PART I. FINANCIAL INFORMATION
ITEM 1.
|
CONSOLIDATED FINANCIAL STATEMENTS.
|
MEDICINOVA, INC.
CONSOLIDATED BALANCE SHEETS
|
|
September 30,
|
|
|
|
|
December 31,
|
|
|
|
2020
|
|
|
|
|
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
61,661,341
|
|
|
|
|
$
|
63,792,657
|
|
Prepaid expenses and other current assets
|
|
|
893,843
|
|
|
|
|
|
511,916
|
|
Total current assets
|
|
|
62,555,184
|
|
|
|
|
|
64,304,573
|
|
Goodwill
|
|
|
9,600,240
|
|
|
|
|
|
9,600,240
|
|
In-process research and development
|
|
|
4,800,000
|
|
|
|
|
|
4,800,000
|
|
Property and equipment, net
|
|
|
28,857
|
|
|
|
|
|
40,550
|
|
Other non-current assets
|
|
|
309,112
|
|
|
|
|
|
459,811
|
|
Total assets
|
|
$
|
77,293,393
|
|
|
|
|
$
|
79,205,174
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
376,271
|
|
|
|
|
$
|
451,326
|
|
Accrued expenses and other liabilities
|
|
|
1,428,003
|
|
|
|
|
|
1,776,912
|
|
Total current liabilities
|
|
|
1,804,274
|
|
|
|
|
|
2,228,238
|
|
Long-term deferred revenue
|
|
|
1,694,163
|
|
|
|
|
|
1,694,163
|
|
Deferred tax liability
|
|
|
201,792
|
|
|
|
|
|
201,792
|
|
Other non-current liabilities
|
|
|
39,891
|
|
|
|
|
|
186,358
|
|
Total liabilities
|
|
|
3,740,120
|
|
|
|
|
|
4,310,551
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019; 44,927,560 and 43,908,065 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
|
|
|
44,928
|
|
|
|
|
|
43,908
|
|
Additional paid-in capital
|
|
|
453,539,933
|
|
|
|
|
|
444,016,341
|
|
Accumulated other comprehensive loss
|
|
|
(90,035
|
)
|
|
|
|
|
(92,681
|
)
|
Accumulated deficit
|
|
|
(379,941,553
|
)
|
|
|
|
|
(369,072,945
|
)
|
Total stockholders’ equity
|
|
|
73,553,273
|
|
|
|
|
|
74,894,623
|
|
Total liabilities and stockholders' equity
|
|
$
|
77,293,393
|
|
|
|
|
$
|
79,205,174
|
|
See accompanying notes.
6
MEDICINOVA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and patents
|
|
$
|
2,237,877
|
|
|
$
|
1,150,815
|
|
|
$
|
5,687,658
|
|
|
$
|
4,250,205
|
|
General and administrative
|
|
|
1,492,139
|
|
|
|
1,494,750
|
|
|
|
5,477,223
|
|
|
|
7,556,740
|
|
Total operating expenses
|
|
|
3,730,016
|
|
|
|
2,645,565
|
|
|
|
11,164,881
|
|
|
|
11,806,945
|
|
Operating loss
|
|
|
(3,730,016
|
)
|
|
|
(2,645,565
|
)
|
|
|
(11,164,881
|
)
|
|
|
(11,806,945
|
)
|
Interest income
|
|
|
37,204
|
|
|
|
288,643
|
|
|
|
324,175
|
|
|
|
900,462
|
|
Other expense
|
|
|
(11,008
|
)
|
|
|
(21,582
|
)
|
|
|
(27,902
|
)
|
|
|
(51,087
|
)
|
Net loss applicable to common stockholders
|
|
$
|
(3,703,820
|
)
|
|
$
|
(2,378,504
|
)
|
|
$
|
(10,868,608
|
)
|
|
$
|
(10,957,570
|
)
|
Basic and diluted net loss per common share
|
|
$
|
(0.08
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.26
|
)
|
Shares used to compute basic and diluted net
loss per common share
|
|
|
44,643,736
|
|
|
|
43,343,329
|
|
|
|
44,229,715
|
|
|
|
42,963,287
|
|
Net loss applicable to common stockholders
|
|
$
|
(3,703,820
|
)
|
|
$
|
(2,378,504
|
)
|
|
$
|
(10,868,608
|
)
|
|
$
|
(10,957,570
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
2,761
|
|
|
|
(782
|
)
|
|
|
2,646
|
|
|
|
792
|
|
Comprehensive loss
|
|
$
|
(3,701,059
|
)
|
|
$
|
(2,379,286
|
)
|
|
$
|
(10,865,962
|
)
|
|
$
|
(10,956,778
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
7
MEDICINOVA, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
|
|
Nine Months Ended September 30, 2020
|
|
|
|
Common stock
|
|
|
Additional
paid-in
|
|
|
Accumulated
other
comprehensive
|
|
|
Accumulated
|
|
|
Total
stockholders’
|
|
|
|
Shares
|
|
|
Amount
|
|
|
capital
|
|
|
income (loss)
|
|
|
deficit
|
|
|
equity
|
|
Balance at December 31, 2019
|
|
|
43,908,065
|
|
|
$
|
43,908
|
|
|
$
|
444,016,341
|
|
|
$
|
(92,681
|
)
|
|
$
|
(369,072,945
|
)
|
|
$
|
74,894,623
|
|
Share-based compensation
|
|
—
|
|
|
—
|
|
|
|
596,378
|
|
|
—
|
|
|
—
|
|
|
|
596,378
|
|
Issuance of shares under an employee stock purchase plan (ESPP)
|
|
|
1,979
|
|
|
|
2
|
|
|
|
6,252
|
|
|
—
|
|
|
—
|
|
|
|
6,254
|
|
Issuance of common stock under at-the-market equity distribution
and sales agreements, net of offering costs
|
|
|
68,952
|
|
|
|
69
|
|
|
|
412,623
|
|
|
|
—
|
|
|
|
—
|
|
|
|
412,692
|
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
(2,713,559
|
)
|
|
|
(2,713,559
|
)
|
Foreign currency translation adjustments
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
(120
|
)
|
|
—
|
|
|
|
(120
|
)
|
Balance at March 31, 2020
|
|
|
43,978,996
|
|
|
|
43,979
|
|
|
|
445,031,594
|
|
|
|
(92,801
|
)
|
|
|
(371,786,504
|
)
|
|
|
73,196,268
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
1,147,154
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,147,154
|
|
Issuance of common stock for option exercises
|
|
|
143,863
|
|
|
|
144
|
|
|
|
438,118
|
|
|
—
|
|
|
—
|
|
|
|
438,262
|
|
Issuance of common stock under at-the-market equity distribution
and sales agreements, net of offering costs
|
|
|
140,719
|
|
|
|
141
|
|
|
|
762,342
|
|
|
|
—
|
|
|
|
—
|
|
|
|
762,483
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(4,451,229
|
)
|
|
|
(4,451,229
|
)
|
Foreign currency translation adjustments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
5
|
|
|
|
—
|
|
|
|
5
|
|
Balance at June 30, 2020
|
|
|
44,263,578
|
|
|
|
44,264
|
|
|
|
447,379,208
|
|
|
|
(92,796
|
)
|
|
|
(376,237,733
|
)
|
|
|
71,092,943
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
1,033,971
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,033,971
|
|
Issuance of common stock for option exercises
|
|
|
60,000
|
|
|
|
60
|
|
|
|
187,990
|
|
|
—
|
|
|
—
|
|
|
|
188,050
|
|
Issuance of shares under an employee stock purchase plan (ESPP)
|
|
|
1,855
|
|
|
|
2
|
|
|
|
5,452
|
|
|
|
—
|
|
|
|
—
|
|
|
|
5,454
|
|
Issuance of common stock under at-the-market equity distribution
and sales agreements, net of offering costs
|
|
|
602,127
|
|
|
|
602
|
|
|
|
4,933,312
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,933,914
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(3,703,820
|
)
|
|
|
(3,703,820
|
)
|
Foreign currency translation adjustments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,761
|
|
|
|
—
|
|
|
|
2,761
|
|
Balance at September 30, 2020
|
|
|
44,927,560
|
|
|
$
|
44,928
|
|
|
$
|
453,539,933
|
|
|
$
|
(90,035
|
)
|
|
$
|
(379,941,553
|
)
|
|
$
|
73,553,273
|
|
8
|
|
Nine Months Ended September 30, 2019
|
|
|
|
Common stock
|
|
|
Additional
paid-in
|
|
|
Accumulated
other
comprehensive
|
|
|
Accumulated
|
|
|
Total
stockholders’
|
|
|
|
Shares
|
|
|
Amount
|
|
|
capital
|
|
|
income (loss)
|
|
|
deficit
|
|
|
equity
|
|
Balance at December 31, 2018
|
|
|
42,081,306
|
|
|
$
|
42,081
|
|
|
$
|
429,289,968
|
|
|
$
|
(93,150
|
)
|
|
$
|
(356,131,287
|
)
|
|
$
|
73,107,612
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
2,699,500
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,699,500
|
|
Issuance of shares under an employee stock purchase plan
|
|
|
2,401
|
|
|
|
2
|
|
|
|
16,901
|
|
|
|
—
|
|
|
|
—
|
|
|
|
16,903
|
|
Issuance of common stock under at-the-market equity distribution
and sales agreements, net of offering costs
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,532
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,532
|
)
|
Issuance of common stock for option exercises
|
|
|
977,454
|
|
|
|
978
|
|
|
|
3,919,757
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,920,735
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(4,697,190
|
)
|
|
|
(4,697,190
|
)
|
Foreign currency translation adjustments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,781
|
)
|
|
|
—
|
|
|
|
(1,781
|
)
|
Balance at March 31, 2019
|
|
|
43,061,161
|
|
|
|
43,061
|
|
|
|
435,917,594
|
|
|
|
(94,931
|
)
|
|
|
(360,828,477
|
)
|
|
|
75,037,247
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
1,842,514
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,842,514
|
|
Issuance of common stock for option exercises
|
|
|
38,000
|
|
|
|
38
|
|
|
|
180,332
|
|
|
|
—
|
|
|
|
—
|
|
|
|
180,370
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(3,881,876
