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3……………….

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period Ended December 31, 2022June 30, 2023

Or

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

For the Transition Period from___ to___.

Commission File Number 001-35963

NEUBASE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

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)

(412) 763-3350

(Registrant’s telephone number, including area code)

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

Title of each class

    

Trading Symbol(s)

    

Name of each exchange on which registered

Common 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.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

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

As of February 10,August 11, 2023, 33,155,3562,362,377 shares of the common stock, par value $0.0001, of the registrant were outstanding.

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Table of Contents

PART I.

13

ITEM 1.

FINANCIAL STATEMENTS

13

ITEM 2.

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

1317

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

1723

ITEM 4.

CONTROLS AND PROCEDURES

1823

PART II.

1924

ITEM 1.

LEGAL PROCEEDINGS

1924

ITEM 1A.

RISK FACTORS

1924

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

1925

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

1925

ITEM 4.

MINE SAFETY DISCLOSURES

1925

ITEM 5.

OTHER INFORMATION

1925

ITEM 6.

EXHIBITS

2026

SIGNATURES

2128

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Introductory Note

On April 21, 2023, the Board of Directors of NeuBase Therapeutics, Inc. (together with its subsidiaries, the “Company”) approved a change in the Company’s fiscal year end from September 30 to December 31, effective for the fiscal year beginning January 1, 2023 and ending December 31, 2023. As a result of the change in year end, the Company filed on June 5, 2023 a Transition Report on Form 10-QT for the period from October 1, 2022 through December 31, 2022. The Company’s 2023 fiscal year will run from January 1, 2023 through December 31, 2023.

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Table of Contents

PART I.

ITEM 1. FINANCIAL STATEMENTS

NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Unaudited)

June 30, 

    

December 31,

    

2023

2022

ASSETS

CURRENT ASSETS

 

  

Cash and cash equivalents

$

14,747,424

$

17,386,326

Prepaid insurance

370,833

188,266

Other prepaid expenses and current assets

399,414

 

391,655

Total current assets

15,517,671

17,966,247

 

EQUIPMENT, net

1,509,127

 

1,934,100

 

OTHER ASSETS

 

Right-of-use asset, operating lease asset

5,181,436

5,409,574

Security deposit

125,391

273,215

Total other assets

5,306,827

5,682,789

TOTAL ASSETS

$

22,333,625

$

25,583,136

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES

 

Accounts payable

$

322,131

$

369,505

Accrued expenses and other current liabilities

1,051,501

1,227,656

Warrant liabilities

4,239,496

Operating lease liabilities

490,057

469,118

Finance lease liabilities

20,108

78,987

Total current liabilities

6,123,293

 

2,145,266

Long-term operating lease liability

4,964,011

5,214,074

TOTAL LIABILITIES

11,087,304

7,359,340

 

COMMITMENTS AND CONTINGENCIES

STOCKHOLDERS’ EQUITY

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of June 30, 2023 and December 31, 2022

 

Common stock, $0.0001 par value; 250,000,000 shares authorized; 1,878,146 and 1,657,768 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

188

 

166

Additional paid-in capital

125,899,432

 

125,337,022

Accumulated deficit

(114,653,299)

 

(107,113,392)

TOTAL STOCKHOLDERS’ EQUITY

11,246,321

 

18,223,796

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

22,333,625

$

25,583,136

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

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Table of Contents

NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended June 30,

Six Months Ended June 30, 

    

2023

    

2022

2023

    

2022

OPERATING EXPENSES

 

  

 

  

General and administrative

$

2,403,661

$

3,603,999

$

5,320,976

$

6,697,712

Research and development

1,284,284

 

4,756,609

2,524,530

 

11,592,279

Restructuring

 

6,727

 

TOTAL OPERATING EXPENSES

3,687,945

 

8,360,608

7,852,233

 

18,289,991

 

 

LOSS FROM OPERATIONS

(3,687,945)

 

(8,360,608)

(7,852,233)

 

(18,289,991)

 

 

OTHER INCOME (EXPENSE)

 

  

 

  

Interest expense

(730)

 

(2,819)

(3,084)

 

(6,135)

Interest income

116,048

37,147

294,425

40,592

Loss on issuance of common stock and warrants

(1,311,552)

(1,311,552)

Change in fair value of warrant liabilities

1,430,351

 

1,430,351

 

Other income (expense), net

7,034

(165,437)

(97,814)

(160,212)

Total other income (expense), net

241,151

 

(131,109)

312,326

 

(125,755)

 

  

 

  

NET LOSS

$

(3,446,794)

$

(8,491,717)

$

(7,539,907)

$

(18,415,746)

 

 

BASIC AND DILUTED LOSS PER SHARE

$

(2.04)

$

(5.26)

$

(4.47)

$

(11.34)

 

 

WEIGHTED AVERAGE SHARES OUTSTANDING:

 

  

 

  

BASIC AND DILUTED

1,692,567

 

1,612,933

1,685,034

 

1,623,489

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

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NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

For the Three and Six Months Ended June 30, 2023 and 2022

(Unaudited)

    

December 31, 

    

September 30, 

2022

2022

    

Unaudited

    

Audited

ASSETS

CURRENT ASSETS

 

  

 

  

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

 

 

EQUIPMENT, net

 

1,934,100

 

2,156,851

 

 

OTHER ASSETS

 

 

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

TOTAL ASSETS

$

25,583,136

$

32,693,429

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES

 

 

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

Long-term operating lease liability

5,214,074

5,335,164

TOTAL LIABILITIES

$

7,359,340

$

9,501,549

COMMITMENTS AND CONTINGENCIES

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

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

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.

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NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months ended December 31, 

    

2022

    

2021

OPERATING EXPENSES

 

  

 

  

General and administrative

$

2,596,412

$

2,935,710

Research and development

 

1,351,407

4,369,257

Restructuring

 

652,451

TOTAL OPERATING EXPENSES

 

4,600,270

7,304,967

LOSS FROM OPERATIONS

 

(4,600,270)

(7,304,967)

 

OTHER INCOME (EXPENSE)

 

Interest expense

 

(1,868)

(15,219)

Interest income

147,604

1,254

Equity in losses on equity method investment

 

(415,744)

Other income, net

85,495

5,860

Total other income (expense), net

 

231,231

(423,849)

 

NET LOSS

$

(4,369,039)

$

(7,728,816)

 

BASIC AND DILUTED LOSS PER SHARE

$

(0.13)

$

(0.24)

 

 

WEIGHTED AVERAGE SHARES OUTSTANDING:

 

 

  

BASIC AND DILUTED

 

33,015,035

32,725,718

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

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NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

For the Three Months Ended December 31, 2022 and 2021

(Unaudited)

Additional

Total

Common Stock

Paid-In

Stockholders’

    

Shares

    

Amount

    

Capital

    

Accumulated Deficit

    

Equity

Balance as of December 31, 2022

 

1,657,768

$

166

$

125,337,022

$

(107,113,392)

$

18,223,796

Stock-based compensation expense

 

 

316,689

 

316,689

Exercise of stock options

32,750

3

718

721

Net loss

 

 

 

(4,093,113)

(4,093,113)

Balance as of March 31, 2023

1,690,518

$

169

$

125,654,429

$

(111,206,505)

