Adynxx : Amended Registration statement for face-amount certificate companies

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As filed with the U.S. Securities and Exchange Commission on October 11, 2019

Registration No. 333-232169​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 3 TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

ADYNXX, INC.

(Exact name of registrant as specified in our charter)

​	Delaware	2834	58-2349413	​
​	(State or Other Jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer	​
	Incorporation or Organization)	Classification Code Number)	Identification No.)

Adynxx, Inc.

100 Pine Street, Suite 500

San Francisco, CA 94111

[phone]

(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)

Rick Orr

President and Chief Executive Officer

Adynxx, Inc.

100 Pine Street, Suite 500

San Francisco, CA 94111

[phone]

(Name, address, including zip code, and telephone number, including area code, of agent for service)

​	Laura A. Berezin	Copies to:	Rick A. Werner	​
	John T. McKenna		Haynes and Boone, LLP
	Cooley LLP		30 Rockefeller Plaza, 26th Floor
	3175 Hanover Street		New York, NY 10112
	Palo Alto, CA 94304		[phone]
	[phone]

Approximate date of commencement of proposed sale to the public:

As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of  "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer		☐
Non-accelerated filer	☒	Smaller reporting company		☒
Emerging growth company	☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
		Calculation of Registration Fee
			Proposed Maximum Aggregate	Amount of
Title of Each Class of Securities to be Registered			​​	Offering Price(1)	​​Registration Fee(1) ​
Common stock, par value $0.001 per share			$	10,125,000
Common warrants to purchase shares of common stock and common stock issuable upon exercise thereof		$	10,125,000
Pre-funded warrants to purchase shares of common stock and common stock issuable upon exercise thereof		$	10,125,000(2)
Placement agent warrants to purchase shares of common stock and common stock issuable upon exercise thereof		$	759,375(3)
Total				$	31,134,375(4)	$4,042

1. Estimated solely for purposes of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended. The registrant previously paid $1,818 in connection with a prior filing of this Registration Statement.
2. The proposed maximum aggregate offering price of the common stock proposed to be sold in the offering will be reduced on a dollar-for-dollar basis based on the aggregate offering price of the pre-funded warrants offered and sold in the offering (plus the aggregate exercise price of the common stock issuable upon exercise of the pre-funded warrants), and as such the proposed aggregate maximum offering price of the common stock and pre-funded warrants (including the common stock issuable upon exercise of the pre-funded warrants), if any, is $10,125,000.
3. Represents warrants issuable to the placement agent or its designees to purchase a number of shares of common stock equal to 7.5% of the number of shares of common stock and pre-funded warrants being offered at an exercise price equal to 125% of the public offering price. See "Plan of Distribution."
4. Pursuant to Rule 416 under the Securities Act of 1933, as amended, the securities being registered hereunder include such indeterminate number of additional securities as may be issuable to prevent dilution resulting from stock splits, dividends or similar transactions.

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, as amended, 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.

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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, and we are not soliciting offers to buy these securities, in any jurisdiction where the offer or sale is not permitted.

Subject to Completion, Dated October 11, 2019

PRELIMINARY PROSPECTUS

7,500,000 Shares of Common Stock

Pre-Funded Warrants to Purchase Shares of Common Stock Common Warrants to Purchase 7,500,000 Shares of Common Stock

Adynxx, Inc. is offering 7,500,000 shares of common stock and accompanying common warrants to purchase an aggregate of 7,500,000 shares of our common stock. The accompanying common warrants will be exercisable immediately and will expire five years from the date of issuance. Each common warrant has an exercise price of  $     per share of common stock.

We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the 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 common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants, in lieu of shares of common stock 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 common stock. Each pre-funded warrant is exercisable for one share of our common stock and will be accompanied by a common warrant to purchase one share of common stock. The purchase price of each pre-funded warrant is equal to the price at which a share of common stock is sold to the public in this offering, minus $0.01, and the exercise price of each pre-funded warrant will be $0.01 per share. 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.

This offering also relates to the shares of common stock issuable upon exercise of the accompanying common warrants and any pre-funded warrants sold in this offering. For each pre-funded warrant that we sell, the number of shares of common stock we are offering will be reduced on a one-for-one basis. Therefore, the number of common warrants sold in this offering will not change as a result of a change in the mix of the shares of our common stock and pre-funded warrants sold. The shares of common stock and pre-funded warrants, and the accompanying common warrants, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

Our common stock is presently quoted on The OTCQB Market tier of the OTC Markets Group, Inc., or OTCQB, under the symbol "ADYX." On October 9, 2019, the last reported sale price of our common stock was $1.35 per share. The prices quoted on the OTCQB may not be indicative of the market price of our common stock on a national securities exchange. There is no established public trading market for the pre-funded warrants and the accompanying common warrants, and we do not expect a market to develop. In addition, we do not intend to apply for a listing of our common stock, the pre-funded warrants or the accompanying common warrants on any national securities exchange or other nationally recognized trading system.

