UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
(Mark one) | ||
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 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) |
300 East Main Street, Suite 201
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(s) | Name of Each Exchange on Which Registered |
Common Stock, par value $0.001 per share | DFFN | 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 and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit 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 November 8, 202114, 2022 was 101,920,3292,039,442 shares.
DIFFUSION PHARMACEUTICALS INC.
FORM 10-Q
SEPTEMBER 30, 20212022
INDEX
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PART I – FINANCIAL INFORMATION | 1 |
ITEM 1. FINANCIAL STATEMENTS | 1 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 14 |
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 |
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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.Company and all share and per share amounts related to our common stock give effect to our 1-for-50 reverse stock split effected April 18, 2022. We have also used several other defined terms in this Quarterly Report, many of which are explained or defined below:
1 Defined terms table to be updated after MD&A is revised.
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 |
Annual Report | our Annual Report on Form 10-K for the year ended December 31, |
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 |
FDA | U.S. Food and Drug Administration |
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G&A | general and administrative |
GAAP | U.S. generally accepted accounting principles |
GBM | glioblastoma multiforme brain cancer |
Hypoxic Solid Tumor Program | our ongoing clinical development program |
ILD | interstitial lung disease |
ILD-DLCO Trial | our |
IND | investigational new drug application |
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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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Oxygenation Trials | collectively, the TCOM Trial, the Altitude Trial, and the ILD-DLCO Trial |
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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 of 1933, as amended |
Reverse Stock Split | the reclassification and combination of all shares of our common stock outstanding at a ratio of one-for-50 approved by our stockholders at the Special Meeting and effective April 18, 2022 |
RT | radiotherapy |
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 |
SOC | standard of care |
Special Meeting | the special meeting of our stockholders held on April 18, 2022 |
TCOM | transcutaneous oxygen measurement |
TCOM Trial | 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 |
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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 outcome and timing of our ongoing strategic review process, including any transaction we may undertake in connection therewith; |
• | 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 |
• | 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; |
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| 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 |
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• | 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; |
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• | 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 |
• | other risks and uncertainties, including those discussed under the heading "Risk Factors" in |
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 Trademarks, Trade Names and Service Marks
This Quarterly Report contains certain trademarks, trade names, and service marks of ours, including “DIFFUSIO2N.“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)
September 30, 2021 | December 31, 2020 | September 30, 2022 | December 31, 2021 | |||||||||||||
Assets | ||||||||||||||||
Current assets: | ||||||||||||||||
Cash and cash equivalents | $ | 40,335,045 | $ | 18,515,595 | $ | 6,587,018 | $ | 37,313,558 | ||||||||
Marketable securities | 19,270,940 | — | ||||||||||||||
Prepaid expenses, deposits and other current assets | 380,097 | 260,825 | 464,884 | 510,015 | ||||||||||||
Total current assets | 40,715,142 | 18,776,420 | 26,322,842 | 37,823,573 | ||||||||||||
Property and equipment, net | 81,896 | 149,198 | ||||||||||||||
Intangible asset | 0 | 8,639,000 | ||||||||||||||
Right of use asset | 67,886 | 149,162 | ||||||||||||||
Other assets | 15,579 | 15,771 | — | 15,578 | ||||||||||||
Total assets | $ | 40,880,503 | $ | 27,729,551 | $ | 26,322,842 | $ | 37,839,151 | ||||||||
Liabilities and Stockholders’ Equity | ||||||||||||||||
Current liabilities: | ||||||||||||||||
Accounts payable | $ | 678,036 | $ | 545,844 | 807,372 | 947,495 | ||||||||||
Accrued expenses and other current liabilities | 2,002,981 | 1,776,470 | 1,463,280 | 1,980,189 | ||||||||||||
Current operating lease liability | 67,886 | 113,469 | ||||||||||||||
Total current liabilities | 2,748,903 | 2,435,783 | 2,270,652 | 2,927,684 | ||||||||||||
Deferred income taxes | 0 | 443,893 | ||||||||||||||
Noncurrent operating lease liability | 0 | 35,693 | ||||||||||||||
Total liabilities | 2,748,903 | 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 September 30, 2021 and December 31, 2020, respectively | 101,904 | 64,016 | ||||||||||||||
Common stock, $0.001 par value: 1,000,000,000 shares authorized: 2,039,236 and 2,038,185 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 2,039 | 2,038 | ||||||||||||||
Additional paid-in capital | 164,560,366 | 130,659,550 | 165,657,681 | 164,914,540 | ||||||||||||
Accumulated other comprehensive loss | (86,955 | ) | — | |||||||||||||
Accumulated deficit | (126,530,670 | ) | (105,909,384 | ) | (141,520,575 | ) | (130,005,111 | ) | ||||||||
Total stockholders' equity | 38,131,600 | 24,814,182 | 24,052,190 | 34,911,467 | ||||||||||||
Total liabilities and stockholders' equity | $ | 40,880,503 | $ | 27,729,551 | $ | 26,322,842 | $ | 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 September 30, | Nine Months Ended September 30, | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||
Research and development | $ | 2,105,815 | $ | 3,137,553 | $ | 6,994,866 | $ | 6,845,203 | $ | 798,247 | $ | 2,105,815 | $ | 5,332,698 | $ | 6,994,866 | ||||||||||||||||
Intangible asset impairment charge | 8,639,000 | 0 | 8,639,000 | 0 | — | 8,639,000 | — | 8,639,000 | ||||||||||||||||||||||||
General and administrative | 1,930,082 | 2,112,375 | 5,510,365 | 4,964,440 | 2,124,785 | 1,930,082 | 6,390,663 | 5,510,365 | ||||||||||||||||||||||||
Depreciation | 19,100 | 24,192 | 67,302 | 78,233 | — | 19,100 | — | 67,302 | ||||||||||||||||||||||||
Loss from operations | 12,693,997 | 5,274,120 | 21,211,533 | 11,887,876 | 2,923,032 | 12,693,997 | 11,723,361 | 21,211,533 | ||||||||||||||||||||||||
Other income: | ||||||||||||||||||||||||||||||||
Interest income | (50,710 | ) | (29,233 | ) | (146,354 | ) | (89,246 | ) | (124,710 | ) | (50,710 | ) | (207,897 | ) | (146,354 | ) | ||||||||||||||||
Loss from operations before income tax benefit | (12,643,287 | ) | (5,244,887 | ) | (21,065,179 | ) | (11,798,630 | ) | (2,798,322 | ) | (12,643,287 | ) | (11,515,464 | ) | (21,065,179 | ) | ||||||||||||||||
Income tax benefit | (443,893 | ) | (805,676 | ) | (443,893 | ) | (1,675,381 | ) | — | (443,893 | ) | — | (443,893 | ) | ||||||||||||||||||
Net loss | $ | (12,199,394 | ) | $ | (4,439,211 | ) | $ | (20,621,286 | ) | $ | (10,123,249 | ) | $ | (2,798,322 | ) | $ | (12,199,394 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | ||||||||
Deemed dividend arising from warrant exchange | 0 | 0 | 0 | (1,950,378 | ) | |||||||||||||||||||||||||||
Net loss attributable to common stockholders | $ | (12,199,394 | ) | $ | (4,439,211 | ) | $ | (20,621,286 | ) | $ | (12,073,627 | ) | ||||||||||||||||||||
Per share information: | ||||||||||||||||||||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (0.12 | ) | $ | (0.07 | ) | $ | (0.22 | ) | $ | (0.24 | ) | $ | (1.37 | ) | $ | (5.99 | ) | $ | (5.65 | ) | $ | (10.76 | ) | ||||||||
Weighted average shares outstanding, basic and diluted | 101,903,979 | 64,011,342 | 98,810,420 | 50,216,239 | 2,039,089 | 2,037,978 | 2,038,716 | 1,916,107 | ||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||
Net loss | $ | (2,798,322 | ) | $ | (12,199,394 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | ||||||||||||||||||||
Unrealized loss on marketable securities | (372 | ) | — | (86,955 | ) | — | ||||||||||||||||||||||||||
Comprehensive loss: | $ | (2,798,694 | ) | $ | (12,199,394 | ) | $ | (11,602,419 | ) | $ | (20,621,286 | ) |
See accompanying notes to unaudited interim consolidated financial statements.
Diffusion Pharmaceuticals Inc.
