Form 6-K REPLICEL LIFE SCIENCES For: Jun 30
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of June, 2019
Commission File Number 000-50112
RepliCel Life Sciences Inc.
(Translation of registrant’s name into English)
Suite 900 – 570 Granville Street, Vancouver, British Columbia V6C 3P1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [X] Form
40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) [ ]
Note: Regulation S-T Rule 101(b)(1) only permits
the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits
the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or
legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not
been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
SUBMITTED HEREWITH
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.
RepliCel Life Sciences Inc.
/s/ Lee Buckler
Lee Buckler, President
Date: August 23, 2019
REPLICEL LIFE SCIENCES INC.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(unaudited)
For the three and six months ended June 30, 2019
(Stated in Canadian Dollars)
REPLICEL LIFE SCIENCES INC.
Consolidated Statements of Financial Position
(Stated in Canadian Dollars)
(Unaudited)
|
As at
|
Notes
|
June 30, 2019
|
December 31, 2018
|
|||||||||
|
Assets
|
||||||||||||
|
Current assets
|
||||||||||||
|
Cash and cash equivalents
|
$
|
271,839
|
$
|
2,418,521
|
||||||||
|
Sales taxes recoverable
|
18,318
|
49,504
|
||||||||||
|
Prepaid expenses and deposits
|
333,009
|
510,741
|
||||||||||
|
Contract asset
|
6
|
25,261
|
25,261
|
|||||||||
|
648,427
|
3,004,027
|
|||||||||||
|
Non-current assets
|
||||||||||||
|
Contract Asset
|
6
|
202,607
|
215,237
|
|||||||||
|
Equipment
|
5
|
7,083
|
8,167
|
|||||||||
|
Total assets
|
$
|
858,117
|
$
|
3,227,431
|
||||||||
|
Liabilities
|
||||||||||||
|
Current liabilities
|
||||||||||||
|
Accounts payable and accrued liabilities
|
8, 9
|
$
|
525,193
|
$
|
1,277,642
|
|||||||
|
Contract liability
|
6
|
252,609
|
252,609
|
|||||||||
|
777,802
|
1,530,251
|
|||||||||||
|
Non-current liabilities
|
||||||||||||
|
Contract liability
|
6
|
2,026,059
|
2,152,363
|
|||||||||
|
Total liabilities
|
2,803,861
|
3,682,614
|
||||||||||
|
Shareholders’ deficiency
|
||||||||||||
|
Common shares
|
7
|
29,003,179
|
28,745,992
|
|||||||||
|
Contributed surplus
|
7
|
4,376,379
|
4,357,922
|
|||||||||
|
Accumulated deficit
|
(35,325,302
|
)
|
(33,559,097
|
)
|
||||||||
|
Total shareholders’ deficiency
|
(1,945,744
|
)
|
(455,183
|
)
|
||||||||
|
Total liabilities and shareholders’ deficiency
|
$
|
858,117
|
$
|
3,227,431
|
||||||||
|
Continuance of Operations
|
2(a)
|
|
Commitments and Contingencies
|
10
|
|
Events after the reporting date
|
13
|
Approved on behalf of the Board:
|
/s/ “David Hall”
|
/s/ “Lee Buckler”
|
|||
|
Director
|
Director
|
The accompanying notes form an integral part of these condensed consolidated interim financial statements.
2
REPLICEL LIFE SCIENCES INC.
Condensed Consolidated Interim Statements of Comprehensive Loss
(Stated in Canadian Dollars)
(Unaudited)
|
|
For the three months ended
|
For the six months ended
|
||||||||||||||
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
|
2019
|
2018
|
2019
|
2018
|
|||||||||||||
|
Revenue
|
||||||||||||||||
|
Licensing fees (Note 6)
|
$
|
63,153
|
$
|
-
|
$
|
126,305
|
$
|
-
|
||||||||
|
Expenses
|
||||||||||||||||
|
Research and development (Note 8)
|
722,883
|
245,737
|
1,466,300
|
303,783
|
||||||||||||
|
General and administrative (Note 8)
|
273,748
|
344,608
|
518,685
|
772,891
|
||||||||||||
|
Loss before other items
|
(933,478
|
)
|
(590,345
|
)
|
(1,858,680
|
)
|
(1,076,674
|
)
|
||||||||
|
Other items:
|
||||||||||||||||
|
Foreign exchange gain (loss)
|
(5,687
|
)
|
(8,999
|
)
|
107
|
(15,136
|
)
|
|||||||||
|
Gain on debt settlement (Note 7 (b)i)
|
-
|
-
|
92,368
|
-
|
||||||||||||
|
|
||||||||||||||||
|
Net and comprehensive loss
|
$
|
(939,165
|
)
|
$
|
(599,344
|
)
|
$
|
(1,766,205
|
)
|
$
|
(1,091,810
|
)
|
||||
|
Basic and diluted loss per share
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.05
|
)
|
||||
|
Weighted average shares outstanding
|
27,057,727
|
21,442,649
|
27,019,478
|
21,442,629
|
||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements.
3
REPLICEL LIFE SCIENCES INC.
Condensed Consolidated Interim Statements of Cash Flows
For the six months ended
(Stated in Canadian Dollars)
(Unaudited)
|
June 30,
2019
|
June 30,
2018
|
|||||||
|
Operating activities
|
||||||||
|
Net loss
|
$
|
(1,766,205
|
)
|
$
|
(1,091,810
|
)
|
||
|
Add items not involving cash:
|
||||||||
|
Amortization of contract asset
|
12,630
|
-
|
||||||
|
Revenue from contract liability (Note 6)
|
(126,304
|
)
|
-
|
|||||
|
Depreciation (Note 5)
|
1,084
|
1,498
|
||||||
|
Gain on debt settlement (Note 6 & 7 (b) i)
|
(92,368
|
)
|
-
|
|||||
|
Stock-based compensation (Note 7 (e))
|
18,457
|
-
|
||||||
|
Changes in non-cash working capital balances:
|
||||||||
|
Sales taxes recoverable
|
31,186
|
(18,904
|
)
|
|||||
|
Prepaid expenses and deposits
|
177,732
|
162,301
|
||||||
|
Accounts payable and accrued liabilities
|
(402,894
|
)
|
498,654
|
|||||
|
Net cash used in operating activities
|
(2,146,682
|
)
|
(448,261
|
)
|
||||
|
Decrease in cash and cash equivalents during the period
|
(2,146,682
|
)
|
(448,261
|
)
|
||||
|
Cash and cash equivalents, beginning of the period
|
2,418,521
|
497,093
|
||||||
|
Cash and cash equivalents, end of the period
|
$
|
271,839
|
$
|
48,832
|
||||
The accompanying notes form an integral part of these consolidated financial statements.
REPLICEL LIFE SCIENCES INC.
Condensed Consolidated Interim Statements of Changes in Equity
For the six months ended June 30 2019 and 2018
(Stated in Canadian Dollars)
(Unaudited)
|
|
||||||||||||||||||||
|
Common
|
Contributed
|
Accumulated
|
||||||||||||||||||
|
|
Shares
|
Amount
|
Surplus
|
Deficit
|
Total
|
|||||||||||||||
|
Balance, January 1, 2019
|
26,800,529
|
$
|
28,745,992
|
$
|
4,357,922
|
(33,559,097
|
)
|
$
|
(455,183
|
)
|
||||||||||
|
Common shares issued for debt (Note 7(b)(i))
|
735,904
|
257,187
|
-
|
-
|
257,187
|
|||||||||||||||
|
Stock-based compensation – Note 7 (d)
|
-
|
-
|
18,457
|
-
|
18,457
|
|||||||||||||||
|
Net loss for the period
|
-
|
-
|
-
|
(1,766,205
|
)
|
(1,766,205
|
)
|
|||||||||||||
|
Balance, June 30, 2019
|
27,536,433
|
$
|
29,003,179
|
$
|
4,376,379
|
(35,325,302
|
)
|
$
|
(1,945,744
|
)
|
||||||||||
|
|
||||||||||||||||||||
|
Common
|
Contributed
|
Accumulated
|
||||||||||||||||||
|
|
Shares
|
Amount
|
Surplus
|
Deficit
|
Total
|
|||||||||||||||
|
Balance, January 1, 2018
|
21,442,629
|
$
|
26,182,073
|
$
|
4,287,947
|
$
|
(30,790,017
|
)
|
$
|
(319,997
|
)
|
|||||||||
|
Net loss for the period
|
-
|
-
|
-
|
(1,091,810
|
)
|
(1,091,810
|
)
|
|||||||||||||
|
Balance, June 30, 2018
|
21,442,629
|
$
|
26,182,073
|
$
|
4,287,947
|
$
|
(31,881,827
|
)
|
$
|
(1,411,807
|
)
|
|||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements.
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
|
1.
|
Corporate Information
|
RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) was incorporated under the Ontario Business Corporations Act on April 24, 1967 but was continued from Ontario to British Columbia on June 22, 2011. Its common shares are listed for trading in Canada on the TSX Venture
Exchange, trading under the symbol RP, and in the United States on the OTCQB, trading under the symbol REPCF.
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that treat functional cellular
deficits including chronic tendon injuries, androgenetic alopecia and skin aging.
The address of the Company’s corporate office and principal place of business is Suite 900 – 570 Granville Street, Vancouver,
BC, V6C 3P1.
|
2.
|
Basis of Presentation
|
These condensed consolidated interim financial statements for the six-month period ended June 30, 2019 have been prepared in
accordance with IAS 34 Interim Financial Reporting. They do not include all disclosures that would otherwise be required in a complete set of financial
statements and should be read in conjunction with the Company’s 2018 annual financial statements which have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
(IASB).
Subsidiaries are entities controlled by RepliCel. The financial statements of subsidiaries are included in the consolidated
financial statements from the date that control commences until the date that control ceases. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies.
Intra-group balances and transactions, and any unrealized income and expenses arising from intra-group transactions are eliminated in preparing the consolidated financial statements. The accompanying consolidated financial statements include the
account of RepliCel Life Sciences Inc. and its wholly-owned subsidiary, Trichoscience Innovations Inc. (“Trichoscience”).
The condensed consolidated interim financial statements have been prepared using accounting policies consistent with those used
in the Company’s 2018 annual financial statements, except as disclosed in Note 4. The condensed interim financial statements are presented in Canadian dollars, which is also the Company’s functional currency, unless otherwise indicated.
The condensed consolidated interim financial statements were authorized for issue by the Board of Directors on August 29, 2019.
The preparation of financial statements in compliance with IFRS requires management to make certain critical accounting
estimates. It also requires management to exercise judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment of complexity, or areas where assumptions and estimates are significant to the financial
statements are disclosed in Note 3.
|
a)
|
Continuance of Operations
|
These consolidated financial statements have been prepared on a going concern basis, which assumes that the Company will
continue to realize its assets and discharge its obligations and commitments in the normal course of operations. At June 30, 2019, the Company is in the research stage, has accumulated losses of $35,325,302 since its inception and expects to incur
further losses in the development of its business. The Company incurred a consolidated net loss of $1,766,205 during the six month period ended June 30, 2019. The Company will require additional funding to continue its research and development
activities which may not be available, or available on acceptable terms. This will result in material uncertainties which casts substantial doubt about the Company’s ability to continue as a going concern.
6
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 2. |
Basis of Presentation - continued
|
|
a)
|
Continuance of Operations - continued
|
The Company’s ability to continue as a going concern is dependent upon its ability to generate future profitable operations
and/or to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. Management has a plan in place to address this concern and intends to obtain additional funds by
equity financing to the extent there is a shortfall from operations. While the Company is continuing its best efforts to achieve the above plans, there is no assurance that any such activity will generate funds for operations.
If the going concern assumptions were not appropriate for these condensed consolidated interim financial statements, then
adjustments would be necessary to the carrying value of assets and liabilities, the reported net loss and the financial position classifications used.
| 3. |
Critical Accounting Estimates and Judgements
|
RepliCel Life Sciences Inc. makes estimates and assumptions about the future that affect the reported amounts of assets and
liabilities. Estimates and judgements are continually evaluated based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. In the future, actual experience may
differ from these estimates and assumptions.
The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the
period of the change, if the change affects that period only, or in the period of the change and future periods, if the change affects both.
Information about critical judgments in applying accounting policies that have the most significant risk of causing material
adjustment to the amounts reported in these financial statements are discussed below:
Share Based Payments
The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity
instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires determining the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This estimate also
requires determining the most appropriate inputs to the valuation model including the expected life of the share option, volatility and dividend yield and making assumptions about them. The assumptions and models used for estimating the fair value
for share-based payment transactions are disclosed in Note 7(e).
