Alarum Technologies Announces Fourth Quarter and Annual 2024 Results

A Pivotal Year, Marking Accomplishment of Strategic Shift to Data Collection,

Hits Milestones Toward Becoming a Driving Force in the AI Revolution

2024
revenue increased to $31.8 million, of which $7.4 million was in the fourth quarter
;

2024
net profit rose to $5.8 million
and
adjusted EBITDA reached $9.4 million;

Cash
and liquid investments
balance at year-end amounted to $25 million

TEL AVIV, Israel, March 20, 2025 (GLOBE NEWSWIRE) — Alarum Technologies Ltd. (Nasdaq, TASE: ALAR) (“Alarum” or the “Company”), a global provider of web data collection solutions, today announced financial results for the fourth quarter and full year ended December 31, 2024.

Shachar Daniel, Chief Executive Officer of Alarum, said: “2024 was a landmark year for Alarum, as we successfully executed our strategic vision, to focus on data collection. This transformation comes at a time when AI is reshaping the world at an unprecedented pace. As data fuels intelligence, the companies that will lead this revolution are those that anticipate change, build a strong foundation, and position themselves for long-term success. This is exactly what we are striving for – taking it step by step.”

Market Trends Shaping Business Short-and Long-Term

  • Alarum Engaged in AI Model Training Trial Projects: as AI trends accelerated toward the end of 2024, collecting accurate data at massive scales has become increasingly critical. In the fourth quarter of 2024 and the first quarter of 2025, leading global companies, including one of the world’s largest online marketplace corporates, have selected Alarum’s Data Collection solutions for initial AI model training of mega-scale trial projects.
     
  • Industry Trends and Market Dynamics: With the growing demand for data, AI companies and data providers are forced to adapt to a rapidly evolving landscape, with websites implementing new technological barriers to data collection. This dynamic environment has led to revenue fluctuation across the industry. Alarum’s financial strength and operational efficiency allow it to capitalize on long-term market growth, leveraging its robust technological foundation, established customer base, and strategic engagements with industry leaders.
     
  • F
    inancial Resilience: Alarum’s solid balance sheet and efficient operations enable it to stay ahead of the competition, seize opportunities promptly and adapt its long-term plans as required.
     
  • Long-term Product Strategy and Vision: Evolving market needs validate Alarum’s focus on in-depth research and aligned roadmaps. Recognizing the current era as a paramount opportunity, the Company continues to prioritize and allocate resources to seize and focus mainly on long-term growth opportunities, aiming to elevate its position to the next level.

Recent Developments and Business Highlights

  • Network Expansion: Alarum significantly scaled its IP network (IPPN) infrastructure in 2024, reinforcing its position as a key player in large-scale data collection. Its leadership was also acknowledged in the comprehensive public report on the IPPN industry, the 2024 PROXYWAY Market Research1, which named Alarum’s NetNut Ltd. (“NetNut”) as a top performer.

  • Introducing Innovative
    Data Collection & Labeling Solutions: Alarum has introduced cutting-edge solutions, designed to provide seamless and scalable access to high-quality data. In the second half of 2024, the Company recorded initial sales from the Website Unblocker and SERP API (Search Engine Results Page Application Programming Interface) products, and it also made progress with the development of an AI Data Collector.

  • NetNut
    ’s
    Net Retention Rate (“NRR”)
    2 reached 1.27 as of December 31, 2024, compared to 1.53 as of December 31, 2023, yet another consecutive quarter of achieving an NRR well-above 1.

Chen Katz, Chairman of The Board of Alarum, commented: “Our 2024 results showcase the success of our strategic shift, which is well supported by our financial resilience. With a sharp focus on data collection, we have built a solid foundation for long term sustainability in the AI data-driven era. I am excited to see how our continued innovation and execution will shape the future of our company.”

 
Summary of Financial Results
3
(in millions of U.S. dollars, rounded, except per share amounts and margins)
 
  For the

Year Ended

December 31,
  For the

Three Months Ended

December 31,
  2024     2023   2024   2023
  (Audited)   (Audited)   (Unaudited)   (Unaudited)
               
Total Revenue   31.8       26.5       7.4       7.1  
of which, Web Data Collection Revenue was   30.9       21.3       7.2       6.7  
Gross profit   23.9       18.8       5.3       5.3  
Gross margin (in percentage)   75.1 %     70.9 %     72.4 %     75.0 %
Non-IFRS gross margin (in percentage)   77.0 %     74.3 %     74.3 %     77.2 %
Total operating expenses   17.2       24.3       5.0       3.6  
Financial income (expense), net   0.3       (0.6 )     0.2       (0.1 )
Tax benefit (expense)   (1.2 )     0.5       (0.1 )     (* )
Net profit (loss) from continuing operations   5.8       (5.6 )     0.4       1.7  
Adjusted EBITDA from continuing operations   9.4       5.2       1.5       2.2  
Basic earnings (loss) per ADS from continuing operations (in U.S. dollars) $ 0.87     $ (1.35 )   $ 0.06     $ 0.28  
Non-IFRS basic earnings (loss) per American Depository Share (“ADS”) from continuing operations (in U.S. dollars) $ 1.26     $ (1.14 )   $ 0.20     $ 0.38  
                             
Cash, cash equivalents and debt investments (including accrued interest)4   25.0       10.9       25.0       10.9  
Shareholders’ equity3   26.4       13.2       26.4       13.2  
                               
* Less than $0.1 million                        
                         

Fourth Quarter and Full Year 2024 Financial Analysis

  • Revenue in Q4 2024 grew 4% year-over-year to $7.4 million (Q4 2023: $7.1 million). The increase is attributed to our NetNut web data collection business, which grew 7% to $7.2 million in Q4 2024, up from $6.7 million in Q4 2023. Revenue for the whole year 2024 grew 20%, rising to a record of $31.8 million (2023: $26.5 million). The Web Data Collection revenue reached a Company record $30.9 million in 2024, achieving 45% year-over-year growth (2023: $21.3 million).
  • Cost of revenue in Q4 2024 was $2.0 million (Q4 2023: $1.8 million). Full year 2024, cost of revenue was $7.9 million, (2023: $7.7 million). During these periods, costs have shifted towards investment in the Company’s IP network, as per its strategic decision announced in July 2023 to focus solely on its web data collection business.
  • Operating expenses in Q4 2024 totalled $5.0 million (Q4 2023: $3.6 million). The quarterly change was driven mainly by the increase in the NetNut Data Collection operations, primarily research and development salary costs. For the full year 2024, operating expenses were down to $17.2 million (2023: $24.3 million), mainly due to 2023-related impairment costs of goodwill and intangible assets and the strategic decision to scale down the Company’s consumer internet access business operations, partially offset by the increase in Data Collection operating expenses.
  • Financial income, net, in Q4 2024 was $0.2 million (Q4 2023: financial expense, net, of $0.1 million). Financial income, net, for 2024, increased to $0.3 million (2023: financial expense, net, of $0.6 million). This shift to financial income, net, from an expense, net, was mainly due to the increase in interest income from cash deposits as well as lower financial expenses related to short- and long-term loans.
  • 2024 cash flow from operating activities rose 93%, to $8.9 million, compared to last year (2023: $4.6 million).
  • Bottom line, 2024 net profit from continuing operations rose to a record $5.8 million (2023: loss of $5.6 million), and the corresponding 2024 Adjusted EBITDA was up at a Company record $9.4 million (2023: $5.2 million).
  • As of December 31, 2024, shareholders’ equity doubled, totalling $26.4 million, up from $13.2 million as of December 31, 2023. The increase was driven by the switch to net profit from net loss as well as warrants and options exercises.
  • Outstanding ordinary share count as of December 31, 2024, was approximately 69.1 million shares, or 6.9 million in ADSs.

Financial Outlook

“In line with our guidance, total fourth quarter 2024 revenues increased to $7.4 million, of which $7.2 million were attributed to Web Data Collection, and fourth quarter 2024 Adjusted EBITDA reached $1.5 million. Our cash and liquid investment balance on December 31, 2024, increased to $25 million, demonstrating once again success in cashflow generation,” said Mr. Shai Avnit, Chief Financial Officer of Alarum.

“As we look ahead, our revenue guidance reflects the ongoing shifts in the global data collection. First quarter 2025 revenues are estimated at $7.3 million ±3% and Adjusted EBITDA for the first quarter 2025 is expected to range from $0.8 million to $1.2 million. We are navigating a period of adjustment as the industry evolves, and while short-term revenue growth may be lower than in previous quarters, we remain focused on the bigger picture, and on generating long-term and sustainable value for the Company’s stakeholders,” Mr. Avnit concluded.

