UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
  
 For the quarterly period ended September 30, 2022March 31, 2023

 

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
  
 For the transition period from ______________ to ______________

 

Commission file number: 001-38362

 

PROLUNG,INC.

(Exact name of registrant as specified in its charter)

 

Delaware 20-1922768

(State or other jurisdiction of

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

350 W. 800 N., Suite 214  
Salt Lake City, Utah 84103
(Address of principal executive offices) (Zip Code)

 

(801) 736–0729

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common None None

 

Indicate by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “accelerated filer”, “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):

 

 Large accelerated filerAccelerated filer 
 Non-accelerated filerSmaller reporting company 
    Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒.

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: As of November 14, 2022May 22, 2023 the issuer had 4,610,1494,614,989 shares of common stock, $0.001 par value, outstanding.

 

 

 

 

 

PROLUNG, INC.

 

TABLE OF CONTENTS

 

 Part I – Financial Information3
   
Item 1Financial Statements3
   
 Condensed Balance Sheets, March 31, 2023 (Unaudited), September 30, 2022 and December 31, 202120223
   
 Condensed Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30,March 31, 2023 and 2022 and 20214
   
 Condensed Statements of Cash Flows (Unaudited) for the NineThree Months Ended September 30,March 31, 2023 and 2022 and 20215
   
 Condensed Statement of Stockholders’ Deficit (Unaudited) for the Three and Nine Months Ended September 30, 2021March 31, 2023 and 20226
   
 Notes to the Unaudited Financial Statements7
   
Item 2Management’s Discussion and Analysis of Financial Condition and Results of Operations1312
   
Item 3Quantitative and Qualitative Disclosures about Market Risk1917
   
Item 4Controls and Procedures1917
   
 Part II – Other Information2018
   
Item 1Legal Proceedings2018
   
Item 1ARisk Factors2018
   
Item 2Unregistered Sales of Equity Securities And Use Of Proceeds2018
   
Item 3Defaults Upon Senior Securities2018
   
Item 4Mine Safety Disclosures2018
   
Item 5Other Information2018
   
Item 6Exhibits2119
   
Signatures2220

 

2

 

PART I – FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

ProLung, Inc.

Condensed Balance Sheets

 2023  2022 
 September 30, December 31,  March 31, December 31, 
 2022 2021  2023  2022 
 (Unaudited)    (Unaudited)   
Assets                
Current Assets                
Cash $732,676  $745,003  $842,131  $296,496 
Total Current Assets  732,676   745,003   842,131   296,496 
                
Property and equipment, net  6,755   21,183   5,793   6,274 
Operating lease right-of-use asset  133,650   - 
Operating lease right of use asset  113,026   123,431 
Intangible assets, net  110,758   117,929   105,978   108,368 
        
Total Assets $983,839  $884,115  $1,066,928  $534,569 
               
Liabilities and Stockholders’ Deficit                
Current Liabilities                
Accounts payable $30,197  $13,733  $124,661  $76,540 
Accrued liabilities  2,400,728   1,775,849   2,823,620   2,610,804 
Operating lease liability - current  38,977   -   42,980   40,959 
Payable for research and development - current  315,000   315,000   315,000   315,000 
Convertible notes payable, related party, net - current  439,000   434,687   566,843   439,000 
Convertible notes payable - current, net  10,018,022   9,895,742   

10,607,045

   10,018,022 
Derivative liability  143,630   - 
Total Current Liabilities  13,241,924   12,435,011   14,623,779   13,500,325 
        
Long-Term Liabilities                
Operating lease liability – net of current portion  94,992   - 
Operating lease liability - long term  72,279   83,748 
Total Long-Term Liabilities  94,992   -   72,279   83,748 
        
Total Liabilities  13,336,916   12,435,011   14,696,058   13,584,073 
        
Stockholders’ Deficit:                
Preferred stock, $0.001 par value; 10,000,000 shares authorized; none issued and outstanding  -   -   -   - 
Common stock, $0.001 par value; 120,000,000 shares authorized; 4,610,149 and 4,122,130 shares issued and outstanding  4,609   4,122 
Common stock, $0.001 par value; 120,000,000 shares authorized; 4,614,989 and 4,591,399 shares issued and outstanding  4,614   4,591 
Additional paid-in capital  31,595,058   28,571,741   31,661,166   31,497,065 
Subscription receivable  (162,500)  -   -   (65,000)
Accumulated deficit  (43,790,244)  (40,126,759)  (45,294,910)  (44,486,160)
Total Stockholders’ Deficit  (12,353,077)  (11,550,896)  (13,629,130)  (13,049,504)
        
Total Liabilities and Stockholders’ Deficit $983,839  $884,115  $1,066,928  $534,569 

The accompanying notes are an integral part of these unaudited condensed financial statements

 

3

 

ProLung, Inc.

Condensed Statements of Operations

(Unaudited)

  2022  2021  2022  2021 
  For the Three Months Ended  For the Nine Months Ended 
  September 30,  September 30, 
  2022  2021  2022  2021 
Revenues:                
Revenue $-  $-  $-  $- 
Total revenue  -   -   -   - 
Cost of revenue:  -   -      - 
Gross margin  -   -   -   - 
Operating expenses:                
Research and development expense  214,733   161,569   1,173,803   554,933 
Selling, general and administrative expense  560,889   557,896   1,737,372   1,304,217 
Total operating expenses  775,622   719,465   2,911,175   1,859,150 
Loss from operations  (775,622)  (719,465)  (2,911,175)  (1,859,150)
Other income (expense):                
Interest expense  (214,839)  (338,267)  (752,310)  (930,483)
Gain on settlement of liabilities  -   2,752   -   136,891 
Total other expense  (214,839)  (335,515)  (752,310)  (793,592)
Net loss $(990,461) $(1,054,980)  (3,663,485)  (2,652,742)
                 
Basic and diluted loss per share $(0.21) $(0.26)  (0.82)  (0.65)
                 
Weighted-average common shares outstanding, basic and diluted  4,610,149   4,122,130   4,460,811   4,105,215 

The accompanying notes are an integral part of these unaudited condensed financial statements

4

ProLung, Inc.

Condensed Statements of Cash Flows

(Unaudited)

  2022  2021 
  For the Nine Months Ended 
  September 30, 
  2022  2021 
Cash flows from operating activities:        
Net loss $(3,663,485) $(2,652,742)
Adjustments to reconcile net loss to net cash flows from operating activities:        
Depreciation and amortization  25,503   46,213 
Amortization of right of use asset  3,366   - 
Stock-based compensation - share issuance and options/warrants  1,035,722   513,816 
Amortization of loan discount  126,593   329,709 
Gain on settlement of liabilities  -   (136,891)
Change in assets and liabilities:        
Prepaid expenses  -   5,427 
Accounts payable  16,464   (74,498)
Accrued liabilities  624,879   570,350 
Operating lease liability  (3,047)  - 
Net cash flows used in operating activities  (1,834,005)  (1,398,616)
         
Cash flows from investing activities:        
Purchase of property and equipment  (3,904)  (2,137)
Net cash flows used in investing activities  (3,904)  (2,137)
         
Cash flows from financing activities:        
Payment for placement of convertible notes payable  -   (259,086)
Payment on convertible notes payable  -   (864,284)
Proceeds from exercise of warrants  1,825,582   36,000 
Proceeds from convertible notes payable - related party  -   - 
Proceeds from convertible notes payable  -   3,448,779 
Net cash flows provided by financing activities  1,825,582   2,361,409 
         
Net increase (decrease) in cash  (12,327)  960,656 
Cash at beginning of period  745,003   185,126 
Cash at end of period $732,676  $1,145,782 
Supplemental disclosure of cash flow information:        
Cash paid for interest $-  $30,514 
Supplemental disclosure of non-cash investing and financing activities:        
Exercise of warrants where funds yet received $162,500  $- 
Common stock issued for cashless exercise of warrants $52  $- 
Right of use asset $137,016   - 
Transfer of short term loans payable to convertible note payable $-  $100,181 
Discount recorded on convertible debt issuance $-  $292,401 
Non-cash partial settlement of research and development liability $-  $50,000 
Transfer of accrued interest to convertible notes payable $-  $43,931 
Conversion of debt to equity $-  $87,085 

The accompanying notes are an integral part of these unaudited condensed financial statements

5

ProLung, Inc.

