Renalytix plc Reports Financial Results for First Quarter of Fiscal Year 2025

News provided by

Nov 20, 2024, 07:00 ET

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:*

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 [email protected]
Paul McManus / Alice Woodings	Mob: 07980 541 893 / 07407 804 654

CapComm Partners
Peter DeNardo	Tel: 415-389-6400 or [email protected]

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)