Renalytix
plc
("Renalytix" or the
"Company")
Financial Results for First
Quarter of Fiscal Year 2025
LONDON and NEW YORK, 20 November, 2024 - Renalytix plc
(LSE: RENX) (OTCQB: RNLXY), an artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical
management of kidney disease to drive improved patient outcomes and
advance value-based care, reports its financial results for the
fiscal quarter of 2025 ended September 30, 2024.
First Quarter Fiscal 2025 and recent
highlights
•
|
Continued test ordering momentum at
a large New York-based physician group practice, after test
ordering and processing commenced in September 2024
|
•
|
Cash burn to be reduced to an
approximate run rate of £560,000
(approximately $725,000) or less per month by the end of fiscal
year 2025
|
•
|
Financing comprising £11.8m (approximately US$14.9 million after
expenses) in commitments completed subsequent to the end of the
quarter
|
•
|
Company believes that as of November
2024, it now has sufficient cash on the balance sheet to fund
current operations
|
•
|
Issued first guidance on multi-year
revenue generation: c. $3.2m in FY25, $8.5m in FY26 and $17.5m in
FY27
|
•
|
Accomplished life sciences industry
veteran Julian Baines MBE appointed as Executive
Chairman
|
James McCullough, CEO of Renalytix commented:
"We are pleased
to have positioned Renalytix financially and commercially for what
we believe will be an exciting fiscal year that represents a
breakout from our development phase into a commercially focused
business leveraging growth within the large and unaddressed market
we serve. Following our fundraise, for which we appreciate our
investors' support, we believe the wind is now behind our back and
we are excited to propel the Company's growth while supporting
better patient outcomes through adoption of our kidneyintelX.dkd
test by physicians and hospital systems."
First Quarter 2025 Financial Results
During the three months ended
September 30, 2024, the Company recognized $0.52 million of
revenue, compared to $0.46 million for the three months ended
September 30, 2023. Cost of revenue for the three months ended
September 30, 2024 and 2023, was $0.42 million and $0.50 million,
respectively.
Total operating expenses for the
three months ended September 30, 2024 were $4.2 million, and down
over 50% from $8.8 million during the prior year period.
Within operating expenses, research
and development expenses were $0.9 million for the three months
ended September 30, 2024, decreasing by $1.9 million from $2.8
million for the three months ended September 30, 2023. The decrease
was attributable to a decrease in external R&D projects and
studies, lower compensation and related benefits and a reduction in
operating expenses.
General and administrative expenses
were $3.3 million for the three months ended September 30, 2024,
decreasing by $2.8 million from $6.1 million for the prior year
period with the decrease driven by significant cost cutting
measures.
Net loss was $4.7 million for the
three months ended September 30, 2024, down over 50% from a net
loss of $10.1 million for the prior year period.
Cash and cash equivalents totaled
$0.9 million as of September 30, 2024.
Equity financing rounds, restructuring of liabilities and
reduction in expenses allow sufficient cash for at least next
twelve months
During October and November 2024 the
Company secured additional rounds of equity financing comprising
£11.8m (approximately US$14.9 million) in commitments and
concurrently restructured a number of liabilities on the balance
sheet. This additional equity funding, the reduction of cash
expenses related to the Company's liabilities, and an overall
reduction in General and Administrative Expenses have significantly
changed the Company's financial position relative to cash
needs. As a result, the Company believes that as of November
2024, it now has sufficient cash on the Balance Sheet to fund
current operations. While the possibility exists that the Company
may seek additional capital, it is not required to sustain current
operations for the next twelve months.
For further information,
please contact:
Renalytix plc
|
www.renalytix.com
|
James McCullough, CEO
|
Via Walbrook
PR
|
|
|
Stifel (Nominated Adviser and Joint Broker)
|
Tel: 020 7710
7600
|
Nicholas Moore / Nick Harland / Ben
Good
|
|
|
|
Oberon Capital (Joint Broker)
|
Tel: 020 3179
5300
|
Mike Seabrook / Nick
Lovering
|
|
|
|
Walbrook PR Limited
|
Tel: 020 7933
8780 or renalytix@walbrookpr.com
|
Paul McManus / Alice
Woodings
|
Mob: 07980
541 893 / 07407 804 654
|
|
|
CapComm Partners
|
|
Peter DeNardo
|
Tel:
415-389-6400 or investors@renalytix.com
|
|
| |
About Renalytix
Renalytix (LSE: RENX) (OTCQB: RNLXY)
is an artificial intelligence enabled in-vitro diagnostics and
laboratory services company that is the global founder and leader
in the field of bioprognosisâ„¢ for kidney health. In late 2023, our
kidneyintelX.dkd test was recognized as the first and only
FDA-authorized prognostic test to enable early-stage CKD (stages
1-3b) risk assessment for progressive decline in kidney function in
T2D patients. By understanding how disease will progress, patients
and clinicians can take action earlier to improve outcomes and
reduce overall health system costs. For more information,
visit www.renalytix.com.
