UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one) | ||
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☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 20212022
☐ | 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,300 East Main Street, Suite 200201
Charlottesville, VA 22902
(Address of principal executive offices, including zip code)
(434) 220-0718
(Registrant’s telephone number including area code)
Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered |
Common Stock, par value $0.001 per share | DFFN | The Nasdaq Capital Market |
Securities registered pursuant to Section 12(g) of the Act:
None
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 every Interactive Data File required to be submitted 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 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 ☒ | 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 May 7, 202111, 2022 was 101,903,9792,038,592 shares.
DIFFUSION PHARMACEUTICALS INC.
FORM 10-Q
MARCH 31, 20212022
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 |
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
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ITEM 4. CONTROLS AND PROCEDURES |
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PART II – OTHER INFORMATION |
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ITEM 1. LEGAL PROCEEDINGS | 20 |
ITEM 1A. RISK FACTORS |
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES |
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ITEM 4. MINE SAFETY DISCLOSURES |
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ITEM 5. OTHER INFORMATION |
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ITEM 6. EXHIBITS |
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Note Regarding Company References and Other Defined Terms1
Unless the context otherwise requires, in this Quarterly Report, (i) references to the “Company,” “we,” “our,” or “us” refer to Diffusion Pharmaceuticals Inc. and its subsidiaries and (ii) references to “common stock” refer to the common stock, par value $0.001 per share, of the Company. We have also used several other defined terms in this Quarterly Report, many of which are explained or defined below:
Term | Definition |
2015 Equity Plan | Diffusion Pharmaceuticals Inc. 2015 Equity Incentive Plan, as amended |
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401(k) Plan | Diffusion Pharmaceuticals Inc. 401(k) Defined Contribution Plan |
Altitude Trial | our Phase 1b clinical trial evaluating TSC in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or “simulated altitude” |
Annual Report | our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 16, 2021 |
ASC | Accounting Standard Codification of the FASB |
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CRO | contract research organization |
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DLCO | diffusion capacity of lung for carbon monoxide |
Exchange Act | Securities Exchange Act of 1934, as amended |
FASB | Financial Accounting Standards Board |
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G&A | general and administrative |
GAAP | U.S. generally accepted accounting principles |
GBM | glioblastoma multiforme brain cancer |
| our |
| interstitial lung disease |
ILD-DLCO Trial | our |
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Nasdaq | Nasdaq Stock Market, LLC |
Nasdaq Staff | the staff of the listing qualifications department of Nasdaq |
NOL | net operating loss |
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Planned |
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Quarterly Report | this Quarterly Report on Form 10-Q |
R&D | research and development |
Regulation S-K | Regulation S-K promulgated under the Securities Act |
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SEC | U.S. Securities and Exchange Commission |
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Series C Preferred Stock | the Company's previously outstanding Series C Convertible Preferred Stock, par value $0.001 per share |
Special Meeting | the special meeting of our stockholders held on April 18, 2022 |
TCOM | transcutaneous oxygen measurement |
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| our Phase 1b clinical trial evaluating the effects of TSC on peripheral tissue oxygenation in healthy normal volunteers using a TCOM device, completed in March 2021 |
TSC | trans sodium crocetinate |
U.S. | United States |
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Note Regarding Forward-Looking Statements
This Quarterly Report (including, for purposes of this Note Regarding Forward-Looking Statements, any information or documents incorporated herein by reference) includes express and implied forward-looking statements. 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 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, liquidity, and prospects may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition, liquidity, and prospects are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of actual results or reflect unanticipated developments in future periods.
Forward-looking statements appear in a number of places throughout this Quarterly Report . 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 also include statements regarding our intentions, beliefs, projections, outlook, analyses or expectations concerning, among other things:
the success and timing of our clinical and preclinical studies, including our ability to enroll subjects in our ongoing and planned clinical studies at anticipated rates;
our ability to obtain and maintain regulatory approval of our product candidates and, if approved, our products, including the labeling under any approval we may obtain;
our plans and ability to develop and commercialize our product candidates and the outcomes of our research and development activities;
the accuracy of our estimates of the size and characteristics of the potential markets for our product candidates, the rate and degree of market acceptance of any of our product candidates that may be approved in the future, and our ability to serve those markets;
the success of products that are or may become available which also target the potential markets for 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 and the potential for others to infringe upon our intellectual property rights;
our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
the performance of third parties, including contract research organizations, manufacturers, suppliers, and outside consultants, to whom we outsource certain operational, staff and other functions;
our ability to obtain additional financing in the future and continue as a going concern;
our estimates regarding expenses, future revenues, capital requirements, and needs for additional financing;
regulatory developments in the U.S., European Union, and other foreign jurisdictions;
recently enacted and future legislation related to the healthcare system, including trends towards managed care and healthcare cost containment, the impact of any significant spending reductions or cost controls affecting publicly funded or subsidized healthcare programs, or any replacement, repeal, modification, or invalidation of some or all of the provisions of the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act;
any significant breakdown, infiltration, or interruption of our information technology systems and infrastructure;
our ability to satisfy the continued listing requirements of the NASDAQ Capital Market or any other exchange on which our securities may trade in the future;
uncertainties related to general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic; and
other risks and uncertainties, including those discussed under the heading "Risk Factors" in our Annual Report and elsewhere in our other public filings.
• | the success and timing of our clinical and preclinical studies, including our ability to enroll subjects in our ongoing and planned clinical studies at anticipated rates and our ability to manufacture an adequate amount of drug supply for our studies; |
• | obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology; |
• | the performance of third parties, including contract research organizations, manufacturers, suppliers, and outside consultants, to whom we outsource certain operational, staff and other functions; |
• | our ability to obtain additional financing in the future and continue as a going concern; |
• | our ability to obtain and maintain regulatory approval of our product candidates and, if approved, our products, including the labeling under any approval we may obtain; |
• | our plans and ability to develop and commercialize our product candidates and the outcomes of our research and development activities; |
• | our estimates regarding expenses, future revenues, capital requirements, and needs for additional financing; |
• | 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, the rate and degree of market acceptance of any of our product candidates that may be approved in the future, and our ability to serve those markets; |
• | the success of products that are or may become available which also target the potential markets for our product candidates; |
• | our ability to operate our business without infringing the intellectual property rights of others and the potential for others to infringe upon our intellectual property rights; |
• | any significant breakdown, infiltration, or interruption of our information technology systems and infrastructure; |
• | recently enacted and future legislation related to the healthcare system, including trends towards managed care and healthcare cost containment, the impact of any significant spending reductions or cost controls affecting publicly funded or subsidized healthcare programs, or any replacement, repeal, modification, or invalidation of some or all of the provisions of the Affordable Care Act; |
• | other regulatory developments in the U.S., E.U., and other foreign jurisdictions; |
• | our ability to satisfy the continued listing requirements of the NASDAQ Capital Market or any other exchange on which our securities may trade in the future; |
• | uncertainties related to general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic, inflationary pressures, and geopolitical conflicts; and |
• | other risks and uncertainties, including those discussed under the heading "Risk Factors" in our Annual Report and elsewhere in our other public filings. |
As a result of these and other factors, known and unknown, actual results could differ materially from our intentions, beliefs, projections, outlook, analyses, or expectations expressed in any forward-looking statements in this Quarterly Report. Accordingly, we cannot assure you that the forward-looking statements contained or incorporated by reference in this Quarterly Report will prove to be accurate or that any such inaccuracy will not be material. You should also understand that it is not possible to predict or identify all such factors, and you should not consider any such list to be a complete set of all potential risks or uncertainties. In light of the foregoing and 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. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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 or by the rules and regulations of the SEC, 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 current and any prior period results are not intended to express any ongoing or future trends or indications of future performance, unless explicitly expressed as such, and should only be viewed as historical data.
Note Regarding Stock Splits
Unless the context otherwise requires, in this Quarterly Report, all share and per share amounts related to our common stock give effect to our 1-for-50 reverse stock split effective April 18, 2022.
Note Regarding Trademarks, Trade Names and Service Marks
This Quarterly Report contains the followingcertain trademarks, trade names, and service marks of ours, including “DIFFUSIO2N.” All other trade names, trademarks, and service marks appearing in this Quarterly Report are, to the knowledge of Diffusion, the property of their respective owners. To the extent any such terms appear without the trade name, trademark, or service mark notice, such presentation is for convenience only and should not be construed as being used in a descriptive or generic sense.
PART I – FINANCIAL INFORMATION
ITEM 1. | FINANCIAL STATEMENTS |
Diffusion Pharmaceuticals Inc.