$

14,448,093

Stock-based compensation expense

245,012

245,012

Issuance of common stock

187,700

19

19

Cash paid in lieu of fractional shares from reverse stock split

(72)

(9)

(9)

Net loss

(3,446,794)

(3,446,794)

Balance as of June 30, 2023

1,878,146

$

188

$

125,899,432

$

(114,653,299)

$

11,246,321

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

Stock-based compensation expense

 

 

793,204

 

 

793,204

Issuance of restricted stock for services

4,441

Exercise of stock options

42,250

4

38

42

Net loss

 

 

 

(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

  

 

  

 

  

 

  

 

  

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

Additional

Total

Common Stock

Paid-In

Stockholders’

    

Shares

    

Amount

    

Capital

    

Accumulated Deficit

    

Equity

Balance as of December 31, 2021

 

1,638,409

$

164

$

123,830,758

$

(76,696,719)

$

47,134,203

Stock-based compensation expense

 

 

952,828

 

 

952,828

Forfeiture of common stock

(25,476)

(3)

3

Net loss

 

 

 

(9,924,029)

 

(9,924,029)

Balance as of March 31, 2022

1,612,933

$

161

$

124,783,589

$

(86,620,748)

$

38,163,002

Stock-based compensation expense

641,046

641,046

Net loss

(8,491,717)

(8,491,717)

Balance as of June 30, 2022

1,612,933

$

161

$

125,424,635

$

(95,112,465)

$

30,312,331

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

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NeuBase Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

Three months ended December 31,

Six Months Ended June 30, 

    

2022

    

2021

    

2023

    

2022

Cash flows from operating activities

  

 

  

Net loss

$

(4,369,039)

$

(7,728,816)

$

(7,539,907)

$

(18,415,746)

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

 

 

 

Stock-based compensation

 

(509,072)

793,204

561,701

 

1,593,874

Loss on issuance of common stock and warrants

1,311,552

Change in fair value of warrant liabilities

(1,430,351)

Depreciation and amortization

 

198,563

181,490

376,310

386,254

Loss on marketable securities

30

Loss on disposal of fixed assets

 

65,532

7,595

53,610

(7,595)

Equity in losses on equity method investment

 

415,744

Amortization of right-of-use assets

120,094

228,138

255,707

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

(190,326)

 

(616,880)

Other long-term assets

 

160,423

Security deposit

147,824

(19,600)

Accounts payable

(1,496,850)

(680,142)

(47,374)

 

515,803

Accrued expenses and other current liabilities

 

(501,649)

665,134

(333,696)

 

(544,020)

Operating lease liability

(120,008)

(63,973)

(229,124)

(253,263)

Net cash used in operating activities

 

(5,687,848)

(5,268,446)

(7,091,643)

 

(17,105,466)

 

  

Cash flows from investing activities

 

 

Purchase of laboratory and office equipment

 

(49,844)

(123,876)

(13,447)

 

(319,029)

Purchase of marketable securities

(14,986,818)

Sale of marketable securities

14,986,788

Proceeds received on sale of equipment

8,500

Net cash used in investing activities

 

(49,844)

(123,906)

(4,947)

 

(319,029)

Cash flows from financing activities

 

 

Principal payment of financed insurance

(148,385)

Proceeds from issuance of common stock and warrants, net of issuance costs paid

4,515,855

Principal payment of finance lease liability

(28,645)

(26,632)

(58,879)

(54,740)

Payment in lieu of fractional shares from reverse stock split

(9)

Proceeds from exercise of stock options

 

 

42

721

Net cash used in financing activities

(28,645)

(174,975)

Net cash provided by (used in) financing activities

4,457,688

 

(54,740)

Net decrease in cash and cash equivalents

(5,766,337)

(5,567,327)

(2,638,902)

(17,479,235)

Cash and cash equivalents, beginning of period

23,152,663

52,893,387

17,386,326

47,326,060

Cash and cash equivalents, end of period

$

17,386,326

$

47,326,060

$

14,747,424

$

29,846,825

 

  

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

$

13,447

$

12,243

Right-of-use asset obtained in exchange for operating lease liabilities

$

$

164,613

Common stock and warrant issuance costs incurred but not paid

$

157,541

$

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

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1.  Organization, Description of Business and Liquidity

NeuBase Therapeutics, Inc. and its subsidiaries (the “Company” or “NeuBase”) ishas historically been a preclinical-stage biopharmaceutical company developing a modular peptide-nucleicpeptide nucleic acid (“PNA”) antisense oligo (“PATrOL™”) platform to address genetic diseases with a single, cohesive approach. NeuBase plansplanned to use its platform to address diseases which have a genetic source, with an initial focus on gene silencing in myotonic dystrophy type 1 (“DM1”), Huntington’s disease (“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.

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.oncology.

In October 2022, the Company announced plans to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The

In August 2023, the Company is currently identifyingannounced that its Board of Directors (the “Board”) had made the determination to halt further development of the Company’s programs and evaluating multiple indicationsto conduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value. As part of this evaluation process, the Board will explore potential strategic alternatives for potential future development.the Company that may include, but are not limited to, an acquisition, merger, business combination, or other transaction.

Liquidity and Going Concern

The Company has had no revenues from product sales and has incurred operating losses since inception. As of December 31, 2022,June 30, 2023, the Company had $17.4$14.7 million in cash and cash equivalents, and during the threesix months ended December 31, 2022,June 30, 2023, incurred a loss from operations of $4.6$7.9 million and used $5.7$7.1 million of cash in operating activities.

The Company expects to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future and may never become profitable. 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,August 2023, as further discussed below, the Company announcedBoard approved a plan to halt further development of the Company’s programs and to conduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value. This restructuring plan is expected to reduce its operating expenses and extend itsthe Company’s cash runway into the secondfourth quarter of calendar year 20242025 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 resources on hand to fund operations through at least the next twelve months from the date these consolidated financial statements were available to be 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;

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

its ability to negotiate and consummate any transaction arising from its exploration of strategic alternatives;
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

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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.

Change in Year End

On April 21, 2023, the Board approved a change in the Company’s fiscal year end from September 30 to December 31, effective for the fiscal year beginning January 1, 2023 and ending December 31, 2023.  As a result of the change in year end, the Company filed on June 5, 2023 a Transition Report on Form 10-QT for the period from October 1, 2022 through December 31, 2022.  The Company’s 2023 fiscal year will run from January 1, 2023 through December 31, 2023.

Reverse Stock Split

The Company effected a 1-for-20 reverse stock split of its outstanding shares of common stock on June 14, 2023. The reverse stock split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the reverse stock split.

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, 2022 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 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.

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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 considerations related to the impacts that the 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.

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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.

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.

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,June 30, 2023 and 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:

As of December 31, 

As of June 30, 

    

2022

    

2021

    

2023

    

2022

Common stock purchase options

 

7,310,686

7,197,404

314,672

 

410,639

Restricted stock units

 

10,000

19,823

 

Common stock purchase warrants

 

180,000

875,312

5,794,071

 

9,000

7,490,686

8,082,716

6,128,566

 

419,639

Common Stock Warrant Liabilities

The Company has issued freestanding warrants to purchase shares of its common stock in connection with its financing activities and accounts for them in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Warrants classified as liabilities are remeasured each period they are outstanding. Any resulting gain or loss related to the change in the fair value of the warrant liabilities is recognized in change in fair value of warrant liabilities, a component of other income (expense) in the Condensed Consolidated Statements of Operations.

