As
filed with the Securities and Exchange Commission on October 14, 2022
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
POLARITYTE,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
2836 |
|
06-1529524 |
(State
or Other Jurisdiction of
Incorporation
or Organization) |
|
(Primary Standard Industrial
Classification Code Number) |
|
(I.R.S.
Employer
Identification
Number) |
1960
S. 4250 West, Salt Lake City, UT 84104
Telephone:
(800) 560-3983
(Address,
including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Mark
E. Lehman
Chief
Legal Officer
PolarityTE,
Inc.
1960
S. 4250 West, Salt Lake City, UT 84104
(385)
266-3151
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
With
copies to:
David
Marx, Esq.
Dorsey
& Whitney LLP
111
S. Main Street, Suite 2100
Salt
Lake City, UT 84111
(801)
933-7360
Approximate
date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933 check the following box: ☒
If
this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ☐
If
this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ☐ |
|
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
|
Smaller
reporting company ☒ |
|
|
Emerging
growth company ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act. ☐
The
registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the
registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date
as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration
statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does
it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS (Subject to Completion) |
Dated
October 14, 2022 |
PolarityTE,
Inc.
Up
to $15,000,000
Shares of Common Stock
Pre-Funded
Warrants, Each Pre-Funded Warrant to Purchase One Share of Common Stock
Common Warrants,
including Underwriter Warrants, to Purchase
Shares of Common Stock
Shares
of Common Stock Underlying the Pre-Funded Warrants
Shares
of Common Stock Underlying the Common Warrants and Underwriter Warrants
We
are offering, pursuant to this prospectus, up to an aggregate of $15,000,000
of shares of common stock, or the “Common
Shares,” together with common warrants to
purchase shares of
common stock, or “Common Warrants,” at an assumed public offering price of $ per share and Common
Warrant, which is equal to the last reported sale price per share of our common stock on The Nasdaq Capital Market, on
, 2022. The Common
Shares and Common Warrants will be sold in a fixed combination, with each Common Share accompanied by
Common Warrant to purchase
share of common stock. Each Common Warrant will be immediately exercisable for one share of common stock at an assumed exercise
price of $ and will expire on the fifth anniversary of the original issuance date.
We
are also offering, pursuant to this prospectus, to those purchasers, if any, whose purchase of Common Shares in this offering would
otherwise result in such purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99%
(or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock immediately following the consummation of
this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants, or “Pre-Funded
Warrants,” to purchase shares of common stock in lieu of the offered Common Shares that would otherwise result in such
purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of
common stock. For each Pre-Funded Warrant we sell, the number of Common Shares we are offering will be decreased on a one-for-one
basis. Each Pre-Funded Warrant is being offered together with Common Warrant in the same form as that being offered with each Common
Share. The assumed public offering price for each Pre-Funded Warrant and accompanying Common Warrant is
$ , which is equal to the last reported sale price of our common
stock on The Nasdaq Capital Market on
, 2022, less the $0.0001
per share exercise price of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be exercised at any
time until all of the Pre-Funded Warrants are exercised in full.
The
Common Shares or Pre-Funded Warrants, as the case may be, and the accompanying Common Warrants can only be purchased together in
this offering but are immediately separable and will be issued separately. Because we will issue
Common Warrant for each
Common Share and for each Pre-Funded Warrant sold in this offering, the number of Common Warrants sold in this offering will not
change as a result of a change in the mix of Common Shares and Pre-Funded Warrants sold. The shares of common stock issuable from
time to time upon exercise of the Pre-Funded Warrants and the Common Warrants are also being offered by this prospectus. The number
of Common Shares, Common Warrants, and Pre-Funded Warrants, and all other relevant information are based on an assumed public
offering price of $ per Common Share or Pre-Funded Warrant, as applicable, and
accompanying Common Warrant. The actual public offering price per Common Share and Common Warrant and the actual public offering
price per Pre-Funded Warrant and Common Warrant will be determined between us and the underwriter at the time of pricing and may be
at a discount to this assumed public offering price. Therefore, the assumed public offering price used throughout this prospectus
may not be indicative of the final offering price.
Our
common stock is listed on The Nasdaq Capital Market under the symbol “PTE.” On October 13, 2022, the closing price
for our common stock, as reported on The Nasdaq Capital Market, was $0.7777 per share. There is no established public trading
market for the Pre-Funded Warrants or Common Warrants, and we do not expect such a market to develop. We do not intend to apply for a
listing of the Pre-Funded Warrants or Common Warrants on any national securities exchange or other nationally recognized trading system.
Investing
in our securities involves a high degree of risk. You should carefully review the risks and uncertainties referenced under the heading
“Risk Factors” contained in this prospectus beginning on page 6 and under similar headings in the other documents
that are incorporated by reference into this prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
A.G.P./Alliance
Global Partners, or the “Underwriter,” is acting as sole book-running manager and underwriter of the offering. The Underwriter
is selling the securities being offered in this offering on a “best efforts” basis. Therefore, the Underwriter is not required
to sell any minimum number or dollar amount of securities but will use its best efforts to sell the securities offered by this prospectus.
We have agreed to pay the Underwriter a discount equal to 7.0% of the aggregate gross proceeds raised in this offering as set forth in
the table below, except that, with respect to purchases from certain identified investors, the Underwriter has agreed that the underwriting
discount will be reduced to 3.5% or 6.0%. See “Underwriting” beginning on page 19 of this prospectus for more information.
| |
Per Common Share and Common Warrant | | |
Per Pre-Funded Warrant and Common Warrant(1) | | |
Total(6) | |
Public offering price | |
$ | | | |
$ | | | |
$ | | |
Underwriting Discount(2)(3)(4) | |
$ | | | |
$ | | | |
$ | | |
Proceeds to us, (before expenses)(5) | |
$ | | | |
$ | | | |
$ | | |
(1)
Excludes proceeds from exercise of the Pre-Funded Warrants in cash, if any.
(2)
The total underwriting discount and the total proceeds to us, before expenses, reflect the reduced discount for the shares to be purchased
by certain identified investors.
(3)
Underwriting compensation does not include $ we are obligated to pay to H.C. Wainwright & Co., LLC (“Wainwright”), under
a prior agreement for investment banking services that includes a tail fee payable if we place securities with an investor who participated
in the offering of securities we closed on June 8, 2022. The tail fee also includes common stock purchase warrants (the “HCW Warrants”).
See “Underwriting” beginning on page 19 of this prospectus.
(4)
We have also agreed to reimburse the Underwriter for certain expenses, including a non-accountable expense allowance equal to 0.5% of
the gross proceeds we receive in this offering, and issue to the Underwriter, or its designees, warrants to purchase shares of our common
stock, underlying shares of which are also being registered hereby, as additional compensation. See “Underwriting” beginning
on page 19 of this prospectus for a description of the underwriting discounts, expenses payable to the Underwriter, and other terms
of the underwriter warrants.
(5)
Excludes fees and expenses payable to the Underwriter and proceeds from the exercise of the Common Warrants in cash, if any.
(6)
Because there is no minimum offering amount required as a condition to closing in this offering, the actual public offering amount, underwriting
discount, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts
set forth above.
The
Underwriter is offering the securities for sale on a “best efforts” basis. The Underwriter expects to deliver the Common
Shares, Pre-Funded Warrants (if any), and Common Warrants to purchasers on or about , 2022.
A.G.P.
The
date of this Prospectus is , 2022.
TABLE
OF CONTENTS
We
have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus. We
take no responsibility for and can provide no assurance as to the reliability of any other information that others may give you. This
prospectus is an offer to sell only the securities offered by this prospectus, but only under circumstances and in jurisdictions where
it is lawful to do so. The information contained in this prospectus is current only as of its date. Our business, financial condition,
results of operations, and prospects may have changed since that date.
For
investors outside the United States: We have not done anything that would permit the sale of the securities offered by this prospectus
in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who
come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities
and the distribution of this prospectus outside the United States.
Unless
the context otherwise indicates, references in this prospectus to “PolarityTE,” the “Company,” “we,”
“us,” and “our” refer, collectively, to PolarityTE, Inc., a Delaware corporation, and its subsidiaries.
We
use various trademarks and trade names in our business, including without limitation our corporate name and logo. All other trademarks
or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and
trade names in this prospectus may be referred to without the ® and ™ symbols, but such references should not be construed
as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this prospectus or in filings we make with the Securities and Exchange
Commission (“SEC”) that are incorporated herein by reference. This summary does not contain all the information that you
should consider before deciding to invest in our securities. You should read the entire prospectus, including the information incorporated
by reference herein, carefully, including the section titled “Risk Factors,” included elsewhere in this prospectus, and in
the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and our financial statements and the related notes included in our annual report on Form 10-K for the fiscal year
ended December 31, 2021, and our quarterly report on Form 10-Q for the quarterly period ended June 30, 2022, which are incorporated herein
by reference. Some of the statements in this prospectus constitute forward-looking statements. See “Special Note Regarding Forward-Looking
Statements.”
Overview
PolarityTE
is a clinical stage biotechnology company developing regenerative tissue products and biomaterials. PolarityTE’s first regenerative
tissue product is SkinTE, which is intended for the repair, reconstruction, replacement, and supplementation of skin in patients who
have a need for treatment of acute or chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional
skin grafts.
Since
the beginning of 2017, PolarityTE has incurred substantial operating losses and its operations have been financed primarily by public
equity financings. The clinical trials for SkinTE and the regulatory process will likely result in an increase in PolarityTE’s
expenses. PolarityTE will continue to incur substantial operating losses as we pursue an investigational new drug application (“IND”)
and biologics license application (“BLA”), and PolarityTE expects to seek financing from external sources over the foreseeable
future to fund its operations.
Regenerative
Tissue Product
Our
first regenerative tissue product is SkinTE. On July 23, 2021, we submitted an IND for SkinTE to the U.S. Food and Drug Administration
(the “FDA”) through our subsidiary, PolarityTE MD, Inc. (“PTE-MD”), as the first step in the regulatory process
for obtaining licensure for SkinTE under Section 351 of the Public Health Service Act. The FDA subsequently issued clinical hold correspondence
to us identifying certain issues that needed to be addressed before the IND could be approved. We provided responses to the FDA, and
on January 14, 2022, the FDA notified us that the clinical hold had been removed. Our first planned pivotal study under our IND is a
multi-center, randomized controlled trial evaluating SkinTE in the treatment of diabetic foot ulcers (“DFUs”) classified
as Grade 2 in the Wagner classification system entitled “Closure Obtained with Vascularized Epithelial Regeneration for DFUs with
SkinTE,” or “COVER DFUs Trial.” We plan to enroll up to 100 subjects at up to 20 sites in the U.S. in the COVER DFUs
Trial, which will compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. We have been enrolling subjects
in the COVER DFUs Trial since the end of April 2022. The primary endpoint is the incidence of DFUs closed at 24 weeks. Secondary endpoints
include percent area reduction (“PAR”) at 4, 8, 12, 16, and 24 weeks, improved quality of life, and new onset of infection
of the DFU being evaluated.
In
March 2022, we submitted to the FDA a request for a Regenerative Medicine Advanced Therapy (“RMAT”) designation for SkinTE
under our IND. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development
and review processes for promising regenerative medicine products, including human cellular and tissue-based therapies. A regenerative
medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening
disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical
needs for such disease or condition. RMAT designation provides the benefits of intensive FDA guidance on efficient drug development,
including the ability for early interactions with the FDA to discuss potential ways to support accelerated approval and satisfy post-approval
requirements, potential priority review of a BLA, and other opportunities to expedite development and review. By letter dated May 11,
2022, we were advised by the FDA that it concluded SkinTE meets the criteria for RMAT designation for the treatment of DFUs and venous
leg ulcers (VLUs).
