Company Quick10K Filing
Oncolix
Price0.01 EPS-0
Shares108 P/E-0
MCap1 P/FCF-1
Net Debt6 EBIT-7
TEV7 TEV/EBIT-1
TTM 2018-09-30, in MM, except price, ratios
10-Q 2018-09-30 Filed 2018-11-19
10-Q 2018-06-30 Filed 2018-08-09
10-Q 2018-03-31 Filed 2018-05-14
S-1 2018-03-21 Public Filing
10-K 2017-12-31 Filed 2018-03-14
10-Q 2017-09-30 Filed 2017-10-23
10-Q 2017-06-30 Filed 2017-08-18
10-Q 2017-03-31 Filed 2017-05-15
10-K 2016-12-31 Filed 2017-04-05
10-Q 2016-09-30 Filed 2016-11-22
10-Q 2016-06-30 Filed 2016-08-12
10-Q 2016-03-31 Filed 2016-05-16
10-K 2015-12-31 Filed 2016-04-14
10-Q 2015-09-30 Filed 2015-11-16
10-Q 2015-06-30 Filed 2015-08-19
10-Q 2015-03-31 Filed 2015-05-20
10-K 2014-12-31 Filed 2015-03-26
8-K 2019-07-02
8-K 2019-03-06
8-K 2019-02-18
8-K 2019-01-23
8-K 2018-11-29
8-K 2018-10-11
8-K 2018-06-26
8-K 2018-06-25
8-K 2018-06-01
8-K 2018-04-27

ONCX 10Q Quarterly Report

Part I. Financial Information
Item 1. Financial Statements.
Note 1 - Background and Basis of Presentation
Note 2 - Summary of Significant Accounting Policies
Note 3 - Stockholders' Deficit
Note 4 - Loss per Common Share
Note 5 - Notes Payable
Note 6 - Related-Party Transactions
Note 7 - Commitments and Contingencies
Note 8 - Events Subsequent To September 30, 2018
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Item 4. Controls and Procedures.
Part II. Other Information
Item 1. Legal Proceedings.
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Item 3. Defaults Upon Senior Securities
Item 4. Mine Safety Disclosures
Item 5. Other Information.
Item 6. Exhibits
EX-31.1 oncx_ex311.htm
EX-32.1 oncx_ex321.htm

Oncolix Earnings 2018-09-30

Balance SheetIncome StatementCash Flow
1.7-0.6-3.0-5.3-7.7-10.02014201520172019
Assets, Equity
0.0-1.0-1.9-2.9-3.8-4.82014201520172019
Rev, G Profit, Net Income
4.82.91.0-1.0-2.9-4.82014201520172019
Ops, Inv, Fin

10-Q 1 oncx_10q.htm FORM 10-Q oncx_10q.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2018

or

¨ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT

 

For the transition period from __________ to __________.

 

Commission file number 333-192405

 

Oncolix, Inc.

(Exact Name of Registrant as specified in its charter)

 

Florida

 

46-3046340

(State or jurisdiction of

Incorporation or organization

 

(I.R.S Employer Identification No.)

 

 

 

14405 Walters Road, Suite 780, Houston, Texas

 

77014

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code 281-402-3167

 

Indicate by check mark whether the registrant (1) 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. x Yes    ¨ No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). x Yes    ¨ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer” “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer 

¨

Accelerated filer 

¨

Non-accelerated filer

¨

Smaller reporting company

x

(Do not check if a smaller company)

Emerging growth company

x

 

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 x.

 

The number of shares of the issuer’s common stock, par value $.0001 per share, outstanding as of November 12, 2018 was 114,227,936.

 

 
 
 
 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

 

Factors Affecting Forward-Looking Statements

 

3

 

 

 

 

Part I. Financial Information

 

4

 

 

 

 

Item 1.

Financial Statements.

 

4

 

 

Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017 (unaudited).

 

4

 

 

Condensed Consolidated Statements of Operations for the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017 (unaudited).

 

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (unaudited).

 

6

 

 

Notes to Condensed Consolidated Financial Statements (unaudited).

 

7

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

16

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

22

 

Item 4.

Controls and Procedures.

 

22

 

 

 

 

Part II. Other Information.

 

23

 

 

 

 

Item 1.

Legal Proceedings.

 

23

 

Item 1A.

Risk Factors

 

23

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

 

23

 

Item 3.

Defaults Upon Senior Securities.

 

23

 

Item 4.

Mine Safety Disclosures.

 

23

 

Item 5.

Other Information.

 

23

 

Item 6.

Exhibits.

 

24

 

 

 

 

Signatures

 

25

 

 
2
 
Table of Contents

 

Factors Affecting Forward-Looking Statements

 

This Form 10-Q Quarterly Report (“Form 10-Q”) contains certain “forward-looking statements,” which statements involve substantial risks and uncertainties. In some cases, it is possible to identify forward-looking statements because they contain words such as “anticipates,” believes,” “contemplates,” “continue,” “could,” “estimates,” “expects,” “future,” “intends,” “likely,” “may,” “plans,” “potential,” “predicts,” “projects,” “seek,” “should,” “target” or “will,” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Many factors could cause our actual operations or results to differ materially from the operations and results anticipated in forward-looking statements. These factors include, in particular, risks relating to:

 

 

· the early stage of development of our product candidates;

 

 

 

 

· the timing, cost or results of our clinical trials;

 

 

 

 

· our need for substantial additional funds and uncertainties regarding our ability to raise such funds on acceptable terms, if at all;

 

 

 

 

· our ability to make arrangements to repay indebtedness, and the possible loss of assets or our ability to operate if we are unable to do so on acceptable terms;

 

 

 

 

· uncertainties relating to the decisions of regulatory agencies;

 

 

 

 

· uncertainties related to reimbursement policies by payors;

 

 

 

 

· uncertainties regarding current and future government regulations of our business;

 

 

 

 

· uncertainties relating to patent and intellectual property matters;

 

 

 

 

· our dependence on third parties, including our contract manufacturer, clinical research organizations, and consultants;

 

 

 

 

· competition; and

 

 

 

 

· other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (“SEC”).

 

For additional discussion of such risks, uncertainties and assumptions, see "Part I. Financial Information - Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources" included elsewhere in this Form 10-Q and “Risk Factors” included in the Annual Report on Form 10-K filed with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. 

  

 
3
 
Table of Contents

 

Part I. Financial Information

Item 1. Financial Statements.

 

The following unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Rule 8-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (which include only normal recurring adjustments) considered necessary for a fair statement of the interim periods presented have been included. The year-end balance sheet data was derived from audited financial statements but does not include all the disclosures required by accounting principles generally accepted in the United States of America. Operating results for the three- and nine-month periods ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.

 

Oncolix, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2018

 

 

2017

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$ 123,300

 

 

$ 494,410

 

Prepaid services with related parties

 

 

150,000

 

 

 

313,777

 

Prepaid expenses

 

 

17,877

 

 

 

81,210

 

Total current assets

 

 

291,177

 

 

 

889,397

 

Property and equipment, net

 

 

-

 

 

 

-

 

Deferred offering costs

 

 

5,464

 

 

 

-

 

Total assets

 

$ 296,641

 

 

$ 889,397

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$ 46,031

 

 

$ 43,035

 

Related party payable and accrued expenses

 

 

17,919

 

 

 

261,157

 

Convertible notes and accrued interest payable, net of discount

 

 

6,207,671

 

 

 

897,111

 

Accounts payable to Greenville Health System

 

 

 

 

 

 

 

 

and affiliates

 

 

61,935

 

 

 

61,935

 

Total current liabilities

 

 

6,333,556

 

 

 

1,263,238

 

Deferred compensation

 

 

1,268,013

 

 

 

1,268,013

 

Total liabilities

 

 

7,601,569

 

 

 

2,531,251

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders' deficit

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 8,000,000,000 shares

 

 

 

 

 

 

 

 

authorized, 108,477,936 and 104,477,936 shares

 

 

 

 

 

 

 

 

issued and outstanding at September 30, 2018 and

 

 

 

 

 

 

 

 

December 31, 2017, respectively

 

 

10,848

 

 

 

10,448

 

Series A preferred stock, $0.0001 par value, 150,000,000

 

 

 

 

 

 

 

 

shares authorized, 63,038,284 and 63,038,284 shares

 

 

 

 

 

 

 

 

issued and outstanding at September 30, 2018 and

 

 

 

 

 

 

 

 

December 31, 2017, respectively

 

 

6,304

 

 

 

6,304

 

Additional paid-in capital

 

 

22,118,375

 

 

 

20,960,237

 

Accumulated deficit

 

 

(29,440,455 )

 

 

(22,618,843 )

Total stockholders' deficit

 

 

(7,304,928 )

 

 

(1,641,854 )

Total liabilities and stockholders' deficit

 

$ 296,641

 

 

$ 889,397

 

  

See accompanying condensed notes to consolidated financial statements.

 

 
4
 
Table of Contents

 

Oncolix, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenue

 

$ -

 

 

$ -

 

 

$ -

 

 

$ -

 

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

211,197

 

 

 

76,013

 

 

 

379,092

 

 

 

153,108

 

General and administrative expenses

 

 

221,633

 

 

 

350,303

 

 

 

815,451

 

 

 

1,144,427

 

Total operating expenses

 

 

432,830

 

 

 

426,316

 

 

 

1,194,543

 

 

 

1,297,535

 

Loss on debt refinancing

 

 

-

 

 

 

-

 

 

 

1,706,733

 

 

 

-

 

Gain on extinguishment of debt

 

 

-

 

 

 

(437,184 )

 

 

-

 

 

 

(437,184 )

Interest expense on convertible notes

 

 

626,299

 

 

 

814,054

 

 

 

3,078,789

 

 

 

1,276,733

 

Net loss

 

 

(1,059,129 )

 

 

(803,186 )

 

 

(5,980,065 )

 

 

(2,137,084 )

Imputed dividend for adjustment of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A conversion price into

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

-

 

 

 

-

 

 

 

841,517

 

 

 

-

 

Net loss attributable to Common Stock

 

$ (1,059,129 )

 

$ (803,186 )

 

$ (6,821,582 )

 

$ (2,137,084 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and diluted

 

$ (0.010 )

 

$ (0.009 )

 

$ (0.065 )

 

$ (0.027 )

Weighted average common shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

outstanding - basic and diluted

 

 

106,336,632

 

 

 

92,190,551

 

 

 

105,104,310

 

 

 

78,302,103

 

 

See accompanying condensed notes to consolidated financial statements.

 

 
5
 
Table of Contents

 

Oncolix, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

Cash flows from operating activitities

 

 

 

 

 

 

Net loss

 

$ (5,980,065 )

 

$ (2,137,084 )

Adjustments to reconcile net loss to net

 

 

 

 

 

 

 

 

cash used in operating activities

 

 

 

 

 

 

 

 

Warrant issued for services

 

 

591

 

 

 

-

 

Accretion of discount on notes payable

 

 

2,676,665

 

 

 

1,122,415

 

Gain on extinguishment of debt

 

 

-

 

 

 

(437,184 )

Loss on debt refinancing

 

 

1,706,733

 

 

 

-

 

Changes in operating assets and liabilities

 

 

 

 

 

 

 

 

Prepaid and other current assets

 

 

221,646

 

 

 

50,000

 

Related party accounts payable

 

 

 

 

 

 

 

 

and accrued expenses

 

 

(243,238 )

 

 

(45,012 )

Accounts payable and accrued

 

 

 

 

 

 

 

 

Increase (Decrease) in Accounts Payable and Accrued Liabilities expenses

 

 

298,029

 

 

 

(107,078 )

Net cash used in operating activities

 

 

(1,319,639 )

 

 

(1,553,943 )

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

-

 

 

 

1,000

 

Proceeds from sale of convertible

 

 

 

 

 

 

 

 

notes and warrants

 

 

948,529

 

 

 

3,018,267

 

Payment of secured notes

 

 

-

 

 

 

(120,000 )

Net cash provided by financing activities

 

 

948,529

 

 

 

2,899,267

 

Net increase in cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

(371,110 )

 

 

1,345,324

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at beginning of period

 

 

494,410

 

 

 

15,264

 

Cash and cash equivalents at end of period

 

$ 123,300

 

 

$ 1,360,588

 

Non-cash financing activities

 

 

 

 

 

 

 

 

Stock issued to pay interest and other liabilities

 

$ -

 

 

$ 56,926

 

Stock issued in cashless exercise of warrants

 

$ -

 

 

$ 90

 

Stock issued in conversion of secured notes

 

$ 120,000

 

 

$ -

 

Beneficial conversion feature of notes issued

 

$ -

 

 

$ 1,822,248

 

Stock assumed in reverse merger

 

$ -

 

 

$ 3,177

 

Warrants issued in debt modifications

 

$ -

 

 

$ 19,900

 

Warrants issued to placement agent

 

$ 25,290

 

 

$ 267,422

 

Debt discount related to warrants issued

 

$ 171,110

 

 

$ 1,639,005

 

Inputed dividend for adjustment of Series A

 

 

 

 

 

 

 

 

conversion price into Common Stock

 

$ 841,547

 

 

$ -

 

Interest paid in cash

 

$ 107,090

 

 

$ 12,248

 

 

See accompanying condensed notes to consolidated financial statements.

 

 
6
 
Table of Contents

 

Oncolix, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 1 – Background and Basis of Presentation

 

On April 8, 2017, Oncolix, Inc., a private Delaware corporation (“Oncolix/DE”) acquired approximately 66% of the outstanding common stock of Advanced Environmental Petroleum Producers, Inc., a Florida corporation (“AEPP”), a public entity traded on the over-the-counter market with limited or no operating activities and no indebtedness. On August 3, 2017, pursuant to a reverse merger, AEPP acquired all of the outstanding equity interest of Oncolix/DE and assumed responsibility for the issuance of equity securities under Oncolix/DE’s options, warrants and convertible debt (the “Merger”) as described further herein. The Merger was treated as a reverse acquisition of AEPP for financial accounting and reporting purposes. As such, Oncolix/DE was treated as the acquirer and AEPP was treated as the acquired entity for accounting and financial reporting purposes.

 

Accordingly, the financial statements of AEPP for all periods prior to August 3, 2017 are those of Oncolix/DE. Because of the acquisition of a controlling interest on April 8, 2017, the financial statements of AEPP are consolidated with Oncolix/DE since April 2017. The $365,000 purchase price for stock of AEPP by Oncolix/DE was treated as an expense of the merger, and the shares of AEPP Common Stock not owned by Oncolix/DE are treated as shares issued and outstanding subsequent to April 2017. AEPP’s assets, liabilities and results of operations for periods after April 2017 are the consolidated assets, liabilities and results of operations of AEPP and Oncolix/DE.

 

Contemporaneously with the Merger, Oncolix issued a series of short-term senior secured convertible notes (the “August 2017 Notes”) and related warrants to acquire Common Stock (i) in exchange for prior indebtedness of Oncolix/DE and (ii) for cash proceeds of $2 million. During June 2018, the terms of the August 2017 Notes were renegotiated, and additional secured convertible notes (the “June 2018 Notes”) and related warrants were issued for approximately $1.1 million in cash. See Note 5.

 

On September 27, 2017, AEPP filed an amendment with the Florida Secretary of State and changed its name to Oncolix, Inc. As used in these consolidated financial statements, “We”, “Us”, “Our”, “Oncolix” or the “Company” refers to Oncolix/DE prior to April 2017 and the consolidated Oncolix and Oncolix/DE subsequent to such date.

 

These condensed consolidated financial statements are unaudited; however, in the opinion of management, these condensed statements reflect all adjustments necessary for a fair statement of the results for the periods reported. All such adjustments are of a normal recurring nature unless disclosed otherwise. These condensed consolidated financial statements, including notes, have been prepared in accordance with the applicable rules of the SEC and do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. These interim condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. The results of operations for the three-month and six-month periods ending September 30, 2018 are not necessarily indicative of the results to be expected for the full year.

 

Description of business

We are developing medical therapies for the treatment of cancer. The Company’s activities are focused on the development of Prolanta™ for the treatment of gynecological cancers and Cyclosam™ a radiopharmaceutical licensed in October 2018. See Note 8. Oncolix is incorporated in Florida, and we commenced operations on January 24, 2007. At the commencement of our operations, certain intellectual property was transferred to us by a subsidiary of Greenville Health Corporation (collectively, “GHC”), a component unit of Greenville Health System (“GHS”) of South Carolina. Prior to the Merger in August 2017, GHC was the majority stockholder of Oncolix. See Notes 3, 6 and 7.

 

As a clinical-stage biotechnology company, we have no revenues and must raise substantial additional capital to support the completion of our development and commercialization activities. The Company’s business is subject to significant risks and uncertainties, including the risk of failure to secure additional funding for the Company’s future operations and to repay its existing indebtedness.

 

Going concern

We have experienced negative cash flows from operations since the commencement of operations, and we expect these losses to continue into the foreseeable future as we continue the development and clinical testing of our principal product candidate, Prolanta™, and seek regulatory approval to market products. In June 2018, we completed a debt financing through the issuance of the June 2018 Notes which are expected to fund our operations into December 2018. See Note 5. To fund our operations beyond this date, we have commenced a private placement for the sale of units of our Common Stock and warrants to acquire Common Stock. See Note 8. The August 2017 Notes and the June 2018 Notes mature in five installments during 2019. Accordingly, our continued operations are dependent on our ability to complete the current private placement, and then to subsequently raise additional capital through the sale of equity or debt securities or through the licensing of our products. In the event we are unable to raise sufficient funds, we would have to substantially alter, or possibly even discontinue or curtail operations, or sell assets at distressed prices. This uncertainty raises substantial doubt about our ability to continue as a going concern, as noted in the opinion of our independent registered public accounting firm in the audited financial statements as of December 31, 2017. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 
7
 
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Note 2 - Summary of Significant Accounting Policies

 

Use of estimates

To prepare our condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”), we are required to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. In addition, significant estimates were made regarding the realization of deferred tax assets, the calculation of the fair value of stock options and warrants awarded, the estimation of the value of warrants issued in conjunction with capital stock, and the projected realization of the carrying basis of our assets. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from the estimates and assumptions used.

 

Cash and cash equivalents

Our cash balances are not restricted from use and we have no investments or marketable securities during the periods reported. Marketable securities with maturities of three months or less are considered to be cash equivalents.

 

Research and development

Research and development costs, which are comprised of costs incurred in performing research and development activities including wages and associated employee benefits of employees engaged in research; the cost of consultants engaged in our research activities; the cost of developing methods to manufacture our investigational drug products; the costs of production of investigation drugs for use in research, animal and human testing; the costs of the testing of our products in animal models and in human testing; the cost of research conducted on our behalf at academic institutions; the depreciation of equipment used in research; the cost of obtaining patents for the protection of our intellectual property; and other costs associated with these activities. These costs are accounted for in accordance with Accounting Standards Codification (“ASC”) subtopic 730, “Research and Development,” which requires all research and development costs to be charged to expense as incurred.