The Company estimates the fair value of common stock warrant liabilities using the Black-Scholes Model. The assumptions used in calculating the fair value represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

Fair Value Measurements

Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

Level 1 - defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;

Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The following tables present the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis at June 30, 2023:

    

Fair Value Measurements 

as of June 30, 2023

(Level 1)

    

(Level 2)

    

(Level 3)

    

Total

Liabilities

 

  

 

  

 

  

 

  

Warrant liabilities

$

 

 

4,239,496

$

4,239,496

The following assumptions were used in determining the fair value of the warrant liabilities as of June 30, 2023:

As of June 30, 2023

Remaining contractual term (years)

1.5 - 5.5

Common stock price volatility

86.1% - 102.8%

Risk-free interest rate

3.94% - 5.02%

Expected dividend yield

The change in fair value of the warrant liabilities for the three and six months ended June 30, 2023 is as follows:

Warrant

Liabilities

Balance as of March 31, 2023

$

Fair value of warrants issued

5,669,847

Change in fair value

 

(1,430,351)

Balance as of June 30, 2023

$

4,239,496

Recent Accounting Pronouncements

In May 2021, the Financial 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 No. 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance”,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 the fiscal year ending September 30,December 31, 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,December 31, 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, 2023, and interim periods within those fiscal years. Early adoption is permitted for 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 is permitted. The Company is currently evaluating theadopted this guidance as of January 1, 2023, with minimal impact of this standard on its consolidated financial statements and related disclosures.

upon adoption.

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40), to simplify the accounting for certain financial instruments with characteristics of liabilities and equity. The FASB reduced the number of accounting models for convertible debt and convertible preferred stock instruments and made certain disclosure amendments to improve the information provided to users. In addition, the FASB amended the derivative guidance for the “own stock” scope exception and certain aspects of the EPS guidance. The Company adopted this new accounting guidance on a prospective basis on January 1, 2023, and the adoption did not have a material effect on its consolidated financial statements.

3.  Other Prepaid Expenses and Current Assets

The Company’s prepaid expenses and other current assets consisted of the following:

As of December 31, 

As of September 30, 

    

As of June 30, 

    

As of December 31, 

2022

2022

2023

2022

    

Unaudited

    

Audited

Unaudited

Unaudited

Prepaid research and development expense

$

67,027

$

805,542

$

$

67,027

Accounts receivable

150,000

150,000

Franchise tax receivable

127,715

Other prepaid expenses and current assets

 

174,628

 

243,046

Other prepaid expenses and other current assets

 

399,414

 

174,628

Total

$

391,655

$

1,176,303

$

399,414

$

391,655

4.  Equipment

The Company’s equipment consisted of the following:

As of December 31, 

As of September 30, 

As of June 30, 

As of December 31, 

2022

2022

    

2023

    

2022

    

Unaudited

    

Audited

Unaudited

    

Unaudited

Laboratory equipment

$

3,048,579

$

3,175,019

$

2,964,069

$

3,048,579

Office equipment

 

259,978

 

259,978

259,978

 

259,978

Leasehold improvements

17,958

17,958

31,405

17,958

Total

 

3,326,515

 

3,452,955

3,255,452

 

3,326,515

Accumulated depreciation and amortization

 

(1,392,415)

 

(1,296,104)

(1,746,325)

 

(1,392,415)

Equipment, net

$

1,934,100

$

2,156,851

$

1,509,127

$

1,934,100

Depreciation expense for the three months ended December 31,June 30, 2023 and 2022 and 2021 was approximately $0.2 million and $0.2 million, respectively. Depreciation expense for the six months ended June 30, 2023 and 2022 was approximately $0.4 million and $0.4 million, respectively.

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 June 30, 

As of December 31, 

2022

2022

    

2023

    

2022

    

Unaudited

    

Audited

    

Unaudited

    

Unaudited

Accrued compensation and benefits

$

171,572

$

768,324

$

579,171

$

171,572

Accrued consulting settlement

225,000

150,000

75,000

 

225,000

Accrued professional fees

 

241,808

 

191,516

162,435

 

241,808

Accrued research and development

 

20,684

 

512,570

10,009

 

20,684

Accrued franchise tax

217,440

36,542

29,680

217,440

Accrued restructuring

316,032

316,032

Other accrued expenses

 

35,120

 

3,708

195,206

 

35,120

Total

$

1,227,656

$

1,662,660

$

1,051,501

$

1,227,656

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

6.  Stockholders’ Equity

Equity Purchase Agreement

On December 28, 2022, the Company entered into a purchase agreement (the “Equity Purchase Agreement”) with Alumni Capital LP, a Delaware limited partnership (“Alumni Capital”), pursuant to which the Company agreed to sell, and Alumni Capital agreed to

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

purchase, upon request of the Company in one or more transactions, a number of shares of the Company’s common stock providing aggregate gross proceeds to the Company of up to $3,000,000 (subject to the right, but not the obligation, of the Company to increase such amount up to $10,000,000 pursuant to the terms of the 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 sale of shares of common stock of up to $500,000 (subject to the right of the Company and Alumni Capital to 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 146,6997,335 shares of common stock to Alumni Capital. The Company will 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 Investment 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 equal to one-half of one percent (0.5%) of the 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,June 30, 2023, the Company has not sold any shares of common stock under the Equity Purchase Agreement.

Concurrent Registered Direct Offering and Private Placements

On June 28, 2023, the Company entered into a securities purchase agreement (the “Registered Direct Purchase Agreement”) in connection with a registered direct offering (the “Registered Direct Offering”) and concurrent private placement with an institutional investor (the “Registered Direct Purchaser”). On June 28, 2023, the Company also entered into a securities purchase agreement (the “PIPE Purchase Agreement” and, together with the Registered Direct Purchase Agreement, the “Purchase Agreements”) and a registration rights agreement (the “Registration Rights Agreement”) in connection with a concurrent private placement (the “PIPE Private Placement”) with the same institutional investor (the “PIPE Purchaser” and, together with the Registered Direct Purchaser, the “Purchaser”).

Pursuant to the Registered Direct Purchase Agreement, the Company agreed to offer and sell in the Registered Direct Offering 187,700 shares of the Company’s common stock, $0.0001 par value per share (the “Common Stock”), and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 390,997 shares of Common Stock. The Pre-Funded Warrants have an exercise price of $0.001 per share, are immediately exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. Each share of Common Stock was sold at an offering price of $2.57 per share, and each Pre-Funded Warrant was sold at an offering price of $2.569, which is equal to the purchase price per share of Common Stock less $0.001.

Pursuant to the Registered Direct Purchase Agreement, in a concurrent private placement, the Company also agreed to issue to the Registered Direct Purchaser unregistered long-term warrants (the “RD Series A Warrants”) to purchase up to an aggregate of 578,697

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

shares of Common Stock and unregistered short-term warrants (the “RD Series B Warrants”) to purchase up to an aggregate of 578,697 shares of Common Stock. Each RD Series A Warrant has an exercise price of $2.32 per share, is exercisable immediately upon issuance, and will expire five and one-half years following the date of issuance. Each RD Series B Warrant has an exercise price of $2.32 per share, is exercisable immediately upon issuance, and will expire 18 months following the date of issuance.

