Correspondence 0001104659-23-033373 from NeuBase Therapeutics, Inc. (CIK 0001173281)
NeuBase Therapeutics, Inc. (CIK 0001173281)
Date: March 16, 2023 · CIK: 0001173281 · Accession: 0001104659-23-033373
AI Filing Summary & Sentiment
Referenced dates: March 8, 2023
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March 16, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jenn Do
Kevin Vaughn
Re: NeuBase Therapeutics, Inc.
Form 10-K for Fiscal Year Ended September 30, 2022
Filed December 21, 2022
File No. 1-35963
Ladies and Gentlemen:
This letter is submitted on behalf of NeuBase Therapeutics, Inc.
(the “Company”) in response to the comment of the staff of the Division of Corporation Finance (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Annual Report on
Form 10-K for the fiscal year ended September 30, 2022, filed with the Commission on December 21, 2022, as set forth in the
Staff’s letter to the Company dated March 8, 2023 .
For your convenience, the Company has set forth below the Staff’s
comment in italics, followed by the Company’s response thereto.
Form 10-K for the Fiscal Year Ended September 30, 2022
Management's Discussion and Analysis of Financial Condition and
Results of Operations, page 89
1. Given the significant fluctuations in research and development
expense during the years presented as well as in the subsequent interim period, please revise your future filings to disclose the drivers
of the changes. As part of your response, address the following:
• To the extent possible, quantify the impact of your October 2022 restructuring and refocusing of development projects on the amounts
incurred.
• Disclose the costs incurred during each period presented for each of your key research and development projects. If you do not
track your research and development costs by project, please disclose that fact and explain why you do not maintain and evaluate research
and development costs by project. Provide other quantitative or qualitative disclosure that provides more transparency as to the type
of research and development expenses incurred (i.e., by nature or type of expense) which should reconcile to total research and development
expense on the Statements of Operations.
Response:
The Company respectfully acknowledges the Staff’s comment and
advises the Staff that the Company does not have the ability to track research and development costs in sufficiently reliable detail to
disclose such expenses by project. The Company is a pre-commercial discovery company, and most of the research and development costs the
Company incurs are related to early-stage activities; the Company respectfully submits that to track and disclose such costs on a project-by-project
basis would be unduly burdensome and potentially speculative. The Company’s outsourced research and development costs are shared
among various potential programs at different stages of development, often across multiple target indications in a combinatorial approach,
which inhibits the Company’s ability to accurately track such outsourced development costs by project.
In October 2022, the Company announced a strategic restructuring 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 has deferred preclinical activities for its myotonic dystrophy type 1 (DM1), Huntington’s
disease (HD), and KRAS programs.
The Company’s focus is on the advancement of its gene editing
platform, and in future filings the Company intends to include disclosure regarding the costs incurred for each of its key research and
development categories, including such quantitative and/or qualitative disclosure that provides more transparency as to the type of research
and development expenses incurred. By way of example, the Company intends to include disclosure similar to the below in the section entitled
Management’s Discussion and Analysis of Financial Condition and Results of Operations of future Annual Reports on Form10-K
(form presented for the Annual Report on Form 10-K for the fiscal year ended September 30, 2022 for illustrative purposes).
The following table summarizes our research and development expenses
for the years ended September 30, 2022 and 2021:
Year Ended September 30,
2022
2021
Change
Research and development
Professional consultation & other analytical work
$
$
$
Lab Supplies, chemicals & manufacturing expenses
Employee wages, benefits, & payroll taxes
Stock-based compensation expense
Facility, depreciation, and other expenses
Total research and development expenses
$ 21,448,592
$ 11,475,201
$ 9,973,391
The increase of approximately $10.0 million of research and development
expenses was primarily attributable to $[•] of [increased/decreased] professional consultation and other analytical work; $[•]
[increased/decreased] lab supplies, chemicals, and manufacturing expenses; $[•] [increase/decrease] of employee wages, benefits,
and payroll taxes; $[•] of [increased/decreased] stock-based compensation expense; and $[•] of [increased/decreased]
equipment, depreciation, and facility costs, primarily related to [•].
Further, the Company intends to include disclosure similar to the below
in the section entitled Management’s Discussion and Analysis of Financial Condition and Results of Operations of future Quarterly
Reports on Form10-Q (form presented for the Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2022 for illustrative
purposes), as well as disclosure similar to the below to quantify the applicable impact of the Company’s October 2022 restructuring
in future periodic reports.
The following table summarizes our research and development expenses
for the three months ended December 31, 2022 and 2021:
Three Months Ended December 31,
2022
2021
Change
Research and development
Professional consultation & other analytical work
$
$
$
Lab Supplies, chemicals & manufacturing expenses
Employee wages, benefits, & payroll taxes
Stock-based compensation expense
Facility, depreciation, and other expenses
Total research and development expenses
$ 1,351,407
$ 4,369,257
$ (3,017,850 )
The decrease of approximately $3.0 million of research and development
expenses was primarily attributable to $[•] of [increased/decreased] professional consultation and other analytical work; $[•]
of [increased/decreased] lab supplies, chemicals, and manufacturing expenses; $[•] [increase/decrease] of employee wages, benefits,
and payroll taxes; $[•] of [increased/decreased] stock-based compensation expense; and $[•] of [increased/decreased]
equipment, depreciation, and facility costs. The overall decrease is primarily related to [•].
Restructuring charges relate primarily to the
Company’s strategic restructuring to expand its focus to include the advancement of the differentiated gene editing capabilities
of its platform. The Company recognized restructuring costs of $0.7 million during the three months ended December 31, 2022, 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.
The following table summarizes the Company’s
restructuring expenses incurred during the three months ended December 31, 2022:
Restructuring
Charges
Employee-related costs
$ 97,627
Research and development contract termination costs
540,058
Other
14,766
Total restructuring expense
$ 652,451
We appreciate the time you have taken to review the Company’s
public filings. The Company’s future filings will reflect the responses set forth herein, as applicable.
Sincerely,
NeuBase Therapeutics, Inc.
By:
/s/ Todd Branning
Todd P. Branning
Chief Financial Officer
(Principal Financial and Accounting Officer)