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Powers On… Top 5 crypto legal and regulatory developments of 2021

While still leading the securities litigation, hedge fund and SEC defense national practices at my last law firm, BakerHostetler, my practice team members and I would prepare an annual list of key developments and cases in the area each December. It was..

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While still leading the securities litigation, hedge fund and SEC defense national practices at my last law firm, BakerHostetler, my practice team members and I would prepare an annual list of key developments and cases in the area each December.

It was usually a top 10 list that was then published by Wolters Kluwer in one of its CCH publications and by BakerHostetler as a separate publication to our law firm clients. Now that I am officially retired from law firm practice and these days devote most of my professional attention to the blockchain and crypto space, my editor, Max Yakubowski, and I thought it made sense to do something similar for Cointelegraphs readers.


Powers On… is a monthly opinion column from Marc Powers, who spent much of his 40-year legal career working with complex securities-related cases in the United States after a stint with the SEC. He is now an adjunct professor at Florida International University College of Law, where he teaches a course on Blockchain, Crypto and Regulatory Considerations.


So, here is my top five list for 2021. It has some caveats attached. For one, the blockchain space has so many dimensions, some implicating finance and many that do not. The use cases for this ledger technology expand each year, constrained only by human ingenuity. This list focuses on developments this year that affect financial transactions and systems. It also focuses on what I perceive as key regulation, legislation and litigation affecting the ecosystem. Next, this is a top five list, not a top 10 one. While yes, there are dozens of issues and items that are transformative, that would be a much longer piece. Finally, some of the items on the list I have already written about in prior columns, so they will be familiar to regular readers. As a result, I dont feel the need to provide lengthy explanations as to why an item made the list.

 

 

 

 

1. El Salvador adopts BTC as a national currency

Back in June, at the Bitcoin 2021 conference in Miami, Salvadoran President Nayib Bukele announced he would seek to have El Salvador adopt Bitcoin as a national currency. At the time, the country had used the U.S. dollar as its official currency since 2001, abandoning at the time its local currency, the coln. In short order, the countrys legislative body adopted laws mandating that beginning in September, all commercial establishments must accept Bitcoin as legal tender, with some exceptions. Wallets containing $30 in BTC have also been made available to citizens by the tiny countrys banks. This was not a voluntary choice for businesses; rather, it was required, which makes this event so significant.

It was a watershed moment for sovereign nations, as other countries have begun efforts to do the same, including Panama and Ukraine. While other countries have adopted blockchain technology for parts of their financial and governmental systems such as Georgia mandating that government real estate auctions occur on a blockchain this is different and more significant. It is for the entire countrys economy.

2. The United States woke legislation on blockchain transactions

In November, Congress finally passed the Biden administrations $1.2 trillion infrastructure legislation at least the piece of the proposed legislation that actually was directed at building and rebuilding our bridges, roads, rails and telecommunications. As part of the bill, formally called the Infrastructure Investment and Jobs Act, there is an amendment to Section 6045 of the tax code, which requires the reporting to citizens engaged in securities transactions, with an overly broad definition of brokers. It mandates tax reporting information by traditional brokerage firms of their customers. However, the bill arguably could be interpreted to impose this significant reporting requirement on blockchain miners and developers, which many in Congress believe is bad for crypto and overbearing.

 

 

 

 

The importance of this tax provision is that it is one of the first efforts of the federal government to better incorporate digital assets, like virtual currency, into our nations tax code, according to a Dec. 14 letter from six senators to Treasury Secretary Janet Yellen, whether Yellen does as they ask or not. These senators are Rob Portman, Mark Warner, Kyrsten Sinema, Cynthia Lummis, Pat Toomey and Mike Crapo members of both major political parties. It is also significant that not only is there support for the technology in the Senate, there is now also a Congressional Blockchain Caucus.

