus solely due to Arbutus’s previous “aggression” towards them. Nonetheless, regardless of such claims, the trouble and price inherent within the authorized problem reveals that, on the very least, Moderna takes the specter of Arbutus’s mental property claims very critically.

The precise reply appears to lie in Moderna being keen to publicly declare that their LNP know-how is totally different sufficient from the Arbutus-derived system lined by the patents however unwilling to launch any proof — whether or not in court docket, to its personal buyers, or to the general public — that it’s the truth is totally different. The newer twists and turns of this protracted authorized battle, together with a pivotal 2020 choice that was very unfavorable for Moderna, are mentioned in Half II of this collection.

Something to Assist a Slumping Inventory Worth

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Nasdaq constructing on the day of Moderna’s 2018 IPO. Supply: Nasdaq

Simply earlier to Ciaramella’s resignation, Moderna had claimed to have “solved the scientific points that made its earlier mRNA therapies too poisonous for medical trials,” in keeping with media stories. These stories additionally claimed that, consequently, “Moderna believes it has steered again heading in the right direction,” although the corporate didn’t present proof to assist that declare.

Nonetheless, the promise allowed the corporate to finish a brand new spherical of financing, throughout which it raised an extra $500 million from “an investor syndicate unusual in biotech” that included the governments of Singapore and the United Arab Emirates.

Some observers have been puzzled as to how Moderna had managed to lift a lot cash regardless of the excellent questions in regards to the science underpinning its excessive valuation.

The reply got here with the publication of Moderna’s confidential investor slide deck by STAT’s Damian Garde, which confirmed that the corporate had predicted that medication that that they had solely been examined in mice would quickly be value billions and that its vaccine income would quantity to $15 billion yearly.

The slide deck, deemed “fairly absurd” and “geared at hopeful generalists that may dream massive” per one skeptical investor, made it clear why the corporate’s final funding spherical had appealed to “unconventional” biotech buyers moderately than veteran buyers centered on the trade.

A veteran biotech investor, who spoke anonymously as a result of slide deck’s confidentiality, said that “it is a deck designed to inform the ‘we will be large’ story to a gaggle of moderately unsophisticated buyers — and it does that superbly … Simply sufficient science and platform stuff to convey the ‘We all know what we’re doing’ sentiment, however not sufficient to engender technical questions.”

Per those that sat by means of Moderna’s pitch, the corporate was “very beneficiant on the market-size assumptions for his or her packages,” with one former Moderna collaborator putting the real-world worth of a remedy the corporate had claimed was value billions yearly at nearer to “$100 million to 250 million.”

In fact, that income estimate comes with the caveat that the remedy, examined to this point solely in mice, would sometime show to work in people. A former Moderna worker in its uncommon ailments division said on the time that Moderna “proceed[s] to hurry ahead and over-promise the potential for broad use of mRNA previous to any proof past vaccines or very early experiments in mice.”

Regardless of Moderna’s potential to persuade “unsophisticated” and/or “unconventional” buyers to again its early 2018 funding spherical, it seems that considered one of its most essential guarantees used to draw buyers — that it had solved the nanolipid particle toxicity subject — was not true.

In a submitting with the Securities and Trade Fee dated November 2018, months after Moderna had claimed to have fastened the problems with its lipid nanoparticle supply system, the corporate made a number of claims that seem to contradict its purported growth of a brand new, safer nanoparticle know-how. For instance, the submitting states on web page 33:

Most of our investigational medicines are formulated and administered in an LNP [lipid nanoparticle] which can result in systemic negative effects associated to the parts of the LNP which can not have ever been examined in people. Whereas we now have continued to optimize our LNPs, there might be no assurance that our LNPs is not going to have undesired results.

Our LNPs may contribute, in entire or partly, to a number of of the next: immune reactions, infusion reactions, complement reactions, opsonation [sic] reactions, antibody reactions together with IgA, IgM, IgE or IgG or some mixture thereof, or reactions to the PEG from some lipids or PEG in any other case related to the LNP.