 

Our agreements with both the manufacturer of our drug Prolanta and the organizations that will provide monitoring and regulatory services for our clinical trials provide that our capital stock was issued for part of the value of the total services rendered. The original value of the stock issued was recorded as a prepayment of future services and is expensed as the services are rendered. The remaining balance is reflected as prepaid services in the accompanying condensed balance sheets.

 

Property and equipment

Property and equipment are stated at cost, less accumulated depreciation. For financial reporting purposes, depreciation is recognized using the straight-line method, allocating the cost of the assets over their estimated useful lives of five years for laboratory equipment and three years for office furniture and equipment. Property and equipment is fully depreciated, and there was no depreciation expense recorded in any period presented.

 

Intangible assets

The costs of obtaining patent protection for our intellectual property are expensed as incurred given the uncertainty of successful development, ultimate regulatory approval and commercialization of products developed using this technology.

 

Deferred offering costs

Oncolix defers legal and certain other costs related to financing activities until the completion or termination of the offering. If the financing to which such costs are related is terminated, such costs are expensed. If the costs are related to a debt financing, the costs are amortized as additional interest expense over the period prior to maturity.

 

Concentrations of risk

We have engaged a contract manufacturer to develop methods of production of Prolanta and to produce quantities necessary for our animal and human testing. Accordingly, our operations are dependent upon the manufacturer’s ability to manufacture suitable quantities of Prolanta in compliance with regulatory requirements and within acceptable timeframes, and to maintain regulatory licenses for its operations. Failure to maintain such regulatory requirements would have a material impact on our operations. We incurred contract manufacturing costs of $63,679 and $3,600 during the three months ended September 30, 2018 and 2017, respectively, and $73,604 and $7,076 during the nine months ended September 30, 2018 and 2017, respectively.

 

 
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Financial instruments

Our financial instruments consist of cash and cash equivalents, accounts payable and notes payable. We believe that the carrying amounts of the financial instruments classified as current assets and liabilities approximate their fair values because of their short-term nature. As discussed in Note 5, certain of our notes payable have a conversion feature at a discount to future equity offerings. We evaluate the carrying value of these notes payable at the closing of any offering to determine of an adjustment is appropriate. As of September 30, 2018, no adjustments were required.

 

Income taxes

We account for income taxes under the asset and liability method, which requires recognition of deferred tax assets, subject to valuation allowances, and liabilities for the expected future tax consequences of events that have been included in the condensed financial statements or tax returns. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. A valuation allowance is established if it is more likely than not that all or a portion of the net deferred tax assets will not be realized.

 

If substantial changes in our ownership should occur, as defined in Section 382 of the Internal Revenue Code, there could be limitations on the amount of net loss carry forwards that could be used to offset future taxable income. Changes in ownership that occurred in 2017 may restrict the use of accumulated tax attributes prior to such date, but this is not expected to affect our federal tax liability for the foreseeable future given the early stage of development of our product candidates and the expected future tax losses from future development activities.

 

We will recognize the impact of an uncertain tax position only if that position is more likely than not of being sustained upon examination by the taxing authority based on the technical merits of the position. We will account for interest and penalties relating to an uncertain tax position in the current period statement of operations, as necessary.

 

Stock-based compensation

We maintained an equity compensation plan under which incentive stock options and non-qualified stock options were granted to employees, independent members of our Board of Directors and outside consultants. The right to make grants under this plan expired on December 31, 2016, and we expect a new plan will be adopted in 2018 or 2019. We recognize stock-based compensation in accordance with ASC topic 718, “Compensation.”

 

Deferred compensation

The officers of the Company have voluntarily deferred the payment of certain compensation in varying amounts from 2012 through 2016, and such deferral has varied with the financial resources available to Oncolix. During 2015, these officers agreed that the deferred compensation would be paid only from the proceeds of future equity offerings or the sale of assets, and not be paid using the then-existing current assets of the Company. These officers extended this deferral commitment in conjunction with the June 2018 Notes. Accordingly, the cumulative unpaid compensation is included in the accompanying condensed balance sheets as a non-current liability, deferred compensation. As of September 30, 2018, $1,268,013 is reflected as deferred compensation in the accompanying condensed balance sheets.

 

Recent accounting standards

On February 25, 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases. ASU No. 2016-02 requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet for all leases of property, plant and equipment with lease terms greater than 12 months. Prior to this accounting standard, only capital leases were recognized on the balance sheet. ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. This ASU must be applied using a retrospective approach upon adoption. The Company believes this ASU will not have a significant effect on its financial statements.

 

Note 3 - Stockholders’ Deficit

 

We have 8,000,000,000 authorized shares of Common Stock, $0.0001 par value, and 250,000,000 authorized shares of preferred stock, of which 150,000,000 are designated as Series A Preferred Stock, $0.0001 par value. As of September 30, 2018, 108,477,936 shares of Common Stock were issued and outstanding, and 63,038,284 shares of Series A Preferred Stock, convertible into 105,064,017 shares of Common Stock, were issued and outstanding.

 

 
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In addition, as of September 30, 2018, we have outstanding options to acquire up to 6,800,000 shares of Common Stock, warrants to acquire up to 49,477,380 shares of Series A Preferred Stock (which upon exercise would be convertible into 82,462,465 shares of Common Stock) and warrants to acquire up to 251,513,750 shares of Common Stock. We may issue an additional 220,123,951 shares of Common Stock if holders of secured notes voluntarily convert. If all derivative and convertible securities were fully exercised and converted into Common Stock, there would be a total of 774,442,119 shares of Common Stock outstanding. In addition, we may be obligated to issue an additional 14,000,000 shares of Series A Preferred Stock in exchange for future clinical research services in the amount of $1,050,000.

 

Series A Preferred Stock

Each share of Series A Preferred Stock is currently convertible into 1.666667 shares of Common Stock, reflecting an adjustment related to the modification of the terms of the August 2017 Notes and related warrants and the issuance of the June 2018 Notes and related warrants as described below. This conversion ratio is subject to further adjustment for certain dilutive events. If a liquidation event occurs, each share of Series A Preferred Stock is entitled to a liquidation preference of $0.075 per share, and then each share will receive distributions ratably with the Common Stock based on the then-existing conversion ratio. As of December 31, 2017, and September 30, 2018, the liquidation preference of the outstanding shares of Series A Preferred Stock is $4,727,871.

 

During June 2018, the modification of the terms of secured notes and related warrants and the issuance of new notes and related warrants resulted in anti-dilution adjustments to the Series A Preferred Stock. The conversion price of the Series A Preferred Stock was adjusted from $0.0707 as of December 31, 2017 to $0.0450 as of September 30, 2018, and the shares of Series A Preferred Stock may be converted into Common Stock at any time at the ratio of 1.66667 shares of Common Stock for every share of Series A Preferred Stock (an increase from 1.0608 as of December 31, 2017). The change in the number of Common shares into which the Series A shares may convert was treated as a dividend and valued at the closing market price on the date of the change. This “dividend” of $841,547 is recorded in the accompanying financial statements as an increase in Additional Paid in Capital and an increase in Accumulated Deficit.

 

The holders of Series A Preferred Stock have voting rights with the Common Stock based on the then-existing conversion ratio, and also have certain separate voting rights for certain matters. As long as at least 14,000,000 shares of Series A Preferred Stock are outstanding, the holders of the Series A Preferred Stock have certain protective rights to nominate a director to the Board of Directors, who shall have the right to approve certain transactions. In addition, as long as at least 14,000,000 shares of Series A Preferred Stock are outstanding, the holders of the Series A Preferred Stock have the right to vote separately as a class to approve certain amendments to the certificate of incorporation, any liquidation event, and certain issuances of capital stock.

 

The Series A Preferred Stock will automatically convert upon either the written consent of the holders of the majority of such shares or the closing of a firm-commitment underwritten public offering with gross proceeds of at least $10 million.

 

GHC liquidation rights

On January 24, 2007, the Company issued 24,000,000 shares of Common Stock to GHC in exchange for certain intellectual property and a commitment by GHC to invest $3.0 million to fund the Company’s operations. GHC retains the rights to the contributed intellectual property in the event of a bankruptcy or liquidation of the Company. GHC has subordinated these rights in connection with the Company’s borrowings.

 

Clinical research arrangements and payment in equity

During August 2011, we agreed to pay 10% of the cost of services rendered by a non-US based clinical research organization through the issuance of 333,340 shares of Common Stock at $0.15 per share. The $50,000 value of the Common Stock was recorded as a prepayment of future services. As of September 30, 2018, the unearned portion of the value of the equity issued, $43,090, was expensed as a result of changes in the contractual relationship.

 

During January 2015, as part of a financing transaction described below, we agreed to pay the cost of services by a US-based clinical research organization through the issuance of Series A Preferred Stock and warrants to acquire Series A Preferred Stock. The $450,000 value of the initial issuance of Series A Preferred Stock was recorded as a prepayment of future services. As of September 30, 2018, the unearned portion of the value of the equity issued reflected as a prepayment in the accompanying condensed balance sheets was $150,000. Additionally, the clinical research organization may perform an additional $1,050,000 in services and receive an additional 14,000,000 shares of Series A Preferred Stock.

