Actualización de desarrollo financiero, empresarial y de cartera
RNS 06 March 2024
InmuPharma PLC
("InmuPharma" o de "Empresa")
Financial, Business and Portfolio Development Update
ImmuPharma PLC (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce a positive and comprehensive financial, business and portfolio development update.
This follows on from our announcement on 19 December 2023, where we provided a detailed update on our late stage P140 (Lupuzor?) program, en pacientes con lupus eritematoso sistémico ("LES/Lupus").
Resumen Financiero
ImmuPharma would firstly like to confirm that the financing position of the Company is sufficient for its immediate requirements and it has no current plans to raise equity through the capital markets.
Future cash requirements are fully expected to be met through non-dilutive income derived from the Company's portfolio of assets including, inter alia, new commercial deals on the development portfolio, including the non-US rights for P140 (SLE/Lupus); the worldwide rights for CIDP and for BioAMB. The Company is in active discussions with a broad range of potential commercial partners with the objective of completing deals across the portfolio in 2024.
To put this all into perspective, since the reorganisation of the Company, which was initiated in August 2021, the Board of Directors has greatly simplified the Group corporate structure; reduced staff levels; eliminated unnecessary and expensive overhead costs and most importantly, focused the development portfolio into two areas; Autoimmune and Anti-Infectives.
ImmuPharma now has two late-stage autoimmune development programs through its P140 platform, for both SLE and CIDP. Also in the portfolio are two earlier anti-infective programs, BioAMB and BioCin. Prior to 2021, the portfolio was primarily focused on only P140 for SLE (Lupus). It is from this enhanced and improved development portfolio that our shareholders will see the future value accretion.
From an ongoing financial management perspective, we have seen a massive reduction of more than 75% in the annual overhead cost of the Company, compared to prior to the reorganisation. Hence, the cash needs of the Company are significantly less than historically and, as a consequence, much easier to forecast and manage.
We are expecting to announce our audited Full Year Results in May 2024.
Actualización comercial
Our business model is clear, focused and simple, for the Company to internally advance its development portfolio up to the point whereby we can enter into commercial deals with larger companies within the industry that then assume the responsibility to fund and complete the clinical development of each product through to registration and ultimately, market launch.
The financial business model underlying this approach provides an optimum number of opportunities across a range of indications and commercial deals.
In each of these potential deals we would expect to receive significant up-front payments on signing, with further receipts on achievement of development and/or sales milestones plus royalties on sales.
The therapeutic indications of our products will be entering markets which offer the realistic prospect of multi-billion dollar annual sales, which in turn, will be reflected in the levels of income we expect to be receiving in both the short, medium and long term.
It is this expectation which will drive the fundamental value of the Company and deliver the return on investment to our shareholders.
The re-focus and expansion of our portfolio development including the recent important advances in determining the clinical path through for our late stage P140 platform and elucidating its unique mechanism of action ("MOA") has generated significant interest from a wide range of potential commercial partners.
This commercial interest includes discussions on the non-US rights for P140 ("SLE"); the worldwide rights for P140 ("CIDP") and the worldwide rights for BioAMB.
Whilst there can be no guarantee of completing commercial deals, there are a broad range of discussions currently taking place and the objective is to complete deal(s) across the portfolio in 2024.
Development Portfolio
P140 | SLE/Lupus Program
Further to our update announcement on 19 December 2023 and in collaboration with Simbec-Orion, the preparatory steps for the new Phase 3 study are continuing to progress. As we reach key milestones within the study, such as: site initiations; patient recruitment and patient dosing, we will announce updates accordingly.
As a reminder, the progress update in December included:
· Simbec-Orion appointed as the Contract Research Organisation ("CRO"), for the P140 (Lupuzor?) Phase 3 study in SLE;
· Decision to go straight into an international Phase 3 dose-range study, rather than the longer and more expensive Phase 2/3 adaptive study;
· Confirmation that the current Phase 3 study is substantially different from the previous Phase 3 study completed by the Company and incorporates many changes in the protocol, including significantly higher doses; and
· Important further insights into P140's mechanism of action ("MOA") supporting its position as the only non-immunosuppressing molecule in clinical development in the industry, creating a 'first-in-class' treatment for many autoimmune diseases.
P140 | CIDP Program
Progress has also been made in our second late-stage development program, for chronic idiopathic demyelinating polyneuropathy ("CIDP").
We are pleased to announce that Simbec-Orion, has been appointed as the CRO for this program.
In conjunction with Simbec-Orion, an IND application ("INDA") has been prepared for submission to the FDA, incorporating all their previous guidance points.
In addition, an application for Orphan Drug status for CIDP is being submitted in parallel to the INDA.
As background, in 2023, the Company received positive feedback from the FDA at a pre-Investigational New Drug meeting, that confirmed that a Phase 2/3 adaptive clinical trial will be the first pivotal stage study of P140 in patients with CIDP.
The FDA feedback recognised that P140 is suitable to be studied in another disease indication in addition to SLE and this strongly supports the underlying science and mechanism of action of P140 across several auto-immune/inflammatory diseases, again a significant breakthrough for the P140 platform.
Anti-Infectives Program | BioAMB | for systemic fungal infections
BioAMB is a novel drug that offers a potential improvement on the limiting side effects and poor administration regime of current Amphotericin-B ("AMB") formulations. AMB is one of a last line of agents against serious and life-threatening fungal infections caused by the aspergillus family of fungi.
Although AMB is highly effective, currently marketed AMB formulations may cause serious kidney toxicity and other severe reactions. BioAMB is not a typical reformulation but a Bio-drug entity, which releases AMB as the active agent.
BioAMB, is a groundbreaking amphotericin-B variant that promises both efficiency and safety.
After multiple in vivo studies assessing the Pharmacokinetic/Pharmacodynamic ("PK/PD") and safety profile of BioAMB, the dose-effect relationship has now been assessed in Part 1 of a new dose-range pharmacodynamic study in an aspergillosis rat model. Part 1 has now been completed.
We are pleased to announce that no toxicity related to BioAMB was observed at the active dose.
We will now move forward to Part 2 of the study which will further evaluate the safety of BioAMB at the active dose and confirm the advantage of BioAMB over the other forms of AMB.
It is the intention of ImmuPharma to partner this programme and initial discussions have commenced.
Incanthera - Financial Asset
In December 2023, ImmuPharma highlighted that Incanthera plc ("Incanthera"), the dermatology and oncology specialist, had concluded a significant commercial skincare deal with Marionnaud (part of the A.S. Watson Group) initially across Europe and with further roll outs across Asia. It confirmed that this deal is expected to generate significant revenues and profitability for Incanthera, in 2024 and beyond.
Since then, Incanthera's share price has performed strongly.
ImmuPharma owns 9.9 million shares in Incanthera, representing a 10.8% holding with a value of £916k (as at close of business on 05 March). In addition, the Company also has 7.3 million warrants in Incanthera, which are exercisable at any time.
This represents a significant financial asset for ImmuPharma.
With progressive positive news flow expected from Incanthera during 2024, it would be anticipated this will have a significant positive impact on the value of the Company's underlying shareholding.
Al comentar sobre el anuncio, Tim McCarthy, director ejecutivo de ImmuPharma, dijo:
"Since our update in December 2023, ImmuPharma has continued to make positive progress within our key programs, as highlighted in this statement.
Against a backdrop of continued market volatility, that has adversely affected many small companies' share prices, including our own, the Board believes the underlying value of our assets continues to be strengthened.
ImmuPharma has a unique portfolio, including two late-stage assets that now have overwhelming evidence to be potential first line treatments in debilitating auto-immune diseases such as Lupus and CIDP, markets of high unmet medical need and multi-billion-dollar revenues.
It is this profile that has generated so much interest from potential commercial partners and our focus for 2024 is to secure commercial deals for these programs.
