UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

⌧

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

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

For the quarterly period ended September 30, ~~2019~~2020

◻

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

☐~~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 001-36714

JAGUAR HEALTH, INC.

(Exact name of registrant as specified in its charter)

Delaware		46-2956775
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

~~201 Mission~~200 Pine Street, Suite ~~2375~~400

San Francisco, California ~~94105~~94104

(Address of principal executive offices, zip code)

(415) 371-8300

(Registrant’s telephone number, including area code)

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, 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 ☒⌧

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


Title of each class:	Trading Symbol(s)	Name of each exchange on which registered:
Common Stock, Par Value $0.0001 Per Share	JAGX	The NASDAQ Capital Market

As of November ~~8, 2019~~6, 2020 there were ~~10,852,125~~69,441,067 shares of voting common stock, par value $0.0001 per share, outstanding, ~~40,301,237~~21,821,410 shares of non-voting common stock, par value $0.0001 per share, outstanding (convertible into ~~38,382~~20,782 shares of voting common stock), ~~5,524,926~~6,559 shares of Series AB-2 convertible preferred stock, par value $0.0001 per share, outstanding (convertible into 473,565 shares of voting common stock, subject to certain voting restrictions as provided in the Certificate of Designation for the convertible preferred stock), 1,971 shares of Series B convertible preferred stock, par value $0.0001 per share, outstanding (convertible into 985,500 shares of voting common stock, subject to certain voting restrictions as provided in the Certificate of Designation for the convertible preferred stock), and 63 shares of Series B-1 convertible preferred stock, par value $0.0001 per share, outstanding (convertible into 630,0631,246,210 shares of voting common stock, subject to certain restrictions as provided in the Certificate of Designation for the Series B-2 convertible preferred stock)., 571,600 shares of Series C perpetual preferred stock, par value $0.0001 per share, outstanding, and 853,771 shares of Series D perpetual preferred stock, par value $0.0001 per share, outstanding.

Table of Contents

	Page No.
PART I. — FINANCIAL INFORMATION	1
Item 1. ~~Unaudited~~ Condensed Consolidated Financial Statements	1
Condensed Consolidated Balance Sheets	1
Condensed Consolidated Statements of Operations	2
Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ ~~Equity/~~Equity (Deficit)	3
Condensed Consolidated Statements of Cash Flows	67
Notes to ~~the~~ Condensed Consolidated Financial Statements	89
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations	3954
Item 3. Quantitative and Qualitative Disclosures About Market Risk	5878
Item 4. Controls and Procedures	5879
PART II. — OTHER INFORMATION	6081
Item 1. Legal Proceedings	6081
Item 1A. Risk Factors	82
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	6083

Item 3. Defaults upon senior securities	83
Item 4. Mine safety disclosures	83
Item 5. Other Information	6083
Item 6. Exhibits	6184
SIGNATURE	6286

Table of Contents

PART I. — FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

~~(Unaudited)~~


	September 30,		December 31,
	2019		2018

					September 30,		December 31,
(In thousands, except share and per share data)					2020		2019
Assets		(Unaudited)				(unaudited)
Current assets:
Cash	$	2,069,534	$	2,568,191	$	1,349	$	3,495
Restricted cash						—		388
Accounts receivable		1,593,531		995,683		1,505		1,692
Accounts receivable - pledged						3,150		—
Other receivable		—		6,118		3		2
Inventory		2,322,137		3,342,177		2,219		2,129
Operating lease - right-of-use asset						—		553
Prepaid expenses and other current assets		1,563,458		1,237,772		2,497		1,263
Total current assets		7,548,660		8,149,941		10,723		9,522
Property and equipment, net		720,345		760,617		686		710
Operating lease - right-of-use asset		730,840		—
Intangible assets, net		26,445,555		31,710,556		24,759		26,024
Other assets		181,144		420,831		66		154
Total assets	$	35,626,544	$	41,041,945	$	36,234	$	36,410


Liabilities, convertible preferred stock and stockholders' equity
Current liabilities:
Accounts payable	$	4,752,097	$	5,414,260	$	5,456	$	5,352
Accrued liabilities		3,364,021		4,939,441		6,975		2,922
Warrant liability		10,029		220,376		126		3
Convertible debt, net of discount		—		11,239,170
Operating lease liability		442,017		—		—		337
Notes payable, net of discount		—		4,845,575		6,781		6,778
Series D perpetual preferred stock: $0.0001 par value; 977,300 and zero shares authorized at September 30, 2020 and December 31, 2019, respectively; 848,117 and zero shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; (redemption amount of $6,785 and zero at September 30, 2020 and December 31, 2019, respectively; liquidation preference of $6,785 and zero at September 30, 2020 and December 31, 2019, respectively)						6,430		—
Total current liabilities		8,568,164		26,658,822		25,768		15,392
Notes payable long term, net of discount		6,678,461		—
Notes payable long term						2,660		450
Total liabilities	$	15,246,625	$	26,658,822		28,428		15,842


Commitments and contingencies (See Note 6)

Series A convertible preferred stock: $0.0001 par value, 10,000,000 shares authorized at September 30, 2019 and December 31, 2018; 5,524,926 shares issued and outstanding at September 30, 2019 and December 31, 2018; (redemption value and liquidation preference of $12,738,822 and $9,199,002 at September 30, 2019 and December 31, 2018, respectively)	$	9,000,002	$	9,000,002

Stockholders' equity:
Series B convertible preferred stock: $0.0001 par value, 11,000 and zero shares authorized at September 30, 2019 and December 31, 2018, respectively; 1,971 and zero shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively		409,401		—
Common stock - voting: $0.0001 par value, 150,000,000 shares authorized at September 30, 2019 and December 31, 2018, respectively; 9,395,458 and 351,472 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively		940		35
Common stock - non-voting: $0.0001 par value, 50,000,000 shares authorized at September 30, 2019 and December 31, 2018; 40,301,237 shares issued and outstanding at September 30, 2019 and December 31, 2018		4,030		4,030

Series A redeemable convertible preferred stock: $0.0001 par value, zero and 5,524,926 shares authorized at September 30, 2020 and December 31, 2019, respectively; zero and 5,524,926 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; (redemption amount of zero and $12,739 at September 30, 2020 and December 31, 2019, respectively; liquidation preference of zero and $9,199 at September 30, 2020 and December 31, 2019, respectively)						—		9,895

Stockholders' equity
Series B convertible preferred stock: $0.0001 par value, zero and 11,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; zero and 1,971 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively						—		476
Series B-2 convertible preferred stock: $0.0001 par value, 10,165 shares authorized at September 30, 2020 and December 31, 2019; 7,534 and 10,165 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively						916		1,236
Series C perpetual preferred stock: 1,011,000 and zero shares authorized at September 30, 2020 and December 31, 2019, respectively; 849,521 and zero shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; (redemption amount of $6,796 and zero at September 30, 2020 and December 31, 2019, respectively; liquidation preference of $6,796 and zero at September 30, 2020 and December 31, 2019, respectively)						4,773		—
Common stock - voting: $0.0001 par value, 150,000,000 shares authorized at September 30, 2020 and December 31, 2019; 48,862,970 and 14,273,061 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively						5		1
Common stock - non-voting: $0.0001 par value, 50,000,000 shares authorized at September 30, 2020 and December 31, 2019; 40,301,237 shares issued and outstanding at September 30, 2020 and December 31, 2019						4		4
Additional paid-in capital		138,096,378		99,929,835		160,238		142,046
Accumulated deficit		(127,130,832)		(94,550,779)		(158,130)		(133,090)
Total stockholders' equity	$	11,379,917	$	5,383,121		7,806		10,673
Total liabilities, convertible preferred stock and stockholders' equity	$	35,626,544	$	41,041,945	$	36,234	$	36,410

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

~~(Unaudited)~~

(Unaudited)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2019		2018		2019		2018

									Three Months Ended				Nine Months Ended
									September 30,				September 30,
(In thousands, except share and per share data)									2020		2019		2020		2019
Product revenue	$	972,779	$	1,132,067	$	4,268,206	$	2,642,880	$	2,773	$	973	$	6,809	$	4,268
Collaboration revenue		—		—		—		177,389
Total revenue		972,779		1,132,067		4,268,206		2,820,269		2,773		973		6,809		4,268
Operating expenses
Cost of product revenue		947,495		736,733		3,072,800		1,808,918		784		948		2,491		3,073
Research and development		1,307,296		1,481,166		4,426,308		3,843,918		1,522		1,307		4,509		4,426
Sales and marketing		1,698,440		2,716,752		5,436,635		7,119,204		1,529		1,698		4,728		5,436
General and administrative		3,106,633		2,703,628		9,816,909		8,761,776		4,313		3,107		11,218		9,817
Settlement of Tempesta Royalty License Agreement		640,000		—		640,000		—		—		640		—		640
Impairment of indefinite-lived intangible assets		—		—		4,000,000		—		—		—		—		4,000
Series B convertible preferred stock inducement expense										—		—		1,647		—
Series 3 warrants inducement expense										—		—		3,696		—
Total operating expenses		7,699,864		7,638,279		27,392,652		21,533,816		8,148		7,700		28,289		27,392
Loss from operations		(6,727,085)		(6,506,212)		(23,124,446)		(18,713,547)		(5,375)		(6,727)		(21,480)		(23,124)
Interest expense		(1,352,845)		(872,044)		(5,556,953)		(2,185,868)		(581)		(1,353)		(1,259)		(5,557)
Other income (expense)		28,784		9,540		49,392		322,244
Change in fair value of warrants, derivative liability and conversion option liability		841,834		26,231		1,002,865		(119,134)
Gain on Valeant settlement		—		1,204,133		—		1,204,133
Other income, net										194		29		190		49
Change in fair value of financial instruments										(2,104)		842		(2,491)		1,003
Loss on extinguishment of debt		(335,753)		—		(4,940,911)		—		—		(336)		—		(4,941)
Loss before income tax		(7,545,065)		(6,138,352)		(32,570,053)		(19,492,172)		(7,866)		(7,545)		(25,040)		(32,570)
Income tax expense		(10,000)		—		(10,000)		—		—		(10)		—		(10)
Net loss and comprehensive loss		(7,555,065)		(6,138,352)		(32,580,053)		(19,492,172)		(7,866)		(7,555)		(25,040)		(32,580)
Deemed dividend attributable to Series A preferred stock		—		—		—		(995,000)
Deemed dividend attributable to accretion of Series A redeemable convertible preferred stock										(349)		—		(1,332)		—
Deemed dividend attributable to Series B preferred stock		(3,875,778)		—		(3,875,778)		—		—		(3,876)		—		(3,876)
Stock dividend attributable to Series C perpetual preferred stock										(56)		—		(56)		—
Deemed dividend attributable to the Series 1 warrant modification		(252,106)		—		(252,106)		��		—		(252)		—		(252)
Deemed dividend attributable to Series 1, Series 2 and Bridge warrant holders										—		—		(856)		—
Net loss attributable to common shareholders	$	(11,682,949)	$	(6,138,352)	$	(36,707,937)	$	(20,487,172)	$	(8,271)	$	(11,683)	$	(27,284)	$	(36,708)
Net loss per share, basic and diluted	$	(2.00)	$	(37.77)	$	(13.37)	$	(143.25)	$	(0.21)	$	(2.00)	$	(1.03)	$	(13.37)
Weighted-average common shares outstanding, basic and diluted		5,841,790		162,506		2,746,523		143,012		40,218,324		5,841,790		26,467,423		2,746,523

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED ~~STATEMENT~~STATEMENTS OF CHANGES

IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ ~~EQUITY/~~EQUITY(DEFICIT)

~~(Unaudited)~~

(Unaudited)


	Series A			Series B			Series B-2			Series C
	Convertible Preferred Stock			Convertible Preferred Stock			Convertible Preferred Stock			Perpetual Preferred Stock			Common Stock - voting			Common Stock - non-voting			Additional		Accumulated		Total Stockholders'
(In thousands, except share data)	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		paid-in capital		deficit		Equity
Balances as of June 30, 2020	5,524,926	$	10,878	—	$	—	7,534	$	916	—	$	—	32,408,421	$	3	40,301,237	$	4	$	150,885	$	(150,264)	$	1,544
Shares issued on exercise of Series 3 warrants	—		—	—		—	—		—	—		—	8,248,330		1	—		—		5,992		—		5,993
Shares issued on exercise of Series 1 and Series 2 warrants	—		—	—		—	—		—	—		—	1,154,266		—	—		—		565		—		565
Series A convertible preferred stock redeemed and Series C perpetual preferred issued under the exchange transaction	(5,524,926)		(11,227)	—		—	—		—	842,500		4,717	—		—	—		—		150		—		4,867
Stock dividend attributable to Series C perpetual preferred stock of $8 per share	—		—	—		—	—		—	7,021		56	—		—	—		—		(56)		—		—
Shares issued to third party for services	—		—	—		—	—		—	—		—	2,289,474		—	—		—		879		—		879
Shares issued in exchange of CVP Exchange Notes	—		—	—		—	—		—	—		—	4,761,904		1	—		—		1,497		—		1,498
Accretion to redemption value of redeemable preferred stock	—		349	—		—	—		—	—		—	—		—	—		—		(349)		—		(349)
Fractional shares	—		—	—		—	—		—	—		—	20		—	—		—		—		—		—
Shares issued upon exercise of stock options	—		—	—		—	—		—	—		—	555		—	—		—		—		—		—
Stock-based compensation	—		—	—		—	—		—	—		—	—		—	—		—		675		—		675
Net loss	—		—	—		—	—		—	—		—	—		—	—		—		—		(7,866)		(7,866)
Balances as of September 30, 2020	—	$	—	—	$	—	7,534	$	916	849,521	$	4,773	48,862,970	$	5	40,301,237	$	4	$	160,238	$	(158,130)	$	7,806

Series A

Series B

Common

Common

Total

Preferred Stock

Preferred Stock

stock - voting

stock - non-voting

Additional

Accumulated

Stockholders'


Shares

Amount


Shares

Amount


Shares

Amount

Shares

Amount

paid-in capital

deficit

Equity
Beginning Balance June 30, 2019

5,524,926

$
9,000,002

—

$
—

1,799,381

$
180

40,301,237

$
4,030

$
117,927,532

$
(119,575,767)

$
(1,644,025)
Issuance of Series B convertible preferred stock, net

—

—

10,787

2,240,594

—

—

—

—

—

—

2,240,594
Beneficial conversion feature of the Series B convertible preferred stock

—

—

—

(3,875,778)

—

—

—

—

3,875,778

—

—
Deemed dividend on the Series B convertible preferred stock

—

—

—

3,875,778

—

—

—

—

(3,875,778)

—

—
Issuance of common stock in Class A Units, net

—

—

—

—

2,886,500

289

—

—

1,198,833

—

1,199,122
Issuance of Series 1 warrants in Class A and B Units

—

—

—

—

—

—

—

—

5,304,989

—

5,304,989
Issuance of Series 2 warrants in Class A and B Units

—

—

—

—

—

—

—

—

5,304,989

—

5,304,989
Modification of Series 1 warrants

—

—

—

—

—

—

—

—

252,106

252,106
Deemed dividend attributable to Series 1 warrant modification

—

—

—

—

—

—

—

—

(252,106)

(252,106)
Bridge warrant reclassification from liability to equity

—

—

—

—

—

—

—

—

4,259,327

—

4,259,327
LOC warrant reclassification from liability to equity

—

—

—

—

—

—

—

—

71,079

—

71,079
Issuance of common stock upon conversion of Series B convertible preferred stock

—

—

(8,816)

(1,831,193)

4,408,000

441

—

—

1,830,752

—

—
Issuance of common stock in exchange of CVP Exchange Notes

—

—

—

—

301,577

30

—

—

1,088,768

—

1,088,798
Stock-based compensation

—

—

—

—

—

—

—

—

1,110,109

—

1,110,109
Net loss

—

—

—

—

—

—

—

—

—

(7,555,065)

(7,555,065)
Three Months Ended September 30, 2019

5,524,926

$
9,000,002

1,971

$
409,401

9,395,458

$
940

40,301,237

$
4,030

$
138,096,378

$
(127,130,832)

$
11,379,917

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED ~~STATEMENT~~STATEMENTS OF CHANGES

IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ ~~EQUITY/~~EQUITY (DEFICIT) (continued)

~~(Unaudited)~~

(Unaudited)

Series A

Series B

Common

Common

Total

Preferred Stock

Preferred Stock

Stock - voting

Stock - non-voting

Additional

Accumulated

Stockholders'


Shares

Amount


Shares

Amount


Shares

Amount

Shares

Amount

paid-in capital

deficit

Equity
Beginning Balance January 1, 2018

—

$
—

—

$
—

59,721

$
6

42,617,893

$
4,262

$
79,661,456

$
(62,404,722)

$
17,261,002
Issuance of preferred stock and common stock in a private placement

5,524,926

9,000,002

—

—

28,011

3

—

—

4,999,997

—

5,000,000
Beneficial conversion feature of the series A convertible preferred stock

—

(995,000)

—

—

—

—

—

—

995,000

—

995,000
Deemed dividend on the series A convertible preferred stock

—

995,000

—

—

—

—

—

—

(995,000)

—

(995,000)
Issuance of common stock

—

—

—

—

17,075

2

—

—

2,055,872

—

2,055,874
Issuance of common stock in exchange for redemption of convertible debt

—

—

—

—

13,665

1

—

—

1,607,420

—

1,607,421
Issuance of common stock in exchange for services

—

—

—

—

47

—

—

—

6,425

—

6,425
Issuance of common stock in exchange for payment of interest expense

—

—

—

—

4,081

—

—

—

704,725

—

704,725
Conversion of non-voting common stock to voting common stock

—

—

—

—

2,206

—

(2,316,656)

(232)

232

—

-
Issuance of common stock in exchange for payment of interest expense (Kingdon)

—

—

—

—

4,582

—

—

—

479,808

—

479,808
Issuance of common stock July 2018

—

—

—

—

6,725

1

—

—

624,896

—

624,897
Issuance of common stock in debt financing September 2018

—

—

—

—

1,071

—

—

—

48,000

—

48,000
Issuance of warrants in debt financing September 2018

—

—

—

—

—

—

—

—

118,149

—

118,149
Issuance of warrants for September 2018 office lease

—

—

—

—

—

—

—

—

493,688

—

493,688
Fractional common stock shares repurchased

—

—

—

—

—

—

—

—

(30)

—

(30)
Stock-based compensation

—

—

—

—

—

—

—

—

1,416,791

—

1,416,791
Net loss

—

—

—

—

—

—

—

—

—

(19,492,172)

(19,492,172)
Nine Months Ended September 30, 2018

5,524,926

$
9,000,002

—

$
—

137,184

$
13

40,301,237

$
4,030

$
92,217,429

$
(81,896,894)

$
10,324,578


	Series A			Series B			Series B-2			Series C
	Convertible Preferred Stock			Convertible Preferred Stock			Convertible Preferred Stock			Perpetual Preferred Stock			Common Stock - voting			Common Stock - non-voting			Additional		Accumulated		Total Stockholders'
(In thousands, except share data)	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		paid-in capital		deficit		Equity
Balances as of June 30, 2019	5,524,926	$	9,000	—	$	—	—	$	—	—	$	—	1,799,381	$	1	40,301,237	$	4	$	117,925	$	(119,576)	$	(1,646)
Issuance of Series B convertible preferred stock, net	—		—	10,787		2,241	—		—	—		—	—		—	—		—		—		—		2,241
Beneficial conversion feature of the Series B convertible preferred stock	—		—	—		(3,876)	—		—	—		—	—		—	—		—		3,876		—		—
Deemed dividend on the Series B convertible preferred stock	—		—	—		3,876	—		—	—		—	—		—	—		—		(3,876)		—		—
Issuance of common stock in Class A Units, net	—		—	—		—	—		—	—		—	2,886,500		—	—		—		1,201		—		1,201
Issuance of Series 1 warrants in Class A and B Units	—		—	—		—	—		—	—		—	—		—	—		—		5,305		—		5,305
Issuance of Series 2 warrants in Class A and B Units	—		—	—		—	—		—	—		—	—		—	—		—		5,305		—		5,305
Modification of Series 1 warrants	—		—	—		—	—		—	—		—	—		—	—		—		252		—		252
Deemed dividend attributable to Series 1 warrant modification	—		—	—		—	—		—	—		—	—		—	—		—		(252)		—		(252)
Bridge warrant reclassification from liability to equity	—		—	—		—	—		—	—		—	—		—	—		—		4,259		—		4,259
LOC warrant reclassification from liability to equity	—		—	—		—	—		—	—		—	—		—	—		—		71		—		71
Issuance of common stock upon conversion of Series B convertible preferred stock	—		—	(8,816)		(1,831)	—		—	—		—	4,408,000		—	—		—		1,831		—		—
Shares issued in exchange of CVP Exchange Notes	—		—	—		—	—		—	—		—	301,577		—	—		—		1,089		—		1,089
Stock-based compensation	—		—	—		—	—		—	—		—	—		—	—		—		1,110		—		1,110
Net loss	—		—	—		—	—		—	—		—	—		—	—		—		—		(7,555)		(7,555)
Balances as of September 30, 2019	5,524,926	$	9,000	1,971	$	410	—	$	—	—	$	—	9,395,458	$	1	40,301,237	$	4	$	138,096	$	(127,131)	$	11,380

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

statements.

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES

IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (continued)

(Unaudited)

Series A

Series B

Common

Common

Total

Preferred Stock

Preferred Stock

stock - voting

stock - non-voting

Additional

Accumulated

Stockholders'


Shares

Amount


Shares

Amount


Shares

Amount

Shares

Amount

paid-in capital

deficit

Equity
Beginning Balance - January 1, 2019

5,524,926

$
9,000,002

—

$
—

351,472

$
35

40,301,237

$
4,030

$
99,929,835

$
(94,550,779)

$
5,383,121
Issuance of common stock to Oasis, put exercise

—

—

—

—

195,319

20

—

—

2,602,876

—

2,602,896
Issuance of common stock to Oasis, registered offering

—

—

—

—

19,019

1

—

—

266,265

—

266,266
Issuance of common stock in exchange of CVP Notes

—

—

—

—

395,970

40

—

—

8,224,883

—

8,224,923
Issuance of common stock in exchange for payment of interest expense (Kingdon)

—

—

—

—

19,752

2

—

—

446,727

—

446,729
Issuance of common stock in exchange of CVP Exchange Notes

—

—

—

—

1,119,440

112

—

—

6,672,838

—

6,672,950
Issuance of Series B convertible preferred stock, net

—

—

10,787

2,240,594

—

—

—

—

—

—

2,240,594
Beneficial conversion feature of the Series B convertible preferred stock

—

—

—

(3,875,778)

—

—

—

—

3,875,778

—

—
Deemed dividend on the Series B convertible preferred stock

—

—

—

3,875,778

—

—

—

—

(3,875,778)

—

—
Issuance of common stock in Class A Units, net

—

—

—

—

2,886,500

289

—

—

1,198,833

—

1,199,122
Issuance of Series 1 warrants in Class A and B Units

—

—

—

—

—

—

—

—

5,304,989

—

5,304,989
Issuance of Series 2 warrants in Class A and B Units

—

—

—

—

—

—

—

—

5,304,989

—

5,304,989
Modification of Series 1 warrants

—

—

—

—

—

—

—

—

252,106

252,106
Deemed dividend attributable to Series 1 warrant modification

—

—

—

—

—

—

—

—

(252,106)

(252,106)
Bridge warrant reclassification from liability to equity

—

—

—

—

—

—

—

—

4,259,327

—

4,259,327
LOC warrant reclassification from liability to equity

—

—

—

—

—

—

—

—

71,079

—

71,079
Issuance of common stock upon conversion of Series B convertible preferred stock

—

—

(8,816)

(1,831,193)

4,408,000

441

—

—

1,830,752

—

—
Fractional common stock shares repurchased

—

—

—

—

(14)

—

—

—

—

—

—
Stock-based compensation

—

—

—

—

—

—

—

—

1,982,985

—

1,982,985
Net loss

—

—

—

—

—

—

—

—

—

(32,580,053)

(32,580,053)
Nine Months Ended September 30, 2019

5,524,926

$
9,000,002

1,971

$
409,401

9,395,458

$
940

40,301,237

$
4,030

$
138,096,378

$
(127,130,832)

$
11,379,917


	Series A			Series B			Series B-2			Series C
	Convertible Preferred Stock			Convertible Preferred Stock			Convertible Preferred Stock			Perpetual Preferred Stock			Common Stock - voting			Common Stock - non-voting			Additional		Accumulated		Total Stockholders'
(In thousands, except share data)	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		paid-in capital		deficit		Equity
Balances as of January 1, 2020	5,524,926	$	9,895	1,971	$	476	10,165	$	1,236	—	$	—	14,273,061	$	1	40,301,237	$	4	$	142,046	$	(133,090)	$	10,673
Shares issued on exercise of Series 1, Series 2, and 2019 Bridge Note warrants	—		—	—		—	—		—	—		—	548,962		—	—		—		392		—		392
Shares issued on exercise of Series 2 warrants and inducement offer conversion of Series B-1 convertible preferred stock	—		—	—		—	—		—	—		—	1,250,000		1	—		—		2,340		—		2,341
Shares issued on exercise of Series 1, Series 2, and 2019 Bridge Note warrants, net of issuance costs of $461; May 2020	—		—	—		—	—		—	—		—	8,670,852		1	—		—		3,787		—		3,788
Shares issued on conversion of Series 1, Series 2, and 2019 Bridge Note warrants; June 2020	—		—	—		—	—		—	—		—	732,315		—	—		—		359		—		359
Shares issued on exercise of Series 3 warrants	—		—	—		—	—		—	—		—	8,248,330		1	—		—		5,992		—		5,993
Shares issued on exercise of Series 1 and Series 2 warrants	—		—	—		—	—		—	—		—	1,154,266		—	—		—		565		—		565
Issuance of common stock in PIPE financing, net of issuance costs of $51	—		—	—		—	—		—	—		—	1,714,283		—	—		—		668		—		668
Shares issued in Underwriter settlement agreement	—		—	—		—	—		—	—		—	100,000		—	—		—		45		—		45
Warrants issued in Underwriter settlement agreement	—		—	—		—	—		—	—		—	—		—	—		—		31		—		31
Underwriter settlement offering cost	—		—	—		—	—		—	—		—	—		—	—		—		(185)		—		(185)
Conversion of Series B-2 convertible preferred stock into common stock	—		—	—		—	(2,631)		(320)	—		—	499,890		—	—		—		320		—		—
Conversion of Series B convertible preferred stock into common stock	—		—	(1,971)		(476)	—		—	—		—	4,423,251		—	—		—		476		—		—
Shares issued to Oasis as consideration under the March 2020 equity purchase agreement	—		—	—		—	—		—	—		—	68,807		—	—		—		33		—		33
Shares issued to Oasis under the March 2020 equity purchase agreement, put option exercise, net of issuance costs of $13	—		—	—		—	—		—	—		—	52,000		—	—		—		10		—		10
Series A convertible preferred stock redeemed and Series C perpetual preferred issued under the exchange transaction	(5,524,926)		(11,227)	—		—	—		—	842,500		4,717	—		—	—		—		150		—		4,867
Stock dividend attributable to Series C perpetual preferred stock of $8 per share	—		—	—		—	—		—	7,021		56	—		—	—		—		(56)		—		—
Shares issued to third party for services	—		—	—		—	—		—	—		—	2,364,474		—	—		—		916		—		916
Shares issued in exchange of CVP Exchange Notes	—		—	—		—	—		—	—		—	4,761,904		1	—		—		1,497		—		1,498
Accretion to redemption value of redeemable preferred stock	—		1,332	—		—	—		—	—		—	—		—	—		—		(1,332)		—		(1,332)
Fractional shares	—		—	—		—	—		—	—		—	20		—	—		—		—		—		—
Shares issued upon exercise of stock options	—		—	—		—	—		—	—		—	555		—	—		—		—		—		—
Stock-based compensation	—		—	—		—	—		—	—		—	—		—	—		—		2,184		—		2,184
Net loss	—		—	—		—	—		—	—		—	—		—	—		—		—		(25,040)		(25,040)
Balances as of September 30, 2020	—	$	—	—	$	—	7,534	$	916	849,521	$	4,773	48,862,970	$	5	40,301,237	$	4	$	160,238	$	(158,130)	$	7,806

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF ~~CASH FLOWS~~CHANGES

~~(Unaudited)~~ IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (continued)

(Unaudited)

Nine Months Ended

September 30,

September 30,


2019

2018
Cash flows from operating activities

Net loss

$
(32,580,053)

$
(19,492,172)
Adjustments to reconcile net loss to net cash used in operating activities:

  Depreciation and amortization expense

1,304,946

989,116
  Impairment of indefinite-lived intangible assets

4,000,000

—
  Interest paid on the conversion of debt to equity

—

21,275
  Common stock issued in exchange for services rendered

—

6,425
  Loss on extinguishment of debt

4,940,911

—
  Amortization of operating lease right-of-use-assets

554,017

—
  Stock-based compensation

1,982,985

1,416,791
  Amortization of debt issuance costs and debt discount

5,032,214

1,461,133
  Change in fair value of warrants, conversion option and derivative liability

(1,002,865)

(178,461)
Changes in assets and liabilities

Accounts receivable

(597,848)

(561,012)
Other receivable

6,118

(175,009)
Inventory

1,020,040

(477,217)
Prepaid expenses and other current assets

(465,610)

(635,622)
Deferred offering costs

—

(1,255,554)
Other non-current assets

—

(289,828)
Deferred collaboration revenue

—

(177,389)
Operating lease liabilities

(346,679)

52,665
Accounts payable

(662,163)

(904,577)
Accrued expenses

(503,526)

2,370,682
Total cash used in operating activities

(17,317,513)

(17,828,754)
Cash flows from investing activities

Purchase of equipment

—

(6,527)
Total cash used in investing activities

—

(6,527)
Cash flows from financing activities

Proceeds from issuance of long-term debt

—

2,310,000
Repayment of notes payable

(100,000)

(1,689,200)
Proceeds from issuance of convertible debt

—

500,000
Proceeds from issuance of common stock through a stock purchase agreement with a private investor

—

1,305,774
Proceeds from the issuance of common stock in a private investment in public entities with existing investors

—

750,100
Proceeds from the issuance of common stock, March 2018

—

5,000,000
Proceeds from the issuance of convertible preferred stock, March 2018

—

9,000,002
Proceeds from issuance of common stock July 2018

—

624,897
Fractional common shares repurchased

—

(30)
Proceeds from issuance of short-term notes payable

5,050,000

—
Repayment of short-term notes payable

(5,050,000)

—
Proceeds from the issuance of common stock, January to April 2019

2,602,896

—
Proceeds from the issuance of common stock, March 2019

266,266

—
Proceeds from the issuance of common stock in Class A Units, net of issuance costs, July 2019

2,074,244

—
Payment of underwriting discounts, commissions and other associated offering costs for Class A Units

(875,122)

—
Proceeds from the issuance of Series 1 Warrants in Class A and B Units, July 2019

5,304,989

—
Proceeds from the issuance of Series 2 Warrants in Class A and B Units, July 2019

5,304,989

—
Proceeds from the Issuance of Series B convertible preferred stock, net of issuance costs, July 2019

3,875,778

—
Payment of underwriting discounts, commissions and other associated offering costs for Class B Units

(1,635,184)

—
Total cash provided by financing activities

16,818,856

17,801,543
Net increase (decrease) in cash

(498,657)

(33,738)
Cash at beginning of period

2,568,191

759,867
Cash at end of period

$
2,069,534

$
726,129


	Series A			Series B			Series B-2			Series C
	Convertible Preferred Stock			Convertible Preferred Stock			Convertible Preferred Stock			Perpetual Preferred Stock			Common Stock - voting			Common Stock - non-voting			Additional		Accumulated		Total Stockholders'
(In thousands, except share data)	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		paid-in capital		deficit		Equity
Balances as of January 1, 2019	5,524,926	$	9,000	—	$	—	—	$	—	—	$	—	351,472	$	—	40,301,237	$	4	$	99,930	$	(94,551)	$	5,383
Issuance of common stock, net of offering costs	—		—	—		—	—		—	—		—	195,319		—	—		—		2,602		—		2,602
Issuance of common stock, net of offering costs, March 2019	—		—	—		—	—		—	—		—	19,019		—	—		—		266		—		266
Issuance of common stock in exchange of notes payable and accrued interest	—		—	—		—	—		—	—		—	395,970		1	—		—		8,223		—		8,224
Issuance of common stock in exchange of accrued interest, January 2019	—		—	—		—	—		—	—		—	19,752		—	—		—		447		—		447
Issuance of common stock in exchange of CVP Exchange Notes	—		—	—		—	—		—	—		—	1,119,440		—	—		—		6,673		—		6,673
Issuance of Series B convertible preferred stock, net	—		—	10,787		2,241	—		—	—		—	—		—	—		—		—		—		2,241
Beneficial conversion feature of the Series B convertible preferred stock	—		—	—		(3,876)	—		—	—		—	—		—	—		—		3,876		—		—
Deemed dividend on the Series B convertible preferred stock	—		—	—		3,876	—		—	—		—	—		—	—		—		(3,876)		—		—
Issuance of common stock in Class A Units, net	—		—	—		—	—		—	—		—	2,886,500		—	—		—		1,201		—		1,201
Issuance of Series 1 warrants in Class A and B Units	—		—	—		—	—		—	—		—	—		—	—		—		5,305		—		5,305
Issuance of Series 2 warrants in Class A and B Units	—		—	—		—	—		—	—		—	—		—	—		—		5,305		—		5,305
Modification of Series 1 warrants	—		—	—		—	—		—	—		—	—		—	—		—		252		—		252
Deemed dividend attributable to Series 1 warrant modification	—		—	—		—	—		—	—		—	—		—	—		—		(252)		—		(252)
Bridge warrant reclassification from liability to equity	—		—	—		—	—		—	—		—	—		—	—		—		4,259		—		4,259
LOC warrant reclassification from liability to equity	—		—	—		—	—		—	—		—	—		—	—		—		71		—		71
Issuance of common stock upon conversion of Series B convertible preferred stock	—		—	(8,816)		(1,831)	—		—	—		—	4,408,000		—	—		—		1,831		—		—
Fractional shares	—		—	—		—	—		—	—		—	(14)		—	—		—		—		—		—
Stock-based compensation	—		—	—		—	—		—	—		—	—		—	—		—		1,983		—		1,983
Net loss	—		—	—		—	—		—	—		—	—		—	—		—		—		(32,580)		(32,580)
Balances as of September 30, 2019	5,524,926	$	9,000	1,971	$	410	—	$	—	—	$	—	9,395,458	$	1	40,301,237	$	4	$	138,096	$	(127,131)	$	11,380

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)


	Nine Months Ended
	September 30,		September 30,
(in thousands)	2020		2019
Cash flows from operating activities
Net loss	$	(25,040)	$	(32,580)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		1,296		1,305
Impairment of indefinite-lived intangible assets		—		4,000
Loss on assignment of receivables		30		—
Loss on extinguishment of debt		—		4,941
Amortization of operating lease right-of-use-assets		553		554
Expense on modification of warrants		86		—
Series B convertible preferred stock inducement expense		1,647		—
Series 3 warrants issued as an inducement to exercise equity-classified Series 1, Series 2 and Bridge warrants		3,696		—
Stock-based compensation		2,184		1,983
Issuance of common stock in exchange for services		916		—
Issuance of warrants and common stock in Underwriter settlement agreement		76		—
Issuance of common stock as consideration paid under the Oasis Capital Equity Purchase Agreement		33		—
Amortization of debt issuance costs and debt discount		693		5,032
Change in fair value of financial instruments		2,491		(1,003)
Changes in assets and liabilities
Accounts receivable		(2,963)		(598)
Other receivable		(1)		6
Inventory		(90)		1,020
Prepaid expenses and other current assets		(1,061)		(466)
Other non-current assets		88		—
Operating lease liabilities		(337)		(347)
Accounts payable		4		(662)
Accrued expenses		4,482		(502)
Total cash used in operating activities		(11,217)		(17,317)
Cash flows from investing activities
Purchase of equipment		(7)		—
Total cash used in investing activity		(7)		—
Cash flows from financing activities
Proceeds from issuance of notes payable, net of issuance costs and debt discount		350		—
Proceeds from insurance premium financing		776		—
Proceeds from sale of receivables, net of debt discount and issuance costs of $640		4,542		—
Proceeds from issuance of short-term notes payable		—		5,050
Repayment of short-term notes payable		—		(5,050)
Repayment of notes payable		(3,140)		(100)
Proceeds from issuance of common stock		—		2,869
Proceeds from the issuance of common stock in Class A Units, net of issuance costs, July 2019		—		2,074
Payment of underwriting discounts, commissions and other associated offering costs for Class A Units		—		(875)
Proceeds from the issuance of Series 1 Warrants in Class A and B Units, July 2019		—		5,305
Proceeds from the issuance of Series 2 Warrants in Class A and B Units, July 2019		—		5,305
Proceeds from the Issuance of Series B convertible preferred stock, net of issuance costs, July 2019		—		3,876
Payment of underwriting discounts, commissions and other associated offering costs for Class B Units		—		(1,635)
Proceeds from issuance of common stock in PIPE financing, net of issuance costs		668		—
Proceeds from shares issued on exercise of 2019 Bridge warrants; February 2020		173		—
Proceeds from shares issued on exercise of Series 1 warrants; February 2020		144		—
Proceeds from shares issued on exercise of Series 2 warrants; March 2020		708		—
Issuance costs of Ionic Series 2 Warrants; March 24, 2020		(25)		—
Shares issued on exercise of Series 1, Series 2, and 2019 Bridge Note warrants, net of issuance costs of $461; May 2020		3,752		—
Shares issued on conversion of Series 1, Series 2, and 2019 Bridge Note warrants; June 2020		359		—
Shares issued on exercise of Series 1 and Series 2 warrants		565		—
Issuance costs from shares issued on Underwriter settlement agreement		(185)		—
Proceeds from shares issued on exercise of Oasis Capital an Equity Purchase Agreement put options, net of issuance costs of $13		10		—
Payments of deferred offering costs		(7)		—
Total cash provided by financing activities		8,690		16,819
Net decrease in cash		(2,534)		(498)
Cash at beginning of period		3,883		2,568
Cash at end of period	$	1,349	$	2,070

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

Table of Contents

JAGUAR HEALTH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)

(Unaudited)

Nine Months Ended

September 30,

September 30,

2019

2018
Supplemental disclosure of cash flow information

Interest paid on long-term debt

$
-

$
19,344

Supplemental schedule of non-cash financing and investing activities

Common stock issued as redemption of notes payable and related interest

$
-

$
1,153,408
Common stock issued as redemption of notes payable and related interest

$
-

$
1,638,546
Common stock issued with September 2018 Promissory Notes

$
-

$
48,000
Warrants issued with the September 2018 Promissory Notes

$
-

$
118,148
Deemed dividend attributable to Series A preferred stock

$
-

$
995,000
Deemed dividend attributable to modification of Series 1 warrants

$
252,106

$
-
Deemed dividend attributable to Series B convertible preferred stock

$
3,875,778

$
-
Common stock issued in exchange for CVP Exchange Note 1 principal and related interest

$
6,672,950

$
-
Common stock issued in payment of accrued interest on Kingdon notes payable

$
446,729

$
-
Common stock issued in payment of CVP Note Payable principal and related interest

$
8,224,923

$
-
Common stock issued upon conversion of Series B convertible preferred stock

$
1,831,193

$
-
Issuance of Bridge Notes warrants

$
5,005,739

$
-
Reclassification of Bridge Note warrants from liability to equity

$
4,259,327

$
-
Issuance of March 2019 LOC warrant

$
116,297

$
-
Reclassification of March 2019 LOC warrants from liability to equity

$
71,079

$
-


	Nine Months Ended
	September 30,		September 30,
	2020		2019
Supplemental schedule of cash flow information
Cash paid for interest	$	343	$	—
Supplemental schedule of non-cash financing and investing activities
Common stock issued as redemption of notes payable and related interest	$	1,498	$	15,345
Deemed dividend attributable to modification of Series 1 warrants	$	—	$	252
Deemed dividend attributable to Series B convertible preferred stock	$	—	$	3,876
Common stock issued upon conversion of Series B convertible preferred stock	$	—	$	1,831
Issuance of warrants with Notes Payable	$	—	$	5,006
Reclassification of Bridge Note warrants from liability to equity	$	—	$	4,259
Issuance of March 2019 letter of credit warrant	$	—	$	116
Reclassification of March 2019 LOC warrants from liability to equity	$	—	$	71
Accretion to redemption value of Series A contingently redeemable convertible preferred stock	$	1,332	$	—
Offering costs included in accounts payable and accrued expenses	$	166	$	—
Conversion of Oasis Series B-2 convertible preferred stock into common stock	$	320	$	—
Shares issued on exercise of Series B convertible preferred shares	$	476	$	—
Extinguishment of Series A redeemable convertible preferred stock	$	11,227	$	—
Issuance of Series C perpetual preferred stock	$	4,717	$	—
Issuance of Series D perpetual preferred stock	$	6,359	$	—
Extinguishment of Series A redeemable convertible preferred stock	$	150	$	—
Shares issued on exercise of Series 3 warrants; July and August 2020	$	5,993	$	—
Stock dividend attributable to Series C perpetual preferred stock	$	56	$	—
Deemed dividend attributable to Series 1, Series 2 and Bridge warrant holders	$	856	$	—

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

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JAGUAR HEALTH, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Organization and Business

Jaguar Health, Inc. (“Jaguar”, “we” or the “Company”), formerly known as Jaguar Animal Health, Inc., was incorporated on June 6, 2013 (inception) in Delaware. The Company was a majority-owned subsidiary of Napo Pharmaceuticals, Inc. (“Napo” or the “Former Parent”) until the close of the Company's initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class gastrointestinal products for companion and production animals and horses. The Company's first commercial product, Neonorm Calf, was launched in 2014 and Neonorm Foal was launched in the first quarter of 2016. The Company's activities are subject to significant risks and uncertainties, including failing to secure additional funding in order to timely complete the development and commercialization of products.

