Novoheart Holdings Inc.
(“
Novoheart” or the
“
Company”) reports financial
results for the three months ended March 31, 2020. Amounts, unless
specified otherwise, are expressed in Canadian dollars and are in
accordance with International Financial Reporting Standards (IFRS).
“Since the outbreak of COVID-19, the well-being
of our employees, partners and the communities we operate in has
been our primary focus. Where possible, our labs and offices remain
open and operational with appropriate measures in place to protect
the health and safety of our employees. As we face uncertain times,
I am proud of how the Novoheart team has remained agile and started
preparing early for the potential impacts to our business,” said
Dr. Ronald Li, Chief Executive Officer of Novoheart. “Novoheart
will continue to monitor the situation closely and optimize our
business during this unprecedented time.”
Business
Highlights:
- Ranked among the
TSV Venture Exchange’s (“TSX-V”) top 50 best performing
companies
- Entered into a
commercial agreement with a multinational company (“Multinational
Company”) to study the effects of cigarette smoke (“CS”) extract
and modified risk tobacco product (“MRTP”) extract on cardiac
contractility
- Successful outcome
of the initial commercial agreement with an international leading
gene-editing company (“Leading Gene-Editing Company”) led to a
second commercial agreement
Ranked among the TSX-V's top 50
best performing companies
On February 20, 2020, the Company announced that
it has been named a 2020 Venture 50 Company, ranked among the
TSX-V’s top 50 best performing companies.
The ranking comprised of ten companies from each
of the five key industry sectors. Novoheart was one of the ten best
performers within the Clean Technology and Life Sciences sector.
Ranking was based on three equally weighted criteria: market
capitalization growth, share price appreciation and trading
volume.
Entered into a commercial
agreement with a Multinational Company to study the effects of CS
extract and MRTP extract on cardiac
contractility
In March 2020, Novoheart signed a commercial
agreement with a Multinational Company, to study the effects of CS
extract and MRTP extract found in electronic cigarettes or e-vapor
products used as alternative to cigarettes for smokers who are
unable or unwilling to quit. Pursuant to the agreement, Novoheart
will perform research using the MyHeart™ Platform of
engineered human cardiac tissue models. This study will contribute
to a better understanding of the effects of CS and MRTP effects on
the heart as well as serve as a pilot study to evaluate the
feasibility of using in vitro assays as a means to align with the
principles of 3Rs (Replacement, Reduction and Refinement) for
performing animal-free research.
Successful outcome of the
initial commercial agreement with a Leading Gene-Editing Company
led to a second commercial agreement
Working with a Leading Gene-Editing Company,
Novoheart proposed a novel experimental approach to allow
differentiating the properties of engineered human ventricular
Cardiac Tissue Strips (“hvCTSs”) fabricated with cell lines derived
from healthy donors, from those fabricated with cell lines derived
from patients afflicted with a rare genetic disease that affects
the heart. The approach is expected to lead to the development of a
cardiac disease model that is a better predictor of clinical
outcome for these patients. Using this approach, Novoheart
successfully identified and differentiated hvCTS derived from
healthy donors from those derived from patients with the rare
genetic disease. Moreover, the study was performed blinded such
that the state of the donor material (healthy vs diseased) was
unknown to Novoheart, highlighting the potential importance of
using this novel approach in the future development of treatments
for this rare disease. Building on the initial success, a second
agreement was signed in April 2020 with the goal of further
refining and optimizing the experimental conditions in an effort to
prepare for a new set of studies. Notably, these studies include
recording contractions from patient-derived engineered cardiac
tissue strips that have been treated using a unique technology that
enables altering their genetic material in an effort to correct and
treat their disease.
Financial Results for the three
months ended March 31, 2020
The Company recorded a net loss after tax of
$2,833,246 (loss per share of $0.02) for the three months ended
March 31, 2020 compared to a net loss after tax of $1,179,198 (loss
per share of $0.01) for the three months ended March 31, 2019.
Revenue and Cost of Sales
For the three months ended March 31, 2020, the
Company recorded revenue of $10,120 and cost of sales of $3,854
compared to revenue of $107,955 and cost of sales of $49,123 for
the three months ended March 31, 2019. The decrease in revenue was
mainly due to delays in signing and executing commercial agreements
directly or indirectly related to COVID-19. Although the Company
has implemented business continuity measures to mitigate the impact
of COVID-19 on our operations, the global economic slowdown has
impacted a number of our partners (including shutdown of some of
their offices), which resulted in significant project delays.