|
)
|
|
|
(3,881,876
|
)
|
Foreign currency translation adjustments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,355
|
|
|
|
—
|
|
|
|
3,355
|
|
Balance at June 30, 2019
|
|
|
43,099,161
|
|
|
|
43,099
|
|
|
|
437,940,440
|
|
|
|
(91,576
|
)
|
|
|
(364,710,353
|
)
|
|
|
73,181,610
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
373,844
|
|
|
|
—
|
|
|
|
—
|
|
|
|
373,844
|
|
Issuance of shares under an employee stock purchase plan (ESPP)
|
|
|
1,541
|
|
|
|
2
|
|
|
|
10,415
|
|
|
|
—
|
|
|
|
—
|
|
|
|
10,417
|
|
Issuance of common stock, net of offering costs
|
|
|
347,902
|
|
|
|
348
|
|
|
|
3,164,107
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,164,455
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,378,504
|
)
|
|
|
(2,378,504
|
)
|
Foreign currency translation adjustments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(782
|
)
|
|
|
—
|
|
|
|
(782
|
)
|
Balance at September 30, 2019
|
|
|
43,448,604
|
|
|
$
|
43,449
|
|
|
$
|
441,488,806
|
|
|
$
|
(92,358
|
)
|
|
$
|
(367,088,857
|
)
|
|
$
|
74,351,040
|
|
See accompanying notes.
9
MEDICINOVA, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
Operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,868,608
|
)
|
|
$
|
(10,957,570
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation
|
|
|
2,777,503
|
|
|
|
4,915,858
|
|
Depreciation and amortization
|
|
|
15,487
|
|
|
|
18,347
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
(225,543
|
)
|
|
|
(452,515
|
)
|
Accounts payable, accrued liabilities and other liabilities
|
|
|
(576,116
|
)
|
|
|
(244,725
|
)
|
Net cash used in operating activities
|
|
|
(8,877,277
|
)
|
|
|
(6,720,605
|
)
|
Investing activities:
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment
|
|
|
(3,794
|
)
|
|
|
(4,013
|
)
|
Net cash used in investing activities
|
|
|
(3,794
|
)
|
|
|
(4,013
|
)
|
Financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, exercise of common
stock options and warrants, net of issuance costs
|
|
|
6,735,401
|
|
|
|
7,257,028
|
|
Proceeds from issuance of equity awards under ESPP
|
|
|
11,708
|
|
|
|
27,320
|
|
Net cash provided by financing activities
|
|
|
6,747,109
|
|
|
|
7,284,348
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
2,646
|
|
|
|
(241
|
)
|
Net change in cash and cash equivalents
|
|
|
(2,131,316
|
)
|
|
|
559,489
|
|
Cash and cash equivalents, beginning of period
|
|
|
63,792,657
|
|
|
|
62,313,418
|
|
Cash and cash equivalents, end of period
|
|
$
|
61,661,341
|
|
|
$
|
62,872,907
|
|
See accompanying notes.
10
MEDICINOVA, INC.
Notes to Consolidated Financial Statements
(Unaudited)
1. Interim Financial Information
Organization and Business
MediciNova, Inc. (the “Company” or “MediciNova”) was incorporated in the state of Delaware in September 2000 and is a public company. The Company’s common stock is listed in both the United States and Japan and trades on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange. MediciNova is a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs with a commercial focus on the United States market. The Company’s current strategy is to focus its development activities on BC-PIV vaccine for COVID-19 (Coronavirus Disease 2019), MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence and alcohol dependence), as well as for acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). The Company’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers.
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.
These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by GAAP for complete financial statements.
Principles of Consolidation
The consolidated financial statements include the accounts of MediciNova, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in a single operating segment – the acquisition and development of therapeutics for the treatment of serious diseases with unmet medical needs.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and other highly liquid investments including money market accounts.
