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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For
the Quarterly Period Ended
March 31, 2022
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For
the Transition Period from _________ to _________
Commission
file number:
000-21990
Oncotelic Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
13-3679168 |
(State
or other jurisdiction
of
incorporation or organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
29397 Agoura Road
Suite 107
Agoura Hills,
CA
|
|
91301 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(650)
635-7000
(Registrant’s
telephone number, including area code)
Mateon Therapeutics, Inc.
(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 exchange on which registered |
None |
|
OTLC |
|
N/A |
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a small reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” a “smaller
reporting company” and an “emerging growth company” in Rule 12b-2
of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act: ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of
May 16, 2022, there were
378,630,104 shares of the registrant’s common stock
outstanding.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
(Formerly
Mateon Therapeutics, Inc.)
FORM
10-Q
FOR
THE QUARTERLY PERIOD ENDED MARCH 31, 2021
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
The
accompanying footnotes are an integral part of these unaudited
consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
For the Three MONTHS ended MARCH 31, 2022 and
2021
(Unaudited)
The
accompanying footnotes are an integral part of these unaudited
consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2022
(Unaudited)
The
accompanying footnotes are an integral part of these unaudited
consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2021
|
|
|
Shares |
|
|
|
Amount |
|
|
|
Shares |
|
|
|
Amount |
|
|
|
Capital |
|
|
|
Deficit |
|
|
|
Interests |
|
|
|
Equity |
|
|
|
Preferred
Stock |
|
|
Common
Stock |
|
|
Additional
Paid-in
|
|
|
Accumulated |
|
|
Non-controlling |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Interests |
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at January 1, 2021 |
|
|
278,188 |
|
|
$ |
2,782 |
|
|
|
90,601,912 |
|
|
$ |
906,019 |
|
|
$ |
32,493,086 |
|
|
$ |
(21,630,008 |
) |
|
$ |
708,954 |
|
|
$ |
12,480,833 |
|
Balance |
|
|
278,188 |
|
|
$ |
2,782 |
|
|
|
90,601,912 |
|
|
$ |
906,019 |
|
|
$ |
32,493,086 |
|
|
$ |
(21,630,008 |
) |
|
$ |
708,954 |
|
|
$ |
12,480,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
shares issued upon partial conversion of debt |
|
|
(278,188 |
) |
|
|
(2,782 |
) |
|
|
278,187,847 |
|
|
|
2,781,878 |
|
|
|
(2,779,096 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Common
shares issued upon partial conversion of debt |
|
|
- |
|
|
|
- |
|
|
|
657,200 |
|
|
|
6,572 |
|
|
|
203,729 |
|
|
|
- |
|
|
|
- |
|
|
|
210,301 |
|
Beneficial
conversion Feature on convertible debt |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
605,719 |
|
|
|
- |
|
|
|
- |
|
|
|
605,719 |
|
Warrants
issued in connection with private placement |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
166,575 |
|
|
|
- |
|
|
|
- |
|
|
|
166,575 |
|
Non-controlling
interest of Edgepoint |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
620,052 |
|
|
|
620,052 |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,803,080 |
) |
|
|
(319,557 |
) |
|
|
(3,122,637 |
) |
Balance
at March 31, 2021 |
|
|
- |
|
|
$ |
- |
|
|
|
369,446,959 |
|
|
$ |
3,694,469 |
|
|
$ |
30,690,013 |
|
|
$ |
(24,433,088 |
) |
|
$ |
1,009,449 |
|
|
$ |
10,960,843 |
|
Balance |
|
|
- |
|
|
$ |
- |
|
|
|
369,446,959 |
|
|
$ |
3,694,469 |
|
|
$ |
30,690,013 |
|
|
$ |
(24,433,088 |
) |
|
$ |
1,009,449 |
|
|
$ |
10,960,843 |
|
The
accompanying footnotes are an integral part of these unaudited
consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND
2021
(Unaudited)
The
accompanying footnotes are an integral part of these unaudited
condensed consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE
1 – DESCRIPTION OF
BUSINESS AND BASIS OF PRESENTATION
Description
of Business
Oncotelic
Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.)
(“Oncotelic”), was formed in the State of New York in 1988
as OXiGENE, Inc., was reincorporated in the State of Delaware in
1992, and changed its name to Mateon Therapeutics, Inc. in 2016,
and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic
conducts business activities through Oncotelic and its wholly owned
subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data,
Inc. (“PointR”), a Delaware corporation: and EdgePoint AI,
Inc. (“Edgepoint”), a Delaware Corporation for which there
are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR
and Edgepoint are collectively called the “Company” or
“We”). The Company is currently developing OT-101 for
various cancers and COVID-19, Artemisinin for COVID-19 and AI
technologies for clinical development and manufacturing. The
Company has acquired apomorphine for Parkinson’s Disease, erectile
dysfunction and female sexual dysfunction. In addition, the Company
is evaluating the further development of its product candidates
OXi4503 as a treatment for acute myeloid leukemia and
myelodysplastic syndromes and CA4P in combination with a checkpoint
inhibitor for the treatment of advanced metastatic
melanoma.
In
April 2019, Oncotelic completed a merger with Oncotelic Inc., which
became a wholly owned subsidiary of Oncotelic. The merger was
treated as a recapitalization and reverse acquisition for financial
accounting purposes. Oncotelic Inc. is considered the acquirer for
accounting purposes, and Oncotelic Inc.’s historical financial
statements before the merger have been replaced with the historical
financial statements of Oncotelic Inc. prior to the merger in the
financial statements and filings with the Securities and Exchange
Commission (“SEC”). For more information on this merger,
refer to our 2020 Annual Report on Form 10-K filed with the SEC on
April 15, 2021.
In
August 2019, the Company entered into an Agreement and Plan of
Merger with PointR Date, Inc. PointR survived the merger as a
wholly-owned subsidiary of the Company. The PointR Merger was
intended to create a publicly-traded artificial intelligence
(“AI”) driven immuno-oncology company with a robust pipeline
of first in class TGF-β immunotherapies for late stage cancers such
as gliomas, pancreatic cancer and melanoma. In November 2019,
pursuant to the terms of the PointR Merger Agreement, the Company
completed the PointR Merger. For more information on this merger,
refer to our 2020 Annual Report on Form 10-K filed with the SEC on
April 15, 2021.
In
February 2020, the Company formed a subsidiary, Edgepoint.
Edgepoint was formed as a start-up company, with plans to develop
technologies and IP related to various unmet issues within the
pharma and medical device industries. The Company may spin off
Edgepoint into a separate public company in the future.
The
Company is a cancer immunotherapy company dedicated to the
development of first in class self-immunization protocol
(“SIP™”) candidates for difficult to treat cancers. The
Company’s proprietary SIP™ candidates offer advantages over other
immunotherapies because they do not require extraction of the tumor
or isolation of the antigens, and they have the potential for
broad-spectrum applicability for multiple cancer types. The
Company’s proprietary product candidates have shown promising
clinical activity in phase 2 trials for the treatment of gliomas
and pancreatic cancers. The Company aims to translate its unique
insights, which span more than three decades of original work using
RNA therapeutics, into the deployment of antisense as a RNA
therapeutic for diseases which are caused by TGF-β overexpression,
starting with cancer and expanding to Duchenne Muscular Dystrophy
(“DMD”) and others. Oncotelic Inc.’s product candidate,
OT-101, is being developed as a broad-spectrum anti-cancer drug
that can also be used in combination with other standard cancer
therapies to establish an effective multi-modality treatment
strategy for difficult-to-treat cancers. Together, the Company
plans to initiate phase 3 clinical trials for OT-101 in both
high-grade glioma and pancreatic cancer, and any other indications
that may evolve. The Company is evaluating the further development
of its product candidates OXi4503 as a treatment for acute myeloid
leukemia and myelodysplastic syndromes and CA4P in combination with
a checkpoint inhibitor for the treatment of advanced metastatic
melanoma.
The
Company is also developing OT-101 for the various epidemics and
pandemics, similar to the current coronavirus (“COVID-19”)
pandemic. In this connection, the Company entered into an agreement
and supplemental agreement with Golden Mountain Partners
(“GMP”) for a total of $1.2 million to render services
for the development of OT-101. Such amount was recorded as revenue
upon completion of all performance obligations under the agreement.
Further, In June 2020, the Company secured $2 million in debt financing from GMP
to conduct a clinical trial evaluating OT-101 against COVID-19. The
Company discontinued enrollment in its OT-101 clinical trial in
patients with COVID-19 in June 2021. In September 2021, the Company
secured a further $1.5 million in debt from GMP to
complete the study. The trial completed randomization of 32 out of
36 patients planned, on an intent to treat basis. The
discontinuance of the trial was due to the continuing rise of more
severe variants in Latin America, leading to exhaustion of medical
care infrastructure in Latin America.
In
2020 and 2021, the Company was developing Artemisinin as a
potential therapy for COVID-19. Artemisinin, purified from a plant
Artemisia annua. It can inhibit TGF-β activity and is able
to neutralize COVID-19. The Company initially conducted a study and
the test results during an in vitro study at Utah State University
showed Artemisinin having an EC50 of 0.45 ug/ml, and a Safety Index
of 140. Artemisinin can target multiple viral threats, including
COVID-19, by suppressing both viral replication and clinical
symptoms that arise from viral infection. Viral replication cannot
occur without TGF-β. In a clinical study undertaken in India,
clinical consequences related to the TGF-β surge, including ARDS
and cytokine storm, were suppressed by targeting TGF-β with
Artemisinin. The ARTI-19 trials were conducted in India by Windlas
Biotech Limited (“Windlas”), the Company’s business partner
in India. Windlas had applied for regulatory approval for its
Artemisinin based product, ArtiShieldTM, but has not
been able to obtain regulatory approval for use of
ArtiShieldTM as a COVID-19 therapy and as such, no
significant revenues have been reported by Windlas nor have we
accrued any royalties on Artemisinin due from Windlas. We intend to
focus future development on Artemisinin against other respiratory
viruses with unmet needs.
Between
October 2021 and March 2022, GMP provided $1.0 million to the
Company to fund operations on the way to complete a JV with the
Company.
Fundraising
J.H. Darbie Financing Notes & Issuance of Oncotelic
Warrants
Between
July 2020 and March 2021, the Company issued and sold a total of
100 units
(“Units”), with each Unit consisting of (i) 25,000 shares of
Edgepoint common stock, par value $0.01 per share (“Edgepoint
Common Stock”), for a price of $1.00 per share
of Edgepoint Common Stock; (ii) one convertible promissory note
issued by the Company (the “Unit Note”), convertible into up
to 25,000 shares of
EdgePoint Common Stock at a conversion price of $1.00
per share, or up to 138,889 shares of
the Company’s Common Stock, at a conversion price of $0.18
per share; and (iii) 100,000
warrants, consisting of (a) 50,000
warrants to purchase an equivalent number of shares of EdgePoint
Common Stock at $1.00 per
share (“Edgepoint Warrant”), and (b) 50,000
warrants to purchase an equivalent number of shares of Company
Common Stock at $0.20
per share (“Oncotelic Warrant”) (collectively, the “JH
Darbie Financing”).
In
June 2021, the Company and the Investors agreed to extend the
maturity date of the Notes from June 30, 2021, to March 31, 2022. In
addition, the Company and JHDarbie identified an error in the
Oncotelic Warrants and JH Darbie Financing documents which intended
to have the investors to purchase $50,000 of shares of
Common Stock or Edgepoint Common Stock. However, the Company only
issued
50,000 Oncotelic Warrants, with an aggregate exercise price
of $10,000. The error
was corrected by the Company and the Company issued to the
Investors an aggregate of 20.0 million
additional Oncotelic Warrants, and 2.0 million
additional Oncotelic Warrants to J.H. Darbie., as placement agent.
Each Investor was entitled to receive 200,000 additional
Oncotelic Warrants for each Unit purchased. The issuance of the
additional warrants resulted in the Company recording an expense of
$2,023,552 in the Company’s
statement of operations during the year ended December 31, 2021. No
similar expense was recorded in the same period in 2020. Management
reviewed the guidance per ASC 470-60 Troubled debt
restructurings and ASC 470-50 Debt-Modifications and
Extinguishments and concluded that the terms of the agreements
were not substantially different as of June 30, 2021, and,
accounted for the transaction as a debt modification.
In
February 2022, the Company and 99 out of 100 of the Investors
agreed to extend the maturity date of the Notes from March 31,
2022, to March 31, 2023. In addition, the Company issued
approximately
33 million
Oncotelic Warrants to purchase $50,000
of
shares of Common Stock in connection with agreeing to extend the
maturity date by one year. The issuance of the additional warrants
resulted in the Company recording an expense of approximately
$2.9
million
in the Company’s statement of operations during the three months
ended March 31, 2022. No similar expense was recorded in the same
period in 2020. Management reviewed the guidance per ASC 470-60
Troubled debt restructurings and ASC 470-50
Debt-Modifications and Extinguishments and concluded that
the terms of the agreements were not substantially different as of
June 30, 2021, and, accounted for the transaction as a debt
extinguishment.
Equity Purchase Agreement
In
May 2021, the Company entered into an Equity Purchase Agreement
(the “EPL”) and Registration Rights Agreement (the
“Registration Rights Agreement”) with Peak One Opportunity
Fund, L.P. (“Peak One”), pursuant to which the Company shall
have the right, but not the obligation, to direct Peak One to
purchase up to $10.0
million (the “Maximum Commitment Amount”) in shares of the
common stock, par value $0.01 per share (“Common
Stock”) in multiple tranches. The Company has directed Peak
One, on ten occasions, for an aggregate of
3.7 million shares of Common Stock for aggregate net cash
proceeds of approximately $0.4
million.
The
Company filed a post-effective amendment to reregister the EPL on
April 26, 2022 and the post effective amendment was found effective
by the SEC on May 6, 2022.
