UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended December 31, 20212022
Or
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☐ | 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 333-88480001-35963
NEUBASE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
| 46-5622433 |
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
350 Technology Drive, Pittsburgh, PA 15219
(Address of principal executive offices and zip code)
(646412) 450-1790763-3350
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
Common Stock, $0.0001 par value per share | | NBSE | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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.
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Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
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| 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 ☒
As of February 4, 2022, 32,768,18410, 2023, 33,155,356 shares of the common stock, par value $0.0001, of the registrant were outstanding.
Table of Contents
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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-i-
PART I.
ITEM 1. FINANCIAL STATEMENTS
NeuBase Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
| | | | | | |
|
| December 31, |
| September 30, | ||
|
| 2021 |
| 2021 | ||
ASSETS | | | | | | |
CURRENT ASSETS |
| |
|
| |
|
Cash and cash equivalents | | $ | 47,326,060 | | $ | 52,893,387 |
Prepaid insurance | | | 313,577 | | | 499,061 |
Other prepaid expenses and current assets | |
| 844,404 | |
| 1,536,186 |
Total current assets | |
| 48,484,041 | |
| 54,928,634 |
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|
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|
|
EQUIPMENT, net | |
| 2,464,643 | |
| 2,463,882 |
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|
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|
|
OTHER ASSETS | |
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Investment | |
| 0 | |
| 415,744 |
Right-of-use asset, operating lease asset | | | 5,841,696 | | | 5,945,295 |
Security deposit | | | 253,615 | | | 253,615 |
Other long-term assets | | | 0 | | | 160,423 |
Total other assets | | | 6,095,311 | | | 6,775,077 |
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TOTAL ASSETS | | $ | 57,043,995 | | $ | 64,167,593 |
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|
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | |
CURRENT LIABILITIES | |
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|
|
Accounts payable | | $ | 1,193,713 | | $ | 1,807,885 |
Accrued expenses and other current liabilities | | | 2,412,880 | | | 1,747,746 |
Insurance note payable | | | 0 | | | 148,385 |
Operating lease liabilities | |
| 429,507 | |
| 382,576 |
Finance lease liabilities | | | 111,513 | | | 107,632 |
Total current liabilities | |
| 4,147,613 | |
| 4,194,224 |
| | | | | | |
Long-term operating lease liability | | | 5,683,192 | | | 5,794,096 |
Long-term finance lease liability | | | 78,987 | | | 109,500 |
TOTAL LIABILITIES | | | 9,909,792 | | | 10,097,820 |
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|
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COMMITMENTS AND CONTINGENCIES | | | | | | |
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STOCKHOLDERS’ EQUITY | |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2021 and September 30, 2021 | |
| 0 | |
| 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized; 32,768,184 and 32,721,493 shares issued and outstanding as of December 31, 2021 and September 30, 2021, respectively | |
| 3,276 | |
| 3,272 |
Additional paid-in capital | |
| 123,827,646 | |
| 123,034,404 |
Accumulated deficit | |
| (76,696,719) | |
| (68,967,903) |
Total stockholders’ equity | |
| 47,134,203 | |
| 54,069,773 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 57,043,995 | | $ | 64,167,593 |
| | | | | | |
|
| December 31, |
| September 30, | ||
| | 2022 | | 2022 | ||
|
| Unaudited |
| Audited | ||
ASSETS | | | | | | |
CURRENT ASSETS |
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Cash and cash equivalents | | $ | 17,386,326 | | $ | 23,152,663 |
Prepaid insurance | | | 188,266 | | | 319,699 |
Other prepaid expenses and current assets | |
| 391,655 | |
| 1,176,303 |
Total current assets | |
| 17,966,247 | |
| 24,648,665 |
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EQUIPMENT, net | |
| 1,934,100 | |
| 2,156,851 |
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OTHER ASSETS | |
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Right-of-use asset, operating lease asset | | | 5,409,574 | | | 5,614,698 |
Security deposit | | | 273,215 | | | 273,215 |
Total other assets | | | 5,682,789 | | | 5,887,913 |
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TOTAL ASSETS | | $ | 25,583,136 | | $ | 32,693,429 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | |
CURRENT LIABILITIES | |
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Accounts payable | | $ | 369,505 | | $ | 1,843,027 |
Accrued expenses and other current liabilities | | | 1,227,656 | | | 1,662,660 |
Operating lease liabilities | |
| 469,118 | |
| 553,066 |
Finance lease liabilities | | | 78,987 | | | 107,632 |
Total current liabilities | |
| 2,145,266 | |
| 4,166,385 |
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Long-term operating lease liability | | | 5,214,074 | | | 5,335,164 |
TOTAL LIABILITIES | | $ | 7,359,340 | | $ | 9,501,549 |
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COMMITMENTS AND CONTINGENCIES | |
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STOCKHOLDERS’ EQUITY | |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of December 31, 2022 and September 30, 2022 | | $ | — | | $ | — |
Common stock, $0.0001 par value; 250,000,000 shares authorized; 33,155,356 and 33,008,657 shares issued and outstanding as of December 31, 2022 and September 30, 2022, respectively | | | 3,315 | | | 3,300 |
Additional paid-in capital | | | 125,333,873 | | | 125,932,933 |
Accumulated deficit | | | (107,113,392) | | | (102,744,353) |
TOTAL STOCKHOLDERS’ EQUITY | | | 18,223,796 | | | 23,191,880 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 25,583,136 | | $ | 32,693,429 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
NeuBase Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
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| | Three Months Ended | | | | | | | ||||
| | December 31, | | Three Months ended December 31, | ||||||||
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| 2021 |
| 2020 |
| 2022 |
| 2021 | ||||
OPERATING EXPENSES |
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General and administrative | | $ | 2,935,710 | | $ | 2,641,470 | | $ | 2,596,412 | | $ | 2,935,710 |
Research and development | |
| 4,369,257 | |
| 2,019,924 | |
| 1,351,407 | | | 4,369,257 |
Restructuring | |
| 652,451 | | | — | ||||||
TOTAL OPERATING EXPENSES | |
| 7,304,967 | |
| 4,661,394 | |
| 4,600,270 | | | 7,304,967 |
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LOSS FROM OPERATIONS | |
| (7,304,967) | | | (4,661,394) | |
| (4,600,270) | | | (7,304,967) |
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OTHER INCOME (EXPENSE) | |
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Interest expense | |
| (15,219) | |
| (9,737) | |
| (1,868) | | | (15,219) |
Interest income | | | 1,254 | | | 0 | | | 147,604 | | | 1,254 |
Change in fair value of warrant liabilities | |
| 0 | |
| 630,112 | ||||||
Equity in losses on equity method investment | |
| (415,744) | |
| (25,412) | |
| — | | | (415,744) |
Other income, net | | | 5,860 | | | 0 | | | 85,495 | | | 5,860 |
Total other (expense) income, net | |
| (423,849) | |
| 594,963 | ||||||
Total other income (expense), net | |
| 231,231 | | | (423,849) | ||||||
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NET LOSS | | $ | (7,728,816) | | $ | (4,066,431) | | $ | (4,369,039) | | $ | (7,728,816) |
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BASIC AND DILUTED LOSS PER SHARE | | $ | (0.24) | | $ | (0.18) | | $ | (0.13) | | $ | (0.24) |
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WEIGHTED AVERAGE SHARES OUTSTANDING: | |
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BASIC AND DILUTED | |
| 32,725,718 | |
| 23,174,168 | |
| 33,015,035 | | | 32,725,718 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
NeuBase Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders’ Equity
For the Three Months Ended December 31, 20212022 and 20202021
(Unaudited)
| | | | | | | | | | | | | | |
| | Common Stock | | Additional Paid-In | | Accumulated | | Total Stockholders’ | ||||||
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | ||||
Balance as of September 30, 2020 |
| 23,154,084 | | $ | 2,315 | | $ | 74,850,935 | | $ | (43,558,602) | | $ | 31,294,648 |
Stock-based compensation expense | | — | | | — | | | 1,176,585 | | | — | | | 1,176,585 |
Issuance of restricted stock for services | | 1,931 | | | — | | | — | | | — | | | — |
Exercise of stock options | | 21,576 | | | 2 | | | 112,444 | | | — | | | 112,446 |
Net loss | | — | | | — | | | — | | | (4,066,431) | | | (4,066,431) |
Balance as of December 31, 2020 | | 23,177,591 | | $ | 2,317 | | $ | 76,139,964 | | $ | (47,625,033) | | $ | 28,517,248 |
| | | | | | | | | | | | | | | ||||||||||||||
| | | | | | | Additional | | | | Total | |||||||||||||||||
| | Common Stock | | Paid-In | | | | | Stockholders’ | |||||||||||||||||||
| | | | | | | | | | | | | | |
| Shares |
| Amount |
| Capital |
| Accumulated Deficit |
| Equity | ||||
Balance as of September 30, 2021 | | 32,721,493 | | $ | 3,272 | | $ | 123,034,404 | | $ | (68,967,903) | | $ | 54,069,773 | | 32,721,493 | | $ | 3,272 | | $ | 123,034,404 | | $ | (68,967,903) | | $ | 54,069,773 |
Stock-based compensation expense | | — |
| | — | |
| 793,204 | |
| — | |
| 793,204 | | — |
| | — | |
| 793,204 | |
| — | |
| 793,204 |
Issuance of restricted stock for services | | 4,441 | | | — | | | — | | | — | | | — | | 4,441 | | | — | | | — | | | — | | | — |
Exercise of stock options | | 42,250 | | | 4 | | | 38 | | | — | | | 42 | | 42,250 | | | 4 | | | 38 | | | — | | | 42 |
Net loss | | — |
| | — | |
| — | |
| (7,728,816) | |
| (7,728,816) | | — |
| | — | |
| — | |
| (7,728,816) | |
| (7,728,816) |
Balance as of December 31, 2021 | | 32,768,184 | | $ | 3,276 | | $ | 123,827,646 | | $ | (76,696,719) | | $ | 47,134,203 | | 32,768,184 | | $ | 3,276 | | $ | 123,827,646 | | $ | (76,696,719) | | $ | 47,134,203 |
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Balance as of September 30, 2022 | | 33,008,657 | | $ | 3,300 | | $ | 125,932,933 | | $ | (102,744,353) | | $ | 23,191,880 | ||||||||||||||
Stock-based compensation expense | | — | | | — | | | (509,072) | | | — | | | (509,072) | ||||||||||||||
