As
filed with the Securities and Exchange Commission on July 25, 2023
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
CINGULATE
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
2834 |
|
86-3825535 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(Primary
Standard Industrial
Classification
Code Number) |
|
(I.R.S.
Employer
Identification
Number) |
1901
W. 47th Place
Kansas
City, KS 66205
(913)
942-2300
(Address,
including zip code, and telephone number, including
area
code, of registrant’s principal executive offices)
Shane
J. Schaffer
Chief
Executive Officer
Cingulate
Inc.
1901
W. 47th Place
Kansas
City, KS 66205
(913)
942-2300
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Copies
to:
Michael
J. Lerner, Esq.
Steven
M. Skolnick, Esq.
Lowenstein
Sandler LLP
1251
Avenue of the Americas
New
York, New York 10020
(212)
262-6700 |
Lawrence
Metelitsa, Esq.
Soyoung
Lee, Esq.
Lucosky
Brookman LLP
101
Wood Avenue South, 5th Floor
Woodbridge,
New Jersey 08830
(732)
395-4400 |
Approximate
date of commencement of proposed sale to public:
As
soon as practicable after this Registration Statement is declared effective.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, check the following box. ☐
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
|
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
|
Smaller
reporting company ☒ |
|
|
Emerging
growth company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. ☐
The
Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date
as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration
statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS |
|
SUBJECT
TO COMPLETION |
|
DATED
JULY 25, 2023 |
6,493,506
Shares of Common Stock
Cingulate
Inc.
We
are offering 6,493,506 shares of common stock, par value $0.0001 per share.
Our
common stock is listed on the Nasdaq Capital Market, or Nasdaq, under the symbol “CING.” The closing price of our common
stock on Nasdaq on July 24, 2023 was $0.73 per share.
Certain
information in this prospectus is based on an assumed public offering price of $0.77 per share (the last reported sale price of our common
stock on Nasdaq on July 19, 2023). The actual public offering price per share will be determined between us and the underwriters based
on market conditions at the time of pricing, and may be at a discount to the current market price of our common stock.
We
are an “emerging growth company” under applicable Securities and Exchange Commission rules and will be subject to reduced
public company reporting requirements.
Investing
in our securities is highly speculative and involves a high degree of risk. See “Risk Factors” beginning on page 5
of this prospectus and in the documents incorporated by reference into this prospectus for a discussion of information that should be
considered in connection with an investment in our securities.
| |
Per Share | | |
Total | |
Public offering price | |
$ | | | |
$ | | |
Underwriting discounts and commissions(1) | |
$ | | | |
$ | | |
Proceeds to us, before expenses | |
$ | | | |
$ | | |
(1) |
We
have agreed to reimburse the underwriters for certain out-of-pocket expenses, including the fees and disbursements of their counsel.
We have also agreed to issue to Bancroft Capital, LLC, or its designees, warrants to purchase shares of our common stock equal to
three percent (3%) of the aggregate number of shares of common stock issued in this offering and exercisable at a price per share
equal to one hundred and twenty percent (120%) of the public offering price. See “Underwriting” for additional information
regarding the compensation payable to the underwriters. |
The
underwriters may also exercise their option to purchase up to an additional 974,025 shares from us at the public offering price, less
the underwriting discount, for 45 days after the closing of the offering. If the underwriters exercise the option in full, the total
underwriting discounts and commissions payable by us will be $ , and the total proceeds to us, before expenses, will be approximately
$ .
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The
underwriters expect to deliver the shares against payment therefor on or about , 2023.
Joint
Bookrunning Managers
Bancroft
Capital, LLC |
|
Brookline
Capital Markets
a division of Arcadia Securities, LLC |
The
date of this prospectus is , 2023.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
We
incorporate by reference important information into this prospectus. You may obtain the information incorporated by reference without
charge by following the instructions under “Where You Can Find More Information.” You should carefully read this prospectus
as well as additional information described under “Information Incorporated By Reference,” before deciding to invest in our
securities.
We
have not, and the underwriters and their affiliates have not, authorized anyone to provide you with any information or to make any representation
not contained or incorporated by reference in this prospectus or any related free writing prospectus. We do not, and the underwriters
and its affiliates do not, take any responsibility for, and can provide no assurance as to the reliability of, any information that others
may provide to you. This prospectus is not an offer to sell or an offer to buy common stock in any jurisdiction where offers and sales
are not permitted. The information in this prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus
or any sale of common stock. You should also read and consider the information in the documents to which we have referred you under the
caption “Where You Can Find More Information” in the prospectus.
Neither
we nor the underwriters have done anything that would permit a public offering of the common stock or possession or distribution of this
prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United
States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering
of the common stock and the distribution of this prospectus outside of the United States.
The
information incorporated by reference or provided in this prospectus contains statistical data and estimates, including those relating
to market size and competitive position of the markets in which we participate, that we obtained from our own internal estimates and
research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Industry publications,
studies and surveys generally state that they have been obtained from sources believed to be reliable. While we believe our internal
company research is reliable and the definitions of our market and industry are appropriate, neither this research nor these definitions
have been verified by any independent source.
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider
before making your investment decision. Before investing in our securities, you should carefully read this entire prospectus and the
documents incorporated by reference herein, including the “Risk Factors” section in this prospectus and under similar captions
in the documents incorporated by reference into this prospectus. If any of the risks materialize, our business, financial condition,
operating results, and prospects could be materially and adversely affected. In that event, the price of our securities could decline,
and you could lose part or all of your investment. Unless we state otherwise or the context otherwise requires, the terms “we,”
“us,” “our,” “our business,” “the Company” and “Cingulate” refer to and similar
references refer: (1) on or following the consummation of the Reorganization Merger (as defined below), including our initial public
offering, to Cingulate Inc. and its consolidated subsidiaries, including Cingulate Therapeutics LLC, or CTx, and (2) prior to the consummation
of the Reorganization Merger, including our initial public offering, to CTx and its consolidated subsidiaries.
Overview
We
are a biopharmaceutical company using our proprietary Precision Timed ReleaseTM (PTRTM) drug delivery platform
technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering
from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial
focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), we are identifying and evaluating additional therapeutic areas
where our PTR technology may be employed to develop future product candidates, such as anxiety disorders. Our PTR platform incorporates
a proprietary Erosion Barrier Layer (EBL) designed to allow for the release of drug substance at specific, pre-defined time intervals,
unlocking the potential for once-daily, multi-dose tablets.
We
are targeting the ADHD stimulant-based treatment market, with an estimated US market size of $18 billion as of September 2022. Stimulants
are the most commonly prescribed class of medications for ADHD and account for more than 90% of all ADHD medication prescriptions in
the United States, where approximately 80 million stimulant prescriptions were written during the 12-months ended September 2022. By
contrast, non-stimulant medications are typically employed only in the second-line or adjunctive therapy setting and account for 10%
of all ADHD medication prescriptions. Extended-release, or long-acting, dosage forms of stimulant medications are most frequently deployed
as the first-line treatment for ADHD and constitute approximately 59% of ADHD stimulant prescriptions by volume and nearly 83% of the
dollars. Most of these extended-release dosage forms are approved for once-daily dosing in the morning and were designed to eliminate
the need for re-dosing during the day. However, with the current ‘once-daily’ extended-release dosage forms, most patients
still receive a second or “booster” dose for administration later in the day (typically in the early afternoon) to achieve
entire active-day coverage and suffer from a multitude of unwanted side effects as a result. We believe there is a significant, unmet
need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and superior side effect
profiles to better serve the needs of patients throughout their entire active-day.
Our
two proprietary, first-line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), are being developed
for the treatment of ADHD in the three main patient segments: children (ages 6 -12), adolescents (ages 13-17), and adults (ages18+).
Both CTx-1301 and CTx-1302 are designed to address the key shortcomings of currently approved stimulant therapies by: providing an immediate
onset of action (within 30 minutes); offering ‘entire active-day’ duration; eliminating the need for a ‘booster/recovery’
dose of short-acting stimulant medications; minimizing or eliminating the rebound/crash symptoms associated with early medication ‘wear-off;’
and providing favorable tolerability with a controlled descent of drug blood levels. Furthermore, by eliminating the ‘booster’
dose used by up to 60% of ADHD patients in conjunction with their primary medication, we believe our product candidates will provide
important societal and economic benefits: reducing the abuse and diversion associated with short-acting stimulant medications; allowing
physicians to prescribe one medication versus two; allowing patients to pay for one medication versus two; and allowing payers to reimburse
one medication versus two.
