BioSenic reports half year 2023 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.
The BioSenic Phase 2 clinical study with arsenic trioxide
in the first-line treatment of chronic Graft versus Host disease
(cGvHD) has been completed and provided positive results. In 2024,
the BioSenic Group expects to prioritize the use of the proceeds of
anticipated future fundraising for the progression of the Phase 3
clinical trial in cGvHD. |
Mont-Saint-Guibert, Belgium, 7 September
2023, 7am CEST –
BioSenic (Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, today publishes its
business update for the first half, ended 30 June 2023, prepared in
accordance with IFRS as adopted by the European Union, and the
outlook for the remainder of the year.
"BioSenic has made the best of its efforts on
restructuring and accomplishing important technical steps in
implementing key features of its Arsenic salts (ATO) and its cell
repair platforms after succeeding its reverse merger between
Medsenic and Bone Therapeutics 10 months ago” said François
Rieger, PhD, Chairman and Chief Executive Officer of
BioSenic “Successfully interpreting clinical and
scientific complex data – and specifically those inherited from the
former Bone Therapeutics – gives us now the essential
basic elements to develop our activities on licensing
opportunities and further Phase 2/3 clinical trials. Our immediate
leading project is a Phase 3 confirmatory trial on the efficacy of
an oral formulation of arsenic trioxide on chronic
Graft-versus-Host Disease, an autoimmune rare condition following
allogeneic hematopoietic cells used for treating several types of
leukaemia. We now expect a productive end of 2023 for further
developing the best values of BioSenic."
Operational and Corporate
highlights
- In January 2023, BioSenic strengthened its scientific team with
the appointment of Dr. Carole Nicco, as Chief Scientific Officer
(CSO).
- In January 2023, BioSenic appointed Yves Sagot as a member of
the Board of Directors and Independent Director.
- In March 2023, BioSenic re-evaluated the results of its Phase 3
trial of its enhanced viscosupplement JTA-004 targeting knee
osteoarthritis (OA). The Company indeed announced that it has used
the statistical analysis capabilities of Artialis to study the
results of the Phase 3 JTA-004 trial in the subset of patients with
the most painful and inflammatory form of knee osteoarthritis (OA).
This allows BioSenic to distinguish a group of patients,
representing about one third of the total patients, who show a
pain-relieving effect of JTA-004 not only superior to placebo but
also to the active comparator. This new post-hoc analysis changes
the therapeutic profile of the molecule and potentially allows for
the possibility of stratifying patients for a new, optimized Phase
3 clinical study.
- In March 2023, BioSenic published new data on the mechanism of
action of arsenic trioxide (ATO) to prevent autoimmune diseases has
now been published in a peer-reviewed paper (Frontiers in
Immunology). This new data shows that combination of ATO with
copper salts can allow BioSenic to work towards reducing the dosage
of ATO in future trials overall and maintain efficacy. This new
formulation data has been completed following pre-clinical
activities and does not constitute data validated through clinical
trial.
- In April 2023, BioSenic appointed Lieven Huysse, MD, as
permanent Chief Medical Officer (CMO).
- In April 2023, BioSenic received European patent from EPO, for
further therapeutic development in cancer, infectious and immune
diseases. The patent covers the therapeutic use of a new composite
formulation of anti-inflammatory compounds with unique advantages.
This new formulation lowers the dosage of arsenic trioxide by
combining it with copper salts to maintain therapeutic efficacy,
with the potential of administration through multiple routes,
including intravenous, oral, and other novel routes of
administration.
- In May 2023, BioSenic identified key biomarkers for cGvHD and
submitted patent to EPO. The technology covered by the patent
applies to a method and kit for diagnosing and monitoring cGvHD in
an individual who has undergone an allogeneic hematopoietic stem
cell transplantation. The patent describes biomarkers to be used to
determine if the condition of a patient worsens or improves
following standard or new treatments for cGvHD. This international
patent could allow the development of an industrial biomarker
analysis kit which could generate a turnover of 30 to 40 million
euros globally.
- In June 2023, BioSenic put Phase 2b ALLOB trial on hold. This
decision follows negative results obtained for the primary endpoint
in the exploratory Phase 2b trial (ALLOB 2b), which focused on
safety and treatment timing efficacy.