As
a result of the RMAT designation we were able to engage in an expedited dialogue with the FDA on the tasks that are likely to be necessary
to support a BLA submission for SkinTE as a treatment of DFUs and VLUs, which were identified in the RMAT designation. Based on that
dialogue we plan to run a second multi-center, randomized controlled trial under our current IND to support approval of a broad DFU indication
for SkinTE in a BLA, and we plan to engage in discussions with the FDA regarding the design and implementation of the second clinical
trial. We believe this strategy will be the fastest and least costly approach to achieving our first BLA submission for SkinTE, with
DFUs representing the largest market opportunity within the category of chronic cutaneous ulcers. We plan to further engage with the
FDA to fully define our development plan for other wound indications.
We
expect to incur significant operating costs in the next three to four years as we pursue the regulatory process for SkinTE with the FDA,
conduct clinical trials and studies, and pursue product research, all while operating our business and incurring continuing fixed costs
related to the maintenance of our assets and business. We expect to incur significant losses in the future, and those losses could be
more severe as a result of unforeseen expenses, difficulties, complications, delays, and other unknown events. Our net losses may fluctuate
significantly from quarter-to-quarter and year-to-year, depending upon the timing, progress, and outcomes of our clinical trials and
our expenditures for satisfying all the conditions of obtaining FDA licensure for SkinTE.
Update
on Securities Class Action Lawsuit
As
previously reported, in September 2021, a class action complaint alleging violations of the Federal securities laws was filed in the
United States District Court, District of Utah, by Marc Richfield against the Company and certain officers of the Company, Case No. 2:21-cv-00561-BSJ.
The Court subsequently appointed a Lead Plaintiff and ordered the Lead Plaintiff to file an amended complaint, which was filed against
the Company, two current officers of the Company, and three former officers of the Company (the “Complaint”). The Complaint
alleges that during the period from January 30, 2018, through November 9, 2021, the defendants made or were responsible for, disseminating
information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material
misstatements or omissions in violation of Sections 10(b) and 20(a) of the Securities and Exchange Act of 1934, as amended, and Rule
10b-5 adopted thereunder. The Company filed a motion to dismiss the Complaint for failure to state a claim, on April 22, 2022. The Lead
Plaintiff filed its memorandum in opposition to the Company’s motion to dismiss on July 18, 2022. The Company filed its reply memorandum
to the Lead Plaintiff’s opposition memorandum on August 11, 2022, and oral argument on the motion to dismiss was held September
8, 2022. At the hearing the judge issued a ruling from the bench dismissing the Complaint without prejudice and granting the Lead Plaintiff
leave to file an amended complaint. The Lead Plaintiff filed an amended complaint (the “Amended Complaint”) on October 3,
2022, alleging additional facts. We are required to file a pleading responsive to the Amended Complaint by November 2, 2022, and our
intention is to file a motion to dismiss the Amended Complaint for failure to state a claim. At this stage of the proceedings, we are
unable to make any prediction regarding the outcome of a second motion to dismiss, should we decide to file such a motion, or the ultimate
outcome of the litigation.
Recent
Developments
On
May 16, 2022, we implemented a 1-for-25 reverse split of our issued and outstanding common stock. All stock figures and related dollar
amounts for exercise or conversion prices or amounts in the prospectus give effect to the reverse stock split. The reverse stock split
combined each 25 shares of our outstanding common stock into one share of common stock, without any change in the par value per share.
As a result, the number of shares of our common stock subject to outstanding options, warrants, and convertible securities was reduced
by a factor of 25, and the exercise price or conversion price by a factor was increased by a factor of 25. Except as otherwise indicated,
all historical share and per-share amounts in this prospectus have been adjusted to reflect the 1-for-25 reverse stock split, as if it
was effective and as if it had occurred at the beginning of the earliest period presented.
Company
Background
Majesco
Entertainment Company, a Delaware corporation (“Majesco DE”), was incorporated in the state of Delaware on May 8, 1998. On
December 1, 2016, Majesco Acquisition Corp., a Nevada corporation and wholly owned subsidiary of Majesco DE, entered into an Agreement
and Plan of Reorganization with PolarityTE, Inc., a Nevada corporation (“Polarity NV”) and the sole stockholder of Polarity
NV. The asset acquisition was subject to stockholder approval, which was received on March 10, 2017, and the transaction closed on April
7, 2017. In January 2017, Majesco DE changed its name to “PolarityTE, Inc.” (“Polarity”). Majesco Acquisition
Corp. was then merged with Polarity NV, which remains a subsidiary of Polarity. Majesco Acquisition Corp. II, formed in November 2016
under Majesco Entertainment Company, changed its name to “PolarityTE MD, Inc.,” and remains a wholly owned subsidiary of
Polarity.
Our
principal executive offices are located at 1960 S. 4250 West, Salt Lake City, Utah 84104, and our telephone number is (385) 266-3151.
We maintain a website at www.PolarityTE.com. Information contained in or accessible through our website does not constitute a part of
this prospectus.
THE
OFFERING
Issuer |
|
PolarityTE,
Inc., a Delaware corporation |
|
|
|
Common stock outstanding prior to this offering |
|
7,219,974 shares as of
September 30, 2022 |
|
|
|
Common Shares offered |
|
Common Shares, based on the sale of our Common Shares at an assumed public offering price of
$ per Common Share and accompanying Common Warrant,
which is the last reported sale price of our common stock on , 2022, and no sale of any
Pre-Funded Warrants. The actual public offering price per Common Share and Common Warrant will be determined between us and the
Underwriter based on market conditions at the time of pricing and may be at a discount to the market price at the time of
pricing. |
|
|
|
Pre-Funded Warrants offered |
|
We
are offering to certain purchasers whose purchase of Common Shares in this offering would otherwise result in such purchaser,
together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser,
9.99%) of our outstanding shares of common stock immediately following the consummation of this offering, the opportunity to
purchase Pre-Funded Warrants to purchase shares of common stock in lieu of Common Shares that would otherwise result in such
purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of
common stock. The purchase price of each Pre-Funded Warrant is equal to the offering price per Common Share being sold to the public
in this offering, minus $0.0001, the exercise price of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable
and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. Each Pre-Funded Warrant will be sold
together with Common Warrant, and the
number of Common Shares we are offering will be decreased on a one-for-one basis for each Pre-Funded Warrant we sell. |
|
|
|
Common stock outstanding after this offering |
|
shares, assuming no exercise of the Pre-Funded Warrants or Common Warrants. Assuming all of the Pre-Funded Warrants (and none of the
Common Warrants) are immediately exercised, there would be shares of our common stock outstanding. |
|
|
|
Common Warrants |
|
Common Warrants based on the sale of our Common Shares at an assumed public offering price of $
per Common Share and accompanying Common Warrant, which is
the last reported sale price of our common stock on ,
2022. The actual public offering price will be determined between us and the Underwriter based on market conditions at the time of
pricing and may be at a discount to the assumed public offering price. Each Common Share and each Pre-Funded Warrant will be sold
together with Common Warrant but will be issued separately and will be immediately separable upon issuance. Each Common Warrant has
an assumed exercise price of $ per share of common
stock and expires on the fifth anniversary of the original issuance date. |
Reasonable best efforts |
|
The Underwriter is not
required to buy or sell any minimum number or dollar amount of the securities offered hereby, but it will use its reasonable best
efforts to solicit offers to purchase the securities offered by this prospectus. See “Underwriting” on page 19 of this
prospectus. |
|
|
|
Use of proceeds |
|
We expect to use the net
proceeds of this offering for general corporate purposes and working capital, including among other things, capital expenditures
and research and development expenses. See “Use of Proceeds” on page 12 of this prospectus. |
|
|
|
|
|
|
Risk Factors |
|
Investing in our securities
involves a high degree of risk. See “Risk Factors” beginning on page 6 and other information included and incorporated
by reference in this prospectus for a discussion of factors that you should carefully consider before deciding to invest in our securities. |
|
|
|
Nasdaq Listing |
|
Our common stock is listed
on Nasdaq under the symbol “PTE.” |
The
number of shares of our common stock to be outstanding immediately after this offering and, unless otherwise indicated, the information
in this prospectus is based on 7,219,974 shares of our common stock outstanding as of September 30, 2022, and excludes as of that date:
|
● | 189,441 shares
of our common stock issuable upon the exercise of outstanding stock options having a weighted-average exercise price of $183.96 per share; |
|
| |
|
● | 89,669 shares of
our common stock issuable upon the vesting of outstanding restricted stock units; |
|
| |
|
● | 211,217 shares
of our common stock reserved for issuance in connection with future grants under our equity compensation plans; |
|
| |
|
● | 21,580 shares of
our common stock issuable upon the exercise of warrants sold in our public offering that closed on February 14, 2020, expire seven years
from the original issuance date, and have an exercise price of $2.40 per share(1); |
|
| |
|
● | 25,651
shares
of common stock issuable upon the exercise of warrants issued December 23, 2020, to a placement
agent in a registered direct offering that expire five years from the original issuance date,
and have an exercise price of $23.39 per share; |
|
| |
|
● | 363,636
shares
of our common stock issuable upon the exercise of warrants sold in our registered direct
offering that closed on January 14, 2021, expire five years from the original issuance date,
and have an exercise price of $8.75 per share; |
|
| |
|
● | 21,818
shares
of common stock issuable upon the exercise of warrants issued January 14, 2021, to a placement
agent in a registered direct offering that expire five years from the original issuance date,
and have an exercise price of $34.83 per share; |
|
| |
|
● | 19,238
shares
of common stock issuable upon the exercise of warrants issued January 22, 2021, to a placement
agent in a registered direct offering that expire five years from the original issuance date,
and have an exercise price of $30.00 per share; |
|
| |
|
● | 320,641
shares
of our common stock issuable upon the exercise of warrants issued in our registered
direct offering that closed on January 25, 2021, expire five years from the original issuance
date, and have an exercise price of $8.75 per share; |
|
| |
|
● | 655,738
shares of our common stock issuable upon the exercise of warrants issued in our registered
direct offering that closed on March 16, 2022, expire five years from the original issuance
date, and have an exercise price of $8.75 per share; |
|
| |
|
● | 32,787
shares
of common stock issuable upon the exercise of warrants issued March 16, 2022, to a placement
agent in a registered direct offering that expire five years from the original issuance date,
and have an exercise price of $30.00 per share; |
|
| |
|
● | 3,168,318 shares
of our common stock issuable upon the exercise of preferred investment options sold in our registered direct offering that closed on
June 8, 2022, expire five years from the original issuance date, and have an exercise price of $2.40 per share; and |
|
| |
|
● | 158,416 shares
of common stock issuable upon the exercise of warrants issued June 8, 2022, to a placement agent in a registered direct offering that
expire five years from the original issuance date, and have an exercise price of $3.1563 per share. |
(1)
These warrants to purchase 21,580 shares of our common stock contain a “full-ratchet” anti-dilution provision which,
subject to limited exceptions, provides that in the event we issue common stock, or securities convertible into or exercisable to
purchase common stock, at a price per share lower than the exercise price then in effect, the exercise price of the warrants would
reduce to such lower price. At an assumed public offering price of $ per
Common Share, this “full-ratchet” anti-dilution provision will be triggered reduce the exercise price of
warrants.