Consolidated Balance Sheets
(unaudited)
March 31, 2021 | December 31, 2020 | March 31, 2022 | December 31, 2021 | |||||||||||||
Assets | ||||||||||||||||
Current assets: | ||||||||||||||||
Cash and cash equivalents | $ | 46,634,977 | $ | 18,515,595 | $ | 9,872,330 | $ | 37,313,558 | ||||||||
Marketable securities | 22,680,303 | 0 | ||||||||||||||
Prepaid expenses, deposits and other current assets | 678,693 | 260,825 | 1,021,496 | 510,015 | ||||||||||||
Total current assets | 47,313,670 | 18,776,420 | 33,574,129 | 37,823,573 | ||||||||||||
Property and equipment, net | 124,751 | 149,198 | ||||||||||||||
Intangible asset | 8,639,000 | 8,639,000 | ||||||||||||||
Right of use asset | 120,110 | 149,162 | ||||||||||||||
Other assets | 15,580 | 15,771 | 0 | 15,578 | ||||||||||||
Total assets | $ | 56,213,111 | $ | 27,729,551 | $ | 33,574,129 | $ | 37,839,151 | ||||||||
Liabilities and Stockholders’ Equity | ||||||||||||||||
Current liabilities: | ||||||||||||||||
Accounts payable | 952,909 | 545,844 | $ | 813,197 | $ | 947,495 | ||||||||||
Accrued expenses and other current liabilities | 1,048,904 | 1,776,470 | 2,142,633 | 1,980,189 | ||||||||||||
Current operating lease liability | 111,291 | 113,469 | ||||||||||||||
Total current liabilities | 2,113,104 | 2,435,783 | 2,955,830 | 2,927,684 | ||||||||||||
Deferred income taxes | 443,893 | 443,893 | ||||||||||||||
Noncurrent operating lease liability | 8,819 | 35,693 | ||||||||||||||
Total liabilities | 2,565,816 | 2,915,369 | ||||||||||||||
Commitments and Contingencies (Note 7) | ||||||||||||||||
Commitments and Contingencies (Note 9) | ||||||||||||||||
Stockholders’ Equity: | ||||||||||||||||
Common stock, $0.001 par value: | ||||||||||||||||
Common stock, $0.001 par value: 1,000,000,000 shares authorized: 101,903,979 and 64,015,441 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 101,904 | 64,016 | ||||||||||||||
Series C convertible preferred stock, $0.001 par value: 10,000 shares authorized; 10,000 and 0 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 5,000 | 0 | ||||||||||||||
Common stock, $0.001 par value: 1,000,000,000 shares authorized; 2,038,392 and 2,038,185 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 2,038 | 2,038 | ||||||||||||||
Additional paid-in capital | 164,098,694 | 130,659,550 | 165,192,671 | 164,914,540 | ||||||||||||
Accumulated other comprehensive loss | (49,658 | ) | 0 | |||||||||||||
Accumulated deficit | (110,553,303 | ) | (105,909,384 | ) | (134,531,752 | ) | (130,005,111 | ) | ||||||||
Total stockholders' equity | 53,647,295 | 24,814,182 | 30,618,299 | 34,911,467 | ||||||||||||
Total liabilities and stockholders' equity | $ | 56,213,111 | $ | 27,729,551 | $ | 33,574,129 | $ | 37,839,151 |
See accompanying notes to unaudited interim consolidated financial statements.
Diffusion Pharmaceuticals Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
Three Months Ended March 31, | Three Months Ended March 31, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 2,916,378 | $ | 1,534,467 | $ | 2,425,898 | $ | 2,916,378 | ||||||||
General and administrative | 1,743,510 | 1,393,808 | 2,128,552 | 1,743,510 | ||||||||||||
Depreciation | 24,447 | 27,020 | 0 | 24,447 | ||||||||||||
Loss from operations | 4,684,335 | 2,955,295 | 4,554,450 | 4,684,335 | ||||||||||||
Other income: | ||||||||||||||||
Interest income | (40,416 | ) | (34,100 | ) | (27,809 | ) | (40,416 | ) | ||||||||
Loss from operations before income tax benefit | (4,643,919 | ) | (2,921,195 | ) | ||||||||||||
Income tax benefit | — | (362,380 | ) | |||||||||||||
Net loss | $ | (4,643,919 | ) | $ | (2,558,815 | ) | $ | (4,526,641 | ) | $ | (4,643,919 | ) | ||||
Per share information: | ||||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (0.06 | ) | $ | (0.07 | ) | $ | (2.22 | ) | $ | (2.81 | ) | ||||
Weighted average shares outstanding, basic and diluted | 83,420,184 | 34,507,496 | 2,038,323 | 1,649,969 | ||||||||||||
Comprehensive loss: | ||||||||||||||||
Net loss | $ | (4,526,641 | ) | $ | (4,643,919 | ) | ||||||||||
Unrealized loss on marketable securities | (49,658 | ) | 0 | |||||||||||||
Comprehensive loss | $ | (4,576,299 | ) | $ | (4,643,919 | ) |
See accompanying notes to unaudited interim consolidated financial statements.
Diffusion Pharmaceuticals Inc.
Consolidated Statements of Changes in Stockholders' Equity
Three Months Ended March 31, 20202021 and 20212022
(unaudited)
Stockholders' Equity | Common Stock | Additional Paid-in | Accumulated | Total Stockholders' | ||||||||||||||||||||||||||||||||||||
Common Stock | Additional |
| Total | Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||||||||||||||||||
Shares | Amount | Paid-in Capital | Accumulated Deficit | Stockholders' Equity | ||||||||||||||||||||||||||||||||||||
Balance at January 1, 2020 | 33,480,365 | 33,481 | $ | 111,824,859 | $ | (91,724,078 | ) | 20,134,262 | ||||||||||||||||||||||||||||||||
Balance at January 1, 2021 | 1,280,207 | $ | 1,280 | $ | 130,722,286 | $ | (105,909,384 | ) | $ | 24,814,182 | ||||||||||||||||||||||||||||||
Sale of common stock | 673,171 | 673 | $ | 31,093,629 | 0 | 31,094,302 | ||||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants, net of issuance costs | 1,124,071 | 1,124 | 133,674 | — | 134,798 | 84,600 | 85 | 2,201,365 | 0 | 2,201,450 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | — | — | 191,380 | — | 191,380 | — | 0 | 181,280 | 0 | 181,280 | ||||||||||||||||||||||||||||||
Net loss | — | — | — | (2,747,809 | ) | (2,558,815 | ) | — | 0 | 0 | (4,643,919 | ) | (4,643,919 | ) | ||||||||||||||||||||||||||
Balance at March 31, 2020 | 34,604,436 | $ | 34,605 | $ | 112,149,913 | $ | (94,471,887 | ) | $ | 17,901,625 | ||||||||||||||||||||||||||||||
Balance at March 31, 2021 | 2,037,978 | $ | 2,038 | $ | 164,198,560 | $ | (110,553,303 | ) | $ | 53,647,295 |
Stockholders' Equity | ||||||||||||||||||||
Common Stock | Additional |
| Total | |||||||||||||||||
Shares | Amount | Paid-in Capital | Accumulated Deficit | Stockholders' Equity | ||||||||||||||||
Balance at January 1, 2021 | 64,015,441 | 64,016 | $ | 130,659,550 | $ | (105,909,384 | ) | $ | 24,814,182 | |||||||||||
Sale of common stock, net of issuance costs | 33,658,538 | 33,658 | 31,060,644 | — | 31,094,302 | |||||||||||||||
Issuance of common stock upon exercise of warrants | 4,230,000 | 4,230 | 2,197,220 | — | 2,201,450 | |||||||||||||||
Stock-based compensation expense | — | — | 181,280 | — | 181,280 | |||||||||||||||
Net loss | — | — | — | (4,643,919 | ) | (4,643,919 | ) | |||||||||||||
Balance at March 31, 2021 | 101,903,979 | $ | 101,904 | $ | 164,098,694 | $ | (110,553,303 | ) | $ | 53,647,295 |
Series C Convertible Preferred Stock | Common Stock | Additional Paid-in | Accumulated Other Comprehensive | Accumulated | Total Stockholders' | |||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Loss | Deficit | Equity | |||||||||||||||||||||||||
Balance at January 1, 2022 | 0 | $ | 0 | 2,038,185 | $ | 2,038 | $ | 164,914,540 | $ | 0 | $ | (130,005,111 | ) | $ | 34,911,467 | |||||||||||||||||
Sale of series C preferred stock to related parties | 10,000 | 5,000 | 0 | 0 | 0 | 0 | 0 | 5,000 | ||||||||||||||||||||||||
Stock-based compensation expense and vesting of restricted stock units | 0 | 0 | 207 | 0 | 278,131 | 0 | 0 | 278,131 | ||||||||||||||||||||||||
Unrealized loss on marketable securities | — | 0 | — | 0 | 0 | (49,658 | ) | 0 | (49,658 | ) | ||||||||||||||||||||||
Net loss | — | 0 | — | 0 | 0 | 0 | (4,526,641 | ) | (4,526,641 | ) | ||||||||||||||||||||||
Balance at March 31, 2022 | 10,000 | $ | 5,000 | 2,038,392 | $ | 2,038 | $ | 165,192,671 | $ | (49,658 | ) | $ | (134,531,752 | ) | $ | 30,618,299 |
See accompanying notes to unaudited interim consolidated financial statements.
Diffusion Pharmaceuticals Inc.
Consolidated Statements of Cash Flows
(unaudited)
Three Months Ended March 31, | Three Months Ended March 31, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Operating activities: | ||||||||||||||||
Net loss | $ | (4,643,919 | ) | $ | (2,558,815 | ) | $ | (4,526,641 | ) | $ | (4,643,919 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
Depreciation | 24,447 | 27,020 | 0 | 24,447 | ||||||||||||
Stock-based compensation expense | 181,280 | 191,380 | 278,131 | 181,280 | ||||||||||||
Change in deferred income taxes | — | (362,380 | ) | |||||||||||||
Amortization of premium and discount on marketable securities | (13,546 | ) | 0 | |||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||
Prepaid expenses, deposits and other assets | (417,677 | ) | (346,030 | ) | (495,903 | ) | (417,677 | ) | ||||||||
Accounts payable, accrued expenses and other liabilities | (320,501 | ) | (455,489 | ) | 28,146 | (320,501 | ) | |||||||||
Net cash used in operating activities | (5,176,370 | ) | (3,504,314 | ) | (4,729,813 | ) | (5,176,370 | ) | ||||||||
Cash flows used in investing activities: | ||||||||||||||||
Purchases of marketable securities | (22,716,415 | ) | 0 | |||||||||||||
Net cash used in investing activities | (22,716,415 | ) | 0 | |||||||||||||
Cash flows provided by financing activities: | ||||||||||||||||
Proceeds from the sale of common stock, net of issuance costs | 31,094,302 | — | 0 | 31,094,302 | ||||||||||||
Proceeds received from the exercise of common stock warrants | 2,201,450 | 393,425 | 0 | 2,201,450 | ||||||||||||
Payment of financing costs that were previously classified in accounts payable | — | (238,232 | ) | |||||||||||||
Proceeds from the sale of series C preferred stock to related parties | 5,000 | 0 | ||||||||||||||
Net cash provided by financing activities | 33,295,752 | 155,193 | 5,000 | 33,295,752 | ||||||||||||
Net increase (decrease) in cash and cash equivalents | 28,119,382 | (3,349,121 | ) | |||||||||||||
Cash and cash equivalents at beginning of period | 18,515,595 | 14,177,349 | ||||||||||||||
Net (decrease) increase in cash and cash equivalents | (27,441,228 | ) | 28,119,382 | |||||||||||||
Cash and cash equivalents at beginning of year | 37,313,558 | 18,515,595 | ||||||||||||||
Cash and cash equivalents at end of period | $ | 46,634,977 | $ | 10,828,228 | $ | 9,872,330 | $ | 46,634,977 | ||||||||
Supplemental disclosure of non-cash financing activities: | ||||||||||||||||
Offering costs in accounts payable and accrued expenses | $ | — | $ | 258,627 | ||||||||||||
Supplemental disclosure of non-cash activities: | ||||||||||||||||
Unrealized loss on marketable securities | $ | 49,658 | $ | 0 |
See accompanying notes to unaudited interim consolidated financial statements.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
1. | Organization and Description of Business |
Diffusion Pharmaceuticals Inc., a Delaware corporation, is an innovativea biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to the areas where it is needed most. The Company’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.conditions, including hypoxic tumors.
In additionOn April 18, 2022, the Company effected a 1-for-50 reverse split of its common stock. Any references in the unaudited condensed consolidated financial statements and related notes to TSC, the Company's product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR pathway inhibitor, is in early-stage development. The Company previously completed two Phase 1 clinical trials evaluating DFN-529 in age-related macular degeneration. DFN-529 was also previously in preclinical development in oncology, specifically GBMshare or per share amounts give retroactive effect to this reverse stock split.
2. | Liquidity |
The Company has not generated any revenues from product sales and has funded operations primarily from the proceeds of public and private offerings of equity, convertible debt 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 at all, or that the Company’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. The Company 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; consider other various strategic alternatives, including a merger or sale of the 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 such arrangements or if it entered into such arrangements at later stages in the product development process.
Operations of the Company are subject to certain risks and uncertainties including various internal and external factors that will affect whether and when the Company’s product candidates become approved drugs and how significant their market share will be, some of which are outside of the Company’s 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 expects that its existing cash, and cash equivalents and marketable securities as of March 31, 20212022 will enable it to fund its operating expenses and capital expenditure requirements including expected costs related tothrough 2023.
3. | Basis of Presentation and Summary of Significant Accounting Policies |
As of the planned TSC Oxygenation Trials anddate of this Quarterly Report, the Planned Hypoxia-related Indication Trials, through 2023.Summary of Significant Accounting Policies included in the Company's Annual Report have not materially changed, except as set forth below.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
|
|
The Summary of Significant Accounting Policies included in the Company's Annual Report for the year ended December 31, 2020 have not materially changed, except as set forth below.
Basis of Presentation
The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with GAAP for interim financial information as found in the ASC and ASUs of the FASB, and with the instructions to Form 10-Q10-Q and Article 10 of Regulation S-XS-X promulgated by the SEC. In the opinion of management, the accompanying unaudited interim 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 March 31, 2021,2022, and its results of operations and cash flows for the three months ended March 31, 20212022 and 2020.2021. Operating results for the three months ended March 31, 20212022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.2022. The unaudited interim consolidated financial statements presented herein do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited interim 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, 20202021 filed with the SEC as part of the Company's Annual Report on Form 10-K on March 16, 2021.Report.
Use of EstimateEstimates
The preparation of unaudited interim consolidated financial statements in conformity with GAAP requires managementthe Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenseexpenses during the reporting period. The COVID-19 pandemic had no material impact on
On an ongoing basis, the Company'sCompany evaluates its estimates using historical experience and other factors, including the current economic environment. Significant items subject to such estimates are assumptions used in the preparationfor purposes of the unaudited interim consolidated financial statementsdetermining stock-based compensation and accounting for the quarterly period ended March 31, 2021. However, the full extent to which the ongoing COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including sales, expenses, reserves and allowances, clinical studies, 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, governmental and business responsesactivities. Management believes its estimates to be reasonable under the pandemic, further actions taken to contain or treat COVID-19, the ongoing economic impact on local, regional, national and international markets, and the speed of the anticipated economic recovery. Due to the uncertainty of factors surrounding these estimates or judgments, actualcircumstances. Actual results may materially varycould differ significantly from those estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined. The Company's future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in material impacts to the consolidated financial statements in future reporting periods.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, including cash equivalents and accounts payable approximate fair value due to the short-term nature of those instruments.
Intangible AssetConcentration of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed federally insured limits.
Cash and Cash Equivalents
The Company's DFN-529 (formerly RES-529) intangible asset is assessedCompany considers any highly-liquid investments, such as money market funds and commercial paper with an original maturity of three months or less to be cash and cash equivalents.
Marketable securities
The Company classifies its marketable securities as available-for-sale, which include commercial paper and U.S. government debt securities with original maturities of greater than three months from date of purchase. The Company considers its marketable securities as available for impairment annuallyuse in current operations, and therefore classify these securities as current assets on October the consolidated balance sheet. These securities are carried at fair market value, with unrealized gains and losses reported in comprehensive loss and accumulated other comprehensive loss within stockholders’ equity. Gains or losses on marketable securities sold will be based on the specific identification method.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Reverse Stock Split
On April 18, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effect the Reverse Stock Split at a ratio of 1-to-50. NaN fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise would have been entitled to receive fractional shares of common stock are entitled to receive an amount in cash (without interest or deduction) equal to the fraction of one share to which such stockholder would otherwise be entitled multiplied by $12.93, representing the split-adjusted average closing price of the Company’s fiscal year or more frequently if impairment indicators exist. There was no impairmentcommon stock on the Nasdaq Capital Market for the five consecutive trading days immediately preceding the effective date of the Reverse Stock Split. Proportional adjustments were made to the Company’s DFN-529 intangible asset recognized duringoutstanding warrants, stock options and other equity securities and to the three months ended March 31, 20212015 Equity Plan to reflect the Reverse Stock Split, in each case, in accordance with the terms thereof. Unless the context otherwise requires, all share and 2020.per share amounts in this Quarterly Report have been adjusted to reflect the Reverse Stock Split.