 

Texas Emerging Technology Fund Investment

The Texas Emerging Technology Fund (“TETF”), an economic development affiliate of the State of Texas, is the majority holder of the Company’s Series A Preferred Stock as of September 30, 2018. We agreed to certain conditions related to the TETF investment, including certain representations and warranties. Our obligations to TETF generally expire on September 30, 2020. In the event that we do not maintain our principal place of business or principal executive offices in Texas, TETF may require us to repay the $3.9 million investment plus eight percent interest per annum, compounded annually, from the date of the investment, essentially as a stipulated damage or penalty, and TETF will retain its shares of Series A Preferred Stock. In the event of a breach of other conditions of the investment or representations and warranties, TETF may seek any remedies it may have in law or equity. We can terminate our obligations to TETF at any time by the repayment of the amount invested plus 8% interest calculated as described above.

 

 
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Warrants to Acquire Series A Preferred Stock

As of September 30, 2018, we have issued warrants to acquire up to 49,477,380 shares of Series A Preferred Stock (the “Preferred Warrants”). The Preferred Warrants expire if not otherwise exercised at various dates commencing on January 16, 2020 and ending May 12, 2022. The exercise price is $0.0825 per share, subject to adjustment for certain dilutive transactions. The Preferred Warrants may be exercised on a cash-less basis. Upon exercise, the Series A Preferred shares underlying the warrants would be convertible into 82,462,465 shares of Common Stock.

 

Warrants to Acquire Common Stock

As of September 30, 2018, we have issued warrants to acquire up to 251,513,750 shares of Common Stock (the “Common Warrants”). The terms are summarized in the following table:

 

 

 

Number of Common Shares

 

 

Exercise Price

 

 

Expiration

Date(s)

 

Issued with August 2017 Notes

 

 

176,418,511

 

 

$ 0.030

 

 

August 2022

 

Issued to Placement Agents of August 2017 Notes

 

 

16,761,852

 

 

$ 0.030

 

 

August 2022

 

Issued with June 2018 Notes

 

 

51,481,332

 

 

$ 0.036

 

 

May 2023

 

Issued to Placement Agents of June 2018 Notes

 

 

4,952,055

 

 

$ 0.036

 

 

May 2023

 

Issued to Directors of Oncolix

 

 

1,900,000

 

 

$ 0.036

 

 

December 2022 to June 2023

 

Total

 

 

251,513,750

 

 

 

 

 

 

 

 

 

These warrants may be exercised on a cash-less basis and have anti-dilution provisions for issuances below the then-current exercise price. These “down round” protections do not prevent the warrants being linked to our Common Stock under the provisions of ASU 2017-11, and the warrants are settleable only for Common Stock. Accordingly, the warrants are not treated as a derivative in the accompanying financial statements.

 

2007 Stock Option Plan

The authority to make grants under the 2007 Stock Option Plan expired on December 31, 2016, and no further grants may be made. We expect to adopt a new plan in 2018 or 2019. As of September 30, 2018, options to acquire 6,800,000 shares of Common Stock were outstanding. These options are fully vested and are exercisable at an average price of approximately $0.01 per share.

 

We recognize stock-based compensation expense for equity awards over the requisite service period of each grant using the Black-Scholes option pricing model to estimate the fair value of the stock options on the date of grant. There was no unamortized stock-based compensation expense recognized related to stock options during any period in 2018 and 2017.

 

Note 4 – Loss Per Common Share

 

Basic loss per Common share is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed using the average shares outstanding for the period and applying the treasury stock method to potentially dilutive outstanding options and warrants. In all applicable periods, all potential Common Stock equivalents were anti-dilutive and, accordingly, were not included in the computation of diluted loss per share.

 

The Common Stock equivalents and other potentially dilutive securities excluded from the loss per share computation during the nine months ended September 30, 2018 and 2017 included the following:

 

 

 

Common-Equivalent

Shares as of September 30,

 

 

 

2018

 

 

2017

 

Series A Preferred Stock outstanding, Common equivalent

 

 

105,064,017

 

 

 

63,038,284

 

Warrants to acquire Series A Preferred Stock, Common equivalent

 

 

82,462,465

 

 

 

49,477,380

 

Options to acquire Common Stock

 

 

6,800,000

 

 

 

6,800,000

 

Warrants to acquire Common Stock

 

 

251,513,750

 

 

 

64,660,120

 

Shares issuable upon conversion of Notes

 

 

220,123,951

 

 

 

55,872,837

 

 

 

 

665,964,183

 

 

 

239,848,621

 

 

See Notes 3 and 5 for the terms of these securities.

 

 
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Note 5 – Notes Payable

 

As of September 30, 2018, the outstanding debt of the Company is comprised of senior secured convertible notes due commencing in 2019. The carrying basis (excluding accrued interest) of the notes is reflected in the accompanying balance sheet net of unamortized discount associated with the valuation of warrants issued in conjunction with the debt and net of the expenses incurred in the issuance of the debt:

 

 

 

As of September 30, 2018

 

Principal due at maturity,

 

 

 

    including 10% bonus

 

$ 7,264,091

 

Unamortized issue costs and

 

 

 

 

    discount

 

 

(1,421,294 )
Carrying amount in the 

 

 

 

 

    accompanying Balance Sheet

 

$ 5,842,797

 

Accrued interest payable

 

$ 364,874

 

 

 

Sale of 2016 Secured Notes

During the second half of 2016, we sold units of a 10% secured note payable (the “2016 Notes”) and a warrant to acquire shares of Series A Preferred Stock. As of December 31, 2016, we issued $200,000 in principal amount of the 2016 Notes and warrants to acquire 2,666,700 shares of Series A Preferred Stock at $0.0825 per share. The original maturities of the 2016 Notes were between March 2017 and May 2017 and the 2016 Notes secured by the assets of Oncolix. The warrants are exercisable through January 2022, and were assigned a value of $41,365 using a Black-Scholes formula, which was recorded as a discount to the notes. Upon maturity, if the noteholders were not offered an option to convert the notes into a new equity offering by the Company, the noteholder will also be entitled to receive an additional 20% of the principal amount of the 2016 Notes. The discount attributable to the value of the warrants, the 20% premium, and an additional discount related to the fees and expenses of the issuance of the 2016 Notes of $16,000 was accreted as additional interest expense over the life of the notes.

 

The 2016 Notes had the right to voluntarily convert into the units sold in 2017, as described in the sections below. As a result, the principal of the 2016 Notes was convertible into Common Stock at the price of $0.075 per Common share.

 

During March 2017, $100,000 of principal amount of the 2016 Notes was exchanged for a new series of notes being sold in 2017 – see the following section. The maturity date of the remaining $100,000 of principal of 2016 Notes was extended through May 12, 2017, in exchange for an increase in the interest rate to 18% and the issuance of a warrant to acquire 500,000 shares of Series A Preferred Stock. The warrant is exercisable at $0.0825 per share and expires if not exercised on or prior to March 14, 2022. The discount attributable to the value of this additional warrant ($8,465) was being accreted as additional interest expense over the extended maturity period of the 2016 Note. In May 2017, the maturity of this note was further extended in July 2017, and we issued a second warrant to acquire 500,000 shares of Series A Preferred Stock. The warrant is exercisable at $0.0825 per share and expires if not exercised on or prior to May 12, 2022. The discount attributable to the value of this additional warrant ($11,435) was being accreted as additional interest expense over the extended maturity period of the 2016 Note. During August 2017, the balance of this debt ($120,000) was paid.

 

During the three months and nine months ended September 30, 2017, respectively, we recorded $3,256 and $89,222 of interest expense attributable to the 2016 Notes, of which $1,293 and $77,814 was accretion. No amounts were recorded in 2018.

 

 
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Sale of Convertible Notes in 2017

During 2017 we sold units consisting of a convertible promissory note (the “2017 Notes”) and a warrant to acquire shares of Common Stock at $0.0825 per share. The 2017 Notes were secured by the assets of the Company and subordinated to the 2016 Notes. As of August 3, 2017, we had issued units for $1,185,000 in cash and the exchange for 2016 Notes, with a principal balance of $1,320,621 and warrants to acquire 17,608,280 shares of Common Stock. We paid fees to the placement agent of $103,500 in cash and were obligated to issue warrants to acquire 1,580,000 shares of Common Stock. These warrants a were assigned a value of $389,421 using a Black-Scholes formula, and these warrants were exchanged for new warrants in the August debt sale as described below. In addition, we incurred cash expenses of $93,889.

 

The maturity of the 2017 Notes was extended to November 2018. At maturity, if we had not offered the noteholders an option to exchange the 2017 Notes for equity securities in an offering with at least $5 million in gross proceeds, each noteholder would also receive an additional payment equal to 20% of the principal of the 2017 Note. The discount attributable to the value of the warrants, the 20% premium, and an additional discount related to the fees and expenses of the issuance of the notes of $197,389 were being accreted as additional interest expense over the life of the notes.

 

The 2017 Notes could also be converted by each holder into shares of Common Stock at a price of $0.075 per Common Shares.

 

The 2017 Notes and accrued interest were exchangeable at a discount into a new equity offering. Interest of 10% was payable quarterly in arrears, and could be paid in our Common Stock at $0.075 per share. On March 31, 2017, and June 30, 2017, we elected to pay accrued interest as of such date by issuing 178,100 and 447,400 shares of our Common Stock, respectively. Such Common Stock was issued in April 2017 and July 2017, respectively.

 

During August 2017, all of the 2017 Notes and related warrants were exchanged for a new series of units of convertible debt and warrants. See below.

 

During the three months and nine months ended September 30, 2017, respectively, we recorded $269,494 and $646,208 of interest expense attributable to the 2017 Notes, of which $256,379 and $586,810 is accretion. No amounts were recorded in 2018.

