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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of report (Date of earliest event reported): August 14, 2023
TFF PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
| Delaware |
|
001-39102 |
|
82-4344737 |
(State
or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification Number) |
1751
River Run, Suite
400
Fort Worth, Texas 76107
(Address
of principal executive offices)
(817) 438-6168
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant
under any of the following provisions.
| ☐ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 pursuant to Section 13(a) of the Exchange Act.
Securities
registered pursuant to Section 12(b)of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common stock: Par value $.001 |
|
TFFP |
|
Nasdaq Stock Market |
Item
1.01 Entry into a Material Definitive Agreement.
On August 14, 2023, TFF
Pharmaceuticals, Inc. (the “Company”) entered into an Underwriting Agreement (the “Agreement”) with The Benchmark
Company, LLC (the “Underwriter”) relating to an underwritten offering (the “Offering”) of 19,896,000 shares (“Shares”)
of common stock of the Company (“Common Stock”). Pursuant to the Agreement, the
Company has granted the Underwriter a 30-day over-allotment option to purchase up to an additional 2,984,400 shares
of Common Stock. The Company estimates that gross proceeds from the Offering will be $4,974,000, before deducting underwriting discounts
and commissions and estimated Offering expenses, and assuming no exercise of the Underwriter’s over-allotment option.
The
Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-249870) previously filed
with the Securities and Exchange Commission (the “SEC”) and a preliminary prospectus supplement relating to the Offering.
The closing of the Offering is expected to take place on August 17, 2023, subject to the satisfaction of customary closing conditions.
The
Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing,
obligations of the parties and termination provisions. Additionally, the Company has agreed to indemnify the Underwriter against
certain liabilities, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”), or to contribute to payments the
Underwriter may be required to make because of any of those liabilities. The foregoing description of the Agreement is not
complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as
Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
A
copy of the legal opinion and consent of Greenberg Traurig, LLP relating to the Shares is attached hereto as Exhibit 5.1.
The
Company issued press releases announcing the launch and pricing of the Offering on August 14, 2023 and August 15, 2023, respectively.
Copies of these press releases are attached hereto as Exhibits 99.1 and 99.2, respectively.
This
Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein,
nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities laws of any such state.
Item 2.02 Results
of Operations and Financial Condition.
On
August 15, 2023, the Company issued a press release announcing its financial results for the fiscal quarter ended June 30, 2023.
A copy of the press release is attached as Exhibit 99.3 to this Current Report.
The
information in this Item 2.02, including the press release attached as Exhibit 99.3 hereto, is furnished pursuant to Item 2.02
but shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it
be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, whether
made before or after the date hereof, regardless of any general incorporation language in such filing.
Item
7.01 Regulation FD.
Attached hereto as Exhibit
99.4 is a corporate update and presentation by the Company.
The information in this Item 7.01, including the presentation attached
as Exhibit 99.4 hereto, is furnished pursuant to Item 7.01 but shall not be deemed “filed” for any purpose, including for
the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be deemed to be
incorporated by reference into any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits
The
following exhibits are filed with this report, except for Exhibits 99.3 and 99.4 which are furnished by way of this report:
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
TFF
PHARMACEUTICALS, INC. |
| |
|
| Dated:
August 15, 2023 |
/s/
Kirk Coleman |
| |
Kirk
Coleman |
| |
Chief
Financial Officer |
3
Exhibit 1.1
TFF PHARMACEUTICALS,
inc.
19,896,000 SHARES OF
COMMON STOCK
UNDERWRITING
AGREEMENT
August 14, 2023
The Benchmark Company, LLC
150 East 58th Street, 17th Floor
New York, NY 10155
Ladies and Gentlemen:
TFF Pharmaceuticals, a
Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated in this agreement
(this “Agreement”), to issue and sell to The Benchmark Company, LLC (the “Underwriter”), an
aggregate of 19,896,000 authorized but unissued shares (the “Firm Shares”) and, at the election of the
Underwriter, up to 2,984,400 additional shares (the “Additional Shares”), in each case of common stock, par value
$0.001 per share (the “Common Stock”) of the Company, in an offering under its registration statement on Form S-3
(File No. 333-249870) (the Firm Shares and the Additional Shares being collectively called the “Shares”).
The Company and the Underwriter
hereby confirm their agreement with respect to the purchase and sale of the Shares as follows:
1. REGISTRATION
STATEMENT AND PROSPECTUS. The Company has prepared and filed with the Securities and Exchange Commission (the “Commission”)
a registration statement on Form S-3 (File No. 333-249870) under the Securities Act of 1933, as amended (the “Securities Act”),
and the rules and regulations (the “Rules and Regulations”) of the Commission thereunder, and such amendments to such
registration statement as may have been required to the date of this Agreement. Such registration statement has been declared effective
by the Commission. Such registration statement, at any given time, including amendments thereto at such time, the exhibits and any schedules
thereto at such time, the documents incorporated by reference therein pursuant to Item 12 of Form S-3 under the Securities Act at such
time and the documents and information otherwise deemed to be a part thereof or included therein by Rule 430B under the Securities Act
or otherwise pursuant to the Rules and Regulations at such time, is herein called the “Registration Statement.” The
Registration Statement at the time it originally became effective is herein called the “Original Registration Statement.”
The Company proposes to file
with the Commission pursuant to Rule 424 under the Securities Act a final prospectus supplement relating to the Shares to a form of prospectus
included in the Registration Statement in the form heretofore delivered to the Underwriter. Such prospectus in the form in which it appears
in the Registration Statement is hereinafter called the “Base Prospectus.” Such supplemental form of prospectus, in
the form in which it shall be filed with the Commission pursuant to Rule 424(b) (including the Base Prospectus as so supplemented) is
hereinafter called the “Prospectus.” Any preliminary form of Prospectus which is filed or used prior to filing the
Prospectus is hereinafter called a “Preliminary Prospectus.” Any reference herein to the Base Prospectus, any Preliminary
Prospectus or the Prospectus shall be deemed to include the documents incorporated by reference therein pursuant to Item 12 of Form S-3
under the Securities Act as of the date of such prospectus.
For purposes of this Agreement,
all references to the Registration Statement, the Base Prospectus, any Preliminary Prospectus, the Prospectus or any amendment or supplement
to any of the foregoing shall be deemed to include the copy filed with the Commission pursuant to its Electronic Data Gathering, Analysis
and Retrieval System (“EDGAR”). All references in this Agreement to amendments or supplements to the Registration Statement,
the Base Prospectus, any Preliminary Prospectus or the Prospectus shall be deemed to mean and include the subsequent filing of any document
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is deemed to be incorporated by reference
therein or otherwise deemed by the Rules and Regulations to be a part thereof.
2. REPRESENTATIONS
AND WARRANTIES OF THE COMPANY.
(a) The
Company represents and warrants to, and agrees with, the Underwriter as follows:
(i) No
order preventing or suspending the use of the Registration Statement, any Preliminary Prospectus or the Prospectus has been issued by
the Commission and each such document, at the time of filing or the time of first use within the meaning of the Rules and Regulations,
complied in all material respects with the requirements of the Securities Act and the Rules and Regulations and did not contain an untrue
statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein,
in the light of the circumstances under which they were made, not misleading; except that the foregoing shall not apply to statements
in or omissions from the Registration Statement, any Preliminary Prospectus or the Prospectus made in reliance upon and in conformity
with written information furnished to the Company by the Underwriter specifically for use in the preparation thereof.
(ii) The
Company has complied to the Commission’s satisfaction with all requests of the Commission for additional or supplemental information,
if any. The Registration Statement has become and remains effective as provided in Section 8 of the Securities Act. No stop order suspending
the effectiveness of the Registration Statement is in effect and no proceedings for such purpose have been instituted or are pending or,
to the knowledge of the Company, are contemplated or threatened by the Commission.
(iii) Each
part of the Registration Statement and any post-effective amendment thereto, at the time such part became effective (including each deemed
effective date with respect to the Underwriter pursuant to Rule 430B under the Securities Act), at all other subsequent times until the
expiration of the Prospectus Delivery Period (as defined below), and at the Closing Date (as hereinafter defined), and the Prospectus
(or any amendment or supplement to the Prospectus), at the time of filing or the time of first use within the meaning of the Rules and
Regulations, at all subsequent times until expiration of the Prospectus Delivery Period, and at the Closing Date complied and will comply
in all material respects with the applicable requirements and provisions of the Securities Act, the Rules and Regulations and the Exchange
Act and did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein
or necessary to make the statements therein not misleading. The Prospectus, as amended or supplemented, as of its date, or the time of
first use within the meaning of the Rules and Regulations, at all subsequent times until the expiration of the Prospectus Delivery Period,
and at the Closing Date, did not and will not contain any untrue statement of a material fact or omit to state a material fact necessary
in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The interactive
data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement and the Prospectus
fairly presents the information called for in all material respects and is prepared in accordance with the rules and regulations of the
Commission applicable thereto. The representations and warranties set forth in the two immediately preceding sentences do not apply to
statements in or omissions from the Registration Statement or any post-effective amendment thereto, or the Prospectus, or any amendments
or supplements thereto, made in reliance upon and in conformity with written information relating to the Underwriter furnished to the
Company by the Underwriter specifically for use in the preparation thereof.
(iv) Neither
(A) the Issuer General Free Writing Prospectus(es) issued at or prior to the Time of Sale, the Statutory Prospectus and the information
set forth in Schedule I to this Agreement, all considered together (collectively, the “Time of Sale Disclosure Package”),
and together with the price to the public, the number of Firm Shares and the number of Additional Shares to be included on the cover page
of the Prospectus nor (B) any individual Issuer Limited-Use Free Writing Prospectus, when considered together with the Time of Sale Disclosure
Package, includes or included as of the Time of Sale any untrue statement of a material fact or omits or omitted as of the Time of Sale
to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were
made, not misleading. The preceding sentence does not apply to statements in or omissions from any Statutory Prospectus included in the
Registration Statement or any Issuer Free Writing Prospectus made in reliance upon and in conformity with written information furnished
to the Company by the Underwriter specifically for use in the preparation thereof. As used in this paragraph and elsewhere in this Agreement:
(1) “Time
of Sale” means 8:30 a.m. (Eastern time) on the date of this Agreement.
(2) “Statutory
Prospectus” as of any time means the Preliminary Prospectus that is included in the Registration Statement immediately prior
to that time. For purposes of this definition, information contained in a form of prospectus that is deemed retroactively to be a part
of the Registration Statement pursuant to Rule 430B under the Securities Act shall be considered to be included in the Statutory Prospectus
as of the actual time that form of prospectus is filed with the Commission pursuant to Rule 424(b) under the Securities Act.
(3) “Issuer
Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 under the Securities
Act, relating to the Securities that (A) is required to be filed with the Commission by the Company, or (B) is exempt from filing pursuant
to Rule 433(d)(5)(i) under the Securities Act because it contains a description of the Shares or of the offering that does not reflect
the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form
retained in the Company’s records pursuant to Rule 433(g) under the Securities Act.
(4) “Issuer
General Free Writing Prospectus” means any Issuer Free Writing Prospectus that is intended for general distribution to prospective
investors, as evidenced by its being specified in Schedule II to this Agreement.
(5) “Issuer
Limited-Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is not an Issuer General Free Writing Prospectus.
(v) Each Issuer
Free Writing Prospectus, as of its date and at all subsequent times through the Prospectus Delivery Period or until any earlier date that
the Company notified or notifies the Underwriter as described in Section 4(a)(iii)(B), did not, does not and will not include any information
that conflicted, conflicts or will conflict with the information contained in the Registration Statement, any Statutory Prospectus or
the Prospectus. The foregoing sentence does not apply to statements in or omissions from any Issuer Free Writing Prospectus made in reliance
upon and in conformity with written information furnished to the Company by the Underwriter specifically for use in the preparation thereof.
(A) At
the earliest time after the filing of the Registration Statement that the Company or another offering participant made a bona fide offer
(within the meaning of Rule 164(h)(2) under the Securities Act) of the Shares and at the date hereof, the Company was not and is not an
“ineligible issuer,” as defined in Rule 405 under the Securities Act, including the Company or any subsidiary in the preceding
three years not having been convicted of a felony or misdemeanor or having been made the subject of a judicial or administrative decree
or order as described in Rule 405 (without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary
that the Company be considered an ineligible issuer), nor an “excluded issuer” as defined in Rule 164 under the Securities
Act.
(B) Each
Issuer Free Writing Prospectus satisfied, as of its issue date and at all subsequent times through the Prospectus Delivery Period, all
other conditions to use thereof as set forth in Rules 164 and 433 under the Securities Act.
(vi) No
forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in either
the Registration Statement, the Time of Sale Disclosure Package and the Prospectus has been made or reaffirmed without a reasonable basis
or has been disclosed other than in good faith. Any statistical, industry-related and market-related data included or incorporated by
reference in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, are based on or derived from sources
that the Company reasonably and in good faith believes to be reliable and accurate, and such data agree with the sources from which they
are derived.
(vii) The
financial statements of the Company, together with the related notes, included or incorporated by reference in the Registration Statement,
the Time of Sale Disclosure Package and the Prospectus comply in all material respects with the requirements of the Securities Act and
the Exchange Act and fairly present in all material respects the consolidated financial condition of the Company and its subsidiaries
as of the dates indicated and the consolidated results of operations and changes in cash flows for the periods therein specified (subject
to normal year-end audit adjustments for interim financial statements) and have been prepared in conformity with generally accepted accounting
principles in the United States of America consistently applied throughout the periods involved; and the supporting schedules included
in the Registration Statement, if any, present fairly in all material respects the information required to be stated therein. No other
financial statements or schedules are required to be included in the Registration Statement, the Time of Sale Disclosure Package or the
Prospectus. There is no pro forma or as adjusted financial information which is required to be included in the Registration Statement,
the Time of Sale Disclosure Package, or the Prospectus or a document incorporated by reference therein in accordance with the Securities
Act and the Rules and Regulations which has not been included or incorporated as so required. To the Company’s knowledge, Marcum,
LLP, which has expressed its opinion with respect to the audited financial statements and schedules filed as a part of the Registration
Statement and included in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, is an independent public
accounting firm within the meaning of the Securities Act and the Rules and Regulations and such accountant is not in violation of the
auditor independence requirements of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).
(viii) The
Company and each of its subsidiaries has been duly organized under the laws of its jurisdiction of organization. The Company and each
of its subsidiaries is validly existing as a corporation (or as applicable, such other legal entity) in good standing under the laws of
its jurisdiction of organization. Each of the Company and its subsidiaries has the corporate (or as applicable, such other legal entity)
power and authority to own its properties and conduct its business as currently being carried on and as described in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus, and is duly qualified to do business as a foreign corporation (or other
legal entity) in good standing in each jurisdiction in which it owns or leases real property or in which the conduct of its business makes
such qualification necessary and in which the failure to so qualify would result in a Material Adverse Change (as defined below) or affect
its ability to execute or perform its obligations under this Agreement.
(ix) Except
as contemplated in the Time of Sale Disclosure Package and in the Prospectus, subsequent to the respective dates as of which information
is given in the Time of Sale Disclosure Package, neither the Company nor any of its subsidiaries has incurred any liabilities or obligations,
direct or contingent, which are material to the Company and its subsidiaries taken as a whole, entered into any transactions not in the
ordinary course of business which are material to the Company and its subsidiaries taken as a whole, declared or paid any dividends or
made any distribution of any kind with respect to its capital stock; and except as disclosed in the Time of Sale Disclosure Package and
in the Prospectus, there has not been any change in the capital stock (other than grants under the Equity Compensation Plans (as defined
below) or a change in the number of outstanding shares of Common Stock due to the issuance of shares (i) upon the exercise or conversion
of outstanding options, warrants or convertible notes or vesting of any outstanding restricted stock units or (ii) sold in the Company’s
current at-the-market offering pursuant the Open Market Sale Agreement, dated June 10, 2022, as amended, under the prospectus supplement
dated June 10, 2022, as amended, to the Registration Statement No. 333-249870 (the “ATM Offering”), any material change
in the Company’s short-term or long-term debt except for the extinguishment thereof, any issuance of options, warrants, convertible
securities or other rights to purchase the capital stock of the Company or any of its subsidiaries, or any material adverse change in
the financial condition, business, prospects, property, operations or results of operations of the Company and its subsidiaries, taken
as a whole (“Material Adverse Change”).
(x) Except
as set forth in the Time of Sale Disclosure Package and the Prospectus, there is not pending or, to the knowledge of the Company, threatened
or contemplated, any action, suit or proceeding (an “Action”) to which the Company or any of its subsidiaries is a
party or of which any property or assets of the Company or any of its subsidiaries is the subject before or by any court or governmental
agency, authority or body, or any arbitrator, which, individually or in the aggregate, would result in any Material Adverse Change. Except
as disclosed in the Time of Sale Disclosure Package and in the Prospectus, neither the Company nor any subsidiary, nor any director or
officer thereof, is or has within the last 10 years been the subject of any Action involving a claim of violation of or liability under
federal or state securities laws or a claim of breach of fiduciary duty. There has not been, and to the knowledge of the Company, there
is not pending or contemplated, any investigation by the Commission or Regulatory Authorities (as hereinafter defined) involving the Company
or any subsidiary or their respective assets or any current or former director or officer of the Company. To the Company’s knowledge,
the Commission has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company
under the Exchange Act or the Securities Act.
