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Immix Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
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Immix Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-09-26
Immix Biopharma, Inc.
Summary
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Company responded
2023-09-26
Immix Biopharma, Inc.
Summary
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Immix Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-01-06
Immix Biopharma, Inc.
Summary
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Company responded
2023-01-09
Immix Biopharma, Inc.
Summary
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Immix Biopharma, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2021-09-27
Immix Biopharma, Inc.
Summary
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Company responded
2021-10-06
Immix Biopharma, Inc.
References: September 27, 2021
Summary
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Company responded
2021-10-15
Immix Biopharma, Inc.
References: October 13, 2021
Summary
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Company responded
2021-12-13
Immix Biopharma, Inc.
Summary
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Company responded
2021-12-13
Immix Biopharma, Inc.
Summary
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Immix Biopharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-10-13
Immix Biopharma, Inc.
Summary
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Immix Biopharma, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-08-16
Immix Biopharma, Inc.
Summary
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Company responded
2021-09-16
Immix Biopharma, Inc.
References: August 16, 2021
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-16 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2026-01-16 | SEC Comment Letter | Immix Biopharma, Inc. | DE | 333-292665 | Read Filing View |
| 2023-09-26 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-09-26 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-01-09 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-12-13 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-12-13 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-15 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-09-27 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-09-16 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-08-16 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-16 | SEC Comment Letter | Immix Biopharma, Inc. | DE | 333-292665 | Read Filing View |
| 2023-09-26 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-09-27 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-08-16 | SEC Comment Letter | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-16 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-09-26 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-01-09 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-12-13 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-12-13 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-15 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
| 2021-09-16 | Company Response | Immix Biopharma, Inc. | DE | N/A | Read Filing View |
2026-01-16 - CORRESP - Immix Biopharma, Inc.
CORRESP 1 filename1.htm January 16, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Tyler Howes Re: Immix Biopharma, Inc. Registration Statement on Form S-3 Filed January 9, 2026 File No: 333-292665 Dear Mr. Howes, Immix Biopharma, Inc. (the " Registrant ") hereby requests that the effective date of the above-referenced Registration Statement on Form S-3 (File No. 333-292665), be accelerated by the U.S. Securities and Exchange Commission (the " Commission ") to become effective on Tuesday, January 20, 2026 , at 5:00 p.m ., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow, Esq. and Melissa Palat Murawsky of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (212) 885-5358 or Ms. Murawsky at (215) 569-5732 with any questions you may have concerning this request, and please notify either of them when this request for acceleration has been granted. Very truly yours, IMMIX BIOPHARMA, INC. By: /s/ Gabriel Morris Name: Gabriel Morris Title: Chief Financial Officer cc: Leslie Marlow, Esq., Blank Rome LLP Melissa Murawsky, Esq., Blank Rome LLP
2026-01-16 - UPLOAD - Immix Biopharma, Inc. File: 333-292665
January 16, 2026
Ilya Rachman
Chief Executive Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Registration Statement on Form S-3
Filed January 9, 2026
File No. 333-292665
Dear Ilya Rachman:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Melissa Murawsky, Esq.
2023-09-26 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
IMMIX
BIOPHARMA, INC.
11400
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
VIA
EDGAR
September
26, 2023
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Re:
Immix Biopharma, Inc.
Acceleration
Request for Registration Statement on Form S-3
Filed
September 25, 2023
File
No. 333-274684
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Immix Biopharma, Inc. hereby requests that the effective date and time of the
above-referenced registration statement be accelerated to September 28, 2023, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable.
If
you have any questions regarding this request, please contact Melanie R. Levy of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
at (858) 314 -1873.
Sincerely,
IMMIX
BIOPHARMA, INC.
/s/
Gabriel Morris
Gabriel
Morris
Chief
Financial Officer
cc:
Ilya Rachman, Immix Biopharma, Inc.
Melanie
R. Levy, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2023-09-26 - UPLOAD - Immix Biopharma, Inc.
United States securities and exchange commission logo
September 26, 2023
Gabriel Morris
Chief Financial Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Registration Statement on Form S-3
Filed September 25, 2023
File No. 333-274684
Dear Gabriel Morris:
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 N. Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Melanie Levy
2023-01-09 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
Immix
Biopharma, Inc.