Pursuant to the PIPE Purchase Agreement, the Company agreed to offer and sell in the PIPE Private Placement unregistered pre-funded warrants (the “PIPE Pre-Funded Warrants”) to purchase up to an aggregate of 1,366,829 shares of Common Stock, at an offering price of $2.569. The PIPE Pre-Funded Warrants have an exercise price of $0.001 per share, are immediately exercisable and can be exercised at any time after their original issuance until such PIPE Pre-Funded Warrants are exercised in full. Pursuant to the PIPE Purchase Agreement, the Company also agreed to issue to the PIPE Purchaser unregistered long-term warrants to purchase up to 1,366,829 shares of Common Stock (the “PIPE Series A Warrants”) and unregistered short-term warrants to purchase up to 1,366,829 shares of Common Stock (the “PIPE Series B Warrants”). Each PIPE Series A Warrant has an exercise price of $2.32 per share, is exercisable immediately upon issuance, and will expire five and one-half years following the date of issuance. Each PIPE Series B Warrant has an exercise price of $2.32 per share, is exercisable immediately upon issuance, and will expire 18 months following the date of issuance.

The Company received aggregate gross proceeds of approximately $5.0 million from the Registered Direct Offering and PIPE Private Placement (collectively, the “Offerings”), before deducting placement agent fees and other estimated offering expenses payable by the Company.

Pursuant to an engagement letter, dated as of June 12, 2023, as amended on June 28, 2023 (as amended, the “Engagement Letter”), between the Company and H.C. Wainwright & Co., LLC (the “Placement Agent”), the Company agreed to pay the Placement Agent a cash fee equal to 8.0% of the gross proceeds received from the Purchaser (including a 1.0% management fee) and also agreed to issue to the Placement Agent (or its designees) warrants (the “Placement Agent Warrants”) to purchase up to 136,187 shares of Common Stock (which represents 7.0% of the aggregate number of shares of Common Stock, Pre-Funded Warrants and PIPE Pre-Funded Warrants sold in the Offerings) on substantially the same terms as the PIPE Series A Warrants and the PIPE Series B Warrants except that the exercise price of the Placement Agent Warrants is $3.2125 (or 125% of the offering price per share of Common Stock in the Registered Direct Offering) and an expiration date of June 28, 2028, which is the five-year anniversary of the commencement of the sales pursuant to the Offerings. The Company also agreed to pay the Placement Agent in connection with the Offerings $75,000 for non-accountable expenses and $7,389 for clearing fees. Pursuant to the Engagement Letter, the Company also agreed that, upon exercise of any of the RD Series B Warrants or the PIPE Series B Warrants, the Company will pay the Placement Agent a cash fee equal to 8.0% of the gross proceeds received from the exercise of the RD Series B Warrants or the PIPE Series B Warrants (including a 1.0% management fee) and will also issue to the Placement Agent (or its designees) additional Placement Agent Warrants to purchase a number of shares of Common Stock equal to 7.0% of the aggregate number of shares of Common Stock issued upon such exercise of the RD Series B Warrants or the PIPE Series B Warrants.

Warrants

Below is a summary of the Company’s issued and outstanding warrants as of December 31, 2022:June 30, 2023:

Warrants

Expiration date

    

Exercise Price Per Share

    

Outstanding

    

Exercise Price

    

Warrants Outstanding

July 6, 2023

 

8.73

 

105,000

$

174.60

5,256

September 20, 2024

6.50

75,000

$

130.00

3,750

December 30, 2024

$

2.32

1,945,526

June 28, 2028

$

3.21

136,187

January 2, 2029

$

2.32

1,945,526

No expiration date

$

0.001

1,757,826

 

180,000

 

5,794,071

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

1013

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

    

    

    

Weighted-

Average

Weighted-

Remaining 

Average

Contractual

Exercise

Life

Warrants

Price

(in years)

Outstanding as of December 31, 2022

9,006

$

156.03

Issuances:

PIPE Series A Warrants

1,366,829

2.32

PIPE Series B Warrants

1,366,829

2.32

PIPE Pre-Funded Warrants

1,366,829

0.001

RD Series A Warrants

578,697

2.32

RD Series B Warrants

578,697

2.32

Pre-Funded Warrants

390,997

0.001

Placement Agent Warrants

136,187

3.21

Outstanding as of June 30, 2023

5,794,071

1.88

3.5

Exercisable as of June 30, 2023

 

5,794,071

$

1.88

 

3.5

The Company issued approximately 1.4 million PIPE Pre-Funded Warrants and approximately 0.4 million Pre-Funded Warrants at an exercise price of $0.001 per share. The PIPE Pre-Funded Warrants and Pre-Funded Warrants have no expiration dates.

7.  Stock-Based Compensation

As of December 31, 2022,June 30, 2023, an aggregate of 6,018,136366,924 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, 2022, 935,495June 30, 2023, 122,328 shares of common sharesstock were available for future grants under the 2019 Plan. As of December 31, 2022, 291,667June 30, 2023, an aggregate of 14,584 shares of common stock were authorized under the Company’s 2016 Consolidated Stock Incentive Plan (the “2016 Plan”) and 228,04113,334 shares of common sharesstock 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 and six months ended December 31, 2022June 30, 2023 and 2021:2022:

Three Months ended December 31,

    

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

2023

    

2022

2023

    

2022

General and administrative

$

276,336

$

327,131

$

209,522

$

507,435

$

481,732

$

1,062,096

Research and development

 

(785,408)

466,073

 

35,490

 

133,611

 

79,969

 

531,778

Total

$

(509,072)

$

793,204

$

245,012

$

641,046

$

561,701

$

1,593,874

Stock-based compensation expense for the three months ended December 31, 2022

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NeuBase Therapeutics, Inc. 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.Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Stock Options

Below is a table summarizing the options issued and outstanding as of and for the threesix months ended December 31, 2022:June 30, 2023:

Weighted

Weighted-

Weighted-

Weighted

Average

Total

Average

Average

Total

Average

Remaining

Aggregate

    

Exercise

Remaining

Aggregate

Exercise

Contractual Life

Intrinsic

Price Per

Contractual

Intrinsic

    

Stock Options

    

Price Per Share

    

(in years)

    

Value

    

Stock Options

    

Share

    

Life (in years)

    

Value

Outstanding at September 30, 2022

7,629,281

$

3.08

Outstanding at December 31, 2022

365,287

$

53.27

Granted

390,000

0.28

1,875

4.34

Exercised

(32,750)

0.02

Forfeited

(708,595)

5.01

(19,740)

94.82

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

Outstanding at June 30, 2023

314,672

55.91

6.0

$

172,296

Exercisable as of June 30, 2023

240,712

$

58.15

5.2

$

172,296

As of December 31, 2022,June 30, 2023, unrecognized compensation costs associated with the stock options of $1.4$1.0 million will be recognized over an estimated weighted average amortization period of 1.1 years.