Consolidated Statement of Changes in Stockholders' Equity
Three and Nine Months Ended September 30, 20202021 and 2022
(unaudited)
Stockholders' Equity | ||||||||||||||||||||
Common Stock | Additional |
| Total | |||||||||||||||||
Shares | Amount | Paid-in Capital | Accumulated Deficit | Stockholders' Equity | ||||||||||||||||
Balance at July 1, 2020 | 63,998,298 | $ | 63,999 | $ | 130,220,772 | $ | (97,408,116 | ) | $ | 32,876,655 | ||||||||||
Issuance of common stock upon exercise of warrants | 17,143 | 17 | 7,483 | 0 | 7,500 | |||||||||||||||
Stock-based compensation expense | — | 0 | 279,473 | 0 | 279,473 | |||||||||||||||
Net loss | — | 0 | 0 | (4,439,211 | ) | (4,439,211 | ) | |||||||||||||
Balance at September 30, 2020 | 64,015,441 | $ | 64,016 | $ | 130,507,728 | $ | (101,847,327 | ) | $ | 28,724,417 |
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 July 1, 2022 | — | $ | — | 2,038,914 | $ | 2,038 | $ | 165,475,801 | $ | (86,583 | ) | $ | (138,722,253 | ) | $ | 26,669,003 | ||||||||||||||||
Stock-based compensation expense and vesting of restricted stock units | — | — | 322 | 1 | 181,880 | — | — | 181,881 | ||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | (372 | ) | — | (372 | ) | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (2,798,322 | ) | (2,798,322 | ) | ||||||||||||||||||||||
Balance at September 30, 2022 | — | $ | — | 2,039,236 | $ | 2,039 | $ | 165,657,681 | $ | (86,955 | ) | $ | (141,520,575 | ) | $ | 24,052,190 |
Stockholders' Equity | ||||||||||||||||||||
Common Stock | Additional |
| Total | |||||||||||||||||
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 | ||||||||||
Sale of common stock and warrants, net of issuance costs | 11,428,572 | 11,429 | 10,330,202 | 0 | 10,341,631 | |||||||||||||||
Issuance of common stock upon exercise of warrants | 19,106,504 | 19,106 | 7,768,370 | 0 | 7,787,476 | |||||||||||||||
Stock-based compensation expense | — | 0 | 584,297 | 0 | 584,297 | |||||||||||||||
Net loss | — | 0 | 0 | (10,123,249 | ) | (10,123,249 | ) | |||||||||||||
September 30, 2020 | 64,015,441 | $ | 64,016 | $ | 130,507,728 | $ | (101,847,327 | ) | $ | 28,724,417 |
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 | — | $ | — | 2,038,185 | $ | 2,038 | $ | 164,914,540 | $ | — | $ | (130,005,111 | ) | $ | 34,911,467 | |||||||||||||||||
Sale of Series C preferred stock to related parties | 10,000 | 5,000 | — | — | — | — | — | 5,000 | ||||||||||||||||||||||||
Conversion of Series C preferred stock to common stock | (10,000 | ) | (5,000 | ) | 200 | 5,000 | — | — | — | |||||||||||||||||||||||
Stock-based compensation expense and vesting of restricted stock units | — | — | 851 | 1 | 738,141 | — | — | 738,142 | ||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | (86,955 | ) | — | (86,955 | ) | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (11,515,464 | ) | (11,515,464 | ) | ||||||||||||||||||||||
Balance at September 30, 2022 | — | $ | — | 2,039,236 | $ | 2,039 | $ | 165,657,681 | $ | (86,955 | ) | $ | (141,520,575 | ) | $ | 24,052,190 |
See accompanying notes to unaudited interim consolidated financial statements.
Stockholders' Equity | ||||||||||||||||||||
Common Stock | Additional Paid-in | Accumulated | Total Stockholders' | |||||||||||||||||
Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
Balance at July 1, 2021 | 2,037,978 | $ | 2,038 | $ | 164,495,840 | $ | (114,331,276 | ) | $ | 50,166,602 | ||||||||||
Stock-based compensation expense | — | — | 164,392 | — | 164,392 | |||||||||||||||
Net loss | — | — | — | (12,199,394 | ) | (12,199,394 | ) | |||||||||||||
Balance at September 30, 2021 | 2,037,978 | $ | 2,038 | $ | 164,660,232 | $ | (126,530,670 | ) | $ | 38,131,600 |
Diffusion Pharmaceuticals Inc.
Consolidated Statement of Changes in Stockholders' Equity
Three and Nine Months Ended September 30, 2021
(unaudited)
Stockholders' Equity | ||||||||||||||||||||
Common Stock | Additional |
| Total | |||||||||||||||||
Shares | Amount | Paid-in Capital | Accumulated Deficit | Stockholders' Equity | ||||||||||||||||
Balance at July 1, 2021 | 101,903,979 | $ | 101,904 | $ | 164,395,974 | $ | (114,331,276 | ) | $ | 50,166,602 | ||||||||||
Stock-based compensation expense | — | 0 | 164,392 | 0 | 164,392 | |||||||||||||||
Net loss | — | 0 | 0 | (12,199,394 | ) | (12,199,394 | ) | |||||||||||||
Balance at September 30, 2021 | 101,903,979 | $ | 101,904 | $ | 164,560,366 | $ | (126,530,670 | ) | $ | 38,131,600 |
Stockholders' Equity | Stockholders' Equity | |||||||||||||||||||||||||||||||||||||||
Common Stock | Additional |
| Total | Common Stock | Additional Paid-in | Accumulated | Total Stockholders' | |||||||||||||||||||||||||||||||||
Shares | Amount | Paid-in Capital | Accumulated Deficit | Stockholders' Equity | Shares | Amount | Capital | Deficit | Equity | |||||||||||||||||||||||||||||||
Balance at January 1, 2021 | 64,015,441 | $ | 64,016 | $ | 130,659,550 | $ | (105,909,384 | ) | $ | 24,814,182 | 1,280,207 | $ | 1,280 | $ | 130,722,286 | $ | (105,909,384 | ) | $ | 24,814,182 | ||||||||||||||||||||
Sale of common stock and warrants, net of issuance costs | 33,658,538 | 33,658 | 31,060,644 | 0 | 31,094,302 | 673,171 | 673 | 31,093,629 | — | 31,094,302 | ||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants | 4,230,000 | 4,230 | 2,197,220 | 0 | 2,201,450 | 84,600 | 85 | 2,201,365 | — | 2,201,450 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | — | 0 | 642,952 | 0 | 642,952 | — | — | 642,952 | — | 642,952 | ||||||||||||||||||||||||||||||
Net loss | — | 0 | 0 | (20,621,286 | ) | (20,621,286 | ) | — | — | — | (20,621,286 | ) | (20,621,286 | ) | ||||||||||||||||||||||||||
Balance at September 30, 2021 | 101,903,979 | $ | 101,904 | $ | 164,560,366 | $ | (126,530,670 | ) | $ | 38,131,600 | $ | 2,037,978 | $ | 2,038 | $ | 164,660,232 | $ | (126,530,670 | ) | $ | 38,131,600 |
See accompanying notes to unaudited interim consolidated financial statements.
Diffusion Pharmaceuticals Inc.
Consolidated Statements of Cash Flows
(unaudited)
Nine Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Operating activities: | ||||||||||||||||
Net loss | $ | (20,621,286 | ) | $ | (10,123,249 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
Depreciation | 67,302 | 78,233 | — | 67,302 | ||||||||||||
Stock-based compensation expense | 642,952 | 584,297 | 738,142 | 642,952 | ||||||||||||
Amortization of premium and discount on marketable securities | (122,157 | ) | — | |||||||||||||
Intangible asset impairment charge | — | 8,639,000 | ||||||||||||||
Deferred income taxes | (443,893 | ) | (1,675,381 | ) | — | (443,893 | ) | |||||||||
Intangible asset impairment charge | 8,639,000 | 0 | ||||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||
Prepaid expenses, deposits and other assets | (119,080 | ) | (224,224 | ) | 60,709 | (119,080 | ) | |||||||||
Accounts payable, accrued expenses and other liabilities | 358,703 | 1,202,283 | (657,032 | ) | 358,703 | |||||||||||
Net cash used in operating activities | (11,476,302 | ) | (10,158,041 | ) | (11,495,802 | ) | (11,476,302 | ) | ||||||||
Cash flows provided by investing activities: | ||||||||||||||||
Purchase of marketable securities | (37,985,738 | ) | — | |||||||||||||
Maturities of marketable securities | 18,750,000 | — | ||||||||||||||
Net cash used in investing activities | (19,235,738 | ) | — | |||||||||||||
Cash flows provided by financing activities: | ||||||||||||||||
Proceeds from the sale of common stock and warrants, net of issuance costs | 31,094,302 | 10,827,100 | ||||||||||||||
Proceeds from the sale of preferred stock | 5,000 | — | ||||||||||||||
Proceeds from the exercise of common stock warrants | 2,201,450 | 8,046,103 | — | 2,201,450 | ||||||||||||
Payment of financing costs | 0 | (982,328 | ) | |||||||||||||
Proceeds from the sale of common stock | — | 31,094,302 | ||||||||||||||
Net cash provided by financing activities | 33,295,752 | 17,890,875 | 5,000 | 33,295,752 | ||||||||||||
Net increase in cash and cash equivalents | 21,819,450 | 7,732,834 | ||||||||||||||
Net (decrease) increase in cash and cash equivalents | (30,726,540 | ) | 21,819,450 | |||||||||||||
Cash and cash equivalents at beginning of period | 18,515,595 | 14,177,349 | 37,313,558 | 18,515,595 | ||||||||||||
Cash and cash equivalents at end of period | $ | 40,335,045 | $ | 21,910,183 | $ | 6,587,018 | $ | 40,335,045 | ||||||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||||||||||
Unrealized loss on marketable securities | $ | 86,955 | $ | — |
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 a biopharmaceutical company developing novel therapies that may 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 developedinvestigated 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 solid tumors like GBM. In October 2022, the Company announced that its Board has authorized a thorough review and evaluation of a range of potential strategic opportunities in the interest of enhancing stockholder value including transactional opportunities to better leverage the potential of TSC and the Company’s other assets.
