LONDON and NEW
YORK, Nov. 20, 2024 /PRNewswire/ -- 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:
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Renalytix plc
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www.renalytix.com
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James McCullough,
CEO
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Via Walbrook PR
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Stifel (Nominated Adviser and Joint
Broker)
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Tel: 020 7710 7600
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Nicholas Moore / Nick
Harland / Ben Good
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Oberon Capital (Joint Broker)
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Tel: 020 3179 5300
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Mike Seabrook / Nick
Lovering
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Walbrook PR Limited
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Tel: 020 7933 8780 or
renalytix@walbrookpr.com
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Paul McManus / Alice
Woodings
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Mob: 07980 541 893 /
07407 804 654
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CapComm Partners
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Peter
DeNardo
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Tel: 415-389-6400 or
investors@renalytix.com
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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 bioprognosis™ 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)
|
|
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SOURCE Renalytix plc