Startup funding will be more competitive after Silicon Valley Bank collapse

By Ashley Portero

March 14, 2023

Raising money for a startup can be challenging in the best environment.

But founders should expect more competition than ever after the failure of Silicon Valley Bank.

The California bank was a major player in the technology and venture capital industry before it was seized by federal regulators last week. The bank’s failure — the second largest in U.S. history — reverberated across South Florida’s startup scene and sent founders scrambling to secure funds for payroll and other expenses.

Silicon Valley Bank, which opened a branch in the Brickell Financial District last year, worked with a number of local ventures, including medical tech firm Neocis and elder tech startup Papa. It also signed on as a partner of the eMerge Americas conference, a global technology conference taking place in Miami Beach next month.

It’s unclear if the bank failure will delay or impact the eMerge conference. A representative did not respond to a request for comment.

Miami-based Papa had minimal exposure to the bank collapse, a spokesperson told Miami Inno. A majority of the startup’s funds are held at another bank.

On Monday U.S. regulators said it would insure all of the deposits at the Silicon Valley Bank in a move to promote confidence in the nation’s banking system. Under the plan all depositors, even those whose holdings exceed the $250,000 insurance limit, can access their funds. The government stressed the deposits will not be covered by taxpayers, but will come from a $100 billion fund set up after the 2008 financial crisis.

Several startups affiliated with accelerator Endeavor Miami were depositors at Silicon Valley Bank, said Managing Director Claudia Duran. The news that deposits would be covered was a relief, but she is still advising founders to monitor their costs and prepare for a challenging funding environment.

“They should reach out to their current investors if they need funding or ensure that their financials are in order before pitching their business to potential investors,” Duran said.

Four of Fuel Venture Capital’s 33 portfolio companies had exposure to Silicon Valley Bank, said Managing Partner Maggie Vo. The Miami-based venture capital firm has been in communication with those businesses to come up with contingency plans, if needed. So far, none of the companies are at financial risk. However, the firm is advising those businesses to forecast their minimum cash requirements as a precaution.

Vo said being headquartered in Miami is a factor that reduced the firm’s exposure to the bank failure.

“Most founders in Miami have a relationship with SVB but it’s not the only bank that companies turn to,” she said. “You’ll find a little bit more diversity by nature because we’re here.”

Entrepreneurs should remember that investors are going to be hyper-focused on minimizing risk. Founders should be in frequent communication with their current investors and focus on highlighting the value proposition of their product to customers.

“This will test the founders and their ability to bounce back and be resilient during tough times,” Vo said. “This is a factor investors will look into before backing a company.”

James Cassel, chairman and co-founder of Miami-based investment banking firm Cassel Salpeter & Co., said it was too soon to know what the long-term impact could be for the region’s tech economy. As of now, it’s unclear how many local companies had relationships with Silicon Valley Bank.

“A large part of the fallout may be based on the psychological effect of the collapse,” he said. “Keep in mind that before the last few days, tech companies and biotech companies were already in a challenging environment to raise capital.”

At the end of the day, great companies will always stand out, said Florida Funders Partner Saxon Baum.

He expects other debt providers will eventually emerge to replace Silicon Valley Bank and become larger players in the state’s tech ecosystem. Fewer checks may be written, but the capital is still there to back innovative ventures.

“I think that the best founders and their companies will still be effective in raising money,” he said.

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Banks seek to reassure South Florida depositors their accounts are safe

By David Lyons

March 13, 2023

There’s no need for South Florida consumers to make a run on their local banks, even though the stock prices of financial institutions large and small took a pounding on Wall Street, industry executives and advisers said Monday.

Between federal insurance and the strength of the region’s financial institutions, bank customers can be confident that their money is safe after regulators took over two banks in California and New York during the weekend.

“The depositors have nothing to be concerned about because all of our banks in South Florida are very strong,” said Ken Thomas, a longtime analyst who is president of Community Development Fund Advisors in Miami.

“Any bank with an FDIC label is really safe,” Thomas said, referring to the industry-backed Federal Deposit Insurance Corp. fund that protects accounts up to $250,000.

[ RELATED: President Biden tells US to have confidence in banks after Silicon Valley Bank and Signature Bank collapse ]

That is, unless the person is a stockholder in the “banks that have taken hits.”

Those banks — Silicon Valley Bank of Santa Clara, California, and Silvergate Bank of New York — were designated as risks to the banking system by the federal government over the weekend, a move that empowered regulators to shore up uninsured deposits. Authorities also created a new path to funding for any bank in need of additional cash.

Nonetheless, bank executives were busy speaking to their customers on Monday to calm their nerves and reassure them that the Silicon Valley Bank and Silvergate Bank takeovers did not constitute a repeat of the financial collapse of 2008, when bad housing loans nearly tanked the entire economy.

“My sense is that a lot of bankers and executives are reaching out to their client base,” said attorney Greg Bader, who advises banks for the Gunster law firm in Fort Lauderdale.” The Florida Bankers Association is supporting its members. The association is coordinating efforts to provide outreach to depositors to give them information so they can see the state of the industry and reassure them about the government efforts that took place.”

“I’d have to say hats off to them,” he said of federal regulators. “They did a very good job of backstopping depositors here.”