 

Sale of July 2017 Secured Notes

During July 2017, we sold an $160,000 in principal of secured notes the (“July Notes”) and warrants to acquire 3,200,000 shares of Common Stock at $0.0825 per share. The July Notes were due in February 2018 and the warrants are exercisable through July 2022. The July Notes were secured by all of the assets of the Company and by Oncolix (Delaware). As noted in the following paragraph, the July 2017 Notes were exchanged in a subsequent debt offering in August 2017.

 

During the three months and nine months ended September 30, 2017, respectively, we recorded $103,914 and $103,914 of interest expense attributable to the 2017 Notes, of which $87,914 and $87,914 is accretion. No interest expense was recorded in 2018 related to these notes.

 

Sale of August 2017 Secured Notes

On August 3, 2017, we (i) exchanged $1,561,894 of the outstanding balance of debt plus accrued under the 2017 Notes and the July Notes and amounts payable under a consulting agreement and (ii) received $2,000,000 cash for an aggregated purchase price of $3,561,894 in consideration for the issuance of a new series of secured notes (the “August 2017 Notes”) with a stated principal balance of $4,190,463. The August 2017 Notes were issued at a 15% discount as noted. In addition, holders of the 2017 Notes exchanged warrants to acquire 17,608,280 shares of Common Stock at $0.0825 per share for new Warrants to acquire Common Stock at $0.09 per share as described below. The total warrants issued were 55,872,836 shares. These warrants to acquire Common Stock have a five-year term, cashless exercise provisions and anti-dilution protections.

 

During June 2018, the terms of the August 2017 Notes and the related warrants were modified as described below.

 

The feature of the August 2017 Notes allowing conversion into Common Stock was not bifurcated and treated separately as a derivative in the financial statements. This conversion feature, which includes “down round” protection to the noteholders, is considered linked to our Common Stock under the guidance of ASU 2017-11, which was early-adopted by the Company. This conversion feature is considered settleable only for Common Stock and would be classified as equity if bifurcated from the August 2017 Notes. Similarly, the related warrants are also considered linked to our Common Stock under the provisions of ASU 2017-11, and are settleable only for Common Stock. Accordingly, the warrants are not accounted for as a derivative.

 

We incurred cash offering costs of $277,289 in connection with the offering, including $164,800 paid to a placement agent. In addition, the placement agent surrendered its rights to receive warrants in connection with the 2017 Notes and received warrants to acquire 5,587,284 shares at $0.09 per share. These warrants a were assigned a value of $267,422 using a Black-Scholes formula. The closing Oncolix Common Stock price on the date of issuance was $0.109, and the warrants have a five-year term. Because of the limited trading history of Oncolix Common Stock, we continue to use 40% as an estimate of volatility rather than use the historical trading activity of the pre-merger shell (with a volatility of less than 10%).

 

On the date of issuance, the August 2017 Notes were convertible into Common Stock at $0.075 per share, or at a conversion price below the closing market price of $0.109. This “discount” is considered a beneficial conversion feature for accounting purposes. The allocation of carrying basis between the warrants issued and the notes was determined based on relative valuation. The carrying basis attributable to the warrants to acquire Common Stock was $1,194,934. The discount of the initial conversion price from market related to the beneficial conversion feature of the debt was approximately $1,822,000, and such amount was recorded as a reduction of debt and increase in Additional paid-in capital. After deducting offering costs of $544,711 (including the placement agent warrant), the initial net carrying basis of the August 2017 Notes was reduced to zero. The principal due at maturity ($4,190,463) plus the 10% bonus payable was being accreted as additional interest over the original life of the notes.

  

 
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In June 2018, the terms of the August 2017 Notes were modified to change the payment terms, increase the principal amount due at maturity, and change the conversion price into Common Stock. This modification was accounted for as an extinguishment and reissuance of debt in accordance with ASC 470-20 and 470-50. The remaining unaccreted discount as of the date of modification, $1,706,733, was expensed in the accompanying financial statements as a loss on the refinancing of debt. The resulting amount due at maturity of $4,609,509 (including the 10% bonus payable at maturity) was treated as the face value exchanged for the modified debt. Pursuant to the terms of the modification, the principal value of the August 2017 Notes was increased by 30% to $5,447,602. The modified amount due at maturity is $5,992,362 (including the 10% bonus due at maturity). The issue costs related to the modification of the August 2017 Notes and the issuance of new debt totaled $136,171. The resulting discount of $1,519,023 is being accreted as additional interest expense over the life of the debt.

 

The August 2017 Notes bear interest at a rate of 10% per annum, payable monthly commencing on April 1, 2019 until the maturity date on August 1, 2019. The interest is payable in cash or, at the option of the Company, subject to compliance with certain strict volume and price conditions, in fully tradable Common Stock at a 25% discount to the average of the five lowest closing bid prices for the 20 trading days prior to the interest payment date. The final maturity of the August 2017 Notes is August 1, 2019, but commencing on April 1, 2019 and on the first day of each month thereafter until maturity, we are required to redeem an amount of the August 2017 Notes equal to 1/5th of the original principal amount, plus 10% of such monthly redemption amount as a bonus. The principal payments shall be made in cash or, subject to the satisfaction of with certain strict volume and price conditions, in Common Stock valued at a 25% discount to the average of the five lowest closing bid prices for the 20 trading days prior to the amortization date.

 

As modified, the August 2017 Notes are convertible at the option of the holders at a conversion price equal to $0.03 per share of Common Stock. The August 2017 Notes contain customary anti-dilution protection, including full-ratchet anti-dilution adjustments in the event of certain dilutive issuances (that adjust both price and share amounts).

 

In the event of a closing of an $8 million financing in connection with a change in listing of the Common Stock to Nasdaq or the NYSE, the August 2017 Notes shall be subject to mandatory conversion into Common Stock at a 30% discount to the offering price. We are required to offer to prepay in cash the aggregate principal amount of the August 2017 Notes at 120% of the principal amount thereof plus any unpaid accrued interest to the date of repayment, at maturity, on the sale of substantially all of the assets of the Company, upon a change of control, upon a qualified offering, or upon a “fundamental transaction” of the Company (such as a reverse merger); in such an event, the holders shall have the right to convert the August 2017 Notes prior to the date of any such prepayment.

 

The August 2017 Notes contain standard negative covenants customary for transactions of this type. The events of default are also customary for transactions of this type, including default in timely payment of principal or interest, failure to observe or perform any covenant or agreement in the note agreements, the commencement of bankruptcy or insolvency proceedings, failure to timely deliver conversion shares underlying the August 2017 Notes, failure to timely file Securities and Exchange Commission filings, and failure to satisfy certain market conditions.

 

The terms of the warrants to acquire Common Stock issued with the August 2017 Notes were also modified. The exercise price was reduced to $0.03 per share, and the warrant became exercisable for 176,418,508 shares. Using a Black-Scholes formula, the calculated value of the modified warrants was $966,691, less than the value calculated for the warrants at issuance. The warrant issued to the placement agent of the warrants was also modified. Accordingly, the carrying value of the warrants was not modified. The closing Oncolix Common Stock price on the date of modification was $0.022, and the warrants have a 4.6-year remaining term. Because of the limited trading history of Oncolix Common Stock, we continue to use 40% as an estimate of volatility rather than use the historical trading activity of the pre-merger shell (with a volatility of less than 10%).

 

During August, 2018, the principal amount of $120,000 was converted into 4,000,000 shares of Common Stock by the holders.

 

During the three months and nine months ended September 30, 2018, we recorded $495,731 and $2,902,948 of interest expense, respectively, attributable to the August 2017 Notes, of which $357,968 and $2,544,022 is accretion. No amounts were recorded in the comparable periods in 2017.

 

Sale of June 2018 Notes

During June 2018 we sold additional senior secured convertible notes (the “June 2018 Notes”) on terms substantially equivalent to the modified terms of the August 2017 Notes in exchange for $1,084,699 in cash. The June 2018 Notes are convertible into Common Stock at a price of $0.03 per share. The June 2018 Notes were issued at a 15% discount and have a stated principal value of $1,276,116. The convertible notes bear interest at a rate of 10% per annum, with accrued interest payable commencing April 1, 2019, then on the first day of each calendar month thereafter until maturity. The maturity of the convertible notes is August 1, 2019, but commencing on April 1, 2019 and on the first day of each calendar month thereafter until maturity, the Company is required to redeem an amount of the convertible notes equal to 1/5th of the original principal amount, plus 10% of such monthly redemption amount as a bonus.

 

In conjunction with the sale of these notes, we issued warrants to acquire 51,481,332 shares of Common Stock at an exercise price of $0.036 per share. These warrants to acquire Common Stock have a five-year term, cashless exercise provisions and anti-dilution protections. An identical warrant was issued to a placement agent for 4,952,055 shares of Common Stock. Using a Black Scholes formula, the values assigned to the related warrant and the placement agent warrant were $171,110 and $25,290, respectively, resulting in a recorded value of the June 2018 Notes of $888,299. The related discount of $196,401 is being accreted as additional expense over the life of the debt.

 

During the three months and nine months ended September 30, 2018, we recorded $130,568 and $175,841 of interest expense, respectively, attributable to the June 2018 Notes, of which $98,005 and $132,644 is accretion. No amounts were recorded in the comparable periods in 2017.

  

 
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Note 6 - Related-Party Transactions

 

As of September 30, 2018, an affiliate of GHS holds approximately 40% of the voting interest in Oncolix. An affiliate of GHS is the site for clinical trial activities. Accounts payable to GHS and its affiliates for services were approximately $61,935 at September 30, 2018 and December 31, 2017, respectively.

 

We have engaged a contract manufacturer and clinical research firms and certain of the costs incurred have been paid or will be paid through the issuance of capital stock. See Note 3.