On 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 share 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.
In July 2022, the Company entered into an at-the-market sales agreement (the "2022 Sales Agreement") with BTIG, LLC, ("BTIG") as agent, pursuant to which the Company may sell up to an aggregate of $20.0 million in shares of the Company’s common stock, from time to time through BTIG, by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. To date, the Company has not sold any shares pursuant to the 2022 Sales Agreement.
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 currently expects that its existing cash, and cash equivalents and marketable securities as of September 30, 20212022 will enable it to fund its operating expenses and capital expenditure requirements throughinto the 2023.first quarter of 2024, subject to the outcome and timing of the Company's ongoing strategic review process.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
3. | Basis of Presentation and Summary of Significant Accounting Policies |
The Summary of Significant Accounting Policies included in the Company's Annual Report for the year ended December 31, 20202021 have not materially changed.
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-Q and Article 10 of Regulation S-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 September 30, 2021,2022, and its results of operations for the three and nine months ended September 30, 20212022 and 20202021 and cash flows for the nine months ended September 30, 20212022 and 2020.2021. Operating results for the nine months ended September 30, 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 consolidated interim 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 Estimates
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 three and nine months ended September 30,2021. 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 trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, 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 the Company’sthose 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 Company’s 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
In the third quarter of 2021, the Board of Directors decided to no longer dedicate financial resources to the Company's DFN-529 (formerly RES-529) intangible asset and any future internal development efforts were abandoned. In connection with this decision,Financial instruments that potentially expose the Company concluded that DFN-529 was impaired in its entiretyto 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 considers any highly-liquid investments, such as such, the Company recognized a non-cash impairment charge of $8.6 million during the third quartermoney market funds and commercial paper with an original maturity of 2021.three months or less to be cash and cash equivalents.
Marketable Securities
The abandonment also resultedCompany 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 use in an income tax benefit of $0.4 million due tocurrent operations, and therefore classify these securities as current assets on the tax effect ofconsolidated balance sheet. These securities are carried at fair 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 reduction in the deferred tax liability associated with the asset.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 implement the Reverse Stock Split at a ratio of 1-to-50. No 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 became 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 common 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 outstanding warrants, stock options, and other equity securities, as well as to the reserve of shares available for future issuance under the 2015 Equity Plan, to reflect the Reverse Stock Split, in each case, in accordance with the respective terms thereof.
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 September 30,2022 and 2021have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive as of the dates indicated below:anti-dilutive:
As of September 30, | As of September 30, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Common stock warrants | 6,499,469 | 9,100,112 | 111,891 | 129,989 | ||||||||||||
Stock options | 3,799,815 | 2,040,204 | 141,500 | 75,990 | ||||||||||||
Unvested restricted stock awards | 291,800 | 153,000 | 4,162 | 5,836 | ||||||||||||
10,591,084 | 11,293,316 | 257,553 | 211,815 |
Recently Adopted Accounting Pronouncements
In December 2019,June 2016, the FASB issued ASU No.20192016-12,13, Income TaxesFinancial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments (Topic 740326): Simplifying. The standard amends the Accountingimpairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for Income Taxes.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 applies to all entities and aims to reduce the complexity of tax accounting standards while enhancing reporting disclosures. This guidance wasis effective for fiscal years beginning afterthe Company as of December 15, 2020January 1, 2023. and interim periods therein. The Company adoptedis currently evaluating the impact of this ASU No.2019-12 in the first quarter of 2021 and the adoption didbut does not expect that adoption of this standard will have a material impact on the Company's consolidated financial statements.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 dates indicated:
September 30, 2022 | December 31, 2021 | |||||||
Cash in banking institutions | $ | 1,276,935 | $ | 30,308,075 | ||||
Money market funds | 4,317,557 | 7,005,483 | ||||||
Commercial paper | 992,526 | — | ||||||
Total | $ | 6,587,018 | 37,313,558 |
The following is a summary of the Company's marketable securities as of September 30,2022:
Amortized cost | Unrealized gains | Unrealized losses | Fair Value | |||||||||||||
Commercial paper | $ | 15,357,565 | $ | — | $ | (56,985 | ) | $ | 15,300,580 | |||||||
U.S. treasury bonds | 4,000,330 | — | (29,970 | ) | 3,970,360 | |||||||||||
Total | $ | 19,357,895 | $ | — | $ | (86,955 | ) | $ | 19,270,940 |
The Company did not have any marketable securities as of December 31, 2021. The Company's marketable securities generally have contractual maturity dates between 3 and 12 months. All of the Company’s marketable securities are in an unrealized loss position at September 30,2022. Unrealized losses on marketable securities as of September 30,2022 were not significant and were primarily due to changes in interest rates, and not due to increased credit risks associated with specific securities. Accordingly, no other-than-temporary impairment was recorded for the nine months ended September 30,2022 and there were no realized gains or losses recorded during the nine months ended September 30,2021.
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 table presents the Company’s assets that are measured at fair value on a recurring basis (amounts in thousands):
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) | ||||||||||
September 30, 2022: | ||||||||||||
Cash equivalents: | ||||||||||||
Money market funds | $ | 4,317,557 | $ | — | $ | — | ||||||
Commercial paper | — | 992,526 | — | |||||||||
Total cash equivalents | $ | 4,317,557 | $ | 992,526 | $ | — | ||||||
Marketable securities | ||||||||||||
Commercial paper | — | 15,300,580 | — | |||||||||
US treasury | — | 3,970,360 | — | |||||||||
Total marketable securities | $ | — | $ | 19,270,940 | $ | — | ||||||
Total financial assets | $ | 4,317,557 | $ | 20,263,466 | $ | — |
The fair values 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 general, a market approach is utilized if there is readily available and relevant market activity for an individual security. This valuation technique may change from period to period, based on the relevance and availability of market data.
6. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following as of the dates indicated below:
September 30, 2021 | December 31, 2020 | September 30, 2022 | December 31, 2021 | |||||||||||||
Accrued payroll and payroll related expenses | 773,917 | 653,899 | $ | 944,684 | $ | 879,971 | ||||||||||
Accrued professional fees | 59,126 | 31,809 | 58,789 | 247,704 | ||||||||||||
Accrued clinical studies expenses | 1,081,453 | 1,055,398 | 357,851 | 786,579 | ||||||||||||
Other accrued expenses | 88,485 | 35,364 | 101,956 | 65,935 | ||||||||||||
Total | $ | 2,002,981 | $ | 1,776,470 | $ | 1,463,280 | $ | 1,980,189 |
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
| Stockholders' Equity and Common Stock Warrants |
February 2021 Common Stock OfferingWarrants
In February 2021, During its evaluation of equity classification for the Company's common stock warrants issued in previous periods, the Company completedconsidered the conditions as prescribed within ASC February 2021 815Offering in which it offered-40,Derivatives and sold 33,658,538 shares of its common stockHedging, Contracts in an underwritten, public offeringEntity’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 a purchase pricethe scope exception as they are indexed to the public of $1.025 per share, inclusive of shares offeredCompany’s own stock and sold pursuant to the exercise-in-full by the underwriter of its 30-day option to purchase additional shares. The February 2021 Offering resultedwould be classified in aggregate net proceeds to the Company of $31.1 million, after deducting underwriting commissions, discounts, and expenses but prior to deducting other offering costs. In addition, at the closings of the February 2021 Offering, the Company issued to designees of the underwriter of the transaction warrants to purchase up to an aggregate of 1,682,927 shares of common stock to designees. The underwriter warrants have an exercise price of $1.28125 per share and a term of five years from the date of issuance.
Common Stock Warrantspermanent equity if freestanding.
As of September 30, 2021,2022, the Company had the following warrants outstanding to acquire shares of its common 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 the 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 | 213,570 | $0.35 | 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 | May 2025 | ||||||||
Common stock warrants issued related to 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 | ||||||||
6,499,469 |
Outstanding | Range of exercise price per share | Expiration dates | ||||||||
Common stock warrants issued in 2018 related to the January 2018 Offering | 23,639 | $599.71 | - | $749.76 | January 2023 | |||||
Common stock warrants issued related to the May 2019 Offering | 27,648 | $250.09 | - | $306.04 | May and December 2024 | |||||
Common stock warrants issued related to the November 2019 Offering | 4,269 | $17.51 | November 2024 | |||||||
Common stock warrants issued related to the December 2019 Offering | 6,264 | $21.68 | - | $34.92 | December 2024 and June 2025 | |||||
Common stock warrants issued related to the May 2020 Offering | 11,424 | $65.65 | March 2025 | |||||||
Common stock warrants issued related to May 2020 Investor Warrant Exercise | 4,998 | $29.70 | November 2025 | |||||||
Common stock warrants issued related to the February 2021 Offering | 33,649 | $64.08 | February 2026 | |||||||
111,891 |
During the nine months ended September 30, 2022, 30,2021, 53,57018,077 warrants expired and 4,230,000 warrants were exercised for aggregate proceeds of approximately $2.2 million.expired.