Research, Development and Patents
Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, facilities and depreciation, research and development supplies, licenses and outside services. Such research and development costs totaled $2.1 million and $1.1 million for the three months ended September 30, 2020 and 2019, respectively and $5.4 million and $4.0 million for the nine months ended September 30, 2020 and 2019, respectively.
11
Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. The Company includes all external costs related to the filing of patents on developments in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for each of the three months ended September 30, 2020 and 2019, respectively and $0.3 million for each of the nine months ended September 30, 2020 and 2019, respectively.
Clinical Trial Accruals and Prepaid Expenses
Costs for preclinical studies, clinical studies and manufacturing activities are recognized as research and development expenses based on an evaluation of the progress by Company vendors towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided to the Company by such vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of studies, or the services completed. The Company’s estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Costs that are paid in advance of performance are deferred as a prepaid expense and amortized over the service period as the services are provided.
Impact of COVID-19 on the Company’s Business
The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect the Company’s business. Although the pandemic resulted in a decrease in the number of patient visits at certain of the Company’s clinical trial sites, the Company expects this effect to be temporary. The Company has seen an increase in the number of patient visits compared to earlier in the pandemic and the Company continues to enroll patients in clinical trials. Throughout the pandemic, the Company has continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, the Company designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. Based on the Company’s current assessment, the Company does not expect a material negative impact on its clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce.
Use of Estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.
Recent Accounting Pronouncements
In August 2018, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2018-13, Fair Value Measurement (Topic 820), which eliminates, adds and modifies certain disclosure requirements for fair value measurements. The modified standard eliminates the requirement to disclose changes in unrealized gains and losses included in earnings for recurring Level 3 fair value measurements and requires that changes in unrealized gains and losses be included in other comprehensive income for recurring Level 3 fair value measurements of instruments. The standard also requires the disclosure of the range and weighted average used to develop significant unobservable inputs and how weighted average is calculated for recurring and nonrecurring Level 3 fair value measurements. The amendment was effective for fiscal years beginning after December 15, 2019 and interim periods within that fiscal year with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020 with no material impact on its consolidated financial statements.
2. Revenue Recognition
Revenue Recognition Policy
Revenues consist mainly of research and development services performed under a contract with a customer. The Company evaluates the separate performance obligation(s) under each contract, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations over time or at a point in time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance (2) the vendor creates or enhances an asset controlled by
12
the customer (3) the vendor’s performance does not create an asset for which the vendor has an alternative use, and the vendor has an enforceable right to payment for performance completed to date.
Kissei Pharmaceutical Co., Ltd
In October 2011, the Company entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., (“Kissei”), to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $2.5 million. Under the terms of the agreement, the Company is responsible for all costs to be incurred in the performance of these services. The Company assessed the services in accordance with the authoritative guidance and concluded that the two studies to be performed under the agreement represented two separate performance obligations. The transaction price was allocated among the two studies that were deemed separate performance obligations based on the expected costs to be incurred for each obligation. Revenue is recognized proportional to the total costs expected for each performance obligation as incurred over the service period. The first study was completed in 2013 and the timing of the second study is undetermined as of September 30, 2020. The amount received from Kissei and allocated, net of the amount recorded as revenue, is included on the balance sheet as long-term deferred revenue and will be recognized as revenue as the remaining performance obligation is satisfied. No revenue was recognized for the three and nine months ended September 30, 2020 and 2019 in connection with the collaboration agreement with Kissei.
3. Fair Value Measurements
Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1:
|
Observable inputs such as quoted prices in active markets;
|
|
|
Level 2:
|
Inputs are quoted prices for similar items in active markets or quoted prices for identical or similar items in markets that are not active near the measurement date; and
|
|
|
Level 3:
|
Unobservable inputs due to little or no market data, which require the reporting entity to develop its own assumptions.
|
Cash equivalents, including money market accounts of $694,109 and $691,649 measured at fair value as of September 30, 2020 and December 31, 2019, respectively, are classified within Level 1.
4. Stock-based Compensation
Stock Incentive Plans
In June 2013, the Company adopted the 2013 Equity Incentive Plan, or 2013 Plan, under which the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. The 2013 Plan is the successor to the Company’s Amended and Restated 2004 Stock Incentive Plan, or 2004 Plan. A total of 8,700,000 shares of common stock are reserved for issuance under the 2013 Plan. In addition, “returning shares” that may become available from time to time are added back to the plan. “Returning shares” are shares that are subject to outstanding awards granted under the 2004 Plan that expire or terminate prior to exercise or settlement, are forfeited because of the failure to vest, are repurchased, or are withheld to satisfy tax withholding or purchase price obligations in connection with such awards. Although the Company no longer grants equity awards under the 2004 Plan, all outstanding stock awards granted under the 2004 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the 2004 Plan. As of September 30, 2020, 2,872,135 shares remain available for future grants under the 2013 Plan.
