Quarterly Activities/Appendix 4C Cash Flow Report
Released
Released
Announcement PDF
July 29th, 2025
ASX Announcement
Quarterly Activity Report Q4 FY25
Atomo sees significant commercial progress in several strategic areas
Lumos announces a large supply agreement for the Pascal FebriDx with PHASE
Scientific for the US market, and indicates the clinical study to support US CLIA waiver
is expected to be completed in August
Progress in the Australian HIV Self-Test business with orders worth ~$680k
received for supply to public health funded National Vending Machine and National
mail-out HIV Self-Test programs
Positive preliminary performance data for the Atomo Active Syphilis test
demonstrating a significant improvement in distinguishing between Active and Priortreated Syphilis infections, when compared to existing rapid tests on the market
Board renewal process completed seeing two new Australian based directors with
extensive IVD Point-of-Care test experience join the Board, which reduces in size
Atomo secures ~$2.6 million in new capital, primarily through support from existing
shareholders. Capital to be used to meet working capital requirements and funding of
ongoing business objectives
Revenue: $1.07m (unaudited) revenue in Q4 FY25, bringing total revenue and
income from grant funding for the year (unaudited) to ~$4.2m
Cash receipts: Cash receipts from customers during the quarter were $1.04m, in
addition to payment of $485k also received for the CRC-P active syphilis grant
SYDNEY Australia, 29 July 2025 – Atomo Diagnostics Limited (ASX: AT1) (Atomo) is
pleased to release its Appendix 4C and quarterly activity report for the three months ended 30
June 2025 (Q4 FY25).
Q4 has been an extremely busy period for Atomo as it completed its reset for FY 25/26 and
readied itself to capitalise on increasing demand emergent for its existing products and
commercialisation of new products. The reset included strengthening of the balance sheet,
implementing a restructure to increase focus whilst reducing costs, and a Board refresh
reducing director numbers, but with two new industry experienced members being appointed.
OEM Pascal Supply Business:
Atomo’s strategic partner Lumos Diagnostics (ASX: LDX) recently secured a six-year
exclusive U.S. distribution agreement for FebriDx® with U.S. company PHASE Scientific. The
FebriDx® test, which is delivered to the user in Atomo’s patented Pascal test cassette for
improved usability and reliability in point of care settings, has already secured 510k clearance
from the US FDA and is well progressed through a CLIA waiver study that is expected to be
completed in August. Atomo is the exclusive manufacturer and supplier of the Pascal cassette
to Lumos for its FebriDx.
Lumos indicated that it expects the agreement with PHASE to generate FebriDx product sales
of up to US$316 million (A$486 million) over the six-year term, assuming CLIA waiver is
granted and contracted MOQ’s achieved. With this agreement now in place, Atomo anticipates
a significant increase in demand for its Pascal cassette from Lumos in the coming years. The
company intends to use revenues from OEM Pascal supply to fund commercialisation of its
own Pascal diagnostic product pipeline.
The Pascal FebriDx® test securing CLIA waiver would also support subsequent Pascal based
rapid test applications being progressed through to CLIA waiver in the key US market,
including Atomo’s novel Active Syphilis rapid test currently in development.
HIV Self-Test Business Growth:
Australian HIV Self-Test sales for FY25 totalled $1.4m, compared with total Australian HIV
revenue of $575k for the FY24 period, representing growth of 143% year on year. Scale up
of public health funded procurement of HIV self-testing in Australia during FY25 reflects
growing market for sexual health self-testing as part of public health policy.
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
During the quarter Atomo secured several purchase orders from Australian organisations
implementing the Federal Government’s HIV Self-Test programs now being scaled up
nationally. The order from NAPWHA, worth approximately $450k, supports ongoing delivery
of the national free-to-user HIV Self-Testing program.
This second large order from NAPWHA follows an initial order placed in April by Thorne
Harbour Health valued at $230k, this order supports the national scale-up of a Federal
Government funded vending machine HIV Self Testing Program.
Active Syphilis Test – Funded Development and Licencing Agreements now in place
In November 2024 Atomo executed a $2.44 million Cooperative Research Centres Projects
(CRC-P) grant with the Commonwealth Government. These funds have enabled significant
progress to be made towards development of a rapid syphilis test over the last six months.
The World Health Organization estimates 8.0 million cases of syphilis globally among
individuals aged 15–49 in 2022. In Australia, syphilis cases have tripled over the past decade,
with 6,6001 notifications recorded in 2023, and Syphilis is increasingly being recognised by
public health agencies globally as an emerging challenge. Current generation rapid Syphilis
tests are reactive for antibodies that are present in patients who have previously been treated
for past Syphilis infections as well as those with active Syphilis infections. This means that
these tests offer very poor specificity in screening programs, materially impacting their clinical
utility in point of care settings. This is of particular issue in higher risk cohorts that account for
a higher proportion of syphilis infections, and where prior infections are more common.