Recent
Developments
Our
Phase 3 CTx-1301-022 study (NCT05631626), which assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults
(age range: 18-55 years) with ADHD in an adult laboratory classroom setting did not achieve statistical significance on the primary efficacy
endpoint but demonstrated a trend towards significance despite its modest sample size in improving ADHD symptoms with a rapid onset of
action and entire active-day duration. After a 5-week dose optimization period, subjects were either randomized to their optimized dose
of CTx-1301 or placebo.
The
overall Permanent Product Measure of Performance (PERMP) data showed a trend toward significance with a p-value of 0.089 despite
the modest sample size. A meta-analysis conducted by Faraone and Glatt (Clinical Psychiatry 71:6 June 2010) using 11 published studies
with long-acting stimulants in adults demonstrated the average effect size to be 0.73 (approximate range 0.5 to 0.9). In this trial subjects
randomized to CTx-1301 demonstrated an effect size of 1.41 at 30 minutes and an effect size of 0.98 at 16 hours with an average effect
size of 1.79 (range 0.88 to 2.60). Effect size represents the magnitude of a change in an outcome or the strength of a relationship,
the practical significance. Effect size measures the magnitude of differences in outcomes between two groups in a study.
In
addition, the secondary outcome using the Clinical Global Impression (CGI) Scale for severity of illness was associated with a decrease
in the severity of illness in subjects randomized to CTx-1301 compared to placebo. This is noteworthy as the purpose of this study was
to obtain estimates of effect size and it was not anticipated that significant treatment differences would be observed. CTx-1301 was
well tolerated; 9% (n=1) of the subjects that were randomized to CTx-1301 experienced treatment emergent adverse events (TEAEs), while
30% (n=3) of subjects that were randomized to placebo experienced TEAEs. Patient reported outcomes on the overall satisfaction with CTx-1301
compared to subject’s prior ADHD medication was favorable.
Our
Organizational Structure
Cingulate
Inc. is a Delaware corporation that was formed to serve as a holding company. In connection with our initial public offering, we effected
certain organizational transactions. On September 29, 2021, Cingulate acquired Cingulate Therapeutics LLC, or CTx, through the merger
of a wholly-owned acquisition subsidiary of Cingulate with and into CTx (the “Reorganization Merger”). As a result of the
Reorganization Merger, CTx became a wholly-owned subsidiary of Cingulate. Unless otherwise stated or the context otherwise requires,
all information in this prospectus reflects the consummation of the Reorganization Merger.
Corporate
Information
Our
primary executive offices are located at 1901 West 47th Place, Kansas City, Kansas 66205 and our telephone number is (913)
942-2300. Our website address is www.cingulate.com. The information contained on, or that can be accessed through, our website
is not part of this prospectus and should not be considered as part of this prospectus or in deciding whether to purchase our securities.
Cingulate,
PTR, Cingulate Therapeutics, Enfoqis, Enfoqus, Trodesca, Ivoqus, Taylerza, Tymprezi, Accomplish, Mastery and our logo are some of our
trademarks used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of other
organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus may appear without the ® and
™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under
applicable law, our rights or the right of the applicable licensor to these trademarks and tradenames.
Implications
of Being an Emerging Growth Company
As
a company with less than $1.235 billion in revenue during our most recently completed fiscal year, we qualify as an “emerging growth
company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage
of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions
include:
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● |
reduced
obligations with respect to financial data, including presenting only two years of audited financial statements and only two years
of selected financial data in this prospectus; |
|
|
|
|
● |
an
exception from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, as amended,
or the Sarbanes-Oxley Act; |
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|
|
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● |
reduced
disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; and |
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● |
exemptions
from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements. |
We
may take advantage of exemptions for up to five years or such earlier time that we are no longer an emerging growth company. Accordingly,
the information contained herein may be different than the information you receive from other public companies in which you hold stock.
We would cease to be an emerging growth company upon the earliest to occur of: (1) the last day of the fiscal year in which we have more
than $1.235 billion in annual gross revenue, (2) December 31, 2026, (3) the date we are deemed to be a “large accelerated filer”
as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act, and (4) the date on which we have during the previous
three-year period issued more than $1.0 billion in non-convertible debt securities.
The
JOBS Act also permits us, as an emerging growth company, to take advantage of an extended transition period to comply with the new or
revised accounting standards applicable to public companies and thereby allow us to delay the adoption of those standards until those
standards would apply to private companies. We have irrevocably elected to avail ourselves of this exemption and therefore, we will not
be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
THE
OFFERING
The
following summary contains basic information about this offering. The summary is not intended to be complete. You should read the full
text and more specific details contained elsewhere in this prospectus and in the documents incorporated by reference.
Common
Stock Offered |
|
6,493,506
shares. |
|
|
|
Option
to Purchase Additional Shares |
|
We
have granted the underwriters an option, exercisable for 45 days after the closing of the offering, to purchase up to an additional 974,025
shares from us. |
|
|
|
Common
Stock Outstanding prior to this Offering (1) |
|
13,835,643
shares. |
|
|
|
Common
Stock Outstanding after this Offering (1) |
|
20,329,149
shares (or 21,303,174 shares if the underwriters exercise their option to purchase additional shares in full). |
|
|
|
Use
of Proceeds |
|
We
estimate that the net proceeds of this offering, after deducting estimated underwriting discounts and commissions and estimated offering
expenses, will be approximately $4.3 million (or approximately $5.0 million if the underwriters exercise their option to purchase
additional shares in full). We intend to use all of the net proceeds we receive from this offering for continued research and development
and commercialization activities of CTx-1301, and for working capital, capital expenditures and general corporate purposes, including
investing further in research and development efforts. See “Use of Proceeds.” |
|
|
|
Nasdaq
Capital Markets Symbol |
|
Our
common stock is listed on the Nasdaq Capital Market under the symbols “CING.” |
|
|
|
Lock-up |
|
All
of our directors and executive officers have agreed with the underwriter, subject to certain exceptions, not to sell, transfer or
dispose of, directly or indirectly, any of our common stock or securities convertible into or exercisable or exchangeable for our
common stock for a period of 90 days after the date of this prospectus. See “Underwriting” for more information |
|
|
|
Underwriter
Warrants |
|
We
have agreed to issue to Bancroft Capital, LLC, or its designees, warrants to purchase shares of our common stock equal to three percent
(3%) of the aggregate number of shares of common stock issued in this offering (including any shares sold through the exercise
of the over-allotment option) and exercisable at a price per share equal to one hundred and twenty percent (120%) of the public
offering price. See “Underwriting” for additional information. |
|
|
|
Risk
Factors |
|
Investment
in our securities involves a high degree of risk and could result in a loss of your entire investment. See “Risk Factors”
beginning on page 5, and the other information included and incorporated by reference in this prospectus for a discussion
of the factors you should consider carefully before deciding to invest in our securities. |
(1)
The number of shares of our common stock to be outstanding immediately after this offering is based on 13,835,643 shares of our common
stock outstanding as of July 13, 2023 and excludes, as of such date, the following:
|
● |
1,348,679
shares of our common stock issuable upon exercise of outstanding stock options issued under our 2021 Equity Incentive Plan (the “2021
Plan”), with a weighted average exercise price of $3.17 per share; |
|
|
|
|
● |
1,437,631
shares of our common stock that are available for future issuance under the 2021 Plan; and |
|
|
|
|
● |
4,999,998
shares of common stock issuable upon the exercise of the warrants with a weighted average exercise price of $6.06 per share. |
RISK
FACTORS
An
investment in our securities involves a high degree of risk. Before deciding whether to purchase our securities, including the shares
of common stock offered by this prospectus, you should carefully consider the risks and uncertainties described under “Risk Factors”
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, any subsequent Quarterly Report on Form 10-Q and our other
filings with the SEC, all of which are incorporated by reference herein. If any of these risks actually occur, our business, financial
condition and results of operations could be materially and adversely affected and we may not be able to achieve our goals, the value
of our securities could decline and you could lose some or all of your investment. Additional risks not presently known to us or that
we currently believe are immaterial may also significantly impair our business operations. If any of these risks occur, our business,
results of operations or financial condition and prospects could be harmed. In that event, the market price of our common stock and the
value of the warrants could decline, and you could lose all or part of your investment.
