Hexima : Quarterly Activities Report and Appendix 4C - Jun-22 Qtr

For personal use only

HEXIMA LIMITED

ASX ANNOUNCEMENT

21 July 2022

QUARTERLY ACTIVITIES REPORT

Second Calendar Quarter 2022

MELBOURNE, AUSTRALIA (21 July 2022): Hexima Limited (ASX:HXL) a clinical stage biotechnology company today releases its Appendix 4C and Use of Funds Statement and sets out below its quarterly activities report for the quarter ended 30 June 2022.

During the quarter under review Hexima:

• Filed an Investigational New Drug Application (IND #142947) with FDA to initiate a Phase I clinical trial in the US evaluate the safety of pezadeftide in a maximal use setting. This IND is now open.
• Completed preparations for the initiation of the phase I US safety study.
• Initiated a 9-month chronic dermal toxicology program of pezadeftide.

On 24 June 2022 Hexima announced that "based on its preliminary review, the results of its phase II clinical study of pezadeftide for the treatment of onychomycosis (HXP124-ONY-002) are inconclusive and will require further detailed investigation and evaluation. The results seen in this study do not appear to correlate with results observed in its prior phase I study (HXP124-ONY-001) and do not support moving directly into a phase III program. Hexima intends to conduct a detailed review of the complete clinical trial data set and study conduct and expects to report its findings when complete."

Following that further detailed review Hexima announced on 11 July 2022 that the study "data provide evidence of modest activity of pezadeftide in the treatment of onychomycosis, an observation generally supported by a post hoc and blinded review of the clinical appearance of the treated nails conducted by an independent clinician, a member of Hexima's Scientific Advisory Board. However, after careful consideration Hexima does not believe the data support the Company's goal of developing a safe, more effective and convenient topical therapy with a shorter course of treatment.

"Accordingly, Hexima intends to wind down its development program of pezadeftide for the treatment of onychomycosis in an orderly fashion and will make no further significant investment."

And continued- "Hexima has initiated a process of exploring strategic options for the Company seeking to secure value for Hexima's intellectual property and residual cash resources. These discussions are very preliminary and the contemplated transaction or transactions may or may not occur. The Board is unable to provide further information at this stage"

This announcement is authorised for release to ASX by Michael Aldridge, Managing Director & CEO Enquiries:

Dr Nicole van der Weerden Chief Operating Officer [e-mail]

To join our email database and receive company announcements please click here

LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086

1

For personal use only

Expected and Actual Use of Funds

				Expected			Actual Use of Funds
	Categories					1 October 2020 to			% of total
			Use of Funds [1]
					30 Jun 2022
				$000's
						$000's
	Phase IIb clinical trial[2]	3,400		5,609		165
	Scale-up of HXP124
	manufacture and production of
	material for toxicology studies[3]	1,200		3,681		307
	Formulation, stability and
	chemistry, manufacture and
	controls[4]	700		1,611		230
	Toxicology studies[5]	2,000		1,839		92
	Market research	100		68		68
	Costs of the offer	700		703		100
	Working capital	2,300		5,402		235
	Totals	10,400		18,913		182

1. Expected Use of Proceeds and Current Cash as set out on page 10 of the Company's Prospectus dated

1. October 2020. Expected Use of Funds is net of the estimated R&D Tax Incentive rebate of 43.5% on eligible activities. For eligible R&D activities, the actual use of funds (when on budget) will therefore be approximately 177% of the expected use of funds.

1. Costs of the phase IIb clinical trial were in line with expectations. Early COVID-19-related delays in recruitment were previously disclosed and have resulted in this expenditure being delayed relative to initial expectations.
2. Costs of the scale-up of HXP124 manufacture were approximately 75% higher than expected due to completion of two additional manufacturing runs to produce material for toxicology studies and to further optimise the manufacturing process.
3. Costs of formulation, stability and chemistry, manufacture and controls were approximately 30% higher than expected due to additional costs relating to manufacture of drug product for toxicology studies and formulation optimisation.
4. Spending on toxicology studies has been lower than expected as an anticipated study that was budgeted was not required and another was rescheduled.

Level 4 LIMS 2, Kingsbury Drive, La Trobe University VIC 3086

1

Rule 4.7B

Appendix 4C

For personal use only

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

Name of entity
Hexima Limited
ABN	Quarter ended ("current quarter")
64 079 319 314	30 June 2022
Consolidated statement of cash flows	Current quarter	Year to date
	$A'000	(12 months)
		$A'000

1. Cash flows from operating activities

1.1	Receipts from customers	113	441
1.2	Payments for
	(a) research and development	(2,934)	(10,435)

1. product manufacturing and operating costs
2. advertising and marketing
3. leased assets

(e)	staff costs	(563)	(2,045)
(f)	administration and corporate costs	(453)	(1,924)

1.3 Dividends received (see note 3)

1.4

Interest received

1

1

1.5 Interest and other costs of finance paid

1.6	Income taxes paid	(1)	(2)
1.7	Government grants and tax incentives	22	3,683
1.8	Other - GST Refund	81	513
1.9	Net cash from / (used in) operating	(3,734)	(9,768)
	activities

2. Cash flows from investing activities

2.1 Payments to acquire or for:

1. entities
2. businesses
3. property, plant and equipment
4. investments
5. intellectual property

ASX Listing Rules Appendix 4C (17/07/20)	Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B

For personal use only

Consolidated statement of cash flows	Current quarter	Year to date
	$A'000	(12 months)
		$A'000

1. 1. other non-current assets
2. Proceeds from disposal of:
3. 1. entities
   2. businesses
   3. property, plant and equipment
   4. investments
   5. intellectual property
   6. other non-current assets
4. Cash flows from loans to other entities
5. Dividends received (see note 3)
6. 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)

11,000

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	(699)
	equity securities or convertible debt
	securities

3.5 Proceeds from borrowings

3.6

Repayment of borrowings

(6)

(24)

1. Transaction costs related to loans and borrowings
2. Dividends paid
3. Other (provide details if material)

3.10 Net cash from / (used in) financing	(6)	10,343
activities

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

4.1 Cash and cash equivalents at beginning of

	period	7,622	3,422
4.2	Net cash from / (used in) operating	(3,734)	(9,768)
	activities (item 1.9 above)

4.3 Net cash from / (used in) investing activities (item 2.6 above)

ASX Listing Rules Appendix 4C (17/07/20)	Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B

For personal use only

Consolidated statement of cash flows	Current quarter	Year to date
		$A'000	(12 months)
			$A'000
4.4	Net cash from / (used in) financing activities	(6)	10,343
	(item 3.10 above)
4.5	Effect of movement in exchange rates on	75	(40)
	cash held
4.6	Cash and cash equivalents at end of	3,957	3,957
	period
5.	Reconciliation of cash and cash	Current quarter	Previous quarter
	equivalents	$A'000	$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	3,956	7,621

1. Call deposits
2. Bank overdrafts

5.4	Other - Petty cash	1	1
5.5	Cash and cash equivalents at end of	3,957	7,622
	quarter (should equal item 4.6 above)
6.	Payments to related parties of the entity and their		Current quarter
	associates		$A'000

1. Aggregate amount of payments to related parties and their associates included in item 1
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)	Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.