11400
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
January
9, 2023
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Lauren Hamill
Re:
Immix
Biopharma, Inc.
Registration
Statement on Form S-3
File
No. 333-269100
Filed
January 3, 2023
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Immix Biopharma,
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 4:30 p.m., Eastern Time, on Wednesday, January 11, 2023, or as soon thereafter as possible. In
making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Please
notify Jeffrey Fessler of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as
to the time the Registration Statement has been declared effective pursuant to this acceleration request.
Very
truly yours,
IMMIX
BIOPHARMA, INC.
By:
/s/
Ilya Rachman
Name:
Ilya
Rachman
Title:
CEO
cc:
Jeffrey
Fessler, Sheppard Mullin Richter & Hampton LLP
2023-01-06 - UPLOAD - Immix Biopharma, Inc.
United States securities and exchange commission logo
January 6, 2023
Ilya Rachman
Chief Executive Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Registration Statement on Form S-3
Filed January 3, 2023
File No. 333-269100
Dear Ilya Rachman:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler
2021-12-13 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
IMMIX
BIOPHARMA, INC.
1140
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
December
13, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F. Street, NE
Washington,
DC 20549
Attention:
Gary Newberry
Al Pavot
Jane Park
Laura Crotty
Re:
Immix Biopharma, Inc.
Registration Statement on Form S-1, as amended
File No. 333-259591
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Immix Biopharma,
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 4:45 p.m.., Eastern Standard Time, on Wednesday, December 15, 2021, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
Thank
you,
IMMIX
BIOPHARMA, INC.
By:
/s/
Ilya Rachman
Name:
Ilya
Rachman
Title:
Chief
Executive Officer
2021-12-13 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
December
13, 2021
Via
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, NE
Washington, D.C. 20549
Attn:
Jane
Park
Laura
Crotty
Re:
Immix
Biopharma, Inc. (the “Company”)
Registration
Statement on Form S-1/A
File
No. 333-259591
Acceleration
Request
Requested
Date: December 15, 2021
Requested
Time: 4:45 p.m., Eastern Standard Time
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), ThinkEquity LLC, as representative
of the several underwriters, hereby joins the Company in requesting that the Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the Registration Statement on Form S-1/A (File No. 333-259591) (the “Registration Statement”)
to become effective on Wednesday, December 15, 2021, at 4:45 p.m., Eastern Standard Time, or as soon as practicable thereafter.
Pursuant
to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus,
to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement.
We
have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, to the extent applicable.
[Signature
Page Follows]
Securities
and Exchange Commission, p. 2
December
13, 2021
Very
truly yours,
ThinkEquity
LLC
By:
/s/ Eric Lord
Name:
Eric
Lord
Title:
Head
of Investment Banking
cc:
Ilya
Rachman, Immix Biopharma, Inc.
Jeffrey
Fessler, Sheppard, Mullin, Richter & Hampton LLP
Anthony
Epps, Dorsey & Whitney LLP
2021-10-15 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
IMMIX
BIOPHARMA, INC.
11400
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
October
15, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F. Street, NE
Washington,
DC 20549
Attention:
Gary
Newberry
Al
Pavot
Jane
Park
Laura
Crotty
Re:
Immix
Biopharma, Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
October 6, 2021
File
No. 333-259591
Dear
Ladies and Gentlemen:
This
letter sets forth responses on behalf of Immix Biopharma, Inc., a Delaware corporation (the “Company”), to the comments
received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth
in your letter dated October 13, 2021 (“Comment Letter”) regarding the Company’s Amendment No. 1 to its
Registration Statement on Form S-1 (the “Registration Statement”).
For
the convenience of the Staff, each comment from the Comment Letter corresponds to the numbered paragraphs in this letter and is restated
prior to the response to such comment.
Amendment
No. 1 to Form S-1 filed October 6, 2021
Prospectus
Summary, page 4
1.
Please clarify the meaning of the term “ODD” the first time it is used in the Summary to ensure that lay readers will understand
the disclosure.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
2.
