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RenovoRx, Inc.
Awaiting Response
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RenovoRx, Inc.
Response Received
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RenovoRx, Inc.
Awaiting Response
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RenovoRx, Inc.
Response Received
1 company response(s)
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RenovoRx, Inc.
Response Received
1 company response(s)
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RenovoRx, Inc.
Response Received
1 company response(s)
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RenovoRx, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-11-16
RenovoRx, Inc.
Summary
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RenovoRx, Inc.
Response Received
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RenovoRx, Inc.
Response Received
9 company response(s)
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RenovoRx, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-05-28
RenovoRx, Inc.
Summary
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RenovoRx, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-05-03
RenovoRx, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2025-08-13 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2025-07-29 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2025-07-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2025-07-10 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2024-05-08 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2024-05-01 | SEC Comment Letter | RenovoRx, Inc. | DE | 333-278964 | Read Filing View |
| 2024-04-24 | SEC Comment Letter | RenovoRx, Inc. | DE | 333-278841 | Read Filing View |
| 2023-05-17 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2023-05-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-25 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-25 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-24 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-12 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-05 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-07-29 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-28 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-03 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2025-07-29 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2025-07-10 | SEC Comment Letter | RenovoRx, Inc. | DE | 001-40738 | Read Filing View |
| 2024-05-01 | SEC Comment Letter | RenovoRx, Inc. | DE | 333-278964 | Read Filing View |
| 2024-04-24 | SEC Comment Letter | RenovoRx, Inc. | DE | 333-278841 | Read Filing View |
| 2023-05-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-16 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-07-29 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-28 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-03 | SEC Comment Letter | RenovoRx, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2025-07-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2023-05-17 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-18 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-25 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-25 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-24 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-12 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
| 2021-08-05 | Company Response | RenovoRx, Inc. | DE | N/A | Read Filing View |
2025-08-28 - UPLOAD - RenovoRx, Inc. File: 001-40738
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 28, 2025 Ronald B. Kocak VP Controller and Principal Accounting Officer RenovoRx, Inc. 2570 West El Camino Real, Suite 320 Mountain View, California 94040 Re: RenovoRx, Inc. Form 10-K for the fiscal year ended December 31, 2024 File No. 001-40738 Dear Ronald B. Kocak: We have completed our review of your filings. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-08-13 - CORRESP - RenovoRx, Inc.
CORRESP 1 filename1.htm RenovoRx, Inc. 2570 West El Camino Real, Suite 320 Mountain View, California 94040 VIA EDGAR August 13, 2025 U.S. Securities & Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Jenn Do Vanessa Robertson Re: RenovoRx, Inc. Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended March 31, 2025 File No. 001-40738 Dear Ms. Do and Ms. Roberston: RenovoRx, Inc. (the " Company ," " we ," " our " or " us ") hereby transmits our response to the comment letter, dated July 29, 2025, received by the Company from the staff (the " Staff, " " you " or " your ") of the U.S. Securities and Exchange Commission (the " Commission ") related to our Form 10-K for the fiscal year ended December 31, 2024 and Form 10-Q for the quarterly period ended March 31, 2025 previously filed with the Commission. For the Staff's convenience, we have repeated below the Staff's comments in bold, and have followed each comment with the Company's response. Disclosure changes made in response to the Staff's comments have been made in the Company's Form 10-Q for the period ended June 30, 2025 (the " June Form 10-Q "), which we expect to file with the Commission on August 14, 2025. Form 10-K for the fiscal year ended December 31, 2024 Controls and Procedures, page 87 1. We have read your response to comment 1. Notwithstanding the correction of the typo referring to "December 31, 2022" which relates specifically to the evaluation of disclosure controls and procedures only, you were required to provide a management report on internal control over financial reporting (ICFR) beginning with your Form 10-K for the year ended December 31, 2023, as that was when your transition period of being a newly public company ended. The information provided on pages 87-88 under section (b) of this Item 9A. does not constitute a management report on ICFR as it does not comply with the disclosure requirements of Item 308(a) of Regulation S-K. Therefore, please tell us management's assessment of effectiveness of ICFR as of December 31, 2024 and, as previously requested, confirm that you will revise your future filings to provide management's conclusion regarding the effectiveness of your internal control over financial reporting. The Company thanks the Staff for its comment and acknowledges that, notwithstanding the Company's overall disclosures in Item 9A of the referenced Form 10-K regarding the material weaknesses identified by our management and the steps to remediate the same, Item 9A, section (b) of the referenced Form 10-K does not contain a required statement of management's conclusion regarding the effectiveness of the Company's internal control over financing reporting. In light of the Staff's comment, the Company confirms that (i) our management's assessment and conclusion regarding the effectiveness of the Company's internal control over financial reporting as of December 31, 2024 was that such internal control was not effective as of such date for the reasons disclosed and (ii) its Item 9A, section (b) disclosures in its Annual Report on Form 10-K for the fiscal year ending December 31, 2025 and future applicable filings shall contain a required