- In August 2023, BioSenic received a Chinese patent protecting
the combined use of metal ions and arsenic salts. This patent
(ZL202080040613.1) covers the use of its ATO platform in
combination with metal ions like copper, which has the potential to
improve the treatment of autoimmune diseases.
Financial highlights
- In February 2023, BioSenic received EUR 1 million from Pregene
in accordance with terminated license agreement.
- In June 2023, BioSenic has obtained an official appointment of
Yves Brulard to reach a negotiated agreement with certain main
creditors to preserve the value of BioSenic for the benefit of all
stakeholders.
- In June 2023, BioSenic entered into an agreement with the ABO
Securities subsidiary, Global Tech Opportunities 15, to secure
short term financing based on the existing convertible bond
program. Subject to the terms and conditions of the agreement,
BioSenic shall be entitled to draw down three tranches of each EUR
0.3 million in June, July, and August under the existing
convertible bond program, for an aggregate principal amount of EUR
0.9 million.
- In July 2023, BioSenic has achieved a standstill agreement from
the main historical creditors for a period of 3 to 4 months. Given
this agreement with the main creditors and the one obtained on 30
June 2023 with Global Tech Opportunities 15 to secure short-term
financing based on the existing convertible bond program, BioSenic
anticipates having sufficient cash to carry out its business
objectives until October 2023.
- During the first six months of 2023, total operating income
amounted to EUR 0.37 million, a slight increase compared to the
same period in 2022 (EUR 0.13 million).
- Operating loss for the period amounted to EUR 3.90 million,
compared to EUR 3.96 million in H1 2022.
- BioSenic ended the first six months of 2023 with EUR 0.52
million in cash and cash equivalents. Net cash used for the period
amounted to EUR 1.33 million, compared to EUR 0.39 million over the
same period of 2022.
Outlook for the remainder of 2023 and
2024
- In March 2023, BioSenic has obtained new statistical analysis
results from the JTA-004 Phase 3 clinical trial data. BioSenic,
which does not intend to allocate R&D resources to support the
clinical development of JTA-004, is seeking to collaborate with
existing and potential partners to explore options for the future
development of JTA-004 based on this new post-hoc analysis.
Following disappointing Phase 3 clinical results, Biosenic
terminated the agreement with the Walloon Region and Mr Bastianelli
in 2022. The agreement with the Walloon Region has since been
resumed, but there is still no agreement with Mr Enrico
Bastianelli, which could give rise to co-ownership problems.
- The Medsenic Phase 2 clinical study with arsenic trioxide in
the first-line treatment of cGvHD has been completed and provided
positive results. A Phase 3 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 2a 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 2 clinical trial on
systemic sclerosis ("SSc"). Phase 2b clinical trials for SLE and
SSc are in the planning stage with the protocols for both studies
being ready.
- BioSenic is currently preparing a fundraising to be organized
in Q3/Q4 2023. BioSenic Group expects for 2024 to use the proceeds
of anticipated future fundraisings in priority for progressing the
Phase 3 clinical trial in cGvHD. As a result, 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
2 clinical trials is therefore not envisioned before 2024.