On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017 by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo's representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as ~~our~~the Company’s wholly-owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the Merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly-owned subsidiary of Jaguar focused on human health and the ongoing commercialization of Mytesi, a Napo drug product approved by the U.S. Food and Drug Administration (“FDA”) for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

The Company manages its operations through two segments—human health and animal health and is headquartered in San Francisco, California.

~~Reverse stock-splits~~Nasdaq Communication and Compliance

Minimum Stockholders’ Equity Requirement

On August 17, 2020, the Company received a letter from the Staff of the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it no longer complies with Nasdaq Listing Rule 5550(b)(1) due to the Company’s failure to maintain a minimum of $2,500,000 in stockholders’ equity (or meet the alternatives of market value of listed securities of $35 million or net income from continuing operations). The Company reported stockholders’ equity of $1,544,000 in its Form 10-Q for the fiscal quarter ended June 30, 2020. Under Nasdaq Listing Rule 5810(c)(2), the Company had 45 calendar days, or until October 1, 2020, to submit a plan to regain compliance.

On ~~May 29, 2018,~~September 9, 2020, the Company received a letter from Nasdaq stating that, based on the Company’s Current Report on Form 8-K filed on September 2, 2020, the ~~Certificate of Second Amendment~~Staff has determined that the Company complied with Nasdaq Listing Rule 5550(b)(1). However, if the Company failed to evidence compliance with Nasdaq Listing Rule 5550(b)(1) upon filing its ~~Third Amended and Restated Certificate of Incorporation~~next periodic report, the Company may be subject to delisting.

Minimum Bid Price Requirement

On September 11, 2020, the Company received written notice from Nasdaq indicating that, based upon the Company’s continued non-compliance with the ~~Secretary~~minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market (the “Rule”), as set forth in Nasdaq Listing Rule 5550(a)(2), as of ~~State~~September 11, 2020, and notwithstanding the Company’s compliance with the quantitative criteria necessary to obtain a second 180-day period within which to evidence compliance with the Rule, as set forth in Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq determined to delist the Company’s securities from Nasdaq unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”).

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The Company submitted a compliance plan to Nasdaq before the ~~State~~October 1, 2020 deadline.

On October 22, 2020, the hearing was held with the Panel. On October 28, 2020, the Company received formal notice that the Panel granted the Company an extension through December 23, 2020 to evidence compliance with the Rule. In order to comply with the Rule, the Company must have a closing bid price of ~~Delaware~~at least $1.00 per share for a minimum of ten consecutive business days by December 23, 2020.

The Company seeks to obtain approval through a special shareholders meeting to be held on December 9, 2020 to effect a ~~1-for-15~~ reverse ~~stock~~ split of the Company’s issued and outstanding ~~shares of~~ voting common stock ~~effective June 1, 2018. The reverse split has been retrospectively reflected~~at a ratio not less than 1-for-2 and not greater than 1-for-20 that would result in all voting common stock, warrants, and common stock option shares disclosed in these condensed consolidated financial statements. The non-voting common stock and the convertible preferred stock were excluded from the reverse split.

~~On June 3, 2019, the Company filed the Certificate of Fifth Amendment to its Third Amended and Restated Certificate of Incorporation~~a per share price that will comply with the ~~Secretary of State of the State of Delaware~~Rule. The Company plans to effect a 1-for-70 reverse stock split of the Company’s issued and outstanding shares of voting common stock, effective June 7, 2019. The reverse split has been retrospectively reflected in all voting common stock, warrants, and common stock option shares disclosed in these condensed consolidated financial statements. The non-voting common stock and the convertible preferred stock were excluded from the reverse split.take steps to timely evidence compliance; however, there can be no assurance that it will be able to do so.

Liquidity and Going Concern

The accompanying unaudited condensed consolidated financial statements have been prepared ~~assuming the Company will continue as~~on a going ~~concern.~~concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The Company, since its inception, has incurred recurring operating losses ~~since inception~~and negative cash flows from operations and has an accumulated deficit of ~~$127.1~~$158.1 million as of September 30, ~~2019. The net loss for the nine months ended September 30, 2019 was $32.6 million.~~2020. The Company expects to incur substantial losses and negative cash flows in future periods. Further, the ~~Company's~~Company’s future operations are dependent on the success of the ~~Company's~~Company’s ongoing development and commercialization efforts, as well as securing of additional ~~financing.~~financing and generating positive cash flows from operations. There is no assurance that ~~profitable operations, if ever achieved,~~the Company will have adequate cash balances to maintain its operations. In addition, as a result of the recent outbreak of novel COVID-19, the Company may experience disruptions in fiscal year 2020 until November 2021 that could ~~be sustained on a continuing basis.~~severely impact its supply chain, ongoing and future clinical trials and commercialization of Mytesi.

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~~The~~Although the Company plans to finance its operations and ~~capital funding~~cash flow needs through equity and/or debt financing, collaboration arrangements with other entities, license royalty agreements, as well as revenue from future product ~~sales. We do~~sales, the Company does not believe ~~our~~its current ~~capital is~~cash balances are sufficient to fund ~~our~~its operating plan through one year from the issuance of these unaudited condensed consolidated financial statements. The Company has an immediate need to raise cash. There can be no assurance that additional funding will be available to the Company on acceptable terms, or on a timely basis, if at all, or that the Company will generate sufficient cash from operations to adequately fund operating ~~needs or ultimately achieve profitability.~~needs. If the Company is unable to obtain an adequate level of financing needed for short-term operations and the long-term development and commercialization of its products, the Company will need to curtail planned activities and reduce costs. Doing so will likely have an adverse effect on the Company's ability to execute on its business ~~plan. These matters raise~~plan; accordingly, there is substantial doubt about the ability of the Company to continue in existence as a going ~~concern within one year after the issuance date of the condensed consolidated financial statements.~~concern. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

~~July 2019 Underwritten Public Offering~~

In July 2019, the Company entered into an underwriting agreement, relating to a public offering, which was comprised of (1) 2,886,500 Class A Units, priced at $2.00 per unit, with each unit consisting of (i) one share of the Company’s voting common stock, (ii) one Series 1 warrant to purchase one share of Common Stock, and (iii) one Series 2 warrant to purchase one share of Common Stock, and (2) 10,787 Class B Units, priced at a price of $1,000 per unit, with each unit consisting of (i) one share of Series B convertible preferred stock, convertible into 500 shares of Common Stock, (ii) 500 Series 1 Warrants and (iii) 500 Series 2 Warrants.

In total, the Company sold 2,886,500 shares of common stock (see Note 10), 10,787 shares of Series B convertible preferred stock (see Note 9), Series 1 warrants to purchase 8,280,000 shares of common stock and Series 2 warrants to purchase 8,280,000 shares of common stock (see Note 8), including the full exercise of the over-allotment option. The total gross proceeds to the Company from the offering was $16,560,000, or $14,049,697 net of issuance and other costs of $2,510,303.

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, ~~2019,~~2020, or for any other future annual or interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in ~~our~~the Annual Report on Form 10-K for the year ended December 31, ~~2018.~~2019. The condensed consolidated balance sheet at December 31, 2019 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements.

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There has been ano material change to the Company's significant accounting policies during the three ~~months~~ and nine months ended September 30, ~~2019,~~2020, as compared to the significant accounting policies described in Note 2 of the “Notes to ~~Condensed~~ Consolidated Financial Statements” in the Company's Annual Report on Form 10-K for the year ended

December 31, ~~2018. The Company adopted ASC (“Accounting Standards Codification”) 842 “Leases”~~2019.

Except as noted above, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, ~~implemented~~in the opinion of management, reflect all adjustments of a ~~new policy~~normal recurring nature considered necessary to ~~account~~present fairly the financial position as of September 30, 2020, results of operations for ~~modifications of~~the three and nine months ended September 30, 2020 and 2019, changes in convertible preferred stock ~~using~~and stockholders' equity for the ~~model in ASC 470-50.~~ three and nine months ended September 30, 2020 and 2019, and cash flows for the nine months ended September 30, 2020 and 2019. The interim results are not necessarily indicative of the results for any future interim periods or for the entire year.

~~Principals~~Principles of Consolidation

The unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its wholly-owned subsidiary. All inter-company transactions and balances have been eliminated in consolidation.

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Use of Estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make judgments, assumptions and estimates that affect the amounts reported in its unaudited condensed consolidated financial statements and the accompanying notes. The accounting policies that reflect the Company’s more significant estimates and judgments and that the Company believes are the most critical to aid in fully understanding and evaluating its reported financial results are the valuation of stock ~~options;~~options, valuation of Series C perpetual preferred stock and Series D perpetual preferred stock, valuation of warrant ~~liabilities; valuation of derivative liability, impairment testing of goodwill,~~liabilities, acquired in-process research and development (“IPR&D"), and ~~long lived assets;~~ useful lives ~~for depreciation and amortization;~~assigned to long-lived assets; valuation adjustments for excess and obsolete inventory; allowance for doubtful accounts; deferred taxes and valuation allowances on deferred tax assets; evaluation and measurement of contingencies; and recognition of revenue, including estimates for product returns. Those estimates could change, and as a result, actual results could differ materially from those estimates.

The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers, markets and economies.

Cash and Restricted Cash

Our cash on deposit may exceed United States federally insured limits at certain times during the year. We maintain cash accounts with certain major financial institutions in the United States. Restricted cash represents cash not available to us for immediate and general use.

Accounts Receivable

Accounts receivable is recorded net of allowances for discounts for prompt payment and credit losses. The Company estimates an allowance for credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in general and administrative expenses. The credit loss allowance was immaterial as of September 30, 2020.

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Concentrations

Cash is the financial instrument that potentially subjects the Company to a concentration of credit risk as cash is deposited with a bank and cash balances are generally in excess of Federal Deposit Insurance Corporation insurance limits. ~~The carrying value of cash approximates fair value at September 30, 2019 and December 31, 2018.~~

For the three and nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, substantially all of the Company’s revenue has been derived from the sale of Mytesi. For the three ~~months~~ and nine months ended September 30, ~~2019,~~2020, the Company earned Mytesi revenue primarily from one pharmaceutical distributor in the United States. For the three and nine months ended September 30, 2018, the Company earned Mytesi revenue primarily from three pharmaceutical distributors in the United States, each of whom amounted to a percentage of total net revenue of at least 10%. Revenue earned from each as a percentage of total net revenue is as follows:

Consolidated (percentage of total net sales)

Three Months Ended

Nine Months Ended

September 30,

September 30,


2019

2018


2019

2018

Customer 1

100
%
34
%

90
%
28
%
Customer 2

—
%
28
%

—
%
28
%
Customer 3

—
%
25
%

—
%
25
%


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	(unaudited)				(unaudited)
	2020		2019		2020		2019
Customer 1	100	%	100	%	100	%	90	%

The Company is subject to credit risk from its accounts receivable related to its sales. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. The Company's significant pharmaceutical distributors and their related accounts receivable balance as a percentage of total accounts receivable were as follows:

As of

As of

September 30,

September 30,


2019

2018

Customer 1

99.6
%
35.0
%
Customer 2

—
%
29.0
%
Customer 3

—
%
26.0
%

No other customer represented more than 10% of the Company's accounts receivable balances as of those dates.

The Company is subject to ~~credit~~concentration risk from its ~~inventory~~ suppliers. The Company sources ~~drug substance~~raw material used to produce the active pharmaceutical ingredient in Mytesi from two suppliers and is dependent on a single ~~supplier and drug product from a single supplier.~~

~~Table~~third-party contract manufacturer, both for the supply of ~~Contents~~the active pharmaceutical ingredient in Mytesi, as well as for the supply of finished products for commercialization.

Fair Value

The Company’s financial instruments include ~~cash,~~ accounts receivable, accounts payable, accrued expenses, preferred stock, warrant liabilities, derivative ~~liability, debt conversion option liability,~~assets and liabilities, equity-linked financial instruments and debt. The recorded carrying amount of accounts receivable, accounts payable, and accrued expenses reflect their fair value due to their short-term nature. The carrying value of the interest-bearing debt approximates fair value based upon the borrowing rates currently available to the Company for bank loans with similar terms and maturities. See Note 3 for the fair value measurements.

~~Inventories~~Inventory

~~Inventories are~~Inventory is stated at the lower of cost or net realizable value. Cost is initially recorded at the invoiced amount of raw materials or active pharmaceutical ingredient, including the sum of qualified expenditures and charges in bringing the inventory to its existing condition and location. The Company calculates inventory valuation adjustments when conditions indicate that net realizable value is less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand or reduction in selling price. Inventory write-downs are measured as the difference between the cost of inventory and net realizable value.

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Land, Property and Equipment

Land is stated at cost, reflecting the fair value of the property at July 31, 2017, the date of the Napo merger. Equipment is stated at cost, ~~less~~net of accumulated depreciation. Equipment begins to be depreciated when it is placed into service. Depreciation is calculated using the straight-line method over ~~the~~ estimated useful lives ofranging between 3 to 10 years.

Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their estimated useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in the unaudited condensed consolidated statements of ~~operations and comprehensive loss.~~operations.

~~Long-Lived~~Long-lived Assets

The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment, to determine whether indicators of impairment may exist that warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objectives.

Definite-lived intangible assets are amortized on a straight-line basis over the estimated ~~periods benefited~~useful lives of intangible assets and are reviewed when appropriate for possible impairment.

~~Goodwill and~~ Indefinite-lived Intangible Assets

Goodwill is tested for impairment on an annual basis and in between annual tests if events or circumstances indicate that an impairment loss may have occurred. The test is based on a comparison of the reporting unit's book value to its estimated fair value. The Company performs the annual impairment test during the fourth quarter of each fiscal year using the opening consolidated balance sheet as of the first day of the fourth quarter, with any resulting impairment recorded in the fourth quarter of the fiscal year. The Company did not record an impairment of goodwill during the three and nine months ended September 30, 2019 and 2018.

Acquired ~~in-process research and development (“~~IPR~~&D”)~~&D are intangible assets acquired in the July 2017 Napo merger. Under ASC 805, IPR&D are initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the development period, these assets will not be amortized as charges to earnings; instead, these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. An impairment loss is measured based on the excess of the carrying amount over the asset’s fair value. There were no impairment charges recorded in the three and nine months ended
September 30, 2020. The Company recorded an impairment of zero and $4,000,000 in the three and nine months ended September 30, 2019, respectively. ~~There were no impairment charges recorded in the three and nine months ended September 30, 2018. The impairment loss is measured based on the excess~~

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of the carrying amount over the asset’s fair value. Definite-lived intangible assets are amortized on a straight-line basis over the estimated periods benefited and are reviewed when appropriate for possible impairment.

Leases

ASC 842, Leases, requires lessees to recognize right-of-use assets and lease liabilities for all leases with a term of greater than 12 months regardless of their classification on the balance sheet and to provide expanded disclosures about leasing arrangements. The Company adopted ASC 842 on January 1, 2019 using the optional transition method with no restatements of comparative periods. There was no effect on accumulated deficit at adoption.

The Company elected to adopt the package of practical expedients to (i) not reassess whether expired or existing contracts are or contain leases, (ii) not reassess the lease classification for any expired or existing leases and (iii) not reassess the accounting for initial direct costs.

The adoption of the new leases standard resulted in the following adjustments to the condensed consolidated balance sheet as of January 1, 2019:


	December 31, 2018		Adoption Impact		January 1, 2019
			(unaudited)

(in thousands)							December 31, 2018		Adoption Impact		January 1, 2019
Operating lease right-of-use assets	$	—	$	1,111,214	$	1,111,214	$	—	$	1,111	$	1,111
Operating leases liabilities, current portion		—		336,647		336,647		—		337		337
Operating leases liabilities, long term		—		394,703		394,703		—		395		395
Deferred rent		379,864		(379,864)		—		380		(380)		—

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At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. Because the interest rate implicit in lease contracts is typically not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

Operating Lease

The Company ~~has~~had a non-cancelable operating lease with CA-Mission Street Limited Partnership for its offices in San Francisco, California, through September 1,30, 2020. The lease agreement ~~calls~~called for monthly base rents between ~~$38,391~~$38,000 and ~~$40,730~~$41,000 over the term of the lease.

~~Prior to~~The Company entered into a sublease agreement with Peacock Construction Inc., a California corporation, for office space located at 200 Pine Street, Suite 400, San Francisco, California. The term of the ~~Company’s adoption of ASC 842~~sublease began on ~~January 1, 2019, the Company recorded lease expense for its operating leases~~August 31, 2020 and will expire on May 31, 2021, unless earlier terminated in accordance with ~~ASC 840.~~the contract. The rent under the sublease is $15,000 per month beginning October 1, 2020, which includes operating expenses and taxes. On October 1, 2020, the Company transitioned its operations from its existing premises at 201 Mission Street, Suite 2375, San Francisco, California to the sublease premises, which the Company expects will serve as its principal administrative headquarters.

Research and Development Expense

Research and development expense ~~consists~~consist of expenses incurred in performing research and development activities including related salaries, clinical ~~trial~~trials and related drug and non-drug product costs, contract services and other outside service expenses. Research and development expense is charged to operating expense in the period incurred.

Revenue Recognition

The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), which was adopted on January 1, 2018, using the modified retrospective method, which was elected to apply to all active contracts as of the adoption date. Application of the modified retrospective method did not impact amounts previously reported by the Company, nor did it require a cumulative effect adjustment upon adoption, as the Company's method of recognizing revenue under ASC 606 yielded similar results to the method utilized immediately

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~~prior to adoption. Accordingly, there was no effect to each financial statement line item as a result of applying the new revenue standard.~~.

Practical Expedients, Elections, and Exemptions

The Company recognizes revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those goods or services.

The Company elected a practical expedient available under ASC 606‑10‑65‑1(f)4 that permits it to consider the aggregate effect of all contract modifications that occurred before the beginning of the earliest period presented when identifying satisfied and unsatisfied performance obligations, transaction price, and allocating the transaction price to the satisfied and unsatisfied performance obligations.

~~The Company~~ also elected a practical expedient available under ASC ~~606‑10‑32‑18~~606-10-32-18 that permits it to not adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less.

The Company has elected to treat shipping and handling activities as fulfillment costs.

Additionally, the Company elected to record revenue net of sales and other similar taxes.

Contracts - Cardinal Health

Effective January 16, 2019, Napo ~~Pharmaceuticals, Inc.~~ engaged Cardinal Health as its exclusive ~~third party~~third-party logistics distribution agent for commercial sales for the Company’s Mytesi product and to perform certain other services which include, without limitation, storage, distribution, returns, customer support, financial support, Electronic Data Interchange (“EDI”) and system access support (the “Exclusive Distribution Agreement”).

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In addition to the terms and conditions of the Exclusive Distribution Agreement, Cardinal Health’s purchase of products, and assumption of title therein, is set forth in the Title Model Addendum. The Title Model Addendum states that upon receipt of product at the 3PL Facility (Cardinal Health in La Vergne, Tennessee) from the Company, title and risk of loss for the Mytesi product purchased by Cardinal Health (excluding consigned inventory) shall pass to Cardinal Health, and title and risk of loss for consigned inventory shall remain with the Company until purchased by Cardinal Health in accordance with the Title Model Addendum. Napo ~~Pharmaceuticals, Inc.~~ considers Cardinal Health the Company’s exclusive customer for Mytesi products per the Exclusive Distribution Agreement.

Jaguar's Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers. Since 2014, the Company has entered into several distribution agreements with established distributors such as Animart, Vedco, VPI, RJ Matthews, Henry Schein, and Stockmen Supply to distribute the Company's products in the United States, Japan, and China. The distribution agreements and the related purchase ~~order~~orders together meet the contract existence criteria under ASC ~~606‑10‑25‑1.~~606-10-25-1. Jaguar sells directly to its customers without the use of an agent.

Performance obligations

For animal products sold by Jaguar Health, the single performance obligation identified above is the Company’s promise to transfer the Company’s animal products to distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance type warranties that do not represent a performance obligation. For the Company’s human product, Mytesi, which is sold by Napo, ~~Pharmaceuticals Inc.,~~ the single performance obligation identified above is the Company’s promise to transfer Mytesi to Cardinal Health, the Company’s exclusive distributor for the product, based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement. ~~The product warranties are assurance type warranties that do not represent a performance obligation.~~

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Transaction price

For contracts with Cardinal Health, for both Jaguar and Napo, the transaction price is the amount of consideration to which the Company expects to collect in exchange for transferring the promised goods or services to a customer. The transaction price of Mytesi and Neonorm is the Wholesaler Acquisition Cost (“WAC”), net of discounts, returns, and price adjustments.

Allocate transaction price

For contracts with Cardinal Health, for both Napo and Jaguar, the entire transaction price is allocated to the single performance obligation contained in each contract.

~~Point in time~~Revenue recognition

For contracts with Cardinal Health, for both Napo and Jaguar, a single performance obligation is satisfied at a point in time, upon the free on board (“FOB”) terms of each contract when control, including title and all risks, has transferred to the customer.

Disaggregation of Product Revenue

Human

Sales of Mytesi are recognized as revenue when the products are delivered to the wholesaler. ~~Revenues~~Net revenues from the sale of Mytesi were ~~$957,059~~$2.8 million and ~~$1,107,682~~$1.0 million for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues from the sale of Mytesi were ~~$4,184,912~~$6.7 million and ~~$2,545,121~~$4.2 million for the nine months ended September 30, 2020 and 2019, ~~and 2018,~~ respectively. ~~The increase in sales of Mytesi is due to the more streamlined distribution channel and increased sales presence.~~

Out of period adjustment - During the period ended September 30, 2019, the Company identified a prior period product donation incorrectly recorded as revenue. The adjustment, totaling ~~$336,934~~$337,000 related to revenue and accounts receivable, was corrected within the current quarter. The impact of the adjustment was an increase to net loss of ~~$336,934.~~

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$337,000. This adjustment does not affect Mytesi revenue associated with sales in the nine months ended
September 30, 2019. Management has determined that this out of period correcting adjustment is not material to any prior period consolidated financial statements impacted by the adjustment and has therefore recorded it in the three months ended September 30, 2019.

Animal

The Company recognized Neonorm revenues of ~~$15,720~~$13,000 and ~~$24,385~~$16,000 for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues from the sale of Neonorm were ~~$83,294~~$61,000 and ~~$97,759~~$83,000 for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues are recognized upon shipment, which is when title and control is transferred to the buyer. Sales of Neonorm Calf and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances.

Contracts - Atlas Sciences

Effective April 15, 2020, the Company entered into a patent purchase agreement with Atlas Sciences, LLC (“Atlas”), pursuant to which Atlas agreed to purchase certain patents and patent applications relating to Napo’s NP-500 drug product candidate (the “Patent Rights”) for an upfront cash payment of $1,500,000.

Concurrent with the Patent Rights sale, the Company entered into a license agreement with Atlas (the “License Agreement”), pursuant to which Atlas granted the Company an exclusive 10-year license to use the Patent Rights and improvements thereon to develop and commercialize NP-500 in all territories worldwide except Greater China (i.e., China, Hong Kong, Taiwan and Macau), inclusive of the right to sublicense NP-500 development and commercialization rights (“the License”). Except for the License retained by the Company, Atlas retains all rights, title and interest in and to the Patent Rights, including all improvements and enhancements to the Patent Rights made or created by the Company under the License Agreement or made or created by or on behalf of Atlas during the term of the License Agreement.

Included in the arrangement with Atlas, the Company is obligated to initiate a proof of concept Phase 2 study of NP-500 under an investigational new drug (“IND”) application with the U.S. Food and Drug Administration or an IND-equivalent dossier under appropriate regulatory authorities (the “Phase 2 study”) within nine months of

April 15, 2020. The Company will incur a trial delay fee if the Company fails to initiate the Phase 2 study by this date, for any reason, including the timely receipt of adequate funding to initiate the Phase 2 study. Atlas has the right to terminate the License in the event that the Company (i) fails to complete the Phase 2 study within five years of
April 15, 2020 or (ii) has not timely initiated the Phase 2 study and thereafter fails to make three or more consecutive Trial Delay Payments.

As of September 30, 2020, the Company determined not to proceed with the scheduled proof of concept of the Phase 2 study and incurred and recorded a liability for a trial delay fee. See Note 15 for a description of the trial delay fee settlement agreement entered into by the Company.

Performance obligations

The Patent Rights sale to Atlas and the Phase 2 study to be performed by the Company, identified above, represent a single transaction with two separate performance obligations; with the sale of the Patent Rights, the Company transferred control of the internally generated Patent Rights to Atlas at the date of sale.

As of September 30, 2020, the Company determined not to proceed with the Phase 2 study, which will result in the Company having no performance obligation to transfer the services to Atlas.

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Transaction price

For the contract with Atlas, the upfront payment of $1,500,000 from Atlas as consideration for the Patent Rights sale and the Phase 2 study, is variable consideration that is fully constrained due to the potential incurrence of a Trial Delay Fee of $2,515,000 if the Phase 2 study had not been initiated by January 15, 2021. The Company’s method for estimating the variable consideration was to use the most likely amount method. The Company fully constrained the value of the variable consideration based on inherent uncertainty of timing of clinical trials. Accordingly, at inception, the total transaction price of $1,500,000 is deferred and the transaction price is zero.

As of September 30, 2020, the total deferred transaction price of $1,500,000 will be derecognized as a result of the non-performance of the Company’s obligation to initiate the Phase 2 study.

Allocate transaction price

For the contract with Atlas, the transaction price of $1,500,000 is allocated as follows: (i) $1,196,000 was allocated to the Phase 2 study using the cost-plus margin approach based on the price quoted by a third-party contract research organization, and (ii) $583,000 was allocated to the Patent sale using the Residual method.

As of September 30, 2020, the allocated deferred transaction price of $1,500,000 will be derecognized as a result of the non-performance of the Company’s obligation to initiate the Phase study.

Revenue recognition

For the contract with Atlas, control of the Patent Rights transferred to Atlas on the date of sale (at a point-in-time); and with the Phase 2 study, the services were to be transferred to Atlas over the estimated 13.2 months of the study, which was set to run between October 2020 and November 2021.

As of September 30, 2020, the Company made the decision not to initiate the Phase 2 study and intended to negotiate the payment of the Trial Delay Fee of $2.5 million and terminate this obligation in the contract. Because of this decision, the allocated transaction price for that performance obligation will not be recognized as revenue. Likewise, the allocated transaction price for the Patent sale will not be recognized as revenue, as its recognition was dependent on initiating the Phase 2 study on or before January 15, 2021.

The Company derecognized $1.5 million in deferred revenue and the excess of the Trial Delay Fee was recognized in "General and Administrative Expenses" in the unaudited condensed consolidated statement of operations. The authoritative guidance treats consideration payable to a customer as a reduction of the transaction price and, therefore, an adjustment to revenues unless the payment is for a distinct good or service received from the customer. In some cases, a payment to a customer that is not in exchange for a distinct good or service could exceed the transaction price for the current contract. This is a case of a payment to a customer that is not in exchange for a distinct good or service. Accounting for the excess payment (“negative revenue”) requires judgment as the standard does not explicitly address whether it is appropriate to reclassify revenue to expense.

The Company evaluated the nature of the consideration payable to the customer and the rights and obligations in the related contract and concluded that the excess payment or loss should be presented as part of the "General and Administrative Expenses" due to the following factors:

●

No revenue has been recognized from the transaction as performance obligations were not satisfied.

●

The Company settled the Trial Delay Fee in full in October 2020, which constitutes termination of the customer relationship considering that Atlas cannot compel the Company or has no recourse to force the Company to initiate the Phase 2 Study. The Company does not anticipate future revenue contract with Atlas.

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●

The trial delay fee is a penalty in its economic term, subject to accounting for contingencies and provisions under relevant authoritative guidance.

The Company recorded the excess loss amount of $1.0 million in the three and nine months ended September 30, 2020.

Disaggregation of Patent Sales and Clinical Trial Services

Patent Rights Sale

Patent Rights sales are recognized when control of the Patent Rights is transferred to the purchaser (at a point-in-time). However, due to the failure of the Company to initiate the Phase 2 study, which put the full constraint on the variable consideration of $1,500,000, no revenue was recognized from the sale of Patent Rights to Atlas for the three and nine months ended September 30, 2020.

Clinical Trials

Revenue from clinical trials is recognized over time, as the services are performed, as the Company's performance enhances the Patent Rights asset that Atlas controls. The Phase 2 study to be performed under the Atlas License was expected to begin in October 2020 and run through November 2021. The expected first patient dose in the study was expected to occur in December 2020, at which point revenue from the Phase 2 study would begin to be recognized.

As of September 30, 2020, the Company determined not to proceed with the Phase 2 study and incurred a trial delay fee of $2,515,000. Refer to Note 6 for a description of the contingent liability recorded. Due to the Company abandoning the Phase 2 study, the arrangement with Atlas to perform the clinical trial is terminated and the deferred revenue recorded for the variable consideration of $1,500,000 was derecognized.

Contracts – Glenmark Life Sciences

On September 3, 2020, Napo entered into a manufacturing and supply agreement (the “Agreement”) with Glenmark Life Sciences Limited (“Glenmark”), pursuant to which Glenmark will continue to serve as Napo’s manufacturer of crofelemer for use in Mytesi, the Company and Napo’s human prescription drug product approved by the U.S. Food and Drug Administration, and for other crofelemer-based products manufactured by Napo or its affiliates for human or animal use. The term of the Agreement is approximately 2.5 years (i.e., until March 31, 2023) and may be extended for successive two-year renewal terms upon mutual agreement between the parties thereto. Pursuant to the terms of the Agreement, Glenmark will supply crofelemer to Napo and its affiliates. The Agreement contains provisions regarding the rights and responsibilities of the parties with respect to manufacturing specifications, forecasting and ordering, delivery arrangements, payment terms, confidentiality and indemnification, as well as other customary provisions. The Agreement includes a commitment for the purchase from Glenmark of a minimum quantity of 300 kilograms of crofelemer per year, pro-rated for partial years, where the Company may be obligated to pay any shortfall. Either party may terminate the Agreement for any reason with 12 months prior written notice to the other party. In addition, either party may terminate the Agreement upon written notice as a result of a material breach of the Agreement that remains uncured for a period of 90 days. If the Company terminates the Agreement as a result of a material breach caused by Glenmark, the Company will not be obligated to pay for any minimum quantity shortfall.

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Collaboration Revenue

On January 27, 2017, the Company entered into a licensing, development, co-promotion and commercialization agreement with Elanco US Inc. (“Elanco”) to license, develop and commercialize Canalevia, the Company's drug product candidate under investigation for treatment of acute and chemotherapy-induced diarrhea in dogs, and other drug product formulations of crofelemer for treatment of gastrointestinal diseases, conditions and symptoms in cats and other companion animals. On November 1, 2017, the Company received a letter from Elanco serving as formal notice of their decision to terminate the agreement by giving the Company 90 days written notice. According to the agreement, termination became effective on January 30, 2018. Under the terms of the agreement, the Company received revenue of $0 and $177,389 in the nine months ended September 30, 2019 and 2018, respectively. There was no revenue recognized in the three months ended September 30, 2019 and 2018.

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On September 24, 2018, the Company entered into a Distribution, License and Supply Agreement ("(“License ~~Agreement"~~Agreement”) with Knight Therapeutics ~~Inc.~~ ("Knight"). The License Agreement has a term of 15 years (with automatic renewals) and provides Knight with an exclusive right to commercialize current and future Jaguar human health products (including Crofelemer, Lechlemer, and any product containing a proanthocyanidin or with an anti-secretory mechanism) in Canada and Israel. ~~In addition,~~ Knight ~~was granted a~~forfeited its right of first negotiation for expansion to Latin America. Under the License Agreement, Knight is responsible for applying for and obtaining necessary regulatory approvals in the territory of Canada and Israel, as well as marketing, sales and distribution of the licensed products. Knight will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, Jaguar may receive payments from Knight in an aggregate amount of up to approximately $18 million payable throughout the initial 15-year term of the agreement. The Company did not have any ~~license~~collaboration revenues infor the three ~~months~~ and nine months ended September 30, ~~2019~~2020 and ~~2018.~~2019.

Modifications to ~~equity-classified instruments~~Equity-classified Instruments

In the nine months ended September ~~2019,~~30, 2020, the Company modified ~~its~~certain equity-classified ~~Series 1 Warrants~~warrants (see Note 7)8). It is the Company’s policy to determine the impact of ~~such~~modifications to equity-classified ~~modifications~~warrants by analogy to the share-based compensation guidance of ASC 718, Compensation - Stock Compensation(“ASC 718”). The model for a modified share-based payment award that is classified as equity and remains classified in equity after the modification is addressed in ASC 718-20-35-3. Pursuant to that guidance, the incremental fair value from the modification is recognized as an expense in the ~~income statement~~statements of operations to the extent the modified instrument has a higher fair ~~value. The Company uses a similar model for measuring the effects of a modification to equity-classified warrants,~~value; however, in ~~contrast to the 718 model,~~certain circumstances, such as when an entire class of warrants are modified, the measured increase in fair value may be more appropriately recorded as a deemed dividend, depending upon the nature of the warrant modification.

In the nine months ended September 30, 2020, the Company modified the terms of its Series B convertible preferred stock, and Series 1, 2 and Bridge warrants (see Note 9). For amendments to preferred stock, it is the Company’s policy to measure the impact by analogy to ASC 470-50 in determining if such an amendment is an extinguishment or a modification. If the amendment results in an extinguishment, the Company follows the SEC staff guidance in ASC 260-10-S99-2 and ASC 470-20. If the amendment results in a modification, the Company follows the model in either ASC 718 or ASC 470-50, depending on the nature of the amendment.

Stock-based Compensation

The Company's Stock Incentive Plans (see Note 12) provide for the grant of stock options, restricted stock and restricted stock unit awards.

The Company measures stock awards granted to employees, non-employees and directors at fair value on the date of grant and recognizes the corresponding compensation expense of the awards, net of estimated forfeiture over the requisite service periods, which correspond to the vesting periods of the awards. The Company issues stock awards with only service-based vesting conditions, and records compensation expense for these awards using the straight-line method.

The Company uses the grant date fair market value of its common stock to determine the grant date fair value of options granted to employees, non-employees and directors.

Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of

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assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

Comprehensive ~~Income (Loss)~~Loss

For all periods presented, the comprehensive ~~income (loss)~~loss was equal to the net ~~income (loss);~~loss; therefore, a separate statement of comprehensive ~~income (loss)~~loss is not included in the accompanying unaudited condensed consolidated financial statements.

Recent Accounting Pronouncements

~~Except as described in Note 2~~ ~~– Basis of Presentation, there have been no other new accounting pronouncements adopted by the Company besides the adoption of~~ ~~ASC 842 “Leases” and implementation of a new policy to account for modifications of preferred stock using the model in ASC 470-50~~ ~~during the three months and nine months ended September 30, 2019, that the Company believes are of significance or potential significance to the Company.~~

~~In June 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-07,~~ ~~Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting~~. This update expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. The amendments in ASU 2018-07 are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The Company adopted this standard on January 1, 2019, and this standard did not have a material impact on the Company’s financial position, results of operations or disclosures.

~~In August 2018, the FASB issued ASU 2018-15,~~ ~~Intangible - Goodwill and Other - Internal-Use Software (Subtopic 350-40)~~, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or

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obtain internal-use software. ASU 2018-15 is effective for the Company in the first quarter of 2020. Early adoption is permitted. ASU 2018-15 permits either a prospective or retrospective transition approach. The Company is currently evaluating ASU 2018-15 to determine the impact to its condensed consolidated financial statements and related disclosures. ~~The Company is evaluating the impact of the adoption of ASU 2016-13 on its Condensed Consolidated Financial Statements.~~

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. The ~~new guidance modifies~~primary focus of the standard is to improve the effectiveness of the disclosure requirements onfor fair value measurements. The changes affect all companies that are required to include fair value measurement disclosures. The standard requires the use of the prospective method of transition for disclosures related to changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop fair value measurements categorized within Level 3 of the fair value hierarchy, and narrative description of measurement uncertainty. All other amendments in the standard are required to be adopted retrospectively. We adopted the standard on January 1, 2020. The adoption of this standard did not have a material effect on the Company’s unaudited condensed consolidated financial statements and related disclosures.

In November 2018, the FASB issued ASU ~~2018-13~~2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606. ASU 2018-18 provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The standard also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The standard is to be applied retrospectively to the date of the initial application of Topic 606 which also requires recognition of the cumulative effect of applying the amendments as an adjustment to the opening balance of retained earnings of the later or the earliest annual period presented and the annual period inclusive of the initial application of Topic 606. We adopted the standard on January 1, 2020. The adoption of this standard did not have a material effect on the Company’s unaudited condensed consolidated financial statements and related disclosures.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects related to accounting for income taxes. The standard also removes certain exceptions to the general principles in Topic 740 and clarifies and amends existing guidance to improve consistent application. The pronouncement is effective for the Company beginning ~~in the first quarter of 2020 and must be adopted on a modified retrospective basis,~~January 1, 2021 with ~~certain exceptions. Early~~early adoption is permitted. The Company ~~does not expect~~is still evaluating the impact of the adoption of this standard.

In August 2020, the FASB issued ASU ~~2018-13 to have a significant~~2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The pronouncement is effective for the Company beginning January 1, 2022 with early adoption permitted. The Company is still evaluating the impact ~~to its condensed consolidated financial statements and related disclosures.~~of the adoption of this standard.

3. Fair Value Measurements

ASC 820 “Fair Value ~~Measurements,”~~Measurements” defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of

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observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

●

Level 1— Observable inputs such as quoted prices (unadjusted) for identical instruments in active markets.

●

Level 2— Observable inputs such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model derived valuations whose significant inputs are observable.

●

Level 3— Unobservable inputs that reflect the reporting entity’s own assumptions.

The following tables set forth the fair value of the Company’s financial instruments that were measured at fair value on a recurring basis as of September 30, ~~2019~~2020 and December 31, ~~2018.~~2019.

		��
	September 30, 2020
	(unaudited)
(in thousands)	Level 1		Level 2		Level 3		Total
Warrant liability	$	—	$	—	$	126	$	126
Series D perpetual preferred stock liability		—		—		6,430		6,430
Total fair value	$	—	$	—	$	6,556	$	6,556


	December 31, 2019
(in thousands)	Level 1		Level 2		Level 3		Total
Warrant liability	$	—	$	—	$	3	$	3
Total fair value	$	—	$	—	$	3	$	3

The Series D perpetual preferred stock liability represents 848,117 of 8% cumulative perpetual preferred shares. The shares are redeemable at $8.00 per share on December 31, 2024, the date in which contractual cash outflows of the Exchange Note 2 (See Note 7) require the entire settlement or redemption of the Series D perpetual preferred stock liability. The shares are entitled to stock dividends at the rate of 8% per annum, compounded monthly for twenty-four consecutive calendar months, based on the outstanding number of shares, including any dividend in arrears. Since the shares are mandatorily redeemable on a specified date they are recognized as liabilities.

The fair value of the Series D perpetual preferred stock liability amounting to $6,430,000 as of
September 30, 2020 was based on weighted discounted cash flows representing the settlement value of the shares and cumulative dividends issued using a current borrowing rate adjusted for counterparty. They were classified as level 3 fair values in the fair value hierarchy due to the use of unobservable inputs, including the Company’s own credit risk.

The Company determined and performed the valuations of the Series D perpetual preferred stock liability with the assistance of an independent valuation service provider. On a quarterly basis, the Company considers the main level 3 inputs used derived as follows:

●

Discount rates for Series D perpetual preferred stock were determined using comparison of various effective yields on investments as of the valuation date.

●

Weighted probability of cash outflows was estimated based on the entity's knowledge of the business and how the current economic environment is likely to impact the timing of the cash outflows.