We refer to the first, third and fourth rows in your pipeline table, which indicate that soft tissue sarcoma (SST), colorectal cancer
and ulcerative colitis/severe Crohn’s disease are orphan drug indications. We also note your disclosure on pages 4, 64 and 84 that
soft tissue sarcoma and fistulating Crohn’s disease are orphan drug disease indications, that the FDA has granted orphan drug designation
to IMX-110 for SST and that you plan to apply for orphan drug disease designation from the FDA for IMX-120 in fistulating CD. Please
revise your pipeline table on pages 5 and 60 to clarify whether colorectal cancer has been granted orphan drug disease designation from
the FDA and if not, that the FDA has not given any indication as to whether any of your product candidates will receive orphan drug designation.
Please also advise of any correspondence you have received from the FDA confirming the status of orphan drug indications for colorectal
cancer and ulcerative colitis/severe Crohn’s disease.
RESPONSE:
The
Company has revised the Registration Statement to indicate that other than IMX-110, the FDA
has not given any indication as to whether any of the Company’s other product candidates
will receive orphan drug disease designation. In addition, the Company has not received any
correspondence from the FDA confirming the status of orphan drug indications for colorectal
cancer or ulcerative colitis/severe Crohn’s disease.
Sincerely,
Immix
Biopharma, Inc.
/s/ Ilya Rachman
By:
Ilya
Rachman
Title:
Chief
Executive Officer
2021-10-13 - UPLOAD - Immix Biopharma, Inc.
United States securities and exchange commission logo
October 13, 2021
Ilya Rachman
Chief Executive Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed October 6, 2021
File No. 333-259591
Dear Dr. Rachman:
We have reviewed your amended 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.
Amendment No. 1 to Form S-1 filed October 6, 2021
Prospectus Summary, page 4
1.Please clarify the meaning of the term "ODD" the first time it is used in the Summary to
ensure that lay readers will understand the disclosure.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
October 13, 2021 Page 2
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
October 13, 2021
Page 2
2.We refer to the first, third and fourth rows in your pipeline table, which indicate that soft
tissue sarcoma (SST), colorectal cancer and ulcerative colitis/severe Crohn’s disease are
orphan drug indications. We also note your disclosure on pages 4, 64 and 84 that soft
tissue sarcoma and fistulating Crohn’s disease are orphan drug disease indications, that the
FDA has granted orphan drug designation to IMX-110 for SST and that you plan to apply
for orphan drug disease designation from the FDA for IMX-120 in fistulating CD. Please
revise your pipeline table on pages 5 and 60 to clarify whether colorectal cancer has been
granted orphan drug disease designation from the FDA and if not, that the FDA has not
given any indication as to whether any of your product candidates will receive orphan
drug designation. Please also advise of any correspondence you have received from the
FDA confirming the status of orphan drug indications for colorectal cancer and ulcerative
colitis/severe Crohn’s disease.
You may contact Gary Newberry at 202-551-3761 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 Laura Crotty at 202-551-7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-10-06 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
IMMIX
BIOPHARMA, INC.
11400
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
October
6, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F. Street, NE
Washington,
DC 20549
Attention:
Gary
Newberry
Al
Pavot
Jane
Park
Laura
Crotty
Re:
Immix
Biopharma, Inc.
Registration
Statement on Form S-1
Filed
September 17, 2021
File
No. 333-259591
Dear
Ladies and Gentlemen:
This
letter sets forth responses on behalf of Immix Biopharma, Inc., a Delaware corporation (the “Company”), to the comments received
from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter
dated September 27, 2021 (“Comment Letter”) regarding the Company’s Registration Statement on Form S-1 (the “Registration
Statement”).
For
the convenience of the Staff, each comment from the Comment Letter corresponds to the numbered paragraphs in this letter and is restated
prior to the response to such comment.
Form
S-1 filed September 17, 2021
Prospectus
Summary, page 1
1.
We refer to the second and third rows in your pipeline table under the heading IMX-111 and IMX-120. In light of your disclosure that
you plan to conduct IND-enabling studies for IMX-111 and IMX-120 by mid-2022, please shorten the arrows in these rows to show that you
have not yet completed the preclinical trials.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
AxioMx
Master Services Agreement, page 51
2.
We note your response to our prior comment 9 and your disclosure on page 51 that the term of the AxioMx Master Services Agreement was
set to expire on December 22, 2019, unless extended by you and AxioMx. Please revise to include disclosure of any extensions and/or amendments
to the Master Services Agreement and file any amendments as exhibits.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Sincerely,
Immix
Biopharma, Inc.