The caucus is a bipartisan group of members of the House of Representatives dedicated to advancing the technology with a light touch regulatory approach, according to its mission statement. Back in August 2020, it wrote to the Internal Revenue Service seeking clarity on how the agency would be taxing the block rewards arising from the proof-of-stake validation process. As of this writing, the caucus website lists 35 members of the House, a significant number.

3. Federal Reserve Chair Powell is open to the benefits of blockchain for the financial system

On more than one occasion this past year, Federal Reserve Chairman Jerome Powell has stated publicly and in congressional hearings that he sees certain benefits for the world and U.S. financial systems in utilizing blockchain and digital assets. Back in March, he stated on CNBC that while Bitcoin was not a very good store of value or currency, it was a speculative asset like gold. Thereafter, he made clear that the Fed has no intention of banning crypto.

A few days ago, Powell acknowledged that he does not envision the Armageddon that crypto haters see. He made clear he does not see crypto as a danger to the financial system at this time. Regarding stablecoins, he said they can certainly be a useful, efficient consumer-serving part of the financial system if theyre properly regulated.

 

 

 

 

If you think back a few years, cryptocurrencies and the blockchains from where they come were verboten in the federal government. No one was allowed to embrace them. So, it seems to me that there has been a clear evolution and maturation of thinking on the part of Powell about these things and the useful aspects of digital assets for our economy and the worlds financial system. Given Powells considerable influence over our economy and economic stability, likely even more so than our president, this is a very positive development. All of this talk seems like a precursor to a central bank digital currency being issued by the Fed.

4. SEC allows Bitcoin ETF for retail customers

The new Securities and Exchange Commission chairman, Gary Gensler, has a clear bias toward his former employer, the Commodity Futures Trading Commission, where he served as chair from 2009 to 2014. Yet, he is still advancing the ball for crypto, albeit slowly.

For several years now, various financial companies have sought to sell exchange-traded funds based upon Bitcoin and other digital assets. ETFs hold a basket of securities or assets, such as the S&P 500 ETF, which holds all of the securities in the S&P 500 Index. ETFs are generally less costly investment products for retail investors than mutual funds. Yet, pointedly during the chairmanship of former SEC Chair Jay Clayton, each time one of the more than a dozen ETFs were presented to the SEC, it failed to approve the effectiveness of the public offering, effectively killing it.

 

 

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In October, however, things changed. The SEC allowed the first Bitcoin-based ETF to trade in public U.S. markets: the ProShares Bitcoin futures ETF. Yet, there was a catch. The ETF approved is based upon Bitcoin futures, not the underlying BTC itself found in the spot market, revealing Genslers biases from his years at the CFTC. To me, there is no legitimate rationale for allowing a futures-based ETF but not a spot-based one. Indeed, a futures-based ETF, which requires a rolling over of futures contracts, is more expensive to manage.

Also, it is restricted in the number of contracts that can be purchased under current CFTC position limits rules. There is no similar restriction for spot ETFs. The claim that the markets for Bitcoin have been in regulated marketplaces such as the CME for years and thus the futures marketplace is a more stable and orderly marketplace for an ETF is bunk. Nonetheless, at some point, a spot ETF will be approved, and the fact that all retail investors can now buy Bitcoin, even if derivatively, is a significant advancement for both the technology and alternative asset.

5. Ripple fights the SEC in court

In the waning days of the lame-duck Clayton-led SEC in December 2020, the Commission authorized and filed a lawsuit against Ripple and two of its principals, alleging the defendants engaged in unregistered public securities offerings of XRP over a period of years. As discussed in one of my columns earlier this year, it was an ill-advised, overly aggressive action that did not need to be brought.

Among other reasons, it is questionable whether the XRP token was a security under the federal securities laws. Also, another government regulator, the Financial Crimes Enforcement Network, had previously complained in 2013 to Ripple that its offerings constituted currency exchanges, thus subjecting Ripple to register as a money services business exchanger with the agency. So, Ripple registered and was fined $700,000 by FinCEN as a penalty for registration and AML violations in 2015, only to have a separate federal agency the SEC claim five years later that the same offerings were public offerings of securities. Repetitive actions by multiple U.S. regulators for similar underlying transactions are unfair and unnecessary.