September 30, 2019

(unaudited)


Level 1

Level 2

Level 3

Total
Warrant liability

$
—

$
—

$
10,029

$
10,029
Total fair value

$
—

$
—

$
10,029

$
10,029

December 31, 2018


Level 1

Level 2

Level 3

Total
Warrant liability

$
—

$
—

$
220,376

$
220,376
Total fair value

$
—

$
—

$
220,376

$
220,376

1621

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The following table summarizes the quantitative information about the significant unobservable inputs used in level 3 fair value measurements:


	Range of inputs (probability-weighted average)		Relationship of unobservable
Unobservable Inputs	2020	2019	inputs to fair value
Risk Adjusted Discount Rate	12%-15% (14%)	N/A	Lower discount rate (-200 basis points (bps)) would increase FV by $103,000; Higher discount rate (+100 bps) would decrease FV by $117,000
Timing of Cash Flows: Settlement on September 30, 2021	60%-90% (90%)	N/A	If expected cash flows determined by Management would consider a mix of 70%, 15%, and 15% for the respective scenarios, FV would have decreased by $38,000. If expected cash flows determined by Management would consider a mix of 60%, 20%, and 20% for the respective scenarios, FV would have decreased by $57,000.
Timing of Cash Flows: Settlement on December 30, 2021	5%-20% (5%)	N/A	If expected cash flows determined by Management would consider a mix of 70%, 15%, and 15% for the respective scenarios, FV would have decreased by $38,000. If expected cash flows determined by Management would consider a mix of 60%, 20%, and 20% for the respective scenarios, FV would have decreased by $57,000.
Timing of Cash Flows: Settlement on August 31, 2022	5%-20% (5%)	N/A	If expected cash flows determined by Management would consider a mix of 70%, 15%, and 15% for the respective scenarios, FV would have decreased by $38,000. If expected cash flows determined by Management would consider a mix of 60%, 20%, and 20% for the respective scenarios, FV would have decreased by $57,000.

The change in the estimated fair value of Level 3 liabilities is summarized below:


	Nine Months Ended
	September 30, 2019
	Warrant
	Liability
	(unaudited)

			Nine Months Ended
			September 30, 2020
			Warrant Liability		Series D perpetual preferred stock liability
(in thousands)			(unaudited)		(unaudited)
Beginning fair value of Level 3 liability	$	220,376	$	3	$	—
Additions		5,122,039		3,696		6,359
Reclassification to equity		(4,329,521)
Exercises				(5,993)		—
Change in fair value		(1,002,865)		2,420		71
Ending fair value of Level 3 liability	$	10,029	$	126	$	6,430

Warrant Liability

The warrants associated with the Level 3 warrant liability activity for the nine months ended September 30, 2019 were the November 2016 Series A warrants, the October 2018 Underwriter warrants, the March 2019 LOC warrants and the Bridge warrants, which at September 30, 2019 were valued at $49 and $9,980, zero and zero, respectively in the Company’s condensed consolidated balance sheet. At December 31, 2018, the warrants associated with the Level 3 warrant liability were the November 2016 Series A Warrants, ~~and~~ the October 2018 Underwriter Warrants and the May 2020 Series 3 Warrants, which, at September 30, 2020, were valued at ~~$7,388~~zero, $1,000 and ~~$212,988,~~$125,000 respectively, in the Company’s condensed consolidated balance ~~sheet.~~

sheets. The warrants associated with the Level 3 warrant liability activity for the year ended December 31, 2019 were the November 2016 Series A Warrants, the October 2018 Underwriter Warrants, the March 2019 LOC Warrants and the Bridge Warrants, which at December 31, 2019 were valued at zero, $3,000, zero and zero, respectively in the Company’s condensed consolidated balance sheets.

The November 2016 Series A Warrants

The Series A warrant valuation of ~~$7,388~~zero at ~~December 31, 2018~~September 30, 2020 was computed using the Black-Scholes-Merton pricing model using a stock price of ~~$16.10,~~$0.29, a strike price of $787.50 per share, an expected term of ~~3.41~~1.70 years, volatility of ~~135.63%~~148% and a risk-free discount rate of ~~2.46%~~0.13%. The Series A warrant valuation of ~~$49~~zero at ~~September 30,~~December 31, 2019 was computed using the Black-Scholes-Merton pricing model using a stock price of ~~$1.31,~~$0.65, a strike price of $787.50 per share, an expected term of ~~2.66~~2.41 years, volatility of ~~144.31%~~143.41% and a risk-free discount rate of ~~1.56%~~1.62%. ~~For~~The net decrease in the fair value of the warrants of zero for the three and nine months ended September 30, 2020, was recorded as a gain in the change in fair value of financial instruments in the unaudited condensed consolidated statements of operations.

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The October 2018 Underwriter Warrants

The October 2018 Underwriter Warrants valuation of $1,000 at September 30, 2020 was computed using the Black-Scholes-Merton pricing model using a stock price of $0.29, a strike price of $52.50 per share, an expected term of 3.00 years, volatility of 156% and a risk-free discount rate of 0.16%. The October 2018 Underwriter Warrants valuation of $3,000 at December 31, 2019 was computed using the Black-Scholes-Merton pricing model using a stock price of $0.65, a strike price of $52.50 per share, an expected term of 3.76 years, volatility of 143.41% and a risk-free discount rate of 1.69%. The net ~~change~~decrease in the fair value of the warrants of ~~$1,004~~$1,000 and ~~$7,339,~~$3,000 for the three and nine months ended September 30, 2020, respectively, was recorded as a gain in the change in fair value of ~~warrants, derivative liability and conversion option liability~~financial instruments in the unaudited condensed consolidated statements of operations.

The ~~October 2018 Underwriter~~May 2020 Series 3 Warrants

The ~~October 2018 Underwriter~~May 2020 Series 3 Warrants valuation of ~~$212,988~~$123,000 at ~~December 31, 2018~~September 30, 2020 was computed using the Black-Scholes-Merton pricing model using a stock price of ~~$16.10,~~$0.29, a strike price of ~~$52.50,~~$0.00 per share, an expected term of ~~4.76~~5.14 years, volatility of ~~135.63%~~142% and a risk-free discount rate of ~~2.51%~~0.28%. The ~~October 2018 Underwriter~~May 2020 Series 3 Warrants valuation of ~~$9,980~~$3,696,000 at ~~September 30, 2019~~issuance on May 22, 2020 was computed using the Black-Scholes-Merton pricing model using a stock price of ~~$1.31,~~$0.44, a strike price of ~~$52.50~~$0.05 per share, an expected term of ~~4.01~~5.50 years, volatility of ~~144.31%~~143% and a risk-free discount rate of ~~1.55%~~0.34%. ~~For~~The net increase in the fair value of the warrants of $2,034,000 and $2,422,000 for the three and nine months ended September 30, 2020, respectively, was recorded as a loss in the change in fair value of financial instruments in the unaudited condensed consolidated statements of operations.

4. Balance Sheet Components

Inventory

Inventory at September 30, 2020 and December 31, 2019 consisted of the following:


	September 30,		December 31,
(in thousands)	2020		2019
	(unaudited)
Raw Material	$	604	$	457
Work in Process		542		1,211
Finished Goods		1,073		461
Inventory	$	2,219	$	2,129

Property and Equipment

Property and equipment at September 30, 2020 and December 31, 2019 consisted of the following:


	September 30,		December 31,
(in thousands)	2020		2019
	(unaudited)
Land	$	396	$	396
Lab equipment		418		411
Clinical equipment		65		65
Software		63		63
Total property and equipment at cost		942		935
Accumulated depreciation		(256)		(225)
Property and equipment, net	$	686	$	710

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Depreciation expense was $11,000 and $31,000 in the three and nine months ended September 30, 2020. Depreciation expense was $10,000 and $40,000 for the three and nine months ended September 30, 2019, the net change in the fair value of the warrants of $42,285 and $203,008, respectively, was recorded as a gain in the change in fair value of warrants, derivative liability and conversion option liability in the condensed statements of operations

~~March 2019 LOC Warrants~~

The March 2019 LOC Warrants were issued on March 29, 2019 with a valuation at issuance and at March 31, 2019 of $116,297, computed using the Black-Scholes-Merton pricing model using a stock price of $19.60, a strike price of $17.50 per share, an expected term of 5.0 years, volatility of 145.72% and a risk-free discount rate of 2.23%. On July 23, 2019, at which date the exercise price of the March 2019 LOC warrants became fixed, the March 2019 LOC warrants were reclassified from liability classification to equity classification. Immediately prior to reclassification to equity, the March 2019 LOC Warrant liability was valued at $71,079 using the Black-Scholes-Merton pricing model, calculated using a stock price of $1.73, a strike price of $2.00, an expected term of 5.00 years, volatility of 147.43% and a risk-free discount rate of 1.83%. For the three and nine months ended September 30, 2019, there was a gain in the fair

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value of the warrants of $79,891 and $45,218, respectively, which was recorded as a gain in the change in fair value of warrants, derivative liability and conversion option liability in the consolidated statements of operations.

~~2019 Bridge Warrants~~

The 2019 Bridge Warrants were issued between March and June 2019, concurrent to the Company entering into short-term Promissory Notes of $5,050,000 (see Note 7). The Company issued (i) fourteen Notes with a principal balance of $3,550,000 and warrant coverage at 125% of principal, and (ii) seven Notes with a principal balance of $1,500,000 and warrant coverage at 75% of principal. At issuance, the exercise price of the warrants was either (i) the price the Company issued common shares in its next public offering subject to a registration statement or (ii) if no such offering were consummated by the four-month maturity date of the Promissory Notes, then the exercise price would be equal to the closing price of the Company’s common stock on the Notes four-month maturity date. The warrants for all twenty-one Bridge Notes had a collective issuance date fair value of $5,005,739, computed using the Black-Scholes-Merton pricing model using a range of stock prices between $4.84 and $32.90, a range of strike prices between $4.84 and $32.90 per share, an expected term of 5.0 years, a range of volatilities between 145.60% and 145.72%, and a range of risk-free discount rates between 1.76% and 2.23%. At issuance, all twenty-one warrants were liability classified. On July 23, 2019, upon the Company’s filing of a registration statement, the exercise price for all twenty-one warrants became fixed at $2.00, at which point the Bridge warrants were reclassified from liability classification to equity classification. Immediately prior to reclassification, the liability for all twenty-one Bridge Warrants had a collective fair value of $4,259,327, calculated using the Black-Scholes-Merton pricing model using a stock price of $1.73, a strike price of $2.00 per share, an average expected term of 4.80 years, volatility of 145.84% and a risk-free discount rate of 1.76%. For the three and nine months ended September 30, 2019, the net change in the fair value of the warrants of $718,654 and $747,300, respectively, was recorded as a gain in the change in fair value of warrants, derivative liability and conversion option liability in the consolidated statements of operations.

~~4. Balance Sheet Components~~

~~Goodwill~~

~~The change in the carrying amount of goodwill at September 30, 2019 and December 31, 2018 was as follows:~~

September 30,

2019

December 31,

(unaudited)

2018

Beginning balance

$
—

$
5,210,821

Impairment

—

(5,210,821)

Ending balance

$
—

$
—

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respectively.

Intangible Assets

Intangible assets at September 30, ~~2019~~2020 and December 31, ~~2018~~2019 consisted of the following:


	September 30,
	2019		December 31,
	(unaudited)		2018

					September 30,		December 31,
(in thousands)					2020		2019
					(unaudited)
Developed technology	$	25,000,000	$	25,000,000	$	25,000	$	25,000
Accumulated developed technology amortization		(3,611,112)		(2,361,111)		(5,278)		(4,028)
Developed technology, net		21,388,888		22,638,889		19,722		20,972
In-process research and development		8,800,000		8,800,000		4,800		8,800
Impairment		(4,000,000)		—		—		(4,000)
In process research and development, net		4,800,000		8,800,000		4,800		4,800
Trademarks		300,000		300,000		300		300
Accumulated trademark amortization		(43,333)		(28,333)		(63)		(48)
Trademarks, net		256,667		271,667		237		252
Total intangible assets, net	$	26,445,555	$	31,710,556	$	24,759	$	26,024

In June 2019, the Company determined that in-process research and development was impaired and recorded an impairment loss of ~~$4.0 million~~zero and $4,000,000 in the statements of ~~operations. Amortization expense~~ ~~was $421,667 and $1,265,001 for the three and nine~~ ~~months ended September 30, 2019, respectively, and $421,667 and $1,265,001~~operations for the three and nine months ended September 30, ~~2018,~~2019, respectively.

~~The following table summarizes~~ Amortization expense was $422,000 and $1,265,000 for the ~~Company’s estimated future amortization expense of intangible assets with finite lives as of~~three and nine months ended September 30, ~~2019:~~2020 and 2019, respectively.

Amounts
2019 (remaining)

$
421,667
2020

1,686,667
2021

1,686,667
2022

1,686,667
2023

1,686,667
2024

1,686,667
Thereafter

12,790,553

$
21,645,555

5. Related Party Transactions

Management Services Agreement

In March 2018, concurrent with the issuance of the Company’s Series A convertible ~~participating~~ preferred stock to Sagard Capital Partners, L.P. (“Sagard Capital”), the Company entered into a Management Services Agreement with Sagard ~~Capital Partners.~~Capital. Under the agreement, Sagard ~~Partners~~Capital will provide consulting and management advisory service to the Company from March 2018 through March 2021. These services include assistance with strategic planning regarding the Company’s commercial strategy, research and due diligence regarding human resource activities, and strategic advice in financial matters. In consideration for such services, the Company will pay Sagard Capital ~~Partners~~ an annual fee of $450,000, with total fees over the term of the agreement not to exceed $1,350,000. On September 1, 2020, in concurrence with other transactions by and between the Company, Chicago Venture Partners, L.P. (“CVP” or “Chicago Venture Partners”) and its affiliates, and Sagard Capital, the Company and Iliad Research and Trading, L.P., an affiliate of CVP, agreed to issue 2,289,474 shares of the Company’s Common Stock to Sagard Capital pursuant to the Stock Plan Agreement for termination of the Management Services Agreement in lieu of payment of $1,087,500 in accrued consulting and management fees. For the three and nine months ended September 30, 2020, total fees incurred were $112,500 and $337,500, respectively. As of September 30, ~~2019, with respect to this agreement,~~2020, the Company had ~~paid Sagard Capital Partners aggregate fees of $250,000 and has a~~zero balance due ~~of $425,000.~~ to Sagard Capital.

Letter of Credit

ToIn August 2018, to satisfy ~~the~~a letter of credit requirement in the Company’s ~~new~~ office lease agreement (see Note 6), Pacific Capital Management, LLC, one of the Company’s existing shareholders, caused its financial institution to issue a letter of credit

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in the amount of $475,000 on behalf of the ~~Company, dated August 28, 2018.~~Company. In consideration of the letter of credit, in August 2018, the Company issued to Pacific Capital Management, LLC a warrant (see Note 8) to purchase 9,580 shares of the Company’s voting common stock. The warrant is exercisable on or after March 28, 2019 at an exercise price of $49.00 and has a five-year term. The $493,688 fair value of the Warrant was classified in stockholders’ equity (see Note 6). Additionally,As additional consideration, a payment of $45,000 ~~is due~~was made to Pacific Capital Management, LLC in November 2019.

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On March 24, 2020, the Company entered into a letter of credit agreement with Dr. Charles Conte, the brother of Lisa Conte, the Company’s President, CEO and member of the Company’s board of directors, pursuant to which the Company will, subject to CA-Mission Street Partnership’s consent, replace the existing letter of credit in the amount of $475,000 entered into on August 28, 2018 by ~~November 28, 2019.~~the Company with CA-Mission Street Partnership to satisfy the letter of credit requirement in the Company’s office lease agreement with a new letter of credit in the amount of $475,000. In consideration of the new letter of credit, the Company will pay Dr. Conte an amount equal to $10,000 per month and reimburse up to $7,500 for reasonable out-of-pocket expenses incurred. The letter of credit will expire no earlier than December 31, 2020, provided, however that the Company, at no additional cost, may replace it on an earlier date. For the three and nine months ended September 30, 2020, total fees incurred were $30,000 and $65,000, respectively. In October 2020, CA-Mission Street Partnership released the letter of credit agreement with Dr. Conte pursuant to the expiration and termination of the office lease agreement between the Company and CA-Mission Street Partnership on September 30, 2020. As of September 30, 2020, the Company had zero balance due to Dr. Conte. In October 2020, the Company paid Dr. Conte a prorated amount due through the effective date of the release of the letter of credit of $7,000.

2019 Bridge Notes

Between March 18, 2019 and June 26, 2019, three members of the Board of Directors of the Company ~~had~~ entered into short-term Promissory Note Purchase Agreements ~~(see Note 7, the “2019 Bridge Notes”)~~ with the Company: (i) Lisa Conte, the Company’s CEO & President, purchased a short-term Promissory Note of $100,000 which the Company settled in July 2019. In consideration for the short-term financing, the Company issued Ms. Conte a warrant that became exercisable into 37,500 shares of the Company’s common ~~stock;~~stock at an exercise price of $0.49 per share; (ii) James Bochnowski, purchased a short-term Promissory Note of $350,000 which the Company settled in July 2019. In consideration for the short-term financing, the Company issued Mr. Bochnowski a warrant that became exercisable into 218,750 shares of the Company’s common ~~stock;~~stock at an exercise price of $0.49 per share; and (iii) Jonathan Siegel DBA JBS Healthcare Ventures, purchased a short-term Promissory Note of $75,000 which the Company settled in July 2019. In consideration for the short-term financing, the Company issued Mr. ~~Siegal~~Siegel a warrant that became exercisable into 34,375 shares of the Company’s common ~~stock.~~stock at an exercise price of $0.49 per share.

In addition, Sagard Capital ~~Partners~~ purchased a short-term Promissory Note of $500,000, which the Company settled in July 2019. In consideration for the short-term financing, the Company issued Sagard Capital ~~Partners~~ a warrant that became exercisable into 187,500 shares of the Company’s common ~~stock;~~stock at an exercise price of $0.49 per share; and Jonathan Glaser, an existing shareholder, purchased short-term Promissory Notes of $500,000 which the Company settled in July 2019. In consideration for the short-term financing, the Company issued Mr. Glaser warrants that became exercisable into 250,000 shares of the Company’s common ~~stock.~~stock at an exercise price of $0.49 per share.

6. Commitments and Contingencies

Commitments

Leases

On August 28, 2018, the Company entered into an office lease extension agreement for approximately 6,311 square feet of office space in San Francisco, CA. The term of the ~~Lease~~lease began on September 1, 2018 and ~~will expire~~expired on September 30, ~~2020, unless earlier terminated in accordance therewith.~~2020. The monthly base rent under the ~~Lease is~~lease was as follows: ~~$38,392~~$38,000 for the first twelve months, ~~$39,544~~$40,000 for the subsequent twelve months, and ~~$40,730~~$41,000 for the final month. The Company ~~will~~ also ~~pay~~paid an additional monthly amount for the Company’s proportionate share of the building’s operating charges. An existing shareholder provided a standby letter of credit in the amount of $475,000 to the ~~Lessor~~lessor as collateral for the full performance by the Company of all of its obligations under the ~~Lease.~~lease. In consideration of the Letter of Credit, the Company issued the ~~existing~~ shareholder a five-year warrant (see Note 8) to purchase 9,580 shares of the Company’s voting common ~~stock (see Note 5).~~stock. The Warrant is exercisable on or after March 28, 2019 at an exercise price of $49.00 per share. The fair value of the warrant was determined to be $493,688 using the Black-Scholes-Merton model with the following criteria: stock price of $58.80 per share, expected life of 5 years, volatility of 132%, risk-free rate of 2.77% and dividend rate of 0%. The $493,688$494,000 fair value of the Warrant was classified in stockholders’ equity with an offset to ~~Operating lease –~~deferred rent. With the Company’s adoption of ASC 842 on January 1, 2019, the offset to the deferred balance was classified as a right-of-use asset. Each month, ~~$19,748~~$20,000 of

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this ~~rent will be~~deferred balance was recognized as non-cash lease ~~expense.~~expense during the term of the lease, which expired on September 30, 2020.

In December 2018, the Company did not meet a covenant per the terms of the $475,000 Letter of Credit, the result of which required the Company to issue a Letter of Credit of $122,000 to the shareholder who issued the original $475,000 letter of credit. In March 2019, the Company canceled the $122,000 letter of credit in lieu of issuing the shareholder a promissory note for that amount in April 2019, as well as issuing the shareholder a warrant (see Note 7)8).

On August 31, 2020, the Company entered into an office sublease of approximately 5,263 square feet of office space in San Francisco. The term of the sublease will expire on May 31, 2021. The rent sublease is $15,000 per month beginning on October 1, 2020, which includes operating expenses and taxes.

The Company recognizes ~~lease~~rent expense on a straight-line basis over the non-cancelable lease period. ~~Lease~~Rent expense was ~~$152,741~~$191,000 and ~~$554,017~~$588,000 for the three and nine months ended September 30, 2020, respectively, and $153,000 and $554,000 for the three and nine months ended September 30, 2019, ~~and $117,435 and $297,993 for the three and nine months ended September 30, 2018. Lease~~respectively. Rent expense is included in general and administrative ~~expense~~expenses in the unaudited condensed consolidated statements of operations.

Angel Pond Agreement

~~Table~~In October 2019, the Company engaged Angel Pond Capital LLC to explore potential licensing agreements and collaborations for Mytesi in China. In consideration of ~~Contents~~

these services, the Company compensated Angel Pond Capital LLC with $140,000, paid via the issuance of 166,667 shares of the Company’s common stock, for the initial four-month term of the agreement. The Company had the option to extend the agreement term for two months for $30,000 payable in shares of the Company’s common stock. As of September 30, 2020, no qualifying amounts were raised in China and no amounts are owed to Angel Pond as compensation. The Company did not extend the agreement with Angel Pond Capital LLC and it has expired.

Asset transfer and transition commitment ~~update~~

On September 25, 2017, Napo entered into the Termination, Asset Transfer and Transition Agreement dated September 22, 2017 with Glenmark Pharmaceuticals Ltd. (“Glenmark”). As a result of the agreement, Napo now controls commercial rights for Mytesi® for all indications, territories and patient populations globally, and also holds commercial rights to the existing regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe and Botswana. In exchange, Napo agrees to pay Glenmark 25% of any payment it receives from a third party to whom Napo grants a license or sublicense or with whom Napo partners in respect of, or sells or otherwise transfers any of the transferred assets, subject to certain exclusions, until Glenmark has received a total of $7.0 million. No payments have been made to date.

Revenue sharing commitment ~~update~~

On December 14, 2017, the Company announced its entry into a collaboration agreement with Seed Mena Businessmen Services LLC (“SEED”) for Equilevia™, the Company's non-prescription, personalized, premium product for total gut health in equine athletes. According to the terms of the Agreement, the Company will pay SEED 15% of total revenue generated from any clients or partners introduced to the Company by SEED in the form of fees, commissions, payments or revenue received by the Company or its business associates or partners, and the agreed-upon revenue percentage increases to 20% after the first million dollars of revenue. In return, SEED will provide the Company access to its existing United Arab Emirates (“UAE”) network and contacts and assist the Company with any legal or financial requirements. The agreement became effective on December 13, 2017 and will continue indefinitely until terminated by either party pursuant to the terms of the Agreement. ~~Upon termination for any reason, the Company remained obligated to make Revenue Sharing Payments to SEED until the end of 2018.~~ No payments have been made to date.

Legal Proceedings

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Company who held shares on April 12, 2017 and were entitled to vote at the 2017 Special Shareholders Meeting, against the Company and certain individuals who were directors as of the date of the vote (collectively, the “Defendants”), in a matter captioned Tony Plant v. Jaguar Animal Health, Inc., et al., making claims arising under Section 14(a) and Section 20(a) of the Exchange Act and Rule ~~14a‑~~14a 9, 17 C.F.R. § ~~240.14a‑~~240.14a 9, promulgated thereunder by the SEC. The claims alleged false and misleading information provided to investors in the Joint Proxy Statement/Prospectus on Form ~~S‑4~~S-4 (File No. ~~333‑~~333 217364) declared effective by the Commission on July 6, 2017 related to the solicitation of votes from shareholders to approve the merger and certain transactions related thereto. The Company accepted service of the complaint and summons on behalf of itself and the United States-based director Defendants on November 1, 2017. The Company has not accepted service on behalf of, and Plaintiff has not yet served, the non-U.S.-based director Defendants.

On October 3, 2017, Plaintiff filed a motion seeking appointment as lead plaintiff and appointment of Monteverde & Associates PC as lead counsel. That motion was granted. Plaintiff filed an amended complaint against the Company and the United ~~States-based~~States based director Defendants on January 10, 2018. The Defendants filed a motion to dismiss on March 12, 2018, for which oral arguments were held on June 14, 2018. The court dismissed the amended complaint on September 20, ~~2018 but gave~~2018. Plaintiff ~~leave~~was entitled to amend ~~the~~that complaint within 20 days from the date of dismissal. On October 10, 2018, Plaintiff filed a second amended ~~the~~ complaint to focus on the Company’s commercial strategy in support of Equilevia and the related disclosure statements in the Form S-4 described above. On November 6, 2018, the Defendants moved to dismiss the second amended complaint. The Defendants ~~argued~~argue in their motion that the second amended complaint fails to state a claim upon which relief can be granted because the omissions and misrepresentations alleged in the complaint are immaterial as a matter of law. The court denied the Defendants’ motion to dismiss on June 28, 2019. The ~~defendants~~Company answered the second amended complaint on August 2, ~~2019. Discovery~~2019; the answer denied the material allegations of the second amended complaint.

Following the exchange of documents, the parties engaged in a mediation. As a result of the mediation process, the parties have agreed in principle to a payment of $2,600,000 to members of a settlement class consisting of all record and beneficial holders of Jaguar Animal Health, Inc. common stock who purchased, sold, or held such stock during the period from and including June 30, 2017 through and including July 31, 2017, the date the Merger closed, including any and all of their respective predecessors, successors, trustees, executors, administrators, estates, legal representatives, heirs, assigns and transferees (the “Settlement Class”). The following persons are excluded from the Settlement Class: (a) defendants; (b) members of the immediate families of each defendant; (c) any entity in which any defendant has a controlling interest; (d) the legal representatives, heirs, successors, administrators, executors, and assigns of each defendant; and (e) any persons or entities who properly exclude themselves by filing a valid and timely request for exclusion.

The proposed settlement will ~~now proceed. If~~not become effective unless and until it is approved by the ~~Plaintiff were able~~district court, subject to ~~prove his allegations~~rulings upon any objections and any appeals to the court of appeals. Assuming that the proposed settlement is approved by the district court and becomes effective, the settlement consideration will be paid by the Company’s directors and officers liability insurer.

Settlement of Underwriter Fee

In August 2018, the Company entered into an agreement with an underwriter pursuant to which the underwriter would aid the Company in ~~this matter~~identifying certain financing transactions, in exchange for a percentage fee of any such financing and warrants. In the first quarter of 2020, the Company and the underwriter agreed on a final settlement for the underwriter services comprised of a cash payment, warrants and common stock. The cash payment amount totaled $386,560, of which $201,650 had been paid in September 2019, and $184,910 was accrued in March 2020 and was paid in April 2020. The total warrant issuance payment consisted of the Company issuing 1,096 equity-classified warrants to ~~establish~~ the ~~damages he asserts, then~~underwriter in August 2018 and, in April 2020, issuing an ~~adverse ruling could have~~additional 100,780 equity-classified warrants (see Note 8) to the underwriter to purchase shares of common stock at an exercise price of $2.50 per share. The common stock issuance payment consisted of the Company, in April 2020, issuing 100,000 shares of the Company’s common stock to the underwriter with a ~~material impact on~~fair value of $44,900. The Company classified the ~~Company.~~

cash payments, warrant and commons stock issuance payments as issuance costs in the condensed consolidated statements of changes in convertible preferred stock and stockholders’ equity.

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Other than as described above, there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows.

Contingencies

From time to time, the Company may be involved in legal proceedings (other than those noted above) arising in the ordinary course of business. The Company believes there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on the financial position, results of operations or cash flows.

~~Settlement of Tempesta Royalty dispute~~

As of September 30, 2019, the Company was in negotiations with Dr. Michael Tempesta regarding disputes of royalty payments owed by Napo to Tempesta under a license agreement, dated February 8, 1990, between Tempesta and Shaman Pharmaceuticals, a predecessor-in-interest to Napo (the “1990 License”), and a modified license agreement, dated October 16, 2002, between Tempesta and Napo (the “2002 License” and together with the 1990 License, the “License Agreements”) with respect to SP-303, a component of Mytesi, the Company’s FDA-approved drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The Company had ceased payment of royalties to Tempesta in October 2018.

At September 30, 2019, the Company determined that it was probable that a liability in the amount of $640,000 would be paid to Tempesta in the settlement of the royalty dispute. Accordingly, at September 30, 2019 and pursuant to ASC 450, the Company accrued a loss contingency of $640,000 that was charged to operating expenses in the condensed statements of operations.

In October 2019, the Company and Tempesta settled the dispute, pursuant to which Tempesta received $50,000 in cash, an unsecured promissory note issued by the Company in the aggregate principal amount of $550,000 and 40,000 shares of the Company’s common stock in exchange for the cessation of all royalty payments by Napo to Dr. Tempesta under the License Agreements (see Note 14).

7. Debt

Convertible ~~Notes~~Debt

~~Convertible notes at September 30, 2019 and~~ December ~~31, 2018 consist of the following:~~

September 30,

2019

December 31,

(unaudited)

2018
June 2017 convertible debt

$
—

$
740,882
Napo convertible debt

—

10,553,888

—

11,294,770
Less: unamortized debt discount and debt issuance costs

—

(55,600)
Net convertible debt obligation

$
—

$
11,239,170
Convertible debt - non-current, net of discount

—

—
Convertible debt - current, net of discount

$
—

$
11,239,170

~~February 2015 Convertible Note~~

In February 2015, the Company issued a convertible promissory note to an accredited investor in the aggregate principal amount of $150,000. This note was issued pursuant to the convertible note purchase agreement dated December 23, 2014. In March of 2018, the debtor agreed to accept 1,937 shares of the Company’s common stock as payment for all outstanding principal and interest in the amount of $203,408.

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~~June~~ 2017 ~~Convertible~~ Note

On June 29, 2017, the Company issued a secured convertible promissory note to ~~CVP~~Chicago Venture Partners, in the aggregate principal amount of $2,155,000 less an original issue discount of $425,000 and less $30,000 to cover the lender's legal fees for net cash proceeds of $1,700,000 (the “June 2017 Note”). Interest on the outstanding balance will be paid 8% per annum from the purchase price date until the balance is paid in full.

The ~~Note provides for two separate features that result in a derivative liability:~~

Repayment of mandatory default amount upon an event of default—upon the occurrence of any event of default, the lender may accelerate the Note resulting in the outstanding balance becoming immediately due and payable in cash; and

Automatic increase in the interest rate on and during an event of default—during an event of default, the interest rate will increase to the lesser of 17% per annum or the maximum rate permitted under applicable law.

~~The~~ Company computed fair values at the date of issuance of $15,000 and $5,000 for the repayment and the interest rate increase feature, respectively, using the Binomial Lattice Model, which was based on the generalized binomial option pricing formula. The $20,000 combined fair value was carved out and was included as a derivative liability on the Balance Sheet. At September 30, 2018, the derivatives were determined to have a de-minimis fair value and were written-off.

On August 2, 2018, the Company and CVP agreed to an amendment extending the maturity date to
August 26, 2019, and limiting the aggregate amount that CVP is permitted to redeem on a monthly basis to $500,000, which is the maximum aggregate redemption amount for all notes outstanding with CVP. This amendment resulted in the Company accounting for the transaction as a troubled debt restructuring, under which the carrying amount of the note payable remained unchanged but interest expense is computed using a new effective rate that equates the present value of the future cash payments specified by the new terms with the carrying amount of the note.

Between October 2018 and December 2018, the Company and CVP renegotiated the terms of the June 2017 Note agreement such that CVP agreed not to make any redemptions of the June 2017 Note until March 2019. In consideration of this standstill arrangement, the Company paid CVP a total standstill fee of ~~$499,403~~$499,000 for all four CVP ~~Notes.~~Notes (collectively, the June 2017 CVP Note, The December 2017 CVP Note, the February 2018 Note and the March 2018 Note). The standstill fee allocated to the June 2017 Note was ~~$63,296,~~$63,000, of which ~~$37,296~~$37,000 increased the principal balance and $26,000 was paid in cash. These restructurings in whole represented four separate restructurings of the June 2017 ConvertibleNote agreement, resulting in two troubled debt restructurings accounted for under ASC 470-60 and two modificationsaccounted for under ASC 470-50. For the two modifications resulting in troubled debt restructurings, the changes wereaccounted for prospectively and a new effective interest rate was determined that equated the present value of the futurecash payments specified by the new terms with the carrying amount of the June 2017 Note. For the two modifications that resultedin modification accounting, a new effective rate was determined at the date of modification that equated the revisedcash flows to the carrying amount of the Note.

In May 2019,, the Company and CVP amended the June 2017 Note agreement such that the Company made three separate exchanges of principal and related accrued interest for shares of the Company’s common stock. The first two exchanges of principal and accrued interest for common stock were not considered a substantial change to the June 2017 Note and therefore resulted in modification accounting and the determination of a new effective interest rate; the third exchange on May 29, 2019 resulted in the extinguishment of the entire June 2017 Note with a corresponding extinguishment loss of ~~$27,176 for the three months ended June 30, 2019.~~$8,000. At ~~September 30, 2019 and~~ December 31, ~~2018, the net carrying value of~~2019, the June 2017 Note ~~was zero and $685,282, respectively.~~

had been fully extinguished.

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Napo Convertible Notes

March 2017 Convertible ~~Notes~~Debt

In March 2017, Napo entered into an exchangeable Note Purchase Agreement with two lenders for the funding of face amount of ~~$1,312,500~~$1,312,000 in two $525,000 tranches of face amount ~~$656,250.~~$656,000. The notes bore interest at 3% and ~~mature on~~had an original maturity date of December 1, 2017. The Company assumed the notes at fair value of ~~$1,312,500~~$1,313,000 as part of the Napo Merger.

First Amendment to Note Purchase Agreement and Notes

In December 2017, Napo amended the exchangeable note purchase agreement to extend the maturity of the first tranche and second tranche of notes to February 15, 2018 and April 1, 2018, respectively, increase the principal amount by 12%, and reduce the conversion price from $39.20 per share to $14.00 per share. The Company also issued ~~35,601~~166,139 shares of common stock to the lenders in connection with this amendment to partially redeem ~~$299,050~~$299,000 from the first tranche of the notes. The amended face value of the notes was ~~$1,170,950.~~$1,171,000. This amendment resulted in the Company treating the notes as having been extinguished and replaced with new notes for accounting purposes due to meeting the 10% cash flow test. The conversion option in the notes was bifurcated and accounted for as a conversion option liability at its fair value.

Second Amendment to Note Purchase Agreement and Notes

On February 16, 2018, Napo amended the exchangeable note purchase agreement to extend the maturity date of the Second Tranche Notes from April 1, 2018 to May 1, 2018. In addition, the Company also issued ~~54,049~~3,603 shares of common stock to the Purchasers as repayment of the remaining ~~$435,950~~$436,000 aggregate principal amount and ~~$18,063~~$18,000 in accrued and unpaid interest thereon. On March 23, 2018, the Company paid off the remaining $735,000 of principal and ~~$20,699~~$21,000 in interest due on the second tranche debt in cash with proceeds from the March 23, 2018 equity financing. The fair value of the conversion option liability was again revalued at March 23, 2018 using the Black-Scholes-Merton model using the following criteria: stock price of $14.70 per share, expected life of 0.11 years, volatility of 288.16%, ~~risk free~~risk-free rate of 1.69% and dividend rate of 0%, resulting in an increase of ~~$174,754~~$175,000 to the fair value of the conversion option liability and included in the change in fair value of warrants and conversion option liability in the statements of operations. The underlying debt was paid off in March of 2018 and the ~~$286,595~~$287,000 conversion option liability was written off to ~~other income~~loss from operations in the unaudited condensed consolidated statements of operations.

December 2016 Convertible ~~Notes~~Debt

In December 2016, Napo entered into a note purchase agreement which provided for the sale of up to $12,500,000 face amount of notes and issued convertible promissory notes (the ~~Napo~~“Napo December 2016 ~~Notes)~~Notes”) in the aggregate face amount of $2,500,000 to three lenders and received proceeds of $2,000,000 which resulted in $500,000 of original issue discount. In July 2017, Napo issued convertible promissory notes (the ~~Napo~~“Napo July 2017 ~~Notes)~~Notes”) in the aggregate face amount of $7,500,000 to four lenders and received proceeds of $6,000,000 which resulted in $1,500,000 of original issue discount. The Napo December 2016 Notes and the Napo July 2017 Notes mature on December 30, 2019 and bear interest at 10% with interest due each six-month period after December 30, 2016. On June 30, 2017, the accrued interest of ~~$125,338~~$125,000 was added to principal of the Napo December Notes, and the new principal balance became ~~$2,625,338.~~$2,625,000. Interest may be paid in cash or in the stock of Jaguar per terms of the note purchase agreement. In each one year period beginning December 30, 2016, up to one-third of the principal and accrued interest on the notes may be converted into the common stock of the merged entity at a conversion price of $64.75 per share. The Company assumed these convertible notes at fair value of $11,161,000 as part of the Napo Merger. The ~~$1,035,661~~$1,036,000 difference between the fair value of the notes and the principal balance was being amortized over the twenty-nine (29) month period from July 31, 2017 to December 31, 2019. Interest expense is paid every nine months through the issuance of common stock. On March 16, 2018, ~~$534,775~~$535,000 of interest accrued through January 31, 2018 and ~~$169,950~~$170,000 of certain legal expenses were paid through the issuance of 4,081 shares of the Company's common stock. In August 2018, the Company paid ~~$479,808~~$480,000 of accrued interest through July 31, 2018 with the issuance of 4,582 shares of the Company’s common stock. In January 2019, ~~$446,729~~$447,000 of accrued interest was paid through the issuance of 19,751 shares of the Company's common stock.

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Extinguishment and Exchange of the Napo Convertible Notes

In May 2019, in a restructuring of the Notes, ~~Chicago Venture Partners (“CVP”)~~CVP acquired the Napo December 2016 and Napo July 2017 Notes, as well as all rights thereof, and immediately extinguished the two Notes; in their place, the Company issued to CVP a new note (“Exchange Note 1”). The collective carrying amount of the Napo December 2016 and Napo July 2017 Note immediately before the exchange was ~~$10,375,326,~~$10,376,000, or principal of ~~$10,125,339~~$10,125,000 and unamortized premium of ~~$249,987.~~$251,000. The new Exchange Note 1 had an opening principal balance of ~~$10,535,900,~~$10,536,000, consisting of the ~~$10,125,339~~$10,125,000 principal balance of the extinguished notes plus ~~$410,562~~$411,000 in accrued but unpaid interest from the Napo December 2016 and Napo July 2017 Notes. At September 30, ~~2019~~2020 and December 31, ~~2018,~~2019, the balance of the Napo December 2016 and Napo July 2017 Notes was ~~zero and $10,553,888, respectively.~~zero.

Concurrent with the restructuring, CVP also entered into security agreements with Jaguar (the “Jaguar Security Agreement”) and Napo (the “Napo Security Agreement”, and together with the Jaguar Security Agreement, the “Security Agreements”), pursuant to which CVP will receive (i) a security interest in substantially all of the Company’s assets as security for the Company’s obligations under Exchange Note 2 and (ii) a security interest in substantially all of Napo’s assets as security for Napo’s obligations under Exchange Note 1 and Exchange Note 2. Notwithstanding the foregoing, (a) the amount owing under Exchange Note 2 will not be considered part of the obligations secured by the Napo Security Agreement until such time as Jaguar receives permission from a third party and (b) the security interest granted under the Jaguar Security Agreement will be automatically terminated and released upon Jaguar’s receipt of a waiver from such third party.