The Company occasionally issues employee performance-based stock options, the vesting of which is based on a determination made by the board of directors as to the achievement of certain corporate objectives at the end of the performance period. The grant date of such awards is the date on which the board of directors makes its determination. For periods preceding the grant date, the expense related to these awards is measured based on their fair value at each reporting date.
Stock Options
Options granted under the 2013 Plan and the 2004 Plan have terms of ten years from the date of grant unless earlier terminated and generally vest over a three or four year period. The exercise price of all options granted through September 30, 2020 and in 2019, was equal to the market value of the Company’s common stock on the date of grant.
13
A summary of stock option activity and related information as of September 30, 2020 is as follows:
|
|
Number of
Option Shares
|
|
|
Weighted Average
Exercise Price
|
|
|
Outstanding at December 31, 2019
|
|
|
6,802,093
|
|
|
$
|
5.61
|
|
|
Granted
|
|
|
1,367,000
|
|
|
|
6.69
|
|
|
Exercised
|
|
|
(203,863
|
)
|
|
|
3.07
|
|
|
Cancelled
|
|
|
(454,843
|
)
|
|
|
8.92
|
|
|
Outstanding at September 30, 2020
|
|
|
7,510,387
|
|
|
$
|
5.68
|
|
|
Exercisable at September 30, 2020
|
|
|
6,174,387
|
|
|
$
|
5.45
|
|
|
Employee Stock Purchase Plan
Under the Company’s 2007 Employee Stock Purchase Plan (ESPP), 300,000 shares of common stock were originally reserved for issuance. In addition, the shares reserved automatically increase each year by a number equal to the lesser of: (i) 15,000 shares; (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser amount as determined by the Board. The ESPP permits full-time employees to purchase common stock through payroll deductions (which cannot exceed 15% of each employee’s compensation) at the lower of 85% of fair market value at the beginning of the offering period or the end of each six-month offering period. The ESPP is considered a compensatory plan and the Company records compensation expense included in the Company’s statement of operations.
For the nine months ended September 30, 2020, an aggregate of 3,834 shares were issued under the ESPP. As of September 30, 2020, there were 214,102 shares available for future issuance under the ESPP.
Compensation Expense
Stock-based compensation expense for stock option awards and ESPP shares are reflected in total operating expenses for each respective year.
The following table summarizes stock-based compensation expenses for the three and nine months ended September 30, 2020 and 2019, respectively:
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Research, development and patents
|
|
$
|
331,126
|
|
|
$
|
91,089
|
|
|
$
|
843,117
|
|
|
$
|
1,424,737
|
|
General and administrative
|
|
|
702,845
|
|
|
|
282,755
|
|
|
|
1,934,386
|
|
|
|
3,491,121
|
|
Total stock-based compensation expense
|
|
$
|
1,033,971
|
|
|
$
|
373,844
|
|
|
$
|
2,777,503
|
|
|
$
|
4,915,858
|
|
The Company uses the Black-Scholes valuation model for determining the estimated fair value for stock-based awards granted to employees and stock purchased under the ESPP. The following table provides the assumptions used in the Black-Scholes valuation model used to estimate the fair value of options granted and stock purchased under the ESPP during the nine months ended September 30, 2020 and 2019, and to estimate the fair value of performance-based stock options as of September 30, 2020 and 2019.
|
|
Nine months ended
|
|
|
|
September 30, 2020
|
|
|
September 30, 2019
|
|
Stock Option assumptions:
|
|
|
|
|
|
|
|
|
Risk-free interest rate
|
|
0.16 - 1.68%
|
|
|
1.55 - 2.19%
|
|
Expected volatility of common stock
|
|
57.44 - 75.82%
|
|
|
60.64 - 61.9%
|
|
Dividend yield
|
|
0%
|
|
|
0%
|
|
Expected term (in years)
|
|
4.5 - 5.8
|
|
|
4.8 - 5.3
|
|
ESPP assumptions:
|
|
|
|
|
|
|
|
|
Risk-free interest rate
|
|
0.14%
|
|
|
1.83%
|
|
Expected volatility of common stock
|
|
81.70%
|
|
|
59.7%
|
|
Dividend yield
|
|
0.0%
|
|
|
0.0%
|
|
Expected term (in years)
|
|
0.5
|
|
|
0.5
|
|
14
As of September 30, 2020, there was $1.4 million of unamortized compensation cost related to unvested stock option awards which is expected to be recognized over a remaining weighted-average vesting period of 0.43 years, on a straight-line basis.
