Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Results are In. Orion had contract revenues of $159.2 million, a 9% decrease from the prior year’s $174.9 million. We had revenue of $175 million. Gross profit was at $5.8 million or 3.7% of revenue, down from $12.8 million or 7.3% of revenue in the first quarter of 2022. The Company had a net loss of $12.6 million, or $0.07 per share, compared to a loss of $4.9 million, or $0.16 per share. Adjusted EBITDA was a negative $4.1 million, or (2.6)% margin compared to $5.2 million or 3.0% last year.
Credit Facility and Property Sale. The Company had reached an agreement with a private lender and expects to have a new ABL credit facility completed shortly. The facility consists of a $38 million term loan and revolving credit facility of $65 million and will be used to retire Orion’s existing credit facility and for general corporate purposes. As reported previously, Orion has a contract for the East West Jones properties in Texas, with the purchase price being $36 million. It is expected to close in the third quarter of 2023.
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MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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1Q23 Loss Reported With Progress Review. Maia Biotechnology announced a 1Q23 loss of $4.1 million or $(0.38) per share. Progress during the quarter included announcement of preliminary safety data from its lead trial in non-small cell lung cancer, THIO-101, and patient enrollment in Part B. Preclinical data was presented on THIO in liver cancer, an indication planned for the THIO-102 trial later in 2H23. Cash on March 31 was $7.6 million, excluding $5.75 million raised in a public offering completed in late April.
THIO-101 Part A Safety Results Were Presented. THIO-101 is the first trial testing THIO in combination with Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron. The data was from the Part A safety lead-in stage that tested a dose of 360 mg in 6 patients with advanced non-small cell lung cancer. There were no dose-limiting toxicities or safety issues reported. As of April 2023, the first two patients enrolled in Part A were still alive and reached survival endpoints of 10 and 9 months. Both patients have advanced Stage IV metastatic disease and had failed third and fourth line of therapy, with life expectancy of about 6 months.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q23 Results. All-time record revenue of $78.5 million, up 8.2% y-o-y. Currency translation negatively impacted reported revenue by $2.1 million. By geography, Americas revenue rose 17% to $48.4 million, Europe was down 2% on a reported basis and up 5% on a constant currency basis to $23.1 million, and Asia-Pacific revenue of $7 million was down 8% on a reported basis and down 3% on a constant currency basis. We were at $74 million.
Results Continued. But higher direct costs and expenses for advisors negatively impacted operating income. Direct costs were up 11.9% to 62.7% of revenue compared to 60.6% in 1Q22. Operating income was down 9% to $7.1 million from $7.7 million. Net income was down 29% to $3.5 million, or $0.07/sh. Adjusted EPS was $0.12/sh. We had projected EPS of $0.08 and adjusted EPS of $0.12.
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Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Second quarter financial results. Second quarter net income increased 45.6% to $12.3 million, or $0.96 per share (EPS), compared to the prior year period and rose 59.6% compared to the first quarter of fiscal year 2023. Revenues of $152.8 million increased 30.5% on a year-over-year basis and grew 15.2% compared to the prior quarter. The estimated impact from raw material volatility during the quarter resulted in a $1.7 million headwind that compressed gross margin by 1.1% to 20.2%. Adjusted EBITDA increased 38.4% to $22.4 million compared to $16.2 million during the prior year period and rose 37.0% compared to $16.4 million during the prior quarter.
Updating estimates. Management expects earnings in the third quarter to be higher than the second quarter and continues to expect fiscal 2023 earnings to be 15% to 20% higher than during fiscal year 2022. To err on the side of conservatism, we have trimmed our fiscal 2023 EBITDA, net income and EPS estimates to $93.3 million, $51.4 million, and $4.04, respectively, from $94.3 million, $53.1 million, and $4.18. Our revised net income estimate represents 15.1% growth year-over-year compared to 18.9% previously. Our 2024 EBITDA, net income, and EPS estimates are $106.8 million, $60.8 million, and $4.80, respectively.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gray Television is a multimedia company headquartered in Atlanta, Georgia. We are the nation’s largest owner of top-rated local television stations and digital assets in the United States. Our television stations serve 113 television markets that collectively reach approximately 36 percent of US television households. This portfolio includes 80 markets with the top-rated television station and 100 markets with the first and/or second highest rated television station. We also own video program companies Raycom Sports, Tupelo Honey, PowerNation Studios and Third Rail Studios.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Solid Q1 results. The company reported quarterly revenue of $801 million, 2.9% better than our estimate of $778.5 million, and adj. EBITDA of $162 million, which was in line with our estimate. Results are illustrated in Figure #1 Q1 Results. While all business segments reported stronger than expected revenues, political revenues of $8 million was the biggest surprise versus our estimate of $2 million.