But Bader cautioned there could be more failures of banks whose investment situations mirror those of Silicon Valley and Silvergate.

“I certainly don’t think the couple of banks that have failed so far are the last ones,” he said. “There will be definitely more, in my opinion.”

That’s due to the “dramatic rise in interest rates over a short period of time,” which forced the value of bonds purchased by the banks as investments to decline.

Letter of reassurance

Keith Costello, CEO and co-founder of Locality Bank in Fort Lauderdale, which became operational just last year, sent a letter to his customers and investors declaring their money is safe while the bank is in “excellent shape.”

“Fortunately, we are a new FDIC-insured bank, which puts us in a very strong position,” he wrote.

The executive explained that Silicon Valley Bank and Silvergate Bank “took significant losses in the securities they held on their balance sheet. When this was disclosed, and they announced that they needed to raise capital to make up for the losses, depositors panicked and withdrew funds rapidly.”

Costello said Locality’s position is on the opposite end of the spectrum.

“We have been operating in the new higher interest rate environment since we opened in January of last year,” he wrote. “We don’t have a portfolio of low-interest securities or loans. And we are extremely liquid, having only just started.”

[ RELATED: A major bank failed. Here’s why it’s not 2008 again ]

In a telephone interview, Costello said he had been up since 4 a.m. Monday speaking to customers.

“Thankfully the FDIC and the Treasury and Federal Reserve all announced a solution which is what we would expect them to do at a time like this, which is to guarantee that depositors are protected,” he said. “I put myself out there with all of our clients. That’s all people want to do is have a conversation with somebody.”

Keep your eggs in many baskets

Still, Costello is recommending that people should look to establish “multiple bank relationships” instead of keeping their money in one place.

“No matter how big a bank is [remember 2009], they are not immune,” he said in his letter. “The best defense is the old expression, ‘Don’t keep all your eggs in one basket’, especially with the price of eggs!”

John Heller, a Fort Lauderdale-based CPA and director at Marcum, the public accounting and business advisory firm, agreed that multiple individuals and business operators should do business with more than one bank, particularly given the $250,000 ceiling for FDIC-insured deposits.

“I don’t know what percentage of individuals have more than $250,000 in any one bank.” Heller said. “It’s really the businesses that need to be more concerned.”

If there is a run on a bank that’s holding an account owner’s last $10,000 or $1,000 and there’s no access, the depositor is stuck.

“If they need it tomorrow, that’s not helpful,” Heller said.

Consumers weren’t the only ones who were worried after the weekend of regulatory maneuvering in Washington.

[ RELATED: Will it take market crash for Congress to raise debt limit? ]

There is an unknown number of South Florida businesses that are customers of Silicon Valley Bank, which caters to technology company startups. The bank opened a branch on Brickell Avenue in Miami two years ago to take advantage of the city’s growing technology sector.

In a buoyant September 2021 news release, the bank announced its arrival with “a team of commercial bankers” to lend money to participants in “Florida’s dynamic innovation sector.”

The company said it was working with “several hundred Florida-based technology and life science companies and investors,” providing commercial banking, private banking and wealth management services “to technology and life sciences companies of all sizes and their investors.”

Regardless of what happens to the bank, Heller pointed out, borrowers will still have to repay what they owe.

“They should expect to keep repaying their loan,” he said. “They certainly owe the money and somebody is going to collect it. ”

Those who had business loan applications in progress will likely have to go somewhere else to borrow money.

“Every business should keep two or three banking relationships going for when they need to shop,” Heller said.

Commercial lending continues

Technology aside, the rest of the commercial lending business is doing well in South Florida, namely on the strength of continuing strong employment and the influx of new residents, said Jim Cassel, co-founder and chairman of Cassel Salpeter & Co. of Miami, an independent investment banking firm that helps middle market and emerging growth companies.

The firm announced Monday it helped Quick Shift Capital of Boca Raton obtain money for a financing business that caters to independent used car dealers and wholesalers. The money came from Synovus Bank of Georgia.

“The economy’s still doing very well, driven by the consumer and employment increases.” Cassel said. “The community banks are lending; they are just being a little more cautious.”

Yet, he said, there is a lot of existing commercial debt that will be coming due over the next couple of years, “that has to be financed at significantly higher [interest] rates.”

“If the cash flows have grown, the borrowers can support that,” he added. But he can’t believe that South Florida will be immune to a recession that many believe will be the result of an economic slowdown.

“Maybe Palm Beach and Fisher Island will be fine, and maybe off Las Olas [Boulevard] will be fine,” he said. ”Other places will have an effect. We’ve seen it before.”

Staff writer David Lyons can be reached at dvlyons@SunSentinel.com

 

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Deal Opportunities Still Exist in the Lower Middle-Market

By Demitri Diakantonis
March 3,  2023

With daily conversations going on about the lack of deals and a looming recession, how about some positive news? Deals, at least according to one middle-market investment banker, are still happening. But where and how?

“We’re dealing with the lower middle-market, sub-$100M deals,” says James Cassel, co-founder of Miami-based investment bank Cassel Salpeter & Co. “People are being opportunistic. On the buy-side, people are starting to pay lower multiples. We’re starting to see a reset in valuations, but it’s going to take time.”