Notes Payable

Notes payable at September 30, ~~2019~~2020 and December 31, ~~2018~~2019 consist of the following:


	September 30,
	2019		December 31,
	(unaudited)		2018
December 2017 note payable	$	—	$	1,673,237
February 2018 note payable		—		2,359,750
March 2018 note payable		—		1,147,870


					September 30,		December 31,
(in thousands)					2020		2019
						(unaudited)
2019 Exchange Note 1		4,381,535		—	$	3,381	$	4,381
2019 Exchange Note 2		2,296,926		—		2,524		2,297
		6,678,461		5,180,857
Insurance Premium Financing						582		—
Tempesta Note Payable						450		550
Royalty Interest						217		—
Oasis Secured Borrowing						2,619		—
						9,773		7,228
Less: unamortized discount and debt issuance costs		—		(335,282)		(332)		—
Note payable, net	$	6,678,461	$	4,845,575
Note payable, net of discount					$	9,441	$	7,228
Notes payable - non-current, net	$	6,678,461	$	—	$	2,660	$	450
Notes payable - current, net	$	—	$	4,845,575	$	6,781	$	6,778

December 2017 Note

On December 8, 2017, the Company entered into a securities purchase agreement with CVP pursuant to which the Company issued a promissory note (the “December 2017 Note”) in the aggregate principal amount of ~~$1,587,500~~$1,588,000 for an aggregate purchase price of $1,100,000. The December 2017 Note ~~carries~~carried an original issue discount of ~~$462,500,~~$463,000, and the initial principal balance also ~~includes~~included $25,000 to cover CVP’s transaction expenses. The Company used the proceeds for general corporate purposes. The December 2017 Note ~~bears~~bore interest at the rate of 8% per annum and ~~matures on~~had an original maturity date of August 26, 2019.

On August 2, 2018, the Company and CVP amended the December 2017 Note agreement, extending the maturity date from September 8, 2018 to August 26, 2019, and limiting the aggregate amount that CVP is permitted to redeem on a monthly basis to $500,000, which amount iswas the maximum aggregate amount for the ~~CVP~~ Notes collectively. This amendment resulted in the Company accounting for the transaction as a troubled debt restructuring, under which

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the carrying amount of the note payable remained unchanged but interest expense iswas computed using a new effective rate that equates the present value of the future cash payments specified by the new terms with the carrying

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amount of the note. ~~The principal balance of the December 2017 Note is included in notes payable in the current liabilities section of the condensed consolidated balance sheet.~~

Between October 2018 and December 2018, the Company and CVP renegotiated the terms of the December 2017 Note agreement such that CVP agreed not to make any redemptions of the ~~December 2017~~ Note until March 2019. In consideration of this standstill arrangement, the Company paid CVP a total standstill fee of ~~$499,403~~$499,000 for all four CVP Notes. The standstill fee allocated to the December 2017 Note was ~~$141,737,~~$142,000, of which ~~$85,737~~$86,000 increased the principal balance and ~~$56,000~~ was paid in cash. These modifications in whole represented four separate restructurings of the December 2017 Note agreement, resulting in two troubled debt restructurings accounted for under ASC 470-60 and two modifications accounted for under ASC 470-50. For the two restructurings resulting in troubled debt restructurings, the changes were accounted for prospectively and a new effective interest rate was determined that equated the present value of the future cash payments specified by the new terms with the carrying amount of the ~~December 2017~~ Note. For the two modifications that resulted in modification accounting, a new effective rate was determined at the date of modification that equated the revised cash flows to the carrying amount of the ~~December 2017~~ Note.

In March 2019, the Company and CVP amended the December 2017 Note agreement such that the Company prepaid principal and accrued interest of ~~$811,065~~$811,000 and ~~$178,755,~~$179,000, respectively, in ~~57,857~~ shares of the Company’s common stock. The exchange of debt for common stock was considered a substantial change to the ~~December 2017~~ Note and therefore, the exchange resulted in extinguishment accounting and a corresponding extinguishment loss of ~~$243,419.~~ $243,000.

In April 2019,, the Company and CVP amended the December 2017 Note agreement such that the Company made two separate exchanges of principal and related accrued interest for shares of the Company’s common stock. The first exchange resulted in changes to cash flows that were considered substantial, resulting in extinguishment accounting with an extinguishment loss of ~~$100,148;~~$100,000; the second exchange on April 17, 2019 resulted in the extinguishment of the entire December 2017 Note with a corresponding extinguishment loss of ~~$19,494.~~$19,000. At ~~September 30, 2019 and~~ December 31, ~~2018, the net carrying value of~~2019, the December 2017 Note ~~was zero and $1,548,829, respectively.~~had been fully extinguished.

February 2018 Note

On February 26, 2018, the Company entered into a securities purchase agreement with CVP, pursuant to which the Company issued to CVP a promissory note in the aggregate principal amount of ~~$2,240,909~~$2,241,000 for an aggregate purchase price of ~~$1,560,000 (the “February 2018 Note”).~~$1,560,000. The ~~February 2018~~ Note ~~carries~~carried an original issue discount of ~~$655,909,~~$656,000, and the initial principal balance also ~~includes~~included $25,000 to cover CVP's transaction expenses. The ~~February 2018~~Company used the proceeds for general corporate purposes and working capital. The Note ~~bears~~bore interest at the rate of 8% per annum and ~~matures on~~had an original maturity date of August 26, 2019.

Between October 2018 and December 2018, the Company and CVP renegotiated the terms of the February 2018 Note agreement such that CVP agreed not to make any redemptions of the ~~February 2018~~ Note until March 2019. In consideration of this standstill arrangement, the Company paid CVP a total standstill fee of ~~$499,403~~$499,000 for all four CVP Notes. The standstill fee allocated to the February 2018 Note was ~~$198,841,~~$199,000, of which ~~$118,841~~$119,000 increased the principal balance and $80,000 was paid in cash. These modifications in whole represented four separate restructurings of the February 2018 Note agreement, resulting in a debt extinguishment accounted for under ASC 470-50, two troubled debt restructurings accounted for under ASC 470-60 and a debt modification accounted for under ASC 470-50. For the debt extinguishment, the Company recorded an extinguishment loss of ~~$102,296.~~$102,000. For the two troubled debt restructurings, the changes were accounted for prospectively and a new effective interest rate was determined that equated the present value of the future cash payments specified by the new terms with the carrying amount of the ~~February 2018~~ Note. For the modification that resulted in modification accounting, a new effective rate was determined at the date of modification that equated the revised cash flows to the carrying amount of the ~~February 2018~~ Note.

In March 2019, the Company and CVP amended the February 2018 Note agreement such that the Company prepaid principal and accrued interest of ~~$2,044,627~~$2,045,000 and ~~$203,866,~~$204,000, respectively, in ~~114,802~~ shares of the Company’s common stock. The exchange of debt for common stock was considered a substantial change to the ~~February 2018~~ Note and therefore, the exchange resulted in extinguishment accounting and a corresponding extinguishment loss of ~~$487,865.~~

$488,000.

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In April 2019,, the Company and CVP amended the February 2018 Note agreement such that the Company made a single exchange of principal and related accrued interest for ~~20,345~~ shares of the Company’s common stock. The first exchange on April 16, 2019 resulted in the extinguishment of the entire February 2018 Note with a corresponding extinguishment loss of ~~$37,740.~~$38,000. At ~~September 30, 2019 and~~ December 31, ~~2018, the net carrying value of~~2019, the February 2018 Note ~~was zero and $2,290,865, respectively.~~had been fully extinguished.

March 2018 Note

On March 21, 2018, the Company entered into a securities purchase agreement with CVP, pursuant to which the Company issued to CVP a promissory note in the aggregate principal amount of ~~$1,090,341~~$1,090,000 for an aggregate purchase price of ~~$750,000 (the “March 2018 Note” and together with the June 2017~~$750,000. The Note ~~the December 2017 Note and the February 2018 Note, the “CVP Notes”). The March 2018 Note carries~~carried an original issue discount of ~~$315,341,~~$315,000, and the initial principal balance also ~~includes~~included $25,000 to cover CVP's transaction expenses. The ~~March 2018~~Company used the proceeds to fully repay certain prior secured and unsecured indebtedness. The Note ~~bears~~bore interest at the rate of 8% per annum and ~~matures on~~had an original maturity date of September 21, 2019.

Between October 2018 and December 2018, the Company and CVP renegotiated the terms of the March 2018 Note agreement such that CVP agreed not to make any redemptions of the ~~March 2018~~ Note until March 2019. In consideration of this standstill arrangement, the Company paid CVP a total standstill fee of ~~$499,403~~$499,000 for all four CVP Notes. The standstill fee allocated to the March 2018 Note was ~~$95,529,~~$96,000, of which ~~$57,529~~$58,000 increased the principal balance and $38,000 was paid in cash. These modifications in whole represented four separate restructurings of the March 2018 Note agreement, resulting in a debt extinguishment accounted for under ASC 470-50, two troubled debt restructurings accounted for under ASC 470-60, and a debt modification accounted for under ASC 470-50. For the debt extinguishment, the Company recorded an extinguishment loss of ~~$223,824.~~$224,000. For the two troubled debt restructurings, the changes were accounted for prospectively and a new effective interest rate was determined that equated the present value of the future cash payments specified by the new terms with the carrying amount of the ~~March 2018~~ Note. For the modification that resulted in modification accounting, a new effective rate was determined at the date of modification that equated the revised cash flows to the carrying amount of the ~~March 2018 Note.~~Note

Between January 2019 and March 2019, the Company and CVP amended the March 2018 Note agreement such that the Company prepaid principal and accrued interest of ~~$1,050,114~~$1,050,000 and ~~$85,681,~~$86,000, respectively, in ~~95,407~~ shares of the Company’s common stock. These exchanges in whole represented four separate prepayments of principal and accrued interest, resulting in three debt extinguishments and one debt ~~modification accounted.~~modification. For the debt extinguishments, the Company recorded an aggregate extinguishment loss of ~~$1,210,676.~~$1,211,000. For the modification, a new effective rate was determined at the date of modification that equated the revised cash flows to the carrying amount of the ~~March 2018~~ Note. ~~The March 2018 Note was fully extinguished in March 2019.~~ At ~~September 30, 2019 and~~ December 31, ~~2018, the net carrying value of~~2019, the March 2018 Note ~~was zero and $1,005,880, respectively.~~

~~2019 Bridge Notes~~

Between March 18, 2019 and June 26, 2019 the Company entered into Promissory Note Purchase Agreements with certain accredited investors under which the Company issued (i) fourteen promissory notes with a principal balance of $3,550,000 and warrant coverage at 125% of principal, and (ii) seven promissory notes with a principal balance of $1,500,000 and warrant coverage at 75% of principal. Collectively, cash proceeds from the twenty-one promissory notes (collectively, the “Bridge Notes”) was $5,050,000. The Bridge Notes were not convertible and bore interest at 12% with a maturity date of July 18, 2019, at which date all principal and accrued interest were due. The exercise price of the warrants was either (i) the price the Company issued common shares in its next public offering subject to a registration statement or (ii) if no such offering is consummated by the four-month maturity date of the Notes, then the exercise price would be equal to the closing price of the Company’s common stock on the Notes four-month maturity date. The warrants for all twenty-one Bridge Notes had ~~an issuance date fair value of $5,005,739 (see Note 3).~~

Between May and early July 2019, the Company and the Bridge Note investors extended the maturity date of the Bridge Notes from July 18, 2019 to July 31, 2019, or an addition of thirteen days; this amendment to the terms of the Promissory Note Purchase Agreements did not represent a troubled debt restructuring per Subtopic 470-60, nor was it considered a substantial change requiring extinguishment accounting per Subtopic 470-50. Rather, it represented a

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modification under Subtopic 470-50 requiring the determination of a new effective interest rate at the modification date that equated the revised cash flows to the carrying amounts of the Bridge Notes.

On July 23, 2019, the Company paid-off all twenty-one Bridge Notes prior to maturity. The Company paid cash of $5,192,923, or $5,050,000 of principal and $142,923 of accrued interest. The extinguishment of the Bridge Notes resulted in an extinguishment loss of $335,753. been fully extinguished.

2019 Exchange Notes

In May 2019, the Company and CVP entered into an Exchange Agreement whereby CVP purchased the two outstanding Napo convertible notes and all rights thereof from the current debt holders. Subject to the terms of the Exchange Agreement, CVP and the Company agreed to exchange the two Napo convertible notes for a single CVP Note (“CVP Exchange Note 1”). At the Exchange date, the principal balance of the two Napo convertible notes was ~~$10,125,339,~~$10,125,000, or ~~$10,535,900~~$10,536,000 inclusive of accrued but unpaid interest of ~~$410,562.~~$411,000. The beginning principal balance of CVP Exchange Note 1 was ~~$10,535,900,~~$10,536,000, or equal to the principal balance of the two Napo convertible notes and accrued interest thereon. The maturity date of CVP Exchange Note 1 was December 31, 2020, with an interest rate of 10%. Per the terms of the Exchange Agreement, CVP agreed to extend the maturity date of CVP Exchange Note 1 from
December 31, 2019 (the same maturity date carried over from the two Napo convertible ~~notes )~~notes) to December 31, 2020; in consideration of this extension, the Company issued CVP Exchange Note 2 with a principal balance of ~~$2,296,926.~~$2,297,000. The maturity date of CVP Exchange Note 2 is December 31, 2020, with an interest rate of 10%. The exchange of the two outstanding Napo convertible notes for Exchange Note 1 and Exchange Note 2 resulted in the recording of a $2,046,939 loss on extinguishment of debt for the three months ended June 30, 2019.

Between May 2019 and June 2019, the Company and CVP entered into note exchange agreements pursuant to which the Company, in lieu of making a cash payment to CVP on Exchange Note 1, made a prepayment of principal and related accrued interest of $5,144,175 by issuing 817,863 shares of the Company’s common stock to CVP. These exchanges of principal and related accrued interest resulted in a debt extinguishment accounted for under ASC 470-50, with the accompanying recording of a loss on extinguishment of $439,978.

In July 2019, the Company and CVP entered into note exchange agreements pursuant to which the Company ~~in lieu of making a cash payment to CVP on Exchange Note 1,~~ made ~~a prepayment~~prepayments of principal and related accrued interest of ~~$1,100,000~~$6,154,000 and $90,000, respectively, in lieu of making cash payments to CVP on Exchange Note 1, by issuing ~~301,577~~1,119,440 shares of the Company’s common stock to CVP. ~~These exchanges~~

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In September 2020, the Company and CVP entered into note exchange agreements pursuant to which the Company made prepayments of principal and related accrued interest ~~resulted~~of an aggregate amount of $1,500,000, in ~~a debt extinguishment accounted for under ASC 470-50, with~~lieu of making cash payments to CVP on Exchange Note 1, by issuing 1,428,571 shares and 3,333,333 shares of the ~~accompanying recording of a loss~~Company’s common stock to CVP, on ~~extinguishment of $11,202.~~

September 23, 2020 and September 25, 2020, respectively. At September 30, 2020 and December 31, 2019, the carrying value of the Exchange Note 1 is $3,381,000 and $4,381,000, respectively.

In September 2020, the Company and CVP also entered into a global amendment agreement, pursuant to which the maturity date of the Exchange Note 2 is extended to December 31, 2021. In consideration of CVP’s grant of extension, together with the related fees and other accommodation set forth, principal debt is increased equal to 5% of the Outstanding Balance of the Exchange Note 2, which was $2,611,000 as of the global amendment date. The global amendment requires no principal payment shall be made to the Exchange Note 2 until the redemption of Series D Perpetual Preferred Shares. See Note 10 for further discussion. The Company determined the incremental value of cash flows amounting to $228,000 with the assistance of an independent valuation service provider, based on weighted probability assumptions of various settlement conditions and penalties stipulated in the contract therein.

The global amendment agreement was accounted for as a modification; hence a new effective rate was determined at the date of modification that equated the revised cash flows to the carrying amount of the Note. At September 30, 2020 and December 31, 2019, the carrying value of the Exchange Note 2 was $2,310,000 and $2,297,000 respectively.

2019 Tempesta Note

In October 2019, the Company entered into a License Termination and Settlement Agreement with Dr. Michael Tempesta, pursuant to which certain royalty payment disputes between Napo and Tempesta were settled. Per the terms of the Agreement, Tempesta received $50,000 in cash, an unsecured promissory note issued by the Company in the aggregate principal amount of $550,000 and 40,000 shares of the Company’s common stock in exchange for the cessation of all royalty payments by Napo to Dr. Tempesta under the License Agreements. The $550,000 promissory note bears interest at the rate of 2.5% per annum and matures on March 1, 2025. The promissory note provides for the Company to make semi-annual payments equal to $50,000 plus accrued interest beginning on March 1, 2020 until the Note is paid in full. At September 30, 2020, the net carrying value of ~~Exchange Note 1~~the Tempesta note was $450,000.

Sale of Future Royalty Interest

In March 2020, the Company entered into a royalty interest purchase agreement (the “Purchase Agreement”) with Iliad, pursuant to which the Company sold to Iliad a royalty interest entitling Iliad to receive $500,000 of future royalties on sales of Mytesi and ~~Exchange Note 2 was $4,381,535~~certain up-front license fees and ~~$2,296,926, respectively,~~ milestone payments from licensees and/or distributors (the “Royalty Repayment Amount”) for an aggregate ~~principal~~purchase price of $350,000.

Until such time as the Royalty Repayment Amount has been paid in full, the Company will pay Iliad ten percent (10%) of the Company’s Net Sales on Included Products and ten percent (10%) of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses (the “Royalty Payments”). Beginning on the six-month anniversary of the Purchase Price Date and continuing until the 12-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $25,000, and (b) the actual Royalty Payment amount Investor is entitled to for such month. Beginning on the 12-month anniversary of the Purchase Price Date and continuing until the Revenue Repayment Amount has been paid in full, the monthly Royalty Payment shall be the greater of (a) $43,750, and (b) the actual Royalty Payment amount Investor is entitled to for such month.

The Royalty Interest amount of $500,000 (or $350,000 in cash received) is classified as debt, net of a $150,000 discount. Under ASC 470-10-35-3, royalty payments to Iliad will be amortized under the interest method per ASC 835-30. Because there is no set interest rate, and because the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense

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for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 105%.

On July 10, 2020, the Company and Iliad entered into an amendment to the Purchase Agreement to which the parties agreed that no royalty payments or other payment will be due prior to December 10, 2020. The Royalty Payments shall resume as of December 10, 2020, which Royalty Payment will cover Net Sales on Included Products and licensing fees and milestone payments for the month of November. In consideration of the amendment, the balance of ~~$6,678,461.~~the Royalty Repayment Amount as of July 10, 2020 was increased by 10%. All other terms remain unchanged. This amendment resulted in the Company accounting for the transaction as a troubled debt restructuring, under which the carrying amount of the debt remained unchanged but interest expense is computed using a new effective rate that equates the present value of future cash payments specified by the new terms with the carrying amount of the debt. The Company has paid $283,000 of the $500,000 Royalty Interest amount and the remaining amount is outstanding as of September 30, 2020. No Royalty Payments are due until December 10, 2020.

Oasis Secured Borrowing

The Purchase Agreement

In May 2020, the Company, entered into a one-year Accounts Receivable Purchase Agreement (the “Purchase Agreement”) with Oasis Capital (“Oasis”), pursuant to which Oasis may from time to time at its discretion purchase accounts receivable of the Company on a recourse basis, at a purchase price equal to 37.5% of the face amount of the first purchase, and at a purchase price equal to 42.5% for subsequent purchased accounts (“Purchase Price”). With respect to purchased accounts, in the event that Oasis receives more than an amount equal to the sum of (i) the face amount of such purchased account multiplied by 0.0545 and (ii) the Purchase Price (such amount, the “Threshold Price”) from collection on such purchased accounts, then Oasis will return any such excess overage amount (the “Overage”) to the Company, as applicable, within five days after Oasis’s receipt thereof.

In the event Oasis does not receive at least the Threshold Price for a purchased account on or before such account becomes due and payable, the Company will, at Oasis’s election, be obligated to either (i) pay the difference between the Threshold Price and the amount received by Oasis for such account (the “Shortfall”) within 30 days thereof, or (ii) assign or transfer to Oasis additional accounts receivable with a Purchase Price equal to (A) the Shortfall plus (B) an amount equal to 25% of the Shortfall (the “Additional Amount”).

The initial term of the Purchase Agreement is one year, which will automatically renew for successive one-year periods unless notice of non-renewal is provided by the Company at least 30 days prior to the expiration of a term. Notwithstanding the foregoing, either Oasis or the Company may terminate the Purchase Agreement on 60 days’ prior written notice. Under the Purchase Agreement, Oasis is entitled to a transaction fee of $25,000 and may be entitled to additional transaction fees to the extent Oasis acquires additional accounts receivable under the Purchase Agreement, which fees will not exceed $5,000 per transaction.

Per the Purchase Agreement, the Company will service and administer the purchased accounts receivable for Oasis. Oasis appointed the Company to be its agent and servicer for monitoring and collecting the Accounts Receivable subject to the terms of the Purchase Agreement. The Company will perform its duties in a commercially reasonable manner and agrees that Company will not commence any legal action with respect to such servicing and collection efforts and shall not terminate, discharge, discount or write off any accounts receivable without Oasis's prior written consent.

The Company, having determined that it did not meet the criteria per ASC 860-10-40-5 to account for the transactions under the Purchase Agreement as sales, accounts for such transactions as secured borrowings in accordance with ASC 860-30, “Transfers – Secured Borrowings and Collateral.”

May 2020 Oasis Secured Note - Tranche #1

In May 2020, for the first sale under the terms of the Purchase Agreement, the Company received cash proceeds of $1,007,000 from Oasis, or $1,032,000 less a $25,000 transaction fee (the “Tranche #1 Secured Note”). Oasis

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purchased accounts receivable with a carrying value of $1,674,000, or gross accounts receivable of $2,754,000 net of chargebacks and discounts of $1,080,000. The purchase was effectuated pursuant to an Assignment Agreement, dated May 12, 2020, between the Company and Oasis. The Maturity Date, by which date Oasis must collect the $1,182,000 Threshold Price, is on or before July 10, 2020.

The Company recorded the sale as a short-term secured borrowing with a principal amount of $1,007,000, or $1,182,000 net of a $175,000 discount. Though there was no stated interest rate, the effective interest rate was 147.9%. The Tranche #1 Secured Note had a maturity date of July 10, 2020, or earlier if the Threshold amount was received by Oasis prior to that date (payment of the Threshold amount was the maturity date). Accordingly, during the term of the Tranche #1 Secured Note, the effective interest rate was variable, dependent on the amount of any principal payment and payment dates.

On June 30, 2020, the Company made its final required payment to Oasis under the Tranche #1 Secured Note, with total payments equaling the $1,182,000 Threshold amount, and the Tranche #1 Secured Note was extinguished.

June 2020 Oasis Secured Note - Tranche #2

In June 2020, for its second sale under the terms of the Purchase Agreement, the Company received cash proceeds of $1,215,000 from Oasis (the “Tranche #2 Secured Note”). Oasis purchased accounts receivable with a carrying value of $1,738,000, or gross accounts receivable of $2,859,000 net of chargebacks and discounts of $1,121,000. The purchase was effectuated pursuant to an amended Assignment Agreement, effective June 26, 2020, between Napo and Oasis. The Maturity Date, by which date Oasis must collect the $1,371,000 Threshold Price plus the transaction fee of $10,000, was September 2, 2020.

The Company recorded the sale to Oasis as a short-term secured borrowing with a principal amount of $1,215,000, or $1,371,000 net of a $156,000 discount. Though there was no stated interest rate, the effective interest rate at issuance was 77.7%. The Tranche #2 Secured Note had a maturity date of September 2, 2020, or earlier if the Threshold amount was received by Oasis prior to that date (payment of the Threshold amount is the maturity date). Accordingly, during the term of the Tranche #2 Secured Note, the effective interest rate is variable, dependent on the amount of any principal payment and payment dates.

In September 2020, the Company made its final required payment to Oasis under the Tranche #2 Secured Note, with total payments equaling the $1,381,000 Threshold amount plus the transaction fee, and the Tranche #2 Secured Note was extinguished.

August 2020 Oasis Secured Note - Tranche #3

In August 2020, for its third sale under the terms of the Purchase Agreement, the Company received cash proceeds of $1,335,000 from Oasis (the “Tranche #3 Secured Note”). Oasis purchased accounts receivable with a carrying value of $1,908,000, or gross accounts receivable of $3,153,000 net of chargebacks and discounts of $1,245,000. The purchase was effectuated pursuant to an amended Assignment Agreement, effective August 13, 2020, between Napo and Oasis. The Maturity Date, by which date Oasis must collect the $1,512,000 Threshold Price, was October 13, 2020. The secured borrowing gross balance remaining to be paid is $1,512,000 as of September 30, 2020.

The Company recorded the sale to Oasis as a short-term secured borrowing with a principal amount of $1,335,000, or $1,512,000 net of a $177,000 discount. Though there was no stated interest rate, the effective interest rate at issuance was 125.6%. The Tranche #3 Secured Note had a maturity date of October 13, 2020, or earlier if the Threshold amount was received by Oasis prior to that date (payment of the Threshold amount is the maturity date). Accordingly, during the term of the Tranche #3 Secured Note, the effective interest rate is variable, dependent on the amount of any principal payment and payment dates.

The Company has collected cash proceeds of $2,332,000 of the gross receivables pledged to Oasis under the Tranche #3 Secured Note as of September 30, 2020. The pledged balance remaining in the Company’s gross accounts receivables is $821,000 as of September 30, 2020. The Company will be obligated any Shortfall by the maturity date of

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October 12, 2020, otherwise it will be obligated, at Oasis’s election, to either (i) pay the Shortfall amount within 30 days thereof, or (ii) assign or transfer to Oasis additional accounts receivable with a Purchase Price equal to (A) the Shortfall plus (B) an amount a 25% Additional Amount.

September 2020 Oasis Secured Note - Tranche #4

In September 2020, for its third sale under the terms of the Purchase Agreement, the Company received cash proceeds of $985,000 from Oasis (the “Tranche #4 Secured Note”). Oasis purchased accounts receivable with a carrying value of $1,410,000, or gross accounts receivable of $2,330,000 net of chargebacks and discounts of $920,000. The purchase was effectuated pursuant to an amended Assignment Agreement, effective September 9, 2020, between Napo and Oasis. The Maturity Date, by which date Oasis must collect the $1,117,000 Threshold Price, was November 12, 2020. The secured borrowing gross balance remaining to be paid is $1,117,000 as of September 30, 2020.

The Company recorded the sale to Oasis as a short-term secured borrowing with a principal amount of $985,000, or $1,117,000 net of a $132,000 discount. Though there was no stated interest rate, the effective interest rate at issuance was 98.4%. The Tranche #4 Secured Note had a maturity date of November 12, 2020, or earlier if the Threshold amount was received by Oasis prior to that date (payment of the Threshold amount is the maturity date). Accordingly, during the term of the Tranche #4 Secured Note, the effective interest rate is variable, dependent on the amount of any principal payment and payment dates.

The secured borrowing gross balance remaining to be paid is $1,117,000 as of September 30, 2020. The pledged balance remaining in accounts receivables is $2,330,000 as of September 30, 2020. The pledged balance remaining in the Company’s gross accounts receivables is $2,330,000 as of September 30, 2020.

Insurance Premium Financing

In May 2020, the Company entered into a financing agreement for $873,000 for a portion of the Company’s annual insurance premiums. The balance is due in monthly installments over nine (9) months with an annual interest rate of 4.15% and total installment paid is $193,000 as of September 30, 2020. The financing balance was $582,000 as of
September 30, 2020.

8. Warrants

The following table summarizes information about warrants outstanding and exercisable into shares of the Company’s common stock ~~as of~~for the nine months ended September 30, ~~2019~~2020 and ~~2018:~~for the year ended December 31, 2019:


	September 30, 2020	December 31, 2019
	(unaudited)
Warrants outstanding, beginning balance	19,421,892	34,682
Issuances	8,771,632	20,637,761
Exercises	(20,852,665)	(1,250,000)
Expirations and cancelations	(323)	(551)
Warrants outstanding, ending balance	7,340,536	19,421,892

May 2020 Series 3 Warrants

Nine Months Ended

Nine Months Ended

September 30,

September 30,

2019

2018

(unaudited)

Warrants outstanding, beginning balance

34,682

4,590

Issuances

19,387,761

12,713

Expirations and cancellations

(551)

(722)

Warrants outstanding, ending balance

19,421,892

16,581

2836

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under which the holders will receive the aggregate warrants less the number of warrants equal to the exercise price; or (ii) a cashless exercise feature wherein, regardless if there is an effective registration agreement, following the requisite Stockholder Approval, each such Series 3 Warrant will be exercisable into one share of common stock for no consideration (the “Alternate Cashless Exercise”).

The Series 3 Warrants were initially valued at $3,696,000 using the Black-Scholes option pricing model as follows: probability-weighted exercise price of $0.05 per share, stock price of $0.44 per share, expected life of 5.50 years, volatility of 141%, and a risk-free rate of 0.34%. The Series 3 Warrants were classified as liabilities on the Company’s condensed consolidated balance sheets.

~~For~~A Special Meeting of Stockholders was held on July 21, 2020, whereupon a proposal to approve the ~~nine months ended~~“Alternate Cashless Exercise” settlement method for the Series 3 Warrants was approved. The Series 3 Warrants and their underlying common shares were registered per the registration statement on Form S-3 on June 5, 2020.

In July 2020, certain holders of the Series 3 Warrants agreed to exercise 7,695,500 shares for a 1-for-1 exchange of common shares in an Alternate Cashless Exercise. The aggregate fair value of the common stock issued upon the exercise of the Series 3 Warrants as of the exercise date was $5,687,000.

In August 2020, certain holders of the Series 3 Warrants agreed to exercise 552,830 shares for a 1-for-1 exchange of common shares in an Alternate Cashless Exercise. The aggregate fair value of the common stock issued upon the exercise of Series 3 Warrants as of the exercise date is $306,000.

As of September 30, ~~2019,~~2020, the remaining Series 3 Warrants are valued at $123,000 using the Black-Scholes option pricing model with inputs as follows: probability-weighted exercise price of $0 per share, stock price of $0.29 per share, expected life of 5.14 years, volatility of 142%, and a risk-free rate of 0.28%. The Series 3 Warrants are classified as liabilities on the Company’s condensed consolidated balance sheets.

The April 2020 Underwriter Warrants

In April 2020, in consideration of the settlement of a dispute regarding underwriting fees (see Note 6), the Company issued ~~19,387,761~~ warrants to purchase 100,780 shares of common stock at an exercise price of $2.50 per common share. The warrants were valued at $32,000 using the Black-Scholes option pricing model as follows: exercise price of $2.50 per share, stock price of $0.45 per share, expected life of 4.25 years, volatility of 141%, and a risk-free rate of 0.29%. The warrants were equity classified in the condensed consolidated statements of changes in convertible preferred stock and stockholders’ equity.

March 2019 Ladenburg Warrants

In March 2019, in consideration of services provided in the Company’s March 2019 public offering of 19,019 common shares, the Company issued to Ladenburg Thalmann & Co. warrants to purchase an aggregate of 761 shares of common stock at an exercise price of $17.50 per common share. The warrants were valued at ~~$13,028~~$13,000 using the ~~Black-Scholes~~Black- Scholes option pricing model as follows: exercise price of $17.50 per share, stock price of $18.90 per share, expected life of five years, volatility of 146%, and a risk-free rate of 2.21%. The warrants were equity classified in the condensed consolidated statements of changes in convertible preferred stock and stockholders’ equity.

March 2019 LOC Warrant

In March 2019, in consideration of a letter of credit ~~cancellation~~cancelation related to the Company’s office lease, the Company issued a warrant to purchase warrant shares equal to a fixed principal amount divided by a variable exercise ~~price (see Note 3).~~price. The warrants were initially classified as liabilities pursuant to ASC 480-10 due to their debt-like nature. On
July 23, 2019, upon the exercise price of the warrants becoming fixed, the warrants became exercisable into 45,750 shares of the Company’s common stock and were reclassified to additional paid-in-capital with a fair value of ~~$71,079 (see Note 3).~~$71,000.

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2019 Bridge Note Warrants

Between March 18, 2019 and June 26, 2019, concurrent to the Company entering into Promissory Notes of $5,050,000, the Company issued twenty-one warrants to purchase warrant shares equal to a fixed principal amount divided by a variable exercise ~~price (see Note 3).~~price. The warrants for all twenty-one Bridge Notes were initially liability classified pursuant to ASC 480-10 due to their debt-like nature. On July 23, 2019, upon the exercise price of the warrants becoming fixed, the warrants became exercisable into 2,781,250 shares of the Company’s common stock and were reclassified to additional paid-in-capital with a fair value of ~~$4,259,327 (see~~$4,259,000.

February 2020 Modification of Certain 2019 Bridge Note ~~3).~~Warrants

In February 2020, the Company entered into a warrant exercise agreement with a holder of its Bridge warrants, pursuant to which the holder agreed to exercise 250,000 Bridge warrants in consideration of the Company lowering the exercise price of the 250,000 warrants from $2.00 to $0.692. Upon exercise of the warrants, the Company received cash proceeds of $173,000 and, in turn, issued 250,000 common shares. It is the Company’s policy to determine the impact of modifications to equity-classified warrants by analogy to the share-based compensation guidance per ASC 718, Compensation – Stock Compensation. Pursuant to that guidance, and due to the modification being applicable only to a single holder of the Bridge warrants, the incremental increase of $9,000 in fair value of the modified warrants was recorded as an expense in the unaudited condensed consolidated statements of operations for the nine months ended
September 30, 2020.

May 2020 Modification of the 2019 Bridge Note Warrants and Inducement Offer

In May 2020, the Company reduced the exercise price of all outstanding 2019 Bridge Warrants from $2.00 per share to $0.49 per share. The Company determined the impact of this modification to be an increase in the fair value of the warrants of $166,000. Because the modification applied to the entire class of Bridge Warrant holders, the increase in fair value represented a deemed dividend to the entire class of Bridge Warrant holders. The modification did not result in the reclassification of the equity-classified Bridge warrants from additional paid-in-capital to liability classification.

In May 2020, concurrent with the reduction of the exercise price of the Bridge Warrant, the Company entered into a warrant exercise inducement offer with certain holders of the Bridge Warrants, pursuant to which such holders agreed to exercise for cash Bridge Warrants to purchase 93,750 shares of common stock, in exchange for the Company’s issuing to the exercising holders new unregistered Series 3 Warrants to purchase 93,750 shares of common stock.

July 2019 Series 1 Warrants

In July 2019, the Company entered into an underwriting agreement, ~~(see Note 1),~~ relating to a public offering, which was comprised of (1) 2,886,500 Class A Units, priced at $2.00 per unit, with each unit consisting of (i) one share of the Company’s voting common stock, (ii) one Series 1 warrant to purchase one share of ~~Common Stock,~~common stock, and (iii) one Series 2 warrant to purchase one share of ~~Common Stock,~~common stock, and (2) 10,787 Class B Units, priced at a price of $1,000 per unit, with each unit consisting of (i) one share of Series B convertible preferred stock, convertible into 500 shares of ~~Common Stock,~~common stock, (ii) 500 Series 1 Warrants and (iii) 500 Series 2 Warrants.

The Series 1 Warrants ~~have~~had an exercise price of $2.00 and expire on the earlier of (a) 5 years from the date of issuance and (b) 30 calendar days following the public announcement of Positive Interim Results related to the diarrhea results from the HALT-D ~~investigator initiated~~investigator-initiated trial, if and only if certain trading benchmarks are achieved during such 30 calendar day period.

In the offering, the Company sold (i) 2,886,500 Class A Units, which included Series 1 warrants to purchase 2,886,500 shares of the Company’s common stock and (ii) 10,787 Class B Units, which included Series 1 warrants to purchase 5,393,500 shares of the Company’s common stock. In total, 8,280,000 Series 1 warrants were issued, with an initial valuation of ~~$5,304,989~~$5,025,000 computed using the Black-Scholes-Merton pricing model using a stock price of $1.73, a strike price of $2.00, an expected term of 5.0 years, volatility of ~~144.76%~~109.25% and a risk-free discount rate of 1.83%. Upon issuance, the Series 1 warrants were classified in additional paid-in-capital.

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September 2019 Modification of the July 2019 Series 1 Warrants

In September 2019, the Company reduced the exercise price of all 8,280,000 Series 1 Warrants from $2.00 to $1.40. The Company determined the impact of this modification to be an increase in the fair value of the warrants of

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~~$252,106.~~ $522,000. Because the modification applied to the entire class of Series 1 Warrant holders, the increase in fair value represented a deemed dividend to the entire class of Series 1 Warrant holders. The modification did not result in the reclassification of the equity-classified Series 1 warrants from additional paid-in-capital to liability classification.

February 2020 Modification of the July 2019 Series 1 Warrants

In February 2020, the Company entered into a warrant exercise agreement with a holder of its Series 1 Warrants, pursuant to which the holder agreed to exercise 208,022 Series 1 Warrants in consideration of the Company lowering the exercise price of the 208,022 warrants from $2.00 to $0.6920. Upon exercise of the warrants, the Company received cash proceeds of $144,000 and, in turn, issued 208,022 common shares. It is the Company’s policy to determine the impact of modifications to equity-classified warrants by analogy to share-based compensation guidance per ASC 718, Compensation – Stock Compensation. Pursuant to that guidance, and due to the modification being applicable only to a single holder of the Series 1 Warrants, the incremental increase of $6,000 in fair value of the modified warrants was recorded as an expense in the unaudited condensed consolidated statements of operations for the nine months ended September 30, 2020.

May 2020 Modification of the July 2019 Series 1 Warrants and Inducement Offer

In May 2020, the Company reduced the exercise price of all outstanding Series 1 Warrants from $1.40 per share to $0.49 per share. The Company determined the impact of this modification to be an increase in the fair value of the warrants of $284,000. Because the modification applied to the entire class of Series 1 Warrant holders, the increase in fair value represented a deemed dividend to the entire class of Series 1 Warrant holders. The modification did not result in the reclassification of the equity-classified Series 1 Warrants from additional paid-in-capital to liability classification.

In May 2020, concurrent with the reduction of the exercise price of the Series 1 Warrants, the Company entered into a warrant exercise inducement offer with certain holders of the Series 1 Warrants, pursuant to which such holders agreed to exercise for cash Series 1 Warrants to purchase 4,572,040 shares of common stock, in exchange for the Company’s issuing to the exercising holders new unregistered Series 3 Warrants to purchase 4,572,040 shares of common stock.

July 2019 Series 2 Warrants

The Series 2 Warrants have an exercise price of $2.00 and expire on the first date on the earlier of (a) 5 years from the date of issuance and (b) 30 calendar days following the public announcement by the Company that a pivotal phase 3 clinical trial using crofelemer ~~(Mytesi®,~~(Mytesi, or the same or similar product with a different name) for the treatment of cancer therapy-related diarrhea in humans has met its primary endpoint in accordance with the protocol, if and only if certain trading benchmarks are achieved during such 30 calendar day period. In addition, each Series 2 Warrant has an embedded call option that allows the Company to redeem any unexercised warrants if certain contingencies are met.

In the July 2019 offering, the Company sold (i) 2,886,500 Class A Units, which included Series 2 warrants to purchase 2,886,500 shares of the Company’s common stock and (ii) 10,787 Class B Units, which included Series 12 warrants to purchase 5,393,500 shares of the Company’s common stock. In total, 8,280,000 Series 2 warrants were issued, with an initial valuation of ~~$5,304,989~~$5,026,000 computed using the Black-Scholes-Merton pricing model using a stock price of $1.73, a strike price of $2.00, an expected term of 5.0 years, volatility of ~~144.76%~~109.25% and a risk-free discount rate of 1.83%. Upon issuance, the Series 2 Warrants were classified in additional paid-in-capital.

~~For~~March 5, 2020 Modification of the July 2019 Series 2 Warrants

On March 5, 2020, the Company entered into a warrant exercise agreement with a holder of its Series 2 Warrants, pursuant to which the holder agreed to exercise 90,940 Series 2 Warrants in consideration of the Company

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lowering the exercise price of the 90,940 warrants from $2.00 to $0.6050. Upon exercise of the warrants, the Company received cash proceeds of $55,000 and, in turn, issued 90,940 common shares. It is the Company’s policy to determine the impact of modifications to equity-classified warrants by analogy to share-based compensation guidance per ASC 718, Compensation – Stock Compensation. Pursuant to that guidance, and due to the modification being applicable only to a single holder of the Series 2 Warrants, the incremental increase of $6,000 in fair value of the modified warrants was recorded as an expense in the unaudited condensed consolidated statements of operations for the nine months ended September 30, ~~2018,~~2020.

March 23, 2020 Modification of the July 2019 Series 2 Warrants

On March 23, 2020, the Company ~~issued 12,713 warrants, as follows:~~

~~August 2018 LOC~~entered into a Warrant

~~In August 2018,~~ Exercise and Preferred Stock Amendment Agreement (see Note 9) with a holder of its Series 2 Warrants, pursuant to which the holder agreed to exercise in cash its Series 2 Warrants to purchase an aggregate of 1,250,000 shares of common stock, in consideration of the ~~Letter~~Company reducing the Series 2 Warrant exercise price from $2.00 to $0.5227 per share, for gross proceeds to the Company of ~~Credit associated~~approximately $653,000, or $628,000 net of $25,000 of issuance costs. The Company determined the impact of this modification to be an increase in the fair value of the warrants of $65,000. Because the modification applied to a sole holder of Series 2 Warrants, the $65,000 increase in fair value was recorded as an expense in the unaudited condensed consolidated statements of operations for the nine months ended September 30, 2020. The modification did not result in the reclassification of the equity-classified Series 2 Warrants from additional paid-in-capital to liability classification.