Favorable advertising momentum. In spite of the macroeconomic headwinds core advertising is pacing ahead of last year. We believe that a good portion of its positive advertising momentum is coming from revenue synergies. In addition, Auto advertising appears to be rebounding, pacing up double-digits. Looking ahead, the company is also likely to benefit from annual Net Retransmission revenue growth, when it renews 58% of its MVPD contracts later this year. Moreover, management expects Net Retransmission revenue growth to accelerate in 2024.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q23 Results. FAT Brands reported 1Q23 revenue of $105.7 million, up 8.5% y-o-y from $97.4 million in the year ago quarter. System-wide sales growth was 9.9%. Same Store Sales were up 4.3%. FAT reported adjusted EBITDA of $19.2 million in the quarter, up from $15.1 million in 1Q22. Adjusted net loss for the quarter was $23.5 million, or a loss of $1.43 per share, compared to a net loss of $18.5 million, or a loss of $1.13 per share, last year. We had projected revenue of $105 million and a net loss of $17.3 million, or a loss of $1.04 per share.
Organic Growth. Organic growth at FAT Brands remains strong. A total of 41 new units were opened during 1Q and plans are to open 45 additional units in 2Q. For the full year, a total of 175 new units are expected to open, representing over 25% growth from last year. The pipeline remains robust with development agreements for more than 1,000 new locations.
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Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. Energy Fuels also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up commercial-scale production of REE carbonate. Its corporate offices are in Lakewood, Colorado, near Denver, and all its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch in-situ recovery (“ISR”) Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, has the ability to produce vanadium when market conditions warrant, as well as REE carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also on standby and has a licensed capacity of 1.5 million pounds of U3O8 per year. In addition to the above production facilities, Energy Fuels also has one of the largest NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.
Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Energy Fuels reported 2023-1Q results in line with expectations absent non-recurring items. UUUU reported revenues of $19.6 million (versus our $18 million est.) largely due to the previously-announced sale of uranium to the government. Net income was $114.7 million ($0.72 per share) with a $116.5 million net gain on the sale of the Alta Mesa project. Absent the gain, the company would have reported a slight loss, in line with our projections.
UUUU’s rare earth elements (REE) plan is becoming clearer. Phase 1 of a plan to separate rare earth elements such as the valuable NdPr. has begun. When completed in 2023/24, UUUU will be able to produce 800-1,000 metric tons (0.8-1.0 million kg) of “commercial quantities of separated NdPr.” At the current spot price of $64 per kg, sales could approach $64 million. Sales of other separated REE would be incremental. And, production is expected to grow 2-3 times upon completion of Phase 2 in 2026 leading us to believe annual sales from REE could be several hundred million. For a company that has not generated annual revenues above $30 million the last ten years, the prospect of generating hundreds of million in sales is exciting.
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ACCO Brands Corporation is one of the world’s largest designers, marketers and manufacturers of branded academic, consumer and business products. Our widely recognized brands include AT-A-GLANCE®, Esselte®, Five Star®, GBC®, Kensington®, Leitz®, Mead®, PowerA®, Quartet®, Rapid®, Rexel®, Swingline®, Tilibra®, and many others. Our products are sold in more than 100 countries around the world. More information about ACCO Brands, the Home of Great Brands Built by Great People, can be found at www.accobrands.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
A Return to Normalcy? We are hopeful 2023 will transition back to a normal operating environment after nearly three years of COVID impacted results. We are already seeing positive signs of normalcy in the back-to-school business and chip availability should help return PowerA back to its pre-COVID growth trajectory.