(xi) This
Agreement and the Warrant Agreement (as defined herein) have been duly authorized, executed and delivered by the Company, and each constitutes
a valid, legal and binding obligation of the Company, enforceable in accordance with its terms, except as rights to indemnity hereunder
may be limited by federal or state securities laws and except as such enforceability may be limited by bankruptcy, insolvency, reorganization
or similar laws affecting the rights of creditors generally and subject to general principles of equity. The execution, delivery and performance
of this Agreement and the Warrant Agreement and the consummation of the transactions herein contemplated will not result in a breach or
violation of any of the terms and provisions of, or constitute a default under, any statute, any agreement or instrument to which the
Company is a party or by which it is bound or to which any of its property is subject, or any order, rule, regulation or decree of any
court or governmental agency or body having jurisdiction over the Company or any of its properties, except in each case for violations
and defaults that, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Change. The execution,
delivery and performance of this Agreement and the Warrant Agreement and the consummation of the transactions herein contemplated will
not result in a breach or violation of any of the terms and provisions of, or constitute a default under, the Company’s charter
or by-laws, in each case as in effect on the date hereof. No consent, approval, authorization or order of, or filing with, any court or
governmental agency or body is required for the execution, delivery and performance of this Agreement or for the consummation of the transactions
contemplated hereby, including the issuance or sale of the Shares and Warrant Securities (as defined below) by the Company, except such
as have been obtained or may be required under the Securities Act, state securities or blue sky laws, or the rules of the Financial Industry
Regulatory Authority (“FINRA”) or the NASDAQ Capital Market, or consents that, if not obtained, would not, individually
or in the aggregate, have a material adverse effect on the Company’s ability to consummate the transactions contemplated hereby;
and the Company has the power and authority to enter into this Agreement and to authorize, issue and sell the Shares as contemplated by
this Agreement.
(xii) All
of the issued and outstanding shares of capital stock of the Company, including the outstanding shares of Common Stock and preferred stock,
if any, are duly authorized and validly issued, fully paid and non-assessable, have been issued in compliance with all federal and state
securities laws, were not issued in violation of or subject to any preemptive rights or other rights to subscribe for or purchase securities
that have not been waived in writing (a copy of which has been delivered to counsel to the Underwriter); the Shares which may be sold
hereunder and the Warrant Shares that may be issued and sold pursuant to the Warrant Agreement by the Company have been duly authorized
for issuance and sale to the Underwriter pursuant to this Agreement and the Warrant Agreement, and when issued and delivered by the Company
pursuant to this Agreement and the Warrant Agreement against payment of the consideration set forth herein and therein, will be validly
issued, fully paid and non-assessable and not subject to any preemptive or other similar rights of any security holder of the Company;
and the Shares and Warrant Securities conform to the description thereof contained in the Registration Statement, in the Time of Sale
Disclosure Package and in the Prospectus and such description conforms in all material respects to the rights set forth in the instruments
defining the same. Except as otherwise stated in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus,
there are no preemptive rights or other rights to subscribe for or to purchase, or any restriction upon the voting or transfer of, any
shares of the capital stock of the Company pursuant to the Company’s charter, by-laws or any agreement or other instrument to which
the Company is a party or by which the Company is bound. The offering and sale of the Shares and Warrant Securities as contemplated by
this Agreement and Warrant Agreement do not give rise to any rights for or relating to the registration of any shares of Common Stock
or other securities of the Company that have not been waived. All of the issued and outstanding shares of capital stock of each of the
Company’s subsidiaries have been duly and validly authorized and issued and are fully paid and non-assessable, and, except as otherwise
described in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus and the Company owns of record and
beneficially, free and clear of any material security interests, claims, liens, proxies, equities or other encumbrances, all of the issued
and outstanding shares of the capital stock of each of the Company’s subsidiaries. Except as described in the Registration Statement,
in the Time of Sale Disclosure Package and in the Prospectus, there are no options, warrants, agreements, contracts or other rights in
existence to purchase or acquire from the Company or any subsidiary of the Company any shares of the capital stock of the Company or any
subsidiary of the Company. The Company has an authorized and outstanding capitalization as set forth in the Registration Statement, in
the Time of Sale Disclosure Package and in the Prospectus. No Person has any right to cause the Company to effect the registration under
the Securities Act of any securities of the Company in connection with this offering.
(xiii) Except
as described in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus, the Company and each of its
subsidiaries holds, and is operating in compliance in all material respects with, all franchises, grants, authorizations, licenses, permits,
easements, consents, certificates and orders of any governmental or self-regulatory body (collectively, “Regulatory Authorities”)
required for the conduct of its business as described in the Registration Statement, in the Time of Sale Disclosure Package and in the
Prospectus, except for such franchises, grants, authorizations, licenses, permits, easements, consents, certificates and orders the failure
of which to hold or operate in compliance with would not result in a Material Adverse Change, and all such franchises, grants, authorizations,
licenses, permits, easements, consents, certifications and orders are valid and in full force and effect, except in each case as would
not result in a Material Adverse Change; and the Company and each of its subsidiaries is in compliance with all applicable federal, state,
local and foreign laws, regulations, orders and decrees, except in each case as would not result in a Material Adverse Change.
(xiv) Except
as described in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus, the Company’s registration
with any Regulatory Authorities, if any are required, in respect of the Company’s products and services, and all supporting documentation,
materials, correspondence, and information filed by it with any Regulatory Authorities, is in compliance in all material respects with
all applicable laws and all rules applied by such Regulatory Authorities, including with respect to accuracy of filings with such Regulatory
Authorities.
(xv) The
statistical and market related data included in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus
are based on or derived from sources that the Company believes to be reliable and accurate.
(xvi) All
products developed, tested, investigated, produced or manufactured by or on behalf of the Company and its subsidiaries have been, and
are being, developed, tested, investigated, produced and manufactured in compliance in all material respects with the (i) Federal Food,
Drug, and Cosmetic Act of 1938 and the rules and regulations thereunder of the United States Food and Drug Administration (“FDA
Laws”) and (ii) the Therapeutic Goods Act 1989 and the rules and regulations thereunder of the Therapeutic Goods Administration
and Australian Drug Evaluation Committee (together the “Australian Drug Laws”). The Company and its subsidiaries hold all
permits, licenses or other approvals required by applicable FDA Laws and the Australian Drug Laws, including those of the FDA Laws applicable
to 510(k) clearances, development, trials or premarket approvals. The Company and each of its subsidiaries is, and has been, in compliance
in all material respects with all such permits, licenses and other approvals and to the Company’s knowledge, no governmental entity
is considering limiting, suspending or revoking any product’s permits, licenses or other approvals or changing the marketing classification
or labeling of any of the products. There are no actions pending or, to the Company’s knowledge, threatened in writing by or on
behalf of the U.S. Food and Drug Administration (“FDA”), the Therapeutic Goods Administration (the “TGA”) or the
Australian Drug Evaluation Committee (the “ADEC”) or any other governmental entity that has jurisdiction over the operations
of the Company or any of its subsidiaries alleging noncompliance with applicable laws, rules and regulations. The Company and its subsidiaries
have not received any written notice or communication from any governmental entity or third party alleging or asserting noncompliance
with any applicable FDA Law or Australian Drug Laws.
(xvii) The
Company and its subsidiaries have good and marketable title to all personal property described in the Registration Statement, in the Time
of Sale Disclosure Package and in the Prospectus as being owned by them which are material to the business of the Company, in each case
free and clear of all material liens, claims, security interests, other encumbrances or defects except such as are described in the Registration
Statement, in the Time of Sale Disclosure Package and in the Prospectus and except as do not interfere in any material respect with the
conduct of the business of the Company or its subsidiaries and as would not result in a Material Adverse Change. The property held under
lease by the Company and its subsidiaries is held by them under valid, subsisting and enforceable leases with only such exceptions with
respect to any particular lease as do not interfere in any material respect with the conduct of the business of the Company or its subsidiaries
and as would not result in a Material Adverse Change.
(xviii) Except
as disclosed in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus, to the knowledge of the Company,
the Company and each of its subsidiaries owns, possesses or licenses all patents, patent applications, trademarks, service marks, tradenames,
trademark registrations, service mark registrations, copyrights, licenses, inventions, trade secrets and rights necessary for the conduct
of the business of the Company and its subsidiaries as currently carried on and as described in the Registration Statement, in the Time
of Sale Disclosure Package and in the Prospectus, except for any such items that the failure to so own, possess or license would not result
in a Material Adverse Change; except as stated in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus,
there is no pending or, to the knowledge of the Company, threatened action, suit or proceeding that the Company or any of its subsidiaries
infringes or otherwise violates any patents, patent applications, trademarks, service marks, tradenames, trademark registrations, service
mark registrations, copyrights, licenses, inventions, trade secrets or other similar rights of others, except for any pending or threatened
action, suit or proceeding as would not result in a Material Adverse Claim.
(xix) Neither
the Company nor any of its subsidiaries is (A) in violation of its respective charter or by-laws, in each case as in effect on the
date hereof, or (B) in breach of or otherwise in default, and, to the Company’s knowledge, no event has occurred which, with
notice or lapse of time or both, would constitute such a default, in the performance of any material obligation, agreement or condition
contained in any bond, debenture, note, indenture, loan agreement or any other material contract, lease or other instrument to which it
is subject or by which any of them may be bound, or to which any of the material property or assets of the Company or any of its subsidiaries
is subject, except for any breach or default that would not result in a Material Adverse Change.
(xx) There
is no document, contract or other agreement required to be described in the Registration Statement, in the Time of Sale Disclosure Package
or the Prospectus or to be filed as an exhibit to the Registration Statement which is not described or filed as required by the Securities
Act or the Rules and Regulations. Each description of a contract, document or other agreement in the Registration Statement, in the Time
of Sale Disclosure Package or the Prospectus accurately reflects in all material respects the terms of the underlying contract, document
or other agreement. Each contract, document or other agreement described in the Registration Statement, in the Time of Sale Disclosure
Package or the Prospectus or listed in the exhibits to the Registration Statement or incorporated by reference is in full force and effect
and is valid and enforceable by and against the Company or its subsidiaries, as the case may be, in accordance with its terms. Except
as disclosed in the Registration Statement, in the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any of
its subsidiaries, if a subsidiary is a party, nor to the Company’s knowledge, any other party is in default in the observance or
performance of any term or obligation to be performed by it under any such agreement, and no event has occurred which with notice or lapse
of time or both would constitute such a default. Except as disclosed in the Registration Statement, in the Time of Sale Disclosure Package
and the Prospectus, no default exists, and no event has occurred which with notice or lapse of time or both would constitute a default,
in the due performance and observance of any term, covenant or condition, by the Company or its subsidiaries, if a subsidiary is a party
thereto, of any other agreement or instrument to which the Company or any of its subsidiaries is a party or by which Company or its subsidiaries
or their respective properties or businesses may be bound or affected.
(xxi) The
Company and its subsidiaries have timely filed all federal, state and local income tax returns required to be filed and are not in default
in the payment of any taxes which were payable pursuant to said returns or any assessments with respect thereto, other than any which
the Company or any of its subsidiaries is contesting in good faith, except in each case where the failure to so file or pay would not
result in a Material Adverse Change.
(xxii) No
material labor dispute exists or, to the knowledge of the Company and its subsidiaries, is imminent with respect to any of the employees
of the Company or its subsidiaries, which could reasonably be expected to result in a Material Adverse Change. None of the Company’s
or its subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company or such
subsidiary, and neither the Company nor any of its subsidiaries is a party to a collective bargaining agreement, and the Company and its
subsidiaries believe that their relationships with their employees are good. No executive officer or employee of the Company or its subsidiaries,
to the knowledge of the Company, is, or is now expected to be, in violation of any material term of any employment contract, confidentiality,
disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant
in favor of any third party, and the continued employment of each such executive officer or employee does not subject the Company or any
of its subsidiaries to any liability with respect to any of the foregoing matters. The Company and its subsidiaries are in compliance
with all U.S. federal, state, local and foreign laws and regulations relating to employment and employment practices, environment, health,
safety and transportation, exposure to hazardous materials, general occupational safety, terms and conditions of employment and wages
and hours, except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a
Material Adverse Change.
(xxiii) The
Company has not distributed and will not distribute any prospectus or other offering material in connection with the offering and sale
of the Shares other than any Preliminary Prospectus, the Time of Sale Disclosure Package or the Prospectus or other materials permitted
by the Securities Act to be distributed by the Company; provided, however, that, except as set forth on Schedule II,
the Company has not made and will not make any offer relating to the Shares that would constitute a “free writing prospectus”
as defined in Rule 405 under the Securities Act, except in accordance with the provisions of Section 4(a)(xiv) of this Agreement.
(xxiv) The
Common Stock is registered pursuant to Section 12(b) of the Exchange Act and is listed on the NASDAQ Global Market. Except as disclosed
in the Preliminary Prospectus, the Time of Sale Disclosure Package or the Prospectus, the Company has taken no action designed to, or
likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act or delisting the Common Stock from
the NASDAQ Global Market nor has the Company received any notification that the Commission or the NASDAQ Global Market is contemplating
terminating such registration or listing. To the Company’s knowledge, and except as disclosed in the Preliminary Prospectus, the
Time of Sale Disclosure Package or the Prospectus, it has complied in all material respects with the applicable requirements of the NASDAQ
Global Market for maintenance of inclusion of the Common Stock on the NASDAQ Global Market.
(xxv) The
subsidiaries of the Company listed on Schedule III hereto are the Company’s only significant subsidiaries (as such term is
defined in Rule 1-02 of Regulation S-X promulgated by the Commission).
(xxvi) The
Company maintains a system of internal accounting controls designed to provide reasonable assurances that (A) transactions are executed
in accordance with management’s general or specific authorization; (B) transactions are recorded as necessary to permit preparation
of financial statements in conformity with generally accepted accounting principles in the United States of America and to maintain accountability
for assets; (C) access to assets is permitted only in accordance with management’s general or specific authorization; and (D)
the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect
to any differences. Except as described in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus, since
December 31, 2021, there has been (i) no material weakness or significant deficiencies in the Company’s internal control over
financial reporting (whether or not remediated), and (ii) no change in the Company’s internal control over financial reporting that
has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
(xxvii) Other
than as contemplated by this Agreement, the Company has not incurred any liability for any finder’s or broker’s fee or agent’s
commission in connection with the execution and delivery of this Agreement or the consummation of the transactions contemplated hereby.
(xxviii)
The Company carries, or is covered by, insurance in such amounts and covering such risks as the Company reasonably believes is adequate
for the conduct of its business and the value of its properties and as is customary for companies engaged in similar businesses in similar
industries.
(xxix) The
Company is not and, after giving effect to the offering and sale of the Shares, will not be an “investment company,” as such
term is defined in the Investment Company Act of 1940, as amended.
(xxx) As
of the filing date of the Registration Statement and as of any update of the Registration Statement pursuant to Section 10(a)(3) of the
Securities Act (including the filing of any Annual Report on Form 10-K), the Company was eligible to file a “shelf” registration
statement on Form S-3 with the Commission.
(xxxi) The
issuance of the Firm Shares and the Additional Shares is eligible to be registered pursuant to the Prospectus filed as a part of the Registration
Statement.
(xxxii) The
documents filed under the Exchange Act and incorporated by reference in the Registration Statement, in the Time of Sale Disclosure Package
or the Prospectus, when they were filed with the Commission, conformed in all material respects to the requirements of the Exchange Act,
as applicable, and were filed on a timely basis with the Commission and none of such documents contained an untrue statement of a material
fact or omitted to state a material fact necessary to make the statements therein, in light of the circumstances under which they were
made, not misleading; any further documents so filed and incorporated by reference in the Registration Statement, in the Time of Sale
Disclosure Package or the Prospectus, when such documents are filed with the Commission, will conform in all material respects to the
requirements of the Exchange Act, and will not contain an untrue statement of a material fact or omit to state a material fact necessary
to make the statements therein, in light of the circumstances under which they were made, not misleading.
(xxxiii)
The Company is in substantial compliance with all applicable provisions of the Sarbanes-Oxley Act and the rules and regulations of the
Commission thereunder that are effective with respect to the Company and its subsidiaries on the date of this Agreement, except where
such noncompliance would not, individually or in the aggregate, result in a Material Adverse Change.
(xxxiv)
The Company has established disclosure controls and procedures (as defined in Rules 13a-14 and 15d-14 under the Exchange Act) designed
to provide reasonable assurance that material information relating to the Company, including its subsidiaries, is made known to the principal
executive officer and the principal financial officer, and such disclosure controls and procedures were effective as of the last date
of the most recent fiscal quarter for which the Company has filed a quarterly or annual report with the Commission.
(xxxv)
The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause
or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any
of the Shares, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Shares, or (iii) paid
or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in
the case of clauses (ii) and (iii), compensation paid to the Underwriters in connection with the Offering.
(xxxvi) Neither
the Company nor any of its subsidiaries, nor, to the knowledge of the Company, any of its directors, officers, agents, employees, affiliates
or other person acting on their behalf is aware of or has taken any action, directly or indirectly, that has violated or would result
in a violation by such persons of the United States Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder
(the “FCPA”), or the Australian Anti-Money Laundering and Counter-Terrorism Financing Act 2006, as amended and the
rules and regulations thereunder (the “AML/CFT”) including, without limitation, making use of the mails or any means or instrumentality
of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or
other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such
term is defined in the FCPA or the AML/CTF) or any foreign political party or official thereof or any candidate for foreign political
office, in contravention of the FCPA or the AML CTF.
(xxxvii) The
operations of the Company and its subsidiaries are and have been conducted at all times, in compliance with applicable financial recordkeeping
and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of
all applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable rules, regulations or guidelines,
issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”), except as
would not result in a Material Adverse Change; and no action, suit or proceeding by or before any court or governmental agency, authority
or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to
the knowledge of the Company, threatened.