Risks
Related to Our Financial Position and Need for Capital
Following
this offering, we will need to raise additional capital to complete the development and commercialization efforts for CTx-1301, CTx-1302
and/or CTx-2103. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development
programs or other operations.
Following
this offering, we will need to raise additional capital to fund our operations and continue to support our planned development and commercialization
activities. The amount and timing of our future funding requirements will depend on many factors, including:
|
● |
the
timing, rate of progress and cost of any clinical trials and other manufacturing/product development activities for our current and
any future product candidates that we develop, in-license or acquire; |
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|
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● |
the
results of the clinical trials for our product candidates in the United States and any foreign countries; |
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● |
the
timing of, and the costs involved in, FDA approval and any foreign regulatory approval of our product candidates, if at all; |
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● |
the
number and characteristics of any additional future product candidates we develop or acquire; |
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● |
our
ability to establish and maintain strategic collaborations, licensing, co-promotion or other arrangements and the terms and timing
of such arrangements; |
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● |
the
cost of commercialization activities if our current or any future product candidates are approved for sale, including manufacturing,
marketing, sales and distribution costs; |
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● |
the
degree and rate of market acceptance of any approved products; |
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● |
costs
under our third-party manufacturing and supply arrangements for our current and any future product candidates and any products we
commercialize; |
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● |
costs
and timing of completion of any additional outsourced commercial manufacturing or supply arrangements that we may establish; |
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● |
costs
of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights
associated with our product candidates; |
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● |
costs
associated with prosecuting or defending any litigation that we are or may become involved in and any damages payable by us that
result from such litigation; |
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● |
costs
associated with any product recall that could occur; |
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● |
costs
of operating as a public company; |
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● |
the
holder of our $8.0 million amended and restated promissory note not demanding payment prior to maturity; |
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● |
the
emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and
competing products or treatments; |
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● |
costs
associated with any acquisition or in-license of products and product candidates, technologies or businesses; and |
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● |
personnel,
facilities and equipment requirements. |
We
cannot be certain that additional funding will be available on acceptable terms, or at all. In addition, future debt financing into which
we may enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional
debt, pay dividends, redeem our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions.
If
we are unable to raise additional capital when required or on acceptable terms, we may be required to significantly delay, scale back
or discontinue the development or commercialization of one or more of our product candidates, restrict our operations or obtain funds
by entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and
our relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do
not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would
likely result in our securityholders losing some or all of their investment in us. In addition, our ability to achieve profitability
or to respond to competitive pressures would be significantly limited.
In
addition, if we are unable to secure sufficient capital to fund our operations, we may have to enter into strategic collaborations that
could require us to share commercial rights to CTx-1301, CTx-1302, and/or CTx-2103 with third parties in ways that we currently do not
intend or on terms that may not be favorable to us or our securityholders.
Risks
Related to This Offering and Ownership of Our Common Stock
Because
management has broad discretion as to the use of the net proceeds from this offering, you may not agree with how we use them, and such
proceeds may not be applied successfully.
Our
management will have considerable discretion over the use of proceeds from this offering. We currently intend to use the net proceeds
from this offering for continued research and development and commercialization activities for CTx-1301, and for working capital, capital
expenditures, and general corporate purposes, including investing further in research and development efforts. However, our management
will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not
necessarily improve our operating results or enhance the value of our securities, or that you otherwise do not agree with. You will be
relying on the judgment of our management concerning these uses and you will not have the opportunity, as part of your investment decision,
to assess whether the proceeds are being used appropriately. The failure of our management to apply these funds effectively could, among
other things, result in unfavorable returns and uncertainty about our prospects, each of which could cause the price of our securities
to decline.
If
you purchase common stock in this offering, you will suffer immediate dilution of your investment.
You
will incur immediate and substantial dilution as a result of this offering. The public offering price per share of common stock will
be substantially higher than the as adjusted net tangible book value per share of our common stock after giving effect to this offering.
Therefore, if you purchase common stock in this offering, you will pay an effective price per share of common stock you acquire that
substantially exceeds our net tangible book value per share after this offering. Based on an assumed public offering price of $0.77 per
share of common stock (the last reported sale price of our common stock on the Nasdaq Capital Market on July 19, 2023) and our net
tangible book value as of March 31, 2023, you will experience immediate dilution of $0.52 per share, representing the difference
between our as adjusted net tangible book value per share after giving effect to this offering and the assumed public offering price
per share.
If
securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price
and trading volume could decline.
The
trading market for our common stock and warrants will depend in part on the research and reports that securities or industry analysts
publish about us or our business. We currently have limited research coverage by securities and industry analysts. If we fail to maintain
adequate coverage by securities or industry analysts, the trading price for our stock would be negatively impacted. If one or more of
the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price would
likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock
could decrease, which could cause our stock price and trading volume to decline.
Future
sales of our common stock, warrants, or securities convertible into our common stock may depress our stock price.
The
price of our common stock or warrants could decline as a result of sales of a large number of shares of our common stock or warrants
or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult
for us to sell equity securities in the future at a time and at a price that we deem appropriate.
In
addition, in the future, we may issue additional shares of common stock, warrants or other equity or debt securities convertible into
common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. We may also issue
additional shares of common stock to satisfy our outstanding promissory note in favor of Werth Family Investment Associates LLC, an entity
controlled by Peter Werth, a member of our Board of Directors. Any such issuances could result in substantial dilution to
our existing stockholders and could cause the price of our common stock or warrants to decline.
We
do not anticipate paying any cash dividends on our common stock in the foreseeable future.
We
do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain any future earnings
to finance the operation and expansion of our business, and we do not expect to declare or pay any dividends in the foreseeable future.
Consequently, stockholders must rely on sales of their common stock after price appreciation, which may never occur, as the only way
to realize any future gains on their investment. There is no guarantee that shares of our common stock will appreciate in value or even
maintain the price at which stockholders have purchased their shares.
If
we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock
and our ability to access the capital markets could be negatively impacted.
Our
common stock and warrants are currently listed for trading on Nasdaq. On May 16, 2023, we received Notice from Nasdaq stating that the
Company no longer complies with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued
listing. We must satisfy Nasdaq’s continued listing requirements, including, among other things, a minimum stockholders’
equity of $2.5 million or risk delisting, which could have a material adverse effect on our business. We submitted a plan of compliance
to Nasdaq on June 30, 2023.
There
can be no assurance that our plan of compliance will be accepted by Nasdaq or that, if it is, we will be able to regain compliance with
the applicable Nasdaq listing requirements
In
addition, unless our common stock trades above $1.00, we expect to receive a letter from Nasdaq indicating that we are not in compliance
with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq.
We
will continue to monitor the closing bid price of our common stock and may, if appropriate, consider available options, including implementation
of a reverse stock split of our common stock, to regain compliance with the minimum closing bid requirement. If we seek to implement
a reverse stock split in order to remain listed on Nasdaq, the announcement or implementation of such a reverse stock split could negatively
affect the price of our common stock and/or warrants.
If our common stock and warrants are delisted from Nasdaq, it could materially reduce the
liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting
could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in
the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. If our
common stock is delisted, it could be more difficult to buy or sell our common stock or to obtain accurate quotations, and the price
of our common stock could suffer a material decline. Delisting could also impair our ability to raise capital.
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus and any documents we incorporate by reference contain forward-looking statements that involve substantial risks and uncertainties.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,” “target,”
“project,” “estimate,” “believe,” “estimate,” “predict,” “potential”
or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future.
