PDS Biotechnology Corp - Quarter Report: 2020 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| ☒ |
For the quarterly period ended March 31, 2020
| ☐ |
For the transition period from____________to_____________
Commission file number 001-37568
|
PDS Biotechnology Corporation
|
||
|
(Exact name of registrant as specified in its charter)
|
|
Delaware
|
26-4231384
|
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
|
25B Vreeland Road, Florham Park, NJ 07932
|
||
|
(Address of principal executive offices)
|
|
(800) 208-3343
|
||
|
(Registrant’s telephone number)
|
|
(Former name, former address and former fiscal year, if changed since last report)
|
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 $0.00033 per share
|
PDSB
|
Nasdaq Capital Market
|
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 (Section 232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions
of “large accelerated filer”, “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934.
|
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 Securities Exchange Act of 1934). Yes ☐ No ☒
The number of shares of the registrant’s Common Stock, par value $0.00033 per share, outstanding as of May 7, 2020 was 15,361,619.
|
Page
|
|||
| 3 |
|||
|
Item 1.
|
3 |
||
| 3 | |||
| 4 | |||
| 5 | |||
| 6 | |||
| 7 | |||
|
Item 2.
|
17
|
||
|
Item 3.
|
25
|
||
|
Item 4.
|
25
|
||
|
26
|
|||
|
Item 1.
|
26
|
||
|
Item 1A.
|
26
|
||
|
Item 2.
|
31 | ||
|
Item 3.
|
31
|
||
|
Item 4.
|
31 | ||
|
Item 5.
|
31
|
||
|
Item 6.
|
31 | ||
| 32 | |||
| 33 | |||
| PART 1. |
FINANCIAL INFORMATION
|
| ITEM 1. |
FINANCIAL STATEMENTS
|
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
March 31, 2020
|
December 31, 2019
|
|||||||
|
ASSETS
|
(unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
21,037,806
|
$
|
12,161,739
|
||||
|
Prepaid expenses and other
|
2,879,378
|
2,308,462
|
||||||
|
Total current assets
|
23,917,184
|
14,470,201
|
||||||
|
Property and equipment, net
|
17,149
|
21,051
|
||||||
|
Total assets
|
$
|
23,934,333
|
$
|
14,491,252
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
LIABILITIES
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
2,556,703
|
$
|
1,197,720
|
||||
|
Accrued expenses
|
1,220,191
|
1,097,640
|
||||||
|
Restructuring reserve
|
269,887
|
498,185
|
||||||
|
Total current liabilities
|
4,046,781
|
2,793,545
|
||||||
|
Total liabilities
|
4,046,781
|
2,793,545
|
||||||
|
STOCKHOLDERS' EQUITY
|
||||||||
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2020 and December 31, 2019, 15,350,445 shares and 5,281,237 shares issued and
outstanding at March 31, 2020 and December 31, 2019, respectively
|
5,064
|
1,742
|
||||||
|
Additional paid-in capital
|
52,805,601
|
40,633,670
|
||||||
|
Accumulated deficit
|
(32,923,113
|
)
|
(28,937,705
|
)
|
||||
|
Total stockholders' equity
|
19,887,552
|
11,697,707
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
23,934,333
|
$
|
14,491,252
|
||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development expenses
|
$
|
1,971,679
|
$
|
1,030,003
|
||||
|
General and administrative expenses
|
2,060,148
|
3,905,877
|
||||||
|
Total operating expenses
|
4,031,827
|
4,935,880
|
||||||
|
Loss from operations
|
(4,031,827
|
)
|
(4,935,880
|
)
|
||||
|
Other income (expense):
|
||||||||
|
Gain on bargain purchase
|
–
|
11,729,882
|
||||||
|
Interest income
|
46,419
|
23,302
|
||||||
|
Interest expense
|
–
|
(606
|
)
|
|||||
|
Net income (loss) and comprehensive income (loss)
|
$
|
(3,985,408
|
)
|
$
|
6,816,698
|
|||
|
Per share information:
|
||||||||
|
Net income (loss) per share , basic
|
$
|
(0.39
|
)
|
$
|
1.82
|
|||
|
Net income (loss) per share , diluted
|
$
|
(0.39
|
)
|
$
|
1.47
|
|||
|
Weighted average common shares outstanding, basic
|
10,314,761
|
3,748,325
|
||||||
|
Weighted average common shares outstanding, diluted
|
10,314,761
|
4,625,295
|
||||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
|
Balance - December 31, 2018
|
3,417,187
|
$
|
1,128
|
$
|
19,311,529
|
$
|
(21,013,174
|
)
|
$
|
(1,700,517
|
)
|
|||||||||
|
Stock based compensation expense
|
–
|
–
|
2,754,871
|
–
|
2,754,871
|
|||||||||||||||
|
Issuance of common stock, net of issuance costs
|
48,930
|
16
|
749,984
|
–
|
750,000
|
|||||||||||||||
|
Issuance of common stock for antidilution
|
97,960
|
32
|
(32
|
)
|
–
|
–
|
||||||||||||||
|
Issuance of common stock for convertible debt
|
9,683
|
3
|
32,950
|
–
|
32,953
|
|||||||||||||||
|
Equity from merger transaction
|
1,599,178
|
528
|
15,793,109
|
–
|
15,793,637
|
|||||||||||||||
|
Net income
|
–
|
–
|
–
|
6,816,698
|
6,816,698
|
|||||||||||||||
|
Balance - March 31, 2019
|
5,172,938
|
$
|
1,707
|
$
|
38,642,411
|
$
|
(14,196,476
|
)
|
$
|
24,447,642
|
||||||||||
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
|
Balance - December 31, 2019
|
5,281,237
|
$
|
1,742
|
$
|
40,633,670
|
$
|
(28,937,705
|
)
|
$
|
11,697,707
|
||||||||||
|
Stock-based compensation expense
|
–
|
–
|
124,992
|
–
|
124,992
|
|||||||||||||||
|
Issuance of common stock, net of issuance costs
|
10,000,000
|
3,299
|
11,966,703
|
–
|
11,970,002
|
|||||||||||||||
|
Issuance of common stock for warrant exercise
|
65,240
|
22
|
70,437
|
–
|
70,459
|
|||||||||||||||
|
Issuance of common stock from 401K match
|
3,968
|
1
|
9,799
|
–
|
9,800
|
|||||||||||||||
|
Net loss
|
–
|
–
|
–
|
(3,985,408
|
)
|
(3,985,408
|
)
|
|||||||||||||
|
Balance - March 31, 2020
|
15,350,445
|
$
|
5,064
|
$
|
52,805,601
|
$
|
(32,923,113
|
)
|
$
|
19,887,552
|
||||||||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Cash flows from operating activities:
|
||||||||
|
Net (loss) income
|
$
|
(3,985,408
|
)
|
$
|
6,816,698
|
|||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Stock-based compensation expense
|
124,992
|
2,754,871
|
||||||
|
Stock-based 401K company common match
|
9,800
|
–
|
||||||
|
Depreciation expense
|
3,902
|
18,958
|
||||||
|
Bargain purchase gain from merger
|
–
|
(11,729,882
|
)
|
|||||
|
Changes in assets and liabilities:
|
||||||||
|
Prepaid expenses and other assets
|
(570,916
|
)
|
(181,679
|
)
|
||||
|
Accounts payable
|
1,358,983
|
(620,212
|
)
|
|||||
|
Accrued expenses
|
122,551
|
(304,441
|
)
|
|||||
|
Restructuring reserve
|
(228,298
|
)
|
(121,675
|
)
|
||||
|
Net cash used in operating activities
|
(3,164,394
|
)
|
(3,367,362
|
)
|
||||
|
Cash flows from investing activities:
|
||||||||
|
Cash received in reverse merger transaction
|
–
|
29,106,512
|
||||||
|
Net cash provided by investing activities
|
–
|
29,106,512
|
||||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from exercise of warrants
|
70,459
|
–
|
||||||
|
Proceeds from issuance of common stock, net of issuance costs
|
11,970,002
|
750,000
|
||||||
|
Net cash provided by financing activities
|
12,040,461
|
750,000
|
||||||
|
Net increase in cash and cash equivalents
|
8,876,067
|
26,489,150
|
||||||
|
Cash and cash equivalents at beginning of period
|
12,161,739
|
103,695
|
||||||
|
Cash and cash equivalents at end of period
|
$
|
21,037,806
|
$
|
26,592,845
|
||||
|
Supplemental disclosure of cash flow information:
|
||||||||
|
Cash paid for:
|
||||||||
|
Interest
|
$
|
–
|
$
|
150
|
||||
|
Supplemental cash flow information:
|
||||||||
|
Conversion of convertible notes and accrued interest into common stock
|
$
|
–
|
$
|
32,953
|
||||
|
Consideration in connection with reverse merger transaction
|
$
|
–
|
$
|
15,793,638
|
||||
See accompanying notes to the condensed consolidated financial statements.
PDS Biotechnology Corporation, a Delaware corporation (the “Company,” “PDS,” or the “combined company”), PDS is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in
vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS has engineered multiple therapies,
based on combinations of Versamune® and
disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. Our current development pipeline of cancer immunotherapy products and infectious disease vaccines
is based on the Versamune® platform. Our immuno-oncology products can potentially be used as a component of combination products with other leading technologies to
provide effective treatments across a range of cancer types, including Human Papillomavirus (HPV)-based cancers, melanoma, colorectal, lung, breast and prostate cancers or as monotherapies in early-stage disease. PDS is working to expand its
infectious disease pandemic development program, including novel vaccines for COVID-19 and universal influenza, in addition to its previously announced tuberculosis development collaboration with Farmacore Biotechnology.
From the Company's inception, it has devoted substantially all of its efforts to drug development, business planning, engaging regulatory, manufacturing and other technical consultants, acquiring
operating assets, planning and executing clinical trials and raising capital.