If I was a betting man, which I am, I would say the SEC will lose this fight by which I mean the court either will find that XRP is not a security, that the sales of XRP by Ripples principals were not public offerings here in the United States, or that an injunction against the defendants is neither necessary nor granted. This fight and the subsequent decision by Judge Analisa Torres could be monumental.

There you have it, readers my top five list.

Enjoy the holidays, and may we soon defeat COVID-19 worldwide. You will soon be hearing my ruminations again in 2022!

 


Marc Powers is currently an adjunct professor at Florida International University College of Law, where he is teaching Blockchain, Crypto and Regulatory Considerations and Fintech Law. He recently retired from practicing at an Am Law 100 law firm, where he built both its national securities litigation and regulatory enforcement practice team and its hedge fund industry practice. Marc started his legal career in the SECs Enforcement Division. During his 40 years in law, he was involved in representations including the Bernie Madoff Ponzi scheme, a recent presidential pardon and the Martha Stewart insider trading trial.


The opinions expressed are the authors alone and do not necessarily reflect the views of Cointelegraph nor Florida International University College of Law or its affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal or investment advice.


 

 

 

 

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EyePoint poaches medical chief from Apellis; Sandoz CFO, longtime BioNTech exec to retire

Ramiro Ribeiro
After six years as head of clinical development at Apellis Pharmaceuticals, Ramiro Ribeiro is joining EyePoint Pharmaceuticals as CMO.
“The…

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Ramiro Ribeiro

After six years as head of clinical development at Apellis Pharmaceuticals, Ramiro Ribeiro is joining EyePoint Pharmaceuticals as CMO.

“The retinal community is relatively small, so everybody knows each other,” Ribeiro told Endpoints News in an interview. “As soon as I started to talk about EyePoint, I got really good feedback from KOLs and physicians on its scientific standards and quality of work.”

Ribeiro kicked off his career as a clinician in Brazil, earning a doctorate in stem cell therapy for retinal diseases. He previously held roles at Alcon and Ophthotech Corporation, now known as Astellas’ M&A prize Iveric Bio.

At Apellis, Ribeiro oversaw the Phase III development, filing and approval of Syfovre, the first drug for geographic atrophy secondary to age-related macular degeneration (AMD). The complement C3 inhibitor went on to make $275 million in 2023 despite reports of a rare side effect that only emerged after commercialization.

Now, Ribeiro is hoping to replicate that success with EyePoint’s lead candidate, EYP-1901 for wet AMD, which is set to enter the Phase III LUGANO trial in the second half of the year after passing a Phase II test in December.

Ribeiro told Endpoints he was optimistic about the company’s intraocular sustained-delivery tech, which he said could help address treatment burden and compliance issues seen with injectables. He also has plans to expand the EyePoint team.

“My goal is not just execution of the Phase III study — of course that’s a priority — but also looking at the pipeline and which different assets we can bring in to leverage the strength of the team that we have,” Ribeiro said.

Ayisha Sharma


Remco Steenbergen

Sandoz CFO Colin Bond will retire on June 30 and board member Remco Steenbergen will replace him. Steenbergen, who will step down from the board when he takes over on July 1, had a 20-year career with Philips and has held the group CFO post at Deutsche Lufthansa since January 2021. Bond joined Sandoz nearly two years ago and is the former finance chief at Evotec and Vifor Pharma. Investors didn’t react warmly to Wednesday’s news as shares fell by almost 4%.

The Swiss generics and biosimilars company, which finally split from Novartis in October 2023, has also nominated FogPharma CEO Mathai Mammen to the board of directors. The ex-R&D chief at J&J will be joined by two other new faces, Swisscom chairman Michael Rechsteiner and former Unilever CFO Graeme Pitkethly.