RISK
FACTORS
An
investment in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider
carefully the risks described below and discussed under this section, together with other information in this prospectus and the documents
incorporated by reference in this prospectus, including the information set forth under the caption “Risk Factors” in our
annual report on Form 10-K for the fiscal year ended December 31, 2021, and our quarterly report on Form 10-Q for the quarterly period
ended June 30, 2022. If any of these risks actually occurs, our business, financial condition, or results of operations could
be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment.
Risks
Related to Our Business
You
should read and consider risk factors specific to our business before making an investment decision. Those risks are described in the
sections entitled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2021, our quarterly
report on Form 10-Q for the quarterly period ended June 30, 2022, and in other documents incorporated by reference into this prospectus.
Please be aware that additional risks and uncertainties not currently known to us or that we currently deem to be immaterial could also
materially and adversely affect our business, results of operations, financial condition, cash flows, or prospects.
Risks
Related to this Offering
You
may experience dilution as a result of future equity offerings or other equity issuances.
To
raise additional capital, we may in the future offer additional shares of our common stock, preferred stock, or other securities convertible
into or exchangeable for our common stock. We cannot assure you that we will be able to sell shares or other securities in any other
offering at a price per share that is equal to or greater than the price per share paid by investors in our common stock. Investors purchasing
shares or other securities in the future could have rights superior to existing stockholders.
In
addition to the Pre-Funded Warrants and Common Warrants offered hereunder, as of the date of this prospectus, we had a significant number
of securities convertible into, or allowing the purchase of, our common stock, including 4,787,823 common stock purchase warrants
and preferred investment options, 189,441 options to purchase shares of our common stock, 89,669 restricted stock units, and 211,217
shares of common stock reserved for future issuance under our stock incentive plans.
The
Underwriter is selling the securities being offered in this offering on a best efforts basis and, therefore, the amount of proceeds is
uncertain.
The
Underwriter is selling the securities being offered in this offering on a “best efforts” basis, which means that the Underwriter
is not required to sell a minimum amount of securities, but will use its best efforts to sell the securities offered. As a “best
efforts” offering, there can be no assurance that the offering contemplated by this prospectus will raise the amount of proceeds
contemplated by the maximum number of securities registered for sale under this prospectus. The actual amount of proceeds raised in the
offering may be significantly less than we anticipated, which could adversely affect our business.
The
trading price of the shares of our common stock has been and may continue to be volatile, and the market price of our common stock may
drop.
You
should consider an investment in our securities as risky and invest only if you can withstand a significant loss and wide fluctuations
in the market value of your investment. You may be unable to sell your shares of common stock at or above the price paid for the shares
due to fluctuations in the market price of our common stock arising from changes in our operating performance or prospects. Our stock
price has been highly volatile during the 12-month period ended September 30, 2022, with closing stock prices ranging from a high
of $18.19 per share to a low of $0.65 per share. The stock market in general, and the market for biotech companies in particular,
have experienced extreme volatility that, at times, has been unrelated to the operating performance of particular companies. Some of
the factors that may cause the market price of our common stock to fluctuate include:
|
● | the timing or success
of obtaining regulatory licenses or approvals for marketing our products; |
|
| |
|
● | the initiation,
timing, progress, and results of our pre-clinical or clinical trials; |
|
| |
|
● | sufficiency of
our working capital to fund our operations over the next 12-month period and beyond; |
|
| |
|
● | infrastructure
required to support operations in future periods, including the expected costs thereof; |
|
| |
|
● | estimates associated
with revenue recognition, asset impairments, and cash flows; |
|
| |
|
● | variance in our
estimates of future operating costs; |
|
| |
|
● | the impact of new
accounting pronouncements; |
|
| |
|
● | size and growth
of our target markets; |
|
| |
|
● | the initiation,
timing, progress, and results of our research and development programs; |
|
| |
|
● | issues in manufacturing
our product candidates or future approved products; |
|
| |
|
● | regulatory developments
or enforcement in the United States and foreign countries with respect to our product candidates or our competitors’ products; |
|
| |
|
● | competition from
existing products or new products that may emerge; |
|
| |
|
● | developments or
disputes concerning patents, patent applications, or other proprietary rights; |
|
| |
|
● | introduction of
technological innovations or new commercial products by us or our competitors; |
|
| |
|
● | announcements by
us, our collaborators, or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital
commitments; |
|
| |
|
● | changes in estimates
or recommendations by securities analysts, if any, who cover our common stock; |
|
| |
|
● | fluctuations in
the valuation of companies perceived by investors to be comparable to us; |
|
| |
|
● | public concern
over our product candidates or any future approved products; |
|
| |
|
● | threatened or actual
litigation; |
|
| |
|
● | future or anticipated
sales of our common stock; |
|
| |
|
● | share price and
volume fluctuations attributable to inconsistent trading volume levels of our shares; |
|
| |
|
● | additions or departures
of key personnel; |
|
| |
|
● | changes in the
structure of health care payment systems in the United States or overseas; |
|
| |
|
● | failure of any
of our products or product candidates to perform safely or effectively or achieve commercial success; |
|
● | economic and other
external factors or other disasters or crises; |
|
| |
|
● | period-to-period
fluctuations in our financial condition and results of operations; |
|
| |
|
● | general market
conditions and market conditions for biopharmaceutical stocks; and |
|
| |
|
● | overall fluctuations
in U.S. equity markets. |
In
addition, in the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action
litigation against the company that issued the stock. Defending such litigation could result in substantial defense costs and divert
the time and attention of our management, which could seriously harm our business.
In
the event that we fail to satisfy any of the listing requirements of The Nasdaq Capital Market, our common stock may be delisted, which
could affect our market price and liquidity.
Our
common stock is listed on The Nasdaq Capital Market. For continued listing on The Nasdaq Capital Market, we will be required to comply
with the continued listing requirements, including the minimum market capitalization standard, the minimum stockholders’ equity
requirement, the corporate governance requirements, and the minimum closing bid price requirement, among other requirements. In the event
that we fail to satisfy any of the listing requirements of The Nasdaq Capital Market our common stock may be delisted. If our securities
are delisted from trading on The Nasdaq Stock Market, and we are not able to list our securities on another exchange or to have them
quoted on The Nasdaq Stock Market, our common stock could be quoted on the OTC Markets or on the Pink Open Market. As a result, we could
face significant adverse consequences including:
|
● | a limited availability
of market quotations for our securities; |
|
| |
|
● | a determination
that our common stock is a “penny stock,” which would require brokers trading in our common stock to adhere to more stringent
rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
|
| |
|
● | a limited amount
of news and analyst coverage; |
|
| |
|
● | a decreased ability
to obtain additional financing because we would be limited to seeking capital from investors willing to invest in securities not listed
on a national exchange; and |
|
| |
|
● | the inability to
use short-form registration statements on Form S-3, including the registration statement on Form S-3 we filed in February 2022, to facilitate
offerings of our securities. |
The
minimum closing bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) is that
we maintain a minimum closing bid price of $1.00 for 30 consecutive business days. Since September 13, 2022, the minimum closing bid
price for our common stock has not been above $1.00 per share. If this persists so that the closing bid price for our common stock does
not exceed $1.00 per share on or before October 25, 2022, we expect that the staff of the Listing Qualifications Department (the
“Staff”) of the Nasdaq Stock Market would send us a deficiency letter notifying us that we did not meet the $1.00 per share
minimum bid price requirement. Nasdaq Listing Rule 5810(c)(3)(A), provides an initial period of 180 calendar days to regain compliance
with the minimum bid price requirement so, if we receive a deficiency notice from the Staff, we expect we would have an initial period
of 180 calendar days to regain compliance with the minimum bid price requirement. To regain compliance, the bid price for our common
stock must close at $1.00 per share or more for a minimum of 10 consecutive business days. If we fail to maintain a minimum closing bid
price and receive a deficiency notice from the Staff, there is no assurance we will be able to regain compliance within 180 calendar
days so we could be delisted from The Nasdaq Capital Market, which would result in the adverse consequences described above.
Future
sales of our common stock in the public market could cause our stock price to fall.
Sales
of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress
the market price of our common stock, and could impair our ability to raise capital through the sale of additional equity securities.
As of September 30, 2022, we had 7,219,974 shares of common stock outstanding, all of which were eligible for sale in the public market,
subject in some cases to compliance with the requirements of Rule 144, including the volume limitations and manner of sale requirements.
Furthermore, there were 89,669 shares of common stock issuable upon vesting of outstanding restricted stock units that are eligible for
sale in the public market as they vest, except for any limitations on our directors and certain officers under Rule 144.
A
large number of shares of our common stock issuable upon exercise of the Pre-Funded Warrants and Common Warrants sold in this offering
may be sold in the market, which may depress the market price of our common stock.
A
total of
shares of common stock issuable upon exercise of Pre-Funded Warrants and Common Warrants sold under this prospectus, based on the
assumed offering price of $ , are registered for sale so a large number of shares may be sold in the market, which may depress the
market price of our common stock and could cause the market price of our common stock to decline. If there are more shares of our
common stock offered for sale than buyers are willing to purchase, then the market price of our common stock may decline to a market
price at which buyers are willing to purchase the offered shares of our common stock and sellers remain willing to sell the
shares.
Our
Charter, our Restated Bylaws and Delaware law could deter a change of our management, which could discourage or delay offers to acquire
us.
Certain
provisions of Delaware law, of our Charter and by-laws could discourage or make it more difficult to accomplish a proxy contest or other
change in our management or the acquisition of control by a holder of a substantial amount of our voting stock. It is possible that these
provisions could make it more difficult to accomplish, or could deter, transactions that stockholders may otherwise consider to be in
their best interests or in our best interests. These provisions include:
|
● | we have a classified
Board requiring that members of the Board be elected in different years, which lengthens the time needed to elect a new majority of the
Board; |
|
| |
|
● | our Board is authorized
to issue up to 25,000,000 shares of preferred stock without stockholder approval, which could be issued by our Board to increase the
number of outstanding shares or change the balance of voting control and thwart a takeover attempt; |
|
| |
|
● | stockholders are
not entitled to remove directors other than by a two-thirds vote and only for cause; |
|
| |
|
● | stockholders cannot
call a special meeting of stockholders; |
|
| |
|
● | we require all
stockholder actions be taken at a meeting of our stockholders, and not by written consent; and |
|
| |
|
● | stockholders must
give advance notice to nominate directors or submit proposals for consideration at stockholder meetings. |
We
are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates corporate acquisitions
by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders of those companies.
These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They could
also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in your
best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for
our stock.
Because
we do not expect to declare cash dividends on our common stock in the foreseeable future, investors must rely on appreciation of the
value of the securities purchased in this offering for any return on their investment.
