Author: [email protected]

Release – ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Posted on by [email protected]

Research News and Market Data on ZVSA

Mar 25, 2024

Key Highlights:

  • Cholesterol Efflux MediatorTM VAR 200 on target to begin Phase 2a clinical trial in patients with diabetic kidney disease H1-2024.
  • Inflammasome ASC Inhibitor IC 100 preclinical program nearing completion, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
  • Inflammasome ASC Inhibitor IC 100 preclinical research funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) nearing completion, with potential for a second MJFF grant for further research.
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for obesity and metabolic syndrome expected to begin Q2-2024.

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

“Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates. A Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 is on target to be initiated in the first half of this year in patients with diabetic kidney disease; preclinical studies for indication expansion are underway for Parkinson’s disease, atherosclerosis, and obesity with Inflammasome ASC Inhibitor IC 100; and IND submission for IC 100 is expected by end of the year,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We view 2024 as a potentially transformative year for the company based on the value-building milestones that we expect to achieve over the next 12 to 15 months. I look forward to working with my leadership team and fellow Board members to execute a business and clinical strategy that has potential to position ZyVersa as a leading, innovative company developing transformative drugs for underserved patients with renal and inflammasome-mediated inflammatory diseases.” 

BUSINESS Update

CHOLESTEROL EFFLUX MEDIATORTM VAR 200 FOR RENAL DISEASE

  • Phase 2a clinical trial in patients with diabetic kidney disease is on target to begin in the first half of 2024.
  • CRO, George Clinical was engaged in December 2023 to initiate and manage the trial.
  • An IND amendment to study diabetic kidney disease was filed on February 16, 2024.
  • A central Institutional Review Board (IRB) approved the clinical trial protocol for trial initiation.

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

  • Inflammasome ASC Inhibitor IC 100’s preclinical program is nearing completion, with a planned IND submission in Q4-2024, followed by initiation of a Phase 1 clinical trial shortly thereafter.
  • Preclinical research funded by MJFF and conducted by researchers at University of Miami Miller School of Medicine to determine the potential of Inflammasome ASC Inhibitor IC 100 to block the damaging neuroinflammation that induces neural degeneration in Parkinson’s disease is nearing completion.
  • Research update and key findings were provided to MJFF project team on March 8, 2024.
  • Based on the findings, the MJFF project team suggested that the team apply for a second grant to further the research in an established animal model.
  • A scientific collaboration was initiated with an undisclosed partner to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for atherosclerosis in a well-established animal model.
  • Study is expected to conclude in H1-2024.
  • A scientific collaboration with inflammasome and neurology experts at University of Miami Miller School of Medicine to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for obesity and metabolic syndrome is expected to begin in Q2-2024.

YEAR END 2023 FINANCIAL RESULTS

Net losses were $98.3 million for the year ended December 31, 2023 (the “2023 Period”), an increase of $84.2 million compared to a net loss of $14.1 million for the “2022 Period,” which is comprised of the financial results of the company containing our operations prior to our business combination from January 1, 2022 through December 12, 2022, and our financial results after the business combination, from December 13, 2022 through December 31, 2022. A deferred tax benefit of $9.5 million for the 2023 Period, compared to $0.7 million tax benefit during the 2022 Period, resulted from the impairment of the in-process research and development.

Pre-tax losses were $107.8 million for the 2023 Period, an increase of $92.9 million compared to a pre-tax loss of $14.9 million for the 2022 Period. The higher net loss reported for the 2023 Period is primarily due to the impairment of in-process research and development and impairment of goodwill of $81.4 million and $11.9 million, respectively, compared to none for the 2022 Period. The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

Based on its current operating plan, ZyVersa expects its cash of $3.1 million as of December 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties. 

Research and development expenses for the 2023 Period were $3.2 million, a decrease of $2.6 million or 44.8% from $5.8 million for the 2022 Period. The decrease in research and development expenses was primarily due to spending for materials supplies for manufacturing in 2022 that were not required in 2023 as manufacturing was completed in 2022. 

General and administrative expenses for the 2023 Period were $11.2 million, an increase of $3.2 million or 39.7% from $8.0 million for the 2022 Period. The increase is primarily attributed to increased costs for legal and professional fees of $2.7 million, investor and public relations fees of $1.2 million, and increased director and officer insurance of $1.3 million, all due to increased costs associated with being a public company. These were offset by reduced business combination transaction costs of $2.2 million.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, IR Contact

Karen Cashmere
Chief Commercial Officer
[email protected]
786-251-9641

ZYVERSA THERAPEUTICS, INC. 
CONSOLIDATED BALANCE SHEETS 
  
    Successor 
    December 31, 
     2023   2022  
        
Assets       
        
Current Assets:     
 Cash $3,137,674  $5,902,199  
 Prepaid expenses and other current assets 215,459   225,347  
 Vendor deposits  –   235,000  
  Total Current Assets 3,353,133   6,362,546  
Equipment, net  6,933   17,333  
In-process research and development 18,647,903   100,086,329  
Goodwill  –   11,895,033  
Security deposit  98,476   46,659  
Operating lease right-of-use asset 7,839   98,371  
        
  Total Assets$22,114,284  $118,506,271  
        
Liabilities, Temporary Equity and Stockholders’ Equity    
        
Current Liabilities:     
 Accounts payable $8,431,583  $6,025,645  
 Accrued expenses and other current liabilities 1,754,533   2,053,559  
 Operating lease liability 8,656   108,756  
  Total Current Liabilities 10,194,772   8,187,960  
Deferred tax liability  844,914   10,323,983  
  Total Liabilities 11,039,686   18,511,943  
        
Commitments and contingencies    
        
 Redeemable common stock, subject to possible redemption,    
 0 and 1,880 shares outstanding as of December 31, 2023 and    
 2022, respectively –   331,331  
Stockholders’ Equity:     
 Preferred stock, $0.0001 par value, 1,000,000 shares authorized:    
 Series A preferred stock, 8,635 shares designated, 50 and 8,635 shares issued    
 and outstanding as of December 31, 2023 and 2022, respectively –   1  
 Series B preferred stock, 5,062 shares designated, 5,062 shares issued    
 and outstanding as of December 31, 2023 and 2022, respectively 1   1  
 Common stock, $0.0001 par value, 250,000,000 shares authorized;    
 4,052,119 and 257,604 shares issued at December 31, 2023 and 2022,    
 respectively, and 4,052,057 and 257,604 shares outstanding as of    
 December 31, 2023 and 2022, respectively 405   26  
 Additional paid-in-capital 114,300,484   104,584,147  
 Accumulated deficit (103,219,124)  (4,921,178) 
 Treasury stock, at cost, 62 and 0 shares at December 31, 2023    
 and 2022, respectively (7,168)  –  
  Total Stockholders’ Equity 11,074,598   99,662,997  
        