Condensed Statement of Stockholders’ Deficit

For the Nine Months Ended September 30, 2022 and 2021

(Unaudited)

  Shares  Amount  Capital  Receivable  Deficit  Deficit 
  Common Stock  Additional Paid-in  Subscription  Accumulated  Total Stockholders’ 
  Shares  Amount  Capital  Receivable  Deficit  Deficit 
                         
Balance, December 31, 2021  4,122,130  $4,122  $28,571,741  $-  $(40,126,759) $(11,550,896)
Exercise of warrants for cash  253,601   254   1,318,468   -   -   1,318,722 
Cashless exercise of warrants  52,174   52   (52)  -   -   - 
Exercise of warrants for acquired research and development  19,414   20   113,730   -   -   113,750 
Additional shares of common stock issued to warrant holders  27,671   28   254,546   -   -   254,574 
Exercise of warrants for subscription receivable  128,890   127   670,107   (670,234)  -   - 
Issuance of common stock acquired research and development  6,436   6   59,205   -   -   59,211 
Stock-based compensation - options  -   -   182,863   -   -   182,863 
Net loss  -   -   -   -   (1,761,424)  (1,761,424)
Balance, March 31, 2022  4,610,316   4,609   31,170,608   (670,234)  (41,888,183)  (11,383,200)
Funds received for subscription receivable  -   -   -   506,860   -   506,860 
Return of shares for settlement of subscription receivable  (167)  -   (874)  874   -   - 
Stock-based compensation - options  -   -   191,022   -   -   191,022 
Net loss  -   -   -   -   (911,600)  (911,600)
Balance, June 30, 2022  4,610,149   4,609   31,360,756   (162,500)  (42,799,783)  (11,596,918)
Stock-based compensation - options  -   -   234,302   -   -   234,302 
Net loss  -   -   -   -   (990,461)  (990,461)
Balance, September 30 2022  4,610,149  $4,609  $31,595,058  $(162,500) $(43,790,244) $(12,353,077)
                   
Balance, December 31, 2020  4,084,916  $4,085  $27,662,507  $-  $(36,511,730) $(8,845,138)
Exercise of warrants for common stock  10,000   10   35,990   -   -   36,000 
Warrants issued to convertible debt placement agent  -   -   49,871   -   -   49,871 
Stock-based compensation  -   -   50,803   -   -   50,803 
Net loss  -   -   -   -   (725,549)  (725,549)
Balance, March 31, 2021  4,094,916   4,095   27,799,171   -   (37,237,279)  (9,434,013)
Conversion of notes payable to common stock  27,214   27   87,058   -   -   87,085 
Warrants issued to convertible debt placement agent  -   -   5,420   -   -   5,420 
Stock-based compensation  -   -   144,173   -   -   144,173 
Net loss  -   -   -   -   (872,213)  (872,213)
Balance, June 30, 2021  4,122,130   4,122   28,035,822   -   (38,109,492)  (10,069,548)
Stock-based compensation  -   -   318,840   -   -   318,840 
Net loss  -   -   -   -   (1,054,980)  (1,054,980)
Balance, September 30 2021  4,122,130  $4,122  $28,354,662  $-  $(39,164,472) $(10,805,688)

  2023  2022 
  For the Three Months Ended 
  March 31, 
  2023  2022 
Revenues:        
Revenue $-  $- 
Total revenue  -   - 
Cost of revenue:  -   - 
Gross margin  -   - 
Operating expenses:        
Research and development expense  197,223   726,711 
Selling, general and administrative expense  371,441   703,810 
Total operating expenses  568,664   1,430,521 
Loss from operations  (568,664)  (1,430,521)
Other income (expense):        
Interest expense  (240,086)  (330,903)
Total other expense  (240,086)  (330,903)
Net loss $(808,750) $(1,761,424)
         
Basic and diluted loss per share $(0.18) $(0.42)
         
Weighted-average common shares outstanding, basic and diluted  4,592,488   4,157,158 

 

The accompanying notes are an integral part of these unaudited condensed financial statements

 

4

ProLung, Inc.

Condensed Statements of Cash Flows

(Unaudited)

  2023  2022 
  For the Three Months Ended 
  March 31, 
  2023  2022 
Cash flows from operating activities:        
Net loss $(808,750) $(1,761,424)
Adjustments to reconcile net loss to net cash flows from operating activities:        
Depreciation and amortization  2,871   15,464 
Amortization of right of use asset  10,405   172,961 
Stock-based compensation - share issuance and options/warrants  155,868   437,437 
Amortization of loan discount  

24,372

   126,593 
Change in assets and liabilities:        
Accounts payable  48,121   (6,877)
Accrued liabilities  212,816   204,277
Operating lease liability  (9,448)  - 
Net cash flows used in operating activities  (363,745)  (811,569)
         
Cash flows from investing activities:        
Net cash flows used in investing activities  -   - 
         
Cash flows from financing activities:        
Proceeds from settlement of subscription receivable  65,000   - 
Proceeds from exercise of warrants  8,256   1,318,722 
Proceeds from convertible notes payable - related party  150,000   - 
Proceeds from convertible notes payable  686,124   - 
Net cash flows provided by financing activities  909,380   1,318,722 
         
Net increase in cash  545,635   507,153
Cash at beginning of period  296,496   745,003 
Cash at end of period $842,131  $1,252,156
Supplemental disclosure of cash flow information:        
Cash paid for interest $-  $- 
Supplemental disclosure of non-cash investing and financing activities:        
Establishment of convertible note discount/derivative liability $143,630  $- 
Cashless exercise of warrants $22  $52 
Exercise of warrants where funds yet received $-  $670,234 

The accompanying notes are an integral part of these unaudited condensed financial statements

5

ProLung, Inc.

Condensed Statement of Stockholders’ Deficit

For the Three Months Ended March 31, 2022 and 2023

(Unaudited)

  Shares  Amount  Capital  Receivable  Deficit  Deficit  
  Common Stock  Additional Paid-in  Subscription  Accumulated  Total Stockholders’ 
  Shares  Amount  Capital  Receivable  Deficit  Deficit  
Balance, December 31, 2022  4,591,399  $4,591  $31,497,065  $(65,000)  (44,486,160) $(13,049,504)
Exercise of warrants for cash  1,290   1   8,255   -   -   8,256 
Cashless exercise of warrants  22,300   22   (22)  -   -   - 
Settlement of subscription receivable  -   -   -   65,000   -   65,000 
Stock-based compensation  -   -   155,868   -   -   155,868 
Net loss  -   -   -   -   (808,750)  (808,750)
Balance, March 31, 2023  4,614,989  $4,614  $31,661,166  $-  $(45,294,910) $(13,629,130)

  Common Stock  Additional Paid-in  Subscription  Accumulated  Total Stockholders’ 
  Shares  Amount  Capital  Receivable  Deficit  Deficit 
Balance, December 31, 2021  4,122,130  $4,122  $28,571,741  $-  $(40,126,759) $(11,550,896)
Exercise of warrants for cash  253,601   254   1,318,468   -   -   1,318,722 
Cashless exercise of warrants  52,174   52   (52)  -   -   - 
Exercise of warrants for acquired research and development  19,414   20   113,730   -   -   113,750 
Additional shares of common stock issued to warrant holders  27,671   28   254,546   -   -   254,574 
Exercise of warrants funds not yet received  128,890   127   670,107   (670,234)  -   - 
Issuance of common stock acquired research and development  6,436   6   59,205   -   -   59,211 
Stock-based compensation - from option - warrant amortization  -   -   182,863   -   -   182,863 
Net loss  -   -   -   -   (1,761,424)  (1,761,424)
Balance, March 31, 2022  4,610,316  $4,609  $31,170,608  $(670,234) $(41,888,183) $(11,383,200)

