SecProbe.io

June 13, 2025
Michael J. Roberts
President and Chief Executive Officer
Adaptin Bio, Inc.
3540 Toringdon Way, Suite 200, #250
Charlotte, NC 28277
Re:Adaptin Bio, Inc.
Registration Statement on Form S-1
Filed May 16, 2025
File No. 333-287338
Dear Michael J. Roberts:
            We have reviewed 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-1
Cautionary Note..., page iii
1.Please revise to remove the reference to Section 27A and Section 21E. We note that
these safe harbor provisions do not apply to initial public offerings.
Prospectus Summary, page 1
We note that disclosures here, and elsewhere in the prospectus, contain performance
claims as well as statements indicating or suggesting that your product
candidate is safe and/or effective. Because your product candidate is pre-clinical and
because safety and efficacy determinations are in the exclusive purview of FDA and
other similar foreign regulators, please revise or remove these statements. For
example only, we note the following statements:

On page 1, BRiTE "redirects patients' own T cells to recognize and destroy tumor •2.

June 13, 2025
Page 2
cells."
•On page 2, your technology "enable drugs to cross barriers and target tissues,
including the brain[.]"
•On page 39, your product candidate "successfully activates human T cells against
EGFRvIII expressing target cells . . . resulting in the secretion of Th-1-associated
cytokines and tumor-killing."
•On page 39, your product candidate is "similarly effective[.]"
•On page 39, your product candidate "represents a critical conceptual advance in
safety[.]"
•On page 42, you have "demonstrated an effective 'antidote[.]'"
•On page 42 your technology has an "acceptable safety profile."
•On page 42, your preclinical studies demonstrate a "safe, highly effective
therapeutic option[.]"
•On page 49, your product candidate "is able to eliminate malignant glioma
tumors[.]"
Strategy, page 2
3.We note your disclosure that "[d]rawing upon [y]our experience in commercializing
specialty pharmaceutical products, [you] aim to build a specialized yet efficient
infrastructure that will support the entire commercialization continuum[.]" Please
provide the basis for your claim that you have experience "commercializing specialty
pharmaceutical products." In this regard, we note your disclosure on page 8 that you
have generated no revenue from commercial sales and your disclosure on page 18 that
you "do not have experience in selling or marketing[.]"
Summary Risk Factors, page 3
4.Please include in your summary risk factors that you identified material weaknesses in
your internal control over financial reporting that were present as of December 31,
2024 and continued to exist as of March 31, 2025.
Anti-takeover provisions in our charter documents and under Delaware law could make...,
page 30
5.We note your disclosure that your Federal Forum Provision and your "exclusive
forum provision" may "limit a stockholder's ability to bring a claim in a judicial forum
of their choosing[.]" Please revise your disclosure to state that such provisions may
also make it more costly for stockholders to bring a claim against you.
Business of the Company
Our Product Pipeline, page 39
6.We note your inclusion of Figures 1-4 in the registration statement. Please revise each
of these graphics to ensure that all text is legible.
7.Please revise your disclosure to provide further details about the preclinical studies
described in this section, including the structure of the studies, who conducted them
and when they did so.

June 13, 2025
Page 3
APTN-101 Clinical Studies, page 42
8.Please revise your disclosure here to clarify the clinical endpoints of the proposed
Phase 1 study and whether it will be powered for statistical significance.
9.Please revise your disclosure to clarify if the Phase 1 clinical trial has begun. If the
clinical trial has not yet begun, please explain why. In this regard, we note your
reference on page 36, and elsewhere in the prospectus, to the "FDA's acceptance in
May 2023 of the IND for APTN-101 for the treatment of glioblastoma[.]"
10.Please define the term "PK" in the first instance.
License Agreement
Patent License Agreement with Duke University, page 43
11.We note your disclosure that, pursuant to the SRA, Duke University agreed to
perform research exploring the administration methods of your BRiRE Platform for a
fixed fee. Please disclose the fixed fee referenced here.
12.We note your disclosure that you must pay Duke University "low to mid-double-digit
percentages of any sublicensing fees as set forth in the Duke License." Please revise to
specify the range of percentages of sublicensing fees to be within ten percentage
points (i.e., a double-digit percentage in the teens).
13.Please revise your disclosure to state the amount that has been paid under the Duke
License to date.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 51
14.Revise your discussions of research and development expenses to provide a
breakdown by nature or type of costs for each period presented.  As part of your
breakdown, separately quantify your external clinical trial costs as well as in-process
research and development charges.
Committee of the Board of Directors, page 62
15.We note your reference to a Compensation Committee on page 64. Accordingly,
please disclose the composition of the Compensation Committee here.
Compensation of Directors and Executive Officers, page 63
16.We note your disclosure that your board of directors intends to grant each
Independent Director equity awards equal to 0.20% of the Company's fully diluted
shares outstanding at the time of grant. Please provide further details about these
equity awards, including, but not limited to, when these equity awards are scheduled
to be granted and whether they are tied to specific milestones or achievements.
Equity Compensation Plan Information, page 70
17.We note your reference to the "2025 Equity Incentive Plan" on page 70. Where
appropriate, please provide a description of the 2025 Equity Incentive Plan within the
prospectus.

June 13, 2025
Page 4
Description of Capital Stock
Warrants and Placement Agent Warrants, page 77
18.Please explain here, and elsewhere as appropriate, how the Pre-Merger Warrants have
an exercise price of "either $3.30 per share or $4.40 per share." Further, please revise
your disclosure in this section to state when each of the outstanding warrants will
expire.
Exhibits
19.Please remove all references to "information incorporated by reference" and attach all
of your relevant exhibits to this registration statement or provide us with your analysis
regarding your eligibility to incorporate by reference on Form S-1. In this regard, we
note that companies that were either shell companies or blank check companies during
the past three years are ineligible to incorporate by reference on Form S-1. Please
refer to General Instruction VII.D of Form S-1 for guidance.
General
20.Please provide us with a detailed analysis regarding your basis for determining that
this transaction is appropriately characterized as a secondary offering that is eligible to
be made under Rule 415(a)(1)(i) rather than a primary offering. Please refer to
Securities Act Rules Compliance & Disclosure Interpretations Question 612.09.
21.Notwithstanding comment 20 above, we note your disclosure that your common stock
is “presently not traded on any market or securities exchange.”  Because there is no
existing trading market for these securities for purposes of satisfying Item 503(b)(3)
of Regulation S-K, please revise to disclose a fixed price at which the selling
shareholders will offer and sell their shares.
            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 Gary Newberry at 202-551-3761 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please contact Joshua Gorsky at 202-551-7836 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences