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Pfizer, Sanofi-backed LNP outfit goes back to the well and draws $120M for its trek to the clinic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise…

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A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

After Suliman joined the company in January, replacing David Lockhart as CEO, she took a look at the biotech’s overall strategy and decided on what she described as an “expansion and diversification thesis,” which she said made sense for the company at the time.

“So that, coupled with the proximity to the B, allowed us to go back to investors,” Suliman said. Lockhart is currently the company’s president and CSO.

What makes ReCode’s tech unique is essentially a “fifth element.” Most traditional LNPs comprise four components, according to ReCode: an ionizable cationic lipid, a Zwitterionic cationic lipid, a PEGylated lipid and cholesterol. ReCode’s LNPs, which it in-licensed from UT Southwestern researcher Dan Siegwart, contain a fifth lipid that would allow LNPs more flexibility, adding useful properties such as being able to deliver a bigger variety of payloads — mRNA, tRNA, siRNA and gene editing for example, Suliman said — and deliver those drugs to organs outside of the liver.

Siegwart had studied previously under MIT whiz and chemical engineer Bob Langer.

The company had originally formed in early 2020 as the result of a merger between the old upstart ReCode (which had in-licensed Siegwart’s tech and focused on tRNA) and TranscripTx, led by Lockhart and working to develop mRNA therapies. Mega VC OrbiMed backed the merger and co-led a launch round that infused $80 million into the biotech. To date, the biotech has been primarily focused on the rare genetic disorder primary ciliary dyskinesia (PCD) and cystic fibrosis.

Technology behind LNPs has also been taking center stage more as lawsuits have started to come out of the woodwork over the use of this technology. Pfizer and Moderna are two of the biggest names to have been targeted — specifically by Alnylam over patent infringement of what the RNAi giant said of its proprietary LNP tech in the two biggest Covid-19 vaccines on the market.

David Lockhart

And as far as Lockhart is concerned, he said the intellectual property for the five-lipid LNP platform is unique enough that it should shield ReCode from any potential lawsuits over patent infringement.

The biotech noted that the current round should last the company well through 2024, and possibly into 2025 depending on how well assets are allocated. Beyond that, the biotech is looking to expand its platform and push into clinical studies, with two planned IND submissions for later this year and early next year. If things go as planned, ReCode hopes to start dosing humans in clinical trials starting in Q1 and Q3 2023 for PCD and cystic fibrosis.

However, those two indications are not the only ones that ReCode is eyeing — additional indications in CNS diseases and oncology are currently being investigated in the preclinical phase, Suliman added.

“We have preliminary data in CNS, for example, showing that with intrathecal delivery, we can get into the central nervous system, which of course, opens up a world of therapeutic possibilities there for genetic medicines, such as mRNA. We’re going into oncology, so demonstrating proof of activity for in vivo CAR-T applications. So this just gives us the resources and the runway that we need to truly test the limits of the platform,” Suliman said.

In the meantime, Matrix Capital’s managing director Alan Colowick and Leaps by Bayer senior director Rakhshita Dhar will be joining ReCode’s board of directors.

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Government

US: The New Real Hoaxes?

US: The New Real Hoaxes?

Authored by Pete Hoekstra via The Gatestone Institute,

The investigative reporting by these two organizations…

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US: The New Real Hoaxes?

Authored by Pete Hoekstra via The Gatestone Institute,

  • The investigative reporting by these two organizations [the New York Times and the Washington Post] was so thorough and groundbreaking it turned up things that were not even there.

  • For having refused to rescind these awards, the Pulitzer Committee should receive its own Pulitzer -- for fraud.

  • The real hoax appears to have been the CCP's ostensible good behavior and the now-hugely-discredited initial reporting on the virus.

  • Or how about the Hunter Biden laptop cover-up? Once again, On October 14, 2020, just weeks before the 2020 presidential election, a critical story of possible extensive influence-peddling with senior intelligence officers in the CCP, Russia and Ukraine by the son of a presidential candidate. The contents of the laptop raised questions that the candidate at the time, Vice President Joe Biden, could be compromised. The entire subject was decisively pushed aside, along with the potential threat to national security that such an eventuality might entail.

  • Also not allowed during the January 6th hearings have been any witnesses for the defense, any cross-examination, or any exculpatory evidence.

  • One wonders, for instance if the January 6th Committee will consider the July 29, 2022 tweet by General Keith Kellogg, that on January 3, 2021, Trump, in front of witnesses, did indeed ask for "troops needed" for January 6. Kellogg wrote: "I was in the room."

  • The January 6th Committee has also not released any information about government informants or FBI undercover law enforcement officers who might have been in the crowd, and Pelosi is also said to be blocking access to a massive quantity of documents. Finally, according to attorney Mark Levin, under the Constitution's separation of powers, Congress, has no legitimacy even to hold a criminal investigation: that power belongs to the Judiciary. The entire proceeding is illegitimate and a usurpation of power.

  • Is it surprising that after the Pulitzer decision, the Russia collusion hoax, the Whitmer kidnapping hoax, the Covid origin hoax, the Hunter Biden laptop hoax, and now the January 6th Committee hoax, that many Americans believe there is something wrong with the system?

Recently former US President Donald Trump challenged the award of Pulitzer Prizes to the New York Times and the Washington Post for their investigative reporting on alleged collusion between the 2016 Trump campaign and Russia.

The investigative reporting by these two organizations was so thorough and groundbreaking it turned up things that were not even there.

You have to hand it to them for this so-called "great reporting": the Pulitzer Committee sure did.

We now know, of course, the grand conspiracy pushed by these papers is nothing more than thoroughly debunked disinformation. For having refused to rescind these awards, the Pulitzer Committee should receive its own Pulitzer -- for fraud.

The intractability of the Pulitzer Committee is only the latest example of why so many Americans have been losing trust in their institutions, both public and private. Rather than admitting that these awards were a mistake, and that much of the reporting was not investigative reporting, but merely a recitation of fabrications put forward by political hacks for campaign purposes, the Pulitzer Committee announced that it will stand by its initial decision, facts be dammed.

The Russia hoax is emblematic of the model built by the anti-Trump, anti-America First, anti-populist movement that the American people have experienced for the last six years. It embodies many of the characteristics that have frustrated Americans. It is a combination of influential forces -- media, social media, political players, and government -- that put forward information detrimental to one -- oddly always the same -- political viewpoint. In this instance, populists -- believers in the rights, wisdom or virtues of the common people, according to Merriam Webster -- who might embrace the concept of personal freedom espoused by the Constitution, a free market economy, economic growth, energy independence, school choice, equal application of the law and decentralized governance.

Much of the material used to foster the Russia hoax originated from the discredited "Steele Dossier," pedaled by former British spy Christopher Steele, funded by Clinton-linked opposition research firm FusionGPS, and pushed by Clinton campaign lawyer Michael Sussman. This discredited information was shared widely -- and often, it seems, with prior knowledge of its falseness -- through the mainstream media and social media when it was leaked to the press early in 2017 just before Donald Trump was sworn in as president. The material contributed to the launching of the Mueller "Russiagate" investigation, which cast a shadow over the first two years of the Trump administration. Government officials were involved as CIA Director John BrennanFBI Director James Comey and DNI James Clapper all lent their credibility to the supposed authenticity or seriousness of the Russian materials. All of this did tremendous damage to the effectiveness of the Trump administration, as it sought to govern, by putting it under a cloud of suspicion and illegitimacy from the outset.

This, however, was not the only example. Consider the disrupted kidnapping plot against Michigan Governor Gretchen Whitmer in her key swing state for presidential elections. "The FBI got walloped [in April]", according to the New York Post, " when a Michigan jury concluded that the bureau had entrapped two men accused of plotting to kidnap Gov. Gretchen Whitmer. Those men and others were arrested a few weeks before the 2020 election in a high-profile, FBI-fabricated case...."