On Monday, Sandoz said it completed its $70 million purchase of Coherus BioSciencesLucentis biosimilar Cimerli sooner than expected. The FDA then approved its first two biosimilars of Amgen’s denosumab the next day, in a move that could whittle away at the pharma giant’s market share for Prolia and Xgeva.

Sean Marett

BioNTech’s chief business and commercial officer Sean Marett will retire on July 1 and will have an advisory role “until the end of the year,” the German drugmaker said in a release. Legal chief James Ryan will assume CBO responsibilities and BioNTech plans to name a new chief commercial officer by the end of the month. Marett was hired as BioNTech’s COO in 2012 after gigs at GSK, Evotec and Next Pharma, and led its commercial efforts as the Pfizer-partnered Comirnaty received the first FDA approval for a Covid-19 vaccine. BioNTech has also built a cancer portfolio that TD Cowen’s Yaron Werber described as “one of the most extensive” in biotech, from antibody-drug conjugates to CAR-T therapies.

Chris Austin

→ GSK has plucked Chris Austin from Flagship and he’ll start his new gig as the pharma giant’s SVP, research technologies on April 1. After a long career at NIH in which he was director of the National Center for Advancing Translational Sciences (NCATS), Austin became CEO of Flagship’s Vesalius Therapeutics, which debuted with a $75 million Series A two years ago this week but made job cuts that affected 43% of its employees six months into the life of the company. In response to Austin’s departure, John Mendlein — who chairs the board at Sail Biomedicines and has board seats at a few other Flagship biotechs — will become chairman and interim CEO at Vesalius “later this month.”

BioMarin has lined up Cristin Hubbard to replace Jeff Ajer as chief commercial officer on May 20. Hubbard worked for new BioMarin chief Alexander Hardy as Genentech’s SVP, global product strategy, immunology, infectious diseases and ophthalmology, and they had been colleagues for years before Hardy was named Genentech CEO in 2019. She shifted to Roche Diagnostics as global head of partnering in 2021 and had been head of global product strategy for Roche’s pharmaceutical division since last May. Sales of the hemophilia A gene therapy Roctavian have fallen well short of expectations, but Hardy insisted in a recent investor call that BioMarin is “still very much at the early stage” in the launch.

Pilar de la Rocha

BeiGene has promoted Pilar de la Rocha to head of Europe, global clinical operations. After 13 years in a variety of roles at Novartis, de la Rocha was named global head of global clinical operations excellence at the Brukinsa maker in the summer of 2022. A short time ago, BeiGene ended its natural killer cell therapy alliance with Shoreline Biosciences, saying that it was “a result of BeiGene’s internal prioritization decisions and does not reflect any deficit in Shoreline’s platform technology.”

Andy Crockett

Andy Crockett has resigned as CEO of KalVista Pharmaceuticals. Crockett had been running the company since its launch in 2011 and will hand the keys to president Ben Palleiko, who joined KalVista in 2016 as CFO. Serious safety issues ended a Phase II study of its hereditary angioedema drug KVD824, but KalVista is mounting a comeback with positive Phase III results for sebetralstat in the same indication and could compete with Takeda’s injectable Firazyr. “If approved, sebetralstat may offer a compelling treatment option for patients and their caregivers given the long-standing preference for an effective and safe oral therapy that provides rapid symptom relief for HAE attacks,” Crockett said last month.

Steven Lo

Vaxart has tapped Steven Lo as its permanent president and CEO, while interim chief Michael Finney will stay on as chairman. Endpoints News last caught up with Lo when he became CEO at Valitor, the UC Berkeley spinout that raised a $28 million Series B round in October 2022. The ex-Zosano Pharma CEO had a handful of roles in his 13 years at Genentech before his appointments as chief commercial officer of Corcept Therapeutics and Puma Biotechnology. Andrei Floroiu resigned as Vaxart’s CEO in mid-January.