Sure features of our investigational medicines could induce immune reactions from both the mRNA or the lipid in addition to opposed reactions inside liver pathways or degradation of the mRNA or the LNP, any of which may result in vital opposed occasions in a number of of our medical trials. A lot of all these negative effects have been seen for legacy LNPs.

There could also be ensuing uncertainty as to the underlying reason behind any such opposed occasion, which might make it tough to precisely predict negative effects in future medical trials and would end in vital delays in our packages. (emphasis added)

Based mostly on these statements, Moderna gave the impression to be unsure as as to whether its present lipid nanoparticle supply system was any safer than that which led to the indefinite delay of its Crigler-Najjar remedy. As well as, the reference to “opposed reactions inside liver pathways,” one of many essential points that triggered the precise delay of the Crigler-Najjar remedy, suggests a continued reliance on know-how sublicensed from Acuitas.

As can be famous in Half II, the Moderna COVID-19 vaccine additionally seems to make use of the controversial Acuitas know-how that had prompted vital security, authorized, and monetary considerations for Moderna for years.

The November 2018 SEC submitting makes different statements relating to its supposedly fastened lipid nanoparticle supply system which can be value noting:

If vital opposed occasions or different negative effects are noticed in any of our present or future medical trials, we could have issue recruiting trial members to any of our medical trials, trial members could withdraw from trials, or we could also be required to desert the trials or our growth efforts of a number of growth candidates or investigational medicines altogether …

Even when the negative effects don’t preclude the drug from acquiring or sustaining advertising and marketing approval, unfavorable profit threat ratio could inhibit market acceptance of the accredited product attributable to its tolerability versus different therapies. Any of those developments may materially hurt our enterprise, monetary situation, and prospects.

These statements are vital in that they freely counsel no less than one cause for Moderna’s long-standing tendency towards secrecy in publishing knowledge about its therapies, as public information of its know-how’s persistent challenges would threaten its potential to draw trial members, buyers, and, later, customers.

A few month after these troubling admissions have been made in fantastic print, Moderna succeeded in pulling off a record-setting preliminary public providing (IPO) in December 2018. For that IPO, Moderna had retained the companies of 11 funding banks, which is reportedly round “twice the quantity usually seen in biotech choices.”

Nonetheless, its inventory worth tumbled simply hours afterward, “an indication the corporate and its underwriters may need over-estimated demand for the richly valued firm.”

A month after the IPO, Moderna’s inventory continued its downward slide, “doing precisely the alternative of what personal buyers search for in an IPO.” Those that had predicted this post-IPO consequence earlier than Moderna went public had additionally warned that this downward development would seemingly proceed by means of early 2020 if not longer.

Skeptics akin to STAT’s Damian Garde had warned proper earlier than Moderna’s IPO that that the corporate’s sliding inventory worth would seemingly proceed all through 2019 attributable to “a seeming lack of impending information,” provided that “momentum in biotech, optimistic or detrimental, is pushed by catalysts” and “Moderna is in for a reasonably quiet 2019.”

In the meantime, media stories warned, as that they had for years, that Moderna “continues to be within the early days of proving [their] know-how’s potential,” regardless of being a nine-year-old firm. Such stories additionally famous that Moderna’s lack of ability to show its know-how’s value after practically a decade in enterprise was hampered by its “struggl[e] in its preliminary efforts to show mRNA into medication that may be repeatedly dosed, main it to pivot to vaccines, which might be administered simply a few times.”

Traders on the 2019 JP Morgan health-care convention spoke of considerations that “Moderna [has] but to rule out the lingering dangers tied to mRNA, and, even at its depressed valuation, the corporate is just too costly.” Others confided in reporters that they’d be “sitting on the sidelines till Moderna both adjustments the narrative with promising human knowledge or will get considerably cheaper.”

A couple of weeks later, Moderna’s Bancel attended the World Financial Discussion board’s 2019 annual assembly alongside Johnson & Johnson government Paul Stoffels and different pharmaceutical and biotech leaders as a way to “rub elbows with world leaders and one-percenters — and speak about the way forward for healthcare.”

Different health-care figures in attendance included head of the World Well being Group, Tedros Adhanom Ghebreyesus, and “world well being philanthropist” Invoice Gates, whose basis entered into “a worldwide well being undertaking framework” with Moderna in 2016 to “advance mRNA-based growth initiatives for varied infectious ailments.”

