6-K/A
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K/A

Amendment No. 1

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

Date of report: April 29, 2022

Commission File Number: 001-39387

 

 

Renalytix plc

(Translation of registrant’s name into English)

 

 

Finsgate

5-7 Cranwood Street

London EC1V 9EE

United Kingdom

(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 ☐ 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): ☐

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): ☐

 

 

 


 

EXPLANATORY NOTE

This Amendment No. 1 (“Amendment No. 1”) to the Report on Form 6-K of Renalytix plc for the quarter ended December 31, 2021 (the “Form 6-K”), which was originally filed with the U.S. Securities and Exchange Commission on March 31, 2022, is being filed for the purpose of filing a revised version of Exhibit 99.1 which contains interactive data files in inline eXtensible Business Reporting Language (iXBRL).

Except as described above, Amendment No. 1 speaks as of the original filing date of the Form 6-K and does not amend, update or restate any information set forth in the Form 6-K or reflect any events that occurred subsequent to the original filing date of the Form 6-K.

EXHIBIT INDEX

 

Exhibit

 

Description

 

 

99.1

 

Press release dated March 31, 2022.

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

101.PRE

 

Inline VBRL Taxonomy Extension Presentation Linkbase Document

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 

 

 

 

 

 

 


 

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.

 

RENALYTIX PLC

 

 

By:

 

/s/ James McCullough

 

 

James McCullough

 

 

Chief Executive Officer

Date: April 29, 2022


https://cdn.kscope.io/ee3639639ead8d053644c90f65827650-img82659502_0.jpg 

Exhibit 99.1

Renalytix plc

(“Renalytix” or the “Company”)

 

Renalytix Reports Financial Results for Second Quarter of Fiscal Year 2022

 

LONDON and SALT LAKE CITY, March 31, 2022 – Renalytix plc (NASDAQ: RNLX) (LSE: RENX), 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, today reported financial results for the quarter ended December 31, 2021.

 

Recent Highlights

Quarter over quarter growth in KidneyIntelX testing volume
Quarter over quarter growth in active physicians ordering KidneyIntelX
KidneyIntelX now on-line with the Veterans Administration health system (VHA), New York physician led payor program CDPHP, Wake Forest Baptist Health and Atrium Health system
Singing River Health System partnership to deploy KidneyIntelX informed care management to improve kidney health in individuals across the Mississippi Gulf Coast with type 2 diabetes and early-stage chronic kidney disease
Hired, trained, and deployed regional sales managers, sales representatives and medical science liaisons to support KidneyIntelX physician onboarding, education and test ordering
Launch of myIntelX national provider access portal for on-line ordering of KidneyIntelX
Renalytix is now registered as a vendor to provide KidneyIntelX testing services at 16 VHA health centers, with additional health centers expected this calendar year
Continued insurance payment expansion for KidneyIntelX testing services helping ensure patients have access to advanced risk assessment regardless of economic status
22 private insurance coverage contracts now executed, including the first regional Blue Cross Blue Shield plans, with additional coverage contracts expected this calendar year
31 state Medicaid programs now contracted with additional states expected this calendar year
Salt Lake and New York laboratories built and operate to most rigorous standards; CLIA certified, CAP accredited, ISO certified and U.S. Food and Drug Administration compliant
Joint program with American Diabetes Association® to improve overall kidney health in patients with type 2 diabetes in the United States
Launching regionally focused early state kidney disease education programs in partnership with the National Kidney Foundation
Published data in the American Journal of Nephrology demonstrating KidneyIntelX successfully monitored patient response to new drug therapy in 1,325 multinational clinical trial cohort patients
World Congress of Nephrology data showing KidneyIntelX predicts the future rate of decline in kidney function compared with current standard diagnostics in patients with early-stage chronic kidney disease and type 2 diabetes

 

Second Quarter 2022 Financial Results

During the three months ended December 31, 2021, the Company recognized $0.8 million of revenue (Q2 FY21: $0.4 million). Cost of revenue for the three months ended December 31, 2021 was $0.5 million (Q2 FY21: $0.3 million).

Operating expense for the three months ended December 31, 2021 was $14.1 million compared to $8.8 million during the prior year period.