On March 15, 2019, the Company, then operating as Edge Therapeutics, Inc. (“Edge”), completed its reverse merger with privately held PDS Biotechnology Corporation (“Private PDS”), pursuant to and
in accordance with the terms of the Agreement and Plan of Merger (the “Merger Agreement”), dated as of November 23, 2018, as amended on January 24, 2019, by and among the Company, Echos Merger Sub, a wholly-owned
subsidiary of the Company (“Merger Sub”), and Private PDS, whereby Private PDS merged with and into Merger Sub, with Private PDS surviving as the Company’s wholly-owned subsidiary (the “Merger”). In
connection with and immediately following completion of the Merger, the Company effected a 1-for-20 reverse stock split (the “Reverse Stock Split”) and changed its corporate name from Edge Therapeutics, Inc. to PDS Biotechnology Corporation, and
Private PDS changed its name to PDS Operating Corporation.
For accounting purposes, the Merger was treated as a “reverse acquisition” under generally accepted accounting principles in the United States (“U.S. GAAP”) and Private PDS is considered the
accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Private PDS became the Company's historical financial statements, and the historical financial statements of Private PDS are included in the
comparative prior periods. See “Note 4 – Reverse Merger” for more information on the Merger. As part of the Merger, the Company acquired all of Edge's assets relating to current and future research and development.
In December 2019, a coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that
has now spread globally. On January 30, 2020 the World Health Organization (WHO) declared COVID-19 a pandemic (the “COVID-19 Pandemic”). The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under
section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 Pandemic. The full impact of the COVID-19 Pandemic is unknown and rapidly evolving. While the potential economic impact brought by and the duration of the
COVID-19 Pandemic may be difficult to assess or predict, the COVID-19 pandemic began to have a material adverse impact on our business operations, financial operations, and results of operations in the quarter ended March 31, 2020, and we expect
it to continue to adversely affect our business. In addition, a recession or market volatility resulting from the COVID-19 Pandemic could affect the Company’s business.
Note 2 – Summary of Significant Accounting Policies
(A) Unaudited interim financial statements:
The interim balance sheet at March 31, 2020, the statements of operations and comprehensive loss and changes in stockholders' equity for the three months
ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required
by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting
only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the
year ending December 31, 2020 or for any other future annual or interim period. The balance sheet as of December 31, 2019 included herein was derived from the audited condensed consolidated financial statements as of that date. These condensed
consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2019,
filed by the Company with the SEC in its Annual Report on Form 10-K on March 27, 2020.
(B) Use of estimates:
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial
statements. Actual results could differ from those estimates.
(C) Significant risks and uncertainties:
The Company's operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the
clinical and regulatory development of its products, the Company’s ability to preserve its cash resources, the Company’s review of strategic alternatives, the Company’s ability to add product candidates to its
pipeline, the Company's intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company's ability to negotiate
favorable licensing or other manufacturing and marketing agreements for its products, the Company’s ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases,
including the recent COVID-19 pandemic.
The Company currently has no commercially approved products. As such, there can be no assurance that the Company's future research and development programs will be
successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company
operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property.
(D) Business acquisition:
The Company’s consolidated financial statements include the operations of an acquired business after the completion of the acquisition. We
account for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that
the fair value of IPR&D be recorded on the balance sheet. Transaction costs are expensed as incurred.
The Company measures certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. For example, we use fair value
in the initial recognition of net assets acquired in a business combination and when measuring impairment losses. We estimate fair value using an exit price approach, which requires, among other things, that we determine the price that would be
received to sell an asset or paid to transfer a liability in an orderly market. The determination of an exit price is considered from the perspective of market participants, considering the highest and best use of non-financial assets and, for
liabilities, assuming that the risk of non-performance will be the same before and after the transfer.
When estimating fair value, depending on the nature and complexity of the asset or liability, we may use one or all of the following techniques:
| ● |
Income approach, which is based on the present value of a future stream of net cash flows.
|
| ● |
Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
|
| ● |
Cost approach, which is based on the cost to acquire or construct comparable assets, less an allowance for functional and/or economic obsolescence.
|
Our fair value methodologies depend on the following types of inputs:
| ● |
Quoted prices for identical assets or liabilities in active markets (Level 1 inputs).
|
| ● |
Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are
directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs).
|
| ● |
Unobservable inputs that reflect estimates and assumptions (Level 3 inputs).
|
(E) Cash equivalents and concentration of cash balance:
The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company's cash and cash equivalents
in bank deposit accounts, at times, may exceed federally insured limits.
(F) Research and development:
Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company's
research and development projects as well as fees paid to consultants and entities that perform certain research and testing on behalf of the Company.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as
patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs
incurred.
(G) Patent costs:
The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive
loss.
As part of the reverse merger transaction on March 15, 2019, the Company acquired an in-process research and development ("IPR&D") intangible asset valued at $2,974,000 using a discounted cash flow method. In determining the value of IPR&D, management considers, among other factors, the stage of completion of the project, the technological feasibility of the project, whether the project have
an alternative future use, and the estimated residual cash flows that could be generated from the various projects and technologies over their respective projected economic lives. The discount rate used is determined at the time of acquisition
and includes a rate of return which accounts for the time value of money, as well as risk factors reflecting the economic risk that the projected cash flows may not be realized.
The Company reviews all of its long-lived assets for impairment indicators throughout the year. The Company performs
impairment testing for indefinite-lived intangible assets annually and for all other long-lived assets whenever impairment indicators are present. When necessary, the Company records charges for impairments of
long-lived assets for the amount by which the fair value is less than the carrying value of these assets.
(I) Stock-based compensation:
The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees,
directors and non-employees to be recognized as expense in the condensed statements of operations and comprehensive loss based on their grant date fair values. The Company estimates the fair value of options granted using the Black-Scholes option
pricing model for stock option grants to both employees and non-employees. This model requires the following assumptions: (1) the expected volatility of our stock is based on volatilities of a peer group of
similar companies in the biotechnology industry whose share prices are publicly available, (2) the expected term of the award is based on the simplified method, which is the midpoint between the
requisite service period and the contractual term of the option, as we have a limited history of being a public company from March 15, 2019 (the date of the Merger) to develop reasonable expectations about future exercise patterns and
employment duration for our options, (3) the risk-free interest rate based on U.S. Treasury notes with a term approximating the expected life of the option and (4) expected dividend yield of 0, since we have never paid cash dividends and have
no present intention to pay cash dividends.
The Company expenses the fair value of its stock-based compensation awards to employees, directors and non-employees on a straight-line basis over the requisite service period, which is generally
the vesting period. The Company recognizes forfeitures as they occur.
(J) Net income (loss) per common share:
Basic net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average
number of common shares outstanding during the period. All participating securities are excluded from basic weighted-average common shares outstanding. In computing both basic net income (loss) per share attributable to common stockholders and
diluted net income (loss) per share attributable to common stockholders, undistributed earnings are re-allocated to reflect the potential impact of dilutive securities, including stock options and warrants. Diluted net income (loss) per share
attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period. Diluted net income (loss) per share
attributable to common stockholders includes any dilutive effect from outstanding stock options and warrants using the treasury stock method.
The common stock issuable upon the conversion or exercise of the following dilutive securities as of March 31, 2020 has been excluded from the diluted net loss per share
attributable to common stockholders calculation because their effect would have been antidilutive for the period presented.
The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows:
|
Three Months Ended
March 31, 2020
|
||||
|
Stock options to purchase Common Stock
|
|
1,413,073
|
||
|
Warrants to purchase Common Stock
|
197,518
|
|||
|
Total
|
|
1,610,591
|
||
The following is a reconciliation of the numerator (net income or loss) and the denominator (number of shares) used in the calculation of basic and diluted net
income (loss) per share attributable to common stockholders:
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Numerator
|
||||||||
|
Basic and diluted net (loss) income
|
$
|
(3,985,408
|
)
|
$
|
6,816,698
|
|||
|
Denominator
|
||||||||
|
Shares used in computing basic net (loss) income per share
|
10,314,761
|
3,748,325
|
||||||
|
Shares from dilutive securities
|
–
|
876,970
|
||||||
|
Shares used in computing diluted net (loss) income per share
|
10,314,761
|
4,625,295
|
||||||
|
Net (loss) income per share, basic
|
$
|
(0.39
|
)
|
$
|
1.82
|
|||
|
Net (loss) income per share, diluted
|
$
|
(0.39
|
)
|
$
|
1.47
|
|||
(K) Accounting standards adopted:
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles
for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The Company adopted the new lease
standard, as of January 1, 2019, using the optional transition method under which comparative financial information will not be restated and continue to apply the provisions of the previous lease standard in its annual disclosures for the
comparative periods. In addition, the new lease standard provides a number of optional practical expedients in transition. The Company elected the package of practical expedients. As such, the Company did not have to reassess whether expired
or existing contracts are or contain a lease; did not have to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. Furthermore, the Company did not have any leases impacted by
ASC 842 on the adoption date. As part of the purchase price allocation from the reverse merger, the Company recorded a Right of Use asset and Liability of $1.4 million for office space located in Berkeley Heights, New Jersey. The lease for
property in Berkeley Heights was subsequently terminated. As of March 5, 2020 the Company entered into a new sub-lease for office space at Florham Park
commencing May 1, 2020. See note 6 for details.
The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the
short-term lease recognition exemption under which the Company will not recognize right-of-use (“ROU”) assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company
elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office building).
The Company determines if an arrangement is a lease at inception. Operating lease ROU assets and operating lease
liabilities are recognized based on the present value of the future minimum lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or
expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. As of March 31, 2020, there are no active leases accounted
for under ASC 842.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) (“ASU 2018-13”). ASU 2018-13 modifies disclosure requirements related to fair value measurement. On January 1, 2020, the Company adopted ASU 2018-07 and there was no impact to its financial statements.
In August 2018, the FASB issued ASU No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 reduces complexity for the accounting for costs of
implementing a cloud computing service arrangement and 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 obtain internal-use software (and hosting arrangements that include an internal use software license). On January 1, 2020, the Company adopted ASU 2018-07
and there was no impact to its financial statements.