Cassel Salpeter advises on a number of sectors including aerospace and defense, healthcare and technology.

We knew from the beginning that M&A was going to be a challenge this year. Some dealmakers are hopeful that the second half of the year will be better, but no one has a crystal ball of exactly when conditions will improve. Financing remains a problem with higher interest rates. Fundraising for private equity is sputtering.

On the other hand, environments like this tend to favor strategic buyers who can swoop in at lower prices. And the emergence of family offices – another group with a long-term view – can add to the excitement.

All-in-all though, Cassel sees more of a glass half-full given he works in the lower end of the middle market. “I don’t buy that the world is coming to an end,” he adds. “Deals are getting done, but they’re taking longer to close. People are being cautious. I would say more than half our deals are add-on acquisitions. PE has plenty of plenty of money. Corporates are in good shape from cleaning up their balance sheets.”

What’s your view on the road ahead in the lower middle-market? Will deals pick up or stay flat? Let me know your thoughts at ddiakantonis@themiddlemarket.com. – Demitri Diakantonis

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Cassel Salpeter & Co. Secures Debt Financing for Quick Shift Capital LLC

Cassel Salpeter & Co., an independent investment banking firm that provides advisory services to middle market and emerging growth companies in the United States and worldwide, today announced that it represented Quick Shift Capital LLC (“Quick Shift”) in securing commercial debt financing from Synovus Bank; the funding is set to support the continued growth of the business.

Quick Shift is a family-owned company headquartered in Boca Raton, Fla. A floorplan financing company founded in 2017, Quick Shift caters to independent used car dealers and wholesalers, with a focus on luxury vehicles, while demonstrating a sustained commitment to service, customer-centric solutions, and innovation. 

“Enabling founders like Zach to grow their business and reach their full potential is why we do the work we do,” said Cassel Salpeter Managing Director Philip Cassel, who led the assignment helping Quick Shift identify and evaluate financing options and assisting throughout the due diligence and closing process. “Zach and his team will achieve great things and I am excited to see the company grow in the years to come.” 

“We partnered with Cassel Salpeter to help us grow our business by exploring financing options,” added Quick Shift President Zach Green. “Phil helped us find an attractive credit facility that more than exceeded our expectations. It was a pleasure working with Phil and I would not hesitate to give Cassel Salpeter our highest recommendations.”

Other professionals who assisted in closing the transaction include Blake Goddard and James Hauck of the Asset-Based Lending, Specialty Finance group of Synovus Bank; Andrew Comiter of Comiter, Singer, Baseman & Braun LLP, Brian Levy of Brian R Levy PA, Michael Ullman of Ullman & Ullman, P.A., together counsel to the borrower; and Ronald Weiner and Anisa Abdullahi of Arnall Golden Gregory LLP, counsel to the lender.

How to Prepare if Your Company is Being Acquired

By Gail Dutton
January  16, 2023

If the letter of intent to acquire your company has been signed and the news made public, you might be asking what happens next.

If so, you’re not alone. With several acquisitions announced during JP Morgan week and the IPO window all but sealed, M&As will be a top exit strategy for 2023.

How to Prepare if Your Company is Being Acquired

Company executives will hustle to accumulate the relevant documents into a data room and prepare for the transition, and employees will likely wait and worry. Here’s a look – for employees and the overall company – at how to not only survive, but thrive during and after an acquisition.

What Employees Can Do to Prepare

Expect the company culture, policies and procedures to change. Buyers often allow the company they acquired to operate much as it has for a period of time after the deal closes, but eventually, it will be folded into the larger organization.

When the terms of the acquisition are announced, look at the details surrounding compensation, bonuses and stock options. The provisions of the acquisition can be complicated, even for employees. Therefore, “Make certain you understand the rules, and that you get good advice (that’s pertinent to) your own tax situation,” Dave Roberson, president of RoseRyan, a ZRG company, told BioSpace. Roberson has led 25 acquisitions as either buyer or seller throughout his career, including the April acquisition of RoseRyan by ZRG.

The objective, he said, is to make decisions intentionally. Some windows of decision may be open for only 30 days, so it behooves employees to understand their deadlines and act in their own self-interest rather than assuming someone will look out for them.

Looking Out For Your Own Best Interests

Once the acquisition is complete, employees who were acquired should make it a point to prove their value to the acquiring company.

“One of my mentees has been acquired twice in the past 18 months,” Roberson said. “I’ve advised him to really understand the universe he’s moving into. The best thing someone in that position can do is to execute each task very well, so your value is clear to the acquirer.”

That helps you create a place for yourself within the larger company over time, thus enhancing career stability. Remember, he said, “The acquired company will go away at some point.”

In practice, this means positioning yourself for your next career step. This may mean developing a special area of expertise that is likely to become valuable within your industry.

In the case of Roberson’s mentee, it meant transitioning from a generalist to a cloud computing specialist. When his second company was acquired by a cloud company, his new skill set suddenly became more valuable. “The goal is to help the company that just bought your company succeed…and to exceed the targets that were set,” Roberson said.

This entails not only adding value but expanding your network into the acquiring company.

