Renalytix plc
("Renalytix" or the "Company")
Holding(s) in Company
LONDON and NEW YORK, 10 October 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), announces that it has received six TR-1 notifications from Heights Capital Management Inc., covering the period 22 September 2025 to 7 October 2025, which are reproduced below with the most recent TR-1 notification first.
(#1) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
07/10/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
08/10/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
2.96% |
0.00% |
2.96% |
12,001,499 |
||
Position of previous notification (if applicable) |
3.90% |
0.00% |
3.90% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
12,001,499 |
|
2.96% |
|
|||||
SUBTOTAL 8. A |
12,001,499 |
2.96% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
|||||
|
|
|
|
|
|||||
|
|
SUBTOTAL 8. B 1 |
|
|
|||||
|
|||||||||
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
||||
|
|
|
|
|
|
||||
|
|
|
SUBTOTAL 8.B.2 |
|
|
||||
|
|||||||||
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
|
|||
Full chain of controlled undertakings through which the voting rights and/or the |
|
|||
Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
2.96% |
|
2.96% |
|
CVI Investments, Inc. |
2.96% |
|
2.96% |
|
|
||||
10. In case of proxy voting, please identify: |
||||
Name of the proxy holder |
|
|||
The number and % of voting rights held |
|
|||
The date until which the voting rights will be held |
|
|||
|
||||
11. Additional information xvi |
||||
None |
||||
Place of completion |
London, United Kingdom |
Date of completion |
08.10.2025 |
(#2) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
02/10/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
03/10/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
3.90% |
0.00% |
3.90% |
15,823,655 |
||
Position of previous notification (if applicable) |
4.96% |
0.00% |
4.96% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
15,823,655 |
|
3.90% |
|
|||||
SUBTOTAL 8. A |
15,823,655 |
3.90% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
|||||
|
|
|
|
|
|||||
|
|
SUBTOTAL 8. B 1 |
|
|
|||||
|
|||||||||
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
||||
|
|
|
|
|
|
||||
|
|
|
SUBTOTAL 8.B.2 |
|
|
||||
|
|||||||||
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
|
|||
Full chain of controlled undertakings through which the voting rights and/or the |
|
|||
Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
3.90% |
|
3.90% |
|
CVI Investments, Inc. |
3.90% |
|
3.90% |
|
|
||||
10. In case of proxy voting, please identify: |
||||
Name of the proxy holder |
|
|||
The number and % of voting rights held |
|
|||
The date until which the voting rights will be held |
|
|||
|
||||
11. Additional information xvi |
||||
None |
||||
Place of completion |
London, United Kingdom |
Date of completion |
03.10.2025 |
(#3) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
29/09/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
29/09/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
4.96% |
0.00% |
4.96% |
20,100,000 |
||
Position of previous notification (if applicable) |
5.39% |
0.00% |
5.39% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
20,100,000 |
|
4.96% |
|
|||||
SUBTOTAL 8. A |
20,100,000 |
4.96% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
|||||
|
|
|
|
|
|||||
|
|
SUBTOTAL 8. B 1 |
|
|
|||||
|
|||||||||
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
||||
|
|
|
|
|
|
||||
|
|
|
SUBTOTAL 8.B.2 |
|
|
||||
|
|||||||||
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
|
|||
Full chain of controlled undertakings through which the voting rights and/or the |
|
|||
Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
4.96% |
|
4.96% |
|
CVI Investments, Inc. |
4.96% |
|
4.96% |
|
|
||||
10. In case of proxy voting, please identify: |
||||
Name of the proxy holder |
|
|||
The number and % of voting rights held |
|
|||
The date until which the voting rights will be held |
|
|||
|
||||
11. Additional information xvi |
||||
None |
||||
Place of completion |
London, United Kingdom |
Date of completion |
29.09.2025 |
(#4) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
26/09/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
29/09/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
5.39% |
0.00% |
5.39% |
21,850,000 |
||
Position of previous notification (if applicable) |
7.35% |
0.00% |
7.35% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
21,850,000 |
|
5.39% |
|
|||||
|
|
|
|
|
|||||
SUBTOTAL 8. A |
21,850,000 |
5.39% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
|||||
|
|
|
|
|
|||||
|
|
SUBTOTAL 8. B 1 |
|
|
|||||
|
|||||||||
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
||||
|
|
|
|
|
|
||||
|
|
|
SUBTOTAL 8.B.2 |
|
|
||||
|
|||||||||
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
|
|||
Full chain of controlled undertakings through which the voting rights and/or the |
|
|||
Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
5.39% |
|
5.39% |
|
CVI Investments, Inc. |
5.39% |
|
5.39% |
|
|
||||
10. In case of proxy voting, please identify: |
||||
Name of the proxy holder |
|
|||
The number and % of voting rights held |
|
|||
The date until which the voting rights will be held |
|
|||
|
||||
11. Additional information xvi |
||||
None |
||||
Place of completion |
London, United Kingdom |
Date of completion |
29.09.2025 |
(#5) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
25/09/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
29/09/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
7.35% |
0.00% |
7.35% |
24,350,000 |
||
Position of previous notification (if applicable) |
8.86% |
0.00% |
8.86% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
24,350,000 |
|
7.35% |
|
|||||
SUBTOTAL 8. A |
24,350,000 |
7.35% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
|||||
|
|
|
|
|
|||||
|
|
SUBTOTAL 8. B 1 |
|
|
|||||
|
|||||||||
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
|||||||||
Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
||||
|
|
|
|
|
|
||||
|
|
|
SUBTOTAL 8.B.2 |
|
|
||||
|
|||||||||
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
|
|||
Full chain of controlled undertakings through which the voting rights and/or the |
|
|||
Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
7.35% |
|
7.35% |
|
CVI Investments, Inc. |
7.35% |
|
7.35% |
|
|
||||
10. In case of proxy voting, please identify: |
||||
Name of the proxy holder |
|
|||
The number and % of voting rights held |
|
|||
The date until which the voting rights will be held |
|
|||
|
||||
11. Additional information xvi |
||||
None |
||||
Place of completion |
London, United Kingdom |
Date of completion |
29.09.2025 |
(#6) TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii : |
Renalytix plc |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate) |
||||||
Non-UK issuer |
|
|||||
2. Reason for the notification (please mark the appropriate box or boxes with an "X") |
||||||
An acquisition or disposal of voting rights |
X |
|||||
An acquisition or disposal of financial instruments |
|
|||||
An event changing the breakdown of voting rights |
|
|||||
Other (please specify) iii: |
|
|||||
3. Details of person subject to the notification obligation iv |
||||||
Name |
Heights Capital Management, Inc. |
|||||
City and country of registered office (if applicable) |
San Francisco, California |
|||||
4. Full name of shareholder(s) (if different from 3.) v |
||||||
Name |
CVI Investments, Inc. |
|||||
City and country of registered office (if applicable) |
Cayman Islands |
|||||
5. Date on which the threshold was crossed or reached vi : |
22/09/2025 |
|||||
6. Date on which issuer notified (DD/MM/YYYY): |
29/09/2025 |
|||||
7. Total positions of person(s) subject to the notification obligation |
||||||
|
% of voting rights attached to shares (total of 8. A) |
% of voting rights through financial instruments |
Total of both in % (8.A + 8.B) |
Total number of voting rights held in issuer (8.A + 8.B) vii |
||
Resulting situation on the date on which threshold was crossed or reached |
8.86% |
0.00% |
8.86% |
29,350,000 |
||
Position of previous notification (if applicable) |
9.77% |
0.00% |
9.77% |
|
||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii |
|||||||||
A: Voting rights attached to shares |
|||||||||
Class/type of ISIN code (if possible) |
Number of voting rights ix |
% of voting rights |
|||||||
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
GB00BYWL4Y04 |
29,350,000 |
|
8.86% |
|
|||||
SUBTOTAL 8. A |
29,350,000 |
8.86% |
|||||||
|
|||||||||
B 1: Financial Instruments according to DTR5.3.1R (1) (a) |
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Type of financial instrument |
Expiration |
Exercise/ |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights |
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|
|
|
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SUBTOTAL 8. B 1 |
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B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) |
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Type of financial instrument |
Expiration |
Exercise/ |
Physical or cash Settlement xii |
Number of voting rights |
% of voting rights |
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|
|
|
|
|
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|
|
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SUBTOTAL 8.B.2 |
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9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an "X") |
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Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii |
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Full chain of controlled undertakings through which the voting rights and/or the |
|
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Name xv |
% of voting rights if it equals or is higher than the notifiable threshold |
% of voting rights through financial instruments if it equals or is higher than the notifiable threshold |
Total of both if it equals or is higher than the notifiable threshold |
|
Heights Capital Management, Inc. |
8.86% |
|
8.86% |
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CVI Investments, Inc. |
8.86% |
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8.86% |
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10. In case of proxy voting, please identify: |
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Name of the proxy holder |
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The number and % of voting rights held |
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The date until which the voting rights will be held |
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11. Additional information xvi |
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None |
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Place of completion |
London, United Kingdom |
Date of completion |
29.09.2025 |
For further information, please contact:
Renalytix plc |
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James McCullough, CEO |
Via Walbrook PR |
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SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker) |
Tel: +44 (0)20 3470 0470 |
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Jeff Keating / David Hignell (Corporate Finance) Vadim Alexandre (Corporate Broking) |
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Oberon Capital (Joint Broker) |
Tel: +44 (0)20 3179 5300 |
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Mike Seabrook / Nick Lovering |
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Walbrook PR Limited |
Tel: 020 7933 8780 or [email protected] |
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Paul McManus / Alice Woodings |
Mob: 07980 541 893 / 07407 804 654 |
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About Renalytix (www.renalytix.com)
Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes. Renalytix has received FDA approval and Medicare reimbursement for kidneyintelX.dkd which is now offered commercially in the United States.
Unrecognized and uncontrolled kidney disease remains one of the largest barriers to controlling cost and suffering in the United States and the United Kingdom's medical system, affecting over 14 million and 8 million people, respectively. After five years of development and clinical validation, kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic tool capable of understanding a patient's risk with kidney disease early where treatment has maximal effect. kidneyintelX.dkd is now being deployed across large physician group practices and health systems in select regions of the United States.
The over 15,000 patients that have been tested by kidneyintelX.dkd have produced a substantial body of real-world performance data. In patient populations where kidneyintelX.dkd has been deployed, a demonstrated and significant increase in diagnosis, prognosis, and treatment rates have been recorded. kidneyintelX.dkd now has full reimbursement established by Medicare, the largest insurance payer in the United States, at $950 per reportable result. kidneyintelX.dkd is also recommended for use in the international chronic kidney disease clinical guidelines (KDIGO).
KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and equity owners in the Company. In addition, the Icahn School of Medicine at Mount Sinai has equity ownership in Renalytix. For information about the kidneyintelX,dkd test, visit kidneyintelx.com .