UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q 

 

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2020

 

OR

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ________________ to ________________

 

Commission File Number: 001-38803

 

Hoth Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter) 

 

Nevada		82-1553794
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
1 Rockefeller Plaza, Suite 1039
New York, NY		10020
(Address of principal executive offices)		(Zip Code)

 

(646) 756-2997

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value		HOTH		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒  No ☐

 

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 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒

 

The number of shares of the issuer’s common stock, $0.0001 par value per share, outstanding at August 11, 2020 was 13,434,839.

 

 

 

Table of Contents

 

		Page No.
PART I. FINANCIAL INFORMATION		1
Item 1.	Financial Statements	1
	Condensed Consolidated Balance Sheets as of June 30, 2020 (Unaudited) and December 31, 2019	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019 (Unaudited)	2
	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2020 and 2019 (Unaudited)	3
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019 (Unaudited)	5
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4.	Controls and Procedures	23
PART II. OTHER INFORMATION		24
Item 1.	Legal Proceedings	24
Item 1A.	Risk Factors	24
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	26
Item 3.	Defaults Upon Senior Securities	26
Item 4.	Mine Safety Disclosures	26
Item 5.	Other Information	27
Item 6.	Exhibits	27
Signatures		28

  

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

 

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

 

●

our business strategies;

  

●

the timing of regulatory submissions;

  

●

our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;

  

●

risks relating to the timing and costs of clinical trials, the timing and costs of other expenses;

  

●

risks related to market acceptance of products;

  

●

the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;

 

●

intellectual property risks;

  

●

risks associated with our reliance on third party organizations;

 

●

our competitive position;

  

●

our industry environment;

  

●

our anticipated financial and operating results, including anticipated sources of revenues;

  

●

assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches;

  

●

management’s expectation with respect to future acquisitions;

  

●

statements regarding our goals, intensions, plans and expectations, including the introduction of new products and markets; and

  

●

our cash needs and financing plans.

 

All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

 

This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources. 

 

  

PART I — FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS.

 

Hoth Therapeutics, Inc.

Condensed Consolidated Balance Sheets

 

		June 30,				December 31,
		2020				2019
		(Unaudited)
ASSETS
Current assets
Cash		$	4,947,417			$	1,690,866
Marketable securities, at fair value			2,011,529				803,664
Prepaid expenses			56,737				110,072
Deferred offering cost			-				30,484
Total current assets			7,015,683				2,635,086
Property and equipment, net			433				1,043
Investment in joint venture			410,000				-
Restricted cash			-				200,000
Total assets		$	7,426,116			$	2,836,129
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	180,093			$	403,885
Accrued expenses			125,000				36,236
Accrued license fee - current portion			50,000				-
Total current liabilities			355,093				440,121
Accrued license fee			235,000				-
Total liabilities			590,093				440,121
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.0001 par value, 5,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively			-				-
Series A Convertible Preferred Stock, $0.0001 par value, 1,897,250 and 5,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively			-				-
Common stock, $0.0001 par value, 75,000,000 shares authorized, 13,433,267 and 10,119,844 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively			1,343				1,012
Additional paid-in-capital			23,375,090				14,610,638
Accumulated deficit			(16,539,748	)			(12,215,642	)
Accumulated other comprehensive loss			(662	)			-
Total stockholders’ equity			6,836,023				2,396,008
Total liabilities and stockholders’ equity		$	7,426,116			$	2,836,129

 

 The accompanying notes are an integral part of these condensed consolidated financial statements.

 

   

Hoth Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited) 

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2020				2019				2020				2019
Operating costs and expenses
Research and development		$	927,696			$	388,934			$	1,574,924			$	523,684
Research and development - licenses acquired (including stock-based compensation)			354,683				10,000				394,515				20,000
Compensation and related expenses (including stock-based compensation)			391,699				133,486				557,396				454,935
Professional fees (including stock-based compensation)			750,029				544,849				1,556,063				838,364
Rent			2,591				8,234				11,008				15,263
Other expenses			89,119				182,083				238,361				244,705
Total operating expenses			2,515,817				1,267,586				4,332,267				2,096,951
Loss from operations			(2,515,817	)			(1,267,586	)			(4,332,267	)			(2,096,951	)
Other expenses
Other expense, net			18,287				-				8,161				-
Total other expenses			18,287				-				8,161				-
Net loss		$	(2,497,530	)		$	(1,267,586	)		$	(4,324,106	)		$	(2,096,951	)
Weighted average number of common shares outstanding, basic and diluted			12,304,263				9,603,134				11,277,665				8,312,327
Net loss per share, basic and diluted		$	(0.20	)		$	(0.13	)		$	(0.38	)		$	(0.25	)
Net loss		$	(2,497,530	)		$	(1,267,586	)		$	(4,324,106	)		$	(2,096,951	)
Other comprehensive loss
Foreign currency translation adjustment			(662	)			-				(662	)			-
Total comprehensive loss		$	(2,498,192	)		$	(1,267,586	)		$	(4,324,768	)		$	(2,096,951	)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

Hoth Therapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)

 

For the Three Months Ended June 30, 2020

 

		Common Stock								Additional Paid-in				Accumulated				Cumulative Translation				Total Stockholders’
		Shares				Amount				Capital				Deficit				Adjustment				Equity
Balance at March 31, 2020			11,593,701			$	1,159			$	18,865,444			$	(14,042,218	)		$	-			$	4,824,385
Issuance of common stock (net of offering costs of $525,000)			1,818,182				182				4,474,818				-				-				4,475,000
Warrant exercise			18,750				2				18,748				-				-				18,750
Stock-based compensation			2,634				-				16,080				-				-				16,080
Cumulative translation adjustment																			(662	)			(662	)
Net loss			-				-				-				(2,497,530	)							(2,497,530	)
Balance at June 30, 2020			13,433,267			$	1,343			$	23,375,090			$	(16,539,748	)		$	(662	)		$	6,836,023

 

For the Three Months Ended June 30, 2019

 

		Convertible Preferred Stock								Common Stock								Additional Paid-in				Accumulated				Total Stockholders’
		Shares				Amount				Shares				Amount				Capital				Deficit				Equity
Balance at March 31, 2019			-			$	-				9,425,964			$	943			$	10,707,905			$	(5,340,371	)		$	5,368,477
Cashless warrant exercise											223,877				22				(22	)			-				-
Warrant exercise											16,333				2				161				-				163
Stock-based compensation			-				-				2,082				-				87,366				-				87,366
Net loss			-				-				-				-				-				(1,267,586	)			(1,267,586	)
Balance at June 30, 2019			-			$	-				9,668,256			$	967			$	10,795,410			$	(6,607,957	)		$	4,188,420

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

Hoth Therapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)

 

For the Six Months Ended June 30, 2020

 

		Common Stock								Additional Paid-in				Accumulated				Cumulative Translation				Total Stockholders’
		Shares				Amount				Capital				Deficit				Adjustment				Equity
Balance at December 31, 2019			10,119,844			$	1,012			$	14,610,638			$	(12,215,642	)		$	-			$	2,396,008
Issuance of common stock and warrants (net of offering costs of $806,243)			1,449,275				145				4,193,611				-				-				4,193,756
Issuance of common stock (net of offering costs of $525,000)			1,818,182				182				4,474,818				-				-				4,475,000
Cancellation of common stock			(15,000	)			(2	)			2				-				-				-
Warrant exercise			56,250				6				56,244				-				-				56,250
Stock-based compensation			4,716				-				39,777				-				-				39,777
Cumulative translation adjustment			-				-				-				-				(662	)			(662	)
Net loss			-				-				-				(4,324,106	)			-				(4,324,106	)
Balance at Balance at June 30, 2020			13,433,267			$	1,343			$	23,375,090			$	(16,539,748	)		$	(662	)		$	6,836,023

 

For the Six Months Ended June 30, 2019

  

		Convertible Preferred Stock								Common Stock								Additional Paid-in				Accumulated				Total Stockholders’
		Shares				Amount				Shares				Amount				Capital				Deficit				Equity
Balance at December 31, 2018			3,102,480			$	310				5,071,400			$	507			$	4,665,154			$	(4,511,006	)		$	154,965
Conversion of preferred stock to common stock upon completion of the IPO			(3,102,480	)			(310	)			3,102,480				310				-				-				-
Issuance common stock in the IPO, net of offering cost			-				-				1,250,000				126				5,840,042				-				5,840,168
Cashless warrant exercise			-				-				223,877				22				(22	)			-				-
Warrant exercise											16,333				2				161				-				163
Stock-based compensation			-				-				4,166				-				290,075				-				290,075
Net loss			-				-				-				-				-				(2,096,951	)			(2,096,951	)
Balance at June 30, 2019			-			$	-				9,668,256			$	967			$	10,795,410			$	(6,607,957	)		$	4,188,420

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

        

  