Kartik Krishnan

Kartik Krishnan has taken over for Martin Driscoll as CEO of OncoNano Medicine, and Melissa Paoloni has moved up to COO at the cancer biotech located in the Dallas-Fort Worth suburb of Southlake. The execs were colleagues at Arcus Biosciences, Gilead’s TIGIT partner: Krishnan spent two and a half years in the CMO post, while Paoloni was VP of corporate development and external alliances. In 2022, Krishnan took the CMO job at OncoNano and was just promoted to president and head of R&D last November. Paoloni came on board as OncoNano’s SVP, corporate development and strategy not long after Krishnan’s first promotion.

Genesis Research Group, a consultancy specializing in market access, has brought in David Miller as chairman and CEO, replacing co-founder Frank Corvino — who is transitioning to the role of vice chairman and senior advisor. Miller joins the New Jersey-based team with a number of roles under his belt from Biogen (SVP of global market access), Elan (VP of pharmacoeconomics) and GSK (VP of global health outcomes).

Adrian Schreyer

Adrian Schreyer helped build Exscientia’s AI drug discovery platform from the ground up, but he has packed his bags for Nimbus Therapeutics’ AI partner Anagenex. The new chief technology officer joined Exscientia in 2013 as head of molecular informatics and was elevated to technology chief five years later. He then held the role of VP, AI technology until January, a month before Exscientia fired CEO Andrew Hopkins.

Paul O’Neill has been promoted from SVP to EVP, quality & operations, specialty brands at Mallinckrodt. Before his arrival at the Irish pharma in March 2023, O’Neill was executive director of biologics operations in the second half of his 12-year career with Merck driving supply strategy for Keytruda. Mallinckrodt’s specialty brands portfolio includes its controversial Acthar Gel (a treatment for flares in a number of chronic and autoimmune indications) and the hepatorenal syndrome med Terlivaz.

David Ford

→ Staying in Ireland, Prothena has enlisted David Ford as its first chief people officer. Ford worked in human resources at Sanofi from 2002-17 and then led the HR team at Intercept, which was sold to Italian pharma Alfasigma in late September. We recently told you that Daniel Welch, the former InterMune CEO who was a board member at Intercept for six years, will succeed Lars Ekman as Prothena’s chairman.

Ben Stephens

→ Co-founded by Sanofi R&D chief Houman Ashrafian and backed by GSK, Eli Lilly partner Sitryx stapled an additional $39 million to its Series A last fall. It has now welcomed a pair of execs: Ben Stephens (COO) had been finance director for ViaNautis Bio and Rinri Therapeutics, and Gordon Dingwall (head of clinical operations) is a Roche and AstraZeneca vet who led development operations at Mission Therapeutics. Dingwall has also served as a clinical operations leader for Shionogi and Freeline Therapeutics.

Steve Alley

MBrace Therapeutics, an antibody-drug conjugate specialist that nabbed $85 million in Series B financing last November, has named Steve Alley as CSO. Alley spent two decades at Seagen before the $43 billion buyout by Pfizer and was the ADC maker’s executive director, translational sciences.

→ California cancer drug developer Apollomics, which has been mired in Nasdaq compliance problems nearly a year after it joined the public markets through a SPAC merger, has recruited Matthew Plunkett as CFO. Plunkett has held the same title at Nkarta as well as Imago BioSciences — leading the companies to $290 million and $155 million IPOs, respectively — and at Aeovian Pharmaceuticals since March 2022.

Heinrich Haas

→ Co-founded by Oxford professor Adrian Hill — the co-inventor of AstraZeneca’s Covid-19 vaccine — lipid nanoparticle biotech NeoVac has brought in Heinrich Haas as chief technology officer. During his nine years at BioNTech, Haas was VP of RNA formulation and drug delivery.

Kimberly Lee

→ New Jersey-based neuro biotech 4M Therapeutics is making its Peer Review debut by introducing Kimberly Lee as CBO. Lee was hired at Taysha Gene Therapies during its meteoric rise in 2020 and got promoted to chief corporate affairs officer in 2022. Earlier, she led corporate strategy and investor relations efforts for Lexicon Pharmaceuticals.