Issuance of common stock and commitment obligation as fee for future financing | | 146,699 | | | 15 | | | (89,988) | | | — | | | (89,973) | ||||||||||||||
Net loss | | — | | | — | | | — | | | (4,369,039) | | | (4,369,039) | ||||||||||||||
Balance as of December 31, 2022 | | 33,155,356 | | $ | 3,315 | | $ | 125,333,873 | | $ | (107,113,392) | | $ | 18,223,796 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
NeuBase Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| | | | | | |
| | Three Months Ended | ||||
| | December 31, | ||||
|
| 2021 |
| 2020 | ||
Cash flows from operating activities | | |
| | | |
Net loss | | $ | (7,728,816) | | $ | (4,066,431) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | |
| |
Stock-based compensation | |
| 793,204 | |
| 1,176,585 |
Change in fair value of warrant liabilities | |
| 0 | |
| (630,112) |
Depreciation and amortization | |
| 181,490 | |
| 68,117 |
Loss on marketable securities | | | 30 | | | 14,970 |
Loss on disposal of fixed assets | |
| 7,595 | |
| 0 |
Equity in losses on equity method investment | |
| 415,744 | |
| 25,412 |
Non-cash expense from right-of-use assets | | | 103,599 | | | 0 |
Changes in operating assets and liabilities | |
| | |
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Prepaid insurance, other prepaid expenses and current assets | |
| 877,266 | |
| (25,132) |
Long-term prepaid insurance | | | 0 | | | 48,417 |
Security deposit | |
| 0 | |
| (253,565) |
Other long-term assets | |
| 160,423 | |
| 0 |
Accounts payable | | | (680,142) | | | (327,087) |
Accrued expenses and other current liabilities | |
| 665,134 | |
| 187,965 |
Operating lease liability | | | (63,973) | | | 0 |
Net cash used in operating activities | |
| (5,268,446) | |
| (3,780,861) |
Cash flows from investing activities | |
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| |
Purchase of laboratory and office equipment | |
| (123,876) | |
| (193,571) |
Purchase of marketable securities | | | (14,986,818) | | | (15,003,771) |
Sale of marketable securities | | | 14,986,788 | | | 14,988,801 |
| | | | | | |
Net cash used in investing activities | |
| (123,906) | |
| (208,541) |
Cash flows from financing activities | |
| | |
| |
Principal payment of financed insurance | | | (148,385) | | | (138,557) |
Principal payment of finance lease liability | | | (26,632) | | | 0 |
Proceeds from exercise of stock options | |
| 42 | |
| 112,446 |
Net cash used in financing activities | |
| (174,975) | |
| (26,111) |
Net decrease in cash and cash equivalents | |
| (5,567,327) | |
| (4,015,513) |
Cash and cash equivalents, beginning of period | | | 52,893,387 | | | 31,992,283 |
Cash and cash equivalents, end of period | | $ | 47,326,060 | | $ | 27,976,770 |
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Supplemental disclosure of cash flow information: | | | | | | |
Cash paid for interest | | $ | 0 | | $ | 10,400 |
Cash paid for income taxes | | $ | 0 | | $ | 0 |
Non-cash investing and financing activities: | | | | | | |
Purchases of laboratory and office equipment in accounts payable | | $ | 65,970 | | $ | 0 |
| | | | | | |
| | Three months ended December 31, | ||||
|
| 2022 |
| 2021 | ||
Cash flows from operating activities | | |
| | | |
Net loss | | $ | (4,369,039) | | $ | (7,728,816) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | |
| |
Stock-based compensation | |
| (509,072) | | | 793,204 |
Depreciation and amortization | |
| 198,563 | | | 181,490 |
Loss on marketable securities | | | — | | | 30 |
Loss on disposal of fixed assets | |
| 65,532 | | | 7,595 |
Equity in losses on equity method investment | |
| — | | | 415,744 |
Amortization of right-of-use assets | | | 120,094 | | | — |
Non-cash expense from right-of-use assets | | | — | | | 103,599 |
Changes in operating assets and liabilities | |
| | |
| |
Prepaid insurance, other prepaid expenses and current assets | |
| 924,581 | | | 877,266 |
Other long-term assets | |
| — | | | 160,423 |
Accounts payable | | | (1,496,850) | | | (680,142) |
Accrued expenses and other current liabilities | |
| (501,649) | | | 665,134 |
Operating lease liability | | | (120,008) | | | (63,973) |
Net cash used in operating activities | |
| (5,687,848) | | | (5,268,446) |
Cash flows from investing activities | |
| | | | |
Purchase of laboratory and office equipment | |
| (49,844) | | | (123,876) |
Purchase of marketable securities | | | — | | | (14,986,818) |
Sale of marketable securities | | | — | | | 14,986,788 |
Net cash used in investing activities | |
| (49,844) | | | (123,906) |
Cash flows from financing activities | |
| | | | |
Principal payment of financed insurance | | | — | | | (148,385) |
Principal payment of finance lease liability | | | (28,645) | | | (26,632) |
Proceeds from exercise of stock options | |
| — | |
| 42 |
Net cash used in financing activities | | | (28,645) | | | (174,975) |
Net decrease in cash and cash equivalents | | | (5,766,337) | | | (5,567,327) |
Cash and cash equivalents, beginning of period | | | 23,152,663 | | | 52,893,387 |
Cash and cash equivalents, end of period | | $ | 17,386,326 | | $ | 47,326,060 |
| | | | | | |
| | | | | | |
Supplemental disclosure of cash flow information: | | | | | | |
Non-cash investing and financing activities: | | | | | | |
Issuance of common stock and commitment obligation as fee for future financing | | $ | 30,000 | | $ | — |
Equity issuance costs, unpaid | | $ | 59,973 | | $ | — |
Sale of laboratory equipment in other prepaid expenses and current assets | | $ | 8,500 | | $ | — |
Impairment of right-of-use asset and lease liability | | $ | 85,030 | | $ | — |
Purchases of laboratory and office equipment in accounts payable | | $ | — | | $ | 65,970 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization, and Description of Business and Liquidity
NeuBase Therapeutics, Inc. and its subsidiaries (the “Company” or “NeuBase”) is developing a modular peptide-nucleic acid (“PNA”) antisense oligo (“PATrOL™”) platform to address genetic diseases, with a single, cohesive approach. The PATrOL™-enabled anti-gene therapies are designed to improve upon current genetic medicine strategies by combining the advantages of synthetic approaches with the precision of antisense technologies. NeuBase plans to use its platform to address diseases which have a genetic source, with an initial focus on Myotonic Dystrophy Typegene silencing in myotonic dystrophy type 1 (“DM1”), Huntington’s Diseasedisease (“HD”), and oncology, and in gene editing applications.
NeuBase is a preclinical-stage biopharmaceutical company and continues to develop its clinical and regulatory strategy with its internal research and development team, with a view toward prioritizing market introduction as quickly as possible. NeuBase’s disclosed programs are NT-0100 in HD, NT-0200 in DM1 and NT-0300 in KRAS-driven cancers:KRAS-driven cancers.
The NT-0100 program is a PATrOL™-enabled therapeutic program being developed to target the mutant expansion in the HD DNA or RNA. The NT-0100 program includes proprietary PNAs which have the potential to be highly selective for the mutant copy of the gene versus the wild-type allele, the expectation being that the resultant therapy will be applicable for all HD patients as it directly targets the expansion itself, and the potential to be delivered systemically and address the brain and whole-body manifestations of the disease. PATrOL™-enabled drugs also have the unique ability to open DNA and RNA secondary structures and bind to either the primary nucleotide sequences or the secondary and/or tertiary structures. The NT-0200 program is a PATrOL™-enabled therapeutic program being developed to target the mutant expansion in the DM1 disease RNA. The NT-0200 program has the potential to be highly selective for the mutant transcript versus the wild-type transcribed allele and the expectation to be effective for nearly all DM1 patients as it directly targets the expansion itself. The NT-0300 program is a PATrOL™-enabled therapeutic program being developed to target the mutated KRAS gene. The program is comprised of candidate compounds that target two activating mutations in the KRAS gene at the DNA or RNA levels: G12D and G12V. |
NeuBase believes these candidate compounds, and subsequent further optimized compounds, have the potential to inhibit transcription and/or translation of the oncogenic mutations and slow or stop tumor growth.
In October 2022, the Company announced plans to expand its three aforementioned programs address unmet needsfocus to include the advancement of the differentiated gene editing capabilities of its platform. The Company is currently identifying and evaluating multiple indications for diseases that currently have no effective therapeutics that target the etiologies of these conditions. NeuBase further believes there is a large opportunity in the U.S. and European markets for drugs in these areas.potential future development.
Liquidity and Going Concern
The Company has had no revenues from product sales and has incurred operating losses since inception. As of December 31, 2021,2022, the Company had $47.3$17.4 million in cash and cash equivalents, and during the three months ended December 31, 2021,2022, incurred a net loss from operations of $7.7$4.6 million and used $5.3$5.7 million of cash in operating activities.
The Company expects to continue to incur significantsubstantial operating losses and negative cash flows from operations for the foreseeable future and may never become profitable. AsAccordingly, there are material risks and uncertainties that raised substantial doubt about the Company’s ability to continue as a result,going concern. In October 2022, as further discussed below, the Company will likely needannounced a restructuring plan to raise additional capital through one or morereduce its operating expenses and extend its cash runway into the second quarter of the following: the issuance of additional debt or equity or the completion of a licensing transaction for one or more of the Company’s pipeline assets.calendar year 2024 based on current operating plans and estimates. Management believes it is probable that the restructuring plan will be effectively implemented within the next twelve months and that the restructuring plan, when implemented, will mitigate the conditions that gave rise to substantial doubt about the Company’s ability to continue as a going concern. Because the Company has sufficient working capitalresources on hand to fund operations through at least the next twelve months from the date these consolidated financial statements were available to be issued.issued, the substantial doubt has been alleviated. There can be no assurance that the Company will be successful in acquiring additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years.