Cash Flows. Operating cash flow for the first three months was a use of cash of $23.2 million, compared to cash used of $104.2 million in the prior year due to improved working capital. Management continues to expect free cash flow for 2023 to exceed $100 million.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The “Who’s Who” of Tech and Finance Join Forces in Blockchain Collaboration
A new partnership between financial giants, tech behemoths, media monsters, and leaders in digitization just announced plans to launch what they call Canton. What is Canton? In a press release dated May 9, The Canton Network says it is “the industry’s first privacy-enabled interoperable blockchain network designed for institutional assets and built to responsibly unlock the potential of synchronized financial markets.” What does that mean? We’ll take it one piece at a time below.
The announcement describes the Canton Network as building toward being an interoperable blockchain with privacy features designed for the institutional asset management industry. It aims to allow “previously siloed” financial assets to be able to synchronize, making it possible to interconnect diverse financial markets.
The list of partners is a “Who’s Who” list of companies that are considered among the best in their individual specialties.
Canton Participants include, in alphabetical order:
3Homes, ASX, BNP Paribas, Broadridge, Capgemini, Cboe Global Markets, Cumberland, Deloitte, Deutsche Börse Group, Digital Asset, The Digital Dollar Project, DRW, Eleox, EquiLend, FinClear, Gambyl, Goldman Sachs, IntellectEU, Liberty City Ventures, Microsoft, Moody’s, Paxos, Right Pedal LendOS, S&P Global, SBI Digital Asset Holdings, Umbrage, Versana, VERT Capital, Xpansiv, and Zinnia.
The announcement proclaims that The Canton Network will provide “a decentralized infrastructure that connects independent applications built with Daml, Digital Asset’s smart-contract language.” The result will be “a ‘network of networks’, allowing previously siloed systems in financial markets to interoperate with the appropriate governance, privacy, permissioning and controls required for highly regulated industries.”
The Canton Network intends to enable financial institutions to experience a safer and reconciliation-free environment where assets, data, and cash can synchronize freely across applications. The end product will be opportunities for financial institutions to offer new innovative products to their clients while enhancing their efficiency and risk management.
An example provided by Canton is asset registers and cash payment systems which are distinct and siloed systems in today’s markets. With the new Canton Network, a digital bond and a digital payment can be composed across two separate applications into a single transaction, guaranteeing simultaneous exchange without operational risk. Similarly, a digital asset could be used in a collateralized financial transaction via connection to a repo or leveraged loan application.
Bloomberg calls the new venture “a collaborative effort that could be crucial to ledger technology in the finance market.” In addition, the group is striving to integrate “disparate institution applications,” which could have a positive impact on the entire industry.
The press release expalained that until Canton, smart contract blockchain networks have not achieved meaningful adoption among financial institutions and other enterprises because of three significant shortfalls:
The lack of privacy and control over data: other chains have shortcomings around privacy that prevent the use of the technology by multiple regulated participants on the same network. There are currently no other blockchains that can offer data protection or control at any layer of its network.
Other blockchains have had to accept trade-offs between control and interoperability: other chains require operators to forfeit their full control of applications by using a shared pool of validators to gain interoperability.
The inability to scale: with applications competing for global network resources and the inherent capacity limitations caused by how public blockchains operate, achieving the scale and performance financial institutions need remains challenging.
The Canton Network expects to remove these obstacles by balancing the decentralization of a network with the privacy and controls needed to operate within a sound regulatory environment.
The network expects to raise the bar on safety and soundness in blockchain financial interactions by enabling network users to safeguard permissions, exposure, and interactions across Canton, to comply with security, regulatory and legal requirements.
The network can connect innovative blockchain solutions in market today, such as Deutsche Börse Group’s D7 post-trade platform and Goldman Sachs’ GS DAP™, while retaining privacy and permissioning. As more Daml-built applications go into production this year and beyond, the number of connections on the Canton Network are expected to grow exponentially. For example, one application’s monthly notional traded exceeds the most active crypto token volumes.
Canton Network participants will begin testing interoperability capabilities across a range of applications and use cases in July.
The network will bring together blockchain applications built with Daml, the smart-contract language devised by Digital Asset. The team-up is the result of years of blockchain research and development by the tech and finance industry’s giants that are involved.