Net Loss Per Common Share
Basic net loss per share is computed by dividing net loss attributable to common stockholders 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 of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities outstanding as of March 31,2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:
March 31, | ||||||||
2022 | 2021 | |||||||
Common stock warrants | 111,891 | 112,963 | ||||||
Stock options | 116,564 | 62,336 | ||||||
Unvested restricted stock awards | 5,182 | 3,060 | ||||||
233,637 | 178,359 |
Recently Adopted Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13,Financial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments (Topic 326). The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective for the Company as of January 1, 2023. The Company is currently evaluating the impact of this ASU but does not expect that adoption of this standard will have a material impact on the consolidated financial statements and related disclosures.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
4. | Cash, cash equivalents and marketable securities |
The following is a summary of the Company's cash and cash equivalents as of the date indicated:
March 31, 2022 | December 31, 2021 | |||||||
Cash in banking institutions | $ | 1,326,178 | $ | 30,308,075 | ||||
Money market funds | 5,046,607 | 7,005,483 | ||||||
Commercial paper | 3,499,545 | 0 | ||||||
Total | $ | 9,872,330 | $ | 37,313,558 |
The following is a summary of the Company's marketable securities as of March 31, 2022:
Amortized cost | Unrealized gains | Unrealized losses | Fair Value | |||||||||||||
Commercial paper | $ | 19,716,092 | $ | 0 | $ | (39,939 | ) | $ | 19,676,153 | |||||||
U.S. treasury bonds | 3,013,869 | 0 | (9,719 | ) | 3,004,150 | |||||||||||
Total | $ | 22,729,961 | $ | 0 | $ | (49,658 | ) | $ | 22,680,303 |
The Company did not have marketable securities as of December 31, 2021. The Company's marketable securities generally have contractual maturity dates between 3 and 12 months. Most of the Company’s marketable securities are in an unrealized loss position at March 31, 2022. Unrealized losses on marketable securities as of March 31, 2022 were not significant and were primarily due to changes in interest rates, and not due to increased credit risks associated with specific securities. Accordingly, 0 other-than-temporary impairment was recorded for the three months ended March 31, 2022 and there were 0 realized gains or losses recorded during the three months ended March 31, 2022.
5. | 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’s financial instruments, including prepaid expense and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The Company follows the provisions of FASB 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 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). |
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
The following potentially dilutive securities outstanding as of March 31, 2021 and 2020 have been excluded fromtable presents the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:Company’s assets that are measured at fair value on a recurring basis (amounts in thousands):
March 31, | ||||||||
2021 | 2020 | |||||||
Common stock warrants | 6,553,039 | 21,261,070 | ||||||
Stock options | 3,116,819 | 1,182,629 | ||||||
Unvested restricted stock awards | 153,000 | 98,100 | ||||||
9,822,858 | 22,541,799 |
Fair value measurement at reporting date | ||||||||||||
Quoted prices in active markets for identical assets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||
March 31, 2022: | ||||||||||||
Cash equivalents: | ||||||||||||
Money market funds | $ | 5,046,607 | $ | 0 | $ | 0 | ||||||
Commercial paper | 0 | 3,499,545 | 0 | |||||||||
Total cash and cash equivalents | $ | 5,046,607 | $ | 3,499,545 | $ | 0 | ||||||
Marketable securities: | ||||||||||||
Commercial paper | 0 | 19,676,153 | 0 | |||||||||
US treasury | 0 | 3,004,150 | 0 | |||||||||
Total marketable securities | $ | 0 | $ | 22,680,303 | $ | 0 | ||||||
Total financial assets | $ | 5,046,607 | $ | 26,179,848 | $ | 0 |
Recently Adopted Accounting Pronouncements
The fair value of the Company’s Level 2 marketable securities are estimated primarily based on benchmark yields, reported trades, market-based quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, and reference data including market research publications, which represent a market approach. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accountinggeneral, a market approach is utilized if there is readily available and relevant market activity for Income Taxes.an individual security. This guidance appliesvaluation technique may change from period to all entities and aims to reduce the complexity of tax accounting standards while enhancing reporting disclosures. This guidance is effective for fiscal years beginning after December 15, 2020 and interim periods therein. The Company adopted ASU No. 2019-12 in the first quarter of 2021 and the adoption did not have a material impactperiod, based on the Company's consolidated financial statements.relevance and availability of market data.
| Accrued Expenses and Other Current Liabilities |
March 31, 2021 | December 31, 2020 | |||||||
Accrued payroll and payroll related expenses | $ | 510,002 | $ | 653,899 | ||||
Accrued professional fees | 77,258 | 31,809 | ||||||
Accrued clinical studies expenses | 406,439 | 1,055,398 | ||||||
Other accrued expenses | 55,205 | 35,364 | ||||||
Total | $ | 1,048,904 | $ | 1,776,470 |
Accrued expenses and other current liabilities consisted of the following as of the dates indicated below:
March 31, 2022 | December 31, 2021 | |||||||
Accrued payroll and payroll related expenses | $ | 399,847 | $ | 879,971 | ||||
Accrued professional fees | 142,668 | 247,704 | ||||||
Accrued clinical studies expenses | 1,472,119 | 786,579 | ||||||
Other | 127,999 | 65,935 | ||||||
Total | $ | 2,142,633 | $ | 1,980,189 |
| Stockholders' Equity and Common Stock Warrants |
February 2021 CommonPrivate Placement of Series C Preferred Stock Offering
In February 2021, the Company completed the February 2021 Offering in which it offered and sold 33,658,538 shares of its common stock in an underwritten public offering for a purchase price to the public of $1.025 per share, inclusive of shares offered and sold pursuant to the underwriter's fully-exercised 30-day option to purchase additional shares. The February 2021 Offering resulted in aggregate net proceeds to the Company of $31.1 million, after deducting underwriting commissions, discounts, expenses and other offering costs. In addition, at the closings of the February 2021 Offering, On March 18, 2022, the Company issued and sold to designees of the underwriter of the transaction warrants to purchase up toRobert J. Cobuzzi, Jr., Ph.D., its President & Chief Executive Officer, and William R. Elder, its General Counsel & Corporate Secretary, an aggregate of 1,682,92710,000 shares of common stock. The underwriter warrants haveSeries C Preferred Stock at an exerciseoffering price of $1.28125$0.50 per share, and a termrepresenting 100% of five years from the datestated value per share of issuance.the Series C Preferred Stock, for aggregate gross proceeds of $5,000.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
The Series C Certificate provides that, among other things, (i) each share of Series C Preferred Stock is convertible into 0.02 shares of the Company's common stock, representing a conversion price of $25.00 per share, subject to certain conditions, (ii) each share of Series C Preferred Stock outstanding is counted on an as converted basis, together with the Company’s common stock as a single class, for purposes of determining the presence of a quorum at any meeting at which holders are asked to vote on matters related to the Reverse Stock Split (subject to any applicable exchange listing rules), (iii) each share of Series C Preferred Stock outstanding has the right to cast 1,600 votes per share of Series C Preferred Stock on the Reverse Stock Split on a “mirrored” basis — this means that the holders of the Series C Preferred Stock are required to vote their shares in a manner that “mirrors” the proportions of “For” and “Against” votes cast by the holders of the Company’s common stock are voted on the Amendment (excluding, for the avoidance of doubt, any shares of common stock that are not voted), and (iv) the holders of outstanding shares of Series C Preferred Stock are entitled to dividends, on an as converted basis, equal to dividends actually paid, if any, on shares of common stock and participate in any liquidation of the Company on an as converted basis.
On April 18, 2022, following approval of the Reverse Stock Split by the Company's stockholders, all 10,000 shares of Series C Preferred Stock were converted into an aggregate of 200 shares of the Company's common stock in accordance with the terms of the Series C Certificate.
Common Stock Warrants
During its evaluation of equity classification for the Company's common stock warrants issued in previous periods, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity. The conditions within ASC 815-40 are not subject to a probability assessment. The warrants do not fall under the liability criteria within ASC 480Distinguishing Liabilities from Equity as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding.
As of March 31, 2021,2022, the Company had the following warrants outstanding to acquire shares of its common stock outstanding:stock:
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 January 2018 Offering | 1,181,421 | $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 | 267,140 | $0.35 | May 2021 and November 2024 | ||||||
Common stock warrants issued related to the December 2019 Offering | 313,339 | $0.4335 | - | $0.6981 | December 2024 and June 2025 | ||||
Common stock warrants issued related to the May 2020 Offering | 571,429 | $1.31 | March 2025 | ||||||
Common stock warrants issued related to the May 2020 Investor Warrant Exercise | 250,000 | $0.5938 | November 2025 | ||||||
Common stock warrants issued related to the February 2021 Offering | 1,682,927 | $1.28 | February 2026 | ||||||
6,553,039 |
Outstanding | Range of exercise price per share | Expiration dates | |||||||||
Common stock warrants issued related to the January 2018 common stock offering | 23,639 | $599.71 | - | $749.76 | January 2023 | ||||||
Common stock warrants issued related to the May 2019 common stock offering | 27,648 | $250.09 | - | $306.04 | May and December 2024 | ||||||
Common stock warrants issued related to the November 2019 common stock offering | 4,269 | $17.51 | May 2024 | ||||||||
Common stock warrants issued related to the December 2019 common stock offering | 6,264 | $21.68 | - | $34.92 | December 2024 and June 2025 | ||||||
Common stock warrants issued related to the May 2020 common stock offering | 11,424 | $65.65 | March 2025 | ||||||||
Common stock warrants issued related to the May 2020 investor warrant exercise | 4,998 | $29.7 | November 2025 | ||||||||
Common stock warrants issued related to the February 2021 common stock offering | 33,649 | $64.08 | February 2026 | ||||||||
111,891 |
During the three months ended March 31, 2021, no2022, 18,077 warrants expired, and warrants were exercised by multiple holders to purchase a total of 4,230,000 shares of the Company's common stock for aggregate proceeds of approximately $2.2 million.expired.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
| Stock-Based Compensation |
2015 Equity Plan
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’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 board of directors. Accordingly, 2,560,61881,531 shares were added to the reserve as of January 1, 2021, 2022, 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 March 31, 2021, 2022, there were 1,229,00549,039 shares available for future issuance under the 2015 Equity Plan.
The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim consolidated statements of operations for the periods indicated:
Three Months Ended March 31, | Three Months Ended March 31, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Research and development | $ | 33,000 | $ | 96,530 | $ | 58,892 | $ | 33,000 | ||||||||
General and administrative | 148,280 | 94,850 | 219,239 | 148,280 | ||||||||||||
Total stock-based compensation expense | $ | 181,280 | $ | 191,380 | $ | 278,131 | $ | 181,280 |
The following table summarizes the activity related to all stock option grants for the three months ended March 31,2022:
Number of Options | Weighted average exercise price per share | Weighted average remaining contractual life (in years) | Aggregate intrinsic value | |||||||||||||
Balance at January 1, 2022 | 72,454 | $ | 265.85 | |||||||||||||
Granted | 48,300 | 12.00 | ||||||||||||||
Cancelled/forfeited | (4,190 | ) | 75.33 | |||||||||||||
Outstanding at March 31, 2022 | 116,564 | $ | 164.31 | 8.89 | $ | 23,163 | ||||||||||
Exercisable at March 31, 2022 | 52,849 | $ | 346.79 | 8.13 | $ | 1,956 | ||||||||||
Vested and expected to vest at March 31, 2022 | 116,564 | $ | 164.31 | 8.89 | $ | 23,163 |
The weighted average grant date fair value of stock option awards granted was $10.90 during the three months ended March 31, 2022. The total fair value of options vested during the three months ended March 31, 2022 and 2021 was $0.3 million and $0.2 million, respectively. NaN options were exercised during any of the periods presented. At March 31,2022, there was $1.3 million of unrecognized compensation expense that will be recognized over a weighted-average period of 1.97 years.
Options granted were valued using the Black-Scholes-Merton derivative instrument pricing model and assumptions used to value the options granted during the three months ended March 31, 2022 were as follows:
Expected term (in years) | 5.7 | |||
Risk-free interest rate | 1.7 | % | ||
Expected volatility | 134.7 | % | ||
Dividend yield | — |
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
The following table summarizes the activity related to all stock option grants for the three months ended March 31, 2021:
Number of Options | Weighted average exercise price per share | Weighted average remaining contractual life (in years) | Aggregate intrinsic value | |||||||||||||
Balance at January 1, 2021 | 2,240,204 | $ | 8.28 | |||||||||||||
Granted | 876,615 | 1.11 | ||||||||||||||
Outstanding at March 31, 2021 | 3,116,819 | $ | 6.26 | 9.01 | $ | 475,258 | ||||||||||
Exercisable at March 31, 2021 | 1,363,373 | $ | 13.10 | 8.25 | $ | 331,618 | ||||||||||
Vested and expected to vest at March 31, 2021 | 3,116,819 | $ | 6.26 | 9.01 | $ | 475,258 |
The weighted average grant date fair value of stock option awards granted was $1.06 during the three months ended March 31, 2021. The total fair value of options vested during the three months ended March 31, 2021 and 2020 was $0.2 million and $0.2 million, respectively. No options were exercised during any of the periods presented. At March 31, 2021, there was $1.4 million of unrecognized compensation expense that will be recognized over a weighted-average period of 2.29 years. During the three months ended March 31, 2021, the Company granted 385,267 performance-based stock options with an exercise price of $1.11 per share, subject to vesting based on the satisfaction of specified performance criteria. Compensation expense for the performance-based awards is recorded over the estimated service period for each milestone when the performance conditions are deemed probable of achievement. The Company recorded stock-based compensation expense of approximately $27,000 during the three months ended March 31, 2021, for service-based awards and performance conditions deemed probable of achievement and/or achieved. For performance-based awards containing performance conditions which were not deemed probable of achievement at March 31, 2021, no stock compensation expense was recognized.
Options granted were valued using the Black-Scholes-Merton derivative investment instrument pricing model and assumptions used to value the options granted during the three months ended March 31, 2021 were as follows:
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Restricted Stock Unit Awards
During the year ended December 31, 2020, theThe Company granted 153,000issues restricted stock units ("RSU") to variousnewly elected, non-executive members of the board of directors of the Company. The shares begin tothat vest in six, tri-monthly installments beginning 18 months after the respective grant date. The fair value of a RSU is equal to the fair market value price of the Company’s common stock on the date none of which havegrant. RSU expense is recorded on a straight-line basis over the service period.
The following table summarizes activity related to RSU awards during the period indicated:
Number of Units | Weighted average grant date fair value | |||||||
Balance at January 1, 2022 | 5,509 | $ | 34.78 | |||||
Vested (1) | (327 | ) | 25.50 | |||||
Outstanding at March 31, 2022 | 5,182 | $ | 35.36 |
(1) The RSUs vested as of during the three months ended March 31, 2021. 2022 were settled on a hybrid basis. The Company withheld 120 shares of common stock and, in lieu of delivering such shares, paid the RSU holder an amount in cash equal to the fair market value of such shares on vesting date, representing the holder's approximate tax liability associated with such vesting amount in cash equal to the fair market value of such shares on vesting date, representing the holder's approximate tax liability associated with such vesting.
The Company recognized approximately $16,000 and $5,000 in expense related to these awards during the three months ended March 31, 2021. At 2022 and March 31, 2021, respectively. At March 31,2022,there was approximately $77,000$0.1 million of unrecognized compensation cost that will be recognized over a weighted average period of 2.191.90 years.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
| Commitments and Contingencies |
Office Space Lease Commitment
The Company has a non-cancelable operating lease for office and laboratoryshort term agreements to utilize membership-based co-working space in both Charlottesville, Virginia which began in April 2017 and as of March 31, 2021, has a remaining lease term of approximately 1.1 years. The discount rate used to account for the Company's operating lease is the Company’s estimated incremental borrowing rate of 10.0%. The original term of the lease ends in the second quarter of 2022 and the Company has an option to extend for another 5 years. This option to extend was not recognized as part of the Company's measurement of the right-of-use asset and operating lease liability as of March 31, 2021.
Philadelphia, Pennsylvania. Rent expense related to the Company's operating leaseshort-term agreements was approximately $31,000$9,000 and $30,000$31,000 for the three months ended March 31, 20212022 and 2020,2021, respectively. Future minimum rental payments under the Company's non-cancelable operating lease at was as follows as of March 31, 2021:
Rental Commitments | ||||
2021 (remaining) | 89,232 | |||
2022 | 39,735 | |||
Total | 128,967 | |||
Less: imputed interest | (8,857 | ) | ||
Current and noncurrent operating lease liability | $ | 120,110 |
Research and Development Arrangements
In the course of normal business operations, the Company enters into agreements with universities and CROs to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs 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 cash.
Defined Contribution Retirement Plan
The Company has established its 401(k)401(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k)401(k) Plan up to 90.00%90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4.0%4% of the participant’s compensation. The Company made matching contributions under the 401(k)401(k) Plan of approximately $16,000$27,000 and $17,000$16,000 for the three months ended March 31, 2021 2022 and 2020,2021, respectively.
Legal Proceedings
On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company'sCompany’s legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996)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 related hearing for the petition and motion on April 14, 2015, the Courtcourt 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. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the Courtcourt found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020. In August 2020but later postponed due to the ongoing COVID-19COVID-19 pandemic and related restrictions on gatherings in the State of California,California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration hearingin connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was postponedheld on February 23, 2022 at which a trial date of May 24, 2023 was set, and the parties have agreed to August 16, 2021. stipulate to mediation in advance of the trial.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
The Company believes the claims in this matter isare without merit and intends to defend the arbitrationitself vigorously. However, at this stage, the Company is unable to predict itsthe 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.position, results of operations and cash flows.
10. | Subsequent Events |
Special Meeting, Series C Preferred Stock Conversion, Charter Amendment, and Reverse Stock Split
On April 18, 2022, at the Special Meeting, the Company's stockholders approved an amendment to the Company’s certificate of incorporation, as amended, to effect a reverse stock split of the Company’s outstanding shares of common stock by a ratio of any whole number between 1-for-2 and 1-for-50, at any time prior to December 31, 2022, the implementation and timing thereof subject to the discretion of the Company’s board of directors.