statement of management's assessments and conclusions of the Company's internal control over financial reporting and otherwise properly comply with Item 308(a) of Regulation S-K. Form 10-Q for the quarterly period ended March 31, 2025 Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations, page 16 Results of Operations, page 20, page 90 2. We have read your response to comment 2. You have told us, among other things, that "all commercial costs for the production of the RenovoCath device in connection with our commercialization program are capitalized on the balance sheet or charged as cost of goods sold on the income statement." However, you disclose on page 21 that you anticipate selling, general and administrative expenses to increase during 2025 as you progress with your commercialization activities for your RenovoCath device. Please address the following: ● Please tell us the amount and the nature of the commercial costs that were charged to cost of goods sold for the four most recent quarters and explain how these costs are appropriately classified as cost of goods sold. Refer to ASC 330-10-30. Consider enhancing your disclosure of these amounts in future filings. ● Also, tell us and consider revising your future filings to identify the nature of the increased expenses in selling, general and administrative related to the commercialization of your RenovoCath device. As noted in the text of the referenced Management's Discussion and Analysis of Financial Condition and Results of Operations, the Company only first generated revenue from commercial sales of RenovoCath devices during the quarter ended December 31, 2024. The amount charged to cost of goods sold during the quarter ended March 31, 2025 was $94,000 and represents the costs related to the RenovoCath devices sold during the quarter, which are primarily third-party manufacturing costs, including shipping and handling costs. The nature of the costs classified as cost of sales are in line with inventoriable costs (i.e. costs incurred to bring the RenovoCath device to its existing condition and location) pursuant to ASC 330-10-30. The costs associated with the sales of RenovoCath devices during the quarter ended December 31, 2024, totaled $2,000 and were expensed as research and development in prior periods as part of the Company's clinical trial, No commercial sales or cost of goods sold were recorded prior to the quarter ended December 31, 2024. Furthermore, we confirm we will revise our disclosures regarding cost of goods sold in future filings (including the June Form 10-Q), to the effect of the following: Cost of Revenue Cost of revenue consist of costs associated with the sales of RenovoCath devices and represents primarily third-party manufacturing costs and shipping and handling costs. Prior to the commencement of RenovoCath commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC Phase III clinical trial study and expensed as research and development in prior periods. The Staff is further advised that we anticipate selling, general and administrative expenses to increase to some degree during 2025 as we hire additional sales and marketing personnel, to support our commercialization and sales strategy to include, in general, expenses such as payroll and related benefits, share-based compensation expense, travel expenses, and marketing expenses. We further confirm that we will clarify our disclosures related to these expenses accordingly in the June Form 10-Q and other future filings. *** We thank the Staff for its review of the foregoing. If you have further comments, please feel free to contact to our counsel, Lawrence A. Rosenbloom, Esq., at lrosenbloom@egsllp.com or by telephone at (212) 370-1300. Sincerely, /s/ Ronald B. Kocak Ronald B. Kocak VP Controller and Principal Accounting Officer cc: Lawrence A. Rosenbloom, Esq.
2025-07-29 - UPLOAD - RenovoRx, Inc. File: 001-40738
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 29, 2025 Ronald B. Kocak VP Controller and Principal Accounting Officer RenovoRx, Inc. 2570 West El Camino Real, Suite 320 Mountain View, California 94040 Re: RenovoRx, Inc. Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended March 31, 2025 File No. 001-40738 Dear Ronald B. Kocak: We have reviewed your July 18, 2025 response to our comment letter and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our July 10, 2025 letter. Form 10-K for the fiscal year ended December 31, 2024 Controls and Procedures, page 87 1. We have read your response to comment 1. Notwithstanding the correction of the typo referring to "December 31, 2022" which relates specifically to the evaluation of disclosure controls and procedures only, you were required to provide a management report on internal control over financial reporting (ICFR) beginning with your Form 10-K for the year ended December 31, 2023, as that was when your transition period of being a newly public company ended. The information provided on pages 87-88 under section (b) of this Item 9A. does not constitute a management report on ICFR as it does not comply with the disclosure requirements of Item 308(a) of Regulation S-K. Therefore, please tell us management's assessment of effectiveness of ICFR as of December 31, 2024 and, as previously requested, confirm that you will revise your future filings to provide management s conclusion regarding the effectiveness of your July 29, 2025 Page 2 internal control over financial reporting. Form 10-Q for the quarterly period ended March 31, 2025 Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations, page 16 Results of Operations, page 20, page 90 2. We have read your response to comment 2. You have told us, among other things, that "all commercial costs for the production of the RenovoCath device in connection with our commercialization program are capitalized on the balance sheet or charged as cost of goods sold on the income statement." However, you disclose on page 21 that you anticipate selling, general and administrative expenses to increase during 2025 as you progress with your commercialization activities for your RenovoCath device. Please address the following: Please tell us the amount and the nature of the commercial costs that were charged to cost of goods sold for the four most recent quarters and explain how these costs are appropriately classified as cost of goods sold. Refer to ASC 330-10-30. Consider enhancing your disclosure of these amounts in future filings. Also, tell us and consider revising your future filings to identify the nature of the increased expenses in selling, general and administrative related to the commercialization of your RenovoCath device. Please contact Jenn Do at 202-551-3743 or Vanessa Robertson at 202-551-3649 if you have questions regarding comments on the financial statements and related matters. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-07-18 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
2570
West El Camino Real, Suite 320
Mountain
View, California 94040
VIA
EDGAR
July
18, 2025
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
Vanessa
Robertson
Re:
RenovoRx,
Inc.