The intrinsic value of options exercised during the threesix months ended December 31, 2021June 30, 2023 and 2022 was $0.2 million and $0.1 million. No options were exercised during the three months ended December 31, 2022.million, respectively.

The weighted average grant date fair value of options granted during the threesix months ended December 31,June 30, 2023 and 2022 was $3.21 and 2021 was $0.19 and $2.33,$26.55, respectively.

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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 threesix months ended December 31,June 30, 2023 and 2022 and 2021 included:

Three months Ended December 31, 

Six Months Ended June 30, 

    

2022

    

2021

2023

    

2022

Expected term of options (years)

5.3 – 6.1

5.1 – 6.1

5.4 - 6.1

5.3 - 6.1

Expected common stock price volatility

79.2% – 82.4%

73.8% – 74.5%

82.3% - 85.2%

73.7% - 77.2%

Risk-free interest rate

3.8% – 4.3%

1.1% – 1.4%

3.5% - 4.0%

1.4% - 3.1%

Expected dividend yield

Restricted Stock Units

Below is a table summarizing the restricted stock units granted and outstanding as of and for the six months ended June 30, 2023:

Weighted-

Average Grant

Restricted Stock 

Date Fair Value 

    

Units

    

Price

Unvested as of December 31, 2022

 

$

Granted

19,823

4.00

Forfeited

 

 

Unvested as of June 30, 2023

 

19,823

 

4.00

Total unrecognized expense remaining

$

65,602

 

  

Weighted-average years expected to be recognized over

 

1.9

 

  

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NeuBase Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

8. Restructuring

Restructuring charges relate primarily to the Company’s strategic restructuring announced in October 2022 to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The Company recognized restructuring costs of $0.7 million approximately $7 thousand during the threesix months ended December 31, 2022,June 30, 2023, comprised primarily of contract termination costs of $0.6 million and 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.costs.

The following table summarizes activity in the Company’s restructuring-related liability during the threesix months ended December 31, 2022:June 30, 2023:

    

Liability at

    

Restructuring

    

Payments/

    

Liability at

    

September 30, 2022

    

Charges

    

Utilization

    

December 31, 2022

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

    

    

Restructuring

    

Payments/

    

Charges

Utilization

Liability at

(Six Months Ended

(Six Months Ended

Liability at

    

December 31, 2022

    

June 30, 2023)

    

June 30, 2023)

    

June 30, 2023

Research and development contract termination costs

$

311,110

$

2,490

$

(313,600)

$

Other

 

4,922

 

4,237

 

(9,159)

 

Total Accrued restructuring

$

316,032

$

6,727

$

(322,759)

$

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.

10.  Subsequent Events

In August 2023, the Company announced its intention to explore strategic alternatives. This announcement followed a comprehensive review of the Company’s business conducted by the Board. The Board approved a plan to halt further development of the Company’s programs and to conduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value. The Board also approved a reduction in workforce, designed to reduce costs and reallocate resources while maintaining the personnel needed to focus on activities relating to halting further development of the Company’s programs and the pursuit of strategic alternatives (the “Restructuring”). The Company informed employees affected by the Restructuring on August 2, 2023, resulting in a reduction of the Company’s workforce by approximately 83% across different areas and functions. The Company expects to provide severance payments, adjustments to equity compensation grants and continuation of group health insurance coverage for a specified period to the affected employees. The Company estimates that it will incur approximately $400,000 of costs in connection with the reduction in workforce related to severance pay and other related termination benefits, and expects to record a significant portion of these charges in the third quarter of calendar year 2023. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Restructuring.

On July 19, 2023, 204,997 shares were exercised related to the Pre-Funded Warrants at an exercise price of $0.001 per share, and on August 3, 2023, 186,000 shares were exercised related to the Pre-Funded Warrants at an exercise price of $0.001 per share. On August 2, 2023, 93,234 shares were exercised related to employee stock options at an exercise price of $0.022 per share.

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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, 2022, as filed with the United States Securities and Exchange Commission (“SEC”) on December 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.

Overview

We have designed, built, and validated a new technology platform (a peptide-nucleicpeptide 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-nucleicpeptide 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 interacting with cellular machinery that processes mutant genes to halt their ability to manifest a disease.

We have repeatedly demonstrated in proof-of-concept preclinical animal studies 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. 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.

We arehistorically focused on 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, as well as cancer-driving point mutations in KRAS, G12V and G12D, which are involved in many tumor types and have historically been “undruggable”. In October 2022, the Company announced plans to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The

In August 2023, the Company is currently identifying and evaluating multiple indications for potential future development.

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We were incorporated underannounced that its Board had made the lawsdetermination to halt further development 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 proprietary peptide-nucleic acid antisense oligo platform and preclinical-stage therapeutic candidates. Our platform technology and all of our therapeutic candidates are in the preclinical development stage. We have not initiated clinical trials for any of our 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 future success is subject to significant 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 trials for our platform technology and product candidates,Company’s programs and to manufacture and market any product candidates inconduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value. As part of this evaluation process, the event theyBoard will explore potential strategic alternatives for the Company that may include, but are approved for commercial sale. We will likely need additional fundingnot limited to, developan acquisition, merger, business combination, 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 headcount 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 profitabletransaction.

The Company expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future. We willwould 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 data from our current pipeline programs. We have based these estimates on assumptions that may prove to be 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.

14Change in Year End

TableOn April 21, 2023, the Board approved a change in the Company’s fiscal year end from September 30 to December 31, effective for the fiscal year beginning January 1, 2023 and ending December 31, 2023.  As a result of Contentsthe change in year end, the Company filed on June 5, 2023 a Transition Report on Form 10-QT for the period from October 1, 2022 through December 31, 2022.  The Company’s 2023 fiscal year will run from January 1, 2023 through December 31, 2023.

Critical Accounting Estimates and Policies

The preparation of financial statements in accordance with 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, 2022, and there have been no material changes to such policies or estimates during the threesix months ended December 31, 2022.June 30, 2023.

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, 2022,June 30, 2023, reflect the following changes from the three months ended December 31, 2021:June 30, 2022:

    

Three Months Ended December 31,

    

  

    

Three Months Ended June 30, 

    

2022

    

2021

    

Change

    

2023

    

2022

    

Change

OPERATING EXPENSES

  

  

  

 

  

 

  

 

  

General and administrative

$

2,596,412

$

2,935,710

$

(339,298)

$

2,403,661

$

3,603,999

$

(1,200,338)

Research and development

1,351,407

4,369,257

(3,017,850)

 

1,284,284

 

4,756,609

 

(3,472,325)

Restructuring

 

652,451

 

 

652,451

 

 

 

TOTAL OPERATING EXPENSES

 

4,600,270

 

7,304,967

 

(2,704,697)

 

3,687,945

 

8,360,608

 

(4,672,663)

LOSS FROM OPERATIONS

 

(4,600,270)

 

(7,304,967)

 

2,704,697

 

(3,687,945)

 

(8,360,608)

 

4,672,663

OTHER INCOME (EXPENSE)

 

  

 

  

 

  

 

 

 

Interest expense

 

(1,868)

 

(15,219)

 

13,351

 

(730)

 

(2,819)

 

2,089

Interest income

 

147,604

 

1,254

 

146,350

 

116,048

 

37,147

 

78,901

Equity in losses on equity method investment

 