  Total Liabilities, Temporary Equity and Stockholders’ Equity$22,114,284  $118,506,271  
        
ZYVERSA THERAPEUTICS, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS 
  
          
   Successor  Predecessor 
   For the For the period  For the period 
   Year Ended December 13 through  January 1 through 
   December 31, December 31,  December 12, 
    2023   2022    2022  
          
          
          
Operating Expenses:       
 Research and development$3,207,573  $399,894   $5,407,859  
 General and administrative 11,213,201   420,174    7,605,205  
 Impairment of in-process research and development 81,438,426   –    –  
 Impairment of goodwill 11,895,033   –    –  
  Total Operating Expenses 107,754,233   820,068    13,013,064  
          
  Loss From Operations (107,754,233)  (820,068)   (13,013,064) 
          
Other (Income) Expense:       
 Interest (income) expense (457)  –    427,542  
 Change in fair value of derivative liabilities –   –    607,001  
          
  Pre-Tax Net Loss (107,753,776)  (820,068)   (14,047,607) 
  Income tax benefit 9,455,830   745,050    –  
  Net Loss (98,297,946)  (75,018)   (14,047,607) 
  Deemed dividend to preferred stockholders (7,948,209)  –    (10,015,837) 
  Net Loss Attributable to Common Stockholders$(106,246,155) $(75,018)  $(24,063,444) 
          
          
  Net Loss Per Share       
  – Basic and Diluted$(108.97) $(0.29)  $(0.99) 
          
  Weighted Average Number of       
  Common Shares Outstanding       
  – Basic and Diluted 975,035   257,604    24,194,270  

Release – Bitcoin Depot Reports Fourth Quarter and Full Year 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on BTM

March 25, 2024 8:05 AM EDT

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Earnings Webcast

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FY 2023 Record Revenue of $689 Million, Up 7% Year-over-Year

FY 2023 Net Income of $1.6 Million, Down 54% Year-over-Year

FY 2023 Record Adjusted EBITDA (non-GAAP) of $56 Million, Up 37% Year-over-Year

Strengthens Footprint and Continues Business Momentum in the First Quarter of 2024

Provides First Quarter 2024 Guidance for Revenue and Adjusted EBITDA

ATLANTA, March 25, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the fourth quarter and full year ended December 31, 2023. Bitcoin Depot will host a conference call and webcast at 11:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.

“Bitcoin Depot had its strongest year ever in 2023 as we delivered $689 million in revenue, $56 million in Adjusted EBITDA, and had sustained strength in customer traffic and transaction volume,” said Brandon Mintz, CEO and Founder of Bitcoin Depot. “We continued to advance our growth strategy by expanding the number of Bitcoin access points across North America while optimizing our footprint to drive an improvement in profitability. Looking ahead, Bitcoin Depot is well positioned to deliver profitable growth going forward while supporting our mission to safely, securely and efficiently bring Bitcoin to the masses. We see opportunities for accelerated market share growth and aim to have over 8,000 kiosks installed by the end of 2024, the largest installed fleet of Bitcoin ATMs in our history.”

Fourth Quarter and Full-Year 2023 Financial Results

Revenue in the fourth quarter of 2023 was $148.4 million, down 1% from $149.7 million for the fourth quarter of 2022. For the full year, revenue increased 7% to $689.0 million compared to $646.8 million in the prior year.

Gross Profit in the fourth quarter of 2023 was $17.9 million, up 23% from $14.6 million for the fourth quarter of 2022. Gross Profit margin in the fourth quarter of 2023 was 12.1% compared to 9.8% in the fourth quarter of 2022. For the full year, Gross Profit increased 64% to $87.8 million compared to $53.5 million in the prior year and Gross Profit margin was 12.8% compared to 8.3% in the prior year.

Total operating expenses were $17.0 million for the fourth quarter of 2023, compared to $14.8 million for the fourth quarter of 2022.  For the full year, operating expenses were $69.8 million compared to $55.8 million in the prior year.

Net loss for the fourth quarter of 2023 was $1.5 million, compared to a net loss of $0.5 million for the fourth quarter of 2022. For the full year, net income was $1.6 million compared to net income of $3.5 million in the prior year. 

Adjusted EBITDA, a non-GAAP measure, in the fourth quarter of 2023 was $9.0 million, compared to Adjusted EBITDA of $11.4 million for the fourth quarter of 2022. For the full year, Adjusted EBITDA was $56.4 million compared to $41.2 million in the prior year. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Cash and cash equivalents were $26.4 million as of the end of the fourth quarter of 2023.

2023 Highlights

  1. Completed software conversion to BitAccess across the Company’s full BTM fleet. The completion of the conversion vertically integrates Bitcoin Depot’s hardware and software, eliminating previous annual software licensing fees.
  2. Closed its previously announced business combination with GSR II Meteora Acquisition Corp. on June 30th and subsequently began trading on the Nasdaq on July 3rd.
  3. Announced multiple partnerships with convenience store brands with locations spanning across several states to increase Bitcoin Depot’s fleet of deployed kiosks, including FastLane, Gas Express, High’s, Majors Management, Stinker Stores, GetGo® Café + Market, and Jacksons Food Store.
  4. Expanded BDCheckout program into three additional states and over 725 additional locations across a variety of convenience store partners through an ongoing partnership with a leading global payments technology company.
  5. Announced distribution partnership with CORD Financial Services to distribute Bitcoin Depot kiosks across the U.S.
  6. Secured preferred BTM vendor status with National Retail Association, AATAC, a national trade association of retailers, distributors, vendor suppliers and partners for the convenience store and retail industries.
  7. Hired a new Chief Technology Officer to lead software development efforts.

Q1 2024 and Recent Highlights

  • Announced the sale of 50 new BTM kiosks to Sopris Capital as part of the Company’s franchise program.
  • Purchased 900 additional Bitcoin ATMs for Q1 2024 Expansion.
  • Announced expansion deal with a leading operator of convenience stores across 63 stores.
  • Announced deployment of 940 Bitcoin Depot kiosks in convenience store locations across 24 states beginning in Q1 of 2024.
  • Announced the expansion of the Company’s sales team with the hiring of 13 new sales representatives.

Guidance

Based on current market conditions, Bitcoin Depot expects consolidated revenue in the first quarter of 2024 to range between $137 million and $138 million compared to $163.6 million in the first quarter of 2023. Bitcoin Depot expects Adjusted EBITDA (non-GAAP) in the first quarter of 2024 to range between $5 million – $6 million compared to net income of $6.1 million and Adjusted EBITDA of $13.6 million in the first quarter of 2023.

For important disclosures about Adjusted EBITDA, see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Conference Call

Bitcoin Depot will hold a conference call at 11:00 a.m., Eastern time (8:00 a.m. Pacific time), today to discuss its financial results for the fourth quarter and full year ended December 31, 2023.