Note 3 – Liquidity
As of March 31, 2020, the Company had $21.0 million of cash and cash equivalents, primarily provided by $29.1 million of pre-existing cash on Edge’s balance sheets that the Company obtained as a
result of the Merger and net proceeds of $12.8 million from the sale of our common stock. The Company's primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is
impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company's outstanding accounts payable and accrued expenses.
In July 2019, we entered into a common stock purchase agreement, or the Aspire Purchase Agreement, with Aspire Capital, which provides that, upon the terms and
subject to the conditions and limitations set forth therein, at our discretion, Aspire Capital is committed to purchase up to an aggregate of $20.0 million of shares of our common stock, or the Purchased Shares, over the 30-month term of the
Aspire Purchase Agreement. We may sell an aggregate of 1,034,979 shares of our common stock (which represented 19.99% of the Company’s outstanding shares of common stock on the date of the Aspire Purchase Agreement) without stockholder
approval. We may sell additional shares of our common stock above the 19.99% limit provided that (i) we obtain stockholder approval or (ii) stockholder approval has not been obtained at any time the 1,034,979 share limitation is reached and at
all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or greater than $5.76, which was the consolidated closing bid price of our common stock on July 26,
2019.. On July 29, 2019, we issued 100,654 shares of our common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement, which we refer to as the Commitment. As of March 31,
2020 no shares have been sold to Aspire.
In February 2020, we completed an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share. The shares
sold included 769,230 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price. We received gross proceeds of approximately $13 million and net proceeds of approximately $11.9
million after deducting underwriting discounts and commissions.
Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these
expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern
within one year beyond the filing of this Quarterly Report on Form 10-Q. The Company’s budgeted cash requirements in 2020 and beyond include expenses related to continuing development and clinical studies. Based on the Company’s available cash
resources and cash flow projections as of the date the consolidated financial statements were available for issuance, the Company believes there are sufficient funds to continue operations and research and
development programs for at least 12 months from the date of this report. Until the Company can generate significant cash from its operations, the Company expects to continue to fund its operations with its available financial resources. These
financial resources may not be adequate to sustain its operations.
The Company plans to continue to fund its operations and capital funding needs through equity and/or debt financings. However, the Company cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its existing stockholders. The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to its stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict the Company’s operations. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, it may be required to delay,
limit, reduce, or terminate its product development or future commercialization efforts or grant rights to develop and market immunotherapies that the Company would otherwise prefer to
develop and market itself. Any of these actions could harm the Company’s business, results of operations and prospects. Failure to obtain adequate
financing also may adversely affect the Company’s ability to operate as a going concern.
Note 4 – Reverse Merger
On March 15, 2019, the Company (then operating as Edge), Merger Sub and Private PDS completed the Merger in accordance with the Plan of Merger and Reorganization, dated as of November 23, 2018,
as amended on January 24, 2019, pursuant to and in accordance with which Merger Sub merged with and into Private PDS, with Private PDS surviving as the Company’s wholly-owned subsidiary. Immediately following completion of the Merger, the Company
effected the Reverse Stock Split at a ratio of one new share for every twenty shares of its common stock then-outstanding, and changed its corporate name from Edge Therapeutics, Inc. to PDS Biotechnology Corporation, and Private PDS, now the
Company’s wholly-owned subsidiary, changed its name to PDS Operating Corporation. The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section
368(a) of the Internal Revenue Code of 1986, as amended.
In connection with the Merger, each share of Private PDS’s common stock outstanding immediately prior to the Merger was converted into 0.3262 shares (on a post-Reverse Stock Split basis) of the
Company’s common stock. As a result, the Company issued 3,573,760 shares of its common stock to the stockholders of Private PDS in exchange for all of the outstanding shares of common stock of Private PDS.
For accounting purposes, Private PDS is considered to be the accounting acquirer in the Merger because Private PDS’s stockholders owned approximately 70% of PDS’s
common stock immediately following the closing of the Merger. As the accounting acquirer, Private PDS’s assets and liabilities continue to be recorded at their historical carrying amounts and the historical operations that will be reflected in
the Company’s financial statements will be those of Private PDS. All references in the unaudited interim condensed consolidated financial statements to the number of shares and per share amounts of the Company’s common stock have been
retroactively restated to reflect completion of the Merger and the Reverse Stock Split.
Purchase Price
Pursuant to the Merger Agreement, Edge issued to Private PDS's stockholders a number of shares of Edge’s common stock representing approximately 70% of the outstanding shares of common stock of
the combined company. The purchase price, which represents the consideration transferred to Edge’s stockholders in the Merger is calculated based on the number of shares of common stock of the combined company that Edge’s stockholders owned as of
the closing of the Merger on March 15, 2019, which consists of the following:
|
Number of shares of the combined company to be owned by Edge security holders (1)
|
1,600,166
|
|||
|
Multiplied by the price per share of Edge's common stock as of March 15, 2019
|
$
|
9.87
|
||
|
Purchase price (in thousands)
|
$
|
15,794
|
| (1) |
The amount includes 1,576,916 shares of Edge’s common stock outstanding as of March 15, 2019 plus 23,250 stock options of Edge that were in the money and vested immediately upon closing of the Merger. At the closing of the Merger, 753
of in-the-money options and 235 fractional shares paid out in cash to shareholders were not issued as common stock, resulting in 1,599,178 common shares issued.
|
Final Purchase Price Allocation
The Company completed its analysis of the allocation of the purchase price in the fourth quarter of 2019. The purchase price was allocated to the net assets acquired of Edge based upon their
preliminary estimated fair values as of March 15, 2019. The in-process research and development asset (“IPR&D”) that is recognized relates to Edge’s NEWTON 2 clinical trial for EG-1962 that has not
reached technological feasibility. The Company was actively looking to license out EG-1962 and had preliminary discussions with third parties who were actively looking at the data of EG-1962 during the
prior year. Accordingly, the IPR&D was initially capitalized as an indefinite-lived intangible asset and tested for impairment at least annually until it is determined that there is no future economic benefit from EG-1962. As a result of
capitalizing the IPR&D, the Company initially recognized an indefinite life deferred tax liability. During the three months ended June 30, 2019, two adjustments were made to the preliminary allocation. The first was for $275,000 relating to
an offer to purchase equipment that was given a value of $0 in the preliminary allocation. The second was for $65,551 relating to Edge's bonus plan that was effective prior to the date of acquisition. During the three months ended December 31,
2019 two additional adjustments were made to the preliminary valuation. The first was for an increase of $1,751,000 relating to the IPR&D in which the Company finalized the valuation of the IPR&D and as a result recognized an additional
deferred tax liability of $224,513. The second was for a write-off relating to a transition service arrangement that was effective prior to the date of the acquisition for $131,250. In accordance with ASC 805, Business Combinations any the excess
of the fair value of the acquired net assets over the purchase price has been recognized as a bargain purchase gain in the consolidated statement of operations and comprehensive loss. The Company has reassessed whether all the assets acquired,
and the liabilities assumed have been identified and recognized in the purchase price allocation.
The final allocation of the purchase price to the net assets of Edge, based on the fair values as of March 15, 2019, is as follows:
|
Cash and cash equivalents
|
$
|
29,106,513
|
||
|
Prepaid expense and other assets
|
1,585,482
|
|||
|
Right to use asset
|
1,384,810
|
|||
|
Intangible assets-IPR&D
|
2,974,000
|
|||
|
Total identifiable assets acquired
|
35,050,805
|
|||
|
Accounts payable, accrued expenses, other liabilities
|
(4,595,934
|
)
|
||
|
Lease liability
|
(945,152
|
)
|
||
|
Deferred tax liability
|
(381,513
|
)
|
||
|
Total liabilities assumed
|
(5,922,599
|
)
|
||
|
Net identifiable assets acquired
|
29,128,206
|
|||
|
Bargain purchase gain (1)
|
(13,334,568
|
)
|
||
|
Purchase price
|
$
|
15,793,638
|
| (1) |
Due to the aforementioned purchase price adjustments subsequent to March 31, 2019, the preliminary estimate of the bargain purchase gain was adjusted from $11,729,882 and finalized for the year ended December 31, 2019 at $13,334,568.
|
The fair value of the IPR&D was determined using the discounted cash flow method based on probability- adjusted cash flow success scenarios to develop EG-1962 into
a commercial product, estimating the revenue and costs. The rates utilized to discount the net cash flows to the present value are commensurate with the stage of development of the projects and uncertainties in the economic estimates used in the
projections.
During the three months ended December 31, 2019, the Company determined that the intangible asset related to Edge’s NEWTON 2 clinical trial for EG-1962 was
impaired due to significantly reduced activity in the data room and a lack of new interest from third parties to purchase or license the product. Further the Company does not have the internal resources to pursue EG 1962 as an
internal development project and has stated publicly that it had intended to find a partner to fund and run the EG 1962 program. The drop off in interest from third parties and the lack of any new inbound interest has made this an extremely low
probability of success. As a result for the year ended December 31, 2019, the Company recorded an impairment charge - IPR&D of $2,974,000 for the estimated value of the IPR&D asset of $2,974,000 in its
consolidated statement of operations and comprehensive loss.
Note 5 – Fair Value of Financial Instruments
There were no transfers among Levels 1, 2, or 3 during 2020 or 2019.
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
|
Total
|
Quoted Prices in
Active Markets
(Level 1)
|
Quoted Prices in
Inactive Markets
(Level 2)
|
Significant
Unobservable Inputs
(Level 3)
|
|||||||||||||
|
As of March 31, 2020: (unaudited)
|
||||||||||||||||
|
Cash and cash equivalents
|
$
|
21,037,806
|
$
|
21,037,806
|
$
|
–
|
$
|
–
|
||||||||
|
As of December 31, 2019:
|
||||||||||||||||
|
Cash and cash equivalents
|
$
|
12,161,739
|
$
|
12,161,739
|
$
|
–
|
$
|
–
|
||||||||
Note 6 – Leases
On July 8, 2019, the Company entered into a lease termination agreement for its office space located at 300 Connell Drive, Suite 4000, Berkeley
Heights, NJ 07922 effective August 31, 2019 (the “Lease Termination Agreement”). Pursuant to the Lease Termination Agreement, the Company was required to pay 50 percent of the remaining lease payments of $665,802 over three installments on
September 1, 2019, December 1, 2019, and March 1, 2020, which was recorded as lease termination costs in the third quarter of 2019. The Company maintains a month-to-month lease for its research facilities at the Princeton Innovation Center
BioLabs located at 303A College Road E, Princeton NJ, 08540. On August 31, 2019, the right-of-use asset of $1.2 million and operating lease liability of $1.2 million was written off. Leasehold improvements amounting to approximately $0.3 million
were also written off and are included in lease termination costs. The Company entered into a temporary month-to-month lease as of September 1, 2019 for office space located at 830 Morris Turnpike, Short Hills, NJ 07078 until the Company entered
into a new lease for permanent office space. This lease will terminate on May 31, 2020.
Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Florham Park, NJ. The sublease
commenced on May 1, 2020 and will continue for a term of forty (40) months with an option to renew through October 31, 2027. Upon inception of the lease, the Company expects to recognize approximately $0.7 million of a ROU asset and operating
lease liabilities. The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15%.
Note 7 – Accrued Expenses and Restructuring Reserve
Accrued expenses and other liabilities consist of the following:
|
As of
March 31, 2020
|
As of
December 31, 2019
|
|||||||
|
Accrued research and development costs
|
$
|
60,415
|
$
|
16,415
|
||||
|
Accrued professional fees
|
495,189
|
256,062
|
||||||
|
Accrued compensation
|
664,587
|
603,229
|
||||||
|
Accrued rent
|
–
|
221,934
|
||||||
|
Total
|
$
|
1,220,191
|
$
|
1,097,640
|
||||
Restructuring Reserve
|
As of
March 31, 2020
|
As of
December 31, 2019
|
|||||||
|
Restructuring reserve (1)
|
$
|
269,887
|
$
|
498,185
|
||||
|
Total
|
$
|
269,887
|
$
|
498,185
|
||||
| (1) |
Restructuring reserve relates to the severance costs incurred by Edge prior to the Merger and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through September 2020. For the
three months ended March 31, 2020, the Company paid $228,298 of restructuring expense which was previously recorded on Edge’s financials.
|
Note 8 – Stock-Based Compensation
The Company has four equity compensation plans: the 2009 Amended Stock Option Plan, the 2010 Equity Incentive Plan, the 2014 Equity Incentive Plan and the 2018 Stock
Incentive Plan (the “Plans”). Originally, the Company was able to grant up to 27,410 of Common Stock as both incentive stock options (“ISOs”) and nonqualified stock options (“NQs”) under the 2010 Equity Incentive
Plan. In 2013, the Company's stockholders approved an increase to 63,957 shares authorized for issuance under the 2010 Equity Incentive Plan. In 2014, the Board of Directors of the Company (the “Board”) approved an increase to 67,520 shares authorized for issuance under the 2010 Equity Incentive Plan.
In 2014, the Company's stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock
units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015 and each
January 1 thereafter prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock
outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. On January 1, 2016, 2017, 2018 and 2019 the Plan Limit was increased to 152,366 shares, 210,203 shares,
271,941 shares and 323,529 shares, respectively. In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares.
In 2018, the Company's stockholders approved the 2018 Stock Incentive Plan pursuant to which the Company may grant up to 558,071 shares as Stock Options, (ii) Stock
Appreciation Rights, (iii) Restricted Stock, (iv) Deferred Stock, (v) Stock Reload Options and/or (vi) Other Stock-Based Awards.
Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified
otherwise in an individual option agreement, ISOs generally vest over a four-year term and NQs generally vest over a one to five-year terms. Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or
until such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding. As of March 31, 2020 there were 190,799 shares available for grant under the 2018 Stock Incentive Plan.
On June 17, 2019, the Board adopted the 2019 Inducement Plan. The 2019 Inducement Plan provides for the grant of non-qualified stock options.
The 2019 Inducement Plan was recommended for approval by the Compensation Committee of the Board and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
The Board has reserved 200,000 shares of the Company's common stock for issuance pursuant to non-qualified stock options granted under the
2019 Inducement Plan, and the 2019 Inducement Plan will be administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the 2019 Inducement Plan may
only be made to an employee who has not previously been an employee or member of the Board (or any parent or subsidiary of the Company), or following a bona fide period of non-employment by the Company (or a parent or subsidiary of the
Company), if he or she is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with
the Company or such subsidiary. As of March 31, 2020, there were 126,500 shares available for grant under the 2019 Inducement Plan.
The Company’s stock-based compensation expense was recognized in operating expense as follows:
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
(unaudited)
|
||||||||
|
Stock-Based Compensation
|
||||||||
|
Research and development
|
$
|
52,684
|
$
|
440,700
|
||||
|
General and administrative
|
72,308
|
2,314,171
|
||||||
|
Total
|
$
|
124,992
|
$
|
2,754,871
|
||||
The fair value of options and warrants granted during the three months ended March 31, 2020 was estimated using the Black-Scholes option valuation model utilizing the following assumptions:
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Weighted Average
|
Weighted Average
|
|||||||
|
(unaudited)
|
||||||||
|
Volatility
|
92.56
|
%
|
83.00
|
%
|
||||
|
Risk-Free Interest Rate
|
1.56
|
%
|
2.49
|
%
|
||||
|
Expected Term in Years
|
6.01
|
6.25
|
||||||
|
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
||||
|
Fair Value of Option on Grant Date
|
$
|
0.99
|
$
|
6.54
|
||||
The following table summarizes the number of options outstanding and the weighted average exercise price:
|
Number
of Shares
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
|
Options outstanding at December 31, 2019
|
1,421,797
|
$
|
15.95
|
|||||||||||||
|
Granted
|
9,000
|
1.31
|
||||||||||||||
|
Exercised
|
–
|
–
|
||||||||||||||
|
Forfeited
|
–
|
–
|
||||||||||||||
|
Expired
|
(17,724
|
)
|
4.69
|
|||||||||||||
|
Options outstanding at March 31, 2020
|
1,413,073
|
$
|
16.00
|
6.85
|
$
|
–
|
||||||||||
|
Vested and expected to vest at March 31, 2020
|
1,413,073
|
$
|
16.00
|
6.85
|
$
|
–
|
||||||||||
|
Exercisable at March 31, 2020
|
982,643
|
$
|
20.43
|
5.80
|
$
|
–
|
||||||||||
At March 31, 2020 there was approximately $1,565,673 of unamortized stock option compensation expense, which is
expected to be recognized over a remaining average vesting period of 3.13 years.
Note 9 – Income Taxes
In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more
likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to
the expiration of the net operating loss carryforwards. The Company expects to have a loss for 2020 and there will be no current income tax expense. Additionally, there was a full valuation allowance against the net deferred tax assets as of March 31, 2020 and December 31, 2019. As such, the Company recorded no income tax benefit due to realization uncertainties.
The Company’s U.S. statutory rate is 21%. The primary factor impacting the effective tax rate for the three months ended March 31, 2020 is the anticipated full year operating loss which will
require full valuation allowances against any associated net deferred tax assets.
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its
tax positions and has concluded that as of March31, 2020, there were no uncertain positions. The Company's U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination
could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company did not have any unrecognized tax benefits and has not accrued
any interest or penalties for the three months ended March 31, 2020 and for the year ended December 31, 2019.
Note 10 – Commitments and Contingencies
Employment Matters
The Company has entered into employment agreements or offer letters with each of its executive officers. The employment agreements generally provide for, among other things,
salary, bonus and severance payments. The employment agreements generally provide for between 12 months and 24 months of severance benefits to be paid to an executive (as well as certain potential bonus, COBRA and equity award benefits), subject
to the effectiveness of a general release of claims, if the executive terminates his or her employment for good reason or if the Company terminates the executive's employment without cause. Such severance payments may be provided for as long as
24 months in connection with a termination following a change of control. The continued provision of severance benefits is conditioned on each executive's compliance with the terms of the Company's confidentiality and invention and assignment
agreement as well as his or her release of claims.
Rent
For the three months ended March 31, 2020 and 2019, rent was $58,641 and $11,076, respectively, for month-to-month arrangements not impacted by the adoption of ASC 842.
The Company has a 401(k) defined contribution plan for the benefit for all employees and permits voluntary contributions by employees subject to IRS-imposed
limitations. The 401K employer contributions were $9,800 and $0 for the three months ended March 31, 2020 and 2019, respectively.
Note 12– Subsequent Events
Subsequent events have been evaluated through the date these financial statements were issued.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
interim condensed consolidated financial statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with the audited financial statements
and notes thereto of the Company as of and for the year ended December 31, 2019 on Form
10-K filed with the Securities and Exchange Commission, or SEC, on March 27, 2020. As further described in “Note 1 – Nature
of Operations” and “Note 4 – Reverse Merger” in this Quarterly Report, Private PDS was determined to be the accounting acquirer in the Merger and, accordingly, the pre-Merger historical financial information presented in this Quarterly Report
reflects the standalone financial statements of Private PDS and, therefore, period-over-period comparisons may not be meaningful. Except as otherwise indicated herein or as the context otherwise
requires, references in this Quarterly Report to “PDS” “the Company,” “we,” “us” and “our” refer to PDS Biotechnology Corporation, a Delaware corporation, on a post-Merger basis, and the term “Private
PDS” refers to the business of privately held PDS Biotechnology Corporation prior to completion of the Merger.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained
in this Quarterly Report, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable
terminology. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors” below. In light of these risks, uncertainties and assumptions, actual
results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this Quarterly Report and you should not place undue reliance on these forward-looking statements.
These forward-looking statements may include, but are not limited to, statements about:
| ● |
the accuracy of estimates of our expenses, future revenue, capital requirements and our needs for additional financing;
|
| ● |
our ability to obtain funding for our operations in the event we determine the need to raise additional capital;
|
| ● |
our ability to retain key management personnel;
|
| ● |
the accuracy of our estimates regarding expenses, future revenues and capital requirements;
|
| ● |
our ability to maintain our listing on the Nasdaq Stock Market;
|
| ● |
regulatory developments in the United States and foreign countries;
|
|
●
|
unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19;
|
| ● |
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”); and
|
| ● |
other risks and uncertainties, including those listed under Part II, Item 1A. Risk Factors.
|
Any forward-looking statements in this Quarterly Report reflect our views and assumptions only as of the date that this report is signed with respect to future events or to
our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these
forward-looking statements for any reason, even if new information becomes available in the future.