These statements speak only as of the date of this prospectus and involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements to be materially different from any future results, performance
or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our
current expectations and projections about future events and financial trends that we believe may affect our business, financial condition
and results of operations. These forward-looking statements include, without limitation, statements about the following:
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our
lack of operating history and need for additional capital; |
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our
plans to develop and commercialize our product candidates; |
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the
timing of our planned clinical trials for CTx-1301, CTx-1302, and CTx-2103; |
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the
timing of our New Drug Application (NDA) submissions for CTx-1301, CTx-1302, and CTx-2103; |
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the
timing of and our ability to obtain and maintain regulatory approvals for CTx-1301, CTx-1302, CTx-2103, or any other future product
candidate; |
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the
clinical utility of our product candidates; |
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our
commercialization, marketing and manufacturing capabilities and strategy; |
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our
expected use of cash;
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our
competitive position and projections relating to our competitors or our industry; |
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our
ability to identify, recruit, and retain key personnel; |
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the
impact of laws and regulations; |
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our
expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act
of 2012 (the “JOBS Act”); |
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our
plans to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives;
and |
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our
estimates regarding future revenue and expenses. |
Because
forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some
of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events
and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially
from those projected in the forward-looking statements. You should refer to the “Risk Factors” section of this prospectus
and the documents we incorporate by reference for a discussion of important factors that may cause our actual results to differ materially
from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors
and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus and the documents we incorporate
by reference will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking
statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should,
however, review the factors and risks and other information we describe in the reports we will file from time to time with the SEC after
the date of this prospectus.
You
should read this prospectus and the documents that we incorporate by reference in this prospectus and have filed as exhibits to the registration
statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different
from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
USE
OF PROCEEDS
We
estimate that the net proceeds from this offering will be approximately $4.3 million, or approximately $5.0 million if the underwriters
exercise their over-allotment option in full, in each case after deducting underwriting discounts and commissions and estimated offering
expenses payable by us.
We
intend to use all of the net proceeds we receive from this offering for continued research and development and commercialization activities
of CTx-1301, and for working capital, capital expenditures and general corporate purposes, including investing further in research and
development efforts.
Although
we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation
of funds is necessary. The amounts and timing of our actual expenditures will depend upon numerous factors, including our sales and marketing
and commercialization efforts, demand for our products, our operating costs and the other factors described under “Risk Factors”
in this prospectus and the documents incorporated by reference herein. Accordingly, our management will have flexibility in applying
the net proceeds from this offering. An investor will not have the opportunity to evaluate the economic, financial or other information
on which we base our decisions on how to use the proceeds.
Pending
our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments,
including short-term, investment-grade, interest-bearing instruments and U.S. government securities.
DILUTION
If
you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference
between the public offering price per share of our common stock and the as adjusted net tangible book value per share of our common stock
immediately after this offering.
As
of March 31, 2023, we had a net tangible book value of $81,614, or $0.01 per share of common stock. Our net tangible book value per share
represents total tangible assets less total liabilities, divided by the number of shares of our common stock outstanding as of March
31, 2023.
After
giving effect to the sale of 6,493,506 shares of common stock in this offering at an assumed public offering price of $0.77 per share
(the last reported sale price of our common stock the Nasdaq Capital Market on July 19, 2023), and after deducting underwriting discounts
and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2023 would have
been approximately $4.4 million, or approximately $0.25 per share of common stock. This amount represents an immediate increase in as
adjusted net tangible book value of $0.24 per share to our existing stockholders and an immediate dilution of $0.52 per share to investors
participating in this offering. We determine dilution per share to investors participating in this offering by subtracting as adjusted
net tangible book value per share after giving effect to this offering from the assumed public offering price per share paid by investors
participating in this offering.
Assumed public offering price per
share | |
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0.77 |
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Net tangible book value per share of common stock as
of March 31, 2023 | |
$ | 0.01 |
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Increase in net tangible book
value per share attributable to this offering | |
$ | 0.24 |
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As adjusted, net tangible
book value per share after this offering | |
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| | $ |
0.25 |
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Dilution per share to new
investors purchasing shares in this offering | |
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| | $ |
0.52 |
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Each
$0.10 increase or decrease in the assumed public offering price of $0.77 per share, which was the last reported sale price of our common
stock the Nasdaq Capital Market on July 19, 2023, would increase or decrease the as adjusted net tangible book value per share by $0.03
per share and the dilution per share to investors participating in this offering by $0.03 per share, assuming that the number of shares
offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions
and estimated offering expenses payable by us.
We
may also increase or decrease the number of shares we are offering. A 1.0 million share increase in the number of shares offered
by us, as set forth on the cover page of this prospectus, would increase the as adjusted net tangible book value per share by approximately
$0.02 and decrease the dilution per share to new investors participating in this offering by approximately $0.02, based on an assumed
public offering price of $0.77 per share, which was the last reported sale price of our common stock the Nasdaq Capital Market on July
19, 2023, remaining the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.
Similarly, a 1.0 million share decrease in the number of shares offered by us, as set forth on the cover page of this prospectus, would
decrease the as adjusted net tangible book value per share by approximately $0.03 and increase the dilution per share to new investors
participating in this offering by approximately $0.03, based on an assumed combined public offering price of $0.77 per share, which was
the last reported sale price of our common stock the Nasdaq Capital Market on July 19, 2023, remaining the same and after deducting underwriting
discounts and commissions and estimated offering expenses payable by us.
If
the underwriters exercises their option to purchase additional shares in full, the as adjusted net tangible book value per share after
giving effect to this offering would be approximately $0.27 per share, which represents an immediate increase in the as adjusted net
tangible book value of $0.26 per share of our common stock to existing stockholders and an immediate dilution in the as adjusted net
tangible book value of $0.50 per share of our common stock to new investors participating in this offering.
The
table and discussion above are based on 11,309,412 shares of our common stock outstanding as March 31, 2023, and excludes, as of such
date, the following:
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1,239,904
shares of our common stock issuable upon exercise of outstanding stock options issued under the 2021 Plan with a weighted average
exercise price of $3.40 per share; |
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1,546,406
shares of our common stock that are available for future issuance under the 2021 Plan; |
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4,999,998
shares of common stock issuable upon the exercise of outstanding warrants with a weighted average exercise price of $6.06 per
share; |
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1,648,208
shares of common stock issued pursuant to our
at-the-market program after March 31, 2023; and. |
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878,023
shares of common stock issued pursuant to our equity line of credit after March 31, 2023. |
The
information discussed above is illustrative only and will adjust based on the actual public offering price and other terms of this offering
determined at pricing.
DESCRIPTION
OF CAPITAL STOCK
The
following description summarizes the most important terms of our securities. Because it is only a summary, it does not contain all the
information that may be important to you. For a complete description, you should refer to our amended and restated certificate of incorporation
and restated bylaws, copies of which are filed as exhibits to the registration statement of which this prospectus forms a part, which
are incorporated by reference herein.
Authorized
Capitalization
We
have 250,000,000 shares of capital stock authorized under our amended and restated certificate of incorporation, consisting of 240,000,000
shares of common stock with a par value of $0.0001 per share and 10,000,000 shares of preferred stock with a par value of $0.0001 per
share.
As
of July 13, 2023, there were 13,835,643 shares of common stock outstanding, and no shares of preferred stock outstanding.
Common
Stock
Holders
of our common stock are entitled to such dividends as may be declared by our board of directors out of funds legally available for such
purpose. The shares of common stock are neither redeemable nor convertible. Holders of common stock have no preemptive or subscription
rights to purchase any of our securities.
Each
holder of our common stock is entitled to one vote for each such share outstanding in the holder’s name. No holder of common stock
is entitled to cumulate votes in voting for directors.
In
the event of our liquidation, dissolution or winding up, the holders of our common stock are entitled to receive a pro rata share of
our assets, which are legally available for distribution, after payments of all debts and other liabilities. All of the outstanding shares
of our common stock are fully paid and non-assessable.
Preferred
Stock
Our
board of directors has the authority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock
in one or more classes or series and to fix the designations, rights, preferences, privileges and restrictions thereof, without further
vote or action by the stockholders. These rights, preferences and privileges could include dividend rights, conversion rights, voting
rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of,
such class or series, any or all of which may be greater than the rights of common stock. The issuance of our preferred stock could adversely
affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon
our liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in
control of our company or other corporate action. No shares of preferred stock are outstanding, and we have no present plan to issue
any shares of preferred stock.
