For personal use only

27 January, 2022

REPORT FOR THE QUARTER ENDED

31 DECEMBER 2021 (Q4)

PYC established multiple safe and well tolerated doses of its co-lead drug candidate in

non-human primates to guide dose selection in upcoming human trials

The Company remains on course to transition to a clinical-stage genetic medicine

company in 2022

PYC anticipates significant expansion of its drug development pipeline into both common diseases in the eye and new target tissues including the central nervous system in 2022

PERTH, Australia and SAN DIEGO, California - January 27, 2022 - PYC Therapeutics (ASX:PYC) is a biotechnology company combining two complementary platform technologies:

  • RNA drug design capabilities; and
  • a proprietary drug delivery technology.

Together they are being developed to create and deliver a new generation of RNA therapeutics to change the lives of patients with genetic diseases. The Company's initial focus is on blinding diseases of the eye.

PYC's co-lead drug program (known as VP-0011) is the first disease-modifying therapy for patients with a rare blinding eye disease of childhood called Retinitis Pigmentosa type 11. This drug candidate is currently progressing through Investigational New Drug (IND)- enabling studies in the USA. It is scheduled to enter clinical trials in 2022.

During the fourth quarter of 2021, PYC established multiple safe and well-tolerated doses of this drug candidate in studies in Non-Human Primates. These results will help guide selection of the doses in PYC's Good Laboratory Practice (GLP) studies scheduled for early 2022 which, in turn, will inform the starting doses in the upcoming first in human studies of this drug candidate.

Developments in Q4 2021 see PYC making strong progress towards its transition to a clinical-stage company in 2022. Completion of pharmacokinetic studies in Q1 2022 and initial results of the GLP safety studies in Q3 will complete the non-clinical data pack in the Company's co-lead program. This will enable submission of the IND filing required to initiate first in-human studies.

1 VP-001 is being developed by PYC's 90% owned (10% Lions Eye Institute) subsidiary Vision Pharma

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The advancement of this program into clinical development has significant read-through implications for the entire drug development pipeline of the Company. PYC will leverage work performed to-date to advance all of its follow-on drug development programs. Throughout 2022 the drug development pipeline is anticipated to expand in the following areas:

  • non-orphanblinding diseases of the eye with larger patient populations and larger market sizes;
  • neurodegenerative diseases; and
  • additional target tissues beyond the eye and CNS.

Each of these areas represents a considerable unmet patient need.

In addition to its drug development activities, PYC continues to invest in its underlying drug delivery platform. There are two main limitations preventing realisation of the full potential of genetic medicines. These are:

  1. the specificity of delivery of the drug to its intended cellular target; and
  2. the efficiency of delivery to the inside of that target cell.

PYC expects to extend the reach of its technology through progress in these domains through 2022 and will update the market as it progresses towards these objectives.

PYC is validating its genetic medicine platforms at a time of great interest and progress in the field. The advancement of PYC's technology into clinical development is driving heightened commercial interest in the Company's co-lead programs as well as the broader pipeline and enabling platforms. Recent commercial transactions for early pre-clinical genetic medicine candidates have demonstrated the potential for very early accretion of shareholder value in this field of drug development.

Payments in the December quarter to related parties of $294,000 included in item 6 in the attached Appendix 4C comprised fees and remuneration paid to Directors.

About PYC Therapeutics

PYC Therapeutics (ASX: PYC) is a pre-clinical stage biotechnology company pioneering a new generation of RNA therapeutics that utilize PYC's proprietary library of naturally derived cell penetrating peptides to overcome the major challenges of current genetic medicines. PYC believes its PPMO (Peptide conjugated Phosphorodiamidate Morpholino Oligomer) technology enables a safer and more effective RNA therapeutic to address the underlying drivers of a range of genetic diseases for which no treatment solutions exist today. The Company is leveraging its leading-edge science to develop a pipeline of novel therapies including three preclinical stage programs focused on inherited eye diseases and preclinical discovery programs focused on neurodegenerative diseases. PYC's discovery and laboratory operations are located in Australia and its preclinical, clinical, regulatory and business development operations are located in the United States. For more information, visit pyctx.com, or follow us on LinkedInand Twitter.

Forward looking statements

Any forward-looking statements in this ASX announcement have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company's control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this ASX announcement include known and unknown risks. Because actual results could differ materially to assumptions made and the Company's current intentions, plans, expectations and beliefs about the future, you are urged to view all forward-looking statements contained in this ASX announcement with caution. The Company undertakes

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no obligation to publicly update any forward-looking statement whether as a result of new information, future events or otherwise.

This ASX announcement should not be relied on as a recommendation or forecast by the Company. Nothing in this ASX announcement should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

This ASX announcement was approved and authorized for release by the Board of PYC Therapeutics Limited.

CONTACTS:

INVESTORS

MEDIA

info@pyctx.com

Michelle Di Lello

michelle.dilello@pyctx.com

+61 8 6151 0992 | pyctx.com | ACN 098 391 961

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Rule 4.7B

Appendix 4C

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

Name of entity

PYC THERAPEUTICS LIMITED

ABN

Quarter ended ("current quarter")

48 098 391 961

31 December 2021

Consolidated statement of cash flows

Current quarter

Year to date 6

$A'000

months)

$A'000

1.

Cash flows from operating activities

1.1

Receipts from customers

1.2

Payments for

research and development

(4,881)

(9,329)

product manufacturing and operating costs

-

-

advertising and marketing

-

-

leased assets

(76)

(133)

staff costs

(509)

(1,240)

administration and corporate costs

(565)

(1,174)

1.3

Dividends received (see note 3)

-

-

1.4

Interest received

16

18

1.5

Interest and other costs of finance paid

-

-

1.6

Income taxes paid

-

-

1.7

Government grants and tax incentives

4,117

4,117

1.8

Other (provide details if material)

-

-

1.9

Net cash from / (used in) operating

activities

(1,898)

(7,741)

2.

Cash flows from investing activities

2.1

Payments to acquire:

(a) entities

-

-

businesses

-

-

property, plant and equipment

(94)

(129)

investments

-

-

intellectual property

-

-

other non-current assets

18

7

ASX Listing Rules Appendix 4C (01/12/19)

Page 1

+ See chapter 19 of the ASX Listing Rules for defined terms.

For personal use only

Appendix 4C

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

Consolidated statement of cash flows

Current quarter

Year to date 6

$A'000

months)

$A'000

2.2

Proceeds from disposal of:

(a) entities

-

-

businesses

-

-

property, plant and equipment

-

-

investments

-

-

intellectual property

-

-

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

(76)

(122)

3.

Cash flows from financing activities

-

-

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

-

-

3.4

Transaction costs related to issues of

-

-

equity securities or convertible debt

securities

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)

-

-

3.10

Net cash from / (used in) financing

-

activities

-

4. Net increase / (decrease) in cash and cash equivalents for the period

4.1

Cash and cash equivalents at beginning of

45,618

51,502

period

4.2

Net cash from / (used in) operating

activities (item 1.9 above)

(1,898)

(7,741)

4.3

Net cash from / (used in) investing activities

(item 2.6 above)

(76)

(122)

ASX Listing Rules Appendix 4C (01/12/19)

Page 5

+ See chapter 19 of the ASX Listing Rules for defined terms.

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Phylogica Limited published this content on 26 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 January 2022 00:08:13 UTC.