Revenue Recognition
The Company applies the five-step model to contracts when it is probable that the Company will collect
the consideration that it is entitled to in exchange for the goods and services transferred to the customer. For collaborative arrangements that fall within the scope of IFRS 15, the Company applies the revenue recognition model to part or all of the
arrangement, when deemed appropriate. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of IFRS 15, to identify distinct performance obligations. The Company then recognizes as
revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Significant judgement is involved in determining whether the transaction price allocated to the
license fee should be recognized over the collaboration period or at the inception of the contract and the time period over which revenue is to be recognized.
7
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 3. |
Critical Accounting Estimates and Judgements - continued
|
Revenue Recognition - continued
RepliCel Life Sciences Inc. makes estimates and assumptions about the future that affect the reported amounts of assets and
liabilities. Estimates and judgements are continually evaluated based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. In the future, actual experience may
differ from these estimates and assumptions.
|
4.
|
Accounting Standards, Amendments and Interpretations
|
New Standards, Amendments and Interpretations Effective for the first time
IFRS 16 Leases
The new standard replaces IAS 17 Leases
and eliminates the classification of leases as either operating or finance leases by the lessee. The treatment of leases by the lessee will require capitalization of all leases resulting in accounting treatment that is similar to finance leases under
IAS 17 Leases. Management believes that certain IFRS 16 exemptions for leases of very low value or short-term leases will be applicable. The new standard will
generally result in an increase in lease assets and liabilities for the lessee. Under the new standard the treatment of all lease expense is aligned in the statement of earnings with depreciation, and an interest component recognized for each lease,
in line with finance lease accounting under IAS 17 Leases. IFRS 16 is in effect for
annual periods beginning on January 1, 2019.
The Company has reviewed the impact that this standard is expected to have on its consolidated interim financial statements
and were not able to identify any explicitly or implicitly identified contractual arrangement that is subject to the new IFRS 16 Lease standard. Hence, there
is not expected to be any impact on the Company’s condensed consolidated interim financial statements.
IFRIC 23 Uncertainly Over Income Tax
Treatments
This new standard, also to be effective for annual report periods beginning on or after January 1, 2019, clarifies how to
apply the recognition and measurement requirements in IAS 12 Income Taxes when there is uncertainty over income tax treatments, addressing four specific
issues:
|
•
|
Whether an entity considers uncertain tax treatments separately;
|
|
•
|
The assumptions an entity should make about the examination of tax treatments by taxation authorities;
|
|
•
|
How an entity determines taxable profit or loss, taxes bases, unused tax losses, unused tax credits and tax rates; and
|
|
•
|
How an entity considers changes in facts and circumstances.
|
The Company has reviewed the standard and believes that this does not have an impact on the Company’s condensed consolidated
interim financial statements due to its taxable loss position.
There are no other IFRS or IFRIC Interpretations that are not yet effective that would be expected to have a material impact
on the Company.
8
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 5. |
Equipment
|
|
Furniture and Equipment
|
Computer Equipment
|
Total
|
||||||||||
|
Cost:
At January 1, 2019
|
$
|
14,249
|
$
|
41,751
|
$
|
56,000
|
||||||
|
Additions
|
-
|
-
|
-
|
|||||||||
|
Disposals
|
-
|
-
|
-
|
|||||||||
|
At June 30, 2019
|
14,249
|
$
|
41,751
|
$
|
56,000
|
|||||||
|
Depreciation:
At January 1, 2019
|
11,433
|
36,400
|
47,833
|
|||||||||
|
Charge for the period
|
282
|
802
|
1,084
|
|||||||||
|
Elimination on disposal
|
-
|
-
|
-
|
|||||||||
|
At June 30, 2019
|
11,715
|
37,202
|
48,917
|
|||||||||
|
Net book value at June 30, 2019
|
$
|
2,534
|
$
|
4,549
|
$
|
7,083
|
||||||
|
Furniture and Equipment
|
Computer Equipment
|
Total
|
||||||||||
|
Cost:
At December 31, 2017
|
$
|
14,249
|
$
|
41,751
|
$
|
56,000
|
||||||
|
Additions
|
-
|
-
|
-
|
|||||||||
|
Disposals
|
-
|
-
|
-
|
|||||||||
|
At December 31, 2018
|
14,249
|
41,751
|
56,000
|
|||||||||
|
Depreciation:
At December 31, 2017
|
10,729
|
34,106
|
44,835
|
|||||||||
|
Depreciation
|
704
|
2,294
|
2,998
|
|||||||||
|
At December 31, 2018
|
11,433
|
36,400
|
47,833
|
|||||||||
|
Net book value at December 31, 2018
|
$
|
2,816
|
$
|
5,351
|
$
|
8,167
|
||||||
9
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 6. |
Licensing and Collaboration Agreement – YOFOTO (China) Health Industry
Co. Ltd.
|
On July 10, 2018, the Company signed the definitive Licensing and Collaborative Agreement with YOFOTO (China) Health Industry
Co. Ltd. (“YOFOTO”) to commercialize three of RepliCel's programs in Greater China subject to the certain Canadian and Chinese approvals of the transaction (the “Transaction”).
The Transaction represents an investment in RepliCel by YOFOTO with milestone payments, minimum program funding commitments,
and sales royalties in exchange for an exclusive 15-year license to three of RepliCel products for Greater China (Mainland China, Hong Kong, Macau and Taiwan) (the “Territory”).
As part of the deal, YOFOTO agreed to invest CDN $5,090,005 in a private placement of RepliCel common shares at CDN $0.95 per
share to include 20% warrant coverage with each warrant exercisable at CDN $0.95 per share for a period of two years. The warrants have not yet been exercised.
The deal structure also includes milestone payments (of up to CDN $4,750,000), sales royalties, and a commitment by YOFOTO to
spend a minimum of CDN $7,000,000 on the RepliCel programs and associated cell processing manufacturing facility over the next four years in Greater China pursuant to a License and Collaboration Agreement. The License and Collaboration Agreement
contains a provision permitting YOFOTO to put up to 1/3 of the shares issued in YOFOTO’s initial investment back to the Company under certain conditions for a period of 8.5 years from July 10, 2018.
As part of the Transaction, the Company agreed to grant YOFOTO certain financing participation rights along with a board seat
nomination. Upon YOFOTO meeting certain defined conditions, relevant Chinese patents, once issued in China, will be assigned to a YOFOTO-owned Canadian subsidiary, with detailed assignment reversion rights upon failure to meet defined targets.
On October 9, 2018, the Transaction was approved by the TSX Venture Exchange and applicable regulatory authorities including
but not limited to the reviews and approvals by the State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities. On October 9, 2018, the private placement in the sum of $5,090,005 was closed
completing the Transaction with YOFOTO's purchase of 5,357,900 RepliCel common shares which represented 19.9% of RepliCel's issued shares. In association with the YOFOTO deal, the Company has paid a success fee of ten percent (10%) of any upfront
fees received by the Company. A fee of $509,001 has been paid in this respect. In addition, the Company will be paying a success fee of five percent (5%) of any milestone fees and royalty fees received by the Company as a result of this License
Agreement.
The proceeds of $5,090,005 from the placement was allocated to common shares and warrants issued based on their fair value at
the date of issuance which is $2,563,919. The remaining $2,526,086 was allocated to License Fee revenue to be recognized over a period of 10 years from the commencement date of the Agreement. No value was allocated to the put option.
Contract Liability
The Company amortizes and recognizes the revenue earned under the Agreement over a period of 10 years which according to the
Agreement represents the time the Licensee will have to complete the technology transfer and to obtain regulatory approval from local authorities.
10
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 6. |
Licensing and Collaboration Agreement – YOFOTO (China) Health Industry
Co. Ltd. – continued
|
Contract Asset
The finders/success fees paid in connection with the YOFOTO Licensing and Collaboration Agreement of $509,001 was incurred to
secure the YOFOTO License and Collaboration Agreement as well as to close the related private placement. Consequently, the $509,001 finders/success fee was accounted for as a contract asset and as a share issuance cost.
The $509,001 fee was allocated between contract costs, share issuance costs and as an offset to the fair value of the related
warrants. The finders/success fee was allocated based on the relative fair values of these three items. The contract asset is being amortized over the same period of time that the Company recognizes the upfront license revenue.
| 7. |
Share Capital
|
|
a)
|
Authorized:
|
Unlimited common shares without par value
Unlimited preferred shares without par value
b) Issued and Outstanding:
During the six-month period ended June 30, 2019:
| i) |
The Company announced on January 17, 2019 a debt settlement in the amount of $349,555 owed by the Company to certain creditors (“Creditors”) by the issuance
of 735,904 common shares (each, a “Share”) of the Company at a price of $0.475 per Share. The Settlement Agreements were signed on November 20, 2018; however, the debt was not settled until January 15, 2019 when the transaction was
approved by the TSX Venture Exchange. The securities are subject to a statutory hold period of four months and one day. The Company reported a gain on this debt settlement in the amount of $92,368.
|
There were no share activities during the six months period ended June 30, 2018.
11
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 7. |
Share Capital – continued
|
c) Stock Option Plans:
|
(i)
|
On May 21, 2014, the Company approved a Stock Option Plan whereby the Company may grant stock options to directors, officers, employees
and consultants. The maximum number of shares reserved for issue under the plan cannot exceed 10% of the outstanding common shares of the Company as at the date of the grant. The stock options can be exercisable for a maximum of 10 years
from the grant date and with various vesting terms.
|
|
(ii)
|
Under various Founders’ Stock Option Agreements, certain founders of TrichoScience granted stock options to acquire TrichoScience shares
to employees and consultants of TrichoScience. These founders’ options are exercisable at $1 per share expiring after six to seven years. Pursuant to the Share Exchange Agreement, the Founders Stock Option Agreements were converted into
rights to receive the number of Founders’ RepliCel shares acquired by conversion of the founders TrichoScience shares under the Share Exchange Agreement. All other terms remained the same. This modification of stock options resulted in no
incremental value and therefore no additional stock based compensation expense was recognized for the modification.
|
d) Fair value of Company Options Issued
There were no stock options granted during the six-months period ended June 30, 2019 and 2018.
Options Issued to Employees
The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise
price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield, the expected forfeiture rate and the risk free interest rate for the term of the
option.
Options Issued to Non-Employees
Options issued to non-employees, are measured based on the fair value of the goods or services received, at the date of
receiving those goods or services. If the fair value of the goods or services received cannot be estimated reliably, the options are measured by determining the fair value of the options granted, using a valuation model.
12
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 7. |
Share Capital – continued
|
e) Stock-based Compensation
The Company recognized a fair value of $18,457 (2018: $nil), as stock based
compensation expense for stock options granted in 2018 under the Company Stock Option Plan and the Founders Stock Option Agreements for the six month ended June 30, 2019 and June 30, 2018.
A summary of the status of the stock options outstanding under the Company Stock Option Plan for the six months ended June 30,
2019 is as follows:
|
Number of Options
|
Weighted Average Exercise Price
|
|||||||
|
Outstanding, January 1, 2019
|
2,080,000
|
$
|
0.79
|
|||||
|
Granted
|
-
|
-
|
||||||
|
Cancelled
|
(175,000
|
)
|
0.60
|
|||||
|
Outstanding, June 30, 2019
|
1,905,000
|
$
|
0.80
|
|||||
|
Exercisable, June 30, 2019
|
1,780,000
|
$
|
0.83
|
|||||
As at June 30, 2019, the range of exercise prices for options outstanding under the Company Stock Option Plan is $0.36 -
$1.64 and the weighted average remaining contractual life for stock options under the Company Stock Option Plan is 3.96 years.
A summary of the status of the stock options outstanding under the Company Stock Option Plan for the year ended December 31,
2018 is as follows:
|
Number of Options
|
Weighted Average Exercise Price
|
|||||||
|
Outstanding, January 1, 2018
|
1,400,000
|
$
|
2.04
|
|||||
|
Granted
|
1,110,000
|
0.43
|
||||||
|
Cancelled
|
(430,000
|
)
|
0.69
|
|||||
|
Outstanding, December 31, 2018
|
2,080,000
|
$
|
0.79
|
|||||
|
Exercisable, December 31, 2018
|
1,905,000
|
$
|
0.82
|
|||||
As at December 31, 2018, the range of exercise prices for options outstanding under the Company Stock Option Plan is $0.36 -
$1.64 and the weighted average remaining contractual life for stock options under the Company Stock Option Plan is 4.56 years.