Hoth Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

		Six Months Ended June 30,
		2020				2019
Cash flows from operating activities
Net loss		$	(4,324,106	)		$	(2,096,951	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense			610				608
Research and development-acquired license, expensed			362,500				20,000
Warrants issue for acquired license			32,015				-
Stock-based compensation			7,762				290,075
Realized gain on marketable securities			(4,892	)			-
Unrealized loss on marketable securities			(2,973	)			-
Changes in assets and liabilities:
Prepaid expenses			53,335				(88,964	)
Accounts payable			(104,544	)			64,986
Net cash used in operating activities			(3,980,293	)			(1,810,246	)
Cash flows from investing activities
Purchase of investments in joint venture			(410,000	)			-
Purchase of research and development licenses			(77,500	)			(20,000	)
Purchase of marketable securities			(1,500,000	)			-
Sale of marketable securities			300,000				-
Net cash used in investing activities			(1,687,500	)			(20,000	)
Cash flows from financing activities
Proceeds from issuance of common stock in the IPO, net of offering cost			-				5,840,168
Proceeds from issuance common stock and warrants, net of offering cost			4,193,756				-
Proceeds from issuance common stock, net of offering cost			4,475,000				-
Proceeds from exercise of warrants			56,250				163
Net cash provided by financing activities			8,725,006				5,840,331
Effect of exchange rate changes on cash and cash equivalents			(662	)			-
Net increase in cash			3,056,551				4,010,085
Cash and restricted cash, beginning of period			1,890,866				282,621
Cash and restricted cash, end of period		$	4,947,417			$	4,292,706
Non-cash investing and financing activities
Conversion of preferred stock to common stock upon completion of the IPO		$	-			$	310
Unpaid offering cost included in accrued expenses		$	-			$	27,127
Cancellation and retirement of common stock		$	2			$	-
Cashless warrant exercise		$	-			$	22

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 1-Organization and description of business operations

 

Hoth Therapeutics, Inc. (together with its wholly-owned subsidiary, Hoth Therapeutics Australia Pty Ltd., the “Company”) was incorporated under the laws of the State of Nevada on May 16, 2017. The Company’s primary asset is a license agreement with the University of Cincinnati that was assigned to the Company by Chelexa Biosciences, Inc. pursuant to which the University of Cincinnati has granted the Company an exclusive license to use its BioLexa Platform (as defined herein), a proprietary, patented, drug compound platform. The license enables the Company to develop the platform for all indications in humans. The Company’s initial focus will be on the treatment of eczema. The BioLexa Platform combines a U.S. Food and Drug Administration (“FDA”) approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts which trigger symptoms. To the Company’s knowledge, it is the first product candidate intended to prevent the symptom triggering flare-ups rather than simply treating symptoms when they occur.

 

Liquidity and capital resources

 

Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements - Going Concern, requires management to evaluate the Company’s ability to continue as a going concern one year beyond the filing date of the given financial statements. This evaluation requires management to perform two steps. First, management must evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern. Second, if management concludes that substantial doubt is raised, management is required to consider whether it has plans in place to alleviate that doubt. Disclosures in the notes to the condensed consolidated financial statements are required if management concludes that substantial doubt exists or that its plans alleviate the substantial doubt that was raised.

 

The Company has funded its operations from proceeds from the sale of equity and debt securities. The Company will require significant additional capital to make the investments it needs to execute its longer-term business plan. The Company’s ability to successfully raise sufficient funds through the sale of debt or equity securities when needed is subject to many risks and uncertainties and, even if it were successful, future equity issuances would result in dilution to its existing stockholders and future debt securities may contain covenants that limit the Company’s operations or ability to enter into certain transactions.

 

The Company’s current cash is sufficient to fund operations for at least the next 12 months; however, the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, grants or other arrangements to develop and seek regulatory approvals for the Company’s existing and new product candidates. If such funding is not available, or not available on terms acceptable to the Company, the Company’s current development plan and plans for expansion of its general and administrative infrastructure may be curtailed. 

 

Note 2-Significant accounting policies

 

Basis of presentation

 

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed by the Company with the Securities and Exchange Commission (the “SEC”) on March 2, 2020.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Use of estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s condensed consolidated financial statements relate to the stock-based compensation, the valuation of investments  and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

 

Significant Accounting Policies 

 

There have been no material changes to the Company’s significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as filed with the SEC on March 2, 2020.

 

Restricted Cash

 

The following table provides a summary of the Company’s cash and restricted cash total as presented in the condensed consolidated statements of cash flows for the six months ended June 30, 2020 and 2019 and a reconciliation of cash and restricted cash from consolidated balance sheet to consolidated statements of cash flow for the year ended December 31, 2019: 

 

		June 30, 2020				June 30, 2019				December 31, 2019
Cash		$	4,947,417			$	4,092,706			$	1,690,866
Restricted cash			-				200,000				200,000
Total cash and restricted cash		$	4,947,417			$	4,292,706			$	1,890,866

 

The $0.2 million restricted cash was deposited into a third-party escrow account in order to provide a source of funding for certain indemnification obligations the Company has pursuant to its Qualified Independent Underwriter Engagement Agreement. On May 29, 2020, the $0.2 million restricted cash in the escrow account was returned to the Company.

 

Net loss per share

 

Net loss per share is computed by dividing net loss by the weighted average number of common stock outstanding during the period. Since the Company had a net loss in the periods presented, basic and diluted net loss per common share are the same. The following were excluded from the computation of diluted shares outstanding due to the losses for each period presented, as they would have had an anti-dilutive impact on the Company’s net loss: 

 

		As of June 30,
Potentially dilutive securities		2020				2019
Warrants			1,162,803				767,870
Options			525,000				-
Non-vested restricted stock units			15,150				17,364
Total			1,702,953				785,234

 

Investment in joint venture

 

Ownership interests in entities for which the Company has significant influence that are not consolidated are accounted for as equity method investments. SEC Staff Announcement: Accounting for Limited Partnership Investments (codified in Accounting Standards Codification (“ASC”) 323-30-S99-1) guidance requires the use of the equity method unless the investor’s interest “is so minor that the limited partner may have virtually no influence over partnership operating and financial policies.” The SEC staff’s position is that investments in limited partnerships of greater than 3% to 5% are considered more than minor and, therefore, should be accounted for using the equity method or fair value option. Investments accounted for using the equity method may be reported on a lag up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date. The determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis. This investment in joint venture is further described in Note of 6 these financial statements. 

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Recent accounting pronouncements

 

In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements and related disclosures.

 

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if currently adopted, would have an effect on the Company’s condensed consolidated financial statements.

 

Note 3-License agreements

 

The following summarizes the Company’s research and development expenses for licenses acquired (including stock-based compensation) during three and six months ended June 30, 2020 and 2019:

 

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2020				2019
The George Washington University		$	9,683			$	-			$	42,015			$	-
Zylö Therapeutics Inc.							10,000								10,000
University of Maryland and Isoprene Pharmaceuticals, Inc.			-				-				-				10,000
Virginia Commonwealth University			335,000				-				335,000				-
University of Cincinnati			10,000				-				17,500				-
		$	354,683			$	10,000			$	394,515			$	20,000

 

Chelexa Biosciences, Inc. and the University of Cincinnati

 

On May 14, 2020, the Company entered into an Assignment and Assumption Agreement (the “Assignment Agreement”) with Chelexa Biosciences, Inc. (“Chelexa”) pursuant to which Chelexa assigned to the Company its rights and obligations in and to and liabilities under its license agreement with the University of Cincinnati dated February 27, 2013, as amended (the “University of Cincinnati License Agreement”). In consideration for the assignment, the Company agreed to forgive all amounts due to it by Chelexa and to pay to Chelexa certain royalty payments.

 

In connection with the Assignment Agreement, on May 14, 2020, the Company entered into a novation agreement (the “Novation Agreement”) with Chelexa and the University of Cincinnati pursuant to which the parties agreed that the Company would be substituted in place of Chelexa with respect to the rights and obligations of Chelexa set forth in the University of Cincinnati License Agreement.

 

In connection with the Assignment Agreement, on May 14, 2020, the Company entered into a royalty agreement (the “Royalty Agreement”) with Chelexa pursuant to which the Company shall pay Chelexa sales-based royalties at percentages which range from mid to high single digits, with high sales volumes being subject to lower royalty rates and total milestone payments of $3.5 million.

 

Pursuant to the University of Cincinnati License Agreement, the Company was granted an exclusive license to make, use, have made, import, offer for sale, and sell products based upon or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm formation (the “BioLexa Platform” or “BioLexa”). In addition, the University of Cincinnati granted the Company the right to issue exclusive and nonexclusive sublicenses (with the right to further sublicense to third parties) to make, use, have made, import, offer for sale, and sell products based upon the BioLexa Platform. The term of such agreement will expire on the later of April 16, 2034 and the last to expire patent in the patent rights granted to the Company (the “Term”). The Company shall, in its sole discretion, have the first right of refusal to renew the Term. The Company is subject to total milestone payments of $6,000, royalty payments, annual license maintenance fees, and has agreed to pay the University of Cincinnati for certain out-of-pocket expenses including, but not limited to, payments for patent prosecution.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

The George Washington University

 

Effective as of June 1, 2019, the Company and The George Washington University (“GWU”) entered into a sponsored research agreement (the “Sponsored Research Agreement”), as amended on July 29, 2019 and May 29, 2020, with respect to the exploration of the potential use of WEG232 for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Pursuant to the terms of the Sponsored Research Agreement, GWU granted the Company a non-exclusive, license to certain of GWU’s intellectual property. The Company has agreed to pay GWU for all costs incurred in connection with the research; provided, however, such costs shall not exceed approximately $0.5 million. The Sponsored Research Agreement shall terminate on June 30, 2021. The Sponsored Research Agreement may be terminated by either party upon 30 days written notice.