The accompanying notes are an integral part of these unaudited condensed financial statements

6

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

Note 1 – Organization and Summary of Significant Accounting Policies

 

Organization

 

ProLung, Inc. (the “Company”), is a Delaware corporation that was incorporated on November 22, 2004 and is doing business as (dba) “IONIQ Sciences” and “ProLung.” The Company’s headquarters are located in Salt Lake City, Utah. The Company’s business is the development of a modern solution for the early detection of multiple cancers thereby expanding the therapeutic window, significantly improving survivability, and reducing the cost of healthcare. One in two Americans will be diagnosed with cancer during their lifetime and one in five will die. Clinical literature shows that early detection can save lives and money. IONIQ Sciences operates at the confluence of its Electrical Impedance Analytics (EIA) technology or bioimpedance and artificial intelligence (AI). The Company has active projects in lung, breast and gastro-intestinal (GI) cancers. The first planned product utilizing its proprietary analyticdigital platform, the IONIQ ProLung Test™ for lung cancer, has been designated a Breakthrough Device by the U.S. FDA in February 2020. The Company submitted its de novo application to the U.S. FDA in February 2022.2022 and received a substantive review from the FDA outlining additional information that is required for US regulatory clearance. These items include questions and requests related to biocompatibility testing, clinical data, Indications for use and labeling, cybersecurity documentation, electrical safety, special controls, human factors and usability, performance testing, risk analysis, software, sterility and shelf life. IONIQ Sciences remains fully committedremain fully-committed to gaining U.S. FDA regulatory de novo clearance and continue to collaborate with the US FDA so the Company can satisfy their requests and subsequently commercializingcommercialize the IONIQ ProLung Test for lung cancer.

 

Basis of Presentation

 

The accompanying condensed financial statements have been prepared by management in accordance with rules and regulations promulgated by the U.S. Securities and Exchange Commission and therefore certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying condensed financial statements contain all adjustments necessary for them to be presented fairly, with those adjustments consisting only of normal recurring adjustments. These interim financial statements should be read in conjunction with the Company’s annual financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.2022. The results of operations for the three and nine months ended September 30, 2022March 31, 2023 may not be indicative of the results to be expected for the year ending December 31, 2022.2023.

 

Going Concern

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has generated minimal revenues thus far from its operations and no revenue during the current period. Until the Company receives Food and Drug Administration (“FDA”) clearance,approval, the Company will not achieve its planned level of operations in the United States. New European medical device regulations known as the European Medical Device Regulation ((EU) 2017/745) or MDRThe Company has created challengeslicensed a portion of its technology to an entity located in obtaining and maintaining European medical device approval “CE Mark.” The Company’s prior CE certificates are no longer valid and the Company must re-certify to the new MDR regulation to be approved for sale in Europe.China. The Company has incurred substantial and recurring losses to date from operations, continues to have a stockholders’ deficit and is currently dependent on debt and equity financing. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. The accompanying condensed financial statements do not include any adjustments that might result relating to the recoverability and classification of the asset carrying amounts or the amount and classification of liabilities that might result from the outcome of this risk and uncertainty.

 

The ability of the Company to continue as a going concern is dependent on the Company successfully obtaining additional funding, developing products that can be sold profitably, and generating cash through operating activities. Management’s plans include issuing equity or debt securities to fund capital requirements and developing ongoing operations.

 

7

 

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

 

Basic and Diluted Loss Per Share -

The Company computes basic loss per share by dividing net loss by the weighted-average number of common shares outstanding during the period. The Company computes diluted loss per share by dividing net loss by the sum of the weighted-average number of common shares outstanding and the weighted-average dilutive common share equivalents outstanding. The computation of diluted loss per share does not assume exercise or conversion of securities that would have an anti-dilutive effect. As of September 30,March 31, 2023, and 2022, and 2021, the following items were excluded from the computation of diluted net loss per common share as their effect is anti-dilutive:

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Shareshare

         
  September 30, 
  2022  2021 
Warrants to purchase shares  299,761   1,344,985 
Stock options  897,038   747,988 
Convertible notes  3,309,257   3,097,478 
         
 Antidilutive securities excluded from computation of earnings per share  4,516,056   5,190,451 

Convertible Debt

The Company records a beneficial conversion feature (“BCF”) related to the issuance of convertible debt that has conversion features at fixed or adjustable rates that are in-the-money when issued. The BCF for the convertible instruments is recognized equal to the intrinsic value of the conversion features which is credited to additional paid-in capital.

  2023  2022 
  For the Three Months Ended 
  March 31, 
  2023  2022 
Warrants to purchase shares  251,285   316,180 
Stock options  933,720   791,588 
Convertible notes  3,415,179   3,202,149 
         
Antidilutive securities excluded from computation of earning per share  4,600,184   4,309,917 

 

Recent Accounting Pronouncements

Emerging Growth Company– We are an “emerging growth company” under the federal securities laws and will be subject to reduced public company reporting requirements. In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

Leases– In February 2016, the FASB issued ASU No. 2016-02 (ASC 842): Leases. ASC 842 requires companies to generally recognize on the balance sheet operating and financing lease liabilities and corresponding right-of-use assets. The Company formally adopted ASC 842 on January 1, 2022. The Company will use the modified retrospective basis. On September 1, 2022 the Company entered into a three-year lease agreement related to their office space. See the accompany balance sheet, statement of operations, statement of cash flows and Note 7 for the effect ASC 842 had on entering into this lease agreement.

Convertible Notes PayableIn August 2020, the FASB issued ASU 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40),” which simplifies the accounting for convertible instruments, reduces complexity for preparers and practitioners and improves the decision usefulness and relevance of the information provided to financial statement users. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company has not yet determined the impact of adoption this standard on our financial position, results of operations or cash flows.

 

The Company has reviewed other recent accounting pronouncements and has determined that they will not significantly impact the Company’s results of operations or financial position.

8

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

 

Note 2 – Accrued Liabilities

 

Accrued liabilities consisted of the following at September 30, 2022March 31, 2023 and December 31, 2021:2022:

Schedule of Accrued Liabilities

  March 31,  December 31, 
  2023  2022 
       
Accrued interest $2,764,288  $2,551,006 
Accrued royalties  17,873   17,873 
Accrued payroll and payroll taxes  41,459   41,925 
         
Accrued liabilities $2,823,620  $2,610,804 

 

         
  September 30,  December 31, 
  2022  2021 
Accrued interest $2,340,163  $1,714,446 
Accrued royalties  17,873   17,873 
Accrued payroll and payroll taxes  42,692   43,530 
         
Accrued liabilities $2,400,728  $1,775,849 
8

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

 

Note 3 – Convertible Notes Payable

$2 Million Bridge Notes - In February 2023, the company initiated a $2M bridge financing round. As of March 31, 2023, $836,124($150,000 from current board members) in financing has been received. These notes bear interest at 8% and are due September 30, 2023.

The Convertible Notes were convertible upon the occurrence of certain events, including upon a change in control or a next equity financing. The conversion features are described as follows:

The Company determined that the terms that could result in the Bridge Notes automatically converting at 75% of the lowest per-share selling price of the stock sold by the Company in the Next Qualified Equity Financing and are deemed a redemption feature. The Company also concluded that the redemption features require bifurcation from the Bridge Notes and subsequent accounting in the same manner as a freestanding derivative.