13
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 7. |
Share Capital – continued
|
e) Stock-based Compensation – continued
The weighted-average grant date fair value of options granted was estimated using the following weighted average assumptions:
|
June 30, 2019
|
December 31, 2018
|
|
|
Risk fee rate
|
-
|
2.19%
|
|
Expected life (years)
|
-
|
5
|
|
Volatility
|
-
|
104%
|
|
Expected Dividend
|
-
|
$-
|
|
Expected forfeiture rate
|
-
|
0%
|
|
Exercise price
|
-
|
$0.43
|
|
Grant date fair value
|
-
|
$0.33
|
f) Warrants
The number of warrants outstanding at June 30, 2019 and 2018, each exercisable into one common share, is as follows:
|
Warrants Outstanding
|
Weighted Average Exercise Price
|
Expiry
|
|||||||
|
February 24, 2017
|
2,721,604
|
$
|
2.00
|
February 24, 2020
|
|||||
|
October 9, 2018
|
1,071,580
|
$
|
0.95
|
October 9, 2020
|
|||||
|
Outstanding, June 30, 2019 and 2018
|
3,793,184
|
$
|
1.70
|
||||||
|
Warrants
Outstanding
|
Weighted Average Exercise Price
|
|||||||
|
Outstanding, December 31, 2017
|
12,748,898
|
$
|
1.50
|
|||||
|
Expired
|
(111,362
|
)
|
0.45
|
|||||
|
Outstanding, March 31, 2018
|
12,637,536
|
$
|
1.50
|
|||||
|
Issued
|
1,071,580
|
0.95
|
||||||
|
Expired
|
(9,915,932
|
)
|
0.83
|
|||||
|
Outstanding, June 30, 2018 and December 31, 2018
|
3,793,184
|
$
|
1.70
|
|||||
|
Expired
|
-
|
-
|
||||||
|
Outstanding, June 30, 2019
|
3,793,184
|
$
|
1.70
|
|||||
14
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 7. |
Share Capital – continued
|
f) Warrants – continued
The weighted-average grant date fair value of warrants issued was estimated using the following weighted average assumptions:
|
June 30, 2019
|
December 31, 2018
|
|
|
Risk fee rate
|
-
|
2.31%
|
|
Expected life (years)
|
-
|
2
|
|
Volatility
|
-
|
104%
|
|
Expected Dividend
|
-
|
$-
|
|
Expected forfeiture rate
|
-
|
0%
|
|
Exercise price
|
-
|
$0.95
|
|
Grant date fair value
|
-
|
$0.45
|
8. Related Party Transactions
The following amounts due to related parties are included in accounts payable and accrued liabilities:
|
|
June 30, 2019
|
December 31, 2018
|
||||||
|
Companies controlled by directors of the Company
|
$
|
7,512
|
$
|
214,361
|
||||
|
Directors or officers of the Company
|
80,650
|
512,140
|
||||||
|
|
$
|
88,162
|
$
|
726,501
|
||||
These amounts are unsecured, non-interest bearing and have no fixed terms of repayment.
Of the $349,555 debt settlement disclosed in note 7 b i) $277,719 was owed to directors or officers of the Company at December
31, 2018 and was settled during the six months period ended June 30, 2019.
15
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 8. |
Related Party Transactions - continued
|
Related party transactions
The Company incurred the following transactions with companies that are controlled by directors and/or officers of the
Company.
|
|
Three months ended
|
Six months ended
|
||||||||||||||
|
|
30-Jun-19
|
30-Jun-18
|
30-Jun-19
|
30-Jun-18
|
||||||||||||
|
Research and development
|
$
|
17,499
|
$
|
30,000
|
$
|
64,866
|
$
|
60,000
|
||||||||
|
General and administration
|
-
|
9,000
|
-
|
18,000
|
||||||||||||
|
|
$
|
17,499
|
$
|
39,000
|
$
|
64,866
|
$
|
78,000
|
||||||||
Key management compensation
Key management personnel are persons responsible for planning, directing and controlling the activities of an entity, and
include directors, the Chief Executive Officer and the Chief Financial Officer.
|
|
Three months ended
|
Six months ended
|
||||||||||||||
|
|
30-Jun-19
|
30-Jun-18
|
30-Jun-19
|
30-Jun-18
|
||||||||||||
|
General and administrative – salaries and contracts
|
$
|
84,000
|
$
|
60,000
|
$
|
168,000
|
$
|
120,000
|
||||||||
|
Directors' fees
|
21,000
|
13,750
|
42,000
|
27,500
|
||||||||||||
|
Stock-based compensation
|
7,728
|
-
|
18,457
|
-
|
||||||||||||
|
|
$
|
112,728
|
$
|
73,750
|
$
|
228,457
|
$
|
147,500
|
||||||||
9. Financial Instruments and Risk Management
As at June 30, 2019, the Company’s financial instruments are comprised of cash, and accounts payable and accrued liabilities.
The fair values of cash and cash equivalents, accounts payable and accrued liabilities approximate their carrying value due to their short-term maturity.
The Company is exposed through its operations to the following financial risks:
|
•
|
Currency risk;
|
|
•
|
Credit risk;
|
|
•
|
Liquidity risk; and
|
|
•
|
Interest rate risk.
|
16
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 9. |
Financial Instruments and Risk Management – continued
|
In common with all other businesses, the Company is exposed to risks that arise from its use of financial instruments. This
note describes the Company’s objectives, policies and processes for managing those risks and the methods used to measure them. Further quantitative information in respect of these risks is presented throughout these financial statements.
There have been no substantive changes in the Company’s exposure to financial instrument risks, its objectives, policies and
processes for managing those risks or the methods used to measure them from previous periods unless otherwise stated in this note.
Currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes
in foreign exchange rates. The Company has an exposure to the European Euros as certain expenditures and commitments are denominated in European Euros and the Company is subject to fluctuations as a result of exchange rate variations to the extent
that transactions are made in this currency. In addition, the Company holds an amount of cash in US dollars and is therefore exposed to exchange rate fluctuations on these cash balances. The Company does not hedge its foreign exchange risk. At June
30, 2019, the Company held US dollar cash balances of $31,421 (US$22,263). A 1% increase/decrease in the US dollars foreign exchange rate would have an impact of ±$314 (US223) on the cash balance held June 30, 2019.
Credit risk is the risk of an unexpected loss if a customer or third party to a financial instrument fails to meet its
contractual obligations. The Company’s credit risk is primarily attributable to its cash. The Company limits exposure to credit risk by maintaining its cash with large financial institutions. The Company’s maximum exposure to credit risk is the
carrying value of its financial assets.
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company
manages liquidity risk through the management of its capital structure, more specifically, the issuance of new common shares, to ensure there is sufficient capital in order to meet short term business requirements, after taking into account the
Company’s holdings of cash and potential equity financing opportunities. The Company believes that these sources will be sufficient to cover the known short and long-term requirements at this time. There is no assurance that potential equity
financing opportunities will be available to meet these obligations.
The following table sets out the contractual maturities (representing undiscounted contractual cash-flows) of financial
liabilities as at June 30, 2019:
|
Year of expiry
|
Accounts payable and accrued liabilities
|
Total
|
||||||
|
Within 1 year
|
$
|
525,173
|
$
|
525,173
|
||||
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of
changes in market interest rates. As the Company’s cash is currently held in an interest bearing bank account, management considers the interest rate risk to be limited.
There were no changes to the Company’s fair value measurement levels during the period ended June 30, 2019 (2018: no change).
The Company does not have any level 3 fair value measurements (2018: none).
17
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 10. |
Commitments and Contingencies
|
The Company has entered into a Collaboration and Technology Transfer Agreement with Shiseido Company Limited who have alleged RepliCel breached
obligations in the agreement, which may allegedly be terminal to future obligations pursuant to the agreement. The Company has vigorously denied the existence of such a breach and insists on the ongoing validity of the respective obligations on both
parties pursuant to the agreement. No litigation or the triggering of other dispute mechanisms has been entered into by either party and the Company’s management is actively seeking to continue discussions and/or negotiations. Management maintains
the position that any data produced from clinical trials of the technology will, by agreement, be made available to the Company.
From time to time the Company is subject to claims and lawsuits arising from the in the ordinary course of operations. In the opinion of
management, the ultimate resolution of such pending legal proceedings will not have a material adverse effect on the Company’s financial position.
| 11. |
Capital Management
|
The Company’s objective when managing capital is to safeguard the Company’s ability to continue as a going concern in order to pursue business
opportunities. In order to facilitate the management of its capital requirements, the Company prepares periodic budgets that are updated as necessary. The Company manages its capital structure and makes adjustments to it to effectively support the
Company’s objectives. In order to continue advancing its technology and to pay for general administrative costs, the Company will use its existing working capital and raise additional amounts as needed.
Management reviews its capital management approach on an ongoing basis and believes that this approach, given the relative size of the Company, is
reasonable. The Company considers shareholders’ equity and working capital as components of its capital base. The Company can access or increase capital through the issuance of shares, and by sustaining cash reserves by reducing its capital and
operational expenditure program. Management primarily funds the Company’s expenditures by issuing share capital, rather than using capital sources that require fixed repayments of principal and/or interest. The Company is not subject to externally
imposed capital requirements and does not have exposure to asset-backed commercial paper or similar products, with the exception of pooling and escrow shares which are subject to restrictions. The Company believes it will be able to raise additional
equity capital as required, but recognizes the uncertainty attached thereto.
The Company’s investment policy is to hold cash in interest bearing bank accounts, which pay comparable interest rates to highly liquid short-term
interest bearing investments with maturities of one year or less and which can be liquidated at any time without penalties. There has been no change in the Company’s approach to capital management during the six-month period ended June 30, 2019.
| 12. |
Segmental Reporting
|
The Company is organized into one business unit based on its hair cell replication technology and has one reportable operating segment.
18
REPLICEL LIFE SCIENCES INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended June 30, 2019
(Stated in Canadian Dollars)
(Unaudited)
| 13. |
Events after the Reporting Date
|
On May 6, 2019, the Company announced that it intended to conduct a non-brokered private placement offering (the “Offering”) of Class A Preference
Shares (each, a “Class A Share”). These Class A Shares were to carry initial certain rights and restrictions, which have been amended to comply with the requirements of the Toronto Venture Exchange (“TSXV”). The revised and finalized Offering terms
are as follows:
The offering of up to 6,250,000 Class A Shares at a price of $0.40 per Class A Share (the “Issue Price”) will be for aggregate gross proceeds of up
to $2,500,000. The Class A Shares carry certain rights and restrictions, which include:
|
•
|
a fixed dividend rate which shall accrue on a daily basis (based on a 360 day year consisting of 12 30-day months) at a rate of seven
(7%) per annum;
|
|
•
|
the right to convert the paid up amount of each Class A Share, from time-to-time, into shares of the Company (each, a “Share”) at any
time prior to the date that is five (5) years from the date of issuance of the Class A Shares at a conversion price that is equal to the greater of: (i) $0.33; and (ii) the Market Price (as defined in the policies of the TSX Venture
Exchange (“TSXV”)) at the date of such conversion;
|
|
•
|
voting rights only on matters pertaining to Class A Shares until they are converted to common shares at which time all voting rights
attach; and
|
|
•
|
a first priority over all Shares or shares of any other class of the Company as to dividends and upon liquidation.
|
Subject to the earlier conversion by Class A shareholders and compliance with applicable laws, the Company may, in its discretion at any time,
prior to the date that is five (5) years from the date of issuance of the Class A Shares (the “Required Redemption Date”) redeem all of the Class A Shares at a price (the “Redemption Price”) of:
|
(i)
|
$0.468 per Class A Share for the period from the date of issuance (the “Issue Date”) to the date that is the first anniversary of the
Issue Date;
|
|
(ii)
|
$0.536 for the period from the date that is the day after the first anniversary of the Issue Date to the date that is the second
anniversary of the Issue Date;
|
|
(iii)
|
$0.604 for the period from the date that is the day after the second anniversary of the Issue Date to the date that is the third
anniversary of the Issue Date;
|
|
(iv)
|
$0.672 for the period from the date that is the day after the third anniversary of the Issue Date to the date that is the fourth
anniversary of the Issue Date; and
|
|
(v)
|
$0.740 for the period from the date that is the day after the fourth anniversary of the Issue Date and the date that is the fifth
anniversary of the Issue Date.
|
On the Required Redemption Date, the Company must redeem all remaining outstanding Class A Shares at the Redemption Price, subject to compliance
with applicable laws.
Finder’s fees may be paid in connection with the Offering in accordance with the policies of the TSXV.
All of the Class A Shares issued, and any securities into which they may be exchanged or converted, are subject to resale restrictions imposed by
applicable law or regulation, a statutory hold period expiring four months and one day from the date of closing (the “Closing”). The Offering is subject to approval from the TSXV.
On August 20, 2019, the Company approved a loan from a director of the Company in the sum of $115,000 USD (“the Loan”) which will be repayable in
30 days either by cash or shares. If the Company chooses to repay the Loan by way of shares, the share cost will be calculated by using the Loan amount divided by the closing price of the Company’s common shares at the time of the debt conversion.
If the Company chooses to pay the Loan amount in cash, the Company will return the amount in full by September 30, 2019 plus interest accrued at a 12% per annum interest rate.
19
REPLICEL LIFE SCIENCES INC.