We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection
of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Overview
We are a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines that
are designed to overcome the limitations of current approaches. PDS owns Versamune®, a proprietary T-cell activating platform which is designed to train the immune system to better attack and destroy disease. When paired with an antigen, Versamune® has been shown to induce in vivo significantly higher quantity and quality of highly potent (polyfunctional) CD8+ killer T-cells, a specific
sub-type of CD8+ killer T-cell that is powerful at attacking disease. Versamune®-based products have demonstrated the potential to overcome the challenges of infectious disease vaccines and cancer immunotherapy.
The induction of CD8+ killer T-cells is important in both infectious disease vaccines and cancer immunotherapy. Current vaccine approaches focus predominantly on induction of antibody
responses. While that is helpful, we know that the induction of a T-cell response in addition to an antibody response would provide more durable protection against infectious diseases. Similarly, it is well documented that the most critical
attribute of an effective cancer immunotherapy is the induction of high levels of active antigen-specific CD8+ (killer) T-cells. Priming adequate levels of active CD8+ T-cells in-vivo continues to be a
major obstacle facing immunotherapy. PDS0101 in its first human clinical trial confirmed the impressive preclinical study results and demonstrated the unique in-vivo induction of high levels of active
HPV-specific CD8+ T-cells in humans. Since HPV is a virus, this demonstration confirmed the induction of CD8+ T-cells against a viral target, which informed the expansion of the pipeline into infectious disease vaccines.
We believe that the Versamune® platform has the potential to rapidly become an industry-leading immunotherapy
technology and is currently being applied to the development of a robust pipeline of infectious disease vaccines and cancer immunotherapies. We expect substantial value accretion as our development-stage products
successfully progress through planned human Phase 2 clinical trials. PDS planned PDS0101 clinical trials have been delayed as a result of the adverse impact the COVID-19 pandemic has had
on oncology clinical trial operations in the United States.
The unique combination of high potency and excellent safety of the Versamune® platform observed in preclinical
studies appears to be corroborated in a successfully completed 12-patient Phase 1/2a clinical trial. Despite most of the patients being infected with multiple HPV strains other than HPV 16, complete regression
of pre-cancerous lesions was documented in 6 out of 10 patients, which strongly suggested that the
T-cells induced by PDS0101 were clinically active. As a result of this information strongly suggesting the unique ability of PDS0101 to generate potent and biologically active CD8+ T-cells in-vivo, PDS modified its clinical strategy to focus on areas of more severe unmet medical need in which PDS0101 is combined with other immune modulating agents including checkpoint inhibitors
and standard of care e.g. chemoradiotherapy to provide improved clinical benefit to patients. On September 19, 2019, PDS reported retrospective clinical outcome data from this study. The study demonstrated robust treatment-induced
HPV16-specific killer T-cell (CD8+) responses as well as complete regression of lesions in 60% of evaluable patients, and partial regression in 20%. In additional preclinical studies focused on infectious diseases, unique and rapid generation of
neutralizing antibody immune responses have also been demonstrated by Versamune® in seasonal and pandemic influenza strains.
We believe that rational design of combination immunotherapies using agents that promote synergy with each other and reduced the potential for compounded toxicity would
substantially improve potential for combination therapies to deliver improved clinical benefit for cancer patients. Versamune® appears to activate the appropriate
combination of immunological pathways that promote strong CD8+ T-cell induction, while also altering the tumor’s microenvironment to make the tumor more susceptible to T-cell attack, which PDS believes makes it an ideal complement to the
checkpoint inhibitors by enhancing their potency. In addition, the differences in mechanism of action between Versamune® and checkpoint inhibitors, as well as the
initial demonstrated safety profile of Versamune®, suggests that these combinations may be much better tolerated by patients than many or most other combination
therapies involving checkpoint inhibitors.
On October 28, 2019, we entered into an amendment to the clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and
Canada) to evaluate the combination of our lead Versamune®-based immunotherapy, PDS0101, with Merck's
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a Phase II clinical trial. The planned clinical trial will evaluate the efficacy and
safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection. The modification to the clinical trial design to evaluate PDS0101 in
combination with KEYTRUDA® as first-line treatment comes as a result of Merck’s recent approval by the FDA on June 10, 2019 for first line treatment of patients with
metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) using KEYTRUDA® in combination with platinum and fluorouracil (FU) for all
patients and as a single agent for patients whose tumors express PD-L1 as determined by an FDA-approved test.
We previously announced that we had entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer
Institute (NCI) for the development of the PDS0101 HPV cancer immunotherapy in combination with other immune-modulating agents as a potential treatment for advanced HPV-related cancers. Under the agreement, we will collaborate with the NCI’s
Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB) with plans to conduct a Phase 2 clinical study evaluating PDS0101 with novel immune-modulating agents M7824 and NHS-IL12 owned by EMD Serono (Merck
KGaA), and being studied at NCI. The CRADA also involves preclinical evaluation of PDS0101 in combination with other therapeutic modalities upon the mutual agreement of both
parties. In April 2020 this CRADA was expanded to include clinical and pre-clinical development of PDS0103. PDS0103 is an investigational immunotherapy designed to treat cancers associated with the mucin-1 (MUC1) oncogenic C-terminal
region antigen. PDS0103 combines the utility of the Versamune® platform with novel highly immunogenic agonist epitopes of MUC1 developed in by the National Cancer
Institute (NCI). PDS0103 is currently in late preclinical development.
We anticipate a third Phase 2 clinical study with a major cancer research center to begin once the adverse
impact on oncology clinical trials due to COVID-19 improves. If initiated, the clinical study would likely investigate the safety and anti-tumor efficacy of the PDS0101-CRT combination, and their correlation with critical immunological
biomarkers in patients with locally advanced cervical cancer. The T-cell inducing power of Versamune® has the strong potential to enhance efficacy of the current standard of care chemo-radiotherapy. We are currently in negotiations regarding
a definitive agreement concerning the investigator initiated Phase 2 study and the scope and nature of such study will be subject to the terms of the definitive agreement, once agreed to by the parties.
On December 4, 2019, we entered into an Amended and Restated Material Transfer Agreement with Farmacore Biotechnology to develop a novel tuberculosis (TB)
immunotherapy based on Farmacore’s proprietary TB antigens and Versamune®. A prior material transfer
agreement under which preliminary work commenced was amended and restated due to promising early pre-clinical results and to progress to the next development phase. In preliminary evaluations, our Versamune
based TB product, PDS0201, demonstrated highly promising TB-specific T-cell induction in-vivo. We will undertake product development and Farmacore will conduct in-vivo pre-clinical studies to evaluate the efficacy of the product. The term of the agreement extends until the end of the product testing period and
may be terminated at any time by either party with 30 days’ notice.
We are advancing development of our leading COVID-19 vaccine candidate, PDS0203, which will combine Versamune with SARS-CoV-2 specific proteins. This vaccine will be designed to potentially provide long-term and broad protection against
infection from COVID-19 and its potential mutations. Further, our proprietary SARS-CoV-2 protein being administered with Versamune includes less variable regions of the virus. This means that the immune system will be trained to recognize
not only the outer shell of the virus, which are more likely to mutate, but also the more stable center part of the virus. This should help provide improved protection against potential mutations of the virus. We recently initiated
pre-clinical testing on our leading COVID-19 vaccine candidates to evaluate the level of both antibody and T-cell induction. Our goal is to advance a COVID-19 vaccine into human trials as quickly as possible and we are currently in active
discussions with both government agencies and non-governmental organizations to determine the most accelerated path to advance our Versamune-CoV-2 vaccine into clinical trials.
Since our inception in 2005, we have devoted substantially all our resources to developing our Versamune®
platform, advancing preclinical programs, conducting clinical trials, manufacturing PDS0101 for clinical trials, and providing general and administrative support. We have funded our operations primarily from the issuance of common stock. We have
not generated any product revenue.
We have never been profitable and have incurred net losses in each year since our inception. Our net losses were $7.0 million and $3.8 million for the years ended December 31, 2019 and 2018,
respectively. As of March 31, 2020, we had an accumulated deficit of $32.9 million. Substantially all of our net losses have resulted from costs incurred in connection with its research and development programs and from general and administrative
costs associated with these operations.
As of March 31, 2020, we had $21.0 million in cash and cash equivalents.
Our future funding requirements will depend on many factors, including the following:
| ● |
the timing and costs of our planned clinical trials;
|
| ● |
the timing and costs of our planned preclinical studies of our Versamune® platform;
|
| ● |
the outcome, timing and costs of seeking regulatory approvals;
|
| ● |
the impact of COVID-19 on company operations;
|
| ● |
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
|
| ● |
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights;
and
|
| ● |
the extent to which we in-license or acquire other products and technologies.
|
Corporate Information
We currently operate the existing business of Private PDS (as defined below) as a publicly traded company under the name PDS Biotechnology Corporation. We were
incorporated as Edge Therapeutics, Inc., or Edge, on January 22, 2009. Upon closing of the Merger (as defined below), we discontinued Edge’s prior business and acquired the business of PDS Biotechnology Corporation, a privately held Delaware
corporation, which we refer to as Private PDS, which is a clinical-stage biopharmaceutical company developing multi-functional cancer immunotherapies and transformative infectious disease vaccines that are designed to overcome the
limitations of the current approaches.