 

 


Within operating expenses, Research and development expenses were $4.1 million for the three months ended December 31, 2021, an increase of $1.6 million, from $2.5 million for the three months ended December 31, 2020. The increase was driven by employee related expenses and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

General and administrative expenses were $10.1 million for the three months ended December 31, 2021, increasing by $3.5 million from $6.6 million for the three months ended December 31, 2020. The increase was primarily due to a $1.7 million increase in compensation and related benefits, including share-based payments, due to increased headcount, a $1.1 million increase in consulting and professional fees including marketing expense, a $0.3 million related to employee expenses, a $0.2 million increase in computers, software and IT costs, and a $0.2 million increase in other operating expenses.

Net loss attributable to ordinary shareholders was $15.3 million for the three months ended December 31, 2021 compared to $8.9 million for the prior year period.

Cash and cash equivalents totaled $39.9 million as of December 31, 2021.

 

The Company will host a corresponding conference call and live webcast today to discuss the financial results and key topics including business strategy, partnerships and regulatory and reimbursement processes, at 8:30 a.m. (ET) / 1:30 p.m. (GMT).

Conference Call Details:
US/Canada Participant Toll-Free Dial-In Number: (833) 614-1551
US/Canada Participant International Dial-In Number: (914) 987-7290
United Kingdom International Dial-In Number: 0800 0288 438
United Kingdom Local Dial-In Number: 0203 1070 289
Conference ID: 6597955

Webcast Registration link: https://edge.media-server.com/mmc/p/hu7xau2s

For further information, please contact:

 

Renalytix plc

www.renalytix.com

James McCullough, CEO

Via Walbrook PR

 

 

Stifel (Nominated Adviser, Joint Broker)

Tel: 020 7710 7600

Alex Price / Nicholas Moore

 

 

 

Investec Bank plc (Joint Broker)

Tel: 020 7597 4000

Gary Clarence / Daniel Adams

 

 

 

Walbrook PR Limited

Tel: 020 7933 8780 or renalytix@walbrookpr.com

Paul McManus / Lianne Cawthorne

Mob: 07980 541 893 / 07584 391 303

 

 

CapComm Partners

 

Peter DeNardo

 

Tel: 415-389-6400 or investors@renalytix.com

 

About KidneyIntelX

KidneyIntelX, is a first-of-kind decision support and implementation platform that facilitates the identification and promotes the effective management of patients at risk of early-stage diabetic kidney disease, or DKD, progression by combining diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, using a proprietary algorithm to generate a unique patient risk score. This patient risk score enables prediction of progressive decline in kidney function, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

 

 

 


About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is the global founder and leader in the new field of bioprognosis™ for kidney health. The company has engineered a new solution that successfully enables early-stage CKD progression risk assessment. The Company’s lead product, KidneyIntelX, has been granted Breakthrough Designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery (visit www.kidneyintelx.com). For more information, visit www.renalytix.com.

 

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the commercial prospects of KidneyIntelX, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, the rate of testing with KidneyIntelX in health care systems, expectations and timing of announcement of real-world testing evidence, the potential for KidneyIntelX to be approved for additional indications, our expectations regarding regulatory and reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual report on Form 20-F filed with the SEC on October 21, 2021, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

 

 

 


RENALYTIX PLC

 

Operational Update and Financial Results for the three and six months ended December 31, 2021

 

Unless otherwise indicated, all references in this report, to the terms “Renalytix,” “Renalytix plc,” “the company,” “we,” “us” and “our” refer to Renalytix plc together with its subsidiaries. We recommend that you read the discussion below together with our audited financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended June 30, 2021, filed with the Securities and Exchange Commission on October 21, 2021 (our “Annual Report”).

 

The statements in this discussion regarding our expectations regarding our market opportunity, regulatory approval and future performance, as well as all other non-historical statements are forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report and any subsequent reports that we file with the SEC. See also the section titled “Forward-Looking Statements” above.

 

OPERATIONAL REVIEW

About Renalytix

At Renalytix, we are helping lead the charge to introduce simple, more accurate prognosis and effective care management for the estimated 850 million people worldwide with chronic kidney disease. In the United States alone, chronic kidney disease affects close to an estimated 40 million people and is responsible for one of the largest cost drivers in the national medical system. Early identification, prognosis and treatment beginning with primary care physicians is essential if we are to stem the growing social cost and suffering associated with kidney disease.