MANAGEMENT DISCUSSION AND ANALYSIS
FORM 51-102F1
For the six months ended June 30, 2019
FORM 51-102F1
For the six months ended June 30, 2019
Dated as of August 23, 2019
The following management discussion and analysis of the financial position, results of operations and cash flows of RepliCel Life Sciences
Inc. (“the Company”, “RepliCel” or “we”), for the six months ended June 30, 2019 includes information up to and including August 23, 2019 and should be read in conjunction with the annual audited consolidated financial statements for the years ended
December 31, 2018, 2017, and 2016 and the condensed consolidated interim financial statements for the six months ended June 30, 2018.
The financial statements of the Company for the six months ended June 30, 2019 have been prepared in accordance with International Financial
Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).
All amounts included in the condensed consolidated interim financial statements and MD&A are expressed in Canadian dollars unless
otherwise indicated. The reader is encouraged to review the Company’s filings on the SEDAR website at www.sedar.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements included in this MD&A that do not relate to present or historical conditions are “forward‑looking statements”. Forward-looking
statements are projections in respect of future events or the Company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “intend”, “expect”, “plan”, “anticipate”,
“believe”, “estimate”, “predict”, “potential”, or “continue”, or the negative of these terms or other comparable terminology. Forward-looking information presented in such statements or disclosures may, among other things, include the Company’s:
|
•
|
belief that chronic tendon injuries resulting from sports-related or occupational overuse is a significant unmet medical need;
|
|
•
|
belief that RCT-01 has advantages over current treatments such as the use of non-steroidal anti- inflammatory medication or
corticosteroids which are limited in efficacy;
|
|
•
|
belief that the data from a recent phase 1/2 clinical trial to test the safety and efficacy of injections of RCT-01 on patients
suffering from chronic achilles tendinosis in Canada are sufficient to support regulatory approvals to proceed to a phase 2 trial and details of that trial;
|
|
•
|
belief that the data from a recent phase 1 clinical trial to test the safety and certain biological outcomes of injections of
RCS-01 in patients with aging and sun-damaged skin supports regulatory approvals to proceed to a phase 2 trial and details of that trial;
|
|
•
|
research pertaining to and plan to continue to prepare for a phase 2 dose-finding trail for RCH-01 and details of such a trial;
|
|
•
|
belief that the RCI-02 dermal injector device will have applications in certain dermatological procedures and preparation for its
commercialization including building of commercial/clinical-grade prototypes, validation testing of such prototypes, filing of the regulatory submissions seeking a CE mark to market the device will lead to commercial launch, revenue
generation, and commercial partners;
|
|
•
|
expectations regarding regulatory clearances to conduct trials and market products;
|
|
•
|
belief as to the potential of the Company’s products;
|
|
•
|
expectations regarding the performance of its commercial partners, YOFOTO and Shiseido;
|
|
•
|
expectations regarding the performance of critical suppliers and service providers;
|
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forecasts of expenditures;
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•
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expectations regarding our ability to raise capital;
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•
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business outlook;
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•
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plans and objectives of management for future operations; and
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anticipated financial performance.
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Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking
information. Those assumptions and factors are based on information currently available to the Company, including information obtained from third-party industry analysts and other third party sources. In some instances, material assumptions and
factors are presented or discussed elsewhere in this MD&A in connection with the statements or disclosure containing the forward-looking information. You are cautioned that the following list of material factors and assumptions is not exhaustive.
The factors and assumptions include, but are not limited to, our assumption that there be:
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•
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no unforeseen changes in the legislative and operating framework for the business of the Company;
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a stable competitive environment; and
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•
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no significant event occurring outside the ordinary course of business such as a natural disaster or other calamity.
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These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks set out in
the section entitled “Risks and Uncertainties” commencing on page 16, which may cause the Company’s or its industry’s actual results, levels of activity or performance to be materially different from any future results, levels of activity or
performance expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to the following risks:
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•
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negative results from the Company’s clinical trials;
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•
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the effects of government regulation on the Company’s business;
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•
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the viability and marketability of the Company’s technologies;
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•
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the development of superior technology by the Company’s competitors;
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•
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the failure of consumers and the medical community to accept the Company’s technology as safe and effective;
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•
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risks associated with the performance of commercial partners and critical suppliers and service providers;
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•
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risks associated with the Company’s ability to obtain and protect rights to its intellectual property;
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risks and uncertainties associated with the Company’s ability to raise additional capital; and
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•
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other factors beyond the Company’s control.
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Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee
future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any
forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict
all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
statement.
OVERALL PERFORMANCE
The Company was incorporated under the Ontario Business
Corporations Act on April 24, 1967. The Company is a foreign private issuer in the United States. The Company’s common shares are listed for trading in Canada on the TSX Venture Exchange, trading under the symbol “RP”, in the United States
on the OTCQB, trading under the symbol REPCF, and in Germany on the Frankfurt Stock Exchange (FRA) under the symbol P6P2.
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that treat functional cellular deficits. The
diseases currently being addressed are chronic tendinosis, skin aging, and androgenetic alopecia (pattern baldness). Each disease state is consistent with a deficit of a specific cell type which the Company believes is critical to normal function.
All treatments under development are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles. These products are built on the Company’s proprietary manufacturing platforms and are covered by
issued and filed patents, as well as trade secrets. RepliCel is also developing a programmable injector device designed for dermal injections of cells as currently approved dermal filler products.
2
The Potential of Autologous Cell Therapy
The Company’s treatments use autologous cell therapy (“ACT”), which is one of the most rapidly developing areas of regenerative medicine in the development of novel treatments for numerous human disorders. ACT involves isolating an individual’s own cells from harvested tissues and growing
more of those cells, or ‘expanding’ those cells, in controlled conditions in a laboratory. These purified, expanded cells are then reintroduced to the donor to treat a specific condition. The benefits of autologous (derived from the same person)
therapy (as compared to allogeneic derived from a different person) includes minimized risks of systemic immunological (anaphylactic) reactions, bio-incompatibility, and disease transmission. Furthermore, the effects of ACT may be longer lasting than
pharmacological or surgical interventions.
The Company has an extensive intellectual property portfolio that covers RCT-01 (our platform for tendon repair); RCS-01 (our platform for
skin rejuvenation); RCH-01 (our platform for pattern baldness); and RCI-02 (our dermal injection devices). Our intellectual property portfolio includes both patents and patent applications which we have developed and own (discussed in more detail
below).
RCT-01: Treatment for Chronic Tendinosis
Background
Tendinosis refers to a chronic disease of the tendon. It is a function of an imbalance of tendon breakdown and tendon repair initiated first
by an injury which does not heal properly. This leads to cycles of compromised repair and subsequent re-injury until such time as there is no healing and a degenerative process has set in. Typically, this chronic condition is linked to aging,
overuse, and to general health. The Company believes that the current standard of care is failing to provide a satisfactory solution to this chronic condition.
Treatment
The Company believes that chronic tendon injuries resulting from sports-related or occupational overuse is a significant unmet medical need.
Tendons consist of specialized connective tissues that attach muscles to bones, transmitting force and supporting the musculoskeletal system. When mechanical loads exceed the strength of a tendon or tensile range is lost due to aging, micro-tears of
the collagen fibers within tendon occur. Once a tendon is injured, healing can occur intrinsically via tenocyte activation within the injured site or extrinsically via recruitment of collagen-producing cells from the surrounding area. Naturally
healed tendon does not return to the same physiological state as ‘intact’ tendon, but does allow for normal function. Inadequate rest and improper healing often result in re-injury and rupture.
Current treatments manage pain and facilitate healing processes; however, they do not mediate complete recovery and leave patients
demobilized for several months during treatment. The Company believes that improved therapeutic strategies are therefore in considerable demand. The Company’s fibroblast technology for tendinosis, which the Company refers to as RCT-01, has been
developed over five years of research, experimentation and trials. RCT-01 is a tissue-engineered product made from a procedure using collagen-producing fibroblasts isolated from non-bulbar dermal sheath (NBDS) cells within the hair follicle that are
replicated in culture. These fibroblasts are efficient producers of type I collagen and because they are of anagen hair follicle mesenchymal origin, they have the potential to replicate efficiently in culture. The use of these fibroblasts are,
therefore, ideal for treating chronic tendon disorders that arise due to either a degeneration of collagen producing cells or a deficit of active collagen producing cells. Because RCT-01 directly provides a source of collagen expressing cells to the
site of injury, addressing the underlying cause of tendinosis, the Company believes it has advantages over current treatments such as the use of non-steroidal anti-inflammatory medication or corticosteroids which are limited in efficacy. Another
advantage of RCT-01 is the autologous nature of the cellular product, thereby reducing the likelihood of adverse immune reactions upon administration.
3
Pilot Clinical Trial
Phase 1 human pilot clinical trials were conducted by the Company’s collaborative partner, Dr. David Connell, which focused on tendinosis of
the Achilles, patellar and lateral elbow (commonly referred to as tennis elbow) using skin tissue derived fibroblasts. In these trials, where 90 patients were injected with cultured, autologous fibroblasts, no adverse events were reported. The
Company has expanded on Dr. Connell’s approach by isolating NBDS fibroblasts from the hair follicle that express upwards of five times the amount of type I collagen than fibroblasts derived from skin tissue as pursued by Dr. Connell.
Phase 1 Clinical Trial
On December 1, 2014, the Company announced receipt of a “No Objection Letter” from Health Canada in response to its Clinical Trial
Application to Health Canada for its phase 1/2 clinical trial to test the safety and efficacy of injections of RCT-01 on patients suffering from chronic Achilles tendinosis. Health Canada’s clearance to initiate the trial permitted the participation
of subjects who have failed traditional tendon treatments and who are otherwise in good health. Trial design was randomized, double-blinded, placebo-controlled with a treatment-to-placebo ration of 3:1. The mechanics of the Company’s treatment
involve the extraction of as few as 20 hair follicles from the back of a patient’s scalp via a single punch biopsy. NBDS cells are isolated from the hair follicle sheath, replicated in a current Good Manufacturing Practices (cGMP) facility and are
then reintroduced under ultrasound guidance directly into the area of damaged tendon. The collagen rich fibroblast cells are expected to initiate and complete the healing of the chronically injured tendon. After injections are performed, subjects
will return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echotexture, interstitial tears and neovascularity.
This trial commenced in 2015 and final data was announced Q1 2017. The primary end point of safety was met while secondary end points related
to efficacy were also measured at nine-months post-injection of RCT-01. The Company may pursue further indications of other tendon populations including patellar tendinosis (jumper’s knee) and lateral and medial epicondylitis (tennis and golfer’s
elbow).
Further Clinical Trials
The Company is now designing further clinical testing intended to measure efficacy of RCT-01 in patients with chronic tendinosis. The Company
is currently engaged with the Japanese regulators in the reviews necessary to obtain regulatory clearance to conduct its next clinical trial of RCT-01 in Japan with the intention of seeking ‘conditional approval’ from the regulatory agency there (the
Pharmaceutical and Medical Devices Agency) to market the product in Japan after successful completion of such a trial. Other preparations required for the conduct of such a trial have also been initiated in Japan.
In addition to RepliCel’s intended conduct of a clinical trial in Japan, RepliCel’s partner, YOFOTO (see below), is expected to conduct a
clinical trial of RCT-01 in China. This trial is anticipated to be a phase 2 trial designed to answer critical questions related to dosing and treatment frequency.
Collaboration Agreement
The Company has a Collaboration and Technology Transfer Agreement with YOFOTO (China) Health Industry Co. Ltd. (“YOFOTO”). Both companies have agreed to establish a clinical research program in China, with the goal of increasing the available human clinical data on RCT-01. The Company
anticipates that collaborative technology transfer will continue between the companies as any new improvements to the RCT-01 technology are developed by either party. This agreement gives YOFOTO an exclusive 15-year geographic license to develop and
market the Company’s RCT-01 tendon regeneration technology in Greater China (China, Hong Kong, Macau, and Taiwan).
Intellectual Property
The Company has filed patent applications worldwide relating to compositions, methods and uses of NBDS cells for the treatment and repair of
tendons. Representative examples of this portfolio include patent applications filed in a variety of select jurisdictions such as Australia, Brazil, Canada, China, Israel, India, Japan, South Korea, Mexico, New Zealand, Russia, Singapore, South
Africa, the UAE and the United States (see e.g., US Pub No. 20150374757). A patent has recently been granted in (see EP 2956543), and the application in China has been allowed.
4
RCS-01: Treatment for Aging and Sun Damaged Skin
Background
Skin is considered one of the most prominent indicators of one’s age and health. Maintenance of healthy skin is dictated by intrinsic and
extrinsic factors. While intrinsic factors (i.e. chronologic age, sex and genetic makeup) cannot be modified, the adverse effects caused by extrinsic factors such as UV radiation and smoking can be prevented or minimized by lifestyle modification.