Even a Short-Lived Default Would Hurt Money Market Fund Investors
While the U.S. Treasury is now at the mercy of politicians negotiating, positioning, and stonewalling as they work to raise the debt ceiling to avoid an economic catastrophe, money kept on the sidelines may be at risk. Generally, when investors reduce their involvement in stocks and other “risk-on” trades, they will park assets in money market funds. These investment products are now paying the highest interest rates in 15 years, which has made the decision to “take money off the table” even easier for those involved in the markets.
But, are investors experiencing a false sense of security?
Background
Money Market Funds (MMF) are mutual funds that invest in top credit-tier (low-risk) debt securities with fewer than 397 days to maturity. The SEC requires at least 10% to be maturing daily and 30% to be liquid within seven days. The acceptable securities in a general MMF include Treasury bills, commercial paper, and even bank CDs. The sole purpose of a money market fund is to provide investors with a stable value investment option with a low level of risk.
Unlike other mutual funds, money market funds are initially set and trade at a $1 price per share (NAV). As interest accrues, rather than the value of each share rising, investors are granted more shares (or fractional shares) at $1. However, the funds are marketed-to-market each day. Typically market prices don’t impact short-term debt securities at a rate above the daily interest accrual. But “typically” doesn’t mean always. Occasionally, asset values have dropped faster than the daily interest accrual. When this happens, the fund is worth less than $1 per share. It’s called “breaking the buck.”
When a money market fund “breaks the buck,” it means that the net asset value (NAV) per share of the fund falls below $1. In addition to quick valuation changes, it can also happen when the fund’s expense ratio exceeds its income. You may have gotten a notice during the extremely low interest period that your money market fund provider was absorbing expenses. This was to prevent it from breaking the buck.
Nothing is Risk Free
Just under $600 billion has moved into money-market funds in the past ten weeks. This is more than flowed into MM accounts after Lehman Brothers went belly up which set off panic and flights to safety. Currently, $5.3 trillion is invested in these funds; this is approaching an all-time record.
The Federal Reserve has been lifting interest rates at a record pace, the level they have the most control over is the bank overnight lending rate, or Fed Funds. This impacts short-term rates the most. Along with more attractive rates, stock market investors have become nervous. This is another reason asset levels in MMFs are so high – a high-yielding money-market fund that is viewed as risk-free looks attractive compared to the fear of getting caught in a stock market sell-off.
As discussed before, there are risks in money-market funds. And right now, the risks may be peaking. This is because government spending has exceeded the ability for the U.S. to borrow and pay for it under the current debt ceiling limit. The limit was actually reached last January when it was addressed by kicking the problem further down the road. Well, the road now ends sometime in June. In fact, U.S. Treasury Secretary Janet Yellen said the U.S. government may run out of cash by June 1 if Congress doesn’t act, and that economic chaos would ensue if the government couldn’t pay its obligations. Not paying obligations would include not paying interest on maturing U.S. Treasuries.
It isn’t a stretch to say the foundation of all other securities pricing is in relationship with the “risk-free” rate of U.S. debt. That is to say, price discovery has as its benchmark that which can be earned in U.S. debt which has been presumed to be without risk of non-payment.
What Happens to Money Market Funds in a Default?
In a default, the U.S. Treasury wouldn’t pay the full principle it owes on liabilities such as maturing Treasury debt – short term term government debt with extremely short average maturities is a staple of market funds. That is why the price of one-month Treasury debt has dropped recently, sending its yield up to above 5% from a 2023 low of about 3.3%. It has driven expected returns of MMFs up as well, but there is a risk that these short maturities may not get fully paid on time. Many fund providers’ money market funds would then break the $1 share price.
Breaking the buck can have significant consequences for investors, particularly those who rely on money market funds for their cash reserves. Because money market funds are considered a low-risk investment, investors may not expect to lose money on their investment. If a money market fund breaks the buck, it would diminish investor confidence in the stability of these funds, leading to a potential run on the fund and broader implications for the financial system.
Likelihood of Breaking the Buck
Money market funds breaking the buck is a relatively rare occurrence. According to the Securities and Exchange Commission (SEC), there have been only a few instances where MMFs have broken the buck in the history of the industry. The most significant of these occurred in 2008 during the financial crisis when one of the oldest money market funds, Reserve Primary Fund, dropped below $1 due to losses on its holdings of Lehman Brothers debt securities. This event led to a run on many money market funds creating significant instability in the financial system.