August 2021 Notes
In
August 2021, the Company issued Note Purchase Agreements with
Autotelic Inc., the Company’s Chief Financial Officer
(“CFO”), and certain other accredited investors. Under the
terms of the Note Purchase Agreements, the Company issued an
aggregate of $698,500
(the “Principal Amount”) in debt in the form of unsecured
convertible promissory notes (collectively, the “Notes”).
The Notes are unsecured and provide for interest at the rate of
5%
per annum. Such Notes were issued against some of the short-term
debt due as of June 30, 2021. All amounts outstanding under the
Notes become due and payable at such time as determined by the
holders of a majority of the Principal Amount of the Notes (the
“Majority Holders”), on or after (a) the one-year
anniversary of the Notes, or (b) the occurrence of an Event of
Default (as defined in the Note Purchase Agreements) (the
“Maturity Date”).
The Company may prepay the Notes at any time. Events of Default
under the Notes include, without limitation, (i) failure to make
payments under the Notes within thirty (30) days of the Maturity
Date, (ii) breaches of the Note Purchase Agreement or Notes by the
Company which is not cured within thirty (30) days of notice of the
breach, (iii) bankruptcy, or (iv) a change in control of the
Company (as defined in the Note Purchase Agreements). The Majority
Holders have the right, at any time not more than five days
following the Maturity Date, to elect to convert all, and not less
than all, of the outstanding accrued and unpaid interest and
principal on the Notes. The Notes may be converted, at the
election of the Majority Holders, into shares of the Company’s
common stock, par value $0.01
per share (“Common Stock”), at a fixed conversion price of
$0.18
per share.
Joint Venture with GMP Bio
On March 31, 2022, the Company formalized a joint venture
(“JV”) with Dragon Overseas Capital Limited
(“Dragon”) and GMP Biotechnology Limited (“GMP Bio”),
both affiliates of GMP. For more information on the JV, refer to
Note 6 of the Notes and our Current Report on Form 8-K filed with
the SEC on April 6, 2022.
Although no assurances can be given, the Company and GMP currently
intend to conduct an initial public offering of the JV, at a future
date, on either the Hong Kong Exchange or other stock exchange.
In
September 2021, the Company entered into an Unsecured Convertible
Note Purchase Agreement (the “Purchase Agreement”) with GMP,
pursuant to which the Company issued a convertible promissory note
in the aggregate principal amount of $1.5 million (the “September 2021
Note”), which September 2021 Note is convertible into shares of
the Company’s Common Stock.
In
October 2021, the Company entered into an Unsecured Convertible
Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible
promissory note in the aggregate principal amount of $0.5 million (the “October 2021
Note”), which October 2021 Note is convertible into shares of
the Company’s Common Stock.
In
January 2022, the Company entered into an Unsecured Convertible
Note Purchase Agreement (the “January 2022 Purchase
Agreement”) with GMP, pursuant to which the Company issued a
convertible promissory note in the aggregate principal amount of
$0.5 million (the “January 2022
Note”), which January 2022 Note is convertible into shares of
the Company’s Common Stock.
For
more information on the September 2021 Note, the October 2021 Note
and the January 2022 Note, refer to our 2021 Annual Report on Form
10K filed with the SEC on April 15, 2022.
November/December 2021 Notes
In
November and December 2021, the Company entered into various
Securities Purchase Agreements with Talos Victory Fund, LLC (the
(“Talos”), Mast Hill Fund, LP (“Mast”), FirstFire Global
Opportunities Fund, LLC (“FirstFire”), Blue Lake Partners, LLC
(“Blue Lake”) and Fourth Man, LLC (“Fourth Man”), pursuant to which
the Company issued convertible promissory notes in the aggregate
principal amount of $0.25 million
each, aggregating gross $1.25 million
(the “Notes”), which Notes are convertible into shares of the
Company’s common stock, par value $0.01
per share (“Common Stock”).
The
Purchase Agreements were entered into as part of a convertible note
financing round with aggregate gross proceeds to the Company of up
to $1.25 million (the
“Financing”), undertaken by the Company pursuant to that certain
Finder’s Fee Agreement between the Company and JH Darbie & Co.,
Inc. (“JH Darbie”), dated October 26, 2021 (the “Agreement”). All
of the Purchase Agreements and the Note contain identical terms
except with reference to the name of the holders, the use of
proceeds, which include repayment of certain debt, general
corporate expenses and payroll, as applicable and the
jurisdictions.
In
January 2022, three of the five note holders under the November and
December 2021 Notes exercised their warrants to purchase shares of
Common Stock of the Company on a cashless basis. As such, the
Company issued the note holders
3,041,958 shares of Common Stock.
For
more information on the notes, refer to Note 6: November – December
2021 Financing of the Notes to the Unaudited Consolidated Financial
Statements.
Licensing
Agreement with Autotelic Inc.
In
September 2021, the Company entered into an exclusive License
Agreement (the “Agreement”) with Autotelic, Inc.
(“Autotelic”), pursuant to which Autotelic granted
Oncotelic, among other things: (i) the exclusive right and license
to certain Autotelic Patents (as defined in the Agreement) and
Autotelic Know-How (as defined in the Agreement); and (ii) a right
of first refusal to acquire at least a majority of the outstanding
capital stock of Autotelic prior to Autotelic entering into any
transaction that is a financing collaboration, distribution
revenues, earn-outs, sales, out-licensing, purchases, debt,
royalties, merger acquisition, change of control, transfer of cash
or non-cash assets, disposition of capital stock by way of tender
or exchange offer, partnership or any other joint or collaborative
venture, research collaboration, material transfer, sponsored
research or similar transaction or agreements. In exchange for the
rights granted to Oncotelic, Autotelic will be entitled to earn the
milestone payments of up to $50 million upon achievement of certain
financial, development and regulatory milestones. In addition to
the milestone payments, Autotelic would be entitled to earn
royalties equal to 15% of the net sales of any products that
incorporate the Autotelic Patents or Autotelic Know-How. The
Agreement contains representations, warranties and indemnification
provisions of each of the parties thereto that are customary for
transactions of this type.
Principles
of Consolidation
The
consolidated financial statements include the accounts of
Oncotelic, its wholly owned subsidiaries, Oncotelic Inc. and
PointR, and Edgepoint our non-controlled interest entity.
Intercompany accounts and transactions have been eliminated in
consolidation.
Basis
of Presentation
The
accompanying consolidated financial statements have been prepared
by the Company pursuant to the rules and regulations of the
Securities and Exchange Commission including Form 10-Q and
Regulation S-X. The information furnished herein reflects all
adjustments (consisting of normal recurring accruals and
adjustments) which are, in the opinion of management, necessary to
fairly state the operating results for the respective periods.
Certain information and footnote disclosures normally present in
annual financial statements prepared in accordance with accounting
principles generally accepted in the United States of America
(“US GAAP”) have been omitted pursuant to such rules and
regulations.
Liquidity
and Going Concern
The
accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. The
Company has incurred net accumulated losses of approximately
$35.9
million
since inception of Oncotelic Inc., as the Company’s historical
financial statements before the Merger have been replaced with the
historical financial statements of Oncotelic Inc. The Company also
has a negative working capital of approximately $16.7
million
at March 31, 2022, of which approximately $2.6
millioncontingent
liability of issuance of common shares of the Company to PointR
shareholders upon achievement of certain milestones in accordance
with the PointR Merger Agreement. The Company has negative cash
flows from operations for the three months ended March 31, 2022 of
approximately $1.0
million.
These conditions raise substantial doubt about the Company’s
ability to continue as a going concern for a period of one year
from the date of this filing. Management expects to incur
additional losses in the foreseeable future and recognizes the need
to raise capital to remain viable. The accompanying consolidated
financial statements do not include any adjustments that might be
necessary should the Company be unable to continue as a going
concern.
The
Company’s long-term plans include continued development of its
current pipeline of products, in addition to continue the
development of OT-101 which is now the product of the JV, to
generate sufficient revenues, through either technology transfer or
product sales, to cover its anticipated expenses. Until the Company
is able to generate sufficient revenues from its current pipeline,
the Company plans on funding its operations through the sale of
equity and/or the issuance of debt, combined with or without
warrants or other equity instruments.
Although
no assurances can be given as to the Company’s ability to deliver
on its revenue plans, or that unforeseen expenses may arise,
management believes that the potential equity and debt financing or
other potential financing will provide the necessary funding for
the Company to continue as a going concern. Also, management cannot
guarantee any potential debt or equity financing will be available
on favorable terms or at all. As such, management does not believe
the Company has sufficient cash for 12 months from the date of this
report. If adequate funds are not available on acceptable terms, or
at all, the Company will need to curtail operations, or cease
operations completely.
NOTE
2 - SUMMARY OF
SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The
preparation of financial statements in conformity with US GAAP
requires management to make estimates and assumptions that affect
the reported amounts of assets, liabilities, equity-based
transactions and disclosure of contingent liabilities at the date
of the financial statements and revenues and expense during the
reporting period. Actual results could materially differ from those
estimates.
The
Company believes the following critical accounting policies affect
its more significant judgments and estimates used in the
preparation of the financial statements. Significant estimates
include the valuation of goodwill and intangible assets for
impairment, deferred tax asset and valuation allowance, and fair
value of financial instruments.
Cash
As of
March 31, 2022 and December 31, 2021, respectively, the Company
held all its cash in banks in the United States of America. The
Company considers investments in highly liquid instruments with a
maturity of three months or less to be cash equivalents. The
Company did not have any cash equivalents as of March 31, 2022 and
December 31, 2021, respectively. Restricted cash consists of
certificates of deposits held at banks as collateral for various
purposes.
Debt issuance Costs and Debt discount
Issuance
costs are specific incremental costs that are (1) paid to third
parties and (2) directly attributable to the issuance of a debt or
equity instrument. The issuance costs attributable to the initial
sale of the instrument are offset against the associated proceeds
in the determination of the instrument’s initial net carrying
amount.
Debt
issuance costs and debt discounts are being amortized over the
lives of the related financings on a basis that approximates the
effective interest method. Costs and discounts are presented as a
reduction of the related debt in the accompanying balance sheets if
related to the issuance of debt or presented as a reduction of
additional paid in capital if related to the issuance of an equity
instrument. The Company applies the relative fair value to allocate
the issuance costs among freestanding instruments that form part of
the same transaction.
If
the Company amends the terms of its convertible notes, the Company
reviews and applies the guidance per ASC 470-60 Troubled debt
restructurings and ASC 470-50 Debt-Modifications and
Extinguishments, evaluates and concludes whether the terms of
the agreements were or were not substantially different as of a
particular reporting date and accounts the transaction as a debt
modification or a troubled debt restructuring.
Fair Value of Financial Instruments
The
carrying value of cash, accounts payable and accrued expense
approximate their fair values based on the short-term maturity of
these instruments. As defined in ASC 820, “Fair Value Measurements
and Disclosures,” fair value is the price that would be received to
sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date
(exit price). The Company utilizes market data or assumptions that
market participants would use in pricing the asset or liability,
including assumptions about risk and the risks inherent in the
inputs to the valuation technique. These inputs can be readily
observable, market corroborated, or generally unobservable. ASC 820
establishes a fair value hierarchy that prioritizes the inputs used
to measure fair value. The hierarchy gives the highest priority to
unadjusted quoted prices in active markets for identical assets or
liabilities (level 1 measurement) and the lowest priority to
unobservable inputs (level 3 measurement). This fair value
measurement framework applies at both initial and subsequent
measurement.
The
three levels of the fair value hierarchy defined by ASC 820 are as
follows:
● |
Level
1 – Quoted prices are available in active markets for identical
assets or liabilities as of the reporting date. Active markets are
those in which transactions for the asset or liability occur in
sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial
instruments such as exchange-traded derivatives, marketable
securities and listed equities. |
|
|
● |
Level
2 – Pricing inputs are other than quoted prices in active markets
included in Level 1, which are either directly or indirectly
observable as of the reported date. Level 2 includes those
financial instruments that are valued using models or other
valuation methodologies. These models are primarily
industry-standard models that consider various assumptions,
including quoted forward prices for commodities, time value,
volatility factors and current market and contractual prices for
the underlying instruments, as well as other relevant economic
measures. Substantially all of these assumptions are observable in
the marketplace throughout the full term of the instrument, can be
derived from observable data or are supported by observable levels
at which transactions are executed in the marketplace. Instruments
in this category generally include non-exchange-traded derivatives
such as commodity swaps, interest rate swaps, options and
collars. |
|
|
● |
Level
3 – Pricing inputs include significant inputs that are generally
less observable from objective sources. These inputs may be used
with internally developed methodologies that result in management’s
best estimate of fair value. |
The
derivative liabilities associated with its 2019 bridge financing
Convertible Notes (see Note 5), consisted of conversion feature
derivatives at March 31, 2022 and 2021, are Level 3 fair value
measurements.