Although these extrinsic effects can be modulated, the extent to which they can be modified varies significantly among individuals, which largely depends on one’s ability to detoxify and repair such damage.
The dermis and epidermis components of the skin lose thickness with age. Solar radiation, particularly UVA, is known to penetrate deep into
the dermal layer, damaging fibroblasts, collagen and other fibroblasts expressed proteins, which are the major cellular components of the dermis. Similarly, there are some studies reporting that air pollutants/nanoparticles may also penetrate
transepidermally, negatively impacting the dermal layer. The damages caused by external stimuli include DNA strand breaks and mutations, which, if not repaired properly, can lead to cell death. Similarly, oxidative stress caused by smoking leads to
not only damages to DNA but also to other cellular components such as proteins and lipids.
Accumulation of damage to cellular proteins and DNA from years of exposure to extrinsic insults can lead to physiological changes of the skin
that are irreversible. Such changes are often associated with a reduction in fibroblast cells, disorganization of collagen fibrils and decreased production of collagen, elastin and other glycoproteins that provide structural support and stability to
the extra cellular matrix (“ECM”) network. Such changes to the dermal components are detrimental to maintaining mechanical tensile ability and structural
integrity of the skin.
Treatment
The Company’s NBDS-derived fibroblast therapy, which it refers to as RCS-01, provides a promising platform to treat intrinsically and
extrinsically aged/damaged skin by providing UV-naïve collagen-producing fibroblast cells directly to the affected area. The Company’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal
tissues, which elicit more efficient replication potential in culture. Additionally, the Company’s proprietary culture procedures potentiate these cells to maintain plasticity, allowing the cells to adapt to the microenvironment and respond to the
mechanical or surrounding stimuli after injection, leading to robust production of type I collagen and elastin and their proper alignment within the tissue.
On September 1, 2015, the Company announced it had received clearance from the German Competent Authority, the Paul-Ehrlich-Institute, to
initiate a Phase 1 clinical trial to investigate the potential safety and efficacy of injecting RCS-01 into subjects with aged or UV-damaged skin. This trial is a randomized, double-blind, placebo controlled study of intradermal injections of RCS-01
designed to assess local safety as well as systemic safety. In addition, quantitative analysis of skin gaining-related bio-markers is being conducted along with histopathological assessment of treatment sites to determine structural changes. This
trial is now complete with data announced early April 2017 in which the primary endpoint, safety, was successfully established and secondary endpoints related to measurements of the impact on biomarkers related to skin-aging were significantly
positive.
Further Clinical Trials
The Company is now designing further clinical testing of RCS-01 including a multi-centre phase 2 clinical trial intended to measure efficacy
of RCS-01 in a larger population of patients with aging and UV-damaged skin and answer critical questions related to dosing and treatment frequency as well as clinical trials in Japan and China.
5
The Company is currently engaged with the Japanese regulators in the reviews necessary to obtain regulatory clearance conduct its next
clinical study of RCS-01 in Japan with the intention of launching the product on the market in Japan after successful completion of such a trial. Other preparations required for the conduct of such a clinical study have also been initiated in Japan.
In addition to RepliCel’s intended conduct of a clinical trial in Japan, RepliCel’s partner, YOFOTO (see below), is expected to conduct a
clinical trial of RCS-01 in China. This trial is anticipated to be a phase 2 trial designed to answer critical questions related to dosing and treatment frequency.
It is intended that all future clinical trials of RCS-01 will be conducted using prototypes of the RepliCel’s RCI-02 dermal injector.
Collaboration Agreement
The Company has a Collaboration and Technology Transfer Agreement with YOFOTO (China) Health Industry Co. Ltd. (“YOFOTO”). Both companies have agreed to establish a clinical research program in China, with the goal of increasing the available human clinical data on RCS-01. The Company
anticipates that collaborative technology transfer will continue between the companies as any new improvements to the RCS-01 technology are developed by either party. This agreement gives YOFOTO an exclusive 15-year geographic license to develop and
market the Company’s RCS-01 skin rejuvenation technology in Greater China (China, Hong Kong, Macau, and Taiwan).
Intellectual Property
The Company has filed patent applications relating to compositions, methods and uses of NBDS cells for the treatment and repair of aging and
UV-damaged skin. Representative examples of this portfolio include patent applications filed in a variety of select jurisdictions such as Australia, Brazil, Canada, China, Europe, Israel, India, Japan, South Korea, Mexico, New Zealand, Singapore,
and the United States (see e.g., US Pub No. 20160136206).
RCH-01: Treatment for Hair Loss
Background
Androgenetic alopecia (pattern hair loss) can affect up to 70% of men and 40% of women during the course of their lives. Although it is not a
disease that causes physical pain, it does cause mental pain. Currently, over $3 billion is spent each year on hair loss treatments that provide limited results. Androgenetic alopecia is largely an inherited disease. It can be inherited by males and
females from either the mother’s or father’s side of the family. Women with this trait develop thinning hair, but do not commonly become completely bald.
Androgenetic alopecia is a process by which hair follicles shrink and produce smaller hairs thus reducing hair density. These miniaturized
hair fibers have a shorter growth cycle and are structurally smaller. They produce thinner and shorter hair, which results in less scalp coverage. Eventually these follicles can regress to a state where they produce no hair at all.
Treatment
The Company believes its dermal sheath cup (DSC) cell therapy offers several advantages over current hair loss solutions. The current gold
standard in hair loss treatment is hair transplant surgery which requires the surgical removal of a prominent band of hair-bearing scalp or multiple micro-biopsies from the back of the head. This band of resected tissue or biopsies are then dissected
into hair follicles consisting of one to three hairs which are then implanted into balding areas on the scalp. Often a number of similar procedures are required to achieve the desired result and the patient is limited by the number of hairs that can
be redistributed. In contrast, RCH-01 involves the extraction of as few as 20 hair follicles from the back of the patient’s scalp where healthy cycling hair follicles reside. The Company believes these cells are responsible for the continued health
of the hair follicle and the normal cycling of the hair fiber. DSC cells are isolated from the hair follicles and are then replicated in culture at a cGMP compliant
facility utilizing the Company’s proprietary cellular replication process, and are then reintroduced back into balding areas on a patient’s scalp. The implanted cells are expected to rejuvenate damaged quiescent hair follicles leading to the growth
of new healthy hair fibers. The anticipated long-term result of RCH-01 injections is the restoration and maintenance of a patient’s hair.
6
Phase I Clinical Trial
The primary protocol objective of the study was to assess the local (at treatment sites) safety profile of injections of autologous DSC cells
at nine-months post-injection compared to placebo. Secondary protocol objectives were to assess systemic (overall) safety and efficacy (hair growth at treatment sites) at nine-month post-injection and local safety at 24-months post-injection. The
nine-month interim analysis was designed to provide us with safety information to support the regulatory filing for a phase II clinical trial. The nine-month interim analysis results support the continued development of DSC cells for the treatment of
androgenetic alopecia. Participants of the phase I clinical trial were followed for five years. The primary objective of the study was to provide long-term safety profile of injections of cultured DSC cells five years after injection compared to
control. This objective was met with an announcement of the final data from this trial in Q1 2017. In addition to establishing safety of the product through five years of follow-up, the data announcement also included several successful data
measurements related to increased hair density and stabilization of hair loss through the initial 24 months in which these measurements were taken.
Proposed Phase 2 Clinical Trial
The Company has designed a phase 2 clinical trial intended to measure efficacy of RCH-01 in a larger population of patients with mild to
moderate androgenetic alopecia and answer critical questions related to dosing and treatment frequency. The Company is currently engaged in molecular marker research which is expected to lead to improvements in the product identification,
manufacturing, and its clinical effectiveness. The Company may await data from this research and until clinical-grade prototypes of the RCI-02 dermal injector are available for use in clinical studies prior to submitting the clinical trial
application for a phase 2 study of RCH-01 for regulatory approval.
Collaboration Agreement
The Company has a Collaboration and Technology Transfer Agreement with Shiseido Company, Limited (“Shiseido”), one of the world’s largest cosmetic companies. Both companies have agreed to work towards establishing a clinical research program in Asia, with the goal of increasing the
available human clinical data on RCH-01. The Company anticipates that collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party. This agreement gives Shiseido
an exclusive geographic license to use the Company’s RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people. In mid-2016, Shiseido alleged
RepliCel had breached its obligations in the agreement which Shiseido alleged were potentially terminal to future obligations pursuant to the agreement. RepliCel has vigorously denied the existence of such breach and insists on the ongoing validity
of the respective obligations on both parties pursuant to the agreement. No litigation or the triggering of other dispute mechanisms has been entered into by either party and RepliCel management is actively seeking to continue discussions and/or
negotiations with Shiseido to resolve the matter. Shiseido funded a hospital-sponsored clinical study of RCH-01 in Japan which the Company believes is now complete. The clinical data produced in such a trial is, by agreement, to be made available to
the Company. One of the principle investigators of this study recently stated that they expected to have the data from this study in July 2019. The Company believes the data from the study has now been delivered and expects Shiseido to share the
data from this study with the Company in compliance with the Agreement. The Company also awaits an announcement from Shiseido regarding its next steps for RCH-01 in Asia including its commercialization plans for the product in Japan.
Intellectual Property
The Company has filed patent applications on the use of hair follicle derived stem cells. This family of patents describes methods for
isolating stem cells from hair follicles, and the growth and use of these stem cells for the treatment of a variety of medical conditions (including hair loss). Within this portfolio, there are granted patents in Australia (AU 2003246521), Europe
(EP 1509597), the United States (8431400) and Canada (2488057). An additional related patent application is also pending in the United States (USSN 16/032728).
7
RCI-02: Dermal Injector Device
Background
To support the Company’s RCH-01 and RCS-01 products, the Company is developing a second generation dermal injector device. The RCI-02
Injector, the production design of which is now complete, will be able to deliver programmable volumes of substances into programmed depths to specific layers of the skin in a constant form with minimal pressure or shear stress, ensuring the injected
substance is viable and healthy after application. By improving the conditions of substance delivery, the Company improves the chances of success in the treatment of the patient. A significant feature of the new device is the incorporation of a
cooling element at the injection site, thus removing the need for an anesthetic. This is a significant improvement over current syringe-type devices where an anesthetic is required prior to injection.
The Company believes that this device will have applications in certain other dermatological procedures requiring injections of specific
volumes of material at specific depths and as such, is actively exploring licensing opportunities in these areas. In addition to the programmable variables of volume and depth, the device will also have interchangeable heads for different injection
procedures (single and multi-needle). The Company received fully functioning prototypes for testing in Q3 2017, expects to have final prototypes with commercial-grade components in Q3 2019 and to have manufactured its first run of commercial-grade
device units in early Q4 2019. These units will then be tested over the coming months and an application submitted to European regulators for CE-mark approval in Europe in early 2020. A CE mark will allow the Company to commercially launch RCI-02 in
Europe and other countries which allow medical devices to be sold based on CE mark approval including Hong Kong.
A proprietary needle head has also been developed and will be CE-marked in early 2020. Only this needle-head will work with the device and
will be sold/distributed exclusively by RepliCel and its agents.
A CE-mark will also be obtained by RepliCel on the assembled syringe cartridge which is the only cartridge which will work with the device
and will be sold/distributed exclusively by RepliCel and its agents.
Collaboration Agreement
The Company has a Collaboration and Technology Transfer Agreement with YOFOTO (China) Health Industry Co. Ltd. (“YOFOTO”). YOFOTO has agreed to work towards commercializing the RCI-02 device in China. This agreement gives YOFOTO an exclusive 15-year geographic license to commercialize the
Company’s RCI-02 dermal injector in technology in Greater China (China, Hong Kong, Macau, and Taiwan).
Intellectual Property
The Company has also filed numbers patents and patent applications on its dermal injection devices for the delivery of therapeutically useful
cells, as well the delivery of various other injectables. Representative granted patents include in Europe (EP 2623146 and EP 2809381), and the United States (US 9616182). Additional related patent applications are also pending in a variety of other
jurisdictions such as Australia, Canada, China, Europe, Hong Kong, Israel, Japan, South Korea, New Zealand, Singapore, Taiwan, and the United States (US Pub No. 20180021523).
8
DISCUSSION OF OPERATIONS
Three months ended June 30, 2019 compared to three months ended June, 2018
|
Three months ended June 30
|
Change from 2018 to 2019
|
|||||||||||||||
|
Increase/
|
Percentage
|
|||||||||||||||
|
2019
|
2018
|
(Decrease)
|
Change
|
|||||||||||||
|
Revenue
|
63,153
|
-
|
63,153
|
100
|
%
|
|||||||||||
|
Expenses
|
||||||||||||||||
|
Research and development
|
722,883
|
245,737
|
477,146
|
294
|
%
|
|||||||||||
|
General and administrative
|
273,748
|
344,608
|
(70,860
|
)
|
79
|
%
|
||||||||||
|
Other items
|
5,687
|
8,999
|
(3,312
|
)
|
63
|
%
|
||||||||||
|
Total loss
|
939,165
|
599,344
|
339,821
|
157
|
%
|
|||||||||||
There was $63,153 (2018 - $Nil) revenue – License fees from operations for the three months ended June 30, 2019 and 2018.