Since the Reserve Primary Fund incident, regulatory changes have been implemented to strengthen the money market fund industry and reduce the risk of funds breaking the buck. These changes include requirements for funds to maintain a minimum level of liquidity, hold more diversified portfolios, and limit their exposure to certain types of securities.
Take Away
Nothing is risk-free. Banks such as Silicon Valley Bank found that out when their investment portfolio, largely low credit risk, normally stable securities, wasn’t valued at what they needed it to be worth to fund large withdrawals.
Stock market investors that were drawn in invest in to rising bond yields also found that when yields keep rising, the values of their portfolios can drop just as quickly as if they were invested in stocks during a sell-off. While no one truly expects the current tug-of-war over debt levels in Washington to lead to a U.S. default, one can’t be sure at a time when there have been many firsts that we thought could never happen in America.
MIAMI, May 08, 2023 (GLOBE NEWSWIRE) — Motorsport Games Inc. (NASDAQ: MSGM) (“Motorsport Games” or the “Company”), a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world, will report its financial results for the first fiscal quarter of 2023 on Thursday, May 11, 2023, after market close. Management will host a conference call and webcast on the same day at 6:00 p.m. ET to discuss the results.
Participants may access the live webcast on the Company’s investor relations website at https://ir.motorsportgames.com under “Events.” The call may also be accessed by dialing 1 (844) 826-3033 from the U.S., or by dialing 1 (412) 317-5185 internationally.
About Motorsport Games: Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.
Website and Social Media Disclosure:
Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):
NEWTOWN, Pa., May 08, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced an upcoming presentation at the International Society of Investigative Dermatology (ISID) International Epidermolysis Bullosa Symposium, which is being held in Osaka, Japan through May 9, 2023.
The presentation will take place on May 9, 2023, at 1:00 p.m. Japan Standard Time. During the presentation, Onconova and the principal investigators will provide an overview of its investigator-sponsored clinical program evaluating rigosertib monotherapy in squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). The Company previously announced that both of the program’s evaluable participants achieved a complete clinical response of all cancerous skin lesions. Onconova plans to review these findings with regulators to determine the most expeditious path toward approval for rigosertib in RDEB-associated SCC.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “RDEB-associated SCC is an ultra-rare disease with a tragically poor prognosis. The most common cause of death for patients with RDEB is the development of metastatic SCC, driven by the overexpression of PLK-1. Our investigator-sponsored clinical program has produced very promising results based on the complete resolution of the SCCs in patients with RDEB treated to date, suggesting rigosertib can address a pressing unmet need in this indication and may have therapeutic potential in other more common SCCs driven by PLK-1. We look forward to discussing these results with the clinical and scientific community at the upcoming ISID symposium.”
A copy of the slides from the oral presentation will be available on the “Scientific Presentations” section of the Onconova website following the conclusion of the symposium.
About RDEB-associated SCC
RDEB is caused by insufficient expression of type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC1,3.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as evaluating opportunities for potential clinical studies in additional indications.
Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).
Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.
Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Prioritizing Late-Stage Clinical CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication
Topline Results Expected in Fourth Quarter 2023 for Potentially Confirmatory Phase 3 Trial of TNX-102 SL for Fibromyalgia
Potentially Pivotal Phase 2 Trial of TNX-601 ER for Major Depressive Disorder (MDD) Enrolling; TNX-601 ER Represents an Innovative Approach for MDD through Restoration of Neuroplasticity and Neurogenesis
Cash and Cash Equivalents of Approximately $72.0 Million at March 31, 2023
CHATHAM, N.J., May 08, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent operational highlights.
“With much achieved already, we expect 2023 will continue to serve as an important milestone year for Tonix,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “The prioritization of key programs in our pipeline highlights our commitment to helping bring relief and value to patients suffering from diseases with limited or insufficient therapeutic options. We are pleased with the enrollment in our current RESILIENT Phase 3 study for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia. We are looking forward to topline results from the trial in the fourth quarter of this year. If successful, we believe it will be the second and final adequate and well-controlled efficacy trial required for filing a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA). Moreover, we believe we have satisfied all the other clinical and non-clinical requirements for an NDA submission. In addition, we are excited to have initiated enrollment in the potentially pivotal UPLIFT Phase 2 study of TNX-601 ER (tianeptine hemioxalate extended release tablets) for major depressive disorder (MDD). TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine restores neuroplasticity and neurogenesis rather than modulating neurotransmitter levels and activity.”