The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
● | its ability to raise additional funds to finance its operations; |
5
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
● | its ability to maintain compliance with the listing requirements of The Nasdaq Capital Market (“Nasdaq”) |
● | the outcome, costs and timing of preclinical and clinical trial results for the Company’s current or future product candidates; |
● | the extent and amount of any indemnification claims; |
● | litigation expenses and the extent and amount of any indemnification claims; |
● | the emergence and effect of competing or complementary products; |
● | its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
● | its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; |
● | the trading price of its common stock; and |
● | its ability to increase the number of authorized shares outstanding to facilitate future financing events. |
The Company will likely need to raise substantial additional funds through issuance of equity or debt or completion of a licensing transaction for one or more of the Company’s pipeline assets. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. Failure to obtain additional equity or debt financing will have a material, adverse impact on the Company’s business operations. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, any equity financings will likely have a dilutive effect on the holdings of the Company’s existing stockholders.
2. Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto as of and for the year ended September 30, 20212022 included in the Company’s Annual Report on Form 10-K (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (“SEC”) on December 23, 2021.21, 2022. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. In the opinion of management, the accompanying unaudited condensed consolidated financial statements for the periods presented reflect all adjustments, consisting of only normal, recurring adjustments, necessary to fairly state the Company’s financial position, results of operations and cash flows. The unaudited condensed consolidated financial statements for the interim periods are not necessarily indicative of results for the full year. The preparation of these unaudited condensed consolidated financial statements requires the Company to make estimates and judgments that affect the amounts reported in the financial statements and the accompanying notes. The Company’s actual results may differ from these estimates under different assumptions or conditions.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s unaudited condensed consolidated financial statements relate to the valuation of stock-based compensation, the valuation of licenses, the fair value of warrant liabilities and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
6
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company assesses and updates estimates each period to reflect current information, such as the economic considerations related to the impactimpacts that the novel coronavirus disease (“COVID-19”)current economic environment could have on its significant accounting estimates. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Fair Value Measurements
Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value:
Level 1 – Quoted prices in active markets for identical assets or liabilities on the reporting date.
6
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates.
Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed, or initial amounts recorded, may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange.
Marketable Securities
Marketable securities are classified as trading and are carried at fair value. The Company’s marketable securities consist of corporate bonds and highly liquid mutual funds and exchange-traded and closed-end funds which are valued at quoted market prices. The Company had 0 marketable securities as of December 31, 2021 and September 30, 2021.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the dilutive effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options 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 December 31, 20212022 and 20202021 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:
| | | | | | | | |
| | As of December 31, | | As of December 31, | ||||
|
| 2021 |
| 2020 |
| 2022 |
| 2021 |
Common stock purchase options |
| 7,197,404 | | 6,633,554 |
| 7,310,686 | | 7,197,404 |
Restricted stock units |
| 10,000 | | — |
| — | | 10,000 |
Common stock purchase warrants |
| 875,312 | | 820,939 |
| 180,000 | | 875,312 |
| | 8,082,716 | | 7,454,493 | | 7,490,686 | | 8,082,716 |
Recent Accounting Pronouncements
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The adoption of this standard as of October 1, 2021, did not impact the Company's consolidated financial statements and related disclosures.
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This guidance introduces a new model for recognizing credit losses on financial
7
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
instruments based on an estimate of current expected credit losses. ASU 2016-13 also provides updated guidance regarding the impairment of available-for-sale debt securities and includes additional disclosure requirements. The new guidance is effective for public business entities that meet the definition of a Smaller Reporting Company as defined by the SEC for interim and annual periods beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.Recent Accounting Pronouncements
In May 2021, the FASBFinancial Accounting Standards Board (“FASB”) issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2021-04”). This guidance reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. ASU 2021-04 provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. The Company adopted this guidance as of October 1, 2022, with no impact upon adoption.
In November 2021, the FASB issued ASU 2021-04No. 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance”, which amends disclosures to increase transparency of government assistance, including (i) the types of assistance, (ii) accounting for the assistance and (iii) the effect of the assistance on an entity’s financial statements. The standard is effective for all business entities for annual periods beginning after December 15, 2021; therefore, it will be effective beginning with the Company’s financial statements issued for all entitiesthe fiscal year ending September 30, 2023. While the adoption of this guidance will not have an impact on the Company’s consolidated balance sheet or statement of operations, the adoption of this guidance may require additional annual disclosures in the Company’s financial statements for the fiscal year ending September 30, 2023, which the Company is currently in the process of assessing.
In June 2022, the FASB issued ASU 2022-03, “ASC Subtopic 820 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions” (“ASU 2022-03”). ASU 2022-03 amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments.2023, and interim periods within those fiscal years. Early adoption is permitted includingfor both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures.
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This guidance introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. ASU 2016-13 also provides updated guidance regarding the impairment of available-for-sale debt securities and includes additional disclosure requirements. The new guidance is effective for public business entities that meet the definition of a Smaller Reporting Company as defined by the Securities and Exchange Commission for interim and annual periods beginning after December 15, 2022. Early adoption in an interim period.is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.
3. Other Prepaid Expenses and Other Current Assets
The Company’s prepaid expenses and other current assets consisted of the following:
| | | | | | |
| | As of December 31, | | As of September 30, | ||
|
| 2021 |
| 2021 | ||
Prepaid research and development expense | | $ | 453,706 | | $ | 583,267 |
Prepaid rent | | | — | | | 172,518 |
Other prepaid expenses and other current assets | |
| 390,698 | |
| 780,401 |
Total | | $ | 844,404 | | $ | 1,536,186 |
4. Equipment
The Company’s equipment consisted of the following:
| | | | | | |
| | As of December 31, | | As of September 30, | ||
|
| 2021 |
| 2021 | ||
Laboratory equipment | | $ | 2,909,472 | | $ | 2,737,390 |
Office equipment | |
| 259,978 | |
| 259,978 |
Leasehold improvements | | | 10,128 | | | — |
Total | |
| 3,179,578 | |
| 2,997,368 |
Accumulated depreciation | |
| (714,935) | |
| (533,486) |
Property, plant and equipment, net | | $ | 2,464,643 | | $ | 2,463,882 |
Depreciation expense for the three months ended December 31, 2021 and 2020 was approximately $0.2 million and $0.1 million, respectively.
5. Investment
The Company owns common and preferred shares of DepYmed Inc. (“DepYmed”), which represents approximately 15% ownership of DepYmed.
8
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company accounts for its investment in DepYmed common shares using the equity method of accounting3. Other Prepaid Expenses and records its proportionate share of DepYmed’s net income and losses in the accompanying consolidated statements of operations.Current Assets
The Company accounts for its investment in preferred shares of DepYmed at cost, less any impairment, as the Company determined the preferred stock did not have a readily determinable fair value.
The carrying valueCompany’s prepaid expenses and other current assets consisted of the Company’s investment in DepYmed common shares was reduced to zero, therefore, during the three months ended December 31, 2021, the Company recorded its share of equity losses to the extent of its investment in preferred shares of DepYmed. The Company will continue to monitor the operating results of DepYmed and will record equity in earnings when the equity in earnings exceeds the Company’s previously unrecognized losses.
Equity in losses for the three months ended December 31, 2021 and 2020 were approximately $0.4 million and $0.03 million, respectively.
The carrying value of the Company’s total investment in DepYmed is as follows:following:
| | | | | | | | | | | | |
| | As of December 31, | | As of September 30, | | As of December 31, | | As of September 30, | ||||
|
| 2021 |
| 2021 | | 2022 | | 2022 | ||||
Carrying value of DepYmed common shares | | $ | — | | $ | — | ||||||
| | | | | | |
| Unaudited |
| Audited | ||
Fair value of DepYmed preferred shares assumed in connection with acquisition of Ohr Pharmaceutical, Inc., a Delaware corporation that completed a Merger with NeuBase Therapeutics (“Ohr”) | |
| — | |
| 99,020 | ||||||
DepYmed preferred shares received in sale of intellectual property | |
| — | |
| 316,724 | ||||||
Total Investment | | $ | — | | $ | 415,744 | ||||||
Prepaid research and development expense | | $ | 67,027 | | $ | 805,542 | ||||||
Accounts receivable | | | 150,000 | | | — | ||||||
Franchise tax receivable | | | — | | | 127,715 | ||||||
Other prepaid expenses and current assets | |
| 174,628 | |
| 243,046 | ||||||
Total | | $ | 391,655 | | $ | 1,176,303 |
4. Equipment
The Company’s equipment consisted of the following:
| | | | | | |
| | As of December 31, | | As of September 30, | ||
| | 2022 | | 2022 | ||
|
| Unaudited |
| Audited | ||
Laboratory equipment | | $ | 3,048,579 | | $ | 3,175,019 |
Office equipment | |
| 259,978 | |
| 259,978 |
Leasehold improvements | | | 17,958 | | | 17,958 |
Total | |
| 3,326,515 | |
| 3,452,955 |
Accumulated depreciation and amortization | |
| (1,392,415) | |
| (1,296,104) |
Equipment, net | | $ | 1,934,100 | | $ | 2,156,851 |
Depreciation expense for the three months ended December 31, 2022 and 2021 was approximately $0.2 million and $0.2 million, respectively.