“As soon as you go to a new place, get to know your team, get to know everyone your team works with, and then get to know people who don’t work with your team. Start building a network within this new company, so people know you and what you do. That goes a long way toward helping you succeed,” Roberson said.

Ultimately, even if you leave that organization, you will have a larger network that may bring opportunities to your attention.

How Managers Should Prepare

When an acquisition is in the discussion stages, the information should be tightly controlled – not only to stem any insider trading concerns but to staunch the rumor mill and retain staff. “By the time the deal is announced publicly, you already will have briefed your staff and probably will have had at least one town hall meeting to let employees know what’s happening and what to expect,” Ira Leiderman, managing director, healthcare, Cassell Salpeter & Co., told BioSpace.

Retention plans and packages already should be developed, and any new roles for staff should have been identified. At this point, “Internal working groups form to plan for integration while the finance and legal teams work toward closing the transaction.”

“When preparing your staff for the take-over, start (early-on) by formulating a strategy to identify and retain critical talent,” Mike Knowles, a managing director specializing in HR and M&A at BDO, advised BioSpace. Retention bonuses, paid upon the transaction’s closing, are key incentives.

“Non-financial retention strategies also can be effective,” he continued. “They include providing opportunities for high performers to gain valuable transaction knowledge and experience with specific transaction project roles.”

Establish Open Lines of Communication and Build Trust

What generally is more challenging is blending the cultures of the two companies. “Some of the smaller companies are a cross between corporate, family and academic culture, so there’s a lot of camaraderie. That may go away in a more structured or more bureaucratic organization…yet those little cultural things could make a big difference for people,” Leiderman pointed out. “People hate change.”

Establishing an environment of trust is important, and that starts long before any acquisition. “Employees need to trust not only what you’re saying now, but that the deal is good for employees as well as shareholders,” Margery Fischbein, managing director, healthcare, Cassel Salpeter & Co., told BioSpace.

To that point, Knowles elaborated, “Communicate regularly and as transparently as you can with employees who are not ‘inside the tent’ without disclosing sensitive information, even if it’s to say there are no new updates. It helps maintain credibility and trust among employees.

For managers, provide talking points, FAQs and coaching sessions to help them answer direct and challenging questions and concerns from employees.” Be sure to coordinate communications with the buyer’s communications team to ensure consistency in messaging and to foster cooperation.

During the transition period, Roberson said he updated his staff monthly for at least six months.

Importantly, “Make sure the employees understand what’s in it for them,” Roberson said. “They know that the shareholders, owners or founders gets lots of money when they sell the company, but what do they get? Stability? More career opportunity? A bonus?” Unless employees understand the value the acquisition brings to them, resentment can build.

Take Care of Your Employees

Reductions in Force (RIFs) are common features of acquisitions. When they happen, “People need to be treated with respect,” Roberson stressed. That means financial respect, through severance or other financial packages, as well as respect for their capabilities and careers, through references and networking connections. Also, “When you have to do a RIF, get it over with quickly…so people can move on.”

Acquisitions are a fact of life for innovative biopharma companies. When they’re executed with care, they truly can be win-win situations.

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Trustee Makes Further Distribution in 1 Global Capital LLC, 1 West Capital LLC, Bankruptcy Cases

Distribution Represents Cumulative Recovery of 46.5%

December 22, 2022 11:32 ET | Source: 1 GC Collections LLC

Miami, FL, Dec. 22, 2022 (GLOBE NEWSWIRE) — James S. Cassel, the Liquidating Trustee of the 1 GC Collections Creditors’ Liquidating Trust and Chairman and Cofounder of the investment banking firm Cassel Salpeter & Co., today is proud to announce an interim distribution of $6.9 million to more than 3,750 creditors, representing a third distribution of 2.5% yielding a recovery to date of 46.5%, following an intensive team effort to maximize value of the underlying merchant cash advance assets and causes of action of 1 Global Capital LLC.

1 Global Capital and 1 West Capital both operated in the financial services industry, primarily by providing direct merchant cash advances to small businesses across the United States. They filed for bankruptcy in July of 2018 after experiencing a liquidity crisis precipitated by pending SEC investigations and an inability to raise new capital. After the bankruptcy filing, the bankruptcy court appointed the new management team led by Cassel which quickly developed a strategy to aggressively maximize the merchant cash advance portfolio of over $275 million. The team methodically analyzed the underlying assets, market tested values, prepared a detailed plan and strategy to maximize value, and cooperated with the fraud investigations by several federal and state government agencies to forge a path to significant recoveries for investors, while minimizing litigation and related costs.

“We have worked diligently to maximize recoveries via continued liquidation of estate assets and pursuit of causes of action. We have coordinated efforts with the SEC, DOJ on disgorgement and restitution matters and with the SEC appointed receiver on estate claims in related company receivership cases. We have successfully negotiated to resolution significant claims objections,” said Cassel. “It is a testament to the team of professionals who worked diligently to continue the recovery. To date the estate has recovered well over $132 million of value for assets that were distressed by a Chapter 11 bankruptcy, allegations of fraud, and numerous federal and state investigations.”