 

(415,744)

 

415,744

Other income, net

 

85,495

 

5,860

 

79,635

Loss on issuance of common stock and warrants

(1,311,552)

(1,311,552)

Change in fair value of warrant liabilities

 

1,430,351

 

 

1,430,351

Other income (expense), net

 

7,034

 

(165,437)

 

172,471

Total other income (expense), net

 

231,231

 

(423,849)

 

655,080

 

241,151

 

(131,109)

 

372,260

NET LOSS

$

(4,369,039)

$

(7,728,816)

$

3,359,777

$

(3,446,794)

$

(8,491,717)

$

5,044,923

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During the three months ended December 31, 2022,June 30, 2023, our operating loss decreased by $2.7$4.7 million compared to the three months ended December 31, 2021.June 30, 2022. Our net loss decreased by $3.4$5.0 million for the three months ended December 31, 2022,June 30, 2023, as compared to the three months ended December 31, 2021.June 30, 2022. 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 decreased by $0.3$1.2 million for the three months ended December 31, 2022,June 30, 2023, as compared to the three months ended December 31, 2021,June 30, 2022, primarily due to a decrease in consulting and wage expenses.

Research and Development Expenses

The following table summarizes the Company’s research and development expenses for the three months ended June 30, 2023 and 2022:

    

Three Months Ended June 30, 

    

2023

    

2022

    

Change

Research and development

 

  

 

  

 

  

Professional consultation and other analytical work

$

290,659

$

1,745,352

$

(1,454,693)

Lab Supplies, chemicals and manufacturing expenses

 

233,781

 

1,265,396

 

(1,031,615)

Employee wages, benefits, and payroll taxes

 

376,524

 

1,135,271

 

(758,747)

Stock-based compensation expense

 

35,405

 

133,611

 

(98,206)

Facility, depreciation and other expenses

 

347,915

 

476,979

 

(129,064)

Total research and development

$

1,284,284

$

4,756,609

$

(3,472,325)

The decrease of approximately $3.5 million of research and development expenses was primarily attributable to $1.5 million of decreased professional consultation and other analytical work; $1.0 million of decreased lab supplies, chemicals, and manufacturing expenses; $0.8 million decrease of employee wages, benefits, and payroll taxes; $0.1 million of decreased stock-based compensation expense; and $0.1 million of decreased equipment, depreciation, and facility costs. The overall decrease is primarily related to the Company’s strategic restructuring announced in October 2022 to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. As part of the development pipeline shift to gene editing, the Company deferred preclinical activities for its myotonic dystrophy type 1 (DM1), Huntington’s disease (HD), and KRAS programs resulting in the overall decrease in research and development expenses for the three months ended June 30, 2023, as compared to the three months ended June 30, 2022.

Restructuring

No restructuring charges were incurred during the three months ended June 30, 2023 or 2022.

Loss on Issuance of Common Stock and Warrants

For the three months ended June 30, 2023, the loss on issuance of common stock and warrants was approximately $1.3 million. This loss is attributable to the fair value measurement of the warrant liabilities using a Black-Scholes Model to estimate the common stock warrant liabilities associated with the registered direct and concurrent private placement offering we completed in June 2023. There was no comparable loss for the three months ended June 30, 2022.

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities of $1.4 million for the three months ended June 30, 2023 reflects the changes in the warrant liabilities primarily due to changes in our stock price.

Other Income (Expense), net

Other income (expense), net recognized during the three months ended June 30, 2023 was not material. We recognized other income (expense), net of $0.2 million during the three months ended June 30, 2022 related to the correction of a payroll tax expense credit received in a prior period.

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Results of operations for the six months ended June 30, 2023, reflect the following changes from the six months ended June 30, 2022:

Research

    

Six Months Ended June 30, 

    

2023

    

2022

    

Change

OPERATING EXPENSES

 

  

 

  

 

  

General and administrative

$

5,320,976

$

6,697,712

$

(1,376,736)

Research and development

 

2,524,530

 

11,592,279

 

(9,067,749)

Restructuring

 

6,727

 

 

6,727

TOTAL OPERATING EXPENSES

 

7,852,233

 

18,289,991

 

(10,437,758)

LOSS FROM OPERATIONS

 

(7,852,233)

 

(18,289,991)

 

10,437,758

OTHER INCOME (EXPENSE)

 

 

 

Interest expense

 

(3,084)

 

(6,135)

 

3,051

Interest income

 

294,425

 

40,592

 

253,833

Loss on issuance of common stock and warrants

(1,311,552)

(1,311,552)

Change in fair value of warrant liabilities

 

1,430,351

 

 

1,430,351

Other income (expense), net

 

(97,814)

 

(160,212)

 

62,398

Total other income (expense), net

 

312,326

 

(125,755)

 

438,081

NET LOSS

$

(7,539,907)

$

(18,415,746)

$

10,875,839

During the six months ended June 30, 2023, our operating loss decreased by $10.4 million compared to the six months ended June 30, 2022. Our net loss decreased by $10.9 million for the six months ended June 30, 2023, as compared to the six months ended June 30, 2022. Until we are able to generate revenue from product sales, our management expects to continue to incur net losses.

General and DevelopmentAdministrative Expenses

ResearchGeneral and developmentadministrative expenses consist primarily of legal and professional fees, research, development, manufacturing expenses, wages and stock-based compensation. Due to the Company’s restructuring, researchGeneral and developmentadministrative expenses decreased by $3.0$1.4 million for the threesix months ended December 31, 2022,June 30, 2023, as compared to the threesix months ended December 31, 2021,June 30, 2022, primarily due to a decrease in consulting and wage expenses.

Research and Development Expenses

The following table summarizes the Company’s research and development expenses for the six months ended June 30, 2023 and 2022:

    

Six Months Ended June 30, 

    

2023

    

2022

    

Change

Research and development

 

  

 

  

 

  

Professional consultation and other analytical work

$

291,059

$

2,685,378

$

(2,394,319)

Lab Supplies, chemicals and manufacturing expenses

 

696,817

 

5,329,818

 

(4,633,001)

Employee wages, benefits, and payroll taxes

 

768,677

 

2,193,541

 

(1,424,864)

Stock-based compensation expense

 

79,884

 

531,777

 

(451,893)

Facility, depreciation and other expenses

 

688,093

 

851,765

 

(163,672)

Total research and development

$

2,524,530

$

11,592,279

$

(9,067,749)

The decrease of approximately $9.1 million of research and development expenses was primarily attributable to $2.4 million of decreased professional consultation and other analytical work; $4.6 million of decreased lab supplies, chemicals, and manufacturing expenses; $1.4 million decrease of employee wages, benefits, and payroll taxes; $0.5 million of decreased stock-based compensation expense; and $0.2 million of decreased equipment, depreciation, and facility costs. The overall decrease is primarily related to the Company’s strategic restructuring announced in October 2022 to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. As part of the development pipeline shift to gene editing, the Company deferred preclinical activities for its myotonic dystrophy type 1 (DM1), Huntington’s disease (HD), and KRAS programs resulting in the overall decrease in research and development expenses and wages and stock-based compensation.for the six months ended June 30, 2023, as compared to the six months ended June 30, 2022.