(xxxviii) Neither
the Company nor any of its subsidiaries is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control
of the U.S. Treasury Department (“OFAC”) and the similar sanctions of applicable jurisdictions; and the Company will
not directly or indirectly use the proceeds of this offering of the Shares contemplated hereby, or lend, contribute or otherwise make
available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities
of any person currently subject to any U.S. sanctions administered by OFAC or the sanctions of any other applicable jurisdictions.
(xxxix) No
transaction has occurred between or among the Company and any of its officers or directors, shareholders or any affiliate or affiliates
of any such officer or director or shareholder that is required to be described in and is not described in the Registration Statement,
in the Time of Sale Disclosure Package or the Prospectus.
(xl) There
are no affiliations with FINRA among the Company’s officers, directors or, to the best of the knowledge of the Company, any five
percent or greater stockholder of the Company, except as set forth in the Registration Statement or otherwise disclosed in writing to
the Underwriter.
(xli)
No approval of the stockholders of the Company under the rules and regulations of NASDAQ Global Market is required for the Company to
issue and deliver the Shares to the Underwriters pursuant to this Agreement.
(xlii) No
holder of any security of the Company has any right, which has not been waived, to have any security owned by such holder included in
the Registration Statement or to demand registration of any security owned by such holder for a period of 180 days after the Closing Date.
Each director and executive officer of the Company listed on Schedule V hereto has delivered to the Underwriter his or her enforceable
written lock-up agreement in the form attached to this Agreement as Exhibit A hereto (“Lock-Up Agreement”).
(b) Any
certificate signed by any officer of the Company and delivered to the Underwriter shall be deemed a representation and warranty by the
Company to the Underwriter as to the matters covered thereby.
3. PURCHASE,
SALE AND DELIVERY OF SHARES.
(a) On the basis of the
representations, warranties and agreements herein contained, but subject to the terms and conditions herein set forth, (i) the
Company agrees to issue and sell to the Underwriter, and the Underwriter agrees to purchase from the Company, at a purchase price
equal to $0.2325 per share (the “Per Share Price”), the number of Firm Shares as set forth opposite the name of
the Underwriter on Schedule IV hereto, and (ii) in the event and to the extent that the Underwriter shall exercise the election to
purchase Additional Shares as provided below, the Company agrees to issue and sell to the Underwriter, and the Underwriter agrees to
purchase from the Company, at the Per Share Price, that number of Additional Shares as to which such election shall have been
exercised.
As referenced in Section 3(a)(ii)
above, the Company hereby grants to the Underwriter the option to purchase from the Company the Additional Shares, at the Per Share Price.
This option may be exercised by the Underwriter in whole or in part at any time (but not more than once) on or before the date that is
thirty (30) days following the date hereof, by written notice to the Company. Such notice shall set forth the aggregate number of Additional
Shares as to which the option is being exercised, and the date and time when the Additional Shares are to be delivered (such date and
time being herein referred to as the “Option Closing Date”); provided, however, that the Option Closing
Date shall not be earlier than the Closing Date nor later than two business days after the date on which the option shall have been exercised
unless the Company and the Underwriter otherwise agree in writing.
Payment of the purchase price
and delivery for the Additional Shares shall be made at the Option Closing Date in the same manner and at the same office as the payment
for the Firm Shares as set forth in Section 3(b) below.
(b) The
Shares will be delivered by the Company to, or as directed by, the Underwriter and the Underwriter shall deliver or cause to be delivered
to the Company, by wire transfer, same-day funds payable to the order of the Company equal to the aggregate purchase price for the Firm
Shares or the Additional Shares, as appropriate, at the offices of The Benchmark Company, LLC, 150 East 58th Street., 17th
Floor, New York, NY 10155, or such other location as directed by the Underwriter and may be mutually acceptable, (1) with respect to the
Firm Shares, at 11:00 a.m. Eastern time on the two (or if the Firm Shares are priced, as contemplated by Rule 15c6-1(c) under the Exchange
Act, on or after 4:30 p.m. Eastern time, the third) full business day following the date hereof, or at such other time and date as the
Underwriter and the Company determine pursuant to Rule 15c6-1(a) under the Exchange Act (such time and date of delivery being herein referred
to as the “Closing Date”) and (2) with respect to the Additional Shares, at 11:00 a.m. Eastern time on the Option Closing
Date. If the Underwriter so elects, delivery of the Shares may be made by credit through full fast transfer to the account at The Depository
Trust Company designated by the Underwriter.
(c) The
Company, hereby agrees to issue and sell to the Underwriter on the Closing Date and Option Closing Date warrants to purchase that number
of shares of Common Stock equal to an aggregate of 2% of the amount of Firm Shares and Additional Shares, respectively, sold in the Offering
(the “Underwriter’s Warrants”). The Underwriter’s Warrants as evidenced by the Warrant Agreement (the “Warrant
Agreement”), in the form attached hereto as Exhibit B, shall be exercisable as of the 180th day following
the date of this Agreement and expiring five (5) years after the date of this Agreement at an initial exercise price per share of $0.3125.
The Underwriters’ Warrants and the shares of Common Stock issuable upon exercise thereof (“Warrant Shares”) are
sometimes referred to herein collectively as the “Warrant Securities.” The Underwriter understands and agrees that
there are significant restrictions pursuant to FINRA Rule 5110 against transferring the Warrant Securities and by its acceptance thereof
shall agree that it will not, sell, transfer, assign, pledge or hypothecate the Warrant Securities, or any portion thereof, or be the
subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of such
securities other than in accordance with FINRA Rule 5110. Notwithstanding anything in this Agreement to the contrary, the Warrant Securities
may not be sold, transferred, assigned, pledged or hypothecated prior to the date that is three hundred one hundred eighty (180) days
immediately following the date of this Agreement.
4. COVENANTS.
(a) The
Company covenants and agrees with the Underwriter as follows:
(i) During
the period beginning on the date hereof and ending on the later of the Closing Date or such date, as in the opinion of counsel for the
Underwriter and counsel for the Company, the Prospectus is no longer required by law to be delivered (or in lieu thereof the notice referred
to in Rule 173(a) under the Securities Act is no longer required to be provided), in connection with sales by an underwriter or dealer
(the “Prospectus Delivery Period”), prior to amending or supplementing the Registration Statement, the Time of Sale
Disclosure Package or the Prospectus, the Company shall furnish to the Underwriter for review a copy of each such proposed amendment or
supplement.
(ii) During
the Prospectus Delivery Period, the Company shall promptly advise the Underwriter in writing (i) of the receipt of any comments of, or
requests for additional or supplemental information from, the Commission, (ii) of the time and date of any filing of any post-effective
amendment to the Registration Statement or any amendment or supplement to any Preliminary Prospectus, the Time of Sale Disclosure Package
or the Prospectus, (iii) of the time and date that any post-effective amendment to the Registration Statement becomes effective and (iv)
of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment
thereto or of any order preventing or suspending its use or the use of any Preliminary Prospectus, the Time of Sale Disclosure Package,
the Prospectus or any Issuer Free Writing Prospectus, or of any proceedings to remove, suspend or terminate from listing or quotation
the Common Stock from any securities exchange upon which it is listed for trading or included or designated for quotation, or of the threatening
or initiation of any proceedings for any of such purposes. If the Commission shall enter any such stop order at any time, the Company
will use its reasonable efforts to obtain the lifting of such order at the earliest possible moment. Additionally, the Company agrees
that it shall comply with the provisions of Rules 424(b), 430A and 430B, as applicable, under the Securities Act and will use its reasonable
efforts to confirm that any filings made by the Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission
(without reliance on Rule 424(b)(8) or Rule 164(b)).
(iii) During
the Prospectus Delivery Period, the Company will comply as far as it is reasonably able with all requirements imposed upon it by the Securities
Act, as now and hereafter amended, and by the Rules and Regulations, as from time to time in force, and by the Exchange Act so far as
necessary to permit the continuance of sales of or dealings in the Shares as contemplated by the provisions hereof, the Time of Sale Disclosure
Package, and the Registration Statement and the Prospectus. If during such period any event occurs as a result of which the Prospectus
(or if the Prospectus is not yet available to prospective purchasers, the Time of Sale Disclosure Package) would include an untrue statement
of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances then existing,
not misleading, or if during such period it is necessary or appropriate in the opinion of the Company or its counsel or the Underwriter
or counsel to the Underwriter to amend the Registration Statement or supplement the Prospectus (or if the Prospectus is not yet available
to prospective purchasers, the Time of Sale Disclosure Package) to comply with the Securities Act or to file under the Exchange Act any
document which would be deemed to be incorporated by reference in the Prospectus in order to comply with the Securities Act or the Exchange
Act, the Company will promptly notify the Underwriter and will amend the Registration Statement or supplement the Prospectus (or if the
Prospectus is not yet available to prospective purchasers, the Time of Sale Disclosure Package) or file such document (at the expense
of the Company) so as to correct such statement or omission or effect such compliance.
(A) If
at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which
such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement, the Statutory
Prospectus or the Prospectus or included or would include an untrue statement of a material fact or omitted or would omit to state a material
fact necessary in order to make the statements therein, in the light of the circumstances prevailing at that subsequent time, not misleading,
the Company will promptly notify the Underwriter and will amend or supplement, at the Company expense, such Issuer Free Writing Prospectus
to eliminate or correct such conflict, untrue statement or omission.
(iv) The
Company shall use its reasonable efforts to take or cause to be taken all necessary action to qualify the Shares for sale under the securities
laws of such jurisdictions as the Underwriter reasonably designate upon written request and to continue such qualifications in effect
so long as required for the distribution of the Shares, except that the Company shall not be required in connection therewith to qualify
as a foreign corporation or to execute a general consent to service of process in any state.
(v) The
Company will furnish to the Underwriter and counsel for the Underwriter copies of the Registration Statement, each Preliminary Prospectus,
the Prospectus, any Issuer Free Writing Prospectus, and all amendments and supplements to such documents (in each case without exhibits
thereto or documents incorporated therein by reference) as soon as practicable following receipt of a request therefor, in such quantities
as the Underwriter may from time to time reasonably request.
(vi) The
Company will make generally available to its security holders as soon as practicable, but in any event not later than 15 months after
the end of the Company’s current fiscal quarter, an earnings statement (which need not be audited) covering a 12-month period that
shall satisfy the provisions of Section 11(a) of the Securities Act and Rule 158 of the Rules and Regulations.
(vii) The
Company will pay or cause to be paid (A) all expenses (including transfer taxes allocated to the respective transferees) incurred in connection
with the delivery to the Underwriter of the Shares, (B) all expenses and fees in connection with the preparation, printing, filing, delivery,
and shipping of the Registration Statement (including the financial statements therein and all amendments, schedules, and exhibits thereto),
the Shares, each Preliminary Prospectus, the Prospectus, any Issuer Free Writing Prospectus and any amendment thereof or supplement thereto,
and the printing, delivery, and shipping of this Agreement and other underwriting documents, including any Blue Sky Memoranda (covering
the states and other applicable jurisdictions), (C) all filing fees in connection with the qualification of the Shares for offering and
sale by the Underwriter or by dealers under the securities or blue sky laws of the states and other jurisdictions as requested by the
Underwriter and to the extent required by law, (D) the fees and expenses of any transfer agent or registrar for the Shares, (E) the filing
fees incident to any required review and approval by FINRA of the terms of the sale of the Shares, (F) listing fees, if any, (G) all other
costs and expenses incident to the performance by the Company of its obligations hereunder that are not otherwise specifically provided
for herein, (H) all costs and expenses relating to investor presentations or any “road show”, including, without limitation,
the costs of recording and hosting on the Internet of the Company’s road show presentation and any travel expenses of the Company’s
officers and employees and any other expenses of the Company, (I) the fees, disbursements and expenses of the Underwriter’s counsel,
and (J) a non-accountable expense allowance payable to the Underwriter in the amount of $15,000; provided, however,
that the maximum amount of fees, costs and expenses incurred by the Underwriter with respect to subparagraphs (A) through (J) above, on
their own behalf, including, without limitation, the fees, disbursements and expenses of counsel to the Underwriter, that the Company
shall be required to pay under this Section 4(a)(vii) shall be $140,000. The foregoing amount will be less the $50,000 retainer amount
paid on August 4, 2023. If this Agreement is terminated by the Underwriter pursuant to Section 8(i) or (ii) hereof or if the sale of the
Shares provided for herein is not consummated by reason of any failure, refusal or inability on the part of the Company to perform any
agreement on its part to be performed, or because any other condition of the Underwriter’s obligations hereunder required to be
fulfilled by the Company is not fulfilled or waived by the Underwriter, the Company will reimburse the Underwriter, upon presentation
of a written accounting in reasonable detail (but without the need to include the underlying statements or evidence of payment) for reasonable
actual out-of-pocket disbursements (including but not limited to printing expenses, travel expenses, postage, facsimile and telephone
charges) incurred by the Underwriter in connection with their investigation, preparing to market and marketing the Shares or in contemplation
of performing their obligations hereunder and for reasonable fees and disbursements of counsel, not to exceed $100,000 in the aggregate,
less any retainer amount previously paid. Except as provided herein, the Underwriter shall pay all of their own costs and expenses, including,
without limitation, fees and disbursements of their counsel.
(viii) The
Company will apply the net proceeds from the sale of the Shares to be sold by it hereunder for the purposes set forth in the Time of Sale
Disclosure Package and in the Prospectus.
(ix) None
of the Company and its subsidiaries has taken or will take, directly or indirectly, any action designed to or which might reasonably be
expected to cause or result in, or which has constituted, the stabilization or manipulation of the price of any security of the Company
to facilitate the sale or resale of the Shares.
(x) Except
as provided in this Agreement, the Company will not incur any liability for any finder’s or broker’s fee or agent’s
commission in connection with the execution and delivery of this Agreement or the consummation of the transactions contemplated hereby.
(xi) During
the Prospectus Delivery Period, the Company will file on a timely basis with the Commission such periodic reports as required by the Exchange
Act.
(xii) The
Company and its subsidiaries will maintain controls and other procedures, including without limitation those applicable to the Company
and required by Sections 302 and 906 of the Sarbanes-Oxley Act and the applicable regulations thereunder, that are designed to provide
reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including
without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports
that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal
executive officer and its principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions
regarding required disclosure, to ensure that material information relating to Company, including its subsidiaries, is made known to them
by others within those entities, subject to the representation in Section 2(a)(xxii).
(xiii) The
Company and its subsidiaries, to the extent required, will substantially comply with all effective applicable provisions of the Sarbanes-Oxley
Act, subject to the representation in Section 2(a)(xxii) and except where such noncompliance would not, individually or in the aggregate,
result in a Material Adverse Change.
(xiv) The
Company represents and agrees that, unless it obtains the prior written consent of the Underwriter, and the Underwriter represents and
agrees that, unless it obtains the prior written consent of the Company, it has not made and will not make any offer relating to the Shares
that would constitute an “issuer free writing prospectus,” as defined in Rule 433 under the Securities Act, or that would
otherwise constitute a “free writing prospectus,” as defined in Rule 405 under the Securities Act, required to be filed with
the Commission; provided that the prior written consent of the parties hereto shall be deemed to have been given in respect of
the free writing prospectuses included in Schedule II. Any such free writing prospectus consented to by the Company and the Underwriter
is hereinafter referred to as a “Permitted Free Writing Prospectus.” The Company represents that it has treated or
agrees that it will treat each Permitted Free Writing Prospectus as an “issuer free writing prospectus,” as defined in Rule
433, and has complied and will comply with the requirements of Rule 433 applicable to any Permitted Free Writing Prospectus, including
timely Commission filing where required, legending and record keeping.
(xv) From
the date hereof until the earlier of (i) December 31, 2023, or (ii) the Company making a public release of (a) meaningful Phase 2 initial
readout data and/or compassionate use data for TFF-VORI, and (b) meaningful Phase 2 initial readout data for TFF-TAC, neither the Company
nor any subsidiary shall (i) except for the securities to be issued pursuant to this Agreement, issue, enter into any agreement to issue
or announce the issuance or proposed issuance of any shares of Common Stock or any securities which would entitle the holder thereof to
acquire any Common Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that
is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock,
or (ii) file any registration statement or amendment or supplement thereto, other than the Prospectus or filing a registration statement
on Form S-8 in connection with any employee benefit plan; provided, however, this subpart (xv) shall not restrict the Company from (w)
issuing any stock based awards and the underlying award securities pursuant to the Company’s 2018 Stock Incentive Plan and 2021
Stock Incentive Plan ( together the “Equity Compensation Plans”), provided that such stock-based awards have not been
amended since the date of this Agreement to increase the number or such securities or to decrease the exercise price, exchange price or
conversion price of such securities or to extend the term of such securities, (x) issuing any shares of common stock upon exercise of
outstanding warrants issued to National Securities Corporation in 2019, and warrants issued to investors in the November 2022 follow-on
offering, provided that the warrants have not been amended since the date of this Agreement to increase the number or such securities
or to decrease the exercise price, exchange price or conversion price of such securities or to extend the term of such securities, (y)
effecting any sales under the ATM Offering, or (z) for use of or licensing of or similar transaction related to its intellectual property.