Operating Expenses
Operating expenses for the three months ended
March 31, 2020 (“Q1 2020”) was $2,648,237 compared to $1,740,805
for the three months ended March 31, 2019 (“Q1 2019”). The increase
in operating expenses was due to the increases in general and
administrative expenses, research and development expenses, and
intellectual and patent expenses as compared to Q1 2019. The
increase was offset by the decrease of share-based compensation
expenses and depreciation expenses. The increase in general and
administrative expenses is primarily due to increases in occupancy
costs as a result of the lab and office expansion and build-out of
the GMP facility, increase in personnel costs resulting from the
increase in compensation, as well as the increase in professional
and regulatory fees due to the change in year-end and investor
relation activities compared to Q1 2019. Research and development
expenses increased primarily due to the expansion of the Company’s
scientific team and the acquisition of Xellera Therapeutics Limited
which was completed in June 2019.
Liquidity and Outstanding Share
Capital
As at March 31, 2020, the Company had cash and
cash equivalents of $16,119,530. As at May 19, 2020, there were
188,640,774 common shares issued and outstanding, and 8,611,123
common shares issuable upon the exercise of outstanding stock
options at an exercise price range from $0.32 to $0.50 per share
and the issuance of 120,000 vested restricted share units.
Results of Annual General
Meeting
Novoheart is pleased to announce the results of
its annual general meeting of shareholders held on April 29, 2020.
Shareholders elected eight directors to the Company’s board, being
Dr. Ronald Li, Dr. Camie Chan, Victor Chang, Ricky Chiu, Allen Ma,
Dr. Katherine Ngan, Roger Ngan and James Topham.
The shareholders also approved all other matters
proposed, including the appointment of BDO Limited as auditors of
the Company for the ensuing year, the re-approval of the Company’s
stock option plan and the approval of the Company’s amended
restricted share unit plan ( the “amended RSU Plan”), pursuant to
which 5,659,223 shares are reserved for issuance. In combination,
all share compensation arrangements of the Company, including the
amended RSU Plan, will not exceed 10% of the issued and outstanding
Common Shares. The amended RSU Plan has been accepted by the
TSX-V.
ABOUT NOVOHEART HOLDINGS
INC.
Novoheart is a global stem cell biotechnology
company that pioneers an array of next-generation human heart
tissue prototypes. It is the first company in the world to have
engineered miniature living human heart pumps that can
revolutionize drug discovery, helping to save time and money for
developing new therapeutics. Also known as 'human heart-in-a-jar',
Novoheart’s bio-artificial human heart constructs are created using
state-of-the-art and proprietary stem cell and bioengineering
approaches and are utilized by drug developers for accurate
preclinical testing as to the effectiveness and safety of new
drugs, maximizing the successes in drug discovery while minimizing
costs and harm caused to patients. With the acquisition of Xellera
Therapeutics Limited for manufacturing Good Manufacturing Product
(GMP)-grade clinical materials, Novoheart is now developing gene-
and cell-based therapies as well as other next-generation
therapeutics for cardiac repair or regeneration.
Common shares of Novoheart are traded on the TSX
Venture Exchange under the symbol “NVH”.
For further information please
contact:
Novoheart Holdings Inc.Suite 2600, 595 Burrard
StreetVancouver, British ColumbiaV7X 1L3
Ronald LiChief Executive Officer
(604) 398-3170info@novoheart.com
Cautionary Note Regarding
Forward-Looking Statements
Information set forth in this news release may
involve forward-looking statements under applicable securities
laws. Forward-looking statements are statements that relate to
future, not past, events. In this context, forward-looking
statements often address expected future business and financial
performance, and often contain words such as "anticipate",
"believe", "plan", "estimate", "expect", and "intend", statements
that an action or event "may", "might", "could", "should", or
"will" be taken or occur, or other similar expressions. All
statements, other than statements of historical fact, included
herein including, without limitation; statements about the
Company’s future plans, its goals and expectations, and the
potential applications its MyHeartTM platform are forward-looking
statements. By their nature, forward-looking statements involve
known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements, or other
future events, to be materially different from any future results,
performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among others, the
risks identified in the management discussion and analysis section
of Novoheart Holdings Inc.’s interim and most recent annual
financial statement or other reports and filings with the TSX
Venture Exchange and applicable Canadian securities regulators.