Anti-Takeover
Effects of Delaware law and Our Certificate of Incorporation and Bylaws
The
provisions of Delaware law, our amended and restated certificate of incorporation and our amended and restated bylaws described below
may have the effect of delaying, deferring or discouraging another party from acquiring control of us.
Section
203 of the Delaware General Corporation Law
We
are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business
combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder,
with the following exceptions:
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before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in
the stockholder becoming an interested stockholder; |
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upon
completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned
at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining
the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by
persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
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on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting
of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that
is not owned by the interested stockholder. |
In
general, Section 203 defines business combination to include the following:
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any
merger or consolidation involving the corporation and the interested stockholder; |
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any
sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
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subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder; |
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any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series
of the corporation beneficially owned by the interested stockholder; or |
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the
receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or
through the corporation. |
In
general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s affiliates
and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own,
15% or more of the outstanding voting stock of the corporation.
Certificate
of Incorporation and Bylaws
Our
amended and restated certificate of incorporation and amended and restated bylaws provide for:
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classifying
our board of directors into three classes; |
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authorizing
the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued
without stockholder approval; |
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limiting
the removal of directors by the stockholders; |
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requiring
a supermajority vote of stockholders to amend our bylaws or certain provisions our certificate of incorporation; |
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prohibiting
stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; |
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eliminating
the ability of stockholders to call a special meeting of stockholders; |
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establishing
advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon
at stockholder meetings; and |
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establishing
Delaware as the exclusive jurisdiction for certain stockholder litigation against us. |
Potential
Effects of Authorized but Unissued Stock
Pursuant
to our amended and restated certificate of incorporation, we have shares of common stock and preferred stock available for future issuance
without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings
to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.
The
existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly
to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to
obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management.
In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including
voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock,
all to the fullest extent permissible under the Delaware General Corporation Law and subject to any limitations set forth in our certificate
of incorporation. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences
applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred
stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could
have the effect of making it more difficult for a third-party to acquire, or could discourage a third-party from acquiring, a majority
of our outstanding voting stock.
Choice
of Forum
Unless
we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and
exclusive forum for any stockholder to bring (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action
asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of the Company or the Company’s stockholders,
(iii) any action asserting a claim against the Company or any director or officer of the Company arising pursuant to, or a claim against
the Company or any director or officer of the Company, with respect to the interpretation or application of any provision of the DGCL,
our certificate of incorporation or bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine, except for,
in each of the aforementioned actions, any claims to which the Court of Chancery of the State of Delaware determines it lacks jurisdiction.
This provision will not apply to claims arising under the Exchange Act, or for any other federal securities laws which provide for exclusive
federal jurisdiction. However, the exclusive forum provision provides that unless we consent in writing to the selection of an alternative
forum, the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting
a cause of action arising under the Securities Act. Therefore, this provision could apply to a suit that falls within one or more of
the categories enumerated in the exclusive forum provision and that asserts claims under the Securities Act, inasmuch as Section 22 of
the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability
created by the Securities Act or the rules and regulations thereunder. There is uncertainty as to whether a court would enforce such
an exclusive forum provision with respect to claims under the Securities Act.
We
note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the
federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased
consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging
lawsuits against our directors and officers.
Transfer
Agent
The
transfer agent of our common stock is Computershare Trust Company, N.A.
UNDERWRITING
We
have entered into an underwriting agreement with Bancroft Capital, LLC, as the representative (“Bancroft Capital” or the
“Representative”) of the underwriters named below on , 2023. The underwriting agreement provides for the purchase of a specific
number of shares of common stock by each of the underwriters. The underwriters’ obligations are several, which means that each
underwriter is required to purchase a specified number of shares of common stock, but is not responsible for the commitment of any other
underwriter to purchase common stock. Subject to the terms and conditions of the underwriting agreement, each underwriter has severally
agreed to purchase the number of shares of common stock set forth opposite its name below:
Underwriter | |
Number of Shares | |
Bancroft Capital, LLC | |
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Brookline Capital Markets, a division of Arcadia Securities, LLC | |
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Total | |
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The
underwriters have agreed to purchase all of the shares offered by this prospectus (other than those covered by the over-allotment option
described below), if any are purchased.
The
shares are expected to be ready for delivery on or about , 2023 against payment in immediately available funds.
Over-Allotment
Option
We
have granted an option to the underwriters, exercisable for up to 45 days after the closing of the offering, to purchase up to 974,025
additional shares of common stock, representing 15.0% of the shares of common stock sold in the offering, at the public offering price
from us to cover over-allotments. The purchase price to be paid per additional share of common stock will be equal to the public offering
price, less underwriting discounts and commissions. The option is, at the underwriters’ sole discretion. To the extent that this
option is exercised, each underwriter will be obligated, subject to certain conditions, to purchase its pro rata portion of these additional
shares of common stock based on the underwriter’s percentage underwriting commitment in this offering as indicated in the table
at the beginning of this Underwriting section.
Discount,
Commissions and Expenses
The
underwriters are offering the shares subject to various conditions and may reject all or part of any order. The representative of the
underwriters has advised us that the underwriters propose to offer the shares to the public at the public offering price set forth on
the cover page of this prospectus and to dealers at a price less a concession not in excess of $ per share to brokers and dealers. After
the shares are released for sale to the public, the representative of the underwriters may change the offering price, the concession,
and other selling terms at various times.
The
following table provides information regarding the amount of the discounts and commissions to be paid to the underwriters by us before
expenses. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase up to 974,025
additional shares from us:
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Per Share | | |
Total Without Exercise of Over-Allotment Option | | |
Total With Full Exercise of Over-Allotment Option | |
Public offering price | |
$ | | | |
$ | | | |
$ | | |
Underwriting discounts and commissions payable by us (7%) | |
$ | | | |
$ | | | |
$ | | |
Proceeds to us, before other expenses | |
$ | | | |
$ | | | |
$ | | |
We
have also agreed to reimburse Bancroft Capital for certain out-of-pocket expenses, including the fees and disbursements of its counsel,
up to an aggregate of $100,000, and $14,900 for clearing fees. We estimate the total expenses payable by us for this offering will be
approximately $200,000, which amount excludes underwriting discounts and commissions and the expense reimbursement described above.
Underwriter
Warrants
We
have agreed to issue to Bancroft Capital or its designees warrants to purchase up to a total of 3.0% of the shares of common stock sold
in this offering (including any shares sold through the exercise of the over-allotment option). The warrants are exercisable at $ per
share (120% of the public offering price) commencing on a date which is 180 days from the commencement of sales in the offering and expiring
on a date which is no more than five (5) years from the commencement of sales in the offering in compliance with FINRA Rule 5110. The
warrants have been deemed compensation by FINRA and are therefore subject to a 180 day lock-up pursuant to Rule 5110 of FINRA. The underwriters
(or their permitted assignees under the Rule) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities
underlying these warrants, nor will it engage in any hedging, short sale, derivative, put, or call transaction that would result in the
effective economic disposition of the warrants or the underlying securities for a period of 180 days from effectiveness.
Indemnification
We
have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act.
Lock-up
Agreements
Our
directors and executive officers have agreed not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of
or otherwise dispose of any of our common stock or securities convertible into or exchangeable for, or that represent the right to receive,
shares of common stock, for a period of 90 days following the date of this prospectus. This means that, subject to certain
exceptions, for a period of 90 days following the date of this prospectus, such persons may not offer, sell, pledge or
otherwise dispose of these securities without the prior written consent of Bancroft Capital.
We
have agreed, for a period of 60 days following the date of the date of this prospectus, that we will not, without the prior
written consent of Bancroft Capital, issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common
stock, shares or share equivalents, subject to certain exceptions, including (i) the issuance of shares of common stock or options
to employees, consultants, officers or directors of our Company pursuant to any stock or option plan duly adopted for such purpose, approved
by the Company’s stockholders and issued for bona fide services permissible under Form S-8, (ii) the issuance of the shares of
common stock underlying warrants, (iii) the issuance of shares of common stock in conversion of debt and (iv) securities issued pursuant
to certain acquisitions and strategic transactions.