| 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 September 30, 2021,2022, there were 407,33323,664 shares available for future issuance under the 2015 Equity Plan.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim consolidated statements of operations for the periods indicated:
Three Months Ended September 30, | Nine Months Ended September 30, | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||
Research and development | $ | 18,811 | $ | 19,838 | $ | 111,378 | $ | 136,236 | $ | 46,704 | $ | 18,811 | $ | 164,489 | $ | 111,378 | ||||||||||||||||
General and administrative | 145,581 | 259,635 | 531,574 | 448,061 | 135,177 | 145,581 | 573,653 | 531,574 | ||||||||||||||||||||||||
Total stock-based compensation expense | $ | 164,392 | $ | 279,473 | $ | 642,952 | $ | 584,297 | $ | 181,881 | $ | 164,392 | $ | 738,142 | $ | 642,952 |
The following table summarizes the activity related to all stock option grants for the nine months ended September 30, 2021:2022:
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 | 1,732,515 | 0.91 | ||||||||||||||
Forfeited | (172,904 | ) | 1.76 | |||||||||||||
Outstanding at September 30, 2021 | 3,799,815 | $ | 5.22 | 8.79 | $ | 33,791 | ||||||||||
Exercisable at September 30, 2021 | 1,839,079 | $ | 9.85 | 8.17 | $ | 30,113 | ||||||||||
Vested and expected to vest at September 30, 2021 | 3,542,971 | $ | 5.51 | 8.74 | $ | 33,791 |
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 | $ | 265.91 | |||||||||||||
Granted | 77,088 | 9.87 | $ | 6,279 | ||||||||||||
Forfeited | (7,603 | ) | 144.62 | |||||||||||||
Expired | (439 | ) | 1,575.00 | |||||||||||||
Outstanding at September 30, 2022 | 141,500 | $ | 128.77 | 8.7 | — | |||||||||||
Exercisable at September 30, 2022 | 68,062 | $ | 251.37 | 8.0 | — | |||||||||||
Vested and expected to vest at September 30, 2022 | 141,500 | $ | 128.77 | 8.7 | — |
The weighted average grant date fair value of stock option awards granted during the nine months ended September 30, 20212022 was $0.87.$9.87. The total fair value of options vested during the three months ended September 30, 20212022 and 20202021 was $0.3$0.4 million and $0.3 million, respectively. The total fair value of options vested during the nine months ended September 30, 20212022 and 20202021 was $0.6$0.7 million and $0.6 million, respectively. No options were exercised during any of the periods presented. At September 30, 2021,2022, there was $1.2$1.0 million of unrecognized compensation expense that will be recognized over a weighted-average period of 1.801.67 years. During the nine months ended September 30, 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 $0.1 million nine months ended September 30,2021, 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 September 30,2021,no stock compensation expense was recognized and any previously recognized expense related to those awards originally deemed probable was reversed.
Options granted were valued using the Black-Scholes option-pricing model and the weighted average assumptions used to value the options granted during the nine months ended September 30, 20212022 and 20202021 were as follows:
2021 | 2020 | 2022 | 2021 | |||||||||||||
Expected term (in years) | 10 | 7.75 | 5.7 | 10 | ||||||||||||
Risk-free interest rate | 1.5 | % | 0.9 | % | 1.7 | % | 1.5 | % | ||||||||
Expected volatility | 123.8 | % | 119.7 | % | 121.4 | % | 123.8 | % | ||||||||
Dividend yield | 0 | % | 0 | % | — | % | — | % |
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Restricted Stock Unit Awards
Number of Units | Weighted average grant date fair value | |||||||
Balance at January 1, 2022 | 5,509 | $ | 34.78 | |||||
Vested (1) | (1,347 | ) | 30.93 | |||||
Outstanding at September 30, 2022 | 4,162 | $ | 36.02 |
(1) The RSUs vested during the nine months ended September 30,2022 were settled on a hybrid basis. The Company issues restricted stocks ("RSU") to newly elected, non-executive memberswithheld 496 shares of common stock and, in lieu of delivering such shares, paid the board of directors that vestRSU holder an amount in six, tri-monthly installments beginning 18 months after the respective grant date. The fair value of an RSU iscash equal to the fair market value price of the Company’s common stocksuch shares on the vesting date, of grant. RSU expense is recorded on a straight-line basis overrepresenting the service period.holder's approximate tax liability associated with the vesting.
The following table summarizes activity related to RSU stock-based payment awards:
Number of shares | Weighted-average grant date fair value | |||||||
Unvested balance at January 1, 2021 | 153,000 | $ | 0.65 | |||||
Granted | 138,800 | $ | 0.72 | |||||
Unvested balance at September 30, 2021 | 291,800 | $ | 0.69 |
The Company recognized approximately $16,000$17,000 and $4,000$16,000 in expense related to these awards during the three months ended September 30, 2021 2022and 2020,2021, respectively. The Company recognized approximately $27,000$49,000 and $12,000$27,000 in expense related to these awards during the nine months ended September 30, 20212022 and 2020,2021, respectively. At September 30, 2021,2022, there was approximately $0.1 million$79,000 of unrecognized compensation cost that will be recognized over a weighted average period of 2.351.49 years.
| Commitments and Contingencies |
Office Space RentalLease Commitment
TheAs of September 30, 2022, the Company has a non-cancelable operating lease for office and laboratoryhad short term agreements to utilize membership-based co-working space in both Charlottesville, Virginia which began in April 2017, and as of September 30,2021, has a remaining lease term of approximately 0.6 years. The discount rate used to account for the Company's operating lease under ASC 842 is the Company’s estimated incremental borrowing rate of 10%. The original term of the lease ends in the second quarter of 2022 and the Company has an option to extend for another five (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 September 30,2021. The Company also entered into two month-to-month leases for office space during the nine months ended September 30, 2021. The Company adopted the short-term lease election as afforded by ASC 842 and did not recognize a right-of-use asset and operating lease liability related to these short-term leases.
Philadelphia, Pennsylvania. Rent expense related to the Company's operating leasesshort-term agreements for the three months ended September 30, 2022 30,and 2021 and 2020 was approximately $48,000$5,000 and $30,000,$48,000, respectively. Rent expense related to the Company's short-term agreements was approximately $16,000 and $0.1 million for the nine months ended September 30, 20212022 and 2020 was approximately $0.1 million and $91,000, respectively. Future minimum rental payments under the Company's non-cancelable operating lease at September 30,2021, were as follows:respectively.
Rental Commitments | ||||
2021 | $ | 29,801 | ||
2022 | 39,735 | |||
Total | 69,536 | |||
Less: imputed interest | (1,650 | ) | ||
$ | 67,886 |
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 aits 401(k) defined contribution plan thatPlan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of approximately $29,000$26,000 and $11,000 for the three months ended September 30, 2021 and 2020, respectively and matched contributions under the 401(k) Plan of approximately $79,000 and $60,000 and $42,000 duringfor the nine months ended September 30, 202130,2022 and 2020,2021, respectively.
DIFFUSION PHARMACEUTICALS INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
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’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). 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 on April 14, 2015, the court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the court found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in 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 has been scheduled by the court forwas held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to setstipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial date.and certain deadlines related to the mediation in order to allow plaintiff's counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023.
The Company believes the claims in this matter are without merit and intends to defend itself vigorously. However, at this stage, the Company is unable to predict the outcome and 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, results of operations and cash flows.
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Lease Termination
On November 8, 2021, we entered into a Deed of Lease Termination Agreement with the Carlton Landlord providing for the early termination of the Carlton Lease related to our prior corporate headquarters. The Carlton Lease was previously scheduled to expire on April 30, 2022 and, as of September 30, 2021, our aggregate amount of future minimum rental payments thereunder was approximately $69,536. In connection with the termination, we will make a one-time payment to the Carlton Landlord of approximately $14,000, after deducting anticipated returns of deposits in accordance with the Carlton Lease.
In lieu of the fixed office and laboratory space previously available to us under the Carlton Lease, we have recently entered into short term agreements to utilize membership-based co-working space in both Charlottesville, Virginia and Philadelphia, Pennsylvania.
Nasdaq Bid Price Deficiency Notice
As previously disclosed, on May 6, 2021, the Company received a written notice from the staff of the Listing Qualifications Department of Nasdaq relating to the minimum bid price requirement contained in Nasdaq Listing Rule 5550(a)(2). This notice indicated that the Company was not in compliance with such rule because the bid price for the Company’s 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), the Company was provided 180 calendar days, or until November 2, 2021, to regain compliance with the Rule.
On November 3, 2021, the Company received an additional notice from the staff providing that, although the Company had not regained compliance with the bid price rule by November 2, 2021, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Staff has determined that the Company is eligible for an additional 180 calendar days from the date of such notice, or until May 2, 2022, to regain compliance. To regain compliance, the bid price for the Company’s common stock must close at $1.00 per share or more for a minimum of 10 consecutive business days.
The Notice has no effect on the listing or trading of the Company’s common stock at this time, and the Company is currently evaluating its alternatives to resolve this listing deficiency, including, if necessary and subject to the approval of its board of directors and stockholders, implementing a reverse stock split.
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 and under “Part II—Other Information – Item 1A. Risk Factors” in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2021 and June 30, 2021.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 a biopharmaceutical company developing novel therapies that may enhance the body’s ability to deliver oxygen to the areas where it is needed most. Our lead product candidate, TSC, is being developedinvestigated 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.