The assigned fair value of the embedded redemption derivative liability of $143,630 (includes related party amount of $25,767) was recorded as debt discounts to be amortized to interest expense over the respective term using the effective interest method. During the three months ended March 31, 2023, the Company recognized interest expense of $24,372 (includes related party amount of $3,610) from the accretion of the debt discount.

Convertible Notes - In March 2022, all of the Company’s convertible notes were amended with the following new terms: (1) the maturity date was extended to September 30, 2023, (2) there is an expanded automatic contingent conversion to include a qualified financing of at least $10M and (3) added a three-month bonus interest payment in the event an automatic contingent conversion is triggered.

Notes payable are summarized as follows:

Schedule of Convertible Notes Payable

         March 31, December 31, 
 September 30, December 31,  2023 2022 
 2022 2021      
Convertible notes payable; unsecured at 8% due September 2023 (includes related party amount of $439,000) $10,457,022  $10,457,022 
$2 Millon Secured Bridge Notes; interest at 8%; due September 2023 (includes related party amount of $150,000) $836,124  $- 
                
Unamortized discount and loan costs (includes related party amounts of $ - and $4,313, respectively)  -   (126,593)
Convertible notes payable; unsecured; interest at 8%; due September 2023 (includes related party amount of $439,000)  10,457,022   10,457,022 
        
Unamortized loan cost (includes related party amount of $22,157)  

(119,258

)  - 
                
Notes payable, net $10,457,022  $10,330,429  $11,173,888  $10,457,022 
        
Less: current portion, net  (10,457,022)  (10,330,429)  (11,173,888)  (10,457,022)
        
Convertible notes payable - long term, net $-  $-  $-  $- 

Note 4 - Derivative Liability

As described above, the redemption provisions embedded in the Bridge Notes required bifurcation and measurement at fair value as a derivative. The fair value of the Bridge Note embedded redemption derivative liability was calculated by determining the value of the debt component of the Bridge Notes at various conversion or maturity dates using a Probability Weighted Expected Return valuation method. The fair value calculation placed greater probability on the occurrence of the conversion or the maturity date scenario, with little or no weight given to other scenarios. The fair value of the embedded redemption derivative liability is significantly influenced by the discount rate, the remaining term to maturity and the Company’s assumptions related to the probability of a qualified financing or no financing prior to maturity. The Financing Date is the estimated date of an automatic conversion as the result of a Next Qualified Equity Financing.

The Derivative Liability is considered a Level 3 recurring financial instrument and will be revalidated every period. Currently, the derivative liability is the only Level 3 financial instrument the Company has.

Note 45Common Stock Options

 

Equity Incentive Plan

 

In April 2017, the Board, contingent on shareholder approval, approved the ProLung, Inc. Stock Incentive Plan (the “Plan”). The shareholders approved the Plan in July 2017. The Plan authorizes the Board compensation Committee to grant incentive stock options, non-incentive stock options, stock bonuses, restricted stock, and performance-based awards to directors, officers and employees and non-employee agents, consultants, advisers and independent contractors of the Company or any parent or subsidiary of the Company.

Schedule The total number of Fair Valueinitial shares of Options Grants Using Black Scholes MethodCommon Stock authorized for issuance under the Plan was 500,000 shares; the authorized shares will automatically increase on January 1st of each year, for ten consecutive years, commencing on January 1, 2018, by the lesser of (i) 40,000

shares of Common Stock (i.e., 8% of the shares of the shares originally authorized to be issued), or (ii) such number of shares of common stock (if any) the Board may earlier designate in writing. In April 2022, the Board authorized an additional issuance of 500,000 shares on 5/1/2022, 60,000 shares on 1/1/2023, and 60,000 to be issued 1/1/2024.

 

9

 

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

 

As part of an agreement for their service during the ninethree months ended September 30, 2022March 31, 2023 current Board members and advisors accepted the issuance of 60,43516,624 options at an exercise price of $9.209.86 per option. These options vested upon issuance. The fair value of these options was $8.236.29 per option or $497,518104,489 and was expensed upon grant.

In July 2022, the Board’s approved the issuance of 64,816 options to employees of the Company at an exercise price of $9.20 per option. These options vest quarterly over four years. The fair value of these options was $8.96 per option or $580,447 and will be expensed over the relative vesting period.

The fair value was computed using the Black Scholes method using the following weighted-average assumptions:

 Schedule of Fair Value of Options Grants Using Black ScholesBlack-Scholes Method

Expected life 5.8 years 
Exercise price $9.20 
Expected volatility  144% to 164%
Weighted average volatility  160%
Expected dividends  n/a 
Risk-free interest rate  2.37% to 4.24%

  2023 
    
Expected life  4.8 years 
Exercise price $9.86 
Expected volatility  78% to 72%
Weighted average volatility  78%
Expected dividends  n/a 
Risk-free interest rate  3.63%

 

A summary of option activity for the ninethree months ended September 30, 2022March 31, 2023 is presented below:

 Summary of Option Activity

        Weighted  Aggregate 
     Weighted  Average  Intrinsic 
  Shares  Average  Remaining  Value of 
  Under  Exercise  Contractual  Vested 
  Options  Price  Life  Options 
Outstanding at December 31, 2021  771,788  $5.39   6.8 years     
Issued  125,251  $9.20         
Exercised  -  $-         
Forfeited/Expired  -  $-         
Outstanding at September 30, 2022  897,039  $5.93   6.4 years  $2,936,971 
Vested at September 30, 2022  784,295  $5.77   6.4 years  $2,690,887 
        Weighted Aggregate 
     Weighted  Average Intrinsic 
  Shares  Average  Remaining Value of 
  Under  Exercise  Contractual Vested 
  Options  Price  Life Options 
Outstanding at December 31, 2022  917,096  $6.01  6.7 years    
Issued  16,624  $-       
Exercised  -  $-       
Forfeited/Expired/Adjustment  -  $-       
Outstanding at March 31, 2023  933,720  $6.08  6.4 years $3,530,341 
Vested at March 31, 2023  842,086  $5.95  6.1 years $3,292,168 

The Company recorded an expense of $234,302155,868 and $126,679182,863 for the three months ended September 30,March 31, 2023 and 2022 and 2021 and $608,187 and $321,647 for the nine months ended September 30, 2022 and 2021 related to the amortization of options issued under the plan. The remaining unrecognized expense of $768,184533,692 will be recognized through June 2026.2026 (weighed average 2.8 years).

 

Total stock-based compensation expense from options, warrants (Note 5)6) and common stock issuances (Note 56 and Note 6)7) have been included in the statements of operations as follows:

Schedule of Share-based Compensation Expense from Amortization of Options, Warrants and Common Stock Issuances 

                 
  For the Three Months Ended  For the Nine Months Ended 
  September 30,  September 30, 
  2022  2021  2022  2021 
             
Research and development expense $10,545  $4,999  $193,488  $40,288 
Selling, general and administrative expense  223,757   313,841   842,234   473,528 
                 
Total share-based compensation $234,302  $318,840  $1,035,722  $513,816 

  For the Three Months Ended 
  March 31, 
  2023  2022 
       
Research and development expense $9,061  $177,952 
Selling, general and administrative expense  146,807   432,446 
         
Total share-based compensation $155,868  $610,398 

 

10

 

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

Note 56Common Stock Warrants

 

During the ninethree months ended September 30, 2022,March 31, 2023, warrant holders exercised 521,90748,476 warrants as follows:

 

-253,6011,290 warrants were exercised for $1,318,7228,256 in cash proceeds.
   