Call Date: Monday, March 25, 2024 
Time: 11:00 a.m. Eastern time (8:00 a.m. Pacific time)
U.S. dial-in: 646-307-1963
International dial-in: 800-715-9871
Conference ID: 2505953

The conference call will broadcast live and be available for replay here following the call.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

A replay of the call will be available beginning after 3:00 p.m. Eastern time on March 25, 2024 through April 1, 2024.

U.S. replay number: 609-800-9909
International replay number: 800-770-2030
Conference ID: 2505953

About Bitcoin Depot

Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations through its BDCheckout product. The Company has the largest market share in North America with approximately 6,339 kiosk locations as of December 31, 2023. Learn more at www.bitcoindepot.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, worldwide growth in the adoption and use of cryptocurrencies, and our guidance regarding our generation of revenue and Adjusted EBITDA for Q1 2024. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

 
BITCOIN DEPOT INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
 
  As of December 31, 
  2023  2022 
  (unaudited)    
Assets      
Current:      
Cash and cash equivalents $26,388  $37,540 
Cryptocurrencies  712   540 
Accounts receivable, net  245   263 
Prepaid expenses and other current assets  6,538   2,015 
Total current assets  33,883   40,358 
Property and equipment:      
Furniture and fixtures  635   618 
Leasehold improvements  172   172 
Kiosk machines – owned  24,222   15,234 
Kiosk machines – leased  20,524   36,591 
Vehicles  —   17 
Total property and equipment  45,553   52,632 
Less: accumulated depreciation  (20,699)  (13,976)
Total property and equipment, net  24,854   38,656 
Intangible assets, net  3,836   5,351 
Goodwill  8,717   8,717 
Operating lease right-of-use assets, net  484   302 
Deposits  412   17 
Deferred tax assets  4,027   — 
Total assets $76,213  $93,401 
 
BITCOIN DEPOT INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
 
  As of December 31, 
  2023  2022 
  (unaudited)    
Liabilities and Stockholders’ Equity and Member’s Equity      
Current:      
Accounts payable $8,320  $8,119 
Accrued expenses and other current liabilities  19,745   11,309 
Note payable  3,985   8,050 
Income taxes payable  2,272   647 
Deferred revenue  297   19 
Operating lease liabilities, current portion  319   228 
Current installments of obligations under finance leases  6,801   18,437 
Other tax payable  700   — 
Total current liabilities $42,439  $46,809 
Long-term liabilities      
Note payable, non-current  17,101   29,522 
Operating lease liabilities, non-current  279   247 
Obligations under finance leases, non-current  2,848   6,140 
Deferred income tax, net  805   1,239 
Tax receivable agreement liability  2,582   — 
Total Liabilities $66,054  $83,957 
Commitments and Contingencies (Note 22)      
Stockholders’ Equity and Member’s Equity      
Series A Preferred Stock, $0.0001 par value; 50,000,000 authorized, 3,125,000 shares issued and outstanding, at December 31, 2023  —   — 
Class A common stock, $0.0001 par value; 800,000,000 authorized, 13,671,691 shares issued, and 13,551,047 shares outstanding at December 31, 2023  1   — 
Class B common stock, $0.0001 par value; 20,000,000 authorized, no shares issued and outstanding at December 31, 2023  —   — 
Class E common stock, $0.0001 par value; 2,250,000 authorized, 1,075,761 shares issued and outstanding at December 31, 2023  —   — 
Class M common stock, $0.0001 par value; 300,000,000 authorized, no shares issued and outstanding at December 31, 2023  —   — 
Class O common stock, $0.0001 par value; 800,000,000 authorized, no shares issued and outstanding at December 31, 2023  —   — 
Class V common stock, $0.0001 par value; 300,000,000 authorized, 44,100,000 shares issued and outstanding at December 31, 2023  4   — 
Treasury stock  (279)  — 
Additional paid-in capital  17,933   — 
Retained earnings (accumulated deficit)  (30,991)  — 
Equity attributed to Legacy Bitcoin Depot  —   7,396 
Accumulated other comprehensive loss  (203)  (182)
Total Stockholders’ Equity (Deficit) and Equity Attributable to Legacy Bitcoin Depot $(13,535) $7,214 
Equity attributable to non-controlling interests  23,694   2,230 
Total Stockholders’ Equity and Member’s Equity $10,159  $9,444 
Total Liabilities and Stockholders’ Equity and Member’s Equity $76,213  $93,401 
 
BITCOIN DEPOT INC.
CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(in thousands, except share and per share amounts)
 
 Year ended December 31, 
 2023  2022 
 (unaudited)    
Revenue$688,967  $646,830 
Cost of revenue (excluding depreciation and amortization) 588,637   574,535 
Operating expenses:     
Selling, general, and administrative 57,046   36,991 
Depreciation and amortization 12,788   18,783 
Total operating expenses$69,834  $55,774 
Income from operations$30,496  $16,521 
Other (expense) income:     
Interest (expense) (11,926)  (12,318)
Other (expense) income (16,626)  118 
(Loss) gain on foreign currency transactions (289)  (380)
Total other (expense)$(28,841) $(12,580)
Income before provision for income taxes and non-controlling interest 1,655   3,941 
Income tax benefit (expense) (8)  (395)
Net income$1,647  $3,546 
Net income attributable to Legacy Bitcoin Depot unit holders 12,906   3,980 
Net income (loss) attributable to non-controlling interest 13,172   (434)
Net (loss) attributable to Bitcoin Depot Inc.$(24,431) $– 
Other comprehensive income (loss), net of tax     
Net income$1,647  $3,546 
Foreign currency translation adjustments 66   (110)
Total comprehensive income$1,713  $3,436 
Comprehensive income attributable to Legacy Bitcoin Depot unit holders 12,885   3,870 
Comprehensive income (loss) attributable to non-controlling interest 13,259   (434)
Comprehensive loss attributable to Bitcoin Depot Inc.$(24,431) $– 
        

Explanation and Reconciliation of Non-GAAP Financial Measures

Bitcoin Depot reports its financial results in accordance with accounting principles generally accepted in the United States of America (“GAAP”). This press release includes both historical and projected Adjusted EBITDA, Adjusted Gross Profit, and certain ratios and other metrics derived therefrom such as Adjusted EBITDA margin and Adjusted Gross Profit margin, which are not prepared in accordance with GAAP.

