BioSenic reports half year 2024 results
30 September 2024 - 7:00AM
UK Regulatory
BioSenic reports half year 2024 results
REGULATED INFORMATION
The interim financial report is prepared in accordance with article
13 of the Royal Decree on the obligations of issuers of financial
instruments admitted to trading on a regulated market and can be
accessed on the website of Biosenic in the section ‘Financial
reports'. BioSenic publishes its interim financial report in
English. A French translation of the report will also be made
available. In the event of differences between the English and the
French version of the report, the original French version will
prevail.
Mont-Saint-Guibert, Belgium, 30
September 2024, 7am CEST –
BioSenic (Euronext Brussels and Paris: BIOS), the
clinical stage company specializing in serious autoimmune and
inflammatory diseases and cell repair, today publishes its business
update for the first half, ended 30 June 2024, prepared in
accordance with IFRS as adopted by the European Union, and the
outlook for the remainder of the year.
Clinical and corporate highlights of
2024
- In January 2024,
Dr Carole Nicco has been promoted to Chief Operating Officer (COO)
in addition to her position as Chief Scientific Officer (CSO).
- In January 2024,
BioSenic's subsidiary, Medsenic SAS, signed a binding term sheet
with Phebra PTY Ltd. related to an adaptation of the License
Agreement and the MDA signed in May 2021.
- In January 2024,
BioSenic filed for a U.S. patent for JTA-004, a viscosupplement in
late-stage clinical development, following a post hoc analysis
showing its efficacy in a recently defined subtype of
osteoarthritis (OA).
- In January 2024,
BioSenic has been granted a patent by the Canadian Intellectual
Property Office to expand protection of the arsenic trioxide (ATO)
platform. The patent, titled “Use of metal ions to potentiate the
therapeutic effects of arsenic”, covers the use of ATO platform in
combination with metal ions such as copper.
- In March 2024,
BioSenic published an open-access article describing an optimized
schedule for administration of oral arsenic trioxide (OATO)
treatment for chronic graft-versus-host disease (cGvHD), based on
an earlier post-hoc analysis of Phase II data.
- In June 2024,
BioSenic's board of directors acknowledged the resignation of Mr
Yves Sagot as an independent director of the Company, with effect
from the Company's 2024 ordinary general meeting.
- In July 2024,
BioSenic signed of global licensing, supply and commercialization
agreements with Phebra Pty Ltd. related to the adaptation of the
License Agreement and the MDA signed earlier in May 2021, when
Phebra became a minority shareholder in Medsenic SAS.
- In July 2024,
BioSenic filed of the continuation patent application US 18/763,376
with the United States Patent & Trademark Office (USPTO) to
provide protection for the use of arsenic trioxide (ATO) for the
prevention and treatment of sepsis syndrome.
- In July 2024,
BioSenic released new in-depth analysis of its positive phase 2
clinical data for optimal administration scheme for its next
late-stage trial of arsenic trioxide (ATO) targeting cGvHD.
- In August 2024,
BioSenic announced the granting of a key patent by the Japan Patent
Office to expand protection of the arsenic trioxide (ATO)
platform.
- In August 2024,
BioSenic announced that the European Patent Office (EPO) has
granted an important new EU patent to its subsidiary Medsenic
"method for treating relapsing-remitting multiple sclerosis
using arsenic trioxide".
- In September
2024, Véronique Pomi-Schneiter stands down as BioSenic's Deputy
CEO.
Financial highlights of
2024
- In January 2024,
BioSenic signed a new subscription agreement for a maximum EUR 1.2
million convertible bonds facility, arranged by ABO Securities
through its affiliated entity Global Tech Opportunities 15.
- In February
2024, BioSenic raised EUR 500,000 via a private placement.
- In April 2024,
BioSenic filed a debt restructuring plan with the clerk's office of
the Walloon Brabant Enterprise Court, with a view to requesting the
Court to open private judicial reorganization proceedings by
collective agreement and to obtain the agreement of creditors on a
plan to reorganize BioSenic's debt. Please refer to the press
releases of 11 April 2024,12 April 2024 and 26 April 2024 on this
subject for further information.
- In April 2024,
in view of the debt restructuring plan, BioSenic postponed its
annual general meeting of the shareholders.
- In May 2024,
BioSenic provided its business update for the first quarter, ended
the 31 March 2024.
- In May 2024, the
Walloon Brabant Enterprise Court registered the positive votes of
the majority of BioSenic's creditors on the debt restructuring
plan.