The
table below sets forth a summary of the changes in the fair value
of the Company’s derivative liabilities classified as Level 3 as of
March 31, 2022 and 2021:
SUMMARY OF CHANGES IN FAIR VALUE OF
DERIVATIVE LIABILITIES
|
|
|
1 |
|
|
|
2 |
|
|
|
March 31,
2022
Conversion Feature |
|
|
March 31,
2021
Conversion Feature |
|
Balance at
January 1, 2021 and 2020 |
|
$ |
340,290 |
|
|
$ |
777,024 |
|
New
derivative liability |
|
|
- |
|
|
|
- |
|
Reclassification to
additional paid in capital from conversion of debt to common
stock |
|
|
- |
|
|
|
(144,585 |
) |
Change in
fair value |
|
|
190,841 |
|
|
|
536,345 |
|
|
|
|
|
|
|
|
|
|
Balance at
March 31, 2021 and 2020 |
|
$ |
531,131 |
|
|
$ |
1,168,784 |
|
As of
March 31, 2022 and 2021, the Company estimated the fair value of
the conversion feature derivatives embedded in the convertible
debentures based on assumptions used in the Black-Scholes valuation
model. The key valuation assumptions used consists, in part, of the
price of the Company’s Common Stock, a risk-free interest rate
based on the yield of a Treasury note and expected volatility of
the Company’s Common Stock all as of the measurement dates. The
Company used the following assumptions to estimate fair value of
the derivatives as of March 31, 2022 and 2021:
SUMMARY OF ESTIMATE FAIR VALUE OF DERIVATIVE
LIABILITIES
|
|
March 31,
2022 Key Assumptions for fair value of conversions |
|
|
March 31,
2021 Key Assumptions for fair value of conversions |
|
Risk free
interest |
|
|
0.17% to
0.52 |
% |
|
|
0.07% to
0.12 |
% |
Market
price of share |
|
$ |
0.22 to
0.36 |
|
|
$ |
0.36 |
|
Life of
instrument in years |
|
|
0.81 to
1.1 |
|
|
|
1.06 –
1.35 |
|
Volatility |
|
|
94.4 to
148.8 |
% |
|
|
148.79 |
% |
Dividend
yield |
|
|
0 |
% |
|
|
0 |
% |
When
the Company changes its valuation inputs for measuring financial
liabilities at fair value, either due to changes in current market
conditions or other factors, it may need to transfer those
liabilities to another level in the hierarchy based on the new
inputs used. The Company recognizes these transfers at the end of
the reporting period that the transfers occur. For the periods
ended March 31, 2022 and March 31, 2021, there were no transfers of
financial assets or financial liabilities between the hierarchy
levels.
The
$2,625,000 of contingent
consideration, of shares issuable to PointR shareholders which was
recorded and associated with the PointR Merger, is also classified
as Level 3 fair value measurements. The Company initially recorded
the contingency based on a valuation conducted by a third-party
valuation expert. The valuation was based on a probability of the
completion of certain milestones by PointR for the shareholders to
earn additional shares. The Company evaluated the probability of
the earning of the milestones and concluded that the probability of
achievement of the milestones had not changed, primarily due to the
shifting of focus by the Company to develop AI technologies for the
COVID-19 pandemic. As such, the Company did not record any change
to the valuation during the three months ended March 31, 2022 or
2021, respectively.
Net Loss Per Share
Basic
net loss per common share is computed by dividing the net loss by
the weighted-average number of common shares outstanding during the
period. Diluted net loss per share includes the effect of Common
Stock equivalents (notes convertible into Common Stock, stock
options and warrants) when, under either the treasury or
if-converted method, such inclusion in the computation would be
dilutive. The following number of shares have been excluded from
diluted loss since such inclusion would be
anti-dilutive:
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED
FROM COMPUTATION OF EARNINGS PER SHARE
|
|
Three
Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Convertible
notes |
|
|
68,070,034 |
|
|
|
35,388,901 |
|
Stock
options |
|
|
16,590,261 |
|
|
|
3,941,301 |
|
Warrants |
|
|
80,545,259 |
|
|
|
20,737,500 |
|
Potentially dilutive
securities |
|
|
165,205,554 |
|
|
|
60,067,702 |
|
Stock-Based Compensation
The
Company applies the provisions of ASC 718, Compensation—Stock
Compensation (“ASC 718”), which requires the measurement and
recognition of compensation expense for all stock-based awards made
to employees and non-employees, including employee stock options,
in the statements of operations.
For
stock options issued, the Company estimates the grant date fair
value of each option using the Black-Scholes option pricing model.
The use of the Black-Scholes option pricing model requires
management to make assumptions with respect to the expected term of
the option, the expected volatility of the Common Stock consistent
with the expected life of the option, risk-free interest rates and
expected dividend yields of the Common Stock. For awards subject to
service-based vesting conditions, including those with a graded
vesting schedule, the Company recognizes stock-based compensation
expense equal to the grant date fair value of stock options on a
straight-line basis over the requisite service period, which is
generally the vesting term. Forfeitures are recorded as they are
incurred as opposed to being estimated at the time of grant and
revised.
For
warrants issued in connection with fund raising activities, the
Company estimates the grant date fair value of each warrant using
the Black-Scholes pricing model. The use of the Black-Scholes
option pricing model requires management to make assumptions with
respect to the expected term of the warrant, the expected
volatility of the Common Stock consistent with the expected life of
the warrant, risk-free interest rates and expected dividend yields
of the Common Stock. If the warrants are issued upon termination or
cancellation of prior issued warrants, then the Company estimates
the grant date fair value of the new warrants using the
Black-Scholes pricing model and evaluates whether the new warrants
are deemed as equity instruments or liability instruments. If the
warrants are deemed to be equity instruments, the Company records
stock compensation expense and an addition to additional paid in
capital. If however, the warrants are deemed to be liability
instruments, then the fair value is treated as a deemed dividend
and credited to additional paid in capital.
Impairment of Long-Lived Assets
The
Company reviews long-lived assets, including definite-lived
intangible assets, for impairment whenever events or changes in
circumstances indicate that the carrying amount of such assets may
not be recoverable. Recoverability of these assets is determined by
comparing the forecasted undiscounted net cash flows of the
operation to which the assets relate to the carrying amount. If the
operation is determined to be unable to recover the carrying amount
of its assets, then these assets are written down first, followed
by other long-lived assets of the operation to fair value. Fair
value is determined based on discounted cash flows or appraised
values, depending on the nature of the assets. For the three months
ended March 31, 2022 and the year ended December 31, 2021, there
were no
impairment losses recognized for long-lived assets.
Intangible Assets
The
Company records its intangible assets at cost in accordance with
ASC 350, Intangibles – Goodwill and Other. The Company reviews the
intangible assets for impairment on an annual basis or if events or
changes in circumstances indicate it is more likely than not that
they are impaired. These events could include a significant change
in the business climate, legal factors, a decline in operating
performance, competition, sale or disposition of a significant
portion of the business, or other factors. If the review indicates
the impairment, an impairment loss would be recorded for the
difference of the value recorded and the new value. For the three
months ended March 31, 2022 and the year ended December 31, 2021,
there were
no impairment
losses recognized for intangible assets.
Goodwill
Goodwill
represents the excess of the purchase price of acquired business
over the estimated fair value of the identifiable net assets
acquired. Goodwill is not amortized but is tested for impairment at
least once annually, at the reporting unit level or more frequently
if events or changes in circumstances indicate that the asset might
be impaired. The goodwill impairment test is applied by performing
a qualitative assessment before calculating the fair value of the
reporting unit. If, on the basis of qualitative factors, it is
considered not more likely than not that the fair value of the
reporting unit is less than the carrying amount, further testing of
goodwill for impairment would not be required. Otherwise, goodwill
impairment is tested using a two-step approach.
The
first step involves comparing the fair value of the reporting unit
to its carrying amount. If the fair value of the reporting unit is
determined to be greater than its carrying amount, there is no
impairment. If the reporting unit’s carrying amount is determined
to be greater than the fair value, the second step must be
completed to measure the amount of impairment, if any. The second
step involves calculating the implied fair value of goodwill by
deducting the fair value of all tangible and intangible assets,
excluding goodwill, of the reporting unit from the fair value of
the reporting unit as determined in step one. The implied fair
value of the goodwill in this step is compared to the carrying
value of goodwill. If the implied fair value of the goodwill is
less than the carrying value of the goodwill, an impairment loss
equivalent to the difference is recorded. For the three months
ended March 31, 2022 and year ended December 31, 2021, there were
no impairment
losses recognized for Goodwill.
Derivative Financial Instruments Indexed to the Company’s Common
Stock
We
have generally issued derivative financial instruments, such as
warrants, in connection with our equity offerings. We evaluate the
terms of these derivative financial instruments in order to
determine their accounting treatment in our financial statements.
Key considerations include whether the financial instruments are
freestanding and whether they contain conditional obligations. If
the warrants are freestanding, do not contain conditional
obligations and meet other classification criteria, we account for
the warrants as an equity instrument. However, if the warrants
contain conditional obligations, then we account for the warrants
as a liability until the conditional obligations are met or are no
longer relevant. Because no established market prices exist for the
warrants that we issue in connection with our equity offerings, we
must estimate the fair value of the warrants, which is as
inherently subjective as it is for stock options, and for similar
reasons as noted in the stock-based compensation section above. For
financial instruments which are accounted for as a liability, we
report any changes in their estimated fair values as gains or
losses in our Consolidated Statement of Income.
Convertible Instruments
The
Company evaluates and accounts for conversion options embedded in
its convertible instruments in accordance with ASC 815 “Derivatives
and Hedging”.
ASC
815 generally provides three criteria that, if met, require
companies to bifurcate conversion options from their host
instruments and account for them as free-standing derivative
financial instruments. These three criteria include circumstances
in which (a) the economic characteristics and risks of the embedded
derivative instrument are not clearly and closely related to the
economic characteristics and risks of the host contract, (b) the
hybrid instrument that embodies both the embedded derivative
instrument and the host contract is not re-measured at fair value
under otherwise applicable generally accepted accounting principles
with changes in fair value reported in earnings as they occur, and
(c) a separate instrument with the same terms as the embedded
derivative instrument would be considered a derivative instrument.
Professional standards also provide an exception to this rule when
the host instrument is deemed to be conventional as defined under
professional standards as “The Meaning of Conventional Convertible
Debt Instrument.”
The
Company accounts for convertible instruments (when it has
determined that the embedded conversion options should not be
bifurcated from their host instruments) in accordance with ASC
470-20 “Debt – Debt with Conversion and Other Options.”
Accordingly, the Company records, when necessary, discounts to
convertible notes for the intrinsic value of conversion options
embedded in debt instruments based upon the differences between the
fair value of the underlying Common Stock at the commitment date of
the note transaction and the effective conversion price embedded in
the note. Original issue discounts (“OID”) under these
arrangements are amortized over the term of the related debt to
their earliest date of redemption. The Company also records when
necessary deemed dividends for the intrinsic value of conversion
options embedded in preferred shares based upon the differences
between the fair value of the underlying Common Stock at the
commitment date of the note transaction and the effective
conversion price embedded in the note.
ASC
815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity”
provides that, among other things, generally, if an event occurs
that is not within the entity’s control could or would require net
cash settlement, then the contract shall be classified as an asset
or a liability.
Variable
Interest Entity (VIE) Accounting
The
Company evaluates its ownership, contractual relationships and
other interests in entities to determine the nature and extent of
the interests, whether such interests are variable interests and
whether the entities are VIEs in accordance with ASC 810,
Consolidations. These evaluations can be complex and involve
Management judgment as well as the use of estimates and assumptions
based on available historical information, among other factors.
Based on these evaluations, if the Company determines that it is
the primary beneficiary of a VIE, the entity is consolidated into
the financial statements. At March 31, 2022 and December 31, 2021,
the Company identified EdgePoint to be the Company’s sole VIE. At
March 31, 2022 and December 31, 2021, the Company’s ownership
percentage of EdgePoint was
29% and
29%, respectively. The VIE’s net assets were $0.1
million and $0.1
million at March 31, 2022 and December 31, 2021,
respectively.
The Company signed a joint venture agreement (“JVA”) with
Dragon to form a joint venture called GMP Biotechnology, LLC, both
affiliates of GMP, on March 31, 2022. The JVA prescribes certain
requirements to be completed during the three months ended June 30,
2022 to make the JV fully functional and operational, including
issuance of the shares issuable to the Company and Dragon. The
Company will evaluate the accounting for the JV and once these
functional and operational activities are completed, the Company
will appropriately record the transactions.
Revenue Recognition
The
Company recognizes revenue in accordance with ASC Topic 606,
Revenue from Contracts with Customers.
Under
ASC 606, the Company recognizes revenue when its customers obtain
control of the promised good or services, in an amount that
reflects the consideration which the Company expects to receive in
exchange for those goods or services. The Company applies the
following five-step process: (i) identify the contract(s) with a
customer; (ii) identify the performance obligation(s) in the
contract; (iii) determine the transaction price; (iv) allocate the
transaction price to the performance obligation(s) in the contract;
and (v) recognize revenue when (or as) the Company satisfies a
performance obligation.
At
contract inception, once the contract is determined to be within
the scope of ASC 606, the Company identifies the performance
obligation(s) in the contract by assessing whether the goods or
services promised within each contract are distinct. The Company
then recognizes revenue for the amount of the transaction price
that is allocated to the respective performance obligation when (or
as) the performance obligation is satisfied.
The
Company anticipates generating revenues from rendering services to
other third party customers for the development of certain drug
products and/or in connection with certain out-licensing
agreements. In the case of services rendered for development of the
drugs, revenue is recognized upon the achievement of the
performance obligations or over time on a straight-line basis over
the extended service period. In the case of out-licensing
contracts, the Company records revenues either (i) upon achievement
of certain pre-defined milestones when there is no obligation of
the Company achieve any performance obligations in connection with
the said pre-defined milestones, or (ii) upon achievement of the
performance obligations if the milestones require the Company to
provide the performance obligations.
The
Company occasionally collects advance payments from customers
toward commitments to provide services or performance obligations,
in which case the advance payment is recorded as a liability until
the obligations are fulfilled and revenue is recognized.
Research & Development Costs
In
accordance with ASC 730-10-25 “Research and Development”, research
and development costs are charged to expense as and when
incurred.
Recent Accounting Pronouncements
In
August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and
Other Options (Subtopic 470-20) and Derivatives and
Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)”
(“ASU 2020-06”) which simplifies the accounting for
convertible instruments. The guidance removes certain accounting
models which separate the embedded conversion features from the
host contract for convertible instruments. Either a modified
retrospective method of transition or a fully retrospective method
of transition was permissible for the adoption of this standard.