With our lead product, KidneyIntelX, our goal is to shift the conversation from kidney disease to kidney health through a more accurate understanding of early-stage risk. With the deployment of KidneyIntelX this year, Renalytix has become global leader in the new field of bioprognosis, a biology-driven approach to risk assessment that relies on integrating information from a simple blood draw and a patient’s health record to produce an accurate picture of kidney health. A doctor can use KidneyIntelX results to act on patients at high risk of kidney disease progression or failure at an early stage where active management and therapeutics have the best opportunity to impact outcomes and cost before it is too late.

We have crossed key data, reimbursement and regulatory hurdles during a relatively short time-period since we began operations in 2018 through a public listing on AIM, a market of the London Stock Exchange. We subsequently expanded our capital base by raising a further $17 million in July 2019 and then an additional $85 million through a listing on the Nasdaq Global Market in July 2020. The commercial roll-out of our kidney health solution, KidneyIntelX, is underscored by:

A 10-year government-wide contract with the U.S. General Services Administration at $950 per test
Hiring of sales, medical science liaison, and customer service support for national coverage
The Centers for Medicare & Medicaid Services awarding a national price of $950 per test
31 state Medicaid program authorization contracts
Launch of myIntelX national provider access portal for on-line ordering of KidneyIntelX
Partnerships announced with the Mount Sinai Health System, University of Utah, Atrium Health, Wake Forest Baptist Health, Capital District Physicians’ Health Plan (CDPHP), St. Joseph's Health and Singing River Health System
New York State Department of Health approval
A distinct Common Procedural Terminology (CPT) Code for reimbursement granted by the American Medical Association

 

 


22 private payor coverage determinations
Multi-center, peer reviewed clinical studies validating the clinical effectiveness and utility dynamics of KidneyIntelX for identifying patients at high risk for rapid kidney disease progression and/or kidney failure in the earliest stages of kidney disease

About KidneyIntelX

Our novel platform, KidneyIntelX, uses a machine-learning enabled algorithm to process predictive blood biomarkers with key features from a patient’s health record to generate an early and accurate kidney health risk score. The score identifies those patients at the most risk for kidney disease progression and/or failure and further guides ongoing clinical decisions.

KidneyIntelX is initially indicated for use with adults who have diagnosed kidney disease and diabetes – diabetic kidney disease or DKD. Future KidneyIntelX products in development intend to expand the indicated uses to include broader chronic kidney disease, health equity strategies and kidney health monitoring through treatment. Diabetes is the leading cause of chronic kidney disease, representing nearly 40%, and DKD patients are the highest contributors to emergency room dialysis. Unfortunately, many DKD patients are unaware that they either have kidney disease or that their disease has been progressing, often uncontrolled, for many years and now find themselves making difficult decisions about late-stage treatments. We believe this predicament is largely avoidable and have built the KidneyIntelX care model to ultimately provide the estimated 210,000 primary care physicians in the United States with a comprehensive suite of information and guidelines driven follow-on action.

KidneyIntelX was designed as an expandable platform which is able to add indicated uses and a monitoring capability, all within an FDA regulated framework. Expansion may include extending into additional populations of chronic kidney disease patients beyond those with diabetes, including patients of African ancestry with the APOL1 high-risk genotype. We also intend to develop solutions for use in other large chronic disease patient populations, like cardiovascular disease.

Operational Progress

Renalytix is pleased to report quarter over quarter KidneyIntelX testing volume growth under a backdrop of increasing insurance payment and new medical systems coming on-line. In our New York launch market, KidneyIntelX utilization has continued to accelerate through the end of March. We have now provided integrated advanced risk assessment services for over 2,600 patients with kidney disease and diabetes. In addition, over the past six months KidneyIntelX clinical testing has now been brought on-line within the Veterans Administration health system, our Albany New York physician led payor partner, Atrium Health and Wake Forest Baptist Health in the Southeast. We now estimate the our current serviceable, patient population with insurance payment availability for KidneyIntelX testing at greater than one million.

