BioSenic announces 2022 full year results
REGULATED INFORMATION
ALLOB Phase IIb topline results
foreseen in Q2 2023
ATO Phase III to be launched in
2023
Ongoing discussions for key partnerships
with lead clinical
assets
Mont-Saint-Guibert, Belgium,
April 27, 2023, 7am CET
– BIOSENIC (Euronext Brussels and Paris:
BIOS), the company specializing in serious autoimmune and
inflammatory diseases and cell repair, today announces its business
update and full year financial results for the year ending 31
December 2022, prepared in accordance with IFRS as adopted by the
European Union.
“BioSenic’s creation from the merger between
Bone Therapeutics and Medsenic in October 2022 has resulted in a
multi-platform and multi-target biotechnology company. These two
platforms specialize in severe autoimmune/inflammatory diseases, as
well as cellular repair for orthopedics. This increases the chance
of therapeutic and clinical successes, and enables a
cross-pollination between the scientific teams,”
said Prof. François Rieger, President and
CEO of BioSenic. “For
our ATO platform, we are now in final preparations for the launch
of our Phase III study in 2023, and two Phase IIb studies later on.
For our cell therapy platform, the ALLOB Phase IIb trial is
expecting to report in Q2 2023. Having now extended and updated our
senior management and board, BioSenic is well set to establish
value adding business collaborations and to further strengthen our
financial position. This will enable us to drive our therapies
through clinical development and deliver therapeutic options to
patients suffering from a range of conditions with few therapeutic
options.”
Clinical and operational highlights
(including post-period events)
In March 2022, BioSenic redefined its strategic
priorities to concentrate specifically on the development of its
most advanced clinical asset, ALLOB. BioSenic implemented a number
of actions to reduce its cost base to enable completion of its
Phase IIb study. As a result, BioSenic focused its R&D
activities to support the clinical development of ALLOB and all
activities related to the development of the pre-clinical iMSCg
platform as well as all other non ALLOB related activities, had
been stopped.
In July 2022, BioSenic announced an optimized
statistical analysis and the implementation of an interim analysis
for the ongoing Phase IIb clinical trial with its allogeneic bone
cell therapy product, ALLOB. The amendment enabled a reduction of
approximately 20% of the required patient numbers from 178 patients
to 132 evaluable patients while maintaining the same statistical
power. In addition, BioSenic would also introduce an interim
analysis based on the assessment of radiological data from
approximately 66 evaluable patients at 3 months
post-administration. The interim analysis would provide an
opportunity to document the efficacy of ALLOB and to achieve a
relevant clinical milestone at an earlier time point.
In October 2022, BioSenic regained worldwide
rights to its allogeneic, off-the-shelf, bone cell therapy platform
ALLOB further to the unilateral termination notice received from
Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”).
Pregene's termination was, according
to Pregene written communication, "necessitated
by [alleged] regulatory reasons that due to
the [purported] introduction of new laws and regulations,
projects involving foreign human cell and related clinical trials
will be, prohibited [in the future] in mainland
China". Regaining all development manufacture and commercialization
rights of ALLOB from Pregene entitled BioSenic to negotiate rights
for ALLOB with, LinkHealth, and other partners.
In November 2022, BioSenic provided an update on
its systemic autoimmune disease platform. The autoimmune disease
platform had completed a successful phase IIb trial targeting
cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy
of more than 75%. The phase III study of the autoimmune disease
platform in cGvHD has been designed to reach the market as quickly
as possible through the framework of an expedite 505b2 FDA
regulatory pathway. In addition to cGVHD, BioSenic announced the
preparation a randomized placebo-controlled phase IIb study with
ATO in Systemic Lupus Erythematosus. Furthermore, promising
preclinical data gathered by Medsenic provided clinical data to
support a phase II clinical trial with ATO targeting systemic
sclerosis.