Recent Highlights—Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL: small molecule for the management of fibromyalgia (FM)
In March 2023 at the 5th International Congress on Controversies in Fibromyalgia, the Company presented positive efficacy and safety data from Phase 3 RELIEF Study of TNX-102 SL for the management of fibromyalgia. Titled “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results from the Randomized, Placebo Controlled RELIEF Trial”, the presentation displayed the data that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. In addition, TNX-102 SL was well tolerated with the most common adverse event associated with active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and led to only one discontinuation.
The Company recently announced new plans to eliminate the interim analysis to streamline the ongoing Phase 3 RESILIENT trial and to provide topline data in the fourth quarter of 2023. Target enrollment for the TNX-102 SL fibromyalgia study remains approximately 470 participants.
TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
In April 2023, enrollment of 63 participants was completed in the PREVAIL study, a Phase 2 study of TNX-102 SL for fibromyalgia-type Long COVID.
Topline results from the PREVAIL Phase 2 trial are expected in the third quarter of 2023.
In February 2023 at a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, the Company presented its analysis that the majority of Long COVID patients present with a constellation of symptoms including multisite pain, fatigue, sleep disorders and cognitive dysfunction or brain fog. These symptoms overlap with fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be one of several chronic overlapping pain conditions that have in common the neurological process called central sensitization.
TNX-601 ER: a once-daily orally-administered small molecule for the treatment of MDD, Posttraumatic Stress Disorder (PTSD), neurocognitive dysfunction associated with corticosteroid use and potentially Alzheimer’s disease
In March 2023, enrollment was initiated in the potentially pivotal Phase 2 ‘UPLIFT’ Study for the treatment of MDD. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023.
TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine induces a neuroprotective and resilient phenotype in both neurons and microglia under conditions of stress. The Phase 2 UPLIFT study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken orally once-daily for 6 weeks to treat MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 300 participants will be randomized in a 1:1 ratio into the two arms across approximately 30 U.S. sites, enrolling adult patients 18-65 years old. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity-associated binge eating disorder
In February 2023, enrollment began in the Phase 2 PREVENTION study of TNX-1900 for the prevention of migraine headache in chronic migraineurs. The double-blind, placebo-controlled study has a target enrollment of 150 participants at approximately 25 sites across the U.S, with topline results expected in the fourth quarter of 2023.
In January 2023, data from clinical and nonclinical studies were presented at the 16th Annual Headache Cooperative of the Pacific (HCOP) Winter Conference by collaborator Professor David Yeomans. The oral presentation titled, “Primary vs Secondary Sex Hormones and Migraine,” includes research sponsored and licensed by Tonix. Preliminary results from a positron emission tomography study in humans showed that intranasal delivery of a radioisotope of magnesium-potentiated oxytocin is delivered to the trigeminal ganglia, which have known roles in migraine headaches. In addition, preliminary results of data collected from isolated human trigeminal ganglia neurons in vitro show co-expression of oxytocin receptors and calcitonin gene-related peptide, which are believed to represent the first observation of oxytocin receptors in human trigeminal ganglia. Furthermore, the presentation highlights data which suggest a sex difference in oxytocin potency.
Tonix expects to initiate a potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the third quarter of 2023.
As previously disclosed, in 2022, Tonix received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS.
In March 2023, Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the Rare Disease Innovation and Partnership Summit. The presentation displayed data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors. The Mg2+ enhanced formulation of intranasal oxytocin is the basis for TNX-2900, in development to treat hyperphagia, or pathological over-eating, in children and young adult patients with PWS.
Immunology Pipeline
TNX-1500 (anti-CD40L monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
In May 2023, the IND for prevention of organ rejection in patients receiving a kidney transplant was cleared by FDA. A First-in-Human Phase 1 study is expected to initiate in the third quarter of 2023.The first indication for TNX-1500 will be prophylaxis of organ rejection in adult patients receiving a kidney transplant, but multiple additional indications are possible, including autoimmune diseases.