Research and Development expenses totaled $722,883 for the three months ended June 30, 2019 compared to $245,737 for the three months ended
June 30, 2018. Research and Development expenses are significantly higher during the three months ended June 30, 2019 than 2018 as a result of its ability to invest in research and development due to the improvement in working capital stemming from
the private placement with YOFOTO, the Company’s partner in the Licensing and Collaboration Agreement executed on July 20, 2018. The transaction closed during the last quarter of 2018 and consequently, the Company's cash position improved by
$5,090,000 at the time, thus enabling the Company to focus on its Research and Development Activities; primarily its RCI-02 injector device and related consumables. General and administrative expenses for the three months ended June 30, 2019 totaled
$273,748 compared to $344,608, an almost 80% decrease as the Company made a concentrated effort to decrease administrative costs such as investor relations and maximizing expenditures on research and development activities.
Total comprehensive loss for the three months ended June 30, 2019 was $939,165 or $0.03 per share on a basic and diluted basis compared to a
net loss of $599,344 or $0.03 per share on a basic and diluted basis for the three months ended June 30, 2018.
9
Six months ended June 30, 2019 compared to Six months ended June, 2018
|
Six months ended June 30
|
Change from 2018 to 2019
|
|||||||||||||||
|
Increase/
|
Percentage
|
|||||||||||||||
|
2019
|
2018
|
(Decrease)
|
Change
|
|||||||||||||
|
Revenue
|
126,305
|
-
|
126,305.00
|
100.00
|
%
|
|||||||||||
|
Expenses
|
||||||||||||||||
|
Research and development
|
1,466,300
|
303,783
|
1,162,517
|
483
|
%
|
|||||||||||
|
General and administrative
|
518,685
|
772,891
|
(254,206
|
)
|
67
|
%
|
||||||||||
|
Other items
|
(92,475
|
)
|
15,136
|
(107,612
|
)
|
(611
|
%)
|
|||||||||
|
Total loss
|
1,766,205
|
1,091,810
|
674,394
|
162
|
%
|
|||||||||||
There was $126,305 (2018 - $Nil) revenue – License fees from operations for the six months ended June 30, 2019 and 2018.
On July 10, 2018, the Company signed the definitive Licensing and Collaborative Agreement with YOFOTO (China) Health Industry Co. Ltd. (“YOFOTO”) to commercialize three of RepliCel's programs in Greater China subject to the certain Canadian and Chinese approvals of the transaction (the “Transaction”).
The transaction between these parties represents an investment in RepliCel by YOFOTO along with milestone payments, minimum program funding
commitments, and sales royalties in exchange for an exclusive 15-year license to three of RepliCel products for Greater China (Mainland China, Hong Kong, Macau and Taiwan) (the “Territory”).
As part of the deal, YOFOTO agreed to invest CDN $5,090,005 in a private placement of RepliCel common shares at CDN $0.95 per share to
include 20% warrant coverage with each warrant exercisable at CDN $0.95 per share for a period of two years. The warrants are restricted from being exercised without shareholder approval if the exercise of the warrants would increase YOFOTO's
ownership of RepliCel's issued and outstanding shares over 19.9%. At the Company’s Annual General Meeting on December 14, 2018, the Company received shareholder approval for YOFOTO to exercise the warrants and obtain an ownership position in the
Company that may exceed 19.9%. The warrants have not yet been exercised.
The deal structure also includes milestone payments (of up to CDN $4,750,000), sales royalties, and a commitment by YOFOTO to spend a minimum
of CDN $7,000,000 on the RepliCel programs and associated cell processing manufacturing facility over the next four years in Greater China pursuant to a License and Collaboration Agreement. The License and Collaboration Agreement contains a provision
permitting YOFOTO to put up to 1/3 of the shares issued in YOFOTO’s initial investment back to the Company under certain conditions for a period of 8.5 years from July 10, 2018.
As part of the Transaction, the Company agreed to grant YOFOTO certain financing participation rights along with a board seat nomination.
Upon YOFOTO meeting certain defined conditions, relevant Chinese patents, once issued in China, will be assigned to a YOFOTO-owned Canadian subsidiary, with detailed assignment reversion rights upon failure to meet defined targets.
On October 9, 2018, the Transaction was approved by the TSX Venture Exchange and applicable regulatory authorities including but not limited
to the reviews and approvals by the State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities. On October 9, 2011, the private placement in the sum of $5,090,005 was closed completing the
Transaction with YOFOTO's purchase of 5,357,900 RepliCel common shares which represented 19.9% of RepliCel's issued shares. In association with the YOFOTO deal, the Company has paid a success fee of ten percent (10%) of any upfront fees received by
the Company. A fee of $509,001 has been paid in this respect. In addition, the Company will be paying a success fee of five percent (5%) of any milestone fees and royalty fees received by the Company as a result of this License Agreement.
10
The proceeds of $5,090,005 from the placement was allocated to common shares and warrants issued based on their fair value at the date of
issuance which is at $2,563,919. The remaining $2,526,086 was will be allocated License Fees revenue to be recognized over a period of 10 years from the commencement date of the Agreement. No value was allocated to the put option. For the three
months ended March 31, 2019, the Company recognized the sum of $63,152 as revenue – licensing fees.
Research and Development expenses totaled $1,466,300 for the six months ended June 30, 2019 compared to $303,783 for the six months ended
June 30, 2018. Research and Development expenses are significantly higher (483%) during the six months ended June 30, 2019 than 2018 as a result of its ability to invest in research and development due to the improvement in working capital stemming
from the private placement with YOFOTO, the Company’s partner in the Licensing and Collaboration Agreement executed on July 20, 2018. The transaction closed during the last quarter of 2018 and consequently, the Company's cash position improved by
$5,090,000 at the time, thus enabling the Company to focus on its Research and Development Activities; primarily its RCI-02 injector device. General and administrative expenses for the six months ended June 30, 2019 totaled $518,685 compared to
$772,891, a 67% decrease as the Company made a concentrated effort to decrease administrative costs such as investor relations and maximize research and development expenditures.
Other items for the six months ended June 30, 2019 includes a gain on debt settlement of $92,368 which resulted from a share for debt
transaction which occurred on January 17, 2019.
Total comprehensive loss for the three months ended June 30, 2019 was $1,766,205 or $0.07 per share on a basic and diluted basis compared to
a net loss of $1,091,810 or $0.05 per share on a basic and diluted basis for the six months ended June 30, 2018.
SUMMARY OF QUARTERLY RESULTS
The following is a summary of the Company’s financial results for the eight most recently completed quarters in accordance with IFRS.
|
June 30,
2019 $ |
Mar 31,
2019 $ |
Dec 31,
2018 $ |
Sept 30,
2018 $ |
June 30,
2018 $ |
Mar 31,
2018 $ |
Dec 31,
2017 $ |
September 30,
2017 $ |
|||||||||||||||||||||||||
|
Revenues
|
63,153
|
63,152
|
121,114
|
Nil
|
Nil
|
Nil
|
Nil
|
Nil
|
||||||||||||||||||||||||
|
Net loss
|
(939,165
|
)
|
(827,040
|
)
|
(912,190
|
)
|
(765,080
|
)
|
(599,344
|
)
|
(492,466
|
)
|
(619,178
|
)
|
(1,188,920
|
)
|
||||||||||||||||
|
Basic and diluted loss per share
|
(0.03
|
)
|
(0.03
|
)
|
(0.03
|
)
|
(0.04
|
)
|
(0.03
|
)
|
(0.03
|
)
|
(0.02
|
)
|
(0.06
|
)
|
||||||||||||||||
Due to the fact that the Company faced financial constraints and was preparing for the next phase of product testing and development during
the first three quarters ended December 31, 2018, RepliCel drastically reduced spending until the beginning of the 4th quarter ended December 31, 2018 when its financial position improved and focused on research and development
activities.
LIQUIDITY AND CAPITAL RESOURCES
The Company’s condensed consolidated interim financial statements have been prepared on a going concern basis which assumes that the Company
will continue to realize its assets and discharge its obligations and commitments in the normal course of operations. Since its inception, the Company had accumulated $4,367,819 in revenue from its business, had accumulated deficit of $35,325,302 since incorporation and expected to incur further losses in the development of its business, which casts substantial doubt about the Company’s ability to continue as
a going concern. At June 30, 2019, the Company had a working capital deficit of $129,375. Additional working capital will be required for research and development along with general and administrative expenses and to further its business plans. The
Company is currently pursuing both dilutive and non-dilutive financing it expects will satisfy its working capital requirements going forward. Non-dilutive funding includes grant funding and strategic partnerships involving product licenses to
defined geographic markets and for specified applications. The Company’s financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts of and classification of liabilities
that might be necessary in the event that the Company cannot continue as a going concern.
11
The Company’s ability to continue as a going concern is dependent upon its ability to generate future profitable operations and/or to obtain
the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. The Company has financed its operations to date through the issuance of equity. The continued volatility in the
financial equity markets may make it difficult to raise funds by private placements of shares. There is no assurance that the Company will be successful with its financing ventures.
Operating Activities
During the six months period ended June 30, 2019, $2,146,682 was used in net cash from operating activities compared to $448,261 of cash used
in operating activities for the period ended June 30, 2018. The increase in cash used for operating activities was a result of primarily increases in both research and development as well as general and administration activities for the first three
months of the year. This is primarily driven by the fact that the private placement that took place in the 4th quarter of 2018 funded the company in excess of 5 million dollars.
Additional working capital will be required for research and development and general administration expenses and to further our business
plans.
Going Concern
The condensed interim consolidated financial statements prepared as at June 30, 2019 have been prepared on a going concern basis, which
assumes that the Company will continue to realize its assets and discharge its obligations and commitments in the normal course of operations. At June 30, 2019, the Company is in the research stage, has accumulated losses of $35,325,302 since its
inception and expects to incur further losses in the development of its business. The Company incurred a consolidated net loss of $1,766,205 during the six month period ended June 30, 2019. As at date of this report, the Company will require
additional funding to continue its research and development activities which may not be available, or available on acceptable terms. This will result in material uncertainties which casts substantial doubt about the Company’s ability to continue as a
going concern.
The Company’s ability to continue as a going concern is dependent upon its ability to generate future profitable operations and/or to obtain
the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. Management has a plan in place to address this concern and intends to obtain additional funds by equity financing
to the extent there is a shortfall from operations. While the Company is continuing its best efforts to achieve the above plans, there is no assurance that any such activity will generate funds for operations.
If the going concern assumptions were not appropriate for these condensed consolidated interim financial statements, then adjustments would
be necessary to the carrying value of assets and liabilities, the reported net loss and the financial position classifications used.
We anticipate that we will require a minimum of approximately $3,000,000 to proceed with a plan of operations for the twelve-month period
ended June 30, 2020 focused on (1) getting the RCI-02 device and consumables to market launch in Europe and Hong Kong, (2) getting to clinical trial approvals and preparations complete in Japan for RCS-01 and RCT-01, and (3) providing technology
transfer, training and other support to be ready for clinical trial launch of RCS-01 and RCT-01 in China with our partner, YOFOTO. It is anticipated that during this twelve month period, RepliCel will receive a $500,000 milestone payment from YOFOTO
for having received market approval for the device in Hong Kong.
12
The Company does not currently have sufficient capital resources to fund its full plan or operations for the next twelve months. Accordingly,
the Company plans to raise additional capital through the sale of debt or equity securities or through other forms of financing in order to raise the funds necessary to pursue the Company’s plan of operations. The Company currently does not have any
arrangements in place for the completion of any financings and there is no assurance that it will be successful in completing any financings. The Company is currently pursuing both dilutive and non-dilutive financing it expects will satisfy its
working capital requirements going forward. Non-dilutive funding includes grant funding and strategic partnerships involving product licenses to defined geographic markets and for specified applications. There can be no assurance that additional
financing will be available when needed or, if available, on commercially reasonable terms. If the Company is not able to obtain additional financing on a timely basis, it may not be able to pursue its plan of operations or meet its obligations as
they come due, and may be forced to scale down, or perhaps even cease, business operations. The Company is currently actively engaged in several due diligence reviews and partnership discussions. All such discussions involve the injection of new
capital into the Company.
Cash on hand and cash equivalents are currently the Company’s only source of liquidity. The Company does not have any lending arrangements in
place with banking or financial institutions and the Company does not know whether it will be able to secure such funding arrangements in the near future.