-19,41447,186 warrants were exercised as partial settlement ($113,750) related to the Company’s acquisition of research and development.
128,890 warrants within a value of $670,234 have signedcashless exercise agreements, the shares have been issued but the cash proceeds were not initially received. During the 2nd quarter the Company received $whereby 506,860 related to these agreements and 16724,886 shares with a value of $874 were returned. The remaining $162,500 is still receivable on September 30, 2022.
120,000 warrants with exercise prices of $5.20 were exercised cashless based on the fair value of common stock of $9.20, resulting in 52,174 common shares being issued. Also, for professional services rendered by these warrant holders an additional 27,671 shares valued at $254,574 ($9.209.86 per share)share were issued.used to settle the exercise price and the remaining 22,300 shares were issued to the warrant holders.

 

A summary of warrant activity for the ninethree months ended September 30, 2022March 31, 2023 is presented below:

 Schedule of Warrant Activity

     Weighted Aggregate      Weighted Aggregate 
   Weighted Average Intrinsic    Weighted Average Intrinsic 
 Shares Average Remaining Value of  Shares Average Remaining Value of 
 Under Exercise Contractual Vested  Under Exercise Contractual Vested 
 Warrants Price Life Warrants  Warrants Price Life Warrants 
Outstanding at December 31, 2021  1,344,985  $5.25   1.1 years     
Outstanding at December 31, 2022  299,761  $5.16       
Issued  -  $-           -  $-     
Exercised  (521,906) $5.22           (48,476) $5.23     
Expired/Forfeited  (523,318) $5.20           -  $-     
                
Outstanding/Exercisable at September 30, 2022  299,761  $5.16   5.2 years  $1,282,436 
Outstanding at March 31, 2023  251,285  $5.15  5.0 years $1,219,890 

Note 67Stockholders’ Equity

 

Biomeridian License Purchase (OT Acceptance)During the three months ended March 31, 2023, as discussed in Note 6, 48,476 warrants were exercised for the issuance of common stock. Also, $65,000 in cash was received during the three months ended March 31, 2023 in settlement of the subscription receivable.

 

On March 3, 2022, the Company acquired from OT Acceptance, LLC (“OT Acceptance”) certain intellectual property formerly licensed to the Company by OT Acceptance. As a result of this acquisition, the Company now owns, rather than having license rights, to all of the intellectual property used by it with respect to early cancer detection. The aggregate consideration paid by the Company to OT Acceptance under the Agreement was $Note 8 – 134,211, which was paid $75,000 in cashCommitments and the issuance of 6,436Contingencies shares of the Company’s common stock at $9.20 per share. The Company considers the acquisition of intellectual property as research and development and expensed the acquisition as research and development.

Vine Medical Asset Purchase

On March 30, 2022 the Company acquired from Vine Medical LLC (“Vine”) certain intellectual property and designs that are expected to accelerate IONIQ Sciences’ product development efforts. The aggregate consideration paid by the Company to Vine Medical LLC under the Agreement was $313,750, which was $200,000 in cash and the seller’s exercise of 19,414 previously issued warrants, in the amount of $113,750 which represents forgone cash proceeds that would have otherwise been received. The Company considers the acquisition of intellectual property as research and development and expensed upon issuance.Leases

 

11

ProLung, Inc. and Subsidiary

Notes to Condensed Financial Statements

(Unaudited)

Common Shares Issued to Warrant Holders

On March 31, 2022 the Company issued 27,671 common shares valued at $254,574 for professional services rendered by certain warrant holders (see Note 5).

NOTE 7RIGHT OF USE ASSETS AND LIABILITIES

In September 2022, the Company renegotiated their office space lease from a month-to-month lease to a long-term operating lease agreement. The lease agreement is for 36 months requiresrequiring monthly payments as follows:

Schedule of Operating Lease

Beginning Date   Ending Date Payment 
September 2022 - August 2023 $3,960 
September 2023 - August 2024 $4,356 
September 2024 - August 2025 $4,487 

 

On January 1, 2022, the Company adopted Topic 842, Leases which requires a lessee to record a right-of-use asset and a corresponding lease liability at the inception of the lease initially measured at the present value of the lease payments. The Company determined that the fair value of the lease asset and liability at the inception of the leases was $137,016 lease using a discount rate of 8%.8% which was the cost of capital for the Company.

Schedule of Operating lease

Beginning Date   Ending Date  Payment 
September 2022 - August 2023  $3,960 
September 2023 - August 2024  $4,356 
September 2024 - August 2025  $4,487 

 

During the nine-monthsthree months ended September 30, 2022,March 31, 2023, the Company made payments resulting in a $3,0479,448 reduction in the lease liability. As of September 30, 2022,March 31, 2023 the lease liability amounted to $133,969115,259. Topic 842 requires recognition in the statement of operations of a single lease cost, calculated so that the cost of the lease is allocated over the lease term, generally on a straight-line basis. The right-of-use asset on September 30, 2022March 31, 2023 was $133,650113,026, net of amortization of $3,36610,405. The remaining term of the lease is 3529 months on September 30, 2022.March 31, 2023.

The lease expense related to this lease for the three month and nine months ended September 30 2022 and 2021, which includes the portion under a month-to-month agreement, are as follows:

Schedule of Lease Expense

For the Three Months Ended  For the Nine Months Ended 
September 30,  September 30, 
2022  2021  2022  2021 
$7,753  $10,800  $29,353  $32,400 

 

Maturities of the Company’s lease liability is as follows:

 Schedule of Maturities of Lease LiabilitiesLiability

Year Ending December 31,       
   
2022 (three months)  $11,880 
2023   49,500 
2023 (Remaining) $37,620 
2024   52,796   52,796 
2025   35,896   35,896 

Less: Imputed interest/ present value discount

   (16,103)
Less: Interest  (11,053)
Total   $133,969  $115,259 

The above liability is presented on the accompanying balance sheet as follows:

Schedule of Right-of-Use Asset and Lease Liabilities

     
Lease liability - short-term $42,980 
Lease liability - long-term $72,279 

 

     
Lease liability - current $38,977 
Lease liability - long-term $94,992 

Research and Development Agreement

On July 29, 2019, the Company amended a license agreement dated April 10, 2013 between the Company and ProLung Biotech Wuxi / ProLung China (Wuxi). The original agreement allowed Wuxi to utilize the Company’s technology in China in return for royalty payments based on Wuxi’s revenues. Wuxi has yet to earn any revenue but has been conducting clinical trials. The license agreement was amended whereby Wuxi will provide the Company its clinical trial data, know-how and improvements which the Company will use outside the greater China area. This amendment further requires full collaboration (i.e., protocols and methodologies) between the two entities. In consideration for such trial data and know-how, the Company will make cash payments to Wuxi of up to $575,000 and issue up to 347,566 shares of common stock upon the completion of certain events.

Through March 31, 2023, 278,053 shares had been issued based on conditions being met. The final 69,513 shares will be issued once the final milestone is met. Through March 31, 2023, $210,000 in payments had been made plus $50,000 in equipment with the remaining $315,000 currently payable.

Note 9 – Subsequent Events

Bridge Financing

Since March 31, 2023, The Company has raised an additional $100,000 in Bridge Financing through the issuance of Convertible Debt.

 

1211

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis should be read in conjunction with the financial statements and related notes that appear elsewhere in this Quarterly Report on Form 10-Q (this “Report”) and the Annual Report on Form 10-K for the year ended December 31, 20212022 (the “2021“2022 Form 10-K”) of ProLung, Inc. (the “Company”).

 

The statements contained in this Report that are not purely historical are forward-looking statements. Our forward-looking statements include, but are not limited to, statements regarding our expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should” and “would,” as well as similar expressions, may identify forward-looking statements, but the absence of these words does not mean a statement is not forward looking. The forward-looking statements contained in this Report are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties, or assumptions, many of which are beyond our control that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Important factors that could cause these differences include the following:

 

We are a development stage company with limited revenue and no assurance of earning significant revenue over the long term.
  
We will need significant capital to execute our business plan, particularly as we continue to seek clearance from the FDA to market our IONIQ ProLung Test.
  
We are dependent upon financings to fund our operations and may be unable to continue as a going concern.
  
We have issued indebtedness and, if we are unable to repay or refinance it, our creditors could foreclose on our assets and force us into bankruptcy.
  
We are in the early stages of commercialization, and our IONIQ ProLung Test may never receive marketing approval from the FDA or achieve commercial market acceptance.
  
Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  
We are reliant on a single product and if we are not successful in commercializing the IONIQ ProLung Test and are unable to develop additional products, our business will not succeed.
We are subject to litigation risk for product liability if our IONIQ ProLung Test is not effective.
  
We may incur substantial product liability expenses due to manufacturing or design defects, or the use or misuse of our products.
  
We are subject to the risk of product recalls if our products are defective.
  
We may not obtain any, or adequate, third-party coverage and reimbursement for our prospective customers.
  
The absence of, or limits on, reimbursements may affect our revenues and our ability to achieve profitability.
  
If the IONIQ ProLung Test is not accepted by physicians and patients, we will be unable to achieve market acceptance.

 

1312

 

We are a small company and may be unable to compete with competitive technologies.
  
We are dependent upon our suppliers to safely and timely manufacture our products.
  
We are dependent upon third parties for marketing and other aspects of our business.
  
Any clinical trials that we conduct, including our ongoing trial, may not be completed on schedule, or at all, or may be more expensive than we expect, which could prevent or delay regulatory authorization(s) of our products or impair our financial position.
  
We engage in related party transactions, which result in a conflict of interest involving our management.
  
Our clinical studies, including our ongoing clinical study, may produce unfavorable results.
  
Our success depends upon our ability to effectively market our products.
  
We are dependent on key personnel, whose employment may be terminated by the Company or the employee at any time, which could cause significant disruption in our business and lead to significant expenses.
  
We must obtain regulatory clearance or approval in the US and other markets to be able to commence marketing and sales in those markets.
  
Even if we receive regulatory clearance or approval for the IONIQ ProLung Test, we still may not be able to successfully commercialize it and the revenue that we generate from its sales, if any, may be limited.
  
If we obtain FDA clearance or approval, we will be subject to Medical Device Reporting.Reporting (MDR).
  
Recently proposed healthcare reform measures could hinder or prevent the commercial success of our products.
  
We will be subject to healthcare fraud and abuse law regulations.
  
Our business is subject to complex and evolving U.S. and international laws and regulation regarding privacy and data protection. Many of these laws and regulations are subject to change and uncertain interpretation and could result in claims, changes to our business practices, penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.
  
IONIQ Sciences clinical study designs have not been reviewed by the FDA, and there is a risk that the FDA will not agree with our study designs or results.
  
We may be unable to protect our intellectual property rights, which are important to the potential value of our products and company.
  
We may incur significant costs and liability if we infringe, or are accused of infringing on, the intellectual property rights of others.
  
We may need to market the IONIQ ProLung Test under a different name in the EU to avoid the risk of trademark infringement.
  
If outstanding warrants are exercised, or Convertible Debentures are converted, stockholders will be diluted.
  
Our common stock is not quoted or traded in any market, limiting liquidity opportunities for investors.

14

Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.

Our officers and directors have significant voting power and may take actions that may not be in the best interests of other stockholders.
  
Our common stock is not quoted or traded in any market, limiting liquidity opportunities for investors.

13

Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
We are subject to various regulatory regimes, and may be adversely affected by inquiries, investigations and allegations that we have not complied with governing rules and law.laws.
  
If a market develops for our common stock, we expect the market price to be volatile and trading in our common stock to be of limited volume.
  
We have never paid, and do not intend to pay in the future, dividends on our common stock.
  
Although we are capable of internally manufacturing to meet foreseeable demand, we may at some time be dependent upon contract manufacturers to safely and timely manufacture our products.
  
There is no guarantee that FDA clearance will lead to the IONIQ ProLung Test being approved by payors for reimbursement.
  
Our IONIQ ProLung Test may produce false positive and false negative results. In addition, please review the other, and more detailed, risk factors discussed in our 2021 Form 10-K.

 

In addition, please review the other, and more detailed, risk factors discussed in our 20212022 Form 10-K.

 

Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

 

Forward-looking statements speak only as of the date they are made. You should not put undue reliance on any forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions, or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

 

Overview

 

We are a medical technology company with a mission to dramatically improve the cancer landscape with a modern solution for the early detection of multiple cancers thereby expanding the therapeutic window, significantly improving survivability, and reducing the cost of healthcare. One in two Americans will be diagnosed with cancer during their lifetime and one in five will die. Clinical literature shows that early detection can save lives and money. We operate at the confluence of our Electrical Impedance Analytics (EIA) technology and artificial intelligence (AI). We are developing an advanced multi-cancer screening technology for early detection that will expand the therapeutic window, dramatically improve survivability and reduce the cost of healthcare. The first planned product utilizing our proprietary analyticdigital platform, the IONIQ ProLung Test™ for lung cancer, has been designated a Breakthrough Device by the U.S. FDA.FDA in February 2020. We submitted our de novo application to the U.S. FDA in February 2022. and we received a substantive review from the FDA outlining additional information that is required for US regulatory clearance. These items include questions and requests related to biocompatibility testing, clinical data, Indications for Use and labeling, cybersecurity documentation, electrical safety, special controls, human factors and usability, performance testing, risk analysis, software, sterility and shelf life. We remain fully committedfully-committed to gaining U.S. FDA regulatory de novo clearance and continue to collaborate with the US FDA so that we can satisfy their requests and subsequently commercializingcommercialize the IONIQ ProLung Test™Test for lung cancer.

 

Our non-invasive, rapid and radiation-free IONIQ ProLung Test has been developed to assess the risk of malignancy in lung nodules found in the chest by a Computed Tomography “CT” scan, which is currently the primary method used in the United States (“US”) for screening lung cancer. Lung cancer is the leading cause of cancer death in the US and the world according to American Cancer Society and World Health Organization. Earlier detection makes a substantial improvement in survival in individuals at high risk of lung cancer. Timely identification of malignancy is essential for patients and their families. Currently, patients often wait from three months to three and one-half years to have the risk of malignancy assessed through periodic CT scan surveillance. Until malignancy is determined to be likely, invasive biopsy and treatment are typically delayed. Current statistics reflect an average 17% survival rate at five years for those diagnosed with lung cancer.

 

1514

 

We believe the IONIQ ProLung Test, in conjunction with the discovery of a nodule by CT scan, provides a more rapid assessment of the risk of malignancy, which must be determined prior to biopsy. Since a lung biopsy is invasive and may require life threatening thoracic surgery, physicians, patients, and insurance companies typically delay biopsy and therapy until the risk of malignancy outweighs the risk of further diagnostic procedures. For these patients, the delay can reduce the time available to treat the tumor and may cause sustained emotional trauma.

 

In February 2020, the FDA designated the IONIQ ProLung Test a Breakthrough Device. Through the Breakthrough Device program, the FDA will provide ProLung with expedited reviews. This is not a marketing clearance.

We are an “emerging growth company” and a “smaller reporting company” under the federal securities laws and will be subject to reduced public company reporting requirements.

Results of Operations

The following discussion is included to describe our financial position and results of operations. The financial statements and notes thereto contain detailed information that should be referred to in conjunction with this discussion.

Three Months Ended September 30, 2022 compared to the Three Months Ended September 30, 2021

 

Revenues and Cost of Revenue. During the three months ended September 30,March 31, 2023 and March 31, 2022 and September 30, 2021 we had no revenues or cost of revenues.

 

Operating Expenses. Total operating expense for the three months ended September 30, 2022March 31, 2023 was $775,622$568,664 compared to the total operating expenses for the three months ended September 30, 2021March 31, 2022 of $719,465$1,430,521, representing an increasedecrease of $56,157.$861,857. Operating expenses have been classified by management as either research and development or selling, general and administrative based on an assignment of certain expenses directly to these classifications or based on management’s allocation of certain expenses between these classifications.