 

On June 28, 2019 (the “Effective Date”), the Company and GWU entered into a research option agreement (the “Research Option Agreement”) pursuant to which GWU granted the Company an option (the “Option”) until April 30, 2020 to acquire an exclusive license to certain products made or used by the Company (the “GWU Licensed Product”) that involve certain patents owned by GWU (the “Licensed Patents”). On February 1, 2020, the Company exercised the Option and entered into a patent license agreement with GWU. On the Effective Date, the Company paid GWU $2,500, and on February 27, 2020, the Company paid GWU $10,000 as a license initiation fee. Until the first commercial sale of the GWU Licensed Product, the Company shall pay (i) $75,000 per year for the development and commercialization of the GWU Licensed Product, (ii) $2,000 for license maintenance fees on the first anniversary of the Effective Date and (iii) $5,000 for license maintenance fees commencing on the second anniversary of the Effective Date and thereafter. Furthermore, the Company shall be required to pay GWU a sublicense fee equal to a certain percentage of the sum of payments plus the fair market value of all other consideration of any kind received by the Company from sublicensees during each quarter as follows: a 40% sublicense fee until the first anniversary of the Effective Date, a 30% sublicense fee until the third anniversary of the Effective Date and a 20% sublicense fee after the third anniversary of the Effective Date; provided, however, such sublicense fee shall exclude certain fees paid to the Company such as certain royalties, equity investments, loan proceeds and sponsored research funding. The Company shall also pay GWU milestone payments of up to an aggregate of $90,000 and sales-based royalties at a low single digit percentage, subject to certain minimum royalty requirements. In addition, during each Option Exercise Period and Renewal Period (as defined in the Research Option Agreement) the Company shall pay GWU, on a quarterly basis, for all costs and expenses related to the GWU Licensed Patents (the “Patent Costs”).

 

University of Maryland and Isoprene Pharmaceuticals, Inc.

 

On March 8, 2019, the Company entered into a commercial evaluation sublicense and option agreement (the “Commercial Evaluation Sublicense and Option Agreement”) with the University of Maryland, Baltimore (“UMD”) and Isoprene Pharmaceuticals, Inc. (“Isoprene”). Pursuant to the agreement, the Company paid an initial option and material access fee of $5,000 to UMD and $5,000 to Isoprene. In the event that Isoprene enters into a master license agreement with UMD (the “MLA”), UMD shall permit Isoprene to grant an exclusive option to the Company to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology (the “Isoprene-Hoth Option”); provided, however, in the event Isoprene does not enter into the MLA, UMD may grant the Company an option to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology (the “UMD-Hoth Option”). If the Company exercises the Isoprene-Hoth Option, it shall pay Isoprene an option exercise fee of $20,000. If the Company exercises the UMD-Hoth Option, it shall pay UMD an option exercise fee of $20,000.

 

North Carolina State University

 

On November 20, 2019 (the “NCSU Effective Date”), the Company entered into a license agreement with North Carolina State University (“NCSU”) pursuant to which NCSU granted the Company an exclusive license to, among other things, develop, make, use, offer and sell certain licensed products throughout the world with respect to NCSU’s exon skipping approach for treating allergic diseases. The term of the license agreement shall commence on the NCSU Effective Date and shall continue until the date of the expiration of the last to expire patent right granted pursuant to the license agreement unless terminated earlier pursuant to the terms of the agreement. Pursuant to the terms of the license agreement, the Company paid NCSU a one-time license fee $25,000 and is also required to pay (i) sales-based royalties at a low single digit percentage, (ii) minimum royalties ranging from $0 to $50,000 and (iii) milestone payments of up to $585,000.

 

University of Cincinnati

 

On May 18, 2018, the Company entered into an exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies. The genetic marker licensed by the Company from the University of Cincinnati may be used to (i) identify at risk infants in predicting food allergies, including peanut and milk allergies, (ii) identify a person’s predisposition to an allergic reaction, thereby avoiding such reaction and (iii) determine an individual’s propensity to develop atopic dermatitis, such as eczema. The Company intends to utilize the genetic marker for purposes of determining an individual’s propensity to develop eczema as well as to identify and treat allergies in at-risk infants.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Pursuant to the terms of the exclusive license agreement, the Company paid the University of Cincinnati a minimum annual royalty fee of $5,000 and has agreed to pay the University of Cincinnati an annual license fee of $5,000 initially due and payable within 30 days of the one year anniversary of the exclusive license agreement and every year thereafter. In addition, the Company agreed to pay the University of Cincinnati a yearly annual license maintenance fee of $2,500 and a yearly minimum annual royalty of $5,000 and milestone payments of up to $120,000. The exclusive license agreement will continue until the later of (i) the date upon which a valid claim pursuant to the terms of the exclusive license agreement expires or (ii) 10 years after the first commercial sale or unless earlier terminated pursuant to the terms of the exclusive license agreement.

 

During the six months ended June 30, 2020, the Company paid the annual license maintenance fee of $7,500 and the annual royalty fee of $10,000.

 

Virginia Commonwealth University

  

On May 18, 2020 (the “VCU Effective Date”), the Company entered into an Exclusive License Agreement (the “VCU License Agreement”) with the Virginia Commonwealth University Intellectual Property Foundation (“VCU”). Pursuant to the VCU License Agreement, VCU granted the Company an exclusive, royalty bearing license to a novel peptide developed by researchers at VCU that may be used to slow the transmission of SARS-CoV-2 (the “VCU Licensed Patent”) and a non-exclusive royalty bearing, worldwide license with respect to the Licensed Technical Information Patents (as defined in the VCU License Agreement) to make, have made, use, offer to sell, sell and import the Licensed Products (as defined in the VCU License Agreement) and perform the Licensed Services (as defined in the VCU License Agreement). The VCU License Agreement shall commence on the VCU Effective Date and shall continue until the expiration of the last to expire VCU Licensed Patent unless terminated earlier pursuant to the terms of the agreement. Pursuant to the VCU License Agreement, the Company shall pay VCU: (i) an upfront license issue fee, (ii) running royalty payments at a low single digit percentage of Net Sales (as defined in the VCU License Agreement), (iii) annual maintenance fees commencing on the first anniversary of the VCU Effective Date, (iv) annual minimum payments ranging from the mid five figures to low six figures commencing on the second anniversary of the VCU Effective Date and (v) milestone payments ranging from the mid five figures to low six figures. In addition, the Company has agreed to reimburse VCU for certain patent filing and prosecution costs. During the six months ended June 30, 2020, the Company paid the signing fee of $50,000 upon execution of the VCU License Agreement. Pursuant to the VCU License Agreement, the Company agrees to make the following annual minimum payments: (i) $50,000 in Year 2; (ii) $60,000 in Year 3; (iii) $75,000 in Year 4; and (iv) $100,000 in Year 5 and every anniversary thereafter as long as the license is in effect.

 

On June 29, 2020, the Company entered into a Sponsored Project Agreement (the “VCU Sponsored Project Agreement”) with VCU for the development of a potential COVID-19 treatment using the license to a novel peptide granted to the Company by VCU. The VCU Sponsored Project Agreement shall terminate on January 9, 2021, unless earlier terminated pursuant to the terms thereof.

 

Zylö Therapeutics Inc.

 

On August 19, 2019 (the “Zylö Effective Date”), the Company entered into an exclusive sublicense agreement (the “Sublicense Agreement”) with Zylö Therapeutics, Inc. (“Zylö”) pursuant to which Zylö granted to the Company an exclusive sublicense to the Licensed Patent Rights (as defined in the Sublicense Agreement) and the Licensed Technology (as defined in the Sublicense Agreement) to, among other things, develop, make and sell the Licensed Products (as defined in the Sublicense Agreement) and to practice the Licensed Technology in the United States and Canada for any and all uses within the Field. “Field” means all therapeutic uses related to lupus in human beings, subject to the Field Expansion Rights (as defined in the Sublicense Agreement). The term of the Sublicense Agreement shall commence on the Zylö Effective Date and shall continue until the latest of (i) ten years from the date of First Commercial Sale (as defined in the Sublicense Agreement) of the Licensed Product in such country and (ii) expiration of the last to expire Valid Claim (as defined in the Sublicense Agreement) of the Licensed Patent Rights that would be infringed by the composition, use or sale of such Licensed Product in such country. Pursuant to the terms of the Sublicense Agreement, the Company and Zylö shall establish a joint development committee to plan, review, coordinate and oversee the Company’s development activities with respect to the Licensed Products in the Field. Pursuant to the Sublicense Agreement, the Company paid Zylö (i) an upfront license fee of $50,000; (ii) sales-based royalties at percentages which range from high single digits to low double digits, with low sales volumes being subject to lower royalty rates; and total milestone payments of up to $13.5 million. In addition, in connection with the Company’s March 2020 underwritten public offering of shares of its common stock, on May 4, 2020, the Company purchased 30,000 shares of Zylö’s Class B common stock for $60,000. Effective January 1, 2018, the Company adopted ASU 2016-01 concerning recognition and measurement of financial assets and financial liabilities. In adopting this new guidance, the Company has made an accounting policy election to adopt an adjusted cost method measurement alternative for its investment in Zylö.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 4-Related Party

 

A director of the Company, is also the Executive Chairman of Chelexa. During the six months ended June 30, 2020, that director received $15,000 in cash compensation for services provided as a member of the Company’s board of directors (the “Board” or “Board of Directors”).