→ Another Peer Review newcomer, Osmol Therapeutics, has tapped former Exelixis clinical development chief Ron Weitzman as interim CMO. Weitzman only lasted seven months as medical chief of Tango Therapeutics after Marc Rudoltz had a similarly short stay in that position. Osmol is going after chemotherapy-induced peripheral neuropathy and chemotherapy-induced cognitive impairment with its lead asset OSM-0205.

→ Last August, cardiometabolic disease player NeuroBo Pharmaceuticals locked in Hyung Heon Kim as president and CEO. Now, the company is giving Marshall Woodworth the title of CFO and principal financial and accounting officer, after he served in the interim since last October. Before NeuroBo, Woodworth had a string of CFO roles at Nevakar, Braeburn Pharmaceuticals, Aerocrine and Fureix Pharmaceuticals.

Claire Poll

Claire Poll has retired after more than 17 years as Verona Pharma’s general counsel, and the company has appointed Andrew Fisher as her successor. In his own 17-year tenure at United Therapeutics that ended in 2018, Fisher was chief strategy officer and deputy general counsel. The FDA will decide on Verona’s non-cystic fibrosis bronchiectasis candidate ensifentrine by June 26.

Nancy Lurker

Alkermes won its proxy battle with Sarissa Capital Management and is tinkering with its board nearly nine months later. The newest director, Bristol Myers Squibb alum Nancy Lurker, ran EyePoint Pharmaceuticals from 2016-23 and still has a board seat there. For a brief period, Lurker was chief marketing officer for Novartis’ US subsidiary.

→ Chaired by former Celgene business development chief George Golumbeski, Shattuck Labs has expanded its board to nine members by bringing in ex-Seagen CEO Clay Siegall and Tempus CSO Kate Sasser. Siegall holds the top spots at Immunome and chairs the board at Tourmaline Bio, while Sasser came to Tempus from Genmab in 2022.

Scott Myers

→ Ex-AMAG Pharmaceuticals and Rainier Therapeutics chief Scott Myers has been named chairman of the board at Convergent Therapeutics, a radiopharma player that secured a $90 million Series A last May. Former Magenta exec Steve Mahoney replaced Myers as CEO of Viridian Therapeutics a few months ago.

→ Montreal-based Find Therapeutics has elected Tony Johnson to the board of directors. Johnson is in his first year as CEO of Domain Therapeutics. He is also the former chief executive at Goldfinch Bio, the kidney disease biotech that closed its doors last year.

Habib Dable

→ Former Acceleron chief Habib Dable has replaced Kala Bio CEO Mark Iwicki as chairman of the board at Aerovate Therapeutics, which is signing up patients for Phase IIb and Phase III studies of its lead drug AV-101 for pulmonary arterial hypertension. Dable joined Aerovate’s board in July and works part-time as a venture partner for RA Capital Management.

Julie Cherrington

→ In the burgeoning world of ADCs, Elevation Oncology is developing one of its own that targets Claudin 18.2. Its board is now up to eight members with the additions of Julie Cherrington and Mirati CMO Alan Sandler. Cherrington, a venture partner at Brandon Capital Partners, also chairs the boards at Actym Therapeutics and Tolremo Therapeutics. Sandler took the CMO job at Mirati in November 2022 and will stay in that position after Bristol Myers acquired the Krazati maker.

Patty Allen

Lonnie Moulder’s Zenas BioPharma has welcomed Patty Allen to the board of directors. Allen was a key figure in Vividion’s $2 billion sale to Bayer as the San Diego biotech’s CFO, and she’s a board member at Deciphera Pharmaceuticals, SwanBio Therapeutics and Anokion.