Restructuring

Restructuring charges incurred during the three months ended December 31, 2022 relate primarily to the Company’s strategic restructuring announced in October 2022 to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The Company recognized restructuring costs wereof

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approximately $7 thousand during the six months ended June 30, 2023, comprised primarily of contract termination costs of $0.6 million and termination benefits related to headcount reductions of $0.1 million.costs. No restructuring charges were incurred during the threesix months ended December 31, 2021.June 30, 2022.

The following table summarizes activity in the Company’s restructuring-related liability during the six months ended June 30, 2023:

    

    

Restructuring

    

Payments/

    

Charges

Utilization

Liability at

(Six Months Ended

(Six Months Ended

Liability at

    

December 31, 2022

    

June 30, 2023)

    

June 30, 2023)

    

June 30, 2023

Research and development contract termination costs

$

311,110

$

2,490

$

(313,600)

$

Other

 

4,922

 

4,237

 

(9,159)

 

Total Accrued restructuring

$

316,032

$

6,727

$

(322,759)

$

EquityLoss on Issuance of Common Stock and Warrants

For the six months ended June 30, 2023, the loss on issuance of common stock and warrants was approximately $1.3 million. This loss is attributable to the fair value measurement of the warrant liabilities using a Black-Scholes Model to estimate the common stock warrant liabilities associated with the registered direct and concurrent private placement offering we completed in Losses on Equity Method InvestmentJune 2023. There was no comparable loss for the six months ended June 30, 2022.

Change in Fair Value of Warrant Liabilities

We account for our investmentChange in DepYmed common shares using the equity method of accounting and record our proportionate share of DepYmed’s net income and losses. As of December 31, 2022 and September 30, 2022, the carryingfair value of warrant liabilities of $1.4 million for the DepYmed investment was $0 and, as such, the Company did not record its proportionate share of losses during the threesix months ended December 31, 2022. EquityJune 30, 2023 reflects the changes in losses during the three months ended December 31, 2021 was $0.4 million.warrant liabilities primarily due to changes in our stock price.

Other Income (Expense), net

We recognized other income (expense), net of $0.1 million during the threesix months ended December 31,June 30, 2023 primarily related to the buyout of certain leased equipment. We recognized other income (expense), net of $0.2 million during the six months ended June 30, 2022 related to the salecorrection of certain research and development materials. Other income recognized during the three months ended December 31, 2021 was not material.a payroll tax expense credit received in a prior period.

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, 2022,June 30, 2023, we had cash and cash equivalents of $17.4$14.7 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,August 2023, the Company announced a restructuring plan to reduce its operating expenses and extend its cash runway into the secondfourth quarter of calendar year 20242025 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, 2022 to December 31, 2022 to June 30, 2023 by $ 4.7$6.4 million (from $20.5$15.8 million to $15.8$9.4 million). We expect our annual cash burn to decrease in the fiscal year ending September 30,December 31, 2023, due to the restructuring actions that we have implemented since October 2022. We believe our current cash balance will provide sufficient capital2022 and the announcement in August 2023 that we are halting further development of the Company’s research programs and exploring strategic alternatives including, but not limited to, continue operations into the second calendar quarter of 2024.an acquisition, merger, business combination, or other transaction.

We entered into a purchase agreement with Alumni Capital in December 2022, pursuant to which Alumni Capital is obligated to purchase up to $3.0 million of our common stock from time to time at our sole discretion over a 24-month period commencing on December 28, 2022. To date, we have not sold any shares of common stock under the purchase agreement.

At present, we have no bank line of 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

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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 we will be able to obtain the financing needed to achieve our goals

16

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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,

Six Months Ended June 30, 

    

2022

    

2021

    

2023

    

2022

Net cash used in operating activities

$

(5,687,848)

$

(5,268,446)

$

(7,091,643)

$

(17,105,466)

Net cash used in investing activities

(49,844)

(123,906)

 

(4,947)

 

(319,029)

Net cash used in financing activities

(28,645)

(174,975)

Net cash provided by (used in) financing activities

 

4,457,688

 

(54,740)

Net decrease in cash and cash equivalents

$

(5,766,337)

$

(5,567,327)

$

(2,638,902)

$

(17,479,235)

Operating Activities

Net cash used in operating activities was approximately $5.7$7.1 million for the threesix months ended December 31, 2022,June 30, 2023, as compared to approximately $5.3$17.1 million for the threesix months ended December 31, 2021.June 30, 2022. Net cash used in operating activities in the threesix months ended December 31,June 30, 2023 was primarily the result of our net loss, an increase in prepaid insurance, the change in fair value of warrant liabilities, a decrease in accrued expenses and other current liabilities, and a decrease in operating lease liability, partially offset by stock-based compensation expense, the loss on issuance of common stock and warrants, depreciation and amortization expenses, and a decrease in security deposit. Net cash used in operating activities in the six months ended June 30, 2022 was primarily the result of our net loss,  an increase in prepaid expenses and other current assets, 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,lease liability, 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 and other current liabilities.accounts payable.

Investing Activities

Net cash used in investing activities was approximately $0.05$5 thousand for the six months ended June 30, 2023, as compared to $0.3 million for the threesix months ended December 31, 2022, as compared to $0.1 million for the three months ended December 31, 2021.June 30, 2022. Net cash used in investing activities for the threesix months ended December 31,June 30, 2023 was primarily due to the purchase of leasehold improvements, partially offset by proceeds received on sale of lab equipment. Net cash used in investing activities for the six months ended June 30, 2022 and 2021 was primarily due to the purchase of laboratory and office equipment.

Financing Activities

Net cash used inprovided by financing activities was approximately $0.03$4.5 million for the threesix months ended December 31, 2022,June 30, 2023, as compared to net cash used in financing activities of $0.2$0.1 million for the threesix months ended December 31, 2021.June 30, 2022. Net cash used inprovided by financing activities for the threesix months ended December 31, 2022June 30, 2023 primarily reflects net proceeds from the June 2023 issuance of common stock and warrants, partially offset by principal payment of our finance lease liability. Net cash used in financing activities for the threesix months ended December 31, 2021June 30, 2022 primarily reflects 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.liability.

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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

Table of Contents

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, 2022.June 30, 2023. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of December 31, 2022,June 30, 2023, 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, 2022.June 30, 2023.

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PART II.

ITEM 1. LEGAL PROCEEDINGS

We have become involved in certain legal proceedings and claims which arise in the normal course of business. 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.

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, 2022, filed with the U.S. Securities and Exchange Commission (“SEC”) on December 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. ThereOther than the following disclosed risk factors, 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, 2022.

Risks Related to the Company

Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations.

As widely reported, global credit and financial markets have experienced volatility and disruptions in the past several years, including severely diminished liquidity and credit availability, rising inflation, rising interest rates, declines in consumer confidence, declines in economic growth, increases in unemployment rates, uncertainty about economic stability, failures of certain U.S. and international financial institutions and liquidity concerns at other financial institutions.  There can be no assurances that further deterioration in credit and financial markets and confidence in economic conditions will not occur.  Our general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions.  If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive.  Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and price of the Company’s common stock, and could require us to delay or abandon clinical development plans.

We are reviewing strategic alternatives and there can be no assurance that we will be successful in identifying or completing any strategic transaction, that any such strategic transaction will result in additional value for our stockholders or that the process will not have an adverse impact on our business.