May 2020 Modification of the July 2019 Series 2 Warrants and Inducement Offer

In May 2020, the Company reduced the exercise price of all outstanding Series 2 Warrants from $2.00 per share to $0.49 per share. The Company determined the impact of this modification to be an increase in the fair value of the warrants of $406,000. Because the modification applied to the entire class of Series 2 Warrant holders, the increase in fair value represented a deemed dividend to the entire class of Series 2 Warrant holders. The modification did not result in the reclassification of the equity-classified Series 2 Warrants from additional paid-in-capital to liability classification.

In May 2020, concurrent with the ~~Company’s office lease,~~reduction of the exercise price of the Series 2 Warrants, the Company ~~issued~~entered into a warrant exercise inducement offer with certain holders of the Series 2 Warrants, pursuant to ~~an existing shareholder a five-year warrant~~which such holders agreed to exercise for cash Series 2 Warrants to purchase ~~9,580~~4,033,562 shares of common stock, in exchange for the Company’s issuing to the exercising holders new unregistered Series 3 Warrants to purchase 4,005,062 shares of common stock.

As of September 30, 2020, the total of 6,367,635 Series 2 Warrants have been exercised.

December 2019 PIPE Financing Warrants

In December 2019, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company, in a Private Placement, sold (i) an aggregate of 2,500,000 unregistered shares of the Company’s common ~~stock.~~stock, and (ii) warrants to purchase up to an aggregate of approximately 1,250,000 shares of common stock, for an aggregate purchase price of $1,500,000 (see Note 11). The ~~Warrant is exercisable on or after March 28, 2019 at~~warrants have an exercise price of ~~$49.08.~~ $0.78 per share and became exercisable on June 24, 2020 (6 months after their issuance date) and have a five-year term.

The warrants ~~had an~~ ~~issuance-date~~ ~~fair value of $493,688 and classified in~~ ~~additional paid-in-capital~~ ~~with an offset to deferred rent.~~

~~September 2018 L2 Warrants~~

~~Concurrent to entering into~~were valued at $686,000 using the Note Purchase Agreement with L2 Capital in September 2018, the Company issued to L2 Capital a 5-year warrant to purchase 2,649 shares of the Company’s common stock. The warrants had an issuance-date fair value of $100,330 at anBlack-Scholes option pricing model as follows: exercise price of ~~$63.00~~$0.78 per ~~share.~~share, stock price of $0.62 per share, expected life of five years, volatility of 143%, and a risk-free rate of 2.42%. As the common stock and warrants were issued in a unit structure, the aggregate proceeds of $1,500,000 were allocated to the two securities using the relative fair value method, resulting in the common stock and warrants being allocated $1,035,000 and $465,000, respectively. The warrants were ~~recorded~~classified in ~~additional paid-in-capital and treated as a discount to the L2 Capital Promissory note balance.~~stockholders’ equity.

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9. Preferred Stock

At September ~~2018 Conte Warrants~~

~~Concurrent to entering into the Note Purchase Agreement with an accredited investor in September 2018, the Company issued to the accredited investor a 5-year warrant to purchase 484 shares~~30, 2020, preferred stock consisted of the ~~Company’s common stock. The warrants had an issuance-date fair value~~following:


								Liquidation
(in thousands, except share data)	Shares		Issued and		Carrying			Preference
Series	Authorized		Outstanding		Value			per Share
B-2		10,165		7,534	$	916	$	—
C		1,011,000		849,521		4,773		8.00
Total		1,021,165		857,055	$	5,689

At December 31, 2019, preferred stock consisted of ~~$17,818 at an exercise price of $86.10 per share. The warrants were recorded in additional paid-in-capital and treated as a discount to~~ the ~~Conte Promissory note balance.~~following:


								Liquidation
(in thousands, except share data)	Shares		Issued and		Carrying			Preference
Series	Authorized		Outstanding		Value			per Share
A		5,524,926		5,524,926	$	9,895	$	1.665
B		11,000		1,971		476		—
B-1		63		—		—		—
B-2		10,165		10,165		1,236		—
Total		5,546,154		5,537,062	$	11,607

9.Series A Redeemable Convertible Preferred Stock

~~Series A Convertible Preferred Stock~~

In March 2018, the Company entered into a stock purchase agreement with Sagard Capital ~~Partners, L.P.~~ pursuant to which the Company, in a private placement, agreed to issue and sell to Sagard Capital 5,524,926 shares of the Company's Series A convertible ~~participating~~ preferred stock, $0.0001 par value per share, for gross proceeds of ~~$9,199,002,~~$9,199,000, or ~~$9,000,002~~$9,000,000 net of issuance costs. The preferred stock is convertible into approximately 473,565 shares of common stock at the option of the holder at an effective conversion price of ~~$19.425~~$194.25 per share, provided that, at any time prior to the time the Company obtains stockholder approval, as required pursuant to Nasdaq Rule 5635(b) any conversion of Preferred Stock by a holder into shares of the common stock would be prohibited if, as a result of such

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conversion, the holder, together with such holder's attribution parties, would beneficially own more than 19.99% of the total number of shares of the common stock issued and outstanding after giving effect to such conversion.share. Subject to certain limited exceptions, the shares of Preferred Stock ~~cannot~~could not be offered, pledged or sold by Sagard Capital for one year from the date of issuance. The conversion price is subject to certain adjustments in the event of any stock dividend, stock split, reverse stock split, combination or other similar recapitalization.

Holders of the Series A shares are entitled to participate equally and ratably with the holders of shares of common stock ~~shares~~ in all dividends paid and distributions made to the holders of the common stock as if, immediately prior to each record date of the common stock, the shares of Series A then outstanding were converted into shares of common stock.

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or deemed liquidation event, the holders of Series A shares then outstanding shall be entitled to be paid in cash out of the assets of the Company before any payment shall be made to the holders of common stock or shares of any series or class of preferred or other capital stock then outstanding that by its terms is junior to the Series A in respect of the preferences as to distributions and payments upon such liquidation event by reason of their ownership, an amount per share of Series A equal to one times the Series A original issue price.

The ~~redemption and liquidation value~~Series A convertible preferred shares are redeemable by Sagard Capital upon a Redemption Event that is not solely within the control of the ~~Series A preferred stock is $12,738,822 and $9,199,002, respectively, as of September 30, 2019 and December 31, 2018.~~Company. If a Redemption Event ~~occurs~~were to occur as of the Measurement Date (the later of April 30, 2021 and the date on which the Company files its Form 10‑Q for the three months ending
March 31, 2021, but in no event later than September 30, 2021), the holders of at least a majority of the shares of Series A convertible preferred stock then outstanding may require the Company to redeem all Series A shares for cash at a per share purchase price equal to ~~$2.3057; any one~~$2.3057. Anyone of the following conditions can result in a Redemption ~~Event that is not solely within the Company's control: Revenues~~ Event: (i) revenue

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attributable to the Mytesi product for the six-month period ended March 31, 2021 ~~are~~is less than $22.0 ~~million or~~million; (ii) the daily volume weighted average price (“VWAP”) of the Company's common stock on Nasdaq for the 30 days prior to a Measurement Date is less than ~~$105.00.~~

~~On the March 23, 2018 issuance date, the effective conversion price per share was less than the fair value of the underlying common stock. As a result,~~$105.00; (iii) the Company ~~determined that there was a Beneficial Conversion Feature (“BCF”) of approximately $995,000~~. ~~Because~~fails to file with the ~~Company's Series A Preferred Stock does not have a stated conversion date and was immediately convertible at the issuance date, the Company recorded a deemed dividend charge of $995,000~~SEC on or before June 30, 2021, its Form 10-Q for the accretion of the discount on the Series A Preferred Stock. The deemed dividend was a non-cash transaction and is reflected below net loss to arrive at net loss available to common stockholders on the Company's condensed consolidated statements of operations for the ninethree months ~~ended September 30, 2018.~~ending March 31, 2021.

In March 2019, the Company and Sagard Capital ~~Partners, L.P.~~ amended certain terms of the agreement, such that the effective conversion price was adjusted to $19.425 per share.

The preferred stock has been classified outside of stockholders' ~~equity/(deficit)~~equity in accordance with authoritative guidance for the classification and measurement of potentially redeemable ~~securities.~~securities at the option of the holder.

During the three months ended December 31, 2019, the Company determined that a Redemption Event was probable as of July 1, 2019. The Company is accreting the carrying value to the redemption amount of $12,738,822.

In September 2020, the Company and Sagard Capital entered into an exchange agreement, by which the remaining Series A convertible preferred shares were exchanged for (i) 842,500 shares of the Company’s Series C perpetual preferred shares, and (ii) 842,500 shares of the Company’s Series D perpetual preferred shares, all issued to Iliad Research and Trading, L.P. (“Iliad”).

The exchange agreement was entered into to effect a share-for-share exchange transaction. The Series A convertible preferred shares were canceled upon surrender, and the Company issued Iliad the Series C and Series D perpetual preferred shares. The exchange agreement was treated as an extinguishment of the Series A convertible preferred shares. As of the exchange date, the related extinguishment required recording derecognition of the Series A accreted value and recording Series C and Series D at fair value. The related excess of the carrying value over the fair value of the new instruments of $150,000 was recorded to additional paid-in-capital and increased earnings available to common stockholders.

On September 4, 2020, the Company filed a certificate with the Secretary of State of Delaware effecting the retirement and cancellation of the Series A convertible preferred stock. As of September 30, 2020, there were no Series A convertible preferred shares authorized or outstanding.

Series B Convertible Preferred Stock

In July 2019, the Company entered into an underwriting agreement relating to the public offering comprised of (1) 2,886,500 Class A Units, priced at a public offering price of $2.00 per unit, with each unit consisting of (i) one share of the Company’s voting common stock, (ii) one Series 1 warrant to purchase one share of ~~Common Stock~~common stock and (2) 10,787 Class B Units, priced at a public offering price of $1,000 per unit, with each Class B unit consisting of (i) one share of Series B convertible preferred stock with a stated value of $1,000 and convertible into 500 shares of ~~Common Stock,~~common stock, (ii) 500 Series 1 Warrants and (iii) 500 Series 2 Warrants, at a public offering price of $1,000 per Class B Unit.

The Company sold 10,787 Class B Units, comprised of 10,787 shares of Series B convertible preferred stock, Series 1 warrants to purchase 5,393,500 shares of common stock and Series 2 warrants to purchase 5,393,500 shares of common stock. The total gross proceeds to the Company from the offering of the Class B Units ~~was~~were $10,787,000, of

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which ~~$3,875,778~~$4,240,000 was allocated to the Series B convertible preferred stock, ~~$3,455,611~~$3,274,000 to the Series 1 Warrants and ~~$3,455,611~~$3,274,000 to the Series 2 Warrants. Issuance costs of ~~$1,635,184~~$1,635,000 were allocated to the Class B Units.

Holders of the Series B shares are entitled to participate equally and ratably with the holders of shares of common stock ~~shares~~ in all dividends paid and distributions made to the holders of the common stock as if, immediately prior to each record date of the common stock, the shares of Series AB then outstanding were converted into shares of common stock. With certain exceptions, the shares of Series B ~~Preferred Stock~~convertible preferred stock have no voting rights. However, as long as any shares of Series B ~~Preferred Stock~~convertible preferred stock remain outstanding, the Company shall not, without the affirmative vote of holders of a majority of the then outstanding shares of Series B Convertible Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B ~~Preferred Stock~~convertible preferred stock or alter or amend the Series B Certificate of Designation or (b) enter into any agreement with respect to any of the foregoing.Each share

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of Series B ~~Preferred Stock~~convertible preferred stock is convertible at any time at the holder’s option into 500 shares of ~~Common Stock,~~common stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions.

Because the Company's Series B convertible preferred stock does not have a stated conversion date and was immediately convertible at the issuance date, the Company recorded a deemed dividend charge of $4,240,000 for the accretion of the discount on the Series B Convertible Preferred Stock.

The preferred stock has been classified in stockholders' equity in accordance with authoritative guidance.

During July and August 2019, certain investors converted 8,816 Series B convertible preferred shares into 4,408,000 shares of the Company’s common stock at the stated conversion ratio. There were zero and 1,971 shares of Series B convertible preferred stock outstanding as of September 30, 2020 and December 31, 2019, respectively.

In March 2020, the Company entered into a Warrant Exercise and Preferred Stock Amendment Agreement (“Amendment Agreement”) with a holder of its Series 2 Warrants, pursuant to which the holder agreed to exercise in cash its Series 2 Warrants to purchase an aggregate of 1,250,000 shares of common stock, in consideration of the Company reducing the warrant exercise price from $2.00 to $0.5227 per share, for gross proceeds to the Company of approximately $653,000 (see Note 8). As a further inducement to enter into the Amendment Agreement, the Company agreed to reduce the conversion price of the Company’s Series B convertible preferred stock from $2.00 to $0.4456, resulting in the application of accounting per ASC 260-10-S99-2. Because the reduction to the conversion price was an inducement, the Company applied the guidance in ASC 470-20, resulting in the recording of an inducement charge of $1,647,000 in the unaudited condensed consolidated statements of operations for the nine months ended
September 30, 2020.

On September 4, 2020, the Company filed a certificate with the Secretary of State of Delaware effecting the retirement and cancellation of the Series B convertible preferred stock. As of September 30, 2020, there were no Series B convertible preferred shares authorized or outstanding.

Series B-1 Convertible Preferred Stock

In October 2019, the Company entered into a Warrant Exercise Agreement with the sole remaining holder of the Series B convertible preferred stock (the “Exercising Holder”), who owned Series 1 Warrants exercisable for 1,250,000 shares of common stock. Pursuant to the terms of the Warrant Exercise Agreement, the Company had the right (a purchased put option) to require the Exercising Holder to exercise all or a portion of its Series 1 Warrants in accordance with the existing terms of the Series 1 Warrants, in exchange for the Company’s agreement to issue to the Exercising Holder a number of shares of the Company’s Series B-1 Convertible Preferred Stock, with a stated value of $12,000, in an amount equal to one Series B-1 Preferred Share for every 19,841 Series 1 Warrant Shares issued by the Company to the Exercising Holder. The purpose of the Company entering into the agreement was to enable the Company to monetize the remaining Series 1 Warrants. To the extent that all Series 1 Warrants held by the Exercising Holder were exercised at their $1.40 exercise price, the Company would receive aggregate gross proceeds of approximately $1,750,000 and, in turn, have issued 63 shares of Series B-1 Preferred Stock to the Exercising Holder.

On October 3 and October 9, 2019, in two separate transactions, the Company exercised its purchased put option (see Note 3) to require the Exercising Holder to exercise all of its 1,250,000 Series 1 Warrants (see Note 8), upon which the Company issued 1,250,000 common shares to the Exercising Holder in return for aggregate gross proceeds of $1,750,000. In consideration (the strike price) of the exercising the warrants, the Company issued 63 shares of Series B-1 convertible preferred stock to the Exercising Holder.

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On the October 3, 2019 issuance date, the effective conversion price was less than the fair value of the underlying common stock. As a result, the Company determined that there was a Beneficial Conversion Feature of $146,000. Because the Company's Series B-1 convertible preferred stock does not have a stated conversion date and was immediately convertible at the issuance date, the Company recorded a deemed dividend charge of $146,000 for the accretion of the discount on the Series B-1 Convertible Preferred Stock.

On the October 9, 2019 issuance date, the effective conversion price was less than the fair value of the underlying common stock. As a result, the Company determined that there was a Beneficial Conversion Feature of $385,000. Because the Company's Series B-1 Preferred Stock does not have a stated conversion date and was immediately convertible at the issuance date, the Company recorded a deemed dividend charge of ~~$3,875,778~~$385,000 for the accretion of the discount on the Series BB-1 Preferred Stock.

The ~~deemed dividend~~Series B-1 Preferred Stock was ~~a non-cash transaction and is reflected below net loss to arrive at net loss available to common stockholders on~~classified in stockholders' equity in accordance with authoritative guidance.

In December 2019, the ~~Company's condensed consolidated statements~~sole investor in the Series B-1 Preferred Stock converted its entire holding of ~~operations for~~63 shares of the ~~three and nine months ended September 30, 2019.~~

~~During July and August 2019, certain investors converted 8,816~~ Series ~~B preferred shares~~B-1 Preferred Stock into ~~4,408,000~~630,063 shares of the Company’s common shares at the stated conversion ratio. As of December 31, 2019, there were no shares of the Series B-1 Preferred Stock outstanding.

On September 4, 2020, the Company filed a certificate with the Secretary of State of Delaware effecting the retirement and cancellation of the Series B-1 convertible preferred stock. As of September 30, ~~2019,~~2020, there ~~remained 1,971~~were no Series BB-1 convertible preferred shares authorized or outstanding.

Series B-2 Convertible Preferred Stock

In December 2019, the Company entered into an exchange agreement with Oasis Capital, LLC (“Oasis Capital”), pursuant to which Oasis Capital gave up (i) its remaining unexercised Prepaid Forward contracts (see Note 11) exercisable for 1,236,223 shares of the Company’s common stock and (ii) 695,127 common shares held as an investment by Oasis Capital, in exchange for 10,165 shares of the Company’s newly authorized Series B-2 Convertible Preferred Stock.

The holders of the Series B-2 convertible preferred stock are entitled to receive dividends on shares of Series B-2 convertible preferred stock equal (on an as-if-converted-to-Common-Stock basis) to and in the same form as dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of the common stock. No other dividends shall be paid on shares of the Series B-2 Convertible Preferred Stock.

The shares of Series B-2 convertible preferred stock have no voting rights. However, as long as any shares of Series B-2 convertible preferred stock remain outstanding, the Company shall not, without the affirmative vote of holders of a majority of the then outstanding shares of Series B-2 Convertible Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B-2 convertible preferred stock or alter or amend the Series B-2 Certificate of Designation or (b) enter into any agreement with respect to any of the foregoing.

Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the holders of the Series B-2 convertible preferred stock are entitled to receive out of the assets, whether capital or surplus, of the Company the same amount that a holder of common stock would receive if the Series B-2 convertible preferred stock were fully converted to common stock which amounts shall be paid pari passu with all holders of common stock.

Each share of Series B-2 convertible preferred stock is convertible at any time at the holder’s option into 190 shares of common stock, as determined by dividing the $153.90 stated value of each Series B-2 Convertible Preferred Share by the $0.81 conversion price ($153.90 divided by 0.81 = 190 conversion ratio), and which conversion ratio is subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series B-2 Certificate of Designation.

The Series B-2 convertible preferred stock was classified in stockholders' equity in accordance with authoritative guidance.

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In January 2020, a holder of the Series B-2 convertible preferred stock converted 2,631 preferred shares into 499,890 shares of common stock.

Series C Perpetual Preferred Stock

In September 2020, the Company entered into an exchange agreement with Iliad pursuant to which the Company agreed to issue 842,500 shares of the Company's Series C perpetual preferred shares, $0.0001 par value per share, for a non-cash exchange of equity instruments, contemporaneously entered with the issuance of Series D perpetual preferred shares, in exchange of remaining Series A convertible preferred shares totaling to 5,524,926 shares, and accreted value of $11,227,000 as of the exchange date, and entered into an amendment agreement of the Exchange Note 2, with issuance value of $2,296,926 and carrying value of $2,610,677 as of the exchange date, to extend maturity from December 31, 2020 to December 31, 2021, in consideration of 5% increase in the outstanding balance.

Holders of the Series C perpetual preferred shares are not entitled to voting rights. However, as long as any Series C perpetual preferred share is outstanding, the Company is restricted to alter, change, or enter into agreement to alter or change adversely the powers, preferences, or rights given to the shareholders.

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or deemed liquidation event, the holders of Series C perpetual preferred shares then outstanding shall be entitled to be paid in cash out of the assets of the Company before any payment shall be made to the holders of common stock or shares of any series or class of preferred or other capital stock then outstanding that by its terms is junior to the Series C perpetual preferred shares in respect of the preferences as to distributions and payments upon such liquidation event by reason of their ownership, an amount per share of Series C equal to one times the Series C original issue price.

The Series C perpetual preferred shares are redeemable upon the option or discretion of the Company.

The Series C perpetual preferred shares are entitled to receive 10% cumulative stock dividends, to be payable in arrears on a monthly basis for 24 consecutive months. Dividends payable on the Series C perpetual preferred shares shall be payable through the Company’s issuance of Series C perpetual preferred share by delivering to each record holder the calculated number of payment-in-kind (“PIK”) dividend shares.

The Series C perpetual preferred shares are initially measured at fair value using the income approach, which considered the weighted probability of discounted cash flows at various scenarios of redemption by the Company or liquidation event and perpetual holding of the shares. As of the date of exchange, total fair value of the Series C perpetual preferred shares amounted to $4,717,000.

The preferred stock has been classified inas permanent stockholders' ~~equity/(deficit)~~equity in accordance with authoritative ~~guidance.~~guidance for the classification and measurement of perpetual shares without mandatory redemption period because the redemption option is ultimately in the control of the Company.

10. Series D Perpetual Preferred Stock

~~10.~~In September 2020, the Company entered into an exchange agreement with Iliad pursuant to which the Company agreed to issue 842,500 shares of the Company's Series D perpetual preferred shares, $0.0001 par value per share, for a non-cash exchange of equity instruments, contemporaneously entered with the issuance of Series C perpetual preferred shares, in exchange of remaining Series A convertible preferred shares totaling to 5,524,926 shares, and accreted value of $11,227,000 as of the exchange date, and entered into an amendment agreement of the Exchange Note 2, with issuance value of $2,296,926 and carrying value of $2,610,677 as of the exchange date, to extend maturity from December 31, 2020 to December 31, 2021, in consideration of 5% increase in the outstanding balance.

Holders of the Series D perpetual preferred shares are not entitled to voting rights. However, as long as any Series D perpetual preferred share is outstanding, the Company is restricted to alter, change, or enter into agreement to alter or change adversely the powers, preferences, or rights given to the shareholders.

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In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or deemed liquidation event, the holders of Series D perpetual preferred shares then outstanding shall be entitled to be paid in cash out of the assets of the Company before any payment shall be made to the holders of common stock or shares of any series or class of preferred or other capital stock then outstanding that by its terms is junior to the Series D perpetual preferred shares in respect of the preferences as to distributions and payments upon such liquidation event by reason of their ownership, an amount per share of Series D equal to one times the Series D original issue price.

The Series D perpetual preferred shares are redeemable upon the option or discretion of the Company.

The Series D perpetual preferred shares are entitled to receive 8% cumulative stock dividends, to be payable in arrears on a monthly basis for 24 consecutive months. Dividends payable on the Series D perpetual preferred shares shall be payable through the Company’s issuance of Series D perpetual preferred share by delivering to each record holder the calculated number of PIK dividend shares.

The Series D perpetual preferred shares is measured at fair value using the income approach, which considered the weighted probability of discounted cash flows at various scenarios of redemption and perpetual holding of the shares (see Note 3). The Company determined the fair value with the assistance of an independent valuation service provider to be based on discounted cash flows representing the settlement value of the shares and cumulative dividends issued using an effective borrowing rate of 12% to 15% adjusted for counterparty and a maturity date of September 30, 2021. For the three and nine months ended September 30, 2020, total change in fair value of the Series D perpetual preferred shares was $71,000.

In consideration of the Exchange Note 2 global amendment agreement (see Note 7), no principal payment shall be made to the Exchange Note 2 until the redemption of Series D Perpetual Preferred Shares. Due to the restrictive nature of the timing of cash outflows in response to the settlement of the Exchange Note 2, Series D perpetual preference shares are implicitly deemed to be mandatorily redeemable upon the ultimate settlement of the outstanding balance of Exchange Note 2. The shares are redeemable at $8.00 per share on December 31, 2024, the date in which contractual cash outflows of the Exchange Note 2 (See Note 7) require the entire settlement or redemption of the Series D perpetual preferred shares.

The preferred stock has been classified as liabilities in accordance with authoritative guidance for the classification and measurement of perpetual shares with mandatory redemption period corresponding to the timing of contractual cash outflows for the settlement of Exchange Note 2.

11. Stockholders' Equity

Common Stock

As of September 30, ~~2019,~~2020 and December 31, ~~2018,~~2019, the Company had reserved shares of common stock for issuance as follows:


	September 30,	December 31,
	2019	2018
	(unaudited)

			September 30,
			2020	December 31,
			(unaudited)	2019
Options issued and outstanding	3,821,690	42,979	4,483,106	3,902,675
Inducement options issued and outstanding	—	2,985	33,392	74
Options available for grant under stock option plans	554,016	2,327	651,739	479,829
RSU awards issued and outstanding	5,613	5,613
Restricted stock unit awards issued and outstanding			5,613	5,613
Warrants issued and outstanding	19,421,892	34,682	7,340,536	19,421,892
Convertible notes	—	10,849
Convertible preferred stock-Series A	473,565	47,357
Convertible preferred stock-Series B	985,500	—
Series A convertible preferred stock			—	473,565
Series B convertible preferred stock			—	985,500
Series B-2 convertible preferred stock			1,431,460	1,931,350
Total	25,262,276	146,792	13,945,846	27,200,498

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The holders of common stock are entitled to one vote for each share of common stock held. The common stockholders are also entitled to receive dividends whenever funds and assets are legally available and when declared by the Board of directors.

The holders of non-voting common stock are not entitled to vote, except on an as converted basis with respect to any change of control of the Company that is submitted to the stockholders of the Company for approval. Shares of the Company's non-voting common stock have the same rights to dividends and other distributions and are convertible into shares of the Company's common stock on a 1,050-for-one basis upon transfers to non-affiliates of Nantucket ("former creditor of Napo"), upon the release from escrow of certain non-voting shares held by the former creditors of Napo to the legacy stockholders of Napo under specified conditions and at any time on or after April 1, 2018 at the option of the respective holders thereof.

The Company is authorized to issue a total number of 204,475,074 shares, of which 150,000,000 shares are common stock, 50,000,000 are non-voting common stock and 4,475,074 are preferred stock.

Reverse stock-splits

On June 3, 2019, the Company filed the Certificate of Fifth Amendment to its Third Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a 1-for-70 reverse stock split of the Company’s issued and outstanding shares of voting common stock, effective June 7, 2019. The reverse split has been retroactively reflected in all voting common stock, warrants, and common stock option shares disclosed in these unaudited condensed consolidated financial statements. The non-voting common stock and the convertible preferred stock were excluded from the reverse split.

Transactions with Oasis Capital

January 2019 SPA

On January 7, 2019, Jaguar entered into a common stock purchase agreement with Oasis Capital, relating to an offering of an aggregate of up to 76,190 shares of common stock via an equity line of credit. Under the terms of the

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purchase agreement, the Company has the right to "put," or sell, up to 76,190 shares of common stock to Oasis Capital for an amount equal to the product of (i) the number of shares set forth on the applicable put notice (minus the deposit and clearing fees associated with such purchase) and (ii) a fixed price of $52.50 per share or such other price agreed upon between the Company and Oasis Capital. Jaguar had the option to increase the equity line of credit by an additional 114,286 shares of common stock by notifying Oasis Capital at any time after the effective date of the purchase agreement. In March 2019, Jaguar exercised this option. As of March 31, 2019, the Company had sold all of the 76,190 shares of common stock of the equity line and all 114,286 shares of common stock from the option to Oasis Capital, or a total of 190,476 shares.

March 2019 SPA

In March 2019, Jaguar entered into a securities purchase agreement with Oasis Capital pursuant to which Jaguar agreed to issue and sell, in a registered public offering by Jaguar directly to Oasis, an aggregate of 19,019 shares of common stock at an offering price of $14.00 for gross proceeds of approximately ~~$266,266.~~

On April 1, 2019, the Company entered into another common stock purchase agreement (the “April CSPA”) with Oasis Capital relating to an offering (the “April Equity Line Offering”) of an aggregate of up to 285,714 shares (the “April Purchase Shares”) of the Company’s common stock, all of which are being offered in a primary offering consisting of an equity line of credit. Under the terms of the April CSPA, the Company has the right to “put,” or sell, the April Purchase Shares to Oasis Capital for an amount equal to the product of (i) the number of April Purchase Shares set forth in the applicable put notice (minus the deposit and clearing fees associated with such purchase) and (ii) a fixed price of $19.60 per share or such other price agreed upon between the Company and Oasis Capital. The Company had

~~the option to increase the equity line of credit by an additional 285,714 shares of Common Stock by notifying Oasis Capital at any time after the effective date of the April CSPA.~~

~~Effective June 14, 2019, we halted all future offers and sales of our voting common stock, par value $0.0001 per share under the April CSPA and terminated the April CSPA.~~$266,000. Between ~~April 1,~~March 24, 2019, the date of the ~~April~~March CSPA, and ~~June 14, 2019, we~~March 31, 2020, the Company sold an aggregate of ~~4,843~~19,019 shares of ~~Common Stock~~common stock pursuant to the CSPA for aggregate gross proceeds of approximately ~~$100,000.~~$266,000.

~~Issuance~~March 2020 ELOC (Equity Line of ~~Class A Units in July 2019 Underwritten Public Offering~~Credit)

In ~~July 2019,~~March 2020, the Company entered into an ~~underwriting~~equity purchase agreement ~~relating~~(the “March 2020 ELOC”) with Oasis Capital, which provides that Oasis Capital is committed to ~~the public offering comprised~~purchase up to an aggregate of ~~(1) 2,886,500 Class A Units, priced at a public offering price of $2.00 per unit, with each unit consisting of (i) one share~~$2.0 million shares of the Company’s ~~voting~~ common stock ~~(ii) one Series 1 warrant~~over the 36-month term of the March 2020 ELOC.

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Pursuant to ~~purchase one share~~the terms and conditions of ~~Common Stock and (2) 10,787 Class B Units, priced at a public offering price~~the March 2020 ELOC, on any trading day selected by the Company (such date the “Put Date”), after the SEC has declared effective the registration statement registering the sale of $1,000 per unit, with each Class B unit consisting of (i) one share of Series B convertible preferred stock with a stated value of $1,000 and convertible into 500 shares of Common Stock, (ii) 500 Series 1 Warrants and (iii) 500 Series 2 Warrants, at a public offering price of $1,000 per Class B Unit.

~~The Company sold 2,886,500 Class A Units, comprised of 2,886,500 shares of voting common stock, Series 1 warrants to purchase 5,393,500~~the shares of common stock ~~and Series 2 warrants~~that may be issued to Oasis Capital under the March 2020 ELOC, the Company has the right, in its sole discretion, to present to Oasis Capital with a purchase notice (each a “Put Notice”), directing Oasis Capital to purchase ~~5,393,500~~up to the lesser of (i) 200,000 shares of common stock or (ii) 20% of the average trading volume of common stock in the 10 trading days immediately preceding the date of such Put Notice, at a per share price equal to $0.436 (each an “Option 1 Put”), provided that the aggregate of all Option 1 Puts and Option 2 Puts (described below) does not exceed $2.0 million.

In addition, on any date on which Oasis Capital receives shares of common stock in connection with a Put Notice (the “Clearing Date”), the Company also has the right, in its sole discretion, to present to Oasis Capital with a Put Notice (each an “Option 2 Put”) directing Oasis Capital to purchase an amount of common stock equal to the lesser of (i) such amount that equals 10% of the daily trading volume of the common stock on the date of such Put Notice and (ii) $200,000, provided that the aggregate amount of the Option 1 Put and Option 2 Put on any Put Date or Clearing Date does not exceed $500,000 and the aggregate amount of all Option 1 Puts and Option 2 Puts does not exceed $2.0 million. The purchase price per share pursuant to such Option 2 Put is equal to $0.436. The Threshold Price (defined later) and the Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the period used to compute the Threshold Price or the Purchase Price.

On April 15, 2020, the SEC declared effective the registration statement registering the sale of the shares of common stock issued to Oasis Capital under the March 2020 ELOC. The Company will control the timing and amount of sales of common stock to Oasis Capital. Oasis Capital has no right to require any sales by the Company but is obligated to make purchases from the Company as directed by the Company in accordance with the March 2020 ELOC.

In connection with the equity line, the Company agreed to pay Oasis Capital a commitment fee and in April 2020, in settlement of the commitment fee, the Company issued to Oasis Capital 68,807 shares of common stock. ~~The total~~At issuance, the 68,807 shares of common stock had a fair value of $33,027, and were expensed as an issuance cost in the Company’s unaudited condensed consolidated statements of operations.

Per the terms of the equity purchase agreement, the Option Put 1 and Option Put 2 may be exercised only at a price that is always above the trading price of the underlying common stock at the exercise date, thereby rendering any exercise by the Company being out-of-the-money. At inception of the equity line on March 24, 2020, the Put Options were classified as derivative assets with a fair value of zero, and upon an effective registration statement on
April 15, 2020, were reclassified to stockholders’ equity with a fair value of zero.

In April 2020, the Company exercised a single Put Option Put 1 under which the Company sold 52,000 common shares to Oasis for gross proceeds of $22,627. As of September 30, 2020, the Company had not exercised any further put options to require Oasis Capital to purchase common stock under the equity purchase agreement.

March 2020 PIPE Financing

In March 2020, Company entered into a securities purchase agreement (the “PIPE Purchase Agreement”) with certain investors, pursuant to which the Company agreed to issue and sell to the ~~Company from the offering~~Investors in a private placement an aggregate of 1,714,283 shares of the ~~Class A Units was $5,773,000, of which $2,074,244 was allocated to the voting~~Company’s common stock, ~~$1,849,378 to the Series 1 Warrants and $1,849,378 to the Series 2 Warrants. Issuance costs~~for an aggregate purchase price of ~~$875,184 were allocated to the Class A Units.~~approximately $720,000, or $668,578 net of $51,422 of issuance costs.

~~11.~~

12. Stock Incentive Plans

2013 Equity Incentive Plan

Effective November 1, 2013, the Company's board of directors and sole stockholder adopted the Jaguar Health, Inc. 2013 Equity Incentive Plan (the “2013 Plan”). The 2013 Plan allows the Company's board of directors to grant stock options, restricted stock awards and restricted stock unit awards to employees, officers, directors and

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consultants of the Company. Following the effective date of the IPO and after effectiveness of any grants under the 2013 Plan that were contingent on the IPO, no additional stock awards will be granted under the 2013 Plan. Outstanding grants continue to be exercisable; however, any unissued shares under the plan and any forfeitures of outstanding options do not rollover to the 2014 Stock Incentive Plan. As of September 30, ~~2019,~~2020, there were ~~368~~384 options outstanding.

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2014 Stock Incentive Plan

InEffective May 12, 2015, the Company adopted the Jaguar Health, Inc. 2014 Stock Incentive Plan (“2014 Plan”). The 2014 Plan provides for the grant of options, restricted stock and restricted stock units to eligible employees, directors and consultants to purchase the Company's common stock. The 2014 Plan that provides for automatic share increases on the first day of each fiscal year in the amount of 2%5% of the outstanding number of shares of the Company's common stock on the last day of the preceding calendar year. The final 2% increase under the terms of the 2014 Plan was on January 1, 2019, at which time 7,797 additional available shares were added to the 2014 Plan. In February 2019, the Company shareholders approved a 5-year extension of the annual 2% automatic increase from January 1, 2020 through January 1, 2024. The 2014 Plan replaced the 2013 Plan except that all outstanding options under the 2013 Plan remain outstanding until exercised, ~~cancelled~~canceled or ~~expiration.~~expired.

~~In July 2019,~~As of September 30, 2020, there were 4,482,722 options outstanding and 185,057 options available for grant.

2020 New Employee Inducement Award Plan

Effective June 16, 2020, the Company adopted ~~an amendment~~the Jaguar Health, Inc. New Employee Inducement Award Plan (“2020 Inducement Award Plan”) and, subject to the ~~2014~~adjustment provisions of the Inducement Award Plan, ~~to increase the number of~~reserved 500,000 shares of the Company’s common stock ~~authorized~~ for issuance ~~such that~~pursuant to equity awards granted under the ~~aggregate authorized but unissued shares available~~Inducement Award Plan. The 2020 Inducement Award Plan provides for ~~issuance would be equal~~the grant of nonstatutory stock options, restricted stock units, restricted stock, and performance shares. The 2020 Inducement Award Plan was adopted without stockholder approval pursuant to ~~12.5%~~Rule 5635(c)(4) of the ~~issued~~Nasdaq Listing Rules. The terms and ~~outstanding shares~~conditions of ~~Common~~the 2020 Inducement Award Plan are substantially similar to the Company’s 2014 Stock ~~on a fully diluted basis including for purposes~~Incentive Plan, but with such other terms and conditions intended to comply with the Nasdaq inducement award rules. In accordance with Rule 5635(c)(4) of ~~this calculation as if such shares available~~the Nasdaq Listing Rules, the only persons eligible to receive grants of equity awards under the ~~2014~~Inducement Award Plan are individuals who were ~~included in the denominator (and assuming conversion~~not previously an employee or ~~exercise, as applicable, of all outstanding convertible securities, including but not limited to conversion~~director of the ~~Company’s Series A Convertible Participating Preferred Stock and Series B Convertible Preferred Stock~~Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into ~~shares of Common Stock, all issued and outstanding warrants, RSUs and stock options (whether issued under or outside~~employment with the 2014 Plan and the like)), calculated as of the earlier of (i) the day immediately after the consummation of the Company’s next underwritten public equity offering with gross proceeds of $5 million or more or (ii) July 31, 2019 (collectively, the “Calculation Date”). The Calculation Date occurred on July 24, 2019 and the total number of shares of Common Stock approved for issuance under the 2014 Plan increased 4,330,400 shares.Company.

As of September 30, ~~2019,~~2020, there were ~~3,821,690~~33,318 options outstanding and ~~554,016~~466,682 options available for grant.

Stock Options and Restricted Stock Units (“RSUs”)

The following table summarizes incentive plan activity for the nine months ended September 30, ~~2019~~ 2020

(unaudited):

Weighted

Weighted Average

Shares

Stock

Average

Remaining

Aggregate

Available

Options

RSUs

Stock Option

Contractual Life

Intrinsic


for Grant

Outstanding

Outstanding

Exercise Price

(Years)

Value*
Outstanding at December 31, 2018

2,327

42,979

5,613

$
406.36

9.24

$
—
Additional shares authorized

4,330,400

—

—

—

—

Options granted

(4,306,832)

4,306,832

—

1.71

—

—
Options cancelled

528,121

(528,121)

—

4.45

—

—
Outstanding at September 30, 2019

554,016

3,821,690

5,613

$
5.72

9.81

$
—
Exercisable at September 30, 2019

503,943

$
24.61

9.76

$
—
Vested and expected to vest at September 30, 2019

3,197,953

$
6.82

9.81

$
—


				Weighted		Weighted Average
	Shares	Stock		Average		Remaining	Aggregate
	Available	Options	RSUs	Stock Option		Contractual Life	Intrinsic
(in thousands, except share and per share data)	for Grant	Outstanding	Outstanding	Exercise Price		(Years)	Value*
Outstanding at December 31, 2019	479,829	3,902,675	5,613	$	5.20	9.56	$	—
Additional shares authorized	786,229	—	—		—	—		—
Options granted	(953,318)	953,318	—		0.44	—		—
Option exercise	—	(555)	—		0.45	—		—
Options canceled	338,999	(338,999)	—		4.11	—		—
Options canceled not rolled back into the 2013 Plan	—	(15)	—		—	—		—
Outstanding at September 30, 2020	651,739	4,516,424	5,613	$	4.28	8.97	$	—
Exercisable at September 30, 2020		1,870,808		$	8.14	8.86	$	—
Vested and expected to vest at September 30, 2020		4,170,443		$	4.53	8.96	$	—

*	*Fair market value of JAGX common stock on September 30, 2020 was $0.29 per share.

Table of ~~JAGX common stock on September 30, 2019 was $1.31 per share.~~Contents

The intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the Company's common stock for options that were in-the-money.

NoFive hundred fifty-five (555) options were exercised in the nine months ended September 30, ~~2019 and 2018.~~2020.

The weighted average grant date fair value of stock options granted was ~~$1.57~~$0.39 and ~~$128.80~~$1.57 per share during the nine months ended September 30, 2020 and 2019, ~~and 2018,~~ respectively.

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The number of options that vested in the nine months ended September 30, 2020 and 2019 was 1,065,190 and ~~2018 was~~ 496,467, ~~and 6,053,~~ respectively. The grant date weighted average fair value of options that vested in the nine months ended September 30, 2020 and 2019 was $2.12 and ~~2018 was $2,668,737 and $475,123,~~$132.26, respectively.

