Quarterly Activities/Appendix 4C Cash Flow Report
Released
Released
Announcement PDF
ASX Announcement
Quarterly Activities Report & Appendix 4C
Highlights
•
Significant progress in preparing clinical development pathways for Starpharma’s lead
candidates, DEP® SN38 and DEP® cabazitaxel, which is important for ongoing business
development and commercialisation opportunities.
•
DEP® HER2 radiodiagnostic pre-clinical program advancing with valuable feedback from key
opinion leaders (KOLs), clinical sites and contract research organisations (CROs), ensuring we
are well-prepared to begin the first-in-patient clinical trial efficiently.
•
Good progress across existing partnerships, with new collaboration opportunities being
evaluated.
•
Well positioned to accelerate our product pipeline and strategic growth initiatives, with a cash
position of $24.0 million as at 30 September 2024.
Melbourne, Australia; 31 October 2024: Starpharma (ASX: SPL, OTCQX: SPHRY), an innovative
biotechnology company with two decades of experience in advancing dendrimer technology from
the lab to the patient, today releases its Quarterly Activities Report and Appendix 4C for the
quarter ended 30 September 2024 (Q1 FY25). Starpharma’s closing cash balance as at 30
September 2024 was $24.0 million.
Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
“This quarter has been a very important period for advancing the core programs that we anticipate
will deliver the greatest value using our unique, clinically validated dendrimer technology. Our
team remains highly focused on delivering meaningful results through these programs. We are
making significant progress in each of our three strategic priorities outlined in May: maximising
DEP® asset value, accelerating early asset development, and building long-term sustainability.
We are closely monitoring all programs to ensure efficiency and optimal outcomes along with
long-term value creation. We understand that some key results are highly anticipated, and we are
working diligently to achieve these milestones in a timely manner. We look forward to sharing
further updates and engaging with shareholders at the AGM in November.”
Maximising DEP® Asset Value
Ongoing regulatory and business development activities to maximise DEP® asset value
Bringing Starpharma’s priority DEP® clinical candidates, DEP® SN38 and DEP® cabazitaxel, to
market through commercial partners remains the company’s top priority. Following the release of
the Phase II results for these assets and the oral presentations at the American Society of Clinical
Oncology (ASCO) Annual Meeting in June, Starpharma has engaged with multiple companies,
assessed the optimum indications for each asset by region, and prepared clinical development
pathways for interested partners.
In parallel to the Business Development activities, Starpharma has made significant progress with
expert regulatory advisors and key opinion leaders (KOLs) in the relevant cancer fields to outline
the most appropriate clinical development pathway for achieving our desired commercial
outcomes. We will also be meeting with regulators in the coming months to discuss these
indication-specific clinical development pathways. This clinical and regulatory input is being used
to support ongoing business development and scope for commercial deals.
Accelerating Early Asset Development
DEP® radiopharmaceuticals program advancing towards a clinical study
Starpharma has made good progress this quarter in its DEP® radiopharmaceuticals program, both
internally and with potential collaborators in this space.
We are advancing the development of a DEP® HER2 radiodiagnostic candidate with the goal of
advancing a lead candidate that is well-positioned to bring significant value for patients and
provide a competitive advantage in the HER2 diagnostic market. In addition, we have actively
sought input from KOLs and started discussions with potential clinical sites and contract research
organisations (CROs) to ensure we can commence the first-in-patient clinical trial as efficiently
as possible.
Notably, the early-stage data we have generated and presented at conferences in recent months
has sparked significant interest in collaborations from a range of companies in the
radiopharmaceuticals sector.
Research collaborations
A key benefit of Starpharma’s unique dendrimer technology is its applicability across various
therapeutic areas, including drug payloads or radioisotopes. This versatility allows for multiple
parallel collaborations.
This quarter, we have made good progress across our DEP® partnerships, which involve evaluating
Starpharma’s dendrimer technology for the development of early-stage, novel assets. In addition
to our existing collaborations with Petalion, Genentech, and MSD, we are actively engaged with
several companies interested in applying our dendrimer technology to enhance their product
pipelines.