Bitcoin Depot defines Adjusted EBITDA as net income before interest expense, income tax expense, depreciation and amortization, non-recurring expenses, stock-based compensation, expenses related to the PIPE financing and miscellaneous cost adjustments. Such items are excluded from Adjusted EBITDA because these items are non-cash in nature, or because the amount and timing of these items is unpredictable, not driven by core results of operations and renders comparisons with prior periods and competitors less meaningful. In addition, Bitcoin Depot defines Adjusted Gross Profit (a non-GAAP financial measure) as revenue less cost of revenue (excluding depreciation and amortization) and depreciation and amortization adjusted to add back depreciation and amortization. Bitcoin Depot believes Adjusted EBITDA and Adjusted Gross Profit each provide useful information to investors and others in understanding and evaluating Bitcoin Depot’s results of operations, as well as provide a useful measure for period-to-period comparisons of Bitcoin Depot’s business performance. Adjusted EBITDA and Adjusted Gross Profit are each key measurements used internally by management to make operating decisions, including those related to operating expenses, evaluate performance and perform strategic and financial planning. However, you should be aware that Adjusted EBITDA and Adjusted Gross Profit are not measures of financial performance calculated in accordance with GAAP and may exclude items that are significant in understanding and assessing Bitcoin Depot’s financial results, and further, that Bitcoin Depot may incur future expenses similar to those excluded when calculating these measures. Bitcoin Depot primarily relies on GAAP results and uses both Adjusted EBITDA and Adjusted Gross Profit on a supplemental basis. Neither Adjusted EBITDA or Adjusted Gross Profit should be considered in isolation from, or as an alternative to, net income, cash flows from operations or other measures of profitability, liquidity or performance under GAAP and may not be indicative of Bitcoin Depot’s historical or future operating results. Bitcoin Depot’s computation of both Adjusted EBITDA and Adjusted Gross Profit may not be comparable to other similarly titled measures computed by other companies because not all companies calculate such measures in the same fashion. As such, undue reliance should not be placed on such measures.

Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from the projections of Adjusted EBITDA, together with some of the excluded information not being ascertainable or accessible, Bitcoin Depot is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable GAAP measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.

The following table presents a reconciliation of revenue to Adjusted EBITDA for the periods indicated:

 
BITCOIN DEPOT INC.
RECONCILIATION OF NET (LOSS) INCOME TO ADJUSTED EBITDA
 
 Year Ended December 31, 
(in thousands)2023  2022 
 (unaudited) 
Net income$1,647  $3,546 
Adjustments:     
Interest expense 11,926   12,318 
Income tax (benefit) expense 8   395 
Depreciation and amortization 12,788   18,783 
Expense related to the PIPE transaction (1) 14,785   — 
Non-recurring expenses (2) 9,298   4,879 
Stock based compensation 2,523   1,230 
Special bonus (3) 3,040   — 
Expenses associated with the termination of the phantom equity participation plan 350   — 
Adjusted EBITDA$56,365  $41,151 
Adjusted EBITDA margin (4) 8.2%  6.4%
(1) Amounts include the recognition of a non-cash expense of $14.8 million and $2.5 million related to the PIPE transaction, entered into as of close of the Merger on June 30, 2023, for the twelve and three months ended December 31, 2023, respectively.
(2) Comprised of non-recurring professional service fees.
(3) Amount includes (A) Transaction bonus and related taxes to employees of approximately $1.4 million and (B) Founder Transaction bonus as a result of close of the Merger, of approximately $1.6 million, recognized as stock-based compensation, for the year ended December 31, 2023.
(4) Adjusted EBITDA margin is defined as Adjusted EBITDA divided by revenue. The Company uses this measure to evaluate its overall profitability.
   

The following table presents a reconciliation of revenue to Adjusted Gross Profit for the periods indicated:

BITCOIN DEPOT INC.
RECONCILIATION OF REVENUE TO ADJUSTED GROSS PROFIT
 
 Year Ended December 31, 
(in thousands)2023  2022 
 (unaudited) 
Revenue$688,967  $646,830 
Cost of revenue (excluding depreciation and amortization) (588,637)  (574,535)
Depreciation and amortization excluded from cost of revenue (12,455)  (18,783)
Gross Profit$87,875  $53,512 
Adjustments:     
Depreciation and amortization excluded from cost of revenue$12,455  $18,783 
Adjusted Gross Profit$100,330  $72,295 
Gross Profit Margin (1) 12.8%  8.3%
Adjusted Gross Profit Margin (1) 14.6%  11.2%
        
(1) Calculated as a percentage of revenue.
        

Contacts:

Investors 
Cody Slach, Alex Kovtun 
Gateway Group, Inc. 
949-574-3860 
[email protected]

Media 
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
[email protected]

Source: Bitcoin Depot Inc.

Released March 25, 2024

Release – Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Posted on by [email protected]

Research News and Market Data on TNXP

March 25, 2024 8:00am EDT

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating

Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity

CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.

“The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900. With PWS being the most common genetic cause of life-threatening childhood obesity, we are excited that the FDA has recognized this significant unmet need in children and adolescents, particularly for PWS hyperphagia, which currently has no approved treatments1,2,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As PWS is a genetic disorder associated with abnormalities of the oxytocin system, Tonix believes TNX-2900’s unique formulation has the potential to improve intranasal oxytocin’s therapeutic action by addressing limitations in efficacy observed at high-dose intranasal oxytocin that is not Mg2+-potentiated3,4.”

The FDA defines a rare pediatric disease as a serious or life-threating disease that primarily affects individuals aged from birth to 18 years and affects under 200,000 people in the United States.

About FDA’s Rare Pediatric Disease Priority Voucher Program

The FDA’s Rare Pediatric Disease Priority Voucher Program is intended to encourage the development of new drugs to treat certain rare pediatric diseases. Under the FDA’s Rare Pediatric Disease Designation and Voucher Program, if TNX-2900 is approved for marketing, Tonix may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product. Priority review vouchers may also be sold or transferred to another sponsor. The new sponsor can redeem the voucher to receive priority review for a different product, which reduces the review time of NDAs from 10 months to six months. There is no limit on the number of times a priority review voucher can be transferred. A 2020 U.S. Government Accounting Office analysis5 of the voucher program found that in the ten years since launch of the program in 2009, the price of buying priority review vouchers ranged from $67 million to $350 million. More recently, priority review vouchers were acquired by Novo Nordisk for $110 million in June of 2022, and by Novartis for $100 million from Marinus in July of 2022.6   Bluebird Bio sold vouchers for $102 million, $95 million and $103 million in November 2022, January 2023, and October 2023, respectively.7-9 In June of 2023, Novartis bought a priority review voucher from Pharming for $21 million, a price that had been negotiated as part of a purchase agreement when Pharming acquired the asset from Novartis.5

About Prader-Willi Syndrome (PWS)

PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.10 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.11-13 Six clinical trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four studies showed evidence for improvement in PWS-related behaviors/symptoms14-17; three clinical studies reported evidence for improvement in hyperphagia14,15,17; and one clinical study showed an improvement in sucking in infants16.

About TNX-2900 and Tonix’s Potentiated Oxytocin Platform

TNX-2900 is based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulation intended for use by children and adolescents. This formulation is believed to enhance the potency of oxytocin as well as increase specificity for oxytocin receptors relative to vasopressin receptors, potentially reducing unwanted side effects from activating vasopressin receptors. Tonix is also developing a different intranasal formulation, designated TNX-1900 for adolescent obesity, binge eating disorder, bone health in autism, and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish.18 It was initially approved by the U.S. Food and Drug Administration as Pitocin®**, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon®*** (oxytocin nasal 40 units/ml).

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.

**Pitocin® is a trademark of Par Pharmaceutical, Inc.

***Syntocinon® is a trademark of BGP Products Operations GmbH

Citations

  1. Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
  2. Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
  3. Correa-da-Silva F, et al. J Neuroendocrinol. 2021. 33(7):e12994.
  4. Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
  5. U.S. Government Accounting Office, Jan 31, 2020. “Drug Development: FDA’s Priority Review Voucher Programs”. GAO-20-251. https://www.gao.gov/products/gao-20-251.
  6. Waldron, J. Fierce Biotech. June 1, 2023. “Novartis buys priority review voucher from Pharming for discount price of $21 M.” www.fiercebiotech.com/biotech/novartis-buys-priority-review-voucher-pharming-discount-price-21m
  7. BlueBird bio Press Release. Nov. 30, 2022 “bluebird bio Sells Priority Review Voucher for $102 Million”. https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-sells-priority-review-voucher-102-million
  8. Kansteiner, F. Fierce Pharma. Jan 6, 2023 “Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS”. http://www.fiercepharma.com/pharma/bluebird-scores-another-nest-egg-after-selling-second-fda-review-voucher-bms-95m 
  9. Business Wire. October 30, 2023. “bluebird bio Enters into Advance Agreement to Sell Priority Review Voucher, if Granted, for $103 Million.” http://finance.yahoo.com/news/bluebird-bio-enters-advance-agreement-120000768.html
  10. Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
  11. Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
  12. Schaller F, et al. Hum Mol Genet. 2010. 19:4895-4905.
  13. Meziane H, et al. Biol Psychiatry. 2015. 78: 85-94.
  14. Kuppens RJ, et al. Clin Endocrinol. 2016. 85:979-987.
  15. Miller JL et al. Am J Med Genet A. 2017. 173: 1243-1250.
  16. Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
  17. Damen L, et al. Clin Endocrinol. 2020. 94:774-785.
  18. Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released March 25, 2024

Release – Bowlero Corp. Opens Lucky Strike Miami

Posted on by [email protected]

Research News and Market Data on BOWL

03/25/2024

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corporation (NYSE: BOWL), the global leader in bowling entertainment, announced today the opening of Lucky Strike Miami, the second new build using the Lucky Strike brand since it was acquired in September. Lucky Strike Miami is located in the heart of Downtown Miami within Miami Worldcenter, a 27-acre, $6 billion mixed-use destination transforming Miami’s urban core with world-class shopping, dining, hospitality, and residential options, just steps away from the Kaseya Center, home to the Miami Heat.

“Lucky Strike Miami epitomizes our commitment to innovation and excellence,” stated Thomas Shannon, Founder, Chairman, and CEO of Bowlero Corp. “As we continue to strategically expand the Lucky Strike brand nationwide, this new location represents not only a new chapter in our growth but also a testament to our commitment to providing unparalleled experiences for guests across the country.”

Lucky Strike Miami is a 30,000 sq. ft. premier entertainment destination featuring 28 state-of-the-art bowling lanes and a contemporary aesthetic. Beyond bowling, this destination elevates leisure with its expansive arcade, a craft cocktail bar, and an intimate VIP room with six private bowling lanes. Lucky Strike Miami’s menu will consist of dynamic culinary concepts that feature luxe fair with quality ingredients while elevating traditional classics.

“Not only are we thrilled to be welcoming Lucky Strike to Miami Worldcenter, but we are excited to be bringing the beloved bowling brand back to Miami once again following its nearly decade-long run on Miami Beach,” said Nitin Motwani, Managing Partner of Miami Worldcenter Associates. “Lucky Strike will not only enhance Downtown Miami’s status as a family-friendly destination, but it will also be a wonderful complement to Miami Worldcenter’s various food, beverage, and entertainment options.”

Lev Ekster, President of Bowlero Corp., said in closing “Lucky Strike Miami embodies the vibrant ambiance of Miami, redefining the bowling experience for guests of all ages. Our mission extends beyond entertainment; it’s about creating memorable moments and fostering positive guest experiences. We look forward to this next chapter in Miami as we open our doors to the community.”

Lucky Strike Miami will open to the public on March 25th.

About Bowlero Corp.

Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero, and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

About Miami Worldcenter:

Miami Worldcenter is a new $6 billion mixed-use destination in the heart of Downtown Miami. As one of the largest private urban real estate developments underway in the United States, the project occupies 27 acres spanning ten city blocks and offers world-class retail, hospitality, commercial and residential uses. Several phases of the project have already been completed and occupied, including three residential towers, a significant portion of the retail component, and a newly opened citizenM hotel.

Miami Worldcenter Associates serves as the master developer for the overall mixed-use development, led by Managing Partners Art Falcone and Nitin Motwani, in partnership with CIM Group, a community-focused real estate and infrastructure owner, operator, lender and developer. Together they have assembled a best-in-class development team that is currently transforming the urban core of Miami into one of the country’s largest mixed-use destinations. Learn more at www.miamiworldcenter.com.

For Media:

[email protected]

[email protected]

Source: Bowlero Corp

Release – Unicycive Therapeutics to Be Featured In Multiple Presentations At The Upcoming European Renal Association Congress

Posted on by [email protected]

Research News and Market Data on UNCY

March 25, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that multiple presentations will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.

Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “The ERA Congress is one of the most prominent nephrology meetings of the year, and we are excited to deliver presentations on both OLC and UNI-494. In addition to presenting preclinical data supporting both of our programs, we will also be reporting on our two clinical trials in progress. We look forward to participating in this important event.”

Oxylanthanum Carbonate (OLC)

Title:Enhanced Urinary Phosphorous Reduction: Comparative Study of Oxylanthanum Carbonate and Tenapanor in Rats
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:10 p.m. – 12:15 p.m. CEST
  
Title:Oxylanthanum Carbonate for Hyperphosphatemia in End Stage Kidney Disease (ESKD): Tolerability Trial in Progress
Lead Author:Pablo E. Pergola, M.D., Ph.D., Renal Associates, P.A.
Type:ePoster
Date/Time:Available throughout the conference
  

UNI-494

Title:Oral Administration of UNI-494 Ameliorates Acute Kidney Injury in a Rat Model of Delayed Graft Function
Lead Author: Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:00 p.m. – 12:05 p.m. CEST
  
Title:UNI-494 Phase I Tolerability and Pharmacokinetics: Trial in Progress
Lead Author:Guru Reddy, Ph.D., Vice President of Preclinical R&D, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:45 p.m. – 12:50 p.m. CEST
  

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Delayed Graft Function

Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.

Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

[email protected] 
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc

Released March 25, 2024

Release – Comtech Names Telecommunications and Public Safety Leader Jeff Robertson as President of Terrestrial & Wireless Networks Business Segment

Posted on by [email protected]

Research News and Market Data on CMTL

March 21, 2024 04:05 PM Eastern Daylight Time

CHANDLER, Ariz.–(BUSINESS WIRE)–March 21, 2024– Comtech (NASDAQ: CMTL), a global technology leader, today announced the appointment of telecommunications and public safety industry leader Jeff Robertson as the Company’s new President of its Terrestrial and Wireless Networks business segment.

Prior to joining Comtech, Robertson served as President & CEO of Intrado Life Safety, a company specializing in first responder technology in North America. Under his leadership, Robertson enhanced Intrado Life Safety’s operating structure, implemented critical digital transformation initiatives, migrated legacy products to next-generation cloud-based infrastructures, improved employee retention, and strengthened key go-to-market partnerships in under four years. Intrado Life Safety was sold in 2023 for $2.4 billion under Robertson’s leadership.

Throughout his career, Robertson has held numerous leadership roles, including Senior Vice President of Public Safety for startup innovator RapidSOS, CEO of Airbus DS Communications North America, Vice President and General Manager of Intergraph’s public safety software division, CEO of TCI – TelControl, and CML Emergency Services. He was also the founding executive director of the 9-1-1 Industry Alliance.

“Jeff will be instrumental in helping Comtech continue to grow and capitalize on core business objectives,” said John Ratigan, Interim CEO of Comtech. “Jeff brings unique insights and deep industry expertise that are well aligned with our continued One Comtech journey, terrestrial and wireless technology developments, and long-term strategies in key markets.”

As President of the Terrestrial & Wireless Networks segment, Robertson will have P&L responsibility across the enterprise. Robertson will oversee all aspects of engineering, program management, operations, new product development, system design, strategic planning, and customer engagement for all Terrestrial & Wireless Networks areas of focus.

“I am thrilled to be a part of Comtech,” said Robertson. “Comtech already enjoys a leadership position in NG-911 solutions. I am excited to lead this business forward as we continue to help states and local governments around the world to provide the best possible public safety solutions for their communities. Comtech has the right people, products and culture to capture the opportunities ahead of us.”

Robertson has been involved in the field of public safety technology for over 25 years, serving as a sworn officer and deputy sheriff. He also has extensive experience in software development for the public safety sector and was awarded a U.S. Patent for Voice Over IP Delivery of 911 calls, which is widely used across the industry today.

Robertson graduated from the executive program at the Wharton School – University of Pennsylvania and received a degree in telecommunications from Toronto Metropolitan University.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

Contacts

Investor Relations
Maria Ceriello
631-962-7115
[email protected]

Media Contact
Jamie Clegg
480-532-2523
[email protected]

Release – MAIA Biotechnology Welcomes Prominent Medical Oncology Scientist Dr. Saadettin Kilickap to Its Scientific Advisory Board

Posted on by [email protected]

Research News and Market Data on MAIA

March 21, 2024 3:00pm EDT

  • Acclaimed academic researcher has led 40+ multicenter phase 2 and phase 3 clinical studies

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of Professor Saadettin Kilickap, M.D. to its Scientific Advisory Board (SAB).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240321173734/en/

Professor Saadettin Kilickap, M.D., Scientific Advisor to MAIA Biotechnology (Photo: Business Wire)

Dr. Kilickap is a professor at the Istinye University Faculty of Medicine, Department of Medical Oncology, Liv Hospital in Turkey. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy.

“Saadettin has served as principal or sub-investigator in more than 40 national and international multi-center phase 2 and phase 3 studies, many of which were related to lung cancer,” said Chief Executive Officer Vlad Vitoc, M.D. “He is a prominent voice on medical oncology and cancer epidemiology, with a special interest in quality of life for cancer patients. We are delighted to welcome him as Scientific Advisor as we begin to clear major clinical inflection points this year and progress with our groundbreaking cancer research.”

Prior to his current appointment, Dr. Kilickap was a professor at the Preventive Oncology Department of Hacettepe University Cancer Institute of Turkey. Earlier he worked in the Department of Hematology-Oncology at Regensburg University in Germany and was a faculty member at the Sivas Cumhuriyet University Faculty of Medicine, Department of Internal Medicine, in Turkey.

Dr. Kilickap graduated with honors from Gazi University Faculty of Medicine and went on to complete his internal medicine residency training at Hacettepe University Faculty of Medicine, both located in Ankara, Turkey. He completed his fellowship training at Hacettepe and became a medical oncology specialist in 2009. In the same year, he graduated from the Cancer Epidemiology Master’s Program at the Hacettepe University Oncology Institute, Department of Preventive Oncology.

Dr. Kilickap has authored more than 240 scientific articles published in international peer-reviewed journals, and delivered more than 50 poster presentations at international congresses.

About MAIA Biotechnology, Inc.

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.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240321173734/en/

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

Released March 21, 2024

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human

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Research News and Market Data on ELDN

March 21, 2024

Historic kidney xenotransplantation procedure conducted at Massachusetts General Hospital

Tegoprubart administration has now been used investigationally to prevent rejection in both kidney and heart pig-to-human xenotransplantations, as well as in human-to-human kidney transplantation

Eledon recently presented results from its ongoing Phase 1b kidney transplantation study which demonstrated that tegoprubart was generally safe and well tolerated and successfully prevented rejection with post-transplant kidney function above historical averages

IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.

“This first-ever kidney xenotransplant marks a pivotal moment for the transplant community and provides hope that this option may one day help solve the current shortage of available organs,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant. We are thankful to the patient, the entire medical team at Massachusetts General Hospital, and our partner eGenesis for the privilege to participate in this landmark procedure as we work to achieve our goal of developing tegoprubart as a new and better immunosuppressive option for transplant patients.”

Tegoprubart is being administered to the patient investigationally as part of a regimen designed to suppress the immune system and prevent the body from rejecting the transplanted pig organ. Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.

“It is exciting to see the clinical application of xenotransplantation to a patient with end stage renal disease,” said Andrew Adams, MD, PhD, Chief, Division of Transplant Surgery, University of Minnesota. “Based on all of the studies performed in preclinical models to date, it is clear that therapies targeting CD40L, like tegoprubart, are critical to controlling the immune response to the xenograft, potentially leading to superior long-term outcomes compared to other immunosuppressive therapies. CD40L sits at the interface of the adaptive and innate immune responses which may explain why therapies designed to block it have such potent effects in xenotransplantation.”

“This procedure represents a significant milestone in the transplantation field and a promising step to address a medical crisis: the worldwide shortage of available organs,” said Leonardo V. Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital. “Xenotransplantation represents a unique approach with the potential to provide patients with additional options to access life-saving treatments in a timely manner. We commend the courage of our patient and the skill of the entire team involved in the operation, and I look forward to continued advancements in research with the hope that we can make this novel treatment option available to more patients in the future.”