→ In January 2023, Y-mAbs Therapeutics cut 35% of its staff to focus on commercialization of Danyelza. This week, the company has reserved a seat on its board of directors for Nektar Therapeutics CMO Mary Tagliaferri. Tagliaferri also sits on the boards of Enzo Biochem and is a former board member of RayzeBio.

→ The ex-Biogen neurodegeneration leader at the center of Aduhelm’s controversial approval is now on the scientific advisory board at Asceneuron, a Swiss-based company focused on Alzheimer’s and Parkinson’s. Samantha Budd-Haeberlein tops the list of new SAB members, which also includes Henrik Zetterberg, Rik Ossenkoppele and Christopher van Dyck.

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Is the biotech market rally real? Data suggest comeback in private, public markets

After some halting starts, false dawns and fragile rallies, the biotech market may finally be back.
No, really.
In the last several months, several important…

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After some halting starts, false dawns and fragile rallies, the biotech market may finally be back.

No, really.

In the last several months, several important signals have added up to what feels like a rally, with more depth and certainty than some of the short-lived upticks during the doldrums of 2022 and 2023, when only the industry’s most optimistic souls were willing to call it a comeback.

But now, public biotechs are releasing positive data and raising money in follow-on offerings with ease. Biopharmas have already raised $13.7 billion in secondary raises in 2024, according to Stifel’s Tim Opler. Biotech’s benchmark index, the $XBI, is up 56% from last year’s lows and has broken the $100 mark, thanks to gains that go deep into the 120-company index. And in the private markets, crossover rounds are trickling back, and IPOs are showing signs of life.

Investors and executives told Endpoints News that this moment feels different, encouraged by a return to the basics, a focus on data, and signs of a healthier — if smaller — biotech ecosystem.

Chris Garabedian

“We should be beyond any of the lows,” said Chris Garabedian, a venture portfolio manager at Perceptive Advisors and founder of the firm’s early-stage investing unit Xontogeny. “We are going to see continued forward momentum.”

Investor sentiment is “very different from what it was in ‘22 to ‘23, where it was all doom and gloom,” MoonLake Immunotherapeutics CEO Jorge Santos da Silva said. A year ago, “The question was like, ‘What are the 22 ways in which you can die?’ That has really changed.”

The XBI cracking $100 is encouraging, but a deeper look at the index shows more signs of strength. The exchange-traded fund, which lets investors buy shares of its basket of 120 biotech companies, has seen $457 million in net inflows over the past month, according to YCharts data. And about 80% of biotechs on the index — which includes giants like Vertex $VRTX and small companies like Avidity Biosciences $RNA — have seen their stock in the green over the past three months.

Some of that gain is clearly driven by a surge in M&A, including the buyouts of Seagen, Horizon, Cerevel, and Karuna, all of which have returned billions of dollars back to investors who need to put it back to work in the private or public markets. And industry insiders have said there’s also a breadth in the disease areas drawing interest, including obesity, cancer, cardiology, neurology, and inflammation.

Even ARCH Venture Partners managing director Bob Nelsen voiced some broader — albeit measured — optimism for the market.

“For our internal base case, we’re still assuming that things are going to suck like they have in the last couple of years,” Nelsen told Endpoints. “But we all believe that it has turned.”

Nelsen still implores his portfolio companies and limited partners to “assume it’s going to be worse than you think.” But his optimism is driven by two major trends: the easing of macro factors like interest rates and the persistence of M&A. He’s closely watching whether generalist investors — whose huge dollars can swing a sector up or down, as they did dramatically during the pandemic — will come back to biotech.

“The conventional wisdom in Q4 is, they were never coming back in the market,” he said. “Turns out, in Q4 they were buying.”

From atonement to ‘FOMO’

Jorge Santos da Silva

Da Silva said the industry had been “paying for our sins” committed in the boom years of 2019 to 2021, when hundreds of biotechs went public — many far from going into the clinic. Along with layoffs and company closures, it resulted in an infestation of the corporate walking dead in companies trading at values below the amount of cash on their books.