/s/ Ilya Rachman
By:
Ilya
Rachman
Title:
Chief
Executive Officer
2021-09-27 - UPLOAD - Immix Biopharma, Inc.
United States securities and exchange commission logo
September 27, 2021
Ilya Rachman
Chief Executive Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Registration Statement on Form S-1
Filed September 17, 2021
File No. 333-259591
Dear Dr. Rachman:
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 September 17, 2021
Prospectus Summary, page 1
1.We refer to the second and third rows in your pipeline table under the heading IMX-111
and IMX-120. In light of your disclosure that you plan to conduct IND-enabling studies
for IMX-111 and IMX-120 by mid-2022, please shorten the arrows in these rows to show
that you have not yet completed the preclinical trials.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
September 27, 2021 Page 2
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
September 27, 2021
Page 2
AxioMx Master Services Agreement, page 51
2.We note your response to our prior comment 9 and your disclosure on page 51 that the
term of the AxioMx Master Services Agreement was set to expire on December 22, 2019,
unless extended by you and AxioMx. Please revise to include disclosure of any
extensions and/or amendments to the Master Services Agreement and file any
amendments as exhibits.
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 Gary Newberry at 202-551-3761 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 Laura Crotty at 202-551-7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-09-16 - CORRESP - Immix Biopharma, Inc.
CORRESP
1
filename1.htm
IMMIX
BIOPHARMA, INC.
11400
West Olympic Blvd., Suite 200
Los
Angeles, CA 90064
September
16, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F. Street, NE
Washington,
DC 20549
Attention:
Gary
Newberry
Jane
Park
Laura
Crotty
Re:
Immix
Biopharma, Inc.
Draft
Registration Statement on Form S-1
Submitted
July 20, 2021
CIK
No. 0001873835
Dear
Ladies and Gentlemen:
This
letter sets forth responses on behalf of Immix Biopharma, Inc., a Delaware corporation (the “Company”), to the comments received
from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter
dated August 16, 2021 (“Comment Letter”) regarding the Company’s Draft Registration Statement on Form S-1 (the “Registration
Statement”).
For
the convenience of the Staff, each comment from the Comment Letter corresponds to the numbered paragraphs in this letter and is restated
prior to the response to such comment.
Draft
Registration Statement on Form S-1 submitted July 20, 2021
Cover
Page
1.
The prominence of the graphics on page 2, immediately following the cover page, is not appropriate, as this page includes extensive technical
information without context. As such, please move these graphics to the Summary section or elsewhere with the appropriate narrative context
and enlarge all text for legibility. Please refer to Question 101.02 of our Securities Act Forms Compliance and Disclosure Interpretations
for guidance regarding admissible graphics inside the front and back cover pages.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
2.
After moving the pipeline table from page 2 to the Summary and revising to make all text legible, please further revise the table to
include separate columns for each of the preclinical phase and Phases 1, 2 and 3. Progress arrows should be moved to clearly depict the
progress of each candidate to date and should not encroach on phases not commenced. The table on page 53 should also be revised accordingly.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Overview,
page 4
3.
Please clarify in the Summary that you have generated no revenues to date.
RESPONSE:
The
Company has revised the Registration Statement to clarify that it has not generated any revenues to date.
4.
Please clarify the meaning of scientific or technical terms the first time they are used here and in the Business section or in close
proximity thereto in order to ensure that lay readers will understand the disclosure. For example, please briefly explain what you mean
by poly-kinase inhibitor, apoptosis inducer, hypoxia and acidosis, Treg T-cells, CMC processes, moiety, tumorigenicity and high-therapeutic
index drugs.
RESPONSE:
The
Company has revised the Registration Statement to clarify the meaning of scientific and technical terms the first time they are used
in the Overview and Business sections.
5.
We refer to your disclosure on page 4 that your SMARXT Tissue-Specific Platform has produced drug candidates that have resulted in “relatable
safety profiles.” Please note that determinations of safety and efficacy are solely within the authority of the FDA; therefore,
please revise your prospectus to remove all references and/or implications of safety and efficacy, including the reference cited above.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Our
products will face significant competition..., page 25
6.