Update No. 2020-06 is effective for fiscal years beginning after
December 15, 2021, including interim periods within those fiscal
years. Early adoption was permitted no earlier than the fiscal year
beginning after December 15, 2020. The Company has not adopted ASU
2020-06 during the three months ended March 31, 2022 and is
evaluating the impact of implementation on its financial
statements, if any.
All
other newly issued but not yet effective accounting pronouncements
have been deemed to be not applicable or immaterial to the
Company.
Prior Period Reclassifications
Certain
amounts in prior periods may have been reclassified to conform with
current period presentation.
NOTE
3 - GOODWILL AND
INTANGIBLE ASSETS
2019
Reverse Merger with Oncotelic and PointR
The Company completed the merger with Oncotelic Inc. (“Merger”) in
April 2019. The Company completed the merger with PointR Data Inc
(“PointR Merger”) in November 2019. For more details, refer to our
2020 Annual Report on Form 10-K for the year ended December 31,
2020 filed by the Company on April 15, 2021.
The
Oncotelic merger gave rise to Goodwill of $4,879,999. Further, we added goodwill of
$16,182,456
upon the completion of the Merger with PointR. In general, the
goodwill is tested on an annual impairment date of December 31.
However, as of March 31, 2022, since both assets are currently
being developed for various cancer and COVID-19 therapies, the
Company does not believe the there are any factors or indications
that the goodwill is impaired.
Assignment
and Assumption Agreement with Autotelic, Inc.
In
April 2018, Oncotelic Inc. entered into an Assignment and
Assumption Agreement (the “Assignment Agreement”) with
Autotelic Inc., an affiliate company, and Autotelic LLC, an
affiliate company, pursuant to which Oncotelic acquired the rights
to all intellectual property (“IP”) related to a patented
product. As consideration for the Assignment Agreement, Oncotelic
Inc. issued 204,798 shares of its Common
Stock for a value of $819,191. The
Assignment Agreement also provides that Oncotelic Inc. shall be
responsible for all costs related to the IP, including development
and maintenance, going forward.
Intangible
Asset Summary
The
following table summarizes the balances as of March 31, 2022 and
December 31, 2021, of the intangible assets acquired, their useful
life, and annual amortization:
SCHEDULE OF INTANGIBLE
ASSETS
|
|
March
31,
2022 |
|
|
Remaining
Estimated
Useful Life (Years)
|
|
Intangible
asset – Intellectual Property |
|
$ |
819,191 |
|
|
|
16.75 |
|
Intangible
asset – Capitalization of license cost |
|
|
190,989 |
|
|
|
16.75 |
|
|
|
|
1,010,180 |
|
|
|
|
|
Less
Accumulated Amortization |
|
|
(201,180 |
) |
|
|
|
|
Total |
|
$ |
809,000 |
|
|
|
|
|
|
|
December
31,
2021 |
|
|
Remaining
Estimated
Useful
Life (Years)
|
|
Intangible
asset – Intellectual Property |
|
$ |
819,191 |
|
|
|
17.00 |
|
Intangible
asset – Capitalization of license cost |
|
|
190,989 |
|
|
|
17.00 |
|
|
|
|
1,010,180 |
|
|
|
|
|
Less
Accumulated Amortization |
|
|
(188,339 |
) |
|
|
|
|
Total |
|
$ |
821,841 |
|
|
|
|
|
Amortization
of identifiable intangible assets for the three months ended March
31, 2022 and 2022 was $12,841 and
$12,841,
respectively.
The
future yearly amortization expense over the next five years and
thereafter are as follows:
SCHEDULE OF AMORTIZATION OF EXPENSE FOR
INTANGIBLE ASSETS
For the
years ended December 31, |
|
|
|
|
2022 |
|
$ |
38,524 |
|
2023 |
|
|
51,365 |
|
2024 |
|
|
51,365 |
|
2025 |
|
|
51,365 |
|
2026 |
|
|
51,365 |
|
Thereafter |
|
|
577,857 |
|
|
|
$ |
821,841 |
|
In-Process
Research & Development (“IPR&D”) Summary
The
IPR&D assets were acquired in the PointR Merger during the year
ended December 31, 2019. Since January 2021, the Company has
determined that the IPR&D should be reported as an indefinitely
lived asset and therefore will evaluate, on an annual basis, for
any impairment on the IPR&D and will record an impairment if
identified. The balance of IPR&D as of March 31, 2022 and
December 31, 2021 was $1,101,760. The
following table summarizes the balances as of March 31, 2022 and
December 31, 2021 of the IPR&D assets. The Company evaluates,
on an annual basis, for any impairment and records an impairment if
identified. The Company identified no impairment to IPR&D
assets during its evaluation.
NOTE
4 – ACCOUNTS PAYABLE
AND ACCRUED EXPENSES
Accounts
payable and accrued expense consists of the following
amounts:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED
EXPENSES
|
|
|
March 31,
2022
|
|
|
|
December 31,
2021
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,946,179 |
|
|
$ |
1,927,749 |
|
Accrued
expense |
|
|
1,578,923 |
|
|
|
1,164,974 |
|
Accounts payable and accrued liabilities |
|
$ |
3,525,102 |
|
|
$ |
3,092,723 |
|
|
|
|
March
31,
2022
|
|
|
|
December
31, 2021 |
|
|
|
March
31,
2022
|
|
|
December
31, 2021 |
|
|
|
|
|
|
|
|
Accounts
payable – related party |
|
$ |
358,074 |
|
|
$ |
403,423 |
|
NOTE
5 – CONVERTIBLE
DEBENTURES, NOTES AND OTHER DEBT
As of
March 31, 2022, special purchase agreements (SPAs) with convertible
debentures and notes, net of debt discount and including accrued
interest, if any, consist of the following amounts:
SCHEDULE OF CONVERTIBLE DEBENTURES AND
NOTES
|
|
March
31,
2022
|
|
Convertible
debentures |
|
|
|
|
10%
Convertible note payable, due April 23, 2022 – Bridge
Investor |
|
$ |
34,459 |
|
10%
Convertible note payable, due April 23, 2022 – Related
Party |
|
|
159,571 |
|
10%
Convertible note payable, due August 6, 2022 – Bridge
Investor |
|
|
193,325 |
|
|
|
|
387,355 |
|
Fall 2019
Notes |
|
|
|
|
5%
Convertible note payable – Stephen Boesch |
|
|
120,208 |
|
5%
Convertible note payable – Related Party |
|
|
279,358 |
|
5%
Convertible note payable – Dr. Sanjay Jha (Through his family
trust) |
|
|
278,878 |
|
5%
Convertible note payable – CEO, CTO* & CFO– Related
Parties |
|
|
91,382 |
|
5%
Convertible note payable – Bridge Investors |
|
|
187,222 |
|
|
|
|
957,048 |
|
|
|
|
|
|
August
2021 Convertible Notes |
|
|
|
|
5%
Convertible note – Autotelic Inc– Related Party |
|
|
257,158 |
|
5%
Convertible note – Bridge investors |
|
|
384,193 |
|
5%
Convertible note – CFO – Related Party |
|
|
77,147 |
|
|
|
|
718,498 |
|
|
|
|
|
|
JH Darbie PPM
Debt |
|
|
|
|
16%
Convertible Notes - Non-related parties |
|
|
2,312,023
|
|
16% Convertible Notes – CEO – Related Party |
|
|
121,650
|
|
|
|
|
2,433,673
|
|
|
|
|
|
|
November/December 2021
& March 2022 Notes |
|
|
|
|
12%
Convertible Notes – Accredited Investors |
|
|
386,459 |
|
|
|
|
|
|
Debt for
Clinical Trials – GMP |
|
|
|
|
2%
Convertible Notes -
GMP |
|
|
4,591,973 |
|
|
|
|
|
|
Other
Debt |
|
|
|
|
Short term
debt – Bridge investors |
|
|
245,000 |
|
Short term
debt from CFO – Related Party |
|
|
25,050 |
|
Short term
debt – Autotelic Inc– Related Party |
|
|
20,000 |
|
Accrued
Interest on Loans |
|
|
4,597 |
|
|
|
|
294,647 |
|
Total of
convertible debentures & notes and other debt |
|
$ |
9,769,653 |
|
For
information on the special purchase agreements (SPAs) with
convertible debentures and notes, net of debt discount and
including accrued interest, if any, as of December 31, 2022, refer
to our Annual Report on Form 10-K for the year ended December 31,
2021.
* |
The
CTO was a related party till July 2021, when he resigned as the CTO
due to health reasons. |
The
gross principal balances on the convertible debentures listed above
totaled $1,000,000 and included
initial debt discounts totaling $800,140, resulting from the
recording of the original issue discount, the related financing
costs, the beneficial conversion feature (“BCF”) for the
intrinsic value of the non-bifurcated conversion option and the
restricted shares issued contemporaneously with the convertible
notes.
Total
amortization expense related to these debt discounts was $22,918
and $54,572
for the three months ended March 31, 2022, and 2021, respectively.
In addition, during the three months ended March 31, 2022, and
2021, we recorded additional and accelerated amortization of debt
discounts, which was created from the bifurcation of the conversion
option related the host hybrid instruments, of $0 and $24,491,
respectively, upon the partial and/or full conversion of debt by
TFK to shares of the Company’s common stock. The total unamortized
debt discount at March 31, 2022, and December 31, 2021 was
approximately $12,646 and $35,564,
respectively.
All the above notes
issued to Peak One, TFK, our CEO, and the bridge investors reached
the 180 days during the fiscal year ended December 31, 2020. As
such, all the note holders had the ability to convert that debt
into equity at the variable conversion price of 65% of the
Company’s lowest traded price after the first 180 days or at the
lower of the Fixed Price or 55% of the Company’s traded stock price
under certain circumstances. This gave rise to a derivative
liability for the debt instrument of approximately $870,000, since the conversion
option attached to certain notes became convertible into a variable
number of shares of our common stock, and correspondingly debited
additional debt discounts of approximately $258,000 and interest expense of
approximately $612,000.
As of
March 31, 2022, the Company had a derivative liability of
approximately $531,000 and a
change in fair value of approximately $191,000.
Bridge
Financings
TFK
Financing
For
information on the special purchase agreements (SPAs) with
convertible debentures and notes, net of debt discount and
including accrued interest, if any, as of December 31, 2022, refer
to our Annual Report on Form 10-K for the year ended December 31,
2021 filed with the SEC on April 15, 2022.
Notes
with Officer and Bridge Investor
In
April 2019, the Company entered into a Securities Purchase
Agreement (the “Bridge SPA”) with our CEO and the Bridge
Investor with a commitment to purchase convertible notes in the
aggregate of $400,000.
In
April 2019, the Company entered into a convertible note with our
Chief Executive Officer, Vuong Trieu, Ph. D. (the “Trieu
Note”). The Trieu Note has a principal balance of $164,444,
including a
10% OID
of $16,444,
resulting in net proceeds of $148,000,
with a maturity date of
April 23, 2022.
Upon the occurrence
of certain events of default, the Buyer, amongst other remedies,
has the right to charge a penalty in a range of 18% to 40%
dependent on the specific default event. Amounts due under the
Convertible Note may also be converted into shares (the “Trieu
Conversion Shares”) of the Company’s Common Stock at any time,
at the option of the holder, at a conversion price of $0.10 per
share (the “Fixed Price”), at the lower of the Fixed Price
or 65% of the Company’s lowest traded price after the
180th day or at the lower of the Fixed Price or 55% of
the Company’s traded stock price under certain circumstances. The
Company has agreed to at all times reserve and keep available out
of its authorized Common Stock a number of shares equal to at least
two times the full number of Conversion Shares. The Company may
redeem the Convertible Note at rates of 110% to 140% rates over the
principal balance dependent on certain events and redeem the value
with accrued interest thereon, if any.
The
issuance of the Trieu Note resulted in a discount from the
beneficial conversion feature totaling $131,555
related to the conversion feature. Total amortization of the OID
and the discount totaled $14,620
and $18,058 for the three
months ended March 31, 2022, and 2021. Total unamortized discount
on this note was approximately $4,900
and $19,000
as of March 31, 2022, and December 31, 2021,
respectively.
In
April 2019, pursuant to the Bridge SPA the Company entered into
Convertible Note Tranche #1 (“Tranche #1”) with the Bridge
Investor. Tranche #1 has a principal balance of $35,556, an OID of $3,556, resulting in net
proceeds of $32,000, with a
maturity date of April 23, 2022. Upon the
occurrence of certain events of default, the Buyer, among other
remedies, has the right to charge a penalty in a range of 18% to
40% dependent on the specific default event. Amounts due
under Tranche #1 may also be converted into shares (the “Bridge
SPA Conversion Shares”) of the Company’s Common Stock at any
time, at (i) a conversion price, during the first 180 days, of
$0.10 per share (the “Fixed Price”), and then (2) at the lower of
the Fixed Price or 65% of the Company’s lowest traded price after
the first 180 days or at the lower of the Fixed Price or 55% of the
Company’s traded stock price under certain circumstances. The
Company may redeem the Convertible Note at rates of 110% to 140%
rates over the principal balance dependent on certain events and
redeem the value with accrued interest thereon, if
any.
The
issuance of the note resulted in a discount from the beneficial
conversion feature totaling $28,445.
Total amortization of the OID and discount totaled approximately
$3,300
and $4,100
for the three months March 31, 2022, and 2021, respectively. Total
unamortized discount on this note was approximately $1,100
and $4,400
as of March 31, 2022, and December 31, 2021.