Recent data generated by Atomo’s strategic partner, the Burnet Institute, and recently
presented by Burnet at the 2nd Asia Pacific Conference on Point of Care Testing for Infectious
Diseases, demonstrates that the Atomo test significantly improved level of specificity in the
ability to distinguish between active and prior treated Syphilis during screening. Based on this
preliminary data and initial feedback from KOL’s, the company is extremely excited about the
clinical advantages of the test and its potential when compared to standard antibody rapid
tests currently approved and in use globally.
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
New Product Initiatives: Florey
Atomo has successfully completed design work on its Florey clip-in test device, designed
specifically to support testing with existing standard cassettes already on the market.
This device which utilises Atomo’s existing IP and manufacturing processes, offers a simpler
path to adoption as an accessory and has generated interest from a small number of parties
engaged during the development. The company is presenting Florey to the market more
broadly via the ADLM conference now taking place in the US, where a number of meetings
have been scheduled in response to growing interest in the solution.
Unlike Pascal, which incorporates the existing test strip directly into the cassette, Florey is
designed to accept a standard cassette and allows the test procedure to be completed by the
Atomo device. By not having the test directly onboard the Atomo device itself, Florey is
designed to be an accessory to approved standard tests. This makes it suitable for adoption
by companies with tests already approved and commercialised at scale in market, as the
regulatory barriers to adoption of Atomo’s technology are significantly reduced and
manufacturing operations for existing tests unaffected.
Board Renewal Completed
During the period the company underwent a process of board renewal and downsizing:
Directors Ms Deborah Neff, Dr Paul Kasian and Mr John Keith resigned from their
positions as Directors of the Company
Dr Cheri Walker remained on the Board, taking up the position of Chair of the Audit
and Risk Committee and Mr John Kelly was appointed Interim Chair of the Board.
Mr. Anthony May and Mr Patrick Cook joined the Board as Non-Executive Directors
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
Mr May has held various Director roles across international corporations including Hoechst
Germany, Microgenics Corporation USA, Fisher Scientific and Thermo Fisher Scientific. With
extensive experience across public and private pathology laboratories, as well as sales and
management roles in the IVD supply sector
Mr Cook is an experienced Non-Executive Director and Chair with over 20 years of board level
experience and over 30 years’ experience in senior executive positions in medical devices &
point-of-care diagnostics sectors within multinational and listed biotechnology companies
Financials
Total revenue & grant income (unaudited) of $1.07m for Q4 FY25, comprising $685k for HIV
test sales with the remaining amount from development & other fees, plus grant income of
$385k, bringing revenue and grant income for FY25 to ~$4.2m, an increase of 2.7% on FY24.
Operating costs for Q4 FY25 were $1.6m (unaudited) compared to equivalent costs for $1.4m
in Q4 FY24. Despite a slight increase QoQ, overall YoY operating costs reduced from $7.1m
in FY24 to $6.9m in FY25. When taking into account the ~$400k of operating expenses funded
directly by the CRC-P for Syphilis development activities, operating expenses improved 24%.
Cash receipts during the quarter were ~$1.52m, made up of $1.04m from customer receipts
$485k for CRC-P grant payment for active syphilis test. The company also completed a capital
raise by way of share placement and Shareholder Purchase Plan (SPP) that resulted in inflows
of $1.65m net of costs, seeing Atomo finish the quarter debt-free and with cash on hand of
$3.2m. Post year end, a further $926k was collected from the capital raise and an SPP
Shortfall placement.
In accordance with ASX Listing Rule 4.7C.3, Atomo advises that an amount of $155k was
paid during the quarter o Atomo Directors in salary and director’s fees.
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
Key Business Priorities FY26/27:
Growing revenues over the next 12 months from existing product channels
HIV Self-Test business across ANZ, Europe and LMIC, ex: Africa
Pascal supply into Lumos’s contract with PHASE, NG Biotech and securing new
customers post CLIA waiver of the Pascal FebriDx test in the US
Commercialising new Diagnostic Products and Test Devices:
Atomo Active Syphilis Professional and Self-Test variants in advanced development
A pipeline of subsequent applications being planned
Florey introduced as an easy to implement usability upgrade for existing rapid tests
Optimising operational pathways and capabilities:
Improving margins through manufacturing efficiencies on higher volumes
Implementing organisational and operational improvements to increase capability,
whilst reducing costs and creating greater control
For more information, please contact
John Kelly
Atomo Diagnostics
john.kelly@atomodiagnostics.com
Phone: +61 401 922 279
This announcement was authorised by the Board of Directors.
