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    PAB   AU000000PAB9

PATRYS LIMITED

(PAB)
Delayed Australian Stock Exchange  -  02:10 2022-08-10 am EDT
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Patrys : Appendix 4C - Quarterly - 31 March 2022

04/27/2022 | 10:34pm EDT

ASX & Media Release

28 April 2022

Quarterly Activities Report and 4C Quarterly Cash Flow Report

Highlights:

  • Work on second engineering run of PAT-DX1 expected to complete in current quarter;

  • Stable cell line for production of PAT-DX3 established;

  • Receipt of $1.2 million R&D Tax Incentive Refund;

  • Balance sheet capacity with closing cash balance of $10.16M at 31 Mar 2022, with an additional $2M in short-term investments.

_________________________________________________

Melbourne, Australia; 28 April 2022: Patrys Limited (ASX: PAB, "Patrys" or the "Company"), a therapeutic antibody development company, today released its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the quarter ended 31 March 2022.

Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said: "The key focus for this quarter has been on the manufacture of our deoxymabs. While we were clearly disappointed that our first engineering run did not provide sufficient drug product for the final preclinical toxicology studies and to initiate our Phase-1 clinical trial as planned, we are very pleased that the effort put in by Patrys and our Contract Development Manufacturing Organisation (CDMO) has allowed us to commence work on a second engineering run so quickly. We expect this manufacturing run, which will include an improved, large-scale purification process, will complete during the current quarter. We were also pleased to report that we have now established a stable, cell line for the production of our full-sized deoxymab, PAT-DX3 ahead of schedule. With two assets in development we are now attracting global interest in our deoxymab platform and we look forward to updating our shareholders on these developments in coming months.

R&D Update

In January, Patrys advised the market that the first engineering run of PAT-DX1 did not provide the yield anticipated, based on previous, smaller-scale runs. The production yield from the fermentation process for PAT-DX1 was consistent with previous small scale production runs. However, the process for purifying PAT-DX1 from the cell harvest resulted in lower recoveries of drug product than expected. In view of this, the Company announced that an additional engineering run would be required to provide sufficient drug product to complete the final animal toxicology studies and to initiate the planned Phase-1 clinical trial of PAT-DX1. During the quarter, Patrys has worked closely with its CDMO

General enquiries

Media enquiries:

James Campbell

Haley Chartres

Chief Executive Officer

H^CK

P: +61 3 96703273

P: +61 423 139 163

info@patrys.com

haley@hck.digital

2

to develop an improved, large-scale purification process. On the back of this, Patrys' CDMO will undertake a second engineering run of PAT-DX1 which is expected to complete during the current quarter. As announced previously Patrys expects it will now submit a Human Research Ethics Application (HREA) for phase 1 clinical trial in mid 2023.

In February 2022, Patrys announced it has identified and selected an optimised stable cell line for production of its full-sized IgG deoxymab, PAT-DX3. This allows the Company to commence work on developing a commercial scale manufacturing process for GMP-grade (Good Manufacturing Practice) PAT-DX3 deoxymab that is required to commence its clinical development. This milestone was achieved ahead of schedule. Patrys has established that the selected cell line is both stable and able to deliver reproducible and consistent production of PAT-DX3 protein over time. This cell line will be stored as a Master Cell Bank (MCB) which will form the basis for all future production of PAT-DX3.

In March, Patrys was advised that a patent entitled "Antibody-mediated autocatalytic, targeted delivery of nanocarriers to tumors" has been granted by the Indian Patent Office. This new patent provides protection until August 2037.This patent will provide patent protection for the sale of therapeutic products in India as well as enable Patrys to use Indian manufacturers for the commercial-scale production of PAT-DX1.

Corporate Update

During the quarter ended 31 March 2022, Patrys had net cash outflows from operating activities of A$575k, with A$1,161k invested in R&D activities. In January, Patrys announced that its wholly-owned subsidiary Nucleus Therapeutics Pty. Ltd, had received a $1.2 million R&D Tax Incentive Refund for eligible research activities conducted during the 2020/2021 financial year. At 31 March 2022, Patrys held A$10.16M in cash and A$2.0M in short-term investments. Payments to related parties and their associates during the quarter, which are outlined in Section 6 of the accompanying Appendix 4C to this quarterly activity report, were A$153k. These payments include non-executive director fees and consulting services as well as salary (including superannuation) for the CEO and Managing Director.

-Ends-

This announcement is authorised for release by the Board of Directors of Patrys Limited.

For further information, please contact:

Registered Office Address Level 4, 100 Albert Road

South Melbourne VIC 3205

About Patrys Limited

Based in Melbourne, Australia, Patrys (ASX:PAB) is focused on the development of its deoxymab platform of cell-penetrating antibodies as therapies for a range of different cancers. More information can be found at www.patrys.com.