 

A former director of the Company, is also the Chief Executive Officer, Principal Accounting and Financial Officer and a member of the board of directors of AIkido Pharma Inc. (formerly known as Spherix Incorporated). During the six months ended June 30, 2020, that director received $8,700 in cash compensation for services provided as a board member of the Company. On April 15, 2020, this director resigned as a member of the Company’s Board of Directors and its committees.

 

During the six months ended June 30, 2020, the Company issued an aggregate of 4,716 shares of the Company’s common stock to members of the Company’s Board for services rendered.

 

Note 5-Fair Value of Financial Assets

 

FASB ASC 820, Fair Value Measurements, provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.

 

The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:

 

Level 1:	Quoted prices in active markets for identical assets or liabilities.
Level 2:	Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3:	Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.

 

In some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.

 

The Company’s financial instruments include cash, marketable securities and accounts payable. The fair value of these financial instruments approximates their carrying value due to the short-term nature. With respect to the Company’s investment in a joint venture, the fair value of this investment approximates its carrying value due to the minimal transaction activity within this joint venture.

 

The following table presents the Company’s assets and liabilities that are measured at fair value at June 30, 2020 and December 31, 2019:

 

		Fair value measured at June 30, 2020
		Total at June 30,				Quoted prices in active markets				Significant other observable inputs				Significant unobservable inputs
		2020				(Level 1)				(Level 2)				(Level 3)
Assets
Marketable securities - mutual funds		$	2,011,529			$	2,011,529			$	-			$	-

   

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

		Fair value measured at December 31, 2019
		Total at December 31,				Quoted prices in active markets				Significant other observable inputs				Significant unobservable inputs
		2019				(Level 1)				(Level 2)				(Level 3)
Assets
Marketable securities - mutual funds		$	803,664			$	803,664			$	-			$	-

 

Fair Value Measurements on a Non-Recurring Basis

 

The Company measures the fair value of certain assets on a non-recurring basis, generally quarterly, annually, or when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. These assets include the investment in joint venture accounted for using the equity method and investment in Zylö for using cost method. When the Company determines that the carrying value of these assets may not be recoverable, the Company records the assets at fair value with the loss recognized in the condensed consolidated statements of operations and comprehensive loss. In such cases, the Company measures the fair value of these assets using the techniques discussed above under the Level 3 category.

 

Note 6-Investment in HaloVax

 

On March 23, 2020, the Company entered into a Development and Royalty Agreement (the “Development and Royalty Agreement”) with Voltron Therapeutics, Inc. (“Voltron”) to form a joint venture entity named HaloVax, LLC (“HaloVax”) to jointly develop potential product candidates for the prevention of COVID-19  based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a Massachusetts General Hospital). Pursuant to the Development and Royalty Agreement, the Company is entitled to receive sales-based royalties. In addition, pursuant to the terms of the Development and Royalty Agreement, on March 23, 2020, the Company and HaloVax entered into a Membership Interest Purchase Agreement  pursuant to which the Company purchased 5% of HaloVax’s outstanding membership interests for $250,000 on March 27, 2020 (the “Initial Closing Date”) and shall have the option to purchase up to an additional 25% of HaloVax’s membership interests (for $3,000,000 (inclusive of the $250,000)), which option shall expire 30 days after the Initial Closing Date. On May 28, 2020, the Company entered into a membership interest purchase agreement to purchase 1% of HaloVax’s outstanding membership interest for a purchase price of $100,000. As such, the Company accounts for those investments under the equity method. There was no significant change in HaloVax’s operations from March 23, 2020 to June 30, 2020.

 

Note 7-Stockholders’ Equity 

 

Common Stock

 

On January 17, 2020, pursuant to the termination and general release agreement between the Company and FON Consulting LLC, 15,000 of the shares originally issued to FON Consulting LLC were cancelled.

 

On February 5, 2020, the Company issued 12,500 shares of common stock upon exercise of warrants issued to an investor on January 19, 2018, which resulted in gross proceeds of $12,500.

 

On March 6, 2020, the Company issued 25,000 shares of common stock upon exercise of the warrants issued to an investor on December 13, 2017, which resulted in gross proceeds of $25,000.

 

On April 15, 2020, the Company issued each of two directors 3,333 shares of the Company’s common stock pursuant to the Company’s 2018 Equity Incentive Plan which shares vest in 36 equal monthly installments with the first installment vesting on the date of grant.

 

On May 18, 2020, the Company issued 6,250 shares of common stock upon exercise of warrants issued to an investor on February 2, 2018, which resulted in gross proceeds of $6,250.

 

On June 3, 2020, the Company issued 12,500 shares of common stock upon exercise of warrants issued to an investor on November 20, 2017, which resulted in gross proceeds of $12,500.

 

During the six months ended June 30, 2020, the Company issued an aggregate of 4,716 shares of the Company’s common stock to members of the Company’s Board for services rendered.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Public Offering of Securities

 

On March 24, 2020 (the “UA Effective Date”), the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Laidlaw & Company (UK) Ltd. (“Laidlaw”), the representative of the underwriters, relating to a best efforts underwritten public offering of 1,449,275 shares (the “Shares”) of the Company’s common stock at a public offering price of $3.45 per Share. The Company received net proceeds of approximately $4.2 million, after deducting the underwriting discount and offering expenses.

 

In connection with the offering, the Company issued Laidlaw warrants to purchase up to 72,464 shares of the Company’s common stock, representing 5% of the aggregate number of Shares sold in the offering. The Warrants will be exercisable for a period of five years from the UA Effective Date at a price per share equal to $4.14 (120% of the public offering price per Share) and are exercisable on a “cashless” basis. The Company has reimbursed Laidlaw for certain of its out-of-pocket expenses incurred in connection with the offering.

 

On May 21, 2020 (the “Benchmark Effective Date”), the Company entered into another underwriting agreement (the “May Underwriting Agreement”) with The Benchmark Company, LLC (“Benchmark”), as representative of the several underwriters, relating to the public offering of 1,818,182 shares of the Company’s common stock at a price to the public of $2.75 per share. The Company received net proceeds of approximately $4.5 million, after deducting the underwriting discount and offering expenses.

 

In connection with the offering, the Company issued Benchmark warrants to purchase 90,909 shares of the Company’s common stock. The warrants are exercisable for a period of five years commencing six months from the Effective Date at a price per share equal to $2.75 and are exercisable on a “cashless” basis.

 

Restricted Stock Awards

 

On April 15, 2020, the Company issued each of two directors 3,333 shares of the Company’s common stock pursuant to the Company’s 2018 Equity Incentive Plan which shares vest in 36 equal monthly installments with the first installment vesting on the date of grant.

 

A summary of the Company’s restricted stock grants under the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) during the six months ended June 30, 2020 is as follows: 

 

		Number of Units				Weighted Average Grant Day Fair Value
Nonvested at December 31, 2019			13,200			$	0.25
Granted			6,666				3.00
Vested			(4,716	)			0.57
Nonvested at June 30, 2020			15,150			$	1.36

 

As of June 30, 2020, the Company had approximately $16,000 of unrecognized stock-based compensation expense which was related to restricted stock awards. The weighted average remaining contractual terms of unvested restricted stock awards is approximately 1.36 years at June 30, 2020.

 

Stock Options

  

A summary of option activity under the Company’s stock option plan for six months ended June 30, 2020 is presented below: 

 

		Number of Shares				Weighted Average Exercise Price				Total Intrinsic Value				Weighted Average Remaining Contractual Life (in years)
Outstanding as of December 31, 2019			525,000			$	5.32			$	457,250				9.4
Outstanding as of June 30, 2020			525,000			$	5.32			$	-				8.9
Options vested and exercisable			525,000			$	5.32			$	-				8.9

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Warrants

 

Pursuant to the Patent License Agreement between the Company and GWU dated February 1, 2020, on February 27, 2020 (the “Date of Issuance”), the Company issued GWU warrants to purchase up to 22,988 shares of the Company’s common stock at an exercise price of $4.35 per share. The warrants vest as follows: 20% upon the Date of Issuance and the balance, or 80% of the warrants shall vest in four equal annual installments of 20% on each anniversary of the Date of Issuance.

 

In connection with the private placement of securities discussed above, the Company granted to Laidlaw and Benchmark warrants to purchase up to 72,464 and 90,909 shares of the Company’s common stock, respectively.

 

A summary of warrant activity for the six months ended June 30, 2020 is as follows: 

 

		Number of Warrants				Weighted Average Exercise Price				Total Intrinsic Value				Weighted Average Remaining Contractual Life (in years)
Outstanding as of December 31, 2019			1,032,692			$	2.91			$	3,725,745				4.2
Issued			186,361				3.49				-				5.9
Exercised			(56,250	)			1.00				-				-
Outstanding as of June 30, 2020			1,162,803			$	3.09			$	1,478,812				4.2
Warrants exercisable as of June 30, 2020			1,072,254			$	3.06			$	1,478,812				3.8

 

The Company has determined that the warrants should be accounted as a component of stockholders’ equity.