Our commercial focus in calendar year 2022 remains on regions where our health system partnerships provide a base for adoption of KidneyIntelX testing. As of the end of March 2022, we have four regional sales managers and 12 account executives focused on the Veterans Health Administration. We have also added a regional manager and three sales executives focused on the New York market. This sales effort is being complemented by a medical education effort led by a team of seven medical liaisons and our partnership with the National Kidney Foundation to offer chronic kidney disease education nationally. We expect additional health providers to be brought on-line in the next few months, including recently announced St. Josephs Health in central New York State and now expect to exceed 20 health centers running KidneyIntelX patient risk assessment in calendar 2022.

Reimbursement and Regulatory

Insurance payment remains the biggest factor to driving KidneyIntelX adoption and revenue growth. Over the past year, we have consistently demonstrated that we can secure payment for KidneyIntelX from a diverse set of insurance sources. To date, we have received 22 private insurance coverage contracts, and contracted with 31 state Medicaid programs. Our $950 reportable pricing structure has been established by National Medicare and a 10-year government contract covering, among others, payment for patient testing in the VA Medical system.

Under our real-world evidence study program with Mount Sinai Health System, several metrics are pointing to greater efficiencies being achieved with KidneyIntelX physician onboarding, including the fact that time to first KidneyIntelX order from education/training has dropped to three days currently from eleven days in our fiscal second quarter.

 

 


Our partnership model with Mount Sinai Health System under our real-world evidence study program is validating the engagement of population health departments and KidneyIntelX electronic health record integration to improving primary care physician access to advanced prognosis in kidney disease. The advantages of an integrated KidneyIntelX solution in a large hospital system include 1) broad physician education and care pathway support, 2) electronic test ordering and reporting, 3) advanced data analytics, 4) patient education and support.

Our laboratory testing infrastructure and personnel include the capacity to scale efficiently as distribution opportunities expand in fiscal 2022 and 2023. We have now achieved CAP Accreditation and ISO Certification for both Salt Lake City and New York City laboratories, all important parts to expand testing services and qualify for certain reimbursement.

Continuing to build a robust peer-reviewed published data pool is a compelling driver for payer and market adoption. In January, data was published in American Journal of Nephrology demonstrating the value of KidneyIntelX for monitoring patient response to new drug therapy in 1,325 multinational clinical trial cohort patients. And in February, at the World Congress of Nephrology, we provided results demonstrating KidneyIntelX provides robust prognostic information to better predict the future rate of decline in kidney function compared with current standard diagnostics in patients with early-stage chronic kidney disease and type 2 diabetes.

Current trading and outlook

We reported testing revenues of $0.7 million in Q2. This compares favorably with revenues from Q1 of $0.5 million. Volumes with Mount Sinai have continued to increase into Q3 and we anticipate test volume to strengthen further as we progress through the remainder of the fiscal year. As additional hospital systems begin to come on stream into fiscal 2023 and beyond, we anticipate corresponding increases in testing volumes.

In the fiscal second quarter, we made a number of one-time investments pertaining to the recruiting, equipping, training and deploying of our salesforce, and associated marketing and other expenses to enable them to be most successful in the field. We are happy with the sales infrastructure we now have in place to pursue the large VA and commercial hospital revenue that is available to us. Much of this is included in one-time expenses that are not repeating, and indeed our quarterly burn rate is already reduced versus fiscal Q2, and we plan to exercise continued prudent cash discipline

FINANCIAL REVIEW

Financial review of the three-month period ended December 31, 2021

Our operating loss for the three months ended December 31, 2021, was $13.8 million (December 31, 2020: $8.6 million) and the net loss attributable to ordinary shareholders for the three months ended December 31, 2021, was $15.3 million (December 31, 2020: $9.1 million).

Revenue

During the three months ended December 31, 2021, we recognized $0.7 million of revenue related to KidneyIntelX testing and $0.2 million of revenue related to services performed for AstraZeneca. There was $0.4 million of pharmaceutical services revenue for the three months ended December 31, 2020.

Cost of Revenue

During the three months ended December 31, 2021, cost of revenue consisted of $0.5 million primarily attributable to KidneyIntelX testing, including labor and materials costs directly related to revenue generating activities. There was $0.3 million of cost of revenue for the three months ended December 31, 2020.