Multiple clinical and preclinical research efforts are currently underway to evaluate the ability of tegoprubart to reduce the risk of rejection in organ transplant. Eledon is advancing preclinical studies in which tegoprubart is being used as a part of the immunosuppression regimen designed to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant. The company recently presented results from 11 participants enrolled in its ongoing Phase 1b kidney transplantation study, which demonstrated that tegoprubart, as part of a calcineurin inhibitor free immunosuppressive regimen, was generally safe and well tolerated and both successfully prevented rejection as well as permitted above historical average post-transplant kidney function. The company’s Phase 2 BESTOW study, assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation, is currently recruiting participants, and plans to complete enrollment at the end of 2024.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Release – Euroseas Ltd. Announces Completion of Retrofits of its Intermediate Containership, M/V Marcos V, Reducing the Vessel’s Carbon Footprint

Posted on by [email protected]

Research News and Market Data on ESEA

Maroussi, Athens, Greece – March 21, 2024 – Euroseas Ltd. (NASDAQ: ESEA, the “Company” or “Euroseas”), an owner and operator of container carrier vessels and provider of seaborne transportation for containerized cargoes, announced today it has successfully completed the installation of a number of “energy saving devices” on its 6,350 teu intermediate containership, M/V Marcos V, aiming to improve her consumption in the commercial speed range by about 25%. The investment was done in conjunction with the vessel’s scheduled dry docking and special survey and was funded by the charterer of the vessel, who contemporaneously declared their option to extend the charter by an additional minimum seven months to August 2025. In case the vessel is employed after the current charter period, the owners will refund part of the cost to the charterer, up to a maximum of 50%.

The following devices were installed on the ship:

(a) New bulbous bow

(b) A new and lighter propeller

(c) Hub vortex absorbed fins (HVAF)

(d) Pre-shrouded vanes (PSV)

(e) Silicone coating of the ship’s underwater parts

(f) LED lights

(g) Auto pilot upgrade with advanced ecology control

(h) Jacket pre-heater auto control

Aristides Pittas, Chairman and CEO of Euroseas commented: “We are pleased to announce the completion of retrofits for our M/V Marcos V, continuing our retrofitting program, as part of our efforts to minimize the carbon footprint of our fleet. As in the case of the recent retrofit of M/V Synergy Busan, we cooperated closely with the charterer to specify and fund the modifications of the vessel and share the economic benefit from the improved performance.”

About Euroseas Ltd.

Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 150 years. Euroseas trades on the NASDAQ Capital Market under the ticker ESEA.

Euroseas operates in the container shipping market. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company, which is responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements.

The Company has a fleet of 20 vessels, including 13 Feeder containerships and 7 Intermediate containerships. Euroseas 20 containerships have a cargo capacity of 61,661 teu. After the delivery of six feeder containership newbuildings in 2024, Euroseas’ fleet will consist of 26 vessels with a total carrying capacity of 75,461 teu.

Forward Looking Statement

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events and the Company’s growth strategy and measures to implement such strategy, including expected vessel acquisitions and entering into further time charters. Words such as “expects,” “intends,” “plans,” “believes,” “anticipates,” “hopes,” “estimates,” and variations of such words and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include but are not limited to changes in the demand for containerships, competitive factors in the market in which the Company operates; risks associated with operations outside the United States; and other factors listed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Visit our website www.euroseas.gr

Company Contact

Tasos Aslidis

Chief Financial Officer

Euroseas Ltd.

11 Canterbury Lane, Watchung, NJ 07069

Tel. (908) 301-9091

E-mail: [email protected]

Investor Relations / Financial Media

Nicolas Bornozis

Markella Kara

Capital Link, Inc.

230 Park Avenue, Suite 1540 New York, NY 10169

Tel. (212) 661-7566

E-mail: [email protected]

Release – Snail Games Celebrates the Launch of ARK: The Animated Series in U.S. and Canada with Themed In-Game Skins for ARK: Survival Ascended to Broaden Market Base

Posted on by [email protected]

Research News and Market Data on SNAL

March 21, 2024 at 8:00 AM EDT

CULVER CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or “the Company”), a leading global independent developer and publisher of interactive digital entertainment, celebrates the announcement by Paramount+ today that the first six episodes of ARK: THE ANIMATED SERIES, an all-new original series based on the hit adventure video game ARK: Survival Evolved, are available to stream now exclusively on Paramount+ in the U.S. and Canada. The series will debut in all other Paramount+ international markets starting Friday, April 19. Part two of the season will debut with seven new episodes at a later date.

ARK: THE ANIMATED SERIES brings to life the epic saga of Helena Walker, a 21st-century paleontologist navigating a mysterious prehistoric world. This narrative expansion is set to captivate both gamers and mainstream audiences, providing a deeper dive into the ARK lore and offering fans and newcomers alike a new way to engage with its rich, survival-centric narrative. The launch of the series is expected to further enhance the ARK universe’s market presence nationwide and globally, reinforcing the franchise’s status in both the gaming community and mainstream entertainment.

In celebration of the series’ launch, ARK: Survival Ascended will introduce Bob’s “Dear Jane” in-game content which includes four animated character skins. The dual launch aims to broaden the market reach and penetration of the ARK universe. This new content aims to bridge the gaming experience with the animated series, offering fans additional content to enhance immersion in the ARK universe. Moreover, starting April 1st, ARK Survival Ascended (Cloud, PC, Xbox Series X|S) becomes available on Microsoft’s Game Pass, extending its reach to a wider player base.

“The launch of ARK: The Animated Series and the accompanying in-game skins mark a pivotal moment for the ARK franchise,” said Jim Tsai, CEO of Snail, Inc. “Expanding the ARK experience beyond gaming into mainstream media not only boosts our game’s appeal but also establishes ARK universe as a multidimensional brand in entertainment. This strategic move is a testament to our dedication to growing and diversifying the ARK experience for both our dedicated community and newcomers. As we continue to explore new opportunities for growth and expansion for our ARK universe and other game titles, our commitment remains to providing engaging, innovative gaming experiences that exceed player expectations.”

About Snail, Inc.- https://www.snailgamesusa.com/

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Forward Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations.

Contacts:

Investors:

[email protected]

Press:

[email protected]

Release – Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting

Posted on by [email protected]

Research News and Market Data on TNXP

March 21, 2024 8:00am EDT

Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder

TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating

TNX-1900 and TNX-2900 may serve as novel neuroendocrine treatments for certain pain, eating and endocrine disorders 

CHATHAM, N.J., March 21, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the American Chemistry Society (ACS) Spring 2024 Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy of the poster is available under the scientific presentations page of the Tonix website at www.tonixpharma.com.