5. Stockholders’ Equity
At-The-Market Issuance Sales Agreements
On May 22, 2015, the Company entered into an at-the-market issuance sales agreement (the “2015 ATM Agreement”) with MLV & Co. LLC (MLV), pursuant to which the Company could sell common stock through MLV from time to time up to an aggregate offering price of $30.0 million. Sales of the Company’s common stock through MLV, if any, were to be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or to or through a market maker. MLV could also sell the common stock in privately negotiated transactions, subject to the Company’s prior approval. The Company agreed to pay MLV an aggregate commission rate of up to 4.0% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock depended on the number of shares of common stock sold to MLV and the per share purchase price of each transaction.
The Company was not obligated to make any sales of common stock under the sales agreement and could terminate the sales agreement at any time upon written notice. On September 16, 2016, the Company amended the original sales agreement with MLV to also include FBR Capital Markets & Co. as a sales agent. The 2015 ATM Agreement was terminated on August 23, 2019.
On August 23, 2019, the Company entered into an at market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which the Company may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million. Sales of the Company’s common stock through B. Riley FBR, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or through a market maker. B. Riley FBR may also sell the common stock in privately negotiated transactions, subject to the Company’s prior approval. The Company agreed to pay B. Riley FBR an aggregate commission rate of up to 3.5% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock will depend on the number of shares of common stock sold to B. Riley FBR and the per share purchase price of each transaction.
For the nine months ended September 30, 2020 the Company generated net proceeds of $6.1 million under the 2019 ATM Agreement, on sales of 811,798 shares of the Company’s common stock at a weighted average price of $7.77 per share.
6. Net Loss Per Share
The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option agreements. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive.
Potentially dilutive outstanding stock options excluded from diluted net loss per common share due to their anti-dilutive effect totaled 7,510,387 shares and 6,804,493 shares for the three and nine months ended September 30, 2020 and 2019, respectively.
15
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
|
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2019 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 13, 2020. Past operating results are not necessarily indicative of results that may occur in future periods.
This Quarterly Report on Form 10-Q contains forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control. Our actual results may differ from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II of this Quarterly Report on Form 10-Q under the caption “Item 1A. Risk Factors” and under the caption “Item 1A. Risk Factors” in our Annual Report on Form 10-K. The differences may be material. Forward-looking statements discuss matters that are not historical facts. Forward-looking statements include, but are not limited to, statements regarding our plans, strategies, objectives, product development programs, clinical trials, industry, financial condition, liquidity and capital resources, future performance and other statements that are not historical facts. Such forward-looking statements include statements preceded by, followed by or that otherwise include the words “may,” “might,” “will,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “estimate,” “anticipate,” “predict,” “potential,” “plan” or similar words. For such statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not rely unduly on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Overview
We are a biopharmaceutical company focused on developing novel, therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on BC-PIV vaccine for COVID-19, MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), as well as for acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). Our pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers. We were incorporated in Delaware in September 2000.
We have incurred significant net losses since our inception. As of September 30, 2020, from inception, our accumulated deficit was $379.9 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Our goal is to build a sustainable biopharmaceutical business through the successful development of differentiated products for the treatment of serious diseases with unmet medical needs in high-value therapeutic areas. Key elements of our strategy are as follows:
|
•
|
Pursue the development of BC-PIV vaccine for the prevention of COVID-19.
|
|
•
|
Pursue the development of MN-166 (ibudilast) for multiple potential indications with the support of non-dilutive financings.
|
We intend to advance our diverse MN-166 (ibudilast) program through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, and trials funded by us. In addition to providing drug supply and regulatory support, we have funded portions of some of the consortium-sponsored trials. For example, we contributed financially to the Secondary and Primary Progressive Ibudilast NeuroNEXT Trial in Multiple Sclerosis (SPRINT-MS) Phase 2b clinical trial of MN-166 (ibudilast) for the treatment of progressive MS, which was primarily funded by the NIH. In addition, we contributed financially to the clinical trials of MN-166 (ibudilast) that enrolled ALS patients. We intend to pursue additional strategic alliances to help support further clinical development of MN-166 (ibudilast).
|
•
|
Pursue the development of MN-001 (tipelukast) for fibrotic and other diseases.
|
We intend to advance development of MN-001 (tipelukast) through a variety of means, which may include investigator-sponsored trials with or without grant funding as well as trials funded by us.
16
|
•
|
Consider strategic partnerships with one or more leading pharmaceutical companies to complete product development and successfully commercialize our products.
|
We develop and maintain relationships with pharmaceutical companies that are therapeutic category leaders. We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as BC-PIV vaccine, MN-166 (ibudilast), MN-001 (tipelukast), MN-221 (bedoradrine) and MN-029 (denibulin), which could further support our clinical development and product commercialization.