 

Stock Based Compensation

 

Stock-based compensation expense for the three and six months ended June 30, 2020 and 2019 was as follows:

 

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2020				2019				2020				2019
Employee stock option awards		$	-			$	-			$	-			$	199,181
Employee restricted stock awards			6,397				2,761				7,762				6,289
Non-employee stock warrant awards			9,683				84,605				32,015				84,605
		$	16,080			$	87,366			$	39,777			$	290,075

 

Employee related stock-based compensation is recognized as “compensation and related expenses”, non-employee related stock-based compensation is recognized as “professional fees” or “research and development - licenses acquired” in the condensed statements of operations and comprehensive loss. 

 

Note 8-Commitments and contingencies

 

Office lease

 

The Company leases office space for approximately $2,000 a month. Rent expense for the six months ended June 30, 2020 and 2019 was approximately $11,000 and $15,000, respectively.

 

Litigation

 

From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 9-Risk and Uncertainties

 

The outbreak of the novel Coronavirus (COVID-19) has evolved into a global pandemic. The Coronavirus has spread to many regions of the world. The extent to which the Coronavirus impacts the Company’s business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the Coronavirus and the actions to contain the Coronavirus or treat its impact, among others.

 

As a result of the continuing spread of the Coronavirus, certain aspects of the Company’s business operations have been delayed, and the Company may be subject to additional delays or interruptions. Specifically, as a result of the shelter-in-place orders and other mandated local travel restrictions, among other things, the research and development activities of certain of the Company’s partners have been affected, resulting in delays to the Company’s clinical trials, and the Company can provide no assurance as to when such trials will resume at this time or the revised timeline to complete trials once resumed.

 

Furthermore, site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic. If the Coronavirus continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols. For example, quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and the Company may be unable to conduct its clinical trials. Further, if the spread of the Coronavirus pandemic continues and our operations are adversely impacted, the Company risks a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully recoverable or adequately covered by insurance.

 

Infections and deaths related to the pandemic may disrupt the United States’ healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, the Company’s clinical trials. It is unknown how long these disruptions could continue, were they to occur. Any elongation or de-prioritization of the Company’s clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of the Company’s product candidates.

 

The Company currently utilizes third parties to, among other things, manufacture raw materials. If any third-party party in the supply chain for materials used in the production of the Company’s product candidates are adversely impacted by restrictions resulting from the Coronavirus outbreak, the Company’s supply chain may be disrupted, limiting the Company’s ability to manufacture its product candidates for its clinical trials and research and development operations.

 

The spread of the Coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material economic effect on the Company’s business. While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of the Coronavirus could materially and adversely affect the Company’s business and the value of its common stock.

 

The ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, its clinical trials, its research programs, healthcare systems or the global economy as a whole. However, these effects could have a material impact on the Company’s operations, and the Company will continue to monitor the situation closely.

 

Note 10-Subsequent events

 

Option Grants

 

On July 8, 2020, the compensation committee of the Board of Directors approved the issuance of ten-year options to purchase up to 49,212 shares of the Company’s common stock at an exercise price of $2.54 per share pursuant to the 2018 Plan to an advisor for services to be rendered.

 

On July 21, 2020, the Company’s Board of Directors approved the issuance of ten-year options to purchase an aggregate of 200,000 shares of the Company’s common stock at an exercise price of $3.05 per share pursuant to the 2018 Plan to directors and certain officers of the Company in consideration for services rendered.

 

 

Hoth Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Isoprene Sublicense Agreement

 

On July 30, 2020 (the “Isoprene Effective Date”), the Company entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with Isoprene Pharmaceutics, Inc. (“Isoprene”) pursuant to the Commercial Evaluation Sublicense and Option Agreement. Pursuant to the Isoprene Sublicense Agreement, Isoprene granted the Company an exclusive sublicense to certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii) in connection therewith, to use certain inventions and licensed materials and (iii) to practice the Patent Rights (as defined in the Isoprene Sublicense Agreement) for the treatment of dermatological conditions or diseases, excluding among, other things, dermatological oncology conditions or diseases. The Isoprene Sublicense Agreement will continue on a country-by-country basis until the expiration of the last to expire of the Patent Rights in such country, unless earlier terminated pursuant to the Isoprene Sublicense Agreement (the “Isoprene Term”). Pursuant to the Isoprene Sublicense Agreement, the Company shall pay Isoprene, among other things, (i) a license fee, (ii) a royalty rate at a middle single digit percentage, (iii) milestone payments of up to $1,375,000 and (iv) revenue interest at a low single digit percentage based on the net revenue of covered products sold by Isoprene during the Isoprene Term. In addition, the Company shall make an investment of $50,000 in Isoprene in the form of a convertible promissory note within 30 days of the Isoprene Effective Date and shall pay Isoprene a middle double digit percentage of all patent expenses incurred after the Isoprene Effective Date during the Isoprene Term.

 

George Washington University Patent License Agreement

 

On August 7, 2020 (the “GWU Effective Date”), the Company entered into a Patent License Agreement (the “GWU Patent License Agreement”) with the GWU. Pursuant to the GWU Patent License Agreement, GWU granted the Company an exclusive, worldwide, royalty bearing license to certain intellectual property that can be used to develop a device designed to detect the presence of SARS-CoV-2. Specifically, the GWU Patent License Agreement permits the Company  to make, have made, use, import, offer for sale and sell Licensed Products (as defined in the GWU Patent License Agreement) in the field of virus sensing and detection. The GWU Patent License Agreement shall commence on the GWU Effective Date and shall continue until the later of: (a) the expiration or abandonment of the last patent to expire or become abandoned of the Patent Rights (as defined in the GWU Patent License Agreement); or (b) ten years after the first Sale (as defined in the GWU Patent License Agreement) of the first Licensed Product if no patent has issued from the Patent Rights, unless terminated earlier pursuant to the terms of the agreement. Pursuant to the GWU Patent License Agreement, the Company shall pay GWU: (i) an upfront license initiation fee, (ii) annual maintenance fees commencing on the first anniversary of the GWU Effective Date, (iii) milestone payments ranging from the low to mid five figures, (iv) running royalty payments at a middle single digit percentage of Net Sales (as defined in the GWU License Agreement), (iv) quarterly minimum payments ranging from the low four figures for the first four quarters after the first sale to low five figures commencing three years after the first sale and (v) an annual diligence fee of high five figures. In addition, the Company has agreed to reimburse GWU for certain past and future patent filing and prosecution costs. The Company has also agreed to issue GWU ten year warrants to purchase up to 72,463 shares of the Company’s common stock at an exercise price of $2.76 per share, which warrants will vest on the following schedule: 20% at issuance, 20% each year thereafter, resulting in 100% vesting 4 years after issuance.

 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

You should read the following discussion and analysis of our financial condition and results of operations together with and our financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as amended by our Quarterly Reports on Form 10-Q. All amounts in this report are in U.S. dollars, unless otherwise noted.

 

Overview

 

We are a clinical-stage biopharmaceutical company incorporated in May 2017 focused on developing new generation therapies for dermatological disorders. We believe that our pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis (also known as eczema), chronic wounds, psoriasis, asthma and acne.

 

Our primary asset is a license agreement with the University of Cincinnati which was assigned to us by Chelexa Biosciences, Inc. on May 14, 2020 pursuant to which the University of Cincinnati has granted us an exclusive license to make, use, have made, import, offer for sale, and sell products based upon or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm formation (the “BioLexa Platform” or “BioLexa”). The license enables us to develop the platform for any indications in humans. Our initial focus will be on the treatment of eczema through the application of a topical cream. Although our initial focus will be on the treatment of eczema, we intend to develop a second topical cream which, upon application, is intended to reduce post-procedure infections, accelerate healing and improve clinical outcomes for patients undergoing aesthetic dermatology procedures. In addition, we conducted an initial pilot study on the efficacy of BioLexa to accelerate diabetic wound healing and intend to conduct additional studies with respect to the regenerative effects of the BioLexa Platform in the context of chronic diabetic ulcers, with and without substantial bacterial burden. The BioLexa Platform combines a U.S. Food and Drug Administration (“FDA”) approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts which trigger symptoms. To management’s knowledge, it is the first product candidate intended to prevent the symptom triggering flare-ups rather than simply treating symptoms when they occur.

 

We intend to initially use the BioLexa Platform to develop two different topical cream products: (i) a product to treat eczema and (ii) a product that reduces post-procedure infections, accelerates healing and improves clinical outcomes for patients undergoing aesthetic dermatology procedures. Eczema is a disease that results in inflammation of the skin and is characterized by rash, red skin, and itchiness. Eczema is also referred to as atopic dermatitis. We are concentrating our effort and resources to develop the BioLexa Platform, utilizing our novel formulation and approach for these two markets.