 

Note 7 - Commitments and Contingencies

 

Licenses

We licensed certain manufacturing technology for the production of Prolanta. We continue to evaluate processes and methods of manufacturing, but if we utilize this licensed technology we must pay a royalty of up to 2% of future sales.

 

Incentive compensation for equity sales

Prior to the Merger, our Chief Executive Officer received 1% of the gross proceeds from certain sales of equity securities of Oncolix/DE, including services paid through the issuance of stock. Such incentive compensation plan has not yet been adopted by Oncolix. No additional compensation expense was recorded pursuant to these arrangements in 2018 and 2017.

 

Contingent obligations to Texas Emerging Technology Fund

In connection with the investments by the TETF, we agreed to certain conditions, including certain representations and warranties, and the breach of which may result in penalties payable to TETF. See Note 3.

 

Obligation to GHC Upon Bankruptcy or Liquidation

In connection with the contribution of intellectual property upon the formation of the Company, GHC retains the rights to the contributed intellectual property in the event of the bankruptcy or liquidation of Oncolix. GHC has subordinated these rights to the security interests of the August 2017 Notes.

 

Severance Arrangements for Officers

The Company has entered into employment agreements with its officers that provide for a severance payment of 12 to 18 months of the officer’s salary in the event of termination without cause or under certain other conditions.

 

Note 8 – Events Subsequent to September 30, 2018

 

During October, 2018, the Company licensed a radiopharmaceutical product candidate, Cyclosam, and issued 3,250,000 shares of Common Stock. The Company also incurred certain royalty and development obligations. Additionally, during November 2018, the principal amount of $75,000 of the August 2017 Notes was converted into 2,500,000 shares of Common Stock.

 

The Company has commenced a private placement of Common Stock and warrants to fund its continued activities. There can be no assurances that these activities will be successful or that any amounts raised will be sufficient to fund the Company’s expected activities. However, based on current market conditions, the Company expects that the private placement would result in substantial additional adti-dilution adjustments to the conversion price of the existing Series A Preferred Stock, the August 2017 Notes and the June 2018 Notes into Common Stock, and reduce the exercise price of the existing warrants to acquire Common Stock. See Notes 3 and 5.

 

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

 

The following discussion and analysis should be read in conjunction with, and is qualified in its entirety by, the Company’s audited annual financial statements in the Annual Report on Form 10-K for the year ended December 31, 2017, and the unaudited interim condensed consolidated financial statements in Item 1 of this Form 10-Q.

 

Basis of Presentation

On April 8, 2017, Oncolix, Inc., a private Delaware corporation (“Oncolix/DE”) acquired approximately 66% of the outstanding common stock of Advanced Environmental Petroleum Producers, Inc., a Florida corporation (“AEPP”), a public entity traded on the over-the-counter market with limited or no operating activities and no indebtedness. On August 3, 2017, pursuant to a reverse merger, AEPP acquired all of the outstanding equity interest of Oncolix/DE and assumed responsibility for the issuance of equity securities under Oncolix/DE’s options, warrants and convertible debt (the “Merger”) as described further herein. The Merger was treated as a reverse acquisition of AEPP for financial accounting and reporting purposes. As such, Oncolix/DE was treated as the acquirer and AEPP was treated as the acquired entity for accounting and financial reporting purposes.

 

Accordingly, the financial statements of AEPP for all periods prior to August 3, 2017 are those of Oncolix/DE. Because of the acquisition of a controlling interest on April 8, 2017, the financial statements of AEPP are consolidated with Oncolix/DE since April 2017. The $365,000 purchase price for stock of AEPP by Oncolix/DE was treated as an expense of the merger, and the shares of AEPP Common Stock not owned by Oncolix/DE are treated as shares issued and outstanding subsequent to April 2017. AEPP’s assets, liabilities and results of operations for periods after April 2017 are the consolidated assets, liabilities and results of operations of AEPP and Oncolix/DE.

 

Contemporaneously with the Merger, Oncolix issued a series of short-term senior secured convertible notes (the “August 2017 Notes”) and related warrants to acquire Common Stock (i) in exchange for prior indebtedness of Oncolix/DE and (ii) for cash proceeds of $2 million. In June 2018, the terms of the August 2017 Notes were substantially modified in connection with the extension of the maturity date. See Note 5 of Notes to Condensed Consolidated Financial Statements in Item 1 herein.

 

On September 27, 2017, AEPP filed an amendment with the Florida Secretary of State and changed its name to Oncolix, Inc. As used in these consolidated financial statements, “We”, “Us”, “Our”, “Oncolix” or the “Company” refers to Oncolix/DE prior to April 2017 and the consolidated Oncolix and Oncolix/DE subsequent to such date.

 

These condensed consolidated financial statements are unaudited; however, in the opinion of management, these condensed statements reflect all adjustments necessary for a fair statement of the results for the periods reported. All such adjustments are of a normal recurring nature unless disclosed otherwise. These condensed consolidated financial statements, including notes, have been prepared in accordance with the applicable rules of the SEC and do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. These interim condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. The results of operations for the nine-month period ending September 30, 2018 are not necessarily indicative of the results to be expected for the full year.

 

Overview

We are a clinical-stage biopharmaceutical company developing medical therapies for the treatment of cancer. We commenced operations on January 24, 2007, and since 2008, our activities have been focused on the development of Prolanta™, a biological drug for the treatment of cancer. Our initial focus is ovarian cancer, and we commenced a Phase I clinical trial of Prolanta™ in the treatment of ovarian cancer after we received clearance from the FDA. We also believe that Prolanta™ may be effective in the treatment of breast, prostate and other cancers. During October 2018, we licensed certain rights to an additional product candidate, Cyclosam, which will require extensive further development before commercialization.

 

We believe our success primarily will be dependent on (i) the safety and efficacy of our drug candidates, (ii) our ability to retain and attract additional members of management, and (iii) our ability to raise sufficient capital to fund our development plans for our drug candidates and/or acquire other product candidates. There are numerous other factors that will affect our success, such as competitive products, our ability to maintain a proprietary position, and the relative resources of others.

 

In early 2016, we commenced a Phase I clinical trial of Prolanta for the treatment of ovarian cancer. This trial will evaluate three dose-levels of Prolanta according to a protocol submitted to the FDA. We completed the first dosing group in June 2016, and our Data and Safety Monitoring Board (“DSMB”) has given us permission to dose a second group of patients with a higher dose of Prolanta. Solicitation of enrollment of this second group has commenced.

 

We have no revenues, and we will need to complete additional development and testing of Prolanta before we seek governmental approvals to sell the drug for patient use. Also, it is likely we will need to complete some additional development in order to seek a collaboration with a partner to fund development of Prolanta. Accordingly, our liquidity and results of operations are dependent on our ability to obtain additional funds for our development activities.

 

 
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We have experienced negative cash flows from operations since the commencement of operations, and we expect these losses to continue into the foreseeable future as we continue the development and clinical testing of our principal product candidate, Prolanta™, and seek regulatory approval to market products. In June 2018, we completed a debt financing through the issuance of the June 2018 Notes which are expected to fund our operations into December 2018. See Note 5 of Notes to Condensed Consolidated Financial Statements elsewhere herein. The August 2017 Notes and the June 2018 Notes mature in five installments during 2019. Accordingly, our continued operations are dependent on our ability to raise additional capital through the sale of equity or debt securities or through the licensing of our products. In the event we are unable to raise sufficient funds, we would have to substantially alter, or possibly even discontinue or curtail operations, or sell assets at distressed prices. This uncertainty raises substantial doubt about our ability to continue as a going concern, as noted in the opinion of our independent registered public accounting firm in the audited financial statements as of December 31, 2017. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Use of Estimates

The preparation of financial statements in conformity with US generally accepted accounting principles (“GAAP”) requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In addition, significant estimates were made regarding realization of deferred tax assets, the calculation of the fair value of stock options awarded, the estimation of the value of warrants issued in conjunction with capital stock, and the projected realization of the carrying basis of our assets. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from the estimates and assumptions used.

 

Critical Accounting Policies

Our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Form 10-Q.

 

Recent Accounting Standards

On February 25, 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases. ASU No. 2016-02 requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet for all leases of property, plant and equipment with lease terms greater than 12 months. Prior to this accounting standard, only capital leases were recognized on the balance sheet. ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. This ASU must be applied using a retrospective approach upon adoption. The Company believes this ASU will not have a significant effect on its consolidated financial statements.

 

Results of Operations

 

General. We are in the early stage of development of our product candidates which will require extensive testing in humans and regulatory approvals prior to sale for medical use. To date, we have not generated any revenues from operations. While we may in the future generate revenue from a variety of sources, including license fees, milestone payments, research and development payments in connection with strategic partnerships and/or product sales, our product candidates may never be successfully developed or commercialized. At September 30, 2018, Oncolix had an accumulated deficit of $29.4 million primarily as a result of expenditures for research and development and general and administrative expenses. We expect to continue to incur substantial losses from operations for the foreseeable future and there can be no assurance that we will ever generate significant revenues or achieve profitability.

 

Research and Development Expense. Research and development expense includes wages and associated employee benefits of employees engaged in research; stock-based compensation expense related to such employees, the cost of consultants engaged in our research activities; the cost of developing methods to manufacture our investigational drug products; the costs of production of investigation drugs for use in research, animal and human testing; the costs of the testing of our products in animal models and in human testing; the cost of research conducted on our behalf at academic institutions; the depreciation of equipment used in research; the cost of obtaining patents for the protection of our intellectual property; and other costs associated with these activities.