Unaudited Interim Condensed Consolidated
Statement of Comprehensive Income
(in thousands of euros) |
For the six-months period ended |
30/06/2023 |
30/06/2022 |
Revenues |
0 |
0 |
Other operating income |
365 |
125 |
Total revenues and operating income |
365 |
125 |
Research and development expenses |
(2,452) |
(267) |
General and administrative expenses |
(1,813) |
(336) |
Other operating expenses |
(1) |
0 |
Operating profit/(loss) |
(3,900) |
(478) |
Financial Income |
35 |
0 |
Interest income |
30 |
0 |
Impairment expenses |
(16,094) |
0 |
Financial expenses |
(1,136) |
(49) |
Exchange gains/(losses) |
1 |
0 |
|
|
|
Result Profit/(loss) before taxes |
(21,063) |
(527) |
Income taxes |
(24) |
- |
Result Profit/(loss) for the Period |
(21,087) |
(527) |
Thereof attributable to: |
|
|
Owners of the Company |
(20,843) |
(527) |
Non-controlling interests |
(244) |
0 |
|
|
|
Other comprehensive income |
0 |
0 |
|
|
|
TOTAL COMPREHENSIVE INCOME/(LOSS) OF THE
PERIOD |
(21,087) |
(527) |
Thereof attributable to: |
|
|
Owners of the Company |
(20,843) |
(527) |
Non-controlling interests |
(244) |
0 |
|
|
|
Basic and diluted loss per share (in euros) |
(0,17) |
(7,49) |
Unaudited Interim Condensed Consolidated Statement of
Financial Position
Consolidated Assets IFRS per: (in thousands of
euros) |
30/06/2023 |
31/12/2022 |
|
|
Non-current assetsGoodwill |
7,8480 |
24,6981,802 |
|
Intangible assets |
2,995 |
17,293 |
|
Property, plant and equipment |
786 |
1,419 |
|
Finance lease receivable |
469 |
0 |
|
Investments in associates |
12 |
12 |
|
Other non-current assets |
135 |
136 |
|
R&D Tax Credits |
3,452 |
4,036 |
|
|
|
|
|
Current assets |
2,544 |
4,626 |
|
Trade and other receivables |
1,676 |
2,490 |
|
Other current assets |
214 |
290 |
|
Finance lease receivable |
135 |
0 |
|
Cash and cash equivalents |
519 |
1,846 |
|
|
|
|
|
TOTAL ASSETS |
10,392 |
29,324 |
|
Consolidated Equity & Liabilities IFRS per:
(in thousands of euros) |
30/06/2023 |
31/12/2022 |
|
|
Equity attributable to owners of the parent |
(16,882) |
3,526 |
|
Share capital |
5,224 |
4,774 |
|
Share premium |
4,594 |
4,517 |
|
Accumulated losses and other reserves |
(26,652) |
(5,723) |
|
Other reserves |
(48) |
(42) |
|
Equity attributable to owners of the parent |
|
|
|
Non-controlling interests |
(646) |
(402) |
|
Total Equity |
(17,528) |
3,124 |
|
|
|
|
|
Non-current liabilities |
15,764 |
15,847 |
|
Interest bearing borrowings |
15,696 |
15,779 |
|
Other non-current liabilities |
68 |
68 |
|
|
|
|
|
Current liabilities |
12,156 |
10,353 |
|
Interest bearing borrowings |
9,339 |
8,013 |
|
Trade and other payables |
2,728 |
2,236 |
|
Other current liabilities |
89 |
104 |
|
|
|
|
|
Total liabilities |
27,920 |
26,200 |
|
TOTAL EQUITY AND LIABILITIES |
10,392 |
29,324 |
|
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 |
2023 |
2022 |
|
|
|
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
Operating profit/(loss) |
(3,900) |
(478) |
Adjustments for: |
|
|
Depreciation and Amortisation |
101 |
5 |
Grants income related to tax credit |
(115) |
0 |
Grants income related to withholding tax |
(47) |
|
Other |
(68) |
0 |
|
|
|
Movements in working capital: |
|
|
(Increase)/Decrease in Trade and other receivables (excluding
government grants) |
(34) |
14 |
Increase/(Decrease) in Trade and other Payables |
492 |
22 |
|
|
|
Cash used by operations |
(3,570) |
(438) |
Cash received from license agreement |
940 |
0 |
Cash received from grants related to tax credit |
700 |
187 |
Net cash used in operating activities |
(1,930) |
(251) |
|
|
|
CASH FLOW FROM INVESTING ACTIVITIES |
|
|
Disposal of intangible assets |
17 |
0 |
Disposal of property, plant and equipment |
3 |
0 |
Purchases of property, plant and equipment |
(12) |
0 |
Purchases of intangible assets |
(1) |
0 |
Net cash generated from investing activities |
7 |
0 |
|
|
|
CASH FLOW FROM FINANCING ACTIVITIES |
|
|
Repayment of borrowings |
(150) |
(45) |
Proceeds from convertible borrowings |
550 |
0 |
Repayment of lease liabilities |
(84) |
(2) |
Repayment of other financial liabilities |
(75) |
(75) |
Interests paid |
(13) |
(16) |
Transaction costs |
(81) |
|
Proceeds from issue of equity instruments |
450 |
0 |
|
|
|
Net cash generated from financing activities |
596 |
(137) |
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS |
(1,327) |
(388) |
CASH AND CASH EQUIVALENTS at beginning of the
period |
1,846 |
759 |
CASH AND CASH EQUIVALENTS at end of the
period |
519 |
371 |
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 2022 |
664 |
3,969 |
(7,298) |
(5) |
0 |
(2,670) |
Total comprehensive income of the period |
0 |
0 |
(527) |
0 |
0 |
(527) |
Issue of share capital |
74 |
3,837 |
0 |
0 |
0 |
3,911 |
BALANCE AT 30 JUNE 2022 |
738 |
7,806 |
(7,825) |
(5) |
0 |
714 |
|
|
|
|
|
|
|
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) |
About BioSenicThe 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.
