27/03/2025 07:30
CROSSJECT reports financial results for 2024
Télécharger le fichier original

INFORMATION REGLEMENTEE

Press Release

CROSSJECT reports financial results for 2024

• Continued satisfactory production of regulatory batches with a view to filing in Q2
2025.
• Recruitment of Tony Tipton as Chief Operating Officer USA.
• Visibility gained on pipeline programs developed in collaboration with Eton
Pharmaceuticals, Inc (Eton).
• Cash position increasing significantly to 7 million euros as of December 31, 2024.



Dijon, France, March 27, 2025 (07.30 CET) – CROSSJECT (ISIN : FR0011716265 ;
Euronext : ALCJ) a specialty pharmaceutical company in late-stage development and
registration of ZEPIZURE®, its emergency solution for the management of epileptic
seizures, announces progress in its clinical and regulatory development activities and
commercial strategy in the United States, and publishes its financial results for the year
ending December 31, 2024.

Patrick ALEXANDRE, Chairman of the Executive Board of CROSSJECT, announces:
We continue to make progress towards the major inflection points that will transform
CROSSJECT in 2025 and are likely to generate substantial shareholder value in the years to
come.
The execution of our contract with the Department of Health and Human Services;
Administration for Strategic Preparedness and Response / BARDA for $92 million, which
could rise to $155 million if all its options are exercised, has continued as planned and is
accelerating in line with the increase in expenses linked to the development of ZEPIZURE®. In
2024, we recorded research and development costs re-invoicing of 8.2 million euros,
compared with 6.2 million euros in 2023. This contract with BARDA, registered under number
75A50122C00031, includes up to $32 million to advance the development of ZEPIZURE®
through to Food and Drug Administration (FDA) approval for the management of status
epilepticus in adults and children over 2 years of age in the United States. It also provides for
the supply to the US Government of $60 million worth of ZEPIZURE®, following FDA approval
under the Emergency Use Authorization (EUA) procedure. This milestone is the focus of our
activities today.
Our recent exchanges with the FDA have clarified the requirements for our ZEPIZURE®
product in the treatment of epileptic seizures resulting from poisoning by a neurotoxicant or
insecticide under this emergency procedure (EUA), and we estimate that a response from the
FDA might be obtained in 2025.
1
In terms of industrial production, we have achieved major successes in 2024 and in 2025, and
we continue to work with our Contract Development Manufacturing Organisation (CDMO) to
finalize the dossier that BARDA will submit to the FDA.
Our supply-chain organization, which today includes Eurofins Scientific as an injectables
specialty manufacturer, has confirmed its performance and achieved stability for its
regulatory ZEPIZURE® batch produced in July 2024. The manufacture of additional validation
batches, including aseptic filling operations at Eurofins Scientific, is currently underway and
is proceeding successfully. These core production steps support the previously announced
timetable for BARDA's submission to the FDA under the EUA procedure.
At the same time, CROSSJECT expects to file a New Drug Application (NDA) with the FDA in
the by mid-2026 for the commercialization of ZEPIZURE® in the United States for the
treatment of status epilepticus. We are focused on the final stages of development, with the
preparation of a bioequivalence study that will form an integral part of the New Drug
Application (NDA). This study will mimic our previous bioequivalence study, published on
November 02, 2022, yet using a US-registered reference product as comparator, and will be
at the same dose of 10mg. It will also include an arm with a 5mg dose to enable ZEPIZURE®,
from launch, to compare directly with the intranasal competition, while progressing towards
subsequent pediatric approval.
As previously stated, CROSSJECT intends to retain the commercial rights to ZEPIZURE® in
the United States. In this context, we have strengthened our US team with Tony Tipton, US
Chief Operating Officer, a specialty pharmaceutical professional with the experience,
including with BARDA, and leadership necessary for the success of ZEPIZURE®.
The funds obtained from BARDA from their commercial orders, subject to EUA, will timely help
finance ZEPIZURE®'s development towards its NDA in status epilepticus, beyond its EUA, and
in broader epilepsy indications. BARDA's commercial orders will also support the commercial
roll-out of ZEPIZURE®.
Based on historical data, we believe that the ZENEO® platform will continue to demonstrate
its ability to reproduce the intramuscular injections of traditional injectables with a high level
of precision and low variability. These characteristics of ZENEO, now firmly established, will
be essential not only to limit the risks associated with development and the regulatory
environment, but also to promote market acceptance in the face of traditional injectable
products and other delivery methods, particularly intranasal. The latter products have more
variable transmucosal pharmacokinetics, which adds to the practical difficulties of precise
administration during seizures.
Beyond ZEPIZURE®, our next two main R&D programs, ZENEO® Hydrocortisone and
ZENEO® Adrenaline, are also progressing towards filing for registration from H2 2026 onward
in the US or Europe.
In July 2024, we were awarded a €6.9 million BPI grant as part of the France 2030 plan, which
will contribute to the development of ZENEO® Adrenaline.
Furthermore, in March 2025, we announced progress in the development of ZENEO®
Hydrocortisone by our US partner Eton Pharmaceuticals, Inc (Eton). CROSSJECT has
strengthened its collaboration with Eton by making its innovative hydrocortisone formulation
(the “CROSSJECT formulation”) available to address the hospital market for adrenal
insufficiency. CROSSJECT will receive a royalty of around 10% on Eton's net sales. Eton has
confirmed its commitment to finalizing the development and manufacturing stages of its
adrenal insufficiency product range, including such CROSSJECT formulation, referred to as
2
ET-800, and the unique ZENEO® Hydrocortisone crisis management product, with the aim of
capturing a significant share of a total market opportunity of over $200 million in the United
States alone. FDA filings are expected from H2 2026 onward.
All these positive elements have been opportunities to strengthen our balance-sheet, which
we recently consolidated with a financing with Heights Capital Management (HCM) of 12
million euros in February 2024, with a first tranche of 7 millions euros raised at closing, and
amended on the occasion of our private placement in December 2024 of over 7 million euros,
in which HCM and Gemmes Venture participated, as described below. These transactions with
renowned institutional investors, including US investors, were complemented by a capital
increase of 8 million euros in June 2024, which was fully covered by the subscriptions of our
existing investors.
In coordination with the progress of ZEPIZURE® towards its market authorizations and the
progress of our other two R&D programs, we continue to actively explore the best ways of
financing our rapidly expanding global activities.
Philippe Monnot, one of the Founders and Chairman and CEO of Gemmes Venture, our
reference shareholder, has confirmed his support, in addition to Gemmes Venture's
unwavering participation in the June and December 2024 financings:
“The Company's clinical data and recent developments in CROSSJECT's supply chain and
constructive exchanges with the FDA have continued to reinforce our confidence in the
imminence of the introduction of a major treatment for epileptic seizures, a poorly controlled
disease that continues to generate significant clinical needs. What's more, CROSSJECT has
delivered several successes with other product candidates in its pipeline, which are exciting
preludes to future developments and market launches of other revolutionary injectable
products. We reiterate our support for the company and its management.”
Thank you, dear shareholders, for your loyal attention, and for your continued support of our
efforts. Together, we can improve patients' lives and create value for CROSSJECT.



Key financial information at December 31, 2024 (unaudited)
In 2024, we continued to finance the development of ZEPIZURE® and other pipeline
products, as well as our infrastructure, from several sources:

• BARDA invoicing: 8.2 million euros were invoiced as reimbursement of R&D costs
incurred in 2024, compared with 6.2 million euros in 2023.
• Research tax credit: 2.8 million recognized in 2024, stable compared with 2023.
• In February 2024, the company issued a convertible and/or redeemable bond in
two tranches to Heights Capital Management (HCM), an institutional investor
specializing in growth companies, for a maximum amount of 12 million euros at that
date. The first tranche of 7 million euros was received at closing, or 6.3 million euros
net. The second tranche of this bond was cancelled and replaced by a new
agreement in December 2024 concomitant with the private placement, described
below, in which Heights participated, and an issue of a reduced tranche of
Convertible Bonds of 2.5 million euros in February 2025 following our Extraordinary
General Meeting on January 31, 2025.
• In June 2024, the company raised around 7.6 million euros net through a capital
increase without pre-emptive rights to support the development of ZEPIZURE®.


3
• In July 2024, the French government awarded CROSSJECT 6.9 million euros as part
of a call for projects under the France 2030 plan, aimed at supporting companies
with high growth and innovation potential. An advance payment of 1.7 million euros
was made in 2024, with the remainder expected in 2025 and 2026.
• In August 2024, CROSSJECT also finalized the work related to the “Stimulus Plan”
grant and collected the balance of 0.6 million euros in September.
• In December 2024, the company carried out a private placement with mainly US
institutional investors, joined by HCM and Gemmes Venture, accompanied by a
warrant issue for a total net amount of 6.6 million euros. In parallel with the
transaction, the Company has agreed with HCM to amend the terms and conditions
of the existing convertible bonds in February 2024. The amendments, as detailed
below, mainly provide for (i) the issue of a second tranche of around 2.5 million
euros, which would no longer be subject to the FDA's Emergency Use Authorization
for ZEPIZURE® and (ii) an extension of the maturity date of the convertible bonds
to December 28, 2027.


The table below summarizes our income statement for the years ended December 31,
2024 and 2023:

€ thousands, as of 31 December 2024 2023

Operating income 13 256 13 326

Operating expenses -26 219 -25 125

Purchase of raw material and supplies -1 624 -1 595

Other purchases and external expenses -10 439 -8 869

Personal expenses -7 797 -7 714

Taxes and duties -280 -267

Depreciation, amortisation and provision -5 671 -6 186

Other expenses -408 -494

Operating profit/loss -12 962 -11 800

Financial income/expense -1 429 -497

Exceptional income/expense -1 230 791

Corporate tax 2 826 2 867

Net profit/loss -12 795 -8 639
*2024 accounts unaudited.


4
In 2024, we continued to strengthen our research and development activities as well as
our general operations. As a result, we recorded operating income of 13.3 million euros,
stable compared to 2024 but including a marked increase of 2 million euros in BARDA
income.
Operating expenses increased by 4% in 2024 compared to 2023.

In addition, other purchases and external expenses amounted to €10.4 million, compared
with €8.9 million in 2023, while the company has maintained the pace of its production
work and third-party purchases as part of ZEPIZURE® regulatory development and
activities related to other key programs in our pipeline. We have also incurred additional
expenses in connection with fees related to financing transactions.
As of December 31, 2024, CROSSJECT had 106 employees in France and 2 in the US, a
decrease of 5% compared to 2023. Personnel expenses amounted to 7.8 million euros in
2024, compared with 7.7 million euros in 2023, an increase of 1%.
We recorded an operating loss of 13.0 million euros, compared to 11.8 million euros in 2023.
We recorded a net financial result of -1.4 million euros in 2024, compared to -0.5 million
euros in 2023. The increase is mainly due to interest expenses on the HCM convertible
bond for an amount of €0.6 million. and to a depreciation of the securities under self-
control and liquidity contracts of €0.4M.
After taking into account the exceptional result of -1.2 million euros and a tax credit of 2.8
million euros, net profit for 2024 is -12.8 million euros compared to -8.6 million euros in
2023.



Cash position
At 31 December 2024, CROSSJECT had cash of approximately €7 million compared to €2
million in 2023.
Since the beginning of 2025, we have continued to make financing our priority.
Based on its financial resources as at March 31, 2025 and historical relationships with its
lenders and creditors [as well as with its investors, the company is confident in its ability to
finance its business plan until the date when BARDA’s first commercial orders will start.
As the outlook for ZEPIZURE® improves and as CROSSJECT devotes resources to
research and development of its other candidate products, ZENEO® Hydrocortisone and
ZENEO® Adrenaline, the company will continue to actively explore the best ways to
finance its activities through equity, debt, public funding and other types of financing
throughout 2025.



Important steps in 2024
Non-dilutive funding related to ZENEO® Adrenaline
In July 2024, the French Government granted 6.9 million euros to CROSSJECT as part of
projects under the France 2030 plan, aimed at supporting companies with high growth and
innovation potential. An advance of €1.7 million was paid in 2024.

5
Funding with Heights Capital Management
In February 2024, the company issued a convertible and/or repayable bond in two
tranches to Heights Capital Management (HCM), an institutional investor specialized in
growing companies, for a maximum amount of 12 million euros in two tranches, on that
date. CROSSJECT then raised the first tranche of 7 million euros and received 6.3 million
euros net. The second tranche of this bond was cancelled and replaced by a new
agreement in December 2024, concurrent with the private placement, in which Heights
participated and an issue of a reduced tranche of 2,5 million euros in February 2025
following our Extraordinary General Meeting of 31 January 2025, as described below.

Other dilutive financing
In June 2024, CROSSJECT announces the success of its capital increase with
maintenance of the preferential subscription right for a gross amount of approximately
8 million euros, as announced on April 30, 2024, and a net amount of approximately 7.6
million euros. This funding is an important step in the further development and
recording of ZEPIZURE® and the establishment of operations in the United States in
anticipation of its direct marketing. The subscriptions of CROSSJECT’s shareholders,
including Gemmes Venture, allowed for a full coverage of the transaction.
In December 2024, as part of its private placement of 7 million euros, or 6.6 million
euros net, the Company also amended its agreement with HCM to accelerate the
provision of financing, amendments that were approved by the Extraordinary General
Assembly of 31 January 2025.
According to these amendments, the Company agreed with Heights Capital
Management (“HCM”) on a modification of the terms and conditions of the existing
convertible bonds issued for the benefit of an entity advised by Heights (the “Investor”)
in February 2024. These amendments, as detailed below, included the issuance of a
second tranche of approximately €2.5 million, which would no longer be subject to
FDA Emergency Use Authorization for ZEPIZURE® and an extension of the maturity of
convertible bonds until December 28, 2027.


Progress in the production of ZEPIZURE® regulatory batches with Eurofins
Scientific
In July 2024, CROSSJECT achieved several key milestones in the production and batch
stability of ZEPIZURE® products. Indeed, CROSSJECT announced the successful
completion of a new regulatory batch of ZEPIZURE® in the qualified facilities of
Eurofins Scientific. CROSSJECT also announced a new important milestone that
complements the successful results achieved with previous batches in stability
studies, continuing the positive manufacturing data generated since 2021.
Then, in March 2025, CROSSJECT announced the 6-month ambient temperature
stability of its regulatory batch which is adding to 9-month data generated on a
previous batch produced by Eurofins Scientific in December 2023. Historically,
CROSSJECT also reported several positive audits of production sites, conducted in
anticipation of possible inspections that the Food and Drug Administration (FDA) could
conduct as part of the emergency procedure (EUA).

6
These successes are part of the continuity of the positive audits of the Dijon and Gray
CROSSJECT production sites in 2024, which expanded their scope of certification by
the National Agency for Drug and Health Product Safety (ANSM) and crystallized the
previous positive findings of the BARDA audit.
Production batches are a key part of the FDA’s EUA submission for marketing
authorization for ZEPIZURE®. This data will also be part of the US market (NDA)
marketing authorization application for ZEPIZURE®.
Recruitment of Tony Tipton as US Chief Operating Officer
CROSSJECT announced on August 19, 2024 the appointment of Tony Tipton, an
experienced executive in the field of pharmaceutical specialties, as Director of
Operations for the U.S. With more than 25 years of experience in the field of marketing,
he brings his expertise in corporate governance and development, market access,
commercial service management, marketing and business operations. He joined
CROSSJECT after serving as Director of Operations and Commercial Affairs at Xequel
Bio, where he was responsible for marketing strategy and pre-sales commercial
activities for assets funded by BARDA and the American Institutes of Health (NIH) as
well as acquired commercial assets. The appointment of Mr. Tipton will strengthen
CROSSJECT’s pre-commercial activities in the US during the preparation of
ZEPIZURE® market authorization application.
CROSSJECT’s gender equality index reached 93/100 in 2024
For the third year in a row, CROSSJECT’s Gender Equality Index is above 90%. The
Gender Equality Index is a tool to measure progress on gender equality across the EU.
It is rated on a scale of 1 to 100, where 100 means total equality.


Post-period events
In addition to the positive events related to the production of ZEPIZURE® following
the successes of 2024, and the milestones related to the financing announced in
December 2024 described above, CROSSJECT delivered other positive news in the
first quarter of 2025:
Progress in collaboration with license partner Eton Pharmaceuticals, Inc. and initial
market opportunity estimates
As part of the development of ZENEO® Hydrocortisone, CROSSJECT has developed a
unique ready-to-use liquid formulation of hydrocortisone. This formulation represents a
significant innovation in the US market where formulations such as Pfizer’s Solu-Cortef®
are effective solutions but require more than 10 steps for reconstitution and blending. As
part of joint efforts to provide new solutions for patients with adrenal insufficiency, Eton
will develop and market this CROSSJECT formulation as a superior alternative to current
injectable products. CROSSJECT will collect a royalty of close to 10% on net sales by Eton
of this product, called ET-800 in the Eton pipeline, and retain the right to market the
product outside the United States and Canada. Eton hopes to capture a significant share
of this hospital market of approximately $100 million for injectable hydrocortisone
products.


7
At the same time, Eton confirmed its commitment to ZENEO® Hydrocortisone as a
disruptive solution for patients with adrenal insufficiency in its latest investor presentation
dated 18 March 2025. The next stages of development and manufacturing, according to
CROSSJECT’s plans, are expected from early 2026. Eton’s preliminary assessment of the
market opportunity for ZENEO® Hydrocortisone would exceed $100 million.

****
About CROSSJECT

CROSSJECT SA (Euronext: ALCJ; www.CROSSJECT.com) is an emerging specialty
pharmaceuticals company developing medicines for emergency situations harnessing its
award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced
regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a
$60 million contract* with the U.S. Biomedical Advanced Research and Development
Authority (BARDA). The Company’s versatile ZENEO® platform is designed to enable
patients or untrained caregivers to easily and instantly deliver a broad range of emergency
drugs via intramuscular injection on bare skin or even through clothing. The Company’s
other products in development include mainly solutions for allergic shocks and adrenal
insufficiencies, as well as therapies and other emergency indications.

* This project has been supported in whole or in part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and
Development Authority (BARDA), under contract number 75A50122C00031.


For further information, please contact:




Investor Relation
investors@crossject.com




8
APPENDICES – UNAUDITED FINANCIAL STATEMENTS

INCOME STATEMENT (in K€) 31/12/2024 31/12/2023 VARIATION



Revenue 0 145 -145

Other income BARDA 8 168 6 231 1 937

Subsidies 1 332 133 1 199

Stored production 30 591 -561

Capitalized production 2 783 3 594 -811

Reversals of provisions and
944 2 631 -1 687
transfers of expenses
Operating income 13 256 13 326 -70

Purchases of raw materials
2 004 1 625 379
and other supplies
Change in inventory (raw
-381 -29 -352
materials and other supplies)
Other purchases and external
10 439 8 869 1 570
expenses
Taxes and duties 280 267 13

Personnel expenses 7 797 7 714 83

Depreciation, amortization 4 847 4 504 343

Other provisions 825 1 682 -857

Other expenses 408 494 -86

Operating expenses 26 219 25 126 1 093

Operating profit/loss -12 962 -11 800 -1 162

Financial income/expense -1 429 -497 -932

Exceptional income/expense -1 230 791 -2 021

Research Tax Credit 2 826 2 867 -41

Net profit/loss -12 795 -8 639 -4 156

9
BALANCE SHEET - ASSETS (in
31/12/2024 31/12/2023 VARIATION
K€)

FIXED ASSETS

R&D 9 591 10 730 -1 139

Patent and Trademarks 0 0 0

Other intangible assets 5 0 5

Property, plant and equipment 2 126 2 750 -624

Assets under construction 2 924 2 942 -18

Financial assets 1 041 1 544 -503

TOTAL FIXED ASSETS 15 687 17 966 -2 279

CURRENT ASSETS

Raw materials, other supplies 1 970 1 649 321

Work in process 1 448 1 485 -37

Other receivables 4 295 4 778 -483

Marketable securities 0 0 0

Available cash 7 036 2 304 4 732

Prepaid / deferred expenses 1 131 459 672

TOTAL CURRENT ASSETS 15 880 10 675 5 205

TOTAL ASSETS 31 567 28 641 2 926




10
BALANCE SHEET - LIABILITIES (in
31/12/2024 31/12/2023 VARIATION
k€)

CAPITAUX PROPRES

Capital 4 554 3 676 878

Share premium 7 192 785 6 407

Regulated reserve 0 0 0

Retained earnings -2 596 -1 757 -839

Profit/loss for the year -12 795 -8 639 -4 156

Investment subsidies 972 665 307

TOTAL SHAREHOLDERS' EQUITY -2 673 -5 269 2 596

Conditional advances 5 391 7 060 -1 669

Provision for contingencies and
910 694 216
charges

BORROWINGS AND DEBT

Bonds 5 478 19 5 459

Loans 12 874 16 171 -3 297

2 717 2 732 -15
Miscellaneous
4 554 4 324 230
Debts - Trade payables

Total tax and social security 1 700 2 148 -448
liabilities
0 82 -82
Debts on fixed assets
616 681 -65
Deferred income

TOTAL DEBT 27 939 26 156 1 783

TOTAL EQUITY AND LIABILITIES 31 567 28 641 2 926


11
CASH FLOW STATEMENT (IN K€) 31/12/2024 31/12/2023

Net profit / loss - 12 795 - 8 638
Depreciation, amortisation and provision 5 220 3 091
Net Book Value of Assets (NBV) 795 54
Other income and expenses calculated - 28 - 28
Share of subsidy transferred to result - 253 -
Cashflow from operations - 7 061 - 5 521
Change in working capital requirements - 896 - 680

(1) Net cash generated by / (used in) operating - 7 957 - 6 201
activities
Acquisition of fixed assets - 3 527 - 6 403
Disposal of fixed assets 100 3 767
(2) Net cash generated by / (used in) investing
- 3 426 - 2 636
activities
Capital increase 878 13
Exercice of warrants - 333
Additional Paid-in Capital (APIC) 14 207
Bonds 5 460 -
Loans - 8 090
Repayment of borrowings / security deposit - 3 224 - 3 396
Subsidies 560 -
Debts on fixed assets - 82 - 1 682
Repayment advances - 1 668 -

(3) Net cash generated by / (used in) financing 16 130 3 358
activities



Change in cash and cash equivalents (1)+(2)+(3) 4 746 - 5 480


Opening Cash position 2 291 7 770
Closing Cash position 7 038 2 291




12