 

We expect to incur substantial research and development expenses in the foreseeable future as we continue product development. The amount and timing of such costs will depend on various factors, including the availability of resources to fund these activities, the timing or regulatory approvals for stages of testing or commercialization, the results of testing at each stage of product development, the size and length of clinical studies required at each stage of development, the regulatory requirements for commercialization, and the costs of intellectual property protection, among other factors. In general, expenses increase substantially as a product progresses from early to later stages of development, and we expect our research and development expenses to increase in a similar manner. In the event that we license or acquire additional product candidates, research and development expense may increase as a result of the development of such product candidates.

 

 
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General and Administrative Expense. General and administrative expense includes wages and associated employee benefits of employees engaged in administration; stock-based compensation expense related to such employees, professional fees for legal, consulting, audit and tax services, rent and other general operating expenses not otherwise included in research and development.

 

We expect general and administrative expenses to increase as we expand our activities to support our expanded research and development activities and incur costs related to the expanded infrastructure and increased professional fees associated with being a reporting company under the Exchange Act.

 

Comparison of Three Months Ended September 30, 2018 and 2017. The results of operations of the Company for the three months ended September 30, 2018 and 2017 are as follows:

 

 

 

Three Months Ended

September 30,

 

 

Increase (Decrease)

 

 

 

2018

 

 

2017

 

 

$

 

 

%

 

Revenue

 

$ -

 

 

$ -

 

 

$ -

 

 

 

-

%

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

211,197

 

 

 

76,013

 

 

 

135,184

 

 

 

178 %

General and administrative expenses

 

 

221,633

 

 

 

350,303

 

 

 

(128,670 )

 

 

-37

%

Total operating expenses

 

 

432,830

 

 

 

426,316

 

 

 

6,514

 

 

 

2 %

Loss on debt refinancing

 

 

-

 

 

 

-

 

 

 

-

 

 

NM

*

Gain on extinguishment of debt

 

 

-

 

 

 

(437,184 )

 

 

437,184

 

 

 

-100

%

Interest expense on convertible notes

 

 

626,299

 

 

 

814,054

 

 

 

(187,755 )

 

 

-2

%

Net loss

 

 

(1,059,129 )

 

 

(803,186 )

 

 

(255,943 )

 

 

32 %

Imputed dividend for adjustment of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A conversion price into

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

Net loss attributable to Common Stock

 

$ (1,059,129 )

 

$ (803,186 )

 

 

(255,943 )

 

 

32 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and diluted

 

$ (0.010 )

 

$ (0.009 )

 

$ (0.001 )

 

 

14 %

Weighted average common shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

outstanding - basic and diluted

 

 

106,336,632

 

 

 

92,190,551

 

 

 

 

 

 

 

 

 

_________________

* NM - Not meaningful  

 

Research and development expense increased approximately $135,000 from the three months ended September 30, 2017 to the comparable period in 2018, principally as a result of process development and consulting costs incurred in 2018 as the Company evaluated improvements to its manufacturing process and prepared material for continued clinical trials. The Company has commenced enrollment of the second dosing group in its Phase I clinical trial during 2018, but no significant costs have been incurred as of September 30, 2018.

 

General and administrative costs decreased approximately $129,000 from the three months ended September 30, 2017 to the comparable period in 2018. The Company’s public entity costs in 2018 were lower than in 2017 as a result of reduced cash resources.

 

In connection with the August 2017 Notes, certain prior indebtedness was restructured and the Company merged with AEPP. A gain of approximately $437,000 was recognized in 2017 related to these activities.

 

Interest expense decreased approximately $188,000 from the three months ended September 30, 2017 to the comparable period in 2018. While there are higher borrowing level in 2018 after the sale of the August 2017 Notes in August 2017 and the June 2018 Notes in June 2018, the restructuring of the August 2017 Notes in June 2018 reduced the accretion of discount incurred during the remaining life of the notes. See Note 5 of Condensed Notes to Consolidated Financial Statements for a summary of interest expense, including accretion. A lower debt amount was outstanding in the comparable period in 2017.

 

The net loss attributable to Common Stock for the three months ended September 30, 2018, increased approximately $256,000, or 32%, compared to the 2017 period principally as a result of the gain recognized on the extinguishment of debt in 2017 that was not repeated in 2017. Net loss per share also increased, partially offset by the higher number of outstanding shares of Common Stock from the merger of Oncolix/DE and Oncolix in 2017.

 

 
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Comparison of Nine Months Ended September 30, 2018 and 2017. The results of operations of the Company for the nine months ended September 30, 2018 and 2017 are as follows:

 

 

 

Nine Months Ended

September 30,

 

 

Increase (Decrease)

 

 

 

2018

 

 

2017

 

 

$

 

 

%

 

Revenue

 

$ -

 

 

$ -

 

 

$ -

 

 

 

-

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

379,092

 

 

 

153,108

 

 

 

225,984

 

 

 

148 %

General and administrative expenses

 

 

815,451

 

 

 

1,144,427

 

 

 

(328,976 )

 

 

-29

%

Total operating expenses

 

 

1,194,543

 

 

 

1,297,535

 

 

 

(102,992 )

 

 

-8

%

Loss on debt refinancing

 

 

1,706,733

 

 

 

-

 

 

 

1,706,733

 

 

NM

*

Gain on extinguishment of debt

 

 

-

 

 

 

(437,184 )

 

 

437,184

 

 

NM

Interest expense on convertible notes

 

 

3,078,789

 

 

 

1,276,733

 

 

 

1,802,056

 

 

 

141 %

Net loss

 

 

(5,980,065 )

 

 

(2,137,084 )

 

 

(3,842,981 )

 

 

180 %

Imputed dividend for adjustment of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A conversion price into

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

841,517

 

 

 

-

 

 

 

841,517

 

 

NM

*

Net loss attributable to Common Stock

 

$ (6,821,582 )

 

$ (2,137,084 )

 

 

(4,684,498 )

 

 

219 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and diluted

 

$ (0.065 )

 

$ (0.027 )

 

$ (0.038 )

 

 

138 %

Weighted average common shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

outstanding - basic and diluted

 

 

105,104,310

 

 

 

78,302,103

 

 

 

 

 

 

 

 

 

________________ 

* NM - Not meaningful  

 

Research and development expense increased approximately $226,000 from the nine months ended September 30, 2017 to the comparable period in 2018, principally as a result of process development and consulting costs incurred in 2018 as the Company evaluated improvements to its manufacturing process and the preparation of material for continued clinical trials. The Company commenced enrollment of the second dosing group in its Phase I clinical trial during 2018, but no significant costs have been incurred as of September 30, 2018.

 

General and administrative costs decreased approximately $329,000 from the nine months ended September 30, 2017 to the comparable period in 2018. During 2017, the Company acquired an interest in AEPP for $365,000 which was expensed as an acquisition cost of the Merger. This was partially offset by the higher public entity costs in 2018 after the merger with AEPP in August 2017.

 

During 2018, the terms of the August 2017 Notes were modified, and we recognized a loss on this debt refinancing of $1,706,733, comprised of the remaining unrecognized accretion on these notes.

 

Interest expense increased approximately $1,802,000 from the nine months ended September 30, 2017 to the comparable period in 2018. The increase in interest expense is the result of a higher borrowing level in 2018 after the sale of the August 2017 Notes in August 2017 and the June 2018 Notes in June 2018. These notes were sold at substantial discounts to the amounts due at maturity, resulting in higher recorded interest expense for accretion as well as the 10% stated interest rate. See Note 5 of Condensed Notes to Consolidated Financial Statements for a summary of interest expense, including accretion. A lower debt amount was outstanding in the comparable period in 2017.

 

The net loss attributable to Common Stock for the nine months ended September 30, 2018, increased approximately $4,684,000, or 219%, compared to the 2017 period as a result of the loss recognized on the debt refinancing and the higher interest costs and the imputed dividend for the anti-dilution adjustment of the Series A conversion price into Common Stock. Net loss per share also increased, partially offset by the higher number of outstanding shares of Common Stock from the merger of Oncolix/DE and Oncolix in 2017.

 

 
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Liquidity and Capital Resources

 

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of our product candidates for the treatment of cancer. The FDA has granted clearance to conduct a Phase I clinical trial in subjects with ovarian cancer, and we commenced the first phase of this study in early 2016. To complete this study we may require additional drug supplies. If this and other studies are successful, substantial additional resources will be necessary to complete the development of Prolanta and seek regulatory approval to market the drug. Based on our current expectations, we believe this development will require at least $25 million of additional funds. We have not yet determined the estimated development costs required for the Cyclosam product candidate acquired in October 2018.

 

The development of pharmaceutical products requires laboratory and preclinical studies before seeking regulatory approval for human testing, as well various stages of testing in humans. We have completed these laboratory and preclinical studies, but the results of our human studies or requests of regulatory authorities may require additional studies. In addition, the manufacturing of our product candidates must be conducted under controlled conditions, and we may seek to improve the process. After we complete the Phase I clinical trial, the human studies to determine the safety of Prolanta will be conducted in larger and larger groups of patients. All of these activities will require the expenditure of substantial funds. In the event that we obtain or develop additional product candidates, we will incur similar types of costs.

 

We have experienced negative cash flows from operations since the commencement of operations, and we expect these losses to continue into the foreseeable future as we continue the development and clinical testing of our principal product candidate, Prolanta™, and seek regulatory approval to market products. In June 2018, we completed a debt financing through the issuance of the June 2018 Notes which are expected to fund our operations into December 2018. The August 2017 Notes and the June 2018 Notes mature in five installments during 2019. Accordingly, our continued operations are dependent on our ability to raise additional capital through the sale of equity or debt securities or through the licensing of our products.