The media, however, for the most part portrayed the kidnapping plot as the work of domestic terrorists, with the implied inference being they were right-wing Trump supporters. Whitmer went so far as to accuse Trump of being complicit in the plan, even though it emerged that these alleged plotters had also supposedly wanted to hang Trump. The FBI, it was later shown, had been heavily involved in the plot through informants and individuals it had placed in the group. By the time the case came to trial after the election, Biden had won Michigan's electoral votes and the damage had been done.

Consider, also, the COVID pandemic. The "facts" at the time were supposedly that it came from "nature" and that the Chinese Communist Party (CCP) government had supposedly known nothing about its human-to-human transmissibility, even though it had "made whistleblowers disappear and refused to hand over virus samples so the West could make a vaccine."

The CCP, early on, was portrayed as a constructive player in controlling the spread of the virus, even as it was recalling and hoarding all of its Personal Protective Equipment (PPE). This fiction was reinforced by Dr. Anthony Fauci, the World Health Organization, and other prominent participants – apart from Taiwan, which futilely tried to warn the WHO of the coronavirus's fierce human-to-human transmissibility, only to be dismissed.

The mainstream media and social media also quickly began parroting the "official" story line. Social media companies suspended the accounts of whoever might have had a different opinion and some were even canceled.

For the 10 months leading up to the November 2020 election, the narrative was set: COVID-19 was a naturally occurring virus and the CCP was in the clear. Imagine how different the 2020 presidential election might have been if the debate was how the world would have held the CCP accountable for the leak and coverup of COVID from the Wuhan Institute of Virology. Now in 2022, a lab-leak is considered the most "likely cause" of the coronavirus, but again the political damage, and a gigantic amount of non-political damage, has already been done. The real hoax appears to have been the CCP's ostensible good behavior and the now-hugely-discredited initial reporting on the virus.

Or how about the Hunter Biden laptop cover-up? Once again, On October 14, 2020, just weeks before the 2020 presidential election, a critical story of possible extensive influence-peddling with senior intelligence officers in the CCP, Russia and Ukraine by the son of a presidential candidate. The contents of the laptop raised questions that the candidate at the time, Vice President Joe Biden, could be compromised. The entire subject was decisively pushed aside, along with the potential threat to national security that such an eventuality might entail.

Discussion of Hunter Biden's laptop with its reportedly incriminating information about the Biden family business dealings with the CCPRussia, and other actors in what appeared to be a model of pay-for-play, was instantly shut down. Fifty-one former government intelligence officials , who we now know were perfectly well aware that the laptop was real – the FBI had been holding it for months -- wrote a letter describing the contents of the laptop as having "all the classic earmarks of a Russian information operation" designed to damage Joe Biden.

NPR famously downplayed the story, and once again, if you used social media to post information originally reported by the New York Post, you were canceled.

A year and a half after the election, the facts were finally "officially" accepted: Well, what do you know, it really was Hunter Biden's laptop and the material on it "is real!"

Once again, the leadership at the FBI, the media, social media, and former government officials had developed a hoax to damage their political opposition and the people who supported it.

Finally, there is the January 6th Committee, a one-sided investigative body, sometimes called "the third (attempted) impeachment." The Committee appears to have been put in place to stop Trump from running for office again. Before the proceeding even began, its outcome was predetermined: Trump was to be found guilty of -- something. As Stalin secret police chief, Lavrentiy Beria used to say during Soviet Russia's reign of terror, "Find me the man and I'll find you the crime." So the US show trial commenced.

Even its start was ominous. House Speaker Nancy Pelosi, in an unprecedented move, vetoed the committee appointments of Representatives Jim Banks and Jim Jordan. This rebuff led House Minority Leader Kevin McCarthy to pull his five Republican candidates from participating. Pelosi, it appeared, wanted only anti-Trump folks to serve on the Committee. Also not allowed during the January 6 hearings have been any witnesses for the defense, any cross-examination, or any exculpatory evidence.

One wonders, for instance if the January 6th Committee will consider the July 29, 2022 tweet by General Keith Kellogg, that on January 3, 2021, Trump, in front of witnesses, did indeed ask for "troops needed" for January 6. Kellogg wrote:, "I was in the room:"

"Great OpEd. Reinforces my earlier comment on 6 Jan Cmte. Has quote from DOD IG Report regarding 3 Jan 2021 meeting with Actg Def Secy Miller/CJCS Milley in the Oval on the 6 Jan NG request by POTUS on troops needed. I was in the room."