 

The overall increasedecrease in operating expense relates to increased costsis primarily due to inflationequity issuances for purchased research and increasing overall business efforts.development and expense recorded for additional shares issued to warrant holders during 2022.

 

Research and Development Expense. Research and development expense for the three months ended September 30, 2022,March 31, 2023, was $214,733$203,454, compared to research and development expense of $161,569$726,711 for the three months ended September 30, 2021; representing an increase of $53,164. This increase was due to increased costs due to inflation and increased efforts on developing and finalizing uses for the ProLung Test.

Selling, General and Administrative Expense. Selling, general and administrative expense for the three months ended September 30, 2022 was $560,889 compared to selling, general and administrative of $557,896 for the three months ended September 30, 2021; representing an increase of $2,993. This increase was primarily due to increased professional fees offset by a decrease in stock based compensation.

Other Expense. Other expense for the three months ended September 30, 2022 was $214,839 as compared to $335,515 for the three months ended September 30, 2021March 31, 2022; representing a decrease of $120,676. Interest expense decreased by $123,428 during the three months ended September 30, 2022 compared to the previous three-month period. This decrease is due to previous year amortization of additional loan costs.

16

Nine Months Ended September 30, 2022 compared to the Nine Months Ended September 30, 2021

Revenues and Cost of Revenue. During the nine months ended September 30, 2022 and 2021 we had no revenues or cost of revenues.

Operating Expenses. Total operating expense for the nine months ended September 30, 2022 was $2,911,175 compared to $1,859,150 for the nine months ended September 30, 2021 an increase of $1,052,025. Operating expenses have been classified by management as either research and development or selling, general and administrative based on an assignment of certain expenses directly to these classifications or based on management’s allocation of certain expenses between these classifications. The overall increase in operating expense is primarily due to increased equity issuances for purchased research and development and expense recorded for additional shares issued to warrant holders. Also, the value of our common stock increased which made the value of options issued worth more than previously-issued equity instruments.

Research and Development Expense. Research and development expense for the nine months ended September 30, 2022, was $1,173,803, compared to research and development expense of $554,933 for the nine months ended September 30, 2021; representing an increase of $618,870.$523,257. This increase was mostly due to research and development expenses from the acquisition of certain intellectual property from two entities paid for in cash and equity instruments.

 

Selling, General and Administrative Expense. Selling, general and administrative expense for the ninethree months ended September 30, 2022March 31, 2023 was $1,737,372$365,210 compared to selling, general and administrative of $1,304,217$703,810 for the ninethree months ended September 30, 2021;March 31, 2022; representing an increasea decrease of $433,155.$338,600. This increasedecrease was primarily due to shares issued to warrant holders for additional services. Also, the fair valueservices partially offset by increased amortization of the options issued increased substantially due to the increase in value of our common stock when compared to previous issuances.based compensation for employee options.

Other Expense. Other expense for the ninethree months ended September 30, 2022March 31, 2023 was $752,310$240,086 as compared to $793,592$330,903 for the ninethree months ended September 30, 2021March 31, 2022 representing aan decrease of $41,282.$90,817. This decreaseincrease was solely a combination due to a one-time gain on settlement of debt recorded last year offset by a decrease in interest expense. Interest expense decreased by $178,173 duringDuring the ninethree months ended September 30,March 31, 2022 comparedwe completed amortizing cash and non-cash loan costs related to our convertible debt. The Bridge Notes we issued during 2023 had no direct loan costs but did have a discount related to the previous nine-month period.derivative liability redemption feature.

Liquidity and Capital Resources

 

The following is a summary of our key liquidity measures at September 30, 2022March 31, 2023 and December 31, 2021:2022:

 

 September December 31,  March 31, December 31, 
 2022 2021  2023 2022 
          
Cash $732,676  $745,003  $842,131  $296,496 
                
Current assets  732,676   745,003   842,131   296,496 
Current liabilities  (13,241,924)  (12,435,011)  (14,623,779)  (13,500,325)
                
Working capital (deficit) $(12,509,248) $(11,690,008)
Working (deficit) capital $(13,781,648) $(13,203,829)

15

 

We need additional capital to continue our operations. WeDuring the three months ended March 31, 2023, we received $1,825,582$836,124 from the issuance of Convertible Bridge Notes and $73,256 from the exercise of warrants during the nine months ended September 30, 2022 andsettlement of our subscription receivables totaling $162,500.receivable. In order for us to continue operations we will need additional capital which will require us to issue equity securities, debt securities and rights to acquire equity securities. We have no existing commitment to provide capital, and givenGiven our early stage of development, we may be unable to raise sufficient capital when needed and, in any case, will likely be required to pay a high price for capital.

 

Our future capital requirements and adequacy of available funds will depend on many factors including:

 

AbilityOur ability to find a commercial market for our IONIQ ProLung Test and obtain needed regulatory clearance;clearance
Our financial results;
The cost and availability of capital generally; and
The occurrence of unexpected adverse expenses or events.

17

 

Cash provided by (used in) operating, investing and financing activities

 

Cash provided by (used in) operating, investing and financing activities for the nine months ended September 30,Three Months Ended March 31, 2023 and 2022 and 2021 is as follows:

 

 Nine Months Ending September 30,  Three Months Ending 
 2022 2021  2023 2022 
          
Operating activities $(1,834,005) $(1,398,616) $(363,745) $(811,569)
Investing activities  (3,904)  (2,137)  -   - 
Financing activities  1,825,582   2,361,409   909,380   1,318,722 
                
Net increase (decrease) in cash $(12,327) $960,656  $545,635  $507,153 

 

Operating Activities

 

For the ninethree months ended September 30, 2022,March 31, 2023, the differences between our net loss and net cash used in operating activities were due to net non-cash charges totaling $1,188,137$193,516 for stock-based compensation, share issuances, amortization of debt discount and depreciation.

 

For the ninethree months ended September 30, 2021,March 31, 2023, the differences between our net loss and net cash used in operating activities were due to net non-cash charges totaling $752,847$752,455 for stock-based compensation, share issuances, amortization of debt discount a gain on settlement of R&D, and depreciation. We also had a large increase in our accrued interest due to increased debt levels offset by a decrease in accounts payable due to payment and settlement.

Investing Activities

During the nine months ended September 30, 2022 and 2021 we purchased equipment totaling $3,904 and $2,137, respectively.

 

Financing Activities

 

During the ninethree months ended September 30,March 31, 2023, cash flows from financing activities totaled $909,380. This was from the issuance of Convertible Bridge Notes ($836,124), settlement of subscription receivable ($65,000) and the exercise of warrants (8,256).

During the three months ended March 31, 2022, cash flows from financing activities totaled $1,825,582.$1,318,722. This was solely due to the exercise of warrants for cash.

 

During the nine months ended September 30, 2021, cash flows from financing activities totaled $2,361,409. The cash flows were related to proceeds received from the issuance and payment of convertible notes and the exercise of stock warrants.

Critical Accounting Policies and Estimates

 

The accompanying discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and contingencies as of the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. We evaluate our estimates on an on-going basis. We base our estimates on historical experience and on other assumptions that are believed to be reasonable under the circumstances. However, future events may cause us to change our assumptions and estimates, which may require adjustment. Actual results could differ from these estimates. We have determined that for the periods reported in this Quarterly Annual Report on Form 10-Q the following accounting policies and estimates are critical in understanding our financial condition and results of operations.

 

16

Long-lived Assets – Long-lived assets, including property and equipment, and intangible assets are tested for recoverability whenever events or changes in circumstances indicate that their carrying amount may not be recoverable. When such events occur, we compare the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset or asset group to the carrying amount of the long-lived asset or asset group. If this comparison indicates that there is an impairment, the amount of the impairment is calculated based on fair value.