Form
10-K for the fiscal year ended December 31, 2024
Form
10-Q for the quarterly period ended March 31, 2025
File
No. 001-40738
Dear
Ms. Do and Ms. Robertson:
RenovoRx,
Inc. (the " Company ," " we ," " our " or " us ") hereby transmits
our response to the comment letter received from the staff (the " Staff ", " you " or " your ")
of the U.S. Securities and Exchange Commission (the " Commission "), dated July 10, 2025, regarding the Company's
Form 10-K for the fiscal year ended December 31, 2024 and Form 10-Q for the quarterly period ended March 31, 2025.
For
the Staff's convenience, we have repeated below the Staff's comment in bold and have followed each comment with the Company's
response.
Form
10-K for the fiscal year ended December 31, 2024
Controls
and Procedures, page 87
1.
We
note your annual report does not include a report of management's assessment regarding internal control over financial reporting
("ICFR") due to a transition period established by rules of the Securities and Exchange Commission for newly public companies.
Since you were required to file or filed an annual report for the prior year, it appears you are required to report on your management's
assessment of ICFR. Please confirm that you will revise your future filings to provide management's conclusion regarding the
effectiveness of your internal control over financial reporting. Refer to Item 308(a) of Regulation S-K.
The
Staff is advised that the date of "December 31, 2022" disclosed at the end of the first sentence of the first paragraph of
section (a) of Item 9A was a typographical error that should read "December 31, 2024" (please note that the correct date
is included at the beginning of section (b) of Item 9A). We note for the avoidance of doubt that management's conclusion and explanation
regarding the described material weakness in internal control over financial reporting as stated in Item 9A is otherwise accurate. We
will correct the typographical error in all applicable future filings.
Form
10-Q for the quarterly period ended March 31, 2025
Item
2: Management's Discussion and Analysis of Financial Condition and Results of Operations
Results
of Operations
Research
and Development, page 21
2.
You
disclose that you expect research and development expenses to increase during 2025 as you continue your commercialization activities
for your RenovoCath device. Please tell us the extent to which the amounts reported as research and development expense during the
recent periods related to commercialization activities, and explain how commercialization costs meet the definition of research and
development expense under ASC 730-10-20.
As
noted in the text of the referenced Management's Discussion and Analysis of Financial Condition and Results of Operations (" MD&A "),
research and development expense increased during the applicable period due to non-recurring engineering costs related to the development
of the next generation of our RenovoCath device. The next generation of the RenovoCath device is anticipated to continue to support our
current TIGeR-PaC Phase III clinical trial study and other clinical trial studies, including a contemplated post-approval registry trial
and the possibility of a trial to study the use of RenovoCath as a treatment for other cancer indications.
The
Staff is advised that the amount charged to research and development expenses for devices delivered for use in the TIGeR-PaC clinical
trial study was approximately $48,000 in the period ended March 31, 2025. We therefore believe that such costs meet the definition of
research and development expenses under ASC 730-10-20.
The
Staff is further advised that all commercial costs for the production of the RenovoCath device in connection with our commercialization
program are capitalized on the balance sheet or charged as cost of goods sold on the income statement.
To
avoid any potential lack of clarity on this point, in future filings we will revise our text in both the footnotes to the financial statements
and in the MD&A to more clearly indicate non-recurring engineering costs, including the cost for devices charged to the clinical
trial programs, and modify any accompanying language which could conflate research and development expenses and expenses associated with
commercial activities.
We
thank the Staff in advance for its consideration of the foregoing. Should you have any questions, please do not hesitate to contact our
legal counsel, Lawrence A. Rosenbloom, Esq., of Ellenoff Grossman & Schole LLP, at (212) 370-1300.
Sincerely,
By:
/s/
Ronald B. Kocak
Name:
Ronald
B. Kocak
Title:
VP
Controller and Principal Accounting Officer
cc:
Ellenoff Grossman & Schole
LLP
2025-07-10 - UPLOAD - RenovoRx, Inc. File: 001-40738
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
July 10, 2025
Ronald B. Kocak
VP Controller and Principal Accounting Officer
RenovoRx, Inc.
2570 West El Camino Real, Suite 320
Mountain View, California 94040
Re: RenovoRx, Inc.
