UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 10-Q

(Mark one)

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2017

March 31, 2020

 

 

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: 000-24477

 

DIFFUSION PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

Delaware

30-0645032

(State of other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification Number)

 

1317 Carlton Avenue, Suite 400200
Charlottesville, VA 22902

(Address of principal executive offices, including zip code)

 

(434) 220-0718

(Registrant’sRegistrant’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 Stock, par value $0.001 per share

DFFN

Nasdaq Capital Market

 

Indicate by check mark whether the registrant: (1) has 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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☐ (Do not check if a smaller reporting company)

Smaller 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 13(a) of the Exchange Act. ☐

 

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

 

The number of shares of common stock outstanding at November 10, 2017May 8, 2020 was 14,521,73045,989,932 shares.



 

 

DIFFUSION PHARMACEUTICALS INC.

FORM 10-Q

SEPTEMBER 30, 2017MARCH 31, 2020

 

 

INDEX

 

 

 

Page

PART I – FINANCIAL INFORMATION

1

  

ITEM 1.     FINANCIAL STATEMENTS

1

  

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

21

13

  

ITEM 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

3121

  

ITEM 4.     CONTROLS AND PROCEDURES

3121

  

PART II – OTHER INFORMATION

3222

  

ITEM 1.     LEGAL PROCEEDINGS

3222

  

ITEM 1A.  RISK FACTORS

3222

  

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

3224

  

ITEM 3.     DEFAULTS UPON SENIOR SECURITIES

3224

  

ITEM 4.     MINE SAFETY DISCLOSURES

3224

  

ITEM 5.     OTHER INFORMATION

3224

  

ITEM 6.     EXHIBITS

3224

 

Unless the context otherwise requires, in this report, references to the “Company,” “we,” “our” or “us” refer to Diffusion Pharmaceuticals Inc. and its subsidiaries and references to “common stock” refer to the common stock, par value $0.001 per share, of the Company and references to "Series A convertible preferred stock" refer to the Series A convertible preferred stock, par value $0.001 per share, of the Company. On August 17, 2016, the Company effected a 1-for-10 reverse split of its common stock. Unless noted otherwise, any share or per share amounts in this report, the accompanying unaudited condensed consolidated financial statements and related notes give retroactive effect to this reverse stock split.

 

This report contains the following trademarks, trade names and service marks of ours: Diffusion. All other trade names, trademarks and service marks appearing in this quarterly report on Form 10-Q are the property of their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such terms appear without the trade name, trademark or service mark notice for convenience only and should not be construed as being used in a descriptive or generic sense.

 

i

PART I – FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

 

Diffusion Pharmaceuticals Inc.

Condensed Consolidated Balance Sheets

(unaudited)

 

 

September 30,

2017

  

December 31,

2016

  

March 31,

2020

  

December 31,

2019

 

Assets

                

Current assets:

                

Cash and cash equivalents

 $1,216,000  $1,552,852  $10,828,228  $14,177,349 

Certificate of deposit

  10,020,164    

Prepaid expenses, deposits and other current assets

  1,004,361   50,844   888,234   472,464 

Total current assets

  12,240,525   1,603,696   11,716,462   14,649,813 

Property and equipment, net

  479,647   79,755   225,346   252,366 

Intangible asset

  8,639,000   8,639,000   8,639,000   8,639,000 

Goodwill

  6,929,258   6,929,258 

Right of use asset

  223,757   247,043 

Other assets

  38,813   232,675   252,561   322,301 

Total assets

 $28,327,243  $17,484,384  $21,057,126  $24,110,523 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity

        

Liabilities and Stockholders’ Equity

        

Current liabilities:

                

Current portion of convertible debt

 $550,000  $1,880,000 

Accounts payable

  409,423   1,684,158   655,298   1,251,412 

Accrued expenses and other current liabilities

  1,415,707   874,264   519,552   358,532 

Common stock warrant liability

  16,316,054    

Current operating lease liability

  111,970   111,477 

Total current liabilities

  18,691,184   4,438,422   1,286,820   1,721,421 

Convertible debt, net of current portion

     550,000 

Deferred income taxes

  3,279,363   3,279,363   1,756,894   2,119,274 

Other liabilities

     31,915 

Noncurrent operating lease liability

  111,787   135,566 

Total liabilities

  21,970,547   8,299,700   3,155,501   3,976,261 

Commitments and Contingencies

        

Convertible preferred stock, $0.001 par value:

     

Series A - 13,750,000 shares authorized, 12,376,329 and 8,324,032 shares issued and outstanding, respectively at September 30, 2017; No shares authorized, issued or outstanding at December 31, 2016 (liquidation value of $16,814,360 at September 30, 2017)

      

Total convertible preferred stock

      

Stockholders’ Equity:

        

Commitments and Contingencies (Note 7)

        

Stockholders’ Equity:

        

Common stock, $0.001 par value:

                

1,000,000,000 shares authorized; 14,503,976 and 10,345,637 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

  14,504   10,346 

1,000,000,000 shares authorized; 34,604,436 and 33,480,365 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

  34,605   33,481 

Additional paid-in capital

  69,686,744   69,363,575   112,149,913   111,824,859 

Accumulated deficit

  (63,344,552

)

  (60,189,237

)

  (94,282,893

)

  (91,724,078

)

Total stockholders' equity

  6,356,696   9,184,684   17,901,625   20,134,262 

Total liabilities, convertible preferred stock and stockholders' equity

 $28,327,243  $17,484,384 

Total liabilities and stockholders' equity

 $21,057,126  $24,110,523 

 

See accompanying notes to unaudited condensedinterim consolidated financial statements.

 


1

 

Diffusion Pharmaceuticals Inc.

Condensed Consolidated Statements of Operations

(unaudited)

 

  

Three Months Ended

September 30,

  

Nine Months Ended
September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Operating expenses:

                

Research and development

 $1,759,305  $1,941,743  $3,946,420  $5,739,456 

General and administrative

  1,559,399   3,852,406   4,908,424   10,070,878 

Depreciation

  27,374   5,822   39,767   19,520 

Loss from operations

  3,346,078   5,799,971   8,894,611   15,829,854 

Other expense (income):

                

Interest (income) expense, net

  (1,318

)

  1,378   73,290   854 

Change in fair value of warrant liability (Note 11)

  (8,441,616

)

     (18,909,792

)

   

Warrant related expenses (Note 8)

        10,225,846    

Other financing expenses

        2,870,226    

Income (loss) from operations before income tax benefit

  5,096,856   (5,801,349

)

  (3,154,181

)

  (15,830,708

)

Income tax benefit

     (364,796

)

     (364,796

)

Net income (loss)

 $5,096,856  $(5,436,553

)

 $(3,154,181

)

 $(15,465,912

)

Per share information:

                

Net income (loss) per share of common stock, basic

 $0.21  $(0.53

)

 $(0.35

)

 $(1.52

)

Net income (loss) per share of common stock, diluted

 $0.20  $(0.53

)

 $(1.83

)

 $(1.52

)

Weighted average shares outstanding, basic

  13,937,869   10,333,898   11,709,128   10,198,491 

Weighted average shares outstanding, diluted

  14,714,853   10,333,898   12,525,707   10,198,491 
  

Three Months Ended March 31,

 
  

2020

  

2019

 

Operating expenses:

        

Research and development

 $1,534,467  $1,699,845 

General and administrative

  1,393,808   1,200,728 

Depreciation

  27,020   18,272 

Loss from operations

  2,955,295   2,918,845 

Other income:

        

Interest income

  (34,100

)

  (20,684

)

Loss from operations before income tax benefit

  (2,921,195

)

  (2,898,161

)

Income tax benefit

  (362,380

)

  (150,352

)

Net loss

 $(2,558,815

)

 $(2,747,809

)

Per share information:

        

Net loss per share of common stock, basic and diluted

 $(0.07

)

 $(0.81

)

Weighted average shares outstanding, basic and diluted

  34,507,496   3,376,230 

 

See accompanying notes to unaudited condensedinterim consolidated financial statements.

 


2

 

Diffusion Pharmaceuticals Inc.

Condensed Consolidated StatementStatements of Changes in Convertible Preferred Stock and Stockholders' Equity

NineThree Months Ended September 30, 2017March 31, 2019 and 2020

(unaudited)

 

  

Convertible Preferred Stock

  

Stockholders' Equity

 
  

Series A

  

Common Stock

  

Additional

Paid-in

  

Accumulated

  

Total

Stockholders'

 
  

Shares

  

Amount

  

Shares

  

Amount

  Capital  Deficit  Equity 

Balance at January 1, 2017

    $   10,345,637  $10,346  $69,363,575  $(60,189,237

)

 $9,184,684 

Cumulative effect of change in accounting principle(a)

              1,134   (1,134

)

   

Sale of Series A convertible preferred stock and common stock warrants

  12,376,329                   

Common stock issued for advisory services

        17,606   18   49,982      50,000 

Series A cumulative preferred dividend

              (912,946

)

     (912,946

)

Reclassification of accrued dividends upon conversion of Series A

        88,436   88   187,084      187,172 

Conversion of Series A convertible preferred stock to common stock

  (4,052,297

)

     4,052,297   4,052   (4,052

)

      

Beneficial conversion feature for accrued interest of convertible debt

              28,017      28,017 

Stock-based compensation expense

              973,950      973,950 

Net loss

                 (3,154,181

)

  (3,154,181

)

Balance at September 30, 2017

  8,324,032  $   14,503,976  $14,504  $69,686,744  $(63,344,552

)

 $6,356,696 
  

Stockholders' Equity

 
  

Common Stock

  

Additional

Paid-in

  

Accumulated

  

Total

Stockholders'

 
  

Shares

  

Amount

  Capital  Deficit  Equity 

Balance at January 1, 2019

  3,376,230  $3,377  $95,532,881  $(79,924,699

)

 $15,611,559 

Stock-based compensation expense

        91,204      91,204 

Net loss

           (2,747,809

)

  (2,747,809

)

Balance at March 31, 2019

  3,376,230  $3,377  $95,624,085  $(82,672,508

)

 $12,954,954 

 

(a) In 2017, the Company adopted provisions of ASU 2016-09, Improvements to Employee Share Based Payment Accounting, resulting in a cumulative effect adjustment to Accumulated Deficit and Additional Paid-in Capital for previously unrecognized stock-based compensation expense. See Note 3 for further discussion of the impacts of this standard.

  

Stockholders' Equity

 
  

Common Stock

  

Additional

Paid-in

  

Accumulated

  

Total

Stockholders'

 
  

Shares

  

Amount

  Capital  Deficit  Equity 

Balance at January 1, 2020

  33,480,365  $33,481  $111,824,859  $(91,724,078

)

 $20,134,262 

Issuance of common stock upon exercise of warrants, net

  1,124,071   1,124   133,674      134,798 

Stock-based compensation expense

        191,380      191,380 

Net loss

           (2,558,815

)

  (2,558,815

)

Balance at March 31, 2020

  34,604,436  $34,605  $112,149,913  $(94,282,893

)

 $17,901,625 

 

See accompanying notes to unaudited condensedinterim consolidated financial statements.

 


3

 

Diffusion Pharmaceuticals Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

  

Nine Months Ended September 30,

 
  

2017

  

2016

 

Operating activities:

        

Net loss

 $(3,154,181

)

 $(15,465,912

)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation

  39,767   19,520 

Loss on sale or disposal of assets

     6,761 

Stock-based compensation expense

  973,950   1,121,990 

Common stock issued for advisory services

  50,000   1,409,363 

Warrant related expense, change in fair value, and other financing expenses

  (5,813,720

)

   

Abandonment of in-process research and development intangible asset

     951,000 

Change in deferred income taxes

     (364,796

)

Settlement of litigation matter

     2,500,000 

Non-cash interest expense, net

  11,967   7,067 

Changes in operating assets and liabilities:

        

Prepaid expenses, deposits and other assets

  (661,675

)

  50,918 

Accounts payable, accrued expenses and other liabilities

  (1,496,150

)

  410,014 

Net cash used in operating activities

  (10,050,042

)

  (9,354,075

)

         

Cash flows (used in) provided by investing activities:

        

Purchases of property and equipment

  (438,604

)

  (2,331

)

Purchase of certificate of deposit

  (10,000,000

)

   

Cash received in reverse merger transaction

     8,500,602 

Net cash (used in) provided by investing activities

  (10,438,604

)

  8,498,271 

Cash flows provided by financing activities:

        

Proceeds from the sale of Series A convertible preferred stock and warrants, net

  22,129,774    

Payment of offering costs for Series B

  (97,980

)

   

Repayment of convertible debt

  (1,880,000

)

    

Proceeds from the issuance of convertible debt

     1,880,000 

Net cash provided by financing activities

  20,151,794   1,880,000 

Net (decrease) increase in cash and cash equivalents

  (336,852

)

  1,024,196 

Cash and cash equivalents at beginning of period

  1,552,852   1,997,192 

Cash and cash equivalents at end of period

 $1,216,000  $3,021,388 

Supplemental disclosure of cash flow information:

        

Cash paid for interest

 $112,800  $ 

Supplemental disclosure of non-cash investing and financing activities:

        

Series A cumulative preferred dividends

 $(912,946

)

 $ 

Conversion of accrued dividends related to convertible preferred stock

 $187,172  $ 

Conversion of convertible notes and related accrued interest into common stock

 $  $711,495 

Consideration in connection with RestorGenex Corporation merger transaction

 $  $21,261,000 
  

Three Months Ended March 31,

 
  

2020

  

2019

 

Operating activities:

        

Net loss

 $(2,558,815

)

 $(2,747,809

)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation

  27,020   18,272 

Stock-based compensation expense

  191,380   91,204 

Change in deferred income taxes

  (362,380

)

  (150,352

)

Changes in operating assets and liabilities:

        

Prepaid expenses, deposits and other assets

  (346,030

)

  (119,644

)

Accounts payable, accrued expenses and other liabilities

  (455,489

)

  250,871 

Net cash used in operating activities

  (3,504,314

)

  (2,657,458

)

         

Cash flows provided by financing activities:

        

Proceeds received from the exercise of common stock warrants

  393,425    

Payment of financing costs that were previously classified in accounts payable

  (238,232

)

   

Net cash provided by financing activities

  155,193    
         

Net decrease in cash and cash equivalents

  (3,349,121

)

  (2,657,458

)

Cash and cash equivalents at beginning of period

  14,177,349   7,991,172 

Cash and cash equivalents at end of period

 $10,828,228  $5,333,714 
         

Supplemental disclosure of non-cash investing and financing activities:

        

Offering costs in accounts payable and accrued expenses

 $258,627  $28,549 

Operating lease right of use asset and current and noncurrent liability

 $  $334,205 

 

See accompanying notes to unaudited condensedinterim consolidated financial statements.

 


4


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

STATEMENTS

 

1.

Organization and Description of Business

 

Diffusion Pharmaceuticals Inc. (“Diffusion” or the “Company”), a Delaware corporation, is a clinical stage biotechnology company focused on extending the life expectancy of cancer patientsdeveloping new treatments for life-threatening conditions by improving the effectiveness of current standard-of-care treatments, including radiation therapy and chemotherapy.body’s ability to bring oxygen to the areas where it is needed most. The Company is developing its lead product candidate, transcrocetinate sodium, also known as trans sodium crocetinate (“TSC”), for use in many cancer typesthose life-threatening conditions in which tumorcellular oxygen deprivation ("hypoxia"(“hypoxia”) is known to diminish the effectiveness of current treatments.basis for significant unmet medical needs. TSC is designed to safely and selectively target and re-oxygenate the cancer’smicro-environment of hypoxic micro-environment, re-oxygenatingcells, and can potentially be used in many indications, including stroke, oncology and cardiovascular disease. In stroke, TSC helps promote the diffusion of oxygen into those brain cells in which oxygen-deprivation causes neuronal death resulting in patient mortality or morbidity. In cancer, TSC re-oxygenates treatment-resistant cancerous tissue, and making the cancer cells up to three times more susceptible to the therapeutic effects of standard-of-care radiation therapy and chemotherapy. The U.S. Food and Drug Administration (“FDA”) provided Diffusion with final protocol guidance for a Phase 3 trial ofIn addition to the TSC in newly diagnosed inoperable GBM patients andprograms, the Company plansis exploring alternatives regarding how best to begincapitalize upon our product candidate RES-529, which may include possible out-licensing and other options. RES-529 is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase 1 clinical trials for age-related macular degeneration and is in preclinical development in oncology, specifically GBM. RES-529 has shown activity in both in vitro and in vivo glioblastoma animal models and has been demonstrated to be orally bioavailable and capable of crossing the trial by the end of 2017.blood brain barrier.

 

On January 8, 2016, the Company completed a reverse merger (the “Merger”) with RestorGenex Corporation (“RestorGenex”) whereby the Company was considered the acquirer for accounting purposes. The operational activity of RestorGenex is included in the Company’s consolidated financial statements from the date of acquisition. Accordingly, all comparative period information presented in these unaudited condensed consolidated financial statements from January 1, 2016 through January 7, 2016 exclude any activity related to RestorGenex.

2.

Liquidity

 

The Company has not generated any revenues from product sales and has funded operations primarily from the proceeds of public and private placementsofferings of its membership units (prior to the Merger),equity, convertible notesdebt and convertible preferred stock. Substantial additional financing will be required by the Company to continue to fund its research and development activities. No assurance can be given that any such financing will be available when needed or that the Company’sCompany’s research and development efforts will be successful.

 

The Company regularly explores alternative means of financing its operations and seeks funding through various sources, including public and private securities offerings, collaborative arrangements with third parties and other strategic alliances and business transactions. In March 2017, the Company completed a $25.0 million private placement of its securities by offering units consisting of one share of the Company's Series A convertible preferred stock and a warrant to purchase one share of common stock for each share of Series A convertible preferred stock purchased in the offering. The Company sold 12,376,329 units and received approximately $22.1 million in aggregate net cash proceeds from the private placement, after deducting commissions and other expenses of approximately $2.9 million. In addition, the Company granted to its placement agent in the offering warrants to purchase an aggregate 1,179,558 shares of common stock as compensation for its services.

The Company currently does not have any commitments to obtain additional funds and may be unable to obtain sufficient funding in the future on acceptable terms, if at all. If the Company cannot obtain the necessary funding, it will need to delay, scale back or eliminate some or all of its research and development programs or enter into collaborations with third parties to commercialize potential products or technologies that it might otherwise seek to develop or commercialize independently,independently; consider other various strategic alternatives, including a merger or sale of the Company,Company; or cease operations. If the Company engages in collaborations, it may receive lower consideration upon commercialization of such products than if it had not entered into such arrangements or if it entered into such arrangements at later stages in the product development process.

 

On May 26, 2017,Operations of the Company received a written notice from NASDAQ indicating the Company was not in compliance with Nasdaq Listing Rule 5550(b)(2) because the market value of the Company’s listed securities had been below $35.0 million for the previous 30 consecutive business days. NASDAQ also noted that as of such date the Company also did not meet the alternative requirements under Nasdaq Listing Rule 5550(b)(1), dueare subject to the Company's failure to maintain stockholders' equity of at least $2.5 million, or Nasdaq Listing Rule 5550(b)(3), due to the Company's failure to generate net income from continuing operations during its last fiscal year or during two of its last three fiscal years. See Note 12 for further details.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company has prepared its financial statements assuming that it will continue as a going concern, which contemplates realization of assetscertain risks and the satisfaction of liabilities in the normal course of business. The Company has incurred net losses since inception and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its potential product candidates, which raises substantial doubt about the Company’s ability to continue as a going concern. Variousuncertainties including various internal and external factors that will affect whether and when the Company’s product candidates become approved drugs and the extent ofhow significant their market share. The regulatory approval and market acceptanceshare will be, some of which are outside of the Company’s proposed future products (if any),control. The length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the drug approval process will materially affect the Company’s financial condition and future operations. The Company believes its cash and cash equivalents and certificateas of deposit at September 30, 2017March 31, 2020, along with the $4.8 million in proceeds received during the second quarter of 2020 related to warrant exercises, are sufficient to fund operations through June 2018. into the third quarter of 2021.

 

5

DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

3.

Basis of Presentation and Summary of Significant Accounting Policies

 

The Summary of Significant Accounting Policies included in the Company's Form 10-K for the year ended December 31, 2016,2019, filed with the Securities and Exchange Commission on March 31, 201717, 2020, have not materially changed, except as set forth below.

 

Basis of Presentation

 

The accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information as found in the Accounting Standard Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”), and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements of the Company include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present fairly the Company’s financial position as of September 30, 2017,March 31, 2020, and its results of operations for the three and nine months ended September 30, 2017 and 2016 and cash flows for the ninethree months ended September 30, 2017March 31, 2020 and 2016.2019. Operating results for the ninethree months ended September 30, 2017March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017.2020. The unaudited interim condensed consolidated financial statements presented herein do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 20162019 filed with the SEC on Form 10-K on March 31, 2017.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS17, 2020.

 

Use of Estimates

 

The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date the financial statements and reported amounts of expense during the reporting period. ActualThe full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results could differ fromof operations and financial condition, including sales, expenses, reserves and allowances, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates.estimates in future periods. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited condensedinterim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim condensed consolidated financial statements in the period they are deemeddetermined necessary.

 

Cash and Cash Equivalents and Certificate of Deposit

6

DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

The Company considers any highly liquid investments, such as money market funds, with an original maturity of three months or less to be cash and cash equivalents. The Company's certificate of deposit has a maturity greater than three months but within one year of the date of purchase. This certificate of deposit is classified as held-to-maturity, and the estimated fair value of the investment approximates its amortized cost.

Fair Value of Financial Instruments

 

Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’sCompany’s financial instruments, including cash equivalents certificate of deposit,and accounts payable and accrued expenses approximateare shown at cost, which approximates fair value due to the short-term nature of thosethese instruments. AsThe Company follows the provisions of September 30, 2017, theFASB ASC Topic 820, Fair Value Measurement, for financial assets and liabilities measured on a recurring basis. The guidance requires fair value measurements be classified and disclosed in one of the Company's outstanding Series B convertible note was approximately $0.5 million. As of December 31, 2016,following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities.

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity.

The following fair value ofhierarchy table presents information about the Company’s outstanding 2016 convertible note and Series B convertible note was approximately $2.0 million and $0.6 million, respectively. The 2016 convertible note was paid in full during the three month period ended September 30, 2017. Thecash equivalents measured at fair value of the convertible notes is determined usingon a binomial lattice model that utilizes certain unobservable inputs that fall within Level 3 of the fair value hierarchy.recurring basis:

  

March 31, 2020

 
  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Assets

            

Cash equivalents

 $9,916,053  $  $ 

  

December 31, 2019

 
  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Assets

            

Cash equivalents

 $14,006,193  $  $ 

 

Offering CostsIntangible Asset

 

Offering costs are either expensed upon completion or abandonment of the related financing or offset against the proceeds of the offering, depending upon the accounting treatment of the offering. Offering costs consist principally of legal costs incurred through the balance sheet date related to the Company’s private placement financings and are recognized in other assets on the consolidated balance sheet. During the three months ended September 30, 2017, management decided to not move forward with the Series B financing, which was originally contemplated and disclosed in theThe Company's definitive proxy statement filed with the Securities and Exchange Commission on May 1, 2017, and expensed $98,000 of previously capitalized offering costs related to the financing.

Intangible Assets and Goodwill

In connection with the Merger, the Company acquired indefinite-lived In-Process Research and Development Assets (“IPR&D”) RES-529 and RES-440, with estimated fair values of $8.6 million and $1.0 million, respectively, and recognized $6.9 million in goodwill. In the third quarter of 2016, the IPR&Dintangible asset associated with RES-440 was abandoned and written down to $0. RES-529 and goodwill areis assessed for impairment annually on each of October 1 of the Company’sCompany’s fiscal year or more frequently if impairment indicators exist. The Company has a single reporting unit and all goodwill relates to that reporting unit. There werewas no impairment indicators or impairments to the Company’s RES-529 or goodwillintangible asset recognized during both the three and nine months ended September 30, 2017.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTSMarch 31, 2020 and 2019.