On
August 6, 2019, pursuant to the Bridge SPA the Company entered into
Convertible Note Tranche #2 (“Tranche #2”) with the Bridge
Investor. Tranche #2 has a principal balance of $200,000, an OID of $20,000 and debt issuance
costs of $5,000, resulting in net proceeds
of $175,000, with a
maturity date of August 6, 2022. Upon the
occurrence of certain events of default, the Buyer, among other
remedies, has the right to charge a penalty in a range of 18% to
40% dependent on the specific default event. Amounts due
under Tranche #1 may also be converted into Bridge Conversion
Shares of the Company’s Common Stock at any time, at the option of
the holder, at a conversion price equal to the Fixed Price, at the
lower of the Fixed Price or 65% of the Company’s lowest traded
price after the 180th day or at the lower of the Fixed
Price or 55% of the Company’s traded stock price under certain
circumstances. The Company may
redeem the Convertible Note at rates of 110% to
140%
rates over the principal balance dependent on certain events and
redeem the value with accrued interest thereon, if
any.
The
issuance of the note resulted in a discount from the beneficial
conversion feature totaling $175,000.
Total amortization of the OID and discount totaled approximately
$5,000
and $4,900
for the three months ended March 31, 2022, and March 31, 2021,
respectively. Total unamortized discount on this note was
$6,700
and $12,000
as of March 31, 2022, and December 31, 2021.
Fall
2019 Debt Financing
In
December 2019, the Company closed its Fall 2019 Debt Financing,
raising an additional $500,000
bringing the gross proceeds of all debt financings under the Fall
2019 Debt Financing to $1,000,000. The Company entered into
those certain Note Purchase Agreements (the “Fall 2019 Note
Purchase Agreements”) with certain accredited investors and the
officers of the Company for the sale of convertible promissory
notes (the “Fall 2019 Notes”). The Company completed the
initial closing under the Fall 2019 Note Purchase Agreements in
November 2019. The Company issued Fall 2019 Notes in the principal
amount of $250,000
to each of Dr. Vuong Trieu, the Company’s Chief Executive Officer,
and Stephen Boesch, in exchange for gross proceeds of $500,000.
In connection with the second and final closing of the Fall 2019
Debt Financing, the Company issued Fall 2019 Notes to additional
investors including $250,000
to Dr. Sanjay Jha, through his family trust, the former CEO of
Motorola and COO/President of Qualcomm. The Company also offset
certain amounts due to Dr. Vuong Trieu, the Company’s Chief
Executive Officer, Chulho Park, the Company’s Chief Technology
Officer, and Amit Shah, the Company’s Chief Financial Officer, all
related parties as Officers of the Company, and converted such
amounts due into the Fall 2019 Notes. $35,000
due to Dr. Vuong Trieu, $27,000
due to Chulho Park and $20,000 due to Amit Shah were
converted into debt. The Company also issued the Fall 2019 Notes of
$168,000
to two accredited investors.
The
Company repaid $0
and $50,000 of principal in the three
months ended March 31, 2022, and 2021, respectively. The total
unamortized principal amount of the Fall 2019 Notes was $850,000
as of March 31, 2022, and December 31, 2021,
respectively.
All
the Fall 2019 Notes provided for interest at the rate of 5% per annum and are unsecured.
All amounts outstanding under the Fall 2019 Notes became due and
payable upon the approval of the holders of a majority of the
principal amount of outstanding Fall 2019 Notes (the “Majority
Holders”) on or after (a) November 23, 2020 or (b) the
occurrence of an event of default (either, the “Maturity
Date”). The Majority Holders have waived the default in the
maturity of the Fall 2019 Notes and as such there is no event of
default. The Company had the option to prepay the Fall 2019 Notes
at any time. Events of default under the Fall 2019 Notes included
failure to make payments under the Fall 2019 Notes within thirty
(30) days of the date due, failure to observe of the Fall 2019 Note
Purchase Agreement or Fall 2019 Notes which is not cured within
thirty (30) days of notice of the breach, bankruptcy, or a change
in control of the Company (as defined in the Fall 2019 Note
Purchase Agreement).
The Majority
Holders had the right, at any time not more than five (5) days
following the Maturity Date, to elect to convert all, and not less
than all, of the outstanding accrued and unpaid interest and
principal on the Fall 2019 Notes. The Fall 2019 Notes may be
converted, at the election of the Majority Holders, either (a) into
shares of the Company’s Common Stock at a conversion price of $0.18
per share, or (b) into shares of common stock of the Edgepoint, at
a conversion price of $5.00 (based on a $5.0 million pre-money
valuation) of Edgepoint and 1,000,000 shares outstanding.
The issuance of the Fall 2019 notes resulted in a discount from the
BCF totaling $222,222 related
to the conversion feature. Total amortization of the discount
totaled $0
for the three months ended March 31, 2022, and 2021.Total
unamortized discount on this note was $0 as of March 31,
2022, and December 31, 2021.
Further,
the Company recorded interest expense of $10,625 and approximately
$11,460 on these Fall 2019 Notes for
the three months ended March 31, 2022, and 2021, respectively. The
total amount outstanding under the Fall 2019 Notes, net of
discounts and including accrued interest thereon, as of March 31,
2022, and December 31, 2021, was $957,048 and $946,424,
respectively.
GMP
Notes
In
June 2020, the Company secured $2 million
in debt financing, evidenced by a one-year convertible note (the
“GMP Note”) from GMP, to conduct a clinical trial evaluating
OT-101 against COVID-19 bearing 2%
annual interest, and is personally guaranteed by Dr. Vuong Trieu,
the Chief Executive Officer of the Company. The GMP Note is
convertible into the Company’s Common Stock upon the GMP Note’s
maturity of the GMP Note, at the Company’s Common Stock price on
the date of conversion with no discount. GMP has waived the default
in the maturity of the GMP Note and as such there is no event of
default and also agreed to extend the date of maturity of the GMP
Note to June 30, 2022. GMP does not have the option to convert
prior to the GMP Note’s maturity. Such financing will be utilized
solely to fund the clinical trial. The Company’s liability under
GMP Note commenced to accrue when GMP first began to pay for
services related to the clinical trial to our third-party clinical
research organization, up to a maximum of $2 million.
GMP has been invoiced by the clinical research organization for the
full $2 million
as of March 31, 2022, and as such the Company has recognized the
liability as a convertible debt.
In
September 2021, the Company secured a further $1.5 million
in debt financing, evidenced by a one-year convertible note (the
“GMP Note 2”) from GMP, to fund the same clinical trial
evaluating OT-101 against COVID-19 bearing 2%
annual interest. The GMP Note is convertible into the Company’s
Common Stock upon the GMP Note 2’s maturity one year from the date
of the GMP Note 2, at the Company’s Common Stock price on the date
of conversion with no discount. GMP does not have the option to
convert prior to the GMP Note 2’s maturity at the end of one year.
Such financing was to be utilized solely to fund the clinical
trial. As of March 31, 2022, GMP was invoiced by the clinical
research organization for $0.5
million. GMP paid the clinical trial organization the first tranche
of $0.5
million
in October 2021.
In
October 2021, the Company entered into an Unsecured Convertible
Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible
promissory note in the aggregate principal amount of $0.5 million
(the “October 2021 Note”), which October 2021 Note is
convertible into shares of the Company’s Common Stock.
In
January 2022, the Company entered into an Unsecured Convertible
Note Purchase Agreement (the “January Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible
promissory note in the aggregate principal amount of $0.5 million
(the “January 2022 Note”), which January 2022 Note is
convertible into shares of the Company’s Common Stock.
The
GMP Note 2, the October 2021 Note and the January 2022 Note carries
an interest rate of 2% per
annum and matures on the earlier of (a) the one-year anniversary of
the date of the Purchase Agreement, or (b) the acceleration of the
maturity by GMP upon occurrence of an Event of Default (as defined
below). The GMP Note 2, the October 2021 Note and the January 2022
Note contains a voluntary conversion mechanism whereby GMP may
convert the outstanding principal and accrued interest under the
terms of the GMP Note 2, the October 2021 Note and the January 2022
Note into shares of Common Stock (the “Conversion Shares”),
at the consolidated closing bid price of the Company’s Common Stock
on the applicable OTC Market as of the date the Company receives a
Notice of Conversion from GMP. Prepayment of the GMP Note 2, the
October 2021 Note and the January 2022 Note may be made at any time
by payment of the outstanding principal amount plus accrued and
unpaid interest. The October Note contains customary events of
default (each an “Event of Default”). If an Event of Default
occurs, at GMP’s election, the outstanding principal amount of the
GMP Note 2, the October 2021 Note and the January 2022 Note, plus
accrued but unpaid interest, will become immediately due and
payable in cash. The October Purchase Agreement and the January
Purchase Agreement requires the Company to use of the proceeds
received under the October 2021 Note and January 2022 Note to
support the clinical development of OT-101, including payroll and
has been made in continuation of the relationship between the
Company and GMP.
The
total principal outstanding on all the GMP notes, inclusive of
accrued interest, was $4,569,781 and
$4,069,781 as of
March 31, 2022, and December 31, 2021, respectively.
Geneva
Roth Remark Notes
For
information on the special purchase agreements (SPAs) with
convertible debentures and notes, net of debt discount and
including accrued interest, if any, as of December 31, 2022, refer
to our Annual Report on Form 10-K for the year ended December 31,
2021 filed with the SEC on April 15, 2022.
Paycheck
Protection Program
For
information on the special purchase agreements (SPAs) with
convertible debentures and notes, net of debt discount and
including accrued interest, if any, as of December 31, 2022, refer
to our Annual Report on Form 10-K for the year ended December 31,
2021 filed with the SEC on April 15, 2022.
August
2021 Notes
In
August 2021, the Company entered into Note Purchase Agreements with
Autotelic - a related party, our CFO - a related party, and certain
accredited investors (the “August 2021 investors”), whereby the
Company issued four convertible notes in the aggregate principal
amount of $698,500 convertible into
shares of common stock of the Company for net proceeds of
$690,825.
The convertible notes carry a five (5%) percent coupon and mature
one year from issuance. The majority of the August 2021 investors
have the right, but not the obligation, not more than five days
following the maturity date, to convert all, but not less than all,
the outstanding and unpaid principal plus accrued interest into the
Company’s common stock, at a conversion price of $0.18. The Company
determined that the economic characteristics and risks of the
embedded conversion option are not clearly and closely related to
the economic characteristics and risks of the debt host instrument.
Further, the Company determined that the embedded conversion
feature meets the definition of a derivative but met the scope
exception to the derivative accounting required under ASC 815 for
certain contracts involving a reporting entity’s own
equity.
As of
March 31, 2022, and December 31, 2021, the August 2021 convertible
notes, net of debt discount, consist of the following
amounts:
SCHEDULE OF CONVERTIBLE NOTES, NET OF
DISCOUNT
|
|
|
March
31,
2022
|
|
|
|
December
31,
2021
|
|
|
|
March
31,
2022
|
|
|
December
31,
2021
|
|
|
|
|
|
|
|
|
Autotelic Related party
convertible note, 5% coupon August 2022 |
|
$ |
257,158 |
|
|
$ |
256,634 |
|
CFO Related party convertible note, 5%
coupon August 2022 |
|
|
77,147 |
|
|
|
76,531 |
|
Accredited investors convertible note,
5% coupon August 2022 |
|
|
384,193 |
|
|
|
381,123 |
|
Total |
|
$ |
718,498 |
|
|
$ |
714,288 |
|
During
the three months ended March 31, 2022, and 2021, the Company
recognized approximately $5,700
and $0 of interest,
respectively. At March 31, 2022, and December 31, 2021, accrued
interests on these convertible notes totaled approximately
$20,000 and $14,260, respectively.
November
– December 2021 Financing
In
November and December 2021, the Company entered into securities
purchase agreement with five institutional investors, whereby the
Company issued five convertible notes in the aggregate principal
amount of $1,250,000
convertible into shares of common stock of the Company. The
convertible notes carry a twelve (12%)
percent coupon and a default coupon of
16% and mature at the earliest of one year from
issuance or upon event of default. Investors has the right at any
time following issuance date to convert all or any part of the
outstanding and unpaid amount of the note into the Company’s common
stock at a conversion price established at a fixed rate of
$0.07.
The Company granted a total number of
9,615,385 warrants convertible into an equivalent
number of the Company common shares at a strike price of $0.13
up to five years after issuance. The Placement agent was also
granted a total amount of
961,540 as part of a finder’s fee
agreement.
In January 2022, three of the five investors made a cashless
exercise for their warrants. In this connection, the Company issued
approximately 3 million shares of
the Common Stock in exchange of approximately 5.8 million
warrants.
As of
March 31, 2022, and December 31, 2021, convertible notes under the
November-December 2021 Financing, net of debt discount, consist of
the following amounts:
SCHEDULE OF CONVERTIBLE
NOTES
|
|
|
March 31,
2022
|
|
|
|
December 31,
2021
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
|
|
|
|
|
|
|
Mast Hill Convertible
note, 12% coupon November 21 |
|
$ |
250,000 |
|
|
$ |
250,000 |
|
Talos Victory Convertible note, 12%
coupon November 2021 |
|
|
250,000 |
|
|
|
250,000 |
|
First Fire Global Opportunities LLC
Convertible note, 12% coupon, December 2021 |
|
|
250,000 |
|
|
|
250,000 |
|
Blue Lake Partners LLC Convertible
note, 12% coupon, December 2021 |
|
|
250,000 |
|
|
|
250,000 |
|
Fourth Man LLC Convertible note, 12%
coupon December 2021 |
|
|
250,000 |
|
|
|
250,000 |
|
Convertible notes, gross |
|
$ |
1,250,000 |
|
|
$ |
1,250,000 |
|
Less Debt discount recorded |
|
|
(1,250,000 |
) |
|
|
(1,250,000 |
) |
Amortization debt discount |
|
|
386,459 |
|
|
|
76,994 |
|
Convertible notes, net |
|
$ |
386,459 |
|
|
$ |
76,994 |
|
The
Company recognized approximately $48,000 and $0
of accrued interest during the three months ended March 31, 2022,
and 2021, respectively. The Company recognized approximately
$309,500
and $0 of interest expense attributable
to the amortization of the debt discount from the original debt
discount, deferred financing costs, fair value allocated to the
warrants and the beneficial conversion feature during the three
months ended March 31, 2022, and 2021, respectively.