5. CONDITIONS
OF THE UNDERWRITER’S OBLIGATIONS. The obligations of the Underwriter hereunder are subject to the accuracy, as of the date hereof
and at the Closing Date (as if made at the Closing Date) of and compliance with all representations, warranties and agreements of the
Company contained herein (except to the extent any such representations, warranties or agreements expressly relate to a specified earlier
date, in which case, such representations, warranties and agreements shall be accurate or complied with as of such specified earlier date),
to the performance by the Company of its obligations hereunder and to the following additional conditions, in each case unless waived
by the Underwriter:
(a) If
the filing of the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, is required under the Securities
Act or the Rules and Regulations, the Company shall have filed the Prospectus (or such amendment or supplement) or such Issuer Free Writing
Prospectus with the Commission in the manner and within the time period so required (without reliance on Rule 424(b)(8) or Rule 164(b));
the Registration Statement shall remain effective; no stop order suspending the effectiveness of the Registration Statement or any part
thereof, or any amendment thereof, nor suspending or preventing the use of the Time of Sale Disclosure Package, the Prospectus or any
Issuer Free Writing Prospectus shall have been issued; no proceedings for the issuance of such an order shall have been initiated or,
to the Company’s knowledge, threatened; any request of the Commission for additional information (to be included in the Registration
Statement, the Time of Sale Disclosure Package, the Prospectus, any Issuer Free Writing Prospectus or otherwise) shall have been complied
with to the Underwriter’s reasonable satisfaction; and FINRA shall have raised no objection to the fairness and reasonableness of
the underwriting terms and compensation arrangements.
(b) The
Underwriter shall not have advised the Company that the Registration Statement, the Time of Sale Disclosure Package or the Prospectus,
or any amendment thereof or supplement thereto, or any Issuer Free Writing Prospectus, contains an untrue statement of fact which, in
the Underwriter’s opinion, is material, or omits to state a fact which, in the Underwriter’s opinion, is material and is required
to be stated therein or necessary to make the statements therein not misleading, unless, in each case, the Company shall have filed an
amendment or supplement to the Registration Statement, the applicable documents included in the Time of Sale Disclosure Package, the Prospectus
or the Issuer Free Writing Prospectus to correct such statement of fact or omission.
(c) Except
as contemplated in the Time of Sale Disclosure Package and in the Prospectus, subsequent to the respective dates as of which information
is given in the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any of its subsidiaries shall have incurred
any liabilities or obligations, direct or contingent which are material to the Company and its subsidiaries taken as a whole, entered
into any transactions not in the ordinary course of business which are material to the Company and its subsidiaries taken as a whole,
or declared or paid any dividends or made any distribution of any kind with respect to its capital stock; and except as disclosed in the
Time of Sale Disclosure Package and in the Prospectus, there shall not have been any change in the capital stock (other than a change
in the number of outstanding shares of Common Stock due to the issuance of shares (i) upon the exercise or conversion of outstanding as
of the date of this Agreement options, warrants or convertible notes or vesting of any outstanding restricted stock units, or (ii) sold
in the ATM Offering), any material change in the short-term or long-term debt of the Company except for the extinguishment thereof, any
issuance of options, warrants, convertible securities or other rights to purchase the capital stock of the Company or any of the Company’s
subsidiaries (other than the issuance of options, restricted stock units and other awards or shares under the Company’s equity incentive
plans and employee stock purchase plans), or any Material Adverse Change, the effect of which, in any such case described above, in the
Underwriter’s reasonable judgment, makes it impractical or inadvisable to offer or deliver the Shares on the terms and in the manner
contemplated in the Time of Sale Disclosure Package, the Registration Statement and the Prospectus.
(d) On
or after the Time of Sale (i) no downgrading shall have occurred in the rating accorded any of the Company’s securities by any “nationally
recognized statistical rating organization,” as that term is defined by the Commission for purposes of Rule 436(g)(2) under the
Securities Act, and (ii) no such organization shall have publicly announced that it has under surveillance or review, with possible negative
implications, its rating of any of the Company’s securities.
(e) On
the Closing Date and the Option Closing Date, if any, there shall have been furnished to the Underwriter the opinion of Greenberg Traurig,
LLP, counsel for the Company, dated the Closing Date and addressed to the Underwriter, in form and substance reasonably satisfactory to
the Underwriter.
(f) On
the date of the execution of this Agreement, on the effective date of any post-effective amendment to the Registration Statement filed
subsequent to the date of this Agreement and also at each of the Closing Date and the Option Closing Date, if any, the Underwriter shall
have received a letter of Marcum LLP, dated the respective dates of delivery thereof, and addressed to the Underwriter, in form and substance
reasonably satisfactory to the Underwriter.
(g) On
the Closing Date, there shall have been furnished to the Underwriter a certificate, dated the Closing Date and addressed to the Underwriter,
signed by the chief executive officer or the chief financial officer of the Company, to the effect that:
(i) The
representations and warranties of the Company in this Agreement are true and correct, in all material respects, as if made at and as of
the Closing Date (except to the extent any such representations or warranties expressly relate to a specified earlier date, in which case,
such representations and warranties shall be true and correct as of such specified earlier date), and the Company has complied in all
material respects with all the material agreements and satisfied in all material respects all the material conditions on its part to be
performed or satisfied at or prior to the Closing Date (except for any such agreements or conditions that have been waived by the Underwriter);
(ii) No
stop order or other order suspending the effectiveness of the Registration Statement or any part thereof or any amendment thereof or the
qualification of the Shares for offering or sale nor suspending or preventing the use of the Time of Sale Disclosure Package, the Prospectus
or any Issuer Free Writing Prospectus, has been issued, and no proceeding for that purpose has been instituted or, to the signer’s
knowledge, is contemplated by the Commission or any state or regulatory body; and
(iii) The
signer of said certificate has carefully examined the Registration Statement, the Time of Sale Disclosure Package and the Prospectus,
and any amendments thereof or supplements thereto (including any documents filed under the Exchange Act and deemed to be incorporated
by reference into the Time of Sale Disclosure Package, the Registration Statement or the Prospectus), and
(A) each
part of the Registration Statement and the Prospectus, and any amendments thereof or supplements thereto (including any documents filed
under the Exchange Act and deemed to be incorporated by reference into the Prospectus) contain, and contained when such part of the Registration
Statement (or such amendment) became effective, all statements and information required to be included therein, each part of the Registration
Statement, or any amendment thereof, does not contain, and did not contain when such part of the Registration Statement (or such amendment)
became effective, any untrue statement of a material fact or omit to state, and did not omit to state when such part of the Registration
Statement (or such amendment) became effective, any material fact required to be stated therein or necessary to make the statements therein
not misleading, and the Prospectus, as amended or supplemented, does not include and did not include as of its date or the time of first
use within the meaning of the Rules and Regulations, any untrue statement of a material fact or omit to state, and did not omit to state
as of its date or the time of first use within the meaning of the Rules and Regulations, a material fact necessary to make the statements
therein, in light of the circumstances under which they were made, not misleading
(B) neither
(1) the Time of Sale Disclosure Package nor (2) any individual Issuer Limited-Use Free Writing Prospectus, when considered together with
the Time of Sale Disclosure Package, include, nor included as of the Time of Sale, any untrue statement of a material fact or omits, or
omitted as of the Time of Sale, to state any material fact necessary in order to make the statements therein, in the light of the circumstances
under which they were made, not misleading,
(C) since
the Time of Sale, there has occurred no event required to be set forth in an amended or supplemented prospectus which has not been so
set forth, and there has been no document required to be filed under the Exchange Act that upon such filing would be deemed to be incorporated
by reference into the Time of Sale Disclosure Package, the Registration Statement or the Prospectus that has not been so filed,
(D) except
as contemplated in the Time of Sale Disclosure Package and in the Prospectus, subsequent to the respective dates as of which information
is given in the Time of Sale Disclosure Package, neither the Company nor any of its subsidiaries has incurred any liabilities or obligations,
direct or contingent, which are material to the Company and its subsidiaries taken as a whole, entered into any transactions not in the
ordinary course of business which are material to the Company and its subsidiaries taken as a whole, declared or paid any dividends or
made any distribution of any kind with respect to its capital stock, and except as disclosed in the Time of Sale Disclosure Package and
in the Prospectus, there has not been any change in the capital stock (other than a change in the number of outstanding shares of Common
Stock due to the issuance of shares upon the exercise or conversion of outstanding options, warrants or convertible notes or vesting of
any restricted stock units pursuant to the Company’s existing equity incentive plan or employee stock purchase plan), any material
change in the Company’s short-term or long-term debt except for the extinguishment thereof, any issuance of options, warrants, convertible
securities or other rights to purchase the capital stock of the Company or any of its subsidiaries (other than the issuance of options,
restricted stock units and other awards or shares under the Company’s equity incentive plan and employee stock purchase plan), or
any Material Adverse Change, and
(E) except
as stated in the Time of Sale Disclosure Package and in the Prospectus, there is not pending, or, to the knowledge of the Company, threatened
or contemplated, any action, suit or proceeding to which the Company or any of its subsidiaries is a party before or by any court or governmental
agency, authority or body, or any arbitrator, the negative outcome of which, individually or in the aggregate, would result in any Material
Adverse Change.
(h) The
Company shall have furnished to the Underwriter and counsel for the Underwriter such additional documents, certificates and evidence as
the Underwriter or counsel for the Underwriter may have reasonably requested.
All such opinions, certificates,
letters and other documents will be in compliance with the provisions hereof only if they are reasonably satisfactory in form and substance
to the Underwriter and counsel for the Underwriter. The Company will furnish the Underwriter with such conformed copies of such opinions,
certificates, letters and other documents as the Underwriter shall reasonably request.
6. INDEMNIFICATION
AND CONTRIBUTION.
(a) The
Company agrees to indemnify and hold harmless the Underwriter, and each of its respective directors, officers and employees and each person,
if any, who controls any such Underwriter within the meaning of Section 15 of the Act or Section 20(a) of the Exchange Act, against any
losses, claims, damages or liabilities to which the Underwriter may become subject, under the Securities Act or otherwise (including in
settlement of any litigation if such settlement is effected with the written consent of the Company), insofar as such losses, claims,
damages or liabilities (or actions in respect thereof) arise out of or are based upon (i) an untrue statement or alleged untrue statement
of a material fact contained in the Registration Statement, including the information deemed to be a part of the Registration Statement
at the time of effectiveness and at any subsequent time pursuant to Rules 430A and 430B of the Rules and Regulations, if applicable, any
Preliminary Prospectus, the Time of Sale Disclosure Package, the Prospectus, or any amendment or supplement thereto (including any documents
filed under the Exchange Act and deemed to be incorporated by reference into the Prospectus), any Issuer Free Writing Prospectus or in
any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the offering
of the Shares (“Marketing Materials”), including any roadshow or investor presentations made to investors by the Company
(whether in person or electronically) or arise out of or are based upon the omission or alleged omission to state therein a material fact
required to be stated therein or necessary to make the statements therein not misleading, and will reimburse the Underwriter for any legal
or other expenses reasonably incurred by it in connection with investigating or defending against such loss, claim, damage, liability
or action; or (ii) in whole or in part upon any inaccuracy in the representations and warranties of the Company contained herein; or (iii)
in whole or in part upon any failure of the Company to perform its obligations hereunder; provided, however, that the Company
shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon
an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, any Preliminary Prospectus,
the Time of Sale Disclosure Package, the Prospectus, or any such amendment or supplement, any Issuer Free Writing Prospectus or in any
Marketing Materials, in reliance upon and in conformity with written information furnished to the Company by the Underwriter specifically
for use in the preparation thereof.
In addition to their other
obligations under this Section 6(a), the Company agrees that, as an interim measure during the pendency of any claim, action, investigation,
inquiry or other proceeding arising out of or based upon any statement or omission, or any alleged statement or omission, described in
this Section 6(a), it will reimburse the Underwriter on a monthly basis for all reasonable legal fees or other expenses incurred in connection
with investigating or defending any such claim, action, investigation, inquiry or other proceeding upon presentation of a written accounting
in reasonable detail (but without the need to include the underlying statements or evidence of payment), notwithstanding the absence of
a judicial determination as to the propriety and enforceability of the Company’s obligation to reimburse the Underwriter for such
expenses and the possibility that such payments might later be held to have been improper by a court of competent jurisdiction. To the
extent that any such interim reimbursement payment is so held to have been improper, the Underwriter shall promptly return it to the Company,
together with interest, compounded daily, determined on the basis of the prime rate (or other commercial lending rate for borrowers of
the highest credit standing) announced from time to time by Wells Fargo Bank, N.A. (the “Prime Rate”). Any such interim
reimbursement payments which are not made to the Underwriter within 30 days of a request for reimbursement shall bear interest at the
Prime Rate from the date of such request. This indemnity agreement shall be in addition to any liabilities which they may otherwise have.
(b) The
Underwriter will indemnify and hold harmless the Company, each of its directors and officers, and each person who controls the Company
within the meaning of the Securities Act of the Exchange Act, against any losses, claims, damages or liabilities to which the Company,
or any such director, officer or controlling person may become subject, under the Securities Act or otherwise (including in settlement
of any litigation, if such settlement is effected with the written consent of such Underwriter), insofar as such losses, claims, damages
or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material
fact contained in the Registration Statement, any Preliminary Prospectus, the Time of Sale Disclosure Package, the Prospectus, or any
amendment or supplement thereto or any Issuer Free Writing Prospectus, or arise out of or are based upon the omission or alleged omission
to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case
to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made
in the Registration Statement, any Preliminary Prospectus, the Time of Sale Disclosure Package, the Prospectus, or any amendment or supplement
thereto, or any Issuer Free Writing Prospectus in reliance upon and in conformity with written information furnished to the Company by
an Underwriter with respect to such Underwriter specifically for use in the preparation thereof, and will reimburse the Company, or any
such director, officer or controlling person for any legal or other expenses reasonably incurred by the Company, or such director, officer
or controlling person in connection with investigating or defending against any such loss, claim, damage, liability or action as such
expenses are incurred.
(c) Promptly
after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified
party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying
party in writing of the commencement thereof; but the omission so to notify the indemnifying party shall not relieve the indemnifying
party from any liability that it may have to any indemnified party except to the extent such indemnifying party has been materially prejudiced
by such failure. In case any such action shall be brought against any indemnified party, and it shall notify the indemnifying party of
the commencement thereof, the indemnifying party shall be entitled to participate in, and, to the extent that it shall wish, jointly with
any other indemnifying party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified
party, and after notice from the indemnifying party to such indemnified party of the indemnifying party’s election so to assume
the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal or other
expenses subsequently incurred by such indemnified party in connection with the defense thereof other than reasonable costs of investigation;
provided, however, that if, in the sole judgment of the Underwriter, it is advisable for the Underwriter to be represented by separate
counsel, the Underwriter shall have the right to employ a single counsel to represent the Underwriter in any claim in respect of which
indemnity may be sought by the Underwriter under subsection (a) of this Section 6, in which event the reasonable fees and expenses of
such separate counsel shall be borne by the indemnifying party or parties and reimbursed to the Underwriter as incurred (in accordance
with the provisions of the second paragraph in subsection (a) above). In no event shall the indemnifying parties be liable for fees and
expenses of more than one counsel (in addition to any local counsel) separate from their own counsel for all indemnified parties in connection
with any one action or separate but similar or related actions in the same jurisdiction arising out of the same general allegations or
circumstances.
The indemnifying party under
this Section 6 shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such
consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party against any
loss, claim, damage, liability or expense by reason of such settlement or judgment. Notwithstanding the foregoing sentence, if at any
time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel
to which it is entitled under this Section 6, the indemnifying party agrees that it shall be liable for any settlement of any proceeding
effected without its written consent if (i) such settlement is entered into more than 60 days after receipt by such indemnifying party
of the aforesaid request, (ii) such indemnifying party shall have received notice of the terms of such settlement at least 45 days prior
to such settlement being entered into, and (iii) such indemnifying party shall not have reimbursed the indemnified party in accordance
with such request prior to the date of such settlement (other than with respect to fees and expenses that the indemnifying party is contesting
in good faith). No indemnifying party shall, without the prior written consent of the indemnified party, effect any settlement, compromise
or consent to the entry of judgment in any pending or threatened action, suit or proceeding in respect of which any indemnified party
is or could have been a party and indemnity was or could have been sought hereunder by such indemnified party, unless such settlement,
compromise or consent (a) includes an unconditional release of such indemnified party from all liability on claims that are the subject
matter of such action, suit or proceeding and (b) does not include a statement as to or an admission of fault, culpability or a failure
to act by or on behalf of any indemnified party.
(d) If
the indemnification provided for in this Section 6 is unavailable or insufficient to hold harmless an indemnified party under subsection
(a) or (b) above, then each indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of
the losses, claims, damages or liabilities referred to in subsection (a) or (b) above, (i) in such proportion as is appropriate to reflect
the relative benefits received by the Company on the one hand and the respective Underwriter on the other from the offering of the Shares
or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect
not only the relative benefits referred to in clause (i) above but also the relative fault of the Company on the one hand and the respective
Underwriter on the other in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities,
as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the respective
Underwriter on the other shall be deemed to be in the same proportion as the total net proceeds from the offering (before deducting expenses)
received by the Company bear to the total underwriting discounts and commissions received by the respective Underwriter, in each case
as set forth in the table on the cover page of the Prospectus. The relative fault shall be determined by reference to, among other things,
whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates
to information supplied by the Company or the respective Underwriter and the parties’ relevant intent, knowledge, access to information
and opportunity to correct or prevent such untrue statement or omission. The Company and the respective Underwriter agree that it would
not be just and equitable if contributions pursuant to this subsection (d) were to be determined by pro rata allocation or by any other
method of allocation which does not take account of the equitable considerations referred to in the first sentence of this subsection
(d). The amount paid by an indemnified party as a result of the losses, claims, damages or liabilities referred to in the first sentence
of this subsection (d) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection
with investigating or defending against any action or claim which is the subject of this subsection (d). Notwithstanding the provisions
of this subsection (d), the respective Underwriter shall not be required to contribute any amount in excess of the amount by which the
total price at which the Shares were offered to the public exceeds the amount of any damages that the respective Underwriter has otherwise
been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was
not guilty of such fraudulent misrepresentation.