BioSenic reports half year 2023 results
The BioSenic
Phase 2
clinical study with arsenic trioxide in the first-line
treatment of chronic Graft versus Host disease
(cGvHD) has been
completed and provided positive results.
In 2024, the BioSenic
Group expects to prioritize the use of the proceeds of
anticipated future fundraising for the progression of the
Phase 3 clinical trial in
cGvHD. |
Mont-Saint-Guibert,
Belgium, 7 September
2023, 7am CEST
– BioSenic (Euronext Brussels and
Paris: BIOS), the clinical-stage company specializing in serious
autoimmune and inflammatory diseases and cell therapy, today
publishes its business update for the first half, ended 30 June
2023, prepared in accordance with IFRS as adopted by the European
Union, and the outlook for the remainder of the year.
"BioSenic has made the best of its efforts on
restructuring and accomplishing important technical steps in
implementing key features of its Arsenic salts (ATO) and its cell
repair platforms after succeeding its reverse merger between
Medsenic and Bone Therapeutics 10 months ago” said François
Rieger, PhD, Chairman and Chief Executive Officer of
BioSenic “Successfully interpreting clinical and
scientific complex data – and specifically those inherited from the
former Bone Therapeutics – gives us now the essential basic
elements to develop our activities on licensing opportunities and
further Phase 2/3 clinical trials. Our immediate leading project is
a Phase 3 confirmatory trial on the efficacy of an oral formulation
of arsenic trioxide on chronic Graft-versus-Host Disease, an
autoimmune rare condition following allogeneic hematopoietic cells
used for treating several types of leukaemia. We now expect a
productive end of 2023 for further developing the best values of
BioSenic."
Operational and Corporate
highlights
- In January 2023,
BioSenic strengthened its scientific team with the appointment of
Dr. Carole Nicco, as Chief Scientific Officer (CSO).
- In January 2023,
BioSenic appointed Yves Sagot as a member of the Board of Directors
and Independent Director.
- In March 2023,
BioSenic re-evaluated the results of its Phase 3 trial of its
enhanced viscosupplement JTA-004 targeting knee osteoarthritis
(OA). The Company indeed announced that it has used the statistical
analysis capabilities of Artialis to study the results of the Phase
3 JTA-004 trial in the subset of patients with the most painful and
inflammatory form of knee osteoarthritis (OA). This allows BioSenic
to distinguish a group of patients, representing about one third of
the total patients, who show a pain-relieving effect of JTA-004 not
only superior to placebo but also to the active comparator. This
new post-hoc analysis changes the therapeutic profile of the
molecule and potentially allows for the possibility of stratifying
patients for a new, optimized Phase 3 clinical study.
- In March 2023,
BioSenic published new data on the mechanism of action of arsenic
trioxide (ATO) to prevent autoimmune diseases has now been
published in a peer-reviewed paper (Frontiers in Immunology). This
new data shows that combination of ATO with copper salts can allow
BioSenic to work towards reducing the dosage of ATO in future
trials overall and maintain efficacy. This new formulation data has
been completed following pre-clinical activities and does not
constitute data validated through clinical trial.
- In April 2023,
BioSenic appointed Lieven Huysse, MD, as permanent Chief Medical
Officer (CMO).