The
Company recorded an initial debt discount of approximately
$0.4 million representing the
intrinsic value of the conversion option embedded in the
convertible debt instrument based upon the difference between the
fair value of the underlying common stock at the commitment date of
the note transaction and the effective conversion price embedded in
the note. The Company recognized amortization expense related to
the debt discount and debt issuance costs of approximately
$0.3 million for
the three months ended March 31, 2022, which is included in
interest expense in the consolidated statements of
operations.
Other
short-term advances
As of
March 31, 2022 compared to December 31, 2021, other short-term
advances consist of the following amounts obtained from various
employees and related parties:
SCHEDULE OF SHORT-TERM
LOANS
Other Advances |
|
|
March 31,
2022
|
|
|
|
December 31,
2021 |
|
Other Advances |
|
March 31,
2022
|
|
|
December 31,
2021 |
|
Short term advance from
CEO – Related Party |
|
$ |
- |
|
|
$ |
20,000 |
|
Short term advances – bridge
investors |
|
|
245,000 |
|
|
|
265,000 |
|
Short term advances from CFO – Related
Party |
|
|
25,050 |
|
|
|
45,050 |
|
Short term advance – Autotelic Inc. –
Related Party |
|
|
20,000 |
|
|
|
20,000 |
|
Accrued Interest
on advances |
|
|
5,003 |
|
|
|
9,212 |
|
Total |
|
$ |
295,053 |
|
|
$ |
359,262 |
|
During
the year ended December 31, 2020, the Company’s CEO provided
additional funding of $70,000
to
the Company, of which $50,000
was
repaid before December 31, 2020. Further, during the three months
ended March 31, 2022, $20,000
repaidto
the Company’s CEO. As such, $0
and
$20,000
was
outstanding at March 31, 2022 and December 31, 2021,
respectively.
During
the year ended December 31, 2021, Autotelic Inc. provided a
short-term funding of $120,000
to the Company, which was repaid in 2021. In May 2021, Autotelic
provided an additional short-term funding of $250,000
to the Company, which was converted into the August 2021 Notes.
Autotelic provided an additional $20,000 short-term loan to the
Company, and as such, $20,000 was
outstanding and payable to Autotelic at March 31, 2022 a December
31, 2021, respectively.
During
the year ended December 31, 2021, the Company’s CFO, a related
Party, provided short term advances of approximately $45,000.
During the year ended December 31, 2020, the Company’s CFO had
provided a short term advance of $25,000, which was
repaid during the year ended December 31, 2021. $20,000
was repaid to the CFO during the three months ended March 31, 2022.
As such approximately $25,000 and $45,000 was
outstanding at March 31, 2022 and December 31, 2021,
respectively.
NOTE
6 – JOINT VENTURE WITH
GMP AFFILIATES
On
March 31, 2022, the Company entered into (i) a joint venture (the
“JV”) agreement with Dragon and GMP Bio, both affiliates of
GMP, (and the Company, Dragon and GMP Bio are collectively called
the “Parties”) (the “JVA”), (ii) a license agreement
for rights to OT-101 (the “US License Agreement”) for the
territory within the United States of America (the “US”)
with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a
license agreement for rights to OT-101 for the rest of the world
with GMP Bio (the “Ex-US Rights Agreement”, and the US
License Agreement and the Ex-US License Agreement are collectively
called the “Agreements”).
Dragon
and the Company entered into the JVA to regulate their relationship
and the operation and management of the JV. The JVA contains
provisions for the licensed products and licensed technologies
related to OT-101 (the “Licensed products and
technologies”). Pursuant to the JVA the Company is required to
transfer to GMP Bio all of the Company’s rights and obligations
under the research and development agreement dated 3 February 2020
between the Company and Golden Mountain Partners, LLC
(“GMP”), an affiliate of Dragon, as amended, varied and/or
supplemented by a supplement to research and Services Agreement
dated 23 March 2020 between the Company, Mateon Therapeutics, Inc.
(subsequently renamed the Company) and GMP (the “R&D
Agreement”). The JVA permits GMP to seek
conversion of certain convertible promissory notes entered into
between the Company and GMP (see reference to Purchase Agreements
and Notes below) into shares of the Common Stock of the Company
within 15 business days of the execution of the JVA at a price of
$0.2242 per Common Share, the closing price of the Common Share as
traded on the OTCQB the day prior to the execution of the JVA, or
the closing price of the Common Stock prior to the date of
conversion if not within 15 business days of the JVA. Upon the
execution of the JVA, Dragon will pay for and hold 55 shares of GMP
Bio and the Company will pay for and hold 45 shares of GMP Bio,
both to be acquired at $1.00 per share of GMP Bio. Such shares of
GMP Bio were issued shortly after the date of the
JVA. The
JVA required the entering into of the Agreements on or before the
execution of the JVA. The JVA defines the valuation of the
Agreements (taking into account the transfer of the Company’s
rights and obligations under the R&D Agreement) each at
$11,320,237.25,
for an aggregate of $22,640,474.50.
The Parties also agreed that
if a Rare Pediatric Disease (“RPD”) Priority Review Voucher,
upon clinical approval of OT-101 Technologies for treatment of
diffuse intrinsic pontine glioma (the “DIPG Voucher”), is
issued to GMP Bio and GMP Bio, or a subsidiary thereof, sells the
DIPG Voucher to a non-GMP subsidiary, then the Company shall be
eligible to receive up to 50% of the net sales proceeds or $50
million, whichever is less. Dragon shall fund the JVA, for a total
of $27,671,691, based on the conditions contained in the JVA, and
the Company will input the licenses under the Agreements into the
JV. The Company is obligated to (i) (A) rectify the chain of legal
title such that the Company is the sole legal owner of such rights,
(B) complete registration as the sole owner of all the Company’s
Patent Rights and (C) provide evidence of such registration that is
satisfactory to Dragon; (ii) provide Dragon with copies of official
documents issued by the relevant patent offices in the relevant
countries evidencing the Company’s legal ownership of all the
Company’s Patents Rights; and (iii) reflect the Company’s legal
ownership of all the Company’s Patent Rights in the relevant online
registers of the relevant patent offices in the relevant countries.
The JVA intends to raise funding for the JVA through a Series A
round of financing of not less than $20
million.
Dragon can suspend funding the JVA if the Series A round of
financing is not successfully completed by August 31, 2022, in
which case Dragon’s funding obligation would be restricted to
$250,000 per
month to GMP Bio. If Dragon decides to terminate the JVA, the
licenses granted under the Agreements shall be terminated and the
OT-101 assets licensed by the Company will revert back to the
Company. The rest of the JVA deals with the conduct of the JV, the
board of directors of GMP Bio and other administrative matters.
Dragon shall nominate up to three directors of their choosing to
the board of directors of GMP Bio, two of whom are already
nominated as “A” Directors and the Company shall nominate up to two
directors of their choosing to the board of directors of GMP Bio,
one of whom is already nominated as a “B” Director. The JVA defines
how the board of directors will operate as well as the general
management and operations of the JV. Other standard terms on
shareholder rights, indemnification etc. are also defined in the
JVA. Also included are the other terms with relation to insurance,
indemnification, jurisdiction and other customary terms and
conditions.
The
Agreements include terms of an exclusive, irrevocable, perpetual,
royalty-free, sublicensable license under the Licensed Technology
to manufacture, have manufactured, use, import, sell, offer for
sale or otherwise exploit the Licensed Products, which is OT-101,
in the Field, which is all therapeutic uses in humans, and in the
Territories, which is the US and the rest of the world. In
addition, the Company grants a non-exclusive, irrevocable,
perpetual, royalty-free, non-sublicensable license for its sole use
of the Company’s Vision Grid system for monitoring process, man
flow, equipment flow, and material flow in contract development and
manufacturing organization operations. These have been granted to
GMP Bio and Sapu Holdings, LLC as the capital contribution by the
Company to GMP Bio. The Agreements include the contributions by the
key employees, as defined and included in the Agreements, standard
representations and warranties, intellectual property protection,
insurance, indemnification, jurisdiction and other customary terms
and conditions.
The Company is currently evaluating the estimated impact the
accounting for the JV will have on its financial statements upon
completion of the formation.
For
information on the various notes from GMP, refer to Note 5 – GMP
Notes of the Notes to the Consolidated Financial Statements
above.
NOTE
7 - PRIVATE PLACEMENT
AND JH DARBIE FINANCING
During
the period from July 2020 to March 2021 the Company entered into
subscription agreements with certain accredited investors pursuant
to the JH Darbie Financing, whereby the Company issued and sold a
total of 100 Units, for
total gross proceeds of approximately $5 million,
pursuant to the JH Darbie Placement Agreement, with each Unit
consisting of:
|
■ |
25,000
shares of Edgepoint Common Stock for a price of $1.00 per share of
Edgepoint Common Stock. |
|
■ |
One
convertible promissory note, convertible into up to 25,000
shares of Edgepoint Common Stock, at a conversion price of
$1.00 per share or up to
138,889 shares of the
Company’s Common Stock, at a conversion price of $0.18 per
share. |
|
■ |
50,000
warrants to purchase an equivalent number of shares of Edgepoint
Common Stock at $1.00 per share or an
equivalent number of shares of the Company’s Common Stock at
$0.20 per share with a
three-year expiration
date. |
As
March 31, 2022 and December 31, 2021 funds received under the JH
Darbie Financing, net of debt discount, consist of the following
amounts:
SCHEDULE OF FUNDS RECEIVED UNDER THE SUBSCRIPTION
AGREEMENT
|
|
|
March 31,
2022
|
|
|
|
December 31,
2021
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
Convertible promissory notes |
|
|
|
|
|
|
|
|
Subscription agreements -
accredited investors |
|
$ |
2,312,023
|
|
|
$ |
1,520,720 |
|
Subscription
agreements – related party |
|
|
121,650 |
|
|
|
85,664 |
|
Total
convertible promissory notes |
|
$ |
2,433,673
|
|
|
$ |
1,606,384 |
|
The
Company incurred approximately $0.64
million
of issuance costs, including legal costs of approximately
$39,000,
that are incremental costs directly related to the issuance of the
various instruments bundled in the offering.
Concurrently
with the sale of the Units, JH Darbie was granted a warrant,
exercisable over a five-year period, to purchase 10% of the number of
Units sold in the JH Darbie Financing. As such, the Company granted
10 Units to JH Darbie pursuant to the JH Darbie Placement
Agreement.
The
terms of convertible notes are summarized as follows:
|
■ |
Term:
Through March 31, 2022. |
|
■ |
Coupon:
16%. |
|
■ |
Convertible at the option
of the holder at any time in the Company’s Common Stock or
Edgepoint Common Stock. |
|
■ |
The
conversion price is initially set at $0.18 per share
for the Company’s Common Stock or $1.00 for
Edgepoint Common Stock, subject to adjustment. |
The
Company allocated the proceeds among the freestanding financial
instruments that were issued in the single transaction using the
relative fair value method, which affects the determination of each
financial instrument initial carrying amount. The Company utilized
the relative fair value method as none of the freestanding
financial instruments issued as part of the single transaction are
measured at fair value. Under the relative fair value method, the
Company made separate estimates of the fair value of each
freestanding financial instrument and then allocated the proceeds
in proportion to those fair value amounts. The Company recorded
non-controlling interests of approximately $1.8 million
in Edgepoint between July 2020 and March 2021. Non-controlling
interests represent the portion of net assets in consolidated
entities that are not owned by the Company and are reported as a
component of equity in the consolidated balance sheets.
As of the multiple closings of the Company during the three months
ended March 31, 2021, under the private placement memorandum with
JH Darbie, the estimated grant date fair value of approximately
$0.20
per share associated with the warrants to purchase up to
2,035,000 shares of common stock issued in this offering, or
a total of approximately $
0.7 million, was recorded to additional paid-in capital on a
relative fair value basis. All warrants sold in this offering had
an exercise price of $0.20
per share of the Company stock or $1.00
per share of Edge Point, subject to adjustment, are exercisable
immediately and expire three years from the date of
issuance. The fair value of the warrants was estimated using a
Black Scholes valuation models using the following input
values:
SCHEDULE OF FAIR VALUE WARRANTS ESTIMATED USING
BLACK SCHOLES VALUATION MODEL
Expected Term |
|
1.5 years |
|
Expected volatility |
|
|
152.3%-164.8 |
% |
Risk-free interest rates |
|
|
0.09%-0.11 |
% |
Dividend yields |
|
|
0.00 |
% |
As of
the multiple closings of the Company through December 31, 2020,
under the private placement memorandum with JH Darbie, the
estimated grant date fair value of approximately $0.20 per share associated with the
warrants to purchase up to 3,465,000 shares of common stock
issued in this offering, or a total of approximately $0.4 million, was recorded to
additional paid-in capital on a relative fair value basis. All
warrants sold in this offering had an exercise price of $0.20 per share of
the Company stock or $1.00 per share of Edge
Point, subject to adjustment, are exercisable immediately and
expire three years from the date of issuance. The fair value of the
warrants was estimated using a Black Scholes valuation models using
the following input values.
The
Company recorded an initial debt discount of approximately
$0.7
million representing the intrinsic value of the conversion option
embedded in the convertible debt instrument based upon the
difference between the fair value of the underlying common stock at
the commitment date of the note transaction and the effective
conversion price embedded in the note.
In February 2022, the Company and all except one of the Investors
agreed to extend the maturity date of the Notes from March 31,
2022, to March 31, 2023. In consideration for the extension of the
Notes, the Company issued to the Investors an aggregate of
33,000,066
Oncotelic Warrants at a price of $0.15
per share of Company’s Common Stock. Each Investor will be entitled
to receive
333,334
Oncotelic Warrants for each Unit purchased. Upon the amendment of the terms of the convertible
notes under the private placement memorandum. As incentive to
extend the maturity date, approximately 33 million warrants were
issued to the Unit Holders who participated in the amendment, The
Company repaid the 1 unit holder who did not participate in the
amendment shortly after March 31, 2022.