While these cumulative distributions provide a significant recovery to over 3,500 investors who had invested in the companies, the Liquidating Trust will continue to monetize assets and pursue causes of action that will generate further returns to creditors.

Added Cassel: “I would like to thank the team of professionals at Baker McKenzie, Development Specialists, Inc. along with special counsel Genovese Joblove & Battista and Greenberg Traurig for their professionalism and contributions to this collaborative effort.”

About Cassel Salpeter & Co.:

Cassel Salpeter & Co., LLC is an independent investment banking firm that provides advice to middle market and emerging growth companies in the U.S. and worldwide. Together, the firm’s professionals have more than 50 years of experience providing private and public companies with a broad spectrum of investment banking and financial advisory services, including: mergers and acquisitions; equity and debt capital raises; fairness and solvency opinions; valuations; and restructurings, such as 363 sales and plans of reorganization. Co-founded by James Cassel and Scott Salpeter, the firm provides objective, unbiased, results-focused services that clients need to achieve their goals. Personally involved at every stage of all engagements, the firm’s senior partners have forged relationships and completed hundreds of transactions and assignments nationwide. The firm’s headquarters are in Miami. Member FINRA and SIPC. More information is available at www.CasselSalpeter.com

About Development Specialists, Inc. (DSI):

DSI is a leading national provider of management consulting and financial advisory services, including turnaround consulting, fiduciary roles, financial restructuring, litigation support, operational wind-down oversight and forensic accounting services. Clients include business owners, corporate boards of directors, financial services institutions, secured lenders, bondholders, unsecured creditors and creditor committees. For more than 40 years, DSI has been guided by a single objective: maximizing value for all stakeholders. With its highly skilled and diverse team of professionals, offices throughout the United States and in Europe, and an unparalleled range of experience, DSI not only achieves that objective, but has also built a solid reputation as an industry leader. For more, visit www.dsiconsulting.com.

About Baker Mackenzie:

Complex business challenges require an integrated response across different markets, sectors and areas of law. Baker McKenzie’s client solutions provide seamless advice, underpinned by deep practice and sector expertise, as well as first-rate local market knowledge. Across more than 70 offices globally, Baker McKenzie works alongside our clients to deliver solutions for a connected world. www.bakermckenzie.com About

Greenberg Traurig:

Greenberg Traurig, LLP (GT) has approximately 2100 attorneys in 41 locations in the United States, Latin America, Europe, Asia, and the Middle East. GT has been recognized for its philanthropic giving, diversity, and innovation, and is consistently among the largest firms in the U.S. on the Law360 400 and among the Top 20 on the Am Law Global 100. Web: www.gtlaw.com Twitter: @GT_Law.

Media Contacts:
Todd Templin
BoardroomPR
954-370-8999/954-290-0810
ttemplin@boardroompr.com

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Whether Fired or Tired, Young Guns Are Leaving Silicon Valley

With the fear of recession in sight, investors are becoming more cautious and sharpening their demands on start-ups.

In her November 10, 2022 article for Le Monde Caroline Talbot writes a subscriber only article about the recent trend of company founders exiting their companies as they grow and go public.

Talbot interviews Cassel Salpeter Chairman and Cofounder James Cassel among other sources to examine why these unicorn company founders are leaving even as their companies take off.

Citing increasing economic pressures for Silicon Valley, Talbot notes that shareholders and company maturity can take their toll on company founders known for their outside-the-box thinking.

Talbot notes the changes at Twitter culminating in Elon Musk seizing the helm as well as the departures of Ben Silbermann at Pinterest, Emily Weiss at Glossier and Joe Gebbia at Airbnb.

While highlighting how recession worries have investors demanding more control while cutting into founder freedoms, she underscores how some founders are able to find that Goldilocks fit and remain with their companies.

Among other examples when founders remained with their company after being acquired, she cites the $90 million sale of EveryMundo, which helps airlines sell tickets in real time, to Pros.

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Moderna’s Second Act: is the Momentum Sustainable?

By Gail Dutton
September  26, 2022

Moderna catapulted into public consciousness after developing an effective COVID-19 vaccine in less than a year. Now that most people in North America and Europe are vaccinated and the pandemic is diminishing, the company is looking for its second act.

An ambitious plan is well underway to ensure Moderna continues to thrive. Not surprisingly, it is piggybacking off its recent success in mRNA vaccines with nearly four dozen programs in development.

“That’s one of the beauties of the mRNA technology – it has a lot of applications,” said Margery Fischbein, managing director of the healthcare practice at investment bank Cassel Salpeter & Co., in an interview with BioSpace. “Therefore, the portfolio is not as diverse as the numbers would suggest.”

This is because several programs are combinations (such as flu and SARSCoV-2, or multiple SARS-CoV-2 variants) and vaccines for individual viral mutations.

But, this can be very efficient. Melissa J. Moore, Ph.D., CSO, scientific affairs at Moderna, elaborated on the technology’s utility.

“While each mRNA medicine provides a unique instruction set based on the nucleotide sequence in the mRNA, the manufacturing processes and means of mRNA delivery are the same across many different medicines,” she told BioSpace. “Thus, we can create new medicines just by changing the sequence of nucleotides in the mRNA.”