The poster presentation titled, Oxytocin Analogs with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium Formulations, describes the discovery and characterization of novel oxytocin analogues that are candidate treatments for craniofacial pain, excessive eating (including Prader Willi Syndrome), and endocrinological conditions including bone health in autism and insulin resistance.

“Intranasal oxytocin has several potential therapeutic applications,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Preclinical studies have shown that oxytocin, a hypothalamic peptide hormone, simultaneously reduces food intake and increases energy expenditure, leading to weight loss.1-3 Intranasal oxytocin is well-tolerated and in published studies of adults, results in reduced caloric intake, increased fat burning and improved insulin sensitivity.1-3”

Dr. Lederman continued, “There is preclinical evidence that the activity of intranasal oxytocin is dependent on magnesium (Mg++) concentration.4-6 Our current intranasal oxytocin formulations of TNX-1900 and TNX-2900 contain Mg++ to augment the activity. We believe the new oxytocin analogues described in the poster have enhanced binding to Mg++ and consequently their activity does not require Mg++ augmentation.”

Four Phase 2 investigator-initiated studies of TNX-1900 are currently ongoing; three at the Massachusetts General Hospital (MGH) and one at the University of Washington. The Phase 2 ‘POWER’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to induce weight loss and improve indicators of cardiometabolic risk in adolescent patients with obesity. The Phase 2 ‘STROBE’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. The Department of Defense (DoD)-funded Phase 2 ‘BOX’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to improve bone health in children with autism spectrum disorder. In addition, a Phase 2 study at the University of Washington is investigating the potential role of TNX-1900 in enhancing vicarious extinction learning in social anxiety disorder, compared to healthy controls.

About TNX-1900 and TNX-2900

TNX-1900 and TNX-2900 (intranasal potentiated oxytocin) are proprietary formulations of oxytocin. TNX-1900 is in Phase 2 development under investigator-initiated INDs as a candidate for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. TNX-1900 is also planned for development in treating insulin resistance. TNX-2900 is in development as a treatment for Prader Willi Syndrome. TNX-2900 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and its IND has been cleared. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Tonix’s patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. Tonix’s patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians and fish.7 It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal formulation of oxytocin is marketed in some European countries to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml). Oxytocin has no recognized addiction potential. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system. With TNX-1900 and TNX-2900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding8 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models9. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children10. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

About Prader-Willi Syndrome (PWS)

PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.11 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given these serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.12 In addition, oxytocin has potent effects in correcting behavioral characteristics of the neonatal Magel2 knock-out mouse model for PWS and autism13 and intriguing effects in a clinical trial of neonates with PWS.14

*Pitocin® is a trademark of Par Pharmaceutical, Inc.

**Syntocinon® is a trademark of BGP Products Operations GmbH

References

1Lawson EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi: 10.1111/jne.12805.
2Niu J, et al. Front Neurosci 2021;15:743546. doi: 10.3389/fnins.2021.743546.
3Maejima Y, et al. Neuroendocrinology 2018;107(1):91-104.
4Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
5Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
6Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
7Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561.
8Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
9Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
10Yeomans, DC et al. 2017. US patent US2017368095.
11Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
12Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
13Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
14Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact
Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released March 21, 2024

Release – Direct Digital Holdings Announces Rescheduling of Fourth Quarter and FY 2023 Financial Results Release and Conference Call

Posted on by [email protected]

Research News and Market Data on DRCT

March 20, 2024 4:01 pm EDT

HOUSTON, March 20, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the earnings call originally scheduled for March 21, 2024 at 5:00 PM ET will be postponed to March 26, 2024 at 5:00 PM ET to provide additional time to complete the audit of its financial statements.

For further information, please contact [email protected].

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.

Contacts: 

Investors:
Brett Milotte, ICR
[email protected]

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SOURCE Direct Digital Holdings

Released March 20, 2024

Release – AdTheorent Wins 2024 Artificial Intelligence Excellence Award

Posted on by [email protected]

Research News and Market Data on ADTH

Mar 20, 2024

Company honored for AdTheorent Predictive Audiences, Built by ABi™

NEW YORK, March 20, 2024 /PRNewswire/ — AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a machine learning pioneer using privacy-forward solutions to deliver measurable value for programmatic advertisers, today announced that it has been selected by Business Intelligence Group (B.I.G.) as a winner of the 2024 AI Excellence Awards for its AI-based technology innovation. This annual business awards program recognizes organizations, products, and people that are leveraging AI technology to solve real world problems. AdTheorent was recognized for its groundbreaking ID-independent audience targeting solutions: AdTheorent Predictive Audiences, built by ABi™.

   

AdTheorent Predictive Audiences are an ID-independent and algorithm-based method for audience creation and targeting. AdTheorent’s Predictive Audience Builder, or ABi™ is a transformational suite of platform tools designed to enable users to create and activate predictive models which score audience quality. ABi™ leverages customizable and primary-sourced seed data sets to mimic the audience profile of an advertiser’s desired target. In a major departure from industry-standard audience segments, that seed data set is not used for direct targeting. Instead AdTheorent’s machine-learning platform reads signals from those data sets to build a predictive model which scores programmatic inventory based on its likelihood to reach an individual who meets the desired audience profile. This privacy-forward predictive scoring delivers superior audience quality and KPI performance, without the use of cookies or IDs of any kind. When AdTheorent Predictive Audiences are deployed in platform to enhance AdTheorent’s KPI-based impression scoring, the result is a superior level of privacy-forward data-driven accuracy and accountability.

AdTheorent also offers a Health Audience solution, powered by HABi™, which is also ID-independent and not built on or sourced from individualized information, including user browsing activity or observed user location. Rather, HABi™-built Health Audiences are based on anonymized and deidentified datasets constituting over 30 billion records across more than 300 million unique U.S. patients.

“AdTheorent is not new to the AI and machine learning opportunity – we have been refining advanced ML-based solutions since 2012. We remain committed to building and enhancing the most advanced and differentiated machine learning-powered advertising technology and solutions ever deployed in market,” said Jim Lawson, CEO of AdTheorent. “AdTheorent is driving superior performance for our advertisers without the need for cookies – and we sincerely thank the B.I.G. Artificial Intelligence Award judges for this valuable recognition.”

“We are truly honored to recognize AdTheorent with this prestigious award,” stated Maria Jimenez, Chief Nominations Officer for the Business Intelligence Group. “The unwavering commitment of the AdTheorent team to excellence, and their innovative AI-based products and solutions have catapulted them to this remarkable achievement. Congratulations to the entire organization!”

For more information about AdTheorent Predictive Audiences, click here. For more information about the B.I.G. AI Excellence awards, click here.

About AdTheorent 
AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals.

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.

About Business Intelligence Group www.bintelligence.com 
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, these programs are judged by business executives having experience and knowledge. The organization’s proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.

Contact:
Melanie Berger, AdTheorent
850-567-0082
[email protected]

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SOURCE AdTheorent