18

Convertible Debt – The Company records a beneficial conversion feature (“BCF”) related to the issuance of convertible debt that has conversion features at fixed or adjustable rates that are in-the-money when issued. The BCF for the convertible instruments is recognized as a discount equal to the intrinsic value of the conversion features, which is also recorded as an increase to additional paid-in capital.

 

Stock-based Compensation – The Company measures the cost of employee and consulting services received in exchange for an award of equity instruments based on the grant-date fair value of the award. The awards issued are valued using a fair value-based measurement method. The resulting cost is recognized over the period during which an employee or consultant is required to provide services in exchange for the award, usually the vesting period.

 

Emerging Growth Company – We are an “emerging growth company” under the federal securities laws and will be subject to reduced public company reporting requirements. In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. Although we have not delayed the adoption of any accounting standards, we may choose to take advantage of the extended transition period for complying with new or revised accounting standards in the future.

Off Balance Sheet Arrangements

 

The Company has not had any off-balance sheet arrangements.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

This item is not applicable to the Company because the Company is a smaller reporting company.

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of September 30, 2022.March 31, 2023. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

 

Based on that evaluation, our chief executive officer concluded as of September 30, 2022March 31, 2023 that our disclosure controls and procedures were not effective to ensure that the information required to be disclosed in the reports filed or submitted by us under the Exchange Act was recorded, processed, summarized and reported within the requisite time periods and that such information was accumulated and communicated to our chief executive officer, as appropriate to allow for timely decisions regarding required disclosure.

 

The Company did not maintain effective disclosure controls and procedures as defined by the framework issued by COSO. Specifically, the Company did not effectively segregate certain accounting duties due to the small size of the Company’s accounting staff. In order to mitigate these material weaknesses regular meetings are held with the audit committee and the audit committee approves all audit functions. If at any time, we determine a new control can be implemented to mitigate these risks at a reasonable cost, it is implemented as soon as possible.

Changes in Internal Control over Financial Reporting

 

There has been no change in our internal control over financial reporting that occurred in the ninethree months ended September 30, 2022March 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

1917

 

PART II—OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

None.

ITEM 1A. RISK FACTORS

 

We are a smaller reporting company and, as a result, are not required to provide the information under this item.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

The offer and sale of the Notes, and shares of common stock issuable upon conversion of the Note (the “Conversion Shares”) have been effected in reliance upon the exemptions for sales of securities set forth in Rule 506(c) under the Securities Act, based upon the following: (a) we have confirmed in a manner consistent with the requirements of Rule 506(c) that each investor is an “accredited investor,” as defined in Rule 501 promulgated under the Securities Act, (b) each investor has represented to us that the investor has such background, education and experience in financial and business matters as to be able to evaluate the merits and risks of an investment in the securities; (c) the investors have been provided with certain disclosure materials and all other information requested with respect to our company; (d) the investors have acknowledge that all Notes and Conversion Shares being purchased are “restricted securities” for purposes of the Securities Act, and agreed to transfer such securities only in a transaction registered under the Securities Act or exempt from registration under the Securities Act; (e) there are restrictions on transfer on the Notes, and any Conversion Shares are subject to restrictions and a legend, providing that the respective security can be transferred only if subsequently registered under the Securities Act or in a transaction exempt from registration under the Securities Act; and (f) a Form D has been filed with respect to the offering.

 

The Company also had the following unregistered common shares issuances:issuances

 

253,601-1,290 warrants were exercised for $1,318,722$8,256 in cash proceeds.
19,414
-47,186 warrants were exercised as partial settlement ($113,750) related to the Company’s acquisition of research and development.
128,890 warrants within a value of $670,234 have signedcashless exercise agreements, the shares have been issued but the cash proceeds were not initially received. During the 2nd quarter the Company received $506,860 related to these agreements and 167whereby 24,886 shares with a value of $874$9.86 per share were returned. Theused to settle the exercise price and the remaining $162,500 is still receivable on September 30, 2022.
120,000 warrants with exercise prices of $5.2022,300 shares were exercised cashless based onissued to the fair value of common stock of $9.20, resulting in 52,174 common shares being issued. Also, for professional services rendered by these warrant holders an additional 27,671 shares valued at $254,574 ($9.20 per share) were issued.holders.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

None.Utah Division of Securities

On April 23, 2019, the Utah Division of Securities (the “Division”) filed a Notice of Agency Action and an Order to Show Cause before the Division of Securities of the Department of Commerce of the State of Utah against the Company, Jared Bauer (Bauer) and former Board Members (Clark Campbell, Tim Treu, Todd Morgan and Robert Raybould).

 

2018

In January 2020, the Division issued a Stipulation and Consent Order which set forth the following: 1) the Company agrees to settle the matter with the Division by way of the Stipulation and Consent Order; 2) the Stipulation and Consent Order fully resolves all claims the Division has against the Company pertaining to the Order to Show Cause; 3) the Division, the Company and Bauer, agree to promptly file a stipulation and joint motion to dismiss the Company and Bauer from this administrative action, with respect to Count 1 against the Company and Bauer (the only claim brought against Bauer); 4) In or about April 2014, the Company Board of Directors circulated a consent agreement regarding the issuance of 72,763 Company stock certificates to select members of the Company Board of Directors in connection with “financing services provided” by those members; 5) In or about April 2014, the Company issued stock grants of 27,000 shares to Robert W. Raybould, 2,044 shares to Steve Eror, 7,969 shares to Tim Treu; 24,188 shares to Clark Campbell; and 12,188 shares to Todd Morgan; 6) Subsequent to issuance of those shares, ProLung was informed by counsel of potential consequences for Pro Lung employing unlicensed agents and individuals receiving the shares as compensation directly for sale of securities without a securities license, as opposed to receiving shares as compensation for generalized board service. Subsequently, no further shares were issued as compensation for fundraising. Mr. Eror returned his shares to the Company. However, Raybould, Treu, Campbell and Morgan did not return their shares to the Company. The Company did not disclose the potential licensing violation until on or about December 3, 2018, in its Note Purchase Agreements.

As set forth by the Company in its Form 8-K dated November 27, 2019, Campbell, Treu, Morgan, and Raybould entered into Stipulation and Consent Orders wherein they returned shares of stock to the Company’s treasury and paid fines to the Division of Securities.

On January 9, 2020, the Division entered an order as follows: 1) entering certain Findings and Conclusions by the Division, which ProLung admitted via a Stipulation and Consent Order; 2) ordering ProLung to cease and desist from violating Utah Uniform Securities Act (the “Act”) and to comply with the requirements of the Act in all future business in the state of Utah; 3) ordering ProLung to disclose the contents of the order to investors and prospective investors in all future capital raising efforts and disclosure documents of ProLung; and 4) Ordering ProLung to pay a fine of $55,000 to the Division. Through March 31, 2021, the Company had paid the fine in full.

ITEM 6. EXHIBITS

 

Exhibit

Number

 Description
3.1 Third Amended and Restated Certificate of Incorporation, as amended by Certificate of Amendment dated October 10, 2017(1)
3.2 Amended and Restated By-Laws(1)
31.1 Certification Pursuant to Rule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as Amended*
32.1 Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
101 INS Inline XBRL Instance Document*
101 SCH Inline XBRL Schema Document*
101 CAL Inline XBRL Calculation Linkbase Document*
101 LAB Inline XBRL Labels Linkbase Document*
101 PRE Inline XBRL Presentation Linkbase Document*
101 DEF Inline XBRL Definition Linkbase Document*
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith

(1) Incorporated by reference from our Current Report on Form 8-K filed with the SEC on July 19, 2017.

2119

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 PROLUNG, Inc.
   
November 14, 2022May 22, 2023By:/s/ Jared Bauer
DateJared Bauer, Chief Executive Officer

 

2220