The Invoice & Melinda Gates Basis is the one basis listed as a “strategic collaborator” on the Moderna web site. Different “strategic collaborators” embody the US authorities’s Biomedical Superior Analysis and Growth Authority (BARDA), the US navy’s DARPA, and pharmaceutical giants AstraZeneca and Merck.

Moderna first teamed up with the WEF just some years after its founding again in 2013, when it was named to the Discussion board’s neighborhood of International Progress Corporations (GGC). That yr, Moderna was considered one of simply three North American well being firms to obtain the consideration and was moreover acknowledged by the Discussion board as “an trade chief in revolutionary mRNA therapeutics.”

“We’re honored to be acknowledged for our efforts to advance our platform and guarantee its potential is realized on a worldwide scale, and we look ahead to being a member of the World Financial Discussion board neighborhood,” Bancel stated on the time.

stephane bancel at the world economic forum annual meeting
Stéphane Bancel on the World Financial Discussion board Annual Assembly, January 2020. Supply: WEF

As a WEF International Progress Firm, Moderna has intently and often engaged with the Discussion board since 2013 at each the Chinese language-hosted Annual Assembly of the New Champions and the WEF’s regional conferences, whereas additionally getting access to the WEF’s unique networking platform that gives the corporate privileged entry to the world’s strongest enterprise and authorities leaders.

Moreover, such fastidiously chosen firms are given alternatives by the Discussion board “to form world, regional and trade agendas and interact in significant exchanges about methods to proceed on a sustainable and accountable path of progress.”

Basically, the roster of such firms constitutes a consortium of firms which can be promoted and guided by the Discussion board due to their dedication to “enhancing the state of the world,” that’s, their dedication to supporting the Discussion board’s long-term agendas for the worldwide financial system and for world governance.

In April 2019, Moderna revealed some info on modifications to its lipid nanoparticles (mentioned in additional element in Half II). A month later, in Could 2019, Moderna revealed optimistic outcomes within the journal Vaccine for section 1 knowledge on mRNA vaccine candidates for “two potential pandemic influenza strains” administered as two doses three weeks aside.

The corporate’s press launch on the examine said that “future growth of Moderna’s pandemic influenza program is contingent on authorities or different grant funding,” suggesting that it might use the trial outcomes to foyer the federal government for funds for a continuation of this specific program.

Notably, concurrently these outcomes have been revealed, the US Division of Well being and Human Providers Workplace of the Assistant Secretary for Preparedness and Response, then stuffed by Robert Kadlec, was within the midst of conducting Crimson Contagion, a multimonth simulation of a worldwide pandemic involving an influenza pressure that originates in China and spreads globally by means of air journey.

The pressure on the middle of the simulation, referred to as H7N9, is without doubt one of the very strains used within the Moderna examine.

Moderna revealed these outcomes on Could 10, simply 4 days earlier than the Crimson Contagion simulation hosted its federal interagency seminar. BARDA, which the ASPR workplace oversees, is a serious strategic ally of Moderna and was co-developing these “potential pandemic influenza” vaccines which can be talked about on this well timed press launch, that’s, for H10N8 and H7N9 influenza infections.

Crimson Contagion is notable for a number of causes, most importantly for Kadlec’s personal historical past with the Darkish Winter simulations that preceded and eerily predicted the 2001 anthrax assaults. As has been mentioned intimately in a earlier TLAV – Limitless Hangout investigation, the 2001 anthrax assaults conveniently rescued anthrax vaccine producer BioPort, now Emergent Biosolutions, from sure spoil, very similar to the way in which the COVID disaster did for Moderna.

A month later, in June 2019, Moderna once more managed to generate optimistic headlines on making its debut on the American Society of Scientific Oncology annual assembly, the place it sought to advertise its potential to supply the customized most cancers therapies that had been key to wooing buyers each earlier than and after its record-setting IPO.