 

To continue our development program, we expect our research and development expenses to increase in connection with our ongoing activities relating to our product candidates, particularly as we focus on and proceed with our clinical trials for our Prolanta product. In addition, our expenses could increase beyond current expectations if applicable regulatory authorities, including the FDA, require that we perform studies in addition to those that we currently anticipate, assuming we successfully complete our Phase I clinical trials, commence and complete our proposed Phase II clinical trials. We currently estimate that we require approximately $1 million to complete the Phase I clinical trial, depending on the cost and availability of drug supplies. We will still need substantial additional capital in the future in order to complete the clinical trials and obtain regulatory approval of Prolanta. Accordingly, we will need to raise additional capital to fund future operations and we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding may not be available on favorable terms, if at all. Failure to raise additional capital could cause us to curtail operations and result in the loss of your investment in our common stock.

 

If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or to grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

 

Our forecast of the period of time through which our current capital will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

 

As of September 30, 2018, we had cash of approximately $123,000 and secured notes payable with a balance due at maturity of approximately $7.3 million. In addition, we have liabilities to third parties and related parties totaling approximately $126,000 and deferred compensation to our employees of approximately $1,268,000 as of September 30, 2018. We expect our existing cash resources to fund our normal operations into December 2018. We will be required to raise additional funds to continue operations after that date.

 

Our employees have agreed to continue to defer the payment of prior compensation until Oncolix has raised substantial additional equity. We will require additional resources to fund future activities and to complete our Phase I clinical study.

 

We expect to incur substantial expenditures in the foreseeable future for the research, development and potential commercialization of Prolanta. We will require additional financing to develop, obtain regulatory approvals, fund operating losses, and, if deemed appropriate, establish additional manufacturing, sales and marketing capabilities.

 

Accordingly, our continued operations are dependent on our ability to raise additional capital through the sale of equity or debt securities or through the licensing of our products. There can be no assurances that we will be able to obtain funding, or that such arrangements will be on terms attractive to us. In the event we are unable to raise sufficient funds, we would have to substantially alter, or possibly even discontinue, operations, or sell assets at distressed prices. This uncertainty raises substantial doubt about our ability to continue as a going concern, as noted in the opinion of our independent registered public accounting firm in the audited financial statements as of December 31, 2017.

 

 
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The following table shows a summary of the Company’s cash flows for the periods presented.

 

 

 

Nine Months Ended

September 30,

 

 

 

 

 

 

2018

 

 

2017

 

 

Change

 

Net cash used in operating activities

 

$ (1,319,639 )

 

$ (1,553,943 )

 

$ 234,304

 

Net cash provided by financing activities

 

 

948,529

 

 

 

2,899,267

 

 

$ (1,950,738 )

Net increase in cash and cash

 

 

 

 

 

 

 

 

 

 

 

 

equivalents

 

 

(371,110 )

 

 

1,345,324

 

 

$ (1,716,434 )

Cash and cash equivalents at beginning

 

 

 

 

 

 

 

 

 

 

 

 

of period

 

 

494,410

 

 

 

15,264

 

 

 

 

 

Cash and cash equivalents at end of period

 

$ 123,300

 

 

$ 1,360,588

 

 

 

 

 

Non-cash financing activities

 

 

 

 

 

 

 

 

 

 

 

 

Stock issued to pay interest and other liabilities

 

$ -

 

 

$ 56,926

 

 

 

 

 

Stock issued in cashless exercise of warrants

 

$ -

 

 

$ 90

 

 

 

 

 

Stock issued in conversion of secured notes

 

$ 120,000

 

 

$ -

 

 

 

 

 

Beneficial conversion feature of notes issued

 

$ -

 

 

$ 1,822,248

 

 

 

 

 

Stock assumed in reverse merger

 

$ -

 

 

$ 3,177

 

 

 

 

 

Warrants issued in debt modifications

 

$ -

 

 

$ 19,900

 

 

 

 

 

Warrants issued to placement agent

 

$ 25,290

 

 

$ 267,422

 

 

 

 

 

Debt discount related to warrants issued

 

$ 171,110

 

 

$ 1,639,005

 

 

 

 

 

Inputed dividend for adjustment of Series A

 

 

 

 

 

 

 

 

 

 

 

 

conversion price into Common Stock

 

$ 841,547

 

 

$ -

 

 

 

 

 

Interest paid in cash

 

$ 107,090

 

 

$ 12,248

 

 

 

 

 

 

Cash used in operating activities decreased approximately $234,000 from the nine months ended September 30, 2017, to the comparable period in 2018, reflecting the reduction in operating expenses between the periods. Cash provided by financing activities decreased approximately $1,951,000 from the 2017 period to the 2018 period, reflecting reduced borrowing under convertible notes in 2018, net of offering costs, as compared to the comparable period in 2017.

 

Off-Balance Sheet Arrangements

 

We do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts.

 

Quantitative and Qualitative Disclosures about Market Risks

 

We held no marketable securities at any time during the periods presented. Our existing short-term debt is at a fixed rate but has a conversion feature which requires an adjustment in the event of the issuance of additional equity or convertible securities. Because we intend to conduct activities globally, certain of our contracts either will require payment in foreign currencies or will be billed in US dollars based on a specified exchange rate. In particular, payments under our previous manufacturing services agreements were adjusted for certain changes in the exchange rate for Canadian dollars. Our exposure to changes in currency exchange rates will be dependent on the amounts of future billings by each service provider.

 

Tax Net Operating Loss and Tax Credit Carry-Forwards

 

At December 31, 2017 the Company has net operating loss carryforwards (“NOLs”) of approximately $9.2 million and an Orphan Drug Tax Credit of approximately $567,000 which are available to reduce future Federal income taxes. The future utilization of these carryforwards will be severely restricted by various tax regulations as a result of changes in ownership of the Company. These carryforwards begin to expire in 2027, if not utilized. In addition, we have deferred the deduction of approximately $7.6 million in research and administrative costs as of December 31, 2017, and these may be deducted in future federal tax returns.

 

During December 2017, the US enacted the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”), which substantially reduced the federal tax rate for US corporations from 35% to 21% commencing in 2018. The 2017 Tax Act also reduced the benefits available from the Orphan Drug Tax Credit. We previously have recorded a valuation allowance to fully offset our deferred tax assets, which was determined using the previous statutory federal income tax rate of 35%. As of December 31, 2017, we have utilized the newly enacted statutory federal tax rate of 21%, resulting in a reduction in deferred tax assets of approximately $2.8 million. There is substantial uncertainty regarding the ability to utilize our deferred tax assets, and we have recorded a valuation allowance to offset any potential future tax benefit. Accordingly, the 2017 Tax Act did not have an effect on our results of operations or financial position.

 

 
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The utilization of our deferred tax assets is restricted when substantial changes in our ownership occur, as defined in Section 382 of the Internal Revenue Code. We believe changes in stock ownership during 2017 may restrict the use of accumulated tax attributes prior to the end of 2017, but this is not expected to affect our federal tax liability for the foreseeable future given the early stage of development of Prolanta and expected future development costs expected to be incurred in the development of our products.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

We are a Smaller Reporting Company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

 

Item 4. Controls and Procedures.

 

(a) Management’s Conclusions Regarding Effectiveness of Disclosure Controls and Procedures.

The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is a process designed under the supervision of the Company’s Chief Executive/Chief Financial Officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external purposes in accordance with U.S. generally accepted accounting principles.

 

With respect to the period ending September 30, 2018, under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of the design and operations of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934.

 

Based upon our evaluation regarding the period ending September 30, 2018, the Company’s management, including its Principal Executive/Principal Financial Officer, has concluded that its disclosure controls and procedures were not effective due to the Company’s limited internal resources and lack of ability to have multiple levels of transaction review. Material weaknesses noted are lack of an audit committee, lack of a majority of independent directors on the board of directors, resulting in ineffective oversight in the establishment and monitoring of required internal controls and procedures; and management was dominated by two individuals during the three-month period ended September 30, 2018, without adequate compensating controls. Through the use of external consultants and the review process, management believes that the financial statements and other information presented herewith are materially correct.

 

The Company’s disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives. However, the Company’s management, including its Principal Executive and Principal Financial Officer, does not expect that its disclosure controls and procedures will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected.

 

(b) Changes in Internal Controls.

There have been no changes in the Company’s internal control over financial reporting during the period ended September, 2018, that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting.

 

 
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Part II. Other Information

 

Item 1. Legal Proceedings.

 

None.

 

Item 1A. Risk Factors

 

We are a Smaller Reporting Company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item. Please see “Risk Factors” included in the Annual Report on Form 10-K.

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information.

 

None.

 

 

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Item 6. Exhibits

 

31.1*

 

Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**

 

Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(32) of Regulation S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section. Further, this exhibit shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.)

101.INS*

 

XBRL Instance Document

101.SCH*

 

XBRL Taxonomy Extension Schema Document

101.CAL*

 

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF*

 

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB*

 

XBRL Taxonomy Extension Label Linkbase Document

101.PRE*

 

XBRL Taxonomy Extension Presentation Linkbase Document

____________

* Filed herewith.

** Furnished herewith.

 

 
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SIGNATURES

 

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

 

 

Oncolix, Inc.

(Registrant)

       
Date: November 19, 2018 By:

/s/ Michael T. Redman

 

 

Michael T. Redman

President and Chief Executive Officer

(Principal Executive and Principal Financial Officer)

 

 

 

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