(e) The
obligations of the Company under this Section 6 shall be in addition to any liability which the Company may otherwise have and the benefits
of such obligations shall extend, upon the same terms and conditions, to each person, if any, who controls the respective Underwriter
within the meaning of the Securities Act; and the obligations of the respective Underwriter under this Section 6 shall be in addition
to any liability that the respective Underwriter may otherwise have and the benefits of such obligations shall extend, upon the same terms
and conditions, to each director of the Company (including any person who, with his consent, is named in the Registration Statement as
about to become a director of the Company), to each officer of the Company who has signed the Registration Statement and to each person,
if any, who controls the Company within the meaning of the Securities Act.
(f) The
Underwriter confirms and the Company acknowledges that there is no information concerning the Underwriter furnished in writing to the
Company by the Underwriter specifically for inclusion in the Registration Statement, any Preliminary Prospectus, the Time of Sale Disclosure
Package, the Prospectus or any Issuer Free Writing Prospectus, except for the following disclosure contained in the “Underwriting”
section of the Prospectus: (i) the third paragraph, (ii) the first and third paragraphs and the second sentence of the fourth paragraph
under the sub-header “Stabilization” and (iii) the subsection “Affiliations.”
7. REPRESENTATIONS
AND AGREEMENTS TO SURVIVE DELIVERY. All representations, warranties, and agreements of the Company herein or in certificates delivered
pursuant hereto, including but not limited to the agreements of the Underwriter and the Company contained in Section 6 hereof, shall remain
operative and in full force and effect regardless of any investigation made by or on behalf of the Underwriter or any controlling person
thereof, or the Company or any of its officers, directors, or controlling persons, and shall survive delivery of, and payment for, the
Shares to and by the Underwriter hereunder.
8. TERMINATION
OF THIS AGREEMENT.
(a) The
Underwriter shall have the right to terminate this Agreement by giving notice to the Company as hereinafter specified at any time at or
prior to the Closing Date, if (i) the Company shall have failed, refused or been unable, at or prior to the Closing Date, to perform any
material agreement on its part to be performed hereunder, (ii) any condition of the Underwriter’s obligations set forth in
Section 5 hereunder is not fulfilled or waived by the Underwriter, (iii) trading in the Company’s Common Stock shall have been
suspended by the Commission or the tffp Global Market or trading in securities generally on the NASDAQ Global Market shall have been suspended,
(iii) minimum or maximum prices for trading shall have been fixed, or maximum ranges for prices for securities shall have been required,
on the NASDAQ Global Market by such exchange or by order of the Commission or any other governmental authority having jurisdiction (which
includes the Company’s Common Stock), or (iv) a banking moratorium shall have been declared by federal or state authorities which
prevents payment by an Underwriter pursuant to Section 3, in each case of (i) through (iv) herein, the effect of which, in the Underwriter’s
good faith judgment, would make it impracticable to proceed with the offering, sale and/or delivery of the Shares as contemplated by the
Registration Statement and the Prospectus. Any such termination shall be without liability of any party to any other party except that
the provisions of Section 4(a)(vii) and Section 6 hereof shall at all times be effective and shall survive such termination.
(b) If
the Underwriter elects to terminate this Agreement as provided in this Section 8, the Company shall be notified promptly by the Underwriter
by telephone, confirmed by letter as provided in Section 10.
9. DEFAULT
BY THE COMPANY. If the Company shall fail at the Closing Date or at the Option Closing Date to sell and deliver the Shares which it is
obligated to sell hereunder, then this Agreement shall terminate without any liability on the part of the Underwriter or, except as provided
in Section 4(a)(vii), any non-defaulting party. No action taken pursuant to this Section 9 shall relieve the Company from liability,
if any, in respect of such default.
10. NOTICES.
Except as otherwise provided herein, all communications hereunder shall be in writing and, if to the Underwriter, shall be mailed, delivered
to The Benchmark Company, LLC, 150 Eat 58th Street, 17th Floor, New York, New York 10155, Attention: John J. Borer
III, with a copy (which shall not constitute notice) to Golenbock Eiseman Assor Bell & Peskoe LLP, 711 Third Avenue, New York, New
York 10017, Attention: Andrew D. Hudders, Esq.; if to the Company, shall be mailed, delivered or telecopied to it at 1751 River Run, Suite
400, Fort Worth, Texas 76107, Attention: Harlan Weisman, M.D., CEO, with a copy (which shall not constitute notice) to Greenberg Traurig,
LLP, 18565 Jamboree Road, Suite 500, Irvine, California 92612, Attention: Daniel K. Donahue, Esq., or in each case to such other
address as the person to be notified may have requested in writing. Any party to this Agreement may change such address for notices by
sending to the parties to this Agreement written notice of a new address for such purpose.
11. PERSONS
ENTITLED TO BENEFIT OF AGREEMENT. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their respective
successors and assigns and the controlling persons, officers and directors referred to in Section 6. Nothing in this Agreement is intended
or shall be construed to give to any other person, firm or corporation any legal or equitable remedy or claim under or in respect of this
Agreement or any provision herein contained. The term “successors and assigns” as herein used shall not include any purchaser,
as such purchaser, of any of the Shares from the Underwriter.
12. ABSENCE
OF FIDUCIARY RELATIONSHIP. The Company acknowledges and agrees that: (a) the Underwriter has been retained solely to act as underwriter
in connection with the sale of the Shares and that no fiduciary, advisory or agency relationship between the Company and the Underwriter
has been created in respect of any of the transactions contemplated by this Agreement, irrespective of whether the Underwriter has advised
or are advising the Company on other matters; (b) the price and other terms of the Shares set forth in this Agreement were established
by the Company following discussions and arms-length negotiations with the Underwriter and the Company is capable of evaluating and understanding
and understands and accepts the terms, risks and conditions of the transactions contemplated by this Agreement; (c) it has been advised
that the Underwriter and its affiliates are engaged in a broad range of transactions which may involve interests that differ from those
of the Company and that the Underwriter has no obligation to disclose such interest and transactions to the Company by virtue of any fiduciary,
advisory or agency relationship; and (d) it has been advised that the Underwriter is acting, in respect of the transactions contemplated
by this Agreement, solely for the benefit of the Underwriter, and not on behalf of the Company.
13. GOVERNING
LAW; JURISDICTION. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference
to its conflict of laws provisions. The parties hereby irrevocably and unconditionally: submit to the jurisdiction of the federal and
state courts located in the State of New York, for any dispute related to this Agreement or any of the matters contemplated hereby; consent
to service of process by registered or certified mail return receipt requested or by any other manner provided by applicable law; and
waive any right to claim that any action, proceeding or litigation so commenced has been commenced in an inconvenient forum.
14. INTEGRATION;
AMENDMENT. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the Company and the Underwriter
with respect to the subject matter hereof. No provision of this Agreement may be modified or amended except in a written instrument signed
by the Company and the Underwriter.
15. COUNTERPARTS.
This Agreement may be executed in one or more counterparts and, if executed in more than one counterpart, the executed counterparts shall
each be deemed to be an original and all such counterparts shall together constitute one and the same instrument.
[Signature Page Follows]
Please sign and return to
the Company the enclosed duplicates of this letter whereupon this letter will become a binding agreement between the Company and the Underwriter
in accordance with its terms.
| |
Very truly yours, |
| |
|
| |
TFF PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/ Harlan Weisman |
| |
|
Harlan Weisman, M.D.,
Chief Executive Officer |
Confirmed as of the date first above.
| By: |
/s/ John J. Borer III |
|
| |
John J. Borer III |
|
| |
Co-Head of Investment Banking, Senior Managing Director |
|
Schedule I
Time of Sale Disclosure Package
Preliminary Prospectus supplement dated August 14, 2023
Schedule II
Issuer General Free Writing Prospectuses
None.
Schedule III
Subsidiary(ies)
None.
Schedule IV
| Underwriter |
|
Firm Shares |
|
Additional Shares |
| |
|
|
|
|
| The Benchmark Company, LLC |
|
19,896,000 |
|
2,984,400 |
Schedule V
List of Person and Entities Subject to Lock
Up
Dr. Harlan Weisman
Kirk Coleman
Chris Cano
Zamaneh Mikhak
Aaron Fletcher
Brandi Roberts
Steve Rocamboli
Bob Mills
EXHIBIT A
LOCK UP AGREEMENT
August __, 2023
The Benchmark Company, LLC
150 East 58th St., 17th Floor
New York, NY 10155
Ladies and Gentlemen:
The undersigned understands
that you, as the Underwriter (the “Underwriter”) proposes to enter into an Underwriting Agreement (the “Underwriting
Agreement”) with TFF Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and certain stockholders
of the Company named in Schedule V thereto relating to a proposed offering of shares of common stock, par value $0.001
per share (“Common Stock”), of the Company (the “Offering”). All capitalized terms in this letter
agreement not defined herein, shall have the meaning given to them in the Underwriting Agreement.
In consideration of the foregoing,
and in order to induce the Underwriter to participate in the Offering, and for other good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, the undersigned hereby agrees that, without the prior written consent of the Underwriter (which
consent may be withheld in its sole discretion), the undersigned will not, during the period (the “Lock-Up Period”)
beginning on the date hereof and ending on the earlier of December 31, 2023 or (ii) the Company making a public release of (a) meaningful
Phase 2 initial readout data and/or compassionate use data for TFF-VORI, and (b) meaningful Phase 2 initial readout data for TFF-TAC,
(1) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option
or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, or
file (or participate in the filing of) a registration statement with the Securities and Exchange Commission in respect of, any shares
of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock (including without limitation,
shares of Common Stock which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations of
the Securities and Exchange Commission and securities which may be issued upon exercise of a stock option, warrant or unit), (2) enter
into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the shares of
Common Stock, whether any such transaction described in clause (1) or (2) above is to be settled by delivery of shares of Common Stock
or such other securities, in cash or otherwise, (3) make any demand for or exercise any right with respect to, the registration of any
shares of Common Stock or any security convertible into or exercisable or exchangeable for shares of Common Stock, or (4) publicly announce
an intention to effect any transaction specified in clauses (1), (2) or (3) above.
Notwithstanding the foregoing, the restrictions set
forth in clause (1) and (2) above shall not apply to (a) transfers (i) as a bona fide gift or gifts; provided that no filing by any party
under Section 16(a) of the Exchange Act, shall be required or shall be made voluntarily during the Lock-up Period in connection with
such transfer, (ii) if the undersigned is a natural person, by will or intestate succession upon the death of the undersigned or (iii)
to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned; provided, in each case,
that (x) the transferee agrees to be bound in writing by the restrictions set forth herein, and (y) any such transfer shall not involve
a disposition for value, (b) the acquisition or exercise of any restricted stock, restricted stock unit or stock option issued pursuant
to the Company’s existing Compensatory Plan, including any exercise of a stock option effected by the delivery of shares of Common
Stock of the Company held by the undersigned, provided, that the restrictions set forth herein shall apply to any of the undersigned’s
Common Stock issued upon such exercise, (c) the sale of Common Stock pursuant to a contract, instruction or plan that satisfies all of
the requirements of Rule 10b5-1 under the Exchange Act (a “Plan”) adopted at least thirty (30) days prior to the date
of this Agreement and which Plan has not been modified during such thirty (30) day period, (d) any sale of common stock effected for
purposes of funding a tax payment associated with the vesting of restricted stock or a restricted stock unit, and (e) the establishment
of any Plan; provided, that (i) no sales of the undersigned’s Common Stock or other securities shall be made pursuant to such a
Plan prior to the expiration of the Lock-Up Period, and (ii) such a Plan may only be established if no public announcement of the establishment
or existence thereof and no filing with the Securities and Exchange Commission or other regulatory authority in respect thereof or transactions
thereunder or contemplated thereby, by the undersigned, the Company or any other person, shall be required, and no such announcement
or filing is made voluntarily, by the undersigned, the Company or any other person, prior to the expiration of the Lock-Up Period. For
purposes of this Lock-Up Agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more
remote than first cousin.
The foregoing restrictions
are expressly agreed to preclude the undersigned from engaging in any hedging or other transaction which is designed to or reasonably
expected to lead to or result in a sale or disposition of shares of Common Stock even if such securities would be disposed of by someone
other than the undersigned. Such prohibited hedging or other transactions would include without limitation any short sale or any purchase,
sale or grant of any right (including without limitation any put option or “put equivalent position” (within the meaning of
Rule 16a-1(h) under the Exchange Act) or call option or call equivalent position) with respect to any of the shares of Common Stock or
with respect to any security that includes, relates to, or derives any significant part of its value from such shares.
The undersigned hereby represents
and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. All authority herein conferred or
agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal Underwriter
of the undersigned.
The undersigned also agrees
and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar or depositary against the
transfer of the undersigned’s shares of Common Stock except in compliance with the foregoing restrictions.
This agreement may be delivered
via facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions
Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or other transmission method and any counterpart
so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
This Lock-Up Agreement shall
be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles
thereof. The undersigned irrevocably (i) submits to the jurisdiction of any court of the State of New York for the purpose of any suit,
action, or other proceeding arising out of this Agreement (each a “Proceeding”), (ii) agrees that all claims in respect
of any Proceeding may be heard and determined in any such court, (iii) waives, to the fullest extent permitted by law, any immunity from
jurisdiction of any such court or from any legal process therein, (iv) agrees not to commence any Proceeding other than in such courts,
and (v) waives, to the fullest extent permitted by law, any claim that such Proceeding is brought in an inconvenient forum.
The undersigned acknowledges
that the Underwriter will rely on the representations and agreements of the undersigned contained in this agreement in connection with
entering into the Underwriting Agreement and performing the obligations of the Underwriter thereunder.
With respect to the Offering,
the undersigned waives any registration rights relating to registration under the Securities Act of the offer and sale of any Common Stock
owned either of record or beneficially by the undersigned, including any rights to receive notice of the Offering.
The undersigned understands
that, if the Underwriting Agreement is not executed by August 31, 2023, or if the Underwriting Agreement (other than the provisions thereof
which survive termination) shall terminate or be terminated prior to payment for and delivery of the securities to be sold thereunder,
then this Lock-Up Agreement shall be void and of no further force or effect.
| Very truly yours, |
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| Printed Name of Holder |
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| By: |
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Signature |
|
| |
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| Printed Name of Person Signing |
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(and indicate capacity of person signing if
signing as custodian, trustee, or on behalf
of an entity) |
|
EXHIBIT B
UNDERWRITER WARRANT AGREEMENT
THE REGISTERED HOLDER
OF THIS PURCHASE WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS PURCHASE WARRANT EXCEPT AS HEREIN
PROVIDED AND THE REGISTERED HOLDER OF THIS PURCHASE WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS
PURCHASE WARRANT FOR A PERIOD OF ONE HUNDRED EIGHTY DAYS FOLLOWING AUGUST ___, 2023 (THE “EFFECTIVE DATE”) TO ANYONE
OTHER THAN (I) THE BENCHMARK COMPANY, LLC, OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING FOR WHICH THIS PURCHASE WARRANT WAS
ISSUED TO THE UNDERWRITER AS CONSIDERATION (THE “OFFERING”), OR (II) THE OFFICERS OR PARTNERS, REGISTERED PERSONS
OR AFFILIATES OF THE BENCHMARK COMPANY, LLC.
THIS PURCHASE WARRANT
IS NOT EXERCISABLE PRIOR TO FEBRUARY ___, 2024. VOID AFTER 5:00 P.M., EASTERN TIME, AUGUST ____, 2028.
COMMON STOCK PURCHASE
WARRANT
For the Purchase of ______
Shares of Common Stock of
TFF Pharmaceuticals, Inc.
1. Purchase
Warrant. THIS CERTIFIES THAT, in consideration of funds duly paid by or on behalf of The Benchmark Company, LLC (“Holder”),
as registered owner of this Purchase Warrant, to TFF Pharmaceuticals, Inc. a Delaware corporation (the “Company”),
Holder is entitled, at any time or from time to time beginning February ___, 2024 (the “Commencement Date”), and at
or before 5:00 p.m., Eastern time, August ____, 2028 (the “Expiration Date”), but not thereafter, to subscribe for,
purchase and receive, in whole or in part, up to _____ [2% of shares sold] shares (the “Shares”) of common
stock of the Company, par value $0.001 per share (the “Common Stock”), subject to adjustment as provided in Section 6
hereof. If the Expiration Date is a day on which banking institutions are authorized by law to close, then this Purchase Warrant may be
exercised on the next succeeding day which is not such a day in accordance with the terms herein. During the period ending on the Expiration
Date, the Company agrees not to take any action that would terminate this Purchase Warrant. This Purchase Warrant is initially exercisable
at $_____[125% of public offering price] per Share; provided, however, that upon the occurrence
of any of the events specified in Section 6 hereof, the rights granted by this Purchase Warrant, including the exercise price per
Share and the number of Shares to be received upon such exercise, shall be adjusted as therein specified. The term “Exercise
Price” shall mean the initial exercise price or the adjusted exercise price, depending on the context.
2.
Exercise.
2.1 Exercise
Form. In order to exercise this Purchase Warrant, the exercise form attached hereto must be duly executed and completed and delivered
to the Company, together with this Purchase Warrant and payment of the Exercise Price for the Shares being purchased payable in cash by
wire transfer of immediately available funds to an account designated by the Company or by certified check or official bank check. If
the subscription rights represented hereby shall not be exercised at or before 5:00 p.m., Eastern time, on the Expiration Date, this Purchase
Warrant shall become and be void without further force or effect, and all rights represented hereby shall cease and expire. Each exercise
hereof shall be irrevocable. Delivery of the Shares for which exercise has been made shall be delivered as instructed by the Holder within
two (2) business days after the date of exercise of this Purchase Warrant.
2.2 Cashless
Exercise. In lieu of exercising this Purchase Warrant by payment of cash or check payable to the order of the Company pursuant to
Section 2.1 above, Holder may elect to receive the number of Shares equal to the value of this Purchase Warrant (or the portion thereof
being exercised), by surrender of this Purchase Warrant to the Company, together with the exercise form attached hereto, in which event
the Company will issue to Holder Shares in accordance with the following formula:
Where,
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X |
= |
The number of Shares to be issued to Holder; |
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Y |
= |
The number of Shares for which the Purchase Warrant is being exercised if such exercise were by means of a cash exercise rather than a cashless exercise; |
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A |
= |
as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable exercise form if such exercise form is (1) both executed and delivered pursuant to Section 2.2 hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2.2 hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(68) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Exercise Form or (z) the Bid Price of the Common Stock on the principal Trading Market as reported by Bloomberg L.P. as of the time of the Holder’s execution of the applicable Exercise Form if such Exercise Form is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2.2 hereof, which Bid Price shall be shown on supporting documents provided by the Holder to the Company within two Trading Days of delivery of the exercise form, or (iii) the VWAP on the date of the applicable exercise form if the date of such exercise form is a Trading Day and such exercise form is both executed and delivered pursuant to Section 2.2 hereof after the close of “regular trading hours” on such Trading Day; and |
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B |
= |
The Exercise Price. |
“Bid
Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common
Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding
date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from
9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted
average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common
Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink
Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices),
the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share
of Common Stock as determined by an independent appraiser selected in good faith by the Holder and reasonably acceptable to the Company,
the fees and expenses of which shall be paid by the Company.
“VWAP”
means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed
or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date)
on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30
a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average
price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock
is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink Sheets”
published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the daily
volume weighted average price of the Common Stock for such date (or the nearest preceding date), or (d) in all other cases, the fair
market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Holder and reasonably
acceptable to the Company, the fees and expenses of which shall be paid by the Company.
“Trading
Day” means a day on which the New York Stock Exchange is open for trading.
“Trading
Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date
in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York
Stock Exchange (or any successors to any of the foregoing).
3. Transfer.
3.1
General Restrictions. The registered Holder of this Purchase Warrant agrees by his, her or its acceptance hereof,
that such Holder will not: (a) sell, transfer, assign, pledge or hypothecate this Purchase Warrant for a period of one hundred eighty
(180) days following the Effective Date to anyone other than: (i) The Benchmark Company, LLC (“Benchmark”)
or an underwriter or a selected dealer participating in the Offering, or (ii) the officers or partners, registered persons or affiliates
of Benchmark or of any such underwriter or selected dealer, in each case in accordance with FINRA Conduct Rule 5110(e), and (b) cause
this Purchase Warrant or the securities issuable hereunder to be the subject of any hedging, short sale, derivative, put or call transaction
that would result in the effective economic disposition of this Purchase Warrant or the securities hereunder, except as provided for
in FINRA Rule 5110(e)(2). After 180 days after the Effective Date, transfers to others may be made subject to compliance with or exemptions
from applicable securities laws. In order to make any permitted assignment, the Holder must deliver to the Company the assignment form
attached hereto duly executed and completed, together with the Purchase Warrant and payment of all transfer taxes, if any, payable in
connection therewith. The Company shall within five (5) business days transfer this Purchase Warrant on the books of the Company
and shall execute and deliver a new Purchase Warrant or Purchase Warrants of like tenor to the appropriate assignee(s) expressly evidencing
the right to purchase the aggregate number of Shares purchasable hereunder or such portion of such number as shall be contemplated by
any such assignment.
3.2 Restrictions
Imposed by the Act. The securities evidenced by this Purchase Warrant shall not be transferred unless and until: (i) if required
by applicable law, the Company has received the opinion of counsel for the Company that the securities may be transferred pursuant to
an exemption from registration under the Act and applicable state securities laws, or (ii) a registration statement or a post-effective
amendment to the Registration Statement relating to the offer and sale of such securities has been filed by the Company and declared effective
by the U.S. Securities and Exchange Commission (the ”Commission”) and compliance with applicable state securities law
has been established.
4. Reserved.
5. New
Purchase Warrants to be Issued.
5.1 Partial
Exercise or Transfer. This Purchase Warrant may be exercised or assigned in whole or in part. In the event of the exercise or assignment
hereof in part only, upon surrender of this Purchase Warrant for cancellation, together with the duly executed exercise or assignment
form, the Company shall cause to be delivered to the Holder without charge a new Purchase Warrant of like tenor to this Purchase Warrant
in the name of the Holder evidencing the right of the Holder to purchase the number of Shares purchasable hereunder as to which this Purchase
Warrant has not been exercised or assigned.
5.2 Lost
Certificate. Upon receipt by the Company of evidence satisfactory to it of the loss, theft, destruction or mutilation of this Purchase
Warrant and of reasonably satisfactory indemnification or the posting of a bond, determined in the sole discretion of the Company, the
Company shall execute and deliver a new Purchase Warrant of like tenor and date. Any such new Purchase Warrant executed and delivered
as a result of such loss, theft, mutilation or destruction shall constitute a substitute contractual obligation on the part of the Company.
6. Adjustments.
6.1 Adjustments
to Exercise Price and Number of Securities. The Exercise Price and the number of Shares underlying the Purchase Warrant shall be subject
to adjustment from time to time as hereinafter set forth:
6.1.1 Share
Dividends; Split Ups. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Shares
is increased by a stock dividend payable in Shares or by a split up of Shares or other similar event, then, on the effective day thereof,
the number of Shares purchasable hereunder shall be increased in proportion to such increase in outstanding Shares, and the Exercise Price
shall be proportionately decreased.
6.1.2 Aggregation
of Shares. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Shares is
decreased by a consolidation, combination or reclassification of Shares or other similar event, then, on the effective date thereof, the
number of Shares purchasable hereunder shall be decreased in proportion to such decrease in outstanding Shares, and the Exercise Price
shall be proportionately increased.
6.1.3 Replacement
of Securities upon Reorganization, etc. In case of any reclassification or reorganization of the outstanding Shares other than a change
covered by Section 6.1.1 or 6.1.2 hereof or that solely affects the par value of such Shares, or in the case of any share reconstruction
or amalgamation or consolidation or merger of the Company with or into another corporation (other than a consolidation or share reconstruction
or amalgamation or merger in which the Company is the continuing corporation and that does not result in any reclassification or reorganization
of the outstanding Shares), or in the case of any sale or conveyance to another corporation or entity of the property of the Company as
an entirety or substantially as an entirety in connection with which the Company is dissolved, the Holder of this Purchase Warrant shall
have the right thereafter (until the expiration of the right of exercise of this Purchase Warrant) to receive upon the exercise hereof,
for the same aggregate Exercise Price payable hereunder immediately prior to such event, the kind and amount of shares of stock or other
securities or property (including cash) receivable upon such reclassification, reorganization, share reconstruction or amalgamation, or
consolidation, or upon a dissolution following any such sale or transfer, by a Holder of the number of Shares of the Company obtainable
upon exercise of this Purchase Warrant immediately prior to such event; and if any reclassification also results in a change in Shares
covered by Section 6.1.1 or 6.1.2, then such adjustment shall be made pursuant to Sections 6.1.1, 6.1.2 and this Section 6.1.3.
The provisions of this Section 6.1.3 shall similarly apply to successive reclassifications, reorganizations, share reconstructions
or amalgamations, or consolidations, sales or other transfers.
6.1.4 Changes
in Form of Purchase Warrant. This form of Purchase Warrant need not be changed because of any change pursuant to this Section 6.1,
and Purchase Warrants issued after such change may state the same Exercise Price and the same number of Shares as are stated in the Purchase
Warrants initially issued pursuant to this Agreement. The acceptance by any Holder of the issuance of new Purchase Warrants reflecting
a required or permissive change shall not be deemed to waive any rights to an adjustment occurring after the Commencement Date or the
computation thereof.
6.2 Substitute
Purchase Warrant. In case of any consolidation of the Company with, or share reconstruction or amalgamation or merger of the Company
with or into, another corporation (other than a consolidation or share reconstruction or amalgamation or merger which does not result
in any reclassification or change of the outstanding Shares), the corporation formed by such consolidation or share reconstruction or
amalgamation shall execute and deliver to the Holder a supplemental Purchase Warrant providing that the holder of each Purchase Warrant
then outstanding or to be outstanding shall have the right thereafter (until the stated expiration of such Purchase Warrant) to receive,
upon exercise of such Purchase Warrant, the kind and amount of shares of stock and other securities and property receivable upon such
consolidation or share reconstruction or amalgamation, by a holder of the number of Shares of the Company for which such Purchase Warrant
might have been exercised immediately prior to such consolidation, share reconstruction or amalgamation or merger, sale or transfer. Such
supplemental Purchase Warrant shall provide for adjustments which shall be identical to the adjustments provided for in this Section 6.
The above provision of this Section shall similarly apply to successive consolidations or share reconstructions or amalgamations or mergers.
6.3 Elimination
of Fractional Interests. The Company shall not be required to issue certificates representing fractions of Shares upon the exercise
of the Purchase Warrant, nor shall it be required to issue scrip or pay cash in lieu of any fractional interests, it being the intent
of the parties that all fractional interests shall be eliminated by rounding any fraction up or down, as the case may be, to the nearest
whole number of Shares or other securities, properties or rights.
7. Reservation.
The Company shall at all times reserve and keep available out of its authorized Shares, solely for the purpose of issuance upon exercise
of the Purchase Warrants, such number of Shares or other securities, properties or rights as shall be issuable upon the exercise thereof.
The Company covenants and agrees that, upon exercise of the Purchase Warrants and payment of the Exercise Price therefor, in accordance
with the terms hereby, all Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non- assessable
and not subject to preemptive rights of any shareholder.
8. Certain
Notice Requirements.
8.1 Holder’s
Right to Receive Notice. Nothing herein shall be construed as conferring upon the Holders the right to vote or consent or to receive
notice as a shareholder for the election of directors or any other matter, or as having any rights whatsoever as a shareholder of the
Company. If, however, at any time prior to the expiration of the Purchase Warrants and their exercise, any of the events described in
Section 8.2 shall occur, then, in one or more of said events, the Company shall deliver to each Holder a copy of each notice relating
to such events given to the other shareholders of the Company at the same time and in the same manner that such notice is given to the
shareholders.
8.2 Events
Requiring Notice. The Company shall be required to give the notice described in this Section 8 upon one or more of the following
events: (i) if the Company shall take a record of the holders of its Shares for the purpose of entitling them to receive a dividend
or distribution payable otherwise than in cash, or a cash dividend or distribution payable otherwise than out of retained earnings, as
indicated by the accounting treatment of such dividend or distribution on the books of the Company, or (ii) the Company shall offer
to all the holders of its Shares any additional shares of capital stock of the Company or securities convertible into or exchangeable
for shares of capital stock of the Company, or any option, right or warrant to subscribe therefor.
8.3 Notice
of Change in Exercise Price. The Company shall, promptly after an event requiring a change in the Exercise Price pursuant to Section 6
hereof, send notice to the Holders of such event and change (“Price Notice”). The Price Notice shall describe the event
causing the change and the method of calculating same.
8.4 Transmittal
of Notices. All notices, requests, consents and other communications under this Purchase Warrant shall be in writing and shall be
deemed to have been duly made when hand delivered, or mailed by express mail or private courier service: (i) if to the registered
Holder of the Purchase Warrant, to the address of such Holder as shown on the books of the Company, or (ii) if to the Company, to
following address or to such other address as the Company may designate by notice to the Holders:
If to the Holder:
The Benchmark Company, LLC
150 E. 58th Street, 17th Floor
New York, NY 10155
Attention: President
with a copy to (which shall
not constitute notice):
Golenbock Eiseman Assor Bell &
Peskoe, LLP
711 Third Avenue – 17th
Floor
New York, New York 10017
Attention: Andrew D. Hudders
Email: ahudders@golenbock.com
If to the Company:
TFF Pharmaceuticals, Inc.
1751 River Run, Suite 400
Fort Worth, Texas 76107
Attention: Harlan Weisman, M.D.,
Chief Executive Officer
Email: hweisman@tffpharma.com
With copies to (which shall
not constitute notice):
Greenberg Traurig, LLP
18565 Jamboree Road, Suite 500
Irvine, California 92612
Attention: Daniel K. Donahue, Esq.
Email: donahued@gtlaw.com
9. Miscellaneous.
9.1 Amendments.
The Company and Benchmark may from time to time supplement or amend this Purchase Warrant without the approval of any of the Holders in
order to cure any ambiguity, to correct or supplement any provision contained herein that may be defective or inconsistent with any other
provisions herein, or to make any other provisions in regard to matters or questions arising hereunder that the Company and Benchmark
may deem necessary or desirable and that the Company and Benchmark deem shall not adversely affect the interest of the Holders. All other
modifications or amendments shall require the written consent of and be signed by (i) the Company and (ii) the Holder(s) of
Purchase Warrants then-exercisable for at least a majority of the Shares then-exercisable pursuant to all then-outstanding Purchase Warrants.
9.2 Headings.
The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning
or interpretation of any of the terms or provisions of this Purchase Warrant.
9.3. Entire
Agreement. This Purchase Warrant (together with the other agreements and documents being delivered pursuant to or in connection with
this Purchase Warrant) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof, and supersedes
all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof.
9.4 Binding
Effect. This Purchase Warrant shall inure solely to the benefit of and shall be binding upon, the Holder and the Company and their
permitted assignees, respective successors, legal representative and assigns, and no other person shall have or be construed to have any
legal or equitable right, remedy or claim under or in respect of or by virtue of this Purchase Warrant or any provisions herein contained.
9.5 Governing
Law; Submission to Jurisdiction; Trial by Jury. This Purchase Warrant shall be governed by and construed and enforced in accordance
with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any
action, proceeding or claim against it arising out of, or relating in any way to this Purchase Warrant shall be brought and enforced in
the courts located in New York, New York, or in the United States District Court located in New York, New York, and irrevocably submits
to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and
that such courts represent an inconvenient forum. Any process or summons to be served upon the Company may be served by transmitting a
copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 8
hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim.
The Company and the Holder agree that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies)
all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the
preparation therefor. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its stockholders and affiliates)
and the Holder hereby irrevocably waive, to the fullest extent permitted by applicable law, any and all right to trial by jury in any
legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
9.6 Waiver,
etc. The failure of the Company or the Holder to at any time enforce any of the provisions of this Purchase Warrant shall not be deemed
or construed to be a waiver of any such provision, nor to in any way affect the validity of this Purchase Warrant or any provision hereof
or the right of the Company or any Holder to thereafter enforce each and every provision of this Purchase Warrant. No waiver of any breach, non-compliance or non-fulfillment of
any of the provisions of this Purchase Warrant shall be effective unless set forth in a written instrument executed by the party or parties
against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall
be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.
9.7 Exchange
Agreement. As a condition of the Holder’s receipt and acceptance of this Purchase Warrant, Holder agrees that, at any time prior
to the complete exercise of this Purchase Warrant by Holder, if the Company and Benchmark enter into an agreement (“Exchange
Agreement”) pursuant to which they agree that all outstanding Purchase Warrants will be exchanged for securities or cash or
a combination of both, then Holder shall agree to such exchange and become a party to the Exchange Agreement.
[Signature Page Follows]
IN WITNESS WHEREOF, the
Company has caused this Purchase Warrant to be signed by its duly authorized officer as of August ____, 2023.
| TFF Pharmaceuticals, Inc. |
|
| |
|
|
| By: |
|
|
| |
Harlan Weisman, M.D. |
|
| |
Chief Executive Officer |
|
[Form to be used to
exercise Purchase Warrant]
Date: ,
2_
The undersigned hereby
elects irrevocably to exercise the Purchase Warrant for shares
of common stock, par value $0.001 per share (the “Shares”), of TFF Pharmaceuticals, Inc., a Delaware corporation (the
“Company”), and hereby makes payment of $ (at
the rate of $ per Share) in payment of the Exercise Price pursuant
thereto. Please issue the Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if
applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been exercised.
or
The undersigned hereby
elects irrevocably to convert its right to purchase Shares
of the Company under the Purchase Warrant for Shares, as determined
in accordance with the following formula, as more fully set forth in the Purchase Warrant to which this form is attached:
Where,
| |
X |
= |
The number of Shares to be issued to Holder; |
| |
Y |
= |
The number of Shares for which the Purchase Warrant is being exercised; |
| |
A |
= |
The fair market value of one Share which is equal to $ ; and |
| |
B |
= |
The Exercise Price which is equal to $ per share |
The undersigned agrees
and acknowledges that the calculation set forth above is subject to confirmation by the Company and any disagreement with respect to the
calculation shall be resolved by the Company in its sole discretion.
Please issue the Shares,
within two (2) business days of the date of exercise as to which this Purchase Warrant is exercised in accordance with the instructions
given below and, if applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been
converted.