In February 2023, BioSenic announced an
optimization its ongoing Phase IIb clinical trial with its
allogeneic bone cell therapy product, ALLOB and completion of
patient recruitment. The cohort of treated patients, amounting to
57 patients, is found to be sufficient for a sufficient level of
significance. BioSenic’s new statistical analysis plan leads to a
more objective scoring for judging the result of its innovative
cell repair treatment. A RUST score difference higher than 1.26
will be considered statistically relevant. Further to the decision
to end recruitment and proceed towards a full set of meaningful
results, the ALLOB subscription rights shall become exercisable
based on the results at month three after patient treatment,
if the difference in the mean RUST scores between the
placebo's arm patient population and the treated ALLOB population
is found higher than 1.26 in the new statistical analysis on the
effectively recruited 57 patients.
On 16 March 2023, BioSenic announced that it has
used the statistical analysis capabilities of Artialis to study the
results of the Phase III 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. By identifying three subtypes of OA,
amongst which a subtype of OA patients with more severe symptoms
and inflammation, 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 III
clinical study. BioSenic, which does not intend to allocate R&D
resources to support the clinical development of JTA-004 and will
continue to focus its R&D activities on the development of its
autoimmune (ATO) and cell therapy (ALLOB) platforms, 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.
On 30 March 2023, BioSenic published new data
providing additional details about the mechanism of action of its
lead API 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.
On 18 April 2023, BioSenic received a key
European patent from EPO, for further therapeutic development in
cancer, infectious and immune disease. 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.
Corporate highlights (including
post-period events)
In March 2022, BioSenic redefined its strategic
priorities to concentrate specifically on the development of its
most advanced clinical asset, ALLOB. In that context, several
members of BioSenics’ management team transitioned to depart
BioSenic in alignment with the focus in activity. This included
Miguel Forte (CEO), Tony Ting (CSO), Stefanos Theoharis (CBO) and
Lieve Creten (CFO).
In May 2022, BioSenic signed the definitive
subscription agreement for a maximum EUR 5 million convertible
bonds (CBs) facility arranged by ABO Securities, through its
affiliated entity Global Tech Opportunities 15. ABO Securities has
committed to subscribe to up to EUR 5 million in CBs. The CBs would
be issued and subscribed in ten tranches.
In August 2022, BioSenic signed a binding
contribution agreement with Medsenic, a privately held, clinical
stage biopharmaceutical company incorporated in France, to combine
the operations of both companies by means of a share for share
exchange. The acquisition would result in the business combination
of Bone Therapeutics and Medsenic to create BioSenic, a speciality
biopharma company.
In October 2022, BioSenic announced the closing
of its acquisition of a majority participation in Medsenic.
Medsenic' shareholders contributed fifty-one percent (51%) of the
total outstanding share capital of Medsenic, valued at EUR
40,800,207, at a subscription price per share of EUR 0.45, which
valued BioSenic at EUR 10 million. In exchange for the in-kind
contribution of 51% of Medsenic' shares, 90,668,594 shares were
issued by BioSenic to Medsenic shareholders. Pr. Francois Rieger,
chairman and CEO of Medsenic, was appointed as chairman and CEO of
BioSenic SA. Other board members appointed were Ms Véronique
Pomi-Schneiter, deputy CEO of Biosenic, formerly in charge of
Medsenic operations, Mr Jean-François Rax, representing Cap
Innovest, Ms Revital Rattenbach, independent director and Mr Terry
Sadler, independent director. The Executive leadership team
consisted of François Rieger (CEO), Véronique Pomi-Schneiter
(deputy CEO), and Anne Leselbaum (CMO). Furthermore, 24,463,421
ALLOB subscription rights were granted to all existing
shareholders. These subscription rights allow holders to subscribe
for a new share of the company if the ALLOB Phase IIB results are
positive at a subscription price per share of EUR 0.45. The
existing shareholders of Medsenic agreed to contribute in kind the
totality of the remaining Medsenic shares held by within the next
24 - 36 months from the completion of the combination.