Impact of COVID-19 on Our Business
The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. Although the pandemic resulted in a decrease in the number of patient visits at certain of our clinical trial sites, we expect this effect to be temporary. We have seen an increase in the number of patient visits compared to earlier in the pandemic and we continue to enroll patients in our clinical trials. Throughout the pandemic, we have continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, we designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, which was based on positive results of a recently published study of MN-166 (ibudilast) in an animal model of ARDS. During the pandemic, we have been able to continue with routine regulatory activities. For example, we successfully submitted an Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) which was accepted and is now open with the U.S. Food and Drug Administration (FDA). We were also informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed. Based on management’s current assessment, we do not expect a material negative impact on our clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, we are actively monitoring this situation and the possible effects on our financial condition, liquidity, operations, suppliers, industry, and workforce.
Revenues and Cost of Revenues
In October 2011, we entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $2.5 million. Under the terms of the agreement, we are responsible for all costs to be incurred in the performance of these services. We assessed the services in accordance with the authoritative guidance and concluded that the two studies to be performed under the agreement represented two separate performance obligations. The transaction price was allocated between the two studies that were deemed separate performance obligations based on the expected costs to be incurred for each obligation. Revenue is recognized proportional to the total costs expected for each performance obligation as incurred over the service period. The first study was completed in 2013 and the timing of the second study is undetermined as of September 30, 2020. The amount received from Kissei and allocated, net of the amount recorded as revenue, is included on the balance sheet as long-term deferred revenue since it is non-refundable and not expected to be started within the next year and will be recognized as revenue as the remaining performance obligation is satisfied. No revenue was recognized in the three months ended September 30, 2020 and 2019, in connection with the collaboration agreement with Kissei.
Research, Development and Patents Expenses
Our research, development and patents expenses consist primarily of license fees related to our product candidates, salaries and related employee benefits, costs associated with the preclinical and clinical development of our product development programs, costs associated with non-clinical activities, such as regulatory expenses, and pre-commercialization manufacturing development activities. We use external service providers to manufacture our compounds to be used in clinical trials and for the majority of the services performed in connection with the preclinical and clinical development of our product candidates. Research, development and patents expenses include fees paid to consultants, contract research organizations, contract manufacturers and other external service providers, including professional fees and costs associated with legal services, patents and patent applications for our intellectual property. Internal research and development expenses include costs of compensation and other expenses for research and development personnel, supplies, facility costs and depreciation. Research, development and patents costs are expensed as incurred and we expect to increase such costs throughout 2020 as our development programs progress.
The following table summarizes our research, development and patents expenses for the periods indicated for each of our product development programs. To the extent that costs, including personnel costs, are not tracked to a specific product development program, such costs are included in the “Other R&D expense” category (in thousands):
17
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
|
2020
|
|
|
|
2019
|
|
|
|
2020
|
|
|
|
2019
|
|
External development expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MN-221
|
|
$
|
4
|
|
|
$
|
4
|
|
|
$
|
(1
|
)
|
|
$
|
18
|
|
MN-166
|
|
|
1,313
|
|
|
|
563
|
|
|
|
3,346
|
|
|
|
1,459
|
|
MN-001
|
|
|
33
|
|
|
|
46
|
|
|
|
129
|
|
|
|
109
|
|
MN-029
|
|
|
1
|
|
|
|
1
|
|
|
|
3
|
|
|
|
2
|
|
BC-PIV vaccine for COVID-19
|
|
|
110
|
|
|
|
—
|
|
|
|
110
|
|
|
|
—
|
|
Total external development expense
|
|
|
1,461
|
|
|
|
614
|
|
|
|
3,587
|
|
|
|
1,588
|
|
R&D personnel expense
|
|
|
596
|
|
|
|
347
|
|
|
|
1,630
|
|
|
|
2,213
|
|
R&D facility and depreciation expense
|
|
|
12
|
|
|
|
12
|
|
|
|
36
|
|
|
|
35
|
|
Patent expenses
|
|
|
97
|
|
|
|
102
|
|
|
|
295
|
|
|
|
259
|
|
Other R&D expense
|
|
|
72
|
|
|
|
76
|
|
|
|
140
|
|
|
|
155
|
|
Total research, development and patent expense
|
|
$
|
2,238
|
|
|
$
|
1,151
|
|
|
$
|
5,688
|
|
|
$
|
4,250
|
|
General and Administrative
Our general and administrative costs primarily consist of salaries, stock-based compensation, benefits and consulting and professional fees related to our administrative, finance, human resources, business development, legal, information systems support functions, facilities and insurance costs. General and administrative costs are expensed as incurred.