You disclose your key competitors with respect to your product candidates in the Business section, such as on pages 62, 73 and 74. Please
revise the above referenced risk factor to provide more robust disclosure regarding the potential impact on the company of these key
competitors, including whether any are targeting the GLUT1 cancer biomarker and/or developing a poly-kinase inhibitor/apoptosis inducer.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Our
Amended and Restated Bylaws to be effective upon completion of this offering..., page 37
7.
We note your disclosure on page 38 that the forum selection provision in your amended and restated bylaws may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with you and may discourage such lawsuits. Please revise
this risk factor and your disclosure in the Business section to disclose that there is also a risk that your forum selection provision
may result in increased costs for investors to bring a claim.
RESPONSE:
The
Company has revised the Registration Statement to include disclosure that its forum selection provision may result in increased costs
for investors to bring a claim.
Industry
and Market Data, page 41
8.
We note your statement cautioning investors not to give undue weight to projections, assumptions and estimates in your prospectus and
that you have not independently verified the data contained in industry and general publications. These statements may imply an inappropriate
disclaimer of responsibility with respect to third party information; therefore, please either remove the potential disclaiming language
or clearly state in this section that you are liable for such information.
RESPONSE:
The
Company has revised the Registration Statement to include disclosure that the Company may be liable for data contained in third-party
industry and general publications.
Business,
page 53
9.
Please include disclosure in the Business and the MD&A sections to include the material terms of the master services agreement with
AxioMx, Inc. We refer to your disclosure on page F-16, but did not note any further references in the prospectus. Please also file the
master services agreement as an exhibit to the registration statement as required by Item 601(b)(10) of Regulation S-K or tell us why
you believe you are not required to do so.
RESPONSE:
The
Company has revised the Registration Statement to include disclosure regarding the material terms of the Master Services Agreement
with AxioMx, Inc. in the Business and MD&A sections.
10.
For each of the preclinical trials discussed in this section relating to your IMX-110, IMX-111 and IMX-120 product candidates and your
preclinical results discussion starting on page 63, please revise to clarify the scope, size and design; the primary and secondary endpoints
of the studies, as applicable; whether the studies were powered to show statistical significance; and whether any adverse side effects
were observed.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
11.
We note that to your disclosure relating to the preclinical studies for your IMX-110 and IMX-111 product candidates rely on a number
of publications, such as on pages 60-61, 63, 66-67 and elsewhere in the prospectus. Please also clarify in this section and in greater
detail elsewhere to disclose, if true, whether you funded or sponsored the clinical studies and if your employees were involved in both
the studies and publications.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
IMX-110
Development Strategy, page 58
12.
Please remove the statement that you believe that potential accelerated approvals for IMX-110 could be obtained with the completion of
your Phase 2a trial and also one year into your Phase 2b/3 clinical trial, as regulatory approvals are not assured and the timing of
potential approvals is not within the company’s control.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
IMX-110
Composition and Mechanism of Action, page 59
13.
We refer to your conclusion on page 61 that IMX-110’s synergistic combination induces higher rates of tumor cell killing activity
compared to conventional doxorubicin. In addition to the text contained in Figure 13, please revise to include a discussion of the scope,
size and design of the head-to-head study in this section.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Manufacturing,
page 73
14.
We note your disclosure here that in certain cases, the raw materials used to manufacture your product candidates may be sourced from
a single-source supplier. Please expand your disclosure here and on page 19 to discuss your sources, the availability of raw materials
and the names of any principal suppliers. See Item 101(h)(4)(v) of Regulation S-K.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
Intellectual
Property, page 74
15.
We note your disclosure that your patent portfolio includes 4 U.S. and 11 foreign patents and patent applications. Please clarify the
number of patents and patent applications separately, specify whether each patent and patent application is owned or licensed and identify
the type of patent protection covering and the expiration dates for each patent and patent application, as applicable.
RESPONSE:
The
Company has revised the Registration Statement to (i) clarify the number of patents and patent applications in its patent portfolio,
(ii) indicate that each patent and patent application is owned by the Company, (iii) indicate the type of patent protection and (iv)
indicate the expiration dates for each patent and patent application.
IP
License Agreement with Immix Biopharma Australia Pty Ltd., page 74
16.