TSC Development Update
Our Lead Indication: Using TSC to Treat Hypoxic Solid Tumors
Solid tumors comprise approximately 90% of all adult cancers and, according to the American Cancer Society, roughly 1.9 million new cancer cases will be diagnosed in the U.S. during 2021. It is also well-documented in the scientific literature that the prevalence of hypoxic regions across numerous primary solid tumor types directly contributes to treatment resistance whether it be radiotherapy, chemotherapy, and immunotherapy, increasing the metastatic potential of these tumors and the probability of unsuccessful treatment. We believe TSC’s novel mechanism of action lends itself to treating this unmet medical need, so we are designing our Hypoxic Solid Tumor Program to support the use of TSC as a treatment of hypoxic solid tumors.
This program is being designed based on previously obtained data that we believe support the potential benefits of TSC as a treatment forconditions, including hypoxic solid tumors including preclinical evidence supporting TSC’s enhancement of radiotherapy and clinical evidence of TSC's effects in unresectable glioblastoma multiforme tumors from our previous Phase 2 study evaluating TSC in patients with GBM treated with standard of care radiation and chemotherapy. Additionally, with the outcome of the TCOM Trial, originally reported in June 2021, we believe we now have direct evidence of TSC's ability to enhance oxygenation in humans, including additional dosing information that will be integral to designing a clinical study to treat hypoxic solid tumors.
Our plan is to use the information obtained to date on TSC to submit a briefing document related to our development plan for discussion with the FDA during the first quarter of 2022. In addition to questions about clinical trial design and chemistry, manufacturing, and controls, we anticipate the submission will include the information required to obtain FDA feedback on potential accelerated pathways to approval for TSC. In addition, the results of the Altitude Trial and ILD-DLCO Trial, which we anticipate reporting during the first half of 2022 as further described below under the heading, “Our Oxygenation Trials,” will also be used to further guide the design of the program. We believe receiving FDA feedback on the proposed regulatory pathway underlying our Hypoxic Solid Tumor Program will enhance the probability of successfully developing and, if approved, commercializing TSC for use as a treatment for hypoxic solid tumors.
Accordingly, the start of the first study in our Hypoxic Solid Tumor Program, which we currently expect to be a Phase 2 clinical trial, will be subject to the timing of FDA feedback and the availability of clinical drug supply. like GBM.
Our Oxygenation TrialsBusiness Update
TCOM Trial: TSC's Effects on Peripheral Tissue OxygenationOngoing Evaluation of Strategic Opportunities
In June 2021,On October 25, 2022, we reportedannounced that our Board authorized a positive trendthorough review and evaluation of a range of potential strategic opportunities in oxygenation from our TCOM Trial, which evaluated the effectinterest of TSC versus placebo on peripheral tissue oxygenation in healthy normal volunteers using transcutaneous oxygen monitoring. Analysis ofenhancing stockholder value including transactional opportunities to better leverage the primary endpoint data indicated a positive dose-response trend in TCOM readings withpotential TSC as compared to placebo that persisted through the measurement period, and the trends observed in the primary endpoint data indicated an improvement in peripheral oxygenation with TSC with no evidence of hyperoxygenation.
In September 2021, we issued a letter to our stockholders including a further discussion of the results of the TCOM Trial, as well as certain additional facts and figures from our supplemental analysis of the study data.
Figure 1. Effects of TSC on transcutaneous oxygen pressure (tcpO2). The graph was created by subtracting the median placebo response from the dose and time matched median TSC response.
For example, the chart above was created by subtracting the median response observed in the TCOM Trial's placebo group from the median response observed in each TSC dosage group at each of the measurement times during the one-hour period following dosing. As you can see in the chart, these data indicate peripheral tissue oxygenation increased relative to the placebo group following TSC administration and persisted through the one-hour measurement period, particularly at the two highest doses tested (2.0 mg/kg and 2.5 mg/kg).Company’s other assets.
We believeare undertaking this expanded review as part of our previously disclosed, ongoing efforts to identify acquisition and partnership transactions that complement, supplement, or de-risk our current development programs and support the resultsBoard’s commitment to enhancing stockholder value. Our Board has determined to expand its evaluation to a broader range of options which could include a joint venture, licensing, sale or divestiture of some of the TCOM Trial provide clinical evidence that TSC facilitates the passive diffusion of oxygen from areas of high concentration to areas of low concentration without causing hyperoxygenation and, accordingly, representCompany’s proprietary technologies or a positive and meaningful step towards the accomplishmentsale of the overall strategic objectives of our Oxygenation Trials set forthCompany, in November 2020. Moreover,addition to the doses at which the largest effects of TSC were observed in the TCOM study are higher than the doses tested in any of the recent clinical trials of TSC, and these data obtained from the TCOM Trial is being used to guide the design of our remaining Oxygenation Trials – the Altitude Trial and the ILD-DLCO Trial.previously announced opportunities under consideration.
We believeOver the past two remaining Oxygenation Trials,years, we have obtained encouraging data on the Altitude Trial and the ILD-DLCO Trial, remain integral to our overall development plan for TSC, as they are intended to provide further information regarding TSC’s mechanism of action and dose response characteristics, as well as support for what we view as the broad therapeutic potential of TSC to treat a variety of conditions complicated by hypoxia. As described below, the Altitude Trial is designed to provide specific information on TSC’s effects on oxygen consumption and the ILD-DLCO Trial is designed to evaluate the effects of TSC on oxygenation, including the uptakeresults of oxygenour Altitude, TCOM, and COVID-19 Trials. We believe these data further support TSC's potential benefits for patients, particularly as an adjuvant treatment to standard of care therapy for hypoxic solid tumors, like glioblastoma multiforme. However, despite the accelerated, tumor oxygenation data readouts expected from our Study 200-208 trial design described below, we increasingly believe the likelihood of realizing TSC's value and benefits may be more likely achieved in an organization with larger infrastructure and greater resources given the recent downturn in the public financing environment and associated increase in our expected cost of capital as a standalone, single asset company which is one of the rationales underlying the strategic review authorized by our Board.
As of September 30, 2022 we had cash, cash equivalents and marketable securities of $12.68 per share of common stock outstanding. We believe our strong balance sheet and talented team of employees provide us the opportunity to leverage what we have learned from the development of TSC to evaluate a range of potential strategic opportunities to further enhance stockholder value. We believe supplementing, diversifying and expanding our asset portfolio through an acquisition, in-license, merger or other opportunistic transaction has the lungs. Accordingly, wepotential to increase our Company's attractiveness as an investment opportunity and reduce its overall risk profile.
There is no timeline for this review and there is no assurance the Board’s review will result in any transaction being consummated. Diffusion does not intend to continue to execute the Altitude Trial and the ILD-DLCO Trial to developcomment on this additional data in parallel with designing our Hypoxic Solid Tumor Program.process or make further disclosures until it determines an update is appropriate.
Altitude Trial: TSC’s Effects Under Induced Hypoxic ConditionsPhase 2 Trial in Patients with GBM Incorporating Innovative Imaging Methodology (Study 200-208)
This trial willWhile our process to evaluate strategic opportunities is ongoing, the entire Diffusion organization remains focused on executing our strategy to enhance value for our stockholders. We continue to prioritize and advance what we continue to believe to be a double-blind, randomized, placebo-controlled study which will evaluatevalue-creating initiatives within our standalone business, including continued progress towards the effectsinitiation of Study 200-208, further exploration of potential accelerated pathways for regulatory approval of TSC, and taking steps to preserve capital without sacrificing meaningful growth opportunities.
On July 26, 2022, we announced we had aligned with the FDA on maximal oxygen consumption, or VO2,the design of an open-label, dose-escalation, Phase 2 safety 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 (i.e., simulated altitude). The trial will evaluate the difference in effectefficacy study of TSC on oxygen availabilityadministered with standard of care to newly diagnosed GBM patients, which has been designated Study "200-208."GBM is an aggressive, deadly, and consumption compared to placebo. We expect to dose the first patienttreatment-resistant type of malignant brain tumor, affecting approximately 13,000 newly diagnosed patients each year in the Altitude Trial inUnited States. Few treatment options are available for patients with GBM, and none have extended life expectancy beyond a few months. In fact, according to the coming days, to complete dosingNational Brain Tumor Society, the five-year survival rate for GBM is only 6.8 percent with an average survival time of patients in the study in late December 2021 or early January 2022, and anticipate reporting topline results from the study within two months of completion.eight months.
ILD-DLCO Trial: TSC's Effects on Oxygen Transfer Efficiency
This trial willThe tissue microenvironment of tumors such as GBM is well known to be a double-blind, randomized, placebo-controlled study which willhypoxic, and therefore less sensitive to radiation therapy, an important part of standard of care therapy. As such, Study 200-208 has been designed to evaluate the effectsTSC as an adjuvant treatment to standard of TSC on the diffusion of carbon monoxide through the lungs, or DLCO, in patients with previously diagnosed interstitial lung disease who have an abnormal baseline DLCO test result. DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells.care therapy for hypoxic solid tumors. The study will include a dose-escalation phase, enrolling patients in a 3+3+3 design, to evaluate the difference in effectsafety, tolerability, pharmacokinetics, and pharmacodynamics of TSC on improvementat doses of 1.5 mg/kg, 2.0 mg/kg and 2.5 mg/kg administered in DLCO, as well as distance coveredcombination with concomitant standard of care radiotherapy plus temozolomide. An additional 17 subjects will be treated at the highest tolerable dose identified in the dose escalation phase. The primary objective of the study is to evaluate the overall survival of patients with newly diagnosed GBM when treated with TSC administered with standard of care. Secondary objectives of the study are to evaluate progression-free survival at six months and seven months by magnetic resonance imaging, assessment using Response Assessment in Neuro-Oncology criteria.