The Pipeline

Of more than 40 vaccines and therapeutics in development at Moderna, about a dozen are geared to COVID-19. Phase III candidates include three COVID-19 vaccines for wildtype SARS-CoV-2 and the Omicron variant, as well as vaccines for flu, respiratory syncytial virus and cytomegalovirus.

In Phase II, Moderna is advancing vaccines for cancer and Zika virus, as well as five COVID-19 vaccines for combinations of wildtype, Beta and Delta variants.

It’s also developing a next-generation COVID-19 vaccine that can be stored between 2 and 5°C. This would be a significant improvement over the deep-frozen temperature requirements of the initial vaccine.

At the earlier stages, 17 programs are in Phase I development. They include vaccines for HIV, cancer, Nipah, flu, RSV, COVID-19 and three systemic intracellular therapies. Preclinical programs include 13 vaccines for a wide range of applications, including Epstein Barr, flu and COVID-19 and therapeutics for cystic fibrosis and Crigler Najjar syndrome.

The ability to build vaccines using the existing mRNA platform “provides a huge advantage compared to traditional medicines, as we don’t have to reoptimize every parameter (e.g., the PK/PD properties and toxicology profile) for every new medicine,” Moore pointed out.

Another advantage is that Moderna does not need dedicated manufacturing equipment for each vaccine or therapeutic. “One mRNA medicine manufacturing facility can make many different vaccines and therapeutics simply by changing the mRNA sequence,” she explained.

All of these programs, however, are in development. This is, by definition, aspirational. Currently, Moderna is accruing orders, approvals and authorizations for its existing products.

The U.S. government recently agreed to purchase another 66 million doses of Moderna’s bivalent booster containing Omicron and wild-type SARS-CoV-2. The Canadian government purchased another 4.5 million doses of that bivalent booster in late August. The U.K.’s Medicines and Healthcare Products Regulatory Agency recently authorized that bivalent booster and the EMA Committee for medicinal products for human use recommended its use in adolescents in the EU.

Financial Ups and Downs

Moderna’s unaudited financial results for the first half of 2022 show sales of $10.5 billion, and approximately $18.1 billion in cash and investments. The company has bought back 18 million shares of stock so far – 9 million of which were bought in Q2 for $1.3 billion. Recently, it announced an open-ended plan to buy back another $3 billion worth of its stock.

“This is something companies often do when they have excess cash and are profitable,” Fischbein said.

Moderna’s second quarter financial results showed year-over-year growth in product sales of 8%, grant revenue of 32% and collaboration revenue of 94% (due to a project with AstraZeneca). This resulted in a 9% year-over-year increase in revenue.

At the same time, however, the cost of sales increased 84%, R&D costs were up 69% and total operating expenses were 78% greater than in the same quarter of 2021. Overall, net income declined 21%, compared to Q2 2021. Moderna reported Q2 earnings per share were $5.24, which exceeded analysts’ expectations but were still less than the same quarter last year.

Moderna has $21 billion worth of signed, advance purchase agreements but despite strong sales, share prices are down from their high of approximately $430 in October 2020 to around $142 at close of business Friday.

Watching the decline, analysts have generally lowered their target prices for the stock, with a consensus target price of $227.75, according to MarketBeat. Despite authorizations for Moderna’s COVID-19 booster shots in children in the U.S., Canada and Australia, and adolescents in the EU, analysts predict sales to fall throughout 2023 and 2024 before rebounding, according to Investors.com.

Rapid Growth

Moderna is in the fortunate but potentially challenging position of rapid growth. The company has grown from 760 employees in 2018 to more than 3,000 today – quadrupling in only four years.

When any company grows so quickly, maintaining the company culture is challenging, Fischbein said. “A major area where they’ve grown has been in manufacturing, which tends to be both capital- and employee-intensive.”

With that comes the challenge of keeping everyone mission-focused, Ira Z. Leiderman, managing director of the healthcare practice at Cassel Salpeter & Co., added.

“It’s hiring senior level people a notch below the C-suite who can manage their departments and programs and do their best to get a return on investment,” he told BioSpace. “Keeping everyone rowing in the same direction is a challenge for any young company.”

Richard Brandenstein, founding partner at FBR Law, said, “A huge mistake businesses make during periods of rapid growth is not imbursing employees. Your workforce will realize you are growing and high performers who don’t feel they are treated equally may leave.”

Neither Cassel Salpeter & Co. nor FBR was referring directly to the inner workings of Moderna.

Looking Forward

The company appears to have set a positive precedent with regulators.

Already, “Moderna’s platform has been proven safe and efficacious, and it has developed a good rapport with regulators at the FDA and EMA, which is a testament to their clinical affairs staff as well as their ability to execute fairly large clinical studies very effectively and efficiently,” Leiderman said.

Whether Moderna can sustain its current level of success is unknown. “This is biotech,” he said, which often encounters surprises even in late-stage clinical trials. “The good thing is that the company has the resources it needs,” to afford some misses and support some successes.

In the coming decades, Moore said she envisions Moderna as a “leader in mRNA medicines, with a broad portfolio of vaccines and therapeutics,” with rapid development and manufacturing capabilities. There’s a more than fair chance she’s right.