On March 15, 2019, we completed our previously disclosed reverse merger with Private PDS, which we refer to as the Merger, pursuant to and in accordance with
the terms of the Agreement and Plan of Merger, dated as of November 23, 2018, as amended on January 24, 2019, by and among Edge, Echos Merger Sub, a wholly-owned subsidiary of Edge, which we refer to as Merger Sub, and Private PDS, whereby
Private PDS merged with and into Merger Sub, with Private PDS surviving as our wholly-owned subsidiary. In connection with and immediately following completion of the Merger, we effected a 1-for-20 reverse stock split, or the Reverse
Stock Split, and changed our corporate name from Edge Therapeutics, Inc. to PDS Biotechnology Corporation, and Private PDS changed its name to PDS Operating Corporation. All of the outstanding stock of Private
PDS was converted into shares of our common stock or canceled upon closing of the Merger.
Following the Merger, the stockholders of Private PDS effectively control the combined company, and, accordingly, Private PDS is deemed to be the accounting
acquirer in the Merger. Accordingly, upon consummation of the Merger, the historical financial statements of Private PDS became our historical financial statements, and the historical financial
statements of Private PDS are included in the comparative prior periods below. See “Note 4 – Reverse Merger” in the financial notes to our unaudited interim financial statements in Part I for more information on the Merger.
KEY COMPONENTS OF OUR STATEMENT OF OPERATIONS
Revenue
We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future. We may generate revenue in the future
from a combination of research and development payments, license fees and other upfront payments or milestone payments.
Research and Development
Research and development expenses include employee-related expenses, licensing fees to use certain technology in our research and development projects, costs of acquiring,
developing and manufacturing clinical trial materials, as well as fees paid to consultants and various entities that perform certain research and testing on our behalf. Costs for certain development activities, such as clinical trials, are
recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities
are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid or accrued expenses. Costs incurred in connection with
research and development activities are expensed as incurred. The adverse impact of COVID-19 on research and development activities is being monitored closely including its impact on clinical trial initiation and
enrollment.
We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune®-based immuno-oncology candidates into and through clinical trials, pursue regulatory approval of our injectable Versamune® candidates
and prepare for a possible commercial launch, all of which will also require a significant investment in contract and internal manufacturing and inventory related costs.
The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our Versamune®-based products. The probability of successful commercialization of our immuno-oncology and infectious disease candidates may be affected by numerous factors,
including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19 competition, manufacturing capability and commercial viability. As a result, we are unable to
determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Results of Operations
The following table summarizes the results of our operations for the three months ended March 31, 2020 and 2019:
|
Three Months Ended
March 31,
|
Increase (Decrease)
|
|||||||||||||||
|
2020
|
2019
|
$ |
|
%
|
||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development expenses
|
$
|
1,972
|
$
|
1,030
|
$
|
942
|
91
|
%
|
||||||||
|
General and administrative expenses
|
2,060
|
3,906
|
(1,846
|
)
|
(47
|
)%
|
||||||||||
|
Total operating expenses
|
4,032
|
4,936
|
(904
|
)
|
(18
|
)%
|
||||||||||
|
Loss from operations
|
(4,032
|
)
|
(4,936
|
)
|
904
|
(18
|
)%
|
|||||||||
|
Gain on bargain purchase
|
–
|
11,730
|
(11,730
|
)
|
(100
|
)%
|
||||||||||
|
Interest income, net
|
46
|
23
|
23
|
100
|
%
|
|||||||||||
|
Net (loss) and comprehensive gain
|
$
|
(3,985
|
)
|
$
|
6,817
|
$
|
(10,803
|
)
|
(158
|
)%
|
||||||
Research and Development Expenses
Research and development (R&D) expenses increased to $1.9 million for the three months ended March 31, 2020 from $1.0 million for the three months ended March 31, 2019.
The increase of $0.9 million in 2020 was primarily attributable to an increase of $0.1 in personnel costs, $0.2 in professional services, $0.3 in regulatory expenses and $0.3 in clinical studies.
General and Administrative Expenses
General and administrative expenses decreased to $2.1 million for the three months ended March 31, 2020 from $3.9 million for the three months ended March 31, 2019. The
decrease of $1.8 million is primarily attributable to a decrease in personnel costs of $2.4 million, and $0.1 in legal fees, offset by an increase of $0.1 in facilities and office expenses, $0.1 in travel and insurance expense, $0.4 in
professional fees, and $0.1 in board fees.
Gain on Bargain purchase
Gain on Bargain Purchase was $0 for the three months ended March 31, 2020 and $11.7 million during the three months ended March 31, 2019. A
decrease of $11.7 million as compared to the three months ended March 31, 2020, due to the bargain purchase gain as a result of the Merger in March of 2019, resulting in excess of the fair value of net assets acquired over the fair value of the
common stock issued to acquire Private PDS in the Merger.
Interest income
Interest income, net was $0.46 million during the three months ended March 31, 2020, an increase of $0.23 million, as compared to $0.23 million during the three months ended
March 31, 2019, due primarily to interest received on invested cash and cash equivalents.
Liquidity and Capital Resources
In February 2020, we completed an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public
offering price of $1.30 per share. The shares sold included 769,230 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price. We received gross proceeds of approximately $13
million and net proceeds of approximately $11.9 million after deducting underwriting discounts and commissions. Our operations have also been financed from cash of $29.1
million from the consummation of the Merger in March 2019. As of March 31, 2020, we had $21.0 million of cash and cash equivalents.
Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these
expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within
one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation and our current plans, which are subject to change, management believes that our existing cash and cash equivalents as of March 31, 2020 and proceeds
expected to become available through government funding programs will be sufficient to satisfy our operating cash needs for at least one year after the filing of this Quarterly Report on Form 10-Q.
We plan to continue to fund our operations and capital funding needs through equity and/or debt financings. We may also enter into government funding programs and consider selectively partnering
for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt
could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our
product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and
prospects.
On July 29, 2019, we entered into a common stock purchase agreement, or the Aspire Purchase Agreement, pursuant to which, we have the right, in our sole discretion, to present Aspire Capital
Fund, LLC, or Aspire Capital, with a purchase notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of our common stock per business day, in an aggregate amount of up to $20.0 million of our common stock, or the
Purchased Shares, over the term of the Aspire Purchase Agreement at a per share price equal to the lesser of the lowest sale price of our common stock on the purchase date or the arithmetic average of the three lowest closing sale prices for our
common stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date. We may sell an aggregate of 1,034,979 shares of our common stock (which represented 19.99% of the Company’s outstanding shares
of common stock on the date of the Aspire Purchase Agreement) without stockholder approval. We may sell additional shares of our common stock above the 19.99% limit provided that (i) we obtain stockholder approval or (ii) stockholder approval has
not been obtained at any time the 1,034,979 share limitation is reached and at all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or greater than $5.76, which was the consolidated
closing bid price of our common stock on July 26, 2019. The minimum price at which we can sell shares under the Aspire Purchase Agreement is $0.50. On July 29, 2019, we issued 100,654 shares of our common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement, which we refer to as the Commitment Shares. We recorded the fair value of the
shares at July 29, 2019 of $603,924 as an expense in the third quarter of 2019. Concurrently with the Aspire Purchase Agreement, we entered into a registration rights agreement with Aspire Capital, or the Registration Rights Agreement. In
accordance with the Registration Rights Agreement, on August 20, 2019 we filed a Registration Statement on Form S-1 (File No. 333-232988) to cover the resale of the Commitment Shares and any Purchased Shares issuable to Aspire Capital under the
Aspire Purchase Agreement. There is market uncertainty regarding the utilization of financing associated from the Aspire Purchase Agreement. As of March 31, 2020, no
Purchase Shares were sold to Aspire Capital under the Aspire Purchase Agreement.
Cash Flows
The following table shows a summary of our cash flows for each of the periods indicated (in thousands):
|
Three Months Ended March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Net cash used in operating activities
|
$
|
(3,164
|
)
|
$
|
(3,367
|
)
|
||
|
Net cash provided by investing activities
|
–
|
29,106
|
||||||
|
Net cash provided by financing activities
|
12,040
|
750
|
||||||
|
Net increase in cash and cash equivalents
|
$
|
8,876
|
$
|
26,489
|
||||
Net Cash Used in Operating Activities
Net cash used in operating activities was $3.2 million and $3.4 million for the three months ended March 31, 2020 and 2019, respectively. The
decrease in cash used in operating activities of $0.2 million was primarily due to the increase of accounts payable.
Net Cash Provided by Investing Activities
Net cash provided by investing activities for the three months ended March 31, 2019 relates entirely to cash received in the Merger.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2020 was due to the receipt of net proceeds from the issuance of common stock of $12.0 million.
Net cash provided by financing activities for the three months ended March 31, 2019 was primarily due to the
receipt of net proceeds of $0.8 million due to the issuance of common stock.
Operating Capital Requirements
To date, we have not generated any product revenue. We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue unless and until
we obtain regulatory approval and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the
development of, and seek regulatory approvals for, our tablet vaccine candidates, and begin to commercialize any approved vaccine candidates. We are subject to all of the risks incident to the development of new
products, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and anticipate that we
will need substantial additional funding in connection with our continuing operations.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within
one year beyond the filing of this Quarterly Report. Our budgeted cash requirements in 2020 and beyond include expenses related to continuing development and clinical studies. We believe that our existing cash and cash equivalents as of March 31, 2020 are sufficient to continue operations and research and development programs for at least the next 12 months from the date of this Quarterly Report. Until we can generate significant cash from our
operations, we expect to continue to fund our operations with available financial resources. These financial resources may not be adequate to sustain our operations.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because
of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will
depend on many factors, including, but not limited to:
| ● |
the initiation, progress, timing, costs and results of our planned clinical trials;
|
| ● |
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory authorities;
|
| ● |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
| ● |
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
|
| ● |
the effect of competing technological and market developments;
|
| ● |
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our tablet vaccines on our own; and
|
| ● |
the initiation, progress, timing and results of our commercialization of our tablet vaccine candidates, if approved, for commercial sale.
|
Please see the section titled “Risk Factors” elsewhere in the Quarterly Report for additional risks associated with our operations.
Purchase Commitments
We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase order basis.
Critical Accounting Polices and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance
with U.S. GAAP. The preparation of these financial statements requires us to make estimates 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 revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions.