 

The BioLexa Platform has achieved positive results in its initial pre-clinical studies conducted at the University of Miami. BioLexa’s formulation is a new topical dosage form “repurposing” the antibiotic, enabling it to be developed for use in patients following a special regulatory pathway codified in Section 505(b)(2) of the FDA rules. Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act was enacted to enable sponsors to seek New Drug Application (“NDA”) approval for novel repurposed drugs without the need for such sponsors to undertake time consuming and expensive pre-clinical safety studies and Phase 1 safety studies. Proceeding under this regulatory pathway, we will be able to rely upon all of the publicly available safety and toxicology data with respect to gentamicin and zinc chelator in our FDA submissions. We will be required to conduct a Phase 2 study to show the safety of the combination in humans and after such Phase 2 study will be required to proceed to Phase 3 pivotal clinical trials. We believe that this path will dramatically reduce the required clinical development effort, costs and risks as compared to what would be required of us if we were required to conduct pre-clinical safety, toxicology and animal studies together with Phase 1 human safety trials required for new chemical entities which are not eligible to be reviewed pursuant to the Section 505(b)(2) regulatory pathway. We estimate that by using the Section 505(b)(2) regulatory pathway, that the clinical development process may be five to six years shorter than is required for a new chemical entity, and the FDA approval process may be six to nine months shorter than the typical eighteen month period, which we believe may result in lower development costs and shorter development time. As of the date hereof, we have not submitted an NDA to the FDA. In September 2018, we attended the first of a planned series of meetings with the FDA to review the requirements for submission and activation of an investigational new drug application (“IND”) with respect to the BioLexa Platform for use in eczema. In preparation for such pre-IND meeting, we prepared and presented to the FDA our proposed Phase 2 clinical trial plan for the treatment of eczema in patients over the age of one year old. As part of our pre-IND meeting, the FDA provided us with general guidance with respect to specific animal studies, dosing schedules and suggested human safety studies before we commence clinical trials in pediatric or adult patients. We are currently investigating multiple potential venues for conducting such trial both in and outside of the U.S. We have engaged Camargo Pharmaceutical Services, LLC (“Camargo”) to assist us with the FDA process required for Section 505(b)(2) applications and with the evaluation of potential clinical trial venues for the proof of concept study should we determine to undertake such study. Specifically, Camargo has provided and will continue to provide advice and guidance relative to the IND preparation phase for the BioLexa Platform. Camargo will assist us with the refinement of our non-clinical, clinical, clinical pharmacology and biopharmaceutics strategy incorporating the preliminary feedback we received from the FDA during our pre-IND meeting.

 

 

We believe that the key elements for our market success with respect to BioLexa include:

 

	●	the proprietary formulation of two FDA-approved drugs to treat bacterial proliferation reduces development time and costs by giving us the ability to rely on safety and efficacy data from the two approved drugs;
	●	our proprietary formulation is not a topical corticosteroid, and may not be subject to the same FDA black box warning issues as most commonly prescribed treatments currently in use; and
	●	a recent peer-reviewed publication titled “Staphylococcal Bacteria May Cause Eczema, Study Reveals”, published by Dr. Herbert B. Allen, highlights that staph-induced biofilms are the root cause of flare-ups in eczema. Our BioLexa product candidate has been demonstrated to prevent the formation of these biofilms with the promise of delaying or completely arresting flare-ups, rather than merely treating symptoms of a flare-up already underway.

 

In addition to our license agreement with the University of Cincinnati, we entered into the following agreements:

 

●

an exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies. The genetic marker licensed by us from the University of Cincinnati may be used to (i) identify at risk infants in predicting food allergies, including peanut and milk allergies, (ii) identify a person’s predisposition to an allergic reaction, thereby avoiding such reaction and (iii) determine an individual’s propensity to develop AD, such as eczema. We intend to utilize the genetic marker for purposes of determining an individual’s propensity to develop eczema as well as to identify and treat allergies in at-risk infants.

 

●

an exclusive sublicense agreement (the “Sublicense Agreement”) with Zylö Therapeutics, Inc. (“Zylö”) pursuant to which Zylö granted us an exclusive sublicense to the Licensed Patent Rights (as defined in the Sublicense Agreement) and the Licensed Technology (as defined in the Sublicense Agreement) to, among other things, develop, make and sell the Licensed Products (as defined in the Sublicense Agreement) and to practice the Licensed Technology in the United States and Canada for any and all therapeutic uses related to lupus in human beings, subject to the Field Expansion Rights (as defined in the Sublicense Agreement).

 

●

a license agreement with North Carolina State University (“NCSU”) pursuant to which NCSU granted us an exclusive license to, among other things, develop, make, use, offer and sell certain licensed products throughout the world with respect to NCSU’s exon skipping approach for treating allergic diseases.

 

	●	a patent license agreement with The George Washington University (“GWU”)  pursuant to which GWU granted us a license to certain patent rights to, among other things, make, use, offer and sell certain licensed products throughout the world with respect to WEG232 as used in treating side effects from drugs used for the treatment of cancer.
	●	an exclusive license agreement (the “VCU License Agreement”) with the Virginia Commonwealth University Intellectual Property Foundation (“VCU”) pursuant to which VCU granted the Company an exclusive, royalty bearing license (the “VCU License”) to a novel peptide developed by researchers at VCU that may be used to slow the transmission of SARS-CoV-2 and a non-exclusive royalty bearing, worldwide license with respect to certain licensed technical information patents to make, have made, use, offer to sell, sell and import the Licensed Products (as defined in the VCU License Agreement) and perform the Licensed Services (as defined in the VCU License Agreement). In addition, we entered into a Sponsored Project Agreement with VCU for the development of a potential COVID-19 treatment using the VCU License to a novel peptide granted to the Company by VCU.

 

In order to generate revenue from our product candidates, we will need to sell our product candidates either through distribution partnerships or through our own sales efforts. Prior to selling our product candidates, we will need to receive FDA approval of our NDA for each indication that we intend to treat. The first indication we are seeking approval for is the BioLexa Platform for treating eczema. We intend to submit our NDA for such indication by mid to late 2022 with approval of such NDA anticipated to be in 2022; however, no assurances can be given that we will receive approval of the NDA in a timely manner, if at all.  

 

 

Agreements with Chelexa BioSciences, Inc.

 

On May 14, 2020, we entered into an Assignment and Assumption Agreement (the “Assignment Agreement”) with Chelexa Biosciences, Inc. (“Chelexa”) pursuant to which Chelexa assigned to us its rights and obligations in and to and liabilities under its license agreement with the University of Cincinnati dated February 27, 2013, as amended (the “University of Cincinnati License Agreement”). In consideration for the assignment, we agreed to forgive all amounts due to us by Chelexa and pay to Chelexa certain royalty payments as set forth in the Royalty Agreement (as defined below).

 

In connection with the Assignment Agreement, on May 14, 2020, we entered into a novation agreement (the “Novation Agreement”) with Chelexa and the University of Cincinnati pursuant to which the parties agreed that we would be substituted in place of Chelexa with respect to the rights and obligations of Chelexa set forth in the University of Cincinnati License Agreement.

 

In connection with the Assignment Agreement, on May 14, 2020, we entered into a royalty agreement (the “Royalty Agreement”) with Chelexa pursuant to which we shall pay Chelexa sales-based royalties at percentages which range from mid to high single digits, with high sales volumes being subject to lower royalty rates and total milestone payments of $3.5 million. The Royalty Agreement will continue until the earlier of May 31, 2025 or the last to expire patent in the Patent Rights (as defined in the Royalty Agreement), unless sooner terminated pursuant to the terms of the Royalty Agreement. In addition, the Royalty Agreement may be terminated by Chelexa upon written notice to the Company.

 

Recent Developments

 

Isoprene Pharmaceuticals, Inc. Sublicense Agreement

 

On July 30, 2020 (the “Isoprene Effective Date”), we entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with Isoprene Pharmaceutics, Inc. (“Isoprene”) pursuant to the Commercial Evaluation Sublicense and Option Agreement we entered into with the University of Maryland, Baltimore (“UMD”) and Isoprene dated March 8, 2019. Pursuant to the Isoprene Sublicense Agreement, Isoprene granted us an exclusive sublicense to certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii) in connection therewith, to use certain inventions and licensed materials and (iii) to practice the Patent Rights (as defined in the Isoprene Sublicense Agreement) for the treatment of dermatological conditions or diseases, excluding among, other things, dermatological oncology conditions or diseases. The Isoprene Sublicense Agreement will continue on a country-by-country basis until the expiration of the last to expire of the Patent Rights in such country, unless earlier terminated pursuant to the Isoprene Sublicense Agreement (the “Isoprene Term”). Pursuant to the Isoprene Sublicense Agreement, we shall pay Isoprene, among other things, (i) a license fee, (ii) a royalty rate at a middle single digit percentage, (iii) milestone payments of up to $1,375,000 and (iv) revenue interest at a low single digit percentage based on the net revenue of covered products sold by Isoprene during the Isoprene Term. In addition, we shall make an investment of $50,000 in Isoprene in the form of a convertible promissory note within 30 days of the Isoprene Effective Date and shall pay Isoprene a middle double digit percentage of all patent expenses incurred after the Isoprene Effective Date during the Isoprene Term.