The Company reviewed the guidance per ASC 470-60 Troubled debt
restructurings and ASC 470-50 Debt-Modifications and
Extinguishments and concluded that the terms of the agreements were
substantially different as of March 31, 2022, and, accounted for
the transaction as a debt extinguishment. The loss is recognized
equal to the difference between the net carrying amount of the
original debt and the fair value of the modified debt
instrument.
At March 31, 2022, the Company estimated the fair value of the
warrants issued in conjunction with the amendment of the private
placement under the JH Darbie financing based on assumptions used
in the Black-Scholes valuation model. The key valuation assumptions
used consists, in part, of the price of the Company’s Common Stock,
a risk-free interest rate based on the yield of a Treasury note and
expected volatility of the Company’s Common Stock all as of the
measurement date. The Company used the following assumptions to
estimate fair value of the warrants as of March 31,
2022:
All the warrants issued in conjunction with the amendment #5 had an
exercise price of $0.15
per share and are immediately exercisable and expire two years from
the date of issuance or February 9, 2024. The warrants resulted in
an aggregate fair value of approximately $2.9 million.
The
Company recognized amortization expense related to the debt
discount and debt issuance costs of $30,775
and
$373,949
for
the three months ended March 31, 2022 and March 31, 2021
respectively, which is included in interest expense in the
statements of operations.
NOTE
8 - RELATED PARTY
TRANSACTIONS
Master
Service Agreement with Autotelic Inc.
In
October 2015, Oncotelic entered into a Master Service Agreement
(the “MSA”) with Autotelic Inc., a related party that is
partly-owned by the Company’s CEO Vuong Trieu, Ph.D. Dr. Trieu, a
related party, is a control person in Autotelic Inc. Autotelic Inc.
currently owns less than 10% of the Company. The
MSA stated that Autotelic Inc. will provide business functions and
services to the Company and allowed Autotelic Inc. to charge the
Company for these expenses paid on its behalf. The MSA includes
personnel costs allocated based on amount of time incurred and
other services such as consultant fees, clinical studies,
conferences and other operating expenses incurred on behalf of the
Company. The MSA requires a 90-day written termination notice in
the event either party requires to terminate such
services.
Expenses
related to the MSA were approximately $66,000
for the three months ended March 31, 2022 as compared to
approximately $77,000
for the same period of 2021.
In
September 2021, the Company entered into an exclusive License
Agreement (the “Agreement”) with Autotelic, pursuant to which
Autotelic granted Oncotelic, among other things: (i) the exclusive
right and license to certain Autotelic Patents (as defined in the
Agreement) and Autotelic Know-How (as defined in the Agreement);
and (ii) a right of first refusal to acquire at least a majority of
the outstanding capital stock of Autotelic prior to Autotelic
entering into any transaction that is a financing collaboration,
distribution revenues, earn-outs, sales, out-licensing, purchases,
debt, royalties, merger acquisition, change of control, transfer of
cash or non-cash assets, disposition of capital stock by way of
tender or exchange offer, partnership or any other joint or
collaborative venture, research collaboration, material transfer,
sponsored research or similar transaction or agreements. In
exchange for the rights granted to Oncotelic, Autotelic would be
entitled to earn the following milestone payments (collectively,
the “Milestone Payments”).
SCHEDULE OF RELATED PARTY LICENSE
AGREEMENT
Milestones |
|
Transaction
Value |
|
Actions |
|
|
|
|
|
Tranche
1 |
|
$ |
1,000,000 |
|
Upon the earlier to occur of:
(i) the Company receiving an investment of at least $20 million,
and (ii) the uplisting of the Company’s common stock to any NASDAQ
market or the New York Stock Exchange. |
|
|
|
|
|
|
Tranche
2 |
|
$ |
2,000,000 |
|
Upon
approval by the United States Food and Drug Administration of the
Company’s 505(b)2 application for purposes of treating
PD. |
|
|
|
|
|
|
Tranche
3 |
|
$ |
2,000,000 |
|
Upon
first patient in (“FPI”) for any clinical trial supporting
the use of AL-101 for the treatment of PD or ED. |
|
|
|
|
|
|
Tranche
4 |
|
$ |
2,500,000 |
|
Upon
FPI for phase 2 clinical trials supporting the use of AL-101 to
treat FSD. |
|
|
|
|
|
|
Tranche
5 |
|
$ |
2,500,000 |
|
Upon
FPI for phase 3 clinical trials supporting the use of AL-101 to
treat FSD |
|
|
|
|
|
|
Tranche
6 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat
PD. |
|
|
|
|
|
|
Tranche
7 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat
ED. |
|
|
|
|
|
|
Tranche
8 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat
FSD |
|
|
|
|
|
|
Tranche
9 |
|
$ |
10,000,000 |
|
Upon
the earlier of: (i) the Company entering into a licensing agreement
with a third party for the use of AL-101 for the treatment of PD,
ED or FSD with an aggregate licensing value of at least $50
million; and (ii) the Company’s gross revenue derived from sales of
AL-101 for the treatment of PD, ED or FSD reaches at least $50.0
million. |
In
addition to the Milestone Payments, Autotelic will be entitled to
royalties equal to 15% of the net sales of any
products that incorporate the Autotelic Patents or Autotelic
Know-How. The Agreement contains representations, warranties and
indemnification provisions of each of the parties thereto that are
customary for transactions of this type.
Note
Payable and Short Term Loan – Related Parties
In
April 2019, the Company issued a convertible note to Dr. Trieu
totaling $164,444, including OID of
$16,444, receiving net
proceeds of $148,000, which
was used by the Company for working capital and general corporate
purposes. The Company issued a Fall 2019 Note to Dr. Trieu in the
principal amount of $250,000. Dr. Trieu also offset
certain amounts due to him in the amount of $35,000 and was converted into
the Fall 2019 debt. During the year ended December 31, 2020, Dr.
Trieu provided additional short-term funding of $70,000 to the
Company, of which the Company repaid $50,000 prior to
December 31, 2020. Further, the Company repaid $20,000 to Dr. Trieu for the balance
of his short term loan of $20,000.
During the year ended December 31, 2020, Dr. Trieu purchased a
total of 5
Units under the private placement for a gross total of $250,000.
During
the year ended December 2021, Autotelic Inc provided a short term
loans of $270,000, of which
$250,000
was converted into the August 2021 loan and the balance of
$20,000 continues to be
a short term loan. During the three months ended March 31, 2021,
Autotelic Inc, provided a short-term loan of $120,000 to the Company. Such
loan was repaid in April 2021. No loans or repayments were made to
Autotelic Inc. during the same period in 2022.
Artius
Consulting Agreement
On
March 9, 2020, the Company and Artius Bioconsulting, LLC
(“Artius”), for which Mr. King is the Managing Member, entered into
an amendment to the Consulting Agreement dated December 1, 2018,
under which Artius agreed to serve as a consultant to the Company
for services related to the Company’s business from time to time,
effective December 1, 2019 (the “Effective Date”) (the “Artius
Agreement”). In connection with the Artius Agreement, Mr. King also
agreed to assist the Company with strategic advisory services with
respect to transactional and operational contracts, budgetary
input, among other matters in connection with the formation of a
new business unit to develop AI and Blockchain Driven Vision
Systems (“EdgePoint AI”), for which Mr. King is Chief Executive
Officer.
Under
the terms of the Artius Agreement, the Company agreed to grant to
Artius, subject to approval by the Company’s Board of Directors and
pursuant to the Company’s 2017 Equity Incentive Plan, 148,837 restricted
shares of the Company’s common stock, par value $.01 per share
(“Common Stock”), in addition to a 30% pre-financing
ownership stake in EdgePoint AI. The Artius Agreement contemplates that Mr.
King will generally provide his services at a rate of $237 per
hour, not to exceed 44 hours per month and payable monthly, and to
reimburse Mr. King for reasonable and necessary expenses incurred
by him or Artius in connection with providing services to the
Company.
Either
the Company or Artius may terminate the Artius Agreement at any
time, for any reason following the Effective Date. The Artius
Agreement will automatically renew one year from the Effective
Date, unless the Parties agree to terminate the Artius Agreement at
that time.
No expense was recorded
during the three months ended March 31, 2022 or March 31, 2021
related to this Agreement.
Maida
Consulting Agreement
Effective
May 5, 2020, the Company and Dr. Maida entered into an independent
consulting agreement, commencing April 1, 2020 (the “Maida
Agreement”), under which Dr. Maida will assist the Company in
providing medical expertise and advice from time to time in the
design, conduct and oversight of the Company’s existing and future
clinical trials.
Pursuant
to the terms of the Maida Agreement, the Company granted to Dr.
Maida 400,000 restricted
shares of the Company’s Common Stock to vest on May 5, 2021.
The Company will also pay Dr. Maida
$15,000 per month for a minimum of 20 hours per week, in in
addition to reimbursement of reasonable and necessary expenses
incurred by Dr. Maida in connection with his services to the
Company.
Either
the Company or Dr. Maida may terminate the Maida Agreement, for any
reason, upon 30 days advance written notice.
The
Company recorded an expense of $75,000 during the three
months ended March 31, 2022 as compared to $45,000
during the three months ended March 31, 2021 related to this
Agreement.
NOTE
9 - EQUITY PURCHASE
AGREEMENT AND REGISTRATION RIGHTS AGREEMENT
On
May 3, 2021, the Company entered into an Equity Purchase Agreement
(“EPL”) and Registration Rights Agreement with Peak One
Opportunity Fund LP (“Peak One” or the “Investor”).
Under the terms of the EPL, the Company issued 250,000 shares
of Common Stock to Peak One. Further, under the terms of the EPL,
Peak One agreed to purchase from the Company up to $10,000,000
of the Company’s Common Stock upon effectiveness of a registration
statement on Form S-1 filed with the U.S. Securities and Exchange
Commission and subject to certain limitations and conditions set
forth in the Equity Purchase Agreement. The Registration Rights
Agreement provided that the Company would (i) file the Registration
Statement with the SEC by July 2, 2021; and (ii) use its best
efforts to have the Registration Statement declared effective by
the Commission at the earliest possible date (in any event, within
90 days after the execution date of the definitive agreements). The
Company filed a Registration Statement on Form S-1 with the
Commission on May 24, 2021, and the Form S-1 was declared effective
on June 2, 2021.
Following
effectiveness of the Registration Statement, and subject to certain
limitations and conditions set forth in the Equity Purchase
Agreement, the Company shall have the discretion to deliver put
notices to the Investor and the Investor will be obligated to
purchase shares of the Company’s Common Stock based on the
investment amount specified in each put notice. The minimum amount
that the Company shall be entitled to put to the Investor in each
put notice is $20,000 and the maximum
amount is up to the lesser of $1.0 million or two hundred
fifty percent (250%) of the average daily trading volume of the
Company’s Common Stock defined as the average trading volume of the
Company’s Common Stock in the ten (10) days preceding the date on
the put notice multiplied by the lowest closing bid price in the
ten (10) immediately preceding the date of the put notice. Pursuant
to the Equity Purchase Agreement, the Investor will not be
permitted to purchase, and the Company may not put shares of the
Company’s Common Stock to the Investor that would result in the
Investor’s beneficial ownership of the Company’s outstanding Common
Stock exceeding 4.99%. The price of each put share shall be equal
to ninety one percent (91%) of the market price, which is defined
as the lesser of (i) closing bid price of the Common stock on the
trading date immediately preceding the respective put date, or (ii)
the lowest closing bid price of the Common Stock during the seven
(7) trading days immediately following the clearing date associated
with the applicable put notice.
The
Company filed a post-effective amendment Registration Statement on
Form S-1 with the Commission on April 26, 2022, and the Form S-1
was declared effective on May 6, 2022. The Company filed the
prospectus in this connection on May 11, 2022.
.
In
connection with the EPL, the Company issued 250,000
shares of Common Stock to Peak One and recorded a fair value in
lieu of service of approximately $70,000.
During
the three months ended March 31, 2022, the Company sold a total of
300,000 shares
of Common Stock at price of $0.21
for
total gross proceeds of approximately $65,500
and
approximately $51,800, net of issuance costs.
No similar sales were recorded during the three months ended March
31, 2021.
NOTE
10 - STOCKHOLDERS’
EQUITY
The
following transactions affected the Company’s Stockholders’
Equity:
Issuance of Common Stock during the three months ended March 31,
2022
In January 2022, three of the five investors from the
November/December 2021 financing made a cashless exercise for their
warrants. In connection with this exercise, the Company issued
3,041,958 shares of
Common Stock in exchange of approximately 5,769,231
million warrants.
In
March 2022, the Company sold
300,000 shares
of its Common Stock to Peak One under the EPL for net proceeds of
approximately $52 thousand.
Issuance of Common Stock during the three months ended March 31,
2021
In
January 2021, the Company issued 657,200 shares of its common
stock to TFK in connection with the part conversion of their
convertible notes payable.
In
March 2021, the Company converted 278,188
shares of our Series A Preferred Stock to 278,187,847 shares
of its common stock.
NOTE
11 – STOCK-BASED
COMPENSATION
Options
Pursuant
to the Merger, the Company’s Common Stock and corresponding
outstanding options survived. The below information details the
Company’s associated option activity.
As of
March 31, 2022, options to purchase Common Stock were outstanding
under three stock option plans – the 2017 Equity Incentive Plan
(the “2017 Plan”), the 2015 Equity Incentive Plan (the
“2015 Plan”) and the 2005 Stock Plan (the “2005
Plan”). Under the 2017 Plan, up to 2,000,000
shares of the Company’s Common Stock may be issued pursuant to
awards granted in the form of nonqualified stock options,
restricted and unrestricted stock awards, and other stock-based
awards. Under the 2015 and 2005 Plans, in aggregate, up to
7,250,000
shares of the Company’s Common Stock may be issued pursuant to
awards granted in the form of incentive stock options, nonqualified
stock options, restricted and unrestricted stock awards, and other
stock-based awards.