As a result of the impairment and write-off of the IPR&D asset at year end, the only critical accounting policy and estimate we have for the three months ended March 31,
2020 is related to the stock based compensation.
Impact of the CARES Act
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted and signed into law, and GAAP requires recognition of the
tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the
2017 Tax Cuts and Jobs Act, including, permitting net operating losses, or NOLs, carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019,
and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The CARES Act provides other reliefs and stimulus measures. We are currently evaluating the impact of the CARES Act, however, at present we do not expect that any provision of the CARES Act would result in a material cash benefit to us or have a material impact on our financial statements or internal controls over financial
reporting.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards
apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Furthermore, we anticipate that we will no longer be an emerging growth company as of
December 31, 2020.
| ITEM 3: |
The primary objectives of our investment activities are to ensure liquidity and to preserve principal, while at the same time maximizing the income we receive from our cash
and marketable securities without significantly increasing risk. As of March 31, 2020, we had cash equivalents of $21.0 million that were held in a non-interest-bearing money operating account and an institutional U.S. Treasury money market fund.
Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, we
do not believe that an immediate 100 basis point change in interest rates would have a material effect on the fair market value of our cash equivalents. To minimize the risk in the future, we intend to maintain our portfolio of cash equivalents
and short-term investments in institutional market funds that are comprised of U.S. Treasury and Treasury backed repurchase agreements.
| ITEM 4: |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Principal Accounting Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2020.
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, or DCPs, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by
a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. DCPs include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on the evaluation of our DCPs, our Chief Executive Officer and Principal Accounting Officer concluded that, due to a previously reported material weakness, our
internal control over financial reporting was not effective as of March 31, 2020. Specifically, we identified a material weakness in four components of internal control as defined by COSO 2013 (Control Environment, Risk Assessment, Control
Activities and Information & Communication). These material weaknesses resulted in the immaterial error correction of the consolidated financial statements and related notes as of December 31, 2018 and for the year then ended and immaterial
errors corrected within the consolidated financial statements as of and for the year then ended December 31, 2019.
Control Environment - We did
not have adequate finance and accounting personnel with the appropriate U.S. GAAP technical expertise to identify, evaluate and account for complex and non-routine transactions.
Risk Assessment – We did not
maintain an effective risk assessment that successfully identified and assessed risks of misstatement to ensure controls were designed and implemented to respond to the risks related to the reverse-merger transaction.
Information & Communication – We did not maintain an effective information and communication process to identify, capture and process relevant financial information necessary for financial accounting and reporting.
As a consequence, we did not have effective control activities related to the design, implementation and operation for process level control activities related to
equity transactions, stock- based compensation, recognition of intangible assets, debt extinguishment, and business combination transaction costs.
A material weakness is a deficiency, or combination of control deficiencies, in internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), or
ICFR, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
Remediation Efforts to Address Material Weakness
As previously described in Item 9A of our Annual Report on Form 10-K for the year ended December 31, 2019, we began implementing a remediation plan to address the
material weaknesses mentioned above.
While we believe that we have improved our organizational capabilities, the material weaknesses remained unremediated as of March 31, 2020 and our remediation
activities are continuing to take place in 2020. We continue to strengthen our internal control over financial reporting and we are committed to ensuring
that such controls are designed and operating effectively.
The material weakness will not be considered remediated until the applicable controls are designed, implemented and operating for a sufficient period of time and management has concluded, that
these controls are operating effectively.
Changes in Internal Control over Financial Reporting
In addition to our identification and assessment of the material weakness described above, we are currently integrating our pre-Merger business into the
pre-established internal control framework of Edge through the acquisition, including internal controls and information systems. This work began upon completion of the Merger in March 2019 and will continue throughout calendar year 2020. We have
modified some of our internal control procedures due to the COVID-19 restrictions.
Edge was previously subject to the provisions of the Sarbanes-Oxley Act of 2002, as amended, whereas Private PDS a private, non-reporting operating company was not. Our company has an appropriate
structure for internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report.
| PART II. |
OTHER INFORMATION
|
| ITEM 1. |
We, and our subsidiaries, are not currently a party to, and our property is not currently the subject of, any material pending legal proceedings; however, we may become
involved in various claims and legal actions arising in the ordinary course of business.
| ITEM 1A. |
Any investment in our business involves a high degree of risk. Before making an investment decision, you should carefully consider the information we include in
this Quarterly Report on Form 10-Q, including our unaudited interim condensed consolidated financial statements and accompanying notes, and the additional information in the other reports we file with the Securities and Exchange Commission.
These risks may result in material harm to our business and our financial condition and results of operations. In this event, the market price of our common stock may decline and you could lose part or all of your investment. The risks described below may not be the only ones relating to our company. Additional risks that we currently believe are immaterial may also
impair our business operations. Our business, financial conditions and future prospects and the trading price of our common stock could be harmed as a result of any of these risks. Investors should
also refer to the other information contained or incorporated by reference in our Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 27, 2020, including our financial statements and related notes, and our other
filings from time to time with the Securities and Exchange Commission or SEC.
The risk factors set forth below contain material changes from, or additions to, the risk factors previously disclosed and included in our
Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 27, 2020.
Risks Related to Our Business, Financial Position and Capital Requirements
We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future
and may never achieve or maintain profitability.
We have never generated any product revenues and expect to continue to incur substantial and increasing losses as we continue to develop PDS0101 and other Versamune® based Products. PDS0101 has not been approved for marketing in the United States and may never receive such approval. As a result, we are uncertain when or if we will
achieve profitability and, if so, whether we will be able to sustain it. Our ability to generate revenue and achieve profitability is dependent on our ability to complete development, obtain necessary regulatory approvals, and have PDS0101
manufactured and successfully marketed. We cannot assure you that we will be profitable even if we successfully commercialize PDS0101 or other Versamune® Products.
If we successfully obtain regulatory approval to market PDS0101, our revenues will be dependent, in part, upon, the size of the markets in the territories for which regulatory approval is received, the number of competitors in such markets for
the approved indication, and the price at which we can offer PDS0101. If the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment
guidelines, we may not generate significant revenue from sales of PDS0101, even if approved. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become and
remain profitable the market price of our common stock and our ability to raise capital and continue operations will be adversely affected.
We expect research and development expenses to increase significantly for PDS0101 and other Versamune® Products. In addition, even if we obtain regulatory approval, significant sales and marketing expenses will be required to commercialize PDS0101. As a result, we expect to continue to incur significant and increasing operating
losses and negative cash flows for the foreseeable future. These losses have had and will continue to have an adverse effect on our financial position and working capital. As of the three months ended March 31,
2020, we had an accumulated deficit of $32.9 million.
We will require additional capital to fund our operations, and if we fail
to obtain necessary financing, we may not be able to complete the development and commercialization of PDS0101.
Based upon our current operating plan, we believe that our cash reserves will be sufficient to fund our operating expenses and
capital expenditure requirements for at least the next 12 months from the date of this report. Our estimate as to what we will be able to accomplish is based on assumptions that may prove to be inaccurate, and we could exhaust our available
capital resources sooner than is currently expected. Because the length of time and activities associated with successful development of PDS0101 is highly uncertain, we are unable to estimate the actual funds we will require for development and
any approved marketing and commercialization activities. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:
| ● |
| ● |
the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authority;
|
| ● |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
| ● |
the cost of defending potential intellectual property disputes, including any patent infringement actions brought by third parties against us now or in the future;
|
| ● |
the effect of competing technological and market developments;
|
| ● |
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize PDS0101 on our own; and
|
| ● |
the initiation, progress, timing and results of the commercialization of PDS0101, if approved, for commercial sale.
|
Additional funding may not be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient
amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of PDS0101 or potentially discontinue operations. In July 2019, we
entered into a common stock purchase agreement, or the Aspire Purchase Agreement, with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth therein, at our discretion, Aspire Capital is
committed to purchase up to an aggregate of $20.0 million of shares of our common stock, or the Purchased Shares, over the 30-month term of the Aspire Purchase Agreement. We may sell an aggregate of 1,034,979 shares of our common stock (which represented 19.99% of
the Company’s outstanding shares of common stock on the date of the Aspire Purchase Agreement) without stockholder approval. We may sell additional shares of our common stock above the 19.99% limit provided that (i) we obtain stockholder
approval or (ii) stockholder approval has not been obtained at any time the 1,034,979 share limitation is reached and at all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or
greater than $5.76, which was the consolidated closing bid price of our common stock on July 26,
2019. On July 29, 2019, we issued 100,654 shares of our common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement, which we refer to as the Commitment Shares. As of March 31, 2020, no Purchase Shares have
been sold to Aspire Capital under the Aspire Purchase Agreement. Further, our use of the Aspire Purchase Agreement is subject to certain additional limitations set forth elsewhere in this report. As such, our ability to use the Aspire Purchase
Agreement to raise additional capital is uncertain.
We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.
Our future financial performance and our ability to commercialize PDS0101 and compete effectively will depend, in part, on our ability to effectively manage any future growth. As of March 31, 2020, we had 16 employees and 5 consultants. We expect to hire additional employees for our managerial, clinical, scientific and engineering, operational, manufacturing, sales
and marketing teams. Additionally, as part of our material weakness remediation plan, we intend to hire a new Chief Financial Officer and accounting and finance personnel as needed. We may have operational difficulties in connection with
identifying, hiring and integrating new personnel. Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate and integrate additional employees, consultants
and contractors. Also, our management may need to divert a disproportionate amount of our attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively
manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected
growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of PDS0101. If we are unable to effectively manage our growth, our expenses may increase more than expected, our
ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy.
Many of the other pharmaceutical companies that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles and a longer history
in the industry than us. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates and consultants than what it has to offer. If we
are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can select and develop PDS0101 and our business will be limited.
We have identified material weaknesses in our internal control over financial reporting, and if we are unable to
remediate such material weaknesses and to maintain effective internal control over financial reporting in the future, there could be an elevated possibility of a material misstatement, and such a misstatement could cause investors to lose
confidence in our financial statements, which could have a material adverse effect on our stock price.
As disclosed in Item 4 of this report, we have identified material weaknesses in our internal control over financial reporting.