 

George Washington University Patent License Agreement

 

On August 7, 2020 (the “GWU Effective Date”), we entered into a Patent License Agreement (the “GWU Patent License Agreement”) with the GWU. Pursuant to the GWU Patent License Agreement, GWU granted us an exclusive, worldwide, royalty bearing license to certain intellectual property that can be used to develop a device designed to detect the presence of SARS-CoV-2. Specifically, the GWU Patent License Agreement permits us  to make, have made, use, import, offer for sale and sell Licensed Products (as defined in the GWU Patent License Agreement) in the field of virus sensing and detection. The GWU Patent License Agreement shall commence on the GWU Effective Date and shall continue until the later of: (a) the expiration or abandonment of the last patent to expire or become abandoned of the Patent Rights (as defined in the GWU Patent License Agreement); or (b) ten years after the first Sale (as defined in the GWU Patent License Agreement) of the first Licensed Product if no patent has issued from the Patent Rights, unless terminated earlier pursuant to the terms of the agreement. Pursuant to the GWU Patent License Agreement, we shall pay GWU: (i) an upfront license initiation fee, (ii) annual maintenance fees commencing on the first anniversary of the GWU Effective Date, (iii) milestone payments ranging from the low to mid five figures, (iv) running royalty payments at a middle single digit percentage of Net Sales (as defined in the GWU License Agreement), (iv) quarterly minimum payments ranging from the low four figures for the first four quarters after the first sale to low five figures commencing three years after the first sale and (v) an annual diligence fee of high five figures. In addition, we have agreed to reimburse GWU for certain past and future patent filing and prosecution costs. We have also agreed to issue GWU ten year warrants to purchase up to 72,463 shares of our common stock at an exercise price of $2.76 per share, which warrants will vest on the following schedule: 20% at issuance, 20% each year thereafter, resulting in 100% vesting 4 years after issuance.

 

 

COVID-19

 

The outbreak of the novel Coronavirus (COVID-19) has evolved into a global pandemic, and the Coronavirus has spread to many regions of the world. The extent to which the Coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the Coronavirus and the actions to contain the Coronavirus or treat its impact, among others.

 

As a result of the continuing spread of the Coronavirus, certain aspects of our business operations have been delayed, and we may be subject to additional delays or interruptions. Specifically, as a result of the shelter-in-place orders and other mandated local travel restrictions, among other things, the research and development activities of certain of our partners have been affected, resulting in delays to our clinical trials, and we can provide no assurance as to when such trials will resume at this time or the revised timeline to complete trials once resumed.

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2020 and 2019

 

Operating Costs and Expenses

 

Research and Development Expenses

 

For the three months ended June 30, 2020, research and development expenses were approximately $1.3 million, of which approximately $0.4 million was related to licenses acquired and approximately $0.9 million was related to other research and development expenses.

 

For the three months ended June 30, 2019, research and development expenses were approximately $0.4 million, of which $10,000 was related to a term sheet entered into between the Company and Zylö Therapeutics Inc. (the “Zylö Term Sheet”) and approximately $0.4 million was related to other research and development expenses.

 

We expect our research and development activities to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with the following:

 

●

employee-related expenses, which include salaries and benefits, and rent expenses;

 

●

fees  and other expenses related to in-licensed products and technology;

 

●

expenses incurred under agreements with contract research organizations, investigative sites and consultants that conduct our clinical trials and a substantial portion of our preclinical activities;

 

●

the cost of acquiring and manufacturing clinical trial materials; and

 

●

costs associated with non-clinical activities, and regulatory approvals.

 

Compensation, Professional Fees, Rent and Other (“General and Administrative Expenses”)

 

For the three months ended June 30, 2020, General and Administrative Expenses were approximately $1.2 million, which primarily consisted of approximately $0.4 million related to payroll expenses and stock-based compensation, approximately $0.8 million for professional fees and approximately $91,000 for rent and other expenses.

 

For the three months ended June 30, 2019, General and Administrative Expenses were approximately $0.9 million, which primarily consisted of approximately $0.1 million related to payroll expenses and stock-based compensation, approximately $0.5 million for professional fees and approximately $0.2 million for other expenses.

 

 

We anticipate that our General and Administrative Expenses will increase in future periods, reflecting continued and increasing costs associated with:

 

●

support of our research and development activities;

 

●

stock compensation granted to key employees and non-employees;

 

●

support of business development activities; and

 

●

increased professional fees and other costs associated with the regulatory requirements.

 

Comparison of the Six Months Ended June 30, 2020 and 2019

 

Operating Costs and Expenses

 

Research and Development Expenses

 

For the six months ended June 30, 2020, research and development expenses were approximately $2.0 million, of which approximately $0.4 million was related to licenses acquired and approximately $1.5 million was related to other research and development expenses.

 

For the six months ended June 30, 2019, research and development expenses were approximately $0.5 million, of which $10,000 was related to the Zylö Term Sheet, an aggregate of $10,000 was related to a license acquired from UMD and Isoprene, and approximately $0.4 million was related to other research and development expenses.

 

Compensation, Professional Fees, Rent and Other

 

For the six months ended June 30, 2020, General and Administrative Expenses were approximately $2.4 million, which primarily consisted of approximately $0.6 million related to payroll expenses and stock-based compensation, approximately $1.6 million for professional fees and approximately $0.2 million for other expenses.

 

For the six months ended June 30, 2019, General and Administrative Expenses were approximately $1.6 million, which primarily consisted of approximately $0.5 million related to payroll expenses and stock-based compensation, approximately $0.8 million for professional fees and approximately $0.3 million for other expenses.

 

Liquidity and Capital Resources

 

We have incurred substantial operating losses since inception, and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of June 30, 2020, we had cash of approximately $4.9 million, marketable securities of approximately $2.0 million, working capital of approximately $6.8 million and an accumulated deficit of approximately $16.4 million.

 

Our current cash is sufficient to fund operations for at least the next 12 months; however, we will need to raise additional funding through strategic relationships, public or private equity or debt financings, grants or other arrangements to develop and seek regulatory approvals for our existing and new product candidates. If such funding is not available, or not available on terms acceptable to us, our current development plan and plans for expansion of our general and administrative infrastructure may be curtailed. 

 

Cash Flows from Operating Activities

 

For the six months ended June 30, 2020, net cash used in operations was approximately $4.0 million, which primarily resulted from a net loss of approximately $4.3 million.

 

For the six months ended June 30, 2019, net cash used in operations was $1.8 million, which primarily resulted from a net loss of $2.1 million.

 

Cash Flows from Investing Activities

 

For the six months ended June 30, 2020, net cash used in investing activities was approximately $1.7 million, which was primarily related to the purchase of marketable securities of $1.5 million and purchase of investments in HaloVax and Zylö of $0.4 million, partially offset by the sale of marketable securities of $0.3 million.

 

For the six months ended June 30, 2019, net cash used in investing activities was $20,000, which was related to the purchase of research and development licenses.

 

 

Cash Flows from Financing Activities

 

For the six months ended June 30, 2020, net cash provided by financing activities was approximately $8.7 million. The cash provided by financing activities primarily resulted from approximately $8.7 million in net proceeds from the issuance of common stock and warrants.

 

For the six months ended June 30, 2019, net cash provided by financing activities was $5.8 million, including $0.2 million restricted cash, from the net proceeds of the our initial public offering (the “IPO”). The $0.2 million restricted cash has been deposited into a third-party escrow account in order to provide a source of funding for certain indemnification obligations the Company has pursuant to its Qualified Independent Underwriter Engagement Agreement.

 

On February 20, 2019, we closed the IPO pursuant to which we issued 1,250,000 shares of our common stock for net proceeds of approximately $5.8 million, after deducting underwriting discounts and commissions and offering expenses.

 

Off-Balance Sheet Arrangements; Commitments and Contractual Obligations

 

As of June 30, 2020, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K and did not have any commitments or contractual obligations.

 

JOBS Act

 

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

 

We have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.

 

 

Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the IPO; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act

 

ITEM 4. CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of June 30, 2020, our disclosure controls and procedures were effective.

 

Changes in Internal Control

 

There were no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on Effectiveness of Controls and Procedures

 

In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

 

 

PART II — OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.

 

ITEM 1A. RISK FACTORS.

 

Risk factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual Report. Except as set forth below, there have been no material changes in our risk factors from those previously disclosed in our Annual Report. You should carefully consider the risks described in our Annual Report, which could materially affect our business, financial condition or future results. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. If any of the risks actually occur, our business, financial condition, and/or results of operations could be negatively affected.

 

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

 

We depend upon the success of the BioLexa Platform, which has not yet demonstrated efficacy in Phase 2 clinical trials, as well as our other licensed products and technologies. If we are unable to generate revenues from the BioLexa Platform or our other licensed products and technologies, our ability to create stockholder value will be limited.

 

We intend to conduct our first Phase 1 study in healthy adults with an immediate transition to a randomized, vehicle controlled Phase 1b trial in adolescent eczema patients comparing BioLexa to the base vehicle. Following our Phase 1b trial, we intend to conduct up to two Phase 2 trials in atopic dermatitis patients comparing BioLexa to the base vehicle. We expect the clinical program to be completed, subject to receipt of funding by us, by the end of 2020 or early 2021 with an NDA submission targeted for mid to late 2021.

 

In addition, we have licensed a genetic marker for food allergies, products and technology for therapeutic uses related to lupus in human beings, patents related to an exon skipping approach for treating allergic diseases, patents related to WEG232 which is used to treat side effects from drugs used for the treatment of cancer, a license to a novel peptide that may be used to slow the transmission of SARS-CoV-2 and a sublicense to a novel retinamides for the treatment of certain dermatological diseases.  Furthermore, we formed a joint venture entity, HaloVax, LLC (“HaloVax”), with Voltron Therapeutics, Inc. (“Voltron”) to commence preclinical studies for the development of vaccine prospects for Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center at The General Hospital Corporation (d/b/a Massachusetts General Hospital) (“Mass Gen”). We do not generate revenues from any drug products. We may not be successful in obtaining acceptance from the regulatory authorities to start our clinical trials. If we do not obtain such acceptance, the time in which we expect to commence clinical programs for any product candidate will be extended and such extension will increase our expenses and increase our need for additional capital. Moreover, there is no guarantee that our clinical trials will be successful or that we will continue clinical development in support of an approval from the regulatory authorities for any indication. We note that most drug candidates never reach the clinical stage and even those that do commence clinical development have only a small chance of successfully completing clinical development and gaining regulatory approval. Therefore, our business currently depends entirely on the successful development, regulatory approval and commercialization of our product candidates, which may never occur.