Following the completion of the Special Meeting, in accordance with Section 8(a) of the Series C Certificate, the Company delivered to the holders of the Series C Preferred Stock written notice of the Company’s intent to implement the Reverse Stock Split and the Mandatory Conversion (as defined in the Series C Certificate) of all 10,000 shares of Series C Preferred Stock outstanding into an aggregate of 200 shares of the Company’s common stock.
As described in further detail above under, Note 3. Basis of Presentation and Summary of Significant Accounting Policies, on April 18, 2022, following the completion of the Special Meeting and the Series C Preferred Stock conversion, the Company implemented the Reverse Stock Split at a ratio of 1-for-50 and beginning with the opening of trading on April 19, 2022, the Company’s common stock was available for trading on the Nasdaq Capital Market on a Reverse Stock Split adjusted basis.
Nasdaq Bid Price Requirement Compliance
On May 3, 2022, the Company received a written notice from the Nasdaq Staff confirming that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed above $1.00 per share for the previous ten (10) consecutive business days ending May 2, 2022. As previously reported, on May 6, 2021, the Company received a written notice from the Nasdaq Staff indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business day. The May 3, 2022 letter confirmed this matter is now closed.
ITEM 2. | MANAGEMENT’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 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-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-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, 2020.Annual Report. These risks could cause our actual results to differ materially from any future performance suggested below.
Diffusion Pharmaceuticals: Enhancing Oxygen, Fueling Life
We are an innovativea biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to the areas where it is needed most. Our lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. In addition to TSC, our product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR pathway inhibitor, is in early-stage development.
Highlights from the First Quarter of 2021
2022
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| Expanded Scientific Advisory Board – On February |
Business Update
In the first quarter of 2022, we continued to advance the development of TSC for the treatment of hypoxia and as a platform to enhance standard-of-care treatment for conditions complicated by hypoxia with a particular near-term focus on hypoxic solid tumors.
As of the date of the Quarterly Report, TSC has been administered to more than 220 subjects across 11 clinical trials. Data from these clinical trials support our understanding of the safety, tolerability, pharmacokinetics and pharmacodynamic effects of TSC. Evidence of clinical effect with TSC was reported from a Phase 2 clinical study conducted in patients with PAD with claudication. In addition, post hoc analyses of two prior studies involving patients with COVID-19 and unresected GBM tumors have provided preliminary evidence of TSC’s potential. Although the results small Phase 2 studies were not statistically significant, we believe the results were compelling and subsequent analyses helped identify certain data gaps that have been focus of recent development, including the relationship between TSC dose and oxygenation.
During 2021, to address these identified gaps in our TSC knowledge base, and guide the future of our TSC development program, we designed and executed on our Oxygenation Trials. The Oxygenation Trials are a series of three short-term, clinical studies designed to provide clinical evidence of the relationship between TSC dose and the effects on oxygenation, each specifically tailored to evaluate the effects of TSC on a different component of the oxygen delivery pathway. We completed the first of these studies, the TCOM Trial, in March 2021. The first participants in the second Oxygenation Trial, the Altitude Trial, were dosed in November 2021 and on April 11, 2022, we announced the completion of dosing for the final participant in the study. Topline data from the Altitude Trial are expected to be available in June 2022. In December 2021 we announced the dosing of the first patients in the final Oxygenation Trial, the ILD-DLCO Trial. We currently expect to complete dosing in this study in the second half of 2022 and to report top line results within two months of study completion.
The extensive preclinical and clinical data regarding TSC Development Updateobtained to date, including data recently obtained from our Oxygenation Trials and our COVID-19 Trial completed in February 2021, provide significant information related to TSC’s effects on oxygenation, dose response characteristics, pharmacokinetics, and pharmacodynamics. In November 2021, based on the available data and the significant unmet medical need, we announced our intention to focus the next steps in our efforts to develop TSC as an adjunct to standard of care therapy for hypoxic solid tumors. We believe the aforementioned collection of information will allow us to be more efficient and increase our likelihood of success, compared to the Company’s past efforts to develop TSC as a cancer treatment, which were terminated in 2019 due to financial constraints.
In November 2020, weDuring the first quarter of 2022 continued to work with our advisors including our new Scientific Advisory Board members announced plans to modifyin February 2022, on the TSC development programdesign of the Hypoxic Solid Tumor Program including the preliminary design of our Planned Phase 2 Hypoxic Tumor Trial protocol and updating our oncology-related IND previously filed with the intent of accomplishing two principal strategic objectives: 1) Optimize the clinical dose and dosing frequency for TSC; and 2) Evaluate TSC in clinical models designed to establish proof of concept for improvement in oxygenation. Given the totality of available data, including clinical data from the more than 200 subjects included in our TSC clinical studies to-date, we have initiated a plan to execute three, short-term TSC Oxygenation Trials during 2021, to be conducted in the U.S. and funded with cash-on-hand, to explore the relationship between TSC dose and change in oxygenation. FDA.
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The first of the three Oxygenation Trials was the TSC TCOM Trial, for which the treatment of study participants was both commenced and completed dosing in March 2021. The transcutaneous oxygen monitoring, device directly measures the release of oxygen from the blood vessels through the skin and is commonly usedWe currently expect to predict the likelihood of wound healing, the potential for success with hyperbaric therapy, and to map the appropriate location for limb amputation. The study was a double-blind, randomized, placebo-controlled study in healthy volunteers breathing 100% oxygen designed to test single, ascending doses of TSC in an attempt to establish the dose-response relationship between TSC and enhanced oxygen delivery. Thirty healthy volunteers were enrolled and randomized into one of six subgroups with each subject receiving supplemental oxygen and a single intravenous dose of placebo or one of five different doses of TSC ranging from 0.5 mg/kg to 2.5 mg/kg in a before/after design. The study was designed and statistically powered to evaluate the pharmacodynamic effects of TSC on peripheral tissue oxygenation. We anticipate data collection and analyses from the TSC TCOMcommence our Planned Phase 2 Hypoxic Tumor Trial will be completed and topline data will be announced by the end of the second quarter of 2021. Dosing data from the TSC TCOM Trial will also be used to guide dose selection for the TSC Induced Hypoxia Trial and TSC DLCO Trial.
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The second TSC Oxygenation Trial is our planned TSC Induced Hypoxia Trial, which will evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions. The TSC Induced Hypoxia Trial is expected to be a double-blind, randomized, placebo-controlled study, and primary endpoints in the study will be change from baseline in VO2 and PaO2 after receiving a single intravenous dose of TSC. The study will be statistically powered to evaluate the difference in effect of TSC versus placebo on oxygen availability and consumption. We anticipate this study will be initiated and completed in the second half of 2021, with topline results available within two months2022, subject to FDA feedback and the availability of study completion.clinical drug supply.
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The third TSC Oxygenation Trial is our planned TSC DLCO Trial, which will evaluate the effectsIn parallel, we continue to undertake preclinical studies and other opportunities to obtain additional data designed to demonstrate TSC’s potential uses in a broad spectrum of TSC on the diffusion of carbon monoxide through the lungs, also known as DLCO, in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal. DLCO testing is commonly performed as part of standard pulmonary function testing and aids in the diagnosis or dyspnea, also known as shortness of breath,non-cancer indications, as well as our work to track improvement or progression over time on prescribed treatments. DLCO provides a surrogate measurefurther improve the TSC manufacturing process and support the continued and support the continued availability of oxygen transfer efficiency, or uptake,high-quality drug product.
Finally, we believe we can leverage what we have learned from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells. The TSC DLCO Trial is expected to be a double-blind, randomized, placebo-controlled study which will test varied dosesdevelopment of TSC in an attemptand the significant skills and experience of our team to establish the exposure-response relationship betweenopportunistically identify and acquire or in-license novel product candidates that complement TSC and oxygen transfer efficiency. The study will be statistically powered to evaluate the difference in effect of TSC versus placebo on improvement in DLCO.our overall strategy. We anticipate this study will be initiatedalso believe diversifying our asset portfolio through and completed in the second half of 2021, with topline results available within two months of study completion.acquisition or in-license would reduce our Company’s overall risk profile as an investment.
We believe positive data from any one or more of the three Oxygenation Trials would provide evidence of a definitive effect of TSC on oxygenation. If such positive data are obtained from one or more of the Oxygenation Trials, we expect to announce in the fourth quarter of 2021 the identity of up to two hypoxia-related indications in which TSC would be studied as part of our clinical development strategy aimed at supporting regulatory approval and commercialization of TSC. The plan would be to initiate the identified clinical studies in the first quarter of 2022.