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Who’s Flying Now?

Enabling more team members to travel by private jet or charter makes sense— except when it doesn’t.

By Dale Buss
July 29, 2022

The boom in corporate travel on private aircraft is taking on a new dimension: It’s not just for CEOs and board members any longer.

More executives and managers at lower levels now are getting on company planes or taking charters as a productivity measure. A growing number of companies also are using the prospect of private flying as a perk to lure executive or managerial talent. Employers are scrambling to formulate policies to cover this new twist: Who gets to go private, and when?

“Larger aircraft for longer range are still mainly being used for board activity,” says John Owen, CEO of private-flight provider Airshare. “But we’re also seeing engagement teams using smaller aircraft. There’s a little more carte blanche for them to use private aircraft when they need them, versus the previous practice of having to travel [only] with someone who ranks above them.”

Doug Gollan sees this expansion as founder of Private Jet Car Comparisons, a buyer’s guide for time-share seats. “Companies, having bought 25 or 50 hours for a CEO, now are buying a couple hundred hours after the CEO sees how efficient it is, and allowing more of the management team to fly privately,” he says.

The practice has caught on in part because the productivity benefits of private aviation have become more apparent in the last couple of years. “Face-to-face meetings have become really important again,” says Ramy Sidholm, head of PNC Aviation Finance. Meetings are easy on planes and insulated from distractions. Executives don’t get snarled in the vagaries of commercial travel or exposed to its riskier environs while Covid still rages.

The difficulties of airline travel have shunted more lower-level corporate travel to private aviation. Even as commercial schedules have recovered, pilot shortages and other factors mean airlines have drastically culled routes to many of America’s secondary and tertiary cities.

“If you’re a large, multinational corporation and you’re putting a factory, a switching station or a data warehouse in a relatively inexpensive place like Tucson, Arizona, or Alliance, Texas, you stuck it there because it’s inexpensive to build and operate there,” says Greg Raiff, CEO of Private Jet Services. “But it’s tough to get there by air.”

In fact, dangling private flights has become a recruiting tool. “With the Great Resignation, so many people are looking for perks, certainly at the senior level, and if a company has a vast footprint, it’s something many executives are considering more than ever,” says Joseph Smith, aviation director for the Cassel Salpeter investment-banking firm.

Essentially, more companies are pivoting to the sort of approach that Walmart has used for decades. America’s largest retailer employs its fleet of a couple dozen private planes as a corporate livery service, dispatching lower-level executives and managers to string together visits to its 10,500 stores in 24 countries. In the U.S., per Walmart’s business model, most stores are still in smaller places like Gardner, Kansas, and Easley, South Carolina.

But not every company is going in this direction. It’s understood, for instance, that General Motors hasn’t budged on its private-flight policies lately, though the automaker operates 118 facilities scattered across the United States.

Here are some ideas for dealing with this trend:

  • Work it forward. The broadening of private air travel within an organization should cascade back into any planning for new aircraft or budgeting for time shares on planes, especially at a time of continued tight supplies of both planes for purchase and time-share seats.
    “We work with new prospects to give them a total trip and cost analysis on an annual basis before they buy anything,” Owen says. “This will help them build a budget for each department or individual, which creates a little more structure around what they’re going to put into effect.”
  • Ponder the perk. CEOs and boards can use private flying as a lure or reward on an individual basis, or open up the practice to new categories, such as vice presidents. “Companies need to think about the development of their people, their business, whether they want to convey a change in culture that the best and brightest are going to be allowed to use these kinds of assets to do their job and to do it right and fast,” says David Mayer, partner with the Shackelford, Bowen, McKinley & Norton law firm.
  • Expect pleasant surprises. Private flying is increasingly cost competitive with airline flights these days, especially if the destination is a second- or third-tier city, the travel is frequent and regular, and a number of employees are involved. “If you start seeing that the company has four or more employees traveling the exact same route two days a week, for instance, chances are you should be looking at some version of a corporate shuttle,” Raiff says.
    Joseph Smith, Cassel Salpeter Adds Smith, “You may not do it for one person unless it’s an emergency. But for a team performing due diligence or looking for a new acquisition, it can be very efficient to pack six to a dozen people on a private plane.”
  • Attune the bureaucracy. Many corporate travel departments planners have stayed away from private aviation “because it’s high stakes and highly visible; they don’t mess with it,” Raiff says. But with more of their traditional internal clientele now becoming eligible for private travel, this part of corporate operations may need to rise to the occasion.
    “Find a consultant and get smart before you start spending money,” he says. “Learn about the private-aviation space. It’s here and it’s not going away.”
  • Beware tax snares. With expanded rosters of individual participants comes potential exposure of more travelers to the IRS. So aircraft-use policies should take into account the tax ramifications of business and personal transportation of permitted passengers on an employer-provided aircraft.
    “It can involve the flight’s ‘fringe-benefit’ value to these new travelers unless they otherwise pay for the flight,” Mayer says.
  • Don’t over-glamorize. C-Suite and board members may still get to ride on bigger, faster and more expensive planes than underlings. But the differences in their on-board environs are mainly going to be a matter of a little more personal space and maybe a guaranteed bathroom on the plane, or the presence of a flight attendant.