~~The Company granted 2,993 inducement options in fiscal year 2018 to new employees. The weighted average grant-date fair value of the options was $93.80 per share.~~

Stock-Based Compensation

The following table summarizes stock-based compensation expense related to stock options, inducement stock options and RSUs for the three and nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, and are included in the unaudited condensed consolidated statements of operations as follows:


									Three Months Ended				Nine Months Ended
									September 30,				September 30,
									2020		2019		2020		2019

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2019		2018		2019		2018
	(unaudited)				(unaudited)
(in thousands)									(unaudited)				(unaudited)
Research and development expense	$	332,636	$	175,772	$	548,524	$	400,521	$	175	$	333	$	580	$	549
Sales and marketing expense		41,122		39,210		87,215		59,762		54		41		167		87
General and administrative expense		736,351		465,112		1,347,246		956,508		446		736		1,437		1,347
Total	$	1,110,109	$	680,094	$	1,982,985	$	1,416,791	$	675	$	1,110	$	2,184	$	1,983

As of September 30, ~~2019,~~2020, the Company had ~~$5,555,383~~$3,173,000 of unrecognized stock-based compensation expense for options, inducement options and restricted stock units outstanding, which is expected to be recognized over a weighted-average period of ~~2.31~~1.44 years.

The estimated grant-date fair value of stock option grants for the nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 was calculated using the Black-Scholes - Merton option-pricing model using the following range of weighted-average assumptions:


					Nine Months Ended
					September 30,
					2020		2019

	Nine Months Ended
	September 30,
	2019		2018
	(unaudited)
					(unaudited)
Weighted-average volatility	142.9 - 145.9	%	95.6 - 95.9	%	150.1 - 172.4	%	142.9 - 145.9	%
Weighted-average expected term (years)	5.6 - 5.8		5.8		1.0 - 5.0		5.6 - 5.8
Risk-free interest rate	1.5 - 1.9	%	2.8 - 3.1	%	0.1 - 0.5	%	1.5 - 1.9	%
Expected dividend yield	—		—		—		—

401(k) Plan

The Company sponsors a 401(k) defined contribution plan covering all employees. There were no employer contributions to the plan from plan inception through September 30, ~~2019~~.2020.

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~~12.~~13. Net Loss Per Share

The following table presents the calculation of basic and diluted net loss per share of common stock for the periods indicated:


									Three Months Ended				Nine Months Ended
									September 30,				September 30,
(In thousands, except share and per share data)									2020		2019		2020		2019

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2019		2018		2019		2018
	(unaudited)					(unaudited)
									(unaudited)					(unaudited)
Net loss attributable to common shareholders (basic and diluted)	$	(11,682,949)	$	(6,138,352)	$	(36,707,937)	$	(20,487,172)	$	(8,271)	$	(11,683)	$	(27,284)	$	(36,708)
Shares used to compute net loss per common share, basic and diluted		5,841,790		162,506		2,746,523		143,012		40,218,324		5,841,790		26,467,423		2,746,523
Net loss per share attributable to common shareholders, basic and diluted	$	(2.00)	$	(37.77)	$	(13.37)	$	(143.25)	$	(0.21)	$	(2.00)	$	(1.03)	$	(13.37)

Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company's potentially dilutive securities which include stock options, convertible preferred stock, Series 3 warrants and common stock warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding due to the Company's net loss position.

The following outstanding common stock equivalents have been excluded from diluted net loss per common share for the three and nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 because their inclusion would be anti-dilutive.


			September 30,
			2020	2019

	September 30,	September 30,
	2019	2018
	(unaudited)
			(unaudited)
Options issued and outstanding	3,821,690	42,979	4,483,106	3,821,690
Inducement options issued and outstanding	—	2,994	33,392	906
Options available for grant under stock options plans	554,016	3,402
Restricted stock unit awards issued and outstanding	5,613	5,613
Restricted stock units issued and outstanding			5,613	5,613
Warrants issued and outstanding	19,421,892	16,582	7,340,536	19,421,892
Convertible notes	—	23,469
Series A convertible preferred stock	473,565	—	—	473,565
Series B convertible preferred stock	985,500	—	—	985,500
Series B-2 convertible preferred stock			1,431,460	—
Total	25,262,276	95,039	13,294,107	24,709,166

As of November 6, 2020 there were 20,578,097 shares of common stock issued after the balance sheet date. Including these shares will have a material effect on the diluted net loss per common share in future periods.

~~13.~~

14. Segment Information

~~Prior to the merger with Napo, the Company managed its operations as a single segment for the purposes of assessing performance and making operating decisions.~~ The Company ~~reorganized its segments to reflect the change in the organizational structure resulting from the merger with Napo. Post-merger, the Company manages its operations through~~has two reportable ~~segments—human~~segments-human health and animal health. The human health segment is focused on developing and commercializing human products and the ongoing commercialization of Mytesi™, which is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The animal health segment is focused on developing and commercializing prescription and non-prescription products for companion and production animals.

The human health segment is focused on developing and commercializing of human products and the ongoing commercialization of Mytesi, which is approved by the U.S. FDA for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

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The Company's reportable segments net revenues and net loss for the three and nine months ended
September 30, ~~2019~~2020 and ~~2018~~2019 consisted of:


									Three Months Ended				Nine Months Ended
									September 30,				September 30,
(in thousands)									2020		2019		2020		2019

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2019		2018		2019		2018
	(unaudited)				(unaudited)
									(unaudited)				(unaudited)
Revenue from external customers
Human Health	$	957,059	$	1,107,682	$	4,184,912	$	2,545,121	$	2,760	$	957	$	6,748	$	4,185
Animal Health		15,720		24,385		83,294		275,148		13		16		61		83
Consolidated Totals	$	972,779	$	1,132,067	$	4,268,206	$	2,820,269	$	2,773	$	973	$	6,809	$	4,268

Segment profit (loss)

Segment net loss
Human Health	$	(3,955,115)	$	(3,145,782)	$	(16,585,956)	$	(10,519,413)	$	(1,912)	$	(3,955)	$	(6,721)	$	(16,586)
Animal Health		(3,599,950)		(2,992,570)		(15,994,097)		(8,972,759)		(5,954)		(3,600)		(18,319)		(15,994)
Consolidated Totals	$	(7,555,065)	$	(6,138,352)	$	(32,580,053)	$	(19,492,172)	$	(7,866)	$	(7,555)	$	(25,040)	$	(32,580)

The Company's reportable segments assets consisted of the following:

September 30,

December 31,


2019

2018
Segment assets




Human Health

$
33,571,477

$
37,985,935
Animal Health

64,797,329

54,893,593
Total

$
98,368,806

$
92,879,528

The reconciliation of segments assets to the consolidated assets is as follows:

September 30,

December 31,

2019

2018
Total assets for reportable segments

98,368,806

92,879,528
Less: Investment in subsidiary

(29,240,965)

(29,240,965)
Less: Intercompany loan

(33,501,296)

(22,596,618)
Consolidated Totals

$
35,626,544

$
41,041,945


	September 30,		December 31,
(in thousands)	2020		2019
Segment assets	(unaudited)
Human Health	$	33,930	$	32,432
Animal Health		69,466		68,169
Total	$	103,396	$	100,601

~~14.~~The reconciliation of segments assets to the consolidated assets is as follows:


	September 30,		December 31,
	2020		2019
(in thousands)	(unaudited)
Total assets for reportable segments	$	103,396	$	100,601
Less: Investment in subsidiary		(29,241)		(29,241)
Less: Intercompany loan		(37,921)		(34,950)
Consolidated Totals	$	36,234	$	36,410

15. Subsequent Events

~~Series 1 Warrant Exercise Agreement~~ATM Program

InOn October ~~2019,~~5, 2020, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Ladenburg Thalmann & Co. Inc., as agent (“Ladenburg”). The Company registered on its Form S-3 the sale of up to $7 million worth of shares of common stock. The Company will pay Ladenburg a ~~Warrant Exercise Agreement with the sole remaining holder~~commission of up to three percent (3.0%) of the ~~Series B Preferred Stock (the “Exercising Holder”), which Exercising Holder owns Series 1 warrants exercisable~~gross sales proceeds of any Shares sold through Ladenburg. The Company has not issued any shares under the ATM.

Phase 3 Clinical Trial for ~~1,250,000 shares~~Cancer-therapy related Diarrhea

On October 5, 2020, Napo entered into a Master Services Agreement for clinical research organization services and a service order with Integrium, LLC (“Integrium”). The Service Order covers Napo’s planned pivotal Phase 3 clinical trial for cancer-therapy related diarrhea. Napo will pay Integrium a total amount of ~~Common Stock (the “Series 1 Warrant Shares”). Pursuant~~up to approximately $12.4 million over the Warrant Exercise Agreement, the Company had the right, with 2 trading days’ prior notice, to require the Exercising Holder to exercise all or a portion of its Series 1 warrants in accordance with the existing termsterm of the ~~Series 1 warrants, in exchange for~~engagement, based on the ~~Company’s agreement to issue to the Exercising Holder a number~~achievement of Series B-1 Convertible Preferred Stock, with a stated value of $12,201, in an amount equal to one Series B-1 Convertible Preferred Share for every 19,841 Series 1 Warrant Shares issued by the Company to the Exercising Holder.

In October 2019, the Exercising Holder exercised its 1,250,000 Series 1 warrants for common stock, with the Company receiving aggregate gross proceeds of approximately $1,750,000. In consideration of the exercise, and in accordance with the terms of the Warrant Exercise Agreement, the Company in turn issued to the Exercising Holder 63 shares of Series Convertible B-1 Preferred Stock.

certain milestones.

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~~Designation of Series B-1 Convertible Preferred Stock~~

InOn October 2019, the Company created a new series of authorized preferred stock, designated as the “Series B-1 Convertible Preferred Stock.” The Series B-1 Certificate of Designation became effective with the Secretary of State of the State of Delaware upon filing. The shares of Series B-1 Preferred Stock rank on par with the shares of the Common Stock, in each case, as to dividend rights and distributions of assets upon liquidation, dissolution or winding up of the Company.

With certain exceptions, as described in the Series B-1 Certificate of Designation, the shares of Series B-1 Convertible Preferred Stock have no voting rights. However, as long as any shares of Series B-1 Convertible Preferred Stock remain outstanding, the Series B-1 Certificate of Designation provides that the Company shall not, without the affirmative vote of holders of a majority of the then outstanding shares of Series B-1 Convertible Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B-1 Convertible Preferred Stock or alter or amend the Series B-1 Certificate of Designation or (b) enter into any agreement with respect to any of the foregoing.

Each share of Series B-1 Convertible Preferred Stock is convertible at any time at the holder’s option into 10,001 shares of Common Stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series B-1 Certificate of Designation. Notwithstanding the foregoing, the Series B-1 Certificate of Designation further provides that the Company shall not effect any conversion of the shares of Series B-1 Convertible Preferred Stock, with certain exceptions, to the extent that, after giving effect to an attempted conversion, the holder of shares of Series B-1 Preferred Stock (together with such holder’s affiliates and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of Common Stock in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance of Series B-1 Convertible Preferred Stock) of the shares of Common Stock then outstanding. At the holder’s option, upon notice to the Company, the holder may increase or decrease this beneficial ownership limitation not to exceed 9.99% of the shares of Common Stock then outstanding, with any such increase becoming effective upon 61 days’ prior notice to the Company.

~~Issuance of Series B-1 Convertible Preferred Stock~~

In October 2019, per the terms of a Warrant Exercise Agreement, the Company issued 63 shares of Series B-1 Convertible Preferred Stock in consideration of an existing Series 1 Warrant holder exercising 1,250,000 Series 1 warrants for the Company’s common stock. The Company received aggregate gross proceeds of approximately $1,750,000 from the exercise of the Series 1 Warrants.

~~Termination of Tempesta Royalty License Agreement~~

~~In October 2019,~~6, 2020, the Company entered into a ~~License Termination and Settlement~~Stock Plan Agreement for Payment of Contracted Research Fees with ~~Dr. Michael Tempesta, pursuant to which certain disputes between Napo and Tempesta were settled.~~PoC Capital, LLC (“PoC”). The disputes related to royalty payments owed by Napo to Tempesta under a license agreement, dated February 8, 1990, between Tempesta and Shaman Pharmaceuticals, a predecessor-in-interest to Napo (the “1990 License”), and a modified license agreement, dated October 16, 2002, between Tempesta and Napo (the “2002 License” and together with the 1990 License, the “License Agreements”) with respect to SP-303, a component of Mytesi, the Company’s FDA-approved drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. At September 30, 2019, the Company ~~had recorded a loss contingency of $640,000 in regard to the probable settlement of the royalty dispute (see Note 6).~~

~~Pursuant to the terms of the Agreement, Tempesta received $50,000 in cash, an unsecured promissory note~~ issued ~~by the Company in the aggregate principal amount of $550,000 and 40,000~~1,333,333 shares of ~~the Company’s~~ common stock to PoC at par value of $0.0001 per share in ~~exchange~~consideration for ~~the cessation~~PoC’s assumption of ~~all royalty payments by~~$0.4 million obligations of Napo ~~to Dr. Tempesta~~ under the ~~License Agreements.~~Service Order with Integrium. The promissory note bears interest at the rate of 2.5% per annum and matures on March 1, 2025. The promissory note provides for the Company to make semi-annual payments equal to $50,000 plus accrued interest beginning on March 1,

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~~2020 until the Note is paid in full. The 40,000 shares are subject to lock-up restrictions and are not tradeable by Tempesta until October 1, 2020.~~

~~Angel Pond Agreement~~

~~In October 2019, the Company engaged Angel Pond Capital LLC to explore potential licensing agreements and collaborations for Mytesi~~® in China. In consideration of these services, the Company compensated Angel Pond Capital LLC with $140,000 in the Company’s common stock for the initial four-month term of the agreement. The Company has the option to extend the agreement term for two months for $30,000 payable in the Company’s common stock.

If a definitive commercial agreement is executed by the Company with an entity that does all or substantially all of its business in China and one with whom Angel Pond Capital LLC has had substantial contact on the Company’s behalf prior to the expiration or termination of this Agreement, Angel Pond Capital LLC will be paid compensation equal to 6% (6.5% for certain engaged entities) of the amounts actually received by the Company from such engaged entity in the form of upfront licensing fees and regulatory milestone payments pursuant to such Definitive Commercial Agreement.

The Company will pay to Angel Pond Capital LLC sales milestone payments equal to $300,000 after the first $50,000,000 of “Net Sales” (as defined in a Definitive Commercial Agreement) has been achieved in China by an engaged entity, and $300,000 after each and every additional $50,000,000 in cumulative net sales in China by such engaged entity; provided, however, such milestone payments will be capped at 6% of the cumulative sales royalty payments received by the Company from such engaged entity.

If Angel Pond Capital LLC is able to raise equity capital for the Company from an engaged entity prior to the expiration or termination of the Agreement, Angel Pond Capital LLC will receive compensation equal to 6% of the total dollar amount raised.

If Angel Pond Capital LLC is instrumental in arranging for the sale of the Company to an engaged entity prior to the expiration or termination of the Agreement, then Angel Pond Capital LLC will be compensated determinant upon any such sale price.

~~Securities Purchase Agreement~~

On November 13, 2019, Jaguar Health, Inc. (“Jaguar” or the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with the purchasers named therein (each, an “Investor” and collectively, the “Investors”), pursuant to which the Company agreed to issue and sell, in a registered public offering by the Company directly to the Investors (the “Offering”), pre-funded warrants to purchase up to an aggregate of 2,222,223 shares of the Company’s common stock (“Common Stock”) at aneffective offering price of ~~$0.80~~common stock is at $0.30 per share, ~~(the “Pre-Funded Warrants”),~~ which ~~when added together with the exercise price of $0.01 per share, equals~~is the Minimum Price as defined under Nasdaq Listing Rule 5635(d).

3(a)(9) Exchanges

On October 6, 2020, the Company issued 3,350,000 shares of common stock to a noteholder in exchange for a $1.0 million reduction in the outstanding balance of CVP Exchange Note 1.

On the same date, the Company issued 500,186 shares of common stock to a holder of the Company’s Series B-2 convertible preferred stock in exchange for 975 shares of Series B-2 Convertible Preferred Stock.

Preferred Stock Exchange

On October 8, 2020, the Company entered into an exchange agreement with Iliad, pursuant to which the Company and Iliad agreed to exchange the 285,000 shares Series C Perpetual Preferred Stock (see Note 9) for (i) 250,000 shares of Common Stock and (ii) Pre-Funded warrants to purchase 7,057,692 shares of Common Stock. Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of $0.0001 per share. As of November 6, 2020, Iliad exercised 6,700,000 Pre-funded Warrants for $1,000.

Fee Settlement Agreement

On October 7, 2020, the Company entered into a fee settlement agreement with Atlas pursuant to which the Company will issue to Atlas 2,000,000 shares of common stock and pre-funded warrants to purchase 6,218,954 shares of common stock as complete settlement and satisfaction of a trial delay fee of $2.5 million that the Company expects to incur pursuant to its license agreement with Atlas dated April 15, 2020. As of October 23, 2020, the shares of common stock have all been issued and the pre-funded warrants have all been exercised. Refer to Note 2 for further discussion.

Royalty Transaction

On October 8, 2020, the Company entered into another Purchase Agreement with Iliad, pursuant to which the Company sold to Iliad a royalty interest (the “Royalty Interest”) entitling Iliad to receive $12 million Royalty Repayment Amount for an aggregate purchase price of $6 million. Interest will accrue on the Royalty Repayment Amount at a rate of 10% per annum, compounding quarterly. The Company will be obligated to make minimum royalty payments on a monthly basis beginning on May 10, 2021 in an amount equal to the greater of (i) $250,000 (which increases to $400,000 beginning on October 9, 2021, $600,000 beginning on April 9, 2022, and $750,000 beginning on October 9, 2022) and (ii) 10% of the Company’s net sales of Mytesi and 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses. If the weekly volume weighted average price of the Company’s Common Stock (“VWAP”) is not equal to or greater than the Minimum VWAP ($0.3035) at least twice during each calendar month during the six-month period beginning on November 1, 2020, then the Royalty Repayment Amount will automatically be increased by $6,000,000 at the end of such six-month period. Upon mutual agreement the parties may agree to consummate additional royalty financings of approximately $5 million and $6 million in February 2021 and July 2021, respectively. Under the Purchase Agreement, the Company is subject to certain covenants, for which the Company’s failure to comply may be subject to certain liquidated damages, including a right for Iliad to increase the Royalty Repayment Amount by 15%.

Fourth Amendment to Accounts Receivable Purchase Agreement with Oasis Capital, LLC

On October 9, 2020, for its fifth sale under the terms of the Purchase Agreement, the Company received cash proceeds of $900,097 from Oasis (the “Tranche #5 Secured Note”). Oasis purchased accounts receivable with a carrying value of 900,000, or gross ~~proceeds from~~accounts receivable of $2,118,000 net of chargebacks and discounts of $1,218,000. The

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purchase was effectuated pursuant to an amended Assignment Agreement, effective October 9, 2020, between Napo and Oasis.

Per the ~~Offering were approximately $1.8 million before deducting offering expenses.~~terms of the agreement, Oasis will receive a fee of 5.45% (the "Fee") of the $2,118,000 gross accounts receivable. The Maturity Date, by which date Oasis must collect the $1,015,000 Threshold Price, was December 16, 2020. Oasis will return to the Company within five days any amounts collected that exceeds the sum of the Purchase Price and the Fee. As with all Mytesi gross sales, the accounts receivable will be reduced by Medicare, ADAP 340B chargebacks, returns, and wholesale distribution fees based on historical trends to determine net sales.

Under the agreement, Oasis is entitled to a transaction fee of $5,000 and may be entitled to additional transaction fees to the extent Oasis purchases additional accounts receivable under the agreement, which fees will not exceed $5,000 per transaction.

The initial term of the agreement is one year, during which period Oasis, can purchase additional receivables. The agreement will automatically renew for successive one-year periods unless notice of non-renewal is provided by the Company at least 30 days prior to the expiration of a term. Notwithstanding the foregoing, either Oasis or the Company may terminate the agreement on 60 days' prior written notice.

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes included in Item 1 of Part I of this Quarterly Report on Form ~~10‑Q,~~10-Q, and with our audited consolidated financial statements and the related notes included in our Annual Report on Form ~~10‑K~~10-K for the year ended December 31, ~~2018.~~2019.

The discussion and analysis below includes certain forward-looking statements related to our research and development and commercialization of our products in the U.S., our future financial condition and results of operations and potential for profitability, the sufficiency of our cash resources, our ability to obtain additional equity or debt

~~Table~~ financing or other means of ~~Contents~~

~~financing,~~accelerating the payment of accounts receivable, if needed, possible partnering or other strategic opportunities for the development of our products, as well as other statements related to the progress and timing of product development, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods, which are all forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These statements represent, among other things, the expectations, beliefs, plans and objectives of management and/or assumptions underlying orour judgments concerning the future financial performance and other matters discussed in this document. The words “may,” “will,” “should,” “plan,” “believe,” “estimate,” “intend,” “anticipate,” “project,” and “expect” and similar expressions are intended to connote forward-looking statements. All forward-looking statements involve certain risks, uncertainties and other factors described in our Annual Report on Form ~~10‑K,~~10-K, that could cause our actual commercialization efforts, financial condition and results of operations, and business prospects and opportunities to differ materially from these expressed in, or implied by, those forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise forward-looking statements.

Overview

We are a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (“Napo”), focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. Our Mytesi ~~(crofelemer)~~(“Crofelemer”) product is approved by the U.S. Food and Drug Administration ~~(“FDA”)~~ for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

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Jaguar was founded in San Francisco, California as a Delaware corporation on June 6, 2013. Napo formed Jaguar to develop and commercialize animal health products. Effective as of December 31, 2013, Jaguar was a wholly-owned subsidiary of Napo, and Jaguar was a majority-owned subsidiary of Napo until the close of the Company's initial public offering on May 18, 2015. On July 31, 2017, the merger of Jaguar Animal Health, Inc. and Napo became effective, at which point Jaguar Animal Health's name changed to Jaguar Health, Inc. and Napo began operating as a wholly-owned subsidiary of Jaguar focused on human health and the ongoing commercialization of, and development of follow-on indications for, Mytesi. Most of the activities of the Company are now focused on the commercialization of Mytesi and development of follow-on indications for crofelemer and a second-generation anti-secretory product, lechlemer. In the field of animal health, we have limited activities which are focused on developing and commercializing first-in-class gastrointestinal products for dogs, dairy calves, foals, and high value horses.

We believe Jaguar is poised to realize a number of synergistic, value adding benefits—an expanded pipeline of potential blockbuster human follow-on indications, a second-generation anti-secretory agent, as well as a pipeline of important animal indications for crofelemer —upon which to build global partnerships. As previously announced, Jaguar, through Napo, now holds extensive global rights for Mytesi, and crofelemer manufacturing is being conducted at a multimillion-dollar commercial manufacturing facility that has been FDA-inspected and approved. Additionally, several of the drug product candidates in Jaguar's Mytesi pipeline are backed by what we believe are strong Phase 2 and proof of concept evidence from completed human clinical trials.

Mytesi is a novel, first-in-class anti-secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple disorders. Mytesi is in development for multiple possible follow-on indications, including cancer therapy-related diarrhea; orphan-drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome (SBS); supportive care for inflammatory bowel disease (IBD); irritable bowel syndrome (IBS); and for idiopathic/functional diarrhea. In addition, a second-generation anti-secretory agent, lechlemer, is in development for cholera. Mytesi previously received orphan-drug designation for SBS.

Financial Operations Overview

On a consolidated basis, we have not yet generated enough revenue to date to achieve break even or positive cash flow, and we expect to continue to incur significant research and development and other expenses. Our net loss was

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~~$32.6~~ $25.0 million and ~~$19.5~~$32.6 million for the nine months ended September 30, ~~2019~~2020 and ~~2018, respectively. Our net loss was $7.6 million and $6.1 million for the three months ended September 30,~~ 2019, ~~and 2018,~~ respectively. As of
September 30, ~~2019,~~2020, we had a total stockholders' equity of ~~$11.4~~$7.8 million, an accumulated deficit of ~~$127.1~~$158.1 million, and cash of ~~$2.1~~$1.3 million. We expect to continue to incur losses and experience increased expenditures for the foreseeable future as we expand our product development activities, seek necessary approvals for our product candidates, conduct species-specific formulation studies for our non-prescription products, establish API manufacturing capabilities and begin additional commercialization activities.

Revenues

Our product and collaboration revenue consist of the following:

●

Revenues from the sale of our human drug Mytesi, which is sold through distributors and wholesalers.

●

Revenues from the sale of our animal products branded as Neonorm Calf and Neonorm Foal. Our Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers.

~~Revenues from our collaborative agreement with Elanco to license, develop and commercialize Canalevia. This agreement was terminated in January 2018.~~

See “Results of Operations” below for more detailed discussion on revenues

Cost of Revenue

Cost of revenue consists of direct drug substance and drug product materials expense, direct labor, distribution fees, royalties and other related expenses associated with the sale of our products.

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Research and Development Expense

Research and development expenses consist primarily of clinical and contract manufacturing expense, personnel and related ~~benefit~~benefits expense, stock-based compensation expense, employee travel expense, and reforestation expenses. Clinical and contract manufacturing expense consists primarily of costs to conduct stability, safety and efficacy studies, and manufacturing startup at an outsourced API provider in Italy. It also includes expenses with a third-party provider for the transfer of the Mytesi manufacturing process, and the related feasibility and validation activities.

We typically use our employee and infrastructure resources across multiple development programs. We track outsourced development costs by prescription drug product candidate and non-prescription product and we track personnel or other internal costs related to development to specific programs or development compounds.

The timing and amount of our research and development expenses will depend largely upon the outcomes of current and future trials for our prescription drug product candidates as well as the related regulatory requirements, the outcomes of current and future species-specific formulation studies for our non-prescription products, manufacturing costs and any costs associated with the advancement of our line extension programs. We cannot determine with certainty the duration and completion costs of the current or future development activities.

The duration, costs and timing of trials, formulation studies and development of our prescription drug and non-prescription products will depend on a variety of factors, including:

●

the scope, rate of progress, and expense of our ongoing, as well as any additional clinical trials, formulation studies and other research and development activities;

●

future clinical trial and formulation study results;

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potential changes in government regulations; and

●

the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a prescription drug product candidate or non-prescription product could mean a significant change in the costs and timing associated with our development activities.

We expect research and development expense to increase ~~significantly as we add personnel, commence additional~~due to the start-up costs associated with our clinical ~~studies and~~trials for other ~~activities to develop our prescription drug product candidates and non-prescription products.~~indications.

Sales and Marketing Expense

Sales and marketing expenses consist of personnel and related ~~benefit~~benefits expense, stock-based compensation expense, direct sales and marketing expense, employee travel expense, and management consulting expense. We currently incur sales and marketing expenses to promote Mytesi. We do not currently have any marketing or promotional expenses related to Neonorm Calf or Neonorm Foal in the ~~three and~~ nine months ended September 30, ~~2019.~~2020.

We expect sales and marketing expense to ~~decrease~~increase going forward as we ~~consolidate Mytesi sales territories for HIV promotion,~~ focus on expanding our market access activities and commercial partnerships for the development of follow-on indications of Mytesi and Crofelemer.

General and Administrative Expense

General and administrative expenses consist of personnel and related ~~benefit~~benefits expense, stock-based compensation expense, employee travel expense, legal and accounting fees, rent and facilities expense, and management consulting expense.

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In the near term, we expect general and administrative expense to remain ~~the same~~flat as we ~~consolidate sales territories and simultaneously~~ focus on our pipeline ~~development.~~development and market access expansion. This will include ~~growing~~efforts to grow the ~~business without adding headcount or increasing facilities.~~business.

Interest Expense

Interest expense consists primarily of non-cash and cash interest costs related to our borrowings.

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Critical Accounting Policies and Significant Judgments and Estimates

The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles, or U.S. GAAP, requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures in the consolidated financial statements. Critical accounting policies are those accounting policies that may be material due to the levels of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change, and that have a material impact on financial condition or operating performance. While we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances, actual results may differ from these estimates under different assumptions or conditions. We believe the following critical accounting policies used in the preparation of our consolidated financial statements require significant judgments and estimates. For additional information relating to these and other accounting policies, see Note 2 to our audited consolidated financial statements and the related notes included in our Annual Report on Form ~~10‑K~~10-K for the year ended December 31, ~~2018.~~2019.

Revenue Recognition

Practical Expedients, Elections, and Exemptions

We recognize revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services.

We used a practical expedient available under ASC ~~606‑10‑65‑1(f)~~606-10-65-1(f)4 that permits us to consider the aggregate effect of all contract modifications that occurred before the beginning of the earliest period presented when identifying satisfied and unsatisfied performance obligations, transaction price, and allocating the transaction price to the satisfied and unsatisfied performance obligations.

We also used a practical expedient available under ASC ~~606‑10‑32‑18~~606-10-32-18 that permits us not to adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less.

We have elected to treat shipping and handling activities as fulfillment costs.

Additionally, we have elected to record revenue net of sales and other similar taxes.

Contracts - Cardinal Health

Effective January 16, 2019, Napo ~~Pharmaceuticals, Inc.~~ engaged Cardinal Health as its exclusive third party logistics distribution agent for commercial sales for the Company’s Mytesi product and to perform certain other services which include,

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without limitation, storage, distribution, returns, customer support, financial support, ~~EDI~~Electronic Data Interchange (“EDI”) and system access support ~~(Exclusive~~(the “Exclusive Distribution ~~Agreement)~~Agreement”).

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and title and risk of loss for consigned inventory shall remain with ~~Client~~the Company until purchased by Cardinal Health in accordance with ~~this~~the Title Model Addendum. Napo ~~Pharmaceuticals, Inc.~~ considers Cardinal Health the Company’s exclusive customer for Mytesi products per the ~~Cardinal Health~~ Exclusive Distribution ~~agreement.~~ Agreement.

~~Our~~Jaguar's Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers. Since 2014, wethe Company has entered into several distribution agreements with established distributors such as Animart, Vedco, VPI, RJ Matthews, Henry Schein, and Stockmen Supply to distribute the Company's products in the United States, Japan, and China. The distribution agreements and the related purchase ~~order~~orders together meet the contract existence criteria under ASC ~~606‑10‑25‑1.~~606-10-25-1. Jaguar sells directly to its customers without the use of an agent.

Performance obligations

For ~~the~~animal products sold by ~~each of Napo and~~ Jaguar Health, the single performance obligation identified above is ~~our~~the Company’s promise to transfer ~~our Mytesi product~~the Company’s animal products to ~~Distributors~~distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance type warranties that ~~does~~do not represent a performance obligation. For the Company’s human product, Mytesi, which is sold by Napo, the single performance obligation identified above is the Company’s promise to transfer Mytesi to Cardinal Health, the Company’s exclusive distributor for the product, based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement.

Transaction price

For contracts with Cardinal Health, for both Jaguar and ~~our~~ Napo, ~~subsidiary,~~ the transaction price is the amount of consideration to which ~~we expect~~the Company expects to collect in exchange for transferring the promised goods or services to a customer. The transaction price of Mytesi and Neonorm is the Wholesaler Acquisition Cost (“WAC”), net of discounts, returns, and price adjustments.

Allocate transaction price

For contracts with Cardinal Health, for both ~~Jaguar~~Napo and ~~our Napo subsidiary,~~Jaguar, the entire transaction price is allocated to the single performance obligation contained in each contract.

~~Point in time~~Revenue recognition

For contracts with Cardinal Health, for both ~~Jaguar~~Napo and ~~our Napo subsidiary,~~Jaguar, a single performance obligation is satisfied at a point in time, upon the ~~FOB~~free on board (“FOB”) terms of each contract when control, including title and all risks, has transferred to the customer.

Disaggregation of Product Revenue

Human

Sales of Mytesi are recognized as revenue when the products are delivered to the wholesaler. ~~Revenues~~Net revenues from the sale of Mytesi were ~~$957,059~~$2.8 million and ~~$1,107,682~~$1.0 million for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues from the sale of Mytesi were ~~$4,184,912~~$6.7 million and ~~$2,545,121~~$4.2 million for the nine months ended
September 30, 2020 and 2019, ~~and 2018,~~ respectively. ~~The increase in sales~~

Table of ~~Mytesi is due to the more streamlined distribution and increased sales presence.~~ Deductions from revenue are derived from reserves for estimated product returns based on historical returns experience. If actual returns differed from our historical experience, changes to the reserved could be required in future periods. Additional deductions are wholesaler fees which are based on our agreement with Cardinal Health, sales discounts, and Medicare rebates which are derived from data collected by Cardinal Health through various sources.Contents

Animal

The Company recognized Neonorm revenues of ~~$15,720~~$13,000 and ~~$24,385~~$16,000 for the three months ended
September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues from the sale of Neonorm were ~~$83,294~~$61,000 and ~~$97,759~~$83,000 for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Revenues are recognized upon shipment which is when title and control is transferred to the buyer. Sales of Neonorm Calf and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances.

Contracts - Atlas Sciences

Performance obligations

As of September 30, 2020, the Company determined not to proceed with the Phase 2 study, which will result in the Company having no performance obligation to transfer the services to Atlas.

Transaction price

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Allocate transaction price

~~Goodwill~~For the contract with Atlas, the transaction price of $1,500,000 is allocated as follows: (i) $1,196,000 was allocated to the Phase 2 study using the cost-plus margin approach, and ~~Indefinite-lived Intangible Assets~~(ii) $583,000 was allocated to the Patent sale using the Residual method.

~~Goodwill~~

~~Goodwill is tested for impairment on an annual basis and in-between annual tests if events or circumstances indicate that an impairment loss may have occurred. The test is based on~~As of September 30, 2020, the allocated deferred transaction price of $1,500,000 will be derecognized as a ~~comparison~~result of the ~~reporting unit's book value~~non-performance of the Company’s obligation to initiate the Phase study.

Revenue recognition

As of September 30, 2020, the Company made the decision not to initiate the Phase 2 study and intended to negotiate the payment of the Trial Delay Fee of $2.5 million and terminate the contract. Because of this decision, the allocated transaction price for that performance obligation will not be recognized as revenue. Likewise, the allocated transaction price for the Patent sale will not be recognized as revenue, as its ~~estimated fair market value. We~~recognition was dependent on initiating the Phase 2 study on or before January 15, 2021.

The Company derecognized $1.5 million in deferred revenue and the excess of the Trial Delay Fee was recognized in "General and Administrative Expenses" in the condensed consolidated statement of operations. The authoritative guidance treats consideration payable to a customer as a reduction of the transaction price and, therefore, an adjustment to revenues unless the payment is for a distinct good or service received from the customer. In some cases, a payment to a customer that is not in exchange for a distinct good or service could exceed the transaction price for the current contract. This is a case of a payment to a customer that is not in exchange for a distinct good or service. Accounting for the excess payment (“negative revenue”) requires judgment as the standard does not explicitly address whether it is appropriate to reclassify revenue to expense.

The Company evaluated the nature of the consideration payable to the customer and the rights and obligations in the related contract and concluded that the excess payment or loss should be presented as part of the general and administrative expenses due to the following factors:

●

No revenue has been recognized from the transaction as performance obligations were not satisfied.

●

The trial delay fee is a penalty in its economic term, subject to accounting for contingencies and provisions under relevant authoritative guidance.

The Company recorded the excess loss amount of $1.0 million in the three and nine months ended September 30, 2020

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Disaggregation of Patent Sales and Clinical Trial Services

Patent Rights Sale

Patent Rights sales are recognized when control of the Patent Rights is transferred to the purchaser (at a point-in-time). Due to the full constraint on the variable consideration of $1,500,000, there was no revenue recognized from the sale of Patent Rights to Atlas for the three and nine months ended September 30, 2020 and 2019.

Clinical Trials

Revenue from clinical trials are recognized over time, as the services are performed, as the Company's performance enhances the Patent Rights asset that Atlas controls. The Phase 2 study to be performed under the Atlas License was expected to begin in October 2020 and run through November 2021. The expected first patient dose in the study was expected to occur in December 2020, at which point revenue from the Phase 2 study would begin to be recognized.

As of September 30, 2020, the Company determined to not proceed with the Phase 2 study and incurred a trial delay fee of $2,515,000. Refer to Note 6 for a description of the contingent liability recorded. Due to the Company abandoning the Phase 2 study, the arrangement with Atlas to perform the ~~annual impairment test during~~clinical trial is terminated and the ~~fourth quarter~~deferred revenue recorded for the variable consideration of ~~each fiscal year using the opening condensed consolidated balance sheet as of the first day of the fourth quarter, with any resulting impairment recorded in the fourth quarter of the fiscal year.If the carrying value of a reporting unit's net assets exceeds its fair value, the goodwill would be considered impaired and would be reduced to its fair value.~~$1,500,000 was derecognized.

Indefinite-lived Intangible Assets

Acquired ~~in-process research and development (IPR&D)~~IPR&D are intangible assets initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the development period, these assets will not be amortized as charges to earnings; instead these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. In connection with each annual impairment assessment and any interim impairment assessment in which indicators of impairment have been identified, we compare the fair value of the asset as of the date of the assessment with the carrying value of the asset on the condensed consolidated balance ~~sheet.~~sheets. If impairment is indicated by this test, the intangible asset is written down by the amount by which the discounted cash flows expected from the intangible asset exceeds its carrying value. Fair value determinations require considerable judgement and are sensitive to changes in underlying assumptions, estimates regarding our future plans, as well as industry and economic conditions. These assumptions and estimates include projected revenues and income growth rates, terminal growth rates, competitive and consumer trends, market-based discount rates, and other factors. If current expectations of growth rates are not met or market factors outside of our control, such as discount rates, change significantly, this may lead to a further impairment in the future. ~~Acquired in-process research~~We recorded no impairment in the three and development (“IPR&D”) are intangible assets initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the development period, these assets will not be amortized as charges to earnings; instead these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. Wenine months ended September 30, 2020. The Company recorded an impairment of zero and ~~$4,000,000~~$4 million in the three and nine months ended September 30, 2019, respectively. ~~There were no impairment charges recorded in the three and nine months ended September 30, 2018.~~ The impairment loss is measured based on the excess of the carrying amount over the asset’s fair value. Definite-lived intangible assets are amortized on a straight-line basis over the estimated periods benefited and are reviewed when appropriate for possible impairment.

Accrued Research and Development Expenses

As part of the process of preparing our unaudited condensed consolidated financial statements, we are required to estimate accrued research and development expenses. Estimated accrued expenses include fees paid to vendors and clinical sites in connection with our clinical trials and studies. Clinical and contract manufacturing expense consists primarily of costs to conduct stability, safety and efficacy studies, and manufacturing startup at an outsourced API provider in Italy. It also includes expenses with a third-party provider for the transfer of the Mytesi manufacturing process, and the related feasibility and validation activities.

We review new and open contracts and communicate with applicable internal and vendor personnel to identify services that have been performed on our behalf and estimate the level of service performed and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost for accrued

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expenses. The majority of our service providers invoice us monthly in arrears for services performed or as milestones are achieved in relation to our contract manufacturers. We make estimates of our accrued expenses as of each reporting date.

We base our accrued expenses related to clinical trials and studies on our estimates of the services received and efforts expended pursuant to contracts with vendors, our internal resources, and payments to clinical sites based on enrollment projections. The financial terms of the vendor agreements are subject to negotiation, vary from contract to

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contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of animals and the completion of development milestones. We estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the related expense accrual accordingly on a prospective basis. If we do not identify costs that have been incurred or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. To date, we have not made any material adjustments to our estimates of accrued research and development expenses or the level of services performed in any reporting period presented.

The Company expenses the total cost of a certain long-term manufacturing development contract ratably over the estimated life of the contract, or the total amount paid if greater.

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Results of Operations

Comparison of the Nine Months Ended September 30, ~~2019~~2020 and ~~2018~~2019

The following table summarizes the Company’s results of operations with respect to the items set forth in such table for the nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 together with the change in such items in dollars and as a percentage.