 

Net Income (Loss)Loss Per Common Share

 

For the three and nine months ended September 30, 2017, the Company used the two-class method to compute basicBasic net incomeloss per common share because the Company has issued securities ("Series A convertible preferred stock") that entitle the holder to participate in dividends and earnings of the Company. Under this method,is computed by dividing net income is reduced by any dividends earned during the period. The remaining earnings ("undistributed earnings") are allocatedloss attributable to common stock and the Series A convertible preferred stock to the extent that the Series A convertible preferred stock may share in earnings. In periods of net loss, losses are not allocated to participating securities as the holders of such securities have no obligation to fund losses. The total earnings allocated to common stock is then dividedstockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, convertible preferred stock, common stock warrants, stock options and unvested restricted stock that would result in the issuance of incremental shares outstanding to determineof common stock. In computing the basic earnings per share. 

For purposes of calculatingand diluted net loss per share applicable to common share, the denominator includes bothstockholders, the weighted average common shares outstanding and the number of common stock equivalents ifshares remains the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include stock options, unvested restricted stock awards and warrants usingsame for both calculations due to the treasury stock method. The Company considersfact that when a net loss exists, dilutive shares are not included in the potential dilutivecalculation as the impact of its convertible debt instruments using the "if-converted" method. In addition, the Company considers the potential dilutive impact of its convertible preferred shares using the “if-converted” method if more dilutive than the two-class method. For convertible preferred shares, the two-class method was more dilutive than the “if-converted” method for the three months ended September 30, 2017.is anti-dilutive.

 


7


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The following table sets forth the computation of basic and diluted earnings per share:

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Basic net income (loss) per common share calculation:

                

Net income (loss)

 $5,096,856  $(5,436,553

)

 $(3,154,181

)

 $(15,465,912

)

Accretion of Series A cumulative preferred dividends

  (366,641

)

     (912,946

)

   

Undistributed earnings to participating securities

  (1,838,354

)

         

Net income (loss) attributable to common stockholders

 $2,891,861  $(5,436,553

)

 $(4,067,127

)

 $(15,465,912

)

                 

Weighted average shares outstanding, basic

  13,937,869   10,333,898   11,709,128   10,198,491 

Net income (loss) per share of common, basic

 $0.21  $(0.53

)

 $(0.35

)

 $(1.52

)

                 

Diluted net income (loss) per common share calculation:

                

Net income (loss) attributable to common stockholders

  2,891,861   (5,436,553

)

  (4,067,127

)

  (15,465,912

)

Change in fair value of warrant liability

        (18,909,792

)

    

Interest on convertible debt

  28,891          

Diluted net loss

  2,920,752   (5,436,553

)

  (22,976,919

)

  (15,465,912

)

Weighted average common shares outstanding, basic

  13,937,869   10,333,898   11,709,128   10,198,491 

Common stock equivalents arising from stock options

  20,608          

Common stock equivalents arising from warrants

        816,579    

Common stock equivalents arising from convertible debt

  756,376          

Common stock equivalents

  14,714,853   10,333,898   12,525,707   10,198,491 

Net income (loss) per share of common stock, diluted

 $0.20  $(0.53

)

 $(1.83

)

 $(1.52

)

STATEMENTS

 

The following potentially dilutive securities outstanding as of September 30, 2017March 31, 2020 and 20162019 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:

 

 

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

  

March 31,

 
 

2017

  

2016

  

2017

  

2016

  

2020

  

2019

 

Convertible debt

     749,280   213,879   749,280 

Common stock warrants

  14,003,608   460,721   447,721   460,721   21,261,070   2,087,012 

Stock options

  2,521,605   2,010,409   2,545,989   2,010,409   1,182,629   256,057 

Unvested restricted stock awards

  4,599   10,738   4,599   10,738   98,100    
  16,529,812   3,231,148   3,212,188   3,231,148   22,541,799   2,343,069 

 

Amounts in the table reflect the common stock equivalents of the noted instruments.Recently Adopted Accounting Pronouncements

 

      Recent Accounting Pronouncements

In July 2017,August 2018, the FASB issued ASU 2017-11,2018-13, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. The first part of this update addresses the complexity of accounting for certain financial instruments with down round features and the second part addresses the complexity of distinguishing liabilities from equity. The guidance is applicable to public business entities for fiscal years beginning after December 15, 2018 and interim periods within those years. The Company is currently evaluating the potential impact of the adoption of this standard on its consolidated results of operations, financial position and cash flows and related disclosures.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

In May 2017, the FASB issued ASU No. 2017-09, Modification Accounting for Share-Based Payment Arrangements, which amends the scope of modification accounting for share-based payment arrangements. The ASU provides guidance on the types of changesDisclosure Framework-Changes to the terms or conditions of share-based payment awards to Disclosure Requirements for Fair Value Measurements, which an entity would be required to apply modification accounting under ASC 718. Specifically, an entity would not apply modification accounting ifchanges the fair value vesting conditions, and classificationmeasurement disclosure requirements of ASC 820. The goal of the awards areASU is to improve the same immediately beforeeffectiveness of ASC 820's disclosure requirements by providing users of the financial statements with better information about assets and afterliabilities measured at fair value in the modification. The guidance is applicable to public business entities for fiscal years beginning after December 15, 2017financial statements and interim periods within those years. Early adoption is permitted, including adoption in any interim period.notes thereto. The Company doesadopted ASU No. 2018-13 in the first quarter of 2020 and the adoption did not expect this new guidance to have a material impact on its condensedthe Company's consolidated financial statements.

 

In March 2016, the FASB issued ASU 2016-09, Compensation – Improvements to Employee Share-Based Payment Accounting, which simplifies several aspects of the accounting for employee share-based payment transactions including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is applicable to public business entities for fiscal years beginning after December 15, 2016 and interim periods within those years. The Company adopted this standard in 2017 by electing to account for forfeitures in the period that they occur. Under ASU 2016-09, accounting changes adopted using the modified retrospective method must be calculated as of the beginning of the period adopted and reported as a cumulative-effect adjustment. As a result, the Company recognized cumulative-effect adjustment of approximately $1,000 on January 1, 2017.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The FASB issued the update to require the recognition of lease assets and liabilities on the balance sheet of lessees. The standard will be effective for fiscal years beginning after December 15, 2018, including interim periods within such fiscal years. The ASU requires a modified retrospective transition method with the option to elect a package of practical expedients. Early adoption is permitted. The Company is currently evaluating the potential impact of the adoption of this standard on its consolidated results of operations, financial position and cash flows and related disclosures.

4.

Acquisition

Reverse Merger with RestorGenex

On January 8, 2016, the Company completed a reverse merger transaction with RestorGenex. The Company entered into the Merger transaction in an effort to provide improved access to the capital markets in order to obtain the resources necessary to accelerate development of TSC in multiple clinical programs and continue to build an oncology-focused company.

The purchase price was calculated as follows:

Fair value of RestorGenex shares outstanding

 $19,546,000 

Estimated fair value of RestorGenex stock options outstanding

  1,321,000 

Estimated fair value of RestorGenex warrants outstanding

  384,000 

CVRs – RES-440 product candidate

  10,000 

Total purchase price

 $21,261,000 


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Merger transaction has been accounted for using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date. The valuation technique utilized to value the IPR&D was the cost approach.

The following table summarizes the allocation of the purchase price to the assets acquired and liabilities assumed as of the acquisition date:

Cash and cash equivalents

 $8,500,602 

Prepaid expenses and other assets

  195,200 

Property and equipment

  57,531 

Intangible assets

  9,600,000 

Goodwill

  6,929,258 

Accrued liabilities

  (377,432

)

Deferred tax liability

  (3,644,159

)

Net assets acquired

 $21,261,000 

Qualitative factors supporting the recognition of goodwill due to the Merger transaction include the Company’s anticipated enhanced ability to secure additional capital and gain access to capital market opportunities as a public company and the potential value created by having a more well-rounded clinical development portfolio by adding the earlier stage products acquired in the reverse merger transaction to the Company’s later stage product portfolio. The goodwill is not deductible for income tax purposes.

Pro Forma Financial Information (Unaudited)

The following pro forma financial information reflects the condensed consolidated results of operations of the Company as if the acquisition of RestorGenex had taken place on January 1, 2016. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date.

  

Nine Months Ended September 30, 2016

 
     

Net revenues

 $ 

Net loss

  (13,900,691

)

Basic and diluted loss per share

 $(1.36

)

Non-recurring pro forma transaction costs directly attributable to the Merger were $1.6 million for the nine months ended September 30, 2016 and have been deducted from the net loss presented above. The costs deducted from the nine months ended September 30, 2016 period includes a success fee of $1.1 million and approximately 46,000 shares of common stock with a fair market value of $0.5 million paid to a financial adviser upon the closing of the Merger on January 8, 2016. Additionally, RestorGenex incurred approximately $3.0 million in severance costs as a result of resignations of executive officers immediately prior to the Merger and approximately $2.7 million in share based compensation expense as a result of the acceleration of vesting of stock options at the time of the Merger. These costs are excluded from the pro forma financial information for the nine months ended September 30, 2016. No such costs were recorded in the three and nine months ended September 30, 2017 or in the three months ended September 30, 2016.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

5.

Prepaid expenses, deposits and other current assets

Prepaid expenses, deposits and other current assets consisted of the following:

  

September 30,

2017

  

December 31,

2016

 

Prepaid research and development expense

 $844,521  $12,725 

Prepaid insurance expense

  126,733   9,731 

Prepaid other

  33,107   28,388 

Total

 $1,004,361  $50,844 

 6.

Other Accrued Expenses and Liabilities

 

Other accrued expenses and liabilities consisted of the following:

 

 

September 30,

2017

  

December 31,

2016

  

March 31,

2020

  

December 31,

2019

 

Accrued interest payable

 $36,029  $29,359 

Accrued Series A dividends

  725,774    

Accrued payroll and payroll related expenses

  398,859   399,740  $149,620  $182,708 

Accrued professional fees

  114,268   72,855   338,627   48,338 

Accrued clinical studies expenses

  88,175   220,978   9,100   57,378 

Other accrued expenses

  52,602   151,332   22,205   70,108 

Total

 $1,415,707  $874,264  $519,552  $358,532 

 

7.5.

Convertible DebtStockholders' Equity and Common Stock Warrants

 

The components of debt outstanding at September 30, 2017 and December 31, 2016 are as follows:

  

September 30,

2017

  

December 31,

2016

 

2016 Convertible notes

 $  $1,880,000 

Series B convertible notes

  550,000   550,000 
   550,000   2,430,000 

Less current portion

  (550,000

)

  (1,880,000

)

Long-term debt, net of current portion

 $  $550,000 

Upon maturity of the 2016 Convertible Notes during the third quarter of 2017, the Company repaid the outstanding principal and interest of $1.9 million and $0.1 million, respectively. The accrued interest related to the Company’s Series B Convertible Note is included within accrued expenses and other current liabilities within the unaudited condensed consolidated balance sheets. As of September 30, 2017, the Company had accrued interest of approximately $36,000.

8.

Convertible Preferred Stock and2019 Common Stock Warrants

In contemplation of completing the private placement described below, the Company amended and restated its articles of incorporation and authorized 13,750,000 shares of Series A convertible preferred stock. The Company has classified its Series A convertible preferred stock outside of stockholders’ equity because the shares contain deemed liquidation rights that are contingent redemption features not solely within the control of the Company.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Series A Convertible Preferred Stock TransactionOfferings

 

In March 2017,December 2019, the Company completed an offering (the “December 2019 Offering”) of 6,266,787 shares of its common stock and warrants to purchase 6,266,787 shares of common stock. The shares of common stock and warrants were sold for a combined purchase price of $0.5585 per share for net proceeds of $3.0 million. The December 2019 Offering warrants are exercisable beginning on the date of their issuance until June 13, 2025 at an initial exercise price equal to $0.4335 per share.

In addition, at the closing of the December 2019 Offering, the Company issued warrants to purchase up to 313,339 shares of common stock to designees of the placement agent. The placement agent's warrants have an exercise price of $0.6981 per share and a term of five years from the date of issuance.

In November 2019, the Company completed a $25.0 million private placementregistered direct public offering (the “November 2019 Offering”) of 5,104,429 shares of its securities in which the Company offered and sold units consisting of one share of the Company’s Series A convertible preferredcommon stock, and a warrant6,324,143 pre-funded warrants each to purchase one share of common stock, for each share of Series A convertible preferred stock purchased in the offering. Each share of Series A convertible preferred stock entitles the holdertogether with warrants to an 8.0% cumulative dividend payable inpurchase up to 22,857,144 shares of our common stock at a combined public offering price of $0.35 per share and associated warrants for total net proceeds of $3.3 million. The warrants were issued with an exercise price of $0.35 per warrant and are exercisable beginning on their date of issuance. Of the warrants issued, 11,428,572 have a semi-annual basis. The holders may,term of 18 months and 11,428,572 have a term of five years. During the year ended December 31, 2019, 11,091,716 of those warrants were exercised for proceeds of $3.9 million.

8

DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

In addition, at their option, convert each share of Series A convertible preferred stock into one sharethe closing of the Company’s common stock based onNovember 2019 Offering, the initial conversion price of $2.02 per share, subject to adjustment. Each warrant entitles the holderCompany issued warrants to purchase one shareup to 571,429 shares of common stock to designees of the placement agent. The placement agent's warrants have an exercise price of $0.4375 per share and a term of five years from the date of issuance.

In May 2019, the Company completed a registered direct public offering (the “May 2019 Offering”) of 1,317,060 shares of common stock and a private placement of warrants to purchase 1,317,060 shares of common stock. The shares of common stock and warrants were sold for a combined purchase price of $4.895 for total net proceeds of $5.6 million. The warrants are exercisable beginning on the date of their issuance until November 29, 2024 at an initial exercise price of $2.22, subjectequal to adjustment and expires on the fifth anniversary of their original issuance date.$5.00.

 

The Company sold 12,376,329 units in the private placement and received approximately $22.1 million in aggregate net cash proceeds, after deducting commissions and other expenses of approximately $2.9 million. In addition, as compensation for its services,at the closing of the May 2019 Offering, the Company granted to its placement agent in the offeringissued warrants to purchase an aggregate of 1,179,558up to 65,853 shares of common stock atto designees of the placement agent. The placement agent's warrants have an initial exercise price of $2.22$6.11875 per share which expire on the fifth anniversaryand a term of their original issuance date.

During its evaluation of equity classification for the common stock warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity (“ASC 815-40”). The conditions within ASC 815-40 are not subject to a probability assessment. As the Company is obligated to issue a variable number of shares to settle the cumulative dividends on the Series A convertible preferred stock, the Company cannot assert there will be sufficient authorized shares available to settle the warrants issued in connection with the Series A offering. Accordingly, these warrants are classified as liabilities. The Company will continue to classify such warrants as liabilities until they are exercised, expire, or are no longer required to be classified as liabilities.

As the fair value of the warrants upon issuance was in excess of the proceeds of the Series A offering, there are no proceeds allocated to the Series A convertible preferred stock. The excess fair value of the warrants over the gross proceeds of the Series A offering and the fair value of the warrants granted to its placement agent was $10.2 million in the aggregate and was recorded as warrant related expenses in the statement of operations for the nine months ended September 30, 2017.

Dividends

The Company shall pay a cumulative preferential dividend on each share of the Series A convertible preferred stock outstanding at a rate of 8.0% per annum, payable only in shares of common stock, semi-annually in arrears on April 1 and October 1 of each year commencing on October 1, 2017. This cumulative preferential dividend is not subject to declaration. The Company recognized approximately $0.4 million and $0.9 million in dividends, respectively, for the three and nine months ended September 30, 2017. 

Voting

Subject to certain preferred stock class votes specified in the Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Preferred Stock (the “Certificate of Designation”) or as required by law, the holders of the Series A convertible preferred stock votes together with the holders of common stock as a single class on an adjusted as-converted basis. In accordance with NASDAQ listing rules, in any matter voted on by the holders of our common stock, each share of Series A convertible preferred stock entitles the holder thereof to a number of votes based upon the closing price of our common stock on the NASDAQ Capital Market onfive years from the date of issuance of such shares of Series A convertible preferred stock. Accordingly, shares of Series A convertible preferred stock issued in the initial closing of the private placement on March 14, 2017 are entitled to 0.84874 votes per share and shares of Series A Preferred Stock issued in the final closing of the private placement on March 31, 2017 are entitled to 0.50627 votes per share, in each case, subject to adjustment as described in the Certificate of Designation.


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Liquidation Preference

The Series A convertible preferred stock is senior to the common stock. In the event of a liquidation, dissolution or winding up of the Company, either voluntary or involuntary, or in the event of a deemed liquidation event, which includes a sale of the Company as defined in the Certificate of Designation, the holders of the Series A convertible preferred stock shall be entitled to receive their original investment amount. If upon the occurrence of such event, the assets and funds available for distribution are insufficient to pay such holders the full amount to which they are entitled, then the entire remaining assets and funds legally available for distribution shall be distributed ratably among the holders of the Series A convertible preferred stock in proportion to the full amounts to which they would otherwise be entitled.issuance.

 

Conversion

The Series A convertible preferred stock is convertible, at the holder’s option, into common stock. At the Company’s option, the Series A convertible preferred stock can be converted into common stock upon (a) the thirty-day moving average of the closing price of the Company’s common stock exceeding $8.00 per share, (b) a financing of at least $10.0 million or (c) upon the majority vote of the voting power of the then outstanding shares of Series A convertible preferred stock. The conversion price of the Series A convertible preferred stock is subject to adjustment as described in the Certificate of Designation.

Upon any conversion, any unpaid dividends shall be payable to the holders of Series A convertible preferred stock. During the three and nine months ended September 30, 2017, 2,125,306 and 4,052,297 shares of Series A convertible preferred stock, respectively, were converted into common stock. During the three and nine months ended September 30, 2017, approximately $0.1 million and $0.2 million in accrued dividends, respectively, were converted into 62,701 and 88,436 shares of common stock, respectively.

Make-Whole Provision

Until March 2020 and subject to certain exceptions, if the Company issues at least $10.0 million of its common stock or securities convertible into or exercisable for common stock at a per share price less than $2.02 (such lower price, the “Make-Whole Price”) while any shares of Series A convertible preferred stock remain outstanding, the Company will be required to issue to these holders of Series A convertible preferred stock a number of shares of common stock equal to the additional number of shares of common stock that such shares of Series A convertible preferred stock would be convertible into if the conversion price of such shares was equal to 105% of the Make-Whole Price (the “Make-Whole Adjustment”). The Make-Whole Adjustment was evaluated and was not required to be bifurcated from the Series A convertible preferred stock.

Common Stock Warrants

 

As of September 30, 2017,March 31, 2020, the Company had the following warrants outstanding to acquire shares of its common stock:

 

  

Outstanding

  

Range of exercise

price per share

 

Common stock warrants issued prior to Merger

  447,721  $20.00-$750.00 

Common stock warrants issued in Series A

  13,555,887   $2.22  
   14,003,608      


  

Outstanding

 

Range of exercise

price per share

 

Expiration dates

Common stock warrants issued in 2017 related to Series A convertible preferred stock offering

  903,870  $33.30  

March 2022

Common stock warrants issued in 2018 related to the common stock offering

  1,181,375 $12.00-

$15.00

 

January 2023

Common stock warrants issued related to the May 2019 Offering

  1,382,913 $5.00-

$6.11875

 

May and December 2024

Common stock warrants issued related to the November 2019 Offering

  11,212,786 $0.35-

$0.4375

 

May 2024

Common stock warrants issued related to the December 2019 Offering

  6,580,126 $0.4335-

$0.6981

 

December 2024

and June 2025

   21,261,070      

DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

During the ninethree months ended September 30, 2017, 13,000March 31, 2020, no warrants issued prior to the Merger, expired. These common stockexpired, and 1,124,071 warrants will expire periodically through 2019. The common stock warrants issued in connection with the March 2017 Series A private placement expire in March 2022. During the three and nine months ended September 30, 2017, the Company recognized a net gainwere exercised at an exercise price of $8.4 million and $5.8 million in warrant related charges associated with the Series A private placement, which consisted primarily of the change in fair value of the common stock warrants from issuance and the excess fair value of the common stock warrants over the gross cash proceeds of the Series A offering. $0.35 per warrant.

 

9.6.

Stock-Based Compensation

 

2015 Equity Plan

 

The Diffusion Pharmaceuticals Inc. 2015 Equity Incentive Plan, as amended (the "2015 Equity Plan"), provides for increases to the number of shares reserved for issuance thereunder each January 1 equal to 4.0% of the total shares of the Company’sCompany’s common stock outstanding as of the immediately preceding December 31, unless a lesser amount is stipulated by the Compensation Committee of the Company's Boardboard of Directors.directors. Accordingly, 413,8251,339,215 shares were added to the reserve as of January 1, 2017,2020, which shares may be issued in connection with the grant of stock-based awards, including stock options, restricted stock, restricted stock units, stock appreciation rights and other types of awards as deemed appropriate, in each case, in accordance with the terms of the 2015 Equity Plan. As of September 30, 2017,March 31, 2020, there were 114,291485,602 shares of common stock available for future issuance under the 2015 Equity Plan.

9

DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim condensed consolidated statements of operations for the periods indicated:

 

  

Three Months Ended

September 30,

  

Nine Months Ended
September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Research and development

 $14,333  $174,932  $81,737  $601,260 

General and administrative

  278,168   215,425   892,213   520,730 

Total stock-based compensation expense

 $292,501  $390,357  $973,950  $1,121,990 

 


  

Three Months Ended

March 31,

 
  

2020

  

2019

 

Research and development

 $96,530  $13,596 

General and administrative

  94,850   77,608 

Total stock-based compensation expense

 $191,380  $91,204 

DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The following table summarizes the activity related to all stock option grants to employees and non-employees for the nine months ended September 30, 2017:

  

Number of

Options

  

Weighted

average

exercise price

per share

  

Weighted

average

remaining

contractual life

(in years)

 

Balance at January 1, 2017

  2,207,409  $8.09     

Granted

  340,041   2.49     

Expired

  (1,461

)

  15.00     

Outstanding at September 30, 2017

  2,545,989  $7.34   7.37 

Exercisable at September 30, 2017

  1,746,809  $8.51   6.62 

Non-employee Stock Options

Non-employee options are remeasured to fair value each period using a Black-Scholes option-pricing model until the options vest. During the nine months ended September 30, 2017, the Company granted 9,394 stock options to non-employees. The total fair value of non-employee stock options vested during the three months ended September 30, 2017 and 2016 was approximately $7,000 and $0.2 million, respectively. The total fair value of non-employee stock options vested during the nine months ended September 30, 2017 and 2016 was approximately $83,000 and $0.7 million, respectively. At September 30, 2017, there were 18,572 unvested options subject to remeasurement and approximately $26,000 of unrecognized compensation expense that will be recognized over a weighted-average period of 1.64 years.March 31, 2020:

 

Employee Stock Options

  

Number of

Options

  

Weighted

average

exercise price

per share

  

Weighted

average

remaining

contractual

life

(in years)

  

Aggregate intrinsic value

 

Balance at January 1, 2020

  309,276  $55.78      $ 

Granted

  873,500   0.47         

Expired

  (147

)

  142.50         

Outstanding at March 31, 2020

  1,182,629  $14.91   9.0  $ 

Exercisable at March 31, 2020

  560,524  $30.60   8.2  $ 

 

During the nine months ended September 30, 2017, the Company granted 330,647 stock options to employees. The weighted average grant date fair value of stock option awards granted to employees was $2.12$0.36 during the nine months ended September 30, 2017. During the three months ended September 30, 2017March 31, 2020. The total fair value of options vested during the three months ended March 31, 2020 and 2016 the Company recognized stock-based compensation expense of $0.32019 was $0.2 million and $0.1 million, respectively. During the nine months ended September 30, 2017 and 2016, the Company recognized stock-based compensation expense $0.9 million and $0.4$0.2 million, respectively. No options were exercised during any of the periods presented. At September 30, 2017,March 31, 2020, there was $2.8$0.4 million of unrecognized compensation expense that will be recognized over a weighted-average period of 5.331.81 years.

 

Options granted were valued using the Black-Scholes model and the weighted average assumptions used to value the options granted during the first ninethree months of 2017ended March 31, 2020 were as follows:

 

Expected term (in years)

  6.035.70 

Risk-free interest rate

  2.01.7

%

Expected volatility

  114.9113.7

%

Dividend yield

  

%

 

Restricted Stock Awards

 

As of September 30, 2017, there were 4,599 unvested shares of restricted stock. During the three months ended September 30, 2017 and 2016, there were 1,533 and 1,534 shares that vested, respectively andMarch 31, 2020, the Company recognized stock-based compensation expensegranted 98,100 restricted stock awards to a member of approximately $3,000 and $3,000, respectively. During the nineboard of directors of the Company. The grant date fair value of each restricted stock award granted during the three months ended September 30, 2017 and 2016, there were 4,599 and 4,603March 31, 2020 was $0.51. The shares that vested, respectively andbegin to vest 18 months after the grant date. The Company recognized stock-based compensationapproximately $4,000 in expense of approximately $9,000related to this award during the three months ended March 31, 2020 and, $9,000, respectively. At September 30, 2017,at March 31, 2020, there was approximately $9,000$46,000 of unrecognized compensation expensecost that will be recognized over a weighted-averageweighted average period of less than 1.0 year.2.83 years.

 


10


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

STATEMENTS

 

10.7.

Commitments and Contingencies

 

Office Space Lease CommitmentRental

 

The Company leaseshas a non-cancelable operating lease for office and laboratory facilitiesspace in Charlottesville, Virginia. On MarchVirginia, which began in April 2017 and, as of December 31, 2017,2019, has a remaining lease term of approximately 2.3 years. The Company adopted ASC 842 in the first quarter of 2019 and as a result of the adoption, the Company entered intorecognized a current operating lease liability of $0.1 million and a noncurrent operating lease liability of $0.2 million with a corresponding ROU asset of the combined amounts, which is based on the present value of the minimum rental payments of the lease. The discount rate used to account for its officethe Company's operating lease under ASC 842 is the Company’s estimated incremental borrowing rate of 10%. The original term of the lease ends in the second quarter of 2022 and laboratory facilities at a new location in Charlottesville, Virginia. During the nine months ended September 30, 2017, the Company capitalized approximately $0.4 million in leasehold improvementshas an option to extend for another five years. This option to extend was not recognized as part of the build outCompany's measurement of the new officeROU asset and laboratory location. operating lease liability as of March 31, 2020.

Rent expense related to the Company's operating leaseslease was approximately $30,000 and $20,000 for the three months ended September 30, 2017March 31, 2020 and 2016 was $28,000 and $34,000,2019, respectively. Rent expense for the nine months ended September 30, 2017 and 2016 was $80,000 and $115,000, respectively. For the new operating lease, lease payments commenced on May 1, 2017 and expire on April 30, 2022. The Company will continue to recognize rent expense on a straight-line basis over the lease period and will accrue for rent expense incurred but not yet paid. Future minimum rental payments under the Company's new non-cancelable operating lease at September 30, 2017 was as follows:follows as of March 31, 2020:

 

  

Rental

Commitments

 

2017

 $27,746 

2018

  112,354 

2019

  114,409 

2020

  116,464 

2021

  118,519 

Thereafter

  58,232 

Total

 $547,724 
  

Rental Commitments

 

2020 (remaining)

 $87,691 

2021

  118,519 

2022

  39,735 

Total

  245,945 

Less: imputed interest

  (22,188

)

Current and noncurrent operating lease liability

 $223,757 

 

Arrangement with Clinical Research Organizationand Development Arrangements

 

On July 5, 2017,In the course of normal business operations, the Company enteredenters into a Master Services Agreement ("MSA")agreements with auniversities and contract research organization ("CRO")organizations, or CROs, to provide clinical trial services for individual studies and projects by executing individual work orders. The MSA and associated work orders are designed such that quarterly payments are to be madeassist in advancethe performance of the work to be performed.  The Company recognized research and development expensesactivities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to this MSACROs represent a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of $0.6 millioncash.

Defined Contribution Retirement Plan

The Company has established a 401(k) defined contribution plan (the “401(k) Plan”) that covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of approximately $17,000 and $18,000 for the three months ended September 30, 2017.  As of September 30, 2017, there was $1.0 million of prepaid researchMarch 31, 2020 and development costs that are estimated to be recognized during the fourth quarter of fiscal 2017.2019, respectively.

 

Legal Proceedings

 

On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the Company’sCompany’s former Chief Executive Officer under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys’ fees and costs. On December 30, 2014, the Company filed a petition to compel arbitration and a motion to stay the action. On April 1, 2015, the plaintiff filed a petition in opposition to the Company’s petition to compel arbitration and a motion to stay the action. After a hearing for the petition and motion on April 14, 2015, the Court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. NoOn November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the Court found sufficient grounds not to dismiss the case, and an arbitration hearing has yet been scheduled.scheduled for November 2020. The Company believes this matter is without merit and intends to defend the arbitration vigorously. Because this matter is in an early stage, the Company is unable to predict its outcome and the possible loss or range of loss, if any, associated with its resolution or any potential effect the matter may have on the Company’s financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company’s financial position.

 


11


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

STATEMENTS

 

11.8.

Fair Value MeasurementsSubsequent Events

 

Certain assetsIn April 2020, the Company announced the pre-IND submission to the U.S. Food and liabilitiesDrug Administration (“FDA”) of a planned clinical program using TSC in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Under federal regulations, the FDA has up to 60 days to hold an advisory meeting with the Company, but for COVID-19-related submissions, the FDA has announced its intention to significantly shorten this period under its Coronavirus Treatment Acceleration Program. Clinical trial start-up preparations are carried at fair value under GAAP. Fair value is definedcontinuing as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) inCompany awaits the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:FDA’s response.

 

      Level 1—Quoted prices in active markets for identical assets or liabilities.

      Level 2—Observable inputs (other than LevelFrom April 1, quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

     Level 3—Unobservable inputs that are supported by little or no market activity and that are significant2020 through May 8, 2020, warrants were exercised to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Accordingly, transfers between levels within the valuation hierarchy occur when there are significant changes to the inputs, such as increases or decreases in market activity, changes to the availability of current prices, changes to the transparency to underlying inputs, and whether there are significant variances in quoted prices. Transfers in and/or out of any level are assumed to occur at the end of the period.

The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis:

  

September 30, 2017

 
  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Assets

            

Cash and cash equivalents

 $1,216,000  $  $ 

Certificate of deposit

 $10,020,164         
             

Liabilities

            

Common stock warrant liability

 $  $  $16,316,054 


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

  

December 31, 2016

 
  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Assets

            

Cash and cash equivalents

 $1,552,852  $  $ 

The reconciliation of the common stock warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows:

  

Common Stock

Warrant Liability

 

Balance at December 31, 2016

 $ 

Issued in connection with the Series A convertible preferred stock

  35,225,846 

Change in fair value

  (18,909,792

)

Balance at September 30, 2017

 $16,316,054 

The common stock warrants issued in connection with the Series A convertible preferred stock are classified as liabilities on the accompanying balance sheet at September 30, 2017. The liability is marked-to-market each reporting period with the change in fair value recorded as either income or expense in the accompanying statements of operations until the warrants are exercised, expire or other facts and circumstances lead the liability to be reclassified to stockholders’ equity. The fair value of the warrant liability is estimated using the Black-Scholes model and assumptions used to value the warrant liability as of September 30, 2017 were as follows:

Stock price

 $1.66 

Exercise price

 $2.22 

Expected term (in years)

  4.5 

Risk-free interest rate

  1.8

%

Expected volatility

  109.3

%

Dividend yield

   


DIFFUSION PHARMACEUTICALS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

12.

Subsequent events

On November 1, 2017 the Company held a Special Shareholders meeting, requesting shareholders, both common and Series A, to approve a proposed amendment to the Company’s Certificate of Incorporation to permit the Company to pay dividends on the Company’s Series A Convertible Preferred Stock in either cash orpurchase 6,385,496 shares of the Company’s Common Stock, which was approved by the shareholders. As a resultcommon stock for gross proceeds of this amendment,approximately $2.5 million.

On May 8, 2020, the Company is ablecompleted a warrant exchange and related private placement (the “Exchange”). In the Exchange, an existing holder of the Company’s warrants exercised warrants to assert there will be sufficient authorizedpurchase 5,000,000 shares availableof the Company’s common stock and also purchased new unregistered warrants to settlepurchase up to 5,000,000 shares of common stock (the “New Warrants”), for gross proceeds of approximately $2.4 million. The New Warrants have an exercise price of $0.5263 per share, are exercisable immediately upon issuance, and which have a term of exercise equal to five and one-half years. In connection with the Series A warrants. Upon this assertion,Exchange, the Series ACompany issued warrants were reclassified from liabilities to stockholders’ equity. Priorpurchase up to 250,000 shares of the Company’s common stock (the “May 2020 PA Warrants”) to the amendment,H.C. Wainwright & Co. LLC, as compensation for accounting purposes, the warrants were recordedits role as a liability under U.S. generally accepted accounting principles.placement agent in such Exchange. The warrant liability resulted in a reductionMay 2020 PA Warrants have an exercise price of our stockholders’ equity, as of March 31, 2017$0.5938 per share, are exercisable immediately upon issuance, and June 30, 2017, below the required level under the Nasdaq Capital Market’s continued listing standards. The Charter Amendment, by permitting the Companyhave an exercise term equal to assert share settlement of the warrants, resulted in a reclassification of the warrant liability to stockholders’ equity as of the date of the amendment.five and one-half years.

 

It is therefore the belief of the Company that this fundamental change will allow the Company to regain its NASDAQ compliant status. The following pro-forma information shows adjustments to the September 30, 2017 balances to (i) remove the Series A warrant liability of $16.3 million as of September 30, 2017 from total liabilities, (ii) show the reclassification of the fair value of the Series A warrants of $13.2 million as of November 1, 2017 to APIC, and (iii) to adjust the accumulated deficit balance for the change in fair value of the Series A warrants from September 30, 2017 to November 1, 2017 of $3.2 million.

  

As of September 30, 2017

 
  

Actual

  

Adjustments

   

Pro-forma

 

Total assets

 $28,327,243  $   $28,327,243 

Total liabilities

  21,970,547   (16,316,054

)

(i)

  5,654,493 

Convertible preferred stock

          

Stockholders' equity

             

Common stock

  14,504       14,504 

Additional paid-in-capital

  69,686,744   13,153,524 

(ii)

  82,840,268 

Accumulated deficit

  (63,344,552

)

  3,162,530 

(iii)

  (60,182,022

)

Total stockholders' equity

  6,356,696   16,316,054    22,672,750 

Total liabilities, convertible preferred stock and stockholders' equity

 $28,327,243  $   $28,327,243 

 


12

 

ITEM 2.

MANAGEMENT’SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion of our financial condition and results of operations together with the unaudited interim condensed consolidated financial statements and the notes thereto included elsewhere in this report and other financial information included in this report. The following discussion may contain predictions, estimates and other forward lookingforward-looking statements that involve a number of risks and uncertainties, including those discussed under “Part I — Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Special Note Regarding Forward LookingForward-Looking Statements” in this report and under “Part I — Item 1A. Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2016.2018. These risks could cause our actual results to differ materially from any future performance suggested below.

 

Business Overview

 

We are a clinical stage biotechnology company focused on extending thedeveloping new treatments for life expectancy of cancer patientsthreatening conditions by improving the effectiveness of current standard-of-care treatments, including radiation therapy and chemotherapy.body’s ability to bring oxygen to the areas where it is needed most. We are developing our lead product candidate, transcrocetinate sodium,, also known as trans sodium crocetinate or TSC,(“TSC”), for use in the many cancer typesthose life-threatening conditions in which tumorcellular oxygen deprivation (“hypoxia”) is known to diminish the effectiveness of current treatments.basis for significant unmet medical needs. TSC is designed to safely and selectively target and re-oxygenate the cancer’smicro-environment of hypoxic micro-environment, re-oxygenatingcells, and can potentially be used in many indications, including stroke, oncology, multiple organ failure and cardiovascular disease. In stroke, TSC helps promote the diffusion of oxygen into those brain cells in which oxygen-deprivation causes neuronal death resulting in patient mortality or morbidity. In cancer, TSC re-oxygenates treatment-resistant cancerous tissue, and making the cancer cells up to three times more susceptible to the therapeutic effects of standard-of-care radiation therapy and chemotherapy. In multiple organ failure, we have begun a cooperative research effort with University of Virginia Health (UVA) and the Integrated Translational Research Institute of Virginia (iTHRIV), to evaluate TSC in patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 infection. iTHRIV is a National Institutes of Health (NIH)-funded Clinical and Translational Awards (CTSA) program.

A range of tissue types, including both normal and cancerous cells, has been shown to be safely re-oxygenated in our preclinical and clinical studies using TSC’s novel mechanism of action. We believe TSC’s ability to re-oxygenate normal (i.e. non-cancerous) tissue that has become oxygen-deprived provides opportunities for new therapeutic approaches to conditions ranging from stroke and emergency medicine - including multiple organ failure associated with Acute Respiratory Distress Syndrome (ARDS) - to cardiovascular and neurodegenerative diseases. In the treatment of cancerous tissue, we believe TSC’s therapeutic potential to lessen the tumors treatment resistance to radiation and chemo-therapy is not limited to one specific tumor type, thereby making it potentially useful to improve standard-of-care treatments in many life-threatening cancers. Given TSC's safety profile and animal data, we could, with appropriate funding, move directly into Phase 2 studies for TSC in other cancers. The successful completion of trials for TSC or any other potential product candidate in these or any other indication is dependent upon our ability to further raise necessary capital.

We believe that TSC has potential applications in stroke and emergency medicine. In stroke, a Phase 2 trial in cooperation with the University of California Los Angeles (UCLA) and the University of Virginia (UVA) to test TSC in the treatment of acute ischemic or hemorrhagic stroke is currently enrolling patients. Stroke is the 5th leading cause of death in the U.S. and the No. 1 cause of adult disability. Our stroke trial, which features in-ambulance dosing of TSC, is named the “PreHospital Acute Stroke Therapy - TSC” (PHAST - TSC) study, and is expected to enroll 160 patients, with 80 in the treatment arm and 80 in the control arm. We believe in-ambulance dosing of TSC will significantly cut the time in which the stroke-related oxygen deprivation to brain cells goes untreated, potentially leading to a better outcome for stroke victims treated in this manner. Near term enrollment in this trial is expected to be minimal for the duration of the COVID-19 pandemic.

Patients with COVID-19 infections are at risk for developing ARDS, which can lead to death from systemic hypoxemia (general lack of oxygen to body tissue and vital organs). We, along with researchers affiliated with UVA and iTHRIV, believe the oxygen-enhancing mechanism of action of TSC could benefit COVID-19 patients by mitigating the multiple organ failure that often accompanies systemic hypoxemia, and are, together, exploring avenues to advance TSC’s development as quickly as possible for this use. Preclinical data indicate TSC increases oxygen availability in animal models of acute lung injury, mitigating the negative effects of systemic hypoxemia. Preclinical publications also indicate TSC’s ability to mitigate systemic hypoxemia in other animal models, including hemorrhagic shock. Clinical data from 150 patients receiving TSC for other indications demonstrate that the drug has an acceptable safety profile in both healthy and critically ill patients.

13

We, together with UVA/iTHRIV, have engaged in initial discussions with the U.S. Food and Drug Administration (FDA) to assess possible regulatory pathways for the evaluation of TSC in ARDS-related COVID-19 patients.

 

Our lead development programs targetoncology program targets TSC against cancers known to be inherently treatment-resistant including brain cancers and pancreatic cancer. A Phase 2 clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed glioblastoma multiforme (“GBM”)., a particularly deadly form of primary brain cancer. GBM affects approximately 12,000 patients annually in the United States and approximately 35,000 patients annually worldwide. This open label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC when combined with GBM’s standard of care, including a 37% improvement in overall survival over the control group at two years. A particularly strong efficacy signal was seen in the inoperable patients, where survival of TSC-treated patients at two years was increased by almost four-fold over the controls. The U.S. Food and Drug Administration, or FDA, provided Diffusion with final protocol guidance for aIn December 2017, we initiated the INvestigation of TSC Against Cancerous Tumors (INTACT) Phase 3 trial of TSC in the newly diagnosed inoperable GBM patients. The Company has responded to all outstanding points raised by the FDA and plans to begin the trial under the protocol agreed to by the FDA by the end of 2017.patient population. The trial willis designed to enroll 236 patients in total, 118 in each arm. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in our preclinical and clinical studies. Diffusion believes its therapeutic potential is not limited to specific tumors, thereby making it potentially useful to improve standard-of-care treatments of other life-threatening cancers. Given TSC's safety profile and animal data, we can move into Phase 2 studies in metastatic brain cancer or pancreatic cancer. We also believe that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine. For example, our stroke program is now in advanced discussions with doctors from UCLA and the University of Virginia, with whom we have established a joint team dedicated to developing a program to test TSC118 in the treatment of stroke,arm and 118 in the control arm.

The trial began with an in-ambulance trialFDA-mandated open label 8 patient safety run-in for which enrollment has completed and is now closed. With the FDA’s permission, a total of 19 patients were enrolled to ensure that at least 8 complete data sets meeting the FDA’s specified 4-month exposure period would be available for review. The INTACT Trial Data Safety Monitoring Board (DSMB) met in the third quarter of 2019 and, based on their analysis, recommended that the study be continued. The DSMB concluded that no adverse safety signal had been observed, and unanimously recommended continuing the study as planned using the highest tested dose of TSC - 1.5 mg/kg - during the adjuvant treatment chemotherapy period with temozolomide. We believe that a preliminary efficacy signal was also received. A total of 10 patients were enrolled into the higher dose cohorts and 9 in stroke under consideration. Planning for suchthe lower dose cohorts. In the higher dose patients, where the best results were expected, 3 discontinued treatment before meeting the FDA exposure period criteria. Of the 7 patients who met the criteria, 5 remain alive as of March 12, 2020. Commencement of enrollment in the randomization portion of the INTACT Phase 3 Trial is contingent upon our entering into a trial is on-going.strategic partnership providing the necessary resources to undertake the full trial.

 

In addition to the TSC programs, we are exploring alternatives regarding how best to capitalize upon our product candidate RES-529, which may include possible out-licensing and other options. RES-529 is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase 1 clinical trials for age-related macular degeneration and was in preclinical development in oncology, specifically GBM. RES-529 has shown activity in both in vitro and in vivo glioblastoma animal models and has been demonstrated to be orally bioavailable and can crosscapable of crossing the blood brain barrier.

 


Summary of Current Product Candidate PipelineCOVID-19 Pandemic

 

The following table,spread of COVID-19 during 2020 has caused an economic downturn on a global scale, as well as significant volatility in the financial markets. In March 2020 the World Health Organization declared COVID-19 a pandemic. As of September 30, 2017, summarizesMay 11, 2020, we have experienced some disruptions to clinical operations, including with respect to patient enrollment in our clinical trials. In this time of uncertainty as a result of the targetedCOVID-19 pandemic, we are continuing to conduct trials at certain clinical indicationstrial sites while taking precautions to provide a safe work environment for Diffusion’s lead molecule, TSC:our trial participants and employees. However, some in-person visits are currently on hold and other activities are being conducted remotely to the extent possible. We have also made internal resource allocation decisions in order to deliver on key business objectives and to increase our financial flexibility, including, for example, by pausing the development of certain preclinical research programs, delaying the start of certain longer-term clinical studies, limiting staff hiring and reducing the number of contract workers, and delaying or limiting information technology and facilities infrastructure projects. We may have to take further actions that we determine are in the best interests of our trial participants and employees or as required by federal, state, or local authorities.

 

As the pandemic continues to unfold, the extent of the pandemic’s effect on our operational and financial performance will depend in large part on future developments, which cannot be predicted with confidence at this time. Future developments include changes in the duration, scope and severity of the pandemic, the actions taken to contain or mitigate its impact, the impact on governmental programs and budgets, the development of treatments or vaccines, and the resumption of widespread economic activity. Any prolonged material disruption on recruiting or retaining patients in our clinical trials, the ability of our suppliers to provide materials for our product candidates, or the regulatory review process could cause additional delays with respect to product development activities and could negatively impact our consolidated financial position, consolidated results of operations and consolidated cash flows.

14

 

Financial Summary

 

InAs of March 2017, we completed a $25.0 million private placement of our securities by offering units consisting of one share of our Series A convertible preferred stock and a warrant to purchase one share of our common stock for each share of Series A convertible preferred stock purchased in the offering. We sold 12,376,329 units and received approximately $22.1 million in aggregate net cash proceeds from the private placement, after deducting commissions and other expenses of approximately $2.9 million. In addition, we granted our placement agent in the offering warrants to purchase an aggregate of 1,179,558 shares of our common stock as compensation for its services.

At September 30, 2017,31, 2020, we had cash and cash equivalents of $1.2 million and a certificate of deposit of $10.0$10.8 million. We have incurred operating losses since inception, have not generated any product sales revenue and have not achieved profitable operations. We had net income of $5.1 million and incurred a net loss of $3.2$2.6 million for the three and nine months ended September 30, 2017, respectively. Our net income for the three months ended September 30, 2017 was primarily related to the remeasurement of our common stock warrant liability at September 30, 2017 which resulted in a $8.4 million gain (see Notes 8 and 11 to the accompanying unaudited condensed consolidated financial statements).March 31, 2020. Our accumulated deficit as of September 30, 2017March 31, 2020 was $63.3$94.3 million, and we expect to continue to incur substantial losses in future periods. We anticipate that our operating expenses will increase substantially as we continue to advance our lead, clinical-stage product candidate, TSC. We anticipate that our expenses will substantially increase as we:

 

complete regulatory and manufacturing activities and commencebegin one or more clinical trialsprograms using TSC in COVID-19 patients;

continue our Phase 2 clinical trial for TSC;TSC in stroke;

 

continue the research, development and scale-up manufacturing capabilities to optimize products and dose forms for which we may obtain regulatory approval;

 


conduct other preclinical and clinical studies to support the filing of a New Drug Application (“NDA”) for TSC with the FDA;

 

maintain, expand and protect our global intellectual property portfolio;

 

hire additional clinical, manufacturing, and scientific personnel; and

 

add, acquire or develop operational, financial and management information systems and personnel, including personnel to support our drug development and potential future commercialization efforts.

 

We intend to use our existing cash and cash equivalents and certificate of deposit for working capital and to fund the research and development of TSC for use in the treatment of GBM, pancreatic cancer, stroke and brain metastases.TSC. We believe that our cash and cash equivalents and our certificate of deposit as of September 30, 2017March 31, 2020, along with the $4.8 million in proceeds received in the second quarter of 2020 related to warrant exercises, will enable us to fund our operating expenses and capital expenditure requirements through June 2018. However, we will need to secure additional funding in(including our clinical trials) into the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out our planned research and development activities with respect to TSC and our other product candidates.third quarter of 2021.

 

Financial Operations Overview

 

Revenues

 

We have not yet generated any revenue from product sales. We do not expect to generate revenue from product sales for the foreseeable future.

 

Research and Development Expense

 

Research and development costs are charged to expense as incurred. These costs include, but are not limited to, expenses related to, third-party contract research arrangements, employee-related expenses, including salaries, benefits, stock-based compensation and travel expense reimbursement, as well as impairment of our in-process research and development, or IPR&D assets.reimbursement. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As we advance our product candidates, we expect the amount of research and development costs will continue to increase for the foreseeable future. Research and development costs are charged to expense as incurred.

 

General and Administrative Expense

 

General and administrative expenses consist principally of salaries and related costs for executive and other personnel, including stock-based compensation, expenses associated with investment bank and other financial advisory services, and travel expenses. Other general and administrative expenses include costs associated with the Merger, professional fees, that were incurred in connection with preparing to operate and operating as a public company, facility-related costs, communication expenses and professional fees for legal, patent prosecution and maintenance, and consulting and accounting services.

 


Interest Expense, NetIncome

 

Interest expense, net consists principally of the interest expense recorded in connection with our convertible debt instruments offset by theincome is interest earned from our cash and cash equivalents and certificate of deposit.equivalents.

 

Change in Fair Value of Warrant Liabilities, Warrant Related Expenses, and Other Financing ExpensesIncome Tax Benefit

 

In connection with our private placement in March 2017, we recorded warrant expense associated with the change in fair valueWe recognize income tax benefit to utilize indefinite deferred tax liabilities as a source of income against indefinite lived portions of the common stock warrants from issuance, the excess fair value of the common stock warrants over the gross cash proceeds from the Series A convertible preferred stock offering, and placement agent commissions and other offering costs.Company’s deferred tax assets.

15

 

Results of Operations

Comparison of for Three Months Ended September 30, 2017 and 2016March 31, 2020 Compared to Three Months Ended March 31, 2019

 

The following table sets forth our results of operations for the three months ended September 30, 2017March 31, 2020, and 2016.2019.

 

 

Three Months Ended September 30, 2017

      

Three Months Ended March 31,

     
 

2017

  

2016

  

Change

  

2020

  

2019

  

Change

 

Operating expenses:

                        

Research and development

 $1,759,305  $1,941,743  $(182,438

)

 $1,534,467  $1,699,845  $(165,378

)

General and administrative

  1,559,399   3,852,406   (2,293,007

)

  1,393,808   1,200,728   193,080 

Depreciation

  27,374   5,822   21,552   27,020   18,272   8,748 

Loss from operations

  3,346,078   5,799,971   (2,453,893

)

  2,955,295   2,918,845   36,450 

Other expense (income):

            

Interest (income) expense, net

  (1,318

)

  1,378   (2,696

)

Change in fair value of warrant liabilities

  (8,441,616

)

     (8,441,616

)

Other income:

            

Interest income

  (34,100

)

  (20,684

)

  (13,416

)

Loss from operations before income tax benefit

  (2,921,195

)

  (2,898,161

)

  (23,034

)

Income tax benefit

     (364,796

)

  364,796   (362,380

)

  (150,352

)

  (212,028

)

Net income (loss)

 $5,096,856  $(5,436,553

)

 $10,533,409 

Net loss

 $(2,558,815

)

 $(2,747,809

)

 $188,994 

 

We recognized $1.8$1.5 million in research and development expenses during the three months ended September 30, 2017March 31, 2020 compared to $1.9$1.7 million during the three months ended September 30, 2016.March 31, 2019. The decrease in research and development expense was mainly attributable to a $1.0 million impairment charge recognized in the third quarter of 2016, a $0.2 million decrease in expense associated with animal toxicology studies and a $0.1 million decrease in stock-based compensation expense. These amounts were partially offset by a $0.9 million increase in costs associated with our GBM trials, a $0.1 million increase in API and drug manufacturing costs and a $0.1 million increase in salary related expenses.

General and administrative expenses were $1.6 million during the three months ended September 30, 2017 compared to $3.9 million during the three months ended September 30, 2016. The decrease in general and administrative expense was primarily due to a $2.5 million decrease in litigation settlement fees, partially offset by an increase in salary and stock-based compensation expense of $0.1 million and an increase in professional fees of $0.1 million.


The decrease in interest expense, net for the three months ended September 30, 2017 compared to the three months ended September 30, 2016 is primarily attributable to the interest earned on our certificate of deposit, partially offset by interest expense on our convertible notes that were issued in September 2016.

In connection with the private placement of our Series A convertible preferred stock and common stock warrants, we determined the warrants to be classified as liabilities and subject to remeasurement at each reporting period. As a result of the liability classification, during the three months ended September 30, 2017, we recorded a $8.4 million non-cash gain for the change in fair value of our common stock warrant liabilities which was primarily attributable to the decrease in the market price for our common stock.

Comparison of Nine Months Ended September 30, 2017 and 2016

The following table sets forth our results of operations for the Nine Months Ended September 30, 2017 and 2016.

  

Nine Months Ended
September 30,

     
  

2017

  

2016

  

Change

 

Operating expenses:

            

Research and development

 $3,946,420  $5,739,456  $(1,793,036

)

General and administrative

  4,908,424   10,070,878   (5,162,454

)

Depreciation

  39,767   19,520   20,247 

Loss from operations

  8,894,611   15,829,854   (6,935,243

)

Other expense (income):

            

Interest (income) expense, net

  73,290   854   72,436 

Change in fair value of warrant liabilities

  (18,909,792

)

     (18,909,792

)

Warrant related expenses

  10,225,846      10,225,846 

Other financing expenses

  2,870,226      2,870,226 

Net loss

 $(3,154,181

)

 $(15,465,912

)

 $12,311,731 

We recognized $3.9 million in research and development expenses during the nine months ended September 30, 2017 compared to $5.7 million during the nine months ended September 30, 2016. The decrease in research and development expense was attributable to a $1.0 million impairment charge recognized in the third quarter of 2016, a $1.2 million decrease in animal toxicology expenses, a $0.9$0.4 million decrease in expense related to our pancreatic cancer program, and a $0.5 million decreasePhase 3 GBM trial. The lead-in portion of the Phase 3 GBM trial was completed in stock-based compensation expense.the fourth quarter of 2019. This decrease was partially offset by a $0.9$0.1 million increase in manufacturing costs and an increase of $0.1 million in expense related to our GBM trials, $0.5 million increase in API manufacturing costs and a $0.2 million increase in salary related expenses.Phase 2 stroke trial.


 

General and administrative expenses were $4.9increased by $0.2 million during the ninethree months ended September 30, 2017March 31, 2020 compared to $10.1 million during the ninethree months ended September 30, 2016. The decrease in general and administrative expense was primarilyMarch 31, 2019, mainly due to a $2.7 million decrease in costs attributable to the reverse merger transaction in January 2016, a $2.5 million decrease in legal settlement costs, and a decrease in insurance related expenses of $0.4 million. This decrease was offset by an increase in salaryprofessional fees and stock-based compensation expense of $0.5 million.salaries and wages.

 

The increase in interest expenseincome for the ninethree months ended September 30, 2017March 31, 2020 compared to the ninethree months ended September 30, 2016March 31, 2019 is primarily attributable to having a larger cash and cash equivalents balance earning more interest during the issuance of our convertible promissory note with a notional value of $1.9 million in September 2016.three months ended March 31, 2020 compared to the three months ended March 31, 2019.

 

AsWe recognized income tax benefit of $0.4 million and $0.2 million during the three months ended March 31, 2020 and 2019, respectively, to reflect the utilization of indefinite deferred tax liabilities as a resultsource of income against indefinite lived portions of the liability classification, for the nine months ended September 30, 2017, we recorded a $18.9 million non-cash gain for the change in fair value of our common stock warrant liabilities which was primarily attributable to the decrease in the market price for our common stock. We also recognized $10.2 million in excess fair value of the common stock warrants over the gross proceeds from our private placement and $2.9 million in placement agent commissions and other offering costs.deferred tax assets.

16

 

Liquidity and Capital Resources

 

Working Capital

 

To date, we have funded our operations primarily through the sale and issuance of preferred stock, common stock and convertible promissory notes. In March 2017, we sold 12,376,329 units, consisting of shares of Series A convertible preferred stock and warrants to purchase shares of common stock in a private placement and received approximately $22.1 million in aggregate net cash proceeds, after deducting commissions and other expenses of approximately $2.9 million. As of September 30, 2017,March 31, 2020, we had $1.2$10.8 million in cash and cash equivalents, $10.0 million in a certificate of deposit, working capital deficit of $6.5$10.4 million and an accumulated deficit of $63.3$94.3 million. We expect to continue to incur net losses for the foreseeable future. We intend to use our existing cash and cash equivalents to fund our working capital and research and development of our product candidates.

 

 Cash Flows

 

The following table sets forth our cash flows for the ninethree months ended September 30, 2017March 31, 2020 and 2016:2019:

 

 

Nine Months Ended September 30,

 
 

2017

  

2016

  

Three Months Ended March 31,

 

Net cash (used in) provided by:

         

2020

  

2019

 

Operating activities

 $(10,050,042

)

 $(9,354,075

)

 $(3,504,314

)

 $(2,657,458

)

Investing activities

  (10,438,604

)

  8,498,271 

Financing activities

  20,151,794   1,880,000   155,193    

Net increase in cash and cash equivalents

 $(336,852

)

 $1,024,196 

Net decrease in cash and cash equivalents

 $(3,349,121

)

 $(2,657,458

)

 


Operating Activities

 

Net cash used in operating activities of $10.1$3.5 million during the ninethree months ended September 30, 2017March 31, 2020 was primarily attributable to our net loss of $3.2$2.6 million, $5.8 million in non-cash warrant related and other financing expenses and our net change in operating assets and liabilities of $2.2$0.8 million and our change in deferred income taxes of $0.4 million. This amount was offset by $1.0$0.2 million in stock-based compensation expense and depreciation expense. The net change in our operating assets and liabilities is primarily attributable to thea decrease in our accounts payable and accrued expenses due to the timing of our payments to our vendors offset by an increase in accrued expenses due to additional accrued interest and dividendsemployees as well as an increase in our prepaid expenses, mainly related to prepaid researchdeposits and development and insurance costs.other current assets.

 

Net cash used in operating activities of $9.4$2.7 million during the ninethree months ended September 30, 2016March 31, 2019 was primarily attributable to our net loss of $15.5$2.7 million the $0.4 reductionand our change in our deferred tax liability thatincome taxes of $0.2 million. This amount was offset by $6.0 million of non-cash charges and $0.5 million for theour net change in our operating assets and liabilities. Noncash charges primarily consistedliabilities of $0.1 million and $0.1 million in stock-based compensation expense of $1.1 million, $1.0 million impairment charge in connection abandoning our future development efforts of RES-440, $2.5 million litigation settlement charge, and the issuance of 148,073 shares of our common stock for advisory services at an estimated fair value of $1.4 million.depreciation expense. The net change in our operating assets and liabilities is primarily attributable to thean increase in our accounts payable and accrued expenses due to the timing in processingof our payroll and paymentpayments to our vendors, for professional servicesslightly offset by an increase in our prepaid expenses, deposits and costs associated with our clinical and preclinical activities.

Investing Activities

During the nine months ended September 30, 2017, we purchased a certificate of deposit in the amount of $10.0 million and had approximately $0.4 million in fixed asset purchases. During the nine months ended September 30, 2016, net cash provided by investing activities was $8.5 million and was attributable to the cash acquired in connection with the reverse merger transaction with RestorGenex.other current assets.

 

Financing Activities

 

Net cash provided by financing activities was $20.2$0.2 million during the ninethree months ended September 30, 2017,March 31, 2020, which was attributable to the $22.1 million in proceeds received upon the closing of our Series A private placement offset by approximately $98,000 in payments for Series B offering costs. This amount was further offset by the repayment of our convertible note in the amount of $1.9 million. During the nine months ended September 30, 2016, net cash provided by financing activities was attributable to the $1.9$0.4 million in proceeds received from our convertible note borrowings.the exercise of common stock warrants, offset by approximately $0.2 million in payments for offering costs.

We had no financing activities during the three months ended March 31, 2019.

17

 

Capital Requirements

 

We expect to continue to incur substantial expenses and generate significant operating losses as we continue to pursue our business strategy of developing our lead product candidate, TSC, for use in the treatment of ARDS, stroke, GBM, pancreatic cancer,and other hypoxia related indications. Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts of cash to advance the clinical development of our product candidates. At the current time, the bulk of our cash resources for clinical development is dedicated to the Phase 2 trial for TSC in acute stroke, and brain metastases.

if approved by the FDA, clinical work for TSC in the treatment of ARDS in COVID-19 patients. While we believe we have adequate cash resources to continue operations into the third quarter of 2021, we will need to raise additional funds in order to complete these trials. We do not expect to commence any clinical trials beyond these trials unless we are able to raise additional capital, enter into strategic collaborations, or make alternative financing arrangements for any such trials. To date, we have funded our ongoing business operations and short-term liquidity needs, primarily through the sale and issuance of preferred stock, common stock and convertible promissory notes.debt. We expect to continue this practice for the foreseeable future. We believe our cash and cash equivalents and our certificate of deposit as of September 30, 2017 will be sufficientfuture, however, we may enter into strategic partnerships or transactions in order to fund our planned operations through June 2018.ongoing capital requirements.

 

As of September 30, 2017,March 31, 2020, we did not have credit facilities under which we could borrow funds or any other sources of committed capital. We maywill seek to raise additional funds through various sources, such as equity and debt financings, or through strategic collaborations and licenseor licensing agreements. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or be on terms acceptable to us.us, or that potential delays in clinical trials due to the impact of COVID-19 could increase the anticipated cost of completing our clinical trials. This risk may increase if economic and market conditions deteriorate. If we are unable to obtain additional financing when needed, we may need to terminate, significantly modify or delay the development of our product candidates and our operations, or we may need to obtain funds through collaborators that may require us to relinquish rights to our technologies or product candidates that we might otherwise seek to develop or commercialize independently. If we are unable to raise any additional capital in the near-term and/or we cannot significantly reduce our expenses and are forced to terminate our operations, investors may experience a complete loss of their investment.


 

To the extent that we raise additional capital through the sale of our common stock, the interests of our current stockholders may be diluted. Also, the Company’s outstanding warrants, if exercised, or any future warrants, if exercised, will dilute the interests of our current stockholders. If we issue additional preferred stock, or convertible debt securities, it could affect the rights of our common stockholders or reduce the value of our common stock or any outstanding classes of preferred stock. In particular, specific rights granted to future holders of preferred stock or convertible debt securities may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

 

On May 26, 2017, we received a written notice from NASDAQ indicating we were not in compliance with Nasdaq Listing Rule 5550(b)(2) because the market value of our listed securities had been below $35.0 million for the previous 30 consecutive business days. NASDAQ also noted that as of such date the Company also did not meet the alternative requirements under Nasdaq Listing Rule 5550(b)(1), due to the Company's failure to maintain stockholders' equity of at least $2.5 million, or Nasdaq Listing Rule 5550(b)(3), due to the Company's failure to generate net income from continuing operations during its last fiscal year or during two of its last three fiscal years. See Note 12 of our unaudited condensed consolidated statements for further details.

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, as defined by the rules and regulations of the SEC that have or are reasonably likely to have a material effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources. As a result, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these arrangements.

 

Critical Accounting Policies

 

The Critical Accounting Policies included in our Form 10-K for the year ended December 31, 2016,2019, filed with the SEC pursuant to Section 13 or 15(d) under the Securities Act on March 31, 2017, as amended to this date,17, 2020 have not changed, except as follows:changed.

 


18

 

Estimated fair value of Common Stock Warrants

Common stock warrants issued in conjunction with our Series A convertible preferred stock offering are accounted for as freestanding financial instruments. These warrants are classified as liabilities on our condensed consolidated balance sheet and are recorded at their estimated fair value. At the end of each reporting period, changes in the estimated fair value during the period are recorded in our condensed consolidated statement of operations. On November 1, 2017, we held a Special Shareholders meeting, requesting shareholders, both common and Series A, to approve a proposed amendment to our Certificate of Incorporation to permit us to pay dividends on our Series A Convertible Preferred Stock in either cash or shares of our Common Stock, which was approved by the shareholders. As a result of this amendment, we have asserted there will be sufficient authorized shares available to settle the Series A warrants. Upon this assertion, the Series A warrants were remeasured on November 1, 2017 and reclassified from liabilities to stockholders’ equity. The warrants will no longer be adjusted to fair value after November 1, 2017. The estimated fair value of common stock warrants is determined by using the Black-Scholes option-pricing model.

SpecialCautionary Note Regarding Forward-Looking Statements

 

This report includes forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this Quarterly Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain regulatory and maintain regulatoryother approvals for our product candidates, our intellectual property position, our ability to maintain our Nasdaq listing, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial functions, expectations regarding clinical trial data, general business and market conditions, our results of operations, the sufficiency of the Company’s cash, needs,the Company’s need for and ability to obtain additional financing or partnering arrangements, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

 

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained or incorporated by reference in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained or incorporated by reference in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained or incorporated by reference in this Quarterly Report, they may not be predictive of results or developments in future periods.

 

Actual results could differ materially from our forward-looking statements due to a number of factors, including risks related to:

 

 

our ability to obtain additional financing, including the overhang and restrictive provisions of the Series A convertible preferred stock and related warrants;financing;

 

 

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;


our ability to continue as a going concern;

obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;

 

 

the success and timing of our preclinical studies and clinical trials;trials, including our ability to enroll an adequate number of patients in a timely fashion;

 

 

the difficulties in obtaining and maintaining regulatory approval of our products and product candidates, and the labeling under any approval we may obtain;

our plans and ability to develop and commercialize our product candidates;

 

 

our failure to recruit or retain key scientific or management personnel or to retain our executive officers;

 

 

the accuracy of our estimates of the size and characteristics of the potential markets for our product candidates and our ability to serve those markets;

 

 

regulatory developments in the United States and foreign countries;

 

19

the rate and degree of market acceptance of any of our product candidates;

obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;

 

our ability to operate our business without infringing the intellectual property rights of others;

 

 

recently enacted and future legislation regarding the healthcare system;

 

 

our ability to satisfymaintain our listing on the continued listing requirements of the NASDAQNasdaq Capital Market or any other exchange that our securities may trade on in the future;Market;

 

 

our plans and ability to develop and commercialize our product candidates;

the rate and degree of market acceptance of any of our product candidates;continue as a going concern;

 

 

the success of competing products that are or may become available;

risks associated with the COVID-19 pandemic, which may adversely impact our preclinical studies and clinical trials; and

 

 

the performance of third parties, including contract research organizations, and manufacturers.

 

You should also read carefully the factors described in the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 31, 2017,17, 2020, as amended, and elsewhere in our public filings to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements contained or incorporated by reference in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

 

Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and, except as required by applicable law, we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

 


20

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

This Item 3 is not applicable to us as a smaller reporting company and has been omitted.

 

ITEM 4.

CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) that are designed to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’sSEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we are required to apply our judgment in evaluating the cost-benefit relationship of possible internal controls. Our management evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered in this report. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the end of such period to provide reasonable assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding disclosure.

 

Change in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934, as amended) that occurred during the quarter ended September 30, 2017March 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 


21

 

PART II – OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

 

For this item, please refer to Note 10,7, Commitments and Contingencies to the Notes to the Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

 

ITEM 1A.

RISK FACTORS

 

In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in Part I, Item 1AIA - “Risk"Risk Factors," in our Annual Report on Form 10-K for the year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the period ended March 31, 2017,2019, which could materially affect our business, financial condition or future results.

 

AsEvents outside of our control, including public health crises such as the COVID-19 pandemic, could negatively affect our business and our operating results.

The novel coronavirus (“COVID-19”) pandemic has resulted in significant financial market volatility, and its impact on the global economy and our operations remains uncertain. A continuation or worsening of the datepandemic could have a material adverse impact on our business, results of this Quarterly Reportoperations and financial condition and on Form 10-Q, therethe market price of our common stock.

On March 12, 2020, the World Health Organization declared COVID-19 to be a pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries worldwide have imposed quarantines, business closures and unprecedented restrictions on travel. The outbreak and government measures taken in response, have had a significant impact, both direct and indirect, on economic activity, as worker shortages have occurred, supply chains have been no material changesdisrupted, facilities and production have been suspended and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services has fallen.

As a result of the COVID-19 pandemic, we may experience disruptions that could severely impact our business and clinical trials, including:

delays or difficulties in enrolling patients in our clinical trials;

delays or difficulties in clinical trial site activities, including difficulties in recruiting clinical trial staff;

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (i.e., those that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

interruption of, or delays in receiving, supplies for productions of our product candidates from our third party suppliers due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

interruptions in preclinical studies due to restricted or limited operations at laboratory facilities; and

interruption or delays to our clinical activities.

22

Any negative impact that the COVID-19 pandemic has on recruiting or retaining patients in our clinical trials, the ability of our suppliers to provide materials for our product candidates, or the regulatory review process could cause additional delays with respect to product development activities, which could materially and adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses, affect our ability to raise additional capital, and have a material adverse effect on our financial results. In addition, our clinical trial patients who contract COVID-19 may have adverse health outcomes that could impact the Company’s riskresults of our clinical trials.

The COVID-19 pandemic has resulted in significant financial market volatility and uncertainty in recent weeks and continues to rapidly evolve. The extent to which the outbreak impacts our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on the market price of our common stock.

We face risks related to the planned clinical program to test TSC as a treatment for COVID-19, which has not been approved by the FDA or any other regulatory authority.

In response to the recent global outbreak of COVID-19, on April 24, 2020, we submitted a Pre-Investigational New Drug Application (Pre-IND) to the FDA related to a planned clinical program using TSC in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Under federal regulations, the FDA has up to 60 days to hold an advisory meeting with us, but for COVID-19-related submissions, the FDA has notified us of its intention to accelerate its review of the Pre-IND submission under its Coronavirus Treatment Acceleration Program. Clinical trial start-up preparations are continuing as we await the FDA’s response. The estimated timing of regulatory approval is based on factors previously disclosed on Form 10-Kbeyond our control, including but not limited to, unforeseen scheduling difficulties and unfavorable results at various stages in the pre-market application process. This FDA approval or clearance process may be time-consuming and costly. Moreover, there is no guarantee that the pre-IND submission will ultimately be acceptable to the FDA for an IND submission or that the FDA will not require significant changes that might take significant time to implement, if at all, or that any such required changes will be financially feasible for the year ended December 31, 2016 and Form 10-QCompany. Even if the Pre-IND or a revised protocol is acceptable to the FDA for an IND submission, there can be no assurance as to when the FDA might provide such guidance or when the program might be able to commence, if at all. We intend to work closely with the FDA to determine the best path forward to obtain approval, but we cannot guarantee that these efforts will be successful. Even if FDA approval for trials evaluating TSC for the period ended March 31, 2017.treatment of ARDS is ultimately granted and we are able to move forward with clinical trials, such trials may entail significant additional time, effort and expense, particularly in light of the difficulty of doing business during the COVID-19 pandemic. In addition, there is no assurance of favorable results from any clinical trials, or that one or more of such trials will be completed in the currently anticipated timelines or at all. Further, we may make a strategic decision to discontinue clinical testing of TSC in COVID-19 patients, including in the event that other parties are successful in developing a more effective treatment for COVID-19.

 

We have committed significant capital and resources to begin funding and supplying the clinical trials for the COVID-19 program. If we are unable to obtain regulatory approvals, or if clinical trials fail to demonstrate the clinical safety profile or the efficacy of TSC for the treatment of ARDS in COVID-19 patients, or if we make a strategic decision to discontinue testing TSC as a treatment for COVID-19 patients, we will be unable to recoup our significant expenses incurred to date and in the future related to the clinical program and the FDA approval process.

23

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Unregistered Sales of Equity Securities

 

None.

 

 Issuer Purchases of Equity Securities

 

None.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.

MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.

OTHER INFORMATION

 

None.

 

ITEM 6.

EXHIBITS

 

See attached Exhibit Index.

 


24

SIGNATURES

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

Date: November 13, 2017

DIFFUSION PHARMACEUTICALS INC.

By:

/s/ David G. Kalergis

David G. Kalergis

Chairman and Chief Executive Officer

(Principal Executive Officer)

By:

/s/ Ben L. Shealy

Ben L. Shealy

Senior Vice President, Finance, Treasurer and Secretary

(Principal Financial Officer)



 

DIFFUSION PHARMACEUTICALS INC.

QUARTERLY REPORT ON FORM 10-Q

EXHIBIT INDEX

 

 

Exhibit

No.

 

Description

 

Method of Filing

10.1

Separation Agreement, dated March 12, 2020, by and between Diffusion Pharmaceuticals Inc, and John L. Gainer

Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 18, 2020

10.2

Consulting Agreement, dated March 12, 2020, by and between Diffusion Pharmaceuticals Inc, and John L. Gainer

Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 18, 2020

31.1

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 and SEC Rule 13a-14(a)

Filed herewith

31.2

Certification of principal financial officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 and SEC Rule 13a-14(a)

Filed herewith

32.1

Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Furnished herewith

32.2

Certification of principal financial officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Furnished herewith

101

The following materials from Diffusion’sDiffusion’s quarterly report on Form 10-Q for the quarter ended September 30, 2017,March 31, 2020, formatted in XBRL (Extensible Business Reporting Language): (i) the Unaudited Condensed Consolidated Balance Sheets, (ii) the Unaudited Condensed Consolidated Statements of Operations, (iii) the Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity, (Deficit), (iv) the Unaudited Condensed Consolidated Statements of Cash Flows, and (v) Notes to Unaudited Condensed Consolidated Financial Statements

Filed herewith

 

25

 

34SIGNATURES

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

Date: May 11, 2020

DIFFUSION PHARMACEUTICALS INC.

By:

/s/ David G. Kalergis

David G. Kalergis

Chairman and Chief Executive Officer

(Principal Executive Officer)

By:

/s/ William Hornung

William Hornung

Chief Financial Officer

(Principal Financial and Accounting Officer)

26