We are unable to present a reconciliation of our estimated Adjusted EBITDA to net profit from continuing operations as we are unable to predict with reasonable certainty, and without unreasonable effort, the impact and timing of certain expenses on our net profit from continuing operations. The financial impact of these expenses is uncertain and is dependent on various factors, including timing, and could be material to our consolidated statements of profit or loss and other comprehensive income (loss).

Fourth Quarter 2024 Financial Results Conference Call

Mr. Shachar Daniel, Chief Executive Officer of Alarum, and Mr. Shai Avnit, Chief Financial Officer of Alarum, will host a conference call today, March 20, 2025, at 8:30 a.m. ET, 5:30 a.m. Pacific time, 2:30 p.m. Israel, to discuss the fourth quarter and full year 2024 results and the first quarter 2025 outlook, followed by a Q&A session. To attend, please dial one of the following numbers, at least five minutes before the call starts: 1-877-407-0789 or 1-201-689-8562. If you are unable to connect using the toll-free number, please try the international dial-in number. An Israeli toll-free number is: 1 809 406 247. Participants will be required to state their name and company upon dialling in. 

Replay: The conference call will be broadcast live and available for replay here, after 11:30 a.m. ET on March 20, 2025, through April 20, 2025. Toll-free replay numbers: 1-844-512-2921 or 1-412-317-6671, ID: 13751807.

Forward-Looking Statements

  • This press release contains forward-looking statements within the meaning of the “safe harbor” words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Alarum is using forward-looking statements in this press release when it discusses strategic vision, benefits, advantages and capabilities of Alarum’s solutions, the growing demand for data, that Alarum’s financial strength and operational efficiency allow it to capitalize on long-term market growth, that Alarum’s solid balance sheet and efficient operations enable it to stay ahead of the competition, seize opportunities promptly and adapt its long-term plans as required, that the Company continues to prioritize and allocate resources to seize and focus mainly on long-term growth opportunities and its aim to elevate its position to the next level, the estimates of the revenues for the first quarter 2025 revenues and Adjusted EBITDA, that short-term revenue growth may be lower than in previous quarters, and the Company’s focus on the bigger picture, and on generating long-term and sustainable value for the Company’s stakeholders. Because such statements deal with future events and are based on Alarum’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alarum could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Alarum’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and in any subsequent filings with the SEC. Except as otherwise required by law, Alarum undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Alarum is not responsible for the contents of third-party websites.
 

Condensed Consolidated Statements of Financial Position

(in thousands of U.S. dollars)
   
  December 31
,
  2024   2023  
  (Audited)
Assets      
Current assets:      
Cash and cash equivalents 15,081     10,872  
Trade receivables, net 3,231     1,994  
Other receivables 503     399  
  18,815     13,265  
       
Non-current assets:      
Long-term deposits 121     104  
Other non-current assets 85     145  
Property and equipment, net 130     88  
Right-of-use assets 498     779  
Deferred tax assets 422     181  
Debt investments at fair value through other comprehensive income 9,256      
Debt investments at fair value through profit or loss 555      
Intangible assets, net 811     1,386  
Goodwill 4,118     4,118  
Total non-current assets 15,996     6,801  
Total assets 34,811     20,066  
       
Liabilities and equity      
Current liabilities:      
Trade payables 251     369  
Other payables 4,484     2,439  
Current maturities of long-term loan 938     290  
Contract liabilities 1,987     1,983  
Derivative financial instruments 148     109  
Short-term lease liabilities 359     370  
Total current liabilities 8,167     5,560  
       
Non-current liabilities:      
Long-term lease liabilities 261     523  
Long-term loans, net of current maturities 32     802  
Total non-current liabilities 293     1,325  
Total liabilities 8,460     6,885  
       
Equity:      
Ordinary shares      
Share premium 111,892     100,576  
Other equity reserves 11,012     14,938  
Accumulated deficit (96,553 )   (102,333 )
Total equity 26,351     13,181  
Total liabilities and equity 34,811     20,066  
           
           

 

Condensed Consolidated Statements of Profit or Loss

(in thousands of U.S. dollars, except per share amounts)

 
  For the

Year Ended

December 31,
  For the

Three Months Ended

December 31,
  2024   2023   2024   2023
  (Audited)   (Audited)   (Unaudited)   (Unaudited)

Continuing operations
             
Revenue   31,824     26,521     7,370     7,107  
Cost of revenue   7,915     7,711     2,032     1,778  
Gross profit   23,909     18,810     5,338     5,329  
                 

Operating expenses:
               
Research and development   4,495     3,557     1,210     795  
Sales and marketing   7,033     10,035     1,988     1,579  
General and administrative   5,661     4,406     1,749     1,207  
Impairment of goodwill       6,311          
Total operating expenses   17,189     24,309     4,947     3,581  
                 
Operating profit (loss)   6,720     (5,499 )   391     1,748  
                 
Financial income (expense), net   281     (590 )   163     (54 )
Profit (loss) from continuing operations before income tax   7,001     (6,089 )   554     1,694  
Tax benefit (expense)   (1,221 )   482     (112 )   (22 )
Profit (loss) from continuing operations, net of income tax   5,780     (5,607 )   442     1,672  
Profit from discontinued operations, net of income tax       82          
Net profit (loss) for the period   5,780     (5,525 )   442     1,672  
Other comprehensive income (loss) for the period

Change in fair value of debt investments
  (80 )       (80 )    
Total comprehensive income (loss) for the period   5,700     (5,525 )   3
62
    1,672  
                 
Basic profit (loss) per share:                
Continuing operations $ 0.09     (0.14 )   0.01     0.03  
                 
Discontinued operations       *        
  $ 0.09     (0.14 )   0.01     0.03  
                 
Diluted profit (loss) per share:                
Continuing operations $ 0.08     (0.14 )   0.01     0.03  
                 
Discontinued operations       *        
  $ 0.08     (0.14 )   0.01     0.03  
                 
Basic profit (loss) per ADS:              
               
Continuing operations $ 0.87     (1.35 )   0.06     0.28  
                 
Discontinued operations       *        
  $ 0.87     (1.35 )   0.06     0.28  
* Less than $0.01
 

Use of Non-IFRS Financial Results

In addition to disclosing financial results calculated in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board, this press release contains non-IFRS financial measures of EBITDA (EBITDA loss), Adjusted EBITDA (Adjusted EBITDA loss), non-IFRS net profit (loss), non-IFRS gross profit, non-IFRS gross margin and non-IFRS basic earnings (loss) per share or ADS for the periods presented. The Company defines EBITDA (EBITDA loss) as net profit (loss) from continuing operations before depreciation, amortization and impairment of intangible assets, financial income (expense) and income tax; defines Adjusted EBITDA (Adjusted EBITDA loss) as EBITDA (EBITDA loss) as further adjusted to remove the impact of (i) impairment of goodwill (if any); and (ii) share-based compensation; defines non-IFRS net profit (loss) as net profit (loss) from continuing operations before depreciation, amortization and impairment of intangible assets, impairment of goodwill, financial income (expense) effects primarily related to derivative financial instruments as well as long-term loans, deferred tax effects and share-based compensation; defines non-IFRS gross profit as gross profit from continuing operations adjusted to remove the impact of depreciation, amortization and impairment of intangible assets and share-based compensation recorded under cost of revenues; defines non-IFRS gross margin as the percentage of the non-IFRS gross profit out of revenues; and defines non-IFRS basic earnings (loss) per share or ADS as non-IFRS net profit (loss) divided by the weighted average number of ordinary shares or ADSs. The Company’s management believes the non-IFRS financial information provided in this press release is useful to investors’ understanding and assessment of the Company’s ongoing operations. Management also uses both IFRS and non-IFRS information in evaluating and operating its business internally, and as such deemed it important to provide this information to investors. The non-IFRS financial measures disclosed by the Company should not be considered in isolation, or as a substitute for, or superior to, financial measures calculated in accordance with IFRS, and the financial results calculated in accordance with IFRS and reconciliations to those financial statements should be carefully evaluated. Investors are encouraged to review the reconciliations of these non-IFRS measures to their most directly comparable IFRS financial measures provided in the financial statement tables herein.