It was the primary time the corporate had publicly introduced knowledge on a most cancers remedy, and this specific remedy was being co-developed with Merck. The information confirmed optimistic leads to stopping relapses in most cancers sufferers whose strong tumors had been eliminated by way of surgical procedure, however the trial failed to indicate any definitive impact in most cancers sufferers whose tumors had not been eliminated.

Thus, the early knowledge appeared to point that Moderna’s remedy would solely assist most cancers sufferers keep in remission after different medical interventions had been carried out. Although the information allowed Moderna to indulge in some much-needed optimistic press and to advertise its oncology merchandise in growth, some stories rightly famous that it was “nonetheless too early for any definitive judgment” on the most cancers remedy’s medical profit.

Regardless of this obvious advance, by September 2019, Moderna’s inventory worth continued to say no, resulting in a lack of about $2 billion in market worth from the corporate’s $7.5 billion valuation on the time of its record-setting IPO.

The primary components for this have been the identical persistent issues the corporate had been dealing with for years — lack of progress, together with lack of merchandise available on the market; persistent security issues with its mRNA know-how; and the dearth of information displaying that advances have been being made to make that know-how commercially possible.

In mid-September 2019, Moderna gathered buyers collectively to showcase scientific proof it claimed would lastly show that its mRNA know-how may “flip the physique’s personal cells into medicine-making factories” and hopefully “flip skeptical buyers into believers.” This knowledge, which was derived from a really preliminary examine that concerned solely 4 wholesome members, had problems.

Three of the 4 members had negative effects that prompted Moderna to state on the assembly that they would wish to reformulate the mRNA remedy to incorporate steroids, whereas one of many members suffered heart-related negative effects, together with a speedy coronary heart price and an irregular heartbeat.

Moderna, which asserted that not one of the heart-related negative effects was critical, couldn’t “definitively pinpoint the reason for the center signs.” But, as beforehand talked about, it was seemingly associated to the security points that had been plaguing its experimental merchandise for years.

The corporate’s preliminary knowledge, which was promoted in yet one more bid to maintain buyers from leaving, additionally included the caveat that Moderna had determined to pause trials for this specific product, which was a single-injection mRNA remedy for the chikungunya virus. That remedy was being developed in partnership with the Pentagon’s DARPA.

Different extra optimistic knowledge from a preliminary trial have been additionally launched at this assembly. That trial, nonetheless, was for an mRNA remedy for cytomegalovirus, “a standard virus that’s often saved in test by the physique’s immune system and barely causes issues in wholesome folks,” that means its mRNA vaccine for that situation was unlikely to ever be profitable.

Not lengthy after this lackluster buyers assembly, on September 26, 2019, the as soon as extremely secretive Moderna introduced it might collaborate with researchers at Harvard College “in hopes that the analysis will spur new medication,” as its product pipeline appeared to have stalled.

Moderna president Stephen Hoge described the collaboration as choose Harvard researchers receiving “a package deal of stuff that we put our blood, sweat, and tears in, after which somebody’s going to do one thing with it. We’ll discover out afterward how that went.” For a corporation lengthy identified for its excessive secrecy in an already secretive trade, Moderna’s association with Harvard, which it admitted was “uncommon,” got here throughout as considerably determined.

A month later, on the 2019 Milken Institute Way forward for Well being Summit, there was a panel dialogue on common flu vaccines and the way a “disruptive” occasion could be wanted to upset the long-existing bureaucratic vaccine-approval course of to facilitate wider adoption of “nontraditional” vaccines, akin to these produced by Moderna.

Panel audio system together with former FDA commissioner Margaret Hamburg, a veteran of the 2001 Darkish Winter train and scientific advisor to the Gates basis, in addition to Anthony Fauci of the Nationwide Institutes of Well being’s Nationwide Institute of Allergy and Infectious Ailments (NIAID) and Rick Brilliant of BARDA, who beforehand labored for the Gates-funded PATH.

The panel dialogue notably happened shortly after the controversial coronavirus pandemic simulation referred to as Occasion 201, whose moderators and sponsors had been intimately concerned in 2001’s Darkish Winter.

2019 milken institute universal flu vaccine panel
Screengrab from the 2019 Milken Institute Common Flu Vaccine panel. Full video accessible right here.