On August 3, 2023, we announced that our Board had initiated a process to explore potential strategic alternatives, possibly including, but not limited to, an acquisition, merger, business combination or other transaction, aimed at increasing stockholder value. There can be no assurance that the review of strategic alternatives will result in the identification or consummation of any transaction. Our Board may also determine that our most effective strategy is to continue to execute on our current strategy. The Board has also approved a reduction in workforce, designed to reduce costs and reallocate resources while maintaining the personnel needed to focus on activities relating to halting further development of the Company's programs and the pursuit of strategic alternatives.

The process of reviewing strategic alternatives may be costly, time consuming and disruptive to our business operations and, if we are unable to effectively manage the process, our business, financial condition and results of operations could be adversely affected. We have incurred, and may in the future incur, significant costs associated with identifying, evaluating and negotiating potential strategic alternatives, such as legal, financial advisor and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this process. A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed, decreasing cash available for use in our business. We do not intend to comment regarding the evaluation of strategic alternatives until such time as we have determined that further disclosure is necessary or appropriate.

24

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There can be no assurance that any potential transaction, or series of transactions, or other strategic alternative, if consummated, will provide greater value to our stockholders than that reflected in the current price of our common stock. Until the review process is concluded, perceived uncertainties related to our future may impact our business performance and volatility in the market price of our common stock and may make it more difficult for us to attract and retain qualified personnel and key employees. Our Board has not set a timetable for the conclusion of this review, nor has it made any definitive decisions related to taking any further actions or potential strategic options at this time or at all.

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

Exhibit
Number

Description

 

Form

 

File
Number

 

Filing Date

 

Exhibit

2.1+

Agreement and Plan of Merger and Reorganization, dated as of January 2, 2019, by and among Ohr Pharmaceutical, Inc., Ohr Acquisition Corp. and NeuBase Therapeutics, Inc.

8-K

001-35963

1/3/2019

2.1

2.2

First Amendment to the Agreement and Plan of Merger and Reorganization, dated as of June 27, 2019, by and among Ohr Pharmaceutical, Inc., Ohr Acquisition Corp. and NeuBase Therapeutics, Inc.

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

3.2

Certificate of Amendment to the Amended and Restated Certificate of Incorporation of NeuBase Therapeutics, Inc., filed with the Secretary of State of the State of Delaware on June 14, 2023.

8 K

001-35963

6/14/2023

3.1

3.3

Amended and Restated Bylaws of the Company.

8-K

001-35963

9/23/2019

3.1

4.1

Form of Series A Warrant issued to investors pursuant to the Securities Purchase Agreement, dated December 7, 2016, by and among Ohr Pharmaceutical, Inc. and the purchasers listed therein.

8-K

001-35963

12/8/2016

4.1

4.2

Form of Warrant issued to investors pursuant to the Securities Purchase Agreement, dated as of April 5, 2017, by and among Ohr Pharmaceutical, Inc. and the purchasers listed therein.

8-K

001-35963

4/6/2017

4.1

4.3

Form of Common Stock Certificate.

S-8

333-233346

8/16/2019

4.17

4.4

Form of Series A Common Stock Purchase Warrant issued to investors pursuant to the Securities Purchase Agreements, dated as of June 28, 2023, by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

4.1

4.5

Form of Series B Common Stock Purchase Warrant issued to investors pursuant to the Securities Purchase Agreements, dated as of June 28, 2023, by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

4.2

4.6

Form of Pre-Funded Common Stock Purchase Warrant (Registered Direct Offering) issued to investors pursuant to the Securities Purchase Agreements, dated as of June 28, 2023, by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

4.3

4.7

Form of Pre-Funded Common Stock Purchase Warrant (PIPE Private Placement) issued to investors pursuant to the Securities Purchase Agreements, dated as of June 28, 2023, by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

4.4

4.8

Form of Placement Agent Common Stock Purchase Warrant issued to investors pursuant to an engagement letter, dated as of June 12, 2023, as amended on June 28, 2023, between the Company and H.C. Wainwright & Co., LLC.

8-K

001-35963

6/30/2023

4.5

10.1***

Securities Purchase Agreement, dated as of June 28, 2023 (Registered Direct Offering), by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

10.1

26

Table of Contents

Incorporated by Reference

Exhibit
Number

Description

 

Form

 

File
Number

 

Filing Date

 

Exhibit

2.1+

Agreement and Plan of Merger and Reorganization, dated as of January 2, 2019, by and among Ohr Pharmaceutical, Inc., Ohr Acquisition Corp. and NeuBase Therapeutics, Inc.

8-K

001-35963

1/3/2019

2.1

2.2

First Amendment to the Agreement and Plan of Merger and Reorganization, dated as of June 27, 2019, by and among Ohr Pharmaceutical, Inc., Ohr Acquisition Corp. and NeuBase Therapeutics, Inc.

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

3.2

Amended and Restated Bylaws of the Company.

8-K

001-35963

9/23/2019

3.1

4.1

Form of Series A Warrant issued to investors pursuant to the Securities Purchase Agreement, dated December 7, 2016, by and among Ohr Pharmaceutical, Inc. and the purchasers listed therein.

8-K

001-35963

12/8/2016

4.1

4.2

Form of Warrant issued to investors pursuant to the Securities Purchase Agreement, dated as of April 5, 2017, by and among Ohr Pharmaceutical, Inc. and the purchasers listed therein.

8-K

001-35963

4/6/2017

4.1

4.3

Form of Common Stock Certificate.

S-8

333-233346

8/16/2019

4.17

10.1

Purchase Agreement, dated December 28, 2022, by and between NeuBase Therapeutics, Inc. and Alumni Capital LP

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.

31.2*

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**

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

101.INS* 

XBRL Instance Document.

101.SCH*

XBRL Taxonomy Extension Schema Document.

101.CAL*

XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF* 

XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*

XBRL Taxonomy Extension Label Linkbase Document.

101.PRE* 

XBRL Taxonomy Extension Presentation Linkbase Document.

Incorporated by Reference

Exhibit
Number

Description

 

Form

 

File
Number

 

Filing Date

 

Exhibit

10.2***

Securities Purchase Agreement, dated as of June 28, 2023 (PIPE Private Placement), by and among NeuBase Therapeutics, Inc. and the purchasers listed therein.

8-K

001-35963

6/30/2023

10.2

10.3

Registration Rights Agreement, dated as of June 28, 2023, by and among NeuBase Therapeutics, Inc. and the purchaser listed therein

8-K

001-35963

6/30/2023

10.3

31.1*

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.

32.1**

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

101.INS* 

XBRL Instance Document.

101.SCH*

XBRL Taxonomy Extension Schema Document.

101.CAL*

XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF* 

XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*

XBRL Taxonomy Extension Label Linkbase Document.

101.PRE* 

XBRL Taxonomy Extension Presentation Linkbase Document.

*Filed herewith.

** Furnished herewith.

*** Non-material schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the omitted schedules and exhibits upon request by the SEC.

+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: FebruaryAugust 14, 2023

/s/ Todd Branning

 

Todd Branning

 

Chief Financial Officer

 

(Principal Financial and Accounting Officer)

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