Form 10-K for the fiscal year ended December 31, 2024
Form 10-Q for the quarterly period ended March 31, 2025
File No. 001-40738
Dear Ronald B. Kocak:
We have limited our review of your filing to the financial statements
and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.
After reviewing your response to this letter, we may have additional
comments.
Form 10-K for the fiscal year ended December 31, 2024
Controls and Procedures, page 87
1. We note your annual report does not include a report of management s
assessment
regarding internal control over financial reporting ("ICFR") due to a
transition period
established by rules of the Securities and Exchange Commission for newly
public
companies. Since you were required to file or filed an annual report for
the prior year,
it appears you are required to report on your management s assessment
of ICFR.
Please confirm that you will revise your future filings to provide
management's
conclusion regarding the effectiveness of your internal control over
financial
reporting. Refer to Item 308(a) of Regulation S-K.
Form 10-Q for the quarterly period ended March 31, 2025
Item 2: Management's Discussion and Analysis of Financial Condition and Results
of
Operations
Results of Operations
July 10, 2025
Page 2
Research and Development, page 21
2. You disclose that you expect research and development expenses to
increase during
2025 as you continue your commercialization activities for your
RenovoCath device.
Please tell us the extent to which the amounts reported as research and
development
expense during the recent periods related to commercialization
activities, and explain
how commercialization costs meet the definition of research and
development
expense under ASC 730-10-20.
In closing, we remind you that the company and its management are
responsible for
the accuracy and adequacy of their disclosures, notwithstanding any review,
comments,
action or absence of action by the staff.
Please contact Jenn Do at 202-551-3743 or Vanessa Robertson at
202-551-3649 with
any questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
</TEXT>
</DOCUMENT>
2024-05-08 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RENOVORX,
INC.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
May
8, 2024
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
DC 20549
Attention:
Tamika Sheppard
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-3
Filed
April 26, 2024
File
No. 333-278964
Dear
Ms. Sheppard:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”) hereby requests acceleration
of effectiveness of the above referenced Registration Statement, as amended, so that it will become effective at 4:30 p.m., Eastern time,
on Friday, May 10, 2024 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq. of Ellenoff
Grossman & Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one or more requests
for any potential deferral of the Effective Time.
Very truly yours,
/s/ Shaun
R. Bagai
Shaun R. Bagai
Chief Executive Officer
2024-05-08 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RENOVORX,
INC.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
May
8, 2024
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
DC 20549
Attention:
Chris Edwards
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-3
Filed
April 19, 2024
File
No. 333-278841
Dear
Mr. Edwards:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”) hereby requests acceleration
of effectiveness of the above referenced Registration Statement, as amended, so that it will become effective at 4:30 p.m., Eastern time,
on Friday, May 10, 2024 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq. of Ellenoff
Grossman & Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one or more requests
for any potential deferral of the Effective Time.
Very
truly yours,
/s/
Shaun R. Bagai
Shaun
R. Bagai
Chief
Executive Officer
2024-05-01 - UPLOAD - RenovoRx, Inc. File: 333-278964
United States securities and exchange commission logo
May 1, 2024
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite B1
Los Altos, CA 94022
Re:RenovoRx, Inc.
Registration Statement on Form S-3
Filed April 26, 2024
File No. 333-278964
Dear Shaun Bagai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence Rosenbloom
2024-04-24 - UPLOAD - RenovoRx, Inc. File: 333-278841
United States securities and exchange commission logo
April 24, 2024
Shaun R. Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite B1
Los Altos, CA 94022
Re:RenovoRx, Inc.
Registration Statement on Form S-3
Filed April 19, 2024
File No. 333-278841
Dear Shaun R. Bagai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Scott M. Miller, Esq.
2023-05-17 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, California 94022
May
17, 2023
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-3
Filed
May 12, 2023
File
No. 333-271882
Acceleration
Request
Requested Date:
May 19, 2023
Requested Time:
4:00 p.m. Eastern Time,
or as soon thereafter as practicable
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”) hereby respectfully requests
that the above-referenced Registration Statement on Form S-3 (File No. 333-271882) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the
Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and
Exchange Commission.
Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich &
Rosati, Professional Corporation, by calling Michael Coke at (650) 565-3596.
Please
direct any questions or comments regarding this acceleration request to Michael Coke.
Very
truly yours,
RenovoRx,
Inc.
/s/
Shaun R. Bagai
Shaun
R. Bagai
Chief
Executive Officer
cc:
Michael
E. Coke, Wilson Sonsini Goodrich & Rosati, Professional Corporation
2023-05-16 - UPLOAD - RenovoRx, Inc.
United States securities and exchange commission logo
May 16, 2023
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite B1
Los Altos, CA 94022
Re:RenovoRx, Inc.
Registration Statement on Form S-3
Filed May 12, 2023
File No. 333-271882
Dear Shaun Bagai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Coke, Esq.