- In April 2023,
BioSenic received European patent from EPO, for further therapeutic
development in cancer, infectious and immune diseases. The patent
covers the therapeutic use of a new composite formulation of
anti-inflammatory compounds with unique advantages. This new
formulation lowers the dosage of arsenic trioxide by combining it
with copper salts to maintain therapeutic efficacy, with the
potential of administration through multiple routes, including
intravenous, oral, and other novel routes of administration.
- In May 2023,
BioSenic identified key biomarkers for cGvHD and submitted patent
to EPO. The technology covered by the patent applies to a method
and kit for diagnosing and monitoring cGvHD in an individual who
has undergone an allogeneic hematopoietic stem cell
transplantation. The patent describes biomarkers to be used to
determine if the condition of a patient worsens or improves
following standard or new treatments for cGvHD. This international
patent could allow the development of an industrial biomarker
analysis kit which could generate a turnover of 30 to 40 million
euros globally.
- In June 2023,
BioSenic put Phase 2b ALLOB trial on hold. This decision follows
negative results obtained for the primary endpoint in the
exploratory Phase 2b trial (ALLOB 2b), which focused on safety and
treatment timing efficacy.
- In August 2023,
BioSenic received a Chinese patent protecting the combined use of
metal ions and arsenic salts. This patent (ZL202080040613.1) covers
the use of its ATO platform in combination with metal ions like
copper, which has the potential to improve the treatment of
autoimmune diseases.
Financial
highlights
- In February
2023, BioSenic received EUR 1 million from Pregene in accordance
with terminated license agreement.
- In June 2023,
BioSenic has obtained an official appointment of Yves Brulard to
reach a negotiated agreement with certain main creditors to
preserve the value of BioSenic for the benefit of all
stakeholders.
- In June 2023,
BioSenic entered into an agreement with the ABO Securities
subsidiary, Global Tech Opportunities 15, to secure short term
financing based on the existing convertible bond program. Subject
to the terms and conditions of the agreement, BioSenic shall be
entitled to draw down three tranches of each EUR 0.3 million in
June, July, and August under the existing convertible bond program,
for an aggregate principal amount of EUR 0.9 million.
- In July 2023,
BioSenic has achieved a standstill agreement from the main
historical creditors for a period of 3 to 4 months. Given this
agreement with the main creditors and the one obtained on 30 June
2023 with Global Tech Opportunities 15 to secure short-term
financing based on the existing convertible bond program, BioSenic
anticipates having sufficient cash to carry out its business
objectives until October 2023.
- During the first
six months of 2023, total operating income amounted to EUR 0.37
million, a slight increase compared to the same period in 2022 (EUR
0.13 million).
- Operating loss
for the period amounted to EUR 3.90 million, compared to EUR 3.96
million in H1 2022.
- BioSenic ended
the first six months of 2023 with EUR 0.52 million in cash and cash
equivalents. Net cash used for the period amounted to EUR 1.33
million, compared to EUR 0.39 million over the same period of
2022.
Outlook for the remainder of
2023 and
2024
- In March 2023,
BioSenic has obtained new statistical analysis results from the
JTA-004 Phase 3 clinical trial data. BioSenic, which does not
intend to allocate R&D resources to support the clinical
development of JTA-004, is seeking to collaborate with existing and
potential partners to explore options for the future development of
JTA-004 based on this new post-hoc analysis. Following
disappointing Phase 3 clinical results, Biosenic terminated the
agreement with the Walloon Region and Mr Bastianelli in 2022. The
agreement with the Walloon Region has since been resumed, but there
is still no agreement with Mr Enrico Bastianelli, which could give
rise to co-ownership problems.
- The Medsenic
Phase 2 clinical study with arsenic trioxide in the first-line
treatment of cGvHD has been completed and provided positive
results. A Phase 3 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 2a 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 2 clinical trial on
systemic sclerosis ("SSc"). Phase 2b clinical trials for SLE and
SSc are in the planning stage with the protocols for both studies
being ready.
- BioSenic is currently preparing a
fundraising to be organized in Q3/Q4 2023. BioSenic Group expects
for 2024 to use the proceeds of anticipated future fundraisings in
priority for progressing the Phase 3 clinical trial in cGvHD. As a
result, 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 2 clinical trials is therefore not
envisioned before 2024.