- In June 2024,
BioSenic announced its business update and full year financial
results for the year ending 31 December 2023, prepared in
accordance with IFRS.
- In June 2024,
BioSenic received the homologation judgment for the restructuring
plan filed with the Enterprise Court of Nivelles, making it binding
on all deferred creditors, and the measures provided for therein
will continue until June 2029, the end of the five-year period set
by law. The restructuring plan can be accessed via the following
link: https://biosenic.com/sites/default/files/2024-
04/PRJ_BioSenic_FR.pdf
- In June 2024,
BioSenic signed a new subscription agreement for a maximum EUR 2.1
million convertible bonds facility, arranged by ABO Securities
through its affiliated entity Global Tech Opportunities 15.
- During the first
six months of 2024, total operating income amounted to EUR 2.69
million, compared to EUR 0.37 million in H1 2023.
- Operating loss
for the period amounted to EUR 0.47 million, compared to EUR 3.90
million in H1 2023.
- BioSenic ended
the first six months of 2024 with EUR 0.82 million in cash and cash
equivalents. Net cash used for the period amounted to EUR 0.70
million, compared to EUR 1.33 million over the same period of
2023.
Outlook for the remainder of 2023 and
2024
- Following the
homologation judgement of 13 June 2024, BioSenic will take the
necessary decisions to implement the approved plan and, notably, to
retrocede its rights to the JTA and ALLOB technologies to the
Walloon Region and to stop all activities in relation to such
technologies.
- The Medsenic
Phase II clinical study with arsenic trioxide in the first-line
treatment of cGvHD has been completed and provided positive
results. A Phase III study with oral arsenic trioxide in the
first-line treatment of cGvHD, for which Medsenic received positive
pre-IND response from the FDA, is currently anticipated to start in
2024. A Phase IIa clinical trial for systemic lupus erythematosus
("SLE") had previously established safety for the patient and
efficacy on the course of the autoimmune disease. Positive
preclinical work gives good grounds for a Phase II clinical trial
on systemic sclerosis ("SSc"). Phase IIb clinical trials for SLE
and SSc are in the planning stage with the protocols for both
studies being ready.
- It will only be possible to start
the SLE and SSc Phase 2b clinical trials if the BioSenic Group
succeeds in concluding a strong partnership with a
biopharmaceutical company or if it manages to successfully
out-license some of its technology. The start of SLE and SSc Phase
II clinical trials is therefore not envisioned before 2025.
- Maximum cost reduction and
disciplined cash management will remain a key priority, and the
situation will be closely and actively monitored.
- The Company will actively initiate
the search for new assets through M&A processes.
- Negotiations with BioSenic's
creditors will also be initiated as part of the potential sale of
BioSenic's stake in Medsenic and other intellectual property assets
held by BioSenic, and with a view to continuing the debt
restructuring effort initiated following the court's approval of
the plan.
- The Company has also invited
Medsenic's representatives to urgently carry out a refinancing of
Medsenic in which BioSenic will not participate.
- Financing for the next few months
has been secured by means of an amendment to the convertible bond
contract with GTO 15, allowing up to EUR 1.5 million to be drawn
down, including at least two tranches of EUR 0.2 million net
without any liquidity conditions.
Unaudited Interim Condensed
Consolidated Statement of Comprehensive
Income
(in thousands of euros)
|
For the six-months period ended |
30/06/2024 |
30/06/2023 |
Revenues |
0 |
0 |
Other operating income |
2,694 |
365 |
Total revenues and operating income |
2,694 |
365 |
Research and development expenses |
(1,628) |
(2,452) |
General and administrative expenses |
(1,532) |
(1,813) |
Other operating expenses |
(1) |
(1) |
Operating profit/(loss) |
(467) |
(3,900) |
Financial Income |
1,579 |
35 |
Interest income |
24 |
30 |
Impairment expenses |
0 |
(16,094) |
Financial expenses |
(787) |
(1,136) |
Exchange gains/(losses) |
1 |
1 |
|
|
|
Result Profit/(loss) before taxes |
349 |
(21,063) |
Income taxes |
0 |
(24) |
Result Profit/(loss) for the Period |
349 |
(21,087) |
Thereof attributable to: |
|
|
Owners of the Company |
495 |
(20,843) |
Non-controlling interests |
(146) |
(244) |
|
|
|
Other comprehensive income |
0 |
0 |
|
|
|
TOTAL COMPREHENSIVE INCOME/(LOSS) OF THE
PERIOD |
349 |
(21,087) |
Thereof attributable to: |
|
|
Owners of the Company |
495 |
(20,843) |
Non-controlling interests |
(146) |
(244) |
|
|
|
Basic and diluted loss per share (in euros) |
0.003 |
(0.17) |
Unaudited Interim Condensed
Consolidated Statement of Financial Position
Consolidated Assets IFRS per:
(in thousands of euros)
|
30/06/2024
|
31/12/2023
|
Non-current assets |
6,808 |
7,713 |
Intangible assets |
2,984 |
2,989 |
Property, plant and equipment |
591 |
698 |
Finance lease receivable |
322 |
398 |
Investments in associates |
12 |
12 |
Other non-current assets |
53 |
135 |
R&D Tax Credits |
2,845 |
3,480 |
|
|
|
Current assets |
2,540 |
1,846 |
Trade and other receivables |
1,187 |
1,315 |
Other current assets |
437 |
272 |
Finance lease receivable |
148 |
141 |
Cash and cash equivalents |
816 |
117 |
|
|
|
TOTAL ASSETS |
9,396 |
9,559 |
Consolidated Equity & Liabilities IFRS
per:
(in thousands of euros)
|
30/06/2024
|
31/12/2023
|
Equity attributable to owners of the parent |
(20,465) |
(22,912) |
Share capital |
8,175 |
6,275 |
Share premium |
5,839 |
5,720 |
Accumulated losses and other reserves |
(34,396) |
(34,887) |
Other reserves |
(82) |
(20) |
|
|
|
Non-controlling interests |
61 |
207 |
Total Equity |
(20,403) |
(22,705) |
|
|
|
Non-current liabilities |
23,313 |
16,420 |
Interest bearing borrowings |
23,233 |
16,340 |
Other non-current liabilities |
80 |
80 |
|
|
|
Current liabilities |
7,434 |
15,844 |
Interest bearing borrowings |
3,561 |
11,821 |
Trade and other payables |
2,831 |
3,871 |
Current tax liabilities |
0 |
5 |
Other current liabilities |
94 |
147 |
|
|
|
Total liabilities |
29,799 |
32,264 |
TOTAL EQUITY AND LIABILITIES |
9,396 |
9,559 |
Unaudited Interim Condensed
Consolidated Statement of Cash Flows
Consolidated Statement of Cash Flows
(in thousands of euros)
|
For the six-month period ended 30 June |
2024 |
2023 |
|
|
|
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
Operating profit/(loss) |
(467) |
(3,900) |
Adjustments for: |
|
|
Depreciation and Amortisation |
106 |
101 |
Share-based compensation |
(63) |
0 |
Grants income related to tax credit |
(48) |
(115) |
Grants income related to withholding tax |
(5) |
(47) |
Other |
(141) |
(68) |
|
|
|
Movements in working capital: |
|
|
(Increase)/Decrease in Trade and other receivables (excluding
government grants) |
(125) |
(34) |
Increase/(Decrease) in Trade and other Payables |
(827) |
492 |
|
|
|
Cash used by operations |
(1,569) |
(3,570) |
Cash received from license agreement |
0 |
940 |
Cash received from grants related to tax credit |
735 |
700 |
Net cash used in operating activities |
(834) |
(1,930) |
|
|
|
CASH FLOW FROM INVESTING ACTIVITIES |
|
|
Disposal of intangible assets |
0 |
17 |
Disposal of property, plant and equipment |
0 |
3 |
Purchases of property, plant and equipment |
0 |
(12) |
Purchases of intangible assets |
0 |
(1) |
Net cash generated from investing activities |
0 |
7 |
|
|
|
CASH FLOW FROM FINANCING ACTIVITIES |
|
|
Repayment of borrowings |
(122) |
(150) |
Proceeds from borrowings |
210 |
0 |
Proceeds from convertible borrowings |
1,200 |
550 |
Repayment of lease liabilities |
(9) |
(84) |
Repayment of other financial liabilities |
(125) |
(75) |
Interests paid |
(12) |
(13) |
Transaction costs |
(109) |
(81) |
Proceeds from issue of equity instruments |
500 |
450 |
|
|
|
Net cash generated from financing activities |
1,533 |
596 |
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS |
699 |
(1,327) |
CASH AND CASH EQUIVALENTS at beginning of the
period |
117 |
1,846 |
CASH AND CASH EQUIVALENTS at end of the
period |
816 |
519 |
Unaudited Interim Condensed
Consolidated Statement of Changes in Shareholders'
Equity
Attributable to owners of the parent |
Non-controlling interests
|
TOTAL EQUITY
|
(in thousands of euros) |
Share capital |
Share premium |
Accumulated Losses & other reserves |
Other elements of comprehensive income |
|
|
|
|
|
|
|
BALANCE AT 1 JANUARY 2023 |
4,774 |
4,517 |
(5,723) |
(42) |
(402) |
3,124 |
Total comprehensive income of the period |
0 |
0 |
(20,843) |
0 |
(244) |
(21,087) |
Issue of share capital |
450 |
158 |
0 |
0 |
0 |
609 |
Transaction costs for equity issue |
0 |
(81) |
0 |
0 |
0 |
(81) |
Other |
0 |
0 |
(85) |
(6) |
0 |
(91) |
BALANCE AT 30 JUNE 2023 |
5,224 |
4,594 |
(26,652) |
(48) |
(646) |
(17,528) |
|
|
|
|
|
|
|
BALANCE AT 1 JANUARY 2024 |
6,275 |
5,720 |
(34,887) |
(20) |
207 |
(22,705) |
Total comprehensive income of the period |
0 |
0 |
495 |
0 |
(146) |
349 |
Issue of share capital |
1,900 |
228 |
0 |
0 |
0 |
2,128 |
Transaction costs for equity issue |
0 |
(109) |
0 |
0 |
0 |
(109 |
Share-based payment |
0 |
0 |
0 |
(63) |
0 |
(63) |
Other |
0 |
0 |
(4) |
0 |
0 |
(4) |
BALANCE AT 30 JUNE 2024 |
8,175 |
5,839 |
(34,396) |
(82) |
61 |
(20,405) |
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued
from its Medsenic’s arsenic trioxide (ATO) platform. Key target
indications for the autoimmune platform include
graft-versus-host-disease (GvHD), systemic lupus erythematosus
(SLE), and now systemic sclerosis (SSc).
Following the merger in October 2022, BioSenic combined the
strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger specifically enables
Medsenic/Biosenic to develop an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO).
BioSenic is based in the Louvain-la-Neuve
Science Park in Mont-Saint-Guibert, Belgium. Further information is
available at http://www.biosenic.com.
About the main Medsenic/BioSenic
technology platform
The ATO
platform provides derived active products with
immunomodulatory properties and fundamental effects on the
activated cells of the immune system. One direct application is its
use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in
its chronic, established stage. cGvHD is one of the most common and
clinically significant complications affecting long-term survival
of allogeneic hematopoietic stem cell transplantation
(allo-HSCT).
Medsenic has been successful in a phase 2
trial with its intravenous formulation,
Arscimed®, which has orphan
drug designation status by FDA and EMA. The company is heading
towards an international phase 3 confirmatory study, with its new,
IP-protected, OATO formulation. Another selected target is
moderate-to-severe forms of systemic lupus erythematosus (SLE),
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae, and the gastrointestinal tract). Systemic sclerosis is now
full part of the clinical pipeline of Medsenic/BioSenic. This
serious chronic disease badly affects skin, lungs, or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a phase 2 clinical protocol, using new
immunomodulatory formulations of APIs recognized to be active on
the immune system.
The company is currently focusing its
present R&D and clinical activities on a selective, accelerated
development of its autoimmune platform.
For further information, please
contact:
BioSenic SA
Finsys Management SRL, represented by its permanent
representative Jean-Luc Vandebroek, managing-director ad
interim
Tel : +32 478 27 68 42
investorrelations@biosenic.com
Certain statements, beliefs and opinions in
this press release are forward-looking, which reflect the company
or, as appropriate, the company directors’ current expectations and
projections about future events. By their nature, forward-looking
statements involve a number of risks, uncertainties and assumptions
that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
risks, uncertainties and assumptions could adversely affect the
outcome and financial effects of the plans and events described
herein. A multitude of factors including, but not limited to,
changes in demand, competition and technology, can cause actual
events, performance or results to differ significantly from any
anticipated development. Forward looking statements contained in
this press release regarding past trends or activities should not
be taken as a representation that such trends or activities will
continue in the future. As a result, the company expressly
disclaims any obligation or undertaking to release any update or
revisions to any forward-looking statements in this press release
as a result of any change in expectations or any change in events,
conditions, assumptions or circumstances on which these
forward-looking statements are based. Neither the company nor its
advisers or representatives nor any of its subsidiary undertakings
or any such person’s officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
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