Please revise your disclosure to discuss the nature and scope of the intellectual property transferred under the IBAPL License Agreement
and the duration of the royalty term. Please also quantify any upfront fees, the aggregate amounts received to date, and the aggregate
amount of milestone payments to be paid under the agreement, if any.
RESPONSE:
The
Company has revised the Registration Statement to discuss the nature and scope of the intellectual property transferred under the
IBAPL License Agreement (“License Agreement”), the duration of the royalty term and to indicate that the Company has
not received any payments to date. The License Agreement does not provide for any upfront fees or milestone fees.
General
17.
We note that the registration statement contains many blank sections, including information regarding the intended listing venue, authorized
and outstanding shares, related party transaction information, use of proceeds and the terms of the company’s warrants, convertibles
notes, and registration rights agreement. Please include the required disclosure for each of these items, and all material missing information,
in the next draft.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
18.
Certain graphics in your prospectus, including Figures 6, 13, 16, 17, 19 and 20, contain text that are illegible and include descriptions
of studies and publications that are not otherwise included in the prospectus. Please revise and provide further detail, as applicable.
RESPONSE:
The
Company has revised the Registration Statement to address this comment.
19.
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.
RESPONSE:
The
Company will supplementally provide the Staff with copies of all written communications, as defined in Rule 405 under the Securities
Act, that the Company, or anyone authorized to do so on its behalf, present to potential investors in reliance on Section 5(d) of
the Securities Act.
Sincerely,
Immix
Biopharma, Inc.
/s/
Ilya Rachman
By:
Ilya
Rachman
Title:
Chief
Executive Officer
2021-08-16 - UPLOAD - Immix Biopharma, Inc.
United States securities and exchange commission logo
August 16, 2021
Ilya Rachman
Chief Executive Officer
Immix Biopharma, Inc.
11400 West Olympic Blvd., Suite 200
Los Angeles, CA 90064
Re:Immix Biopharma, Inc.
Draft Registration Statement on Form S-1
Submitted July 20, 2021
CIK No. 0001873835
Dear Dr. Rachman:
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 July 20, 2021
Cover Page
1.The prominence of the graphics on page 2, immediately following the cover page, is not
appropriate, as this page includes extensive technical information without context. As
such, please move these graphics to the Summary section or elsewhere with the
appropriate narrative context and enlarge all text for legibility. Please refer to Question
101.02 of our Securities Act Forms Compliance and Disclosure Interpretations for
guidance regarding admissible graphics inside the front and back cover pages.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
August 16, 2021 Page 2
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
August 16, 2021
Page 2
2.After moving the pipeline table from page 2 to the Summary and revising to make all text
legible, please further revise the table to include separate columns for each of the
preclinical phase and Phases 1, 2 and 3. Progress arrows should be moved to clearly depict
the progress of each candidate to date and should not encroach on phases not
commenced. The table on page 53 should also be revised accordingly.
Overview, page 4
3.Please clarify in the Summary that you have generated no revenues to date.
4.Please clarify the meaning of scientific or technical terms the first time they are used here
and in the Business section or in close proximity thereto in order to ensure that lay readers
will understand the disclosure. For example, please briefly explain what you mean by
poly-kinase inhibitor, apoptosis inducer, hypoxia and acidosis, Treg T-cells, CMC
processes, moiety, tumorigenicity and high-therapeutic index drugs.
5.We refer to your disclosure on page 4 that your SMARXT Tissue-Specific Platform has
produced drug candidates that have resulted in “relatable safety profiles.” Please note that
determinations of safety and efficacy are solely within the authority of the FDA; therefore,
please revise your prospectus to remove all references and/or implications of safety and
efficacy, including the reference cited above.
Our products will face significant competition..., page 25
6.You disclose your key competitors with respect to your product candidates in the Business
section, such as on pages 62, 73 and 74. Please revise the above referenced risk factor to
provide more robust disclosure regarding the potential impact on the company of
these key competitors, including whether any are targeting the GLUT1 cancer biomarker
and/or developing a poly-kinase inhibitor/apoptosis inducer.