Price
Stabilization, Short Positions and Penalty Bids
Rules
of the SEC may limit the ability of the underwriters to bid for or purchase shares of common stock before the distribution of the shares
of common stock is completed. However, the underwriters may engage in the following activities in accordance with the rules:
|
● |
Stabilizing
transactions – The representative may make bids or purchases for the purpose of pegging, fixing or maintaining
the price of the shares of common stock, so long as stabilizing bids do not exceed a specified maximum. |
|
|
|
|
● |
Over-allotments
and syndicate covering transactions – The underwriters may sell more shares of common stock in connection with
the offering than the number of shares of common stock that they have committed to purchase. This over-allotment creates a short
position for the underwriters. This short sales position may involve either “covered” short sales or “naked”
short sales. Covered short sales are short sales made in an amount not greater than the underwriters’ over-allotment option
to purchase shares of common stock in the offering described above. The underwriters may close out any covered short position either
by exercising its over-allotment option or by purchasing shares of common stock in the open market. To determine how they will close
the covered short position, the underwriters will consider, among other things, the price of the shares of common stock available
for purchase in the open market, as compared to the price at which they may purchase shares of common stock through the over-allotment
option. Naked short sales are short sales in excess of the over-allotment option. The underwriters must close out any naked short
position by purchasing shares of common stock in the open market. A naked short position is more likely to be created if the underwriters
are concerned that, in the open market after pricing, there may be downward pressure on the price of the shares of common stock that
could adversely affect investors who purchase shares of common stock in the offering. |
|
● |
Penalty
bids – If the representative purchases shares of common stock in the open market in a stabilizing transaction
or syndicate covering transaction, it may reclaim a selling concession from the underwriters and selling group members who sold those
shares of common stock as part of the offering. |
|
|
|
|
● |
Passive
market making – Market makers in the shares of common stock who are underwriters or prospective underwriters
may make bids for or purchases of shares of common stock, subject to limitations, until the time, if ever, at which a stabilizing
bid is made. |
Similar
to other purchase transactions, the underwriters’ purchases to cover the syndicate short sales or to stabilize the market price
of the shares of common stock may have the effect of raising or maintaining the market price of the shares of common stock or preventing
or mitigating a decline in the market price of the shares of common stock. As a result, the price of the shares of common stock may be
higher than the price that might otherwise exist in the open market. The imposition of a penalty bid might also have an effect on the
price of the shares of common stock if it discourages resales of the shares of common stock.
Neither
we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the
price of the shares of common stock. These transactions may occur on the Nasdaq Capital Market or otherwise. If such transactions are
commenced, they may be discontinued without notice at any time.
Determination
of Offering Price
The
actual public offering price of the shares we are offering has been negotiated between us and the underwriters based on the trading of
our shares of common stock prior to this offering, among other things. Other factors considered in determining the public offering price
of the securities we are offering include our history and prospects, the stage of development of our business, our business plans for
the future and the extent to which they have been implemented, an assessment of our management, the general conditions of the securities
markets at the time of this offering and such other factors as were deemed relevant.
Stock
Exchange
Our
shares of common stock are listed on The Nasdaq Capital Market under the symbols “CING.” The closing price of our common
stock on the Nasdaq Capital Market on July 24, 2023 was $0.73 per share.
Electronic
Distribution
A
prospectus in electronic format may be delivered to potential investors by one or more of the underwriters participating in the offering.
The prospectus in electronic format will be identical to the paper version of such prospectus. Other than the prospectus in electronic
format, the information on any underwriter’s website and any information contained in any other website maintained by an underwriter
is not part of this prospectus or the registration statement of which this prospectus forms a part.
Affiliations
The
underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include
securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment,
hedging, financing and brokerage activities. The underwriters and their affiliates may from time to time in the future engage with us
and perform services for us or in the ordinary course of their business for which they will receive customary fees and expenses. In the
ordinary course of their various business activities, the underwriters and their respective affiliates may make or hold a broad array
of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including
bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve
securities and/or instruments of us. The underwriters and their respective affiliates may also make investment recommendations and/or
publish or express independent research views in respect of these securities or instruments and may at any time hold, or recommend to
clients that they acquire, long and/or short positions in these securities and instruments.
Offer
Restrictions Outside the United States
Other
than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered
by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be
offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with
the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result
in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are
advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus.
This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in
any jurisdiction in which such an offer or a solicitation is unlawful.
LEGAL
MATTERS
The
validity of the shares of common stock offered by this prospectus will be passed upon for us by Lowenstein Sandler LLP, New York, New
York. Certain legal matters relating to the offering will be passed upon for the underwriters by Lucosky Brookman LLP, Woodbridge, New
Jersey.
EXPERTS
Our
consolidated financial statements as of December 31, 2022 and 2021, and for each of the years in the two-year period ended December 31,
2022, have been incorporated by reference herein in reliance upon the report of KPMG LLP, independent registered public accounting firm,
incorporated by reference herein, and upon the authority of said firm as experts in accounting and auditing. The audit report covering
the December 31, 2022 and 2021 consolidated financial statements contains an explanatory paragraph that states that our recurring losses
from operations and net capital deficiency raise substantial doubt about the entity’s ability to continue as a going concern. The
consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
following documents filed with the SEC are incorporated by reference into this prospectus:
|
● |
our
Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 10, 2023; |
|
|
|
|
● |
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed on May 10, 2023; |
|
|
|
|
● |
our
Current Reports on Form 8-K, filed on January 3, 2023, January 9, 2023, March 13, 2023, April 25, 2023, May 3, 2023, May 5, 2023,
May 10, 2023, May 19, 2023, June 8, 2023, June 16, 2023, June 29, 2023 and July 11, 2023 (other than any portions thereof deemed
furnished and not filed); |
|
|
|
|
● |
our
Definitive Proxy Statement on Schedule 14A, filed on May 5, 2023 (other than any portions thereof deemed furnished and not filed);
and |
|
|
|
|
● |
the
description of our common stock contained in our Registration Statement on Form 8-A, filed with the SEC on December 3, 2021, including
any amendments thereto or reports filed for the purposes of updating this description, including Exhibit 4.5 to our Annual Report
on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 28, 2022. |
We
also incorporate by reference all documents we file pursuant to Section 13(a), 13(c), 14 or 15 of the Exchange Act (other than any portions
of filings that are furnished rather than filed pursuant to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the date of the
initial registration statement of which this prospectus is a part and prior to effectiveness of such registration statement. All documents
we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to
the termination of the offering are also incorporated by reference and are an important part of this prospectus.
Any
statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded
for the purposes of this registration statement to the extent that a statement contained herein or in any other subsequently filed document
which also is or deemed to be incorporated by reference herein modifies or supersedes such statement. Any statement so modified or superseded
shall not be deemed, except as so modified or superseded, to constitute a part of this registration statement.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus is part of a registration statement we filed with the SEC. This prospectus does not contain all of the information set forth
in the registration statement and the exhibits to the registration statement. For further information with respect to us and the securities
we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part of the
registration statement. You should rely only on the information contained in this prospectus or incorporated by reference into this prospectus.
We have not authorized anyone else to provide you with different information. We are not making an offer of these securities in any jurisdiction
where the offer is not permitted. You should assume that the information contained in this prospectus, or any document incorporated by
reference in this prospectus, is accurate only as of the date of those respective documents, regardless of the time of delivery of this
prospectus or any sale of our securities.
We
are subject to the informational requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports,
proxy statements and other information with the Commission under the Exchange Act. Such reports, proxy statements and other information,
including the Registration Statement, and exhibits and schedules thereto, are available to the public through the Commission’s
website at www.sec.gov.
We
make available free of charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934,
as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Commission.
The registration statement and the documents referred to under “Incorporation of Certain Information by Reference”
are also available on our website cingulate.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a part of
this prospectus.
6,493,506
Shares of Common Stock
PROSPECTUS
Joint
Bookrunning Managers
Bancroft
Capital, LLC |
|
Brookline
Capital Markets
a division of Arcadia Securities, LLC |
,
2023
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution.