Research and Development Costs

Research and development expenses increased by $1.6 million, from $2.5 million for the three months ended December 31, 2020 to $4.1 million for the three months ended December 31, 2021. The increased R&D expense was driven by employee related expenses and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

 

 


General and Administrative Costs

General and administrative expenses increased by $3.5 million, from $6.6 million for the three months ended December 31, 2020 to $10.1 million for the three months ended December 31, 2021. The increase was primarily due to a $1.7 million increase in compensation and related benefits, including share-based payments, due to increased headcount, a $1.1 million increase in consulting and professional fees including marketing expense, a $0.3 million increase related to employee expenses, a $0.2 million increase in computers, software and IT costs, and a $0.2 million increase in other operating expenses.

Performance of Contract Liability to Affiliate

In May 2020, we and the Icahn School of Medicine at Mount Sinai entered into an operating agreement to form a joint venture, Kantaro Biosciences LLC, or Kantaro, for the purpose of developing and commercializing laboratory tests for the detection of antibodies against SARS-CoV-2 originally developed by Mount Sinai. During the three months ended December 31, 2021, we recognized $0.1 million of expense related to the performance of our contract liability with Kantaro compared to $0.3 million during the three months ended December 31, 2020. This represents the allocation of costs related to performing services on behalf of Kantaro.

Foreign Currency Loss

During the three months ended December 31, 2021, we recorded an unrealized foreign exchange loss of $0.2 million primarily attributable to intercompany loans and cash balances denominated in currencies other than the functional currency. We recorded a foreign currency loss of $5.5 million during the three months ended December 31, 2020.

Fair Value Adjustments to VericiDx Investment

We account for our investment in VericiDx using the equity method of accounting and have elected to use the fair value option to value the investment. During the three months ended December 31, 2021, we recorded a loss of $1.4 million to adjust the VericiDx investment to fair value. We recorded a gain of $5.0 million during the three months ended December 31, 2020.

Financial review of the six months ended December 31, 2021

Our operating loss for the six months ended December 31, 2021, was $25.6 million (December 31, 2020: $14.0 million) and the net loss attributable to ordinary shareholders for the six months ended December 31, 2021, was $25.4 million (December 31, 2020: $16.1 million).

Revenue

During the six months ended December 31, 2021, we recognized $1.1 million of revenue related to KidneyIntelX and $0.2 million of revenue related to services performed for AstraZeneca. There was $0.4 million of pharmaceutical services revenue for the six months ended December 31, 2020.

Cost of Revenue

During the six months ended December 31, 2021, cost of revenue consisted of $0.7 million primarily attributable to KidneyIntelX testing, including labor and materials costs directly related to revenue generating activities. There was $0.3 million of cost of revenue for the six months ended December 31, 2020.

Research and Development Costs

Research and development expenses increased by $3.9 million, from $4.2 million for the six months ended December 31, 2020 to $8.1 million for the six months ended December 31, 2021. The increased R&D expense was driven by employee related expenses and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

 

 


General and Administrative Costs

General and administrative expenses increased by $7.5 million, from $10.7 million for the six months ended December 31, 2020 to $18.2 million for the six months ended December 31, 2021. The increase was primarily due to a $3.9 million increase in compensation and related benefits, including share-based payments, due to increased headcount, a $2.0 million increase in consulting and professional fees including marketing expense, a $0.7 million increase in computers, software and IT costs, a $0.5 million increase related to employee expenses, a $0.1 million increase in insurance expense, and a $0.3 million increase in other operating expenses.

Performance of Contract Liability to Affiliate

In May 2020, we and the Icahn School of Medicine at Mount Sinai entered into an operating agreement to form a joint venture, Kantaro Biosciences LLC, or Kantaro, for the purpose of developing and commercializing laboratory tests for the detection of antibodies against SARS-CoV-2 originally developed by Mount Sinai. During the six months ended December 31, 2021, we recognized $0.1 million of expense related to the performance of our contract liability with Kantaro compared to $0.8 million during the six months ended December 31, 2020. This represents the allocation of costs related to performing services on behalf of Kantaro.

Foreign Currency Gain (Loss)

During the six months ended December 31, 2021, we recorded an unrealized foreign exchange gain of $2.1 million primarily attributable to intercompany loans and cash balances denominated in currencies other than the functional currency. We recorded a foreign currency loss of $7.7 million during the six months ended December 31, 2020.

Fair Value Adjustments to VericiDx Investment

We account for our investment in VericiDx using the equity method of accounting and have elected to use the fair value option to value the investment. During the six months ended December 31, 2021, we recorded a loss of $2.0 million to adjust the VericiDx investment to fair value. We recorded a gain of $5.0 million during the six months ended December 31, 2020.

Cash Flows

Net cash used in operating activities

During the six months ended December 31, 2021, net cash used in operating activities was $24.7 million and was primarily attributable to our $25.4 million net loss including $2.3 million in noncash charges and a $1.6 million net change in our operating assets and liabilities. The change in our operating assets and liabilities was primarily attributable to a $2.5 million increase in prepaid expenses and other current assets offset by a $1.4 million decrease in accounts payable and accrued expenses. Noncash charges were primarily related to $1.9 million in share-based compensation and the $2.0 million fair value adjustment of our Verici securities, offset by a $1.9 million unrealized foreign exchange gain.

During the six months ended December 31, 2020, we used $18.6 million of cash in operating activities primarily attributable to our net loss of $16.7 million. This use of cash was partially offset by $0.9 million in noncash items such as share-based compensation and the fair value adjustment of our Verici securities. The net cash outflow of $2.7 million from changes in our operating assets and liabilities was primarily attributable to a $3.2 million increase in our prepaid expenses, partially offset by an increase in accrued expenses and other current liabilities of $1.3 million.

Net cash used in investing activities

During the six months ended December 31, 2021, net cash used in investing activities was $0.4 million, primarily attributable to $0.3 million for purchases of lab and office equipment and $0.1 million in software development costs.

During the six months ended December 31, 2020, net cash used in investing activities was $0.4 million and primarily attributable to $1.0 million in proceeds from short-term investments. This was offset by $0.7 million for the purchase of lab and office equipment, $0.5 million of software development costs and an increase of $0.08 million related to our note receivable from a related party. In addition, cash decreased by $0.06 million due to the deconsolidation of VericiDx.

 

 


Net cash used in financing activities

During the six months ended December 31, 2021, net cash provided by financing activities was $0.3 million and was primarily attributable to $0.1 million in proceeds from the issuance of ordinary shares under our employee stock purchase program as well as $0.2 million in proceeds from the exercise of stock options.

During the six months ended December 31, 2020, net cash provided by financing activities was $76.9 million and was primarily attributable to $79.2 million of proceeds from our IPO on the Nasdaq Global Market which was partially offset by offering costs of $2.3 million associated with the IPO that were paid in the period.

Cash and Cash Equivalents

We had cash and, cash equivalents of $39.9 million as of December 31, 2021, decreased from $65.2 million as of June 30, 2021 due to normal operations as we continue to commercialize KidneyIntelX and grow our business.

 

 


Renalytix plc

Condensed Consolidated balance sheets (Unaudited)

(in thousands, except share and per share data)

 

December 31, 2021

 

 

June 30, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

39,928

 

 

$

65,128

 

Accounts receivable

 

 

823

 

 

 

594

 

Prepaid expenses and other current assets

 

 

3,546

 

 

 

993

 

Note receivable from Kantaro

 

 

75

 

 

 

75

 

Receivable from affiliates

 

 

35

 

 

 

1

 

Total current assets

 

 

44,407

 

 

 

66,791

 

Property and equipment, net

 

 

2,880

 

 

 

2,490

 

Investment in VericiDx

 

 

7,033

 

 

 

9,295

 

Investment in Kantaro

 

 

37

 

 

 

Total assets

 

$

54,357

 

 

$

78,576

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,379

 

 

$

1,403

 

Accounts payable – related party

 

 

1,007

 

 

 

361

 

Accrued expenses and other current liabilities

 

 

4,533

 

 

 

4,602

 

Accrued expenses – related party

 

 

1,337

 

 

 

224

 

Deferred revenue

 

 

67

 

 

 

122

 

Payable to affiliate - current

 

 

219

 

 

 

350

 

Total current liabilities

 

 

8,542

 

 

 

7,062

 

Other liabilities

 

 

15

 

 

 

53

 

Total liabilities

 

 

8,557

 

 

 

