Hyloris Pharmaceuticals : 2022 Half-year Report

2022 HALF-YEAR FINANCIAL REPORT

REFORMULATING THE FUTURE

This report is prepared in accordance with article 13 of the Belgian Royal Decree of November 14, 2007. Hyloris publishes its Interim Financial Report in English and French. In the event of differences of interpretation between the English and the French versions of the Report, the original English version will prevail.

TABLE OF CONTENTS

1.	Business Performance Review ........................................................................................................	1
	Key Highlights and Year-to-Date Events .............................................................................................	1
	Outlook for the Next 12 months.........................................................................................................	3
	Significant Events and Transactions....................................................................................................	4
2.	RESPONSABILITY Statement ...........................................................................................................	5
3. Condensed consolidated INTERIM financial statements ................................................................	6
	Condensed Consolidated Statement of Financial Position.................................................................	6
	Condensed Consolidated Statement of Profit and Loss and Other Comprehensive Income.............	7
	Condensed Consolidated Statement of Changes in Equity.................................................................	8
	Condensed Consolidated Statement of Cash Flow.............................................................................	9
4. Notes to the condensed consolidated Interim financial statements ...........................................	10
	1.	General Information .............................................................................................................	10
	2.	Summary of Significant Accounting Policies .........................................................................	10
	3.	Critical Accounting Estimates and Judgments ......................................................................	12
	4.	Financial Instruments Fair Value Disclosures........................................................................	12
	5.	Operating Segments .............................................................................................................	13
	6.	Intangible Assets ...................................................................................................................	13
	7.	(Other) Financial Assets ........................................................................................................	13
	8.	Other Non-Current Assets.....................................................................................................	14
	9.	Trade Receivables and Other Receivables ............................................................................	14
	10.	Other Assets..........................................................................................................................	14
	11.	Equity ....................................................................................................................................	15
	12.	Borrowings and Other Financial Instruments .......................................................................	15
	13.	Trade and Other Liabilities....................................................................................................	16
	14.	Total Revenue and Other Income .........................................................................................	16
	15.	Expenses by Nature...............................................................................................................	17
	16.	Financial Result .....................................................................................................................	18
	17.	Earnings per Share ................................................................................................................	18
	18.	Share-Based Payments..........................................................................................................	19
	19.	Contingencies........................................................................................................................	20
	20.	Commitments and Contingent Liabilities..............................................................................	21
	21.	Related Party Transactions ...................................................................................................	21
	22.	Events after the End of the Reporting Period.......................................................................	24
5.	Statutory auditor's report.............................................................................................................	25
6.	Glossary of terms ..........................................................................................................................	26

HYLORIS - 2022 HALF-YEAR FINANCIAL REPORT

1. BUSINESS PERFORMANCE REVIEW

Key Highlights and Year-to-Date Events

Commercial products

• Sotalol IV, a novel, patented, IV formulation of oral Sotalol for the treatment of atrial fibrillation, and life-threatening ventricular arrhythmias developed for the US:
  During the first six months of 2022, the partner expanded medical and sales teams in order to accelerate commercial roll-out, inclusion in hospital drug formularies and clinical education of hospital staff.
• Maxigesic® IV, a novel, unique combination for the treatment of post-operative pain is currently licensed to partners covering over 100 countries across the globe.
  During the first six months of 2022, the geographical base where Maxigesic IV is approved has been broadened to 40 countries and additional marketing authorizations have been granted in Italy, Norway, Greece, Indonesia, Oman, Netherlands, Portugal, Finland, Bahrain, Kosovo, Singapore and Hong-Kong.
  Marketing authorisations are pending in several additional countries including Canada, Mexico and the US.
  Maxigesic® IV (for the US):
  In July 2022, the United States Food and Drug Administration (FDA) informed Hyloris' development partner, AFT Pharmaceuticals, via a Complete Response Letter (CRL), that it was unable to complete its review of the NDA for Maxigesic® IV and provided specific recommendations needed to address the application's deficiency. Importantly, the agency did not report any issues related to data generated during Maxigesic® IV's clinical development program, and the deficiency is confined solely to the Quality section of the application dossier and related to drug product packaging. Hyloris will generate additional data on extractables and leachables from the packaging components to respond to the FDA's information request. Both parties remain committed to Maxigesic® IV and ensuring the product fulfils its commercial potential in the US. Additional studies as requested by FDA are under preparation and expected to begin in Q4 2022 and will take a few months to complete. Upon the completion of the studies, the submission to FDA will be made.