	Nine Months Ended
	September 30,
	2019		2018		Variance		Variance %
Product revenue, net	$	4,268,206	$	2,642,880	$	1,625,326	61.5	%
Collaboration revenue		—		177,389		(177,389)	(100.0)	%

									Nine Months Ended
									September 30,
(in thousands)									2020		2019		Variance		Variance %
Product revenue									$	6,809	$	4,268	$	2,541	59.5	%
Total revenue		4,268,206		2,820,269		1,447,937	51.3	%		6,809		4,268		2,541	59.5	%
Operating Expenses
Cost of product revenue		3,072,800		1,808,918		1,263,882	69.9	%		2,491		3,073		(582)	(18.9)	%
Research and development		4,426,308		3,843,918		582,390	15.2	%		4,509		4,426		83	1.9	%
Sales and marketing		5,436,635		7,119,204		(1,682,569)	(23.6)	%		4,728		5,436		(708)	(13.0)	%
General and administrative		9,816,909		8,761,776		1,055,133	12.0	%		11,218		9,817		1,401	14.3	%
Settlement of Tempesta Royalty License Agreement		640,000		—		640,000	100	%
Settlement of Tempesta Royalty Settlement Agreement										—		640		(640)	(100.0)	%
Impairment of indefinite-lived intangible assets		4,000,000		—		4,000,000	100	%		—		4,000		(4,000)	(100.0)	%
Series B convertible preferred stock inducement expense										1,647		—		1,647	100.0	%
Series 3 warrants inducement expense										3,696		—		3,696	100.0	%
Total operating expenses		27,392,652		21,533,816		5,858,836	27.2	%		28,289		27,392		897	3.3	%
Loss from operations		(23,124,446)		(18,713,547)		(4,410,899)	23.6	%		(21,480)		(23,124)		1,644	(7.1)	%
Interest expense		(5,556,953)		(2,185,868)		(3,371,085)	154.2	%		(1,259)		(5,557)		4,298	(77.3)	%
Other income (expense), net		49,392		322,244		(272,852)	(84.7)	%
Change in fair value of warrant, derivative liability and conversion option liability		1,002,865		(119,134)		1,121,999	(941.8)	%
Gain on Valeant settlement		—		1,204,133		(1,204,133)	(100.0)	%
Other income, net										190		49		141	287.8	%
Change in fair value of financial instruments										(2,491)		1,003		(3,494)	(348.4)	%
Loss on extinguishment of debt		(4,940,911)		—		(4,940,911)	(100.0)	%		—		(4,941)		4,941	(100.0)	%
Loss before income tax		(32,570,053)		(19,492,172)		(13,077,881)	67.1	%		(25,040)		(32,570)		7,530	(23.1)	%
Income tax expense		(10,000)		—		(10,000)	100	%		—		(10)		10	(100.0)	%
Net loss and comprehensive loss		(32,580,053)		(19,492,172)		(13,087,881)	67.1	%		(25,040)		(32,580)		7,540	(23.1)	%
Deemed dividend attributable to Series A preferred stock		—		(995,000)		995,000	100	%
Deemed dividend attributable to accretion of Series A redeemable convertible preferred stock										(1,332)		—		(1,332)	100	%
Deemed dividend attributable to Series B preferred stock		(3,875,778)		—		(3,875,778)	100	%		—		(3,876)		3,876	(100)	%
Stock dividend attributable to Series C perpetual preferred stock										(56)		—		(56)	100	%
Deemed dividend attributable to the Series 1 warrant modification		(252,106)		—		(252,106)	100	%		—		(252)		252	(100)	%
Net loss attributable to common stockholders	$	(36,707,937)	$	(20,487,172)	$	(16,220,765)	79.2	%
Deemed dividend attributable to Series 1, Series 2 and Bridge warrant holders										(856)		—		(856)	100	%
Net loss attributable to common shareholders									$	(27,284)	$	(36,708)	$	9,424	(25.7)	%

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Revenue

Sales and Allowances

Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced in order to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales in the nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 were as follows:


	Nine Months Ended
	September 30,
	2019		2018		Variance		Variance %

									Nine Months Ended
									September 30,
(in thousands)									2020		2019		Variance		Variance %
Gross product sales
Mytesi	$	6,054,053	$	3,550,994	$	2,503,059	70.5	%	$	13,895	$	6,054	$	7,841	129.5	%
Neonorm		83,273		98,738		(15,465)	(15.7)	%		61		83		(22)	(26.5)	%
Total gross product sales		6,137,326		3,649,732		2,487,594	68.2	%		13,956		6,137		7,819	127.4	%
Medicare rebates		(368,038)		(80,192)		(287,846)	358.9	%		(1,248)		(368)		(880)	239.1	%
Sales discounts - Mytesi		(1,055,244)		(582,017)		(473,227)	81.3	%
Sales returns - Mytesi		(88,934)		(88,052)		(882)	1.0	%
Wholesaler fee - Mytesi		(356,904)		(256,591)		(100,313)	39.1	%
Sales discounts										(4,307)		(1,055)		(3,252)	308.2	%
Sales returns										(203)		(89)		(114)	128.1	%
Wholesaler fee										(1,389)		(357)		(1,032)	289.1	%
Net product sales	$	4,268,206	$	2,642,880	$	1,625,326	61.5	%	$	6,809	$	4,268	$	2,541	59.5	%

Product Revenue

Our gross product revenues were ~~$6,137,326~~$14.0 million and ~~$3,649,732~~$6.1 million for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Neonorm Calf and Neonorm Foal.

Human

Sales of Mytesi are recognized as revenue when the products are delivered to the wholesalers. Our gross revenues from the sale of Mytesi were ~~$6,054,053~~$13.9 million and ~~$3,550,994~~$6.1 million in the nine months ended September 30, 2020 and 2019, ~~and 2018,~~ respectively. The increase in sales of Mytesi is due to an increase in the ~~more streamlined distribution and increased sales presence.~~wholesaler demand, mostly due to the list price adjustment of Mytesi that occurred in April 2020.

Sales discounts were ~~$1,055,244~~$4.3 million and ~~$582,017~~$1.1 million for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively, an increase of ~~$473,227.~~$3.3 million. Sales discounts include discounts for prompt payments from customers and an estimated allowance for chargebacks on sales. Of the total sales discounts, allowances for chargebacks were ~~$935,694~~$4.1 million and ~~$386,631~~$0.9 million for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. These allowances for chargebacks were approximately ~~15%~~30% and ~~11%~~15% on Mytesi gross product sales for the nine months ended
September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. The increase in allowance is mostly due to the ~~transition~~increase in ~~distributors during 2019.~~list price of Mystesi.

Animal

Our Neonorm product revenues were ~~$83,273~~$61,000 and ~~$98,738~~$83,000 for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Focus on sales and marketing for Neonorm products had decreased during ~~2019.~~2020.

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Cost of Product Revenue


	Nine Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
Cost of Product Revenue
Material cost	$	1,412	$	1,625	$	(213)	(13.1)	%
Direct labor		501		435		66	15.2	%
Distribution fees		331		407		(76)	(18.7)	%
Royalties		32		(11)		43	(390.9)	%
Other		215		617		(402)	(65.2)	%
Total	$	2,491	$	3,073	$	(582)	(18.9)	%

~~Collaboration Revenue~~

~~Collaboration~~Cost of product revenue ~~was derived~~decreased $582,000 from ~~our January 2017 licensing, development, co-promotion and commercialization agreement with Elanco US Inc. to license, develop and commercialize Canalevia. Elanco terminated the arrangement~~$3,073,000 in ~~January 2018 and all remaining deferred revenue was recognized at that time. We recognized collaboration revenues of $0 and $177,389 for~~ the nine months ended September 30, 2019 ~~and 2018, respectively.~~

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~~Cost of Product Revenue~~

~~Comparison of~~to $2,491,000 for the ~~Nine Months Ended September 30, 2019 and 2018~~

Nine Months Ended

September 30,


2019

2018

Variance

Variance %

Cost of Product Revenue

Material cost

$
1,624,970

$
847,264

$
777,706

91.8
%
Direct labor

435,305

407,525

27,780

6.8
%
Distribution fees

406,857

291,300

115,557

39.7
%
Royalties

(10,807)

81,342

(92,149)

(113.3)
%
Other

616,475

181,487

434,988

239.7
%
Total

$
3,072,800

$
1,808,918

$
1,263,882

69.9
%

~~Cost~~same period in 2020. The decrease in cost of product revenue ~~increased $1,263,882 from $1,808,918~~period over period was due to non-recurring costs incurred in the nine months ended September 30, ~~2018 to $3,072,800 for~~2019, including the ~~same period in 2019. The increase in cost~~write-off of ~~product revenue year over year was due to increased sales~~non-conforming inventory of ~~Mytesi, including non-recurring charges for a~~$273,000, campaign batch cancellation fee of $161,000, higher fees of ~~$227,000~~$132,000 from the ~~Company’s~~Company’s former distributor, ~~and the write-off of non-conforming inventory,~~ offset by the reversal of $189,000 of accrued royalties related to the termination of a royalty agreement. Additionally, a year end contractual credit of $93,000 was received from the Company’s contract manufacturer and $112,000 less in inventory costs in the nine months ended September 30, 2020.

Research and Development

~~Comparison of the Nine Months Ended September 30, 2019 and 2018~~

The following table presents the components of research and development (“R&D”) expense for the nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 together with the change in such components in dollars and as a percentage:


	Nine Months Ended
	September 30,
	2019		2018		Variance		Variance %

									Nine Months Ended
									September 30,
(in thousands)									2020		2019		Variance		Variance %
Research and Development:
Personnel and related benefits	$	1,382,646	$	1,708,116	$	(325,470)	(19.1)	%	$	1,270	$	1,383	$	(113)	(8.2)	%
Materials expense and tree planting		95,297		153,595		(58,298)	(38.0)	%		57		95		(38)	(40.0)	%
Travel, other expenses		137,909		108,078		29,831	27.6	%		42		138		(96)	(69.6)	%
Clinical and contract manufacturing		1,105,459		829,312		276,147	33.3	%		1,002		1,105		(103)	(9.3)	%
Stock-based compensation		548,524		400,521		148,003	37.0	%		580		549		31	5.6	%
Other		1,156,473		644,296		512,177	79.5	%		1,558		1,156		402	34.8	%
Total	$	4,426,308	$	3,843,918	$	582,390	15.2	%	$	4,509	$	4,426	$	83	1.9	%

Research and development expense increased ~~$582,390~~$83,000 from ~~$3,843,918~~$4,426,000 in the nine months ended
September 30, ~~2018~~2019 to ~~$4,426,308~~$4,509,000 for the nine months ended September 30, ~~2019~~2020 due primarily to:

●

~~Clinical and contract manufacturing expense~~Other expenses increased ~~$276,147~~$402,000 from ~~$829,312~~$1,156,000 in the nine months ended September 30, ~~2018~~2019 to ~~$1,105,459~~$1,558,000 in the same period in 2020 consisting primarily of consulting, formulation and regulatory fees. Consulting expenses increased due to an increase in clinical trial consultants, which is consistent with the increased activity in development of multiple follow‑on indications for Mytesi. Direct R&D testing costs also increased due to an increase in R&D work.

●

Clinical and contract manufacturing expense decreased $103,000 from $1,105,000 in the nine months ended September 30, 2019 to $1,002,000 in the same period in 2020 primarily due to ~~an increase~~a decrease in contract manufacturing costs for enhanced manufacturing process ~~improvements the Company is developing to reduce the cost of revenue.~~

improvements.

●

Personnel and related benefits decreased ~~$325,470~~$113,000 from ~~$1,708,116~~$1,383,000 in the nine months ended September 30, ~~2018~~2019 to ~~$1,382,646~~$1,270,000 in the same period in ~~2019~~2020 due to changes in headcount and related salaries.

4865

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We expect research and development expense to increase due to the start-up costs associated with our clinical trials for other indications.

Sales and Marketing

The following table presents the components of sales and marketing (“S&M”) expense for the nine months ended September 30, 2020 and 2019 together with the change in such components in dollars and as a percentage:


	Nine Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
Sales and Marketing:
Personnel and related benefits	$	2,485	$	3,514	$	(1,029)	(29.3)	%
Stock-based compensation		167		87		80	92.0	%
Direct marketing fees and expense		1,467		1,460		7	0.5	%
Other		609		375		234	62.4	%
Total	$	4,728	$	5,436	$	(708)	(13.0)	%

Sales and marketing expense decreased $708,000 from $5,436,000 in the nine months ended
September 30, 2019 to $4,728,000 for the nine months ended September 30, 2020.

●

~~Other expenses, consisting primarily of consulting, formulation~~Personnel and ~~regulatory fees, increased $512,177~~related benefits decreased $1,029,000 from ~~$644,296~~$3,514,000 in the nine months ended September 30, ~~2018~~2019 to ~~$1,156,473~~$2,485,000 in the same period in ~~2019. Consulting~~2020 due to sales force reduction.

●

Other expenses increased by $131,066 due to an increase in clinical trial consultants consistent with the temporary termination of clinical trials and an increase in R&D testing consultant work, net of an increase in Napo consulting expense. Direct R&D testing costs increased $314,000 due to an increase in R&D work. Formulation expenses were relatively constant in the comparative periods. Regulatory expenses decreased by $176,038 due to the Company receiving a waiver of fee payment$234,000 from ~~the FDA. Formulation expenses were relatively constant in the comparative periods.~~

~~Sales and Marketing~~

~~Comparison of the Nine Months Ended September 30, 2019 and 2018~~

Nine Months Ended

September 30,


2019

2018

Variance

Variance %

Sales and Marketing:









Personnel and related benefits

$
3,513,935

$
2,996,262

$
517,673

17.3
%
Stock-based compensation

87,215

59,762

27,453

45.9
%
Direct Marketing Fees

1,460,089

3,088,532

(1,628,443)

(52.7)
%
Other

375,396

974,648

(599,252)

(61.5)
%
Total

$
5,436,635

$
7,119,204

$
(1,682,569)

(23.6)
%

~~Sales and marketing expense decreased $1,682,569 from $7,119,204 in the nine months ended September 30, 2018 to $5,436,635 in the same period in 2019 due primarily to:~~

~~Direct marketing and sales expense decreased $1,628,443 from $3,088,532~~$375,000 in the nine months ended September 30, ~~2018~~2019 to ~~$1,460,089 for~~$609,000 in the same period in ~~2019~~2020 largely due to additional marketing consulting costs of $139,000, partially offset by reduced travel as a ~~decrease in marketing programs for Mytesi.~~

result of the COVID-19 pandemic.

General and Administrative

The following table presents the components of general and administrative expense for the nine months ended September 30, 2020 and 2019 together with the change in such components in dollars and as a percentage:


	Nine Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
General and Administrative:
Personnel and related benefits	$	1,366	$	1,372	$	(6)	(0.4)	%
Audit, tax and accounting services		399		542		(143)	(26.4)	%
Third-party consulting services		747		1,718		(971)	(56.5)	%
Legal services		1,882		1,295		587	45.3	%
Travel, other expenses		31		175		(144)	(82.3)	%
Stock-based compensation		1,437		1,347		90	6.7	%
Rent and lease expense		632		554		78	14.1	%
Public company expense		803		650		153	23.5	%
Other		3,921		2,164		1,757	81.2	%
Total	$	11,218	$	9,817	$	1,401	14.3	%

General and administrative expenses increased $1,401,000 from $9,817,000 in the nine months ended
September 30, 2019 to $11,218,000 for the same period in 2020 primarily due to increases in legal services, public company expense, stock-based compensation, and other expenses, partially offset by a decrease in third-party consulting services, travel expenses, and audit, tax and accounting services:

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●

~~Personnel and related benefits~~Legal services increased ~~$517,673~~$587,000 from ~~$2,996,262~~$1,295,000 in the nine months ended September 30, ~~2018~~2019 to ~~$3,513,935~~$1,882,000 in the same period in ~~2019~~2020 primarily due to ~~severance expenses of $125,865~~$218,000 increase in fees related to legal proceedings, $243,000 increase in fees related to addressing a congressional inquiry, and $59,000 increase in promotional material compliance review to support increase in marketing programs for Mytesi, and $70,000 increase in patent related legal fees.

●

Stock-based compensation expense increased $90,000 from ~~the sales force reduction and increased sales incentive bonuses of $332,334 from increased sales.~~

~~Other expenses decreased $599,252 from $974,648~~$1,347,000 in the nine months ended September 30, ~~2018~~2019 to ~~$375,396~~$1,437,000 in the same period in ~~2019 largely due to reduction in advertising costs of $716,574.~~

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~~General and Administrative~~

~~Comparison of the Nine Months Ended September 30, 2019 and 2018~~

Nine Months Ended

September 30,


2019

2018

Variance

Variance %

General and Administrative:









Personnel and related benefits

$
1,371,634

$
1,321,627

$
50,007

3.8
%
Accounting fees

542,395

423,468

118,927

28.1
%
Third-party consulting fees

1,717,665

1,246,792

470,873

37.8
%
Legal fees

1,295,480

1,692,451

(396,971)

(23.5)
%
Travel

174,965

212,707

(37,742)

(17.7)
%
Stock-based compensation

1,347,246

956,508

390,738

40.9
%
Rent and lease expense

554,017

324,693

229,324

70.6
%
Public company expenses

649,965

508,934

141,031

27.7
%
Other

2,163,542

2,074,596

88,946

4.3
%
Total

$
9,816,909

$
8,761,776

$
1,055,133

12.0
%

General and administrative expenses increased $1,055,133 from $8,761,776 in the nine months ended September 30, 2018 to $9,816,909 for the same period in 2019 primarily due to increases in accounting fees, third-party consulting, stock-based compensation, rent and lease expenses, and public company expenses:

~~Accounting fees increased $118,927 from $423,468 in the nine months ended September 30, 2018 to $542,395 in the same period in 2019, mostly due to change in the timing fees billings.~~

Consulting fees increased $470,873 from $1,246,792 in the nine months ended September 30, 2018 to $1,717,665 in the same period in 2019. This was to supplement the technical accounting and Finance Planning and Analysis needs of the current staff. Human Resource and Information Technology consulting services have also been in place in lieu of regular fulltime employees.

~~Legal fees decreased $396,971 from $1,692,451 in the nine months ended September 30, 2018 to $1,295,480 in the same period in 2019 mostly due to a decrease in patent legal fees.~~

~~Stock-based compensation expense increased $390,738 from $956,508 in the nine months ended September 30, 2018 to $1,347,246 in the same period in 2019~~2020 due to an increase in the volume of option ~~grants~~grants.

●

Other general and administrative expenses increased $1,757,000 from $2,164,000 for the nine months ended September 30, 2019 to ~~new~~$3,921,000 in the same period in 2020 largely due to $1,015,000 charge for Atlas trial delay penalty, an increase in Delaware state taxes of $125,000, an increase in state business and ~~existing employees.~~

manufacturing licenses of $90,000, and $306,000 increase of D&O liability insurance.

●

~~Rent and lease expense increased $229,324~~Third-party consulting services fees decreased $971,000 from ~~$324,693~~$1,718,000 in the nine months ended September 30, ~~2018~~2019 to ~~$554,017~~$747,000 in the same period in ~~2019 primarily due to contractual increases in rent on the Company’s office facilities and the additional increase in rent expense beginning in March 2019~~2020, due to the ~~cost~~switch to fulltime employees instead of consultants in the ~~LOC warrant.~~

Finance department.

●

~~Public company expenses increased $141,031~~Audit, tax and accounting services fees decreased $143,000 from ~~$508,934~~$542,000 in the nine months ended September 30, ~~2018~~2019 to ~~$649,965~~$399,000 in the same period in ~~2019 primarily~~2020, mostly due to ~~increased D&O liability insurance.~~

change in the timing of services received.

●

~~Other general and administrative~~Travel expenses ~~increased $88,946~~decreased $144,000 from ~~$2,074,596~~$175,000 in the nine months ended September 30, ~~2018~~2019 to ~~$2,163,542~~$31,000 in the same period in ~~2019 largely due to personnel recruiting fees.~~

2020 as a result of the COVID-19 pandemic.

In the near term, we expect general and administrative expense to remain the same as we focus on other areas of operations. This will include ~~growing~~efforts to grow the business without adding headcount or increasing facilities.

~~Table~~Settlement of ~~Contents~~Tempesta Royalty License Agreement

A royalty license agreement settlement liability decreased $640,000 in the nine months ended September 30, 2019 to zero in the same period in 2020. In October 2019, the Company and Tempesta settled the dispute, pursuant to which Tempesta received $50,000 in cash, an unsecured promissory note issued by the Company in the aggregate principal amount of $550,000 and 40,000 shares of the Company’s common stock in exchange for the cessation of all royalty payments by Napo to Dr. Tempesta under the License Agreements.

Series B Convertible Preferred Stock Inducement Expense

On March 24, 2020, the Company entered into a Warrant Exercise and Preferred Stock Amendment Agreement with a holder of its Series 2 warrants previously issued in the Company’s registered public offering on July 23, 2019, pursuant to which the holder agreed to exercise in cash its warrants to purchase an aggregate of 1,250,000 shares of common stock, at a reduced exercise price of $0.5227 per share for gross proceeds to the Company of approximately $653,000. As further inducement to enter into the Amendment Agreement, the Company agreed to reduce the conversion price of the Company’s Series B convertible preferred stock from $2.00 to $0.4456, which is equal to the Minimum Price plus $0.01. The modification of the conversion price of the Series B convertible preferred shares were qualitatively considered an extinguishment and the Company followed the guidance in ASC 260-10-S99-2 and recorded an expense of $1,647,000 and derecognizing the Series B convertible preferred shares.

Impairment of Indefinite-lived Intangible Assets

Acquired ~~in-process research and development (“~~IPR~~&D”)~~&D are intangible assets initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the

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development period, these assets will not be amortized as charges to earnings; instead these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. We recorded an impairment of $4,000,000 in the nine months ended September 30, 2019. There were no impairment charges recorded in the nine months ended September 30, ~~2018.~~2020. The impairment loss is measured based on the excess of the carrying amount over the asset’s fair value.

Series 3 Warrants Inducement Expense

In May 2020, concurrent with the May 2020 modification of the exercise price of the Series 1, Series 2 and Bridge Warrants and inducement offer, the Company issued unregistered Series 3 Warrants to purchase 8,670,852 shares of common stock. The Series 3 Warrants have an exercise price of $0.53 per share and are exercisable beginning the earlier of (i) six months from their May 22, 2020 issuance date and (ii) receipt of the requisite Stockholder Approval (defined below), and expire five years thereafter. In addition to the fixed settlement method at $0.53 per warrant share, the Series 3 Warrants have two contingent settlement methods: (i) if at the time of exercise there is no effective registration statement, then the holders of the 8,670,852 warrants may exercise the warrants in a “cashless exercise,” under which the holders will receive the aggregate warrants less the number of warrants equal to the exercise price; or (ii) a cashless exercise feature wherein, regardless if there is an effective registration agreement, following the requisite Stockholder Approval, each such Series 3 Warrant will be exercisable into one share of common stock for no consideration (the “Alternate Cashless Exercise”).

A Special Meeting of Stockholders was held on July 21, 2020, whereupon a proposal to approve the “Alternate Cashless Exercise” settlement method for the Series 3 Warrants was approved. The Series 3 Warrants and their underlying common shares were registered per the registration statement on Form S-3 on June 5, 2020.

In July 2020, certain holders of the Series 3 Warrants agreed to exercise 7,695,500 shares for a 1-for-1 exchange of common shares in an Alternate Cashless Exercise. Aggregate fair value of the common stock issued by the exercise of the Series 3 Warrants as of the exercise date was $5,687,000.

In August 2020, certain holders of the Series 3 Warrants agreed to exercise 552,830 shares for a 1-for-1 exchange of common shares in an Alternate Cashless Exercise. Aggregate fair value of the common stock issued by the exercise of Series 3 Warrants as of the exercise date is $306,000.

As of September 30, 2020, the remaining Series 3 Warrants are valued at $123,000 using the Black-Scholes option pricing model with inputs as follows: probability-weighted exercise price of $0 per share, stock price of $0.29 per share, expected life of 5.14 years, volatility of 142%, and a risk-free rate of 0.28%. The Series 3 Warrants are classified as liabilities on the Company’s condensed consolidated balance sheets.

Interest Expense

Interest expense decreased $4,298,000 from $5,557,000 in the nine months ended September 30, 2019 to $1,259,000 for the same period in 2020 primarily due to interest expense incurred on the March 2019 Bridge Notes and interest expense incurred on warrants issued concurrently.

Change in Fair Value of Financial Instruments

Change in fair value of financial instruments losses increased $3,494,000 from a gain of $1,003,000 in the nine months ended September 30, 2019 to a loss of $2,491,000 for the same period in 2020 primarily due to losses incurred on the change in fair value of liability classified warrants.

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Loss on Extinguishment of Debt

Loss on extinguishment of debt decreased from $4,941,000 in the nine months ended September 30, 2019 to zero for the same period in 2020 is due to the following:

●

$2,558,000 extinguishment losses from exchanges of principal and related accrued interest for shares of the Company’s common stock,

●

$2,047,000 extinguishment loss from the exchange of the two outstanding Napo convertible notes for Exchange Note 1 and Exchange Note 2,

●

$336,000 extinguishment loss from paying off twenty-one Bridge Notes prior to maturity.

Deemed Dividend Attributable to Accretion of Series A Redeemable Convertible Preferred Stock

The Company recorded a deemed dividend charge of $1,332,000 in the nine months ended September 30, 2020 for the accretion of the redemption amount and carrying value of the Series A convertible preferred stock.

Deemed Dividend Attributable to Series B Preferred Stock

On the July 23, 2019 issuance date, the effective conversion price per share was less than the fair value of the underlying common stock. As a result, the Company determined that there was a Beneficial Conversion Feature of $3,876,000. Because the Company's Series B Preferred Stock does not have a stated conversion date and was immediately convertible at the issuance date, the Company recorded a deemed dividend charge of $3,876,000 for the accretion of the discount on the Series B Preferred Stock.

Stock Dividend Attributable to Series C Perpetual Preferred Stock

The Company recorded a $56,000 stock dividend attributable to the Series C perpetual preferred stock in the nine months ended September 30, 2020. The Series C perpetual preferred shares are entitled to receive 10% cumulative stock dividends, to be payable in arrears on a monthly basis for 24 consecutive months. Dividends payable on the Series C perpetual preferred shares shall be payable through the Company’s issuance of Series C perpetual preferred share by delivering to each record holder the calculated number of payment-in-kind dividend shares.

Deemed Dividend Attributable to the Series 1 Warrant Modification

The Company recorded a deemed dividend of $252,000 in the nine months ended September 30, 2020 that resulted from the modification of the Series 1 Warrants in September 2019.

Deemed Dividend Attributable to Series 1, Series 2 and Bridge Warrant Holders

The Company recorded a deemed dividend of $856,000 in the nine months ended September 30, 2020 that resulted from the modification of the Series 1, Series 2 and Bridge Warrants in May 2020.

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Comparison of the Three Months Ended September 30, ~~2019~~2020 and ~~2018~~2019

The following table summarizes the Company’s results of operations with respect to the items set forth in such table for the three months ended September 30, ~~2019~~2020 and ~~2018~~2019 together with the change in such items in dollars and as a ~~percentage:~~percentage.


	Three Months Ended
	September 30,
	2019		2018		Variance		Variance %

									Three Months Ended
									September 30,
									2020		2019		Variance		Variance %
(in thousands)
Product revenue	$	972,779	$	1,132,067	$	(159,288)	(14.1)	%	$	2,773	$	973	$	1,800	185.0	%
Collaboration revenue		—		—		—	—	%
Total revenue		972,779		1,132,067		(159,288)	(14.1)	%		2,773		973		1,800	185.0	%
Operating Expenses
Operating expenses
Cost of product revenue		947,495		736,733		210,762	28.6	%		784		948		(164)	(17.3)	%
Research and development		1,307,296		1,481,166		(173,870)	(11.7)	%		1,522		1,307		215	16.4	%
Sales and marketing		1,698,440		2,716,752		(1,018,312)	(37.5)	%		1,529		1,698		(169)	(10.0)	%
General and administrative		3,106,633		2,703,628		403,005	14.9	%		4,313		3,107		1,206	38.8	%
Settlement of Tempesta Royalty License Agreement		640,000		—		640,000	100.0			—		640		(640)	(100.0)	%
Total operating expenses		7,699,864		7,638,279		61,585	0.8	%		8,148		7,700		448	5.8	%
Loss from operations		(6,727,085)		(6,506,212)		(220,873)	3.4	%		(5,375)		(6,727)		1,352	(20.1)	%
Interest expense, net		(1,352,845)		(872,044)		(480,801)	55.1	%
Other income (expense), net		28,784		9,540		19,244	201.7
Change in fair value of warrants, derivative liability and conversion option liability		841,834		26,231		815,603	3,109.3	%
Gain on Valeant settlement		—		1,204,133		(1,204,133)	(100.0)	%
Interest expense										(581)		(1,353)		772	(57.1)	%
Other income, net										194		29		165	569.0	%
Change in fair value of financial instruments										(2,104)		842		(2,946)	(349.9)	%
Loss on extinguishment of debt		(335,753)		—		(335,753)	(100.0)			—		(336)		336	(100.0)	%
Loss before income tax		(7,545,065)		(6,138,352)		(1,406,713)	22.9	%		(7,866)		(7,545)		(321)	4.3	%
Income tax expense		(10,000)		—		(10,000)	100	%		—		(10)		10	(100.0)	%
Net loss and comprehensive loss		(7,555,065)		(6,138,352)		(1,416,713)	23.1	%		(7,866)		(7,555)		(311)	4.1	%
Deemed dividend attributable to accretion of Series A redeemable convertible preferred stock										(349)		—		(349)	100	%
Deemed dividend attributable to Series B preferred stock		(3,875,778)		—		(3,875,778)	100	%		—		(3,876)		3,876	(100)	%
Stock dividend attributable to Series C perpetual preferred stock										(56)		—		(56)	100	%
Deemed dividend attributable to the Series 1 warrant modification		(252,106)		—		(252,106)	100	%		—		(252)		252	(100)	%
Net loss attributable to common shareholders	$	(11,682,949)	$	(6,138,352)		(5,544,597)	90.3	%	$	(8,271)	$	(11,683)		3,412	(29.2)	%

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Revenue

Sales and Allowances

Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced in order to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales in the three months ended September 30, ~~2019~~2020 and ~~2018~~2019 were as follows:


	Three Months Ended
	September 30,
	2019		2018		Variance		Variance %

									Three Months Ended
									September 30,
(in thousands)									2020		2019		Variance		Variance %
Gross product sales
Mytesi	$	1,897,417	$	1,592,801	$	304,616	19.1	%	$	6,303	$	1,897	$	4,406	232.3	%
Neonorm		15,699		24,630		(8,931)	(36.3)	%		13		16		(3)	(18.8)	%
Total gross product sales		1,913,116		1,617,431		295,685	18.3	%		6,316		1,913		4,403	230.2	%
Adjustment for product donations		(336,934)		—		(336,934)	100.0	%		—		(337)		337	(100.0)	%
Medicare rebates		(98,912)		(80,192)		(18,720)	23.3	%		(588)		(99)		(489)	493.9	%
Sales discounts - Mytesi		(318,394)		(262,927)		(55,467)	21.1	%
Sales returns - Mytesi		(30,999)		(42,403)		11,404	(26.9)	%
Wholesaler fee - Mytesi		(155,098)		(99,842)		(55,256)	55.3	%
Sales discounts										(2,218)		(318)		(1,900)	597.5	%
Sales returns										(107)		(31)		(76)	245.2	%
Wholesaler fees										(630)		(155)		(475)	306.5	%
Net product sales	$	972,779	$	1,132,067	$	(159,288)	(14.1)	%	$	2,773	$	973	$	1,800	185.0	%

Product Revenue

Our gross product revenues were ~~$1,913,116~~$6.3 million and ~~$1,617,431~~$1.9 million for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Neonorm Calf and Neonorm Foal.

Human

~~Gross sales~~Sales of Mytesi are recognized as revenue when the products are delivered to the wholesalers. Our gross revenues from the sale of Mytesi were ~~$1,897,417~~$6.3 million and ~~$1,592,801~~$1.9 million in the three months ended September 30, 2020 and 2019, ~~and 2018,~~ respectively. The increase in sales of Mytesi is due to ~~the more streamlined distribution and increased sales presence.~~

~~Out of period adjustment~~ - During the period ended September 30, 2019, the Company identified a prior period product donation incorrectly recorded as revenue. The adjustment, totaling $336,934 related to revenue and accounts receivable, was corrected within the current quarter. The impact of the adjustment was a reduction to net income of $336,934. This adjustment does not affect Mytesi revenue associated with salesan increase in the ~~three months ended September 30, 2019. Management has determined that this out of period correcting adjustment is not material~~wholesaler demand, mostly due to the ~~prior period consolidated financial statements and has therefore recorded it~~list price adjustment of Mytesi that occurred in ~~the three months ended September 30, 2019.~~April 2020.

Sales discounts were ~~$318,394~~$2.2 million and ~~$262,927~~$0.3 million for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively, an increase of ~~$55,467.~~$1.9 million. Sales discounts include discounts for prompt payments from customers and an estimated allowance for chargebacks on sales. Of the total ~~amount of~~ sales discounts, allowances for chargebacks were ~~$323,867~~$2.1 million and ~~$176,010~~$0.3 million for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. These allowances for chargebacks were approximately ~~21%~~33% and ~~11% of~~16% on Mytesi gross product sales for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. The increase in allowance is mostly due to the ~~transition~~increase in ~~distributors during 2019.~~list price of Mystesi.

Animal

~~We recognized~~Our Neonorm ~~gross~~product revenues ~~of $15,699~~were $13,000 and ~~$24,630~~$16,000 for the three months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. Focus on sales and marketing for Neonorm products had decreased during ~~2019.~~2020.

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Cost of Product Revenue


	Three Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
Cost of Product Revenue
Material cost	$	402	$	576	$	(174)	(30.2)	%
Direct labor		154		139		15	10.8	%
Distribution fees		193		252		(59)	(23.4)	%
Royalties		5		(115)		120	(104.3)	%
Other		30		96		(66)	(68.8)	%
Total	$	784	$	948	$	(164)	(17.3)	%

~~Comparison of the Three Months Ended September 30, 2019 and 2018~~

Three Months Ended

September 30,


2019

2018

Variance

Variance %

Cost of Product Revenue

Material cost

$
575,752

$
371,108

$
204,644

55.1
%
Direct labor

138,851

141,822

(2,971)

(2.1)
%
Distribution fees

251,507

128,182

123,325

96.2
%
Royalties

(114,564)

38,119

(152,683)

(400.5)
%
Other

95,949

57,502

38,447

66.9
%
Total

$
947,495

$
736,733

$
210,762

28.6
%

Cost of product revenue ~~increased $210,762~~decreased $164,000 from ~~$736,733~~$948,000 in the three months ended September 30, ~~2018~~2019 to ~~$947,495~~$784,000 for the same period in ~~2019.~~2020. The ~~increase~~decrease in cost of product revenue ~~quarter~~period over ~~quarter~~period was due to ~~increased sales~~non-recurring write-off of ~~Mytesi, including a~~non-conforming inventory and campaign batch cancellation ~~fee of $161,000,~~ fees ~~of $227,000 from the Company’s former distributor, and offset by the reversal of $189,000 of accrued royalties related to the termination of a royalty agreement.~~

~~Research and Development~~

~~Comparison of the Three Months Ended September 30, 2019 and 2018~~

Three Months Ended

September 30,


2019

2018

Variance

Variance %

Research and Development:









Personnel and related benefits

$
411,542

$
562,643

$
(151,101)

(26.9)
%
Materials expense and tree planting

29,782

47,271

(17,489)

(37.0)
%
Travel, other expenses

48,397

60,982

(12,585)

(20.6)
%
Clinical and contract manufacturing

273,188

209,886

63,302

30.2
%
Stock-based compensation

332,636

175,772

156,864

89.2
%
Other

211,751

424,612

(212,861)

(50.1)
%
Total

$
1,307,296

$
1,481,166

$
(173,870)

(11.7)
%

~~Research and development expense decreased $173,870 from $1,481,166~~ in the three months ended September 30, 2019.

Research and Development

The following table presents the components of research and development expense for the three months ended September 30, 2020 and 2019 together with the change in such components in dollars and as a percentage:


	Three Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
Research and Development:
Personnel and related benefits	$	458	$	412	$	46	11.2	%
Materials expense and tree planting		10		29		(19)	(65.5)	%
Travel, other expenses		1		48		(47)	(97.9)	%
Clinical and contract manufacturing		398		273		125	45.8	%
Stock-based compensation		175		333		(158)	(47.4)	%
Other		480		212		268	126.4	%
Total	$	1,522	$	1,307	$	215	16.4	%

Research and development expense increased $215,000 from $1,307,000 in the three months ended
September 30, 2019 to ~~$1,307,296~~$1,522,000 for the ~~same period in 2019 largely~~three months ended September 30, 2020 due primarily to:

●

Clinical and contract manufacturing expense increased ~~$63,302~~$125,000 from ~~$209,886~~$273,000 in the three months ended September 30, ~~2018~~2019 to ~~$273,188~~$398,000 in the same period in ~~2019~~2020 primarily due to an increase in contract manufacturing costs for enhanced manufacturing process ~~improvements the Company is developing to reduce the cost of revenue.~~

improvements.

●

~~Personnel and related benefits decreased $151,101 from $562,643 in the three months ended September 30, 2018 to $411,542 in the same period in 2019 due to changes in headcount and related salaries.~~

Stock-based compensation increased $156,864 from $175,772 in the three months ended September 30, 2018 to $332,636 in the same period in 2019 due to an increase in the volume of option grants to new and existing employees.

Other expenses, consisting primarily of consulting, formulation and regulatory fees, ~~decreased $212,861~~increased $268,000 from ~~$424,612~~$212,000 in the three months ended September 30, ~~2018~~2019 to ~~$211,751~~$480,000 in the same period in ~~2019.~~2020. Consulting expenses increased ~~by $28,715~~ due to an increase in clinical trial consultants, which is consistent with the increased activity in development of multiple follow‑

on indications for Mytesi. Direct R&D testing costs increased due to an increase in R&D work.

●

Stock-based compensation expense decreased $158,000 from $333,000 in the three months ended September 30, 2019 to $175,000 in the same period in 2020 due to higher prior year expense incurred for options granted with upfront vesting to existing employees

We expect research and development expense to increase due to the pivotal Phase 3 clinical trial for cancer-therapy related diarrhea that commenced in the third quarter of 2020.

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temporary termination of clinical trials and an increase in R&D testing consultant work, net of an increase in Napo consulting expense. Direct R&D testing costs decreased $328,930. Formulation expenses were relatively constant in the comparative periods. Regulatory expenses decreased by $13,960 due to the Company receiving a waiver of fee payment from the FDA. Formulation expenses were relatively constant in the comparative periods.

Sales and Marketing

~~Comparison~~The following table presents the components of sales and marketing expense for the ~~Three Months Ended~~three months ended September 30, 2020 and 2019 together with the change in such components in dollars and ~~2018~~

as a percentage:


	Three Months Ended
	September 30,
	2019		2018		Variance		Variance %

									Three Months Ended
									September 30,
(in thousands)									2020		2019		Variance		Variance %
Sales and Marketing:
Personnel and related benefits	$	1,002,044	$	1,312,164	$	(310,120)	(23.6)	%	$	812	$	1,002	$	(190)	(19.0)	%
Stock-based compensation		41,122		39,210		1,912	4.9	%		54		41		13	31.7	%
Direct marketing fees and expense		466,908		887,481		(420,573)	(47.4)	%		512		467		45	9.6	%
Other		188,366		477,897		(289,531)	(60.6)	%		151		188		(37)	(19.7)	%
Total	$	1,698,440	$	2,716,752	$	(1,018,312)	(37.5)	%	$	1,529	$	1,698	$	(169)	(10.0)	%

Sales and marketing expense decreased ~~$1,018,312~~$169,000 from ~~$2,716,752~~$1,698,000 in the three months ended
September 30, 2019 to $1,529,000 for the three months ended September 30, 2020. The components of S&M expense for the years ended are:

●

Personnel and related benefits decreased $190,000 from $1,002,000 in the three months ended
September 30, 2019 to $812,000 in the same period in 2020 due to sales force reduction and reduced travel as a result of the COVID-19 pandemic.

General and Administrative

The following table presents the components of general and administrative expense for the three months ended September 30, 2020 and 2019 together with the change in such components in dollars and as a percentage:


	Three Months Ended
	September 30,
(in thousands)	2020		2019		Variance		Variance %
General and Administrative:
Personnel and related benefits	$	452	$	474	$	(22)	(4.6)	%
Audit, tax and accounting services		127		181		(54)	(29.8)	%
Third-party consulting services		171		414		(243)	(58.7)	%
Legal services		497		181		316	174.6	%
Travel, other expenses		5		76		(71)	(93.4)	%
Stock-based compensation		446		736		(290)	(39.4)	%
Rent and lease expense		220		153		67	43.8	%
Public company expense		384		248		136	54.8	%
Other		2,011		644		1,367	212.3	%
Total	$	4,313	$	3,107	$	1,206	38.8	%

General and administrative expenses increased $1,206,000 from $3,107,000 in the three months ended September 30, ~~2018~~2019 to ~~$1,698,440 in~~$4,313,000 for the same period in ~~2019 largely~~2020 primarily due to increases in legal services, public company expense, and other expenses, partially offset by a decrease in ~~marketing programs~~third-party consulting services and ~~advertising costs for Mytesi.~~stock-based compensation:

●

~~Direct marketing and sales expense decreased $420,573~~Legal services increased $316,000 from ~~$887,481~~$181,000 in the three months ended September 30, ~~2018~~2019 to ~~$466,908 for~~$497,000 in the same period in ~~2019~~2020 primarily due to a $93,000 increase in fees related to addressing a congressional inquiry, $81,000 increase in fees related to timing of patent license fees, $217,000 increase in public company and financing related legal services, partially offset by $57,000 decrease in ~~marketing programs for Mytesi.~~

fees related to legal proceedings.