Unaudited Interim Condensed
Consolidated Statement
of Comprehensive
Income
(in thousands of
euros) |
For the six-months period ended |
30/06/2023 |
30/06/2022 |
Revenues |
0 |
0 |
Other operating income |
365 |
125 |
Total revenues and operating income |
365 |
125 |
Research and development expenses |
(2,452) |
(267) |
General and administrative expenses |
(1,813) |
(336) |
Other operating expenses |
(1) |
0 |
Operating profit/(loss) |
(3,900) |
(478) |
Financial Income |
35 |
0 |
Interest income |
30 |
0 |
Impairment expenses |
(16,094) |
0 |
Financial expenses |
(1,136) |
(49) |
Exchange gains/(losses) |
1 |
0 |
|
|
|
Result Profit/(loss) before taxes |
(21,063) |
(527) |
Income taxes |
(24) |
- |
Result Profit/(loss) for the Period |
(21,087) |
(527) |
Thereof attributable to: |
|
|
Owners of the Company |
(20,843) |
(527) |
Non-controlling interests |
(244) |
0 |
|
|
|
Other comprehensive income |
0 |
0 |
|
|
|
TOTAL COMPREHENSIVE INCOME/(LOSS) OF THE
PERIOD |
(21,087) |
(527) |
Thereof attributable to: |
|
|
Owners of the Company |
(20,843) |
(527) |
Non-controlling interests |
(244) |
0 |
|
|
|
Basic and diluted loss per share (in euros) |
(0,17) |
(7,49) |
Unaudited Interim Condensed
Consolidated Statement of Financial
Position
Consolidated Assets IFRS per: (in thousands of
euros) |
30/06/2023 |
31/12/2022 |
Non-current assetsGoodwill |
7,8480 |
24,6981,802 |
Intangible assets |
2,995 |
17,293 |
Property, plant and equipment |
786 |
1,419 |
Finance lease receivable |
469 |
0 |
Investments in associates |
12 |
12 |
Other non-current assets |
135 |
136 |
R&D Tax Credits |
3,452 |
4,036 |
|
|
|
Current assets |
2,544 |
4,626 |
Trade and other receivables |
1,676 |
2,490 |
Other current assets |
214 |
290 |
Finance lease receivable |
135 |
0 |
Cash and cash equivalents |
519 |
1,846 |
|
|
|
TOTAL ASSETS |
10,392 |
29,324 |
Consolidated Equity & Liabilities IFRS per:
(in thousands of euros) |
30/06/2023 |
31/12/2022 |
Equity attributable to owners of the parent |
(16,882) |
3,526 |
Share capital |
5,224 |
4,774 |
Share premium |
4,594 |
4,517 |
Accumulated losses and other reserves |
(26,652) |
(5,723) |
Other reserves |
(48) |
(42) |
Equity attributable to owners of the parent |
|
|
Non-controlling interests |
(646) |
(402) |
Total Equity |
(17,528) |
3,124 |
|
|
|
Non-current liabilities |
15,764 |
15,847 |
Interest bearing borrowings |
15,696 |
15,779 |
Other non-current liabilities |
68 |
68 |
|
|
|
Current liabilities |
12,156 |
10,353 |
Interest bearing borrowings |
9,339 |
8,013 |
Trade and other payables |
2,728 |
2,236 |
Other current liabilities |
89 |
104 |
|
|
|
Total liabilities |
27,920 |
26,200 |
TOTAL EQUITY AND LIABILITIES |
10,392 |
29,324 |
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 |
2023 |
2022 |
|
|
|
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
Operating profit/(loss) |
(3,900) |
(478) |
Adjustments for: |
|
|
Depreciation and Amortisation |
101 |
5 |
Grants income related to tax credit |
(115) |
0 |
Grants income related to withholding tax |
(47) |
|
Other |
(68) |
0 |
|
|
|
Movements in working capital: |
|
|
(Increase)/Decrease in Trade and other receivables (excluding
government grants) |
(34) |
14 |
Increase/(Decrease) in Trade and other Payables |
492 |
22 |
|
|
|
Cash used by operations |
(3,570) |
(438) |
Cash received from license agreement |
940 |
0 |
Cash received from grants related to tax credit |
700 |
187 |
Net cash used in operating activities |
(1,930) |
(251) |
|
|
|
CASH FLOW FROM INVESTING ACTIVITIES |
|
|
Disposal of intangible assets |
17 |
0 |
Disposal of property, plant and equipment |
3 |
0 |
Purchases of property, plant and equipment |
(12) |
0 |
Purchases of intangible assets |
(1) |
0 |
Net cash generated from investing activities |
7 |
0 |
|
|
|
CASH FLOW FROM FINANCING ACTIVITIES |
|
|
Repayment of borrowings |
(150) |
(45) |
Proceeds from convertible borrowings |
550 |
0 |
Repayment of lease liabilities |
(84) |
(2) |
Repayment of other financial liabilities |
(75) |
(75) |
Interests paid |
(13) |
(16) |
Transaction costs |
(81) |
|
Proceeds from issue of equity instruments |
450 |
0 |
|
|
|
Net cash generated from financing activities |
596 |
(137) |
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS |
(1,327) |
(388) |
CASH AND CASH EQUIVALENTS at beginning of the
period |
1,846 |
759 |
CASH AND CASH EQUIVALENTS at end of the
period |
519 |
371 |
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 2022 |
664 |
3,969 |
(7,298) |
(5) |
0 |
(2,670) |