6.5. Accrued Expenses and Other Current Liabilities
The Company’s accrued expenses and other current liabilities consisted of the following:
| | | | | | | ||||||
| | | | | | | | As of December 31, | | As of September 30, | ||
| | As of December 31, | | As of September 30, | | 2022 | | 2022 | ||||
|
| 2021 |
| 2021 |
| Unaudited |
| Audited | ||||
Accrued compensation and benefits | | $ | 1,095,617 | | $ | 880,707 | | $ | 171,572 | | $ | 768,324 |
Accrued consulting settlement | | | 300,000 | | | 200,000 | | | 225,000 | | | 150,000 |
Accrued professional fees | |
| 203,816 | |
| 299,557 | |
| 241,808 | |
| 191,516 |
Accrued research and development | |
| 720,875 | |
| 297,047 | |
| 20,684 | |
| 512,570 |
Accrued franchise tax | | | 77,120 | | | 30,720 | | | 217,440 | | | 36,542 |
Accrued restructuring | | | 316,032 | | | — | ||||||
Other accrued expenses | |
| 15,452 | |
| 39,715 | |
| 35,120 | |
| 3,708 |
Total | | $ | 2,412,880 | | $ | 1,747,746 | | $ | 1,227,656 | | $ | 1,662,660 |
7. Notes Payable
6. Stockholders’ Equity
Insurance Note PayableEquity Purchase Agreement
As ofOn December 31, 2021 and September 30, 2021,28, 2022, the Company hadentered into a purchase agreement (the “Equity Purchase Agreement”) with Alumni Capital LP, a Delaware limited partnership (“Alumni Capital”), pursuant to which the following insurance note payable outstanding:
| | | | | | | | | | | | | |
| | | | Stated | | | | | Balance at | | Balance at | ||
| | Maturity | | Interest | | Original | | December 31, | | September 30, | |||
|
| Date |
| Rate |
| Principal |
| 2021 |
| 2021 | |||
Insurance Note Payable |
|
|
|
|
| |
|
| |
|
| |
|
2021 Insurance Note |
| January 2022 |
| 4.99 | % | $ | 391,625 | | $ | — | | $ | 148,385 |
Company agreed to sell, and Alumni Capital agreed to
9
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
8. Leases
In October 2020,purchase, upon request of the Company entered intoin one or more transactions, a ten-year operating lease agreement with annual escalating rental payments for approximately 14,189 square feetnumber of office and laboratory space in Pittsburgh, Pennsylvania. The leased premises will serve asshares of the Company’s headquarters. The first and second amendmentscommon stock providing aggregate gross proceeds to the lease agreement were executed in December 2020 and April 2021, respectively (collectively withCompany of up to $3,000,000 (subject to the lease agreement, referred to herein asright, but not the “Lease”). In November 2020,obligation, of the Company prepaid rentto increase such amount up to $10,000,000 pursuant to the terms of $0.3 million and paidthe Equity Purchase Agreement) (the “Maximum Investment Amount”). The Equity Purchase Agreement expires upon the earlier of the aggregate gross proceeds from the sale of shares of common stock meeting the Maximum Investment Amount or December 28, 2024.
Among other limitations, unless otherwise agreed upon by Alumni Capital, each individual sale of shares of common stock will be limited to a security depositsale of $0.3 million forshares of common stock of up to $500,000 (subject to the Lease. The Lease commenced on May 1, 2021, andright of the Company was obligatedand Alumni Capital to begin making rental payments on this date.mutually agree to increase such figure to $1,000,000) and further limited to no more than the number of shares of common stock that would result in the direct or indirect beneficial ownership by Alumni Capital of more than 9.99% of the then-outstanding shares of common stock. Alumni Capital will purchase the shares of common stock under the Equity Purchase Agreement at the lowest traded price of the common stock during the three (3) business days immediately prior to the date of purchase of the shares of common stock multiplied by 95%.
Upon execution of the Equity Purchase Agreement, the Company issued 146,699 shares of common stock to Alumni Capital. The Company appliedwill issue to Alumni Capital, on December 28, 2023, shares of common stock in an amount equal to one-half of one percent (0.5%) of the prepaidInvestment Amount (as defined in the Equity Purchase Agreement) divided by the closing price of the common stock on the third business day prior to the date of issuance and delivery of such shares of common stock. In addition, the Company will issue to Alumni Capital, on the date of expiration of the Equity Purchase Agreement, shares of common stock in an amount towardequal to one-half of one percent (0.5%) of the rental payments through December 2021.Investment Amount divided by the closing price of the common stock on the third business day prior to the date of issuance and delivery of such shares of common stock. If the Company elects to increase the Maximum Investment Amount, it shall issue to Alumni Capital Increase Commitment Shares (as defined in the Equity Purchase Agreement) (based on each increase of Investment Amount) within five (5) business days of the Company’s written notice of such election. The Company recorded the commitment shares issued and future commitment share obligation as additional paid-in capital during the three months ended December 31, 2022.
As of December 31, 2022, the Company has not sold any shares of common stock under the Equity Purchase Agreement.
Warrants
Below is also entitled to use halfa summary of the security deposit towards rental payments in MayCompany’s issued and June 2022. The Company measured and recognized an initial right-of-use (“ROU”) asset and operating lease liability upon lease commencement. The Company has the right to extend the termoutstanding warrants as of the Lease for an additional five-year term; however, this extension has not been included in the calculation of the lease liability and ROU asset at the lease inception as the exercise of the option was not reasonably certain.
The Company continued to operate under its operating lease in Pittsburgh until the Company moved into its new headquarters and laboratory space, which occurred in June 2021. The Company’s prior office and operating space was leased under operating leases with original terms of less than 12 months which expired at various dates through November 2021; therefore, the Company’s previous operating leases are not recognized as ROU assets on the consolidated balance sheet. The Company also maintained a short-term rental of office space in San Diego and New York, which expired in November 2021. . In October 2021, the Company commenced a one-year lease for the rental of office space in Boston, which extends through October 2022.
In August 2021, the Company entered into a two-year finance lease for certain laboratory equipment. The Company measured and recognized an initial right-of-use (“ROU”) asset and finance lease liability upon lease commencement.
At December 31, 2021 and September 30, 2021, ROU assets and lease liabilities were as follows:2022:
| | | | | | | | |
| | | | As of December 31, | | As of September 30, | ||
|
| |
| 2021 |
| 2021 | ||
Assets: |
| Classification | | | | | | |
Operating lease right-of-use-asset |
| Operating lease asset | | $ | 5,841,696 | | $ | 5,945,295 |
Financing lease right-of-use-asset |
| Equipment, net | |
| 188,252 | |
| 216,490 |
| | | | $ | 6,029,948 | | $ | 6,161,785 |
| | | | | | | | |
Liabilities: | |
| |
|
| |
|
|
Current | | Classification | |
|
| |
|
|
Operating | | Operating lease liability | | $ | 429,507 | | $ | 382,576 |
Financing | | Financing lease liability | |
| 111,513 | |
| 107,632 |
Long-term | |
| |
|
| |
|
|
Operating | | Long-term portion of operating leases liability | |
| 5,683,192 | |
| 5,794,096 |
Financing | | Long-term portion of financing leases liability | |
| 78,987 | |
| 109,500 |
| | | | $ | 6,303,199 | | $ | 6,393,804 |
| | | | | |
| | | | | Warrants |
Expiration date |
| Exercise Price Per Share |
| Outstanding | |
July 6, 2023 | |
| 8.73 |
| 105,000 |
September 20, 2024 | | | 6.50 | | 75,000 |
| |
| | | 180,000 |
| | | | | | | |
| | | | | | | Weighted- |
| | | | Weighted- | | Average | |
| | | | Average | | Remaining | |
| | | | Exercise | | Contractual Life | |
|
| Warrants |
| Price Per Share |
| (in years) | |
Outstanding as of September 30, 2022 | | 180,000 | | $ | 7.80 | | |
Expired | | — | | | — | | |
Outstanding as of December 31, 2022 | | 180,000 | | | 7.80 | | 1.0 |
Exercisable as of December 31, 2022 | | 180,000 | | $ | 7.80 | | 1.0 |
10
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following tables summarize quantitative information about the Company’s leases for the three months ended December 31, 2021 and 2020:
| | | | | | |
|
| Three Months Ended December 31, | ||||
|
| 2021 |
| 2020 | ||
Operating cash flows - operating lease | | | 176,578 | | $ | 0 |
Operating cash flows - financing leases | | | 3,807 | | | 0 |
Financing cash flows - financing leases | | | 26,632 | | | 0 |
| | | | | | |
Right-of-use asset obtained in exchange for operating lease liabilities | | | 0 | |
| 0 |
Finance lease assets obtained in exchange for finance lease liabilities | | | 0 | | | 0 |
|
|
|
|
|
|
| |
|
| ||
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
| | | | | | |
| | Three Months Ended | ||||
| | December 31, | ||||
|
| 2021 |
| 2020 | ||
Operating leases |
| |
|
| |
|
Operating lease cost | | $ | 216,204 | | $ | 0 |
Variable lease costs | | | 0 | | | 0 |
Operating lease cost | | | 216,204 | | | 0 |
Short-term lease rent expense | |
| 13,716 | |
| 28,026 |
Financing leases | | | | | | |
Amortization of leased assets | | | 28,238 | | | 0 |
Interest on lease liabilities | | | 3,807 | | | 0 |
Financing lease cost | | | 32,045 | | | 0 |
Net lease cost | | $ | 261,965 | | $ | 28,026 |
As of December 31, 2021, future minimum lease payments under the non-cancelable leases were as follows:
| | | | | | |
| | Operating | | Financing | ||
|
| Lease | | Leases | ||
Nine Months Ending September 30, 2022 | | | 646,083 | | | 121,752 |
Year Ending September 30, 2023 | |
| 867,367 | | | 111,606 |
Year Ending September 30, 2024 | |
| 874,320 | | | 0 |
Year Ending September 30, 2025 | |
| 881,391 | | | 0 |
Year Ending September 30, 2026 | |
| 888,627 | | | 0 |
Thereafter | |
| 4,401,029 | | | 0 |
Total | |
| 8,558,817 | | | 233,358 |
Less present value discount | |
| (2,446,118) | | | (42,858) |
Operating lease liabilities | | $ | 6,112,699 | | $ | 190,500 |
11
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
9. Fair Value
As of December 31, 2021 and September 30, 2021, the fair value of warrants measured at fair value was $0. The fair value of the warrant liabilities was determined using level 3 inputs and the Black-Scholes option pricing model. The following assumptions were used in determining the fair value of the warrant liabilities:
| | | | |
| | As of December 31, | | As of September 30, |
|
| 2021 |
| 2021 |
Remaining contractual term (years) |
| 0.3 | | 0.2 - 0.5 |
Common stock price volatility |
| 62.5% | | 60.6% - 62.5% |
Risk-free interest rate |
| 0.1% | | 0.04% |
Expected dividend yield |
| — | | — |
The change in fair value of the warrant liabilities for the three months ended December 31, 2020 was $0.6 million.
As of December 31, 2021 and September 30, 2021, the carrying value of cash and cash equivalents, accounts payable and the insurance note payable approximate fair value due to the short-term nature of these instruments.