Financial Summary
As of March 31, 2021,2022, we had cash, and cash equivalents and marketable securities of $46.6 million.$32.6 million, in the aggregate. We have incurred operating losses since inception, have not generated any product sales revenue and have not achieved profitable operations. We incurred a net loss of $4.6$4.5 million for the three months ended March 31, 2021.2022. Our accumulated deficit as of March 31, 20212022 was $110.6$134.5 million, and we expect to continue to incur substantial losses in future periods. We also anticipate that our operating expenses will increase substantially as we continue to advance the development of TSC, including any costs related to:
our ongoing and planned clinical trials, including the ongoing and planned TSC Oxygenation Trials and our Planned Hypoxia-related Indication Trials;
any additional studies we may undertake, including other preclinical and clinical studies to support the filing of any new drug application with the U.S. Food and Drug Administration;
other research, development, and manufacturing activities designed to develop and optimize formulation, manufacturing processes, dosage, dose forms, and other characteristics prior to regulatory approval;
the maintenance, expansion, and protection our global intellectual property portfolio;
the hiring of additional clinical, manufacturing, scientific, sales, or other personnel; and
investments in operational, financial, and management information systems.
• | our ongoing and planned clinical trials, including our Planned Phase 2 Hypoxic Tumor Trial; |
• | any additional studies we may undertake, including other preclinical and clinical studies to support the filing of any new drug application with the FDA; |
• | other research, development, and manufacturing activities designed to develop and optimize formulation, manufacturing processes, dosage, dose forms, and other characteristics prior to regulatory approval; |
• | the maintenance, expansion, and protection our global intellectual property portfolio; |
• | the hiring of additional clinical, manufacturing, scientific, sales, or other personnel; and |
• | investments in operational, financial, and management information systems. |
We currently intend to use our existing cash, and cash equivalents and marketable securities for working capital and to fund the research and development of TSC, including the TSC TCOM Trial, the TSC VO2 Trial, and the TSC DLCO Trial.TSC. We expect that our cash, and cash equivalents and marketable securities as of March 31, 20212022 will enable us to fund our operating expenses and capital expenditure requirements including expected costs related to the planned TSC Oxygenation Trials and our Planned Hypoxia-related Indication Trials through 2023.
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
R&D expenses include, but are not limited to, third-party CRO arrangements and employee-related expenses, including salaries, benefits, stock-based compensation, and travel expense reimbursement. R&D 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 studies. As we advance our product candidates, we expect the amount of R&D costs will continue to increase for the foreseeable future. R&D costs are charged to expense as incurred.
General and Administrative Expense
G&A expenses consist principally of salaries and related costs for executive and other personnel, including stock-based compensation, other employee benefit costs, expenses associated with investment bank and other financial advisory services, and travel expenses. Other G&A expenses include, facility-related costs, communication expenses and professional fees for legal, patent prosecution and maintenance, consulting, accounting, and other professional services.
Interest Income
Interest income is interest earned from our cash, cash equivalents and cash equivalents.marketable securities.
Income Tax Benefit
Prior to 2021, we recognized income tax benefit to utilize indefinite deferred tax liabilities as a source of income against indefinite lived portions of our deferred tax assets. As of December 31, 2020, we recognized the full income tax benefit allowed by the 2017 Tax Act to utilize indefinite deferred tax liabilities as a source of income against indefinite lived portions of our deferred tax assets. Our NOLs and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of a greater than 50.0% cumulative change in the ownership interest of significant stockholders over a three year period, as defined under Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. These limitations may, in certain cases, limit the amount of income tax benefit that can be utilized annually to offset taxable income or tax liabilities in future periods. The amount of the annual limitation is determined based on the Company’s value immediately prior to the ownership change, and subsequent ownership changes may further affect the limitation in future years. In 2019, due to the significant changes to our stockholder base as a result of the equity financing we complete during that year, we performed an analysis under Section 382 of the Internal Revenue Code and, as a result, reduced the magnitude of our NOL carryforwards to account for the ownership changes. In addition, the cumulative benefit of our NOLs was remeasured, resulting in tax expense recognized during the year ended December 31, 2019. We have not yet performed an analysis to determine whether or not ownership changes that have occurred in year ended December 31, 2020 or during the three months ended March 31, 2021 give rise to any further limitations.
Results of Operations for Three Months Ended March 31, 20212022 Compared to Three Months Ended March 31, 20202021
The following table sets forth our results of operations for the three months ended March 31, 2021,2022, and 2020.2021.
Three Months Ended March 31, | Three Months Ended March 31, | |||||||||||||||||||||||
2021 | 2020 | Change | 2022 | 2021 | Change | |||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ | 2,916,378 | $ | 1,534,467 | $ | 1,381,911 | $ | 2,425,898 | $ | 2,916,378 | $ | (490,480 | ) | |||||||||||
General and administrative | 1,743,510 | 1,393,808 | 349,702 | 2,128,552 | 1,743,510 | 385,042 | ||||||||||||||||||
Depreciation | 24,447 | 27,020 | (2,573 | ) | — | 24,447 | (24,447 | ) | ||||||||||||||||
Loss from operations | 4,684,335 | 2,955,295 | 1,729,040 | 4,554,450 | 4,684,335 | (129,885 | ) | |||||||||||||||||
Other income: | ||||||||||||||||||||||||
Interest income | (40,416 | ) | (34,100 | ) | (6,316 | ) | (27,809 | ) | (40,416 | ) | 12,607 | |||||||||||||
Loss from operations before income tax benefit | (4,643,919 | ) | (2,921,195 | ) | (1,722,724 | ) | ||||||||||||||||||
Income tax benefit | — | (362,380 | ) | 362,380 | ||||||||||||||||||||
Net loss | $ | (4,643,919 | ) | $ | (2,558,815 | ) | $ | (2,085,104 | ) | $ | (4,526,641 | ) | $ | (4,643,919 | ) | $ | 117,278 |
We recognized $2.9$2.4 million in research and development expenses during the three months ended March 31, 20212022 compared to $1.5$2.9 million during the three months ended March 31, 2020.2021. A significant portion of this increasedecrease was attributable to the $0.7 milliontiming of costs incurred related to our TSC COVID Trial, which was initiatedclinical trials and drug manufacturing, offset by an increase in September 2020, and $0.6 million of costs incurred related to our TSC TCOM trial, which was initiated in March 2021. Manufacturing costs also increased by $0.5 million to support these trials. Additionally, salaries and wages increased by $0.2 million. These increases were slightly offset by decreases of $0.5 million and $0.1 millionstock-based compensation related to the wind-down of our TSC Stroke Trial and our TSC GBM Trial, respectively.increased headcount.
General and administrative expenses increased by $0.3$0.4 million during the three months ended March 31, 20212022 compared to the three months ended March 31, 2020,2021, mainly due to an increase in salaries and wages and stock-based compensation and professional fees, including additional amounts related to increased headcount as well as an increase in outside professional fees.
The decrease in depreciation for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 is related to the disposal of property and costs associated withequipment during the separation of former executives that will not recur in future years.year-ended December 31, 2021.
The increasedecrease in interest income for the three months ended March 31, 20212022 compared to the three months ended March 31, 20202021 is primarily attributable to having a largerlower interest earned on cash and cash equivalents balance earning more interestinvestments during the three months ended March 31, 20212022 compared to the three months ended March 31, 2020.2021.
During the three months ended March 31, 2020, we recognized income tax benefit of $0.4 million during the three months ended March 31, 2020, to reflect the utilization of indefinite deferred tax liabilities as a source of income against indefinite lived portions of the our deferred tax assets. Prior to 2021, we recognized the full income tax benefit allowed by the 2017 Tax Act to utilize indefinite deferred tax liabilities as a source of income against indefinite lived portions of our deferred tax assets. No additional benefit was recognized during the three months ended March 31, 2021 as the benefit was fully realized in prior periods.
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. As of March 31, 2021,2022, we had $46.6$9.9 million in cash and cash equivalents, $22.7 million in marketable securities, working capital of $45.2$30.6 million and an accumulated deficit of $110.6$134.5 million. We expect to continue to incur net losses for the foreseeable future. We intend to use our existing cash, and cash equivalents and marketable securities 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 three months ended March 31, 20212022 and 2020:2021:
Three Months Ended March 31, | Three Months Ended March 31, | |||||||||||||||
Net cash (used in) provided by: | 2021 | 2020 | 2022 | 2021 | ||||||||||||
Operating activities | $ | (5,176,370 | ) | $ | (3,504,314 | ) | $ | (4,729,813 | ) | $ | (5,176,370 | ) | ||||
Investing activities | (22,716,415 | ) | — | |||||||||||||
Financing activities | 33,295,752 | 155,193 | 5,000 | 33,295,752 | ||||||||||||
Net increase (decrease) in cash and cash equivalents | $ | 28,119,382 | $ | (3,349,121 | ) | |||||||||||
Net (decrease) increase in cash and cash equivalents | $ | (27,441,228 | ) | $ | 28,119,382 |
Operating Activities
Net cash used in operating activities of $4.7 million during the three months ended March 31, 2022 was primarily attributable to our net loss of $4.5 million and our net change in operating assets and liabilities of $0.5 million. This amount was offset by $0.3 million in stock-based compensation expense. The net change in our operating assets and liabilities is primarily attributable to an increase in our prepaid expenses, deposits and other current assets.