Other Developments Related to Maxigesic® IV:

Additional patents were granted across multiple jurisdictions including Japan, Singapore, Canada, Mexico, China and the US. , which range in exclusivity from 2035-2038

R&D and regulatory update

• Aspirin IV is a first-in-class intravenous (IV) formulation of acetylsalicylic acid that could significantly improve treatment outcomes of patients with acute coronary syndromes, or ACS. Hyloris and its partner have completed the clinical phase of the study to assess the pharmacokinetics of this product candidate. Hyloris has contracted with a manufacturing organization to produce registration batches in preparation for an NDA submission to the FDA.
• Milrinone is a novel, patented, extended-release capsule that has been developed for twice- a-day, convenient oral dosing for end-stage heart failure (HF) patients with an implanted left ventricular assist device (LVAD) who have developed right HF. The extended release formulation of milrinone in an oral form would provide a steady and predictable exposure of milrinone as well as allow for longer term use in a capsule form. The Company reported it held

HYLORIS - 2022 HALF-YEAR FINANCIAL REPORT

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a successful Type C meeting with the FDA, confirming development plans for an extended- release milrinone capsule in this patient population with a high unmet need.

• • Oral Tranexamic Acid Solution formulation (HY-004):The program is being developed for patients on anti-coagulanttherapies undergoing dental procedures that have a risk of bleeding complication, is progressing to a Phase 3 clinical trial after positive data reported from healthy subjects undergoing tooth extraction.
• AlenuraTM:
  The partner has written and soon will submit to FDA several protocols for the next clinical trials as part of the development of AlenuraTM, a first-line drug treatment for acute pain in interstitial cystitis /bladder pain syndrome (IC/BPS), and the first of these clinical trials should start later this year.
• Miconazole/DB:
  Hyloris is co-developing a topical synergistic combination treatment for Recurrent Vulvovaginal Candidiasis (rVVC), a condition that affects nearly 10 % of women during their lifetime. MCZ/DB has a strong scientific and business rationale. A Phase 2 clinical trial is ongoing and recruitment should be completed by the end of the year.

Other programs:

These added-value programs are on track as planned as stated 6 months ago. Several discussions are being held with regulatory agencies to confirm and validate development plans.

Corporate update

• Successfully raised a total of €17.8 million in gross proceeds, from new and existing, local and international investors, through (1) an equity offering by means of a private placement via an accelerated bookbuild and (2) execution of transaction warrants.
• Renegotiated the Shareholder loan terms resulting in

1. Lower interest rate at 0.75% versus 4% as from 1 January 2022

• 1. Setup new credit line from shareholders covering the portion of reimbursed capital allowing to guarantee the same level of liquidity for the company.
• Hyloris' shareholders approved all resolutions at the 2022 Annual General Meeting.
• Further strengthened the team and built internal capabilities with key hires.

Key Financial Highlights and Analysis of Results of Operations

	Period ended 30 June
(in € thousand)	2022	2021	Variance
Total revenue and income	1,229	1,145	7%
Revenues	1,033	838	23%
Other operating income	196	307 i	(36%)
Cost of sales	(61)	(42)	45%
Operating expenses	(5,986)	(9,016)	(34%)
Research and development expenses	(4,712)	(1,560)	202%
General and administration expenses	(1,274)	(1,608)	(21%)
Other operating expenses (one-off)ii	--	(5,770)	(100%)
Operating result	(4,876)	(7,913)	(38%)

HYLORIS - 2022 HALF-YEAR FINANCIAL REPORT

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