In December 2022, BioSenic appointed Michel
Wurm, M.D. as Chief Medical Officer ad interim to succeed Anne
Leselbaum, M.D. Michel was responsible for the development of both
of BioSenic’s cell therapy and autoimmune disease platforms.
On 18 January 2023, BioSenic appointed Dr Carole Nicco as Chief
Scientific Officer. Carole oversees the development of pipeline
across BioSenic’s cell therapy and autoimmune disease platform and
is responsible for R&D programs.
On 27 January 2023, BioSenic appointed Yves Sagot as Independent
Director. Yves Sagot replaced Terry Sadler as an Independent
Director and Member of the Board at BioSenic.
On 21 February 2023, BioSenic announced it
received EUR 1 million (minus 6% taxes) from Pregene in accordance
with the terminated license agreement. BioSenic regained worldwide
rights to its allogeneic, off-the-shelf, bone cell therapy platform
ALLOB further to the unilateral termination notice received from
Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”) in October 2022.
BioSenic has started preliminary discussions with Pregene, Link
Health and other potential partners to move forward with the
development and commercialization of ALLOB in other geographies,
including the US.
On 3 April 2023, BioSenic appointed Lieven
Huysse, MD, as Chief Medical Officer to succeed Michel Wurm, M.D.
Lieven is responsible for continued progression of both BioSenic
late-stage assets (ALLOB MSC platform and autoimmune ATO
platform).
Outlook for the remainder of
2023
In the ongoing Phase IIb ALLOB clinical study in
difficult tibial fractures, BioSenic expects to report topline
results by the second quarter of 2023.
In October 2022, BioSenic regained worldwide
rights to develop, manufacture and commercialised ALLOB following
the termination by Shenzhen Pregene Biopharma Co., Ltd ("Pregene")
of the exclusive license agreement entered into between BioSenic,
Pregene and Link Health Pharma Co., Ltd ("LinkHealth") in October
2020. Although regulatory changes in China have halted
establishment of ALLOB in the Chinese market, BioSenic is
conducting preliminary discussions with Pregene, LinkHealth and
other potential partners to reach an agreement for the development
and commercialization of ALLOB in other geographies, including in
the U.S.
In March 2023, BioSenic has obtained new
statistical analysis results from the JTA-004 Phase III clinical
trial data. 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 III clinical
study. 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.
The Medsenic Phase II clinical study with
arsenic trioxide in the first-line treatment of cGvHD is complete
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 2023. 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.
BioSenic Group, however, expects to use the
existing cash and the proceeds of anticipated future fundraisings
(via shares or (convertible) bonds) in priority for continuing the
Phase IIb clinical trial for ALLOB and for progressing the Phase
III clinical trial in cGvHD. As a result, it will only be possible
to start the SLE and SSc Phase IIb clinical trials in 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 2024.
Following the restructuring of the management
team and the appointment of Mr François Rieger as CEO and executive
director, Ms Véronique Pomi-Schneiter as Deputy-CEO and executive
director, Alexia Rieger as CIRO, Carole Nicco as CSO and Lieven
Huysse as CMO, BioSenic is in the process of completing the
management team with a new CFO.
The Company plans to raise funds in the form of
a private placement of new shares in Q2 2023 in order to finance
its activities. In addition, the Company continues to evaluate
other funding options, such as the extension of the existing
convertible bond program.
Disciplined cost and cash management will remain
a key priority. The operating cash burn for the full year 2023 is
in the range of €8-10 million and a financing cash burn of
approximately EUR 1.7 million. The situation will be actively and
closely monitored. BioSenic anticipates having sufficient cash to
carry out its business objectives until June 2023, assuming amongst
other full issuance of the Convertible Bonds and the renegotiation
of the terms of the ongoing loans that will otherwise fall due in
June 2023.