10. Stockholders’ Equity
Warrants
Below is a summary of the Company’s issued and outstanding warrants as of December 31, 2021:
| | | | | |
| | | | | Warrants |
Expiration date |
| Exercise Price |
| Outstanding | |
April 10, 2022 | | $ | 20.00 |
| 695,312 |
July 6, 2023 | |
| 8.73 |
| 105,000 |
September 20, 2024 | | | 6.50 | | 75,000 |
| |
| | | 875,312 |
| | | | | | | |
| | | | | | | Weighted |
| | | | Weighted | | Average | |
| | | | Average | | Remaining | |
| | | | Exercise | | Contractual Life | |
|
| Warrants |
| Price |
| (in years) | |
Outstanding as of September 30, 2021 | | 895,939 | | $ | 18.35 | | |
Expired | | (20,627) | | | 55.00 | | |
Outstanding as of December 31, 2021 | | 875,312 | | | 17.49 | | 0.6 |
Exercisable as of December 31, 2021 | | 837,812 | | $ | 17.98 | | 0.5 |
12
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
11.7. Stock-Based Compensation
As of December 31, 2021,2022, an aggregate of 6,018,136 shares of common stock were authorized under the Company’s 2019 Stock Incentive Plan (the “2019 Plan”), subject to an “evergreen” provision that will automatically increase the maximum number of shares of common stock that may be issued under the term of the 2019 Plan. As of December 31, 2021, 1,869,7702022, 935,495 common shares were available for future grants under the 2019 Plan. As of December 31, 2021,2022, 291,667 shares of common stock were authorized under the Company’s 2016 Consolidated Stock Incentive Plan (the “2016 Plan”) and 147,041228,041 common shares were available for future grants under the 2016 Plan.
The Company recorded stock-based compensation expense in the following expense categories of its unaudited condensed consolidated statements of operations for the three months ended December 31, 20212022 and 2020:2021:
| | | | | | | | | | | | |
| | Three Months Ended December 31, | | Three Months ended December 31, | ||||||||
|
| 2021 |
| 2020 |
| 2022 |
| 2021 | ||||
General and administrative | | $ | 327,131 | | $ | 842,279 | | $ | 276,336 | | $ | 327,131 |
Research and development | |
| 466,073 | |
| 334,306 | |
| (785,408) | | | 466,073 |
Total | | $ | 793,204 | | $ | 1,176,585 | | $ | (509,072) | | $ | 793,204 |
Stock-based compensation expense for the three months ended December 31, 2022 and 2021 includes the reversal of expense previously recognized for unvested stock options of $0.8 million that were forfeited during the period. The stock-based compensation expense benefit included in the Research and development expense category is primarily the result of stock options forfeited in connection with the Company’s restructuring, see Note 8.
Stock Options
Below is a table summarizing the options issued and outstanding as of and for the three months ended December 31, 2021:2022:
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | Weighted | | | | | | | | | | Weighted | | | |
| | | | Weighted | | Average | | Total | | | | Weighted | | Average | | Total | ||||
| | | | Average | | Remaining | | Aggregate | | | | Average | | Remaining | | Aggregate | ||||
| | | | Exercise | | Contractual Life | | Intrinsic | | | | Exercise | | Contractual Life | | Intrinsic | ||||
|
| Stock Options |
| Price |
| (in years) |
| Value |
| Stock Options |
| Price Per Share |
| (in years) |
| Value | ||||
Outstanding at September 30, 2021 | | 7,397,154 | | $ | 3.13 | |
| | |
| ||||||||||
Outstanding at September 30, 2022 | | 7,629,281 | | $ | 3.08 | | | | | | ||||||||||
Granted | | 105,000 | | | 3.59 | |
| | |
| | 390,000 | | | 0.28 | | | | | |
Exercised | | (42,250) | | | 0.00 | | | | | | ||||||||||
Forfeited | | (262,500) | | | 5.07 | | | | | | | (708,595) | | | 5.01 | | | | | |
Outstanding at December 31, 2021 | | 7,197,404 | | | 3.08 | | 6.9 | | $ | 9,185,031 | ||||||||||
Exercisable as of December 31, 2021 | | 5,360,067 | | $ | 2.33 | | 6.2 | | $ | 9,184,698 | ||||||||||
Outstanding at December 31, 2022 | | 7,310,686 | | | 2.66 | | 6.4 | | $ | 476,723 | ||||||||||
Exercisable as of December 31, 2022 | | 5,048,630 | | $ | 2.76 | | 5.3 | | $ | 476,723 |
As of December 31, 2021,2022, unrecognized compensation costs associated with the stock options of $3.5$1.4 million will be recognized over an estimated weighted-averageweighted average amortization period of 1.41.1 years.
The intrinsic value of options exercised during the three months ended December 31, 2021 and 2020 was $0.1 million and $0.1 million, respectively.million. No options were exercised during the three months ended December 31, 2022.
The weighted average grant date fair value of options granted during the three months ended December 31, 2022 and 2021 was $0.19 and 2020 was $2.33, and $5.20, respectively.
1311
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Key assumptions used to estimate the fair value of the stock options granted during the three months ended December 31, 2022 and 2021 included:
| | | | |
| | Three months Ended December 31, | ||
|
| 2022 |
| 2021 |
Expected term of options (years) | | 5.3 – 6.1 | | 5.1 – 6.1 |
Expected common stock price volatility | | 79.2% – 82.4% | | 73.8% – 74.5% |
Risk-free interest rate | | 3.8% – 4.3% | | 1.1% – 1.4% |
Expected dividend yield | | — | | — |
Key assumptions used8. Restructuring
Restructuring charges relate primarily to estimate the fair valueCompany’s strategic restructuring to expand its focus to include the advancement of the stock options granteddifferentiated gene editing capabilities of its platform. The Company recognized restructuring costs of $0.7 million during the three months ended December 31, 20212022, comprised primarily of contract termination costs of $0.6 million and 2020 included:termination benefits related to headcount reductions of $0.1 million. Employee termination benefits were recognized at the date employees were notified and post-employment benefits were accrued as the obligation was probable and estimable.
| | | | |
| | Three Months Ended December 31, | ||
|
| 2021 |
| 2020 |
Expected term of options (years) | | 5.1 - 6.1 | | 6.0 |
Expected common stock price volatility | | 73.8% - 74.5% | | 83.1% - 83.3% |
Risk-free interest rate | | 1.1% - 1.4% | | 0.6% - 0.7% |
Expected dividend yield | | — | | — |
During the fiscal year ended September 30, 2021, the Company granted a stock option to purchase 225,000 shares to a consultant, which was cancelled and reissued in June 2021 in recognition of future service to the Company as an employee. The exercisability and vesting of the stock option are subject to the consultant’s effective date of employment with the Company, which had not yet occurred as of December 31, 2021, and as a result, the grant-date of such option has not occurred under GAAP. Therefore, the number and fair value of the shares subject to this option are not reflectedfollowing table summarizes activity in the table summarizing the options issued and outstanding as of and for the three months ended December 31, 2021, and did not have impact on unrecognized compensation costs or the estimated weighted-average amortization period above as of December 31, 2021.
Restricted Stock
A summary of the changes in the unvested restricted stockCompany’s restructuring-related liability during the three months ended December 31, 2021 is as follows:2022:
| | | | | | |
| | | | | Weighted Average | |
| | | | | Grant Date | |
|
| Unvested Restricted |
| Fair Value | ||
| | Stock | | Price | ||
Unvested as of September 30, 2021 |
| | 0 | | $ | 0 |
Granted | | | 4,441 | | | 3.94 |
Vested |
| | (4,441) | |
| 3.94 |
Unvested as of December 31, 2021 |
| | 0 | | | 0 |
Total unrecognized expense remaining | | $ | 0 | |
|
|
Weighted-average years expected to be recognized over | |
| — | |
|
|
Restricted Stock Units
Below is a table summarizing the restricted stock units granted and outstanding as of and for the three months ended December 31, 2021:
| | | | | | | | | | | | | | | | | | |
| | | | | Weighted Average |
| Liability at |
| Restructuring |
| Payments/ |
| Liability at | |||||
| | | | | Grant Date |
| September 30, 2022 |
| Charges |
| Utilization |
| December 31, 2022 | |||||
| | Restricted Stock | | Fair Value | ||||||||||||||
|
| Units |
| Price | ||||||||||||||
Unvested as of September 30, 2021 |
| | 10,000 | | $ | 5.09 | ||||||||||||
Granted |
| | — | |
| | ||||||||||||
Unvested as of December 31, 2021 |
| | 10,000 | |
| 5.09 | ||||||||||||
Total unrecognized expense remaining | | $ | 35,580 | | | | ||||||||||||
Weighted-average years expected to be recognized over | |
| 1.7 | | | | ||||||||||||
Employee-related costs | | $ | — | | $ | 97,627 | | $ | (97,627) | | $ | — | ||||||
Research and development contract termination costs | |
| — | | | 540,058 | |
| (228,948) | |
| 311,110 | ||||||
Other | |
| — | |
| 14,766 | |
| (9,844) | |
| 4,922 | ||||||
Total Accrued restructuring | | $ | — | | $ | 652,451 | | $ | (336,419) | | $ | 316,032 |
14
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
12.9. Commitments and Contingencies
Litigation
The Company has become involved in certain legal proceedings and claims which arise in the normal course of business. The Company believes that an adverse outcome is unlikely, and it cannot reasonably estimate the potential loss at this point. If an unfavorable ruling were to occur, there exists the possibility of a material adverse impact on the Company’s results of operations, prospects, cash flows, financial position and brand. Costs associated with the Company’s involvement in legal proceedings are expensed as incurred.
Securities Class Action Lawsuit
On February 14, 2018, plaintiff Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr and several current and former officers and directors, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc., filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint, but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. We and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On September 20, 2019, the district court entered an order granting the defendants’ motion to dismiss. On October 23, 2019, the plaintiffs filed a notice of appeal of that order dismissing the action and other related orders by the district court. After full briefing and oral argument, on October 9, 2020, the U.S. Court of Appeals for the Second Circuit issued a summary order affirming the district court’s order granting the motion to dismiss and remanding the action to the district court to make a determination on the record related to plaintiffs’ request for leave to file an amended complaint. On remand, the district court denied plaintiffs’ subsequent request to amend and dismissed with prejudice plaintiffs’ claims. On December 16, 2020, plaintiffs filed a notice of appeal of that order denying plaintiffs leave to amend. On December 16, 2021, the Second Circuit affirmed the decision and order of the district court denying plaintiffs’ motion for leave to amend, thereby dismissing the appeal and action in its entirety. Plaintiffs have not sought reconsideration of the Second Circuit’s decision, and the current deadline for plaintiffs to file a writ of certiorari for review by the Supreme Court of the United States is March 15, 2022.