Total comprehensive income of the period |
0 |
0 |
(527) |
0 |
0 |
(527) |
Issue of share capital |
74 |
3,837 |
0 |
0 |
0 |
3,911 |
BALANCE AT 30 JUNE 2022 |
738 |
7,806 |
(7,825) |
(5) |
0 |
714 |
|
|
|
|
|
|
|
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) |
About
BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from: (i)
the arsenic trioxide (ATO) platform (with key target indications
including Graft-versus-Host Disease (GvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the
development of innovative products to meet unmet needs in
orthopedics.
Following a reverse merger in October 2022,
BioSenic combined a strategic positionings and strengths to use,
separately and combined, an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO) with its
innovative cell therapy platform and strong IP for tissue repair
protection.
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 BioSenic technology
platforms
BioSenic’s technology is based on two main
platforms:
1) The ATO platform, which has
been successfully developed, has immunomodulatory properties with
fundamental effects on the activated cells of the immune system.
The first effect is the increase of the cell oxidative stress in
activated B, T and other cells of the innate/adaptative immune
system to the point they will enter a cell death program
(apoptosis) and be eliminated. The second effect is potent
immunomodulatory properties on several cytokines involved in
inflammatory or autoimmune cell pathways, with return to
homeostasis. 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).
cGvHD is primarily mediated by the transplanted immune cells that
can lead to severe multiorgan damage. BioSenic has been successful
in a Phase 2 trial with its intravenous formulation, 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) in an early Phase 2a study.
Systemic sclerosis is also part of the clinical pipeline of
BioSenic. This serious chronic disease badly affects skin, lungs or
vascularization, and has no actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 clinical protocol.
2) The allogeneic cell and gene therapy platform
developed by BioSenic, with differentiated bone marrow sourced
Mesenchymal Stromal Cells (MSCs), which can be stored at the point
of use in hospitals. ALLOB represents a unique and proprietary
approach to organ repair and specifically to bone regeneration, by
turning undifferentiated stromal cells from healthy donors into
bone-forming cells on the site of injury. ALLOB has recently been
evaluated in a randomized, double-blind, placebo-controlled Phase
2b study in patients with high-risk tibial fractures, using its
optimized production process, after a successful first safety and
efficacy study (Phase 1/2a) on fractured long bones, with
late-delayed union. However, in June 2023, BioSenic decided to
suspend its interventional trial on fracture healing using ALLOB,
following negative results obtained for the primary endpoint in
this exploratory Phase 2b clinical trial, interpreted as a failure
of a too early cell injection, just after fracture. BioSenic is now
focusing on determining the best time to optimise the efficacy of
ALLOB (choice between early or late treatment).Note: Biosenic has
reevaluated a previous important and years-long clinical
development program. In March 2023, after the clinical
identification of distinct OA subtypes, BioSenic delivered a new
post-hoc analysis of its Phase 3 JTA-004 trial on knee OA,
demonstrating positive action on the most severely affected patient
subpopulation. This new post-hoc analysis drastically changes the
therapeutic profile of the combined components and allows for
better patient targeting in future clinical developments. This
leads to a next generation of JTA, off-the-shelf enhanced
viscosupplement to treat knee osteoarthritis (OA), made of a unique
combination of mammalian plasma proteins, derivatives of hyaluronic
acid (a natural component of synovial fluid in the knee) and a
third active component. JTA or some derivatives are intended to
provide effective lubrication and protection to the cartilage of
the arthritic joint and to alleviate osteoarthritic (OA) pain and
inflammation. The company, will nevertheless focus its present
R&D and clinical activities on a selective, accelerated
development of its autoimmune (ATO/OATO) platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor
Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
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.