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from:
(i), the allogeneic cell therapy platform ALLOB and (ii) the
Arsenic TriOxide (ATO) platform. Key target indications for the
platforms include Graft versus Host Disease (GvHD), Systemic lupus
erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial
fractures.Following the merger in October 2022, BioSenic combines
the strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger also enables Biosenic to add to its
innovative cell therapy platform and strong IP for tissue repair
protection with an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of 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 BioSenic
technology
BioSenic’s technology is based on two main platforms:
1) The allogeneic cell and gene
therapy platform, developed by BioSenic with differentiated bone
marrow sourced Mesenchymal Stromal Cells (MSCs) that can be stored
at the point of use in hospitals. Its current investigational
medicinal product, ALLOB, represents a unique, 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 after a single local
injection. These cells are produced via a BioSenic's scalable
manufacturing process. Following the CTA approval by regulatory
authorities in Europe, BioSenic has initiated patient recruitment
for the Phase IIb clinical trial with ALLOB in patients with
difficult tibial fractures, using its optimized production process.
ALLOB is currently being evaluated in a randomized, double-blind,
placebo-controlled Phase IIb 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. The patient
recruitment has been halted late February 2023 with 57 patients and
the new rules permitted for statistical analysis should allow
BioSenic to get the main results of this trial much earlier than
anticipated in the original protocol, since they are expected by
mid-2023. 2) The Arsenic TriOxide (ATO) platform
developed by Medsenic. The immunomodulatory properties of ATO have
demonstrated a double basic effect on cells of the immune system.
The first effect is the increase of the cell oxidative stress in
activated B, T or 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 pro-inflammatory cytokines
involved in inflammatory or autoimmune cell pathways. One direct
application is its use in onco-immunology to treat GvHD
(Graft-versus-Host Disease) in its chronic, established stage. GvHD
is one of the most common and clinically significant complications
affecting long-term survival of allogeneic hematopoietic stem cell
transplantation (allo-SCT). GvHD is primarily mediated by the
transplanted immune system that can lead to severe multiorgan
damage. Medsenic had been successful in a Phase II trial with its
intravenous formulation, allowing arsenic trioxide to be granted an
orphan drug designation status by FDA and EMA and is heading
towards an international Phase III confirmatory study, with a new,
IP protected, oral (OATO) formulation. Moderate to Severe forms of
Systemic Lupus erythematosus (SLE) is another selected target,
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastro-intestinal tract) in a Phase IIa study.
Systemic Sclerosis is, in addition, part of the clinical pipeline
of BioSenic. Preclinical studies on pertinent animal models are
positive. This gives good grounds to launch a Phase II clinical
protocol for this serious disease that badly affects skin, lungs or
vascularization, and with no actual current effective
treatment.
In addition, BioSenic is developing an
off-the-shelf next-generation improved viscosupplement, JTA-004,
consisting of a unique combination of plasma proteins, hyaluronic
acid - a natural component of knee synovial fluid, and a
fast-acting analgesic. JTA-004 intends to provide added lubrication
and protection to the cartilage of the arthritic joint and to
alleviate osteoarthritic pain (OA) and inflammation. In March 2023,
after the identification of new OA subtypes, BioSenic delivered a
new post-hoc analysis of its Phase III JTA-004 trial on knee OA
with positive action on the most severely affected patient
population. 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 III clinical
study. BioSenic, which does not intend to allocate R&D
resources to support the clinical development of JTA-004 and will
continue to focus its R&D activities on the development of its
autoimmune (ATO) and cell therapy (ALLOB) platforms, is now 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.
For further information, please contact:
BioSenic SAFrançois Rieger,
PhD, Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
For Belgian Media and Investor
Enquiries:BepublicBert BouserieTel: +32 (0)488 40
44 77bert.bouserie@bepublicgroup.be
For International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media Enquiries:NewCap
MediaAnnie-Florence LoyerTel: +33 (0)1 44 71 00
12afloyer@newcap.fr
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.
- BIOS_PR_2023-04-27_FY 2022_EN_Long_vfinal
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