Forward-looking statements are made based on management's beliefs,
estimates and opinions on the date that statements are made and the
respective companies undertake no obligation to update
forward-looking statements if these beliefs, estimates and opinions
or other circumstances should change, except as required by
applicable securities laws. Investors are cautioned against
attributing undue certainty to forward-looking statements.
NOVOHEART HOLDINGS
INC.Condensed Consolidated Interim Statements of
Financial Position (unaudited)(Expressed in Canadian dollars)
|
|
March 31,
2020 |
|
|
December 31, 2019 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
16,119,530 |
|
$ |
12,167,583 |
|
Pledged bank deposit |
|
- |
|
|
5,004,000 |
|
Accounts and other receivables |
|
296,107 |
|
|
317,819 |
|
Prepaid expenses and deposits |
|
530,951 |
|
|
475,638 |
|
|
|
16,946,588 |
|
|
17,965,040 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
294,864 |
|
|
532,589 |
|
Right-of-use assets |
|
7,257,869 |
|
|
6,996,852 |
|
Intangible assets, net |
|
225,147 |
|
|
231,052 |
|
Construction in progress |
|
223,972 |
|
|
- |
|
Goodwill |
|
8,806,998 |
|
|
8,806,998 |
|
|
|
|
|
|
|
|
|
$ |
33,755,438 |
|
$ |
34,532,531 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
808,099 |
|
$ |
921,672 |
|
Lease liabilities – current |
|
1,290,058 |
|
|
1,124,678 |
|
Contract liabilities |
|
54,889 |
|
|
22,549 |
|
Deferred government grants |
|
3,168 |
|
|
8,253 |
|
Due to related parties |
|
- |
|
|
32,835 |
|
|
|
2,156,214 |
|
|
2,109,987 |
|
|
|
|
|
|
|
|
Lease liabilities –
non-current |
|
5,756,446 |
|
|
5,555,838 |
|
Restoration provision |
|
495,831 |
|
|
451,937 |
|
Long-term license payable |
|
26,592 |
|
|
24,238 |
|
|
|
|
|
|
|
|
|
|
8,435,083 |
|
|
8,142,000 |
|
|
|
|
|
|
|
|
Shareholders' Equity |
|
|
|
|
|
|
Share capital |
|
52,179,118 |
|
|
52,179,118 |
|
Contributed surplus |
|
2,097,581 |
|
|
1,888,156 |
|
Accumulated other comprehensive income |
|
1,866,272 |
|
|
312,627 |
|
Accumulated deficit |
|
(30,822,616 |
) |
|
(27,989,370 |
) |
|
|
25,320,355 |
|
|
26,390,531 |
|
|
|
|
|
|
|
|
|
$ |
33,755,438 |
|
$ |
34,532,531 |
|
|
NOVOHEART HOLDINGS
INC.Condensed Consolidated Interim Statements of
Loss and Comprehensive Loss (unaudited)(Expressed in Canadian
dollars, except number of common shares)
For the three months ended |
|
March 31, 2020 |
|
|
March 31, 2019 |
|
|
|
|
|
|
|
|
Revenue |
$ |
10,120 |
|
$ |
107,955 |
|
Cost of sales |
|
3,854 |
|
|
49,123 |
|
|
|
6,266 |
|
|
58,832 |
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
Research and development |
|
725,417 |
|
|
533,678 |
|
Intellectual property and patent |
|
153,771 |
|
|
62,393 |
|
General and administrative |
|
1,284,843 |
|
|
577,135 |
|
Marketing |
|
145,668 |
|
|
167,265 |
|
Share-based compensation |
|
209,425 |
|
|
232,107 |
|
Depreciation and amortization |
|
129,113 |
|
|
168,227 |
|
|
|
2,648,237 |
|
|
1,740,805 |
|
LOSS FROM OPERATIONS |
|
(2,641,971 |
) |
|
(1,681,973 |
) |
|
|
|
|
|
|
|
Government grants |
|
54,241 |
|
|
464,327 |
|
Other income |
|
75,558 |
|
|
187 |
|
Loss on disposal |
|
(185,692 |
) |
|
- |
|
Finance expense |
|