Forward-Looking
Statements
This announcement (including any
information incorporated by reference in this announcement) and
other information published by the Company contain statements about
the Company that are or may be deemed to be forward looking
statements. Without limitation, any statements preceded or followed
by or that include the words "targets", "plans", "believes",
"expects", "aims", "intends", "will", "may", "anticipates",
"estimates", "projects" or words or terms of similar substance or
the negative thereof, may be forward looking statements.
These forward-looking statements are
not guarantees of future performance. Such forward-looking
statements involve known and unknown risks and uncertainties that
could significantly affect expected results and are based on
certain key assumptions. Many factors could cause actual results to
differ materially from those projected or implied in any
forward-looking statements. Due to such uncertainties and risks,
readers should not rely on such forward-looking statements, which
speak only as of the date of this announcement. The Company
disclaims any obligation or responsibility to update publicly or
review any forward-looking or other statements contained in this
announcement, except as required by applicable law.
The distribution of this
announcement in jurisdictions outside the United
Kingdom may be restricted by law and therefore persons into
whose possession this announcement comes should inform themselves
about, and observe, such restrictions. Any failure to comply with
the restrictions may constitute a violation of the securities law
of any such jurisdiction.
RENALYTIX
PLC
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)
|
|
For the Three Months Ended
September 30,
|
|
(in thousands, except share and per
share data)
|
|
2024
|
|
|
2023
|
|
Revenue
|
|
$
|
522
|
|
|
$
|
459
|
|
Cost of revenue
|
|
|
422
|
|
|
|
502
|
|
Gross profit (loss)
|
|
|
100
|
|
|
|
(43
|
)
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
|
|
921
|
|
|
|
2,787
|
|
General and
administrative
|
|
|
3,271
|
|
|
|
6,059
|
|
Total operating expenses
|
|
|
4,192
|
|
|
|
8,846
|
|
Loss from operations
|
|
|
(4,093
|
)
|
|
|
(8,889
|
)
|
|
|
|
|
|
|
|
Foreign currency gain,
net
|
|
|
37
|
|
|
|
289
|
|
Fair value adjustment to VericiDx
investment
|
|
|
97
|
|
|
|
(447
|
)
|
Fair value adjustment to convertible
notes
|
|
|
(762
|
)
|
|
|
(1,207
|
)
|
Other (expense) income,
net
|
|
|
(5
|
)
|
|
|
100
|
|
Net loss before income
taxes
|
|
|
(4,726
|
)
|
|
|
(10,154
|
)
|
Income tax expense
|
|
|
(2
|
)
|
|
|
-
|
|
Net loss
|
|
|
(4,728
|
)
|
|
|
(10,154
|
)
|
|
|
|
|
|
|
|
Net loss per ordinary
share-basic
|
|
$
|
(0.04
|
)
|
|
$
|
(0.11
|
)
|
Net loss per ordinary
share-diluted
|
|
$
|
(0.04
|
)
|
|
$
|
(0.11
|
)
|
Weighted average ordinary
shares-basic
|
|
|
105,697,401
|
|
|
|
94,767,841
|
|
Weighted average ordinary
shares-diluted
|
|
|
105,697,401
|
|
|
|
94,767,841
|
|
|
|
|
|
|
|
|
Other comprehensive income
(loss):
|
|
|
|
|
|
|
Changes in the fair value of the
convertible notes
|
|
|
(125
|
)
|
|
|
75
|
|
Foreign exchange translation
adjustment
|
|
|
(461
|
)
|
|
|
42
|
|
Comprehensive loss
|
|
$
|
(5,314
|
)
|
|
$
|
(10,037
|
)
|
RENALYTIX
PLC
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share and per
share data)
|
|
|
|
September 30,
2024
|
|
|
June 30,
2024
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
909
|
|
|
$
|
4,680
|
|
Accounts receivable, net
|
|
|
|
|
902
|
|
|
|
722
|
|
Prepaid expenses and other current
assets
|
|
|
|
|
1,068
|
|
|
|
716
|
|
Total current assets
|
|
|
|
|
2,879
|
|
|
|
6,118
|
|
Property and equipment,
net
|
|
|
|
|
202
|
|
|
|
216
|
|
Investment in VericiDx
|
|
|
|
|
776
|
|
|
|
698
|
|