While
we have in the past declared and paid cash dividends on our capital stock, we currently anticipate that we will retain future earnings
for the development, operation, and expansion of our business and do not expect to declare or pay any additional cash dividends in the
foreseeable future. As a result, only appreciation of the price of our common stock, if any, will provide a return to investors with
respect to our common stock.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference herein and therein include “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact are “forward-looking
statements” for purposes of this prospectus and the documents incorporated by reference herein and therein. In some cases, you
can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “seek,” “should,” “target,”
“would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are
not limited to, statements about:
|
● | our ability to
raise capital to fund our operations; |
|
● | the timing or success
of obtaining regulatory licenses or approvals for initiating clinical trials or marketing our products; |
|
● | the initiation,
timing, progress, cost, and results of clinical trials under our open IND for DFUs; |
|
● | the initiation,
timing, progress, cost, and results of other INDs for SkinTE in additional indications and the clinical trials that may be required under
those INDs; |
|
● | sufficiency of
our working capital to fund our operations in the near and long term, which raises doubt about our ability to continue as a going concern; |
|
● | infrastructure
required to support operations in future periods, including the expected costs thereof; |
|
● | estimates associated
with revenue recognition, asset impairments, and cash flows; |
|
● | variance in our
estimates of future operating costs; |
|
● | future vesting
and forfeitures of compensatory equity awards; |
|
● | our ability to
maintain our listing on The Nasdaq Capital Market; |
|
● | the effectiveness
of our disclosure controls and our internal control over financial reporting; |
|
● | the impact of new
accounting pronouncements; |
|
● | size and growth
of our target markets; and |
|
● | the initiation,
timing, progress, and results of our research and development programs. |
Factors
that may cause actual results to differ materially from those contemplated by such forward-looking statements include, without limitation:
|
● | the need for, and
ability to obtain, additional financing in the future; |
|
● | the ability to
comply with regulations applicable to the development, production, and distribution of SkinTE; |
|
● | the timing and
requirements associated with obtaining FDA acceptance of our second clinical trial; |
|
● | the ability to
obtain subject enrollment in our trials at a pace that allows the trials to progress on the schedules we have established with our clinical
research organization; |
|
● | unexpected developments
or delays in the progress of our clinical trials; |
|
● | the scope of protection
we can establish and maintain for intellectual property rights covering our product candidates and technology; |
|
● | the ability to
gain adoption by healthcare providers of our products for patient care; |
|
● | developments relating
to our competitors and industry; |
|
● | new discoveries
or the development of new therapies or technologies that render our products or services obsolete or unviable; |
|
● | the ability to
find and retain skilled personnel; |
|
● | outbreaks of disease,
including the COVID-19 pandemic, and related stay-at-home orders, quarantine policies and restrictions on travel, trade, and business
operations; |
|
● | political and economic
instability, whether resulting from natural disasters, wars (such as the conflict between Russia and Ukraine), terrorism, pandemics,
or other sources; |
|
● | changes in economic
conditions, including inflation, rising interest rates, lower consumer confidence, and volatile equity capital markets; |
|
● | inaccuracies in
estimates of our expenses, future revenues, and capital requirements; |
|
● | future accounting
pronouncements; and |
|
● | unauthorized access
to confidential information and data on our information technology systems and security and data breaches. |
Forward-looking
statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other
factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance,
or achievements expressed or implied by these forward-looking statements. Any forward-looking statement in this prospectus and the documents
incorporated by reference herein and therein reflects our current view with respect to future events and is subject to these and other
risks, uncertainties, and assumptions relating to our operations, results of operations, industry, and future growth. Given these uncertainties,
you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update
or revise these forward-looking statements for any reason, even if new information becomes available in the future.
INDUSTRY
AND MARKET DATA
This
prospectus and the documents incorporated by reference herein and therein contain estimates, projections and other information concerning
our industry, our business, and the markets for certain products, including data regarding the estimated size of those markets, their
projected growth rates and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts,
projections, market research, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may
differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry,
business, market, and other data from our own research as well as from reports, research surveys, studies, and similar data prepared
by market research firms and other third parties, industry, medical and general publications, government data, and similar sources. These
data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Projections,
assumptions, and estimates of our future performance and the future performance of the industry in which we operate is necessarily subject
to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and elsewhere
in this prospectus. These and other factors could cause results to differ materially from those expressed in the estimates made by independent
third parties and by us.
USE
OF PROCEEDS
We
estimate that the net proceeds from this offering will be approximately $ , after deducting estimated underwriting discounts and commissions,
estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants, Common Warrants,
and the underwriter warrants issued in this offering, based on the sale of Common Shares in the offering at an assumed public offering
price of $ (the last reported sale price of our common stock on The Nasdaq Capital Market on , 2022) and $ per Pre-Funded Warrant. However,
this is a best efforts offering with no minimum, and we may not sell all or any of these securities. As a result, there can be no assurance
that the offering contemplated hereby will ultimately be consummated for the full amount.
We
intend to use the net proceeds from this offering for general corporate purposes and working capital, including among other things, capital
expenditures and research and development expenses. These expected uses represent our intentions based upon our current plans and business
conditions, which could change in the future as our plans and business conditions evolve. We have not determined the amounts we plan
to spend or the timing of expenditures. As a result, our management will have broad discretion to allocate the net proceeds from the
sale of the securities that we may offer under this prospectus and the accompanying prospectus.
Pending
their ultimate use, we intend to invest the net proceeds in a variety of securities, including commercial paper, government, and non-government
debt securities and/or money market funds that invest in such securities.
DESCRIPTION
OF THE SECURITIES
We
are offering shares of our common stock (the “Common Shares”), pre-funded warrants to purchase shares of common stock in
lieu of the offered Common Shares that would otherwise result in such purchaser’s beneficial ownership exceeding 4.99% (or, at
the election of the purchaser, 9.99%) of our outstanding shares of common stock (the “Pre-Funded Warrants”), and
warrants to purchase shares of our common stock (the “Common Warrants”). Each Common Share and Pre-Funded Warrant will
be sold together with
Common Warrant.
Authorized
Capital Stock
Our
authorized capital stock consists of 250,000,000 shares of common stock, par value $0.001 per share, and 25,000,000 shares of preferred
stock, par value $0.001 per share, all of which are undesignated preferred stock. As of September 30, 2022, there were 7,219,974 shares
of common stock outstanding and no shares of preferred stock outstanding. The transfer agent for our common stock is Equity Stock Transfer,
LLC. Its address is 237 West 37th Street, Suite 602, New York, NY 10018.
Common
Stock
The
holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The
holders of our common stock do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any
dividends declared by our board of directors out of funds legally available for that purpose, subject to any preferential dividend rights
of any outstanding preferred stock. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption
or sinking fund provisions.
In
the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets
remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock. All outstanding
shares are fully paid and non-assessable.
Shares
of common stock issued or issuable upon exercise of the Pre-Funded Warrants and Common Warrants will be fully paid and non-assessable
and will not have, or be subject to, any preemptive or similar rights.
Pre-Funded
Warrants
The
following summary of certain terms and provisions of the Pre-Funded Warrants that are being offered hereby is not complete and is subject
to, and qualified in its entirety by, the provisions of the form of Pre-Funded Warrant, which is filed as an exhibit to the registration
statement of which this prospectus is a part. Prospective investors should carefully review the terms and provisions set forth in such
form for a complete description of the terms and conditions of the Pre-Funded Warrants.
Duration
and Exercise Price. Each Pre-Funded Warrant offered hereby has an initial exercise price per share equal to $0.0001. The Pre-Funded
Warrants are immediately exercisable and may be exercised at any time until the Pre-Funded Warrants are exercised in full. The exercise
price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends,
stock splits, reorganizations, or similar events affecting our common stock. The Pre-Funded Warrants will be issued separately from the
accompanying Common Warrants and may be transferred separately immediately thereafter.
Exercisability.
The Pre-Funded Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of
a cashless exercise as discussed below). Each purchaser of Pre-Funded Warrants in this offering may elect to deliver its exercise notice
following the pricing of the offering and prior to the issuance of the Pre-Funded Warrants at closing to have its Pre-Funded Warrants
exercised immediately upon issuance and receive shares of common stock underlying the Pre-Funded Warrants upon closing of this offering.
A holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrant to the extent that the holder would own
more than 4.99% of the outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election
to a lower percentage at any time or to a higher percentage not to exceed 9.99% upon 61 days’ notice to us. The purchaser of Pre-Funded
Warrants in this offering may also elect prior to the issuance of the Pre-Funded Warrants to have the initial exercise limitation set
at 4.99% of our outstanding common stock. No fractional shares of common stock will be issued in connection with the exercise of the
Pre-Funded Warrants. In lieu of fractional shares, at our election, we will either round up to the nearest whole number or we will pay
a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the exercise price.
Cashless
Exercise. A holder may elect to receive upon exercise of its Pre-Funded Warrants (either in whole or in part) the net number of shares
of common stock determined according to a formula set forth in the Pre-Funded Warrants in lieu of making the cash payment otherwise contemplated
to be made to us upon such exercise in payment of the aggregate exercise price.
Transferability.
Subject to applicable laws, a Pre-Funded Warrant may be transferred at the option of the holder upon surrender of the Pre-Funded Warrant
to us together with the appropriate instruments of transfer.
Trading
Market. There is no trading market for the Pre-Funded Warrants on any securities exchange or nationally recognized trading system.
We do not intend to list the Pre-Funded Warrants on any securities exchange or nationally recognized trading system. The shares of common
stock issuable upon exercise of the Pre-Funded Warrants are currently listed on The Nasdaq Capital Market under the symbol “PTE.”
Rights
as a Stockholder. Except as otherwise provided in the Pre-Funded Warrants or by virtue of such holder’s ownership of shares
of our common stock, the holders of Pre-Funded Warrants do not have the rights or privileges of holders of our common stock, including
any voting rights, until they exercise their Pre-Funded Warrants.
Fundamental
Transaction. In the event of any fundamental transaction, as described in the Pre-Funded Warrants and generally including any merger
with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our
common stock, then upon any subsequent exercise of Pre-Funded Warrants, the holder will have the right to receive as alternative consideration,
for each share of our common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental
transaction, the number of shares of common stock of the successor or acquiring corporation or of our company, if it is the surviving
corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares
of our common stock for which the Pre-Funded Warrant is exercisable immediately prior to such event.
Common
Warrants
The
following summary of certain terms and provisions of the Common Warrants that are being offered hereby is not complete and is subject
to, and qualified in its entirety by, the provisions of the form of Common Warrant, which is filed as an exhibit to the registration
statement of which this prospectus is a part. Prospective investors should carefully review the terms and provisions set forth in such
form for a complete description of the terms and conditions of the Common Warrants.
Duration
and Exercise Price. Each Common Warrant offered hereby has an initial exercise price per share equal to $ . The Common Warrants are
immediately exercisable and will expire on the five-year anniversary of the original issuance date. The exercise price and number of
shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations,
or similar events affecting our common stock. The Common Warrants will be issued separately from the accompanying Common Shares and Pre-Funded
Warrants sold in the offering and may be transferred separately immediately thereafter.
Exercisability.
The Common Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of
a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the Common Warrant to
the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, which percentage may
be changed at the holder’s election to a lower percentage at any time or to a higher percentage not to exceed 9.99% upon 61 days’
notice to us. The purchaser of Common Warrants in this offering may also elect prior to the issuance of the Common Warrants to have the
initial exercise limitation set at 4.99% of our outstanding common stock. No fractional shares of common stock will be issued in connection
with the exercise of the Common Warrants. In lieu of fractional shares, at our election, we will either round up to the nearest whole
number or we will pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the exercise
price.
Cashless
Exercise. If, at the time a holder exercises its Common Warrants, a registration statement registering the issuance of our shares
of common stock underlying the Common Warrants under the Securities Act is not then effective or available for the issuance of such shares,
then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise
price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock
determined according to a formula set forth in the Common Warrants, which generally provides for a number of shares equal to (A) (1)
the volume weighted average price on (x) the trading day preceding the notice of exercise, if the notice of exercise is executed and
delivered on a day that is not a trading day or prior to the opening of “regular trading hours” on a trading day or (y) the
trading day of the notice of exercise, if the notice of exercise is executed and delivered after the close of “regular trading
hours” on such trading day, or (2) the bid price on the day of the notice of exercise, if the notice of exercise is executed during
“regular trading hours” on a trading day and is delivered within two hours thereafter, less (B) the exercise price, multiplied
by (C) the number of shares of common stock the Common Warrant was exercisable into, with such product then divided by the number determined
under clause (A) in this sentence.
Transferability.