Building Long-Term Sustainability
Ongoing initiatives to increase revenue from VivaGel® BV and Viraleze™
Starpharma's partner for VivaGel® BV in the Middle East and North Africa (MENA) region, ITROM,
is progressing in preparing for the launch of VivaGel® BV in Saudi Arabia. During the quarter,
Starpharma received its first payment from ITROM for supplying product to Saudi Arabia.
Starpharma has parties interested in licensing VivaGel® BV in Europe, including the UK, and we
have advanced technical due diligence and negotiations. The European region is a key market for
the sale of VivaGel® BV, where we have achieved regulatory certification under the new EU Medical
Device Regulations (MDR).
On 18 October 2024, Starpharma announced the withdrawal of its application for marketing
authorisation of the SPL7013 Nasal Spray in Australia. This decision was made after careful
consideration of expert regulatory advice, the long duration of the review and the current status,
and position of the regulator. The Board and management believe that focusing the company’s
resources on higher-priority programs is in the best interest of Starpharma and our shareholders.
The SPL7013 Nasal Spray is registered in over 35 countries, including the UK and Europe, and we
will continue to market the product in these regions with ongoing advertising campaigns in key
2
markets. This quarter, two peer-reviewed journal articles on the SPL7013 (astodrimer) Nasal Spray
were published in the Nature journal, Scientific Reports, and Pharmaceutics.
Q1 FY25 Financial Summary
Starpharma’s cash balance as at 30 September 2024 was $24.0 million, with net cash inflows of
$0.6 million for the quarter. Cash receipts in the quarter included $5.5 million under the Australian
Government’s R&D Tax Incentive program and customer receipts of $0.7 million related to sales
of Viraleze™ and VivaGel® BV and R&D service fees.
Cash outflows for the quarter included research and development (R&D) costs of $2.2 million,
which included close-out expenses associated with the DEP® clinical programs and expenditures
on the DEP® radiopharmaceuticals program. Staffing costs were $2.5 million, including payments
to non-executive and executive directors of $310,000.
About Starpharma
Starpharma ASX: SPL, OTCQX: SPHRY) is an innovative biotechnology company with two decades of experience in advancing
dendrimer technology from the lab to the patient. Our mission is to help patients with significant illnesses, such as cancer, achieve
improved health outcomes and quality of life through the application of our unique dendrimer technology.
Dendrimers are precise, synthetically manufactured, nanoscale molecules. Their unique properties—including their size, structure,
high degree of branching, polyvalency, and water solubility—are advantageous in medical and pharmaceutical applications.
Starpharma’s portfolio of dendrimer-based products includes three clinical-stage DEP® (dendrimer enhanced product) assets,
preclinical radiopharmaceutical assets, research collaborations, and three commercially marketed over-the-counter (OTC) products.
For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn.
The Quarterly Activities Report & Appendix 4C is not subject to formal external audit or review. Management has procedures in place
with relevant staff to allow the CEO and CFO to make appropriate certifications prior to approval.
WE Communications
Hannah Howlett
+61 450 648 064
WE-AUStarPharma@weworldwide.com
Starpharma Holdings Limited
Cheryl Maley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by the
Chair, Mr Rob Thomas.
Forward-Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking
terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”,
“potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied
discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance
or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s
and other authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be
approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding
the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional
analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain
patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and
additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from
those described herein as anticipated, believed, estimated, or expected. Starpharma is providing this information as of the date of this document and
does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or
developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not
necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or
reasonableness of future results. Nothing contained in this document, nor any information made available to you is, or shall be relied upon as, a promise,
representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
3
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
Starpharma Holdings Limited
ABN
Quarter ended (“current quarter”)
20 078 532 180
30-Sep-24
Consolidated statement of cash flows
1.