OUTSTANDING SHARE DATA
Common Shares Outstanding
As of August 23, 2019, there were 27,536,433 common shares issued and outstanding.
As of August 23, 2019, there were stock options entitling the holders to acquire an aggregate of 2,080,000 common shares.
As of August 23, 2019, there were share purchase warrants outstanding entitling the holders to acquire an aggregate of 3,793,184 common
shares.
As of August 23, 2019, there were no agent’s options outstanding.
RELATED PARTY TRANSACTIONS
Related Party Transactions
The following amounts due to related parties are included in trade payables and accrued liabilities:
|
|
June 30, 2019
|
December 31, 2018
|
||||||
|
Companies controlled by directors of the Company
|
$
|
7,512
|
$
|
214,361
|
||||
|
Directors or officers of the Company
|
80,650
|
512,140
|
||||||
|
|
$
|
88,162
|
$
|
726,501
|
||||
These amounts are unsecured, non-interest bearing and have no fixed terms of repayment.
Of the $349,555 debt settlement disclosed in note 7 b i) $277,719 belong to directors or officers of the Company and
were settled during the six month period ended June 30, 2019.
The Company incurred the following transactions with companies that are controlled by directors and/or officers of the
Company. The transactions were measured at the exchange amount which approximates fair value, being the amount established and agreed to by the parties.
13
|
|
Three months ended
|
Six months ended
|
||||||||||||||
|
|
30-Jun-19
|
30-Jun-18
|
30-Jun-19
|
30-Jun-18
|
||||||||||||
|
Research and development
|
$
|
17,499
|
$
|
30,000
|
$
|
64,866
|
$
|
60,000
|
||||||||
|
General and administration
|
-
|
9,000
|
-
|
18,000
|
||||||||||||
|
|
$
|
17,499
|
$
|
39,000
|
$
|
64,866
|
$
|
78,000
|
||||||||
OFF BALANCE SHEET ARRANGEMENTS
As at August 23 2019, the Company did not have any off-balance sheet arrangements, as defined by applicable securities regulators in Canada
and the United States that have, or are material effect on our results of operations or financial position.
PROPOSED TRANSACTIONS
None.
EVENTS AFTER REPORTING DATE
On May 6, 2019, the Company announced that it intended to conduct a non-brokered private placement offering (the “Offering”) of Class A
Preference Shares (each, a “Class A Share”). These Class A Shares were to carry initial certain rights and restrictions, which have been amended to comply with the requirements of the Toronto Venture Exchange (“TSXV”). The revised and finalized
Offering terms are as follows:
The offering of up to 6,250,000 Class A Shares at a price of $0.40 per Class A Share (the “Issue Price”) will be for aggregate gross proceeds
of up to $2,500,000. The Class A Shares carry certain rights and restrictions, which include:
|
•
|
a fixed dividend rate which shall accrue on a daily basis (based on a 360 day year consisting of 12 30-day months) at a rate of
seven (7%) per annum;
|
|
•
|
the right to convert the paid up amount of each Class A Share, from time-to-time, into shares of the Company (each, a “Share”) at
any time prior to the date that is five (5) years from the date of issuance of the Class A Shares at a conversion price that is equal to the greater of: (i) $0.33; and (ii) the Market Price (as defined in the policies of the TSX Venture
Exchange (“TSXV”)) at the date of such conversion;
|
|
•
|
voting rights only on matters pertaining to Class A Shares until they are converted to common shares at which time all voting
rights attach; and
|
|
•
|
a first priority over all Shares or shares of any other class of the Company as to dividends and upon liquidation.
|
Subject to the earlier conversion by Class A shareholders and compliance with applicable laws, the Company may, in its discretion at any
time, prior to the date that is five (5) years from the date of issuance of the Class A Shares (the “Required Redemption Date”) redeem all of the Class A Shares at a price (the “Redemption Price”) of:
|
(i)
|
$0.468 per Class A Share for the period from the date of issuance (the “Issue Date”) to the date that is the first anniversary of
the Issue Date;
|
|
(ii)
|
$0.536 for the period from the date that is the day after the first anniversary of the Issue Date to the date that is the second
anniversary of the Issue Date;
|
|
(iii)
|
$0.604 for the period from the date that is the day after the second anniversary of the Issue Date to the date that is the third
anniversary of the Issue Date;
|
|
(iv)
|
$0.672 for the period from the date that is the day after the third anniversary of the Issue Date to the date that is the fourth
anniversary of the Issue Date; and
|
|
(v)
|
$0.740 for the period from the date that is the day after the fourth anniversary of the Issue Date and the date that is the fifth
anniversary of the Issue Date.
|
14
On the Required Redemption Date, the Company must redeem all remaining outstanding Class A Shares at the Redemption Price, subject to
compliance with applicable laws.
Finder’s fees may be paid in connection with the Offering in accordance with the policies of the TSXV.
All of the Class A Shares issued, and any securities into which they may be exchanged or converted, are subject to resale restrictions
imposed by applicable law or regulation, a statutory hold period expiring four months and one day from the date of closing (the “Closing”). The Offering is subject to approval from the TSXV.
On August 20, 2019, the Company approved a loan from a director of the Company in the sum of $115,000 USD (“the Loan”) which will be
repayable in 30 days either by cash or shares. If the Company chooses to repay the Loan by way of shares, the share cost will be calculated by using the Loan amount divided by the closing price of the Company’s common shares at the time of the debt
conversion. If the Company chooses to pay the Loan amount in cash, the Company will return the amount in full by September 30, 2019 plus interest accrued at a 12% per annum interest rate.
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS
RepliCel Life Sciences Inc. makes estimates and assumptions about the future that affect the reported amounts of assets and liabilities.
Estimates and judgements are continually evaluated based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. In the future, actual experience may differ from
these estimates and assumptions.
The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the period of the
change, if the change affects that period only, or in the period of the change and future periods, if the change affects both.
Information about critical judgments in applying accounting policies that have the most significant risk of causing material adjustment to
the amounts reported in these financial statements are discussed below:
Share Based Payments
The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the
date at which they are granted. Estimating fair value for share-based payment transactions requires determining the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This estimate also requires
determining the most appropriate inputs to the valuation model including the expected life of the share option, volatility and dividend yield and making assumptions about them. The assumptions and models used for estimating the fair value for
share-based payment transactions are disclosed in Note 7(e) to the condensed consolidated interim financial statements.
Revenue Recognition
The Company applies the five-step model to contracts when it is probable that the Company will collect the
consideration that it is entitled to in exchange for the goods and services transferred to the customer. For collaborative arrangements that fall within the scope of IFRS 15, the Company applies the revenue recognition model to part or all of the
arrangement, when deemed appropriate. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of IFRS 15, to identify distinct performance obligations. The Company then recognizes as
revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Significant judgement is involved in determining whether the transaction price allocated to the
license fee should be recognized over the collaboration period or at the inception of the contract and the time period over which revenue is to be recognized.
RepliCel Life Sciences Inc. makes estimates and assumptions about the future that affect the reported amounts of assets and liabilities.
Estimates and judgements are continually evaluated based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. In the future, actual experience may differ from
these estimates and assumptions.
15
The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the period of the
change, if the change affects that period only, or in the period of the change and future periods, if the change affects both.
FINANCIAL INSTRUMENTS AND OTHER INSTRUMENTS
As at June 30, 2019, the Company’s financial instruments are comprised of cash and cash equivalents, and accounts payable and accrued
liabilities. The fair values of cash and cash equivalents, accounts payable and accrued liabilities approximate their carrying value due to their short-term maturity. The Company is exposed through its operations to currency, credit, liquidity and
interest rate risk.
In common with all other businesses, the Company is exposed to risks that arise from its use of financial instruments. For more information,
see the Company’s annual audited consolidated financial statements.
RISKS AND UNCERTAINTIES
Risks Relating to the Company’s Business
In addition to the other risks and uncertainties set out earlier in this MD&A, the Company is also exposed to the following risks and
uncertainties:
The Company currently does not generate recurring revenue from its operations, and as a result, it faces a high risk of
business failure.
The Company has generated $4,367,819 in licensing revenues from its operations to date. This revenue was the payment of an upfront fee of
$4,367,819 pursuant to a Collaboration and Technology Transfer Agreement with Shiseido and the License and Collaboration Agreement with YOFOTO. This revenue was not recurring revenue from its operations and the Company may not obtain similar revenue
in the future.
YOFOTO – License and Collaboration Agreement
The Company is exposed to certain risks that should YOFOTO not be obtain local regulatory approvals and therefore able to commercialize its
licensed products,
The deal structure also includes milestone payments (of up to CDN $4,750,000), sales royalties, and a commitment by YOFOTO to spend a minimum
of CDN $7,000,000 on the RepliCel programs and associated cell processing manufacturing facility over the next five years in Greater China pursuant to a License and Collaboration Agreement. The License and Collaboration Agreement contains a provision
permitting YOFOTO to put up to 1/3 of the shares issued in YOFOTO’s initial investment back to the Company under certain conditions for a period of 8.5 years from July 10, 2018.
Replicel is at risk of a possibility of YOFOTO not being able to discharge its obligations in the Agreement and thereby causing Replicel not
to receive its scheduled milestone payments. Should it be deemed not to be YOFOTO’s fault in not meeting its milestone targets, the Company may have the risk of having YOFOTO exercising its put options and have Replicel buy back 1/3 of the shares.
There is potentially risk of YOFOTO not protecting Replicel’s intellectual property in the Licensed Territory in the event an actual or
alleged infringement, by a third party, of the Licensed Technology or the Issued Patents or any right with respect to the Licensed Technology or the Issued Patents in the License Territory.
As of June 30, 2019, the Company had an accumulated deficit of $35,325,302 since inception. The Company’s business is focused on developing
autologous cell therapies that treat functional cellular deficits including chronic tendon injuries, androgenetic alopecia and skin aging. In order to generate revenues, the Company will incur substantial expenses in the development of its business.
The Company therefore expect to incur significant losses in the foreseeable future. The Company recognizes that if it is unable to generate significant revenues from its activities, the Company’s entire business may fail. There is no history upon
which to base any assumption as to the likelihood that the Company will be successful in its plan of operation, and the Company can provide no assurance to investors that it will generate operating revenues or achieve profitable operations in the
future.
16
The Company had cash and cash equivalents in the amount of $271,839 and a working capital deficit of $129,375 as of June 30, 2019 and the
Company anticipates that it will require $3,000,000 to proceed with its plan of operations focused on completing the RCI-02 device, meeting its obligations to support YOFOTO's activities in Greater China, and preparing for next-phase clinical
development and commercialization in Japan over the twelve-month period ended June 30, 2020.
In order to fund its plan of operations for the next twelve months, the Company may seek to sell additional equity or debt securities or
obtain a credit facility. The sale of convertible debt securities or additional equity securities could result in additional dilution to its shareholders. The incurrence of indebtedness would result in increased debt service obligations and could
result in operating and financing covenants that would restrict its operations and liquidity.
Management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern.
The Company has incurred a deficit of $35,325,302 for the cumulative period from September 7, 2006 (inception) to June 30, 2019. The Company
anticipates generating losses for at least the next 12 months. Therefore, there is substantial doubt about its ability to continue operations in the future as a going concern, as described in Note X of the Company’s condensed consolidated interim
financial statements. The Company’s financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts of and classification of liabilities that might be necessary in the event
that the Company cannot continue in existence. The Company’s business operations may fail if its actual cash requirements exceed its estimates and the Company is not able to obtain further financing. If the Company cannot continue as a viable entity,
its shareholders may lose some or all of their investment in the Company.
The Company’s business is at an early stage of development and difficulties obtaining regulatory approval, technical
deficiencies and other challenges may hinder the development and marketing of its autologous cell therapies.
The Company’s autologous cell therapy technology is at an early stage of development and the Company may not develop a cell replication
technology that can be commercialized. The Company is still in the early stages of identifying and conducting research on its technology. The Company’s technology will require significant research and development and preclinical and clinical testing
prior to regulatory approval, if required, being obtained in the United States or other countries. The Company may not be able to obtain regulatory approvals, if required, to complete necessary clinical trials for its cell replication technology, or
to commercialize it. The Company’s technology may prove to have undesirable and unintended side effects, or other characteristics adversely affecting its safety, efficacy or cost-effectiveness could prevent or limit its use. The Company’s technology
may fail to provide its intended benefit, or achieve benefits equal to or better than its competitor’s products at the time of testing or production and, if so, its business may fail.
The Company’s clinical trials may fail to produce successful results or could be suspended due to unacceptable safety
risks, which could cause its business to fail.
Clinical trials are subject to extensive regulatory requirements, and are very expensive, time-consuming and difficult to design and
implement, in part because they may be subject to rigorous regulatory requirements. The Company’s products may fail to achieve necessary safety and efficacy endpoints during clinical trials. The Company believes that its clinical trials will take a
substantial period of time to complete. Furthermore, failure can occur at any stage of the trials, and the Company could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be
delayed by several factors, including: unforeseen safety issues; lack of effectiveness during clinical trials; slower than expected rates of patient recruitment; and inability to monitor patients adequately during or after treatment. In addition, the
Company or regulatory officials may suspend the Company’s clinical trials at any time if it appears that the Company is exposing participants to unacceptable health risks. If the Company’s clinical trials fail to produce successful results, or are
suspended due to unacceptable safety risks, the Company’s business may fail.
17
The Company’s success depends on the acceptance of its cell replication technology by the medical community and consumers
as a safe and effective solution.
The success of its cell replication technology will depend on its acceptance by potential consumers and the medical community. Because its
technology is new in the treatment of functional cellular deficits including chronic tendon injuries, androgenetic alopecia and skin aging, the long term effects of using its new cell replication technology are unknown. The results of short-term
clinical trials do not necessarily predict long-term clinical benefit or reveal adverse effects. If results obtained from future commercial experience indicate that its cell replication technology is not as safe or effective as other treatments,
adoption of this technology by consumers and the medical community may suffer and its business will be harmed.
The Company faces significant competition and if it is unable to successfully compete, the Company’s business may suffer
a material negative impact.
The life sciences industry is highly competitive. The Company anticipates that it will continue to face increased competition as existing
companies develop new or improved products and as new companies enter the market with new technologies. Many of its competitors are significantly larger than us and have greater financial, technical, research, marketing, sales, distribution and other
resources than us. There can be no assurance that its competitors will not succeed in developing or marketing technologies and products that are more effective or commercially attractive than the products the Company is developing or that such
competitors will not succeed in obtaining regulatory approval, or introducing or commercializing any such products, prior to us. Such developments could have a material adverse effect on its business, financial condition and results of operations.
Also, even if the Company is able to compete successfully, there can be no assurance that it could do so in a profitable manner.
If the Company is not able to effectively protect its existing intellectual property, the Company’s business may suffer a
material negative impact and may fail.
The success of the Company will be dependent on its ability to protect and develop its technology. The Company currently has registered
patents for its cell replication technology in Australia, the United States, Japan and the European Union. If the Company is unable to protect its intellectual property, its business may be materially adversely affected. Further, the Company cannot
be sure that its activities do not and will not infringe on the intellectual property rights of others. If the Company is compelled to prosecute infringing parties, defend its intellectual property or defend itself from intellectual property claims
made by others, it may face significant expense and liability, as well as the diversion of management’s attention from the Company’s business, any of which could negatively impact its business or financial condition.
The actual protection afforded by a patent varies on a product-by-product basis, from country to country and depends on many factors,
including the type of patent, the scope of its coverage, the availability of regulatory related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patents. The Company’s ability to
maintain and solidify its proprietary position for its products will depend on its success in obtaining effective claims and enforcing those claims once granted. The Company’s registered patents and those that may be issued in the future, or those
licensed to us, may be challenged, invalidated, unenforceable or circumvented, and the rights granted under any issued patents may not provide us with proprietary protection or competitive advantages against competitors with similar products. The
Company also relies on trade secrets to protect some of its technology, especially where it is believed that patent protection is not appropriate or obtainable. However, trade secrets are difficult to maintain. While the Company uses reasonable
efforts to protect its trade secrets, its employees, consultants, contractors or scientific and other advisors may unintentionally or wilfully disclose the Company’s proprietary information to competitors. Enforcement of claims that a third party has
illegally obtained and is using trade secrets is expensive, time consuming and uncertain. In addition, non-U.S. courts are sometimes less willing than U.S. courts to protect trade secrets. If the Company’s competitors independently develop equivalent
knowledge, methods and know-how, the Company would not be able to assert its trade secrets against them and its business could be harmed.
18
The successful acquisition and maintenance of patent rights is critical to its business and any failure in this regard
could hinder the development and marketing of its technology.
The Company currently has patent applications pending in several other countries around the world. The Company’s pending patent applications
may not result in the issuance of any patents. The applications may not be sufficient to meet the statutory requirements for patentability in all cases or may be the subject of interference proceedings by patent offices. These proceedings determine
the priority of inventions and, thus, the right to a patent for technology. In the past, its patent applications have experienced delays and its patent applications may be delayed in the future. If others file patent applications or obtain patents
similar to those the Company has licensed, such patents may restrict the use of its discoveries. The Company cannot predict the ultimate scope and validity of existing patents and patents that may be granted to third parties, nor can it predict the
extent to which it may wish or be required to obtain licenses to use such patents, or the availability and cost of acquiring such licenses. To the extent that licenses are required, the owners of the patents could bring legal actions against us to
claim damages or to stop its manufacturing and marketing of the affected technology. If the Company becomes involved in patent litigation, it could consume a substantial portion of its resources.
The Company may be subject to changes and uncertainties in laws and government regulations.
The Company is subject to regulation by domestic and foreign governmental agencies with respect to many aspects of developing autologous cell
replication technology. In addition, relevant new legislation or regulation could occur. Any such new legislation or regulation, the application of laws and regulations from jurisdictions whose laws do not currently apply to the Company’s business,
or the application of existing laws and regulations to cell replication technology, could have a material adverse effect on the Company’s business, prospects, financial condition and results of operations.
Risks Relating to the Company’s Management
The Company is dependent on the services of certain key consultants and the loss of any of these key consultants may have
a materially adverse effect on the Company.
While engaged in the business of developing a new cell replication technology, the Company’s ability to continue to develop a competitive
edge in the marketplace will depend, in large part, on its ability to attract and maintain qualified key management personnel. Competition for such personnel is intense, and it may not be able to attract and retain such personnel. The Company’s
growth has depended, and in the future will continue to depend, on the efforts of its key management consultants. Loss of any of these people would have a material adverse effect on the Company. Currently, the Company does not have key-man life
insurance.
Conflicts of interest may arise as a result of the Company’s directors and officers being directors or officers of other
life sciences companies.
Certain of the Company’s directors and officers are, or may become, directors or officers of other life sciences companies. While the Company
is engaged in the business of developing a new autologous cell replication technology, such associations may give rise to conflicts of interest from time to time. The Company’s directors are required by law to act honestly and in good faith with a
view to the Company’s best interests and to disclose any interest that they may have in any project or opportunity. If a conflict of interest arises at a meeting of the Company’s board of directors, any director in a conflict must disclose his
interest and abstain from voting on such matter. In determining whether or not the Company will participate in any project or opportunity, the Company’s directors will primarily consider the degree of risk to which the Company may be exposed and its
financial position at the time.
The Company’s articles contain provisions indemnifying its officers and directors against all costs, charges and expenses
incurred by them.
The Company’s articles contain provisions limiting the liability of its officers and directors for all acts, receipts, neglects or defaults
of themselves and all of its other officers or directors or for any loss, damage or expense incurred by the Company which may happen in the execution of the duties of such officers or directors. Such limitations on liability may reduce the likelihood
of derivative litigation against the Company’s officers and directors and may discourage or deter its shareholders from suing the Company’s officers and directors based upon breaches of their duties to the Company, though such an action, if
successful, might otherwise benefit the Company and its shareholders.
19
As a majority of the Company’s directors and officers are residents of countries other than the United States, investors
may find it difficult to enforce, within the United States, any judgments obtained against the Company, directors and officers.
A majority of the Company’s directors and officers are nationals and/or residents of countries other than the United States, and all or a
substantial portion of such persons’ assets are located outside the United States. Consequently, it may be difficult for United States investors to effect service of process in the United States upon those directors or officers who are not residents
of the United States, or to realize in the United States upon judgments of United States courts predicated upon civil liabilities under United States legislation. There is substantial doubt whether an original action based solely upon such civil
liabilities could be brought successfully in Canada against any of such persons or the Company.
Risks Relating to the Company’s Common Stock
If the Company’s business is unsuccessful, its shareholders may lose their entire investment.
Although shareholders will not be bound by or be personally liable for its expenses, liabilities or obligations beyond their total original
capital contributions, should it suffer a deficiency in funds with which to meet its obligations, the shareholders as a whole may lose their entire investment in the Company.
Trading of the Company’s common shares on the OTCQB (operated by the OTC Markets Group) and the TSX Venture Exchange is
limited and sporadic, making it difficult for the Company’s shareholders to sell their shares or liquidate their investments.
The trading price of the Company’s common shares has been and may continue to be subject to wide fluctuations. The stock market has generally
experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of companies with little or no current business operations. There can be no assurance that trading prices and price
earnings ratios previously experienced by the Company’s common shares will be matched or maintained. These broad market and industry factors may adversely affect the market price of the common shares, regardless of the Company’s operating
performance. In the past, following periods of volatility in the market price of a company’s securities, securities class-action litigation has often been instituted. Such litigation, if instituted, could result in substantial costs for the Company
and a diversion of management’s attention and resources.
Investors’ interests in the Company will be diluted and investors may suffer dilution in their net book value per share
if it issues additional options to any of its officers, directors, employees or consultants.
Because the Company’s success is highly dependent upon its directors, officers and consultants, it has granted, and may again in the future
grant, options to some or all of its key officers, directors, employees and consultants to purchase its common shares as non-cash incentives. Options may be granted at exercise prices below that of its common shares prevailing in the public trading
market at the time or may be granted at exercise prices equal to market prices at times when the public market is depressed. To the extent that significant numbers of such options may be granted and exercised, the interests of the Company’s other
shareholders may be diluted.
Investors’ interests in the Company will be diluted and investors may suffer dilution in their net book value per share
if the Company issues additional shares or raises funds through the sale of equity securities.
In the event that the Company is required to issue additional shares in order to raise financing, investors’ interests in the Company will be
diluted and investors may suffer dilution in their net book value per share depending on the price at which such securities are sold. The dilution may result in a decline in the market price of the Company’s shares.
20
Penny stock rules limit the ability of the Company’s shareholders to sell their stock.
The Securities and Exchange Commission has adopted regulations which generally define “penny stock” to be any equity security that has a
market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. The Company’s securities are covered by the penny stock rules, which impose additional sales practice requirements
on broker-dealers who sell to persons other than established customers and accredited investors. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized
risk disclosure document in a form prepared by the Securities and Exchange Commission, which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with
current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and
offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer’s
confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for
the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the stock that is subject to these penny stock
rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade its securities.
The Financial Industry Regulatory Authority, or FINRA, has adopted sales practice requirements which may also limit a
shareholder’s ability to buy and sell the Company’s stock.
In addition to the “penny stock” rules described above, FINRA has adopted rules that require that in recommending an investment to a
customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable
efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities
will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy its common stock, which may limit your ability to buy and sell its stock and have an adverse effect
on the market for its shares.
The Company does not intend to pay dividends on any investment in the shares of stock of the Company.
The Company has never paid any cash dividends and currently do not intend to pay any dividends for the foreseeable future. To the extent that
the Company requires additional funding currently not provided for in its financing plan, its funding sources may prohibit the payment of a dividend. Because the Company does not intend to declare dividends, any gain on an investment in the Company
will need to come through an increase in the stock’s price. This may never happen and investors may lose all of their investment in the Company.
21
OTHER INFORMATION
The Company’s website address is www.replicel.com. Other information
relating to the Company may be found on SEDAR at www.sedar.com
BOARD APPROVAL
The board of directors of the Company has approved this MD&A.
22
Form 52-109FV2
Certification of Interim Filings
Venture Issuer Basic Certificate
I, Lee Buckler, President and Chief Executive Officer of RepliCel Life Sciences Inc., certify the following:
| 1. |
Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of RepliCel Life Sciences Inc., (the “issuer”) for the interim period ended June 30, 2019.
|
| 2. |
No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact
required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
|
| 3. |
Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present
in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
|
Date: August 23, 2019
/s/ Lee Buckler
Lee Buckler
President & Chief Executive Officer
RepliCel Life Sciences Inc.
NOTE TO READER
In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and
maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating
to the establishment and maintenance of
| i) |
controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or
other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
|
| ii) |
a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with the issuer’s GAAP.
|
The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support
the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined
in NI 52-109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.
Form 52-109FV2
Certification of Interim Filings
Venture Issuer Basic Certificate
I, Simon Ma, Chief Financial Officer of RepliCel Life Sciences Inc., certify the following:
| 1. |
Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of RepliCel Life Sciences Inc., (the “issuer”) for the interim period ended June 30, 2019.
|
| 2. |
No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact
required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
|
| 3. |
Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present
in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
|
Date: August 23, 2019
/s/ Simon Ma
Simon Ma
Chief Financial Officer
RepliCel Life Sciences Inc.
NOTE TO READER
In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and
maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating
to the establishment and maintenance of
| i) |
controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or
other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
|
| ii) |
a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with the issuer’s GAAP.
|
The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support
the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined
in NI 52-109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.
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