 

 

Risks Relating to Our Intellectual Property Rights

 

We rely on licenses granted to us by the University of Cincinnati, Zylö, NCSU, GWU, Voltron, VCU and Isoprene (collectively, the “Licensors”), and if such licensors do not adequately defend such licenses, our business may be harmed.

 

Our primary asset is a license agreement with the University of Cincinnati pursuant to which the University of Cincinnati granted us an exclusive license to use its BioLexa Platform, a proprietary, patented, drug compound platform. The license enables us to develop the platform for any indications in humans. In addition, we entered into (i) an exclusive license agreement with the University of Cincinnati with respect to a patented, novel genetic marker for food allergies; (ii) the Sublicense Agreement with Zylö in connection with the development of a treatment for patients suffering from CLE including patents with respect thereto developed by Albert Einstein College of Medicine; (iii) a license agreement with NCSU with respect to NCSU’s exon skipping approach for treating allergic diseases; (iv) a license agreement with GWU with respect to WEG232 as used in treating side effects from drugs used for the treatment of cancer; (v) a Royalty and Development Agreement (the “Voltron Agreement”) with Voltron with respect to the formation of HaloVax, a joint venture entity formed to commence preclinical studies for the development of vaccine prospects for Coronavirus (COVID-19), (vi) the VCU License Agreement with respect to a novel peptide that may be used to slow the transmission of SARS-CoV-2 and (vi) the Isoprene Sublicense Agreement with respect to a novel retinamides for the treatment of certain dermatological disease (the “Isoprene Retinamides”) (collectively, the “Hoth Licensed Products”). We rely on the Licensors to protect the intellectual property, including the patents, covered by our licenses. We have limited control over the activities of the Licensors or over any other intellectual property that may be related to the Hoth Licensed Products. For example, we cannot be certain that activities by the Licensors have been or will be conducted in compliance with applicable laws and regulations. We may have no control or input over whether, and in what manner, the Licensors may enforce or defend patents against a third-party. The Licensors may enforce or defend patents less vigorously than if we had enforced or defended the patents ourselves. Further, the Licensors may not necessarily seek enforcement in scenarios in which we would feel that enforcement was in our best interests. For example, the Licensors may not enforce the patents against a competitor of ours who is not a direct competitor of the Licensors. Furthermore, if we fail to meet our obligations to our Licensors, our Licensors may terminate our licenses, and we will be unable to continue to use the Hoth Licensed Products in our business. Although we may choose to terminate our license agreements, doing so may allow a third party to seek and obtain an exclusive license to the Hoth Licensed Products. If a third party obtains an exclusive license to intellectual property with respect to the Hoth Licensed Products, then the third party may seek to enforce the intellectual property against us which may have a material adverse effect on our business.

 

We are dependent upon Zylö with respect the development of a treatment for patients suffering from CLE, Voltron with respect to the development of a treatment for Coronavirus (COVID-19) and Isoprene with respect to the development of a treatment for certain dermatological diseases; however, we have no control over the license agreement between Zylö and Albert Einstein College of Medicine, the license agreement between Voltron and Mass Gen and the license agreement between Isoprene and UMD.

 

Our agreements with Zylö, Voltron and Isoprene are subject to many risks and uncertainties. Although we are dependent on Zylö with respect the development of a treatment for patients suffering from CLE, Voltron with respect the development of a treatment for Coronavirus (COVID-19) and Isoprene with respect to the development of a treatment for certain dermatological diseases, we have no control over the license agreement between Zylö and Albert Einstein College of Medicine pursuant to which Albert Einstein College of Medicine licensed certain patent rights relating to CLE to Zylö, Voltron and Mass Gen pursuant to which Mass Gen licensed certain patent rights relating to VaxCelerate, a self-assembling vaccine platform, to Voltron or Isoprene and UMD pursuant to which UMD licensed certain patent rights relating to the Isoprene Retinamides for certain dermatological diseases to Isoprene. In the event that Zylö is unable to fulfill its obligations to Albert Einstein College of Medicine pursuant to the terms of its license agreement, Albert Einstein College of Medicine may terminate the license thereby voiding the Sublicense Agreement. Similarly, in the event that Voltron is unable to fulfill its obligations to Mass Gen pursuant to the terms of its license agreement, Mass Gen may terminate the license thereby voiding the Voltron Agreement. Furthermore, in the event Isoprene is unable to fulfill its obligations to UMD pursuant to the terms of its license agreement, UMD may terminate the license thereby voiding the Isprene Agreement. In the event that the license agreement between Zylö and Albert Einstein College of Medicine, the license between Voltron and Mess Gen is or the license agreement between Isoprene and UMD is terminated, there may be a material adverse effect upon our business.

 

 

Risks Related to the Company

 

Our business may be adversely affected by the ongoing Coronavirus pandemic.

 

The outbreak of the novel Coronavirus (COVID-19) has evolved into a global pandemic. The Coronavirus has spread to many regions of the world. The extent to which the Coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the Coronavirus and the actions to contain the Coronavirus or treat its impact, among others.

 

As a result of the continuing spread of the Coronavirus, certain aspects of our business operations have been delayed, we may be subject to additional delays or interruptions. Specifically, as a result of the shelter-in-place orders and other mandated local travel restrictions, among other things, the research and development activities of certain of our partners have been affected, resulting in delays to our clinical trials, and we can provide no assurance as to when such trials will resume at this time or the revised timeline to complete trials once resumed.

 

Furthermore, site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic. If the Coronavirus continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols. For example, quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable to conduct our clinical trials. Further, if the spread of the Coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully recoverable or adequately covered by insurance.

 

Infections and deaths related to the pandemic may disrupt the United States’ healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials. It is unknown how long these disruptions could continue, were they to occur. Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

 

We currently utilize third parties to, among other things, manufacture raw materials. If any third-party party in the supply chain for materials used in the production of our product candidates are adversely impacted by restrictions resulting from the Coronavirus outbreak, our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research and development operations.

 

The spread of the Coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of the Coronavirus could materially and adversely affect our business and the value of our common stock.

 

The ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects could have a material impact on our operations, and we will continue to monitor the situation closely.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

During the six months ended June 30, 2020, the Company issued an aggregate of 4,716 shares of the Company’s common stock to members of the Company’s Board for services rendered.

 

On May 18, 2020, the Company issued 6,250 shares of common stock upon exercise of warrants issued to an investor in February 2018, which resulted in gross proceeds of $6,250.

 

On June 3, 2020, the Company issued 12,500 shares of common stock upon exercise of warrants issued to an investor in November 2017, which resulted in gross proceeds of $12,500.

 

The foregoing issuances were exempt from registration under Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

Not applicable.

 

 

ITEM 5. OTHER INFORMATION.

 

None. 

  

ITEM 6. EXHIBITS.

 

Exhibit No.		Description
4.1		Form of Warrant (Incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed on May 22, 2020)
10.1##		Exclusive License Agreement between the Company and Virginia Commonwealth University Intellectual Property Foundation dated May 18, 2020 (Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed on May 19, 2020)
10.2		Membership Interest Purchase Agreement by and between the Company and HaloVax, LLC dated May 28, 2020 (Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed on May 29, 2020)
10.3*##		License Agreement by and between the University of Cincinnati and Chelexa BioSciences, Inc. dated February 27, 2013 assigned to the Company on May 14, 2020
10.4*##		First Amendment to Exclusive License Agreement by and between the University of Cincinnati and Chelexa BioSciences, Inc. dated April 17, 2013 assigned to the Company on May 14, 2020
10.5*##		Second Amendment to Exclusive License Agreement by and between the University of Cincinnati and Chelexa BioSciences, Inc. dated February 27, 2013 assigned to the Company on May 14, 2020
10.6*		Assignment and Assumption Agreement by and between the Company and Chelexa BioSciences, Inc. dated May 14, 2020
10.7*##		Royalty Agreement by and between the Company and Chelexa BioSciences, Inc. dated May 14, 2020
10.8*		Novation Agreement by and among the Company, Chelexa BioSciences, Inc. and the University of Cincinnati dated May 14, 2020
10.9##		Patent License Agreement by and between the Company and the George Washington University dated August 7, 2020

 

31.1*		Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*		Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*		Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*		Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*		XBRL Instance Document
101.SCH*		XBRL Taxonomy Extension Schema Document
101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		XBRL Taxonomy Extension Presentation Linkbase Document

 

*	Filed herewith.

 

##	Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

	HOTH THERAPEUTICS, INC.
Date:  August 13, 2020	By:	/s/ Robb Knie
		Robb Knie, Chief Executive Officer (Principal Executive Officer)
Date:  August 13, 2020	By:	/s/ David Briones
		David Briones, Chief Financial Officer (Principal Financial and Accounting Officer)

 

 

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