2022-11-18 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, California 94022
November
18, 2022
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
November 10, 2022
File
No. 333-268316
Acceleration
Request
Requested
Date:
November
21, 2022
Requested
Time:
4:00
p.m. Eastern Time,
or
as soon thereafter as practicable
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”) hereby respectfully requests
that the above-referenced Registration Statement on Form S-1 (File No. 333-268316) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the
Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and
Exchange Commission.
Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich &
Rosati, Professional Corporation, by calling Michael Coke at (650) 565-3596.
Please
direct any questions or comments regarding this acceleration request to Michael Coke.
Very
truly yours,
RenovoRx,
Inc.
/s/
Shaun R. Bagai
Shaun
R. Bagai
Chief
Executive Officer
cc:
Michael
E. Coke, Wilson Sonsini Goodrich & Rosati, Professional Corporation
2022-11-18 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, California 94022
November
18, 2022
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-3
Filed
November 10, 2022
File
No. 333-268302
Acceleration Request
Requested
Date:
November
21, 2022
Requested
Time:
4:00
p.m. Eastern Time,
or
as soon thereafter as practicable
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”) hereby respectfully requests
that the above-referenced Registration Statement on Form S-3 (File No. 333-268302) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the
Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and
Exchange Commission.
Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich &
Rosati, Professional Corporation, by calling Michael Coke at (650) 565-3596.
Please
direct any questions or comments regarding this acceleration request to Michael Coke.
Very
truly yours,
RenovoRx,
Inc.
/s/
Shaun R. Bagai
Shaun
R. Bagai
Chief
Executive Officer
cc:
Michael
E. Coke, Wilson Sonsini Goodrich & Rosati, Professional Corporation
2022-11-16 - UPLOAD - RenovoRx, Inc.
United States securities and exchange commission logo
November 16, 2022
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite B1
Los Altos, CA 94022
Re:RenovoRx, Inc.
Registration Statement on Form S-3
Filed November 10, 2022
File No. 333-268302
Dear Shaun Bagai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Coke, Esq.
2021-08-25 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
August
25, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane Park
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Wednesday, August 25, 2021, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
RENOVORX, INC.
By:
/s/
Shaun Bagai
Name:
Shaun
Bagai
Title:
Chief
Executive Officer
1
2021-08-25 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
Roth
Capital Partners, LLC
888
San Clemente Drive
Newport
Beach, CA 92660
August
25, 2021
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx,
Inc. (the “Company”)
Registration
Statement on Form S-1 (File No. 333-258071)
Ladies
and Gentlemen:
In
connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Act”), Roth Capital Partners, LLC, as the representative of the underwriters, hereby joins in the request of the Company
that the effective date of such registration statement be accelerated to 5:00 p.m. (Eastern time) on Wednesday, August 25, 2021, or as
soon thereafter as practicable.
In
making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public offering
of securities pursuant to the registration statement.
[Signature
Page Follows]
Very
truly yours,
Roth
Capital Partners, LLC,
As
the Representative of the Underwriters
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
2021-08-24 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
August
24, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane Park
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
Reference
is made to the acceleration request letter of RenovoRx, Inc. (the “Company”) dated August 20, 2021 (the “Acceleration
Request”) requesting, pursuant to Rule 461 under the Securities Act of 1933, as amended, and Rule 12d1-2(b) under the Securities
Exchange Act of 1934, as amended, the Securities and Exchange Commission (the “Commission”) to accelerate the effective
date of the above-referenced Registration Statement and declare the Registration Statement, as then amended, effective as of 5:00 p.m.,
Eastern Daylight Time, on Tuesday, August 24, 2021, or as soon thereafter as practicable.
The
Company hereby notifies the Commission of its withdrawal of the Acceleration Request for the above-referenced time until such time as
the Company may subsequently request.
RENOVORX,
INC.
By:
/s/
Shaun R. Bagai
Name:
Shaun
R. Bagai
Title:
Chief
Executive Officer
2021-08-20 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
August
20, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane Park
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Tuesday, August 24, 2021, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
RENOVORX,
INC.
By:
/s/
Shaun Bagai
Name:
Shaun
Bagai
Title:
Chief
Executive Officer
2021-08-20 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
Roth
Capital Partners, LLC
888
San Clemente Drive
Newport
Beach, CA 92660
August
20, 2021
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-258071)
Ladies
and Gentlemen:
In
connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Act”), Roth Capital Partners, LLC, as the representative of the underwriters, hereby joins in the request of the Company
that the effective date of such registration statement be accelerated to 5:00 p.m. (Eastern time) on Tuesday, August 24, 2021, or as
soon thereafter as practicable.
In
making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public offering
of securities pursuant to the registration statement.