Other Metrics

Net retention rate (NRR) is a key indicator of customer base health and revenue expansion. It is based on NRR point in time, which measures the revenue growth of customers over the past four quarters, compared to the revenue generated from these customers during the same period a year earlier.
NRR is calculated as an average of the NRR points in time for the end of the current period and the three preceding quarters.
NRR > 1 (or 100%): Indicates revenue growth driven by existing customers, where upsells and cross-sells outweigh churn.
NRR < 1 (or 100%): Shows revenue loss due to churn exceeding gains from upsells or cross-sells.

Non-IFRS Financial Measures

(in millions of U.S. dollars, rounded)

The following tables present the reconciled effect of the above on the Company’s Adjusted EBITDA (EBITDA loss); non-IFRS net profit (loss); and non-IFRS gross profit for the year and three months ended December 31, 2024 and 2023:

  For the

Year Ended

December 31,
  For the

Three Months Ended

December 31,
  2024   2023   2024   2023
               
Net profit (loss) from continuing operations 5.8     (5.6 )   0.4     1.7
Adjustments:              
Depreciation, amortization and impairment of intangible assets 0.6     3.5     0.2     0.1
Financial expense (income), net (0.4 )   0.6     (0.1 )   0.1
Tax expense (benefit) 1.4     (0.5 )   0.1     *
EBITDA (EBITDA loss) 7.4     (2.0 )   0.6     1.9
Adjustments:              
Impairment of goodwill     6.3        
Share-based compensation 2.0     0.9     0.9     0.3
Adjusted EBITDA for the period 9.4     5.2     1.5     2.2
* Less than $0.1 million
                     

   
  For the

Year Ended

December 31,
  For the

Three Months Ended

December 31,
  2024   2023   2024   2023
Net profit (loss) from continuing operations 5.8     (5.6 )   0.4     1.7
Adjustments:              
Depreciation, amortization and impairment of
intangible assets
0.6     3.5     0.2     0.1
Financial expense (income), net effects 0.1     0.1     (* )   0.2
Deferred tax effects (0.1 )   (0.5 )   (0.1 )   *
Impairment of goodwill     6.3        
Share-based compensation 2.0     0.9     0.9     0.3
Non-IFRS net profit for the period 8.4     4.7     1.4     2.
3
* Less than $0.1 million
                     

       
  For the

Year Ended

December 31,
  For the

Three Months Ended

December 31,
  2024   2023   2024   2023
Gross profit from continuing operations 23.9   18.8   5.
3
  5.3
Adjustments:              
Depreciation, amortization and impairment of
intangible assets
0.6   0.9   0.2   0.2
Share-based compensation *   *   *   *
Non-IFRS gross profit for the period 24.5   19.7   5.5   5.5
* Less than $0.1 million
               

About Alarum Technologies Ltd.

Alarum Technologies Ltd. (Nasdaq, TASE: ALAR) is a global provider of web data collection solutions, empowering organizations to gain a competitive edge by streamlining the collection, extraction, and analysis of large-scale structured data from public online sources. Our data collection solutions by NetNut, are based on our world’s fastest and most advanced and secured hybrid proxy network, which comprises both exit points based on our proprietary reflection technology and hundreds of servers located at our ISP partners around the world. Pushing the boundaries of innovation in data collection, we are building a robust platform, complemented by the Website Unblocker, Data Collector, Data Sets and AI data collector. As the impact of the AI revolution unfolds, Alarum, with its robust market-leading data collection offerings is preparing itself to play a meaningful role as the world reshapes in a new form.

For more information about Alarum and its web data collection solutions, please visit www.alarum.io.

Follow us on Twitter

Subscribe to our YouTube channel

Investor Relations Contact:

[email protected]

________________________
1https://proxyway.com/research/proxy-market-research-2024
2 See definition under “Other Metrics”
3 The table below contains certain non-IFRS financial measures. See “Use of Non-IFRS Financial Results” for additional information regarding these measures and reconciliations to the most comparable IFRS measures.
4 As of the last day of the period.



Shareholder Alert: The Ademi Firm Investigates the Proposed Acquisition of Guess?, Inc. by WHP Global

Shareholder Alert: The Ademi Firm Investigates the Proposed Acquisition of Guess?, Inc. by WHP Global

MILWAUKEE–(BUSINESS WIRE)–
The Ademi Firm is investigating the proposed acquisition of Guess? (NYSE: GES) by WHP Global to determine if the interests of public shareholders are being protected.

Click here to learn how to join our investigation and obtain additional information or contact us at [email protected] or toll-free: 866-264-3995. There is no cost or obligation to you.

In the proposed transaction, Guess? shareholders would receive only $13.00 per share in cash, other than shares held by certain existing shareholders, including Paul Marciano, Maurice Marciano and Carlos Alberini, whose shares will be rolled over and reinvested. Guess? has formed a Special Committee of independent and disinterested directors to evaluate WHP Global’s proposal.

We will be investigating the conduct of the Guess? board of directors with respect to the WHP Global proposed acquisition, and whether the Guess? Board will be fulfilling their fiduciary duties to all shareholders.

We specialize in shareholder litigation involving buyouts, mergers, and individual shareholder rights. For more information, please feel free to call us. Attorney advertising. Prior results do not guarantee similar outcomes.

Ademi & Fruchter LLP

Guri Ademi

Toll Free: (866) 264-3995

Fax: (414) 482-8001

KEYWORDS: United States North America Wisconsin

INDUSTRY KEYWORDS: Class Action Lawsuit Professional Services Legal

MEDIA:

Logo
Logo

MetaVia Reports Year End 2024 Financial Results and Provides Corporate Update

PR Newswire

Top-Line Data From MAD Part
 2
 of the Phase 1 Trial of DA-1726 Expected in April of 2025

Announced Positive Top-Line 16-Week Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH, in December, Demonstrating Direct Hepatic Action in Addition to Its Glucose Lowering Effect


$16.0 Million in Cash at

 End of Fourth Quarter E
xpected to Fund the Company Into the Third Quarter of 2025


CAMBRIDGE, Mass.
, March 20, 2025 /PRNewswire/ — MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2024 and provided a corporate strategic update.

“Throughout 2024, we made exceptional progress advancing the clinical development of our two, next generation cardiometabolic assets. We eagerly anticipate reporting top-line results from the expanded cohorts of the multiple ascending dose (MAD) Part 2 of our Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “In light of the strong safety profile from the planned cohorts of the SAD Part 1 and MAD Part 2 of the study, we are adding additional cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. It is important to note that many patients using current GLP-1 agonists discontinue treatment due to tolerability issues, with 20% to 30% stopping within the first two months and up to 70% discontinuing within a year. Based on the preclinical data gathered so far and DA-1726’s balanced activation of GLP1R and glucagon receptors, which enhances energy expenditure, we remain confident that DA-1726 has the potential to become a best-in-class obesity drug, offering superior tolerability compared to currently marketed GLP-1 agonists and those in late-stage clinical trials. The top-line data from the MAD Part 2 study, expected shortly, will give us an early read on clinical efficacy. We remain committed to the rapid clinical development of DA-1726 and continue to plan for an early proof-of-concept study to assess the efficacy and safety of DA-1726, which is expected to commence during the fourth quarter of 2025.”

Mr. Kim continued, “In December, we reported positive top-line 16-week results from the two-part Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). DA-1241 met the primary endpoint, achieving a reduction in alanine transaminase (ALT) levels through direct hepatic effects, along with key secondary endpoints, including significantly lower hemoglobin A1C (HbA1C) levels compared to placebo. These are very positive results especially given the small study size. Importantly, DA-1241 demonstrated excellent tolerability, with mostly mild adverse events and no drug-related serious adverse events in the treatment groups. Based on these findings, we remain confident that DA-1241’s novel mechanism of action, which targets the inflammation associated with MASH, has the potential to result in a safe and effective treatment for this disease. We continue to conduct preclinical studies with a focus on exploring combination therapies for DA-1241, which has the potential to offer further benefits across the full spectrum of MASH. We look forward to reporting the complete data set, which we intend to present at a major medical meeting. Additionally, we anticipate scheduling an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025.”

Fourth Quarter 2024 and Subsequent Highlights

  • January 2025: Held an Advisory Committee meeting at the 9th Annual MASH-TAG 2025 Conference, to discuss the positive top-line 16-week results from the two-part Phase 2a clinical trial of DA-1241.
  • December 2024: Announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. In this trial, DA-1241 (100mg) demonstrated a statistically significant reduction in ALT levels at weeks 4 and 8, with a near statistically significant reduction at week 16. Statistically significant results were also achieved in multiple secondary endpoints including reductions in controlled attenuation parameter (CAP) and HbA1c. DA-1241 demonstrated similar trends in other liver enzymes including aminotransferase (AST) and gamma-glutamyl transferase (GGT).
  • November 2024: Announced a strategic realignment with a name change from “NeuroBo Pharmaceuticals, Inc.” to “MetaVia Inc.”, reflecting the Company’s focus on cardiometabolic diseases. In parallel, the Company’s common stock began trading on the Nasdaq Stock Market under the new ticker symbol, “MTVA.”
  • November 2024: Announced completion of the last patient visit in the Company’s two-part, Phase 2a clinical trial evaluating the efficacy and safety of DA-1241 for the treatment of patients with presumed MASH.