While purportedly examining in detail every decision and action by Trump and his team, the Committee refuses to question Pelosi, among the leading figures responsible for the security of the Capitol. She reportedly "turned down" requests for greater security. According to the Federalist:

"Four days after the riot, former Capitol Police Chief Steven Sund, who resigned his post in the aftermath, told The Washington Post his request for pre-emptive reinforcement from the National Guard ahead of Jan. 6 was turned down. Sund said House Sergeant at Arms Paul Irving, overseen by Pelosi, thought the guard's deployment was bad "optics" two days before the raid.... Despite the Associated Press and Washington Post's best efforts to run interference for the speaker, suddenly exonerating her of duties overseeing Capitol security, the riot on Jan. 6 was a security failure Pelosi owns. If the "speaker trusts security professionals to make security decisions," then why, as the police breach unfolded, did Irving feel compelled to seek the speaker's approval to dispatch the National Guard, as The New York Times reported? How could Pelosi also order the extended shut down of the Capitol to visitors, citing coronavirus, and install metal detectors in the House chamber?"

The Committee has not evaluated the performance of the Capitol Police or other law enforcement agencies, but it has targeted the "private records of individuals with no connection to the violence."

The January 6th Committee has also not released any information about government informants or FBI undercover law enforcement officers who might have been in the crowd, and Pelosi is also said to be blocking access to a massive quantity of documents. Finally, according to attorney Mark Levin, under the Constitution's separation of powers, Congress, has no legitimacy even to hold a criminal investigation: that power belongs to the Judiciary. The entire proceeding is illegitimate and a usurpation of power. The Committee's narrative is clear: Donald Trump is responsible for the events of January 6, now let us manufacture the evidence to prove it.

This article has not even delved into the 28 states that "changed voting rules to boost mail-in ballots." Some States apparently omitted both state law and the need for states' legislatures to be the sole arbiters of election law, as required by the Constitution; the $400 million spent by Facebook founder Mark Zuckerberg; the 2000-plus "mules" and the algorithms that sent conservative emails to spam while emails with liberal content went through to the addressees.

Is it any wonder that many Americans have lost faith in their institutions and leaders? Is it surprising that after the Pulitzer decision, the Russia collusion hoax, the Whitmer kidnapping hoax, the Covid origin hoax, the Hunter Biden laptop hoax, and now the January 6th Committee hoax, that many Americans believe there is something wrong with the system? The media, social media, government officials and others have been complicit in undermining our rule of law and possibly even subverting an election.

*  *  *

Peter Hoekstra was US Ambassador to the Netherlands during the Trump administration. He served 18 years in the U.S. House of Representatives representing the second district of Michigan and served as Chairman and Ranking member of the House Intelligence Committee. He is currently Chairman of the Center for Security Policy Board of Advisors and a Distinguished Senior Fellow at Gatestone Institute.

Tyler Durden Fri, 08/12/2022 - 23:55

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Government

CDC Admits It Gave False Information About COVID-19 Vaccine Surveillance

CDC Admits It Gave False Information About COVID-19 Vaccine Surveillance

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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CDC Admits It Gave False Information About COVID-19 Vaccine Surveillance

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Centers for Disease Control and Prevention (CDC) is admitting it gave false information about COVID-19 vaccine surveillance, including inaccurately saying it conducted a certain type of analysis over one year before it actually did.

A general view of the Centers for Disease Control headquarters in Atlanta on April 23, 2020. (Tami Chappell/AFP via Getty Images)

The false information was conveyed in responses to Freedom of Information Act (FOIA) requests for the results of surveillance, and after the CDC claimed COVID-19 vaccines are being monitored “by the most intense safety monitoring efforts in U.S. history.”

“CDC has revisited several FOIA requests and as a result of its review CDC is issuing corrections for the following information,” a CDC spokeswoman told The Epoch Times in an email.