Signature ___________________________
Signature Guaranteed_____________
INSTRUCTIONS FOR REGISTRATION
OF SECURITIES
| Name: |
|
|
| |
(Print in Block Letters) |
|
NOTICE: The signature
to this form must correspond with the name as written upon the face of the Purchase Warrant without alteration or enlargement or any change
whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered
national securities exchange.
[Form to be used to
assign Purchase Warrant]
ASSIGNMENT
(To be executed by the registered Holder to
effect a transfer of the within Purchase Warrant):
FOR VALUE RECEIVED,
does hereby sell, assign and transfer unto the right to purchase shares of Common Stock, par value $0.001 per share, of TFF Pharmaceuticals,
Inc., a Delaware corporation (the “Company”), evidenced by the Purchase Warrant and does hereby authorize the Company
to transfer such right on the books of the Company.
Dated: ,
2____
Signature___________________
Signature Guaranteed___________________
NOTICE: The signature to this form must correspond
with the name as written upon the face of the within Purchase Warrant without alteration or enlargement or any change whatsoever, and
must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national
securities exchange.
Exhibit 5.1
GREENBERG
TRAURIG, LLP
18565
Jamboree Road, Suite 500
Irvine,
CA 92612
August
15, 2023
TFF
Pharmaceuticals, Inc.
1751
River Run, Suite 400
Fort
Worth, Texas 76107
| Re: | Prospectus
Supplement to Registration Statement on Form S-3 |
Ladies
and Gentlemen:
We have acted as counsel to
TFF Pharmaceuticals, Inc., a Delaware corporation (the “Company”), in connection with (i) the Registration Statement
on Form S-3 (SEC File No. 333-249870) (the “Registration Statement”) filed with the Securities and Exchange Commission
(“Commission”) under the Securities Act of 1933, as amended, relating to the registration by the Company of, among
other things, common stock, par value $0.001 per share (the “Common Stock”), which may be issued from time to time
as set forth in the Registration Statement and the prospectus contained therein; and (ii) the prospectus supplement dated August 14, 2023
(the “Prospectus Supplement”) relating to the issue and sale pursuant to the Registration Statement of up to 22,880,400
shares (the “Shares”) of Common Stock, which includes up to 2,984,400 Shares subject to an underwriter’s over-allotment
option.
The
Shares are to be sold by the Company pursuant to an underwriting agreement (the “Underwriting Agreement”) dated as
of August 14, 2023 between the Company and the underwriter named therein. The Underwriting Agreement will be filed with the Commission
as Exhibit 1.1 to the Company’s Current Report on Form 8-K dated August 14, 2023 (“Form 8-K”).
You
have requested our opinion as to the matters set forth below in connection with the issuance of the Shares. For purposes of rendering
this opinion, we have examined the Registration Statement, the Prospectus Supplement, forms of the Second Amended and Restated Certificate
of Incorporation, as further amended to date, First Amended and Restated Bylaws of the Company currently in effect, the Underwriting
Agreement, and the corporate action of the Company that provides for the issuance of the Shares and execution of the Underwriting Agreement,
and we have made such other investigation as we have deemed appropriate. We have examined and relied upon certificates of public officials
and, as to certain matters of fact that are material to our opinion, we have also relied on a certificate of an officer of the Company.
We have not independently verified the matters set forth in such certificates.
We
express no opinion herein as to the laws of any state or jurisdiction other than the General Corporation Law of the State of Delaware
and the federal laws of the United States of America.
Based
upon and subject to the foregoing, it is our opinion that the Shares are duly authorized for issuance by the Company and, when issued
and paid for as described in the Prospectus Supplement, will be validly issued, fully paid and non-assessable.
We
hereby consent to the filing of this opinion as an exhibit to the Form 8-K and to the reference to our name under the caption “Legal
Matters” in the Prospectus Supplement.
| |
Very
truly yours, |
| |
|
| |
/s/
GREENBERG TRAURIG, LLP |
Exhibit 99.1
August 14, 2023
TFF
Pharmaceuticals Announces Proposed Public Offering of Common Stock
FORT WORTH, Texas, August 14, 2023 (GLOBE
NEWSWIRE) – TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (the “Company”), a clinical-stage biopharmaceutical company focused
on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced
that it intends to offer and sell shares of its common stock in an underwritten public offering. All
of the shares of common stock in the underwritten public offering are to be sold by the Company. The Company also expects to grant
the underwriters a 30-day option to purchase additional shares of common stock offered in the public offering. The offering is subject
to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms
of the offering.
The Company intends to use the net proceeds
from the proposed offering for working capital and general corporate purposes.
The Benchmark Company, LLC is acting
as sole book-running manager for the offering. The Liquid Venture Partners group at The Benchmark Company, LLC is responsible for sourcing
and executing the offering.
A shelf registration statement relating
to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (“SEC”)
and declared effective by the SEC. A preliminary prospectus supplement relating to the proposed offering has been filed with the SEC and
is available on the SEC’s website at http://www.sec.gov. A final prospectus supplement describing the terms of the proposed offering
will be filed with the SEC. The offering will be made only by means of the prospectus supplement and the accompanying base prospectus,
as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. Copies
of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from The Benchmark
Company, LLC, 150 East 58th Street, 17th floor, New York, NY 10155, by email at prospectus@benchmarkcompany.com, or by calling +1 (212)-312-6700.
This press release shall not constitute
an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in
which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such
state or jurisdiction.
About TFF Pharmaceuticals
TFF Pharmaceuticals,
Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines
into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile Thin Film Freezing (TFF)
technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into
an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and
topically to the skin.
Safe Harbor
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the proposed public offering and the intended use
of proceeds from the offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when
the offering may be completed or as to the actual size or terms of the offering. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that could cause actual results to differ materially, including those risks disclosed in under
the caption “Risk Factors” in the preliminary prospectus supplement related to the offering. TFF Pharmaceuticals cautions
readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake and specifically disclaims
any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required
by law.
Exhibit 99.2
August 15, 2023
TFF
Pharmaceuticals Prices $5 Million Public Offering of Common Stock
FORT WORTH, Texas, August 15, 2023 (GLOBE NEWSWIRE)
– TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (the “Company”), a clinical-stage biopharmaceutical company focused on developing
and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that
it has priced its underwritten public offering of 19,896,000 shares of its common stock at a public offering price of $0.25 per share.
All of the securities in the underwritten public offering are to be sold by the Company. The Company expects the gross proceeds from this
offering to be $4.97 million, before deducting the underwriting discount and other estimated offering expenses. The Company has granted
the underwriter a 30-day option to purchase up to 2,984,400 additional shares of common stock. The Company expects to close the offering,
subject to customary conditions, on August 17, 2023.
The Company intends to use the net proceeds
from the proposed offering for working capital and general corporate purposes.
The Benchmark Company, LLC is acting
as sole book-running manager for the offering. The Liquid Venture Partners group at The Benchmark Company, LLC is responsible for sourcing
and executing the offering.
A shelf registration statement relating
to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (“SEC”)
and declared effective by the SEC. A preliminary prospectus supplement relating to the proposed offering has been filed with the SEC and
is available on the SEC’s website at http://www.sec.gov. A final prospectus supplement describing the terms of the proposed offering
will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus relating to this offering may be
obtained, when available, from The Benchmark Company, LLC, 150 East 58th Street, 17th floor, New York, NY 10155, by email at prospectus@benchmarkcompany.com,
or by calling +1 (212)-312-6700.
This press release shall not constitute
an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in
which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such
state or jurisdiction.
About TFF Pharmaceuticals
TFF Pharmaceuticals,
Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines
into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile Thin Film Freezing (TFF)
technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into
an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and
topically to the skin.
Safe Harbor
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the expected closing of the public offering and the
intended use of proceeds from the offering. The offering is subject to market and other conditions and there can be no assurance as to
whether or when the offering may be completed. Forward-looking statements involve known and unknown risks, uncertainties and other
factors that could cause actual results to differ materially, including those risks disclosed in under the caption “Risk Factors”
in the preliminary prospectus supplement related to the offering. TFF Pharmaceuticals cautions readers not to place undue reliance on
any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements
to reflect new circumstances or unanticipated events as they occur, except as required by law.
Exhibit
99.3
TFF Pharmaceuticals Reports
Second Quarter 2023 Financial
Results
And Provides Corporate Update
| ● | Announced pricing of
approximately $5 million equity financing (approximately $5.7 million if underwriter’s overallotment option is exercised in full);
expected to extend cash runway through initial clinical data readouts and first quarter 2024 |
| ● | >80% of TFF VORI
clinical sites activated, pre-screening activities increased approximately 5-fold in the past 4 months; enrollment in Voriconazole Inhalation
Powder (TFF VORI) and Tacrolimus Inhalation Powder (TFF TAC) Phase 2 trials ongoing |
| ● | Launched
Expanded Access Program (EAP) for TFF VORI for the treatment of pulmonary aspergillosis and other voriconazole responsive fungal pulmonary
infections; appointed Uniphar Durbin Ireland Limited (Durbin) to implement the EAP in the United States, Australia, United Kingdom, Canada,
and select countries in Europe |
| ● | Awarded an approximately
$3 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) for
continued development of a shelf-stable, universal influenza mucosal vaccine using Thin Film Freezing technology |
| ● | Entered into a Cooperative
Research and Development Agreement (CRADA) with the National Institute of Environmental Health Sciences (NIEHS) |
| ● | Extended contract with
Leidos providing additional funding for TFF’s development of next-generation countermeasures under the DARPA Personalized Protective
Biosystems (PPB) program |
| ● | Conference call and
webcast scheduled today, Tuesday, Aug. 15, 2023, at 11:00 am ET |
FORT WORTH, TX – Aug 15, 2023
– TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused
on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported
financial results for the second quarter of 2023 and provided a corporate update.
“We continue to make solid progress in our Phase 2 trials of
TFF VORI and TFF TAC and expect to announce initial data by the end of 2023,” said Dr. Harlan Weisman, Chief Executive Officer of
TFF Pharmaceuticals. “Over the last several months, we have executed on multiple initiatives to continue to grow patient enrollment
in these two rare disease programs, which include increasing the number of TFF VORI active clinical sites and implementing a protocol
amendment that expands patient eligibility and changes the randomization ratio so more patients can receive TFF VORI. We’ve also
launched our EAP for TFF VORI and partnered with Durbin to implement the program across several countries.
“During the quarter, we announced three separate collaborations,
which included an approximately $3 million SBIR grant from the NIAID for the continued development of a shelf-stable, universal influenza
mucosal vaccine using our TFF technology. We also continue to be mindful of our capital resources. Yesterday, we strengthened our balance
sheet after pricing an approximate $5 million equity financing, with significant participation by our existing institutional investors,
with no warrants issued to investors in this transaction. Including our existing cash reserves, we believe proceeds from this financing
will ensure that we have sufficient resources to communicate initial clinical data by the end of 2023 and extend the Company’s cash
runway through the first quarter of 2024.”
Conference Call and Webcast Information
The Company will host a conference call today, Tuesday,
August 15, 2023, at 11:00 AM Eastern Time, to discuss second quarter 2023 financial results and the corporate update. To participate in
the conference call, please utilize the following information:
Domestic Dial-In Number: Toll-Free: 1-888-886-7786
International Dial-In Number: 1-416-764-8658
Conference ID: 06447489
Call me™: LINK (will be made active 15 minutes
prior to the scheduled start time)
The call will also be broadcast live over the Web
and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at
https://viavid.webcasts.com/starthere.jsp?ei=1624668&tp_key=258da73e48
The conference call will also be available for replay
for one month on the Company’s website in the Events Calendar of the Investors section.
Recent Clinical and Corporate Highlights:
| ● | In August 2023, the Company announced pricing of approximately
$5 million equity financing, before underwriter’s overallotment option which if exercised in full will increase the financing to
approximately $5.7 million. The financing is intended to provide additional capital that will further extend the Company’s cash
runway through initial clinical data readouts by the end of 2023 and extend the Company’s cash runway through the first quarter
2024. No investor warrant coverage was attached to this financing. |
| ● | In July 2023, the Company and Durbin jointly announced the
opening of an EAP for TFF VORI enabling patients access to TFF VORI in the United States, Australia, United Kingdom, Canada and select
countries in Europe. The EAP is meant to provide access to TFF VORI in patients who are not eligible for the ongoing clinical trial and
who have limited or no other treatment options or who have had unfavorable response to adequate standard of care therapy including to
oral or intravenous voriconazole. |
| ● | In June 2023, the Company announced that the NIAID, part
of the National Institutes of Health, awarded TFF Pharmaceuticals an approximately $3 million Direct to Phase II SBIR grant to continue
development of a shelf-stable, universal influenza mucosal vaccine using the Company’s TFF technology. The purpose of the SBIR
is to develop a vaccine that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and
II influenza A viruses and has the added benefit of easy delivery and storage at room temperature to facilitate broad, cost-effective
distribution. |
| ● | In May 2023, the Company entered into a CRADA with the NIEHS
to develop dry powder formulations of high molecular weight hyaluronan (HMW-HA) to prevent and treat respiratory diseases. NIEHS and
TFF Pharmaceuticals will evaluate the pharmacokinetics and therapeutic efficacy of the TFF-HMW-HA formulations using in vitro and in
vivo models of select respiratory diseases, with a primary focus on chronic obstructive pulmonary disorder (COPD) and viral respiratory
diseases caused by SARS-CoV-2, influenza virus, and/or respiratory syncytial virus (RSV). |
| ● | In May 2023, the Company announced an extension of its contract
with Leidos that will provide additional funding to advance next generation personalized protective biosystems under the PPB Program
managed by DARPA. The goal of the program is to develop lightweight materials using TFF technology that protect the military and healthcare
personnel from exposure to chemical and biological threats. |
Financial Results
For the quarter ended June 30, 2023, compared to quarter
ended June 30, 2022
| ● | Cash Position: as of June 30, 2023, TFF Pharmaceuticals reported
cash and cash equivalents of $7.7 million. |
| ● | Research and Development (R&D) expenses: R&D expenses
for the second quarter of 2023 were $2.7 million, compared to $5.1 million for the comparable period in 2022. The $2.4 million decrease
year-over-year is primarily a result of reduced clinical and manufacturing expenses. |
| ● | General & Administrative (G&A) expenses: G&A
expenses for the second quarter of 2023 were $2.7 million, compared to $3.7 million for the comparable period in 2022. The $1.0 million
decrease year-over-year is primarily related to decreased professional fees and patent, insurance, consulting, market research, payroll
and related expenses. |
| ● | Net Loss: TFF Pharmaceuticals reported a net loss for the
second quarter of 2023 of $5.0 million, compared to a net loss of $8.7 million for the comparable period in 2022. |
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF
Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new
chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering
process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical
and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing
challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy.
The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses
compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders
created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that
can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into
easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages
of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals,
Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines
into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform
has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder
highly advantageous for inhalation, or for topical delivery to the eyes, nose and topically to the skin. TFF Pharmaceuticals has two
lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company
continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize
healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally.
To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
SAFE HARBOR
This press release contains forward-looking
statements regarding TFF Pharmaceuticals, Inc., including, plans for releasing initial clinical data by the end of 2023, the adequacy
of the Company’s cash runway to meet its near-term funding needs, and the benefits of the Company’s TFF platform. Those forward-looking
statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among
those factors are: (i) the risk that the Company may not be able to release initial clinical data for TFF VORI and TFF TAC by the end
of 2023 or, if it is able to do so, that such clinical data will be positive, (ii) the risk that the Company’s working capital
after giving effect to the recently announced public offering will not be sufficient to fund the Company’s working capital requirements
through Q1 2024, (iii) the risk that the Company’s preclinical and IND enabling studies of the dry powder formulation of the universal
influenza vaccine may not be successful, (iv) the risk that the Company may not be able to successfully conclude clinical testing of
its TFF VORI or TFF TAC or obtain pre-market approval of any of its dry powder product candidates, (v) success in early phases of pre-clinical
and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily
predict final results, (vi) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated
into a commercial drug product, (vii) the Company has no current agreements or understandings with any large pharmaceutical companies
for the development of a drug product incorporating the TFF Platform, (viii) the risk that the Company will not be able to conclude a
long-term commercial agreement with any third-party, and (ix) those other risks disclosed in the section “Risk Factors” included
in the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2023. TFF Pharmaceuticals cautions
readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically
disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except
as required by law.
Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
cdavis@lifesciadvisors.com
TFF PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | |
Three
Months Ended
June 30, | | |
Six
Months Ended
June 30, | |
| | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| | |
| | |
| | |
| | |
| |
| Grant revenue | |
$ | 333,351 | | |
$ | 28,004 | | |
$ | 384,780 | | |
$ | 95,439 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 2,681,898 | | |
| 5,102,090 | | |
| 6,700,557 | | |
| 10,339,514 | |
| General and administrative | |
| 2,670,363 | | |
| 3,678,119 | | |
| 5,789,579 | | |
| 6,891,317 | |
| Total operating expenses | |
| 5,352,261 | | |
| 8,780,209 | | |
| 12,490,136 | | |
| 17,230,831 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (5,018,910 | ) | |
| (8,752,205 | ) | |
| (12,105,356 | ) | |
| (17,135,392 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 36,120 | | |
| 5,880 | | |
| 71,199 | | |
| 13,065 | |
| Change in fair value of note receivable | |
| (37,416 | ) | |
| - | | |
| (37,416 | ) | |
| - | |
| Total other income (expense), net | |
| (1,296 | ) | |
| 5,880 | | |
| 33,783 | | |
| 13,065 | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (5,020,206 | ) | |
$ | (8,746,325 | ) | |
$ | (12,071,573 | ) | |
$ | (17,122,327 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.14 | ) | |
$ | (0.34 | ) | |
$ | (0.33 | ) | |
$ | (0.67 | ) |
| Weighted average common shares outstanding, basic and diluted | |
| 36,193,085 | | |
| 25,373,706 | | |
| 36,193,085 | | |
| 25,372,749 | |
TFF PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| | |
June 30,
2023 | | |
December 31,
2022 | |
| | |
(Unaudited) | | |
| |
| | |
| | |
| |
| ASSETS | |
| | |
| |
| Current assets: | |
| | |
| |
| Cash and cash equivalents | |
$ | 7,662,968 | | |
$ | 16,612,315 | |
| Research and development tax incentive receivable | |
| 284,169 | | |
| 186,507 | |
| Prepaid assets and other current assets | |
| 1,468,431 | | |
| 2,226,344 | |
| Total current assets | |
| 9,415,568 | | |
| 19,025,166 | |
| Operating lease right-of-use asset, net | |
| 158,541 | | |
| 196,044 | |
| Property and equipment, net | |
| 2,157,512 | | |
| 3,078,342 | |
| Note receivable - Augmenta | |
| 1,830,000 | | |
| 1,812,975 | |
| Other assets | |
| 7,688 | | |
| 7,688 | |
| Total assets | |
$ | 13,569,309 | | |
$ | 24,120,215 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 1,007,001 | | |
$ | 919,607 | |
| Accrued compensation | |
| - | | |
| 4,430 | |
| Deferred research grant revenue | |
| 126,000 | | |
| 126,000 | |
| Current portion of operating lease liability | |
| 81,938 | | |
| 80,625 | |
| Total current liabilities | |
| 1,214,939 | | |
| 1,130,662 | |
| Operating lease liability, net of current portion | |
| 72,328 | | |
| 110,094 | |
| Total liabilities | |
| 1,287,267 | | |
| 1,240,756 | |
| | |
| | | |
| | |
| Commitments and contingencies | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock | |
| 36,193 | | |
| 36,193 | |
| Additional paid-in capital | |
| 121,571,374 | | |
| 120,070,983 | |
| Accumulated other comprehensive loss | |
| (165,530 | ) | |
| (139,295 | ) |
| Accumulated deficit | |
| (109,159,995 | ) | |
| (97,088,422 | ) |
| Total stockholders’ equity | |
| 12,282,042 | | |
| 22,879,459 | |
| Total liabilities and stockholders’ equity | |
$ | 13,569,309 | | |
$ | 24,120,215 | |
6
Exhibit
99.4
1 NASDAQ: TFFP Corporate Update August 2023 BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions
Safe Harbor Statement SPECIAL NOTE REGARDING FORWARD - LOOKING STATEMENTS This document contains forward - looking statements concerning TFF Pharmaceuticals, Inc . (“TFF”, the “Company,” “we,” “us,” and “our”) . The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward - looking statements . These forward - looking statements include, but are not limited to, statements concerning the following : • Our expectations for releasing initial clinical readouts for TFF VORI and TFF TAC by the end of 2023; • our future financial and operating results; • our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in our business; • the timing and success of our plan of commercialization; • our ability to successfully develop and clinically test our product candidates; and • our ability to file for FDA approval of our product candidates through the 505(b)(2) regulatory pathway. These forward - looking statements are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially . Among those factors are : (i) the risk that the Company may not be able to release initial clinical data for TFF VORI and TFF TAC by the end of 2023 or, if it is able to do so, that such clinical data will be positive, (ii) the risk that the Company’s working capital after giving effect to the recently announced public offering will not be sufficient to fund the Company’s working capital requirements through Q 1 2024 , (iii) no drug product incorporating the TFF platform has received FDA pre - market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) success in early phases of pre - clinical and clinicals trials do not ensure later clinical trials will be successful, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10 - Q filed with the SEC on August 14 , 2023 . TFF Pharmaceuticals cautions readers not to place undue reliance on any forward - looking statements . TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law . This document contains only basic information concerning TFF. Because it is a summary it does not contain all of the information you should consider before investing. Please refer to our reports and registration statements on file with the SEC for more comprehensive information concerning TFF Pharmaceuticals. Confidential 2
Investment Highlights Experienced Management; IP Protection • Experienced senior management team with outstanding track record of success in a diverse set of competencies and related disciplines • Robust IP estate with over 120 patents issued or pending Strong Internal Pipeline • TFF VORI (inhaled voriconazole dry powder) for invasive pulmonary aspergillosis: driving efficacy, minimizing systemic toxicities and drug - drug interactions • TFF TAC (inhaled tacrolimus dry powder) for lung transplantation: decreasing rejection, minimizing systemic toxicities and drug - drug interactions • Phase 2 programs initiated (505(b)2 pathway) Broadly Applicable Platform • Created dry powder formulations for a variety of small and large molecules • Significant number of collaborations in place Proprietary Lung Drug Delivery Process • Thin Film Freezing (TFF) is a unique, patented technology with proven ability to convert a wide range of poorly water - soluble drugs into inhalable dry powder formulations Oral Confidential 3 Lower efficacy, Higher adverse events Inhaled Higher efficacy, Lower adverse events
Thin Film Freezing Process Bulk Drug Material x Use proprietary combination of freezing rate and liquid surface to volume ratio x Confers advantages in engineering particles for various routes of administration x Stabilizes biologics not achievable with other process technologies Drying and Lyophilization Brittle Matrix Powder Proprietary Freezing Process Confidential 4
New Vision for TFF Transform from a technology platform company reliant on licensing Previous Focus: • A technology platform company generating value creation from licensing TFF technology to big pharma and biotech companies New Vision: • A product development company focused on bringing to market high value products from our pipeline based on our TFF technology Confidential 5
TFF Investment Opportunity New Corporate Strategy • Leverage our R&D talent and unique technology to accelerate the development of proprietary drugs • Singular focus on advancing therapies that can significantly improve upon the standard of care • Products that can be marketed with a small, specialty - focused salesforce • BD activity to provide upside • Continue to engage pharma/biotech • Inhalation product opportunities • Small molecules, mAbs, vaccines, phages, nucleotides Execution to Create Shareholder Value • Generating strong clinical data in the TFF VORI and TFF TAC programs • Initial Phase 2 data readouts expected by end of 2023 • Compassionate use program • Clearly articulate to investors: • Differentiation of pipeline assets and potential to advance standard of care • Clinical development strategy/pathway to registration • Market opportunity – 2 drugs each with peak sales over $1 billion • Efficient use of capital • Reviewing all operations and eliminating redundancies Confidential 6
Disciplined Approach to Cash Management • Budget cuts instituted in Q1 and Q2 2023 extend cash runway into December 2023 • Hiring slowed and existing headcount reduced • Consulting contracts restructured • Reduction in professional fees and investor relations • Paused market research and public relations spending • $5MM net raise extends runway to April 2024 Confidential 7
TFF VORI Voriconazole Inhalation Powder Clinical Development Program 8
TFF VORI: Update on Clinical Development Strategy Prior Approach: • Focus on invasive pulmonary aspergillosis • 140,000 cases per year worldwide (treatment and prevention) • ≥ $1B TFF VORI peak forecast global sales • Differentiate on safety, tolerability, and drug - drug interactions • Focus on treatment as monotherapy • Traditional approach to trial design • Widespread outreach Confidential 9 New Strategy: • Explore the full range of indications that potentially benefit from voriconazole expanding the market potential • All forms of pulmonary aspergillosis including IPA • Other voriconazole responsive pulmonary fungal infections • Differentiate on efficacy as well as safety/tolerability/drug - drug interactions • Explore treatment as monotherapy and as add - on therapy • Trial design reflecting rare disease indication, large body of historical data and the 505(b)2 regulatory pathway • Continue widespread outreach; orchestrated effort around lung transplant to optimize efficiency
TFF VORI: Clinical Development Rationale TFF VORI is in Phase 2 development for the treatment of pulmonary fungal infections including invasive pulmonary aspergillosis (IPA) • IPA primarily impacts immune compromised patients (hematologic malignancies, solid organ, and stem cell transplant recipients) • Oral and intravenous voriconazole is first - line therapy for the treatment of IPA • High unmet medical need with ~30% mortality in 12 weeks due to high rate of toxicity and drug - drug interactions limiting systemic dosing and overall efficacy. • TFF VORI delivers voriconazole directly to the lung driving local lung concentrations to improve efficacy while limiting systemic exposure thus systemic toxicities and drug - drug interactions; overall improvement of the therapeutic index Confidential 10
TFF VORI: Phase 1 studies and compassionate use experience provided safety, tolerability, pharmacokinetic, and early efficacy data Available Compassionate use data: Two lung transplant recipients with history of recurrent pulmonary fungal infections and toxicities to systemic available standard of care therapy. Following treatment with TFF VORI: • Lung function stabilized/maintained • Lung lesions improved • Aspergillus infection cleared • No need for hospitalization • No drug - drug interactions • No adverse events reported Stabilized Lung Function Decreased Lesions 20% 10% 0% 100% 90% 80% 70% 60% 50% 40% 30% Jun - 21 Jul - 21 Aug - 21 Sep - 21 Oct - 21 Nov - 21 Dec - 21 Jan - 22 Feb - 22 Mar - 22 Apr - 22 May - 22 Jun - 22 Jul - 22 Aug - 22 Sep - 22 Oct - 22 Nov - 22 FEV1 (% predicted) FVC (% predicted) TFF VORI Phase 1 Results: • Phase 1a (n=65 healthy volunteers) and Phase 1b (n=16 patients with mild stable asthma) • Dosages up to 80mg twice daily were well tolerated and showed no signs of the toxicities previously reported for the oral or intravenous forms. Phase 2 study in IPA ongoing in Europe : • Open label randomized study; Oral voriconazole vs. TFF VORI • 12 weeks of treatment; Endpoints: Safety/tolerability; clinical response, radiologic response, mycologic response Confidential 11
TFF VORI: Program Execution Confidential 12 Identified challenges: • First patient was originally projected in the Phase 2 study in 8/22; first site not activated until end of December 2022; Significant CRO challenges Progress since January of 2023: • Changed the CRO project manager and the site activation lead; set up weekly goals for the CRO, set up weekly meetings with upper management to hold CRO accountable for execution of clinical trial • 16 out of 19 sites activated to date; additional site activations expected this quarter • Protocol addendum to broaden eligibility in effect • Protocol amendment to change randomization ratio and allow oral arm crossover to inhaled arm pending full approval in all countries • Pre - screening rate has increased by 5 - fold in the past four months • 2 patients enrolled • Recently launched expanded access (compassionate use) program (EAP): US, Canada, Australia, UK, and select EU countries • 1 patient enrolled in new EAP • Additionally, 2 compassionate use patients treated previously • Meaningful data to guide Phase 3 Go/No - Go decision is anticipated from total of ~10 patients given considerable historical safety and efficacy data with voriconazole and rare disease indication • Initial data readout from TFF VORI Phase 2 and Compassionate use: Expected by End of Year 2023
Significant rise in the number of pre - screened patients (As of July 31, 2023): • Pre - screening in the first 4 months (December to March) = 9 • Pre - screening in the last 4 months (April to July) = 44 • Pre - screening in April = 5 • Pre - screening in May = 11 • Pre - screening in June = 12 • Pre - screening in July = 16 • Most common reason for pre - screen failure: • Patient too ill in palliative care, respiratory failure • Diagnosis not IPA TFF VORI: Phase 2 Pre - Screening Status Exponential Pre - Screening Activity 60 50 40 30 20 10 0 De c Jul Jan Fe b Mar Monthly Pre - screens Apr May Jun Cumulative Pre - screens Confidential 13
TFF VORI: Phase 2 and EAP Enrollment Projection 0 5 10 15 20 25 Dec Jan Feb Mar Apr May Jun Projected Cumulative Enrollment Jul Aug Sep Oct Nov Dec Jan Actual Cumulative Enrollment Feb Mar Apr Patients Enrolled Confidential 14
TFF VORI: Expanded Access Program • Expanded Access Program enrolls patients with the following diagnoses who have limited or no other treatment options or who have had unfavorable response to adequate standard of care therapy: • Pulmonary aspergillosis: • Invasive pulmonary aspergillosis (IPA) • Chronic pulmonary aspergillosis (CPA) • Allergic bronchopulmonary aspergillosis (ABPA) • Aspergillus tracheobronchitis • Aspergillus bronchoanastomotic infection • Voriconazole responsive pulmonary fungal infections • US expanded access protocol prepared and submitted to the FDA; no comments received in > 60 days since submission • Expanded access to be offered in the US, Canada, Australia, UK, and select EU countries • Drug labeled and ready for expanded access use Confidential 15
TFF VORI: Expanded Access Program • Company policy posted on the website introducing the availability of the expanded access program • Program listed on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT05897294 • Program listed on the Reagan - Udall Foundation Expanded Access Navigator: https://navigator.reaganudall.org/company - directory/t • Partnered with Durbin in July 2023 to execute expanded access program across multiple countries • Medical Science Liaison engaging new potential PIs • Interest from major academic institutions • 1 patient enrolled in new EAP (July) • Additionally, 2 compassionate use patients treated previously Confidential 16
TFF TAC Tacrolimus Inhalation Powder Clinical Development Program 17
TFF TAC: Background Information TFF TAC is in Phase 2 development for prevention of rejection in lung transplant recipients; ~40,000 new and existing patients worldwide with ≥ $1 billion peak TFF TAC global forecast • Tacrolimus is first - line calcineurin inhibitor for prevention of rejection in lung transplant • Significant toxicities and drug - drug interactions associated with oral tacrolimus • TFF TAC delivers tacrolimus directly to the lung to drive efficacy through immune suppression locally in the lung, where inflammation leads to rejection and allograft failure, while limiting systemic exposure thus systemic toxicities and drug - drug interactions • High unmet medical need with ~50% mortality in 5 years due to narrow therapeutic index: • Too little immune suppression leads to acute rejection or chronic rejection leading to chronic lung allograft dysfunction (CLAD) • Too much immune suppression leads to infections, chronic kidney disease, and post transplant lymphoproliferative disease • The direct delivery of TFF TAC to the lung is poised to potentially address multiple contributing factors to the 50% 5 - year mortality seen in lung transplant Confidential 18
TFF TAC: Phase 1 study provided safety, tolerability and pharmacokinetic data and enabled Phase 2 planning Phase 1 Results: • Phase 1a healthy volunteer study (n=57 subjects): • Doses up to 5 mg (single dose) and 1.5 mg (repeated dose) daily were generally well tolerated • No dose - related increase in overall treatment - emergent adverse events (TEAEs) was observed Ongoing Phase 2 study in Australia: • Open label study in lung transplant recipients with renal insufficiency • Up to 24 patients; 12 weeks of treatment with option for open label extension • Endpoints: Safety, including assessment of renal function; lung rejection using clinical signs and symptoms (Adverse events assessment), spirometry, lung imaging, donor derived cell free DNA Confidential 19
Sites (As of July 25, 2023) • 1 site activated and actively enrolling; 3 patients enrolled • 2nd site activation expected in August • 3rd site activation projected in September Patients • Significant learning about how to transition patients from oral tacrolimus to TFF TAC • Goal is to prevent rejection and maintain allograft while minimizing toxicity from tacrolimus • Selected sites have a large database of established lung transplant patients for potential enrollment in the study • Protocol amendment planned to fine tune dosing of TFF TAC • Meaningful data to guide Phase 3 Go/No - Go decision is anticipated from total of ~10 patients patients given considerable historical safety and efficacy data with tacrolimus and rare disease indication • Initial data readout expected by end of year 2023 TFF TAC: Phase 2 Status Confidential 20
0 5 10 15 20 25 Dec Jan Feb Mar Apr May Jun Jul * Aug Sep Oct Nov Dec Jan Actual Cumulative Enrollment Feb Mar Apr Patients Enrolled Projected Cumulative Enrollment *1 subject screened in July, enrolled in August Confidential 21 TFF TAC: Phase 2 Enrollment Projection
22 New Opportunities Leveraging TFF’s Platform with Non - Dilutive Funding
May 4, 2023 TFF Pharmaceuticals enters into CRADA with the National Institute of Environmental Health Sciences (NIEHS) to develop dry powder formulations of Hyaluronan to prevent and treat respiratory diseases. May 1, 2023 TFF Pharmaceuticals receives additional funding from Leidos to advance next generation countermeasures for military and healthcare personnel under the DARPA Personalized Protective Biosystems (PPB) program. June 26, 2023 TFF Pharmaceuticals awarded $2.97 million by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institute of Health (NIH), to develop a universal influenza vaccine using the company’s Thin Film Freezing technology. Recent Government Collaborations Recent grants and contracts with various government agencies is further validation of Thin Film Freezing’s potential Confidential 23
Key Takeaways Revolutionary platform enabling inhalable drug delivery across the entire spectrum of pharmaceutical agents (small & large molecules, biologics, vaccines, mRNA), targeting multiple $1 billion+ markets x Ability to convert a wide range of poorly water - soluble drugs into inhalable dry powder formulations x Two proprietary drugs with $1 billion or more sized market potentials x Lower risk clinical programs with significant near - term data readouts x Both with 505(b)(2) regulatory pathway x Recent grants and contracts with various government agencies is further validation of Thin Film Freezing’s potential x Proven management team with multiple successful exits x Over 120 patents issued or pending Strong Internal Pipeline Confidential 24 Broadly Applicable Platform Experienced Management; IP Protection Proprietary Lung Drug Delivery Process
25 THANK YOU
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