Net cash used in operating activities of $5.2 million during the three months ended March 31, 2021 was primarily attributable to our net loss of $4.6 million and our net change in operating assets and liabilities of $0.7 million. This amount was offset by $0.2 million in stock-based compensation expense and depreciation expense. The net change in our operating assets and liabilities is primarily attributable to a decrease in our accrued expenses and other current liabilities due to the timing of our payments to our vendors and employees as well as an increase in our prepaid expenses, deposits and other current assets.
Net cash usedInvesting Activities
During the three months ended March 31, 2022, we purchased $22.7 million in operatingmarketable securities with cash. There were no investing activities of $3.5 million during the three months ended March 31, 2020 was primarily attributable to our net loss of $2.6 million, our net change in operating assets and liabilities of $0.8 million and our change in deferred income taxes of $0.4 million. This amount was offset by $0.2 million in stock-based compensation expense and depreciation expense. The net change in our operating assets and liabilities is primarily attributable to a decrease in our accounts payable and accrued expenses due to the timing of our payments to our vendors and employees as well as an increase in our prepaid expenses, deposits and other current assets.2021.
Financing Activities
Net cash provided by financing activities was $5,000 during the three months ended March 31, 2022, attributable to proceeds received from the sale of our Series C Convertible Preferred Stock.
Net cash provided by financing activities was $33.3 million during the three months ended March 31, 2021, which was attributable to net proceeds of $31.1 million received from the sale of our common stock and $2.2 million in proceeds received from the exercise of common stock warrants.
Net cash provided by financing activities was $0.2 million during the three months ended March 31, 2020, which was attributable to the $0.4 million in proceeds received from the exercise of common stock warrants, offset by approximately $0.2 million in payments for offering costs.
Capital Requirements
We currently expect to continue to incur substantial expenses and generate significant operating losses as we continue to pursue our business strategy of developing TSC. Our operations have consumed substantial amounts of cash since inception and we currently expect to continue to spend substantial amounts of cash to advance the clinical development of TSC DFN-529, and ourany other product candidates.candidates we may in-license or acquire in the future. As of the date of this AnnualQuarterly Report, most of our cash resources for clinical development are dedicated to our ongoing and planned TSC Oxygenation Trials and our Planned Hypoxia-related Indication Trials.clinical trials. While we believe we have adequate cash resources to continue operations through 2023, we anticipate that we will need additional funding in order to complete development of TSC which, if available, could be obtained through additional capital raising transactions, entry into strategic partnerships or collaborations, or alternative financing arrangements.
As of March 31, 2021,2022, we did not have any credit facilities in place under which we could borrow funds or any other sources of committed capital. In the future, we may seek to raise additional funds through various sources. However, 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. 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 TSC or our product candidates, or we may need to obtain funds through collaborations or otherwise on terms 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 adequate additional capital as and when required in the future, we could be forced to cease development activities and terminate our operations, and you could experience a complete loss of your investment.
To the extent that we raise additional capital in the future through the sale of our common stock or securities convertible or exchangeable for common stock such as common stock warrants, convertible preferred stock, or convertible debt instruments, the interests of our current stockholders may be diluted or otherwise impacted. 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.
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
TheAs of the date of this Quarterly Report, the Critical Accounting Policies included in our Form 10-K for the year ended December 31, 2020, filed with the SEC pursuant to Section 13 or 15(d) under the Securities Act on March 16, 2021Annual Report have not changed.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
As a “smaller reporting company” as defined by Item 10 of Regulation S-K promulgated by the SEC under the U.S. Securities Act of 1933, as amended, we are not required to provide the information required by this Item 3.
ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) 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’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) promulgated under the Exchange Act) that occurred during the period ended March 31, 20212022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
ITEM 1. | LEGAL PROCEEDINGS |
For this item, please refer to Note 7,9, Commitments and Contingencies in the notes accompanying the unaudited interim consolidated financial statements included in Part I, Item 1 of this Quarterly Report, which is incorporated herein by reference.
ITEM 1A. | RISK FACTORS |
As of the date of this Quarterly Report, there have been no material changes to our risk factors previously disclosed in our Annual Report other than as set forth below.Report.
If we cannot regain compliance with the Nasdaq Capital Market continued listing standards , our common stock could be delisted, which would harm our business, the trading price of our common stock, our ability to raise additional capital and the liquidity of the market for our common stock.
Our common stock is currently listed on the Nasdaq Capital Market. To maintain the listing of our common stock on the Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, either: (i) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $1 million and stockholders’ equity of at least $2.5 million; or (ii) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $1 million and a total market value of listed securities of at least $35 million.
There is no assurance that we will continue to meet the minimum closing price requirement and other listing requirements. For example, on May 6, 2021, we received a written notice from the staff of the Nasdaq Listing Qualifications Department indicating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for our common stock had closed below $1.00 per share for the previous 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days from the date of such notice, or until November 2, 2021, to regain compliance with the minimum bid price requirement. To regain compliance, the bid price for our common stock must close at $1.00 per share or more for a minimum of 10 consecutive business days. Nasdaq’s written notice has no effect on the listing or trading of our common stock at this time, and we are currently evaluating our alternatives to resolve this listing deficiency. If necessary to regain compliance with Nasdaq listing standards, we intend, subject to approval of our board of directors and stockholders, to implement a reverse stock split. However, there can be no assurance that the reverse stock split will be approved or will result in a sustained higher stock price that will allow us to meet the Nasdaq stock price listing requirements, and there is no guarantee we will continue to satisfy the other Nasdaq Capital Market continued listing standards.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Unregistered Sales of Equity Securities
None.On March 18, 2022, the Company issued and sold to Robert J. Cobuzzi, Jr., Ph.D., its President & Chief Executive Officer, and William R. Elder, its General Counsel & Corporate Secretary, an aggregate of 10,000 shares of Series C Preferred Stock at an offering price of $0.50 per share, representing 100% of the stated value per share of the Series C Preferred Stock, for aggregate gross proceeds of $5,000.
The Series C Certificate provides that, among other things, (i) each share of Series C Preferred Stock is convertible into 0.02 shares of the Company's common stock, representing a conversion price of $25.00 per share, subject to certain conditions, (ii) each share of Series C Preferred Stock outstanding is counted on an as converted basis, together with the Company’s common stock as a single class, for purposes of determining the presence of a quorum at any meeting at which holders are asked to vote on matters related to the Reverse Stock Split (subject to any applicable exchange listing rules), (iii) each share of Series C Preferred Stock outstanding has the right to cast 1,600 votes per share of Series C Preferred Stock on the Reverse Stock Split on a “mirrored” basis — this means that the holders of the Series C Preferred Stock are required to vote their shares in a manner that “mirrors” the proportions of “For” and “Against” votes cast by the holders of the Company’s common stock on the Amendment (excluding, for the avoidance of doubt, any shares of common stock that are not voted), and (iv) the holders of outstanding shares of Series C Preferred Stock are entitled to dividends, on an as converted basis, equal to dividends actually paid, if any, on shares of common stock and participate in any liquidation of the Company on an as converted basis.
On April 18, 2022, following approval of the Reverse Stock Split by the Company's stockholders, all 10,000 shares of Series C Preferred Stock were converted into an aggregate of 200 shares of the Company's common stock in accordance with the terms of the Series C Certificate.
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.
DIFFUSION PHARMACEUTICALS INC.
QUARTERLY REPORT ON FORM 10-Q
EXHIBIT INDEX
Exhibit No. | Description | Method of Filing |
| Incorporated by reference to Exhibit | |
3.2 | Amendment to the Bylaws, as amended, of Diffusion Pharmaceuticals Inc., effective March 18, 2022 | Incorporated by reference to Exhibit 3.2 to the registrant's current report on Form 8-K filed on March 18, 2022 |
3.3 | Incorporated by reference to Exhibit 3.1 to the registrant's current report on Form 8-K filed on March 18, 2022 | |
10.1 | Incorporated by reference to Exhibit 10.1 to the registrant's current report on Form 8-K filed on March 18, 2022 | |
31.1 | Filed herewith | |
31.2 | Filed herewith | |
32.1 | Furnished herewith | |
32.2 | Furnished herewith | |
101 | The following materials from Diffusion’s quarterly report on Form 10-Q for the quarter ended March 31, | Filed herewith |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
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: May 7, 202112, 2022
DIFFUSION PHARMACEUTICALS INC. | |||
By: | /s/ Robert J. Cobuzzi, Jr., Ph.D. | ||
Robert J. Cobuzzi, Jr., Ph.D. | |||
President and Chief Executive Officer | |||
(Principal Executive Officer) | |||
By: | /s/ William Hornung | ||
William Hornung | |||
Chief Financial Officer | |||
(Principal Financial and Accounting Officer) |