1.1
1.2
Current quarter
Year to date
(3 months)
$A’000
$A’000
Cash flows from operating activities
Receipts from customers
Payments for
research and development
(a)
product manufacturing and operating costs
(b)
advertising and marketing
(c)
leased assets
(d)
staff costs
(e)
administration and corporate costs
(f)
Dividends received (see note 3)
Interest received
Interest and other costs of finance paid
Income taxes paid
Government grants and tax incentives
Other
Net cash from / (used in) operating activities
650
650
(2,175)
(431)
(17)
(2,507)
(156)
297
(37)
5,527
1,151
(2,175)
(431)
(17)
(2,507)
(156)
297
(37)
5,527
1,151
(31)
(31)
(31)
-
2.3
2.4
2.5
2.6
Cash flows from investing activities
Payments to acquire or for:
(a)
entities
businesses
(b)
property, plant and equipment
(c)
(d)
investments
(e)
intellectual property
(f)
other non-current assets
Proceeds from disposal of:
(a)
entities
(b)
businesses
(c)
property, plant and equipment
(d)
investments
(e)
intellectual property
(f)
other non-current assets
Cash flows from loans to other entities
Dividends received (see note 3)
Other (provide details if material)
Net cash from / (used in) investing activities
3.
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
Cash flows from financing activities
Proceeds from issues of equity securities (excluding convertible debt securities)
Proceeds from issue of convertible debt securities
Proceeds from exercise of options
Transaction costs related to issues of equity securities or convertible debt securities
Proceeds from borrowings
Repayment of borrowings
Transaction costs related to loans and borrowings
Dividends paid
Other (principal repayments on lease liability in compliance with AASB16)
Net cash from / (used in) financing activities
(330)
(193)
(523)
(330)
(193)
(523)
4.
4.1
4.2
4.3
4.4
4.5
4.60
Net increase / (decrease) in cash and cash equivalents for the period
Cash and cash equivalents at beginning of period
Net cash from / (used in) operating activities (item 1.9 above)
Net cash from / (used in) investing activities (item 2.6 above)
Net cash from / (used in) financing activities (item 3.10 above)
Effect of movement in exchange rates on cash held
Cash and cash equivalents at end of period
23,360
1,151
(31)
(523)
(2)
23,955
23,360
1,151
(31)
(523)
(2)
23,955
1.3
1.4
1.5
1.6
1.7
1.8
1.9
2.
2.1
2.2
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
(31)
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
5.
5.1
5.2
5.3
5.4
5.5
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
Bank balances
Call deposits
Bank overdrafts
Other (provide details)
Cash and cash equivalents at end of quarter (should equal item 4.6 above)
6.
Payments to related parties of the entity and their associates
6.1
6.2
Aggregate amount of payments to related parties and their associates included in item 1
Aggregate amount of payments to related parties and their associates included in item 2
Current quarter
$A’000
Previous quarter
$A’000
531
23,424
23,955
531
22,829
23,360
Current quarter
$A'000
310
-
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
Item 6.1 consists of (a) remuneration paid to the Chief Executive Officer; (b) director's fees paid to non-executive directors.
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
1,354
150
1,504
Amount drawn at
quarter end
$A’000
812
24
836
7.1
7.2
7.3
7.4
Loan facilities
Credit standby arrangements
Other (please specify)
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.
668
Item 7.1 consists of $0.8M National Australia Bank master asset finance facility for leased laboratory equipment,
secured against equipment and a term deposit, interest rate 2.8%.
$A’000
8.
8.1
8.2
8.3
8.4
8.5
Estimated cash available for future operating activities
Net cash from / (used in) operating activities (item 1.9)
Cash and cash equivalents at quarter end (item 4.6)
Unused finance facilities available at quarter end (item 7.5)
Total available funding (item 8.2 + item 8.3)
Estimated quarters of funding available (item 8.4 divided by item 8.1)
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?
1,151
23,955
668
24,623
N/A
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 2
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:
31 October 2024
Authorised by: Rob Thomas, Chairman
(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 3
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