[Signature
Page Follows]
Very truly yours,
Roth
Capital Partners, LLC,
As
the Representative of the Underwriters
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
2021-08-12 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
August
12, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane Park
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
Reference
is made to the acceleration request letter of RenovoRx, Inc. (the “Company”) dated August 10, 2021 (the “Acceleration
Request”) requesting, pursuant to Rule 461 under the Securities Act of 1933, as amended, and Rule 12d1-2(b) under the Securities
Exchange Act of 1934, as amended, the Securities and Exchange Commission (the “Commission”) to accelerate the effective
date of the above-referenced Registration Statement and declare the Registration Statement, as then amended, effective as of 5:00 p.m.,
Eastern Daylight Time, on Thursday, August 12, 2021, or as soon thereafter as practicable.
The
Company hereby notifies the Commission of its withdrawal of the Acceleration Request for the above-referenced time until such time as
the Company may subsequently request.
RENOVORX,
INC.
By:
/s/
Shaun R. Bagai
Name:
Shaun
R. Bagai
Title:
Chief
Executive Officer
2021-08-10 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
Roth
Capital Partners, LLC
888
San Clemente Drive
Newport
Beach, CA 92660
August
10, 2021
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
RenovoRx,
Inc. (the “Company”)
Registration
Statement on Form S-1 (File No. 333-258071)
Ladies
and Gentlemen:
In
connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Act”), Roth Capital Partners, LLC, as the representative of the underwriters, hereby joins in the request of the Company
that the effective date of such registration statement be accelerated to 5:00 p.m. (Eastern time) on Thursday, August 12, 2021, or as
soon thereafter as practicable.
In
making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public offering
of securities pursuant to the registration statement.
[Signature
Page Follows]
Very
truly yours,
Roth
Capital Partners, LLC,
As
the Representative of the Underwriters
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
2021-08-10 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
RenovoRx,
Inc.
4546
El Camino Real, Suite B1
Los
Altos, CA 94022
August
10, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jane Park
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RenovoRx, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Thursday. August 12, 2021, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
RENOVORX,
INC.
By:
/s/
Shaun Bagai
Name:
Shaun
Bagai
Title:
Chief
Executive Officer
2021-08-05 - CORRESP - RenovoRx, Inc.
CORRESP
1
filename1.htm
Sheppard,
Mullin, Richter & Hampton LLP
30
Rockefeller Plaza
New
York, New York 10112-0015
212.653.8700
main
212.653.8701
fax
www.sheppardmullin.com
212.634.3067 direct
jfessler@sheppardmullin.com
August
5, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, NE
Washington,
D.C. 20549
Re:
RenovoRx,
Inc.
Registration
Statement on Form S-1
Filed
July 21, 2021
File
No. 333-258071
Ladies
and Gentlemen:
This
letter sets forth the responses of RenovoRx, Inc., a Delaware corporation (the “Company”), to the comments received
from the Staff on July 28, 2021 (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
concerning its Registration Statement on Form S-1 (File No. 333-258071) filed with the Commission on July 21, 2021 (the “Registration
Statement”).
References
in the text of the responses herein to captions and page numbers refer to Amendment No. 1 to the Registration Statement (“Amendment
No. 1”), which is being filed herewith.
Form
S-1 filed July 21, 2021
Exhibits
1.
Please
revise Article X of your Sixth Amended and Restated Certificate of Incorporation to clearly
state that the federal district courts of the United States of America will be the exclusive
forum for resolving any complain asserting a cause of action arising under the Securities
Act or the Securities Exchange Act of 1934, consistent with your disclosure on page 105.
Alternately, please provide reasonable assurance that you will make future investors aware
of the provision’s limited applicability by including such disclosure in
your
future Exchange Act reports.
RESPONSE:
We have revised Article X of our Sixth Amended and Restated Certificate of Incorporation to clearly state that the federal district
courts of the United States of America will be the exclusive forum for resolving any complain asserting a cause of action arising under
the Securities Act or the Securities Exchange Act of 1934. We are re-filing our Sixth Amended and Restated Certificate of Incorporation
as Exhibit 3.3 to Amendment No. 1.
August
5, 2021
Page
2
If
you have any questions relating to any of the foregoing, please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP
at (212) 653-8700.
Very
truly yours,
/s/
Jeffrey Fessler
Jeffrey
Fessler
for
SHEPPARD, MULLIN, RICHTER & HAMPTON llp
SMRH:4824-5318-5262.1
cc:
Shaun Bagai, CEO
2021-07-29 - UPLOAD - RenovoRx, Inc.
United States securities and exchange commission logo
July 28, 2021
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite 223
Los Altos, CA 94022
Re:RenovoRx, Inc.
Registration Statement on Form S-1
Filed July 21, 2021
File No. 333-258071
Dear Mr. Bagai:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-1 filed July 21, 2021
Exhibits
1.Please revise Article X of your Sixth Amended and Restated Certificate of Incorporation
to clearly state that the federal district courts of the United States of America will be the
exclusive forum for resolving any complain asserting a cause of action arising under the
Securities Act or the Securities Exchange Act of 1934, consistent with your disclosure on
page 105. Alternately, please provide reasonable assurance that you will make future
investors aware of the provision's limited applicability by including such disclosure in
your future Exchange Act reports.