Subject to applicable laws, a Common Warrant may be transferred at the option of the holder upon surrender of the Common Warrant to us
together with the appropriate instruments of transfer.
Trading
Market. There is no trading market for the Common Warrants on any securities exchange or nationally recognized trading system. We
do not intend to list the Common Warrants on any securities exchange or nationally recognized trading system. The shares of common stock
issuable upon exercise of the Common Warrants are currently listed on The Nasdaq Capital Market under the symbol “PTE.”
Rights
as a Stockholder. Except as otherwise provided in the Common Warrants or by virtue of such holder’s ownership of shares of
our common stock, the holders of Common Warrants do not have the rights or privileges of holders of our common stock, including any voting
rights, until they exercise their Common Warrants.
Fundamental
Transaction. In the event of any fundamental transaction, as described in the Common Warrants and generally including any merger
with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our
common stock, then upon any subsequent exercise of Common Warrants, the holder will have the right to receive as alternative consideration,
for each share of our common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental
transaction, the number of shares of common stock of the successor or acquiring corporation or of our company, if it is the surviving
corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares
of our common stock for which the Common Warrant is exercisable immediately prior to such event. In the event of a fundamental transaction
in which the holders of our voting securities immediately prior to such fundamental transaction will not, following such fundamental
transaction, directly or indirectly own more than 50% of the voting securities of the surviving or successor entity, as applicable, and
in which we are not the successor entity or do not continue as a reporting issuer under the Exchange Act, the holder will further have
the right to require us, or our successor entity, to purchase the Common Warrants by paying the same type or form of consideration (and
in the same proportion) at the Black Scholes Value (as defined in the Common Warrant) of the unexercised portion of the warrant that
is being offered and paid to the holders of our common stock in connection with the fundamental transaction, whether that consideration
is in the form of cash, stock or any combination of cash and stock, or whether the holders of our common stock are given the choice to
receive alternative forms of consideration in connection with the fundamental transaction.
Undesignated
Preferred Stock
Our
board of directors is authorized to issue up to 25,000,000 shares of undesignated preferred stock in one or more series without stockholder
approval. Our board of directors may determine the rights, preferences, privileges, and restrictions, including voting rights, dividend
rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.
The
purpose of authorizing our board of directors to issue preferred stock in one or more series and determine the number of shares in the
series and its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. Examples of rights
and preferences that the Board may fix are:
|
● | dividend rights; |
|
| |
|
● | conversion rights; |
|
| |
|
● | voting rights; |
|
| |
|
● | preemptive rights; |
|
| |
|
● | terms of redemption; |
|
| |
|
● | liquidation preferences; |
|
| |
|
● | sinking fund terms;
and |
|
| |
|
● | the number of shares
constituting, or the designation of, such series, any or all of which may be greater than the rights of common stock. |
The
existence of authorized but unissued shares of undesignated preferred stock may enable our board of directors to render more difficult
or to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in
the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests
of us or our stockholders, our board of directors could cause shares of preferred stock to be issued without stockholder approval in
one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer, stockholder,
or stockholder group. The rights of holders of our common stock described above, will be subject to, and may be adversely affected by,
the rights of any preferred stock that we may designate and issue in the future. The issuance of shares of undesignated preferred stock
could decrease the amount of earnings and assets available for distribution to holders of shares of common stock. The issuance may also
adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring, or
preventing a change in control of us.
Antitakeover
Effects of Delaware Law and Provisions of our Restated Certificate of Incorporation and Amended and Restated Bylaws
Certain
provisions of the Delaware General Corporation Law and of our restated certificate of incorporation and amended and restated bylaws could
have the effect of delaying, deferring, or discouraging another party from acquiring control of us unless such takeover or change of
control is approved by the board of directors. These provisions, which are summarized below, are expected to discourage certain types
of coercive takeover practices and inadequate takeover bids and, therefore, they might also inhibit temporary fluctuations in the market
price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions are also designed in part
to encourage anyone seeking to acquire control of us to first negotiate with our board of directors. These provisions might also have
the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish transactions
that stockholders might otherwise deem to be in their best interests. However, we believe that the advantages gained by protecting our
ability to negotiate with any unsolicited and potentially unfriendly acquirer outweigh the disadvantages of discouraging such proposals,
including those priced above the then-current market value of our common stock, because, among other reasons, the negotiation of such
proposals could improve their terms.
Delaware
Takeover Statute. We are subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203
prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder”
for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is
approved in a prescribed manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited
unless it satisfies one of the following conditions:
|
● | before the stockholder
became interested, our board of directors approved either the business combination or the transaction which resulted in the stockholder
becoming an interested stockholder; |
|
| |
|
● | upon consummation
of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85%
of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting
stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances, but not
the outstanding voting stock owned by the interested stockholder; or |
|
| |
|
● | at or after the
time the stockholder became interested, the business combination was approved by our board of directors and authorized at an annual or
special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned
by the interested stockholder. |
Section
203 defines a business combination to include:
|
● | any merger or consolidation
involving the corporation and the interested stockholder; |
|
| |
|
● | any sale, transfer,
lease, pledge, exchange, mortgage, or other disposition involving the interested stockholder of 10% or more of the assets of the corporation; |
|
| |
|
● | subject to exceptions,
any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
|
| |
|
● | subject to exceptions,
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series
of the corporation beneficially owned by the interested stockholder; or |
|
| |
|
● | the receipt by
the interested stockholder of the benefit of any loans, advances, guarantees, pledges, or other financial benefits provided by or through
the corporation. |
In
general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting
stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.
Provisions
of our Restated Certificate of Incorporation and Amended and Restated Bylaws. Our restated certificate of incorporation and amended
and restated bylaws include several provisions that may have the effect of delaying, deferring, or discouraging another party from acquiring
control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with
our board of directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.
|
● | Board composition
and filling vacancies. In accordance with our restated certificate of incorporation, our board is divided into three classes serving
staggered three-year terms, with one class being elected each year, subject to the rights of the holders of shares of any series of our
preferred stock then outstanding to elect additional directors under specified circumstances. Our restated certificate of incorporation
also provides that directors may be removed only for cause and then only by the affirmative vote of the holders of two-thirds or more
of the shares then entitled to vote at an election of directors, subject to the rights of the holders of shares of any series of our
preferred stock then outstanding. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting
from an increase in the size of our board, may only be filled by the affirmative vote of a majority of our directors then in office even
if less than a quorum, or by a sole remaining director, subject to the rights of the holders of any series of our preferred stock then
outstanding. |
|
● | No written consent
of stockholders. Our restated certificate of incorporation provides that all stockholder actions are required to be taken by a vote
of the stockholders at an annual or special meeting, and that stockholders may not take any action by written consent in lieu of a meeting.
This limit may lengthen the amount of time required to take stockholder actions and would prevent the amendment of our bylaws or removal
of directors by our stockholder without holding a meeting of stockholders. |
|
| |
|
● | Meetings of
stockholders. Our bylaws provide that special meetings of stockholders may be called only by the board of directors pursuant to a
resolution adopted by a majority of the total number of authorized directors, whether or not there exist any vacancies in previously
authorized directorships, and upon written request from our corporate secretary, who shall be required to submit such a request stating
the purpose of such a meeting, if at least one-quarter of the voting power of all the then outstanding shares of our capital stock entitled
to vote generally in the election of directors, requesting together as a single class, call for a special meeting. Only those matters
set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our bylaws limit
the business that may be conducted at an annual meeting of stockholders to the election of directors whose terms expire and for the transaction
of such other business as may properly come before the meeting. |
|
| |
|
● | Advance notice
requirements. Our bylaws establish advance notice procedures regarding stockholder proposals pertaining to the nomination of candidates
for election as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of
stockholder proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken.
Generally, to be timely, notice must be received at our principal executive offices not less than 90 days or more than 120 days prior
to the first anniversary date of the annual meeting for the preceding year. The notice must contain certain information specified in
our bylaws. |
|
| |
|
● | Amendment to
certificate of incorporation and bylaws. As required by the Delaware General Corporation Law, any amendment of our certificate of
incorporation must be approved by a majority of our board of directors, and in addition to the vote of the holders of any class or series
of our capital stock required by applicable law or the certificate of incorporation, the affirmative vote of the holders of shares of
voting stock representing two-thirds of the voting power of all of the then outstanding shares of our capital stock entitled to vote
generally in the election of directors, voting together as a single class, shall be required to amend, alter, repeal, or adopt any provision
inconsistent with Articles FIFTH (Management of PolarityTE), SIXTH (Board Size, Vacancies and Removals), SEVENTH (Amendment of the Bylaws),
EIGHTH (Indemnification), NINTH (Director Personal Liability), TENTH (Amendment of the Certificate of Incorporation), and TWELFTH (Section
157 of the Delaware General Corporation Law) of the certificate of incorporation. Our bylaws may be amended or repealed by the affirmative
vote of a majority vote of the total number of authorized directors whether or not there exist any vacancies in previously authorized
directorships, subject to any limitations set forth in the bylaws, or by the affirmative vote of at least two-thirds of the voting power
of all the outstanding shares of our capital stock then entitled to vote at an election of directors, voting together as a single class,
at any meeting at which a proposal to amend or repeal the bylaws is properly presented. |
|
| |
|
● | Undesignated
preferred stock. Our restated certificate of incorporation provides for authorized shares of preferred stock. The existence of authorized
but unissued shares of preferred stock may enable our board of directors to render more difficult or to discourage an attempt to obtain
control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations,
our board of directors were to determine that a takeover proposal is not in the best interests of us or our stockholders, our board of
directors could cause shares of preferred stock to be issued without stockholder approval in one or more private offerings or other transactions
that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder or stockholder group. In this regard,
our restated certificate of incorporation grants our board of directors’ broad power to establish the rights and preferences of
authorized and unissued shares of preferred stock. The issuance of shares of preferred stock could decrease the amount of earnings and
assets available for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers,
including voting rights, of these holders and may have the effect of delaying, deterring, or preventing a change in control of us. |
Underwriting
A.G.P./Alliance
Global Partners, which we refer to herein as the Underwriter, is acting as the sole book-running manager in connection with this offering.
Subject to the terms and conditions of the underwriting agreement dated , 2022, the Underwriter has agreed to purchase from us, and we
have agreed to sell, at the public offering price of the securities set forth on the cover page of this prospectus, less the applicable
underwriting discount, the number of Common Shares and Pre-Funded Warrants, and accompanying Common Warrants listed next to its name
in the following table:
Underwriter |
|
Number
of Common Shares and Accompanying Common Warrants |
|
Number
of Pre-Funded Warrants and Accompanying Common Warrants |
A.G.P./Alliance Global Partners |
|
|
|
|
Total |
|
|
|
|
The
Underwriter is selling the securities being offered in this offering on a “best efforts” basis. Therefore, the Underwriter
is not required to sell any minimum number or dollar amount of securities but will use its best efforts to sell the securities offered
by this prospectus.
The
Underwriter is offering the Common Shares and Pre-Funded Warrants, and accompanying Common Warrants, subject to prior sale, when, as
and if issued to and accepted by them, subject to approval of legal matters by its counsel and other conditions specified in the underwriting
agreement. The Underwriter reserves the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in
part.