Study 200-208 will vary in a standard six-minute walk test. We anticipate initiatingvariety of ways from the ILD-DLCO TrialGBM trials we have conducted in the late fourth quarterpast, including three particularly notable differentiators:
• | The 1.5 mg/kg to 2.5 mg/kg doses of TSC to be administered in the trial will be 6-10-fold higher than the 0.25 mg/kg dose used in conjunction with radiotherapy in our prior GBM trials; |
• | TSC will be administered five days each week approximately 30-60 minutes prior to radiotherapy, as compared to the three days per week regimen in our prior GBM trials; and |
• | The trial will incorporate an innovative use of PET scans to directly evaluate the oxygen enhancing effects of TSC on tumor hypoxia using radiotracers, with initial data readouts from the dose-escalation phase expected to be available within one year of the first patient being dosed. |
We currently intend to use the PET scan data from the dose escalation phase of 2021Study 200-208 to support a discussion with the FDA on a planned pathway to approval of TSC as a treatment for newly diagnosed patients with GBM when administered as an adjunct to radiotherapy as part of standard of care therapy. We intend to initiate these discussions with the FDA concurrently with our planned enrollment of an additional 17 subjects to be treated at the highest tolerable dose identified in the dose escalation phase.
Our internal clinical development efforts continue to be focused on engaging study sites and completingrelated activities that will enable us to dose the studyfirst patient in Study 200-208 in the first quarter of 2022, with topline results reported within two months2023. However, the actual timing of study completion.the study's initiation, the dosing of the first patient and subsequent downstream milestones are subject to the outcome and timing of our ongoing strategic review process described above and the pace of enrollment in the study.
Further, during the third quarter of 2021, we received clearance of our IND for TSC from the Pulmonary, Allergy, and Critical Care division of the FDA, an important step as we prepare to initiate the ILD-DLCO Trial. This also represents the fourth division with which we have an open IND for TSC – joining the Cardiology and Nephrology, Neurology, and Oncology divisions – which we believe underscores TSC’s broad therapeutic potential to treat a variety of conditions complicated by hypoxia.Trial
The informationIn August 2022, satisfied that the positive results observed in our TCOM and Altitude Trials had accomplished our original goals for the Oxygenation Trials, we expectannounced our decision to obtain from the Altitudeterminate recruitment and enrollment in our ILD-DLCO Trial and ILD-DLCO Trial during the first half of 2022 — particularly when combined with the information we have acquired over the last year from the TCOM Trialdedicate additional time and our COVID-19 Trial — will continueresources to refine and enhance our understanding of TSC’s mechanism of action, dose-response effects, and, more specifically, effects on oxygen consumption and uptake of oxygen through the lungs. In addition to providing insights regarding additional, non-oncology indications in which the TSC platform may have potential, the results of the Altitude Trial and ILD-DLCO Trial will also inform our design ofstanding up our Hypoxic Solid Tumor Program studies.
TSC Supply Chain Update
As broadly reported by companies across industrial sectors, supply chain disruptions, shortages, and other issues have been widespread during 2021, and we have also recently been subject to delays and interruptions inthe 200-208 Study, as well as our TSC drug supply. As previously reported in our Annual Report , TSC is currently manufactured by our primary CMO partner at a facility that now manufactures COVID-19 vaccines under the Defense Production Act. In response these delays and interruptions, we are in the process of evaluating opportunities to increase the robustness of our drug supply and overall supply chain to be more responsive to our needs.
We are actively managing this process and believe we are taking the necessary steps to ensure the availability of high-quality drug supply to support the next steps in TSC’s development. However, TSC is a freeze-dried, injectable product requiring a sophisticated manufacturing process. As a result, any change to all or a portion of our manufacturing process, together with uncertainty regarding the general availability of manufacturing materials as a result of more general global supply chain shortages and disruptions, could affect the cost and timing of the available clinical study drug supply of TSC.
Organizational Update
Enhancing Our Organization, Embracing Remote Work
During the third quarter, we continued to enhance our operating team with the addition of new employees in a variety of functions across our organization, including clinical operations, CMC, finance, and, more recently, medical writing. As part of our growth strategy, we have embraced the remote work culture that became prevalent at many organizations during the COVID-19 pandemic. We believe our people are critical to our ability to efficiently and successfully execute our stated strategy, and this remote operating paradigm allows us to enhance our available pool of talented human resources while also conserving financial resources. For example, in November 2021, we negotiated and entered into an agreement providing for the early termination of our lease of the Carlton Avenue facility in Charlottesville, Virginia. We also believe in the power of collaboration. In turn, and in lieu of the fixed office and laboratory space previously available to us under that agreement, we have recently entered into short term agreements to utilize membership-based co-working space in both Charlottesville, Virginia and Philadelphia, Pennsylvania. We believe these arrangements will permit our team combine the advantages of remote and in-person work in environments intended to foster creativity and innovation.business development activities.
At the time the ILD-DLCO study was terminated, 18 of the planned 27 patients had been enrolled and treated in accordance with the planned 2:1 randomization with the 12 patients in the TSC cohort receiving a single, intravenous dose of 2.5mg/kg. Analyses of this partial dataset indicate TSC was safe and well tolerated among all 12 TSC-treated patients at the 2.5 mg/kg dose, which as noted above is the highest dose currently planned to be administered in the 200-208 Study. Although there was no significant change observed in the study’s primary endpoint, diffusion of carbon monoxide into the lungs measured at 30 min post-TSC vs baseline DLCO, the TSC-treated patient cohort did statistically separate from placebo at 60 min post-dose in the 6-minute walk test when compared to the pre-dose baseline, though the change was less than the clinically meaningful change typically found in the scientific literature (30m distance gained or 20% improvement vs baseline (pre-TSC) 6-minute walk test). Further, there was no significant change in the pre-TSC vs. post-TSC Borg Dyspnea Scale measurement or heart rate recovery at completion of the 6-minute walk test.
We believe the data from the ILD-DLCO trial supporting the safety and tolerability of TSC administered at 2.5 mg/kg iv in patients with ILD-DLCO reinforce our plans to target this dose in the 200-208 Study as a treatment for newly diagnosed patients with GBM when administered as an adjunct to radiotherapy as part of standard of care therapy.
Financial Summary
As of September 30, 2021,2022, we had cash, and cash equivalents, and marketable securities of $40.3 million.$25.9 million, in the aggregate. We have incurred operating losses since inception, have not generated any product revenue and have not achieved profitable operations. We incurred net losses of $12.2$2.8 million and $20.6$11.5 million for the three and nine months ended September 30, 2021,2022, respectively. Our accumulated deficit as of September 30, 20212022 was $126.5$141.5 million, and we expect to continue to incur substantial losses in future periods. We anticipate that our operating expenses will increase substantially as we continue to advance the development of TSC and any other assets we may in-license or acquire, including any costs related to:
• | our ongoing and planned clinical trials, including |
• | our |
• | any additional studies we may undertake, including other preclinical and clinical studies to support the filing of any |
• | 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; |
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investments in operational, financial, and management information systems.
We
Subject to the outcome of our ongoing strategic review process, 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.TSC and any future business development activities we may undertake. We currently expect that our cash, and cash equivalents and marketable securities as of September 30, 20212022 will enable us to fund our operating expenses and capital expenditure requirements through 2023.into the first quarter of 2024, subject to the outcome and timing of the aforementioned strategic review process.
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.
Intangible Asset Impairment Charge
In the third quarter of 2021, the Company made a determination to no longer dedicate resources to the Company’s DFN-529 intangible asset and any future development efforts were abandoned. In connection with this decision, the Company concluded that DFN-529 was impaired in its entirety.
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
The Company recorded an income tax benefit of $0.4 million during the three and nine months ended September 30, 2021, respectively. The income tax benefit was due to the tax effect of the reduction in the deferred tax liability associated with the basis difference from the IPR&D indefinite lived intangible asset. The Company maintains a full valuation allowance against its deferred tax assets due to the Company’s history of losses as of September 30, 2021.
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. 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 completed 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 the year ended December 31, 2020 or during the three or nine months ended September 30, 2021 give rise to any further limitations.
Results of Operations for Three Months Ended September 30, 20212022 Compared to Three Months Ended September30, 20202021
The following table sets forth our results of operations for the three months ended September 30, 20212022 and 2020.2021.