Anticipated Clinical Milestones

  • DA-1726 in Obesity: Top-line data from the additional cohorts in the MAD Part 2 is expected in April of 2025. The planned Phase 1 Part 3 will evaluate early proof of concept, with the first patient expected to be enrolled during the fourth quarter of 2025, followed by an interim data readout in or around mid-2026 and top-line results are expected in the second half of 2026.
  • DA-1241 in MASH: The full data set from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected to be presented at a major medical meeting in 2025. The Company expects to have an end-of-Phase 2 meeting with the FDA in the first half of 2025.

Full Year 2024 Financial and Operating Results

  • Research and Development (R&D) Expenses were approximately $21.6 million for the year ended December 31, 2024, as compared to approximately $9.2 million for the year ended December 31, 2023. The increase of approximately $12.4 million was primarily attributable to (i) $9.3 million in higher clinical trial expenditures, (ii) $2.5 million in higher expenditures for investigational drug manufacturing, non-clinical and preclinical costs related to expenses incurred under the Shared Services Agreement with Dong-A, and (iii) $1.2 million in higher employee compensation and benefits. These increases were partially offset by (i) $0.2 million in lower consulting expenditures and (ii) $0.4 million in lower other R&D costs.
  • General and Administrative Expenses were approximately $7.3 million for the year ended December 31, 2024, compared to approximately $6.7 million for the year ended December 31, 2023. The increase of approximately $0.5 million was primarily due to $1.0 million in higher employee compensation and benefits, partially offset by (i) $0.4 million in lower consulting expenditures, and (ii) $0.1 million in legal and professional fees.
  • Total Operating Expenses were approximately $28.8 million for the year ended December 31, 2024, compared to approximately $15.9 million for the year ended December 31, 2023. The approximately $12.9 million increase was attributable to higher R&D and G&A expenses.
  • Other Income was approximately $1.2 million for the year ended December 31, 2024, compared to approximately $3.4 million for the year ended December 31, 2023. The decrease of approximately $2.2 million was primarily attributable to a $2.7 million lower gain related to the change in fair value of warrant liabilities due to warrant exercises in 2023 and the impact of the common stock’s declining stock price during the last few years, partially offset by $0.5 million in higher interest income primarily due to higher average invested amounts in 2024.
  • Net Loss for the year ended December 31, 2024, was $27.6 million, or $3.56 per basic and diluted share, based on 7,757,128 weighted average shares of common stock outstanding, compared with a net loss of $12.5 million, or $2.46 per basic and diluted share, based on 5,071,101 weighted average shares of common stock outstanding for the year ended December 31, 2023.
  • Cash was $16.0 million as of December 31, 2024, compared with $22.4 million as of December 31, 2023. The company expects its cash position will be adequate to fund operations into the third quarter of 2025.

About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.

For more information, please visit www.metaviatx.com.

Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believes”, “expects”, “anticipates”, “may”, “will”, “should”, “seeks”, “approximately”, “potential”, “intends”, “projects”, “plans”, “estimates” or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia’s ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia’s current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia’s contract manufacturers, clinical study partners and others involved in the development of MetaVia’s current and future product candidates; potential negative interactions between MetaVia’s product candidates and any other products with which they are combined for treatment; MetaVia’s ability to initiate and complete clinical trials on a timely basis; MetaVia’s ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia’s clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia’s stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia’s filings with the Securities and Exchange Commission, including MetaVia’s most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia

Marshall H. Woodworth

Chief Financial Officer
+1-857-299-1033
[email protected]

Rx Communications Group

Michael Miller

+1-917-633-6086
[email protected]

– Tables to Follow –


MetaVia Inc.


Consolidated Balance Sheets

(In thousands, except per share amounts)

As of December 31,

2024

2023

Assets

Current assets

 Cash

$

16,017

$

22,435

 Prepaid expenses and other current assets

55

77

Total current assets

16,072

22,512

Property and equipment, net

34

46

Right-of-use asset

133

202

Other assets

21

21

Total assets

$

16,260

$

22,781

Liabilities and stockholders’ equity

Current liabilities

Accounts payable

$

3,879

$

821

Clinical trial accrued liabilities

1,696

3,033

Accrued expenses and other current liabilities

785

592

Warrant liabilities

361

658

Related party payable

1,472

789

Lease liability, short-term

78

67

Total current liabilities

8,271

5,960

Lease liability, long-term

58

136

Total liabilities

8,329

6,096

Commitments and contingencies

Stockholders’ equity

Preferred stock, $0.001 par value per share; 10,000 shares authorized and no shares issued or outstanding as of December 31, 2024 and 2023

Common stock, $0.001 par value per share, 100,000 shares authorized as of December 31, 2024 and 2023; 8,637 and 4,906 shares issued and outstanding as of December 31, 2024 and 2023, respectively

9

5

Additional paid–in capital

143,779

124,945

Accumulated deficit

(135,857)

(108,265)

Total stockholders’ equity

7,931

16,685

Total liabilities and stockholders’ equity

$

16,260

$

22,781

 


MetaVia Inc.


Consolidated Statements of Operations

(In thousands, except share and per share amounts)

Year Ended December 31,

2024

2023

Operating expenses

Research and development

$

21,553

$

9,158

General and administrative

7,256

6,728

Total operating expenses

28,809

15,886

Loss from operations

(28,809)

(15,886)

Other income

     Change in fair value of warrant liabilities

297

2,955

     Interest income

920

461

Total other income

1,217

3,416

Loss before income taxes

(27,592)

(12,470)

Provision for income taxes

Net loss and comprehensive net loss

(27,592)

(12,470)

Loss per share of common stock, basic and diluted

$

(3.56)

$

(2.46)

Weighted average shares of common stock, basic and diluted

7,757,128

5,071,101

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-year-end-2024-financial-results-and-provides-corporate-update-302406932.html

SOURCE MetaVia Inc.

Former Indiana Governor Holcomb Joins Doral Renewables Board of Directors

PR Newswire


PHILADELPHIA
, March 20, 2025 /PRNewswire/ — Doral Renewables LLC, a leading developer, owner, and operator of renewable energy projects, has announced the appointment of former Indiana Governor Eric J. Holcomb to its board of directors. Holcomb recently completed his eight-year term as the 51st Governor of Indiana, during which the state saw record-breaking investments and job creation.

Doral Renewables, an independent power producer, specializes in greenfield development of utility scale renewable energy projects. Its 14 gigawatt (GW) pipeline includes projects such as the 1.3 GW Mammoth Solar in Indiana and the 1.2 GW Vista Sands Solar project in Wisconsin. These two projects alone will power 500,000 Midwestern households.

The company’s Mammoth Solar project in Indiana impacts the Hoosier state’s economy by tapping into Indiana’s leading industries, including utilizing approximately 20,000 tons of Indiana steel. The project is also expected to contribute over $40 million to local municipalities through taxes and economic development payments. One of Doral’s primary efforts focuses on implementing dual-use practices that allow solar energy and farming to co-exist on the same land, offering local family farms the opportunity to increase profitability, and promote food production and heritage farming. Mammoth Solar currently features 2,000 livestock grazing within the project’s perimeter and the cultivation of several food crops.

“Governor Holcomb brings decades of exceptional experience in policymaking and economic development. His vision and leadership have resulted in record-breaking investments in Indiana,” stated Nick Cohen, President and CEO of Doral Renewables. “His innovative mindset aligns with our farmer community, especially as we continue to enhance our agrivoltaics deployment efforts, benefiting both the national grid by diversifying energy resources and cost reduction as well as local farmers by maximizing land use and creating additional revenue streams.”

“I couldn’t be more excited to join the relationship-centric team at Doral Renewables”, said Holcomb. “Doral’s world-class vision and mission are both critically important to meet the communities’ needs and provide them with economic opportunities and increased energy demand we are going to experience in the upcoming years. I look forward to strategically assisting Doral as the months and years unfold.”


About Doral Renewables

Doral Renewables is a Philadelphia-based developer, owner, and operator of renewable energy assets throughout the United States. Our solar and storage development portfolio exceeds 14 GW, which includes 400 MW currently in operation and 950 MW under construction. Doral Renewables operates in 20 states and across seven electricity markets. With a strong focus on community engagement, we aim to integrate agrivoltaics practices throughout our pipeline, creating additional opportunities for farming communities. We have secured over $2.5 billion in long-term wholesale power purchase agreements with U.S. customers. Our global management and leadership team includes the Doral Group (TASE: DORL), Migdal Group (TASE: MGDL), Clean Air Generation, APG, and Apollo Global Management (NYSE: APO). Learn more at doral-llc.com and follow us on LinkedIn and Facebook.


Governor Eric J. Holcomb


Eric J. Holcomb most recently served as the 51st Governor of the State of Indiana. Holcomb is a lifelong Hoosier, born in Indianapolis, Indiana, graduated from Pike High School and Hanover College in southeastern Indiana. He went on to serve six years of active duty in the U.S. Navy, first at Naval Station Great Lakes , and later at Naval Air Station Cecil Field, Florida, and then overseas at CINCIBERLANT NATO Command in Portugal. Holcomb was a trusted advisor to both Governor Mitch Daniels and Senator Dan Coats and served as a former state chairman of the Indiana Republican Party. He just finished serving in his second term as governor having been elected in 2016 and 2020 when he received the most votes for governor in Indiana history. Prior to his election as governor, Holcomb served as Indiana’s 51st Lieutenant Governor alongside then Governor Mike Pence. Holcomb has earned a reputation as a problem-solving, consensus builder focused on creating new opportunities for all. He frequently traveled throughout the state, visiting with Hoosiers about how to make Indiana the best place in the world to live, work, study, play, and stayed focused on economic, workforce, and community development. Under Holcomb’s leadership, Indiana soared to new heights, including record investments and outcomes in infrastructure, education and healthcare and becoming an economic envy in America. Holcomb and his wife, Janet, live with their miniature schnauzer Oliver in central Indiana.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/former-indiana-governor-holcomb-joins-doral-renewables-board-of-directors-302406946.html

SOURCE Doral Renewables LLC

Antitrust and Industrial Organization Expert Matthew Backus Affiliates with Compass Lexecon

WASHINGTON, March 20, 2025 (GLOBE NEWSWIRE) — FTI Consulting, Inc. (NYSE: FCN) today announced that Dr. Matthew Backus has affiliated with the firm’s Compass Lexecon subsidiary.

Dr. Backus is an expert in antitrust, microeconomics and industrial organization. He is a professor at the Haas School of Business and in the Economics Department at the University of California, Berkeley. His work focuses on antitrust, auctions, bargaining, communication and productivity, as well as the development of tools that are used to empirically distinguish between theoretical models of behavior.

Dr. Backus brings expertise that spans multiple industries, including financial, manufacturing, retail and technology. His work has been published in top academic outlets such as EconometricaThe Quarterly Journal of Economics and The Journal of Political Economy.

“Our top-notch roster of affiliates continues to grow at Compass Lexecon, allowing us to leverage a deep bench of experts with unique skillsets, tailored to our clients’ needs,” said Daniel R. Fischel, Chairman of Compass Lexecon. “We are excited to have Dr. Backus join our team as he will add excellent value to our firm and client offerings.”

Dr. Backus is a Research Associate of the National Bureau of Economic Research and a Research Affiliate of the Centre for Economic and Policy Research. His work has been supported by grants from the National Science Foundation as well as the Alfred P. Sloan Foundation.

Commenting on his affiliation, Dr. Backus said, “Today’s markets have grown increasingly complex, and clients are looking for rigorous economic analysis to help them navigate it. I am eager to join the experts at Compass Lexecon to continue the firm’s leading work in this space.”

About FTI Consulting   
FTI Consulting, Inc. is a leading global expert firm for organizations facing crisis and transformation, with more than 8,300 employees in 34 countries and territories as of December 31, 2024. The Company generated $3.69 billion in revenues during fiscal year 2024. In certain jurisdictions, FTI Consulting’s services are provided through distinct legal entities that are separately capitalized and independently managed. More information can be found at www.fticonsulting.com.  

FTI Consulting, Inc.  
555 12th Street NW  
Washington, DC 20004  
+1.202.312.9100 

Investor Contact:  
Mollie Hawkes 
+1.617.747.1791 
[email protected] 

Media Contact:  
Matthew Bashalany 
+1.617.897.1545 
[email protected]  



Nayax Introduces Innovative State-of-Charge Feature for EV Kiosk, Elevating EV Charging Experience

Drivers can now easily access charging information through QR codes without apps or registration

HERZLIYA, Israel, March 20, 2025 (GLOBE NEWSWIRE) — Nayax Ltd. (Nasdaq: NYAX; TASE: NYAX), a global commerce enablement, payments and loyalty platform designed to help merchants scale their business, today announced the launch of its State-of-Charge feature for its EV Kiosk. This new upgrade simplifies electric vehicle (EV) charging by clearly separating card-present payments from mobile access to charging session details. Payments are securely completed directly at the payment kiosk, while detailed charging information is effortlessly accessed on drivers’ smartphones by scanning a QR code—no app downloads or personal details required.

As EVs become increasingly common, convenience and data privacy are top priorities for drivers. Many drivers find managing numerous charging apps inconvenient and worry about protecting sensitive payment data. Nayax’s EV Kiosk solves these challenges by enabling secure, quick, physical payments directly at the kiosk. After paying, drivers simply scan the QR code displayed at the kiosk to see key charging details on their phones, including energy usage, charging speed, session duration, total cost, and kWh charged. Drivers can easily track their charging session remotely and instantly receive a digital e-receipt upon completion.

EV Kiosk’s digital e-receipts are customizable, allowing merchants to strengthen brand visibility and customer relationships. Businesses can leverage receipts for promotions, social media links, engaging video content, or advertisements—encouraging customer loyalty and repeat visits.

“Our goal at Nayax is to deliver payment solutions that make life easier for both the merchant and consumer,” said Yair Nechmad, CEO of Nayax. “With our new State-of-Charge feature, we’ve taken a practical approach to solve the everyday frustrations drivers face when charging EVs. By clearly separating the secure physical payment from mobile charging session management, we’ve made EV charging simpler, faster, and safer—for drivers and charging operators alike.”

To experience Nayax’s EV Kiosk and its latest features, visit Nayax at the EV Charging Summit & Expo in Las Vegas, March 25-27, 2025. Explore the Nayax Highway at booth #141, attend expert-led sessions at the Westgate Convention Center, and join Nayax’s exclusive Happy Hour event at the booth on March 26 at 3:30PM.

Nayax will lead the following speaker sessions during the event:

  • “Fuelling Payment Acceptance for EV Charging Stations Across America” – 1:30PM – 2:00PM, Wednesday, March 26, 2025, led by Siavosh Dana, EVP of Strategy and Business Development, Nayax Energy NA.
  • Keynote: “Elevating the Customer Charging Experience” – 9:00AM – 10:00AM, Thursday, March 27, 2025, by Carly Furman, CEO, Nayax NA.
  • “Accelerating the Future of V2G and Bidirectional Charging” – 1:50PM – 2:20PM, Thursday, March 27, 2025, led by Yinon Raviv, EVP Global Sales, Nayax Energy.

For more details about Nayax’s EV Kiosk, visit www.nayax.com.

Forward-Looking Statements

This report on Form 6-K contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this report on Form 6-K can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to: our expectations regarding general market conditions, including as a result of global economic trends; changes in consumer tastes and preferences; fluctuations in inflation, interest rate and exchange rates in the global economic environment; general economic, political, demographic and business conditions in Israel, including the ongoing war in Israel that began on October 7, 2023 and global perspectives regarding that conflict; and other risk factors discussed under “Risk Factors” in our annual report on Form 20-F filed with the SEC on March 4, 2025 (our “Annual Report”). The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only estimates based upon our current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under “Risk Factors” in our Annual Report. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Each forward-looking statement speaks only as of the date of the particular statement. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason, to conform these statements to actual results or to changes in our expectations.

About Nayax

Nayax is a global commerce enablement, payments and loyalty platform designed to help merchants scale their business. Nayax offers a complete solution including localized cashless payment acceptance, management suite, and loyalty tools, enabling merchants to conduct commerce anywhere, at any time. With foundations and global leadership in serving unattended retail, Nayax has transformed into a comprehensive solution focused on our customers’ growth across multiple channels. As of December 31, 2024, Nayax has 11 global offices, approximately 1,100 employees, connections to more than 80 merchant acquirers and payment method integrations and globally recognized as a payment facilitator. Nayax’s mission is to improve our customers’ revenue potential and operational efficiency. For more information, please visit www.nayax.com

Nayax Public Relations Contact:

Scott Gamm
Strategy Voice Associates
[email protected] 

Nayax Investor Relations Contact:

Aaron Greenberg
Chief Strategy Officer
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/46a8e3ec-5c40-494b-a7e7-51606fb001e0



3 E Network Technology Group Limited Announces Strategic Equity Investment in HashBeaver to Accelerate Blockchain Innovation

Partnership Combines the Company’s B2B IT Expertise with HashBeaver’s Cutting-Edge Cloud Mining Solutions for Cross-Industry Growth

Guangzhou, China, March 20, 2025 (GLOBE NEWSWIRE) — 3 E Network Technology Group Limited (“3e Network” or the “Company”) (Nasdaq: MASK), a business-to-business (“B2B”) information technology (“IT”) business solutions provider, today announced that it has entered into a Memorandum of Understanding (“MoU”) with HASH BEAVER PTE. LTD (“HashBeaver”), a Singapore-based company with a dedicated cloud mining platform in the digital currency financial sector. The MoU outlines the Company’s strategic equity investment in HashBeaver, marking a transformative step to integrate blockchain-driven solutions into its IT ecosystem.

Pursuant to the MoU, 3e Network intends to acquire a​ 4.9% equity stake in HashBeaver, valuing the cloud mining innovator at a ​pre-money valuation of $30 million. The MoU is a non-binding document and the final investment terms are subject to terms in a definitive agreement. The investment outlined in the MoU focused on merging 3e Network’s B2B software expertise with HashBeaver’s advanced blockchain infrastructure.

As a rising player in the digital asset space, HashBeaver has rapidly gained industry recognition for its expertise in cloud mining and cryptocurrency financial services. Leveraging the collective expertise and capital of industry giants, HashBeaver has secured strategic investment from MinerVa Semiconductor, a leading manufacturer of cryptocurrency mining hardware, providing a solid foundation for ongoing innovation and growth. Additionally, HashBeaver has reported the achievement of key milestones, including the management of 9.6 EH/s of computing power, the establishment of 5 global mining facilities, and the completion of 290 MW of capacity, as of July 2, 2024, according to its website. By the end of 2024, the total capacity is expected to reach 425 MW, according to the same source.

Dr. Tingjun Yang, Co-Chief Executive Officer and Director of 3e Network, commented: “We believe this MoU will strengthen our strategic collaboration and pave the way for broader cooperation in the future. By leveraging HashBeaver’s expertise and strong position in cloud mining services, we are confident in expanding our IT business solutions and creating significant value for both companies’ shareholders.”

About HashBeaver

HashBeaver is engaged in cloud mining services, dedicated to revolutionizing the digital currency landscape. The company provides solutions for digital asset management, catering to both individual and institutional clients. As a recipient of strategic investment from MinerVa Semiconductor, a cryptocurrency mining hardware manufacturer, HashBeaver continues to push the boundaries of innovation in computing power services. HashBeaver’s mission is to build secure, transparent, and compliant blockchain infrastructures. Through its global operations and strong emphasis on sustainability, HashBeaver empowers clients to achieve efficient and profitable digital asset management.

About 3 E Network Technology Group Limited

3 E Network Technology Group Limited is a business-to-business (“B2B”) information technology (“IT”) business solutions provider. Through its two subsidiaries, Guangzhou Sanyi Network and Guangzhou 3E Network, the Company began by offering integrated software and hardware solutions for the property management and exhibition services spaces. Over time, 3 E Network expanded its software solutions offerings to serve a variety of sectors, including food establishments, real estate, exhibition and conferencing, and clean energy utilities. The Company’s business comprises two main portfolios: the software development portfolio and the exhibition and conference portfolio. For more information, please visit the Company’s website at http://ir.3etech.cn.

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “assesses,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or similar expressions. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s registration statement and other filings with the U.S. Securities and Exchange Commission.

For more information, please contact:

3 E Network Technology Group Limited

Investor Relations Department
Email: [email protected]



InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones

  • Received European Commission approval for GOHIBIC® (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS)
  • Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG) to enable an expected interim analysis for trial size adaptation or futility by the end of May 2025
  • Dosed first patient in Phase 2a trial for oral C5aR inhibitor, INF904, with topline data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected in summer 2025
  • Multiple data presentations at AAD 2025 highlighting the potential of vilobelimab in reducing systemic inflammation
  • Cash, cash equivalents and marketable securities of €55.2 million as of December 31, 2024
  • Additional €28.7 million ($30.0 million) in gross proceeds subsequently raised by an underwritten public offering of ordinary shares and pre-funded warrants on February 18, 2025
  • InflaRx’s cash runway significantly extended, with sufficient cash, cash equivalents and marketable securities to fund currently planned operations into 2027

JENA, Germany, March 20, 2025 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its financial results for the year ended December 31, 2024, highlighting recent operational achievements and expected milestones for 2025.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “2024 was a highly productive year for InflaRx, with the company achieving all major development and regulatory goals across its pipeline programs and making meaningful progress in addressing critical medical needs in inflammatory diseases.” He continued: “We look forward to a catalyst-rich year in 2025 as we continue to advance our pipeline, including reaching the interim analysis for the Phase 3 trial with vilobelimab in pyoderma gangrenosum and reporting top-line Phase 2a data in chronic spontaneous urticaria and hidradenitis suppurativa with INF904, our oral C5aR inhibitor with best-in-class potential.

Select recent highlights and expected milestones


INF904 in CSU and HS – Topline Phase 2a data expected in summer 2025

In December 2024, InflaRx announced that the first patient had been dosed in its Phase 2a basket study with INF904 in CSU and HS. This is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment in a total of 75 patients (45 in CSU and 30 in HS). The goal of the trial is to generate additional safety and pharmacokinetic (PK) data and to provide signs of clinical benefit. After the 4-week treatment period, patients will be followed for an additional 4 weeks. Topline data from this study are expected in the summer of 2025, with a goal of informing the planning and design of a larger, longer-term Phase 2b study by year-end 2025.

InflaRx believes CSU and HS each has potential addressable markets of $1 billion or more for INF904. The Company also believes INF904 could address meaningful opportunities in additional immuno-dermatology and immuno-inflammatory indications, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, the Company continues to assess and monitor the value of pursuing additional areas and applications via potential future collaborations with partners.


Vilobelimab in PG – Pivotal Phase 3 trial interim analysis expected by the end of May 2025

In November 2024, InflaRx announced that it had achieved the 30-patient recruitment milestone in its ongoing Phase 3 vilobelimab trial in PG. This is expected to enable the interim analysis for trial size adaptation or futility by the end of May 2025. Trial enrollment continues. The study dosed its first patient in November 2023 and has an adaptive design with an interim analysis (unblinded only for the independent data monitoring committee), which is planned when 30 patients randomized 1:1 to the two arms have completed treatment. The interim analysis with a set of predefined rules will consider the then-observed difference in complete target ulcer closure between the two arms and will then determine whether the trial sample size will be adapted or whether the trial should be stopped due to futility. The enrollment period is projected to last at least two years, and its overall period will depend on the total trial size after sample size adaptation.

The Phase 3 trial is a multi-national, randomized, double-blind, placebo-controlled pivotal study assessing the benefit of vilobelimab for treating ulcerative PG, a rare, chronic inflammatory form of neutrophilic dermatosis characterized by accumulation of neutrophils in the affected skin areas. The trial has two arms: (1) vilobelimab plus a low dose of corticosteroids and (2) placebo plus the same dose of corticosteroids, both tapered over an 8-week period. The primary endpoint of the study is complete closure of the target ulcer measured at two consecutive visits at any time up to 26 weeks after initiation of treatment.

Vilobelimab has been granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as fast track designation by the FDA.


Vilobelimab presentations at the 2025 AAD Annual Meeting

During the 2025 American Academy of Dermatology (AAD) Annual Meeting held March 7 – 11 in Orlando, FL, vilobelimab was featured in multiple sessions. Collectively, these data highlighted the utility of vilobelimab in treating multiple inflammatory conditions, including PG and HS, with supporting evidence from clinical efficacy data, safety assessments, and pharmacokinetic and pharmacodynamic analyses.


GOHIBIC (vilobelimab) granted EU marketing authorization

In January 2025, the European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced ARDS who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). GOHIBIC (vilobelimab) is the first and only treatment approved in the European Union (EU) for the treatment of SARS-CoV-2-induced ARDS.

The marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a materially negative impact on its cash burn rate.

In June 2024, InflaRx announced that GOHIBIC (vilobelimab) had been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 clinical platform study exploring potential new options for the treatment of ARDS. Vilobelimab is one of three host-directed investigational drugs assessed in this study, with the safety and efficacy of each investigational drug to be studied in its own patient cohort and compared against placebo. This Phase 2 platform study is expected to collect data in order to define subsets of patients with ARDS who may benefit from specific host-directed therapeutics and to inform the design of potential Phase 3 studies.

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “With our recent successful capital raise and the efficient utilization of our balance sheet, InflaRx is on solid financial footing, enabling us to efficiently advance our key development programs. Importantly, our cash runway into 2027 should allow us to reach several value inflection points, including the end-of-May interim analysis for the vilobelimab Phase 3 study in pyoderma gangrenosum, along with the eventual readout of this trial, as well as the INF904 Phase 2a topline data this summer.”


Financing activities

In February 2025, the company completed an underwritten public offering of ordinary shares and pre-funded warrants leading to gross proceeds from the offering of €28.7 million ($30.0 million), before deducting the underwriting discount and offering expenses.

2024 Financial highlights


Revenue

In 2024, we realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of €0.2 million, which represents an increase of €0.1 million compared to the prior year. Revenues reported are sales to end customers (hospitals). Sales to distributors do not constitute revenue for the Company. All revenues are attributed to sales made in the United States.


Cost of sales

Cost of sales increased by €2.8 million in 2024 compared to the corresponding costs for 2023, primarily due to higher inventory write-downs of €2.8 million as a result of quantities on hand exceeding quantities expected to be sold prior to expiry.


Marketing and sales expenses

Marketing and sales expenses increased by €2.8 million in 2024 compared to 2023, as 2024 represented the first full year of commercial efforts for GOHIBIC (vilobelimab) in the United States. In 2023, marketing and sales expenses were only incurred during the second half of the year.


Research and development expenses

Research and development expenses decreased by €5.7 million to €35.4 million in 2024 compared to the year 2023. This decrease was primarily attributable to €8.7 million lower third-party costs from manufacturing development activities and from clinical trials, offset by €1.6 million higher personnel expenses and €1.4 million higher other expenses compared to the previous year. Other expenses include a one-off milestone contractual payment of $1.0 million (€1.0 million) relating to market authorization for GOHIBIC (vilobelimab) in the EU.


General and administrative expenses

General and administrative expenses increased by €0.4 million to €13.0 million for the year ended December 31, 2024, from €12.6 million for the year ended December 31, 2023. This increase is comprised of higher personnel expenses of €0.9 million and partially offset by a decrease in legal and consulting expenses of €0.4 million and a decrease in insurance expenses of €0.4 million.


Other income

Other income decreased by €7.9 million in 2024 compared to the year 2023 due primarily to lower income from government grants. In June 2023, our grant from the German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of severe COVID-19 patients ended. In 2024, upon qualifying for an allowance under the German Research Allowance Act, we recognized €5.1 million in income relating to expenses, eligible for reimbursement, which were incurred in the years 2020 to 2024. We remain eligible for additional research allowances for eligible expenses to be incurred from 2025 to 2027.


Net financial result

Net financial result increased by €4.7 million to a gain of €6.9 million in 2024 compared to €2.2 million in 2023. This overall net increase is mainly attributable to an increase of €5.5 million in foreign exchange results, partially offset by €0.6 million lower interest income from marketable securities compared to 2023.


Net loss

We incurred a net loss of €46.1 million, or €0.78 per ordinary share, in 2024, compared to €42.7 million, or €0.78 per ordinary share, in 2023.


Liquidity and capital resources

As of December 31, 2024, our total funds available amounted to approximately €55.2 million, comprised of €18.4 million of cash and cash equivalents and €36.8 million of marketable securities.


Net cash used in operating activities

Net cash used in operating activities increased to €48.6 million in 2024, from €37.8 million in 2023, mainly due to lower income recognized from German federal government grants and research allowances


Additional financial information

Additional information regarding these results and other relevant information is included in the notes to the financial statements in “Item 18. Financial Statements”, which are included in InflaRx’s most recent annual report on Form 20-F as filed today with the U.S. Securities and Exchange Commission (SEC).



InflaRx N.V. and subsidiaries




Consolidated statements of operations and comprehensive loss



for the years ended December 31, 2024, 2023 and 2022

    2024    2023    2022 
    (in €, except for share data)
             
Revenues   165,789     63,089      
Cost of sales   (3,317,039 )   (532,262 )    
Gross profit   (3,151,250 )   (469,173 )    
Marketing and sales expenses   (6,756,595 )   (4,001,299 )    
Research and development expenses   (35,363,897 )   (41,024,131 )   (37,526,090 )
General and administrative expenses   (13,024,441 )   (12,628,756 )   (14,869,564 )
Other income   5,287,616     13,219,704     20,159,169  
Other expenses   (297 )   (4,440 )   (1,381 )
Operating result   (53,008,864 )   (44,908,096 )   (32,237,866 )
Finance income   3,196,813     3,804,827     608,679  
Finance expenses   (20,655 )   (35,628 )   (45,250 )
Foreign exchange result   3,670,235     (1,841,872 )   2,442,297  
Other financial result   103,285     313,240     (252,471 )
Income taxes   (5,217 )        
Loss for the period   (46,064,402 )   (42,667,529 )   (29,484,611 )
Other comprehensive income (loss) that may be
reclassified to profit or loss in subsequent periods:
           
Exchange differences on translation of foreign currency   58,344     125,085     4,206,810  
TOTAL COMPREHENSIVE LOSS   (46,006,058 )   (42,542,444 )   (25,277,801 )
             
             
Share information            
Weighted average number of shares outstanding   58,918,678     54,940,137     44,207,873  
Loss per share (basic/diluted)   (0.78 )   (0.78 )   (0.67 )
             



InflaRx N.V.


and subsidiaries




Consolidated statements of financial position as of December 31, 2024 and 2023

    December 31,

2024
  December 31,

2023
ASSETS   (in €)
Non-current assets        
Property and equipment   256,280     289,577  
Right-of-use assets   758,368     1,071,666  
Intangible assets   50,781     68,818  
Other assets   204,233     257,267  
Financial assets   3,092,290     9,052,741  
Total non-current assets   4,361,952     10,740,069  
Current assets        
Inventories   6,897,666     11,367,807  
Current other assets   5,103,402     4,036,649  
Other assets from government grants and research
allowance
  5,081,772      
Tax receivable   1,735,335     3,791,564  
Other financial assets   34,462,352     77,504,518  
Cash and cash equivalents   18,375,979     12,767,943  
Total current assets   71,656,505     109,468,482  
TOTAL ASSETS   76,018,457     120,208,551  
         
EQUITY AND LIABILITIES        
Equity        
Issued capital   7,122,205     7,065,993  
Share premium   334,929,685     334,211,338  
Other capital reserves   44,115,861     40,050,053  
Accumulated deficit   (332,192,221 )   (286,127,819 )
Other components of equity   7,440,510     7,382,166  
Total equity   61,416,039     102,581,730  
Non-current liabilities        
Lease liabilities   399,066     745,716  
Other liabilities   36,877     36,877  
Total non-current liabilities   435,943     782,593  
Current liabilities        
Trade and other payables   11,394,232     11,974,362  
Lease liabilities   406,020     374,329  
Employee benefits   2,064,678     1,609,766  
Other liabilities   301,544     2,885,772  
Total current liabilities   14,166,475     16,844,228  
Total liabilities   14,602,417     17,626,822  
TOTAL EQUITY AND LIABILITIES   76,018,457     120,208,552  