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from: (i)
the arsenic trioxide (ATO) platform (with key target indications
including Graft-versus-Host Disease (GvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the
development of innovative products to meet unmet needs in
orthopedics.
Following a reverse merger in October 2022,
BioSenic combined a strategic positionings and strengths to use,
separately and combined, an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO) with its
innovative cell therapy platform and strong IP for tissue repair
protection.
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 BioSenic technology
platforms
BioSenic’s technology is based on two main
platforms:
- The ATO platform, which has been successfully developed, has
immunomodulatory properties with fundamental effects on the
activated cells of the immune system. The first effect is the
increase of the cell oxidative stress in activated B, T and other
cells of the innate/adaptative immune system to the point they will
enter a cell death program (apoptosis) and be eliminated. The
second effect is potent immunomodulatory properties on several
cytokines involved in inflammatory or autoimmune cell pathways,
with return to homeostasis. 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).
cGvHD is primarily mediated by the transplanted immune cells that
can lead to severe multiorgan damage. BioSenic has been successful
in a Phase 2 trial with its intravenous formulation, 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) in an early Phase 2a study.
Systemic sclerosis is also part of the clinical pipeline of
BioSenic. This serious chronic disease badly affects skin, lungs or
vascularization, and has no actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 clinical protocol.
- The allogeneic cell and gene therapy platform developed by
BioSenic, with differentiated bone marrow sourced Mesenchymal
Stromal Cells (MSCs), which can be stored at the point of use in
hospitals. ALLOB represents a unique and proprietary approach to
organ repair and specifically to bone regeneration, by turning
undifferentiated stromal cells from healthy donors into
bone-forming cells on the site of injury. ALLOB has recently been
evaluated in a randomized, double-blind, placebo-controlled Phase
2b study in patients with high-risk tibial fractures, using its
optimized production process, after a successful first safety and
efficacy study (Phase 1/2a) on fractured long bones, with
late-delayed union. However, in June 2023, BioSenic decided to
suspend its interventional trial on fracture healing using ALLOB,
following negative results obtained for the primary endpoint in
this exploratory Phase 2b clinical trial, interpreted as a failure
of a too early cell injection, just after fracture. BioSenic is now
focusing on determining the best time to optimise the efficacy of
ALLOB (choice between early or late treatment).
Note: Biosenic has reevaluated a previous
important and years-long clinical development program. In March
2023, after the clinical identification of distinct OA subtypes,
BioSenic delivered a new post-hoc analysis of its Phase 3 JTA-004
trial on knee OA, demonstrating positive action on the most
severely affected patient subpopulation. This new post-hoc analysis
drastically changes the therapeutic profile of the combined
components and allows for better patient targeting in future
clinical developments. This leads to a next generation of JTA,
off-the-shelf enhanced viscosupplement to treat knee osteoarthritis
(OA), made of a unique combination of mammalian plasma proteins,
derivatives of hyaluronic acid (a natural component of synovial
fluid in the knee) and a third active component. JTA or some
derivatives are intended to provide effective lubrication and
protection to the cartilage of the arthritic joint and to alleviate
osteoarthritic (OA) pain and inflammation. The company, will
nevertheless focus its present R&D and clinical activities on a
selective, accelerated development of its autoimmune (ATO/OATO)
platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
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.
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024