SEC Comment Letter 0000000000-24-008182 to iBio, Inc. (IBIO)
iBio, Inc.
Date: July 18, 2024 · CIK: 0001420720 · Accession: 0000000000-24-008182
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-280680
Letter
July 18, 2024 Martin Brenner Chief Executive Officer and Chief Scientific Officer iBio, Inc. 11750 Sorrento Valley Road, Suite 200 San Diego, CA 92121 Re:iBio, Inc. Registration Statement on Form S-3 Filed July 3, 2024 File No. 333-280680 Dear Martin Brenner: We have conducted a limited review of your registration statement and have the following comments. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Registration Statement on Form S-3 Prospectus Summary Overview, page 1 1.Please revise your Prospectus Summary Overview to provide context and balance to your discussion of your platform and AI-engine. For instance, please highlight, if true, that you have a limited operating history developing vaccines and therapeutics, that you have not conducted clinical trials on any product candidates, and that there is a risk that you may be unsuccessful in developing or commercializing any product candidates. Please revise to explain your basis for making all performance and leadership claims, including the following ones: •Your belief that you “lead the field with (y)our patented AI-engine uncovering ‘hard to develop’ molecules;” •Your “groundbreaking EngageTx™ technology enables (you) to target bi-specific molecules;”2.
July 18, 2024 Page 2 •Your ability to “navigate sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release;” •Your “unparalleled epitope engine stands out by allowing the ability to target select regions of a protein, potentially removing the lengthy trial and error out of mAb discovery;” •Your AI-engine is expected to “increase the probability of success.” 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. Please contact Daniel Crawford at 202-551-7767 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc:Melissa Palat Murawsky, Esq.
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July 18, 2024
Martin Brenner
Chief Executive Officer and Chief Scientific Officer
iBio, Inc.
11750 Sorrento Valley Road, Suite 200
San Diego, CA 92121
Re:iBio, Inc.
Registration Statement on Form S-3
Filed July 3, 2024
File No. 333-280680
Dear Martin Brenner:
We have conducted a limited review of your registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-3
Prospectus Summary
Overview, page 1
1.Please revise your Prospectus Summary Overview to provide context and balance to your
discussion of your platform and AI-engine. For instance, please highlight, if true, that you
have a limited operating history developing vaccines and therapeutics, that you have not
conducted clinical trials on any product candidates, and that there is a risk that you may
be unsuccessful in developing or commercializing any product candidates.
Please revise to explain your basis for making all performance and leadership claims,
including the following ones:
•Your belief that you “lead the field with (y)our patented AI-engine uncovering ‘hard
to develop’ molecules;”
•Your “groundbreaking EngageTx™ technology enables (you) to target bi-specific
molecules;”2.
July 18, 2024
Page 2
•Your ability to “navigate sequence diversity and promote Human-Cyno cross
reactivity while mitigating cytokine release;”
•Your “unparalleled epitope engine stands out by allowing the ability to target select
regions of a protein, potentially removing the lengthy trial and error out of mAb
discovery;”
•Your AI-engine is expected to “increase the probability of success.”
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.
Please contact Daniel Crawford at 202-551-7767 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Melissa Palat Murawsky, Esq.