The actual combined public offering price per share of common stock and accompanying common warrant or pre-funded warrant and accompanying common warrant, as the case may be, will be determined through negotiation between us and the investors in the offering and may be at a discount to the current market price. Therefore, the recent market price used throughout this prospectus may not be indicative of the offering price. We have retained H.C. Wainwright & Co., LLC to act as our exclusive placement agent in connection with the securities offered by this prospectus. The placement agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The placement agent is not purchasing or selling any of the securities we are offering and the placement agent is not required to arrange the purchase or sale of any specific or minimum number of securities or dollar amount. We have agreed to pay to the placement agent the placement agent fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. See "Plan of Distribution" for more information regarding these arrangements.

Because there is no minimum offering amount required as a condition to the closing of this offering, the actual public offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth below. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus. In addition, because there is no escrow account and no minimum offering amount in this offering, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering.

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading "Risk Factors" beginning on page 8of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

				PER	PER
				PRE-FUNDED	COMMON	TOTAL(2)​
			PER SHARE	WARRANT	WARRANT
	Public offering price	$	$	$		$
	Placement agent's fees (1)	$	$	$	$
	Proceeds, before expenses, to us	$	$	$	$

1. We have agreed to reimburse the placement agent for certain expenses in connection with this offering. See "Plan of Distribution."
2. The public offering price is $     per share of common stock, $     per pre-funded warrant, and $     per accompanying common warrant.

Provided that this offering results in total proceeds to us of at least $5.0 million, excluding the conversion of any debt and proceeds from offered securities sold to Domain Associates or TPG, convertible notes in the aggregate principal amount of  $6.35 million held by entities affiliated with Domain Associates, and any unpaid accrued interest, will automatically convert into 4,874,744 shares of common stock, based upon an assumed combined public offering price of  $1.35 per share of common stock and accompanying common warrant, the last reported sale price of our common stock by OTCQB on October 9, 2019. The issuance of these shares will not be registered under the Securities Act of 1933, as amended.

Entities affiliated with Domain Associates, or Domain, and TPG Biotechnology Partners IV, L.P, or TPG, have indicated an interest in purchasing up to an aggregate of  $4.25 million of securities in this offering at the public offering price per share of common stock and accompanying common warrant or pre-funded warrant and accompanying common warrant, as the case may be. However, because indications of interest are not binding agreements or commitments to purchase, either of Domain or TPG may elect to purchase more, fewer or no securities in this offering or the placement agent may elect to sell more, fewer or no securities in this offering to either of Domain or TPG. The placement agent will receive the same fee from the sale of any of our securities to Domain or TPG as it will from any other of our securities sold to the public in this offering. Any securities purchased by Domain or TPG in this offering will not be subject to the lock-up agreements with the placement agent that are described below.

Delivery of the shares of common stock, pre-funded warrants, and accompanying common warrants is expected to be made on or about          , 2019.

H.C.Wainwright & Co.

           , 2019

TABLE OF CONTENTS

TABLE OF CONTENTS

	Page
Certain Defined Terms	ii
Prospectus Summary	1
Risk Factors	8
Special Note Regarding Forward-Looking Statements	40
Industry and Market Data	42
Use of Proceeds	43
Dividend Policy	44
Capitalization	45
Dilution	47
Market for Our Common Stock	49
Management's Discussion and Analysis of Financial Condition and Results of Operations	50
Our Business	63
Management	95
Executive Compensation of Adynxx	100
Executive Compensation of Alliqua	104
Certain Relationships and Related Person Transactions	108
Principal Stockholders	111
Description of Capital Stock	114
Description of Securities We Are Offering	118
Material U.S. Federal Income Tax Consequences	121
Plan of Distribution	128
Legal Matters	133
Experts	133
Where You Can Find More Information	133
Adynxx Inc. Unaudited Pro Forma Financial Information	134
Index to Financial Statements	F-1

Neither we nor the placement agent have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by us or on our behalf. Neither we nor the placement agent take responsibility for, and can provide no assurance as to the reliability of, any information that others may give you. We and the placement agent are not offering to sell, or seeking offers to buy, the securities offered hereby in any jurisdiction where such offer or sale is not permitted. The information contained in this prospectus or in any applicable free writing prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus or any sale of the securities offered hereby. Our business, financial condition, results of operations and prospects may have changed since that date.

Persons in jurisdictions outside the United States who come into possession of this prospectus and any applicable free writing prospectus must inform themselves about, and observe any restrictions relating to, this offering and the distribution of this prospectus and any applicable free writing prospectus applicable to such jurisdictions.

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CERTAIN DEFINED TERMS

As used in this prospectus, unless the context otherwise requires, references to:

• "Adynxx" or "Private Adynxx" refer to Adynxx, Inc. prior to the consummation of the Merger;
• "Alliqua" refers to Alliqua BioMedical, Inc. and, unless otherwise stated or the context otherwise requires, its consolidated subsidiaries prior to the consummation of the Merger;
• "Merger" refers to the business combination between Adynxx, Inc. and Alliqua BioMedical, Inc., consummated on May 3, 2019, pursuant to which (i) Embark Merger Sub, Inc., a then wholly-owned subsidiary of Alliqua BioMedical, Inc., merged with and into Adynxx, Inc., with Adynxx, Inc. surviving as a wholly-owned subsidiary of Alliqua BioMedical, Inc., (ii) Alliqua BioMedical, Inc. issued shares of its common stock to stockholders of Adynxx, Inc. at an exchange rate of 0.0359 shares of common stock in exchange for each share of Adynxx, Inc. common stock outstanding immediately prior to the Merger (which exchange rate reflects a 1-for-6 reverse stock split of the issued and outstanding share capital of Alliqua BioMedical, Inc. effected on May 3, 2019, or the "Merger Stock Split"). Immediately after the Merger, the former Private Adynxx stockholders, warrantholders and optionholders owned approximately 86% of the fully-diluted common stock of the combined company, and the Alliqua stockholders and optionholders, whose shares of Alliqua common stock remained outstanding after the Merger, owned approximately 14% of the fully-diluted common stock of the combined company, and (iii) Alliqua BioMedical, Inc. was renamed "Adynxx, Inc."; and
• "we," "us," "our," the "Company" and similar references refer: (i) prior to the consummation of the Merger, to Adynxx, Inc., and (ii) following the consummation of the Merger, to Adynxx, Inc. (formerly Alliqua BioMedical, Inc.) and, unless otherwise stated or the context otherwise requires, all of its subsidiaries.

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PROSPECTUS SUMMARY

The following summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our securities, you should carefully read this entire prospectus carefully, including our consolidated financial statements and the related notes included in this prospectus and the information set forth herein under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations."

Overview

We are a clinical stage biopharmaceutical company focused on the development of a new class of therapeutics called transcription factor decoys and bringing to market novel, disease-modifying products to address unmet needs in the treatment of pain and inflammation. Transcription factor decoys are short strands of DNA that specifically bind to and block the activity of their target transcription factors. Transcription factors are proteins that specifically bind to the regulatory regions of one or more target genes and regulate the expression of those genes. Since the founding of Adynxx in 2007, we have leveraged our AYX platform of proprietary transcription factor decoys to identify and develop novel product candidates designed to modify the course of pain.

We believe that our transcription factor decoy technology can transform the treatment of pain, and going forward has the potential to be applied to additional disease states. We plan to continue advancing our AYX platform programs while simultaneously developing new transcription factor decoy candidates, collaborating with twoXAR, our artificial intelligence-driven drug discovery partner, and evaluating in-licensing opportunities in order to expand our pipeline and leverage our business development, clinical development and regulatory expertise.

The AYX Platform of Transcription Factor Decoys

The AYX platform consists of a wide range of transcription factor decoys, each of which has multiple binding sites capable of targeting one or more transcription factors, and we believe that we have the technological expertise to generate additional decoys based on desired therapeutic characteristics. The AYX platform's current drug candidates are intended to treat postoperative pain, or post-surgical, and chronic pain. We plan to leverage our expertise in transcription factor decoy drug discovery and development to identify additional product candidates to treat inflammation-related diseases, including, but not limited to, organ scarring, heart disease and cancer.

Our Product Pipeline

The following table outlines the status of our development programs:

Brivoligide for postoperative pain

Based on data from the Agency for Healthcare Research and Quality's 2014 Healthcare Cost and Utilization Project, there are more than 37 million surgical procedures performed in the United States annually. Postoperative pain remains a significant clinical problem, compromising rehabilitation and

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