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
July 28, 2021 Page 2
FirstName LastName
Shaun Bagai
RenovoRx, Inc.
July 28, 2021
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Kristin Lochhead at 202-551-3664 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jane Park at 202-551-7439 or Joe McCann at 202-551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-05-28 - UPLOAD - RenovoRx, Inc.
United States securities and exchange commission logo
May 28, 2021
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite 223
Los Altos, CA 94022
Re:RenovoRx, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted May 12, 2021
CIK No. 0001574094
Dear Mr. Bagai:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amended Draft Registration Statement submitted May 12, 2021
Overview, page 3
1.We note your revised disclosure in response to prior comment 5. Please revise briefly to
clarify the implications of comparing your studies, which were not randomized or
controlled for potential confinement, against control data that has been randomized and
controlled. Also explain the term "confinement".
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
May 28, 2021 Page 2
FirstName LastName
Shaun Bagai
RenovoRx, Inc.
May 28, 2021
Page 2
You may contact Kristin Lochhead at 202-551-3664 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jane Park at 202-551-7439 or Joe McCann at 202-551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-05-03 - UPLOAD - RenovoRx, Inc.
United States securities and exchange commission logo
May 2, 2021
Shaun Bagai
Chief Executive Officer
RenovoRx, Inc.
4546 El Camino Real, Suite 223
Los Altos, CA 94022
Re:RenovoRx, Inc.
Draft Registration Statement on Form S-1
Submitted April 2, 2021
CIK No. 0001574094
Dear Mr. Bagai:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted April 2, 2021
Overview, page 3
1.Please revise the Summary to clarify the meaning of scientific or technical terms the first
time they are used in order to ensure that lay readers will understand the disclosure. For
example, please briefly explain what you mean by cholangiocarcinoma, hilar CCA and
TIGeR-PaC. Also revise the Business section to explain the terms RECIST criteria and
Cmax.
2.Please revise the opening paragraph to provide context and balance to your disclosure that
you are a "late-stage" clinical biopharmaceutical company. In this regard we refer to your
statement on page 46 that you do not expect to generate any revenue from the sale of
products for several years.
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
May 2, 2021 Page 2
FirstName LastNameShaun Bagai
RenovoRx, Inc.
May 2, 2021
Page 2
3.We refer to your disclosure that your therapy platform, RenovoRx Trans-Arterial Micro-
Perfusion, or RenovoTAMP™ utilizes approved chemotherapeutics with validated
mechanisms of action and well-established safety and side effect profiles. Based on your
disclosures, it appears that your clinical work has focused on a single generic drug,
namely gemcitabine. Accordingly please revise to clarify, if true, that your clinical work
has focused on gemcitabine and clarify that it is a generic drug.
4.We refer to your statements here and elsewhere in your prospectus that your Phase 1/2 and
observational registry studies of RenovoGem have demonstrated “safety.” You also state
on page 74 that your RR2 observational registry study “further validate[d] the safety and
clinical efficacy of the RenovoTAMP procedure” and conclude on page 78 that
RenovoTAMP in patients with LAPC “is sufficiently safe” to permit a large Phase 3
study. Determinations of safety and efficacy are within the sole authority of the FDA.
Although we note your disclosure that FDA has cleared your RenovoCath delivery
system, it is premature for you to suggest that the RenovoTAMP platform or RenovoGem
will be determined to be safe and effective. Please revise your prospectus disclosure
accordingly.
5.We note your disclosure on page 3 comparing the median overall survival rate of 27.9
months in patients treated with RenovoGem and radiation versus the expected survival
rate of 12-15 months in patients receiving IV chemotherapy. Given that you have not
conducted head-to-head trials, please expand your disclosure to discuss any known
differences in trial protocols, conditions and patient populations that could materially
impact the comparability of the trial data presented.
6.We note your disclosure on page 4 that your Phase 1/2 safety study (RR1) enrolled 20
patients with a diagnosis of Stage 3 pancreatic cancer. Please include the number of
patients enrolled (or expected to be enrolled) in each of your trials and studies the first
time they are referenced on page 3 as well. Please also expand your disclosure of your
RR2 observational study to include key inclusion criteria of the 25 patients enrolled in
your study, such as their cancer diagnosis.
7.We note your disclosure on page 3 that you “anticipate launching a Phase 2/3 trial to
evaluate RenovoGem in your second indication” or HCCA in the first half of 2022.
Please revise your disclosure in the Summary to clarify that you have not yet submitted
your proposed Phase 2/3 clinical trial for your second indication to the FDA. While we
note your reference to the Phase 2/3 trial for the treatment of HCCA throughout the
prospectus, we also note disclosure on page 59 of your plans to launch a Phase 2 trial in
the first half of 2022. Please revise to reference the Phase 2 trial for your second
indication or expand your disclosure on the scope of the combined Phase 2/3 trial in the
Summary and elsewhere in the prospectus.