The
following table indicates the expenses to be incurred in connection with the offering described in this registration statement, other
than underwriting discounts and commissions, all of which will be paid by us. All amounts are estimated except the Securities and Exchange
Commission registration fee and the Financial Industry Regulatory Authority, Inc., or FINRA, filing fee.
| |
Amount | |
Securities and Exchange Commission registration fee | |
$ | 657 | |
FINRA filing fee | |
| 1,394 | |
Accountants’ fees and expenses | |
| 50,000 | |
Legal fees and expenses | |
| 150,000 | |
Miscellaneous | |
| 8,000 | |
Total expenses | |
$ | 210,051 | |
Item
14. Indemnification of Directors and Officers.
As
permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate
of incorporation and bylaws that limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care
as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business
judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us
or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:
|
● |
any
breach of the director’s duty of loyalty to us or our stockholders; |
|
|
|
|
● |
any
act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
|
|
|
|
● |
any
act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or |
|
|
|
|
● |
any
transaction from which the director derived an improper personal benefit. |
These
limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and
restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent
permitted under Delaware law.
As
permitted by Section 145 of the Delaware General Corporation Law, our bylaws provide that:
|
● |
we
may indemnify our directors, officers, and employees to the fullest extent permitted by the Delaware General Corporation Law, subject
to limited exceptions; |
|
|
|
|
● |
we
may advance expenses to our directors, officers and employees in connection with a legal proceeding to the fullest extent permitted
by the Delaware General Corporation Law, subject to limited exceptions; and |
|
|
|
|
● |
the
rights provided in our bylaws are not exclusive. |
Our
amended and restated certificate of incorporation, filed as Exhibit 3.1 hereto, and our amended and restated bylaws, filed as Exhibit
3.2 hereto, provide for the indemnification provisions described above and elsewhere herein. We have entered into and intend to continue
to enter into separate indemnification agreements with our directors and elective officers which may be broader than the specific indemnification
provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things,
to indemnify our officers and directors against liabilities that may arise by reason of their status or service as directors or officers,
other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses
incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. In addition,
we have purchased a policy of directors’ and officers’ liability insurance that insures our directors and officers against
the cost of defense, settlement or payment of a judgment in some circumstances. These indemnification provisions and the indemnification
agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement
of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.
Item
15. Recent Sales of Unregistered Securities.
On
July 19, 2021, the Company issued one share of its common stock, par value $0.0001 per share, to Cingulate Therapeutics, LLC for $0.0001.
Such issuance was exempt from registration under 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.
On
September 29, 2021, the Company issued 7,142,746 shares of its common stock, par value $0.0001 per share, to the former holders
of units of Cingulate Therapeutics LLC in connection with the Reorganization Merger. Such issuances were exempt from registration under
4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.
On
August 9, 2022, Cingulate Therapeutics LLC issued a $5 million promissory note (the “August Note”) to Werth Family Investment
Associates LLC (“WFIA”). Peter J. Werth, a member of the Company’s Board of Directors is the manager of WFIA. Such
issuance was exempt from registration under 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.
On May 9, 2023, Cingulate Therapeutics LLC amended and restated the August Note to increase the principal amount to $8.0 million (as
so amended and restated, the “Amended and Restated Note”). WFIA has the right during the first five business days of each
calendar quarter to demand payment of all outstanding principal and interest 120 days following notice to Cingulate Therapeutics LLC.
Cingulate Therapeutics LLC may prepay the Amended and Restated Note, in whole or in part, without premium or penalty; provided, that
no amount repaid may be reborrowed. Such issuance was exempt from registration under 4(a)(2) of the Securities Act of 1933, as amended,
and Regulation D promulgated thereunder.
On
April 24, 2023, we completed a private placement to Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which we
have the right to sell to Lincoln Park up to $12.0 million in shares of common stock, subject to certain limitations, from time to time
over the 36-month period commencing on the date that a registration statement covering the resale of the shares is declared effective
by the SEC. We issued 368,023 Commitment Shares to Lincoln Park as consideration for its commitment to purchase our shares under the
Purchase Agreement. In the Purchase Agreement, Lincoln Park represented to us, among other things, that it was an “accredited investor”
(as such term is defined in Rule 501(a) of Regulation D under the Securities Act). The securities were and will be sold by us under the
Purchase Agreement in reliance upon an exemption from the registration requirements under the Securities Act afforded by Section 4(a)(2)
of the Securities Act.
Item
16. Exhibits and Financial Statement Schedules.
Exhibit
Number |
|
Exhibit
Description |
|
Form |
|
Exhibit |
|
Filing
Date |
1.1** |
|
Form
of Underwriting Agreement |
|
|
|
|
|
|
2.1† |
|
Agreement and Plan of Merger, dated August 30, 2021, among Cingulate, Inc., Cingulate Therapeutics LLC, and Cingulate Pharma LLC |
|
S-1 |
|
2.1 |
|
9/9/2021 |
3.1 |
|
Amended and Restated Certificate of Incorporation of Cingulate Inc. |
|
10-K |
|
3.1 |
|
3/28/2022 |
3.2 |
|
Amended and Restated Bylaws of Cingulate Inc. |
|
10-K |
|
3.2 |
|
3/28/2022 |
4.1 |
|
Specimen Certificate representing shares of common stock of Cingulate Inc. |
|
S-1 |
|
4.1 |
|
9/9/2021 |
4.2 |
|
Form of Underwriter common stock Purchase Warrant (IPO) |
|
S-1 |
|
4.2 |
|
11/10/2021 |
4.3 |
|
Form of common stock Purchase Warrant |
|
S-1 |
|
4.3 |
|
12/9/2021 |
4.4 |
|
Form of Warrant Agent Agreement |
|
S-1 |
|
4.4 |
|
12/9/2021 |
4.5** |
|
Form
of Underwriter Warrant |
|
|
|
|
|
|
5.1** |
|
Opinion
of Lowenstein Sandler LLP |
|
|
|
|
|
|
10.1# |
|
Patent and Know-How License Agreement, dated August 8, 2018, between BDD Pharma Limited, Cingulate Therapeutics LLC and Drug Delivery International Limited |
|
S-1 |
|
10.2 |
|
9/9/2021 |
10.2# |
|
Master Services Agreement between Cingulate Therapeutics LLC and Societal CDMO, Inc., dated October 24, 2022 |
|
8-K |
|
10.1 |
|
10/25/2022 |
10.3+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Shane J. Schaffer |
|
S-1 |
|
10.4 |
|
9/27/2021 |
10.4+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Matthew N. Brams |
|
S-1 |
|
10.5 |
|
9/27/2021 |
10.5+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Laurie A. Myers |
|
S-1 |
|
10.6 |
|
9/27/2021 |
10.6+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Craig S. Gilgallon |
|
S-1 |
|
10.7 |
|
9/27/2021 |
10.7+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Louis G. Van Horn |
|
S-1 |
|
10.8 |
|
9/27/2021 |
10.8+ |
|
Employment Agreement, dated September 23, 2021, between Cingulate Therapeutics LLC and Raul R. Silva |
|
S-1 |
|
10.9 |
|
9/27/2021 |
10.9+ |
|
Amendment to Employment Agreement, effective April 1, 2022, between Cingulate Therapeutics LLC and Raul R. Silva |
|
10-Q |
|
10.1 |
|
8/11/2022 |
10.10+ |
|
Amendment to Employment Agreement, effective January 1, 2023, between Cingulate Therapeutics LLC and Raul R. Silva |
|
10-K |
|
10.10 |
|
3/10/2023 |
10.11+ |
|
Form of Indemnification Agreement |
|
S-1 |
|
10.10 |
|
9/9/2021 |
10.12+ |
|
Cingulate Inc. 2021 Omnibus Equity Incentive Plan |
|
S-1 |
|
10.1 |
|
9/27/2021 |
10.13+ |
|
Form of Nonqualified Stock Option Award under 2021 Plan |
|
10-Q |
|
10.1 |
|
5/12/2022 |
10.14+ |
|
Form of Incentive Stock Option Award under 2021 Plan |
|
10-Q |
|
10.2 |
|
5/12/2022 |
10.15+ |
|
Form of Restricted Stock Unit Award under 2021 Plan |
|
S-1 |
|
10.20 |
|
9/27/2021 |
10.16+ |
|
Form of Restricted Stock Award under 2021 Plan |
|
S-1 |
|
10.21 |
|
9/27/2021 |
10.17 |
|
Amended and Restated Promissory Note, dated May 9, 2023, between Cingulate Therapeutics, LLC and Werth Family Investment Associates |
|
8-K |
|
10.1 |
|
5/10/2023 |
10.18 |
|
At The Market Offering Agreement, dated January 3, 2023, by and between Cingulate Inc. and H.C. Wainwright & Co., LLC |
|
S-3 |
|
1.2 |
|
1/3/2023 |
10.19 |
|
Amendment to ATM Agreement, dated May 2, 2023, by and between Cingulate Inc. and H.C. Wainwright & Co., LLC |
|
10-Q |
|
10.5 |
|
5/10/2023 |
10.20 |
|
Joint Commercialization Agreement, dated March 7, 2023, by and between Cingulate Therapeutics, LLC and Indegene, Inc. |
|
10-K |
|
10.19 |
|
3/10/2023 |
10.21 |
|
Purchase Agreement, dated April 24, 2023, by and between Lincoln Park Capital, LLC and Cingulate Inc. |
|
8.K |
|
10.1 |
|
4/25/2023 |
10.22 |
|
Registration Rights Agreement, dated April 24, 2023, by and between Lincoln Park Capital, LLC and Cingulate Inc. |
|
8.K |
|
10.2 |
|
4/25/2023 |
21.1 |
|
List of Subsidiaries of Cingulate Inc. |
|
10-K |
|
21.1 |
|
3/10/2023 |
23.1* |
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
|
23.2** |
|
Consent
of Lowenstein Sandler LLP (included in Exhibit 5.1) |
|
|
|
|
|
|
24.1* |
|
Power of Attorney (contained in the signature page of this registration statement) |
|
|
|
|
|
|
107* |
|
Filing Fee Table |
|
|
|
|
|
|
†
Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant hereby undertakes to
furnish supplementally a copy of any of the omitted schedules and exhibits to the SEC on a confidential basis upon request.