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
About Atomo
Atomo is an Australian medical device company supplying unique, integrated rapid diagnostic test (RDT) devices
to the global diagnostic market. Atomo’s patented devices simplify testing procedures and enhance usability for
professional users and untrained self-testers. The Company has agreements in place for tests targeting infectious
diseases including HIV, Syphilis, viral vs bacterial differentiation and pregnancy.
See more at www.atomodiagnostics.com.
Forward looking statements
This announcement may contain forward-looking statements which may be identified by words such as
“believes”, “considers”, “could”, “estimates”, “expects”, “intends”, “may”, and other similar words that involve risks
and uncertainties. Such statements are not guarantees of future performance and involve known and unknown
risks, uncertainties, assumptions and other important factors, many of which are beyond the control of Atomo or
its Directors and management and could cause Atomo’s actual results and circumstances to differ materially from
the results and circumstances expressed or anticipated in these statements. The Directors cannot and do not
give any assurance that the results, performance or achievements expressed or implied by the forward-looking
statements contained in this announcement will actually occur and investors are cautioned not to place undue
reliance on these forward-looking statements.
1 https://www.kirby.unsw.edu.au/sites/default/files/documents/Annual_Surveillance_Report_2024_STI_1.pdf
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of Entity
Atomo Diagnostics Limited
ABN
Quarter Ended ("current quarter")
37 142 925 684
30 June 2025
Consolidated statement of cash flows
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Year to date
(12 months)
A$'000
Current Quarter
A$'000
1,040
4,756
(a) research and development
( 62)
( 255)
(b) product manufacturing and operating costs
( 517)
( 3,466)
(c) advertising and marketing
( 40)
( 115)
(d) leased assets
-
-
(e) staff costs
( 803)
( 3,382)
(f) administration and corporate costs
( 437)
( 1,757)
-
-
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
485
2,209
1.8
Other (provide details if material)
1.9
Net cash from / (used in) operating activities
( 323)
( 1,952)
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) entities
-
-
(b) businesses
-
-
10
(c) property, plant and equipment
(d) investments
0
-
(e) intellectual property
(f) other non-current assets
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
59
( 34)
-
0
( 7)
-
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
2.2
Year to date
(12 months)
A$'000
Current Quarter
A$'000
Proceeds from disposal of:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments
(e) intellectual property
(f) other non-current assets
-
-
2.3
Cash flows from loans to other entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash from / (used in) investing activities
3.
Cash flows from financing activities
3.1
0
( 41)
Proceeds from issues of equity securities
(excluding convertible debt securities)
1,762
1,762
3.2
Proceeds from issue of convertible debt
securities
-
-
3.3
Proceeds from exercise of options
-
3.4
Transaction costs related to issues of equity
securities or convertible debt securities
3.5
3.6
( 110)
( 110)
Proceeds from borrowings
-
-
Repayment of borrowings
Transaction costs related to loans and
borrowings
( 51)
( 190)
3.8
Dividends paid
-
3.9
Other (provide details if material)
-
3.10
Net cash from / (used in) financing activities
4.
Net increase / (decrease) in cash and
cash equivalents for the period
3.7
-
1,602
1,462
4.1
Cash and cash equivalents at beginning of
period
1,971
3,688
4.2
Net cash from / (used in) operating activities
(item 1.9 above)
( 323)
( 1,952)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
0
( 41)
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Year to date
(12 months)
A$'000
Current Quarter
A$'000
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
1,602
1,462
4.5
Effect of movement in exchange rates on cash
held
( 31)
62
4.6
Cash and cash equivalents at end of period
3,220
3,220
5.
Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current Quarter
A$'000
Previous Quarter
A$'000
5.1
Bank balances
3,220
1,971
5.2
Term deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of quarter
(should equal item 4.6 above)
3,220
1,971
6.
Payments to related parties of the entity and their
associates
Current Quarter
A$'000
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
155
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.
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
Total facility
amount at quarter
end
A$'000
Amount drawn at
quarter
end
A$'000
sources of finance available to the entity
7.1
Loan facilities
-
-
7.2
Credit standby arrangement
-
-
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.
8.
Estimated cash available for future operating activities
8.1
Net cash from / (used in) operating activities (Item 1.9)
( 323)
8.2
Cash and cash equivalents at quarter end (Item 4.6)
3,220
8.3
Unused finance facilities available at quarter end (Item 7.5)
8.4
Total available funding (Item 8.2 + Item 8.3)
3,220
8.5
Estimated quarters of funding available (item 8.4 divided by
10.00
-
A$'000
-
item 8.1)
8.6
If Item 8.5 is less than 2 quarters, please provide answers to the following questions:
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: Not applicable.
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: Not applicable.
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: Not applicable.
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
2
This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
This statement gives a true and fair view of the matters disclosed.
Date: 29 July 2025
Authorised by: ..........The Board
(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
Share your feedback
Discover