Quarterly Activity Report & Appendix 4C
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Released
Announcement PDF
ASX Announcement
September 2021 Quarterly Activity Report and Appendix 4C
First patient dosed in the Phase 1b/2 AML trial at Chaim Sheba, Israel
Zantrene found to kill melanoma cells that overproduce FTO in preclinical
interim results
Significant progress made in our preclinical and clinical programs despite
COVID-19 restrictions in NSW.
Race updates on preclinical and clinical progress
28 September 2021 - The September 2021 quarter (Q1 FY 2022) was highlighted by the
first patient being dosed in the Phase 1b/2 combination Acute Myeloid Leukemia (AML)
study, where Zantrene is being trialled in patients with relapsed/refractory (R/R) AML (ASX
announcement: 9 August 2021).
A second highlight was the interim preclinical results from our University of Newcastle
collaborators that showed Zantrene to be highly effective at killing a diverse range of
melanoma cell subtypes at low (sub-chemotherapeutic) concentrations. The data also
showed a close association between FTO protein levels in the cancer cells and sensitivity
to Zantrene (ASX announcement: 30 September 2021).
Late in the quarter, Race provided an update on the broader preclinical and clinical
programs given some Covid-related slowdowns (ASX announcement: 30 September
2021). In sum, we continue to make significant progress on all programs and will be
further updating this quarter.
Key events of the quarter
On 9 August 2021, Race announced that the first patient was dosed in its Phase 1b/2
AML clinical trial at the Chaim Sheba Medical Center Israel under Principal Investigator
Prof. Arnon Nagler, MD. Treating the first patient is an important step in any trial. We
look forward to the full clinical data set and trust this may build upon earlier
observations reporting an encouraging 40% overall clinical response rate (ASX
announcement: 16 June 2020).
On 30 September 2021, Race announced that Zantrene kills melanoma cancer cells
that overproduce FTO. The preclinical program led by University of Newcastle
researchers Professor Zhang and Associate Professor Jin identified that Zantrene
sensitivity is correlated with FTO levels, and that high FTO producing cells show up to
60x greater sensitivity than low FTO producing cells. The results support future
Race Oncology Ltd ABN 61 149 318 749
Registered office: L36, 1 Macquarie Place, Sydney NSW 2000
www.raceoncology.com
melanoma clinical trials for Zantrene in combination with standard of care
treatments.
On 30 September 2021 Race shared an update to its preclinical and clinical programs,
noting some COVID-19 related slowdowns in NSW, but with significant progress
occurring outside of the state.
Summary of cash flows and quarterly activity
As of 30 September 2021, Race held cash and equivalents of $8.94 million, compared with
$9.32 million on 30 June 2021. The nominal decline in cash reserves reflects receipts from
the exercise of options and a return to a lower cadence of spending ($0.931m vs $2.807m
in the prior quarter) as projected in the last quarterly update.
Listing rule 4.7C.3
Payments during the quarter to Related Parties amounted to $142k, comprising
payments of salaries to executive directors of $100k and board fees to non-executive
directors of $42k.
Shareholders by holding range
Race is pleased to share that our shareholder numbers were 9,198 on September 30
2021, confirming the continued strong shareholder interest in Race’s progress through
Q1 FY 2022.
Holding Ranges
Holders
Total Units
% Issued Share
Capital
Above 0 up to and including 1,000
4,134
1,860,893
1.27%
Above 1,000 up to and including 5,000
2,891
7,185,041
4.90%
Above 5,000 up to and including 10,000
774
5,878,135
4.01%
Above 10,000 up to and including 100,000
1,190
37,891,693
25.86%
209
93,729,020
63.96%
9,198
146,544,782
100.00%
Above 100,000
Post quarter news
Race announced the issue of two additional US patents (ASX announcements: 6 October
2021 and 19 October 2021). The 5th and 6th US issued patents provide Race with additional
protection around the use, formulation, and compositions that improve the therapeutic
benefit of Zantrene.
Race announced it had entered into a research collaboration with Dr Dan Dominissini of
the Chaim Sheba Medical Center, Israel to develop and analyse FTO biomarker data from
the Phase 1b/2 relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) Zantrene trial
(ASX announcement: 27 October 2021).
Race Oncology Ltd ABN 61 149 318 749
Registered office: L36, 1 Macquarie Place, Sydney NSW 2000
www.raceoncology.com
Expected news
In the current quarter, shareholders can expect updates on the following activities:
Pillar 1 - updates on the progress of FTO-directed preclinical programs in clear cell
renal cell carcinoma and extramedullary AML.
Pillar 2 – preliminary results from the cardiotoxicity preclinical program and a
decision to progress further animal studies.
Pillar 3 – updates on the AML clinical programs, including completion of the Phase 1b
dose escalation stage for the Israel trial, subject to patient recruitment.
Management commentary
Race CEO Phillip Lynch said: “The team continues to successfully progress Race’s preclinical
and clinical programs. We were particularly excited with the interim melanoma results where
Zantrene was shown to inhibit melanomas with high FTO expression. Those results provide a
strong early validation of our thesis that Zantrene could have a significant patient and
economic opportunity. We are now moving to determine appropriate clinical translation
plans.”