Table of Contents

●

~~Personnel and related benefits decreased $310,120~~Public company expense increased $136,000 from ~~$1,312,164~~$248,000 in the three months ended September 30, ~~2018~~2019 to ~~$1,002,044 in the same period in 2019 due to the reduction of our sales headcount in support of Mytesi.~~

~~Other expenses decreased $289,531 from $477,897~~$384,000 in the three months ended September 30, ~~2018~~2020 due to ~~$188,366~~increased spend on communication and public affairs.

●

Other general and administrative expenses increased $1,367,000 from $644,000 for the three months ended September 30, 2019 to $2,011,000 in the same period in ~~2019~~2020 largely due to ~~a decrease~~$1,015,000 charge for Atlas trial delay penalty, $27,000 increase of ~~$216,495 in marketing consulting.~~

Delaware state taxes, and $142,000 increase of D&O liability insurance.

~~General and Administrative~~

~~Comparison of the Three Months Ended September 30, 2019 and 2018~~

Three Months Ended

September 30,


2019

2018

Variance

Variance %

General and Administrative:









Personnel and related benefits

$
473,645

$
442,870

$
30,775

6.9
%
Accounting fees

181,012

68,082

112,930

165.9
%
Third-party consulting fees

413,988

409,678

4,310

1.1
%
Legal fees

181,295

306,259

(124,964)

(40.8)
%
Travel

75,484

59,575

15,909

26.7
%
Stock-based compensation

736,351

465,112

271,239

58.3
%
Rent and lease expense

152,741

125,936

26,805

21.3
%
Public company expenses

248,185

122,503

125,682

102.6
%
Other

643,932

703,613

(59,681)

(8.5)
%
Total

$
3,106,633

$
2,703,628

$
403,005

14.9
%

~~Table of Contents~~

~~General and administrative expenses increased $403,005 from $2,703,628 in the three months ended September 30, 2018 to $3,106,633 for the same period in 2019,~~

●

~~Accounting fees increased $112,930~~Third-party consulting services decreased $243,000 from ~~$68,082~~$414,000 in the three months ended September 30, ~~2018~~2019 to ~~$181,012~~$171,000 in the same period in ~~2019 mostly~~2020, due to the ~~change~~switch to fulltime employees instead of consultants in the ~~timing of fees billings.~~

Finance department.

●

~~Legal fees~~Stock-based compensation expense decreased ~~$124,964~~$290,000 from ~~$306,259~~$736,000 in the three months ended September 30, ~~2018~~2019 to ~~$181,295~~$446,000 in the same period in ~~2019 mostly~~2020 due to ~~a decrease in patent legal fees.~~

higher prior year expense incurred for options granted with upfront vesting to existing employees.

Stock-based compensation expense increased $271,239 from $465,112 in the three months ended September 30, 2018 to $736,351 in the same period in 2019 due to an increase in the volume of option grants to new and existing employees.

~~Public company expenses increased $125,682 from $122,503 in the three months ended September 30, 2018 to $248,185 in the same period in 2019 mostly due to $157,445 increase in D&O liability insurance.~~

~~Other general and administrative expenses decreased $59,681 from $703,613 in three months ended September 30, 2018 to $643,932 in the same period in 2019 largely due to personnel recruiting fees.~~

In the near term, we expect general and administrative expense to remain the same as we ~~consolidate sales territories and simultaneously~~ focus on ~~our pipeline development.~~other areas of operations. This will include ~~growing~~efforts to grow the business without adding headcount or increasing facilities.

Settlement of Tempesta Royalty License Agreement

~~Comparison of the Three Months Ended September 30, 2019 and 2018~~

Three Months Ended

September 30,


2019

2018

Variance

Variance %

Settlement of Tempesta Royalty License Agreement

640,000

—

640,000

100
%
Total

$
640,000

$
—

$
640,000

100
%

A royalty license agreement settlement liability ~~increased~~decreased $640,000 from ~~zero~~$640,000 in the three months ended September 30, ~~2018~~2019 to ~~$640,000~~zero in the same period in ~~2019.~~ 2020. In October 2019, the Company and Tempesta settled the dispute, pursuant to which Tempesta received $50,000 in cash, an unsecured promissory note issued by the Company in the aggregate principal amount of $550,000 and 40,000 shares of the Company’s common stock in exchange for the cessation of all royalty payments by Napo to Dr. Tempesta under the License ~~Agreements (see Note 14).~~Agreements.

~~Deemed Dividends~~Interest Expense

~~Comparison of the Three Months Ended September 30, 2019 and 2018~~

Three Months Ended

September 30,


2019

2018

Variance

Variance %

Deemed dividend attributable to Series B preferred stock

$
(3,875,778)

$
—

$
(3,875,778)

100
%
Deemed dividend attributable to the Series 1 warrant modification

(252,106)

—

(252,106)

100
%
Total

$
(4,127,884)

$
—

$
(4,127,884)

100
%

~~Deemed dividends increased $4,127,884~~Interest expense decreased $772,000 from ~~zero~~$1,353,000 in the three months ended September 30, ~~2018~~2019 to ~~$4,127,884 in~~$581,000 for the same period in ~~2019~~2020 primarily due to interest expense incurred on the March 2019 Bridge Notes and interest expense incurred on warrants issued concurrently.

Change in Fair Value of Financial Instruments

Change in fair value of financial instruments losses increased $2,946,000 from a gain of $842,000 in the three months ended September 30, 2019 to a loss of $2,104,000 for the same period in 2020 primarily due to losses incurred on the change in fair value of liability classified warrants.

Loss on Extinguishment of Debt

Loss on extinguishment of debt decreased from $336,000 in the three months ended September 30, 2019 to zero for the same period in 2020 is due to the following:

●

$336,000 extinguishment loss from paying off twenty-one Bridge Notes prior to maturity.

Deemed Dividend Attributable to Accretion of Series A Redeemable Convertible Preferred Stock

The Company recorded a deemed dividend charge of ~~$3,875,778~~$349,000 in the three months ended September 30, 2020 for the accretion of the ~~discount~~redemption amount and carrying value of the Series A convertible preferred stock.

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Deemed Dividend Attributable to Series B Preferred Stock

Stock ~~issued~~Dividend Attributable to Series C Perpetual Preferred Stock

The Company recorded a $56,000 stock dividend attributable to the Series C perpetual preferred stock in the three months ended September 30, 2020. The Series C perpetual preferred shares are entitled to receive 10% cumulative stock dividends, to be payable in arrears on ~~July 23, 2019, and~~a monthly basis for 24 consecutive months. Dividends payable on the Series C perpetual preferred shares shall be payable through the Company’s issuance of Series C perpetual preferred share by delivering to each record holder the calculated number of payment-in-kind dividend shares.

Deemed Dividend Attributable to the Series 1 Warrant Modification

The Company recorded a deemed dividend ~~charge~~ of ~~$252,106~~$252,000 in the three months ended September 30, 2020 that resulted from the modification of the Series 1 Warrants in September 2019.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred net losses since our inception. For the ~~three~~nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, we had net losses of ~~$7.6~~$25.0 million and ~~$6.1 million, respectively, and for the nine months ended September 30, 2019 and 2018, we had net losses of~~ $32.6 ~~million and $19.5~~ million, respectively. We expect to incur additional losses in the near-term future. At September 30, ~~2019~~2020, we had an accumulated deficit of ~~$127.1~~$158.1 million. To date, we have generated only limited revenue, and we may never achieve revenue sufficient to offset our expenses.

We had cash of ~~$2.1~~$1.3 million as of September 30, ~~2019.~~ 2020. We do not believe our current capital is sufficient to fund our operating plan through one year from the issuance of these unaudited condensed consolidated financial statements. Our independent registered public accounting firm has included an explanatory paragraph in its audit report included in our Annual Report on Form ~~10‑K~~10-K for the year ended December 31, ~~2018~~2019 regarding our assessment of substantial doubt about our ability to continue as a going concern. Our unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty.

We have funded our operations primarily through the issuance of equity and debt financing, in addition to sales of our commercial products. Our funding activities in the nine months ended September 30, ~~2019~~2020 were as follows:

●

~~Between January~~On February 24, 2020, the Company entered into a warrant exercise agreement with a holder of Series 1 Warrants previously issued in the Company’s registered public offering on July 23, 2019 and ~~April~~its warrants previously issued in private placements in March through June of 2019 ~~we issued 76,190 and 4,843~~(“Bridge Warrants”), pursuant to which the Holder agreed to exercise in cash its warrants to purchase an aggregate of 458,022 shares of ~~our~~the Company’s common stock, ~~via equity lines~~par value $0.0001 per share, at a reduced exercise price of ~~credit with Oasis Capital. A further 114,286 shares~~$0.692 per share, which is the Minimum Price (as defined under Nasdaq Listing Rule 5635(d)) as of ~~common stock were issued~~the date of such Exercise Agreement, for gross proceeds to ~~Oasis Capital via an option to increase this equity line~~the Company of ~~credit. In all, 195,319 common shares were issued for total proceeds were $2.6 million.~~

approximately $317,000.

●

~~Between January and June 2019, we~~On March 4, 2020, entered into ~~exchange agreements~~a royalty interest purchase agreement with Iliad Research and Trading, L.P., a Utah limited partnership affiliated with Chicago Venture Partners, ~~L.P.,~~ pursuant to which ~~we issued~~the Company sold a royalty interest entitling Purchaser to ~~CVP 395,970 shares~~receive $500,000 of ~~common stock, with a fair value~~future royalties on sales of ~~$8.2 million, in exchange~~Mytesi and certain up-front license fees and milestone payments from licensees and/or distributors for ~~a reduction~~an aggregate purchase price of ~~approximately $5.8 million in the principal amount of the CVP Promissory Notes and $2.4 million in accrued interest thereon.~~

$350,000.

Between March and June 2019, we entered into securities purchase agreement with selected investors, pursuant to which we issued $5.1 million in short-term promissory notes (the Bridge Notes). We settled these short-term promissory notes and interest accrued thereon in July 2019.

In March 2019, we entered into a securities purchase agreement with Oasis Capital, whereby we issued in a registered direct public offering 19,019 shares to Oasis Capital for gross proceeds of approximately $0.3 million.

~~In March 2019, we issued 19,752 shares of our common stock in lieu of a cash payment of $0.4 million in interest expense on the Napo convertible notes payable.~~

Between May and July 2019, we entered into exchange agreements with Chicago Venture Partners L.P., pursuant to which we issued to CVP 1,119,440 shares of common stock with a fair value of $6.7 million, in exchange for a reduction of approximately $6.2 million in the principal amount of CVP Exchange Note 1 and $0.1 million in accrued interest thereon.

In July 2019, we entered into an underwriting agreement, relating to a public offering, in which we sold 2,886,500 shares of common stock, 10,787 shares of Series B convertible preferred stock, Series 1 warrants to purchase 8,280,000 shares of common stock and Series 2 warrants to purchase 8,280,000

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●

On March 5, 2020, the Company entered into a warrant exercise agreement with a holder of Series 2 Warrants previously issued in registered public offering on July 23, 2019, pursuant to which the Holder agreed to exercise in cash its warrants to purchase an aggregate of 90,940 shares of the Company’s common stock, par value $0.0001 per share, at a reduced exercise price of $0.605 per share, which is the Minimum Price (as defined under Nasdaq Listing Rule 5635(d)) as of the date of such Exercise Agreement, for gross proceeds to the Company of approximately $55,000.

●

On March 23, 2020, the Company entered into a Private Investment in Public Equity (“PIPE”) with certain investors, pursuant to which the Company agreed to issue and sell to the Investors in a private placement an aggregate of 1,714,283 unregistered shares for an aggregate purchase price of approximately $719,000.

●

On March 24, 2020, Jaguar and Ionic Ventures LLC (“Ionic”) entered into a Warrant Exercise and Preferred Stock Amendment Agreement with a holder of Series 2 Warrants previously issued in the Company’s registered public offering on July 23, 2019, pursuant to which the Holder agreed to exercise in cash its warrants to purchase an aggregate of 1,250,000 shares of common stock, at a reduced exercise price of $0.5227 per share, which is a 20% premium to the Minimum Price (as defined under Nasdaq Listing Rule 5635(d)) as of the date of such Amendment Agreement, for gross proceeds of approximately $653,000. As further inducement to enter into the Amendment Agreement, the Company agreed to reduce the conversion price of the Company’s Series B convertible preferred stock from $2.00 to $0.4456, which is equal to the Minimum Price plus $0.01.

●

On May 12, 2020, the Company entered into an accounts receivable purchase agreement (“Purchase Agreement”) with Oasis Capital, pursuant to which Oasis Capital may from time to time in its discretion purchase accounts receivable of the Company on a recourse basis at a purchase price equal to 37.5% of the face amount of each of the purchased accounts. Under the terms of the Purchase Agreement, Oasis Capital initially purchased certain accounts receivable with a face amount of $2,754,000 for a purchase price of $1,032,000.

●

On May 22, 2020, the Company entered into warrant exercise inducement offer letters with certain holders of Series 1 Warrants, Series 2 Warrants, and Bridge Warrants (“Exercising Holders”) pursuant to which such holders agreed to exercise for cash Series 1 Warrants to purchase 4,572,040 shares of common stock, Series 2 Warrants to purchase 4,005,062 shares of common stock, and Bridge Warrants to purchase 93,750 shares of common stock in exchange for the Company’s agreement to issue new Series 3 Warrants to purchase up to 8,670,852 shares of common stock (“Series 3 Warrants”) to such holders as an inducement for the exercise of the Series 1 Warrants, Series 2 Warrants and Bridge Warrants by such holders ( “Warrant Exercise Transaction”). The Company received aggregate gross proceeds of $4.25 million from the exercise of the Original Warrants and the Bridge Warrants by such holders.

●

On June 29, 2020, the Company entered into an amendment to the accounts receivable purchase agreement with Oasis Capital pursuant to which Oasis Capital purchased certain accounts receivable with a face amount of $2,859,000 for a purchase price of $1,215,000.

●

In July and August 2020, the Company received proceeds of $566,000 from holders of Series 1 Warrants, Series 2 Warrants, and Bridge Warrants who exercised warrants to purchase 1,154,266 shares of common stock. ~~We received total gross proceeds from~~

●

On August 13, 2020, the ~~offering was $16.6 million, or $14.0 million net~~Company entered into an amendment to the accounts receivable purchase agreement with Oasis Capital pursuant to which Oasis Capital purchased certain accounts receivable with a face amount of ~~issuance and other costs~~$3,153,000 for a purchase price of ~~$2.6 million.~~

$1,335,000.

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●

On September 9, 2020, the Company entered into an amendment to the accounts receivable purchase agreement with Oasis Capital pursuant to which Oasis Capital purchased certain accounts receivable with a face amount of $2,330,000 for a purchase price of $985,000.

We expect our expenditures will continue to increase as we continue our efforts to develop our products and continue development of our pipeline in the near term. We do not believe our current capital is sufficient to fund our operating plan through one year from the issuance of these unaudited condensed consolidated financial statements. We will need to seek additional funds through public or private equity or debt financings or other sources, such as strategic collaborations. Such financing may result in dilution to stockholders, imposition of debt covenants and repayment obligations or other restrictions that may affect our business. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. We may also not be successful in entering into partnerships that include payment of upfront licensing fees for our products and product candidates for markets outside the United States, where appropriate. If we do not generate upfront fees from any anticipated arrangements, it would have a negative effect on our operating plan. We plan to finance our operations and capital funding needs through equity and/or debt financing as well as revenue from future product sales. However, there can be no assurance that additional funding will be available to us on acceptable terms on a timely basis, if at all, or that we will generate sufficient cash from operations to adequately fund operating needs or ultimately achieve profitability. If we are unable to obtain an adequate level of financing needed for the long-term development and commercialization of our products, we will need to curtail planned activities and reduce costs. Doing so will likely have an adverse effect on our ability to execute on our business plan. These matters raise substantial doubt about the ability of the Company to continue in existence as a going concern within one year after issuance date of the unaudited condensed consolidated financial statements.

Cash Flows for the Nine Months Ended September 30, ~~2019~~2020 Compared to the Nine Months Ended
September 30, ~~2018~~2019

The following table shows a summary of cash flows for the nine months ended September 30, ~~2019~~2020 and ~~2018:~~2019:


	September 30,
	2019		2018

					Nine Months Ended September 30,
(in thousands)					2020		2019
Total cash used in operating activities	$	(17,317,513)	$	(17,828,754)	$	(11,217)	$	(17,317)
Total cash used in investing activities		—		(6,527)		(7)		—
Total cash provided by financing activities		16,818,856		17,801,543		8,690		16,819
Net increase (decrease) in cash	$	(498,657)	$	(33,738)
Net decrease in cash					$	(2,534)	$	(498)

Cash Used in Operating Activities

During the nine months ended September 30, 2020, net cash used in operating activities of $11,217,000 resulted from our net loss of $25,040,000 adjusted by an increase in fair value of financial instruments of $2,491,000, expense on modifications of warrants of $86,000, depreciation and amortization expenses of $1,296,000, amortization of debt discounts and debt issuance costs of $693,000, stock-based compensation of $2,184,000, other stock payments of $1,025,000, amortization of operating lease right-of-use assets of $553,000, inducement charge of $1,647,000 on the modification of Series B convertible preferred shares, $3,696,000 charge for Series 3 Warrants issued as an inducement to exercise equity-classified Series 1, Series 2 and Bridge warrants, loss on assignment of receivables of $30,000, and changes in operating assets and liabilities of $122,000.

During the nine months ended September 30, 2019, net cash used in operating activities of ~~$17,317,513~~$17,317,000 resulted from our net loss of ~~$32,580,053~~$32,580,000 adjusted for an impairment charge of $4,000,000 associated with our indefinite-lived intangible assets, reduction in the fair value of warrants, conversion option and derivative liability of ~~$1,002,865,~~$1,003,000, amortization of debt discounts and debt issuance costs of ~~$5,032,214,~~$5,032,000, stock-based compensation of ~~$1,982,985,~~$1,983,000, depreciation and amortization expenses of ~~$1,304,946,~~$1,305,000, amortization of operating lease right-of-use assets of ~~$554,017,~~$554,000, loss on the extinguishment of debt of ~~$4,940,911~~$4,941,000 and of changes in operating assets and liabilities of ~~$1,549,668.~~ $1,549,000.

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Cash Used in Investing Activities

During the nine months ended September 30, ~~2018,~~2020, cash used in ~~operating~~investing activities of $17,828,754 resulted from our net loss of $19,492,172, adjusted by non-cash accretion of end of term payment, debt discounts and debt issuance costs of $1,461,133, stock-based compensation of $1,416,791, reduction in the fair value of warrants, conversion option and derivative liability of $178,461, common stock issued in exchange for services rendered of $6,425, depreciation and amortization expenses of $989,116, interest paid on the conversion of debt to equity of $21,275, net of changes in operating assets and liabilities of $2,052,861.

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~~Cash Used in Investing Activities~~

was $7,000. During the nine months ended September 30, 2019 no cash was used in investing activities. ~~During the nine months ended September 30, 2018, cash used in investing activities was $6,527 and consisted of cash used to purchase property and equipment.~~

Cash Provided by Financing Activities

During the nine months ended September 30, 2020, net cash provided by financing activities of $8,690,000 consisted of $668,000 in net proceeds received from 1,714,283 shares of common stock issued via a PIPE financing, $350,000 in net proceeds received from issuance of a note payable, $776,000 in insurance premium financings, $4,542,000 received from borrowings secured by the Company’s trade receivables, $5,676,000 in net proceeds received from 12,356,395 shares of common stock issued on exercise of Series 1, Series 2, and 2019 Bridge Note warrants, and $10,000 in net proceeds received from issuance of other shares of common stock, offset by $3,140,000 in principal payments of the note payable and secured borrowings, $185,000 in issuance costs from shares issued as part of the underwriter settlement agreement, and $7,000 other payments of issuance costs.

During the nine months ended September 30, 2019, net cash provided by financing activities of ~~$16,818,856~~$16,819,000 consisted of ~~$2,602,896~~$2,603,000 in net proceeds received from 195,319 shares of common stock issued to Oasis Capital via an option to increase the equity line of credit, ~~$266,266~~$266,000 in net proceeds received from 19,019 shares issued in a registered direct public offering to Oasis Capital, ~~$14,049,694~~$14,050,000 in net proceeds received from the July 2019 public offering, offset by $100,000 in repayments of notes payable.

During the nine months ended September 30, 2018, cash provided by financing activities of $17,801,543 primarily consisted of $1,305,774 and $750,100 received in separate PIPE (“Private Investment in Public Entity”) financings, $14,000,002 million in net proceeds from the Sagard financing, including $5,624,867 in net proceeds received from the issuance of common stock and $9,000,002 in net proceeds received from the issuance of convertible preferred stock, $2,310,000 received in the issuance of non-convertible debt, and $500,000 received in the issuance of convertible debt, offset by $1,689,200 in principal payments of our long-term debt.

JOBS Act

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

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Item 4. Controls and Procedures

Disclosure Controls and Procedures

Our management, Chief Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, ~~2019.~~2020. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit 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 us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of September 30, ~~2019.~~2020. This conclusion was based on the material ~~weakness~~weaknesses in our internal control over financial reporting as further described below.

Material ~~Weakness~~Weaknesses

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated

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financial statements will not be prevented or detected and corrected on a timely basis.

In connection with ~~our~~the preparation of our annual financial statements for the year ended December 31, ~~2018,~~2019, we identified a material weakness in our internal control over financial reporting related to staff turnover in our accounting department. We did not maintain a sufficient complement of internal personnel with appropriate knowledge, experience and/or training commensurate with our financial reporting requirements. We relied on outside consulting technical experts and did not maintain adequate internal qualified personnel to properly supervise and review the information provided by the outside consulting technical experts to ensure certain significant complex transactions and technical matters were properly accounted ~~for, specifically with respect to accurately reflecting all potential accrued services on the balance sheet at December 31, 2018.~~for. In addition, we identified inadequate internal technical staffing levels and expertise to properly supervise and review the information of the outside consulting technical experts to properly apply ASC 815-40 for liability classification of certain warrants and ASC 470-50 and ASC 470-60 to properly reflect the accounting impact to multiple modifications of the Company’s debt instruments. We did not have ~~concluded that~~adequate policies and procedures in place to ensure the timely, effective review of assumptions used in measuring the fair value of certain financial instruments. We did not have adequate policies and procedures in place to ensure the timely, effective review of

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compliance with contractual covenants in certain financial instruments. This material weakness has not been remediated as of September 30, 2020.

In connection with preparation of our interim financial statements for the three months ended September 30, 2020, we ~~must implement new or improved controls~~identified a material weakness in our internal control over financial reporting related to our financial statement ~~close process~~preparation and ~~policies in reviewing information received from our outside consulting technical experts.~~review process. The primary factors contributing to the material weaknesses were as follows:

●

We did not have adequate policies and procedures in place to ensure the timely and effective preparation and review of the financial statements.

●

We did not have sufficient resources with appropriate knowledge, experience and/or training commensurate with our financial reporting requirements to assist us in our timely and efficient preparation and review over our financial reporting.

Remediation Efforts to Address Material ~~Weakness~~Weaknesses

We have prepared a preliminary remediation plan to address the underlying causes of the material ~~weakness~~weaknesses described above. The preliminary remediation plan includes:

●

Reassessing the design and operation of internal controls over financial reporting ~~including interim and annual accruals cutoff procedures~~ and review procedures ~~related~~over the preparation of our financial statements:

●

Hiring and training of permanent accounting personnel or using consultants to provide support during our quarterly and annual preparation, review, and reporting of our financial statements.

●

Maintain adequate internal qualified personnel to properly supervise and review the information ~~received from our~~provided by the outside consulting technical ~~experts;~~

~~We hired two senior level permanent accounting personnel and trained~~experts to ~~further educate the existing staff on the accounting of~~ensure certain significant complex transactions and technical ~~accounting matters;~~

matters were properly accounted for.

~~Continue to reassess the staffing level and implement process improvements to ensure that our remediation plan is successful.~~

We cannot assure you that the measures we may take in response to ~~this~~these material ~~weakness~~weaknesses will be sufficient to remediate such material ~~weakness~~weaknesses or to avoid potential future material weaknesses.

Internal Control over Financial Reporting

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form ~~10‑Q,~~10-Q, our Chief Executive Officer and Principal Financial and Accounting Officer have concluded that, as of such date, our disclosure controls and procedures were not effective due to the existence of a material ~~weakness~~weaknesses in the design of our internal controls over financial reporting relating (i) to staff turnover in our accounting ~~department.~~department, and (ii) to inadequate policies and procedures in place to ensure the timely and effective preparation and review of the financial statements.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected inon a timely basis. We plan to enhance existing controls and design and implement new controls applicable to staff, to ensure that our staff is accurately trained to properly understand and review financial transactions. We plan to devote significant time and attention to remediate the above material ~~weakness~~weaknesses as soon as reasonably possible. As we continue to evaluate our controls, we will make the necessary changes to improve the overall design and operation of our controls. We believe these actions will be sufficient to remediate the identified material ~~weakness~~weaknesses and strengthen our internal control over financial reporting; however, there can be no guarantee that such remediation will be sufficient. We will continue to monitor the effectiveness of our controls and will make any further changes management determines appropriate.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form ~~10‑Q~~10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. — OTHER INFORMATION

Item 1. Legal ~~Proceedings.~~Proceedings

July 2017 Complaint Relating to the Merger

On July 20, 2017, a putative class action complaint was filed in the United States District Court, Northern District of California, Civil Action No. 3:~~17‑cv‑~~17 cv 04102, by Tony Plant (the “Plaintiff”) on behalf of shareholders of the Company who held shares on April 12, 2017 and were entitled to vote at the 2017 Special Shareholders Meeting, against the Company and certain individuals who were directors as of the date of the vote (collectively, the “Defendants”), in a matter captioned Tony Plant v. Jaguar Animal Health, Inc., et al., making claims arising under Section 14(a) and Section 20(a) of the Exchange Act and Rule ~~14a‑~~14a 9, 17 C.F.R. § ~~240.14a‑~~240.14a 9, promulgated thereunder by the SEC. The claims alleged false and misleading information provided to investors in the Joint Proxy Statement/Prospectus on Form ~~S‑4~~S-4 (File No. ~~333‑~~333 217364) declared effective by the Commission on July 6, 2017 related to the solicitation of votes from shareholders to approve the merger and certain transactions related thereto. The Company accepted service of the complaint and summons on behalf of itself and the United States-based director Defendants on November 1, 2017. The Company has not accepted service on behalf of, and Plaintiff has not yet served, the non-U.S.-based director Defendants.

On October 3, 2017, Plaintiff filed a motion seeking appointment as lead plaintiff and appointment of Monteverde & Associates PC as lead counsel. That motion was granted. Plaintiff filed an amended complaint against the Company and the United States-based director Defendants on January 10, 2018. The Defendants filed a motion to dismiss on March 12, 2018, for which oral arguments were held on June 14, 2018. The court dismissed the amended complaint on September 20, ~~2018 but gave~~2018. Plaintiff ~~leave~~was entitled to amend ~~the~~that complaint within 20 days from the date of dismissal. On October 10, 2018, Plaintiff filed a second amended ~~the~~ complaint to focus on the Company’s commercial strategy in support of Equilevia and the related disclosure statements in the Form S-4 described above. On November 6, 2018, the Defendants moved to dismiss the second amended complaint. The Defendants argued in their motion that the second amended complaint ~~fails~~failed to state a claim upon which relief can be granted because the omissions and misrepresentations alleged in the complaint ~~are~~were immaterial as a matter of law. The court denied the Defendants’ motion to dismiss on June 28, 2019. The ~~Defendants~~Company answered the second amended complaint on August 2, ~~2019. Discovery~~2019; the answer denied the material allegations of the second amended complaint.

May 2020 Letter from the Committee on Oversight and Reform of the U.S. House of Representatives

On May 4, 2020, Jaguar Health, Inc. received a letter from the Committee on Oversight and Reform of the U.S. House of Representatives (the “Committee”) regarding the list price adjustment of Mytesi. Among other things, the Committee expressed an interest in ~~this matter~~understanding whether the price adjustment was connected to the Company’s expectation that it could market crofelemer to treat coronavirus patients given the Company’s submission of a request to the U.S. Food and ~~to establish~~Drug Administration for Emergency Use Authorization (“EUA”) for crofelemer for the ~~damages he asserts, then an adverse ruling could~~symptomatic

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relief of diarrhea and other gastrointestinal symptoms in patients with COVID-19 and for patients with COVID-19 who have ~~a material impact~~diarrhea associated with certain antiviral treatments, which submission was denied by the FDA on ~~the Company.~~April 7 as previously disclosed.

The Company ~~believes~~intends to cooperate with the Committee’s inquiry and has prepared a public statement regarding the price adjustment, which is available on the Company’s website at https://jaguarhealth.gcs-web.com/company-statement. In its statement, the Company explains that the decision to adjust the price for crofelemer was made in December 2019 as part of expanding the Company’s comprehensive patient access program, and had the Company received EUA, it ~~is not probable that an asset has been impaired or a liability has been incurred as of~~would have deferred the ~~date of~~price adjustment until after the ~~financial statements and the amount of any potential loss is not reasonably estimable.~~emergency use period ended.

Item 1A. Risk Factors

The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes, before making a decision to invest in our common stock. The risks and uncertainties described below are not the only ones we face. Additional risk and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. If any of the events or circumstances described in the following risk factors actually occur, our business, operating results, financial condition, cash flows, and prospects could be materially and adversely affected. In that event, the market price of our common stock could decline, and you could lose part or all of your investment.

The business, financial condition and operating results of the Company can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause the Company’s actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect the Company’s business, financial condition, operating results, and stock price.

Because of the following factors, as well as other factors affecting the Company’s financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.

The novel coronavirus global pandemic could adversely impact our business, including our supply chain, clinical trials and commercialization of Mytesi.

We are subject to risks and uncertainties as a result of the current COVID-19 pandemic. The COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting our employees, communities and business operations, as well as the U.S. economy and other economies worldwide. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including the duration and severity of the pandemic and the extent and severity of the impact on our customers, new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets.

To date, we have been able to continue the supply of Mytesi to our customer. However, we are dependent on our manufacturing and logistics partners and consequently, disruptions in operations of our partners and customer may affect our ability to supply Mytesi. Furthermore, our ability and that of our third-party contract research organizations (“CRO”) to provide future research and development ("R&D") services will continue to be disrupted as a result of local shelter-in-place orders and any disruptions or delays in operations with whom we collaborate. We are unable to fully

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determine and quantify the extent to which delays in our R&D projects will be affected by the COVID-19 pandemic. We are continuing to assess the potential impact of the COVID-19 pandemic on our business and operations, including our product sales, expenses, and manufacturing.

In the U.S., the impact of COVID-19, including governmental orders governing the operation of non-essential businesses during the pandemic, has caused the temporary closure of our office and halted visits of our salesforce to clinics and healthcare providers. Our employees have been working from home since mid-March 2020, while ensuring essential staffing levels in our operations remain in place.

Our future results of operations and liquidity could be adversely impacted by delays in supply chain disruptions and uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges faced by our customer. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact our financial condition, liquidity, or results of operations is uncertain.

Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches.

Similar to other companies in our industry, we face substantial cybersecurity risk. Despite the implementation of security measures, our internal computer systems and those of our current and future CROs and other contractors, collaborators and consultants may fail and are vulnerable to damage from computer viruses and unauthorized access. While we have not, to our knowledge, experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties for the manufacture of our product candidates, to analyze clinical trial samples and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.

Substantially all of our revenue for recent periods has been received from a single customer.

Substantially all of our revenue has been derived from one customer. Except for the shelter-in-place mandate, we have not been made aware by our customer if they have experienced other issues arising due to COVID-19 that may materially impact our financial condition, liquidity or results of operations. We will continue to have dialogues with our customer.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Other than equity securities issued in transactions disclosed on our Current ~~Report~~Reports on Form ~~8-K/A~~8-K filed with the SEC on ~~July 12, 2019,~~September 2, 2020 and September 28, 2020, there were no unregistered sales of equity securities during the ~~period~~.period.

Item 3. Defaults upon senior securities

None.

Item 4. Mine safety disclosures

Not applicable.

Item 5. Other Information

~~Departure of Directors or Certain Officers~~

On August 9, 2019, Karen Wright resigned her position as Chief Financial Officer and Treasurer of the Company. On August 13, 2019, the board of directors of the Company appointed Carol R. Lizak to serve as the Company’s principal financial and accounting officer.

None.

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Item 6. Exhibits


Exhibit No.		Description
~~Exhibit No.~~3.1		~~Description~~
~~3.1~~		Third Amended and Restated Certificate of Incorporation of Jaguar Health, Inc. (f/k/a Jaguar Animal Health, Inc.) (incorporated by reference to Exhibit 3.1 to the Current Report on Form ~~8‑K~~8-K (No. ~~001‑36714)~~001-36714) filed on August 1, 2017).
3.2		Certificate of Second Amendment of the Third Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Form ~~8‑K~~8-K of Jaguar Health, Inc. filed June 1, 2018, File No. ~~001‑36714)~~001-36714).
3.3		Certificate of Third Amendment of the Third Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Form ~~8‑K~~8-K of Jaguar Health, Inc. filed June 1, 2018, File No. ~~001‑36714)~~001-36714).
3.4		Certificate of Designation of Preferences, Rights, and Limitations of Series BB-2 Preferred Stock (incorporated by reference to Exhibit 3.1 to the Form 8-K of Jaguar Health, Inc. filed ~~July 23,~~December 26, 2019, File No. 001-36714).
~~4.1~~ 3.5		~~Specimen Common Stock~~ Certificate of ~~Jaguar Health, Inc.~~Designation of Preferences, Rights and Limitations of Series C Perpetual Preferred Stock (incorporated by reference to Exhibit ~~4.1~~3.1 to the Form ~~8‑K~~8-K of Jaguar Health, Inc. filed ~~June 1, 2018,~~September 2, 2020, File No. ~~001‑36714)~~001-36714).
~~4.2~~ 3.6		~~Secured Promissory Note,~~Certificate of Designation of Preferences, Rights and Limitations of Series D Perpetual Preferred Stock (incorporated by reference to Exhibit 3.2 to the Form 8-K of Jaguar Health, Inc. filed September 2, 2020, File No. 001-36714).
3.7		Certificate of Retirement of Series A Convertible Participating Preferred Stock, Series B Convertible Preferred Stock and Series B-1 Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Form 8-K of Jaguar Health, Inc. filed September 9, 2020, File No. 001-36714).
4.1		Global Amendment, dated ~~May 28, 2019,~~September 1, 2020, by and among Jaguar Health, Inc., Napo Pharmaceuticals, Inc. and Chicago Venture Partners, L.P. (incorporated by reference to Exhibit 4.1 to the Form ~~8‑K~~8-K of Jaguar Health ~~Inc.~~ filed ~~June 3, 2019,~~September 2, 2020, File No. ~~001‑36714)~~001-36714).
~~4.3~~ 10.1		~~Secured Promissory Note,~~First Amendment to Royalty Interest Purchase Agreement and Related Documents, dated ~~May 28, 2019,~~July 10, 2020, by and ~~among~~between Jaguar Health, Inc.~~, Napo Pharmaceuticals, Inc.~~ and ~~Chicago Venture Partners,~~Iliad Research and Trading, L.P. ~~(incorporated~~(incorporated by reference to Exhibit ~~4.2~~10.1 to the Form ~~8‑K of Jaguar Health, Inc. filed June 3, 2019, File No. 001‑36714).~~
~~4.4~~		~~Form of Series 1 Warrant (incorporated by reference to Exhibit 4.1 to the Form 8‑K~~8-K of Jaguar Health, Inc. filed July ~~23, 2019,~~14, 2020, File No. ~~001‑36714)~~001-36714).
~~4.5~~		~~Form of Series 2 Warrant (incorporated by reference to Exhibit 4.2 to the Form 8‑K/A of Jaguar Health, Inc. filed July 23, 2019, File No. 001‑36714).~~
~~10.1#~~10.2		~~Promotion Letter,~~Exchange Agreement, dated September ~~6, 2019 (incorporated~~1, 2020, by and between Jaguar Health, Inc. and Iliad Research and Trading, L.P. (incorporated by reference to Exhibit 10.1 to the Form 8-K of Jaguar Health, Inc. filed September ~~9, 2019,~~2, 2020, File No. 001-36714).
~~10.2~~ 10.3		~~First Amendment to Landlord Letter~~Stock Plan Agreement for Payment of ~~Credit & Warrant Issuance Agreement,~~Consulting Services, dated September ~~16, 2019,~~1, 2020, by and between Jaguar Health, Inc. and ~~Pacific~~Sagard Capital Partners Management ~~LLC~~Corp. (incorporated by reference to Exhibit ~~10.1~~10.2 to the Form 8-K of Jaguar Health, Inc. filed September ~~20, 2019,~~2, 2020, File No. 001-36714).
10.4*#		Office Sublease Agreement, dated August 31, 2020, by and between Jaguar Health, Inc. and Peacock Construction, Inc.
10.5*		Consent to Sublease Agreement, dated August 31, 2020, by and among M&E, LLC, Jaguar Health, Inc., and Peacock Construction, Inc.
10.6*#		Manufacturing and Supply Agreement, dated September 3, 2020, by and between Glenmark Life Sciences Limited and Napo Pharmaceuticals, Inc.
31.1*		Principal Executive ~~Officer's~~Officer’s Certification Pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
31.2*		Principal Financial ~~Officer's~~Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**		Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002).
32.2**		Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002).
101.INS		XBRL Instance Document
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension Calculation 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

Table of Contents

* Filed herewith.

** In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. ~~34‑~~34 47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form ~~10‑~~10 Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 except to the extent that the registrant specifically incorporates it by reference.

#	Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information (i) is not material and (ii) would be competitively harmful if publicly disclosed.

~~#Management contract or compensatory plan or arrangement.~~

6185

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SIGNATURE

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.

Date: November ~~14, 2019~~16, 2020
	JAGUAR HEALTH, INC.

	By:	/s/ Carol R. Lizak
		Principal Financial and Accounting Officer

6286


	Series A			Series B			Common			Common							Total
	Preferred Stock			Preferred Stock			stock - voting			stock - non-voting			Additional		Accumulated		Stockholders'
	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		paid-in capital		deficit		Equity
Beginning Balance June 30, 2018	5,524,926	$	9,000,002	—	$	—	124,808	$	12	40,301,237	$	4,030	$	89,772,794	$	(75,758,542)	$	14,018,294
Issuance of common stock in exchange for payment of interest expense (Kingdon)	—		—	—		—	4,580		—	—		—		479,808		—		479,808
Issuance of common stock July 2018	—		—	—		—	6,725		1	—		—		624,896		—		624,897
Issuance of common stock in debt financing September 2018	—		—	—		—	1,071		—	—		—		48,000		—		48,000
Issuance of warrants in debt financing September 2018	—		—	—		—	—		—	—		—		118,149		—		118,149
Issuance of warrants for September 2018 office lease	—		—	—		—	—		—	—		—		493,688		—		493,688
Stock-based compensation	—		—	—		—	—		—	—		—		680,094		—		680,094
Net loss	—		—	—		—	—		—	—		—		—		(6,138,352)		(6,138,352)
Three Months Ended September 30, 2018	5,524,926	$	9,000,002	—	$	—	137,184	$	13	40,301,237	$	4,030	$	92,217,429	$	(81,896,894)	$	10,324,578


	As of		As of
	September 30,		September 30,
	2019		2018
Customer 1	99.6	%	35.0	%
Customer 2	—	%	29.0	%
Customer 3	—	%	26.0	%


		September 30, 2019
	(unaudited)
		Level 1		Level 2		Level 3		Total
Warrant liability		$	—	$	—	$	10,029	$	10,029
Total fair value		$	—	$	—	$	10,029	$	10,029


	Amounts
2019 (remaining)	$	421,667
2020		1,686,667
2021		1,686,667
2022		1,686,667
2023		1,686,667
2024		1,686,667
Thereafter		12,790,553
	$	21,645,555


				Weighted		Weighted Average
	Shares	Stock		Average		Remaining	Aggregate
	Available	Options	RSUs	Stock Option		Contractual Life	Intrinsic
	for Grant	Outstanding	Outstanding	Exercise Price		(Years)	Value*
Outstanding at December 31, 2018	2,327	42,979	5,613	$	406.36	9.24	$	—
Additional shares authorized	4,330,400	—	—		—	—
Options granted	(4,306,832)	4,306,832	—		1.71	—		—
Options cancelled	528,121	(528,121)	—		4.45	—		—
Outstanding at September 30, 2019	554,016	3,821,690	5,613	$	5.72	9.81	$	—
Exercisable at September 30, 2019		503,943		$	24.61	9.76	$	—
Vested and expected to vest at September 30, 2019		3,197,953		$	6.82	9.81	$	—

September 30, 2020

December 31,

(unaudited)

Customer 1