Employees,
consultants, and directors are eligible for awards granted under
the 2017 and 2015 Plans. The Company registered an additional total
of 20,000,000
shares of its Common Stock, which may be issued pursuant to the
Registrant’s Amended and Restated 2015 Equity Incentive Plan (the
“Plan”). Such additional shares were approved by the
shareholders of the Company on August 10, 2020 and as reported to
the SEC vide a Current Report on Form 8-K on August 14, 2020. As
such, the total number of shares of the Company’s common stock
available for issuance under the 2015 plan is 27,250,000.
Since the adoption of the 2015 Plan, no further awards may be
granted under the 2005 Plan, although options previously granted
remain outstanding in accordance with their terms.
Compensation-based
stock
option activity for qualified and unqualified stock options for the
three months ended March 31, 2022 is summarized as
follows:
SCHEDULE OF COMPENSATION BASED STOCK OPTION
ACTIVITY
|
|
|
|
|
Weighted |
|
For the three
months ended March 31, 2022 |
|
|
|
|
Average |
|
|
|
Shares |
|
|
Exercise Price |
|
Outstanding at January
1, 2022 |
|
|
16,592,620 |
|
|
$ |
0.30 |
|
Expired or
cancelled |
|
|
(2,359 |
) |
|
|
11.88 |
|
Outstanding at March 31,
2022 |
|
|
16,590,261 |
|
|
$ |
0.30 |
|
Information
on compensation-based stock option activity for qualified and
unqualified stock options for the year ended December 31, 2021 can
be found in our Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on April 15, 2022.
The
following table summarizes information about options to purchase
shares of the Company’s Common Stock outstanding and exercisable at
March 31, 2022:
SCHEDULE OF OPTIONS TO PURCHASE SHARES OF
COMMON STOCK OUTSTANDING AND EXERCISABLE
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
|
Outstanding |
|
|
Remaining Life |
|
|
Exercise |
|
|
Number |
|
Exercise prices |
|
|
Options |
|
|
In Years |
|
|
Price |
|
|
Exercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.14 |
|
|
|
7,150,000 |
|
|
|
9.43 |
|
|
$ |
0.14 |
|
|
|
3,707,500 |
|
|
0.16 |
|
|
|
5,502,761 |
|
|
|
9.27 |
|
|
|
0.16 |
|
|
|
5,502,761 |
|
|
0.22 |
|
|
|
1,750,000 |
|
|
|
4.09 |
|
|
|
0.22 |
|
|
|
1,750,000 |
|
|
0.38 |
|
|
|
900,000 |
|
|
|
3.41 |
|
|
|
0.38 |
|
|
|
900,000 |
|
|
0.73 |
|
|
|
762,500 |
|
|
|
3.04 |
|
|
|
0.73 |
|
|
|
762,500 |
|
|
1.37 |
|
|
|
150,000 |
|
|
|
1.25 |
|
|
|
1.37 |
|
|
|
150,000 |
|
|
1.43 |
|
|
|
300,000 |
|
|
|
3.16 |
|
|
|
1.43 |
|
|
|
300,000 |
|
|
15.00 |
|
|
|
75,000 |
|
|
|
3.16 |
|
|
|
15.00 |
|
|
|
75,000 |
|
|
|
|
|
|
16,590,261 |
|
|
|
7.97 |
|
|
$ |
0.30 |
|
|
|
13,147,761 |
|
The
compensation expense attributed to the issuance of the options is
recognized as they are vested.
The
employee stock option plan stock options are generally exercisable
for ten years from the grant date and vest over various terms from
the grant date to three years.
The
aggregate intrinsic value totaled approximately $1.0
million
and was based on the Company’s closing stock price of $0.23
as of
March 31, 2022, which would have been received by the option
holders had all option holders exercised their options as of that
date. Information on the aggregate intrinsic value for the year
ended December 31, 2021 can be found in our Annual Report on Form
10-K for the year ended December 31, 2021 filed with the SEC on
April 15, 2022.
The
Company amortized approximately $297,000 of stock
compensation expense during the three months ended March 31, 2022
on the grants of certain milestone driven options that were granted
during the year ended December 31, 2021. No similar expense was
recorded during the same period of 2021.
In
August 2019, the Company entered into Employment Agreements and
incentive compensation arrangements with each of its executive
officers, including Dr. Vuong Trieu, the Chief Executive Officer;
Dr. Fatih Uckun, the Chief Medical Officer; Dr. Chulho Park, its
Chief Technology Officer; and Mr. Amit Shah, the Chief Financial
Officer. Details of the agreements and the incentive compensation
is described in detail in Note 11 – Commitments & Contingencies
under “Employment Agreements”. The incentive stock options or the
restricted stock awards granted to the Company’s executive officers
have not been granted as of the date of this filing.
Warrants
Pursuant
to the Merger, the Company’s Common Stock and corresponding
outstanding warrants survived. The below information represents the
Company’s associated warrant activity.
In February 2022,
the Company and all except one of the Investors agreed to extend
the maturity date of the Notes from March 31, 2022, to March 31,
2023.
In consideration for the extension of the Notes, the Company issued
to the Investors an aggregate of approximately
33
million Oncotelic Warrants at a price of $0.15
per share of Company’s Common Stock. At March 31, 2022, the Company
estimated the fair value of the warrants issued in conjunction with
the amendment of the private placement under the JH Darbie
financing based on assumptions used in the Black-Scholes valuation
model. The key valuation assumptions used consists, in part, of the
price of the Company’s Common Stock, a risk-free interest rate
based on the yield of a Treasury note and expected volatility of
the Company’s Common Stock all as of the measurement date. The
Company used the following assumptions to estimate fair value of
the warrants as of March 31, 2022:
All the warrants issued in conjunction with the amendment #5 had an
exercise price of $0.15
per share and are immediately exercisable and expire two years from
the date of issuance or February 9, 2024. The warrants resulted in
an aggregate fair value of approximately $2.9
million.
The
issuance of warrants to purchase shares of the Company’s Common
Stock, including those attributed to debt issuances, as of March
31, 2022 are summarized as follows:
SCHEDULE OF WARRANTS
ACTIVITY
For the three months ended March 31,
2022 |
|
|
|
|
Average |
|
|
|
Shares |
|
|
Exercise Price |
|
Outstanding at January 1, 2022 |
|
|
53,314,424 |
|
|
$ |
0.20 |
|
Issued during the three months ended March 31, 2022 |
|
|
33,000,066 |
|
|
|
0.15-0.20 |
|
Exercised / cancelled during the
three months ended March 31, 2022 |
|
|
(5,769,231 |
) |
|
|
0.13 |
|
Outstanding at December 31,
2021 |
|
|
80,545,259 |
|
|
$ |
0.18 |
|
Information on warrants for the year ended December 31, 2022 can be
found in our Annual Report on Form 10-K for the year ended December
31, 2021 filed with the SEC on April 15, 2022.
The
following table summarizes information about warrants outstanding
and exercisable at March 31, 2022:
SCHEDULE OF WARRANTS OUTSTANDING AND
EXERCISABLE
|
|
|
Outstanding and exercisable |
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
|
Number |
|
|
Remaining Life |
|
|
Exercise |
|
|
Number |
|
Exercise Price |
|
|
Outstanding |
|
|
in Years |
|
|
Price |
|
|
Exercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.20 |
|
|
|
42,737,500 |
|
|
|
1.00 |
|
|
$ |
0.20 |
|
|
|
4,237,500 |
|
|
0.13 |
|
|
|
4,807,693 |
|
|
|
5.00 |
|
|
|
0.13 |
|
|
|
4,807,693 |
|
|
0.15 |
|
|
|
33,000,066 |
|
|
|
2.00 |
|
|
|
0.15 |
|
|
|
33,000,066 |
|
|
|
|
|
|
80,545,259 |
|
|
|
2.15 |
|
|
$ |
0.18 |
|
|
|
80,545,259 |
|
In January 2022, three of the five November/December accredited
investors made a cashless exercise for their warrants. In this
connection, the Company issued 3,041,958 shares of
Common Stock in exchange of approximately 5,769,231
million warrants.
NOTE
12 – INCOME
TAXES
The Company had gross deferred tax assets, which primarily relate
to net operating loss carryforwards. As of
December 31, 2021, the Company had gross federal and state net
operating loss carryforwards of approximately $236.1
million
and $76.3
million,
respectively, which are available to offset future taxable income,
if any. The Company recorded a valuation allowance in the full
amount of its net deferred tax assets since realization of such tax
benefits has been determined by our management to be less likely
than not. Information on our deferred tax assets and liabilities
can be found in our Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on April 15, 2022.
Portions of these
carryforwards will expire through 2038, if not otherwise
utilized. The Company’s utilization of net operating loss
carryforwards could be subject to an annual limitation. as a result
of certain past or future events, such as stock sales or other
equity events constituting a “change in ownership” under the
provisions of Sections 382 and 383 of the Internal Revenue Code of
1986, as amended, and similar state provisions. The annual
limitations could result in the expiration of net operating loss
carryforwards and tax credits before they can be utilized. We have
not performed a formal analysis, but we believe our ability to use
such net operating losses and tax credit carryforwards will be
subject to annual limitations, due to change of ownership control
provisions under Section 382 and 383 of the Internal Revenue Code,
which would significantly impact our ability to realize these
deferred tax assets.
NOTE
13 – COMMITMENTS AND
CONTINGENCIES
Leases
Currently,
the Company is leasing the office located at 29397 Agoura Road,
Suite 107, Agoura Hills, CA 91301 on a month-to-month basis until
such time a new office is identified. The Company believes the
office is sufficient for its current operations.
Legal
Claims
From
time to time, the Company may become involved in legal proceedings
arising in the ordinary course of business. The Company is not
presently a party to any legal proceedings that it currently
believes, if determined adversely to the Company, would
individually or taken together have a material adverse effect on
the Company’s business, operating results, financial condition or
cash flows.
PointR
Merger Consideration
The
total purchase price of $17,831,427 represented the
consideration transferred from the Company in the PointR Merger and
was calculated based on the number of shares of Common Stock plus
the preferred shares outstanding but convertible into Common Stock
outstanding at the date of the PointR Merger and included
$2,625,000 of
contingent consideration of shares issuable to PointR shareholders,
which can increase to $15 million of contingent
consideration, upon achievement of certain milestones. The
$2,625,000 of contingent
consideration of shares issuable to PointR shareholders was
recorded and associated with the PointR Merger is also classified
as Level 3 fair value measurements. The Company initially recorded
the contingency based on a valuation conducted by a third-party
valuation expert. The valuation was based on a probability of the
completion of certain milestones by PointR for the shareholders to
earn additional shares. The Company evaluated the probability of
the earning of the milestones and concluded that the probability of
achievement of the milestones had not changed, primarily due to the
shifting of focus by the Company to develop AI technologies for the
COVID-19 pandemic. As such, the Company did not record any change
to the valuation during the years ended and as of March 31, 2022 or
December 31, 2021, respectively.
NOTE
14 – SUBSEQUENT
EVENTS
March
2022 – Fourth Man Financing
In
March 2022, the Company entered into a securities purchase
agreement with an accredited investor, whereby the Company issued a
promissory note in the aggregate principal amount of $250,000
convertible
into shares of common stock of the Company. The convertible note
carries a twelve (12%)
percent coupon and a default coupon of
16% and
mature one year from issuance. The investor has the right at any
time following issuance date to convert all or any part of the
outstanding and unpaid amount of the note into the Company’s common
stock at a conversion price established at a fixed rate of
$0.10.
The Company also granted a total number of
1,250,000 warrants
convertible into an equivalent number of the Company common shares
at a strike price of $0.20
up to
five years after issuance. As the funds for the Note were received
in April 2022, the Company will record the transaction during the
six months ended June 30, 2022.
Peak
One Equity Purchase Agreement
The
Company filed a post-effective amendment to reregister the EPL on
April 26, 2022 and the post effective amendment was found effective
by the SEC on 6 May, 2022. The Company filed the prospectus in this
connection on May 11, 2022.
Appointments
of Chief Medical Officer and Chief Regulatory
Officer
The
Company appointed Dr. Fatih Uckun and Dr. Seymour Fein as its
Consulting Chief Medical Officer and Chief Regulatory Officer in
May 2022. For more information on the appointments of Drs. Uckun
and Fein, refer to our Current Report on form 8-K filed with the
SEC on May 6, 2022.
Cashless exercise of warrants
On May 13, 2022, the Company received a request from one of the
November/December 2021 note holders for a cashless exercise of
their warrants. The Company will issue 1,403,326
shares of Common Stock to the debt holder in lieu of 1,923,077
warrants.
ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Note
Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q (the “Quarterly Report” or
“Report”) includes a number of forward-looking statements
that reflect management’s current views with respect to future
events and financial performance. Forward-looking statements are
projections in respect of future events or our future financial
performance. In some cases, you can identify forward-looking
statements by terminology such as “may,” “should,” “expects,”
“plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other
comparable terminology. Those statements include statements
regarding the intent, belief or current expectations of us and
members of our management team, as well as the assumptions on which
such statements are based.
Although
we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, or performance. These statements are only
predictions and involve known and unknown risks, uncertainties and
other factors. Some of these risks are included in the section
entitled “Risk Factors” set forth in this Quarterly Report and in
other reports that we file with the SEC. The occurrence of any of
these risks, or others of which we are currently unaware, may cause
our company’s actual results, levels of activity, performance or
achievements to be materially different from any future results,
levels of activity, performance or achievements expressed or
implied by these forward-looking statements. These risks include,
by way of example and without limitation: