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     169  0 Kommentare NeurAxis Reports Third Quarter 2023 Financial Results

    CARMEL, Ind., Nov. 20, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today reported financial results for the third quarter ended September 30, 2023.

    Recent Highlights:

    • Announced the results of a retrospective comparative study led by the Cincinnati Children’s Hospital Medical Center that was published and featured in the September 19th, 2023 Frontiers in Pain Research. The publication, Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders, compared and reviewed the records of 101 adolescent patients with functional abdominal pain disorders (FAPD) treated with IB-Stim therapy or standard-of-care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). The comparative analysis noted:
      • at follow-up, IB-Stim therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034);
      • in a comparison of outcomes between groups, IB-Stim was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); and
      • disability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim (p=0.21).
    • 4 new publications in the third quarter of 2023 bringing our total publications to date to 11, remaining on track with our target of 13 publications in children with FAPD by year-end, with a total of 16 publications by Q1 2024. This progress places the Company in a great position for expanded payor coverage.
    • Announced the signing of an exclusive option agreement with the University of Michigan for the exclusive licensing of its innovative rectal expulsion device (RED).
    • Announced $3 million in committed financing from affiliates of Inspire Health Alliance.
    • Received new policy coverage from CareFirst BCBS in the mid-Atlantic with 3.5 million members, increasing NeurAxis access to 8.25 million covered lives.

    “We continue to execute on our commercialization plan, growing our body of clinical evidence to expand payor coverage and adoption. As anticipated, we are in reach of our overall target of 16 publications, which we now expect by Q1 2024, and we have been receiving positive response from payers on a national level as we close in on all data being published,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “Our sales and marketing efforts for IB-Stim continue to show growth in areas where children’s hospitals have good payer coverage, despite some increased short-term challenges in areas where there is no good written policy coverage combined with some ordering patterns during the third quarter. Our focus remains on growing our body of clinical evidence and accelerating the speed of policy adoption by payers. Additionally, we were happy to announce the exclusive option agreement with the University of Michigan for RED. RED offers a significant market opportunity for us as it aligns with our focus and expertise in the field of disorders of the gut-brain interaction. We anticipate a 510(k)-clearance pathway for RED, targeting commercialization in 2024 and meaningful revenues from RED beginning in 2024. We believe great data leads to strong policy coverage, which in return translates to higher revenues. We look forward to our continuing progress to grow our business, with many upcoming catalysts for growth.”

    Third Quarter 2023 Financial Results
    Revenue for the third quarter of 2023 was $477.5 thousand, representing a decrease of 23% compared to $618.8 thousand in the third quarter of 2022. The decrease was primarily due to ordering patterns of our major customers.

    Gross profit for the third quarter of 2023 was $410.2 thousand, representing a decrease of 26% compared to a gross profit of $551.2 thousand in the third quarter of 2022. Gross margin totaled 85.9% in the third quarter of 2023, compared to 89.1% in the third quarter of 2022. The decrease in gross profit was primarily due to higher cost of goods sold while sales decreased, mainly because of a small amount of devices that were sold below the regular price.

    Selling expenses for the third quarter of 2023 were $64.2 thousand, compared to $81.6 thousand in the third quarter of 2022. The decrease was primarily due to lower commission costs, with the commission rate being lowered at the beginning of 2023.

    Third quarter research and development expenses were $45.0 thousand, compared to $86.2 thousand in the third quarter of 2022. The decrease was primarily due to lower costs associated with completed pipeline indications.

    Lesen Sie auch

    General and administrative expenses for the third quarter of 2023 were $3,323.4 thousand, compared to $1,586.5 thousand in the third quarter of 2022. The increase was driven primarily due to higher wages and professional fees in connection with our initial public offering.

    Third quarter net loss was ($4,904.4) thousand, or ($1.35) per common share, compared to ($2,079.7) thousand, or ($1.14) per common share, for the same period of 2022.

    Forward-Looking Statements
    Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, as well as factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events, and developments or otherwise.

    About NeurAxis, Inc.
    NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com.

    Contacts:

    Company
    NeurAxis, Inc.
    info@neuraxis.com

    Investor Relations
    Gilmartin Group
    IR@neuraxis.com


    NeurAxis, Inc.
    Condensed Statements of Operations
    (unaudited)
     
      For the Three Months Ended
    September 30,
        For the Nine Months Ended
    September 30,
     
      2023     2022     2023     2022  
                           
                           
    Net Sales $ 477,460     $ 618,805     $ 1,928,590     $ 2,071,653  
    Cost of Goods Sold   67,287       67,638       231,000       221,846  
                                   
    Gross Profit   410,173       551,167       1,697,590       1,849,807  
                                   
    Selling Expenses   64,210       81,589       250,933       344,892  
    Research and Development   44,950       86,175       171,536       144,239  
    General and Administrative   3,323,352       1,586,527       6,316,411       3,746,688  
                                   
    Operating Loss   (3,022,339 )     (1,203,124 )     (5,041,290 )     (2,386,012 )
                                   
    Other Income (Expense):                              
    Financing charges         (601,128 )     (2,772 )     (1,473,892 )
    Interest expense   (102,628 )     (100,741 )     (453,869 )     (161,291 )
    Interest income   2,103             2,103        
    Change in fair value of warrant liability   592,853       (90,628 )     791,610       (660,189 )
    Change in fair value of derivative liability   6,394       (68,032 )     198,551       (68,032 )
    Amortization of debt discount and issuance cost   (1,331,030 )     (16,029 )     (4,881,622 )     (28,973 )
    Extinguishment of debt liabilities   (1,058,062 )           71,436        
    Other income   9,931             11,483       11,956  
    Other expense   (1,578 )           (9,008 )      
    Total other income (expense), net   (1,882,017 )     (876,558 )     (4,272,088 )     (2,380,421 )
                                   
    Net Loss $ (4,904,356 )   $ (2,079,682 )   $ (9,313,378 )   $ (4,766,433 )
                                   
    Per-share Data                              
    Basic and diluted loss per share $ (1.35 )   $ (1.14 )   $ (3.65 )   $ (2.70 )
                                   
    Weighted Average Shares Outstanding                              
    Basic and diluted   3,625,519       1,988,758       2,552,007       1,976,380  
                                   


    NeurAxis, Inc.
    Condensed Balance Sheet
    (unaudited)
     
      September 30,
    2023
    (Unaudited)
      December 31,
    2022
     
    Assets            
    Current Assets:            
    Cash and cash equivalents $ 761,249     $ 253,699  
    Accounts receivable, net   132,382       174,399  
    Inventories   34,530       48,133  
    Prepaids and other current assets   38,693       726  
    Total current assets   966,854       476,957  
                 
    Property and Equipment, at cost:   420,586       405,845  
    Less - accumulated depreciation   (340,260 )     (317,834 )
    Property and equipment, net   80,326       88,011  
                 
    Other Assets:            
    Deferred offering costs         736,736  
    Operating lease right of use asset   78,043       101,382  
    Intangible assets, net   110,695       77,558  
    Total Assets $ 1,235,918     $ 1,480,644  
                 
    Liabilities            
                 
    Current Liabilities:            
    Accounts payable $ 566,649     $ 1,592,116  
    Accrued expenses   280,063       834,062  
    Notes payable   194,249       202,834  
    Current portion of operating lease payable   45,194       33,395  
    Notes payable - related party         58,051  
                 
    Notes payable - convertible notes, net of unamortized discount of
    $0 and $3,327,213 as of September 30, 2023 and December 31,
    2022
            228,342  
    Customer deposits   68,972       59,174  
    Share liabilities   934,256        
    Derivative liabilities         1,735,700  
    Warrant liabilities   168,269       2,234,384  
    Total current liabilities   2,257,652       6,978,058  
                 
    Non-current Liabilities:            
    Operating lease payable, net of current portion   39,353       76,199  
    Note payable, net of current portion          
    Total non-current liabilities   39,353       76,199  
                 
    Total liabilities   2,297,005       7,054,257  
    Commitments and contingencies (see note 14)            
                 
    Stockholders’ Equity (Deficit)            
                 
    Convertible Series A Preferred stock, $0.001 par value; 1,000,000
    shares authorized; 0 issued and outstanding as of September 30, 2023
    and 506,637 as of December 31, 2022
            507  
    Convertible Series Seed Preferred Stock, $0.001 par value; 120,000 shares authorized;
    0 issued and outstanding as of September, 2023
    and 115,477 as of December 31, 2022
            115  
    Common stock, $0.001 par value; 100,000,000 shares authorized;
    5,149,340 issued and outstanding as of September, 2023 and
    1,963,322 as of December 31, 2022
      5,149       1,963  
    Additional paid in capital   42,178,570       28,355,230  
    Accumulated deficit   (43,244,806 )     (33,931,428 )
                 
    Total stockholders’ equity (deficit)   (1,061,087 )     (5,573,613 )
                 
    Total Liabilities and Stockholders’ Equity (Deficit) $ 1,235,918     $ 1,480,644  
                   



    NeurAxis, Inc.
    Condensed Statement of Cash Flows
    (unaudited)
     
      For the Nine Months Ended September 30,  
      2023     2022  
    Cash Flows from Operating Activities              
    Net Loss $ (9,313,378 )   $ (4,766,433 )
    Adjustments to reconcile net loss to net cash used by operating activities:              
                   
    Amortization of debt discount and issuance cost   4,881,622       28,973  
    Depreciation and amortization   30,290       25,047  
    Provisions for losses on accounts receivable   6,380       42,795  
    Non-cash lease expense   23,339       19,945  
    Non-cash interest expense   260,777        
    Stock based compensation         27,319  
    Extinguishment of derivative liability   (71,436 )      
    Issuance of common stock for non-cash consideration   2,550,000        
    Finance charges   2,772       1,473,892  
    Change in fair value of debt liabilities   (198,551 )     68,032  
    Change in fair value of warrant liabilities   (791,610 )     660,189  
    Changes in operating assets and liabilities:              
    Accounts receivable   35,637       (247,738 )
    Inventory   13,603       (18,141 )
    Prepaids and other current assets   (37,967 )     (481 )
    Accounts payable   (1,025,467 )     359,652  
    Accrued expenses   (415,181 )     256,184  
    Customer deposits   9,798       7,762  
    Operating lease liability   (25,047 )     (20,686 )
    Net cash used by operating activities   (4,064,419 )     (2,083,689 )
                   
    Cash Flows from Investing Activities              
    Additions to property and equipment   (14,741 )     (11,390 )
    Additions to intangible assets   (41,000 )      
    Net cash used by investing activities   (55,741 )     (11,390 )
                   
    Cash Flows from Financing Activities              
    Proceeds from issuance of common stock, net of issuance costs   5,464,642        
    Offering costs in advance of sale of common stock   (2,417,185 )     (87,694 )
    Principal payments on notes payable   (3,487,578 )     (122,265 )
    Proceeds from notes payable   159,831       122,000  
    Proceeds from convertible notes, net of fees   4,908,000       1,870,000  
    Net cash provided (used) by financing activities   4,627,710       1,782,041  
                   
    Net Increase (decrease) in Cash and Cash Equivalents   507,550       (313,038 )
                   
    Cash and Cash Equivalents at Beginning of Period   253,699       320,858  
                   
    Cash and Cash Equivalents at End of Period $ 761,249     $ 7,820  
    Supplemental Disclosure of Non-cash Cash Activities              
    Cash paid for interest $ 192,015     $ 118,391  
    Cash paid for income taxes          
    Supplemental Schedule of Non-cash Investing and Financing Activities              
    Fair value of warrant liabilities of warrants from convertible notes $ 2,446,502     $ 1,822,435  
    Fair value of derivative liabilities of conversion feature from convertible notes   2,375,378       1,518,092  
    Relative fair value of shares issued with convertible notes         3,365  
    Deferred offering costs in accounts payable         606,830  
                   




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    NeurAxis Reports Third Quarter 2023 Financial Results CARMEL, Ind., Nov. 20, 2023 (GLOBE NEWSWIRE) - NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children …