Our Amended and Restated Bylaws to be effective upon completion of this offering..., page 37
7.We note your disclosure on page 38 that the forum selection provision in your amended
and restated bylaws may limit a stockholder’s ability to bring a claim in a judicial forum
that it finds favorable for disputes with you and may discourage such lawsuits. Please
revise this risk factor and your disclosure in the Business section to disclose that there is
also a risk that your forum selection provision may result in increased costs for investors
to bring a claim.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
August 16, 2021 Page 3
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
August 16, 2021
Page 3
Industry and Market Data, page 41
8.We note your statement cautioning investors not to give undue weight to projections,
assumptions and estimates in your prospectus and that you have not independently
verified the data contained in industry and general publications. These statements may
imply an inappropriate disclaimer of responsibility with respect to third party information;
therefore, please either remove the potential disclaiming language or clearly state in this
section that you are liable for such information.
Business, page 53
9.Please include disclosure in the Business and the MD&A sections to include the material
terms of the master services agreement with AxioMx, Inc. We refer to your disclosure on
page F-16, but did not note any further references in the prospectus. Please also file the
master services agreement as an exhibit to the registration statement as required by Item
601(b)(10) of Regulation S-K or tell us why you believe you are not required to do so.
10.For each of the preclinical trials discussed in this section relating to your IMX-110, IMX-
111 and IMX-120 product candidates and your preclinical results discussion starting on
page 63, please revise to clarify the scope, size and design; the primary and secondary
endpoints of the studies, as applicable; whether the studies were powered to show
statistical significance; and whether any adverse side effects were observed.
11.We note that to your disclosure relating to the preclinical studies for your IMX-110 and
IMX-111 product candidates rely on a number of publications, such as on pages 60-61,
63, 66-67 and elsewhere in the prospectus. Please also clarify in this section and in
greater detail elsewhere to disclose, if true, whether you funded or sponsored the clinical
studies and if your employees were involved in both the studies and publications.
IMX-110 Development Strategy, page 58
12.Please remove the statement that you believe that potential accelerated approvals for
IMX-110 could be obtained with the completion of your Phase 2a trial and also one year
into your Phase 2b/3 clinical trial, as regulatory approvals are not assured and the timing
of potential approvals is not within the company's control.
IMX-110 Composition and Mechanism of Action, page 59
13.We refer to your conclusion on page 61 that IMX-110’s synergistic combination induces
higher rates of tumor cell killing activity compared to conventional doxorubicin. In
addition to the text contained in Figure 13, please revise to include a discussion of the
scope, size and design of the head-to-head study in this section.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
August 16, 2021 Page 4
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
August 16, 2021
Page 4
Manufacturing, page 73
14.We note your disclosure here that in certain cases, the raw materials used to manufacture
your product candidates may be sourced from a single-source supplier. Please expand
your disclosure here and on page 19 to discuss your sources, the availability of raw
materials and the names of any principal suppliers. See Item 101(h)(4)(v) of Regulation
S-K.
Intellectual Property, page 74
15.We note your disclosure that your patent portfolio includes 4 U.S. and 11 foreign patents
and patent applications. Please clarify the number of patents and patent applications
separately, specify whether each patent and patent application is owned or licensed and
identify the type of patent protection covering and the expiration dates for each patent and
patent application, as applicable.
IP License Agreement with Immix Biopharma Australia Pty Ltd., page 74
16.Please revise your disclosure to discuss the nature and scope of the intellectual property
transferred under the IBAPL License Agreement and the duration of the royalty term.
Please also quantify any upfront fees, the aggregate amounts received to date, and the
aggregate amount of milestone payments to be paid under the agreement, if any.
General
17.We note that the registration statement contains many blank sections, including
information regarding the intended listing venue, authorized and outstanding shares,
related party transaction information, use of proceeds and the terms of the company's
warrants, convertibles notes, and registration rights agreement. Please include the required
disclosure for each of these items, and all material missing information, in the next draft.
18.Certain graphics in your prospectus, including Figures 6, 13, 16, 17, 19 and 20, contain
text that are illegible and include descriptions of studies and publications that are not
otherwise included in the prospectus. Please revise and provide further detail, as
applicable.
19.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.
FirstName LastNameIlya Rachman
Comapany NameImmix Biopharma, Inc.
August 16, 2021 Page 5
FirstName LastName
Ilya Rachman
Immix Biopharma, Inc.
August 16, 2021
Page 5
You may contact Gary Newberry at 202-551-3761 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 Laura Crotty at 202-551-7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.