Our general and administrative expenses may increase in future periods if we are required to expand our infrastructure based on the success of our product development programs and in raising capital to support our product development programs or otherwise in connection with increased business development activities related to partnering, out-licensing or product disposition.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with United States generally accepted accounting principles. The preparation of these condensed financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting periods. We base our estimates on historical experience and on various other factors and assumptions that we believe are reasonable under the circumstances at the time the estimates are made, the results of which form the basis for making judgments about the book values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We periodically evaluate our estimates and judgments in light of changes in circumstances, facts and experience.
Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Significant Judgments and Estimates” contained in our Annual Report on Form 10-K for the year ended December 31, 2019. There have not been any material changes to the critical accounting policies discussed therein during the three and nine months ended September 30, 2020.
Results of Operations
Comparison of the three months ended September 30, 2020 and 2019
Research, Development and Patents Expenses
Research, development and patents expenses were $2.2 million and $1.2 million for the three months ended September 30, 2020 and 2019, respectively. The increase of $1.0 million was primarily due to higher clinical trial expenses from the ongoing clinical trial of MN-166 (ibudilast) in ALS.
18
General and Administrative
General and administrative expenses were $1.5 million for each of the three months ended September 30, 2020 and 2019, respectively.
Comparison of the nine months ended September 30, 2020 and 2019
Research, Development and Patents Expenses
Research, development and patents expenses were $5.7 million and $4.3 million for the nine months ended September 30, 2020 and 2019, respectively. The increase of $1.4 million was due to higher clinical trial expenses offset by lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price.
General and Administrative
General and administrative expenses were $5.5 million and $7.6 million for the nine months ended September 30, 2020 and 2019, respectively. The decrease of $2.1 million was primarily due to lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price and a decrease in legal expenses.
Liquidity and Capital Resources
Net cash used in operating activities during the nine months ended September 30, 2020 was $8.9 million compared to $6.7 million during the same period in 2019. Net cash used in operating activities primarily reflects the net loss and changes in operating assets and liabilities for those periods, which was partially offset by non-cash stock-based compensation expense.
Net cash provided by financing activities was $6.7 million during the nine months ended September 30, 2020 compared to $7.3 million during the same period in 2019. Net cash provided by financing activities during the nine months ended September 30, 2020 is primarily due to the sale of 811,798 shares of common stock under the 2019 ATM Agreement for net proceeds of $6.1 million and cash proceeds of $0.6 million from the exercise of options to purchase 203,863 shares of common stock. Net cash provided by financing activities during the nine months ended September 30, 2019 is primarily due to the exercise of 1,015,454 options to purchase common stock for cash proceeds of $4.1 million as well as the sale of 347,902 shares of common stock under the 2015 ATM Agreement and 2019 ATM Agreement for net proceeds of $3.2 million. Cash proceeds from financing activities are used for working capital and general corporate purposes.
On May 22, 2015, we entered into an at-the-market issuance sales agreement (the “2015 ATM Agreement”) with MLV & Co. LLC (MLV), pursuant to which we could sell common stock through MLV from time to time up to an aggregate offering price of $30.0 million. Sales of our common stock through MLV, if any, were to be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or to or through a market maker. MLV could also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay MLV an aggregate commission rate of up to 4.0% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock depended on the number of shares of common stock sold to MLV and the per share purchase price of each transaction. We were not obligated to make any sales of common stock under the sales agreement and could terminate the sales agreement at any time upon written notice. On September 16, 2016, we amended the 2015 ATM agreement to also include FBR Capital Markets & Co. as a sales agent. The 2015 ATM Agreement was terminated on August 23, 2019.
On August 23, 2019, we entered into an at market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which we may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million. Sales of our common stock through B. Riley FBR, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or through a market maker. B. Riley FBR may also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay B. Riley FBR an aggregate commission rate of up to 3.5% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock will depend on the number of shares of common stock sold to B. Riley FBR and the per share purchase price of each transaction.
For the nine months ended September 30, 2020, we generated net proceeds of $6.1 million under the 2019 ATM agreement, on sales of 811,798 shares of our common stock at a weighted average price of $7.77 per share.
19
For the nine months ended September 30, 2019, we generated net proceeds of $2.8 million and $0.4 million under the 2015 ATM Agreement and 2019 ATM Agreement respectively, on sales of 347,902 shares of our common stock at a weighted average price of $9.51 per share.
As of September 30, 2020, we had available cash and cash equivalents of $61.7 million and working capital of $60.8 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through the end of 2021. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.
Off-Balance Sheet Arrangements
At September 30, 2020, we did not have any relationship with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance variable interest, or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements. In addition, we did not engage in trading activities involving non-exchange traded contracts. As a result, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships. We do not have relationships and transactions with persons and entities that derive benefits from their non-independent relationship with us or our related parties except as disclosed herein.