Derivative Lawsuit
On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against certain former directors of Ohr, including Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason S. Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. We and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending the exhaustion of all appeals from the decision of the Southern District of New York dismissing the Khanna action discussed above. These matters could result in substantial costs and a diversion of management’s resources and attention, which could harm our business and the value of our common stock.
15
NeuBase Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Joint Proxy Statement Lawsuit
On March 20, 2019, a putative class action lawsuit was filed in the United States District Court for District of Delaware naming as defendants Ohr and its board of directors, Legacy NeuBase, and Ohr Acquisition Corp., captioned Wheby v. Ohr Pharmaceutical, Inc., et al., Case No. 1:19-cv-00541-UNA (the “Wheby Action”). The plaintiffs in the Wheby Action allege that the preliminary joint proxy/prospectus statement filed by Ohr with the SEC on March 8, 2019, contained false and misleading statements and omitted material information in violation of Section 14(a) of the Exchange Act and SEC Rule 14a-9 promulgated thereunder, and further that the individual defendants are liable for those alleged misstatements and omissions under Section 20(a) of the Exchange Act. The complaint in the Wheby Action has not been served on, nor was service waived by, any of the named defendants in that action. The action seeks, among other things, to rescind the Merger or an award of damages, and an award of attorneys’ and experts’ fees and expenses. The defendants dispute the claims raised in the Wheby Action. Management believes that the likelihood of an adverse decision from the sole remaining action is unlikely; however, the litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm our business and the value of our common stock.
Note 13. Subsequent Events
Subsequent to December 31, 2021, the Company granted approximately 1.3 million stock options to officers and employees of the Company in accordance with the 2019 Plan. The grants have a weighted average exercise price of $2.07 per option and, a contractual term of 10 years.
1612
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Disclosures Regarding Forward-Looking Statements
The following should be read in conjunction with the unaudited condensed consolidated financial statements and the related notes that appear elsewhere in this report as well as in conjunction with the Risk Factors section in our Annual Report on Form 10-K for the fiscal year ended September 30, 2021,2022, as filed with the United States Securities and Exchange Commission (“SEC”) on December 23, 2021.21, 2022. This report and our Form 10-K include forward-looking statements made based on current management expectations pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.
This report includes “forward-looking statements” within the meaning of Section 21E of the Exchange Act. Those statements include statements regarding the intent, belief or current expectations of the Company and its subsidiaries and our management team. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and actual results may differ materially from those projected in the forward-looking statements. These risks and uncertainties include but are not limited to those risks and uncertainties set forth in Part II, Item 1A – Risk Factors of this Quarterly Report and in Part I, Item 1A – Risk Factors of our Annual Report on Form 10-K. In light of the significant risks and uncertainties inherent in the forward-looking statements included in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K, the inclusion of such statements should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. Further, these forward-looking statements reflect our view only as of the date of this report. Except as required by law, we undertake no obligations to update any forward-looking statements and we disclaim any intent to update forward-looking statements after the date of this report to reflect subsequent developments. Accordingly, you should also carefully consider the factors set forth in other reports or documents that we file from time to time with the SEC.
SummaryOverview
NeuBase Therapeutics, Inc. (“NeuBase”, “Company”, “we”, “us” and “our”) is a biotechnology company focused on significantly reducing the burden of untreatable morbidity and mortality across the globe caused by rare and common diseases.
To achieve this goal, we have designed, built, and validated a new precision genetic medicines platform technology able to uniquely drug the double-stranded human genome and address disease at the root of causality without many of the limitations of early precision genetic medicine technologies.
We are poised to file our first Investigational New Drug (“INDs”) applications with the U.S. Food and Drug Administration (“FDA”) beginning in calendar year 2022 and intend to scale into additional indications with increasing speed and efficiency.
Overview
Most diseases remain undruggable with current therapeutic modalities, leaving millions of patients with limited options. These include rare diseases, cancers, common chronic and infectious diseases. Most diseases are genetic, in whole or in part, underscoring the critical importance of new medicines that can drug the human genome for the future of health. Yet the genome has been difficult to target with therapies due to its double-stranded structure, which evolved to protect the fidelity of this essential blueprint of life.
The complexity associated with drugging proteins, each of which is a unique and often dynamic molecular entity, has resulted in a drug development process that is commonly inefficient, time-consuming, and expensive with low probabilities of success. This strategy has, in part, resulted in high drug prices and a high remaining burden of unmet patient need.
These issues could potentially be resolved by targeting the genetic material itself instead of downstream protein products. Precision genetic medicines represent a relatively new class of therapies that target genetic sequences that are the root cause of diseases.
17
We have designed, built, and validated a new technology platform (a peptide-nucleic acid antisense oligonucleobase platform, which we call PATrOL™) that can uniquely Drug the Genome™ to address the three disease-causing mechanisms (i.e., gain-of-function, change-of-function, or loss-of-function of a gene), without the limitations of early precision genetic medicines. The technology is predicated on synthetic peptide-nucleic acid (“PNA”) chemistry and can directly engage the genome in a sequence-specific manner and address root causality of diseases. These compounds operate by temporarily engaging the genome (or single and double-stranded RNA targets, if desired) and interferinginteracting with cellular machinery that processprocesses mutant genes to halt their ability to manifest a disease.
We have repeatedly demonstrated in proof-of-concept preclinical animal studies across FY2020 and FY2021, the ability to address multiple disease-causing genes, and different causal mechanisms, to resolve the disease state without the limitations of early genetic medicine technologies. These limitations, and the data that illustrate that we have likely engineered them out of our platform to potentially unlock broad impact across many diseases, are:
As further validation of our PATrOL™ platform’s capabilities, in FY2021 and FY2022, we described data illustrating that our first-in-class platform technology can address various types of causal insults by Drugging the Genome™ in animal models of a variety of human diseases after patient-friendly routes of administration and does so in a well-tolerated manner.
18
Based on what we believe is a solid foundation, FY2021 marked a transition from a research-stage to a development-stage company. We established new research laboratories and administrative offices in Pittsburgh, PA, expanded our pipeline to include both rare disease and oncology, recruited clinical development and chemistry manufacturing and controls (“CMC”) teams, established offices in Cambridge, MA, nominated a development compound for our DM1 program, initiated good manufacturing practice (“GMP”) manufacturing scale up, finalized the formulation work for subcutaneous and intravenous routes, initiated PK/ADME studies with the DM1 development candidate, and initiated PK/pharmacodynamics (“PD”) studies to define the dosing regimen for initial human studies. In addition, we have continued to optimize candidates for our HD and KRAS programs, illustrating pharmacology in vivo in appropriate animal models of each. Additionally, in FY2021 we developed a proprietary genetic disease database with utility in prioritization of pipeline expansion and partnership opportunities.
We are developing precision genetic medicines targeting rare, monogenic diseases for which there are no approved therapies, as well as more common genetic disorders, including cancers that are resistant to current therapeutic approaches. Our disclosed pipeline includes therapeutic candidates for the treatment of DM1, HD, andas well as cancer-driving point mutations in KRAS, G12V and G12D, which are involved in many tumor types and have historically been “undruggable”.
Based on compelling results from in vitro and in vivo preclinical studies, we plan In October 2022, the Company announced plans to file an IND application for our DM1 investigational therapy inexpand its focus to include the fourth quarter of CY2022. We are targeting CY2023 to file an IND application for an investigational therapy to treat Huntington’s disease. Both are devastating systemic diseases with no effective therapies. Our oncology program has recently been announced (FY2021), together with in vivo activity illustrating allele-selective engagement of mutant KRAS at the DNA and RNA levels, with abrogation of downstream hyperactive signaling through multiple RAS pathway members, resulting in anti-tumor activity. We continue to improve upon our platform while concurrently developing programs, resulting in next-generation compounds that continue to make their way through preclinical development in a parallel manner. We have recently finalized an analysisadvancement of the entire known mutational databasedifferentiated gene editing capabilities of its platform. The Company is currently identifying and selected several additional high-valueevaluating multiple indications for screening andpotential future development.
Figure 4. The initial pipeline in rare disease and oncology, with platform learnings increasing the efficiency and speed additional undisclosed programs, both internally developed and in discussions for co-development with partners.
We are poised to file a series of IND applications for indications with large unmet needs such as DM1, which is expected to reach IND application filing by the end of CY2022, HD expected to reach IND application in CY2023 and cancers (KRAS G12V and G12D mutations) likely thereafter.
1913
In advanceWe were incorporated under the laws of the State of Delaware on August 4, 2009, as successor to BBM Holdings, Inc. (formerly known as Prime Resource, Inc., which was organized March 29, 2002 as a Utah corporation) pursuant to a reincorporation merger. On August 4, 2009, we reincorporated in Delaware as “Ohr Pharmaceutical, Inc.” On July 12, 2019, we completed the merger with NeuBase Corporation (formerly known as NeuBase Therapeutics, Inc.), a Delaware corporation (the “Merger”), and, upon completion of the Merger, we changed our name to “NeuBase Therapeutics, Inc.” Since the Merger, we have focused primarily on the development of our first IND application filingproprietary peptide-nucleic acid antisense oligo platform and preclinical-stage therapeutic candidates. Our platform technology and all of our therapeutic candidates are in the fourth quarterpreclinical development stage. We have not initiated clinical trials for any of CY2022our product candidates, nor have any products been approved for commercial sale, and we have not generated any revenue. To date, we have not completed a clinical trial (including a pivotal clinical trial), obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for a third party to do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization. Drug development is also a highly uncertain undertaking and involves a substantial degree of risk. As a result, we have no meaningful historical operations upon which to evaluate our business and prospects and have not yet demonstrated an ability to obtain marketing approval for any of our product candidates or successfully overcome the risks and uncertainties frequently encountered by companies in the pharmaceutical industry. We also have not generated any revenues from collaboration and licensing agreements or product sales to date and continue to incur research and development and other expenses. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital, and our subsequent planned transitionfuture success is subject to asignificant uncertainty.
For the foreseeable future, we expect to continue to incur operating losses, which we expect will increase significantly from recent historical levels as we advance our gene editing platform, expand our drug development activities, seek regulatory approvals for our product candidates and begin to commercialize them if they are approved by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or comparable foreign authorities. Even if we succeed in developing and commercializing one or more product candidates, we may never become profitable.
We expect to expend substantial funds in research and development, including preclinical studies and clinical stage companytrials for our platform technology and product candidates, and to manufacture and market any product candidates in the event they are approved for commercial sale. We will likely need additional funding to develop or acquire complementary companies, technologies and assets, as well as for working capital requirements and other operating and general corporate purposes. Moreover, an increase in our combined Phase 1/2headcount would dramatically increase our costs in the near and long-term.
Such spending may not yield any commercially viable products. Due to our limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on specific indications. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
Because the successful development of our product candidates is uncertain, we are unable to precisely estimate the actual funds we will require to develop and potentially commercialize them. In addition, we may not be able to generate sufficient revenue, even if we are able to commercialize any of our product candidates, to become profitable
The Company expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future. We will need to seek additional equity or debt financing to provide the capital required to maintain or expand our operations.
In particular, we expect that we will need to obtain additional funding to obtain clinical trial in DM1, the following data sets are plannedfrom our current pipeline programs. We have based these estimates on assumptions that may prove to be disseminated:wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
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There can be no assurance that we will be able to raise sufficient additional capital on acceptable terms or at all. If such additional financing is not available on satisfactory terms, or is not available in sufficient amounts, we may be required to delay, limit or eliminate the development of business opportunities, and our ability to achieve our business objectives, our competitiveness, and our business, financial condition and results of operations may be materially adversely affected. In addition, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
2014
Critical Accounting Estimates and Policies
The preparation of financial statements in accordance with United States generally accepted accounting principles (“U.S. GAAP”)GAAP requires management to make estimates and assumptions that affect the amounts reported in our unaudited condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although these estimates are based on management’s best knowledge of current events and actions that may impact us in the future, the estimation process is, by its nature, uncertain given that estimates depend on events over which we may not have control. If market and other conditions change from those that we anticipate, our unaudited condensed consolidated financial statements may be materially affected. In addition, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material effect in our unaudited condensed consolidated financial statements. We review our estimates, judgments, and assumptions used in our accounting practices periodically and reflect the effects of revisions in the period in which they are deemed to be necessary. We believe that these estimates are reasonable; however, our actual results may differ from these estimates.
Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended September 30, 2021,2022, and there have been no material changes to such policies or estimates during the three months ended December 31, 2021.2022.
Recent Accounting Pronouncements
Please refer to Note 2, Significant Accounting Policies—Recent Accounting Pronouncements, in Item 1, Financial Statements, for a discussion of recent accounting pronouncements.
Results of Operations
Results of operations for the three months ended December 31, 2021,2022, reflect the following changes from the three months ended December 31, 2020:2021:
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| | |
| |
General and administrative | | $ | 2,935,710 | | $ | 2,641,470 | | $ | 294,240 | | $ | 2,596,412 | | $ | 2,935,710 | | $ | (339,298) |
Research and development | |
| 4,369,257 | |
| 2,019,924 | |
| 2,349,333 | | | 1,351,407 | | | 4,369,257 | | | (3,017,850) |
Restructuring |
| | 652,451 |
| | — |
| | 652,451 | |||||||||
TOTAL OPERATING EXPENSES | |
| 7,304,967 | |
| 4,661,394 | |
| 2,643,573 |
| | 4,600,270 |
| | 7,304,967 |
| | (2,704,697) |
LOSS FROM OPERATIONS | |
| (7,304,967) | |
| (4,661,394) | |
| (2,643,573) |
| | (4,600,270) |
| | (7,304,967) |
| | 2,704,697 |
OTHER INCOME (EXPENSE) | |
| | |
| | |
| |
| |
|
| |
|
| |
|
Interest expense | |
| (15,219) | |
| (9,737) | |
| (5,482) |
| | (1,868) |
| | (15,219) |
| | 13,351 |
Interest income | |
| 1,254 | |
| — | |
| 1,254 |
| | 147,604 |
| | 1,254 |
| | 146,350 |
Change in fair value of warrant liabilities | |
| — | |
| 630,112 | |
| (630,112) | |||||||||
Equity in losses on equity method investment | |
| (415,744) | |
| (25,412) | |
| (390,332) |
| | — |
| | (415,744) |
| | 415,744 |
Other income, net | |
| 5,860 | |
| — | |
| 5,860 |
| | 85,495 |
| | 5,860 |
| | 79,635 |
Total other (expense) income, net | |
| (423,849) | |
| 594,963 | |
| (1,018,812) | |||||||||
Total other income (expense), net |
| | 231,231 |
| | (423,849) |
| | 655,080 | |||||||||
NET LOSS | | $ | (7,728,816) | | $ | (4,066,431) | | $ | (3,662,385) | | $ | (4,369,039) | | $ | (7,728,816) | | $ | 3,359,777 |
During the three months ended December 31, 2021,2022, our operating loss increaseddecreased by $2.6$2.7 million compared to the three months ended December 31, 2020.2021. Our net loss increaseddecreased by $3.7$3.4 million for the three months ended December 31, 2021,2022, as compared to the three months ended December 31, 2020.2021. Until we are able to generate revenue from product sales, our management expects to continue to incur net losses.
General and Administrative Expenses
General and administrative expenses consist primarily of legal and professional fees, wages and stock-based compensation. General and administrative expenses increaseddecreased by $0.3 million for the three months ended December 31, 2021,2022, as compared to the three months ended December 31, 2020,2021, primarily due to increases in professional fees, settlement costs, and administrative expenses, partially offset by a decrease in stock-based compensation expense.wage expenses.
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Research and Development Expenses
Research and development expenses consist primarily of professional fees, research, development, and manufacturing expenses, and wages and stock-based compensation. ResearchDue to the Company’s restructuring, research and development expenses increaseddecreased by $2.3$3.0 million for the three months ended December 31, 2021,2022, as compared to the three months ended December 31, 2020,2021, primarily due to increasesa decrease in research, development, and manufacturing expenses, professional fees, employee head count, and the ramp up of researchwages and development activities.stock-based compensation.
Change in Fair Value of Warrant LiabilitiesRestructuring
Change in fair value of warrant liabilities reflects the changes in the fair value of outstanding warrants which is primarily driven by changes in our stock price. The fair value of warrant liabilities was $0 at December 31, 2021 and September 30, 2021, therefore, no change in fair value was recognizedRestructuring charges incurred during the three months ended December 31, 2021. We recognized a gain2022 relate primarily to the Company’s strategic restructuring to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The restructuring costs were comprised primarily of contract termination costs of $0.6 million from the change in fair valueand termination benefits related to headcount reductions of warrant liabilities for$0.1 million. No restructuring charges were incurred during the three months ended December 31, 2020.2021.
Equity in Losses on Equity Method Investment
We account for our investment in DepYmed common shares using the equity method of accounting and record our proportionate share of DepYmed’s net income and losses. TheAs of December 31, 2022 and September 30, 2022, the carrying value of ourthe DepYmed investment was $0 and, as such, the Company did not record its proportionate share of losses during the three months ended December 31, 2022. Equity in DepYmed common shares was reduced to zero, therefore,losses during the three months ended December 31, 2021 we recorded our sharewas $0.4 million.
Other Income, net
We recognized other income of equity losses$0.1 million during the three months ended December 31, 2022 related to the extentsale of our investment in preferred shares of DepYmed. We will continue to monitorcertain research and development materials. Other income recognized during the operating results of DepYmed and will record equity in earnings when the equity in earnings exceeds our previously unrecognized losses.three months ended December 31, 2021 was not material.
Liquidity, Capital Resources, Going Concern, and Financial Condition
We have had no revenues from product sales and have incurred operating losses since inception. As of December 31, 2021,2022, we had cash and cash equivalents of $47.3$17.4 million. We have historically funded our operations through the sale of common stock and the issuance of convertible notes and warrants.
We expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As a result, we will likely need to raise additional capital through one or more of the following: the issuance of additional debt or equity or the completion of a licensing transaction for one or more of our pipeline assets. Accordingly, there are material risks and uncertainties that raised substantial doubt about the Company’s ability to continue as a going concern. In October 2022, the Company announced a restructuring plan to reduce its operating expenses and extend its cash runway into the second quarter of calendar year 2024 based on current operating plans and estimates. Management believes it is probable that the restructuring plan will be effectively implemented within the next twelve months and that the restructuring plan, when implemented, will mitigate the conditions that gave rise to substantial doubt about the Company’s ability to continue as a going concern.
Net working capital decreased from September 30, 20212022 to December 31, 20212022 by $6.4$ 4.7 million (to $44.3(from $20.5 million from $50.7to $15.8 million). Our quarterlyWe expect our annual cash burn has increased compared to prior periodsdecrease in the fiscal year ending September 30, 2023, due to increased research and development and corporate activities, andthe restructuring actions that we expect ithave implemented since October 2022. We believe our current cash balance will provide sufficient capital to continue operations into the second calendar quarter of 2024.
We entered into a purchase agreement with Alumni Capital in December 2022, pursuant to increase in future periods. We expect thatwhich Alumni Capital is obligated to purchase up to $3.0 million of our existing cash and cash equivalents will be sufficientcommon stock from time to fundtime at our operations for at least the next twelve months following the issuance ofsole discretion over a 24-month period commencing on December 31, 2021 financial statements. We have based this expectation on assumptions that may prove to be incorrect, and we may use our available capital resources sooner than we currently expect. In addition, we may elect to raise additional funds before we need them if the conditions for raising capital are favorable due to market conditions or strategic considerations, even if we expect28, 2022. To date we have sufficient funds for our current or future operating plans.not sold any shares of common stock under the purchase agreement.
At present, we have no bank line of credit or other fixed source of capital reserves.credit. Should we need additional capital in the future, we will be primarily reliant upon a private or public placement of our equity or debt securities, or a strategic transaction, for which there can be no warranty or assurance that we may be successful in such efforts. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. Failure to obtain additional equity or debt financing will have a material adverse impact on ourthe Company’s business operations. There can be no assurance that we will be able to obtain the financing needed to achieve our goals on acceptable terms or at all.
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on acceptable terms or at all. Additionally, any equity financings would likely have a dilutive effect on the holdings of the Company’s existing stockholders.