8.Please revise the Summary to provide clear descriptions of the primary endpoints for each
of the programs discussed, and where applicable, whether the product candidate met such
primary endpoints. Please also disclose any reported serious adverse events.
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
May 2, 2021 Page 3
FirstName LastNameShaun Bagai
RenovoRx, Inc.
May 2, 2021
Page 3
Cautionary Statements Concerning Forward-Looking Statements, page 37
9.We note that Section 21E of the Securities Exchange Act of 1934 and Section 27A of the
Securities Act of 1933 do not apply to initial public offerings. Accordingly, please revise
to remove these references.
Use of Proceeds, page 39
10.Please revise your disclosure to include each of the programs listed in your Summary
pipeline table and also indicate how far the proceeds from the offering will allow you to
proceed with continued development of each program listed.
Business, page 56
11.We note your disclosure on page 57 and your website that your Scientific Advisors make
up your Advisory Board. If material, please include disclosure that describes the role or
function of your Scientific Advisors, whether there are any rules of procedures governing
this board, as well as how the Scientific Advisors are compensated.
Research and Development Pipeline, page 58
12.We refer to the second row in your pipeline table under the heading
“Cholangiocarcinoma.” In light of your disclosure that you are not intending to launch the
Phase 2 trial until the first half of 2022, please shorten the arrow in the second row to
show that you have not yet initiated the Phase 2 trial.
Our Platform: RenovoTAMP, page 60
13.Please revise to discuss briefly your development of RenovoCath. In this regard, please
revise to explain when you commenced work designing the delivery system, when you
conducted the studies referenced in this section and when the product received 510(k)
clearance.
Observational Registry Study RR2, page 74
14.We note your disclosure on page 76 that Figure 16 measures the median survival rate
starting from when patients were given their first IA gemcitabine therapy, while Figure 17
measures the overall survival rate of the patients. Please revise the description of Figure
17 to identify the starting point from when the survival rate was measured from (such as
from the date of diagnosis or the start of treatment).
Clinical Development of RenovoGem in HCCA, page 81
15.Please revise the statement that you plan to perform a definitive Phase 2/3 trial with early
discussion with the FDA for approval of your indication based on this study. This
statement is not appropriate given that safety determinations and approvals are in the
purview of the FDA.
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
May 2, 2021 Page 4
FirstName LastName
Shaun Bagai
RenovoRx, Inc.
May 2, 2021
Page 4
Intellectual Property, page 83
16.We refer to the second through fifth rows in Table 3 on page 84. Please revise to identify
the type of patent protection for the specified patents. With respect to the four pending
patents, please expand your disclosure to include the date that each of these patent
applications were submitted, whether the patents are owned or licensed, the technology or
product group each patent relates to, the type of patent protection and their expected
expiration date.
Manufacturing and Supply, page 85
17.We note your disclosure of the material terms of your agreement with Medical Murray,
your single-source contract manufacturer for RenovoCath. Please also file the agreement
as an exhibit to the registration statement or explain to us why you believe you are not
required to do so under Item 101(h)(4) of Regulation S-K.
Directors and Executive Officers, page 91
18.We note that your disclosure on page 101 identifies Kamran Najmabadi as your founder
and as a technical engineering advisor, and further indicates that he holds a 44.6%
beneficial ownership stake in the company. Accordingly, please revise the prospectus,
where appropriate, to discuss Mr. Najmabadi's role in founding the company and describe
his current advisory role, including any compensation derived from his services.
Exclusive Forum, page 104
19.We note that your forum selection provision identifies the State of Delaware as the
exclusive forum for certain litigation, including any “derivative action.” Please disclose
whether this provision applies to actions arising under the Exchange Act. In that regard,
we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all
suits brought to enforce any duty or liability created by the Exchange Act or the rules and
regulations thereunder. If this provision does not apply to actions arising under the
Exchange Act, please also ensure that the exclusive forum provision in the governing
documents states this clearly, or tell us how you will inform investors in future filings that
the provision does not apply to any actions arising under the Exchange Act.
Related Party Transactions, page F-27
20.We note your disclosure of the consulting agreement you have entered into with your
Chief Medical Officer. Please revise to disclose your consulting agreement with your
Chief Financial Officer as well. We refer to your disclosure on page 96.
FirstName LastNameShaun Bagai
Comapany NameRenovoRx, Inc.
May 2, 2021 Page 5
FirstName LastName
Shaun Bagai
RenovoRx, Inc.
May 2, 2021
Page 5
General
21.Please provide us with supplemental copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.
You may contact Kristin Lochhead at (202) 551-3664 or Al Pavot at (202) 551-3738 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jane Park at (202) 551-7439 or Joe McCann at (202) 551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.