Race CSO Daniel Tillett said: “Despite difficulties caused by COVID-19, the Race team and
our collaborators have continued to make excellent progress on our programs. I am looking
forward to sharing further updates on our activities in the near future.”
Race Chairman John Cullity said: “Our Company is on track to deliver for Shareholders. We
look forward with some anticipation to sharing data from ongoing preclinical and clinical
programs.”
-ENDS-
About Race Oncology (ASX: RAC)
Race Oncology is an ASX listed precision oncology company with a Phase 2/3 cancer drug
called Zantrene®.
Zantrene is a potent inhibitor of the Fatso/Fat mass and obesity associated (FTO) protein.
Overexpression of FTO has been shown to be the genetic driver of a diverse range of
cancers. Race is exploring the use of Zantrene as a new therapy for melanoma and clear
cell renal cell carcinoma, which are both frequent FTO over-expressing cancers. The
Race Oncology Ltd ABN 61 149 318 749
Registered office: L36, 1 Macquarie Place, Sydney NSW 2000
www.raceoncology.com
Company also has compelling clinical data for the use of Zantrene as a chemotherapeutic
agent with reduced cardiotoxicity in Acute Myeloid Leukaemia (AML), breast and ovarian
cancers and is investigating its use in these areas.
Race is pursuing outsized commercial returns for shareholders via its ‘Three Pillar’
strategy for the clinical development of Zantrene.
Learn more at www.raceoncology.com.
Release authorised by:
Media contact:
Phil Lynch, CEO/MD on behalf
Jane Lowe
of the Race Board of Directors
+61 411 117 774
phillip.lynch@raceoncology.com
jane.lowe@irdepartment.com.au
Race Oncology Ltd ABN 61 149 318 749
Registered office: L36, 1 Macquarie Place, Sydney NSW 2000
www.raceoncology.com
Rule 4.7B
RACE ONCOLOGY LIMITED (RAC)
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
RACE ONCOLOGY LIMITED (RAC)
ABN
Quarter ended (“current quarter”)
61 149 318 749
Consolidated statement of cash flows
30 September 2021
Current quarter
$A’000
Year to date (3
months)
$A’000
-
-
(a) research and development
(550)
(550)
(b) product manufacturing and operating
costs
(149)
(149)
(c) advertising and marketing
(24)
(24)
-
-
(e) staff costs
(90)
(90)
(f)
(123)
(123)
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
(d) leased assets
administration and corporate costs
1.3
Dividends received (see note 3)
-
-
1.4
Interest received
5
5
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (provide details if material)
-
-
1.9
Net cash from / (used in) operating
activities
(931)
(931)
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
-
-
(d) investments
-
-
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
2.2
Current quarter
$A’000
Year to date (3
months)
$A’000
(e) intellectual property
-
-
(f)
-
-
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
-
-
(d) investments
-
-
(e) intellectual property
-
-
(f)
-
-
other non-current assets
Proceeds from disposal of:
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
-
-
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
550
550
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 (shares yet to be issued)
-
-
3.10
Net cash from / (used in) financing
activities
550
550
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
9,322
9,322
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(931)
(931)
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Current quarter
$A’000
Year to date (3
months)
$A’000
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
-
-
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
550
550
4.5
Effect of movement in exchange rates on
cash held
(5)
(5)
4.6
Cash and cash equivalents at end of
period
8,936
8,936
5.
Reconciliation of cash and cash
equivalents
Current quarter
$A’000
Previous quarter
$A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1
Bank balances
3,436
3,322
5.2
Call deposits
5,500
6,000
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
8,936
9,322
6.
Payments to related parties of the entity and their
associates
Current quarter
$A'000
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
142
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Payment to related parties as disclosed in item 6.1 as follows:
- $42,000 payments for non-executive director fees for the period;
- $100,000 salary payments to executive directors for the period.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 3
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
7.
Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
7.1
Loan facilities
-
-
7.2
Credit standby arrangements
-
-
7.3
Other (please specify)
-
-
7.4
Total financing facilities
-
-
7.5
Unused financing facilities available at quarter end
7.6
Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
-
N/A
8.
Estimated cash available for future operating activities
$A’000
8.1
Net cash from / (used in) operating activities (item 1.9)
(931)
8.2
Cash and cash equivalents at quarter end (item 4.6)
8,936
8.3
Unused finance facilities available at quarter end (item 7.5)
8.4
Total available funding (item 8.2 + item 8.3)
8,936
8.5
Estimated quarters of funding available (item 8.4 divided by
item 8.1)
9.60
-
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6
If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1
Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer:
N/A
8.6.2
Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer:
N/A
8.6.3
Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer:
N/A
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 4
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
1
This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
2
This statement gives a true and fair view of the matters disclosed.
Date:
29 October 2021
Authorised by: The Board of Race Oncology Limited
(Name of body or officer authorising release – see note 4)
Notes
1.
This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2.
If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3.
Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4.
If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5.
If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 5
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