Other assets, net
|
|
|
|
|
937
|
|
|
|
940
|
|
Total assets
|
|
|
|
$
|
4,794
|
|
|
$
|
7,972
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders'
Deficit
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$
|
3,188
|
|
|
$
|
1,590
|
|
Accounts payable - related
party
|
|
|
|
|
2,408
|
|
|
|
1,018
|
|
Accrued expenses and other current
liabilities
|
|
|
|
|
2,162
|
|
|
|
3,354
|
|
Accrued expenses - related
party
|
|
|
|
|
102
|
|
|
|
1,329
|
|
Current lease liability
|
|
|
|
|
11
|
|
|
|
45
|
|
Convertible notes-current
|
|
|
|
|
4,142
|
|
|
|
4,159
|
|
Total current liabilities
|
|
|
|
|
12,013
|
|
|
|
11,495
|
|
Convertible
notes-noncurrent
|
|
|
|
|
4,100
|
|
|
|
4,331
|
|
Total liabilities
|
|
|
|
|
16,113
|
|
|
|
15,826
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' deficit:
|
|
|
|
|
|
|
|
|
Ordinary shares, £0.0025 par value
per share: 173,841,695 shares
authorized; 165,925,513 and 154,368,191 shares issued
and
outstanding at September 30, 2024 and June 30, 2024,
respectively
|
|
|
|
|
515
|
|
|
|
478
|
|
Additional paid-in
capital
|
|
|
|
|
206,705
|
|
|
|
204,893
|
|
Accumulated other comprehensive
loss
|
|
|
|
|
(2,029
|
)
|
|
|
(1,443
|
)
|
Accumulated deficit
|
|
|
|
|
(216,510
|
)
|
|
|
(211,782
|
)
|
Total shareholders'
deficit
|
|
|
|
|
(11,319
|
)
|
|
|
(7,854
|
)
|
Total liabilities and shareholders'
deficit
|
|
|
|
$
|
4,794
|
|
|
$
|
7,972
|
|
RENALYTIX
PLC
CONSOLIDATED STATEMENTS OF
CASH FLOWS (Unaudited)
|
|
For the Three Months Ended
September 30,
|
|
(in
thousands)
|
|
2024
|
|
|
2023
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,728
|
)
|
|
$
|
(10,154
|
)
|
Adjustments to reconcile net loss to
net cash used in operating activities:
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
60
|
|
|
|
127
|
|
Stock-based compensation
|
|
|
254
|
|
|
|
523
|
|
Fair value adjustment to VericiDx
investment
|
|
|
(97
|
)
|
|
|
447
|
|
Realized loss on sale of ordinary
shares in VericiDx
|
|
|
42
|
|
|
|
-
|
|
Realized foreign exchange
gain
|
|
|
(18
|
)
|
|
|
-
|
|
Fair value adjustment to convertible
debt, net interest paid
|
|
|
762
|
|
|
|
945
|
|
Non cash lease expense
|
|
|
-
|
|
|
|
28
|
|
Provision for credit
losses
|
|
|
(25
|
)
|
|
|
-
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(154
|
)
|
|
|
(238
|
)
|
Prepaid expenses and other current
assets
|
|
|
(327
|
)
|
|
|
(153
|
)
|
Accounts payable
|
|
|
1,550
|
|
|
|
250
|
|
Accounts payable - related
party
|
|
|
1,390
|
|
|
|
202
|
|
Accrued expenses and other current
liabilities
|
|
|
(1,312
|
)
|
|
|
(2,060
|
)
|
Accrued expenses - related
party
|
|
|
(1,233
|
)
|
|
|
579
|
|
Net cash used in operating
activities
|
|
|
(3,836
|
)
|
|
|
(9,504
|
)
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
Sale of ordinary shares in VericiDx
investment
|
|
|
23
|
|
|
|
-
|
|
Net cash provided by investing
activities
|
|
|
23
|
|
|
|
-
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
Payment of convertible notes
principal
|
|
|
-
|
|
|
|
(1,060
|
)
|
Payment of offering costs
|
|
|
-
|
|
|
|
(5
|
)
|
Net cash used by financing
activities
|
|
|
-
|
|
|
|
(1,065
|
)
|
Effect of exchange rate changes on
cash
|
|
|
42
|
|
|
|
(222
|
)
|
Net decrease in cash and cash
equivalents
|
|
|
(3,771
|
)
|
|
|
(10,791
|
)
|
Cash and cash equivalents, beginning
of period
|
|
|
4,680
|
|
|
|
24,682
|
|
Cash and cash equivalents, end of
period
|
|
$
|
909
|
|
|
$
|
13,891
|
|
Supplemental noncash investing and
financing activities:
|
|
|
|
|
|
|
Noncash lease liabilities arising
from obtaining right-of-use assets
|
|
$
|
-
|
|
|
$
|
4
|
|
Cash paid for interest on
convertible debt
|
|
$
|
-
|
|
|
$
|
249
|
|
Issuance of shares for debt
repayment
|
|
$
|
(1,588
|
)
|
|
$
|
(1,054
|
)
|