Three Months Ended September 30, | Three Months Ended September 30, 2022 | |||||||||||||||||||||||
2021 | 2020 | Change | 2022 | 2021 | Change | |||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ | 2,105,815 | $ | 3,137,553 | $ | (1,031,738 | ) | $ | 798,247 | $ | 2,105,815 | $ | (1,307,568 | ) | ||||||||||
Intangible asset impairment charge | 8,639,000 | — | 8,639,000 | — | 8,639,000 | $ | (8,639,000 | ) | ||||||||||||||||
General and administrative | 1,930,082 | 2,112,375 | (182,293 | ) | 2,124,785 | 1,930,082 | 194,703 | |||||||||||||||||
Depreciation | 19,100 | 24,192 | (5,092 | ) | — | 19,100 | (19,100 | ) | ||||||||||||||||
Loss from operations | 12,693,997 | 5,274,120 | 7,419,877 | 2,923,032 | 12,693,997 | (9,770,965 | ) | |||||||||||||||||
Other income: | ||||||||||||||||||||||||
Interest income | (50,710 | ) | (29,233 | ) | (21,477 | ) | (124,710 | ) | (50,710 | ) | (74,000 | ) | ||||||||||||
Loss from operations before income tax benefit | (12,643,287 | ) | (5,244,887 | ) | (7,398,400 | ) | 2,798,322 | 12,643,287 | (9,844,965 | ) | ||||||||||||||
Income tax benefit | (443,893 | ) | (805,676 | ) | 361,783 | — | (443,893 | ) | 443,893 | |||||||||||||||
Net loss | $ | (12,199,394 | ) | $ | (4,439,211 | ) | $ | (7,760,183 | ) | $ | (2,798,322 | ) | $ | (12,199,394 | ) | $ | 9,401,072 |
We recognized $2.1$0.8 million in R&D expenses during the three months ended September 30, 20212022 compared to $3.1$2.1 million during the three months ended September 30, 2020.2021. This decrease was due to lower project spending dueattributable to the completion and/or wind-downtiming of our clinical studies evaluating TSC in Covid-19, GBM,trials and stroke.drug manufacturing, as well as a vendor-related refund.
We recognized a non-recurringThe decrease in intangible asset impairment charge is related to the nonrecurring $8.6 million non-cash impairment charge related to the write down of our DFN-529 IPR&D asset.asset during the three months ended September 30, 2021.
G&A expenses were $2.1 million during the three months ended September 30, 2022 compared to $1.9 million during the three months ended September 30, 20212021. The increase was mainly due to increased professional fees related to ongoing business development activity.
The decrease in depreciation for the three months ended September 30, 2022 compared to $2.1the three months ended September 30, 2021 is related to the disposal of property and equipment during the year-ended December 31, 2021.
The decrease in income tax benefit of $0.4 million during the three months ended September 30, 2020. The decrease in G&A expenses was primarily due31, 2022 compared to a $0.5 million decrease in salaries related to executive separation payments recorded in the prior year period as well as a $0.2 million decrease in outside legal and professional fees. This decrease was partially offset by an increase in salaries and other costs associated with the hiring of new employees to support our R&D efforts as well as an increase in insurance costs.
We recognized an income tax benefit of $0.4 millionthree months ended September 31, 2021 is due to the tax effect of the reduction in the deferred tax liability associated with the basis differences from the DFN-529 IPR&D intangible asset that was written down in the third quarter of 2021. We recognized an income tax benefit of $0.8 million during the three months ended September 30, 2020 to reflect the utilization of indefinite deferred tax liabilities as a source of income against indefinite lived portions of 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.
Results of Operations for Nine Months Ended September 30, 20212022 Compared to Nine Months Ended September30, 20202021
The following table sets forth our results of operations for the nine months ended September 30, 20212022 and 2020.2021.
Nine Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2021 | 2020 | Change | 2022 | 2021 | Change | |||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ | 6,994,866 | $ | 6,845,203 | $ | 149,663 | $ | 5,332,698 | $ | 6,994,866 | $ | (1,662,168 | ) | |||||||||||
Intangible asset impairment charge | 8,639,000 | — | 8,639,000 | — | 8,639,000 | (8,639,000 | ) | |||||||||||||||||
General and administrative | 5,510,365 | 4,964,440 | 545,925 | 6,390,663 | 5,510,365 | 880,298 | ||||||||||||||||||
Depreciation | 67,302 | 78,233 | (10,931 | ) | — | 67,302 | (9,420,870 | ) | ||||||||||||||||
Loss from operations | 21,211,533 | 11,887,876 | 9,323,657 | 11,723,361 | 21,211,533 | (9,488,172 | ) | |||||||||||||||||
Other income: | ||||||||||||||||||||||||
Interest income | (146,354 | ) | (89,246 | ) | (57,108 | ) | (207,897 | ) | (146,354 | ) | (61,543 | ) | ||||||||||||
Loss from operations before income tax benefit | (21,065,179 | ) | (11,798,630 | ) | (9,266,549 | ) | (11,515,464 | ) | (21,065,179 | ) | 9,549,715 | |||||||||||||
Income tax benefit | (443,893 | ) | (1,675,381 | ) | 1,231,488 | — | (443,893 | ) | 443,893 | |||||||||||||||
Net loss | $ | (20,621,286 | ) | $ | (10,123,249 | ) | $ | (10,498,037 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | $ | 9,105,822 |
We recognized $7.0$5.3 million in R&D expenses during the nine months ended September 30, 20212022 compared to $6.8$7.0 million during the nine months ended September 30, 2020.2021. This increasedecrease was primarily attributable to a $1.2 million increase in expense related tothe timing of clinical trials and drug manufacturing as described in part above under the heading “TSC Supply Chain Update.” andwell as a $0.6 millionvendor-related refund, offset by an increase in salarysalaries and wages and stock-based compensation related expenses due to increases inincreased headcount. These increases were offset by lower project spending due to the completion and/or wind-down of our clinical studies evaluating TSC in Covid-19, GBM, and stroke.
We recognized aThe decrease in intangible asset impairment charge is related to the nonrecurring $8.6 million non-cash impairment charge related to the write down of our DFN-529 IPR&D asset.asset during the nine months ended September 30, 2021.
G&A expenses were $6.4 million during the nine months ended September 30, 2022 compared to $5.5 million during the nine months ended September 30, 2021 compared to $5.0 million during the nine months ended September 30, 2020.2021. The increase in G&A expense was primarily due to a $1.0 millionan increase in salaries and other costs associated with the hiring of new employees. These amounts were slightly offset by $0.5 million in salariesprofessional fees related to executive separation payments recorded in the prior year period.April reverse stock-split as well as increased salary expense related to additional headcount.
The decrease in depreciation for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 is related to the disposal of property and equipment during the year-ended December 31, 2021.
We recognized anThe increase in interest income for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 is primarily attributable to higher interest earned on cash and investments.
The decrease in income tax benefit of $0.4 million during the nine months ended September 30, 2022 compared to the nine months ended September 31, 2021 is due to the tax effect of the reduction in the deferred tax liability associated with the basis differences from the DFN 529DFN-529 IPR&D intangible asset that was written down in the third quarter of 2021. We recognized an income tax benefit of $1.7 million during the nine months ended 2020 to reflect the utilization of indefinite deferred tax liabilities as a source of income against indefinite lived portions of 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.
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 September 30, 2021,2022, we had $40.3$6.6 million in cash and cash equivalents, working capital of $38.0$24.1 million and an accumulated deficit of $126.5$141.5 million. We expect to continue to incur net losses for the foreseeable future. We intend to use our existing cash and cash equivalents to fund our working capital and research and development of our product candidates.candidates, subject to the outcome and timing of our ongoing strategic review process.
Cash Flows
The following table sets forth our cash flows for the nine months ended September 30, 20212022 and 2020:2021:
Nine Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
Net cash (used in) provided by: | 2021 | 2020 | 2022 | 2021 | ||||||||||||
Operating activities | $ | (11,476,302 | ) | $ | (10,158,041 | ) | $ | (11,495,802 | ) | $ | (11,476,302 | ) | ||||
Investing activities | (19,235,738 | ) | — | |||||||||||||
Financing activities | 33,295,752 | 17,890,875 | 5,000 | 33,295,752 | ||||||||||||
Net increase in cash and cash equivalents | $ | 21,819,450 | $ | 7,732,834 | ||||||||||||
Net (decrease) increase in cash and cash equivalents | $ | (30,726,540 | ) | $ | 21,819,450 |
As of December 31, 2021, we did not own any marketable securities. The decrease in cash and cash equivalents during the nine months ended September 30, 2022 is primarily attributable to purchases of marketable securities during the period intended to preserve capital, fulfill the Company's liquidity needs, and maximize investment performance in accordance with the Company's investment policies and guidelines.
Operating Activities
Net cash used in operating activities of $11.5 million during the nine months ended September 30, 2022 was primarily attributable to our net loss of $11.5 million and our net change in operating assets and liabilities of $0.6 million. This amount was offset by $0.7 million in stock-based compensation expense as well as $0.1 million of amortization of premium and discount on marketable securities. 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 a decrease in our prepaid expenses, deposits and other current assets.
Net cash used in operating activities of $11.5 million during the nine months ended September 30, 2021 was primarily attributable to our net loss of $20.6 million and a change in our deferred income taxes of $0.4 million. These amounts were partially offset by a $8.6 million non cash impairment charge in connection with the write down of our DFN-529 IPR&D asset, $0.6 million in stock-based compensation expense, and a net change in our operating assets and liabilities of $0.2 million.
Net cash used in operating activities of $10.2 million during the nine months ended September 30, 2020 was primarily attributable to our net loss of $10.1 million and our change in deferred income taxes of $1.7 million. These amounts were partially offset by a net change in operating assets and liabilities of $1.4 million, $0.6 million in stock-based compensation expense, and $0.1 million in depreciation expense. The net change in our operating assets and liabilities was primarily attributable to an increase in accounts payable and accrued expenses and was slightly offset by an increase in our prepaid expenses, deposits and other current assets.