About Patrys' deoxymab platform:

Patrys' deoxymab platform is based on the deoxymab antibody that was first identified as an autoantibody in a mouse model of the human disease systemic lupus erythematosus (SLE). While most antibodies bind to cell surface markers, deoxymab penetrates into the cell nuclei and binds directly to DNA where it inhibits DNA repair processes. Cancer cells often have high levels of mutations and underlying deficiencies in the DNA repair mechanisms. For these reasons, the additional inhibition of the DNA repair processes by deoxymab can kill cancer cells, but appears to have little impact on normal cells. As a single agent, deoxymab has been shown to significantly enhance the efficacy of both chemo- and radiotherapies. Further, deoxymabs can be conjugated to nanoparticles to target delivery of chemotherapeutics and imaging agents to tumours.

Patrys has developed two humanised forms of deoxymab, both which have improved activity over the original deoxymab antibody. PAT-DX1 is a dimer (two joined subunits) of the short chain from the binding domain of deoxymab, while PAT-DX3 is a full-sized IgG antibody. In a range of pre-clinical studies, PAT-DX1 has shown significant ability to kill cancer cells in cell models, human tumour explants, xenograft, and orthotopic models. PAT-DX1 has been shown to cross the blood brain barrier, reduce tumour size, and increase survival in multiple animal models of brain cancer, other cancers, and cancer metastases. PAT-DX1 is tumour-agnostic, meaning that it can target many different tumour types in the body, regardless of specific tumour antigens. Patrys believes that PAT-DX1 may have application across a wide range of cancers including gliomas, melanomas, prostate, breast, pancreatic, and ovarian cancers.

Patrys has completed proof of concept studies showing that it is possible to conjugate small molecule payloads to PAT-DX3, and is advancing antibody drug conjugate (ADC) efforts using deoxymabs. In addition, deoxymabs such as PAT-DX1 and PAT-DX3 can be used to target nanoparticles carrying a payload of anti-cancer drugs specifically to tumours. This allows specific delivery of cancer drugs to multiple types of cancer while having minimal impact on normal, healthy cells.

Patrys' rights to deoxymab are part of a worldwide license to develop and commercialise a portfolio of novel anti-DNA antibodies and antibody fragments, variants and conjugates discovered at Yale University as anti-cancer and diagnostic agents. Overall, eight patents in the portfolio have been granted with six patents covering the unconjugated form of deoxymab 3E10 (and derivatives thereof) have already been granted (Europe, Japan, China, and 3 in the USA), and two patents covering nanoparticle conjugation (Australia and India).

Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity

PATRYS LIMITED

ABN

97 123 055 363

Quarter ended ("current quarter")

31 March 2022

Consolidated statement of cash flows

Current quarter

$A'000

Year to date (9 months) $A'000

1.

Cash flows from operating activities

28

28

1.1

Receipts from customers

1.2

Payments for

(1,161)

(5,968)

(a)research and development

(b)product manufacturing and operating costs

-

-

(c)advertising and marketing

-

-

(d)leased assets

-

-

(e)staff costs*

(122)

(469)

(f)administration and corporate costs

(403)

(902)

1.3

Dividends received

-

-

1.4

Interest received

1

8

1.5

Interest and other costs of finance paid

-

-

1.6

Income taxes paid

-

-

1.7

Government grants and tax incentives

1,189

1,189

1.8

Other

  • - IP expenditure

  • - Government Incentive

(107)

-

(212)

-

1.9

Net cash from / (used in) operating activities

(575)

(6,326)

*Some staff costs are reallocated into payments for research and development.

2.

Cash flows from investing activities

-

-

2.1

Payments to acquire or for:

(a) entities

(b) businesses

-

-

(c)property, plant and equipment

-

-

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

3.

Cash flows from financing activities

-

7,833

3.1

Proceeds from issues of equity securities (excluding convertible debt securities)

3.2

Proceeds from issue of convertible debt securities

-

-

3.3

Proceeds from exercise of options

-

66

3.4

Transaction costs related to issues of equity securities or convertible debt securities

-

(345)

3.5

Proceeds from borrowings

-

-

3.6

Repayment of borrowings

-

-

3.7

Transaction costs related to loans and borrowings

-

-

3.8

Dividends paid

-

-

3.9

Other (provide details if material)

- Share issue cost

-

-

3.10

Net cash from / (used in) financing activities

-

7,554

Consolidated statement of cash flows

Current quarter

$A'000

Year to date (9 months) $A'000

(d)investments in term deposits

2

(2,000)

(e)intellectual property

-

-

(f)other non-current assets

-

-

2.2

Proceeds from disposal of:

-

-

(a) entities

(b) businesses

-

-

(c)property, plant and equipment

-

-

(d)investment in term deposits

-

4,000

(e)intellectual property

-

-

(f)other non-current assets

-

-

2.3

Cash flows from loans to other entities

-

-

2.4

Dividends received (see note 3)

-

-

2.5

Other (provide details if material)

-

-

2.6

Net cash from / (used in) investing activities

2

2,000

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Patrys Limited published this content on 27 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 April 2022 02:33:02 UTC.


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