It’s not like the top brass are receiving foot massages while a regional manager can only expect a bag of peanuts. “The wealthiest client we have only wants pizza and sour gummy worms on the plane; it’s not about the caviar,” Raiff says. “What people value about private aviation is that it’s a time machine. It gets there faster. It is, in fact, private, and it allows people to be more productive, and that goes for everyone.”

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mRNA’s Next Act: Cancer Vaccines and Gene Editing

By Gail Dutton
July 26, 2022

The potential for mRNA technology extends far beyond the COVID-19 vaccines that made it a household word. Coming applications include therapeutic vaccines for cancer and other diseases, vaccines for latent conditions such as shingles and herpes, and, eventually, mRNA therapeutics for conditions where immune activation is unnecessary.

“The applications for mRNA are quite broad, because, basically, you are giving information to a cell to make any protein you want,” Pierre Kemula, B.Sc., CFO at CureVac told BioSpace. “That’s the beauty of mRNA.”

Bespoke Vaccines

Vaccine developers are currently exploring multivalent mRNA vaccines. With influenza, for example, “The idea is that you will be able to make your vaccine a bit later in the season and be closer to the circulating strain of virus. Ultimately, this allows researchers to develop bespoke vaccines that are tailored to specific regional outbreaks,” Kemula said. “The more antigens, the broader the efficacy of the vaccine will be.”

Moderna’s bivalent booster vaccine for COVID-19 is another more widely known example. Two vaccines are in Phase II/III trials now, targeting multiple variants of the SARS-CoV-2 virus. The goal is to start a booster campaign for vulnerable populations this fall, involving at least one of those vaccines.

Notably, multivalent vaccines can also target multiple conditions. For example, Kemula said, “With more antigen, you can do combinations, maybe targeting several things, such as flu and COVID.” CureVac’s COVID-19 vaccine candidates are co-developed with GSK and have a second-generation vaccine backbone, engineered to address COVID-19 variants as well as a range of other diseases. There are also potential combination vaccines. One candidate, targeting four strains of flu, entered Phase I earlier this year.

Moderna’s pipeline shows another vaccine, mRNA-1230, currently in preclinical development targeting COVID-19, flu and respirational syncytial virus (RSV).

Beyond Immune Activation: “The Holy Grail”

“Today, the sweet spot of mRNA is prophylactic vaccines – the low-hanging fruit – but the future is to transfer that immune activation potential to cancer vaccines,” Kemula said.

“The goal of cancer vaccines is to elicit a targeted immune response against the tumor to fight the disease or protect the patient by stabilizing the condition,” he explained. “Cancer vaccines have been a challenge for the industry. There’s no real cancer vaccine out there.”

To that end, CureVac acquired Frame Cancer Therapeutics in June. The acquisition offers the ability to identify a broad panel of neoantigens based on structural changes in the cancer genome. “This enables much broader applications. One of the consequences is that – we hope – we’ll be able to have a customized vaccine based upon (combining) a few recurring antigens as well as personalized approaches,” Kemula said.

Cancer vaccines hold great potential but, currently, “A lot of the oncology research (involving mRNA) is in preclinical Phase I trials, so it will be quite a while before we see them,” Margery Fischbein, managing director of the healthcare practice at investment bank Cassel Salpeter & Co. cautioned.

As mRNA therapies advance, “The Holy Grail is to go beyond immune activation,” Kemula said. “There’s a huge field where you can encode for any protein with mRNA.” In theory, it will become possible to inject patients with mRNA that encodes for certain missing or deficient enzymes and thus help them regain homeostasis and potentially cure the disease.

“One of the challenges is that sizeable quantities of mRNA may need to be injected to treat chronic disease, which may result in tolerability issues,” he noted.

There are easier applications within that space, however, and they probably will be tackled first. “Think of the eye. It’s a privileged organ (meaning the immune system does not initially attack), and its small, so you don’t need to inject so much material and thus don’t have as much of an immune response. That’s probably an area where mRNA could be additive to existing therapies,” Kemula suggested.

Gene editing applications also may have potential. Here, mRNA could be used to express cas9 or other proteins, and eliminate the inability for repeat dosing that currently challenges gene therapies. “mRNA is a transient technology,” Kemula pointed out. “You go in, express a protein, and after some time it’s gone.” In certain genomic medicine applications, that can be an advantage.

For prophylactic vaccines – particularly for COVID-19 – development speed and initial antibodies levels were the most important criteria, allowing mRNA vaccines to protect as many people as possible as quickly as possible. For a durable response, however, the body also needs T cell responses. “It’s just a matter of time before the industry gets there,” Kemula predicted.

With a robust pipeline in mRNA therapeutics and vaccines, Ira Z. Leiderman, managing director of Cassel Salpeter predicted, “more and faster approvals, though not as fast as for the SARS-CoV-2 vaccines.” That prediction is based upon regulators’ presumed comfort level with mRNA technology and the vast numbers of people who have received mRNA vaccines with few issues.

That said, whatever happens depends upon the outcome of clinical trials, many of which are just being planned. “There’s still a lot of learning that has to occur,” Fischbein cautioned.

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