The Board is positive about the short, medium and long-term future for ImmuPharma and thanks all those shareholders who continue to support the Company."
This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.
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Notas a los editores
Acerca de ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) es una empresa biofarmacéutica especializada que descubre y desarrolla terapias basadas en péptidos. La cartera de la empresa incluye nuevas terapias peptídicas para enfermedades autoinmunes y antiinfecciosas. El programa principal, P140 (¿Lupuzor?), es un inmunomodulador de autofagia de primera clase para el tratamiento del lupus y los análisis preclínicos sugieren actividad terapéutica para muchas otras enfermedades autoinmunes que comparten el mismo mecanismo de acción de la autofagia.
Para obtener información adicional sobre ImmuPharma, visite www.immupharma.co.uk
P140 MOA
The lack of immunosuppression is explained by our refined MOA. All other molecules in development demonstrate varying degrees of immunosuppression, which give rise to side effects and limit the dose that can be used to achieve efficacy.
Nuevas pruebas muestran que P140 restaura los sistemas de tolerancia al permitir que las células presentadoras de antígenos tolerogénicos (como las células dendríticas) funcionen correctamente. Dado que el mal funcionamiento de los sistemas de tolerancia parece ser la causa fundamental de la mayoría, si no de todas, las enfermedades autoinmunes, se explica por qué P140 es tan ampliamente eficiente en la mayoría de las indicaciones autoinmunes en modelos animales. P140 es la única molécula no inmunosupresora de la industria en desarrollo clínico para el tratamiento del LES.
Esta distinción sienta las bases para una nueva terapia estándar de oro, convenientemente autoadministrada por el paciente, una vez al mes, que es segura y bien tolerada, a diferencia del tratamiento estándar o cualquier otra molécula en desarrollo, que son todos inmunosupresores con importantes advertencias de seguridad.
About Lupus (Systemic Lupus Erythematosus / SLE)
El lupus es una enfermedad inflamatoria crónica que se cree que afecta a unos 16 millones de personas en todo el mundo. El estándar de atención actual todavía consiste en terapias con esteroides y antipalúdicos que tienen muchos efectos secundarios y una respuesta deficiente en muchos pacientes. Recientemente, las terapias monoclonales más dirigidas son Benlysta de GlaxoSmithKline y, más recientemente, Saphnelo de AstraZeneca. Todavía existe una gran necesidad médica no satisfecha de un fármaco que tenga un fuerte perfil de eficacia y seguridad.
About CIDP (Chronic Idiopathic Demyelinating Polyneuropathy)
CIDP is a rare acquired autoimmune disorder of peripheral nerves which is thought to affect some 90,000 individuals across US/Europe. It is a rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. CIDP related disability may be substantial. In addition to the physical burdens imposed by the disease, those affected by CIDP also frequently experience economic and emotional hardship and are often burdened not only by the disease but also by the immunotherapies used to treat the disease. Other than intravenous (IVIG) and subcutaneous immunoglobulin (SCIG), corticosteroids and plasma exchange are the only other treatment options. There is still a huge unmet need for more efficacious drugs that are safer and which affect underlying disease progression.
Acerca de Simbec-Orion
Simbec-Orion, is an experienced, full-service Contract Research Organisation, with offices across the UK, Europe, and the United States. Established for over 45 years, and leveraging deep experience delivering primero en humanos ensayos clínicos, brindando servicios de ensayos clínicos personalizados a socios biotecnológicos y farmacéuticos pequeños y medianos en toda Europa, América del Norte y más allá. En toda la organización, los equipos científicos aprovechan tanto una amplia experiencia terapéutica en farmacología clínica, como SNC, respiratoria, dermatología, vacunas y antiinfecciosos, como una experiencia más especializada en las Fases I-IV. enfermedad rara y oncología.
Para más información visite www.simbecorion.com
Código LEI (Identificador de entidad legal) de ImmuPharma: 213800VZKGHXC7VUS895.
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