*
Filed herewith.
**
To be filed by amendment.
+
Indicates a management contract or compensatory plan.
#
Certain portions of this exhibit have been omitted because the omitted information is (i) not material and (ii) would likely cause competitive
harm to the Company if publicly disclosed.
Item
17. Undertakings.
The
undersigned registrant hereby undertakes to
(a)
Provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered
in such names as required by the underwriters to permit prompt delivery to each purchaser.
(b)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of
the SEC such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim
for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer
or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer
or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
(c)
That:
|
(1) |
For
purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed
as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant
to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time
it was declared effective. |
|
|
|
|
(2) |
For
the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of
prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof. |
(d)
That, for purposes of determining any liability under the Securities Act of 1933, each filing of the Registrant’s annual report
pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee
benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference
in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant
to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Kansas City, Kansas, on the day of July 25, 2023.
|
CINGULATE
INC. |
|
|
|
By: |
/s/
Shane J. Schaffer |
|
Name: |
Shane
J. Schaffer |
|
Title: |
Chief
Executive Officer |
POWER
OF ATTORNEY
We,
the undersigned officers and directors of Cingulate Inc., hereby severally constitute and appoint Shane J. Schaffer and Louis G. Van
Horn, and each of them singly (with full power to each of them to act alone), to sign any and all amendments (including post-effective
amendments) to this registration statement (or any other registration statement for the same offering that is to be effective upon filing
pursuant to Rule 462(b) under the Securities Act of 1933), and to file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power
and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to
all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents
or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities
held on the dates indicated:
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Shane J. Schaffer |
|
|
|
|
Shane
J. Schaffer |
|
Chief
Executive Officer, Chairman (Principal Executive Officer) |
|
July
25, 2023 |
|
|
|
|
|
/s/
Louis G. Van Horn |
|
|
|
|
Louis
G. Van Horn |
|
Chief
Financial Officer (Principal Financial Officer) |
|
July
25, 2023 |
|
|
|
|
|
/s/
Jennifer L. Callahan |
|
|
|
|
Jennifer
L. Callahan |
|
Corporate
Controller (Principal Accounting Officer) |
|
July
25, 2023 |
|
|
|
|
|
/s/
Scott Applebaum |
|
|
|
|
Scott
Applebaum |
|
Director |
|
July
25, 2023 |
|
|
|
|
|
/s/
Peter J. Werth |
|
|
|
|
Peter
J. Werth |
|
Director |
|
July
25, 2023 |
|
|
|
|
|
/s/
Patrick Gallagher |
|
|
|
|
Patrick
Gallagher |
|
Director |
|
July
25, 2023 |
|
|
|
|
|
/s/
Gregg Givens |
|
|
|
|
Gregg
Givens |
|
Director |
|
July
25, 2023 |
|
|
|
|
|
/s/
Curt Medeiros |
|
|
|
|
Curt
Medeiros |
|
Director |
|
July
25, 2023 |
Exhibit
23.1
KPMG LLP
Suite 1100
1000 Walnut Street
Kansas City, MO 64106-2162
Consent
of Independent Registered Public Accounting Firm
We
consent to the use of our report dated March 10, 2023, with respect to the consolidated financial statements of Cingulate Inc., incorporated
herein by reference, and to the reference to our firm under the heading “Experts” in the prospectus.
/s/ KPMG LLP
Kansas
City, Missouri
July
25, 2023
KPMG
LLP, a Delaware limited liability partnership and a member firm of
the KPMG global organization of independent member firms affiliated with
KPMG International Limited, a private English company limited
by guarantee.
Exhibit 107
Calculation of Filing Fee Tables
Form S-1
(Form Type)
Cingulate Inc.
(Exact Name of Each Registrant
as Specified in its Charter)
Table 1: Newly Registered and Carry Forward Securities
| |
Security Type | |
Security
Class Title | |
Fee Calculation or Carry Forward Rule | | |
Amount Registered | | |
Proposed Maximum Offering Price Per Unit | | |
Maximum Aggregate Offering Price(1)(2) | | |
Fee Rate | | |
Amount of Registration Fee | |
Fees to Be Paid | |
Equity | |
Common Stock, par value $0.0001 per share(“Common Stock”)(3) | |
| 457(o | ) | |
| | | |
| | | |
$ | 5,750,000.00 | | |
| 0.00011020 | | |
$ | 633.65 | |
| |
Other | |
Underwriter Warrants to purchase Common Stock | |
| Other | | |
| | | |
| | | |
| - | | |
| | | |
| (4 | ) |
| |
Equity | |
Common Stock underlying the Underwriter Warrants to purchase Common Stock | |
| 457(o | ) | |
| | | |
| | | |
$ | 207,000.00 | | |
| 0.00011020 | | |
$ | 22.82 | |
| |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Total Offering Amounts |
$ | 5,957,000.00 | | |
| 0.00011020 | | |
$ | 656.47 | |
Total Fees Previously Paid |
| | | |
| | | |
| - | |
Total Fee Offsets |
| | | |
| | | |
| - | |
Net Fee Due |
| | | |
| | | |
$ | 656.47 | |
(1) |
Estimated solely for the purpose of calculating the amount of the registration fee in pursuant to Rule 457(o) under the Securities Act of 1933, as amended (the “Securities Act”) |
|
|
(2) |
Includes the aggregate offering price of the additional
shares of Common Stock that the underwriters have the option to purchase to cover over-allotments.
|
|
|
(3) |
Pursuant to Rule 416 under the Securities Act, this registration statement shall also cover any additional shares of the registrant’s securities that become issuable by reason of any share splits, share dividends or similar transactions. |
|
|
(4) |
No separate registration fee is payable pursuant to Rule 457(g) under the Securities Act. We have calculated the proposed maximum aggregate offering price of the Common Stock underlying the underwriter warrants by assuming that such warrants are exercisable at a price per share equal to 120% of the price per share sold in this offering. |
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