7,115

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

Ordinary shares, £0.0025 par value per share: 76,681,831 shares
   authorized;
72,308,930 and 72,197,286 shares issued and
   outstanding at December 31, 2021 and June 30, 2021, respectively

 

 

220

 

 

 

220

 

Additional paid-in capital

 

 

152,662

 

 

 

150,407

 

Accumulated other comprehensive income

 

 

5,788

 

 

 

8,276

 

Accumulated deficit

 

 

(112,870

)

 

 

(87,442

)

Total shareholders’ equity

 

 

45,800

 

 

 

71,461

 

Total liabilities and shareholders’ equity

 

$

54,357

 

 

$

78,576

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 


Renalytix plc

Condensed Consolidated statements of operations and comprehensive loss (Unaudited)

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

Six Months Ended

 

(in thousands, except share data)

 

December 31, 2021

 

 

December 31, 2020

 

 

December 31, 2021

 

 

December 31, 2020

 

Revenue

 

$

845

 

 

$

400

 

 

$

1,327

 

 

$

400

 

Cost of revenue

 

 

492

 

 

 

257

 

 

 

719

 

 

 

257

 

Gross profit

 

 

353

 

 

 

143

 

 

 

608

 

 

 

143

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,134

 

 

 

2,462

 

 

 

8,132

 

 

 

4,207

 

General and administrative

 

 

10,071

 

 

 

6,595

 

 

 

18,203

 

 

 

10,711

 

Performance of contract liability to affiliate

 

 

(70

)

 

 

(301

)

 

 

(131

)

 

 

(759

)

Total operating expenses

 

 

14,135

 

 

 

8,756

 

 

 

26,204

 

 

 

14,159

 

Loss from operations

 

 

(13,782

)

 

 

(8,613

)

 

 

(25,596

)

 

 

(14,016

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in net earnings (losses) of affiliate

 

 

37

 

 

 

(105

)

 

 

37

 

 

 

(221

)

Foreign currency gain (loss)

 

 

(163

)

 

 

(5,541

)

 

 

2,140

 

 

 

(7,688

)

Fair value adjustment to VericiDx investment

 

 

(1,414

)

 

 

5,018

 

 

 

(2,021

)

 

 

5,018

 

Other income, net

 

 

 

 

 

115

 

 

 

12

 

 

 

167

 

Net loss

 

 

(15,322

)

 

 

(9,126

)

 

 

(25,428

)

 

 

(16,740

)

Net loss attributable to noncontrolling interest

 

 

 

 

 

(218

)

 

 

 

 

 

(611

)

Net loss attributable to ordinary shareholders

 

 

(15,322

)

 

 

(8,908

)

 

 

(25,428

)

 

 

(16,129

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange translation adjustment

 

 

97

 

 

 

6,086

 

 

 

(2,488

)

 

 

8,341

 

Comprehensive loss

 

 

(15,225

)

 

 

(3,040

)

 

 

(27,916

)

 

 

(8,399

)

Comprehensive loss attributable to noncontrolling
   interest

 

 

 

 

 

(5

)

 

 

 

 

 

(72

)

Comprehensive loss attributable to Renalytix

 

$

(15,225

)

 

$

(3,035

)

 

$

(27,916

)

 

$

(8,327

)

Net loss per ordinary share—basic and diluted

 

$

(0.21

)

 

$

(0.12

)

 

$

(0.35

)

 

$

(0.23

)

Weighted average ordinary shares—basic and
   diluted

 

 

72,285,941

 

 

 

72,029,634

 

 

 

72,258,372

 

 

 

70,932,808

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 


Renalytix plc

Condensed Consolidated statements of shareholders’ equity (Unaudited)

 

 

 

Ordinary shares

 

 

Additional
paid-in

 

 

Accumulated
other
comprehensive

 

 

Accumulated

 

 

Total
shareholders’
(deficit) equity
attributable to

 

 

Noncontrolling

 

 

Total
shareholders’

 

(in thousands, except share and per share data)

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

RenalytixAI

 

 

interests

 

 

equity

 

Balance at July 1, 2021

 

 

72,197,286

 

 

$

220

 

 

$

150,407

 

 

$

8,276

 

 

$

(87,442

)

 

$

71,461

 

 

$

 

 

$

71,461

 