No CDC employees intentionally provided false information and none of the false responses were given to avoid FOIA reporting requirements, the spokeswoman said.

Heart Inflammation

The Epoch Times in July submitted a FOIA, or a request for non-public information, to the CDC for all reports from a team that was formed to study post-vaccination heart inflammation by analyzing reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a system run by the CDC and the U.S. Food and Drug Administration.

The CDC not only said that the team did not conduct any abstractions or reports through October 2021, but that “an association between myocarditis and mRNA COVID-19 vaccination was not known at that time.”

That statement was false.

Clinical trials of the Pfizer and Moderna COVID-19 vaccines detected neither myocarditis nor pericarditis, two types of heart inflammation. But by April 2021, the U.S. military was raising the alarm about post-vaccination heart inflammation, and by June 2021, the CDC was publicly acknowledging a link.

The CDC previously corrected the false statement but did not say whether its teams had ever analyzed VAERS reports.

In reference to myocarditis abstraction from VAERS reports—this process began in May 2021 and continues to this date,” the CDC spokeswoman said in an email.

The CDC has still not released the results of analyses.

Data Mining

The CDC promised in January 2021 that it would perform a specific type of data mining analysis on VAERS reports called Proportional Reporting Ratio (PRR). But when Children’s Health Defense, a nonprofit, asked for the results, the CDC said that “no PRRs were conducted by the CDC” and that data mining “is outside of th[e] agency’s purview.”

Asked for clarification, Dr. John Su, who heads the CDC’s VAERS team, told The Epoch Times in an email that the CDC started performing PRRs in February 2021, “and continues to do so to date.”

The CDC is now saying that both the original response and Su’s statement were false.

The agency didn’t start performing PRRs until March 25, 2022, the CDC spokeswoman said. The agency stopped performing them on July 31, 2022.

The spokeswoman said it “misinterpreted” both Children’s Health Defense and The Epoch Times.

Children’s Health Defense had asked for the PRRs the CDC had performed from Feb. 1, 2021, through Sept. 30, 2021. The Epoch Times asked if the response to the request was correct.

The spokeswoman said the CDC thought “data mining” referred only to Empirical Bayesian (EB) data mining, a different type of analysis that the Food and Drug Administration has promised to perform on VAERS data.

“The notion that the CDC did not realize we were asking about PRRs but only data mining in general is simply not credible, since our FOIA request specifically mentioned PRRs and their response also mentioned that they did not do PRRs. They did not say ‘data mining in general,'” Josh Guetzkow, a senior lecturer at The Hebrew University of Jerusalem who has been working with Children’s Health Defense, told The Epoch Times via email.

There is also no credible reason why they waited until March 31, 2022, to calculate PRRs, unless it was in response to our initial FOIA filed in December 2021, which was rejected on March 31, 2022—the same day they say they began their calculations. It means the CDC was not analyzing VAERS for early warning safety signals for well over a year after the vaccination campaign began—which still counts as a significant failure,” he added.

Read more here...

Tyler Durden Fri, 08/12/2022 - 15:40

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Spread & Containment

TechCrunch+ roundup: Down-funnel growth metrics, RIF planning, is e-commerce aggregation over?

It’s hard to argue with the proverb “measure twice and cut once,” especially when it comes to laying off employees.

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In the video game Katamari Damacy, players control an avatar who rolls a sticky ball that captures anything it touches. The goal is to create a sphere large enough to become a star or moon.

E-commerce aggregators work in much the same way by purchasing smaller brands, then optimizing their manufacturing and sales channels to boost market share.

This was effective in a pre-vaccine era when consumers stopped visiting stores, but is the brand-rollup model still viable today?


Full TechCrunch+ articles are only available to members
Use discount code TCPLUSROUNDUP to save 20% off a one- or two-year subscription


“Decreased consumer confidence, inflated brand value, and a freeze in investment capital are creating a perfect storm,” says David Wright, co-founder and CEO of Pattern, an e-commerce accelerator. “Unless aggregators change how they operate, their future is bleak at best and nonexistent at worst.”

Scaling an online business until it’s large enough to flip sounds great, but Wright (who clearly has a vested interest) says small brands should partner with companies that can help them navigate the market, not swallow them whole.

“It’s comparable to the financial crisis of 2008, when poor financial products were lumped together in order to diversify risk and make them look better than they actually were,” he writes.

“We all know how that turned out.”

Thanks for reading — I hope you have a great weekend.

Walter Thompson
Editorial Manager, TechCrunch+
@yourprotagonist

Pitch Deck Teardown: Five Flute’s $1.2M pre-seed deck

Follow-on funding is harder to come by, but seed-stage founders who have a strong idea and good presentation skills can still close rounds.

To wit: Five Flute, an issue-tracking platform for hardware product managers, recently raised a $1.2M SAFE note to ramp up its marketing and hire more technical talent.

Five Flute’s founders shared their slightly redacted pitch deck with us. Besides the standard slides for TAM and GTM strategies, their presentation does a compelling job of describing the problems to be solved and why they believe they’re poised for success:

“We’ve felt this pain personally.”

Dear Sophie: Which immigration options are best for a decentralized team in the US?

lone figure at entrance to maze hedge that has an American flag at the center

Image Credits: Bryce Durbin/TechCrunch

Dear Sophie,

We just raised a $20 million Series A, and we need to hire more engineers to fully develop our product.

In addition, we’d like to bring our overseas PEO contractors to the States to join us more locally and in-timezone.

We’re excited about being decentralized — which immigration options are best for us?

— Elated Entrepreneur

To optimize for growth, study your down-funnel metrics

Illustration showing man tweaking funnel with lever to optimize for growth; growth marketing down funnel

Image Credits: erhui1979 (opens in a new window) / Getty Images

Early-stage startups put a lot of time and energy into marketing and acquisition: These levers direct new customers into the top of your sales funnel to drive growth. And investors love growth.

But in August 2022, they like revenue even better, which is why Jonathan Martinez says companies should turn their attention to down-funnel metrics.

“Varying messaging by user cohort is your largest lever for moving users through the funnel,” writes Martinez in his latest TechCrunch+ post.

“It’s imperative to slice users into their respective buckets, because it opens the opportunity for unique targeting and messaging.”

How to conduct a reduction in force: Planning, execution and follow-up

Office chairs piled in corner of empty office

Image Credits: Pulp Photography (opens in a new window) / Getty Images (Image has been modified)

It’s hard to argue with the proverb “measure twice and cut once,” especially when it comes to laying off employees.

Few managers have overseen a reduction in force, which is why Nigel Morris, co-founder and managing partner of QED Investors, has been sharing a five-page document with his portfolio company CEOs to give them guidance.

“We broke the process down into three parts: planning, execution and follow-up,” he writes in a TechCrunch+ post that condenses the advice he’s giving the founders he works with.

“The unavoidable reality is that while you’ll need to conduct the RIFs in an organized manner that is grounded in strong business rationale, there is always an overarching need to deliver the message with empathy and respect.”

7 investors discuss why edtech startups must go back to basics to survive

Graduation cap as a part of laptop; edtech investor survey 2022

Image Credits: Boris Zhitkov (opens in a new window) / Getty Images

Pre-pandemic, edtech was not an especially frothy sector: In 2019, these startups received approximately $7 billion in VC funding, according to Crunchbase.

Last year, that figure rose to $20 billion after efforts to limit the spread of COVID-19 impacted students of every age.

To learn more about how edtech is faring during the current downturn, Natasha Mascarenhas spoke to seven VCs about the advice they’re offering portfolio companies, where edtech is crossing over into other sectors, and how they prefer to be pitched:

  • Ashley Bittner and Kate Ballinger, Firework Ventures
  • Jan Lynn-Matern, founder and partner, Emerge Education
  • Malvika Bhagwat and Kriti Bansal, Owl Ventures
  • Jomayra Herrera, partner, Reach Capital
  • Rebecca Kaden, general partner, Union Square Ventures

“I would say the past few years have been more of an anomaly, and we are getting back to a more sustainable pace,” said Reach Capital partner Jomayra Herrera.

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