Underwriting
Discounts, Commissions and Expenses
The
following table shows the public offering price, underwriting discount and proceeds, before expenses, to us.
|
Per Common
Share and
Accompanying Common
Warrant(1) |
|
Per Pre-Funded
Warrant and Accompanying
Common
Warrant(2) |
|
Total |
|
Public Offering
Price |
$ |
|
|
$ |
|
|
$ |
|
|
Underwriting discounts
and commissions |
$ |
|
|
$ |
|
|
$ |
|
|
Proceeds to us (before
expenses) |
$ |
|
|
$ |
|
|
$ |
|
|
(1) | The underwriting discount
of $ per Common Share and accompanying Common Warrant will
be deducted from the public offering price; except that, with respect to sales to certain investors identified in the underwriting
agreement, the underwriting discount will be $
or $ . |
(2) | The underwriting
discount of $ per Pre-Funded Warrant and accompanying Common Warrant will be deducted from the public offering price;
except that, with respect to sales to certain investors identified in the underwriting agreement, the underwriting discount will be $
or $ . |
We
have also agreed to reimburse the Underwriter for legal and other expenses incurred by them in connection with the offering in an amount
up to $65,000, as well as non-accountable expenses equal to 0.5% of the gross proceeds raised in this offering. We estimate the total
expenses payable by us for this offering, excluding the estimated underwriting discounts, commissions and expenses, will be approximately
$ .
Underwriter
Warrants
Upon
closing of this offering, we will issue to the Underwriter a compensation warrant entitling the Underwriter or its designees to purchase
that number of shares of our common stock equal to 7.0% of the aggregate number of Common Shares and shares of common stock issuable
upon the exercise of Pre-Funded Warrants that we issue in this offering to certain identified investors, subject to any reductions necessary
to comply with the rules and regulations of the Financial Industry Regulatory Authority, Inc., or FINRA. The underwriter warrants will
have an exercise price of $ per share (equal to the exercise price of Common Warrants) and will be exercisable, in whole or
in part, immediately upon the closing of this offering and expire, in accordance with FINRA Rule 5110(g)(8), on the five-year anniversary
of the date of issuance.
The
underwriter warrants and underlying shares of common stock are being registered pursuant to the registration statement of which this
prospectus is a part, and we have agreed to maintain such registration during the term of the underwriter warrants. Pursuant to FINRA
Rule 5110(e), the underwriter warrants and any shares issued upon exercise of the underwriter warrants may not be sold, transferred,
assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put or call transaction that would result
in the effective economic disposition of the securities by any person for a period of 180 days immediately following the date of effectiveness
or commencement of sales of this offering, except the transfer of any security: (i) by operation of law or by reason of our reorganization;
(ii) to any FINRA member firm participating in the offering and the officers or partners thereof, if all securities so transferred remain
subject to the lock-up restriction set forth below for the remainder of the time period; (iii) if the aggregate amount of our securities
held by the underwriter or related persons do not exceed 1% of the securities being offered; (iv) that is beneficially owned on a pro
rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments
by the fund and the participating members in the aggregate do not own more than 10% of the equity in the fund; or (v) the exercise or
conversion of any security, if all securities remain subject to the lock-up restriction set forth below for the remainder of the time
period.
Indemnification
We
have agreed to indemnify the Underwriter against specified liabilities, including liabilities under the Securities Act, and to contribute
to payments the Underwriter may be required to make in respect thereof.
Listing
Our
common stock is listed on The Nasdaq Capital Market under the symbol “PTE.”
Lock-Up
Agreements
Our
directors and officers have entered into lock-up agreements. Under these agreements, these individuals have agreed, subject to specified
exceptions, not to sell or transfer any shares of common stock or securities convertible into, or exchangeable or exercisable for, our
common stock during a period ending 90 days after the date of this prospectus, without first obtaining the written consent of the Underwriter,
subject to certain exceptions. Specifically, these individuals have agreed, in part, not to:
|
● | offer for sale,
sell, pledge, or otherwise transfer or dispose of (or enter into any transaction or device that is designed to, or could be expected
to, result in the transfer or disposition by any person at any time in the future of) any common stock or securities convertible into,
or exercisable or exchangeable for, shares of common stock; |
|
| |
|
● | enter into any
swap or other derivatives transaction that transfers to another, in whole or in part, any of the economic benefits or risks of ownership
of common stock; |
|
| |
|
● | make any demand
for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registration
of any of our securities; or |
|
| |
|
● | publicly disclose
the intention to do any of the foregoing. |
Notwithstanding
these limitations, our securities may be transferred under limited circumstances, including, without limitation, by gift, will, intestate
succession, or operation of law or pursuant to a 10b5-1 plan that is in effect as of the date of the lock-up agreement.
We
have agreed, subject to certain exceptions, not to issue, enter into any agreement to issue or announce the issuance or proposed issuance
of, any shares of common stock or securities convertible into or exercisable for common stock (other than securities granted under our
equity compensation plans) or file any registration statement, including any amendments or supplements thereto (other than the preliminary
prospectus or the prospectus relating to the securities offered hereunder and a registration statement on Form S-8 in connection with
any employee benefit plan), until 90 days after the completion of this offering. We have also agreed not to enter into a variable rate
transaction (as defined in the securities purchase agreement) for 180 days after the completion of this offering.
Stabilization
The
rules of the SEC generally prohibit the Underwriter from trading in our securities on the open market during this offering. However,
the Underwriter is allowed to engage in some open market transactions and other activities during this offering that may cause the market
price of our securities to be above or below that which would otherwise prevail in the open market. These activities may include stabilization,
short sales and over-allotments, syndicate covering transactions and penalty bids in accordance with Regulation M.
|
● | Stabilizing transactions
consist of bids or purchases made by the representative for the purpose of preventing or slowing a decline in the market price of our
securities while this offering is in progress. |
|
| |
|
● | Short sales and
over-allotments occur when the representative sells more of our shares of common stock than it purchases from us in this offering. To
cover the resulting short position, the representative may exercise the over-allotment option described above or may engage in syndicate
covering transactions. There is no contractual limit on the size of any syndicate covering transaction. The representative will make
available a prospectus in connection with any such short sales. Purchasers of shares sold short by the representative are entitled to
the same remedies under the federal securities laws as any other purchaser of shares covered by the registration statement. |
|
| |
|
● | Syndicate covering
transactions are bids for or purchases of our securities on the open market by the representative in order to reduce a short position. |
|
| |
|
● | Penalty bids permit
the representative to reclaim a selling concession from a syndicate member when the shares of Common Stock originally sold by the syndicate
member are purchased in a syndicate covering transaction to cover syndicate short positions. |
Neither
we nor the Underwriter make any representation or prediction as to the effect that the transactions described above may have on the prices
of our securities. These transactions may occur on any trading market. If any of these transactions are commenced, they may be discontinued
without notice at any time.
Other
Activities and Relationships
From
time to time, the Underwriter and/or its affiliates may in the future provide various investment banking, financial advisory and other
services to us and our affiliates and may receive customary fees for which services they have provided. In the course of its business,
the Underwriter and its affiliates may actively trade our securities or loans for its own account or for the accounts of customers, and,
accordingly, the Underwriter and its affiliates may at any time hold long or short positions in such securities or loans. Except for
services provided in connection with this offering, the Underwriter has not provided any investment banking or other financial services
during the 180-day period preceding the date of this prospectus, and we do not expect to retain the Underwriter to perform any investment
banking or other financial services for at least 90 days after the date of this prospectus.
Other
Relationships
Pursuant
to an engagement agreement, dated March 5, 2022 (the “HCW Agreement”), with H.C. Wainwright & Co., LLC (“Wainwright”)
in connection with an offering of securities that closed on June 8, 2022 (the “June Offering”), we are obligated to pay Wainwright
a tail fee consisting of (i) cash equal to 6.5% of the aggregate gross proceeds raised in the offering described in this prospectus from
investors who participated in the June Offering and (ii) warrants to purchase shares of common stock equal to 5.0% of the aggregate number
of Common Shares and Pre-Funded Warrants purchased by investors who participated in the June Offering (the “HCW Warrants”).
The terms of the HCW Warrants are the same as the terms of the Common Warrants, except the exercise price of the HCW Warrants is $ ,
which is 125% of the exercise price of the Common Warrants.
Electronic
Distribution
This
prospectus may be made available in electronic format on websites or through other online services maintained by the Underwriter, or
by its affiliates. Other than this prospectus in electronic format, the information on the Underwriter’s website and any information
contained in any other website maintained by the Underwriter is not part of this prospectus or the registration statement of which this
prospectus forms a part, has not been approved and/or endorsed by us or the Underwriter, and should not be relied upon by any purchaser
of the securities offered pursuant to the registration statement of which this prospectus forms a part.
LEGAL
MATTERS
The
validity of the securities offered hereby will be passed upon for us by Dorsey & Whitney LLP, Salt Lake City, UT. Certain legal matters
related to the offering will be passed upon for the Underwriter by Thompson Hine LLP, New York, New York.
EXPERTS
The
balance sheets of PolarityTE, Inc. and Subsidiaries as of December 31, 2021 and 2020, and the related statements of operations, comprehensive
loss, stockholders’ equity, and cash flows for each of the years then ended have been audited by EisnerAmper LLP, independent registered
public accounting firm, as stated in their report, which is incorporated herein by reference, which report includes an explanatory paragraph
about the existence of substantial doubt concerning the Company’s ability to continue as a going concern. Such financial statements
have been incorporated herein by reference in reliance on the report of such firm given upon their authority as experts in accounting
and auditing.
SEC
POSITION ON INDEMNIFICATION
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling our
company pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against
public policy as expressed in the Securities Act, and is, therefore, unenforceable.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus does not contain all of the information set forth in the registration statement and the exhibits to the registration statement.
For further information with respect to us and the securities we are offering under this prospectus, we refer you to the registration
statement and the exhibits and schedules filed as a part of the registration statement. Neither we nor any agent, underwriter, or dealer
has authorized any person to provide you with different information. We are not making an offer of these securities in any state where
the offer is not permitted. You should not assume that the information in this prospectus is accurate as of any date other than the date
on the front page of this prospectus, regardless of the time of delivery of this prospectus or any sale of the securities offered by
this prospectus.
We
file annual, quarterly, and current reports, proxy statements and other information with the SEC. These periodic reports, proxy statements,
and other information are available on the SEC’s website at www.sec.gov. Our website is located at www.PolarityTE.com. Information
contained on our website is not incorporated by reference into this prospectus and, therefore, is not part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” into this prospectus the information in documents we file with it, which means
that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered
to be a part of this prospectus, and information that we file later with the SEC will automatically update and supersede this information.
Any statement contained in any document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified
or superseded for purposes of this prospectus to the extent that a statement contained in or omitted from this prospectus, or in any
other subsequently filed document that also is or is deemed to be incorporated by reference herein, modifies or supersedes such statement.
Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
We
incorporate by reference the documents listed below and any future documents that we file with the SEC under Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act until the offering of the securities is terminated:
|
● |
our Annual Report on Form
10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 30, 2022; |
|
● |
our Quarterly Reports on
Form 10-Q for the quarter ended March 31, 2022, filed on May 16, 2022, and for the quarter ended June 30, 2022, filed August 11, 2022; |
|
|
|
|
● |
our definitive proxy statement
on Schedule 14A filed with the SEC on April 8, 2022; |
|
|
|
|
● |
our
Current Reports on Form 8-K filed with the SEC on January
18, 2022, February
11, 2022,
February 17, 2022, February
22, 2022,
March 4, 2022,
March 15, 2022,
March 17, 2022, March
23, 2022,
March 25, 2022,
April 18, 2022, May
2, 2022,
May 3, 2022, May
12, 2022, May
16, 2022, (the report filed at 16:16:10 Eastern Time, only), June
2, 2022, June
8, 2022, June
16, 2022, September
8, 2022, September
14, 2022, October
3, 2022; and |
|
|
|
|
● |
the description of our
common stock contained in our Registration Statement on Form 8-A filed with the SEC on January 21, 2005 (File No. 000-51128), as
updated by the description of our common stock included in Exhibit 4.13 to our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020, including any amendment or report filed to update such description. |
We
will not, however, incorporate by reference in this prospectus any documents or portions thereof that are not deemed “filed”
with the SEC, including any information furnished pursuant to Item 2.02 or Item 7.01 of our current reports on Form 8-K unless, and except
to the extent, specified in such current reports.
Upon
written or oral request, we will provide, without charge, to each person to whom a copy of this prospectus is delivered, a copy of the
documents incorporated by reference into this prospectus but not delivered with the prospectus. You may request a copy of these filings,
and any exhibits we have specifically incorporated by reference as an exhibit in this prospectus, at no cost by writing or telephoning
us at the following address:
PolarityTE,
Inc.
1960
S. 4250 West
Salt
Lake City, Utah 84104
(800)
560-3983
You
may also access these documents, free of charge on the SEC’s website at www.sec.gov or on our website at www.PolarityTE.com.
Information contained on our website is not incorporated by reference into this prospectus, and you should not consider any information
on, or that can be accessed from, our website as part of this prospectus.
This
prospectus is part of a registration statement we filed with the SEC. We have incorporated exhibits into this registration statement.
You should read the exhibits carefully for provisions that may be important to you.
You
should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone to provide
you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should
not assume that the information in this prospectus or in the documents incorporated by reference is accurate as of any date other than
the date on the front of this prospectus or those documents.
PolarityTE,
Inc.
Up
to $15,000,000
Shares
of Common Stock
Pre-Funded
Warrants, Each Pre-Funded Warrant to Purchase One Share of Common Stock
Common
Warrants, including Underwriter Warrants, to Purchase
Shares of Common Stock
Shares
of Common Stock Underlying the Pre-Funded Warrants
Shares
of Common Stock Underlying the Common Warrants and Underwriter Warrants
PROSPECTUS
A.G.P.
,
2022
Part
II—INFORMATION NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution
The
expenses payable by PolarityTE, Inc. (the “Registrant” or the “Company”) relating to the issuance and distribution
of the securities being registered (other than underwriting discounts and commissions, if any) are set forth below. Each item listed
is estimated, except for the Securities and Exchange Commission (the “SEC”) registration.
Securities and Exchange Commission
registration fee |
|
$ |
3,421.71 |
|
FINRA filing fee |
|
$ |
5,157.50 |
|
Legal fees and expenses |
|
$ |
|
|
Accounting fees and expenses |
|
$ |
|
|
Miscellaneous |
|
$ |
|
|
Total |
|
$ |
* |
|
*
Estimated expenses not presently known.
Item
14. Indemnification of Directors and Officers
Section
145 of the Delaware General Corporation Law, or the DGCL, permits a corporation to indemnify any director or officer of the corporation
against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred
in connection with any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer of the
corporation, if such person acted in good faith and in a manner that he reasonably believed to be in, or not opposed to, the best interests
of the corporation, and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct
was unlawful. In a derivative action (i.e., one brought by or on behalf of the corporation), indemnification may be provided only for
expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action or
suit if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests
of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to be liable to the corporation,
unless and only to the extent that the court in which the action or suit was brought shall determine that the defendant is fairly and
reasonably entitled to indemnity for such expenses despite such adjudication of liability.
Pursuant
to Section 102(b)(7) of the DGCL, Article NINTH of the Company’s certificate of incorporation eliminates the liability of a director
to the Company or its stockholders for monetary damages for such a breach of fiduciary duty as a director, except for liabilities arising:
|
● |
from any breach of the
director’s duty of loyalty to Polarity or its stockholders; |
|
● |
from acts or omissions
not in good faith or which involve intentional misconduct or a knowing violation of law; |
|
● |
under Section 174 of the
DGCL; or |
|
● |
from any transaction from
which the director derived an improper personal benefit. |
In
addition, the Company’s amended and restated bylaws provide that each person who was or is made a party or is threatened to be
made a party to or is otherwise involved (including, without limitation, as a witness) in any action, suit or proceeding, whether civil,
criminal, administrative or investigative, by reason of the fact that he or she is or was a director or an officer of the Company or
is or was serving at the Company’s request as a director, officer, or trustee of another corporation, or of a partnership, joint
venture, trust or other enterprise, including service with respect to an employee benefit plan, whether the basis of such proceeding
is alleged action in an official capacity as a director, officer or trustee or in any other capacity while serving as a director, officer
or trustee, shall be indemnified and held harmless by the Company to the fullest extent authorized by the DGCL against all expense, liability
and loss (including attorneys’ fees, judgments, fines, ERISA excise taxes or penalties and amounts paid in settlement) reasonably
incurred or suffered by such.
Further,
the Company has entered into indemnification agreements with each of the Company’s directors and executive officers that may be
broader than the specific indemnification provisions contained in the DGCL. These indemnification agreements require the Company, among
other things, to indemnify the Company’s directors and executive officers against liabilities that may arise by reason of their
status or service. These indemnification agreements also require the Company to advance all expenses incurred by the directors and executive
officers in investigating or defending any such action, suit or proceeding.
The
indemnification provisions contained in the DGCL, the limitation of liability and indemnification provisions that are included in the
Company’s certificate of incorporation, amended and restated bylaws and the indemnification agreements that the Company has entered
into with its directors and executive officers may discourage stockholders from bringing a lawsuit against the Company’s directors
and executive officers for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against the
Company’s directors and executive officers, even though an action, if successful, might benefit the Company and other stockholders.
Further, a stockholder’s investment may be adversely affected to the extent that the Company pays the costs of settlement and damage
awards against directors and executive officers as required by these indemnification provisions.
Section
145(g) of the DGCL authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer,
employee or agent of the corporation or is or was serving at the request of the corporation as such at any other enterprise against any
liability asserted against and incurred by such person in such capacity, or arising out of such person’s status as such, whether
or not the corporation would have the power to indemnify such person against such liability under the DGCL. Consistent with the DGCL,
the Company has obtained insurance policies under which, subject to the limitations of the policies, coverage is provided to the Company’s
directors and executive officers against loss arising from claims made by reason of breach of fiduciary duty or other wrongful acts as
a director or executive officer, including claims relating to public securities matters, and to the Company with respect to payments
that may be made by the Company to these directors and executive officers pursuant to the Company’s indemnification obligations
or otherwise as a matter of law.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the
company pursuant to the foregoing provisions, the company has been informed that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is therefore unenforceable.
Item
15. Recent Sales of Unregistered Securities
On
June 5, 2022, the Company entered into a securities purchase agreement with an investor for the purchase and sale of 445,500 registered
shares of its common stock at a purchase price of $2.525 per share, registered pre-funded warrants to purchase 1,138,659 shares of common
stock at a purchase price of $2.524 per share of common stock underlying each such warrant, and unregistered preferred investment options
to purchase up to 1,584,159 shares of common stock. The preferred investment options were exercisable immediately upon issuance at an
exercise price of $2.40 per share and have a five-year term. In a concurrent private placement, the Company entered into a separate securities
purchase agreement with the same investor for the unregistered purchase and sale of pre-funded warrants to purchase 1,584,159 shares
of common stock at a purchase price of $2.524 per share of common stock underlying each such warrant and unregistered preferred investment
options to purchase up to 1,584,159 shares of common stock. With respect to each unregistered pre-funded warrant sold in the private
placement, the exercise price is $0.001 per share of common stock, pre-funded warrant was immediately exercisable, and it does not expire
until fully exercised. The preferred investment options sold in the private placement were exercisable immediately upon issuance at an
exercise price of $2.40 per share and have a five-year term.
The
unregistered pre-funded warrants and preferred investment options described above were offered in reliance on an exemption from registration
under Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. The shares of common stock issuable upon exercise
of the unregistered pre-funded warrants and preferred investment options were subsequently registered for resale under a registration
statement on Form S-1 declared effective June 30, 2022, SEC File No. 333-265693.
The
investor (together with its affiliates) may not exercise any portion of the pre-funded warrants and preferred investment options to the
extent that the investor would own more than 4.99% (or 9.99% at the election of said holder) of the outstanding common stock immediately
after exercise, which percentage may be changed at the investor’s election to a lower percentage at any time or to a higher percentage
not to exceed 9.99% upon 61 days’ notice to the Company.
Item
16. Exhibits
The
following index lists the exhibits that are filed with this report or incorporated by reference, as noted:
1.1 |
|
Sales Agreement dated March 30, 2021, between the Company and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.1 to our Annual Report on Form 10-K filed on March 30, 2021) |
*1.2 |
|
Form of Underwriting Agreement |
3.1 |
|
Restated Certificate of Incorporation of PolarityTE, Inc. (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed on October 1, 2021). |
3.2 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed on March 17, 2022). |
3.3 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 to our Current Report on Form 8-K filed on March 17, 2022). |
3.4 |
|
PolarityTE, Inc., Amended and Restated Bylaws - September 28, 2021 (incorporated by reference to Exhibit 3.2 to our Current Report on Form 8-K filed on October 1, 2021). |
3.5 |
|
Certificate of Elimination of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed with the SEC on June 16, 2022). |
4.1 |
|
Form of Common Stock Warrant Certificate (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on February 14, 2020) |
4.2 |
|
Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on February 14, 2020) |
4.3 |
|
Form of letter agreement for repricing of common stock warrants issued February 14, 2020 (incorporated by reference to Exhibit 99.1 to our Form 8-K filed with the SEC on November 23, 2020) |
4.4 |
|
Form of Series A Common Stock Purchase Warrant dated December 23, 2020 (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on December 23, 2020) |
4.5 |
|
Form of Series B Pre-Funded Common Stock Purchase Warrant dated December 23, 2020 (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on December 23, 2020) |
4.6 |
|
Form of Placement Agent Common Stock Purchase Warrant dated December 23, 2020 (incorporated by reference to Exhibit 4.3 to our Form 8-K filed with the SEC on December 23, 2020) |
4.7 |
|
Form of Series A Common Stock Purchase Warrant – January 2021 (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on January 14, 2021) |
4.8 |
|
Form of Series B Pre-Funded Common Stock Purchase Warrant – January 2021 (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on January 14, 2021) |
4.9 |
|
Form of Placement Agent Common Stock Purchase Warrant – January 2021 (incorporated by reference to Exhibit 4.3 to our Form 8-K filed with the SEC on January 14, 2021) |
4.10 |
|
Form of Common Stock Purchase Warrant – January 2021 (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on January 26, 2021) |
4.11 |
|
Form of Placement Agent Common Stock Purchase Warrant – January 2021 (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on January 26, 2021) |
4.12 |
|
Form of Common Warrant – March 2022 (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on March 17, 2022) |
4.13 |
|
Form of Placement Agent Warrant – March 2022 (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on March 17, 2022) |
4.14 |
|
Form of Pre-Funded Common Stock Purchase Warrant (Registered Direct) dated June 8, 2022 (incorporated by reference to Exhibit 4.1 to our Form 8-K filed with the SEC on June 8, 2022) |
4.15 |
|
Form of Pre-Funded Common Stock Purchase Warrant (Private Placement) dated June 8, 2022 (incorporated by reference to Exhibit 4.2 to our Form 8-K filed with the SEC on June 8, 2022) |
4.16 |
|
Form of Preferred Investment Option dated June 8, 2022 (incorporated by reference to Exhibit 4.3 to our Form 8-K filed with the SEC on June 8, 2022) |
4.17 |
|
Form of Placement Agent Common Stock Purchase Warrant dated June 8, 2022 (incorporated by reference to Exhibit 4.4 to our Form 8-K filed with the SEC on June 8, 2022) |
*4.18 |
|
Form of Pre-Funded Warrant |
*4.19 |
|
Form of Common Warrant |
*4.20 |
|
Form of Underwriter Warrant |
*4.21 |
|
Form of H.C. Wainwright Warrant |
**5.1 |
|
Opinion of Dorsey &
Whitney LLP |
#10.1 |
|
Employment Agreement with David Seaburg (incorporated by reference to Exhibit 10.30 to our Form 10-KT filed with the SEC on March 18, 2019) |
#10.2 |
|
Employment Agreement with Richard Hague (incorporated by reference to Exhibit 10.1 to our Form 10-Q filed with the SEC on May 10, 2019) |
#10.3 |
|
Employment Agreement with Paul Mann (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on September 14, 2018) |
#10.4 |
|
Amendment No. 1 to Employment Agreement with David Seaburg (incorporated by reference to Exhibit 10.2 to our Form 10-Q filed with the SEC on August 8, 2019) |
#10.5 |
|
Amendment No. 1 to Employment Agreement with Richard Hague (incorporated by reference to Exhibit 10.1 to our Form 10-Q filed with the SEC on August 8, 2019) |
#10.6 |
|
Amendment No. 1 to Employment Agreement with Paul Mann (incorporated by reference to Exhibit 10.3 to our Form 10-Q filed with the SEC on August 8, 2019) |
#10.7 |
|
Form of Notice of Restricted Stock Grant and Restricted Stock Award Agreement under the 2019 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to our Form 10-Q filed with the SEC on August 8, 2019) |
#10.8 |
|
Form of Restricted Stock Unit Agreement – 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.20 to our Form 10-K filed with the SEC on January 14, 2019) |
#10.09 |
|
Form of Stock Option Agreement – 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.21 to our Form 10-K filed with the SEC on January 14, 2019) |
#10.10 |
|
Form of Restricted Stock Unit Agreement – 2019 Equity Incentive Plan (incorporated by reference to Exhibit 10.22 to our Form 10-K filed with the SEC on January 14, 2019) |
#10.11 |
|
Form of Stock Option Agreement – 2019 Equity Incentive Plan (incorporated by reference to Exhibit 10.23 to our Form 10-K filed with the SEC on January 14, 2019) |
#10.12 |
|
PolarityTE 2017 Equity Incentive Plan (incorporated by reference to Appendix A of our proxy statement filed with the SEC on February 24, 2017) |
#10.13 |
|
PolarityTE 2019 Equity Incentive Plan (incorporated by reference to Exhibit 99.2 to our Form S-8 registration Statement filed with the SEC on October 5, 2018) |
#10.14 |
|
PolarityTE 2019 Employee Stock Purchase Plan (incorporated by reference to Exhibit 99.1 to our Form S-8 registration Statement filed with the SEC on October 5, 2018) |
#10.15 |
|
PolarityTE 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 99.1 to our Form 8-K filed with the SEC on December 29, 2020) |
#10.16 |
|
Form of Incentive Stock Option Agreement – 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.17 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.17 |
|
Form of Non-qualified Stock Option Agreement – Non-employee Directors – 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.18 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.18 |
|
Form of Non-qualified Stock Option Agreement – Employees – 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.19 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.19 |
|
Form of Non-qualified Stock Option Agreement – Consultants – 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.20 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.20 |
|
Form of Restricted Stock Award – 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.21 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.21 |
|
Form of Restricted Stock Unit Award – Non-employee Directors - 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.22 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.22 |
|
Form of Restricted Stock Unit Award – Employees - 2020 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.23 to our Form 10-K filed with the SEC on March 12, 2020) |
#10.23 |
|
Settlement Terms Agreement dated August 21, 2019, between Denver Lough and the Company (incorporated by reference to Exhibit 10.1 to our Form 10-Q filed with the SEC on November 12, 2019) |
#10.24 |
|
Form of Indemnification Agreement for directors and officers (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on March 25, 2020) |
#10.25 |
|
Employment Agreement with Richard Hague dated August 18, 2021 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on August 24, 2021) |
#10.26 |
|
Employment Agreement with Cameron Hoyler dated August 18, 2021 (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on August 24, 2021) |
#10.27 |
|
Employment Agreement with Jacob Patterson dated August 18, 2021 (incorporated by reference to Exhibit 10.3 to our Form 8-K filed with the SEC on August 24, 2021) |
#10.28 |
|
Consulting Agreement with David Seaburg dated September 1, 2021 (incorporated by reference to Exhibit 10.4 to our Form 10-Q filed with the SEC on November 10, 2021) |
10.29 |
|
Agreement of Lease between the Company and Lefrak SBN Limited Partnership dated October 19, 2018 (incorporated by reference to Exhibit 10.26 to our Form 10-K filed with the SEC on January 14, 2019) |
10.30 |
|
Sublease Agreement by and between the Company and Peter Cohen LLC for office space at 40 West 57th Street, New York, New York 10019 (incorporated by reference to Exhibit 10.27 to our Form 10-K filed with the SEC on January 14, 2019) |
10.31 |
|
Sublease Agreement with Joseph M. Still Burn Centers, Inc., dated April 22, 2019 (incorporated by reference to Exhibit 10.28 to our Form 10-K filed with the SEC on March 12, 2020) |
10.32 |
|
Commercial Lease Agreement by and Between the Company and Adcomp LLC (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on December 29, 2017) |
10.33 |
|
Purchase Agreement dated December 5, 2019, between the Company and Keystone Capital Partners, LLC (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on December 5, 2019) |
10.34 |
|
Note and Loan Agreement dated April 12, 2020, between PolarityTE MD, Inc., and KeyBank National Association (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on April 15, 2020) |
10.35 |
|
Form of Securities Purchase Agreement dated December 21, 2020 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on December 23, 2020) |
10.36 |
|
Form of Securities Purchase Agreement dated January 11, 2021 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on January 14, 2021) |
10.37 |
|
Form of letter agreement for exercise of Series A Common Stock Purchase Warrant dated December 23, 2020 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on January 26, 2021) |
10.38 |
|
Purchase and Sale Agreement between PolarityTE, Inc., and BCG Acquisitions LLC (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on December 17, 2021) |
10.39 |
|
Purchase and Sale Agreement between PolarityTE, Inc., and Adcomp LLC (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on March 15, 2022) |
10.40 |
|
Amendment No. 1 to Purchase and Sale Agreement between PolarityTE, Inc., and BCG Acquisitions LLC (incorporated by reference to Exhibit 10.4 to our Form 8-K filed with the SEC on March 15, 2022) |
10.41 |
|
Form of Securities Purchase Agreement dated March 15, 2022 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on March 17, 2022) |
10.42 |
|
Form of Warrant Amendment Agreement dated March 15, 2022 (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on March 17, 2022) |
10.43 |
|
Stock Purchase Agreement between Utah CRO Services, Inc., and JP Lawrence Biomedical, Inc., dated April 14, 2022 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on April 18, 2022) |
10.44 |
|
Real Estate Purchase and Sale Agreement between IBEX Property LLC, and JP Lawrence Land and Building LLC, dated April 14, 2022 (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on April 18, 2022) |
10.45 |
|
Promissory Note in the Principal Amount of $400,000 dated April 28, 2022 (incorporated by reference to Exhibit 10.3 to our Form 8-K filed with the SEC on May 2, 2022) |
10.46 |
|
Form of Securities Purchase Agreement (Registered Direct) dated June 5, 2022 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed with the SEC on June 8, 2022) |
10.47 |
|
Form of Securities Purchase Agreement (Private Placement) dated June 5, 2022 (incorporated by reference to Exhibit 10.2 to our Form 8-K filed with the SEC on June 8, 2022) |
10.48 |
|
Form of Registration Rights Agreement dated June 5, 2022 (incorporated by reference to Exhibit 10.3 to our Form 8-K filed with the SEC on June 8, 2022) |
#10.49 |
|
Amendment No. 1 dated August 11, 2022, to Employment Agreement with Cameron Hoyler (incorporated by reference to Exhibit 10.8 to our Form 10-Q filed with the SEC on August 11, 2022) |
21.1 |
|
Subsidiaries (incorporated by reference to Exhibit 21.1 to our Registration Statement on Form S-1 filed June 17, 2022, File No. 333-265693) |
**23.1 |
|
Consent of Dorsey &
Whitney LLP (included in Exhibit 5.1) |
*23.2 |
|
Consent of Independent Registered Public Accounting Firm |
*24.1 |
|
Power of Attorney (included in original signature page) |
107 |
|
Filing Fee Table |
# |
Constitutes a management
contract, compensatory plan, or arrangement. |
* |
Filed herewith. |
** |
To be filed by amendment. |
Item
17. Undertakings
(a)
The undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)
To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”);
(ii)
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Securities and Exchange Commission (the “SEC”) pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii)
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement; provided, however, that paragraphs (a)(1)(i), (a)(l)(ii) and (a)(1)(iii)
of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained
in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”) that are incorporated by reference in the registration statement, or is contained
in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement;
(2)
That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof;
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the
termination of the offering;
(4)
That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed by the registrant pursuant
to Rule 424(b)(3) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B
or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as
of the date it is first used after effectiveness; and provided, however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration
statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such
first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such date of first use.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution
of the securities, the undersigned registrant hereby undertakes that in a primary offering of securities of the undersigned registrant
pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities
are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to
the purchaser and will be considered to offer or sell such securities to such purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
424 (§ 230.424 of this chapter);
(ii)
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by
the undersigned registrant;
(iii)
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and
(iv)
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(b)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing
of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof; and
(c)
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons
of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC
such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that
a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel
the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction, the question whether such indemnification
by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
(d)
The undersigned registrant hereby undertakes that:
(1)
For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part
of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule
424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared
effective.
(2)
For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus
shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Salt Lake, State of Utah, on October 14, 2022.
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PolarityTE, Inc. |
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By: |
/s/
Richard Hague |
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Name: |
Richard Hague |
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Title: |
Chief Executive Officer |
KNOW
ALL BY THESE PRESENT, that each person whose signature appears below hereby severally constitutes and appoints each of Richard Hague
and Jacob Patterson, and each of them singly, as such person’s true and lawful attorneys-in-fact and agents, with full power of
substitution and re-substitution, for such person and in such person’s name, place and stead, in any and all capacities, to sign
any or all amendments (including, without limitation, post-effective amendments) to this registration statement (or any registration
statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933), and to
file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting
unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary
to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying
and confirming all that any said attorney-in-fact and agent, or any substitute or substitutes of any of them, may lawfully do or cause
to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this registration statement on Form S-1 has been signed by the following
persons in the capacities and on the dates indicated.
Signature |
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Title |
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Date |
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/s/ Richard
Hague |
|
Chief Executive Officer |
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October 14, 2022 |
Richard Hague |
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(Principal Executive Officer) |
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|
|
/s/ Jacob
Patterson |
|
Chief Financial Officer |
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October 14, 2022 |
Jacob Patterson |
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(Principal Financial and Accounting Officer) |
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|
|
|
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/s/ Peter
Cohen |
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Director |
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October 14, 2022 |
Peter Cohen |
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/s/ Willie
C. Bogan |
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Director |
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October 14, 2022 |
Willie C. Bogan |
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|
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/s/ Chris
Nolet |
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Director |
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October 14, 2022 |
Chris Nolet |
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|
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|
|
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/s/ David
Seaburg |
|
Director |
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October 14, 2022 |
David Seaburg |
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