Shares issued under the employee share
   purchase plan

 

 

10,920

 

 

 

 

 

 

120

 

 

 

 

 

 

 

 

 

120

 

 

 

 

 

 

120

 

Exercise of stock options

 

 

32,500

 

 

 

 

 

 

86

 

 

 

 

 

 

 

 

 

86

 

 

 

 

 

 

86

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

997

 

 

 

 

 

 

 

 

 

997

 

 

 

 

 

 

997

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

(2,585

)

 

 

 

 

 

(2,585

)

 

 

 

 

 

(2,585

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,106

)

 

 

(10,106

)

 

 

 

 

 

(10,106

)

Balance at September 30, 2021

 

 

72,240,706

 

 

$

220

 

 

$

151,610

 

 

$

5,691

 

 

$

(97,548

)

 

$

59,973

 

 

$

 

 

$

59,973

 

Exercise of stock options

 

 

68,224

 

 

 

 

 

 

111

 

 

 

 

 

 

 

 

 

111

 

 

 

 

 

 

111

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

941

 

 

 

 

 

 

 

 

 

941

 

 

 

 

 

 

941

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

97

 

 

 

 

 

 

97

 

 

 

 

 

 

97

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,322

)

 

 

(15,322

)

 

 

 

 

 

(15,322

)

Balance at December 31, 2021

 

 

72,308,930

 

 

$

220

 

 

$

152,662

 

 

$

5,788

 

 

$

(112,870

)

 

$

45,800

 

 

$

 

 

$

45,800

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 


Renalytix plc

Condensed Consolidated statements of shareholders’ equity (Unaudited)

 

 

 

Ordinary shares

 

 

Additional
paid-in

 

 

Accumulated
other
comprehensive

 

 

Accumulated

 

 

Total
shareholders’
(deficit) equity
attributable to

 

 

Noncontrolling

 

 

Total
shareholders’

 

(in thousands, except share and per share data)

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

RenalytixAI

 

 

interests

 

 

equity

 

Balance at July 1, 2020

 

 

59,416,134

 

 

$

179

 

 

$

69,650

 

 

$

(1,200

)

 

$

(52,717

)

 

$

15,912

 

 

$

 

 

$

15,912

 

Sale of ordinary shares in initial public offering on Nasdaq, net of offering costs and underwriting fees of $9,007

 

 

12,613,500

 

 

 

40

 

 

 

76,094

 

 

 

 

 

 

 

 

 

76,134

 

 

 

 

 

 

76,134

 

VericiDx distribution in specie

 

 

 

 

 

 

 

 

1,638

 

 

 

(25

)

 

 

 

 

 

1,613

 

 

 

(1,613

)

 

 

 

Share-based compensation expense

 

 

 

 

 

 

 

501

 

 

 

 

 

 

 

 

 

501

 

 

 

 

 

 

501

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

2,255

 

 

 

 

 

 

2,255

 

 

 

(67

)

 

 

2,188

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,221

)

 

 

(7,221

)

 

 

(393

)

 

 

(7,614

)

Balance at September 30, 2020

 

 

72,029,634

 

 

$

219

 

 

$

147,883

 

 

$

1,030

 

 

$

(59,938

)

 

$

89,194

 

 

$

(2,073

)

 

$

87,121

 

VericiDx noncontrolling interest upon
   deconsolidation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,296

 

 

 

2,296

 

Share-based compensation expense

 

 

 

 

 

 

 

525

 

 

 

 

 

 

 

 

 

525

 

 

 

 

 

 

525

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

6,086

 

 

 

 

 

 

6,086

 

 

 

(5

)

 

 

6,081

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,908

)

 

 

(8,908

)

 

 

(218

)

 

 

(9,126

)

Balance at December 31, 2020

 

 

72,029,634

 

 

$

219

 

 

$

148,408

 

 

$

7,116

 

 

$

(68,846

)

 

$

86,897

 

 

$

 

 

$

86,897

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 


Renalytix plc

Condensed Consolidated statements of cash flows (Unaudited)

(in thousands)

 

Six Months Ended
December 31, 2021

 

 

Six Months Ended
December 31, 2020

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(25,428

)

 

$

(16,740

)

Adjustments to reconcile net loss to net cash used in operating activities