Our management team has taken action to begin to remediate the material weaknesses, primarily through improved processes, policies, training and
skilled personnel, but we cannot be certain when the remediation will be completed. If we fail to fully remediate the material weaknesses or fail to maintain effective internal controls, it could result in a material misstatement of our financial
statements, which could cause investors to lose confidence in our financial statements or cause our stock price to decline. In future periods, we may identify additional deficiencies in our system of internal control over financial reporting
during the course of our remediation efforts that may require additional work to address. Any future material weaknesses in internal control over financial reporting could result in material misstatements in our financial statements and we could
be required to restate our financial results, which could lead to substantial additional costs for accounting and legal fees and shareholder litigation. Moreover, any future disclosures of additional weaknesses, or errors as a result of those
weaknesses, could result in investors losing confidence in our reported financial information and may lead to a decline in the stock price. For more information about these material weaknesses, see Item 4, “Controls and Procedures”.
General Market Risk Factors
Changes in tax laws and regulations or our operations may impact our effective tax rate and may adversely affect our business,
financial condition and operating results.
Changes in tax laws in any jurisdiction in which we operate, or adverse outcomes from any tax audits that we may be subject to in any such
jurisdictions, could result in an unfavorable change in our effective tax rate, which could adversely affect our business, financial condition, and operating results.
On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act, or the Tax Act. The changes included in the
Tax Act are broad and complex. The impact of these changes on how the combined company’s earnings are taxed include, among other items, (i) reducing the U.S. federal corporate tax rate from 35% to 21%; (ii) repealing the corporate alternative
minimum tax and changing how existing credits can be utilized; (iii) temporarily providing for elective immediate expensing for certain depreciable property; (iv) creating a new limitation on the deductibility of interest expense; and (v)
changing rules related to uses and limitations of net operating losses created in tax years beginning after December 31, 2017. We are continuing to evaluate the Tax Act and its impact on our business. It is possible that the Tax Act will be
subject to further changes either in a technical corrections bill or entirely new legislation. The overall impact of the Tax Act also depends on the future interpretations and regulations that may be issued by U.S. tax authorities. We expect
there will be further guidance provided by these authorities potentially having a material adverse effect on our financial condition or results of operations. The impact of broad proposals or of regulatory issuances on our business can vary
substantially depending upon the specific changes or further guidance made and how the changes or guidance are implemented by the authorities.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted and signed into law, and GAAP requires recognition
of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections
to the 2017 Tax Cuts and Jobs Act including permitting NOLs, carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried
back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The CARES Act provides other reliefs and stimulus measures. We are currently evaluating the impact of the CARES
Act, however, at present we do not expect that any provision of the CARES Act would result in a material cash benefit to us or have a material impact on our financial statements or internal controls over financial reporting.
Future sales of shares by existing stockholders could cause our stock price to decline.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after certain legal restrictions on resale lapse, the trading
price of our common stock could decline. As of March 31, 2020, we had 15,350,445 shares of common stock outstanding. Approximately 9,249,000 of such shares are freely tradable, without
restriction, in the public market. Approximately 6,101,445 of such shares of common stock are held by directors, executive officers and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act and
various vesting agreements.
Ownership of our common stock is highly concentrated, which may prevent our stockholders from influencing significant
corporate decisions and may result in conflicts of interest that could cause our stock price to decline.
Our current executive officers and directors as a group beneficially own or control approximately 17.8% of the outstanding shares of our common stock as of March 31, 2020. Accordingly, these
executive officers, directors and their affiliates, acting as a group, will have substantial influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of
all or substantially all of our assets or any other significant corporate transactions. These stockholders may also delay or prevent a change of control of our company, even if such a change of control would benefit our other stockholders. The
significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise.
We are required to meet the Nasdaq Capital Market’s continued listing requirements and other Nasdaq rules meet such rules and requirements, we may be
subject to delisting. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.
We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and
independent committee requirements, minimum stockholders’ equity, minimum share price and certain other corporate governance requirements. In particular, we are required to maintain a minimum bid price for our listed common stock of $1.00 per
share. In response to current volatile stock market conditions as a result of the COVID-19 pandemic, Nasdaq has determined to toll the minimum bid price requirement and the requirement to maintain at least a $1,000,000 market value our common for
at least 30 consecutive business days on the Nasdaq Capital Market. If we do not meet these continued listing requirements, our common stock could be delisted. Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for
trading of these securities on other markets or exchanges, including the OTC BB or QB markets, or on the OTC “pink sheets.” In such case, our stockholders’ ability to trade, or obtain quotations of the market value of our common stock would be
severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices of our securities. There can be no assurance that our securities, if delisted
from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the OTC markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of
potential delisting, would also result in negative publicity, make it more difficult for us to raise additional capital, cause us to lose eligibility to register the sale or resale of our shares on Form S-3 and the automatic exemption from
registration under state securities laws for exchange-listed securities, adversely affect the market liquidity of our securities, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence.
Our business operations, financial condition, results of operations and cash flows have been adversely affected and will
likely continue to be adversely affected by the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic.
Our business could be adversely affected by health epidemics in regions where we have concentrations of clinical trial sites or other business operations, and could cause
significant disruption in the operations of third-party manufacturers and CROs upon whom we rely.
For example, in December 2019, a novel strain of coronavirus, COVID-19, was identified in Wuhan, China. This virus
continues to spread globally and in March 2020, the World Health Organization declared COVID-19 a pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains
and created significant volatility and disruption of financial markets. The COVID-19 pandemic began to have a material adverse impact on our results of operations in the quarter ended March 31, 2020, and we expect it to continue to adversely
affect our business. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been implemented across much of the United States,
Europe and Asia, including in the locations of our offices, clinical trial sites, key vendors and partners. Our clinical development program timelines have been and continue to be negatively affected by COVID-19, as evidenced by the postponement
of the initiation of our Phase 2 VERSATILE-002 trial for PDS0101, which has and could continue to materially and adversely affect our business, financial condition and results of operations. The evolving COVID-19 pandemic has also impacted the
pace of enrollment in clinical trials and we may be affected by similar delays as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no
longer get to the clinic. Such facilities and offices have been and may continue to be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, thereby decreasing availability, in whole or in
part, for clinical trial services. Further, due to “shelter in place” orders and other public health guidance measures, we have implemented a work-from-home policy for all staff members excluding those necessary to
maintain minimum basic operations. Our increased reliance on personnel working from home may negatively impact productivity, or disrupt, delay or otherwise adversely impact our business. In addition, the
COVID-19 pandemic has affected and may continue to affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals.
As a result of the COVID-19 outbreak, or similar pandemics, and related “shelter in place” orders and other public health guidance measures, we
have and may in the future experience disruptions that materially and adversely impact our clinical trials, business, financial condition and results of operations. Potential disruptions include but are not limited to:
| ● |
delays or difficulties in enrolling patients in our clinical trials;
|
| ● |
delays or difficulties in initiating or expanding clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff;
|
| ● |
increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19 or other health conditions or being forced to quarantine;
|
| ● |
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical
trials;
|
| ● |
interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or
interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints;
|
| ● |
interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;
|
| ● |
delays or disruptions in preclinical experiments and investigational new drug application-enabling studies due to restrictions of on-site staff and unforeseen circumstances at contract research
organizations and vendors;
|
| ● |
interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in
delivery systems;
|
| ● |
limitations on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions and “shelter in place” orders;
|
| ● |
limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of
employees to avoid contact with large groups of people; and
|
| ● |
interruption or delays to our sourced discovery and clinical activities.
|
Further, on March 25, 2020, the FDA issued Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic for Industry, Investigators, and
Institutional Review Boards to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practices, and minimizing risks to trial integrity during the COVID-19 Pandemic, or the COVID-19 Guidelines.
The policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services on January 31, 2020. We have implemented
several procedures in accordance with the COVID-19 Guidelines to address patient safety and clinical trial conduct during the COVID-19 pandemic, including remote monitoring of patients through telemedical visits, remote monitoring of sites by our
clinical trial monitors, remote data entry, and follow-up visits at sites other than the site where the patient was initially treated. Our implementation of the COVID-19 Guidelines and
potential disruptions to patient follow up, site monitoring or the timely completion of our trials may have a negative effect on our ability to complete trials and associated regulatory filings.
While the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the
impact of the COVID-19 pandemic on the global financial markets has reduced and may continue to
reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity. We do not yet know the full extent of potential delays or impacts on our business, financing or clinical trial activities or on
healthcare systems or the global economy as a whole. However, these effects have had and may continue to have a material impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely and a recession or market correction resulting from the
spread of COVID-19 could materially affect our business and the value of our common stock. In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic. We will continue to monitor the COVID-19 situation closely.
| ITEM 2. |
There were no unregistered sales of the Company’s equity securities during the three months ended March 31, 2020.
| ITEM 3. |
None.
| ITEM 4. |
Not applicable.
| ITEM 6. |
EXHIBITS
|
A list of exhibits filed with this Quarterly Report or incorporated herein by reference is set forth in the Exhibit Index immediately preceding the signature page of this
report and is incorporated into this Item 6 by reference.
|
Exhibit
Number
|
Exhibit Description
|
|
|
Sublease Agreement, effective as of March 5, 2020, by and between PDS Biotechnology Corporation and COWI North America, Inc. (filed as Exhibit 10.37 to the Company’s Annual Report on
Form 10-K on March 27, 2020 and incorporated herein by reference).
|
||
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
| * |
The certifications furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to accompany this Quarterly Report and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, except to the extent that the Company specifically incorporates it by reference.
|
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
PDS Biotechnology Corporation
|
||
|
May 13, 2020
|
By:
|
/s/ Frank Bedu-Addo
|
|
Frank Bedu-Addo
|
||
|
President and Chief Executive Officer
|
||
|
May 13, 2020
|
By:
|
/s/ Janetta Trochimiuk
|
|
Janetta Trochimiuk
|
||
|
Controller
|
||
|
(Principal Accounting Officer)
|
33