Tonix announced a research agreement with Boston Children’s Hospital to study TNX-1500 for the prevention of graft-versus-host diseases (GvHD) after hematopoietic stem cell transplantation (HCT) in animals. HCT from unrelated donors is a component of the treatment protocol for several hematologic malignancies, but GvHD complicates treatment and limits the success of engraftment after HCT. In April 2023, the Company announced the online publication of two papers in the American Journal of Transplantation by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with Tonix Pharmaceuticals1,2. The publications include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejections with an acceptable level of safety.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine to protect against smallpox and monkeypox (mpox) designed as a single-administration vaccine to elicit T cell immunity.
As previously announced, a Phase 1 study is expected to start in the second half of 2023.
In January 2023, the Company appointed Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease programs. Dr. Rosenberg is responsible for leading the Company’s clinical development efforts for vaccines, including TNX-801.
A publication describing the activity of TNX-801 to protect non-human primates against a lethal challenge with intra-tracheal monkeypox was published in the peer-reviewed journal, Viruses3.
*All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication.
1Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.022
2Miura, S., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025
3Noyce RS, et al. (2023). Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge. Viruses. 15(2):356. doi: 10.3390/v15020356
Recent Highlights—Corporate and Other
In April 2023, Tonix announced it is reallocating resources and cash to streamline its pipeline and focus on its mid- and late-stage clinical programs within its core CNS portfolio. The pipeline realignment prioritizes key near-term value drivers, reduces investment in several longer-term programs, particularly COVID-19-related studies, and delays the start of a PTSD study in Kenya.
Recent Highlights—Financial
As of March 31, 2023, Tonix had $72.0 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Net cash used by financing activities was approximately $11.5 million for first quarter 2023, compared to net cash provided by financing activities of $13.1 million for the same period in 2022.
On April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with AGP of up to $320.0 million in at-the-market offerings (“ATM”) sales. During the quarter ended March 31, 2023, the Company sold approximately 3.2 million shares of common stock under the Sales Agreement, for net proceeds of approximately $2.0 million. Subsequent to March 31, 2023, the Company has sold 0.9 million shares of common stock under the Sales Agreement, for net proceeds of approximately $0.5 million.
In January 1, 2023, the Company repurchased 16,700,269 shares of common stock under its share repurchase programs at an average price per share of $0.82 for a gross aggregate cost of approximately $13.6 million.
Cash used in operations was approximately $32.9 million for the first quarter ended March 31, 2023, compared to $31.0 million for the first quarter ended March 31, 2022.
Cash used by investing activities for the first quarter ended March 31, 2023, and 2022 was approximately $3.8 million and $20.2 million, respectively, related to the purchase of property and equipment.
First Quarter 2023 Financial Results
R&D expenses for the first quarter 2023 were $26.5 million, compared to $18.4 million for the same period in 2022. As planned, R&D expenses will be increasing during 2023 as we move our clinical development programs forward and invest in our development pipeline.
G&A expenses for the first quarter 2023 were $7.4 million, compared to $8.0 million for the same period in 2022. The decrease is primarily due to decreased employee-related and financial reporting expenses.
Net loss was $33.0 million, or $0.52 per share, basic and diluted, for the first quarter 2023, compared to net loss of $26.4 million, or $1.61 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the first quarter 2023 was 63,352,898 compared to 16,445,010 shares for the same period in 2022.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Share and Per Share Amounts) (unaudited)
Three Months Ended March 31,
2023
2022
COSTS AND EXPENSES:
Research and development
$
26,511
$
18,422
General and administrative
7,391
8,014
33,902
26,436
Operating loss
(33,902
)
(26,436
)
Interest income
897
19
Net loss
$
(33,005
)
$
(26,417
)
Net loss per common share, basic and diluted
$
(0.52
)
$
(1.61
)
Weighted average common shares outstanding, basic and diluted
63,352,898
16,445,010
See the accompanying notes to the condensed consolidated financial statements
1The condensed consolidated balance sheet for the year ended December 31, 2022 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