Through the panel, the moderator — Michael Specter of the New Yorker — requested the query: “Why do not we blow the system up? Clearly, we simply cannot flip off the spigot on the system we now have after which say ‘Hey! everybody on the earth ought to get this new vaccine we’ve not given to anybody but,’ however there should be a way.”

Specter then talked about how vaccine manufacturing is antiquated and requested how ample “disruption” may happen to immediate the modernization of the prevailing vaccination growth and approval course of. Hamburg responded first, saying that as a society we’re behind the place we must be in relation to shifting towards a brand new, extra technological strategy and that it’s now “time to behave” to make {that a} actuality.

A number of minutes later, Anthony Fauci said that the superior methodology of vaccine manufacturing includes “not rising the virus in any respect, however getting sequences, getting the suitable protein and it sticking in on self-assembling nanoparticles,” basically referring to mRNA vaccines.

Fauci then said: “The vital problem … is that as a way to make the transition from getting out of the tried and true egg-growing [method] … to one thing that needs to be a lot better, it’s a must to show that this works after which you’ve got to undergo the entire vital trials — section 1, section 2, section 3 — and present that this specific product goes to be good over a interval of years. That alone, if it really works completely, goes to take a decade.”

Fauci later said that there’s a want to change the general public’s notion that the flu will not be a critical illness as a way to enhance urgency and that it might be “tough” to change that notion together with the prevailing vaccine growth and approval course of until the prevailing system takes the posture that “I do not care what your notion is, we will handle the issue in a disruptive manner and an iterative manner.”

Through the panel, Brilliant said that “we have to transfer as shortly as potential and urgently as potential to get these applied sciences that handle pace and effectiveness of the vaccine” earlier than discussing how the White Home Council of Financial Advisers had simply issued a report emphasizing that prioritizing “quick” vaccines was paramount.

Brilliant then added {that a} “mediocre and quick” vaccine was higher than a “mediocre and sluggish” vaccine. He then stated that we are able to make “higher vaccines and make them quicker” and that urgency and disruption have been mandatory to supply the focused and accelerated growth of 1 such vaccine.

Later within the panel, Brilliant stated the easiest way to “disrupt” the vaccine area in favor of “quicker” vaccines could be the emergence of “an entity of pleasure on the market that is fully disruptive, that is not beholden to bureaucratic strings and processes.” He later very instantly stated that by “quicker” vaccines he meant mRNA vaccines.

The Brilliant-led BARDA and the Fauci-led NIAID in just some months’ time grew to become the largest backers of the Moderna COVID-19 vaccine, investing billions and co-developing the vaccine with the corporate, respectively.

As can be defined in Half II of this collection, the partnership between Moderna and the NIH to co-develop what would quickly change into Moderna’s COVID-19 vaccine was being solid as early as January 7, 2020, lengthy earlier than the official declaration of the COVID-19 disaster as a pandemic and earlier than a vaccine was proclaimed as mandatory by officers and different people.

Not solely did the COVID-19 vaccine shortly change into the reply to just about all Moderna’s woes however it additionally offered the disruptive state of affairs mandatory to change the general public’s perceptions of what a vaccine is and eradicate current safeguards and forms in vaccine approval. (Watch the 2019 Common Flu Vaccine occasion right here.)

As Half II of this collection will present, it was an alleged mixture of “serendipity and foresight” from Moderna’s Stéphane Bancel and the NIH’s Barney Graham that propelled Moderna to the entrance of the “Warp Pace” race for a COVID-19 vaccine.

That partnership, together with the disruptive impact of the COVID-19 disaster, created the very “Hail Mary” for which Moderna had been desperately ready since no less than 2017 whereas additionally turning most of Moderna’s government group into billionaires and multi-millionaires in a matter of months.

Nonetheless, Moderna’s “Hail Mary” will not final – that’s, until the mass administration of its COVID-19 vaccine turns into an annual affair for tens of millions of individuals worldwide. Though real-world knowledge since its administration started challenges the necessity for in addition to the security and efficacy of its vaccine, Moderna – and its stakeholders – can’t afford to let this chance slip by means of fingers. To take action would imply the tip of Moderna’s fastidiously constructed home of playing cards.

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