InflaRx N.V. and subsidiaries




Consolidated statements of changes in shareholders’ equity



for the years ended December 31, 2024, 2023 and 2022

in € Issued
capital
  Share
pre­mium



  Other
capital
reserves
  Ac­cu­mu­lated
deficit



  Other
com­­po­nents
of equity
  Total
equity
                     
Balance as of January 01, 2022 5,304,452   280,310,744     30,591,209   (213,975,679 )   3,050,270   105,280,996  
Loss for the Period         (29,484,611 )    —    (29,484,611 )
Exchange differences on translation of foreign currency             4,206,810   4,206,810  
Total Comprehensive Loss         (29,484,611 )   4,206,810   (25,277,801 )
Issuance of ordinary shares 60,000   2,289,624             2,349,624  
Transaction costs   (47,735 )           (47,735 )
Equity-settled share-based pay­ments       6,044,356         6,044,356  
Balance as of December 31, 2022 5,364,452   282,552,633     36,635,564   (243,460,290 )   7,257,080   88,349,440  
Loss for the Period         (42,667,529 )    —   (42,667,529 )
Exchange differences on translation of foreign currency             125,085   125,085  
Total Comprehensive Loss         (42,667,529 )   125,085   (42,542,444 )
Issuance of ordinary shares 1,687,110   54,796,819             56,483,929  
Transaction costs   (3,360,626 )           (3,360,626 )
Equity-settled share-based pay­ments       3,414,489         3,414,489  
Share options exercised 14,431   222,512             236,943  
Balance as of December 31, 2023 7,065,993   334,211,338     40,050,053   (286,127,819 )   7,382,166   102,581,730  
Loss for the Period         (46,064,402 )     (46,064,402 )
Exchange differences on
translation of foreign currency
        —      58,344   58,344  
Total Comprehensive Loss         (46,064,402 )   58,344    (46,006,058 )
Issuance of ordinary shares 56,213   1,042,076             1,098,289  
Transaction costs   (323,729 )           (323,729 )
Equity-settled share-based pay­ments       4,065,807         4,065,807  
Balance as of December 31, 2024 7,062,206   334,929,685     44,115,861   (332,192,221 )   7,440,510   61,416,039  
                     



InflaRx N.V. and subsidiaries




Consolidated statements of cash flows



for the years ended December 31, 2024, 2023 and 2022

    2024    2023    2022 
    (in €)
Operating activities            
Loss for the period   (46,064,402 )   (42,667,529 )   (29,484,611 )
Adjustments for:            
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets   485,114     567,780     596,597  
Net finance income   (6,949,679 )   (2,240,566 )   (2,753,255 )
Share-based payment expense   4,065,807     3,414,489     6,044,356  
Net foreign exchange differences   (37,101 )   413,017     385,359  
             
Changes in:            
Other assets from government grants and research allowances   (5,081,772 )   732,971     (732,971 )
Other assets   1,042,513     7,825,181     (3,308,485 )
Employee benefits   454,912     297,518     (64,024 )
Other liabilities   (2,584,228 )   2,738,164     9,403  
Liabilities from government grants received       (6,209,266 )   (2,090,734 )
Trade and other payables   (580,129 )   6,986,824     (3,586,706 )
Inventories   4,470,141     (11,367,807 )    
Interest received   2,243,197     1,732,284     1,287,200  
Interest paid   (21,064 )   (36,025 )   (44,946 )
Net cash used in operating activities   (48,556,690 )   (37,812,966 )   (33,742,817 )
Investing activities            
Purchase of intangible assets and property and equipment   (46,871 )   (81,100 )   (162,391 )
Purchase of current and non-current financial assets   (35,340,107 )   (104,051,972 )   (64,474,543 )
Proceeds from the maturity of current financial assets   87,751,331     86,436,456     83,995,029  
Net cash from/ (used in) investing activities   52,364,354     (17,696,616 )   19,358,095  
Financing activities            
Proceeds from issuance of ordinary shares   1,098,289     56,483,929     2,349,624  
Transaction costs from issuance of ordinary shares   (323,729 )   (3,360,626 )   (47,735 )
Proceeds from exercise of share options       236,943      
Repayment of lease liabilities   (388,114 )   (373,977 )   (364,430 )
Net cash from financing activities   386,446     52,986,269     1,937,459  
Net in-/decrease in cash and cash equivalents   4,194,110     (2,523,313 )   (12,447,262 )
Effect of exchange rate changes on cash and cash equivalents   1,413,926     (974,099 )   2,462,622  
Cash and cash equivalents at beginning of period   12,767,943     16,265,355     26,249,995  
Cash and cash equivalents at end of period   18,375,979     12,767,943     16,265,355  





About



GOHIBIC (vilobelimab)

In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC (vilobelimab) is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.

A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC (vilobelimab)’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.

In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.

GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC (vilobelimab) website http://www.gohibic.com.



Important Safety Information about GOHIBIC (vilobelimab)

There are limited clinical data available for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab) use.

GOHIBIC (vilobelimab) has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.

The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.

Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths that occur during GOHIBIC (vilobelimab) treatment and are considered to be potentially attributable to GOHIBIC (vilobelimab).

Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: [email protected].

For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com.

The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.



About vilobelimab

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response.

Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the EMA, as well as fast track designation by the FDA.



About INF904

INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days. PK / pharmacodynamic data support the best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.



About InflaRx N.V.

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor.  InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de.



Contacts:

InflaRx N.V. MC Services AG
Jan Medina, CFA
Vice President, Head of Investor Relations
Email: [email protected]
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: [email protected]
Europe: +49 89-210 2280
U.S.: +1-339-832-0752

* Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions provided on the webpage: The InflaRx Commitment Program.


FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indications or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.



Plus Therapeutics Introduces REYOBIQ™, FDA-Accepted Proprietary Name for Lead Drug Candidate

 REYOBIQ™ (rhenium Re186 obisbemeda) continues to be under clinical investigation for Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM)

HOUSTON, March 20, 2025 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the U.S. Food and Drug Administration (FDA) has conditionally accepted the Company’s new proprietary name, REYOBIQ™, for its lead therapeutic candidate. A request for proprietary name review for REYOBIQ™ must be submitted once the marketing application (NDA) is submitted. All communications regarding the USAN-adopted and INN-recommended rhenium Re186 obisbemeda generic name will now utilize the proprietary name REYOBIQ™.

“Branding is an important part of preparing for commercialization, and the establishment of the REYOBIQ™ brand will enable investigators, investors, and potential patients to connect with our rhenium-based radiotherapeutic beyond its chemical identity,” said Russ Havranek, Plus Therapeutics VP of Corporate Strategy and New Product Planning. “We are looking forward to building familiarity with the new REYOBIQ™ name and logo, as we believe it will foster stronger stakeholder engagement and reinforce the promising progress we are making in developing targeted radiotherapeutics for LM and GBM.”

About REYOBIQ(rhenium Re186 obisbemeda)
REYOBIQ™ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ™ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ™ is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

About Plus Therapeutics

Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.

Investor Contact

Jules Abraham
Managing Director, Communications
CORE IR
[email protected]



Quantum BioPharma Continues to Grow Its Crypto Assets and Diversify Its Treasury With the Purchase of Another USD $1,500,000 Worth of Bitcoin (BTC) and Other Cryptocurrencies

TORONTO, March 20, 2025 (GLOBE NEWSWIRE) — Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), is pleased to announce that after receiving approval from the Board of Directors, the Company has purchased an additional USD $1,500,000 worth of Bitcoin (BTC) and other cryptocurrencies, growing and increasing its crypto assets as part of its strategic efforts. This brings the total amount of Bitcoin (BTC), and other cryptocurrencies purchased to USD $3,500,000. As previously announced, the company will continue to allow for future financings and other transactions to be carried out in cryptocurrency.

This move reflects the company’s belief in the potential of Bitcoin (BTC) and other currencies to provide a return on investment for shareholders and to provide some hedge against the dollar. The company is now set up to receive financing in cryptocurrencies as well as executing other types of transactions in cryptocurrencies, improving the prospects of further financing as needed.

The company is holding all its cryptocurrency with a fully compliant custodian. The company emphasizes that all transactions are and will be fully compliant with all relevant financial and audit regulations, ensuring a secure and legal process.

The Company will continue to monitor market conditions and may increase or decrease its holdings of Bitcoin (BTC) or other cryptocurrencies as it deems appropriate.

About Quantum BioPharma Ltd.

Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented UNBUZZD™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of 25.71% (as of June 30, 2024) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd ™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.

Forward-Looking Information

Certain information in this news release constitutes forward-looking statements under applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as “may”, “should”, “anticipate”, “expect”, “potential”, “believe”, “intend” or the negative of these terms and similar expressions. Forward-looking statements in this news release include statements related to such.

Forward-looking information in this press release are based on certain assumptions and expected future events.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission’s website at

www.sec.gov

for a more complete discussion of such risk factors and their potential effects.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

Contacts:

Quantum BioPharma Ltd.

Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: [email protected]  
Telephone: (833) 571-1811

Investor Relations

Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
[email protected]  
www.mzgroup.us