But the number of those companies with negative equity value has dropped in the past few months, suggesting that a much-needed cleanup from the go-go years is well in progress.

“I call it a detox,” da Silva said. “Whatever we did was clearly excessive and everyone knew it at the time. But when you’re at a party, it’s like, ‘Oh my God, this is crazy, but let’s keep going.’ The detox phase is definitely coming to an end.”

Otello Stampacchia

Otello Stampacchia, the managing director of the Boston-based VC firm Omega Funds, said the mood is even “getting a little bit bubblicious” for biotechs with clinical-stage drug candidates in large markets with meaningful milestones in the next 12 to 18 months.

“There’s really a rush to get into those, particularly now that the indices have started flipping their dynamic,” said Stampacchia, who founded Omega two decades ago. “Up until early last fall, nobody wanted to catch the falling knife. It’s now the exact opposite dynamic, and there’s a bit of crowding in some of these names.”

“There’s real FOMO to invest in the right therapeutic products and the right therapeutic companies,” he added.

That’s carried through the private and public markets, Stampacchia said, noting that Omega participated in Alumis’ recent $259 million Series C raise — biotech’s biggest round this year. He said he was “incredibly surprised by the amount of demand there was for the deal.” All told, Omega has seen roughly half a dozen of its portfolio companies raise close to half a billion dollars over the last few months, with increased valuations.

“In each case, it really wasn’t difficult to syndicate,” he said. “There’s real demand.”

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Deflationary pressures in China – be careful what you wish for

Until recently, China’s decelerating inflation was welcomed by the West, as it led to lower imported prices and helped reduce inflationary pressures….

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Until recently, China’s decelerating inflation was welcomed by the West, as it led to lower imported prices and helped reduce inflationary pressures. However, China’s consumer prices fell for the third consecutive month in December 2023, delaying the expected rebound in economic activity following the lifting of COVID-19 controls. For calendar year 2023, CPI growth was negligible, whilst the producer price index declined by 3.0 per cent.

China’s inflation dynamics

China’s inflation dynamics

Chinese consumers are hindered by the weaker residential property market and high youth unemployment. Several property developers have defaulted, collectively wiping out nearly all the U.S.$155 billion worth of U.S. dollar denominated-bonds. 

Meanwhile, the Shanghai Composite Index is at half of its record high, recorded in late 2007. The share prices of major developers, including Evergrande Group, Country Garden Holdings, Sunac China and Shimao Group, have declined by an average of 98 per cent over recent years. Some economists are pointing to the Japanese experience of a debt-deflation cycle in the 1990s, with economic stagnation and elevated debt levels.

Australia has certainly enjoyed the “pull-up effect” from China, particularly with the iron-ore price jumping from around U.S.$20/tonne in 2000 to an average closer to U.S.$120/tonne over the 17 years from 2007. With strong volume increases, the value of Australia’s iron ore exports has jumped 20-fold to around A$12 billion per month, accounting for approximately 35 per cent of Australia’s exports. 

For context, China takes 85 per cent of Australia’s iron ore exports, whilst Australia accounts for 65 per cent of China’s iron ore imports. China’s steel industry depends on its own domestic iron ore mines for 20 per cent of its requirement, however, these are high-cost operations and need high iron ore prices to keep them in business. To reduce its dependence on Australia’s iron ore, China has increased its use of scrap metal and invested large sums of money in Africa, including the Simandou mine in Guinea, which is forecast to export 60 million tonnes of iron ore from 2028.

The Chinese housing market has historically been the source of 40 per cent of China’s steel usage. However, the recent high iron ore prices are attributable to the growth in China’s industrial and infrastructure activity, which has offset the weakness in residential construction.

Whilst this has continued to deliver supernormal profits for Australia’s major iron ore producers (and has greatly assisted the federal budget), watch out for any sustainable downturn in the iron ore price, particularly if the deflationary pressures in China continue into the medium term.

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