(107,905 |
) |
|
(449 |
) |
Foreign exchange gain |
|
2,902 |
|
|
38,710 |
|
|
|
(160,896 |
) |
|
502,775 |
|
|
|
|
|
|
|
|
NET LOSS FOR THE PERIOD BEFORE
TAX |
$ |
(2,802,867 |
) |
$ |
(1,179,198 |
) |
|
|
|
|
|
|
|
Tax expense |
|
30,379 |
|
|
- |
|
|
|
|
|
|
|
|
NET LOSS FOR THE PERIOD |
$ |
(2,833,246 |
) |
$ |
(1,179,198 |
) |
|
|
|
|
|
|
|
OTHER COMPREHENSIVE
INCOME/(LOSS) |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
1,553,645 |
|
|
(36,436 |
) |
|
|
|
|
|
|
|
COMPREHENSIVE LOSS FOR
THE PERIOD |
$ |
(1,279,601 |
) |
$ |
(1,215,634 |
) |
|
|
|
|
|
|
|
Loss per share – Basic and
Diluted |
$ |
(0.02 |
) |
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding –
basic and diluted |
|
188,640,774 |
|
|
94,581,937 |
|
|
NOVOHEART HOLDINGS
INC.Condensed Consolidated Interim Statements of
Cash Flows (unaudited)(Expressed in Canadian dollars)
|
|
|
|
|
|
|
For the three months ended |
|
March 31, 2020 |
|
|
March 31, 2019 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES |
|
|
|
|
|
|
Net loss for the period after tax |
$ |
(2,833,246 |
) |
$ |
(1,179,198 |
) |
Items not affecting cash: |
|
|
|
|
|
|
Share-based compensation |
|
209,425 |
|
|
232,107 |
|
Lease liabilities interests |
|
107,905 |
|
|
- |
|
Amortization of right-of-use assets |
|
395,587 |
|
|
- |
|
Depreciation and amortization |
|
129,113 |
|
|
168,227 |
|
Loss on disposal |
|
185,692 |
|
|
- |
|
|
|
(1,805,524 |
) |
|
(778,864 |
) |
Changes in non-cash working capital items: |
|
|
|
|
|
|
Decrease / (increase) in accounts and other receivables |
|
49,591 |
|
|
(14,801 |
) |
Increase in prepaid expenses and deposits |
|
(19,358 |
) |
|
(26,749 |
) |
Decrease in accounts payable and accrued liabilities |
|
(113,864 |
) |
|
(400,545 |
) |
Decrease in due to related parties |
|
(34,043 |
) |
|
(10,147 |
) |
Decrease in deferred government grants |
|
(5,564 |
) |
|
(5,678 |
) |
Increase in contract liabilities |
|
28,497 |
|
|
529,076 |
|
|
|
(94,741 |
) |
|
71,156 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
(1,900,265 |
) |
|
(707,708 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES |
|
|
|
|
|
|
Acquisition of equipment |
|
(14,432 |
) |
|
(2,534 |
) |
Acquisition of construction in progress |
|
(211,692 |
) |
|
- |
|
Decrease in pledged bank deposit |
|
5,004,000 |
|
|
- |
|
|
|
|
|
|
|
|
Net cash generated from / (used in) investing activities |
|
4,777,876 |
|
|
(2,534 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES |
|
|
|
|
|
|
Proceeds from loans |
|
- |
|
|
847,000 |
|
Payment of lease liabilities and interests |
|
(375,237 |
) |
|
- |
|
|
|
|
|
|
|
|
Net cash (used in) / generated from financing activities |
|
(375,237 |
) |
|
847,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in cash and cash equivalents during the
period |
|
2,502,374 |
|
|
136,758 |
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash held in a foreign
currency |
|
1,449,573 |
|
|
(50,780 |
) |
Cash and cash equivalents, beginning of period |
|
12,167,583 |
|
|
666,494 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of
period |
$ |
16,119,530 |
|
$ |
752,472 |
|
|
|
|
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