Investing Activities
Net cash used in investing activities during the nine months ended September 30, 2022 was attributable to the purchase of $38.0 million of marketable securities and maturities of $18.8 million of marketable securities.
Financing Activities
Net cash provided by financing activities was $5,000 during the nine months ended September 30, 2022, which was attributable to net proceeds received from the sale of our Series C Preferred Stock.
Net cash provided by financing activities was $33.3 million during the nine months ended September 30, 2021, which was attributable to net proceeds of $31.1 million received from the sale of our common stock in connection with the February 2021 Offering and $2.2 million in proceeds received from the exercise of previously issued common stock warrants.
Net cash provided by financing activities of $17.9 million during the nine months ended September 30, 2020, was primarily attributable to $10.8 million in gross proceeds received in connection with the May 2020 Offering and $8.0 million in gross proceeds received in connection with the exercise of previously outstanding warrants to purchase common stock. These cash inflows were offset in part by the payment of $1.0 million in financing 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 and any other product candidates we may in-license or acquire in the TSC platform, as well as associated investments into our manufacturing, regulatory, and other related capabilities.future. As of the date of this Quarterly Report, most of our cash resources for clinical development are dedicated to our remaining Oxygenation Trialsongoing and our Hypoxic Solid Tumor Program, near-term investments intended to improve the quality and robustness of our supplier relationships and overall supply chain, and general operating expenses.planned clinical trials. While we currently believe we have adequate cash resources to continue operations through 2023,into the first quarter of 2024 (subject to the outcome and timing of our ongoing strategic review process), we anticipate that we will need additional funding in order to complete development of TSC and any other assets we may in-license or acquire which, if available, could be obtained through additional capital raising transactions, entry into strategic partnerships or collaborations, or alternative financing arrangements.
In July 2022, into an at-the-market sales agreement, or the 2022 Sales Agreement with BTIG, as agent, pursuant to which the Company may sell up to an aggregate of $20.0 million in shares of the Company’s common stock, from time to time through BTIG, by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. As of September 30, 2021,the date of this filing, we didhave not havesold any credit facilities in placeshares under which we could borrow funds or any other sources of committed capital. the 2022 Sales Agreement.
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, including as a result of unanticipated market shocks, such as the COVID-19 pandemic and ongoing global supply chain disruptions, or inflationary pressure.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.
Critical Accounting Policies
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, 2021 have not changed.
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
As of the date of this Quarterly Report, the Critical Accounting Policies included in our Annual 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 Exchange Act Rules 13a-15(e) and 15d-15(e)) that are designed to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’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 Exchange Act Rule 13a-15(f) that occurred during the quarter ended September 30, 20212022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. | LEGAL PROCEEDINGS |
Please refer to Note 7, 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 and our subsequent quarterly reports on Form 10-Q, other thanexcept as set forth below.below:
Our strategic review process may not result in entering into or completing a transaction, and the process of reviewing strategic alternatives or its conclusion could adversely affect our stock price.
If we cannot regain compliance
We have initiated a process to review strategic alternatives with the Nasdaq Capital Market continued listing standards , our common stock couldgoal of enhancing shareholder value. Potential strategic alternatives to be delisted, which would harm our business,explored and evaluated during the trading pricereview process may include the sale of our common stock,company, a merger, acquisition or other business combination, a strategic partnership with one or more parties, the licensing, sale or divestiture of some of our ability to raise additional capital andproprietary technologies, or a variety of other potential opportunities. We are actively working with an investment bank in this assessment process, Additionally, as part of this process, we are actively seeking a partner for the liquidityfurther development of the market for our common stock.TSC.
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 November 3, 2021, we received a written notice from the staff of the Listing Qualifications Department of Nasdaq relating to the minimum bid price requirement contained in Nasdaq Listing Rule 5550(a)(2). As previously disclosed, on May 6, 2021 the Company received a written notice from the staff indicating that the Company was not in compliance with the minimum bid price rule because the bid price for the Company’s 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), the Company was provided 180 calendar days, or until November 2, 2021, to regain compliance. The November 3 notice stated that, although the Company had not regained compliance prior to November 2, 2021, in accordance with Nasdaq Listing Rule 5810(c)(3)(F), the staff has determined that the Company is eligible for an additional 180 calendar days from the date of the second notice, or until May 2, 2022, to regain compliance.
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 any transaction will result from the Company’s evaluation. Any potential transaction would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to us or third parties in a potential transaction with us on reasonable terms. The process of reviewing strategic alternatives may be time consuming and may involve the dedication of significant resources and may require us to incur significant costs and expenses. It could negatively impact our ability to attract, retain and motivate key employees, and expose us to potential litigation in connection with this process or any resulting transaction. If we are unable to effectively manage the process, our financial condition and results of operations could be adversely affected. In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of our company could cause our stock price to fluctuate significantly. Further, any strategic alternative that may be pursued and completed ultimately may not deliver the anticipated benefits or enhance shareholder value. There can be no guarantee that the reverse stock split will be approved orprocess of evaluating strategic alternatives will result in our company entering into or completing a sustained higherpotential transaction within the anticipated timing or at all.
Our Business could be negatively affected as a result of a proxy contest.
As announced on November 14, 2022, certain entities affiliated with LifeSci Capital ("LifeSci”) have nominated seven individuals for election to our Board at our upcoming 2022 annual meeting of stockholders. If LifeSci does not withdraw its nominations and the proxy contest continues, our business could be adversely affected because, among other things:
• | responding to a proxy contest can be disruptive, costly and time-consuming, and divert the attention of our management, Board and employees; | |
• | perceived uncertainties as to future direction, including, but not limited to, uncertainties related to our the composition of our Board and management team may result in the loss of potential business opportunities, and may make it more difficult to attract and retain qualified personnel or other business partners; and | |
• | if individuals are elected to our Board of Directors with a specific agenda, it may adversely affect our ability to continue to effectively implement our business strategy and create additional value for our stockholders. |
Additional actions taken by activist stockholders could be disruptive and costly and may conflict with or disrupt the strategic direction of our business.
Particularly following our recent announcement of our ongoing strategic review process, activist stockholders may from time to time attempt to effect changes in our strategic direction and seek changes regarding the Company’s corporate governance or structure. Our Board and management team strive to maintain constructive, ongoing communications with all stockholders who wish to speak with us, including activist stockholders, and welcome their views and opinions with the goal of working together constructively to enhance value for all stockholders. However, activist campaigns that contest, or conflict with, our strategic direction could have an adverse effect on the Company or our business. For example, responding to actions by activist stockholders can disrupt our operations, be costly and time consuming, and divert the attention of our Board and senior management from the pursuit of our business strategies. Furthermore, perceived uncertainties as to our future direction may cause (i) instability or lack of continuity, which may be exploited by our competitors, (ii) concern on the part of current or potential collaborators, (iii) loss of business opportunities, and (iv) difficulties in attracting and retaining qualified personnel and business partners. Activist campaigns may also cause significant fluctuations in our stock price based on temporary or speculative market perceptions, or other factors that will allow us to meetdo not necessarily reflect the Nasdaq stock price listing requirements, and there is no guarantee we will continue to satisfy the other Nasdaq Capital Market continued listing standards.fundamental underlying value of our businesses.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Unregistered Sales of Equity Securities
None.
Issuer Purchases of Equity Securities
None.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
ITEM 5. | OTHER INFORMATION |
On November 8, 2021, we entered into a Deed of Lease Termination Agreement with the Carlton Landlord providing for the early termination of the Carlton Lease related to our prior corporate headquarters. The Carlton Lease was previously scheduled to expire on April 30, 2022 and, as of September 30, 2021, our aggregate amount of future minimum rental payments thereunder was approximately $69,536. In connection with the termination, we will make a one-time payment to the Carlton Landlord of approximately $14,000, after deducting anticipated returns of deposits in accordance with the Carlton Lease.
In addition to the economic savings, our decision to terminate the Carlton Lease early was also driven by our more general embrace of the remote work culture that became prevalent at many organizations during the COVID-19 pandemic. We believe our people are critical to our ability to efficiently and successfully execute our stated strategy, and that a remote operating paradigm allows us to enhance our available pool of talented human resources while also conserving financial resources.
We also believe in the value of collaboration. In lieu of the fixed office and laboratory space previously available to us under the Carlton Lease, we have recently entered into short term agreements to utilize membership-based co-working space in both Charlottesville, Virginia and Philadelphia, Pennsylvania. We believe these arrangements will permit our team to combine the advantages of remote and in-person work in environments intended to foster creativity and innovation.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 |
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 September 30, | Filed herewith |
104 | Cover Page Interactive Data File |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: November 10, 202114, 2022
DIFFUSION PHARMACEUTICALS INC. | |||
By: | /s/ Robert J. Cobuzzi, Jr. | ||
Robert J. Cobuzzi, Jr. | |||
President and Chief Executive Officer | |||
(Principal Executive Officer) | |||
By: | /s/ William Hornung | ||
William Hornung | |||
Chief Financial Officer | |||
(Principal Financial Officer and Principal Accounting Officer) |