Crossject presents financial results and business highlights for the first six months of 2024.

• Available cash: €5.95 million, compared with €2.3 million at December 31, 2023.
• Reports stable investment in R&D and consolidation of BARDA operating income
• The company is on track to successfully submit an application for emergency use authorization for the rescue treatment of epilepsy in early 2025.

Dijon, France, September 23, 2024, 6:00 PM CET — Crossject (ISIN: FR0011716265; Euronext: ALCJ), a pharmaceutical company specializing in the development of the award-winning ZENEO® needle-free autoinjector for the delivery of life-saving medications in emergency situations, today announced its financial results for the six months ended June 30, 2024, as well as an update on key business events.

During the reporting period, Crossject continued to work with U.S. regulatory authorities and the U.S. Biomedical Advanced Research and Development Authority (BARDA), confirming its strategy to focus on obtaining regulatory approvals and strengthening its commercial presence in the U.S. as it expects to be able to achieve profitability based on U.S. sales of Zepizure® alone. The company expects to file an Emergency Use Authorization (EUA) application for ZEPIZURE® early next year and receive a response from the FDA shortly thereafter. A positive response will allow the company to fulfill its first sales order from BARDA.¹In parallel, Crossject expects to submit a New Drug Application (NDA) for ZEPIZURE® in the first half of 2025, which would grant marketing authorization as part of its overall U.S. commercialization strategy.

“Crossject has accelerated its progress, strengthened its balance sheet and achieved several new milestones over the past year. We are now at a stage where we can look ahead to our first product candidate, ZEPIZURE®“, coming to market,” said Patrick Alexandre, CEO of Crossject. “We look forward to a number of important milestones to grow our business during 2025. The $92 million agreement with US BARDA (total value of $155 million if all options are exercised) is a cornerstone of our commercialization strategy in our largest market, and we have strengthened our senior management team in the US with two recent additions.”

The Company is progressing through the final stages of development of ZEPIZURE® in epilepsy crises, including an upcoming pivotal 505(b)(2) bioequivalence study, which the Company says will be the final step in its U.S. Non-Drug Adjudication Application (NDA). This will follow on from the successful completion of a bioequivalence clinical study in 2022, the results of which were published in May 2024.

The Company also completed several regulatory and pre-commercialization steps for Zepizure® in the U.S., supported by Syneos Health, a leading biopharmaceutical solutions company, and continued to build its infrastructure in North America. The Company appointed several new senior executives, including Dr. Dan Chiche, a seasoned life sciences executive, as Chief Medical Officer, North America. In Europe, Crossject expanded the geographic scope of its ZEPIZURE® commercialization agreement through 2023, which now includes 11 European countries.

In the first half of 2024, Crossject also strengthened its balance sheet. In February, it issued convertible and/or refundable bonds in two tranches to Heights Capital Management, an institutional investor specializing in growth companies, for a maximum amount of EUR 12 million, of which the company earned EUR 6.3 million. In June, the company raised approximately EUR 7.6 million net through a rights issue aimed at supporting the development of ZEPIZURE®. Given the ongoing contracts, including monthly invoicing for BARDA, and the high visibility that Crossject has gained in recent months, the company is confident in its ability to secure the necessary financing to continue its growth.

Finally, in terms of clinical progress, Crossject published new data on ZEPIZURE® in an article in Neurology and Therapy in May, presenting the full results of a clinical trial conducted in 2022, showing that ZENEO® enables the injection of midazolam for the treatment of epileptic seizures intramuscularly, on bare skin or through clothing, to the same extent as a syringe equipped with a 30 mm needle (Dormicum®). Crossject also highlighted a two-fold lower variability compared to that observed with other routes of administration, such as intranasal.

Outside the reporting period, from 1 July 2024, Crossject has added further important events to the list.

• In July, Crossject completed the registration of a new batch of ZEPIZURE® at Eurofins, the CDMO designated to handle the filling and finishing activities for deliveries to BARDA.
• Also in the same month, the French government awarded Crossject €6.9 million under the call for projects under Plan France 2030, which aims to support companies with exceptional growth and innovation potential.
• In August, Crossject appointed Tony Tipton, an executive with extensive experience in pharmaceutical commercialization, as U.S. chief operating officer.

See also appendices 1 (profit and loss account), 2 (balance sheet, assets) and 3 (balance sheet, liabilities).

About Crossject

Crossject S.A. (Euronext: ALCJ; www.crossject.com) is a growing pharmaceutical company specializing in this field. It is in advanced regulatory development of ZEPIZURE®, a rescue therapy for epilepsy, for which it has a $60 million contract with the U.S. Biomedical Advanced Research and Development Agency (BARDA). ZEPIZURE® is based on the award-winning ZENEO® needle-free autoinjector, designed to enable patients and untrained caregivers to easily and immediately administer rescue medications via intramuscular injection onto bare skin or even through clothing. The company’s other products in development include rescue therapies for allergic shock, adrenal insufficiency, opioid overdose and asthma attacks.

For more information please contact:

Investors Natasha Drapeau Office of Cohesion +41 76 823 75 27 [email protected] Annex 1

Media Sophie Baumont Office of Cohesion +33 6 27 74 74 49 [email protected]

Profit and Loss Account, H1 2024 vs. H1 2023

(Thousands of euros)	06/30/2024	06/30/2023
Operating income	5 766	7 926
BARDA revenues	3 063	2 987
Capitalized production (1)	1 565	3 017
Production of stocks	354	77
Other income	784	1 846
Operating costs	-12 485	-14 461
Purchase of raw materials and supplies	-695	-576
Other purchases and outside expenses	-5 005	-4 456
Personnel costs	-3 950	-4 098
Taxes and customs duties	-100	-120
Depreciation and reserves (1)	-2 517	-4 952
Other expenses	-218	-258
Operating profit/loss	-6 719	-6 535
Financial income/expenditures	-994	-263
Extraordinary income/expense	-330	585
Tax relief for research	1 641	1 651
Net profit/loss	-6 402	-4 562

The financial statements were approved by the Management Board on 23 September 2024 and presented to the Supervisory Board on the same day.

(1) The change in capitalized production and the corresponding depreciation is related to the change in the valuation of research and development expenses capitalized at the end of the 2023 financial year.

In the first half of 2024, Crossject’s operating income from advanced regulatory development work supported by BARDA was $3.3 million, up slightly from $3.2 million in the same period in 2023. Investments in research and development remained stable. Net income variability was primarily due to the amortization of securities, with no significant changes attributable to operating activities.

Annex 2

Balance assetsJune 30, 2024 vs. December 31, 2023

(Thousands of euros)	06/30/2024	31.12.2023	Difference
FIXED ASSETS
Research and development	10 238	10 730	-492
Patents and trademarks	0	0	0
Other intangible assets	0	0	0
Land, real estate, plants and equipment	2 240	2 750	-510
Assets under construction	3 821	2 942	879
Financial assets	996	1 544	-548
TOTAL FIXED ASSETS	17 295	17 966	– 671
CURRENT ASSETS
Raw materials, other supplies	2 021	1 648	373
Work in progress	2 364	1 485	879
Other receivables	4 066	4 778	-712
Cash available	5 952	2 304	3 648
Prepaid/Deferred Expenses	1 430	460	971
TOTAL CURRENT ASSETS	15 833	10 675	5 158
TOTAL ASSETS	33 128	28 641	4 487

Annex 3

Balance debt,June 30, 2024 vs. December 31, 2023

(Thousands of euros)	06/30/2024	31.12.2023	Difference
RIGHT
Capital	4 109	3 676	433
Share premium	110	785	-675
Adjustable reserve	0	0	0
Retained earnings	-2 596	– 1 757	– 839
Profit/loss for the year	-6 402	-8 639	2 237
Investment grants	665	665	0
Total equity capital	-4 114	-5 270	1 156
Conditional advances	5 878	7 060	-1 182
Reserve for unforeseen events and costs	739	694	45
LOANS AND DEBT
Bonds	6 738	19	6 719
Loans	14 526	16 171	-1 645
Various	2 721	2 741	-20
Debts – trade liabilities	4 458	4 323	135
Total tax and social security liabilities	1 510	2 148	-638
Fixed assets debt	0	83	-83
Deferred revenue	672	672	0
TOTAL DEBT	30 625	26 157	4 468
Total equity and liabilities	33 128	28 641	4 487

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¹Contract Number: 75A50122C00031 with Department of Health and Human Services; Strategic Preparedness and Response Administration; Biomedical Research and Development Administration

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