Cash Flow Summary
The following table summarizes selected items in our unaudited condensed consolidated statements of cash flows:
| | | | | | | | | | | | |
|
| Three Months Ended December 31, |
| Three months Ended December 31, | ||||||||
|
| 2021 |
| 2020 |
| 2022 |
| 2021 | ||||
Net cash used in operating activities | | $ | (5,268,446) | | $ | (3,780,861) | | $ | (5,687,848) | | $ | (5,268,446) |
Net cash used in investing activities | |
| (123,906) | |
| (208,541) | | | (49,844) | | | (123,906) |
Net cash used in financing activities | |
| (174,975) | |
| (26,111) | | | (28,645) | | | (174,975) |
Net decrease in cash and cash equivalents | | $ | (5,567,327) | | $ | (4,015,513) | | $ | (5,766,337) | | $ | (5,567,327) |
Operating Activities
Net cash used in operating activities was approximately $5.7 million for the three months ended December 31, 2022, as compared to approximately $5.3 million for the three months ended December 31, 2021, as compared to approximately $3.8 million for2021. Net cash used in operating activities in the three months ended December 31, 2020.2022, was primarily the result of our net loss, a decrease in accounts payable, accrued expenses and other current liabilities, operating lease liability and a net benefit for stock-based compensation expense, partially offset by depreciation and amortization expenses, and a decrease in prepaid insurance, other prepaid expenses and current assets. Net cash used in operating activities in the three months ended December 31, 2021, was primarily the result of our net loss and a decrease in accounts payable, partially offset by stock-based compensation expense, depreciation and amortization expenses, a decrease in prepaid expenses and other current assets and an increase in accrued expenses. Net cash used in operating activities in the three months ended December 31, 2020, was primarily the result of our net lossexpenses and the change in fair value of warrant liabilities, partially offset by our stock-based compensation expense, depreciation and amortization expense and the loss on equity method investment.other current liabilities.
Investing Activities
Net cash used in investing activities was approximately $0.05 million for the three months ended December 31, 2022, as compared to $0.1 million for the three months ended December 31, 2021, as compared to $0.2 million for the three months ended December 31, 2020.2021. Net cash used in investing activities for the three months ended December 31, 20212022 and 20202021 was primarily due to the purchase of laboratory and office equipment.
Financing Activities
Net cash used in financing activities was approximately $0.03 million for the three months ended December 31, 2022, as compared to net cash used in financing activities of $0.2 million for the three months ended December 31, 2021, as compared to $0.03 million2021. Net cash used in financing activities for the three months ended December 31, 2020.2022 primarily reflects principal payment of our finance lease liability. Net cash used in financing activities for both the three month periodsmonths ended December 31, 2021 and 2020 primarily reflectreflects the principal payments of financed insurance and principal payment of our finance lease liability, partially offset by the proceeds received from the exercise of stock options.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this item.
17
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2021.2022. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of December 31, 2021,2022, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed in the reports that 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 management as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting during the quarterly period ended December 31, 2021.2022.
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PART II.
ITEM 1. LEGAL PROCEEDINGS
The Company hasWe have become involved in certain legal proceedings and claims which arise in the normal course of business. The Company believes that an adverse outcome is unlikely, and it cannot reasonably estimate the potential loss at this point. If an unfavorable ruling were to occur, there exists the possibility of a material adverse impact on our results of operations, prospects, cash flows, financial position and brand. Costs associated with the Company’s involvement in legal proceedings are expensed as incurred.
Securities Class Action Lawsuit
On February 14, 2018, plaintiff Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr (which was the name of the Company prior to the completion of the merger with NeuBase Therapeutics, Inc., a Delaware corporation, in accordance with the terms of the Agreement and Plan of Merger and Reorganization entered into on January 2, 2019, as amended, pursuant to which (i) Ohr Acquisition Corp., a subsidiary of Ohr, merged with and into Legacy NeuBase, with Legacy NeuBase (renamed as “NeuBase Corporation”) continuing as a wholly-owned subsidiary of Ohr and the surviving corporation of the merger and (ii) Ohr was renamed as “NeuBase Therapeutics, Inc.” and several current and former officers and directors, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc., filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. We and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On September 20, 2019, the district court entered an order granting the defendants’ motion to dismiss. On October 23, 2019, the plaintiffs filed a notice of appeal of that order dismissing the action and other related orders by the district court. After full briefing and oral argument, on October 9, 2020, the U.S. Court of Appeals for the Second Circuit issued a summary order affirming the district court’s order granting the motion to dismiss and remanding the action to the district court to make a determination on the record related to plaintiffs’ request for leave to file an amended complaint. On remand, the district court denied plaintiffs’ subsequent request to amend and dismissed with prejudice plaintiffs’ claims. On December 16, 2020, plaintiffs filed a notice of appeal of that order denying plaintiffs leave to amend. On December 16, 2021, the Second Circuit affirmed the decision and order of the district court denying plaintiffs’ motion for leave to amend, thereby dismissing the appeal and action in its entirety. Plaintiffs have not sought reconsideration of the Second Circuit’s decision, and the current deadline for plaintiffs to file a writ of certiorari for review by the Supreme Court of the United States is March 15, 2022.
Derivative Lawsuit
On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against certain former directors of Ohr, including Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason S. Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. We and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending the exhaustion of all appeals from the decision of the Southern District of New York dismissing the Khanna action discussed above. These matters couldresult in substantial costs and a diversion of management’s resources and attention, which could harm our business and the value of our common stock.
24
Joint Proxy Statement Lawsuit
On March 20, 2019, a putative class action lawsuit was filed in the United States District Court for District of Delaware naming as defendants Ohr and its board of directors, Legacy NeuBase and Ohr Acquisition Corp., captioned Wheby v. Ohr Pharmaceutical, Inc., et al., Case No. 1:19-cv-00541-UNA (the “Wheby Action”). The plaintiffs in the Wheby Action allege that the preliminary joint proxy/prospectus statement filed by Ohr with the SEC on March 8, 2019 contained false and misleading statements and omitted material information in violation of Section 14(a) of the Exchange Act and SEC Rule 14a-9 promulgated thereunder, and further that the individual defendants are liable for those alleged misstatements and omissions under Section 20(a) of the Exchange Act. The complaint in the Wheby Action has not been served on, nor was service waived by, any of the named defendants in that action. The action seeks, among other things, to rescind the Merger or an award of damages, and an award of attorneys’ and experts’ fees and expenses. The defendants dispute the claims raised in the Wheby Action. Management believes that the likelihood of an adverse decision from the sole remaining action is unlikely; however, the litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm our business and the value of our common stock.
ITEM 1A. RISK FACTORS
We operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material adverse effect on our business, prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, in addition to other information contained in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed under the caption “Risk Factors” that appear in Item 1A of our Annual Report on Form 10-K for the year ended September 30, 2021,2022, filed with the U.S. Securities and Exchange Commission (“SEC”) on December 23, 2021.21, 2022. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations. There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended September 30, 2021.2022.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
���
ITEM 5. OTHER INFORMATION
Not applicable.
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ITEM 6. EXHIBITS
| | | | | | | | | | | | | | | | | | | | | ||
| | | Incorporated by Reference | | | Incorporated by Reference | ||||||||||||||||
Exhibit | | Description |
| Form |
| File |
| Filing Date |
| Exhibit | | Description |
| Form |
| File |
| Filing Date |
| Exhibit | ||
2.1+ | | | 8-K | | 001-35963 | | 1/3/2019 | | 2.1 | | | 8-K | | 001-35963 | | 1/3/2019 | | 2.1 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
2.2 | | | 8-K | | 001-35963 | | 7/3/2019 | | 2.1 | | | 8-K | | 001-35963 | | 7/3/2019 | | 2.1 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
3.1 | | Amended and Restated Certificate of Incorporation of the Company. | | 8-K | | 001-35963 | | 7/12/2019 | | 3.1 | | Amended and Restated Certificate of Incorporation of the Company. | | 8-K | | 001-35963 | | 7/12/2019 | | 3.1 | ||
| | | | | | | | | | | | | | | | | | | | | ||
3.2 | | | 8-K | | 001-35963 | | 9/23/2019 | | 3.1 | | | 8-K | | 001-35963 | | 9/23/2019 | | 3.1 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
4.1 | | | 8-K | | 001-35963 | | 12/8/2016 | | 4.1 | | | 8-K | | 001-35963 | | 12/8/2016 | | 4.1 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
4.2 | | | 8-K | | 001-35963 | | 4/6/2017 | | 4.1 | | | 8-K | | 001-35963 | | 4/6/2017 | | 4.1 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
4.3 | | | S-8 | | 333-233346 | | 8/16/2019 | | 4.17 | | | S-8 | | 333-233346 | | 8/16/2019 | | 4.17 | ||||
| | | | | | | | | | | | | | | | | | | | | ||
10.1+ | | | 8-K | | 0001-35963 | | 1/10/2022 | | 10.1 | |||||||||||||
10.1 | | | 8-K | | 001-35963 | | 12/29/2022 | | 10.1 | |||||||||||||
| | | | | | | | | | | ||||||||||||
| | | | | ||||||||||||||||||
31.1* | | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||||||||||||||||||
| | | | | ||||||||||||||||||
31.2* | | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||||||||||||||||||
| | | | | ||||||||||||||||||
32.1* | | |||||||||||||||||||||
32.1** | | |||||||||||||||||||||
| | | | | ||||||||||||||||||
101.INS* | | XBRL Instance Document. | | XBRL Instance Document. | ||||||||||||||||||
101.SCH* | | XBRL Taxonomy Extension Schema Document. | | XBRL Taxonomy Extension Schema Document. | ||||||||||||||||||
101.CAL* | | XBRL Taxonomy Extension Calculation Linkbase Document. | | XBRL Taxonomy Extension Calculation Linkbase Document. | ||||||||||||||||||
101.DEF* | | XBRL Taxonomy Extension Definition Linkbase Document. | | XBRL Taxonomy Extension Definition Linkbase Document. | ||||||||||||||||||
101.LAB* | | XBRL Taxonomy Extension Label Linkbase Document. | | XBRL Taxonomy Extension Label Linkbase Document. | ||||||||||||||||||
101.PRE* | | XBRL Taxonomy Extension Presentation Linkbase Document. | | XBRL Taxonomy Extension Presentation Linkbase Document. |
*Filed herewith.
#Management compensatory plan or arrangement.** Furnished herewith.
+All schedules and exhibits to the agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| |
| NeuBase Therapeutics, Inc. |
|
|
Date: February | /s/ Todd Branning |
| Todd Branning |
| Chief Financial Officer |
| (Principal Financial and Accounting Officer) |
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